linjc16/ctgov huggingface dataset:
A Randomized-controlled Trial of Social Norm Interventions to Increase Physical Activity

Study Overview
=================
Brief Summary
-----------------
Objective: Physical activity confers numerous health benefits, yet few adults meet recommended physical activity guidelines. The impact of brief messages providing feedback on physical activity was tested in this study. Methods: Young adults were randomly assigned to one of three conditions: (1) feedback on how active others were, (2) feedback on how active others were plus a message of approval or disapproval depending on whether the participant was more or less active than average, or (3) no feedback (control condition). Participants used pedometers for eight weekdays and recorded their step counts each evening. The group receiving feedback on how active others were got information about the average number of steps taken by group members the previous day. The group that also received approval or disapproval received feedback about the group average, as well as a sad face if the participant was below the average or a happy face if the participant was above the average. The control group received no feedback throughout the study. Impacts of these feedback messages were compared on number of steps taken during the study.

Official Title
-----------------
A Randomized-controlled Trial of Social Norm Interventions to Increase Physical Activity

Conditions
-----------------
Physical Activity

Intervention / Treatment
-----------------
* Behavioral: Descriptive Social Norm
* Behavioral: Descriptive-plus-Injunctive Social Norm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older Exclusion Criteria: Answering yes to any questions on the Physical Activity Readiness Questionnaire.

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: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No feedback on progress of other participants. | |
| Experimental: Descriptive Social Norm<br>Average physical activity of other participants in study conveyed to this group. | Behavioral: Descriptive Social Norm<br> <br> |
| Experimental: Descriptive-plus-Injunctive Social Norm<br>Average physical activity of other participants in study and message of approval or disapproval (depending on how one is faring compared to others) conveyed to this group. | Behavioral: Descriptive-plus-Injunctive Social Norm<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of steps | Number of steps taken daily, as measured by a pedometer. | Two weeks |
Yoga for Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the use of Eischens yoga for 8 weeks in one cohort of 20 women with stage I and II breast cancer receiving radiation therapy treatment, while a second cohort of the same type of and number of patients who, instead of yoga will receive standard supportive therapy, Questionnaire measuring cancer-related quality of life (FACT-G instrument) and fatigue (Brief Fatique Inventory) will be given to patients at several points.

Official Title
-----------------
A Randomized Study of the Effect of Yoga in Patients With Breast Cancer Receiving Radiation Therapy

Conditions
-----------------
Women With Stage I or II Breast Cancer Undergoing Active Radiation Therapy

Intervention / Treatment
-----------------
* Other: Yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage I and II breast cancer patients undergoing active radiation therapy Above the age of 18 Must sign informed consent form Must speak English Only women are eligible Exclusion Criteria: Patients with medical restrictions that may interfere with yoga participation per their physicians' decision Those who have smoked in the last 6 months because smoking can interfere with the breathing and relaxation techniques of yoga. Those who have regularly taken yoga in the last 6 months, because they would not come to the intervention with the same baseline as other participants.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Yoga<br> | Other: Yoga<br> <br> |
| No Intervention: Without Yoga<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | One Year |
Sedating Effects of Dexmedetomidine Versus Midazolam in Agitated Patients Undergoing Weaning in Icu.

Study Overview
=================
Brief Summary
-----------------
Comparison of sedating effect of dexmedetomidine and midazolam for sedation in icu patients who put on mechanical ventilation and undergoing weaning. Selction of better sedating agent minimises the drug related side effects like respiratory depression but also helps in weaning in shorter time,give hemodynamic stability and reduce morbidity and mortality in icu..

Official Title
-----------------
Sedating Effects of Dexmedetomidine Versus Midazolam in Agitated Patients Undergoing Weaning in ICU

