linjc16/ctgov huggingface dataset:
B6 Treatment for Nausea and Vomiting in Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine vitamin B6 concentration and whether vitamin B6 is effective in nausea and vomiting of pregnancy.

Official Title
-----------------
Vitamin B6 Concentration and Treatment in Nausea and Vomiting of Pregnancy

Conditions
-----------------
Nausea and Vomiting Complain in Early Pregnancy

Intervention / Treatment
-----------------
* Drug: vitamin B6
* Drug: vitamin B6


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nausea and vomiting of pregnancy Exclusion Criteria: Other medical condition causing nausea and vomiting of pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: highB6<br>high vitamin B6 | Drug: vitamin B6<br>* high dose of vitamin B6<br>|
| Active Comparator: lowB6<br>low vitamin B6 | Drug: vitamin B6<br>* low vitamin B6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting score |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin B6 concentration in nausea and vomiting of pregnancy |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nausea, vomiting, pregnancy, B6
Prevalence of Sarcopenia in Geriatric Patients

Study Overview
=================
Brief Summary
-----------------
To assess the prevalence of sarcopenia among inpatients on acute geriatrics and geriatric rehabilitation wards of a Swiss university department of geriatric medicine using the most recent diagnosis definitions from european guidelines.

Official Title
-----------------
Prevalence of Sarcopenia in Patients Admitted to a Swiss University Department of Geriatric Medicine

Conditions
-----------------
Sarcopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients >65 years old admitted to acute geriatrics and geriatric rehabilitation at the study site Exclusion Criteria: Lack of informed written consent Implanted defibrillation device Acute Sepsis, severe volume overload or dehydration Life expectancy of < 3 months according to treating physician Unremovable bandages Patients in isolation rooms on the ward Measurement is not possible due to organizational reasons Inability to follow the procedures, e.g. due to language problems, psychological disorders

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Presence of Sarcopenia (yes/no) | Using EWGSOP2 cut-off points | Baseline | 
| Muscle quantity, measured by Body Impedance Analysis (kg) |  | Baseline | 
| Hand Grip Strength (kPa) |  | Baseline | 
| Gait Speed (m/s) |  | Baseline | 
| Timed up and go Test (s) |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental Status (Score range from 0 to 30 Points; higher scores reflect better cognitive status) |  | Baseline | 
| Nutritional risk Screening (Score range from 0 to 7 Points; higher scores reflect higher risk of malnutrition) |  | Baseline | 
| Geriatric Depression Scale short version (Score range from 0 to 6 Points; higher scores reflect higher risk of depression) |  | Baseline | 
| Functional Independence Measure at Admission (Score range from 18 to 126 Points; higher scores reflect better functionality) |  | Baseline | 
| Calf and Mid-upper arm Circumference (cm) |  | Baseline | 
| Body Mass Index (kg/m^2) | Weight and height will be combined to report Body Mass Index in kg/m^2 | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevalence, Sarcopenia, Geriatric
Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnancy and Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Given that morbid obesity has been strongly associated with obstetric, neonatal and anesthetic complications, and that scarce reports have evaluated anesthetic and obstetric outcomes after cesarean delivery in morbidly obese patients; This study retrospectively analyzed anesthetic, obstetric and neonatal outcomes in morbidly obese pregnant patients who underwent cesarean delivery at Augusta University Medical Center, during a 2-year period (2015-2016).

Detailed Description
-----------------
This study compared non-obese, obese and morbidly obese patients with respect to maternal, perinatal and anesthetic outcomes. Obstetric aspects included emergent procedure, estimated blood loss, obstetric complications, maternal disposition, length of stay and in-hospital mortality. Neonatal aspects included Apgar scores. Anesthetic aspects included anesthetic technique, intraoperative hemodynamic instability, failed regional anesthesia and anesthetic complications.

