linjc16/ctgov huggingface dataset:
Study of Varencline Effects on Cigarette Smoking Reward and Craving During a Model of Brief Quit Attempt

Study Overview
=================
Brief Summary
-----------------
Study of varenicline 2.0 mg/day treatment for 2 weeks with smoking test done in laboratory on Day 8 and a 1 week quit attempt from Day 8-14.

Official Title
-----------------
Placebo-controlled Study of Varenicline Effects on Nicotine Withdrawal Followed by a Test of Smoking Topography, Reward, and Reinforcement

Conditions
-----------------
Nicotine Dependence

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 10 cigarettes/day Interest in quitting smoking Willgness to comply with overnight smoking abbstiennce period followed by lab smoking test Exclusion Criteria: Pregnancy Axis I psychiatric disorder which require treatment with psychoactive medication and would make study compliance difficult. Clinically significant medical condition in opinion of study clinician Drug or alcohol dependence inlast 12 months Use of other smoking cessation medications ot treatment progams in last 2 months

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Varenicline | Drug: varencline<br>* 2.0 mg/day varencline (1.0 mg BID)<br>* Other names: Chantix;|
| Placebo Comparator: 2<br>placebo | Drug: placebo<br>* matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking reward |  | laboratory test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 week abstinence induced craving and reward |  | Day 8, 9, 11 and 14 questionaires | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cigarette, craving, reward
Prevalence of Gastroesophageal Reflux Disease in Primary Care Patients With Upper Gastrointestinal Symptoms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide data on the gastroesophageal reflux disease (GERD) prevalence as percentage of patients with upper gastrointestinal (GI) symptoms that are identified with GERD using the Gerd-Q Questionnaire.

Official Title
-----------------
A Cross-sectional Study on the Prevalence of GERD in Primary Care Patients With Upper GI Symptoms Using the GERD-Q. The Bulgarian GERD-Q Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with upper gastrointestinal symptoms Exclusion Criteria: History of oesophageal, gastric or duodenal surgery Current treatment with antiinflammatory drugs, including OTC Current treatment with proton pump inhibitors ang H2-blockers

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
-----------------
GERD diagnosis, GERD-Q, GERD patients' characteristics, GERD
Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.

Detailed Description
-----------------
This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep diary.

Official Title
-----------------
A Prospective Randomized, Placebo-Controlled Double-Blind Study to Determine the Efficacy of Ramelteon in REM Sleep Behavior Disorder

Conditions
-----------------
REM Sleep Behavior Disorder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets criteria for RBD as determined by screening PSG's steady bed partner for completion of RBD questionnaire Exclusion Criteria: Hepatic impairment RBD associated with narcolepsy use of fluvoxamine, rifampin, fluconazole or ketoconazole current alcohol or drug abuse

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo control nightly | Drug: placebo<br>* placebo control i pill nightly for 30 nights<br>|
| Active Comparator: 2<br>8 mg ramelteon nightly | Drug: ramelteon<br>* 8 mg nightly for 30 nights<br>* Other names: rozerem;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in polysomnographic scores |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in RBD symptom questionnaire and sleep diary |  | 30 days |
Multiple-Ascending Dose Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of BMS-820836 after multiple doses

Official Title
-----------------
Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-820836 in Healthy Subjects

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: BMS-820836
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Panels 1-6: Healthy Male Subjects Panel 7: Females Ages 21 to 55, inclusive Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Exclusion Criteria: Any major surgery within 4 weeks of study drug administration History of cholecystectomy History of glaucoma or a confirmed intraocular pressure indicative of glaucoma at screening. (Normal IOP <21 mmHg) Confirmed QTc (Fridericia) value ≥ 450 msec Confirmed QT ≥ 500 msec Confirmed PR ≥ 210 msec Confirmed QRS ≥ 120 msec Confirmed resting supine systolic blood pressure > 140 mmHg Confirmed resting supine diastolic blood pressure > 90 mmHg Confirmed resting heart rate < 45 bpm or > 100 bpm Orthostatic vital sign changes (ie., a decrease in systolic blood pressure from supine to standing > 40 mmHg and an increase in heart rate from supine to standing > 20 bpm) or symptoms of orthostasis History of peppermint allergies Exposure to any investigational drug or placebo within 12 weeks of study drug administration