Conditions
-----------------
Agitation on Recovery From Sedation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with age <60 irrespective of gendre Exclusion Criteria: - Patients who refuse to give consent, severely altered conscious level (GCS < 8/15), traumatic injury causing hypoxemia e.g., severe head / chest / facial trauma or pneumothorax, severe pneumonia, arrhythmia, impaired hearing or blindness, severe hepatic or renal disease, on neuromuscular blocking agents, recent myocardial infarction, use of anti-psychotics, hypersensitivity to any of the drug under study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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: Dexmedetomidine<br>Inj.Dexmedetomidine(precidex ) 200mcg/2ml Given to participants in infusion form for 24 hours | Drug: Dexmedetomidine Hydrochloride<br>* Inj dexmedetomidine and inj midazolam given to two groups of participants and effects of both drugs will be observed for 24 hrs<br>* Other names: Midazolam;|
| Experimental: Midazolam<br>Inj.midazolam 5mg/ml given to participants in infusion form for 24 hrs | Drug: Dexmedetomidine Hydrochloride<br>* Inj dexmedetomidine and inj midazolam given to two groups of participants and effects of both drugs will be observed for 24 hrs<br>* Other names: Midazolam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective sedation in icu patients lead to successful weaning in icu patients | Assess patients by using ramsay sedation score (score 1 =awake upto score 6=no response) | Upto 48 hrs |
CIS001 Extension Study of Cyclosporine Inhalation Solution

Study Overview
=================
Brief Summary
-----------------
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.

Official Title
-----------------
CIS002: An Open-Label, Multi-Center, Extension Study of Cyclosporine Inhalation Solution in Subjects Previously Enrolled in the APT Study CIS001

Conditions
-----------------
Lung Transplant

Intervention / Treatment
-----------------
* Drug: Cyclosporine Inhalation Solution (CIS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in study CIS001 Written informed consent for CIS002 Use of an effective means of contraception by women of childbearing potential Exclusion Criteria: Any unresolved or irreversible CIS-related ongoing serious adverse event Subjects who have developed newly emergent conditions, injuries, diagnoses, physical examination findings, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk of treatment complications Subjects with suspected or documented allergy to propylene glycol and/or cyclosporine Women who are pregnant, wishing to become pregnant, or unwilling to use appropriate birth control to avoid becoming pregnant Women who are breastfeeding Subjects unable to comply with all protocol requirements and follow-up procedures Subjects who discontinued from CIS002 to participate in another clinical trial and have received any investigational treatment (other than CIS) within 14 days of titration visit 1/baseline.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Inhaled cyclosporine<br>Extended access to inhaled cyclosporine for patients from treatment and control arms of Phase 3 study CIS001 | Drug: Cyclosporine Inhalation Solution (CIS)<br>* Cyclosporine (USP) Inhalation Solution; 300mg/4.8 mL in propylene glycol (USP) at a concentration of 62.5 mg/mL; 3 times a week for study duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the long-term safety of CIS administration |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung transplant, lung transplant recipient, bronchiolitis obliterans syndrome, bronchiolitis obliterans, single lung transplant, double lung transplant, heart-lung transplant, Aerosol
Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry

Study Overview
=================
Brief Summary
-----------------
This is an investigator initiated registry aimed at assembling a blood/serum and genomic resource (bank) of human blood samples with accompanying clinical data mainly from patients who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may also include other eligible individuals. Funding is from institutional/divisional research funds.

Detailed Description
-----------------
This study is aimed at assembling a blood/serum and genomic resource (bank) of human samples with accompanying clinical data mainly from patients who are scheduled to undergo cardiac catheterization at UC Davis Medical Center, but may also include other eligible individuals. These samples will be analyzed at UC Davis Medical Center for determination of biomarker levels, and concomitantly analyzed at UC San Francisco in an IRB-approved protocol at that institution for genetic analysis (UCSF IRB approval # for this study is H711-15138-03; protocol name is Discovery of Gene Mutations and Polymorphisms that Contribute to the Risk of Atherosclerosis; principal investigator is John P. Kane, MD). All samples sent to UCSF will be de-identified and catalogued using an alphanumeric code. A number of candidate genes will be studied to detect mutations and polymorphisms that could contribute to the risk of atherosclerosis. The technique of hybridization sequencing will be employed for this. The techniques of classical statistical genetics will be employed for both cosegregation analysis and for the genome search approach. Clinical follow-up may be obtained at 6 and 12 months.

Official Title
-----------------
Genetic and Inflammatory Markers in Cardiovascular Disease (GEM) Registry

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual cared for in the UC Davis Health System disorders of lipoproteins or arteriosclerosis Exclusion Criteria: Subjects will be excluded only if they refuse to be in the 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GEM, Arteriosclerosis, biomarkers, Atherosclerosis
Can we Safely Have Our Patients Eat With Cardiac Catheterization - Nix Or alloW: The CHOW NOW Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and effects of fasting or not fasting overnight before a cardiac catheterization (heart procedure). The study will compare patients who have nothing to eat after midnight before the procedure to those who are allowed to eat or drink before the procedure.

