linjc16/ctgov huggingface dataset:
A Study to Identify Participants With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

Study Overview
=================
Brief Summary
-----------------
The purpose of this non-interventional study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.

Official Title
-----------------
Biomarker Study to Identify Subjects With Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

Conditions
-----------------
Urothelial Cancer, Receptors, Fibroblast Growth Factor

Intervention / Treatment
-----------------
* Other: Archival Tumor Tissue Sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transitional cell carcinoma of the urothelium. Urothelial cell carcinoma (UCC) variants are allowed, that is, UCC with squamous and/or glandular differentiation, micropapillary, nested, plasmacytoid, neuroendocrine, and sarcomatoid Diagnosis of one of the following: a) Metastatic or surgically unresectable urothelial cancer (UC) (Stage IV) or, b) localized surgically-resectable or resected UC with a T classification of T2 or above or non-muscle-invasive urothelial carcinoma of the bladder (Ta, T1 and carcinoma in situ [CIS]) Available archival tissue sample for fibroblast growth factor receptor (FGFR) aberration analysis Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Urothelial Cancer,selected FGFR aberrations<br>Participants with urothelial cancer (UC) will be evaluated for the prevalence of positive results of selected fibroblast growth factor receptor (FGFR) aberrations and will be assessed for eligibility status for erdafitinib studies. The primary data source for this study will be the medical records of each participant. | Other: Archival Tumor Tissue Sample<br>* Percentage of participants with UC and selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations | Percentage of participants with selected FGFR gene aberrations will be assessed through molecular testing of their archival tumor tissue. | Up to 3.9 years |
Study Evaluating Safety of Etanercept in Treatment of Patients With Moderate to Severe Psoriasiswith Etanercept

Study Overview
=================
Brief Summary
-----------------
Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.

Official Title
-----------------
Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent signed by patients prior to study entry 18 years of age or older at screening visit Patients with moderate to severe psoriasis Patients who have failed conventional systemic treatment Patients who have a contraindication to conventional systemic therapy Patients who are intolerant to conventional systemic therapy A negative serum pregnancy test at screening in women of childbearing potential Able to self-inject study drug or have a designee who can do so In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etanercept|recommended dose of enbrel is 25mg administered twice weekly.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation |  | 18 months |
The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping in Athletes With Chronic Ankle Instability

Study Overview
=================
Brief Summary
-----------------
There will be a difference in ankle functional ability between athletes with chronic ankle instability in the intervention group and in the control group.

Official Title
-----------------
The Effect of Hydrotherapy and Land-based Rehabilitation Program Combined With Ankle Taping on Ankle Functional Ability and Re-injury Rate in Athletes With Chronic Ankle Instability

Conditions
-----------------
Sports Rehabilitation Program, Hydrotherapy, Ankle Instability

Intervention / Treatment
-----------------
* Procedure: hydrotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent ankle sprain in one year sustain at least one repeated injury or have the experience of ankle instability feelings or giving way not undergoing formal or informal rehabilitation for the unstable ankle in the last three months have residual symptoms after recurrent sprain of the ankle Exclusion Criteria: have the history of fracture or surgical procedures in the lower extremity have the history of neurological disorders affecting the lower extremities vestibular dysfunction or balance disorder allergic to the zinc oxide compound in the adhesive tape

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hydrotherapy<br>hydrotherapy and ankle taping and land based exercise | Procedure: hydrotherapy<br>* hydrotherapy and ankle taping and land-based<br>* Other names: land-based;|
| Active Comparator: land-based<br>land-based and ankle taping program | Procedure: hydrotherapy<br>* hydrotherapy and ankle taping and land-based<br>* Other names: land-based;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect of ankle functional ability between the athletes with chronic ankle instability in the intervention group and the control group |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the effect of active joint position sense, single limb balance, SF-36 and re-injury rate | Parameters active joint position sense in ankle plantarflexion 30 degree and ankle inversion 15 degree single limb balance in standard deviation and Range SF-36 in 8 Items of questionnairs | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hydrotherapy, chronic ankle instability, ankle taping
Vitamin D and Type 2 Diabetes Risk in UK Adults

Study Overview
=================
Brief Summary
-----------------
This study is exploring the association between vitamin D and Type 2 diabetes risk in normal weight and overweight UK adults.

