linjc16/ctgov huggingface dataset:
Cervical Ripening: A Comparison Between Intravaginal Misoprostol Tablet and Intracervical Foley's Catheter and Subsequent Induction of Labor, Safety and Efficacy in Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria.

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.

Detailed Description
-----------------
This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.

Conditions
-----------------
Cervical Ripening and Induction of Labor

Intervention / Treatment
-----------------
* Device: Foley's Catheter
* Drug: prostaglandin E1 analogue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parturients who gave consent has low bishop score (≤5) term singleton cephalic presenting fetus intact membranes no contraindication to vaginal delivery Exclusion Criteria: those who refused consent preterm delivery vaginal infection non-cephalic presentation multiple gestation low lying placenta/previa, vaginal bleeding, previous cesarean section rupture of membranes
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group - 1 Foley's Catheter<br>will have cervical ripening with intracervical extraamniotic Foley's catheter for 24 hours | Device: Foley's Catheter<br>* intracervical extraamniotic Foley's catheter<br>|
| Active Comparator: Group - 2 Prostaglandin E1 Analogue<br>will have cervical ripening with intravaginal misoprostol inserted into the posterior fornix every six hours to a maximum of four doses (24 hours) | Drug: prostaglandin E1 analogue<br>* intravaginal misoprostol<br>* Other names: Misoprostol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop Score of 6 or more |  | 24 hours |
Continuous Delivery of Levodopa in Patients With Advanced Idiopathic Parkinsons Disease - Cost-benefit

Study Overview
=================
Brief Summary
-----------------
An open, observational health economic study to estimate marginal cost and health consequences of replacing conventional Parkinsons disease therapy with intraduodenal levodopa administered continuously

Official Title
-----------------
Continuous Delivery of Levodopa/Carbidopa (Duodopa) in Patients With Advanced Idiopathic Parkinsons Disease - a Health Economic Evaluation

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Levodopa (drug), intraduodenal administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of of idiopathic Parkinsons disease Motor fluctuations despite optimised per oral treatment Exclusion Criteria: Severe dementia, confusion, psychosis or depression Patients with contraindications against levodopa treatment
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levodopa (drug), intraduodenal administration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal cost per QALY of replacing conventional treatment with intraduodenal levodopa |  | one year | 
| Quality of life at three, six, nine and twelve months(Assessed by Nottingham Health Profile (NHP), Parkinson Disease Questionnaire (PDQ39), 15D Quality of life) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson related function at three, six, nine and twelve months(UPDRS, Hoehn and Yahr scores, Schwab and England) |  |  |
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.

Detailed Description
-----------------
This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Official Title
-----------------
Phase 2 Study of ZK-Epothilone (ZK-Epo; ZK219477) Plus Prednisone as First-line Chemotherapy in Patients With Metastatic Androgen-independent Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Sagopilone (ZK 219477) + prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have evidence of confirmed metastatic prostate cancer Serum testosterone must be less than 50 ng/mL Disease must be progressing despite anti-androgen therapy PSA level must be elevated Additional criteria determined at screening visit Exclusion Criteria: Any previous cytotoxic chemotherapy for prostate cancer Use of any investigational drug in the last 4 weeks Symptomatic brain tumors requiring radiation to the brain Active infection Additional criteria determined at screening visit

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sagopilone (ZK 219477) + prednisone<br>* Chemotherapy for hormone refractory prostate cancer; 16mg/m2 (up to 32mg/m2 max) IV on day 1 or each 21 day cycle for 6 cycles or until progression or unacceptable toxicity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA Response to treatment with ZK-Epo plus prednisone after 6 cycles |  | at least 28 days post day 21 of last cycle of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & Tolerability of ZK-Epo plus prednisone |  | until progression, unknown duration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, Metastatic androgen-independent prostate cancer
AVACEN Hand Heating on Fasting Blood Glucose

Study Overview
=================
Brief Summary
-----------------
A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on fasting blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject was tested while using each of these three devices on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 30 minutes that the device was used.

Official Title
-----------------
AVACEN Treatment Method on Fasting and Postprandial Blood Glucose

Conditions
-----------------
Hyperglycemia, Hypertension

Intervention / Treatment
-----------------
* Device: AVACEN 100
* Device: AVACEN 100 Heat Only
* Device: AVACEN Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects Exclusion Criteria: Diabetes diagnosis, diabetes medication, blood pressure medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heat and Vacuum<br>AVACEN 100 device applies heat and vacuum to hand | Device: AVACEN 100<br>* AVACEN 100 pulls a -30mmHg vacuum around hand from wrist down and applies heat (108 farenheit) to the palm and will be applied for 30 minutes<br>|
| Active Comparator: Heat Only<br>AVACEN 100 device with heat only | Device: AVACEN 100 Heat Only<br>* AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes<br>|
| Sham Comparator: Sham<br>AVACEN 100 device with neither heat nor vacuum | Device: AVACEN Sham<br>* AVACEN 100 neither heats nor pulls a vacuum to hand<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Glucose | Change in fasting blood glucose after 30 minutes of use of AVACEN device | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Change in blood pressure after 30 minutes of use of AVACEN device | 30 minutes | 
| Tympanic Temperature | Change in tympanic temperature after 30 minutes of use of AVACEN device | 30 minutes | 
| ASHRAE 7 point thermal sensation scale | Change in subjective temperature after 30 minutes of use of AVACEN device | 30 minutes |
The Predictive Scores for Gastric Cancer in Gastric Intestinal Metaplasia (GIM) Patient: a Recommendation for Thai Population

Study Overview
=================
Brief Summary
-----------------
The predictive scores for gastric cancer in gastric intestinal metaplasia(GIM) patient: a recommendation for Thai population. Objective: To evaluate major risk factors for gastric cancer in gastric intestinal metaplasia(GIM) patient in order to propose the appropriate recommendation for Thai people. Research Design: Single center, retrospective-cohort study.

Detailed Description
-----------------
Study population and Sample size at Faculty of Medicine, Chulalongkorn University The patients who were diagnosed gastric intestinal metaplasia from 1997 to 2012 and then follow up for 5 years. Estimate sample size =280 Investigational product, dosage & route of administration Questionnaire for explore the risk factors EGD with biopsy Blood sampling for gastro panel Duration of participation 5 years or until diagnose gastric cancer Statistical method: Unconditional-binary-logistic regression

Conditions
-----------------
Gastric Intestinal Metaplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients were diagnosed GIM All patients have to sign the consent form Exclusion Criteria: Previous gastric surgery including gastrectomy and bypass surgery Bleeding tendency including decompensated cirrhosis, chronic kidney disease and long-tem antiplatelets or anticoagulants HIV infection History of proton pump inhibitor use within 1 week History of antibiotic use within 4 weeks
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric intestinal metaplasia patient<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of early gastric cancer in gastric intestinal metaplasia(GIM) patient from 5 year-follow-up in Thai population | In Thailand, gastric cancer patients usually presented with advance stage and carried the dismal prognosis. GIM is a well known precancerous lesion. The appropriate follow-up period in high risk GIM patient can increase the prevalence of early gastric cancer and reduce the mortality rate of gastric cancer | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric intestinal metaplasia
Emotional and Cognitive Abilites of Schizophrenia Patients at Various Time Points

Study Overview
=================
Brief Summary
-----------------
Longitudinal investigation of cognitive, emotional and illness awareness of schizophrenia outpatients (Shalvata Mental Health Center). The study uses computerized assessment of cognitive functioning and questionnaire to assess performance of patients assessed in the past as part of a routine clinical assessment.

Official Title
-----------------
Emotional and Cognitive Abilites of Schizophrenia Patients at Various Time Points

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia diagnosis by a senior psychiatrist (according to DSM-4 criteria). Age between 18-65 (male and female). Prior cognitive assessment in the Emotional-Cognitive Research Laboratory (Shalvata Mental Health Center) Signed informed consent by participants. Exclusion Criteria: Hospitalization at the time of experiment. A history of brain-injury or other neurological condition precluding participation in the study. Guardianship. Current alcohol or drug abuse

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Schizophrenia patients who performed earlier cognitive assessment as part of routine assessment for patients in the Shalvata Mental Health Center. | |

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
-----------------
cognition, attention, memory, executive functions, illness-awareness, insight.
Diagnostic Criteria of ARDS at High Altitudes in Western China

Study Overview
=================
Brief Summary
-----------------
The severity of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation.

Detailed Description
-----------------
Will between January 2018 and December 2018 in lanzhou, and so on more than 1500 meters above sea level in qinghai region 10 intensive care patients with ARDS, respectively according to the standard in Berlin, Berlin, diagnosis of high altitude ARDS calibration standards and zhang the plateau region in western China put forward by the diagnosis of ALI/ARDS severity classification, observation group patients were ICU mortality, within 28 days, ICU mortality did not use breathing machine time, mechanical ventilation, ICU length of hospital stay, and the differences in hospitalization days.

Official Title
-----------------
Diagnostic Criteria of ARDS at High Altitudes in Western China

Conditions
-----------------
ARDS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 the primary disease of ARDS caused by systemic infection, shock, severe pneumonia, aspiration and trauma blood gas analysis showed a progressive decline in pulmonary ventilation function PEEP≥5cmH2O Exclusion criteria Receive a large amount of hormone shock therapy in a short period of time Died within a short time (< 24h) after mechanical ventilation Lack of data No chest imaging 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild ARDS<br>Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure | |
| Moderate ARDS<br>Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure | |
| Severe ARDS<br>Oxygenation standards were calculated based on the Berlin diagnostic high element correction formula combined with local atmospheric pressure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality | mortality during treatment in ICU | up to 24 weeks | 
| 28 days mortality | mortality at 28 days of hospitalization | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator Free time | No ventilator use time in ICU | up to 24 weeks | 
| Ventilator time | Ventilator time in ICU | up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ARDS, Definitions, high-altitude
Cooling Vest in Men With Hot Flashes

Study Overview
=================
Brief Summary
-----------------
This study is intended to determine the efficacy of the Cooling Vest in reducing the frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy treatment for prostate cancer.

Detailed Description
-----------------
The Cooling Vest is a vest manufactured by Nanohealth, Inc. It is a cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly. This study attempts to collect data on the effects of the Cooling Vest in men with hot flashes and night sweats due to the side effects of chemotherapy. Participants will use the vest for 4 weeks and questionnaires will be used to determine effect.

Official Title
-----------------
Investigation of a Cooling Vest in Men With Chemotherapy-Induced Hot Flashes

Conditions
-----------------
Hot Flashes

Intervention / Treatment
-----------------
* Device: Cooling Vest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, who are at least 18 years old. Self-reports having at least two (2) daily hot flashes associated with prostate cancer chemotherapy-induced hot flashes and night sweats. Exclusion Criteria: Has another existing medical condition that would prevent study compliance.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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

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: Cooling Vest<br>During the four-week Treatment Period, participants should use the Cooling Vest two times per day (once in the morning for one hour and once in the evening for one hour.) | Device: Cooling Vest<br>* A cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in number of daily hot flashes | diary will be used to record the number of daily hot flashes | 4 weeks | 
| change in the intensity of daily hot flashes | diary will be used to record the severity of daily hot flashes | 4 weeks |