Treatment Trials

16 Clinical Trials for Various Conditions

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RECRUITING
Simple Bone Cysts in Kids
Description

Simple bone cysts (SBCs) are cysts filled with fluid that occur most frequently in the long bones (arms or legs) of children. There are many ways to treat SBCs but it is unclear if one is better than another. The purpose of this research trial is to compare the effectiveness of two common treatments that are used by surgeons today.

Conditions
COMPLETED
Cystic Fibrosis Related Bone Disease: the Role of CFTR
Description

The purpose of this study is to determine whether ivacaftor, a recently FDA-approved CFTR potentiator, improves bone micro-architecture and strength in patients with cystic fibrosis with at least one G551D CFTR mutation.

WITHDRAWN
Pilot E2 for Hypogonadal Women With CFBD
Description

The study is a prospective, double blinded, placebo controlled, randomized study to evaluate the effects of daily oral estrogen supplements on bone health, sexual and reproductive health, quality of life and markers of inflammation and lung function when given to hypogonadal women with Cystic Fibrosis related Bone Disease (CFBD).

COMPLETED
Bone Health of People With Cystic Fibrosis
Description

People with cystic fibrosis (CF) now frequently live into adulthood and with this extended life expectancy has come new clinical problems. Poor bone health, including osteoporosis and bone fractures, is one of these increasingly important conditions. Preventing the negative outcomes of poor bone health in later life is primarily related to ensuring optimal growth (weight and height) and obtaining maximal amount of bone mass during growth and development. This study will identify factors that influence bone health in a sample of children, adolescents and young adults as measured by dual energy x-ray absorptiometry and new bone densitometry methods (peripheral quantitative computerized tomography \[p-QCT\] and bone sonometer). We will also identify factors which influence changes in bone status over a 12-month follow-up period in a subsample of people with CF.

Conditions
RECRUITING
Skeletal Health and Bone Marrow Composition in Adolescents With Cystic Fibrosis
Description

The investigators will be evaluating bone marrow composition via magnetic resonance imaging in adolescents diagnosed with cystic fibrosis (CF) compared to healthy, matched controls. The investigators will also be assessing their bone mineral density via other imaging modalities, including dual-energy X-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT). This longitudinal project will focus on abnormalities in bone marrow composition, and specifically whether adolescents with diagnosed with CF exhibit increased bone marrow fat, its association with bone mineral density (BMD) and the underlying pathophysiology, including glycemic control, inflammation, and bone turnover markers.

Conditions
ACTIVE_NOT_RECRUITING
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Description

Study is looking at the effects of cystic fibrosis treatment on bone muscle.

RECRUITING
Knee Related Subchondral Bone Lesions Treated With IOBP
Description

The study will be a prospective, multicenter clinical study evaluating clinical and patient reported outcome measures of subjects receiving IOBP® surgical technique using Angel cPRP and BMA processing system to treat subchondral bone pathology (SBP).

RECRUITING
Estrogen Supplementation and Bone Health in Women With CF
Description

The goal of this study is to learn about the role of estrogen and other hormones in bone development in adolescent and young adult women with cystic fibrosis (CF). The study has two main components, an observational study and a feasibility sub-study. The main questions it aims to answer are: * How do different forms of hormonal contraception (e.g. birth control pill or other progesterone only methods) impact bone health? * Is a study of transdermal estradiol (estrogen skin patches) feasible in this group? * How does transdermal estradiol impact bone health and quality of life? Participants in the observational study will have three study visits (baseline, 6 months, and 12 months). At all visits, participants will have blood drawn and will complete questionnaires. At the baseline and 12 month visits, participants will additionally have x-rays and DXAs (bone density assessment). Between visits, participants will complete brief questionnaires. Researchers will compare various measurements over time to assess the impact of different forms of hormonal contraception. Participants in the feasibility sub-study will apply transdermal estradiol patches once weekly for 12 months, fill out brief quality-of-life surveys in between study visits, and complete blood draws and questionnaires at four study visits (baseline, 3 months, 6 months, and 12 months). The participants will also have x-rays and DXAs performed at the baseline and 12 month visits. Researchers will examine changes in various measurements to determine the impact of transdermal estradiol.