Detailed Description
-----------------
For years it has been common to have patients fast before a cardiac catheterization. It is believed that fasting may lower the risks of upset stomach, vomiting, and aspiration (stomach contents going to the lungs). New findings show that fasting before the procedure may not be needed. This study will look at the safety and possible benefits of not fasting.

Official Title
-----------------
Strict Versus No Fasting Prior to Cardiac Catheterization: A Prospective Evaluation of Safety and Clinical Outcomes

Conditions
-----------------
Chest Pain

Intervention / Treatment
-----------------
* Other: No Fasting prior to catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are planned for coronary angiogram or percutaneous intervention, either as outpatients or inpatients Exclusion Criteria: Subjects undergoing emergent procedures or requiring post procedure emergent cardiothoracic surgery Pregnant Women Prisoners

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard - Strict Fasting<br>No food after midnight the night before the procedure and will be allowed to drink clear liquids up to 2 hours prior to the procedure. | |
| Experimental: Non Fasting<br>No Fasting prior to catheterization. Usual meal on the day of the procedure and allowed to drink as usual. | Other: No Fasting prior to catheterization<br>* No restriction for oral intake<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite incidence of contrast induced nephropathy, peri procedural hypotension, aspiration pneumonia/pneumonitis, nausea, vomiting, hyperglycemia and hypoglycemia |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction score |  | 72 hours | 
| Total cost of hospitalization |  | 72 hours |
Effects of Remote Intercessory Prayer

Study Overview
=================
Brief Summary
-----------------
Intercessory prayer can improve the outcome of pregnancies?

Official Title
-----------------
Effects of Remote Intercessory Prayer in Outcomes of Pregnants Women: a Randomized Controlled Trial

Conditions
-----------------
Remote Intercessory Prayer

Intervention / Treatment
-----------------
* Other: Intercessory Prayer
* Behavioral: Intercessory Prayer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be pregnant, belong to the public health system Exclusion Criteria: no consent to participate in the research

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Intercessory Prayer|A committed group of six people selected by the chief investigator prayed nine consecutive days for the patients in the intervention group; they were blind to the identity , the patients' first name, were given to the intercessors.|
|Behavioral: Intercessory Prayer|A committed group of six people selected by the chief investigator prayed nine consecutive days for the patients in the intervention group; they were blind to the identity , the patients' first name, were given to the intercessors.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar score |  | birth . The time to collect the outcome must be at least the tenth day after making randomization. If the birth occurs before the patient will be excluded from the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type of delivery complications in childbirth |  | birth or abortion. There isn't a pre-determined time. Must be at least 9 days after randomization to allow time to be done the intervention (intercessory prayer) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intercessory Prayer, pregnants
Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.

Official Title
-----------------
A Two Stage Multicenter Phase II Trial of Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

Conditions
-----------------
KRAS Wild Type, Resectable Type II Gastric Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma T2-4 NX M0 disease ECOG performance status 0-1 adequate hematological status adequate renal function adequate hepatic function adequate metabolic function Exclusion Criteria: pregnant or breast feeding women previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix arterial or venous thromboembolism within 6 months before enrollment clinically significant cardiovascular disease within 1 year before enrollment history of interstitial lung disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>3 cycles(repeated q21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Capecitabine 500mg/m² bid d1-d21 Panitumumab 9mg/kg i.v. d1 | Drug: Epirubicine, Oxaliplatin, Capecitabine, Panitumumab<br>* 3 cycles (repeated q 21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Panitumumab 9mg/kg i.v. d1 Capecitabine 500mg/m² bid d1-21<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Proportion of patients with T0 ant T1 disease after neoadjuvant combined chemoimmunotherapy |  | 
| Safety | Proportion of patients with grade 4 diarrhea |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histopathological response | rate of complete pathological response |  | 
| overall survival after one year |  |  | 
| Progression free survival after one year |  |  | 
| Proportion of patients completing 3 treatment cycles |  |  | 
| Safety | NCI CTCAE v.3 |  |