linjc16/ctgov huggingface dataset:
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-04995274 in healthy volunteers.

Official Title
-----------------
A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: PF-04995274


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04995274<br> | Drug: PF-04995274<br>* Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure response of overall 5HT4 receptor occupancy of PF-04995274 |  | up to 3 days | 
| 5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain |  | up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | up to 3 days | 
| change from baseline in vital signs |  | up to 3 days | 
| Singlet ECG post-dose |  | up to 3 days | 
| Clinical safety laboratory endpoints |  | up to 3 days | 
| Clinical examinations |  | up to 3 days | 
| Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma |  | up to 3 days | 
| Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma |  | up to 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes

Study Overview
=================
Brief Summary
-----------------
The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will be collected through review of medical records from clinical visits with physician. The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.

Official Title
-----------------
An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results and Associated Patient Outcomes

Conditions
-----------------
Cutaneous Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data. 16 Years and older Exclusion Criteria: Less than 16 Years of age

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Adjusted surveillance regimen | Relaxed surveillance for the low risk group; Increased vigilance for early detection in the high risk group. | upon receipt DecisionDX-Melanoma results received and every 6 months thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. |  | Upon receipt DecisionDx-Melanoma results | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melanoma, cutaneous melanoma, DecisionDx-Melanoma
Evaluating Expectancy Effects in Weight Loss Measurement

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to examine potential bias or expectancies in individuals' measurement and recording of weight in a clinical-research setting.

Conditions
-----------------
Accuracy of Clinic-based Weight Measurements

Intervention / Treatment
-----------------
* Other: clinic-based weight measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19+ years-old available to attend clinic sessions on dates provided for data collection Exclusion Criteria: younger than 19 years not available on specified dates of data collection

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| weight data assessors<br>students recruited to weigh individuals in a research-based clinic | Other: clinic-based weight measurements<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of clinic-based weight measurement | Participants will be asked to weigh individuals who they have been told are completing either the treatment or control condition of a weight loss trial (individuals will actually be paid actors playing the role of a study participant). Participants will weigh individuals on calibrated balance-beam scales, and the discrepancy between weights recorded when individuals are thought to be a treatment or control participant will be calculated, which is the primary outcome for this study. | baseline |
Antihypertensive Effect of Simvastatin in Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
Few trials have investigated the hypotensive effect of the Statins. Most were not specifically aimed at this pleiotropic effect or had methodological problems. The possible hypotensive effect may explain part of the favorable results of the Statins use on cardiovascular prevention independently from its action on the cholesterol profile. The purpose of this study is to determine the effect of Simvastatin on the blood pressure

Detailed Description
-----------------
This is a randomized double blind parallel clinical trial where hypertensive patients with controlled or uncontrolled blood pressure and without evidence of target-organ damage will be selected. Subjects will receive Simvastatin 40 mg once daily or placebo and a baseline and eight weeks ABPM will performed. The main outcome will be the difference in systolic BP in the 24h-ABPM.

Official Title
-----------------
Antihypertensive Effect of Simvastatin in Hypertensive Patients: a Randomized Clinical Trial With Ambulatory Blood Pressure Monitoring

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

Intervention / Treatment
-----------------
* Drug: Simvastatin 40mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensive patients with controlled or uncontrolled blood pressure Exclusion Criteria: Secondary causes of hypertension; Systolic Blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg Complain of side effects related to Statins Diabetes Established target-organ damage (myocardial infarction, stroke, angina, heart failure, peripheral vascular disease) Renal disease (creatinine > 1,5 mgdl).

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Simvastatin 40 mg | Drug: Simvastatin 40mg<br>* Simvastatin once daily, orally in the morning period, during eigth weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo once daily, orally in the morning period, during eigth weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure measured with 24-Ambulatory Blood Pressure Monitoring (24h-ABPM) |  | Eigth weeks |
Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester.

Detailed Description
-----------------
Medical termination in the second trimester is performed for many indications. Successful termination is dependant on ripening of the cervix prior to labor induction. Multiple methods of cervical ripening and labor induction have been used for pregnancy termination in the second trimester. These two methods have different mechanisms of action. This study seeks to evaluate the effectiveness of these two methods.

Official Title
-----------------
Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester

Conditions
-----------------
Pregnancy Trimester, Second, Induced Abortion

Intervention / Treatment
-----------------
* Device: Foley bulb
* Drug: misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for pregnancy termination, gestational age from 13-27 weeks Exclusion Criteria: multiple gestation, previous uterine surgery, rupture of membranes, latex allergy

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol Drug<br>This is the misoprostol drug. | Drug: misoprostol<br> <br> |
| Experimental: The Foley Bulb<br>This is the experimental portion to test the Foley Bulb. | Device: Foley bulb<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to vaginal delivery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of chorioamnionitis |  |  | 
| Rate of maternal fever |  |  | 
| Rate of postpartum hemorrhage |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
second trimester, pregnancy termination, misoprostol, foley bulb
Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The investigators think that the two techniques of TOT (inside-out and outside-in) procedures both statistically improve the sexual functions, psychosocial state and quality of life after the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12 were statistically more increase in inside-out group than the outside-in group.