Official Title
-----------------
Anesthetic and Obstetric Outcomes in Morbidly Obese Pregnant Patients Undergoing Cesarean Delivery: Retrospective Analysis of a Single Center Experience

Conditions
-----------------
Morbid Obesity, Cesarean Section Complications, Pregnancy Related

Intervention / Treatment
-----------------
* Other: Retrospective chart review


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant patients who underwent cesarean section at Augusta University Medical Center. Patients older than 18 years. Exclusion Criteria: Gestational age <37 weeks. Patients with chronic pain conditions

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Retrospective chart review|A retrospective chart review was conducted to evaluate the effect of body mass index on obstetric, anesthetic and neonatal complications in patients who underwent cesarean section at our institution|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstetric complications | Perioperative bleeding | From beginning to end of cesarean section (2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthetic complications | Failed epidural | From beginning to end of cesarean section (2 hours) | 
| Neonatal complications | Apgar scores | 1 and 5 minutes after delivery | 
| Other anesthetic complications | Intraoperative hypotension | From beginning to end of cesarean section (2 hours) |
Improvement of Foodallergy Diagnostic in Gastrointestinal Tract

Study Overview
=================
Brief Summary
-----------------
Currently, diagnostic possibilities for the detection of food allergy in the gastrointestinal tract are scarce. The endoscopic segmental Lavage is the method of choice, but it´s controversial. Additional to the endoscopic segmental lavage fluid a cytobrush is used for collecting the mucosa cells and biopsies are taken. Comparative to the Lavage specific IgE antibodies, Tumor necrosis factor- alpha, Eosinophilic cation protein and mastcell tryptase were measured.

Official Title
-----------------
Improvement of Foodallergy Diagnostic in Gastrointestinal Tract With a New Kind of Sampling

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

Intervention / Treatment
-----------------
* Diagnostic Test: Cytobrush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with suspicion of food intolerance and confirmed food allergy Exclusion Criteria: pregnant and patients under allergy medication (antihistaminic, cortison)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Food allergy<br>Patients with confirmed foodspecific- IgE antibodies in blood | Diagnostic Test: Cytobrush<br>* During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.<br>|
| Other: healthy controls<br>participants without foodspecific- IgE antibodies in blood and other gastrointestinal symptoms | Diagnostic Test: Cytobrush<br>* During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.<br>|
| Other: gastointestinal symptoms without foodallergy in blood<br>Patients without foodspecific- IgE antibodies in blood, but with gastrointestinal symptoms | Diagnostic Test: Cytobrush<br>* During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of specific IgE Antibodies in colon |  | 1 hour |
Flu-Bu-Mel Based Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
In this phase II clinical trial, we evaluate the efficacy and feasibility of conditioning regimen of fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2 in patients with lymphoid malignancies.

Official Title
-----------------
Phase II Clinical Trial of Flu-Bu-Mel-E (Fludarabine, Busulfan, Melphalan and Etoposide) as Conditioning Regimen for Patients With Lymphoid Malignancies Undergoing Allogeneic Stem Cell Transplantation

Conditions
-----------------
Lymphoid Neoplasm

Intervention / Treatment
-----------------
* Drug: Flu-Bu-Mel-E


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lymphoid malignancies donor available: HLA matched sibling, unrelated donor or haplo-identical related donor. patients with ECOG <3 Exclusion Criteria: inform consent not provided ECOG >=3 poor liver function (enzyme >2N or bilirubin >2N) poor renal function (Scr >2N) poor cardiac function (EF <45%)

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>treatment arm | Drug: Flu-Bu-Mel-E<br>* Fludarabine 150mg/m2, busulfan 6.4mg/kg, melphalan 100mg/m2 and etoposide 600mg/m2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival | event defined as disease progression, relapse or death of any causes | 1 year after allo-HSCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | event defined as death of any causes | 1 year after allo-HSCT | 
| Non relapse morality | event defined as death of any causes except for disease progression or relapse | 1 year after allo-HSCT | 
| Relapse | event defined as disease progression or relapse | 1 year after allo-HSCT | 
| GVHD-free or relapse-free survival | event defined as disease progression or relapse, death of any cause, grade III-IV aGVHD or moderate to severe cGVHD | 1 year after allo-HSCT |
Study of Colchicine to Treat and Prevent Recurrent Pericarditis After Failure of Conventional Treatment.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.

Detailed Description
-----------------
Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data (observational, non-randomized studies without a control group) have shown that the drug may be effective in treatment of the second and subsequent recurrence and the prevention of further recurrences.

Official Title
-----------------
Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.

