linjc16/ctgov huggingface dataset:
Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if regular and daily repeated application of the ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.

Official Title
-----------------
Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.

Conditions
-----------------
Vulvar Cancer

Intervention / Treatment
-----------------
* Drug: Ciclopirox


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between the ages 18 and 75 years. Patients may be carriers of the Human Immunodeficiency Virus (HIV). Patients must have been diagnosed with precancerous lesion(s) of the vulva by tissue sampling (biopsy-proven vulvar intraepithelial neoplasia grade II or III) Patients must be able to come to University Hospital for their initial appointment in Gynecologic Oncology Clinic, and for the eight follow-up visits in that Clinic required by the protocol. Exclusion Criteria: Pregnant or patients who are breast feeding a baby. Patients who have been diagnosed with a vaginal yeast infection. Patients who have undergone prior surgery for precancerous lesion(s) of the vulva.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

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

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vulva
Pharmacokinetics of Dexmedetomidine in Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective, potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects. The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of the drug in these people is still unknown.This research was designed to study the pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.

Detailed Description
-----------------
For the obese are sensitive to the disease such as hypertension, ischaemic heart disease and diabetes, the changes of the state may affect the pharmacokinetics of dexmedetomidine. Besides,the clearance of dexmedetomidine is parallel with liver function and it is excreted by kidney, so differences in the obese may be expected. About 10 obese patients and 10 matched healthy volunteers with normal weight would be chosen to receive a normal dosage of dexmedetomidine. And venous samples will be collected in different time points. Next the investigators can get the plasma concentration of dexmedetomidine by the use of HPLC-MS. And then the plasma concentration could be analyzed.

Official Title
-----------------
A Study of the Pharmacokinetics of Dexmedetomidine in Morbid Obesity.

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

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight:28≦BMI≦45 and 18.5≦BMI≦24 Written informed consent from the patient or the relatives of the participating patient. Exclusion Criteria: A previous history of intolerance to the study drug or related compounds and additives. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Each team will be administered for 1μg/kg of dexmedetomidine eace one. | Drug: Dexmedetomidine<br>* The volunteers would receive a dosage of dexmedetomidine by 1μg/kg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Concentration of dexmedetomidine |  | 0, 5, 10, 15, 20, 25, 30, 45 , 60, 90, 120, 150,180,240,360,480 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Dexmedetomidine, Obesity
A Study Of 6-Month Duration To Evaluate The Weight Loss Effect Of Various Doses Of CP-945,598 In Obese Subjects

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of 6-month administration of CP-945,598 on: weight loss and waist circumference, blood pressure, cholesterol, glucose other biochemical variables like insulin, leptin, ghrelin, adiponectin, PAI 1, TNF-Î± and hsCRP the relationship between the concentration of the drug on the blood and the above parameters physical and psychosocial functioning, weight related symptoms, treatment satisfaction, appetite/hunger/satiety/craving and mood, anxiety, anhedonia and depression

Official Title
-----------------
A 6-Month, Randomized, Double-Blind, Placebo And Positive-Controlled Phase 2b Study To Evaluate The Effect Of Various Doses Of CP-945,598 On Weight Loss In Obese Subjects

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

Intervention / Treatment
-----------------
* Drug: CP-945,598
* Drug: sibutramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and/or female subjects without clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12 lead ECG and clinical laboratory tests Body Mass Index (BMI) Â³30 and <40 kg/m2, for subjects with no additional co morbidities; BMI Â³27 kg/m2 and <40 kg/m2, for subjects with co morbidities [history of essential hypertension and/or dyslipidemia defined as high LDL (Â³160 mg/dL) or high total cholesterol (Â³240 mg/dL)]; Exclusion Criteria: Subjects with resting sitting systolic blood pressure of 140 mmHg or greater or diastolic blood pressure of 90 mmHg or greater. Subjects with type 2 diabetes or fasting blood glucose concentration Â³126 mg/dL; Subjects with a history of eating disorders like anorexia nervosa or bulimia nervosa Subjects on prescription and non-prescription appetite or weight modifying drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 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: CP-945,598|nan|
|Drug: sibutramine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effect of various doses of CP 945,598 on body weight in obese subjects after 24 weeks of dosing |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of CP 945,598 in a 26 week outpatient setting;; -Explore the effect of CP 945,598 on: waist circumference, PD measurements of selected biochemical variables related to energy deficit and weight loss includ |  |  |
Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers

Study Overview
=================
Brief Summary
-----------------
This study is examining the effectiveness of Al-Anon Intensive Referral (AIR) with Concerned Others (COs) of individuals in treatment for alcohol use disorders (drinkers). AIR's goal is to facilitate Al-Anon participation and positive outcomes among COs.

