linjc16/ctgov huggingface dataset:
UWCCC Molecular Tumor Board Registry

Study Overview
=================
Brief Summary
-----------------
This study seeks to evaluate the clinical utility of the Precision Medicine Molecular Tumor Board, and to track patient outcomes.

Official Title
-----------------
UWCCC Precision Medicine Molecular Tumor Board Registry

Conditions
-----------------
Hematologic Neoplasms, Solid Neoplasm

Intervention / Treatment
-----------------
* Other: PMMTB (Precision Medicine Molecular Tumor Board)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically suspected or histologically confirmed solid or hematological malignancy Undergoing genetic testing of tumor Ability to understand written informed consent document Willingness to sign written informed consent document Exclusion Criteria: Pediatric patients (age<18 years) will be excluded due to a lack of expertise on the molecular tumor committee

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 |
| --- | --- |
| PMMTB<br>This study of the PMMTB will include all patients >= 18 with clinically suspected or histologically confirmed solid or hematological malignancy who will undergo genetic testing of their tumor. All standard of care functions will be performed by standard procedures. | Other: PMMTB (Precision Medicine Molecular Tumor Board)<br>* PMMTB is a clinical intervention, NOT a research intervention. The research component of this study is to observe the outcomes of the PMMTB.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of acceptance of molecular tumor board recommendations | How often the molecular tumor board's recommendations are accepted | Up to 5 years | 
| Benefit from PMMTB recommended treatment | Whether patients benefit from PMMTB recommended treatment | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of mutations with protein overexpression | Correlate mutations identified in tumor tissue with protein overexpression | Up to 5 years | 
| Correlations of mutations with circulating tumor DNA | Correlate mutations identified in tumor tissue with circulating tumor DNA | Up to 5 years | 
| Correlations of mutations with spheroid culture investigations | Correlate mutations identified in tumor tissue with spheroid culture investigations | Up to 5 years |
Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

Study Overview
=================
Brief Summary
-----------------
The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

Official Title
-----------------
Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Conditions
-----------------
Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms, Juxtarenal Aneurysms

Intervention / Treatment
-----------------
* Device: Zenith® Fenestrated AAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm Exclusion Criteria: Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal Renal artery stenosis greater than 50 percent

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

| Intervention/Treatment |
| --- |
|Device: Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Mesh Repair of Anterior Vaginal Wall Prolapse

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether reenforcement with polypropylen mesh compared with traditional anterior colporrhaphy for anterior vaginal wall prolapse results in fewer recurrences.

Detailed Description
-----------------
Anterior vaginal wall prolapse is the most common type of pelvic organ prolapse in postmenopausal women. This anatomic defect has traditionally been repaired with anterior colporrhaphy plication, a series of interrupted stitches being the main surgical component. The procedure is associated with a high recurrence rate, up to 32 % even after using paravaginal repair along with anterior colporrhaphy.It has been sought to resolve the problem of recurrence using artificial mesh as in the repair of abdominal hernias. Comparison: Anterior vaginal wall repair with or without reinforcement with polypropylene mesh were compared in a prospective randomized study

Official Title
-----------------
Low-Weight Polypropylene Mesh for Anterior Vaginal Wall Prolapse: A Prospective Randomized Study

Conditions
-----------------
Anterior Vaginal Wall Prolapse

Intervention / Treatment
-----------------
* Device: Low-weight prolypropylene mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women with symptomatic anterior vaginal wall prolapse to the hymen or beyond when under strain and referred for reconstructive pelvic surgery Exclusion Criteria: an apical defect indicating concomitant vaginal fixation, or stress urinary incontinence necessitating surgery, or her main symptomatic prolapse component was in the posterior vaginal wall.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Low-weight prolypropylene mesh|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of anterior vaginal wall prolapse |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postvoidal residual urine |  |  | 
| Symptom resolution |  |  | 
| Complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
surgery, Cystocele, mesh, genital prolapse
All-Case Surveillance of Ofev in Patients With IPF in Japan

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study based on new data collection to gather real-world information (i.e., data under routine medical practice) on safety and effectiveness of the Ofev® Capsules treatment. The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be followed up until discontinuation of Ofev® Capsules treatment. As this is an observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for IPF must be according to regular medical practice and at the discretion of the physician (i.e., no randomised assignment of patient to treatment is performed). All patients administrated Ofev® Capsules after the launch at the sites contracted with the sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected. However the patient registration continues until the approval condition has been removed. Patients participating in the subsequent follow-up will undergo regular observations. These observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment. Patients will not be followed any longer once they are reported to have discontinued the Ofev® Capsules treatment.

Official Title
-----------------
The Special Drug Use-results Survey (All-Case Surveillance) of Ofev® Capsules in Patients With Idiopathic Pulmonary Fibrosis (IPF) in Japan

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Nintedanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Essentially, patients are diagnosed with IPF based upon the most recent the American Thoracic Society (ATS), the European Respiratory Society (ERS), the Japanese Respiratory Society (JRS), and the Latin American Thoracic Association (ALAT) guideline.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nintedanib<br>Patients with IPF | Drug: Nintedanib<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of this study is the frequency of patients with any suspected Adverse Drug Reactions (ADRs) |  | Week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint of this study is absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 104 |  | Week 104 |
SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Study Overview
=================
Brief Summary
-----------------
Assessing the safety and efficacy of SPP100 (Aliskiren) regimen in patients with severe hypertension

Official Title
-----------------
A Multi-center, Open-label Study Assessing the Safety and Efficacy of 8 Week's Treatment of SPP100 (Aliskiren) Regimen in Patients With Severe Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20 - 80 years old Gender: Male or female Status: Outpatients severe hypertension Exclusion Criteria: Patients with a clinically significant allergy Patients who have received other investigational drug Alcoholic patients Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting systolic and diastolic blood pressure after 8 weeks |  |  | 
| Average sitting systolic blood pressure/mean sitting diastolic blood is < 160/100 mmHg or blood pressure reduction from baseline is > 20/10 mmHg after 8 weeks |  |  | 
| Average sitting diastolic blood pressure < 90 mmHg or a reduction from baseline of > 10 mmHg after 8 weeks. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, aliskiren, blood pressure, rennin
A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept

Official Title
-----------------
A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: tacrolimus
* Drug: CellCept
* Drug: steroids (methylprednisone or prednisone)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patient is between post kidney transplant day 3-7 and no requirement for dialysis Exclusion: Patient is receiving kidney from HLA identical,living donor Patient is a multi-organ transplant recipient Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>early steroid cessation | Drug: tacrolimus<br>* Oral<br>* Other names: FK506;Drug: CellCept<br>* IV or Oral<br>* Other names: Mycophenolate mofetil;Drug: steroids (methylprednisone or prednisone)<br>* IV or Oral<br>* Other names: prednisone;|
| Experimental: 2<br>long-term maintenance steroids | Drug: tacrolimus<br>* Oral<br>* Other names: FK506;Drug: CellCept<br>* IV or Oral<br>* Other names: Mycophenolate mofetil;Drug: steroids (methylprednisone or prednisone)<br>* IV or Oral<br>* Other names: prednisone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of death, graft loss, or severe acute rejection |  | 6 months, 12 months, yearly up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of patient and graf survival |  | 6 months, 12 months, yearly up to 5 years | 
| Incidence and severity of acute rejection |  | 6 months, 12 months, yearly up to 5 years | 
| Need for antilymphocyte treatment |  | 6 months, 12 months, yearly up to 5 years | 
| Graft function |  | 6 month, 12 months, yearly up to 5 years | 
| Framingham Coronary Heart Disease Risk Factors |  | 6 months, 12 months, yearly up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Transplantation, Prograf
The Gastric Cancer Foundation: A Gastric Cancer Registry

Study Overview
=================
Brief Summary
-----------------
The Gastric Cancer Registry will combine data acquired directly from patients with gastric cancer; with a family history of gastric cancer in a first or second degree relative; or persons with a known germline mutation in their CDH1 (E-Cadherin) gene via an online questionnaire with genomic data obtained from saliva, blood and tissue samples. The purpose of this registry is to gain better understanding of the causes of gastric cancer, both environmental and genetic; whether certain genomic data can predict outcomes of treatment and survival.

