linjc16/ctgov huggingface dataset:
Genetic Analysis of Congenital Diaphragmatic Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the genetic causes of congenital diaphragmatic disorders (CDD), namely congenital diaphragmatic hernia (CDH), eventration and hiatal hernia. Specifically, the investigators plan to: Ascertain informative families and sporadic cases with congenital diaphragmatic disorders and obtain appropriate phenotypic data and genetic material (peripheral blood and/or diaphragm tissue sample). Localize the gene(s) for CDD to specific chromosomal segments using linkage analysis, and determine the role of somatic mutations in CDD. Isolate and characterize genes involved in the pathogenesis of CDD. Develop molecular markers that will facilitate accurate diagnosis (including prenatal diagnosis) and permit correlation of phenotypic variation with specific mutations. Compare RNA-sequencing from tissue samples of children without CDH to those children with CDH.

Official Title
-----------------
Genetic Analysis of Congenital Diaphragmatic Disorders

Conditions
-----------------
Congenital Diaphragmatic Hernia, Congenital Diaphragmatic Eventration, Congenital Hiatal Hernia, Congenital Diaphragmatic Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with a congenital diaphragmatic disorder Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genes implicated in CDD can be identified by linkage analysis | Using the Utah Population Database, genes implicated in CDD can be identified by linkage analysis | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Develop molecular markers that will facilitate accurate diagnosis of CDD and CDH. | Develop molecular markers that will facilitate accurate diagnosis (including prenatal diagnosis) and permit correlation of phenotypic variation with specific mutations by localizing the gene(s) for CDH to specific chromosomal segments using linkage analysis in familial cases. In sporadic cases, characterize the role of somatic mutations in CDDs by using a candidate gene approach, and comparative genomic hybridization (CGH) arrays. | 5 years |
BCRL Prevention Pilot

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish feasiblity of recruiting obese breast cancer survivors at the end of treatment, getting those survivors to lose weight and attend follow-up visits for 6 months.

Detailed Description
-----------------
Breast cancer related lymphedema occurs in 20-30% of survivors. Weight loss could prevent onset. We seek to do a pilot study to establish feasibility of 1) recruiting survivors at risk for lymphedema to do a weight loss intervention, 2) achieving 10-15% weight loss over 26 weeks in this population, and 3) attendance at follow-up visits 6 months.

Official Title
-----------------
Weight Loss to Prevent BCRL: A Pilot Study

Conditions
-----------------
Obesity, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women Breast Cancer Survivors who had 5 or more lymph nodes removed and radiation to lymph nodes as part of treatment. Completed all treatments - no metastatic cancers Overweight or obese (BMI greater than or equal to 25 kg/m2) Medically and logistically able to participate in a weight loss and exercise program over 6 months. Diagnosed with breast cancer within the past 2 years. Exclusion Criteria: More than 2 years since breast cancer diagnosis Medical status that would preclude safety of participation in a weight loss and exercise program Metastatic cancer Already enrolled in a weight loss program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Follow-up Appts. | The primary outcome will be the precent of participants who complete 6 month follow-up appointments. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rates | Secondary outcomes will include response rates (% approached who enroll, consent, and attend intervention sessions), weight loss at 6 months, and arm volumes and lymphedema survey responses at 6 months. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obese women (BMI greater than or equal to 30), do not already have a diagnosis of lymphedema, who are done, with surgery, chemotherapy, and radiation therapy, and who were diagnosed with breast cancer within the, past 2 years will be invited to participate.
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Study Overview
=================
Brief Summary
-----------------
In this research study the investigators want to study a safe, radiation-free technique known as contrast-enhanced ultrasound that may improve the ability to diagnose or evaluate renal scarring compared to regular ultrasound. This technique requires injection into a vein of a small amount of contrast material called Lumason. Contrast material is a type of dye that helps the investigators image the structures in the body more clearly. If this technique is successful, the need for DMSA studies may be avoided to diagnose or evaluate kidney scarring. DMSA is a more expensive test, causes radiation exposure, may require sedation and/or injection of contrast agents with the potential to cause allergic reactions.

Official Title
-----------------
Radiation-Free Technique for Evaluating Renal Scarring (RAFTERS)