COMPLETED
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Description

The long-term goal is to study the safety and effectiveness of hormonal contraception for women with cystic fibrosis (CF) and contribute to national guidelines that the Cystic Fibrosis Foundation and the Centers for Disease Control and Prevention (CDC) provide to clinicians. The study objectives are to determine whether hormonal contraceptive methods improve overall pulmonary health, worsen CF-related disease or CF liver disease, or are effective against unwanted pregnancy with concomitant CF transmembrane conductance regulator (CFTR) modulator use. The hypothesis is that hormonal contraceptive methods are safe and do not worsen CF-related complications over time,improve FEV-1 when compared to non-hormonal users, and oral birth control methods with CFTR modulator use.

COMPLETED
Bone Microarchitecture at the Radius: a Pilot Comparison Between Children With Cystic Fibrosis and Healthy Controls
Description

Cystic fibrosis (CF) affects an estimated 30,000 people in the United States and is caused by a mutation in the gene encoding a protein called CF transmembrane regulator (CFTR). The hallmarks of CF are recurrent pulmonary exacerbations and declining pulmonary function. However, there are other problems in CF that affect both health and quality of life. These include CF related diabetes, liver disease, and bone disease. The median age of survival for patients with CF has been increasing steadily and is currently more than 37 years. With this improvement in life expectancy, it has become increasingly important to address the long-term complications of CF. Currently, patients with CF are evaluated annually for bone disease with dual X-ray absorptiometry (DXA), and screening usually starts at age 12. However, this may not be sufficient to detect early bone changes that may impact fracture risk. Furthermore, bone disease in children may manifest earlier than adolescence, which would suggest that screening should start at an earlier age in these vulnerable patients. The following study is therefore proposed to examine the potential role of peripheral quantitative computed tomography (pQCT) as a screening approach for bone disease in children with CF. The investigators expect to find bone problems by pQCT but not DXA.

Conditions
COMPLETED
Combination Chemotherapy, Bone Marrow Transplantation, and Peripheral Stem Cell Transplantation in Treating Patients With Ovarian Epithelial Cancer
Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bone marrow transplantation and peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and cyclophosphamide followed by bone marrow and peripheral stem cell transplantation in treating patients who have advanced ovarian epithelial cancer.

ACTIVE_NOT_RECRUITING
SCP Hip Outcomes Study
Description

Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.

RECRUITING
Marrow Cellution™ vs. Traditional BMA Harvest Project
Description

Six patients with diagnosed bone loss of the hip who have consented to minimally invasive repair will be approached to participate in the study. Participants will have the liquid portion of bone marrow collected using the Zimmer Biomet Biocue system, which is the standard system used by physicians at The Ohio State University, and the novel Marrow Cellutions system™. Bone marrow liquid will be collected from the surgical hip using the Zimmer Biomet Biocue system, and the Marrow Cellutions system™ will be used to collect bone marrow liquid from the non-surgical hip. Following collection, the bone marrow liquid will be processed using the respective systems to concentrate the cells and molecules found in the bone marrow liquid. As part of the standard of care for this arthroscopic procedure, concentrated bone marrow liquid processed using the Zimmer Biomet Biocue system will be delivered to the surgical site as an adjunct to promote healing. Concentrated bone marrow liquid prepared with the Zimmer Biomet Biocue system is given as part of the standard of care for patients undergoing minimally invasive treatment for bone loss of the hip; therefore, the target population for this study are individuals between the ages of 18-50 years with confirmed bone loss of the hip who have consented to minimally invasive repair. In addition to the concentrated bone marrow liquid prepared using the Zimmer Biomet Biocue system, patients will also have bone marrow liquid collected from the non-surgical hip using the Marrow Cellutions™ system. Only concentrated bone marrow liquid produced with the Zimmer Biomet Biocue system will be given to the patient. All concentrated bone marrow liquid produced with the Marrow Cellutions™ system will be sent to the laboratory for analysis. Additionally, white blood cells will be concentrated into an autologous protein solution (APS) using the Zimmer Biomet Plasmax system from blood collected using a routine blood draw. All protein solution produced will be sent to the laboratory for analysis. No protein solution will be given to the patient. As the bone marrow liquid collection using the Marrow Cellutions™ system and the blood draw to produce protein solution using the Zimmer Biomet Plasmax system are being performed for research,