Detailed Description
-----------------
Collect detailed clinical and epidemiological information on eligible patients via an online registry and a detailed patient questionnaire. Participants can opt in to contribute a blood or saliva sample and paraffin block samples from a previous gastric surgery.

Official Title
-----------------
The Gastric Cancer Foundation: A Gastric Cancer Registry

Conditions
-----------------
Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are eligible if they have a histologically proven gastric tumor including gastroesophageal tumors; OR they have a family history of gastric cancer in a first or second degree relative; OR persons with a known germline mutation in their CDH1 (E-Cadherin) gene. 18 years of age or older Adequate English proficiency to complete online consent and questionnaire. Spanish-language proficiency as an alternative to English-language proficiency. Exclusion Criteria: Under 18 years of age No history of gastric cancer or gastric cancer in a family member or a known germline mutation in their CDH1 gene.

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 |
| --- | --- | --- |
| Collect detailed clinical and epidemiological information on patients with gastric cancer; with a family history of gastric cancer in a first or second degree relative; or persons with a known germline mutation in their CDH1 (E-Cadherin) gene |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life
The DEB Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the current study is to test if weight change is differentially affected by consumption of foods that are identical in carbohydrate (i.e. sugar) but vary in food form over 1 month.

Detailed Description
-----------------
Dose: Participants are to consume 1 unit per day of the study product. Diet: Participants will receive no instructions for other dietary modifications; i.e., they will not be told to modify what or how much other food they consume.

Official Title
-----------------
The Diet Composition and Energy Balance Pilot Study

Conditions
-----------------
Nutritional Physiological Phenomena, Obesity

Intervention / Treatment
-----------------
* Other: Sugar Sweetened Solid Treatment
* Other: Sugar Sweetened Beverage Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 20 - 40 Exclusion Criteria: Diabetes (Type 1 or 2) Prediabetes Active cancer Serious digestive disorders Other conditions that affect metabolism or body weight Uncontrolled Thyroid disorder (controlled = 6 months of medication) Unable to consume study foods Non- weight stable (more than 10 lbs weight gain or loss in last 6 months) Pregnancy Intentions of becoming pregnant in the next 2 months Women who have undergone partial hysterectomy with intact ovary function Current or past alcohol or drug abuse problem Allergy or intolerance to study product ingredients. Any other medical, psychiatric or behavioral factors that in the judgment of the Principle Investigator that may interfere with study participation or the ability to follow the protocol

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized parallel arm design trial examining solid sugar vs. SSB treatments will be performed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sugar Sweetened Solid Treatment<br>A solidified food that is made with the SSB syrup concentrate and gelatin. It is equivalent to one 20 oz. soft drink. | Other: Sugar Sweetened Solid Treatment<br>* Consume Sugar Sweetened Solid Treatment (product) daily.<br>|
| Active Comparator: Sugar Sweetened Beverage Treatment<br>20 oz. carbonated sugar sweetened beverage. Added ingredients include:  2.1g whey protein powder. | Other: Sugar Sweetened Beverage Treatment<br>* Consume Sugar Sweetened Beverage Treatment (product) daily.<br>* Other names: SSB Treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Body Weight | Change from baseline in body weight at 1 month | 1 month |
A Study to Determine the Effects of MK0557 in Obese Subjects (0557-006)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of MK0557 on body weight in obese subjects.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: MK0557


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women between 21 and 65 years of age, willing to avoid all prescription and nonprescription medicine to alter body weight for entire study Exclusion Criteria: You are or plan to become pregnant You have smoked or used nicotine within 6 months of the study History of abusing alcohol and/or drugs History of a stroke, you have diabetes mellitus, you are taking medication for high blood pressure, you have had recent surgery, you have been involved in another study within 3 months of study, use of cholesterol or anti-seizure medication during the study Have participated in a weight loss program 3 months before the study or during the course of the study

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0557|nan|

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

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