linjc16/ctgov huggingface dataset:
Safety and Efficacy Study in Subjects With Seborrheic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if two test products are safe and effective in the treatment of seborrheic dermatitis.

Official Title
-----------------
A Parallel-group, Vehicle-controlled, Randomized, Double-blind Study of the Efficacy and Safety of Product 49778 and Product 10156 in Subjects With Seborrheic Dermatitis

Conditions
-----------------
Seborrheic Dermatitis

Intervention / Treatment
-----------------
* Drug: Test Product 49778
* Drug: Test Product 10156
* Drug: Vehicle (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Investigator assessment of seborrheic dermatitis. Additional criteria as identified in the protocol. Exclusion Criteria: History of or ongoing psoriasis of the scalp. History of or ongoing atopic dermatitis of the scalp. Additional criteria as identified in the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 12 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Vehicle<br>Vehicle (placebo) treatment, twice a week for four weeks. | Drug: Vehicle (placebo)<br> <br> |
| Experimental: Test Product 10156<br>Product 10156 treatment, twice a week for four weeks. | Drug: Test Product 10156<br> <br> |
| Experimental: Test Product 49778<br>Product 49778 treatment, twice a week for four weeks. | Drug: Test Product 49778<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Improvement (investigator assessment) | Proportion of subjects with a response of clear or almost clear, and at least a two-grade improvement from baseline to week 4 | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Improvement (subject assessment) | Assess the change in the pruritus score from baseline to week 2 and to week 4. | Weeks 2 and 4 |
Observational, Long-term Extension Study for Participants of Prior VY-AADC01 Studies

Study Overview
=================
Brief Summary
-----------------
An extension study for participants who have completed a prior VY-AADC01 clinical study

Official Title
-----------------
An Observational, Long-Term Extension Study for Participants in Prior VY-AADC01 Clinical Studies

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: 1. Completed participation in the PD-1101 or PD-1102 clinical study of VY-AADC01 gene therapy Key Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants from VY-AADC01 clinical studies:<br>Participants who have completed participation in VY-AADC01 clinical studies (PD-1101 or PD-1102) will be invited to participate in this extension study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Long-term safety of VY-AADC01 as measured by Adverse Events and Serious Adverse Events | Up to 8 years from VY-AADC01 administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AADC enzyme activity | Continued expression of AADC as measured by [18F]-fluorodopa (F-Dopa) positron emission tomography (PET) | Up to 8 years from VY-AADC01 administration | 
| Changes in PD medications | Change from baseline in PD medications, measured as levodopa equivalent dose | Up to 8 years from VY-AADC01 administration | 
| Changes in motor function as assessed by Unified Parkinson's Disease Rating Scale (UPDRS) | Changes from baseline in motor function as assessed by UPDRS, in both Off and On medication states | Up to 8 years from VY-AADC01 administration | 
| Changes in Off and On time as recorded by the participant in Parkinson's Disease (PD) diary | Changes from baseline based on the PD Diary: OFF time; ON time without troublesome dyskinesia; ON time without dyskinesia; ON time with troublesome dyskinesia; and ON time with non-troublesome dyskinesia | Up to 8 years from VY-AADC01 administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's Disease (PD), Gene Therapy, Motor Fluctuations, Neurosurgery, NBIb-1817, Aromatic L-Amino Acid Decarboxylase, Levodopa, Dopamine, AADC, DDC, AAV2-hAADC, AAV, VY-AADC
Bipolar Disorder in Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out how often major mood swings occur in patients treated in a specialty epilepsy center.

Detailed Description
-----------------
Bipolar disorder (a condition of major mood swings) or milder forms of ups and downs in mood may occur with a number to neurological conditions. Recently, one study showed that these mood changes occur fairly often in individuals with epilepsy studied in the general community. We speculate that bipolar symptoms occur with even higher frequency in a tertiary epilepsy center than that encountered in the previous community-based study. The goals of this study are to assess: the rate of bipolar symptoms as measured by a self-reporting screening tool in a tertiary epilepsy center setting the meaning of a positive screening score in epilepsy patients the utility, sensitivity and specificity of alternative screening tools for mood instability in epilepsy patients the correlation of mood instability with seizure-related variables the relation of a positive screening score on quality of life.

Official Title
-----------------
Bipolar Disorder in Epilepsy

Conditions
-----------------
Epilepsy, Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years of age or older Being evaluated at the Long Island Jewish Comprehensive Epilepsy Center Capable of completing self-reporting questionnaires Exclusion Criteria: Patients with mental retardation Patients with pseudoseizures

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
-----------------
Epilepsy, Bipolar Disorder
Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)

Study Overview
=================
Brief Summary
-----------------
Case series of a retrospective study of patients operated for distal adenocarcinoma of the stomach, either by total gastrectomy or distal gastrectomy at Ibn Rochd University Hospital in Casablanca, with the analysis of outcome of patients on a follow up periode of three years and eight months.

Detailed Description
-----------------
Thirty (30) patients were treated for gastric cancer and were included in this study. The average age was 64 years, the sex ratio 1.5. Twenty eight patients underwent a distal gastrectomy and 2 patients underwent total gastrectomy. The median number of lymph nodes resected was 6 following distal gastrectomy versus 26 after total gastrectomy. Resection margins were clean except for three patients who underwent a distal gastrectomy. Postoperative complicationsoccured in 05 patients. They were mainly infectious, anastomotic leakage. Two 2 cases of postoperative mortality (<30 days) among patients with distal gastrectomy was noted. A progression to metastasis was found in 3 patients with subtotal gastrectomy, two of whom had insufficient lymph node clearance, compared to no cases of metastasis in patients with total gastrectomy.

Official Title
-----------------
Evaluation of the Efficacy of Distal Gastrectomy for the Treatment of Gastric Cancer (a Case Series)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients bwith gastric cancer with histologic confirmation Exclusion Criteria: Incomplete patients records

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| Number of patients who died for gastric cancer after distal gastrectomy | Mortality rate for patients who underwent distal gastrectomy for gastric cancer | Fourty four months | 
| Number of patients who developped morbidity after subgastrectmy for gastric cancer | Mortality rate for patients who underwent distal gastrectomy for gastric cancer | Forty for months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric cancer, gastric adenocarcinoma, total gastrectomy, subtotal gastrectomy, distal gastrectomy.
Auscultate Obese Patients Using Electronic and Traditional Stethoscopes

Study Overview
=================
Brief Summary
-----------------
Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more effective in identifying referrable murmurs than using a traditional stethoscope.

Detailed Description
-----------------
Study will enroll subjects who have greater than 30 BMI ratings. Each subject will receive 4 auscultation examinations. Two auscultations will be done by a cardiologist using both an acoustic traditional stethoscope and an electronic stethoscope. Two additional auscultations will be done by a 3rd year medical resident also using both an acoustic traditional stethoscope and an electronic stethoscope. All determinations will be compared to echocardiography results.

Official Title
-----------------
Study EM-05-012530 Benefit of Auscultation With 3M™ Littmann® 3200 Electronic Stethoscope to Diagnose Murmurs and Heart Pathologies in Overweight and Obese Patients With Increased Layers of Adipose Tissue

Conditions
-----------------
Chest Pathology

Intervention / Treatment
-----------------
* Device: Auscultate with electronic or mechanical stethoscope (3M Littmann)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater or equal than 18 years of age Referred for an echocardiogram obese, as defined as having a BMI greater than 30 volunteers to participate in study agrees to provide copy of echocardiogram exam report Exclusion Criteria: -Investigator believes subject should not be included or is unsuitable for inclusion

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 |
| --- | --- |
| Auscultate with mechanical stethoscope<br>Cardiologist & Medical Resident auscultate using mechanical stethoscope | Device: Auscultate with electronic or mechanical stethoscope (3M Littmann)<br> <br> * Other names: 3M Littman Cardiology III Mechanical Stethoscope;|
| Auscultate with electronic stethoscope<br>Cardiologist & Medical Resident auscultate using electronic stethoscope | Device: Auscultate with electronic or mechanical stethoscope (3M Littmann)<br> <br> * Other names: 3M Littman Cardiology III Mechanical Stethoscope;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Most severe cardiac lesion identified by auscultation & echocardiography |  | 0-4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary cardiac lesion identified by auscultation & echocardiography |  | 0 - 4 days | 
| Other heart sounds identified by auscultation & echocardiography |  | 0 - 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chest, pathology
Cancersensor Metastasis Resection

Study Overview
=================
Brief Summary
-----------------
Observational, non randomized study aimed at measuring the effect of surgical resection of metastasis in the urinary concentrations of physiological modified nucleosides in 45 patients with metastatic colorectal cancer.

Official Title
-----------------
Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring, of Cancer Therapy: Impact of Surgical Resection of Metastasis on Urinary Excretion of Modified Nucleosides.

Conditions
-----------------
Metastatic Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically-confirmed metastatic colorectal cancer; 0 to 3 prior chemotherapy lines; Signed informed consent; Good understanding of the protocol and of the follow-up; Estimated life expectancy exceeding 3 months; At least one measurable metastatic lesion (RECIST criteria); Performance Status (WHO) of 0 to 2; Good haematological, hepatic and renal functions. Exclusion Criteria: Poor haematological, hepatic or renal functions; Uncontrolled chronic disease; Serious unhealed wound, ulcer or fracture within the previous month; Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion; Pregnancy or breast-feeding during the previous month; Transmeridian trip of more than 4 time zones within the prior 2 weeks; Person with legal restriction to participate into clinical research, according to the current law in France.

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 |
| --- | --- |
| Patients<br>Patients with metastatic colorectal cancer scheduled for metastatic surgery | |
| Control patients<br>Patients with metastatic colorectal cancer scheduled for general anesthesia without metastatic surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of resection of metastasis on urinary excretion of modified nucleosides | 1 Urine sample per day 3 before and 7 after surgery Measurement of modified nucleoside concentration | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of modified nucleosides as biomarkers for colorectal cancer | Measurement of modified nucleosides in urine samples before and after metastatic resection | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, General anesthesia, Scheduled for surgery, Colorectal, Cancer, Metastatic, Control, Urine, Nucleosides
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets under non-fasting conditions.

Official Title
-----------------
A Relative Bioavailability Study of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Drug: Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)
* Drug: Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)
* Drug: Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)


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: 18 Years
Maximum Age: 40 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical) | Drug: Diclofenac Sodium 75 mg Tablets Under Fasting Conditions (Geneva Pharmaceutical)<br> <br> |
| Experimental: 2<br>Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical) | Drug: Diclofenac Sodium 75 mg Tablets Under Fed Conditions (Geneva Pharmaceutical)<br> <br> |
| Active Comparator: 3<br>Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals) | Drug: Voltaren 75 mg Tablets Under Fed Conditions (Geigy Pharmaceuticals)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 32 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anti-Inflammatory
Community Diabetes Education Program Evaluation Code Evaluation

Study Overview
=================
Brief Summary
-----------------
The study is intended to determine the effectiveness and efficiency of a community diabetes education program administered by a community health worker in a low-cost community clinic. We expect an improvement in overall glycemic control in the experimental group of at least 20%. We also expect to document improvement in diabetes self-management skills, quality of life and an increase in achievement of ADA standards of care4 in the experimental group.

Official Title
-----------------
Community Diabetes Education Program Evaluation

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Education for diabetes self-management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: people with no health insurance Exclusion Criteria: people with any type of health insurance coverage

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education for diabetes self-management|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, Triglycerides, Cholesterol, Urine Microalbumin, Blood Pressure, |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' attitudes and knowledge about diabetes self-management, American Diabetes Association standards of care. |  |  |
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.

Study Overview
=================
Brief Summary
-----------------
This is an observational study of people with severe cystic fibrosis that are eligible for Vertex's triple combination therapy through its expanded access. Pulmonary health, intestinal health, and the overall health of individuals will be tracked for a year to see how effective triple combination therapy is in these people with severe cystic fibrosis disease.

Official Title
-----------------
An Observational Study of the Effects on Clinical Outcomes of Expanded Access Program of Vertex Triple Combination Therapy.

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: Triple combination therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Cystic Fibrosis Ability to reproducibly perform spirometry (according to ATS criteria) Physician decision to treat with TCT through the EAP program Ability to understand and sign a written informed consent or assent and comply with the requirements of the study Exclusion Criteria: History of hypersensitivity to VX 445, VX 659, tezacaftor and/or ivacaftor Any acute lower respiratory symptoms treated with oral, inhaled or IV antibiotics or systemic corticosteroids within the 2 weeks prior to Visit 1. Major or traumatic surgery within 12 weeks prior to Visit 1. Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic saline, azithromycin, TOBI®, Cayston®) within 4 weeks prior to Visit 1. Use of an investigational agent within 28 days prior to Visit 1. History of lung or liver transplantation or listing for organ transplantation.

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| Patients with severe disease<br>Patients that are eligible to enroll in Vertex's triple combination therapy through the expanded access program. | Drug: Triple combination therapy<br>* Triple combination is compromised of the drugs ivacaftor, tezacaftor and Vertex's next generation modulator.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function | FEV1 values. | For a year post initiation of therapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CFQ-R score | cystic fibrosis questionnaire - revised has sections to measure pulmonary health and gastrointestinal health. | For a year following the initiation of triple combination therapy. |