Detailed Description
-----------------
The aim of this study is to assess the link between vitamin D status and glucose homeostasis in a population of normal weight and overweight individuals (BMI> 18.5 Kg/m2).

Official Title
-----------------
Association Between Vitamin D Status and Risk of Type 2 Diabetes in a Population of UK Adults: A Cross-sectional Study.

Conditions
-----------------
Obesity, Overweight

Intervention / Treatment
-----------------
* Other: Normal weight and overweight adults


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal weight and overweight and obese adults (BMI>= 18.5 Kg/m2) with no restriction to ethnicity, occupation or socioeconomic status. Males and females 18-50 years Exclusion Criteria: Patients diagnosed with diabetes type 2, myocardial infarction or coronary heart disease. HbA1c > 6.4% Pregnancy Diagnosis of liver disease (including liver enzymes > 3 times above normal values) Diagnosis of renal disease (creatinine of > 150 mmol/l) Post-menopausal women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Normal weight and overweight adults|Association between vitamin D levels and insulin resistance|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-IR (Homeostasis modelling assessment-Insulin resistance) | A venous blood sample collected for the measurement of insulin and glucose levels. | One venous sample collected after 8 hours of fasting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting bood glucose levels | A venous blood sample collected for the measurement of glucose levels | One venous sample collected after 8 hours of fasting | 
| HbA1C | Fingerprick sample | Sample collected at one single time point with no follow-up | 
| Body fat percentage | Body fat percentage measured through DEXA | Measurement conducted in the morning after 8 hours of fasting | 
| Central and brachial Systolic and Diastolic Blood pressure | Blood pressure measured using a digital sphygmomanometer | Measurement taken 3 times after a-10 minute rest | 
| Augmentation index | Arterial stiffness assessment test | Measurement taken 3 times after a-10 minute rest | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose, Vitamin D, Type 2 diabetes, Insulin resistance
Multi-Center Trial of Anti-Thymocyte Globulin in Treatment of Aplastic Anemia and Other Hematologic Disorders

Study Overview
=================
Brief Summary
-----------------
To determine the therapeutic effects of anti-thymocyte globulin (ATG) in patients with aplastic anemia and related bone marrow failure diseases.

Detailed Description
-----------------
BACKGROUND: Aplastic anemia has been shown to respond to ATG. An immunological basis for aplastic anemia has been suggested by previous observations although the precise mechanism of action of ATG has not been defined. This serum, produced by immunization of horses with human thymocytes, may have broad reactivity with many human cells. DESIGN NARRATIVE: Patients in Group I with acute severe disease were randomized to receive ATG in either ten day or twenty-eight day courses. Patients in Group II with moderate or chronic disease were randomized to receive either ATG for ten days or high doses of the androgen, nandrolone decanoate. Patients in Group III with a variety of bone marrow diseases were also treated with ATG. The study completion date listed in this record was inferred from the last publication listed in the Citations section of this study record.

Conditions
-----------------
Anemia, Aplastic, Hematologic Diseases, Pancytopenia, Blood Disease

Intervention / Treatment
-----------------
* Drug: antilymphocyte serum
* Drug: nandrolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women with moderate or acute, severe, aplastic anemia.

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: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antilymphocyte serum|nan|
|Drug: nandrolone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of GERD

Study Overview
=================
Brief Summary
-----------------
To describe the frequency, type and severity of the symptoms in patients visiting the GI or internal physicians, with symptoms consistent with gastroesophageal reflux disease (GERD)

Official Title
-----------------
Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of the Gastroesophageal Reflux Disease

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients from both sexes, aged 18 years or older Patients complaining of symptoms consistent with reflux disease Exclusion Criteria: Patients with GI cancer and those where the only reason for the visit is renewing the prescription are excluded

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
-----------------
GIS, GERD, heartburn, NIS, PPI
Imaging and Understanding BOS in Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years.

Detailed Description
-----------------
This study is a prospective, non-randomized, longitudinal, observational study that will recruit about 5 lung transplant patients per year for 3 years. We will follow these patients at 6 months and 1 year with Hyperpolarized Helium-3 Magnetic Resonance Imaging and image guided bronchial biopsies to detect early BOS and to better understand BO disease progression. The biopsies will provide future research for rapid determination of cellular and molecular mechanisms that lead to BOS and to facilitate identification and validation of translatable pharmaceutical targets.