Detailed Description
-----------------
In a randomized controlled trial, this 4-year project is evaluating AIR's effectiveness for COs. COs and their drinkers are assessed at baseline and 3-month, 6-month, and 1-year follow-ups. Hypotheses are that, compared to usual care, AIR will increase Al-Anon participation and improve CO outcomes. We will examine hypotheses using generalized mixed-effects regression models (GLMM). This project is built on the foundation that it is essential to help COs because of their own suffering.

Official Title
-----------------
Intensive Referral to Al-Anon: Benefits to Concerned Others and Their Drinkers

Conditions
-----------------
Alcohol Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Al-Anon Intensive Referral (AIR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the drinker is an adult (≥19 years old) entering a treatment episode for the primary substance of alcohol; the drinker signs a release for researchers to contact a CO (also an adult) he or she identifies as a family member or close friend who has had contact with the drinker on at least 12 (40%) of the past 30 days; and the drinker and CO can communicate in English. - Exclusion Criteria: the drinker is <19 years old, not entering a treatment episode for alcohol use disorder; the drinker does not sign a release for researchers to contact a CO; the drinker and CO cannot communicate in English. -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Behavioral: Al-Anon Intensive Referral (AIR)<br>* AIR is intended to facilitate Al-Anon participation.<br>|
| No Intervention: Usual care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health | Items are rated on a 5-point scale (0=never, 4=very often). Mental Health is the mean of 10 items (e.g., How often have you experienced feeling hopeful); negative symptoms (e.g., anxious) are reverse scored. | The outcome measure will be assessed up to 1 year follow-up. |
Carcinologic Speech Severity Index

Study Overview
=================
Brief Summary
-----------------
The hypothesis of the present study is that an automatic assessment technic can measure the impact of the speech disorders on the communication abilities giving a severity index of speech in patients treated for head and neck and particularly for oral and pharyngeal cancer.

Official Title
-----------------
A Speech Disorders Severity Index to Measure the Impact of Oral and Pharyngeal Cavity on Speech Production

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Procedure: automatic speech processing tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Oral and Pharyngeal cancer T2 to T4 for having a wide dynamic of deficit Treatment by surgery and/or radiotherapy and/or chemotherapy Delay after the end of the treatment of minimum 6 months. Exclusion Criteria: Patients with a previous speech disorders (ie stuttering… ) Patients not able to perform the whole task

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

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: speech intelligibility<br>speech intelligibility is registered by an automatic speech processing tool | Procedure: automatic speech processing tool<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carcinologic speech severity index | The main objective is to demonstrate that the carcinologic speech severity index (C2SI), obtained by an automatic speech processing tool, produces equivalent or superior outcomes than a score of speech intelligibility obtained by human listeners, in terms of quality of life foreseeing the speech handicap, after the treatment of oral and/or pharyngeal cancer. | day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
linguistic, quality of life
Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Proton-Pump Inhibitors (PPI) Treatment

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(using GerdQ questionnaire). The secondary objectives are: to measure the response at the current treatment after a 4-week period of systematic treatment and to identify the percentage of patients which require alterations of their treatment (GerdQ questionnaire)

Official Title
-----------------
A Prospective, Non-interventional Study to Evaluate the Change in Symptoms Scores and Treatment Response After 4 Weeks of Systematic Treatment With PPIs in GERD Patients in Primary Care Setting in Romania, Using the Validated GerdQ Questionnaire.

Conditions
-----------------
Gastroesophageal Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Patients known or newly diagnosed with GERD or patients with typical symptoms of GERD- heartburn, regurgitation (in the last case, GerdQ sum score should be ≥8, in the absence of PPI treatment) Exclusion Criteria: Any symptoms at visit 1 suggesting a need for further investigation, judged by the Investigator (alarm symptoms).The alarm symptoms suggesting complicated disease are: dysphagia, odynophagia, bleeding, weight loss without intention or anemia. Previous participation in the present study

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 |
| --- | --- | --- |
| describe the change in GerdQ sum scores, after a 4-week period of systematic treatment with PPIs(GerdQ) |  | 4 weeks(at V1 and V2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure the response at the current treatment after a 4-week period of systematic treatment with PPIs(GerdQ) |  | 4 weeks(at V1 and V2) | 
| identify the percentage of patients which require alterations of their treatment after a 4-week period of systematic treatment with PPIs(GerdQ) |  | 4 weeks(at V1 and V2) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GerdQ questionnaire
A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to determine the feasibility of demonstrating a quantifiable change from baseline in punch biopsy-induced bleeding durations and blood loss volumes in healthy subjects after receiving clopidogrel anti-platelet therapy.