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panels 1 to 7 (BMS-820836 or Placebo)<br> | Drug: BMS-820836<br>* Oral Solution, Oral, 0.1 mg to 4 mg, Once daily, 14 days<br>Drug: Placebo<br>* Oral Solution, Oral, 0 mg, Once daily, 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of BMS-820836 following multiple-dose administration |  | Within 27 days (+/- 2 days) of first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacodynamics of BMS-820836 |  | Within 27 days of first dose |
The Effects of Vibration on Hypoxia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is: To study the effect of whole-body vibration on partial pressure of oxygen in arterial blood (PaO2), under hypobaric hypoxic conditions. To study the effects of whole-body vibration and hypobaric hypoxia on visual contrast sensitivity. To se if there is an increase in cytokines and other biomarkers under different hypobaric hypoxic conditions Our main hypothesis is that whole-body vibration may cause PaO2 to drop to a lower level, at a given altitude; than would be the case if there were no vibration present.

Official Title
-----------------
The Effects of Vibration on Hypoxia

Conditions
-----------------
Hypoxia

Intervention / Treatment
-----------------
* Other: Vibration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exclusion Criteria: Stay at altitude over 2000 m last two weeks prior to study-start. Severe head injury Cardiovascular disease lung disease Decompression sickness
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Vibration|Whole-body vibration, 17 Hz, 1.1ms-2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2 | Assessed at six different altitudes | 14 minutes | 
| PaO2 | Assessed at six dfferent altitudes | 35 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilation | Assessed at six different altitudes, over a period of three minutes. | 14 minutes | 
| Ventilation | Assessed over a periode of three minutes, at six different altitudes. | 35 minutes |
Partial Modified Blair Incision on Benign Tumor Parotidectomy Scar's Characteristics

Study Overview
=================
Brief Summary
-----------------
Parotidectomy is the treatment of choice for tumors in the parotid gland, with the modified Blair is the most common incision used. In our medical center, the incision is tailored to the size and location of the specific parotid tumor. This retrospective analysis aims to determine the incidence of complications and to assess the relation between the mass and scar characteristics in patients who had undergone parotidectomy.

Detailed Description
-----------------
The scar characteristics of patient who had undergone parotidectomy for benign neoplasms at our medical center between 2013 and 2019 will be evaluated. Patients will complete a questionnaire regarding the occurrence of complications.

Official Title
-----------------
Effect of Parotid Mass Location on Benign Tumor Parotidectomy Scar's Characteristics

Conditions
-----------------
Salivary Gland Tumor

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 years during the surgery Clinical diagnosis of a benign parotid pathology Exclusion Criteria: A malignant pathology of the parotid gland Unavailable data

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 |
| --- |
|Other: Questionnaire|QoL questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events as assessed by a questionnaire. | The Warmald Parotidectomy Complications Questionnaire consists of five items, each addressing a complication common to parotidectomy: numbness of the ear on the operated side, Frey's syndrome, facial depression or deformity, noticeable scar, and pain or discomfort in the scar. Subjects are asked to indicate the extent to which they were disturbed by each of these complications on a scale ranging from 1 (never) to 10 (always). | 1 Year |
Biomarkers Study in Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
Study Design: Patients are eligible if (1) enrolled to TCOG 3207(2) received surgery or biopsy for pancreatic cancer; (3) willing to sign informed consent. The pancreatic tumor, tissue specimen and blood sample before or after treatment will be collected from department of pathology, surgery or diagnostic medicine.

Detailed Description
-----------------
We expect to collect tissue samples from 270 pancreatic cancer patients of any stages. Since the enrollment criteria are not limited to new patients, we expect to enroll 67 patients a year. The patient enrollment will be completed in 4 years. Clinical follow-up will be completed in another one year. Data analysis and correlation study may be finished in the end of 5th year of this study.