Official Title
-----------------
Imaging and Understanding BOS in Lung Transplantation

Conditions
-----------------
Bronchiolitis Obliterans Syndrome

Intervention / Treatment
-----------------
* Drug: Hyperpolarized Helium-3 MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung Transplantation within the last 10 years or being assessed for possible lung transplantation. Male or female 0 to 25 years of age. Exclusion Criteria: Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology Inability to perform 10 second breath hold for 3He MRI scan Bleeding disorders

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post transplant subjects<br>Hyperpolarized Helium-3 MRI. Subjects who have had or are scheduled to have a lung transplant | Drug: Hyperpolarized Helium-3 MRI<br>* Subjects will inhale Hyperpolarized Helium-3 gas during the MRI. This gas enhances images and the data collected will be used to determine if it can be used to detect BOS earlier than current standard of care.<br>* Other names: Hp-He3 MRI;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of MRI imaging to detect BOS compared to biopsy | Analysis of MRI imaging to detect BOS compared to biopsy | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, Helium, Lung transplantation
Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV

Study Overview
=================
Brief Summary
-----------------
The high rates of HIV infection in women have brought into sharp focus the problem of violence against women. There is a growing recognition that women and girls' risk of and vulnerability to HIV infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular. The links between intimate partner violence and HIV/AIDS are explained by biological as well as sociocultural and economic factors.

Official Title
-----------------
Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV: a Multi-centric Randomized Trial

Conditions
-----------------
HIV, AIDS, Domestic Violence

Intervention / Treatment
-----------------
* Other: Mico-finance based intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old; Must plan to reside in study areas for the next 12 months Must visit camp at least 1 time per week Must provide contact information of friend or family member Exclusion Criteria: Unwilling to provide local information Psychological disturbance, cognitive impairment or threatening behavior

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (IG)<br>Loans were provided to poor women who enrolled in the intervention group. A participatory learning and action curriculum was integrated into loan meetings, which took place every 2 weeks. | Other: Mico-finance based intervention<br> <br> |
| No Intervention: Control Group (CG)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of New Sexually Transmitted Infections |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women Reporting Physical, Sexual, or Psychological Partner Violence |  | 12 Months | 
| Proportion of unprotected sexual acts with partner |  | 12 month |
Hypertrophic Myopathy in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify the patients seen in our practice who are seen with Hypertrophic Myopathy diagnosis in order to better understand the presenting characteristics of their disease, the diagnostic testing to determine the diagnosis, the methods used to follow the disease progression and management practices used in caring for these patients. The objectives of this data review will be an analysis to determine if there is a methodology that will foster improved diagnostic speed and accuracy, and determine the best management practices based on outcomes in these patients.

Detailed Description
-----------------
The charts of children followed at Sibley Heart Center of Children's Healthcare of Atlanta will be identified using the Mysis system and screening for the appropriate ICD-9 codes for the types of Hypertrophic Myopathy. These codes include: 425.1, 425.4, 425.7, 425.8, and 425.9. Screening will also be done for known anomalies that are associated with hypertrophic myopathy as seen in some syndromes and metabolic disorders. Data Collection: Age at presentation (DOB) History - Prenatal, Family, Current Surgical Procedures Physical Exam results EKG interpretation CXR results Echocardiography results MRI Results Holter monitors results Exercise testing results Radionuclear study results Spiral CT Study results Genetics Testing results Medication usage Enzyme replacement therapy usage Diagnostic laboratory results Statistics: A generalized linear model will be performed. Significance will be defined at P≤ 0.05. Interim monitoring of accumulated data will be performed. One interim analysis will be performed after 3 months of accrual with additional analyses being performed at the end of data collection. Demographic data will be summarized for all subjects. For each patient summary statistics will include the mean, standard deviation, frequency distribution, minimum, maximum and range.

Official Title
-----------------
Retrospective Review of Hypertrophic Myopathy in Children

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: seen at Sibley Heart Center, Children's Healthcare of Atlanta diagnosed with Hypertrophic Myopathy Exclusion Criteria: those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 21 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
-----------------
pediatric, cardiac, hypertrophic Myopathy