Conditions
-----------------
Vesico-Ureteral Reflux

Intervention / Treatment
-----------------
* Drug: Lumason


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients older than or equal to 6 months and less than or equal to 35 years old and scheduled for Boston Children's Hospital (BCH) DMSA scan to evaluate renal function and/or renal scarring Exclusion Criteria: patients with significant congenital renal anatomical abnormalities including horseshoe kidney, kidney malrotation, and multicystic dysplastic kidney (MCDK). Patients with severe cardio-pulmonary diseases will also be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contrast Enhanced Ultrasound<br>Participants will undergo a contrast enhanced ultrasound (CEUS) using Lumason | Drug: Lumason<br>* Lumason will be used as the contrast agent. Standard Lumason dose will be used: 0.03mL/kg up to a maximum dose of 2.4 milliliter (mL) per injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of CEUS result and comparison to DMSA | DMSA will be used as gold standard to evaluate CEUS test performance. Sensitivity and specificity of CEUS renal scarring detection will be calculated accordingly. Bivariate and multivariate analyses will be completed to compare patient characteristics between those with good and poor CEUS performance to investigate if CEUS performs better in patients with specific covariates | 3 months after final participant completes participation |
Medical Marijuana Use in HIV+ Patients Prospective Cohort Study

Study Overview
=================
Brief Summary
-----------------
The investigators are interested in understanding personal factors such as medical conditions and mental health, as well as social and economic factors, that influence marijuana (and other substance) use in HIV-positive patients. Several alternative hypotheses will be evaluated in the proposed project: healthier patients may self-select marijuana use; marijuana use may be associated with consequences that create barriers to seeking healthcare; marijuana use may have medicinal value that reduces the need for such care.

Detailed Description
-----------------
The study will involve a total of 5 interviews with clinical research staff members, the total involvement will be for about 1 year. The first interview will establish a baseline of current behaviors and health status; this will take about 3-4 hours. This interview will take place at the Tolan Park Medical Building, located at 3901 Chrysler Service Dr. The remaining 4 interviews - which will be shorter in length - will be conducted about 3, 6, 9, and 12 months after the baseline interview; each follow-up interview will take about 2 hours.The purpose of the 4 remaining interviews is to assess changes in behaviors and health status over time. We will collect urine samples at each of the 5 interview sessions to assess health and illicit drug use.

Official Title
-----------------
Behavioral Economic Analysis of Medical Marijuana Use in HIV+ Patients Prospective Cohort Study

Conditions
-----------------
HIV Positive, Marijuana Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be patients in the HIV clinic. Participants will have HIV. Participants will sign a single consent form. Participants will be marijuana users. Exclusion Criteria: Participants who test negative for marijuana will be excluded. Volunteers who exhibit signs of drug intoxication or cognitive/mental impairment during the consent process will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV positive, Medical Marijuana
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis

Study Overview
=================
Brief Summary
-----------------
The combination of diclofenac and propolis could enhance the healing of recurrent aphthous ulcers, instantly relieve symptoms, improve the quality of life, and present a de novo and cost-effective regime help in oral ulcer treatment. This study aimed to evaluate the influence of diclofenac and propolis combination as a gel in the treatment of recurrent oral ulceration

Official Title
-----------------
Combination of Diclofenac Potassium and Propolis in the Therapy of Oral Aphthosis

Conditions
-----------------
Oral Mucositis, ORAS, Oral Infection, Oral Ulcer

Intervention / Treatment
-----------------
* Combination Product: Combination of diclofenac potassium and propolis
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients have an oral mucosal ulcer Exclusion Criteria: patients allergic to any component of the diclofenac formulation and other NSAIDs

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical, double-blind, placebo-controlled study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo tube<br>neutral material without any biological effects | Other: placebo<br>* placebo<br>|
| Active Comparator: Combination of diclofenac potassium and propolis<br>active agents combination of diclofenac potassium 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel | Combination Product: Combination of diclofenac potassium and propolis<br>* Patients will be divided into two groups: the first one will be treated with a combination of diclofenac 3% (10 mg/g, 60 g, EMS) and Propolis 5% gel and the second one is placebo group. Participants will be allocated randomly. The patients will be asked to apply gel 2 times per day. The patients will be instructed, not to eat or drink for 1 h after application of the gel<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chronic oral mucosal disease questionnaire | patient response | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ulcer characters | size | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diclofenac, oral disease, oral Aphthosis, propolis
Effect of Hemodialysis on the PK of JTZ-951 in Subjects With End-stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of hemodialysis on the pharmacokinetics (PK) of JTZ-951 and to evaluate the safety of 2 doses of JTZ-951 in subjects with end-stage renal disease (ESRD) receiving hemodialysis

Official Title
-----------------
A Phase 1, Open-label, Sequential Crossover Study to Evaluate the Effect of Hemodialysis on the Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease

Conditions
-----------------
Anemia in Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: JTZ-951


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have ESRD and have been receiving maintenance hemodialysis for at least 12 weeks prior to the Screening Visit Body weight (post-dialysis weight) greater than 45.0 kg and a body mass index between 20.0 and 40.0 kg/m2 (inclusive) at the Screening Visit Exclusion Criteria: Acute coronary syndrome (e.g., myocardial infarction) within 1 year prior to admission Uncontrolled hypertension at the Screening Visit or Day -1