Official Title
-----------------
A Pilot Study to Determine the Impact of Clopidogrel (Plavix®) on Bleeding Associated With Punch Biopsies in Healthy Volunteers

Conditions
-----------------
Haemostasis, Healthy

Intervention / Treatment
-----------------
* Drug: clopidogrel
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PT within normal laboratory range Exclusion Criteria: The receipt of any investigational drug within 1 month prior to this trial Use of anti-coagulation or anti-platelet therapy-defined as vitamin K antagonists, platelet antagonists, heparin (or low molecular weight heparin), aspirin or NSAIDs within 30 days prior to trial African-American race Weight above or equal to 160 kg Recent diagnosis of any illness that would be present concomitant to trial period

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clopidogrel<br> | Drug: clopidogrel<br>* Following a baseline punch biopsy, all subjects will then receive oral clopidogrel (Plavix®) over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy (B1) will be performed<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Following a baseline punch biopsy, all subjects will then receive oral placebo over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy will be performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding duration measured in minutes |  | From onset of bleeding till the end of the bleeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood volume reported in millilitres |  | From onset of bleeding till the end of the bleeding | 
| Adverse events, including special attention to bleeding complications |  | From day 0 to days 11-17 | 
| Change in coagulation-related parameters |  | From baseline to 15 minutes after biopsy B1 |
Awareness and Compliance Among Health Professionals of the Preoperative Fasting Period

Study Overview
=================
Brief Summary
-----------------
Preoperative fasting is mandatory for anesthetic induction. This period of fasting is probably greater due to delays in the surgical theater and changes in daily operation schedules.Investigators want to resarch between the prescribed and the actual preoperative fasting time.

Detailed Description
-----------------
Before surgery, the patients will be asked to liquid, solid fasting times.and whether information is given about the fasting period.In addition, the appropriateness of health personnel to new guidelines for preoperative fasting will be evaluated.At the end of the study, the desired duration of fasting, clinical practice and trends of health personnel will be investigated.

Official Title
-----------------
Awareness and Compliance Among Health Professionals of the Preoperative

Conditions
-----------------
Preoperative Fasting

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 1 day and 80 years Elective surgery Oral fed American Society of Anesthesiologists score of 1 or 3 Exclusion Criteria: Intensive care patient Parenteral nutrition Emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The patients' preoperative fasting period | Determination of fasting period before surgery trends of new guidelines for preoperative fasting. | one time in two months | 
| Training of health workers | Determining health personnel's application | one time in two months |
Effects of White Wine vs. Tea Intake During and an Alcoholic Digestive Following a High Fat, High Calorie Cheese Fondue Meal on Gastric Emptying and Abdominal Symptoms in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Tradition holds that the intake of different drinks with a meal has an important influence on the digestion of food and postprandial symptoms such as fullness, bloating and satiety; however this assumption have never been subjected to controlled study A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry schnapps (Kirsch) are often attributed either positive or negative effects on the gastrointestinal tract. In this study the effect of white wine vs. tea intake during and an alcoholic digestive following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral perception will be investigated using a randomized, controlled study design. The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric emptying by breath-test.

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Dietary Supplement: Ingestion of white wine vs. tea during and an alco


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: • able to communicate well with the investigators and provide written consent • Body Mass Index: 19-30 kg/m2 Exclusion criteria: • physical co-morbidity requiring active treatment psychiatric (DSM IV) disorders limiting the ability to comply with study use of medications influencing upper GI motility evidence of current drug or alcohol abuse history of gastrointestinal disease or surgery except appendicectomy or hernia repair

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Ingestion of white wine vs. tea during and an alco|4 x 50ml glasses of white wine (12% alcohol) or tea will be taken according to a randomization scheme After the meal 1 x 20ml of Kirsch (40% alcohol) or tea will be taken|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of white wine vs. tea on gastric emptying |  | 4 hours |