Official Title
-----------------
Biomarkers Study in Pancreatic Cancer

Conditions
-----------------
Biomarkers Study in Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled to TCOG 3207 study: A Randomized Phase III Study of Adjuvant Gemcitabine versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection. Patients who were not eligible for TCOG 3207 study but received surgery or biopsy for pancreatic cancer. Patients have to sign informed consent for tissue specimen collection, according to the regulation of DOH.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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
-----------------
Biomarkers study
Supernormal Oxygen Delivery for Patients With Severe Burns

Study Overview
=================
Brief Summary
-----------------
This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the goal-directed fluid therapy group to further evaluate significant differences in rate of complications during burn surgery.

Detailed Description
-----------------
This is a randomized double-blinded study to investigate the effect of control group and the goal-directed fluid therapy group on complications during surgery of the burn patients. The groups are designated as the control group and the oal-directed fluid therapy group to further evaluate significant differences in complications during the surgery.

Official Title
-----------------
Supernormal Oxygen Delivery for Patients With Severe Burns：A Randomized Controlled Trial

Conditions
-----------------
Burn Surgery, Dobutamine

Intervention / Treatment
-----------------
* Drug: Dobutamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe burn patients Exclusion Criteria: Patients or families refuse to sign consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution. | |
| Experimental: Goal-directed fluid group<br>Intervention: administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia. Intraoperative fluid management: administration of 2-4 ml/kg/hr of crystalloid solution. | Drug: Dobutamine<br>* administration of dobutamine 0.01 - 0.04 U/min after induction of anesthesia to maintain oxygen delivery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | perioperative complications | One week after operation |
Interindividual Variation in Excretion of Curcumin

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to elucidate the interindividual variations in excretion of curcumin and its metabolites.

Official Title
-----------------
University of Massachusetts Amherst

Conditions
-----------------
Metabolites, Gut Microbiota

Intervention / Treatment
-----------------
* Dietary Supplement: curcumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-30 year old healthy adults Exclusion Criteria: Exclusion criteria included those who are <18 or >30 years old, have a BMI of <20 or >29 kg/m2, have a weight change >4.5 kg in the past 3 months, exceed exercise activities of a curcumin level over the past 3 months, have any diseases, especially intestinal disorders, had abnormal liver or kidney function tests. Those who smoke, consume more than two alcoholic drinks per day, use medication affecting gut microbiota profile (e.g., antibiotics and probiotics) in past three months will also be excluded. Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br>subjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal). | Dietary Supplement: curcumin<br>* subjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the concentration of curcumin and its metabolites in the human fecal samples. | Utilize LC-MSMS to identify and quantify the curcumin and its metabolites in the subjects fecal samples. | 3-4 weeks |
Pulse Analysis for Cholecystitis Patients Before and After Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to record the radial pressure pulse(RPP) of the patients with cholecystitis compared preoperative and postoperative pulse changes in an attempt to determine the relationship between cholecystitis and pulse.

Detailed Description
-----------------
A total of 20 patients were recruited according to the inclusion and exclusion criteria. The patients, aged 32-76 years, were given a diagnosis of cholecystitis by a general surgeon from Taiwan's Taichung Tzu Chi Hospital. All eligible patients included in the study agreed to participated and signed the informed consent form and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC110-12). By measuring and recording the RPP preoperatively and postoperatively, the mean values of the spectral energy (SE0-10 Hz, SE10-50 Hz, and SE13-50 Hz) were obtained for comparison with the preoperative white blood cell (WBC) count.

Official Title
-----------------
Pulse Analysis for Cholecystitis Patients Before and After Cholecystectomy

Conditions
-----------------
Cholecystitis, Cholecystectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with acute or chronic cholecystitis Patient hospitalized for cholecystectomy Patients who were voluntarily involved in this study Exclusion Criteria: Patients who could not cooperate with pulse diagnosis Patients with underlying systemic diseases such as cancer, chronic obstructive pulmonary disease, cardiac failure, chronic renal failure, cirrhosis, etc.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| The changes of spectral energy of radial artery pulse after cholecystectomy | The spectral energy of radial artery pulse was measured before and after cholecystectomy to compare the difference | Baseline (before cholecystectomy) and 24 -48 hours after cholecystectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radial pressure pulse (RPP)