Conditions
-----------------
Quality of Life, Sexual Dysfunction

Intervention / Treatment
-----------------
* Procedure: transobturator tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pure urodynamic SUI sexual active before and 2 months after the surgery married or single aged over 20 have cured after TOT operation Exclusion Criteria: preoperative or postoperative detrusor disfunction previous history of malignancy prior vaginal surgery a partner with sexual incapabilities a concomitant gynecologic disorder patients with pelvic organ prolapse over stage II pelvic radiotherapy and a history of psychological diseases participants who had no sexual activity with in the past two months

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: inside-outside group<br>inside-out transobturator tape approach | Procedure: transobturator tape<br> <br> |
| Active Comparator: outside-inside group<br>outside-in transobturator tape approach | Procedure: transobturator tape<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative differences at emotional-behavioral PISQ-12 score |  | 1 year | 
| postoperative differences at physical PISQ-12 score |  | 1 year |
Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in treating inflammatory bowel diseases. Yet some patients develop severe side effects or initial invalid to conventional therapies. Some studies have already showed that tarcolimus and methotrexate are both effective in inducing and maintaining disease remission. Here we conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in treating refractory inflammatory bowel diseases as rescue therapy.

Official Title
-----------------
Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease: an Open-label, Retrospective Study

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents Exclusion Criteria: Pregnant woman

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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 |
| --- | --- |
| tarcolimus<br>refractory inflammatory bowel disease patents who used tarcolimus to induce and maintain remission | |
| methotrexate<br>refractory inflammatory bowel disease patents who used methotrexate to induce and maintain remission | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease activity assessment after one year treatment | Disease activity is assessed through blood test, radiology and clinical for both Crohn's disease and ulverative colitis. We evaluate clinical response based on Crohn's disease activity index (CDAI) for CD and Mayo score for UC at the end of one year observation. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events. | The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | one year |
Effects of Different Exercise Training Dose on Exercise Performance and Noninvasively Estimated Muscle Oxygen Extraction in Diabetic Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is specifically to investigate (1) the exercising muscle oxygenation response in diabetic postmenopausal women; (2) the dose-response of different physical activity interventions on skeletal muscle oxygenation response; (3) the related mechanisms of training effects.

Official Title
-----------------
Effects of Different Exercise Training Dose on Exercise Performance and Noninvasively Estimated Muscle Oxygen Extraction in Diabetic Postmenopausal Women

Conditions
-----------------
Postmenopausal Diabetes

Intervention / Treatment
-----------------
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sedentary postmenopausal women Ages 45 to 70 years old Exclusion Criteria: Known cardio-respiratory disease Diabetic complication Excessive weight change during last year Cancer and mental disorders

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>moderate exercise training (three times/ week including one home-based training and two supervised training) | Other: exercise<br>* exercise training<br>|
| Experimental: 2<br>intensive exercise training (four times/ week including one home-based training and three supervised training) | Other: exercise<br>* exercise training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skeletal muscle oxygenation response |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopausal women, Diabetes, Skin microcirculation, Exercise capacity, Skeletal muscle oxygenation, Dose-response relationship, postmenopausal diabetic women
Staff Management About Food Allergy Into ResTaurants

Study Overview
=================
Brief Summary
-----------------
Assessment of the knowledge levels of restaurant personnel about food allergies. A structured questionnaire was given through a telephonic interview to evaluate the responses of the respondents.

Detailed Description
-----------------
Food allergy is a common disease affecting children and adults in Europe. It's a burden for patients, with an important impact on quality of life. Dining in restaurants may be dangerous for allergic consumers. Currently in France, little training on food allergies is included in the generic food hygiene training that is compulsory for only a minimum of one member of the staff of a restaurant.

Official Title
-----------------
Staff Management About Food Allergy Into ResTaurants in Metz and Strasbourg

Conditions
-----------------
Food Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Etablished in Metz or Strasbourg Restaurant staff member Exclusion Criteria: -
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 |
| --- | --- | --- |
| knowledge about food allergy | questionnaire | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food Allergy, Restaurant staff
Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome

Study Overview
=================
Brief Summary
-----------------
A case of a patient with cystic fibrosis with bowel obstruction due to a proximal intestinal obstruction syndrome (PIOS) is presented.This syndrome can be diagnosed with the DIOS definition, with the only distinction of a more proximal location in the gastrointestinal tract, such as the stomach, the duodenum, or the jejunum.

Detailed Description
-----------------
Distal Intestinal Obstruction Syndrome is a rare complication in cystic fibrosis patients characterized by the accumulation of viscid fecal material, combined with sticky mucous secretions located in the distal ileum, adhered to the intestinal wall. Only few cases have been reported in the literature.

Official Title
-----------------
Proximal Intestinal Obstruction Syndrome (PIOS) in a Patient With Cystic Fibrosis: A New Syndrome

Conditions
-----------------
Cystic Fibrosis, Bowel Obstruction, Distal Intestinal Obstruction Syndrome

Intervention / Treatment
-----------------
* Other: Diagnostic laparoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult >18 years Cystic fibrosis Bowel obstruction Exclusion Criteria: Pediatric patient <18 years Unknown cause of bowel obstruction
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Diagnostic laparoscopy|A diagnostic laparoscopy was performed where a dilated jejunum was encountered with impaction of fecal content. Surgery was converted to open surgery, where a longitudinal enterotomy of 5 cm after the transition zone was created, evacuating manually the fecal material with mucous secretion.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel obstruction in a patient with cystic fibrosis | A 45 year old patient with cystic fibrosis presented with bowel obstruction. Image studies were performed, without identifying a specific cause of the bowel obstruction. The patient was transferred to surgery. | 3-6 days |