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 JTZ-951<br>Tablets, 1 dose on Day 1 before hemodialysis | Drug: JTZ-951<br> <br> |
| Experimental: Dose 2 JTZ-951<br>Tablets, 1 dose on Day 8 after hemodialysis | Drug: JTZ-951<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax (maximum concentration) of JTZ-951 when administered before and after hemodialysis |  | Days 1 to 4 and 8 to 11 | 
| tmax (time to reach maximum concentration) of JTZ-951 when administered before and after hemodialysis |  | Days 1 to 4 and 8 to 11 | 
| AUC (area under the concentration-time curve) of JTZ-951 when administered before and after hemodialysis |  | Days 1 to 4 and 8 to 11 | 
| t1/2 (elimination half-life) of JTZ-951 when administered before and after hemodialysis |  | Days 1 to 4 and 8 to 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | 14 days | 
| Vital signs and ECG (electrocardiogram) |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End-stage Renal Disease, Hemodialysis, Pharmacokinetics
Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial

Study Overview
=================
Brief Summary
-----------------
The objective of this demonstration project is to compare a novel long-acting starch, Glycosade, a hydrothermally processed high amylopectin maize starch, versus gastrostomy tube-dextrose infusion in maintaining euglycaemia overnight in children with GSD-I. Glycosade has been reported to increase the duration of euglycaemia. Its slow release and longer periods of normal blood sugar achieved would preclude the need for the overnight dextrose infusion and eliminate the need for the surgical insertion of a gastrostomy tube for this purpose. Glycosade also reportedly causes fewer gastrointestinal side effects, thus potentially improving compliance to therapy. The investigators intend to evaluate Glycosade in our patients and determine its efficacy on glucose control, on the length of normoglycemia achieved and to determine if there are reduced side effects in our patients with GSD-I. This will be accomplished by an open label study of Glycosade in GSD-I patients who consent to the protocol.

Official Title
-----------------
Comparison of the Effect of a Novel Starch (Glycosade) Versus Gastrostomy Tube-Dextrose Infusion on Overnight Euglycaemia Control in Children With Glycogen Storage Disease Type I: Open Label Demonstration Trial

Conditions
-----------------
Glycogen Storage Disorder Type 1, Hypoglycemia, Cornstarch, Glycosade

Intervention / Treatment
-----------------
* Dietary Supplement: Glycosade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of GSD Type 1 Age >5 years Exclusion Criteria: n/a

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycosade<br> | Dietary Supplement: Glycosade<br> <br> * Other names: Modified starch;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal Blood Glucose | With the use of Glycosade blood glucose would be maintained for 8 hours. | Overnight |
Implant Placement With Simultaneous Gum Grafting

Study Overview
=================
Brief Summary
-----------------
This study is a comparison of implant placed and simultaneously grafted with either autogenous connective tissue or a connective tissue allograft. The objective is to determine the change in soft tissue thickness and determine if a better result is obtained with the autograft or the allograft. The hypothesis is that there will be no difference in soft tissue thickness over the implant between the autograft and the allograft technique.

Official Title
-----------------
The Effect of Implant Placement and Simultaneous Soft Tissue Augmentation in the Esthetic Zone Using Either Connective Tissue Autograft or Acellular Dermal Matrix Allograft on Peri-implant Hard and Soft Tissue Healing

Conditions
-----------------
Edentulous

Intervention / Treatment
-----------------
* Procedure: connective tissue autograft
* Procedure: connective tissue allograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One edentulous site bordered by 2 teeth needing a dental implant Exclusion Criteria: Systemic diseases that affect the periodontium Previous head and neck radiation Smoking more that 1/2 pack per day Requires prophylactic antibiotics Allergy to meds used in study Previous chemotherapy Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Connective tissue autograft<br>A connective tissue autograft harvested from the palate was grafted onto the facial of a simultaneously placed dental implant and soft tissue thickness was measured at baseline and Time 4. | Procedure: connective tissue autograft<br>* A connective tissue autograft is harvested from the palate and grafted at the site of implant placement on the facial surface.<br>|
| Experimental: connective tissue allograft<br>An acellular dermal matrix allograft was grafted on the facial surface of a simultaneously placed dental implant and soft tissue thickness was measured at baseline and Time 4. | Procedure: connective tissue allograft<br>* An acellular dermal matrix allograft (Alloderm, BioHorizons, Inc, Birmingham, AL, USA) is grafted at the site of implant placement on the facial surface.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft Tissue Thickness Over the Implant | Soft tissue thickness at the facial osseous crest. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
soft tissue thickness, dental implant, soft tissue recession, implant exposure
Expanded Access for Relatlimab

Study Overview
=================
Brief Summary
-----------------
This is an expanded access designed to provide access to Relatlimab for eligible participants.

Intervention / Treatment
-----------------
* Drug: Relatlimab


Participation Criteria
=================

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Relatlimab|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |