linjc16/ctgov huggingface dataset:
Acetabular Fractures of Both Columns

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study a specific acetabular (hip socket) fracture pattern and how its treatment affects the functional, clinical, and x-ray outcomes. There are no experimental procedures involved.

Detailed Description
-----------------
This study will identify a small subset of patients that fall outside the Letournel classification system of acetabular fractures. The fracture pattern, its influence on the surgical treatment decision making process, and the radiographic and outcomes will be detailed. In particular, both-column acetabular fractures with significant posterior deformity have been correlated with poor functional outcomes, increased arthritis radiographically, and worse prognosis in general. Despite these findings, there has been no specific study evaluating these injury patterns to date. We present ten patients with both column acetabular fractures and an associated posterior column/wall piece and their clinical outcomes in an effort to help guide surgical treatment and offer prognostic guidance.

Official Title
-----------------
Both Column Acetabular Fractures With Associated Posterior Deformity Patterns: Implications for Surgical Treatment and Prognosis

Conditions
-----------------
Acetabular Fractures, Both Columns

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients that underwent surgical fixation of the hip at Hershey Medical Center between June 2006 and May 2007 by Dr's J. Spence Reid and David Goodspeed. They will include patients that are admitted directly from the field or are transferred from outside hospitals. Exclusion Criteria: will be those acetabular fractures of non-traumatic etiology (e.g.: secondary to malignancy or fatigue) fractures that have not undergone operative fixation pediatric populations under the age of 18 mentally compromised patients those that do not give consent for the clinical evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
Acetabular Fractures
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy, safety, and durability of response of SP-303 in decreasing stool weight in AIDS patients with diarrhea over 6 days of treatment.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients

Conditions
-----------------
Diarrhea, HIV Infections

Intervention / Treatment
-----------------
* Drug: Crofelemer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV infection meeting CDC criteria for AIDS. History of diarrhea for greater than or equal to 14 days prior to screening period (Day 1). Required: - On stable medical regimen.

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

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

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

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
-----------------
Diarrhea, Acquired Immunodeficiency Syndrome
Biologic Effects of Dehydroepiandrosterone (DHEA) in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether DHEA replacement therapy decreases abdominal fat and improves insulin sensitivity.

Detailed Description
-----------------
Studies on rats and mice have shown that the adrenal hormone dehydroepiandrosterone (DHEA) reduces abdominal visceral fat and protects against insulin resistance. This study was done to learn if DHEA replacement therapy decreases abdominal obesity and improves insulin action in humans. Participants were randomly assigned to receive 50 mg per day of DHEA or a placebo at bedtime for 6 months. Participants underwent magnetic resonance imaging (MRI) and oral glucose tolerance tests at the beginning and conclusion of the study. Other tests included measurements of hormones and lipids.

Official Title
-----------------
Biologic Effects of DHEA in Humans

Conditions
-----------------
Aging, Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Drug: DHEA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 to 78 years old Physically healthy Non-smoker On stable medications for at least 6 months Stable body weight for the past year Exclusion Criteria: Serious active medical problems Hormone therapy Abnormal PSA (prostate specific antigen) in men

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 78 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month change in visceral and subcutaneous abdominal fat |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abdominal fat, dehydroepiandrosterone, Insulin sensitivity
To Demonstrate the Relative Bioavailability of Cilostazol 50 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Eon and Otsuka (Pletal) 50 mg Cilostazol Tablets In Healthy Adults Volunteers Under Fasting Conditions

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)
* Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA) | Drug: Cilostazol 50 mg Tablets (Eon Pharma, LLC, USA)<br> <br> |
| Active Comparator: 2<br>Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA) | Drug: Pletal (Cilostazol) 50 mg Tablets (Otsuka Pharma Co, Ltd., USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 21 days |
Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia. Obesity is associated with markedly elevated plasma insulin levels throughout the day. The concept is that obese subjects predominantly develop lean tissue resistance against the glucoregulatory actions of insulin, but remain relatively sensitive to the lipogenic and antilipolytic effects of insulin in adipose tissue. According to this theory, suppression of hyperinsulinism by diazoxide, a well known inhibitor of glucose stimulated insulin secretion, might be useful to treat obesity because it will help to reverse the process of lipid storage.

Detailed Description
-----------------
The purpose of this study is to explore diazoxide efficacy in treatment of obese men and assessment of maximal insulin suppression in obese men without hyperglycaemia. Study design: This study is an open-labelled, non-randomized, phase IIa study. Treatment: During a 6 month period, the dosage of Diazoxide will be raised gradually until a maximum of 900 mg/day, under control of bloodpressure and glucose levels. Endpoints, monthly determined: body weight abdominal circumference body composition measured by Dual Energy X-ray Absorptiometry glucose tolerance

Official Title
-----------------
Diazoxide-Mediated Insulin Suppression in Hyperinsulinemic Obese Men: a Dose Response Study, Part II

Conditions
-----------------
Obesity, Hyperinsulinism

Intervention / Treatment
-----------------
* Drug: Diazoxide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: fasting glucose < 7.0 mmol/L fasting C-peptide plasma level > 1.0 nmol/L HbA1c of 6.0% or lower Absence of comorbidity Absence of medication use Exclusion Criteria: Plasma Creatinine > 120 micromol/L Liverenzymes > 2 times the upper normal limit Gout Alcohol use > 2 units/day Illicit drug use Quit smoking less than 6 months ago

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  |  | 
| abdominal circumference |  |  | 
| body composition measured by Dual Energy X-ray Absorptiometry |  |  | 
| glucose tolerance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Hyperinsulinism, Diazoxide
Pediatric Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
End-stage renal disease (ESRD) is a rare disease in children. Renal transplantation (RT) is the treatment of choice for ESRD in the pediatric population. In France, around 100 pediatric kidney transplants are performed each year. The aim was to evaluate the surgical management of TR and the long-term results.

Detailed Description
-----------------
End-stage renal disease (ESRD) is a rare pathology in children, whose gold standard treatment is a kidney transplant. In France, around 100 pediatric kidney transplants are performed every year. Although the first adult kidney transplants were performed in 1954, pediatric renal transplantation was considered unsafe compared with dialysis, which was preferred. In the 1980s, improved graft selection, optimized pre-transplant management and a better understanding of the immune system led to the development of pediatric kidney transplantation. Despite considerable progress, graft survival in these long-lived patients remains a major challenge. The aim of this study is to evaluate surgical practices in the four French pediatric transplant centers, and to define risk factors for surgical complications.

Official Title
-----------------
Pediatric Kidney Transplant

Conditions
-----------------
End Stage Renal Disease, Pediatric ALL, Kidney Transplant; Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients who underwent renal transplantation in one of the 4 centers Exclusion Criteria: Multi organ transplant

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 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 |
| --- | --- | --- |
| Surgical outcomes | To assess surgical outcome in pediatric renal transplantation in terms of per operative complications (ClassIntra classification) post operative complications (Clavien Dindo) early < 30 days and late > 30 days | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical complications | Evaluate the surgical morbidity of renal transplantation | 10 years | 
| Graft Survival | Evaluate graft survival at 1, 5 and 10 years post transplantation | 10 years | 
| Return to dialysis | Evaluation of the need to return to dialysis after transplantation : causes and reasons | 10 years | 
| Retransplantation | Evaluation the number of patient undegoing another transplantation | 10 years | 
| Death | Evaluation of the morbidity of this population | 10 years |
3D Ultrasound Breast Imaging

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.

Official Title
-----------------
3D Multimodal Ultrasound Imaging for Breast Cancer

Conditions
-----------------
Breast Tumor

Intervention / Treatment
-----------------
* Diagnostic Test: GE Logiq E10 clinical ultrasound scanner
* Diagnostic Test: Verasonics research scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult women, ≥ 18 years of age. Breast lesion and are scheduled for clinically-indicated biopsy. Exclusion Criteria: < 18 years of age. Previous breast surgery or breast implant. Lacking capacity to consent. Pregnant or lactating. Receiving cancer therapy such as chemotherapy or radiation therapy.

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

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinically indicated breast tumor biopsy<br>Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed | Diagnostic Test: GE Logiq E10 clinical ultrasound scanner<br>* 2D B-mode, Doppler, and shear wave elastography images of the lesion<br>Diagnostic Test: Verasonics research scanner<br>* 3D B-mode imaging, microvessel imaging, and shear wave elastography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BI-RADS Score | BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive. | Baseline |
Gut Organoid Study

Study Overview
=================
Brief Summary
-----------------
The study will compare basic properties of gut epithelia of hypertensive and normotensive reference subjects. The study will determine if there are fundamental differences in the gut epithelium in hypertension compared to normotension.

Official Title
-----------------
Gut Inflammation and Gut-Gut Microbiome Interactions in the Pathogenesis of Hypertension

Conditions
-----------------
Gut Inflammation

Intervention / Treatment
-----------------
* Other: Gene Expression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion/exclusion criteria for hypertension participants Ages: 18-80 years old with a weight greater than or equal to 110 lbs Diagnosis of hypertension or without hypertension for the reference cohort. 2017 ACC/AHA (American College of Cardiology/American Heart Association) definition for hypertension (systolic blood pressure ≥130 mmHg and/or diastolic BP ≥80 mmHg) will be used. Scheduled elective colonoscopy Exclusion Criteria: Hypertensive or reference individuals with history of autoimmune disease or other chronic inflammatory conditions. Pregnant or have been pregnant in the last six months. Antibiotic treatment within two months of study enrollment Currently taking a medication (e.g. antibiotic, anti-inflammatory agents, glucocorticoids, other immune modulating medications, antacids or proton pump inhibitor drugs like Prilosec) known to modify gut microbiota. Unwilling to discontinue using probiotics for at least two weeks before scheduled biopsy. History of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder. History of blood transfusion within 4 weeks. Subjects who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing routine colonoscopy<br>Patients with and without hypertension who routinely undergo colonoscopy | Other: Gene Expression<br>* Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Samples with DNA | Biopsy specimens (formalin fixed and paraffin embedded) which are routinely obtained during the endoscopic procedure are retained according to legal requirements. | Visit 1 day |
Expanded Access Use of Itacitinib to Treat a Single Patient With STAT1 Gain of Function (GOF) Disease

Study Overview
=================
Brief Summary
-----------------
Expanded access use of Itacitinib to treat a single patient with aplastic anemia.

Conditions
-----------------
STAT1 Gain-of-Function Disease

Intervention / Treatment
-----------------
* Drug: Itacitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

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

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
-----------------
STAT1 GOF disease
Suitability of DCE-MRI for Detection of Vascular Changes After VBT

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and after radiotherapy n patients receiving adjuvant brachytherapyfor cervical or endometrial cancer.

Official Title
-----------------
A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes After Vaginal Brachytherapy

Conditions
-----------------
Carcinoma of the Cervix, Carcinoma or Carcinosarcoma of the Uterus

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 18 years of age. Must have histologically confirmed carcinoma of the cervix, carcinoma or carcinosarcoma of the uterus. Subjects are receiving intracavitary brachytherapy. ECOG performance status of 0-2. Creatinine clearance 30. Exclusion Criteria: Subjects with an inability to tolerate MR imaging (i.e. claustrphobia) Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants. Patients who do not speak or read English.

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

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

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: DCE-MRI<br> | Radiation: Radiotherapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events |  | 2 years |