COMPLETED
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
Description

Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase I trial to study the effectiveness of interleukin-12 and trastuzumab in treating patients who have cancer that has high levels of HER2/neu and has not responded to previous therapy

Conditions
Advanced Adult Primary Liver CancerAnaplastic Thyroid CancerBone MetastasesCarcinoma of the AppendixDistal Urethral CancerFallopian Tube CancerGastrinomaGlucagonomaInflammatory Breast CancerInsulinomaLiver MetastasesLocalized Unresectable Adult Primary Liver CancerLung MetastasesMale Breast CancerMalignant Pericardial EffusionMalignant Pleural EffusionMetastatic Gastrointestinal Carcinoid TumorMetastatic Parathyroid CancerMetastatic Transitional Cell Cancer of the Renal Pelvis and UreterNewly Diagnosed Carcinoma of Unknown PrimaryOccult Non-small Cell Lung CancerPancreatic Polypeptide TumorPrimary Peritoneal Cavity CancerProximal Urethral CancerPulmonary Carcinoid TumorRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Adrenocortical CarcinomaRecurrent Adult Primary Liver CancerRecurrent Anal CancerRecurrent Bladder CancerRecurrent Breast CancerRecurrent Carcinoma of Unknown PrimaryRecurrent Cervical CancerRecurrent Colon CancerRecurrent Endometrial CarcinomaRecurrent Esophageal CancerRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerRecurrent Gastric CancerRecurrent Gastrointestinal Carcinoid TumorRecurrent Islet Cell CarcinomaRecurrent Malignant Testicular Germ Cell TumorRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Pancreatic CancerRecurrent Parathyroid CancerRecurrent Prostate CancerRecurrent Rectal CancerRecurrent Renal Cell CancerRecurrent Salivary Gland CancerRecurrent Small Intestine CancerRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Thyroid CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerRecurrent Vaginal CancerRecurrent Vulvar CancerSkin MetastasesSmall Intestine AdenocarcinomaSomatostatinomaStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Adrenocortical CarcinomaStage III Bladder CancerStage III Cervical CancerStage III Colon CancerStage III Endometrial CarcinomaStage III Esophageal CancerStage III Follicular Thyroid CancerStage III Gastric CancerStage III Malignant Testicular Germ Cell TumorStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Ovarian Epithelial CancerStage III Pancreatic CancerStage III Papillary Thyroid CancerStage III Prostate CancerStage III Rectal CancerStage III Renal Cell CancerStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Vaginal CancerStage III Vulvar CancerStage IIIA Anal CancerStage IIIA Breast CancerStage IIIA Non-small Cell Lung CancerStage IIIB Anal CancerStage IIIB Breast CancerStage IIIB Non-small Cell Lung CancerStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Adrenocortical CarcinomaStage IV Anal CancerStage IV Bladder CancerStage IV Breast CancerStage IV Colon CancerStage IV Endometrial CarcinomaStage IV Esophageal CancerStage IV Follicular Thyroid CancerStage IV Gastric CancerStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Pancreatic CancerStage IV Papillary Thyroid CancerStage IV Prostate CancerStage IV Rectal CancerStage IV Renal Cell CancerStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IVA Cervical CancerStage IVA Vaginal CancerStage IVB Cervical CancerStage IVB Vaginal CancerStage IVB Vulvar CancerThyroid Gland Medullary CarcinomaUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder CancerUrethral Cancer Associated With Invasive Bladder CancerWDHA Syndrome
TERMINATED
Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
Description

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.

Conditions
COMPLETED
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer
Description

Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.

Conditions