Treatment Trials

144 Clinical Trials for Various Conditions

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RECRUITING
ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling
Description

The Investigator propose a randomized trial that will assess whether participant involvement in pre-operative counseling for ERAS improves post-surgical pain scores. The Investigator will also assess participant compliance to ERAS-prescribed medications, and functionality (return to school). Each participant who is enrolled in the study will be assigned to 1) pre-operative counseling with participant's caregiver or 2) caregiver-only counseling.

RECRUITING
Gut Microbiome and Treatment for Gynecological Cancer Patients Receiving Immunotherapy
Description

30 participants with advanced or recurrent gynecological cancer from are enrolled for this study. Eligible participants then provide fecal specimen, blood, vaginal swab, oral mucosal swab and receive food dietary recommendation. Additional samples are collected for results analysis.

COMPLETED
Enhanced Recovery After Surgery Gynecology Oncology
Description

The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing open abdominal surgery for gynecologic cancer or suspected gynecologic cancer. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay, without increasing readmission rates. ASD

COMPLETED
Acupuncture for Post-Operative Pain Control for Patients Undergoing Gynecological Surgery
Description

This study investigates the role of acupuncture in controlling post-operative pain in patients who have undergone gynecological surgery.

RECRUITING
Fucoidan for Preventing Chemotherapy-Related Fatigue in Patients with Gastrointestinal or Gynecological Cancer
Description

This clinical trial tests how well fucoidan works in preventing chemotherapy-related fatigue compared to a placebo in patients with gastrointestinal (GI) or gynecological (GYN) cancer. Fatigue poses a burden in patients with malignancies undergoing systemic chemotherapy. Fucoidan is a dietary supplement made of complex sugar that contain sulfate groups attached to their sugar units (sulfated polysaccharide) which found in brown seaweed. It is thought to have anti-inflammatory, anti-viral, anti-thrombotic, anti-diabetic, and anti-tumor effects in pre-clinical models. Giving fucoidan may be effective in preventing chemotherapy-related fatigue in patients with GI or GYN.

RECRUITING
Near Infrared Spectroscopy (NIRS) as a Method for Measuring Oxidative Capacity of Skeletal Muscle Mitochondria in Breast Cancer and All Gynecological Cancer Patients
Description

Participants recruited for this study will be breast cancer or gynecological cancer patients who agree to participate in an exercise study examining the effects of chemotherapy on muscle mitochondrial oxidative capacity, a measure of skeletal muscle health. Participants will ride a stationary bicycle and the quadriceps muscle will be non-invasively evaluated.

TERMINATED
Nitrous Oxide for Pain Management During In-Office Gynecology Procedures
Description

The purpose of this study is to evaluate the pain control, patient satisfaction, and efficiency of nitrous oxide used for anesthesia during in-office gynecologic procedures compared to IV sedation. IV sedation for office-based gynecology procedures provides effective anesthesia but requires a recovery time, IV placement, and a ride provided for the patient. Nitrous oxide can be a viable alternative to IV sedation while also reducing recovery time and omitting the need for an IV, NPO status, and a ride home.

Conditions
RECRUITING
Rectus Sheath Block for Analgesia After Gynecological Laparotomy
Description

Thirty subjects undergoing laparotomy for Gynecologic oncology surgery will be prospectively enrolled and will receive a bilateral rectus sheath block (RSB) under ultrasound guidance using 133 mg liposomal bupivacaine and 20 ml bupivacaine 0.25% per side. Cases will be matched in a 1:2 ratio by age, race, insurance status and duration of surgery with historical controls who received postoperative analgesia using thoracic epidural analgesia.

RECRUITING
Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecological Cancers
Description

The phase II trial evaluates the effectiveness of cryocompression therapy alone or in combination with cilostazol in preventing paclitaxel-induced peripheral neuropathy (numbness, pain or tingling in the feet and hands) for patients with gynecologic cancers. Peripheral neuropathy is a common side effect of many chemotherapeutic agents, including paclitaxel. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Cryocompression is a therapy that combines compression garments or dressings with cooling of the treated area. Cilostazol is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs. Giving cilostazol together with cryocompression may be safe and tolerable in treating patients with gynecological cancers.

COMPLETED
Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology
Description

Pain with intrauterine device (IUD) insertion is very common and there are few options for patients to help reduce this pain. Transcutaneous electric nerve stimulators (TENS) are a non-invasive procedure that may help reduce the pain with IUD insertions. The investigators hope that the information gleaned from this study will result in pain control options for future patients who desire an IUD placement.

RECRUITING
Applying Num Vapocoolant Spray to Cervix Before Paracervical Block to Decrease Pain During Gynecology Procedures
Description

The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.

RECRUITING
Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination with the PARP Inhibitor Olaparib in Patients with KRAS G12C Mutated Advanced Solid Tumors, with a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers
Description

Evaluate safety and tolerability, while establishing the recommended dose of the investigational drug combination of adagrasib and olaparib that can be given to participants with advanced solid tumor(s) with a KRAS G12C and/or KEAP1 mutation.

RECRUITING
Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies
Description

The goal of this open label, randomized, controlled clinical trial is to assess the benefits of providing Reiki therapy to subjects receiving their first brachytherapy treatment for gynecological malignancies. Participants will either receive a session of Reiki therapy or usual care during the standard wait time between the placement of the brachytherapy device and brachytherapy treatment. Questionnaires will be administered at various time points on the day of the participant's first brachytherapy treatment as well as at the three month follow-up time point. Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and physiological measurements.

ENROLLING_BY_INVITATION
EMLA Cream as Analgesic for Outpatient Gynecological Procedures
Description

The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is: • Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy? Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.

Conditions
RECRUITING
IS-001 Injection in Patients Undergoing Robotic-Assisted Gynecological Surgery
Description

This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation.

Conditions
ACTIVE_NOT_RECRUITING
Journey Ahead: Enhancing Coping and Communication for Women Diagnosed With Gynecological Cancer
Description

This study looks at how well the Journey Ahead intervention works in improving coping and communication skills in participants with gynecologic cancers.

COMPLETED
Gynecological Sentinel Lymph Nodes CEUS
Description

This clinical trial compares the use of ultrasound for the detection of sentinel lymph nodes (SLNs) to the standard of care (which varies depending on cancer treatment). The ultrasound contrast agent is called Sonazoid and it consists of tiny gas-filled bubbles about the side of red blood cells. Diagnostic procedures, such as ultrasound with Sonazoid, may help identify more SLNs than standard of care in patients with cervical, vaginal, or vulvar cancer.

RECRUITING
Data Collection Study of Pediatric and Adolescent Gynecology Conditions
Description

Background: Gynecologic conditions are those that are related to the reproductive system. They can be reproductive gland disorders or reproductive system tumors. They can also be inborn anomalies of the reproductive tract. Researchers want to gather data over time from a large group of young people with these conditions. Objective: To create a database about child and teenage gynecologic conditions. Eligibility: Participants of any age with known or suspected pediatric and adolescent gynecologic conditions, and their adult family members Design: Participants will be screened with a review of their medical records. Participants may have a medical history and physical exam. Participants will have blood drawn using a needle. The blood will be used for genetic tests. Participants will have saliva collected. They will spit into a small plastic container. Or their spit will be absorbed from their mouth using a small sponge. The saliva will be used for genetic tests. Participants may have samples collected from their vagina. A small cotton swab will be used to gather the samples. This procedure is optional. If participants have a surgery related to their condition, a small tissue sample will be taken. It will be stored for future research. Participants may complete optional surveys. These surveys ask about their physical and emotional health. They can choose not to answer any of the questions. Researchers will collect medical data from participants standard tests. Such tests may include blood and urine tests, X-rays, nuclear medicine scans, and other tests. Data will also be collected from standard treatments they may receive.

ACTIVE_NOT_RECRUITING
Infertility Survey Among Reproductive Age Women With Gynecological and Breast Cancer
Description

This study develops infertility survey among reproductive age women with gynecological and breast cancer. This study aims to learn how women consider whether or not to try to have a baby after surviving cancer. The advice gathered from this survey may be shared with patients and survivors in the future, so that they have information to inform their decisions about cancer treatment and family planning.

COMPLETED
Patient Perspective of Telemedicine in Gynecology Oncology
Description

Research question: do patients in a gynecologic oncology practice value the use of telemedicine as an adjunct to in-person visits and in what circumstances might patients not find these visits to be sufficient?

Conditions
TERMINATED
PLX2853 as a Single Agent in Advanced Gynecological Malignancies and in Combination With Carboplatin in Platinum-Resistant Epithelial Ovarian Cancer
Description

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in Advanced Gynecological Malignancies with a Known ARID1A Mutation and PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer.

ACTIVE_NOT_RECRUITING
Brachytherapy With Durvalumab or Tremelimumab for the Treatment of Patients With Platinum-Resistant, Refractory, Recurrent, or Metastatic Gynecological Malignancies
Description

This phase II trial studies the side effects and how well brachytherapy with durvalumab or tremelimumab work for the treatment of gynecological malignancies that is resistant to platinum therapy (platinum-resistant), does not respond to treatment (refractory), has come back (recurrent), or has spread to other places in body (metastatic). Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial is being done to see whether brachytherapy with durvalumab or tremelimumab works better in treating patients with gynecological malignancies.

COMPLETED
Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies
Description

This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.

COMPLETED
Factors Influencing Cascade Testing Among Women With Hereditary Gynecological Cancers and Their Relatives
Description

This trial collects information about factors that affect communication of genetic test results, decision-making, and access to genetic testing in women with hereditary gynecological cancers. Studying individuals who are positive for a genetic mutation and immediate biological family members (including a parent, full-sibling, or child) may help identify cancer genes and other persons at risk.

WITHDRAWN
Improving Insulin Resistance in Gynecological Cancer Patients
Description

This is a research study to see if the addition of cinnamon to a provided food plan would improve insulin resistance in gynecological cancer patients. One study suggests that patients with gynecological cancers are more likely to be insulin resistant and/or have higher levels of fasting insulin. The study will be 24 weeks in length.

TERMINATED
The Value of Advanced MR Imaging in Gynecological Tumors and Benign Uterine Fibroids
Description

This research is being done to test new MRI methods called Magnetic Resonance Fingerprinting and Q-space Trajectory Imaging in gynecological abnormalities. The purpose of this research study is to evaluate if these new MRI methods can give additional information in characterizing gynecological tumors compared with conventional MRI.

WITHDRAWN
Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer
Description

This pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience.

Conditions
Endometrial CarcinomaStage 0 Fallopian Tube Cancer AJCC v7Stage I Fallopian Tube Cancer AJCC v6 and v7Stage I Ovarian Cancer AJCC v6 and v7Stage IA Fallopian Tube Cancer AJCC v6 and v7Stage IA Ovarian Cancer AJCC v6 and v7Stage IB Fallopian Tube Cancer AJCC v6 and v7Stage IB Ovarian Cancer AJCC v6 and v7Stage IC Fallopian Tube Cancer AJCC v6 and v7Stage IC Ovarian Cancer AJCC v6 and v7Stage II Cervical Cancer AJCC v7Stage II Fallopian Tube Cancer AJCC v6 and v7Stage II Ovarian Cancer AJCC v6 and v7Stage II Uterine Corpus Cancer AJCC v7Stage IIA Cervical Cancer AJCC v7Stage IIA Fallopian Tube Cancer AJCC v6 and v7Stage IIA Ovarian Cancer AJCC V6 and v7Stage IIA1 Cervical Cancer AJCC v7Stage IIA2 Cervical Cancer AJCC v7Stage IIB Cervical Cancer AJCC v6 and v7Stage IIB Fallopian Tube Cancer AJCC v6 and v7Stage IIB Ovarian Cancer AJCC v6 and v7Stage IIC Fallopian Tube Cancer AJCC v6 and v7Stage IIC Ovarian Cancer AJCC v6 and v7Stage III Cervical Cancer AJCC v6 and v7Stage III Fallopian Tube Cancer AJCC v7Stage III Ovarian Cancer AJCC v6 and v7Stage III Primary Peritoneal Cancer AJCC v7Stage III Uterine Corpus Cancer AJCC v7Stage IIIA Cervical Cancer AJCC v6 and v7Stage IIIA Fallopian Tube Cancer AJCC v7Stage IIIA Ovarian Cancer AJCC v6 and v7Stage IIIA Primary Peritoneal Cancer AJCC v7Stage IIIA Uterine Corpus Cancer AJCC v7Stage IIIB Cervical Cancer AJCC v6 and v7Stage IIIB Fallopian Tube Cancer AJCC v7Stage IIIB Ovarian Cancer AJCC v6 and v7Stage IIIB Primary Peritoneal Cancer AJCC v7Stage IIIB Uterine Corpus Cancer AJCC v7Stage IIIC Fallopian Tube Cancer AJCC v7Stage IIIC Ovarian Cancer AJCC v6 and v7Stage IIIC Primary Peritoneal Cancer AJCC v7Stage IIIC Uterine Corpus Cancer AJCC v7Stage IIIC1 Uterine Corpus Cancer AJCC v7Stage IIIC2 Uterine Corpus Cancer AJCC v7Stage IV Cervical Cancer AJCC v6 and v7Stage IV Fallopian Tube Cancer AJCC v6 and v7Stage IV Ovarian Cancer AJCC v6 and v7Stage IV Primary Peritoneal Cancer AJCC v7Stage IV Uterine Corpus Cancer AJCC v7Stage IVA Cervical Cancer AJCC v6 and v7Stage IVA Uterine Corpus Cancer AJCC v7Stage IVB Cervical Cancer AJCC v6 and v7Stage IVB Uterine Corpus Cancer AJCC v7Uterine CarcinosarcomaUterine Corpus Sarcoma
UNKNOWN
The Use of Pycnogenol® to Alleviate Menopausal Symptoms Induced or Increased by Breast and Gynecological Cancer Treatments
Description

This is a pilot study to test whether PYC can improve climacteric symptoms for women who have experienced either surgically or medically induced menopause as part of their treatment for breast or gynecologic cancers.

COMPLETED
Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery
Description

This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.

COMPLETED
A Standardized Bundle Protocol to Optimize Outcomes With Patients Undergoing Gynecological Surgery
Description

Difference in outcome measures with the addition of post-operative evidence based bundle pre-operative education compared to standard pre-operative education given to patients prior to hysterectomy.

Conditions