Conditions
-----------------
Pericarditis, Recurrence

Intervention / Treatment
-----------------
* Drug: Colchicine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the second and subsequent attack of recurrent pericarditis, Age≥ 18 years, Informed consent. Exclusion Criteria: Suspected neoplastic, tuberculous, or purulent etiology, Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality, serum creatinine>2.5 mg/dl, Serum CK over the upper limit of normality or Known myopathy, Known gastrointestinal or blood disease, Pregnant or lactating women or women not protected by a contraception method, Known hypersensibility to colchicine, Treatment with colchicine at the enrolment.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine<br>Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months | Drug: Colchicine<br>* Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months<br>|
| Placebo Comparator: Placebo<br>Placebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months | Drug: Placebo<br>* Placebo comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate at 18 months |  | 18 m onths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study. |  | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pericarditis, Recurrence, Therapeutics, Prevention, Colchicine
A Study of RO4995819 in Healthy Elderly Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability and pharmacokinetics of RO4995819 in healthy elderly volunteers. Volunteers will be randomized to receive once daily doses of RO4995819 or matching placebo. The anticipated time on study treatment is 14 days.

Official Title
-----------------
A Randomized, Double-Blind, Multiple Dose, Placebo-Controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of RO4995819 Following Oral Administration in Healthy Elderly Subjects.

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: RO4995819


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy volunteer, 65-85 years of age Body Mass Index (BMI) between 18.0 to 30.0 kg/m2 inclusive and a total body weight >50 kg (110 lbs) Able to participate and willing to give written informed consent and to comply with the study restrictions Exclusion Criteria: Any history or suspicion of drug or alcohol abuse Clinically significant or unstable cardiovascular or bronchopulmonary diseases, or any type of cancer History of liver disease Significant past or present neurological disorder History of psychiatric disorders Participation in an investigational drug or device study within 12 weeks prior to screening Donation of blood over 500 mL within three months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo to RO4995819 once daily for 14 days<br>|
| Experimental: RO4995819<br> | Drug: RO4995819<br>* RO4995819 doses once daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (incidence of adverse events) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: area under the concentration time curve (AUC) |  | Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 22, 20, 36, 62 |
Walking for Stress Reduction

Study Overview
=================
Brief Summary
-----------------
The effectiveness of a mindfulness walking program is tested in subjects with a high level of subjectively perceived stress.

Official Title
-----------------
Effectiveness of Mindfulness Walking on Stress Reduction

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Walking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women between 18 and 65 years Increased level of stress (visual analog scale >40 mm (0-100)) Exclusion Criteria: Regular walking training in the last 6 weeks Medical therapy with psychopharmacological drugs Regular mindfulness based meditations/exercises in the last 6 weeks CAM therapies against stress in the last 6 weeks medium or severe chronic diseases Stress due to chronic diseases Acute disease at inclusion Not being able to walk

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness walking<br> | Behavioral: Mindfulness Walking<br>* Mindful walking in a small group twice a week for 60 minutes within 4 weeks.<br>|
| No Intervention: No intervention (waiting list)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cohens Perceived Stress Scale 14 Items |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (SF 36) |  | Baseline, 4 weeks, 12 weeks | 
| Subjective Stress Level (Visual Analogue Scale) |  | Baseline, 4 weeks, 12 weeks | 
| Assessment of effect on a Likert - Scale |  | 4 weeks, 12 weeks |
Chinese Cohort Study of Coronary Heart Disease

Study Overview
=================
Brief Summary
-----------------
Construction of coronary heart disease cohort of more than 10000 patients in China. Investigation on current situation of secondary prevention of CHD will be carried out and the effect of physician training and patient education will be evaluated.

Detailed Description
-----------------
More than 40 hospitals of 16 provinces will enroll patients for this study. The study will include patients with diagnosed coronary heart disease. Investigators and all the physicians who will involve in daily care of CHD patients will have a brief training on guideline of secondary prevention in CHD and take a test on that. Questionnaires are used to evaluate patient's cognition of their diseases and knowledge on coronary heart disease. Patient education will be carried out during a 2 years follow up of all the patient enrolled before they are required to fill out another questionnaire. Physicians will also take a second test on secondary prevention of CHD at that time. Patients will take blood lipids and glucose test according to their physician's requirement.The effect of physician training and patient education will be evaluated by comparing the results of questionnaires and tests at the beginning of the study and in the end of the 2 years follow up.

Official Title
-----------------
Cross-Sectional Investigation of Secondary Prevention on Coronary Heart Disease and Generalization of Standardized Secondary Prevention in Chinese Coronary Heart Disease Patients

Conditions
-----------------
Coronary Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed coronary heart disease Confirmed by coronary angiography; Diagnosed myocardial infarction; Typical symptom of ischemic chest pain with positive stress test; Willing to sign an inform consent. Exclusion Criteria Patients won't sign an inform consent or will not comply with the follow up.
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
-----------------
coronary heart disease, secondary prevention