linjc16/ctgov huggingface dataset:
GN Tobacco Use Survey

Study Overview
=================
Brief Summary
-----------------
Smoking can contribute to many health problems for mothers and their babies. In developing countries, there is little information about the number of pregnant women that smoke and the reasons why some pregnant women choose to smoke. The purpose of this multi-site tobacco use survey is to obtain information on knowledge, attitudes and behaviors among pregnant women in diverse populations regarding tobacco products.

Detailed Description
-----------------
Smoking is regarded as one of the few potentially preventable factors associated with low birth weight, very preterm birth and perinatal death. In an effort to determine the prevalence of tobacco use (smoking and smokeless tobacco) and to collect relevant data in support of a potential smoking prevention or cessation intervention, a multi-site tobacco use survey is being conducted in several countries. The survey will be used to obtain information on knowledge, attitudes and behaviors among pregnant women in diverse populations regarding tobacco products. The primary outcome is tobacco use status during pregnancy. Secondary outcomes include: knowledge and attitudes regarding tobacco products, health hazards of tobacco use and environmental tobacco smoke (ETS) exposure. Sample size of 750 per country was calculated under the assumptions that the prevalence of tobacco use could be as low as 0.05 with a coefficient of variation of approximately 15% and a prevalence of 0.10 with a CV of approximately 11%.

Official Title
-----------------
Survey on Tobacco Use in the GN Sites

Conditions
-----------------
Smoking

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women of legal consent and child-bearing age (18-45) Attendance at a participating clinic Exclusion Criteria: Pregnant women with disabilities such as deafness, serious mental illness, or mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Tobacco use |  | Cross sectional | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Global Network, Maternal and child health, International, Women's health, Tobacco, Smoking, Africa, Latin America, South America, Guatemala, Zambia, India, Argentina, Democratic Republic of the Congo
Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of a new exercise device (TREDLR) designed to facilitate repetitive ankle flexion/extension movements (i.e., treadling) through a momentum-driven internal flywheel while seated. The specific goals of this project are to explore improvements in mobility and exercise capacity in individuals who treadle compared to a control group.

Official Title
-----------------
A Momentum-enabled Treadling Methodology to Improve Gait and Enhance Mobility in Patients With Peripheral Arterial Disease

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Behavioral: Treadwell Tredlr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be able to walk without an assistive aid (i.e., walker, cane) Have the capacity the provide written informed consent Have previously diagnosed peripheral arterial disease (by self-report) Exclusion Criteria: Lower extremity injury or fracture within the last 6 months Have a leg prosthesis Prisoners Individuals clearly lacking the capacity to provide informed consent Vestibular impairment

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 99 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
Interventional Model Description: Subjects will be randomized into a treadling group (n=15) or a control group (n=15). Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. The control group will be instructed to continue their normal daily activities.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadling Group<br>Treadling subjects will do so 3x per week (15 min sessions) for 6 weeks. | Behavioral: Treadwell Tredlr<br>* Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.<br>|
| No Intervention: Control Group<br>Control Subjects continue their normal daily activities. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overground Walking Speed After Intervention | Measured from the time taken to walk 6 meters. | Baseline, 6 weeks | 
| Change in 6-min Walk Distance | Measured from the distance walked in 6 minutes. | Baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stride Length | Measured using motion capture as the distance between heel markers across successive steps. | Baseline, 6 weeks | 
| Change in Peak Ankle Power | Measured using motion capture and instrumented treadmill forces as the peak positive power generated by the calf muscles during the push-off phase of walking. | Baseline, 6 weeks |
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Patients with macular hole <400µm will be randomized for ILM flap Transposition and ILM Peeling for surgical repair of macular holes

Detailed Description
-----------------
Patients with macular hole with a diameter larger than 400µm have better sucess with ILM flap transposition, but there are no data published examining the outcome of macular hole with a diameter <400µm. Therefore, patients with macular hole with a diameter <400µm will be randomized for ILM flap transposition and ILM peeling for surgical repair of macular holes

Official Title
-----------------
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study

Conditions
-----------------
Macular Holes

Intervention / Treatment
-----------------
* Procedure: ILM flap transposition
* Procedure: ILM peeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: macular hole with a diameter <400µm Exclusion Criteria: Prior ILM peeling

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ILM flap<br>vitrectomy with ILM flap transposition and gas-tamponade will be performed | Procedure: ILM flap transposition<br>* during ILM flap Transposition, an ILM flap is placed on the macular hole<br>|
| Active Comparator: ILM peeling<br>vitrectomy with ILM peeling and gas-tamponade will be performed | Procedure: ILM peeling<br>* during ILM Peeling the ILM is removed around the macular hole<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| closure of the macular hole | closure of the macular hole will be assessed | 3 months |
Med Diet Prevention Metabolic Syndrome Men Undergoing Androgen Deprivation Therapy Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess for changes in a patient's overall energy level and well-being (quality of life) after 8 weeks of dietary intervention.

Detailed Description
-----------------
Primary Objective: To assess for changes in the following measurements after 8 weeks of following a Mediterranean diet-- LDL, HDL, TG, FBS, creatinine, serum testosterone, triglycerides, serum insulin, CRP, 1bs, Waist circumference, blood pressure, body weight

Official Title
-----------------
Eight Week Plant-based Mediterranean Diet as Prevention of Metabolic Syndrome in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer: A BrUOG Pilot Study

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

Intervention / Treatment
-----------------
* Dietary Supplement: Olive Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented carcinoma of the prostate On treatment with androgen deprivation therapy for at least 3 months Required laboratory values: Serum creatinine less than 2.5 Triglycerides <300 Fasting glucose < 126 Testosterone level <50 Exclusion Criteria: No diabetes mellitus (Type 1 or 2) No renal failure (Serum creatinine > 2.5) No active cardiac disease -no history of myocardial infarction/stroke within the last 12 months, no recurrent unstable angina, uncontrolled/unstable arrhythmias, uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >100) No severe peripheral vascular disease No commencement of lipid lowering agent within 8 weeks of enrollment the study or change in dose throughout the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olive Oil<br>At least 3 tablespoons of olive oil each day | Dietary Supplement: Olive Oil<br>* Minimum of 3 tablespoon of olive oil per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Blood Chemistry (Fasting Triglycerides) After 8 Weeks of Following a Mediterranean Diet | Based on overall percentage change at baseline versus post diet | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess Changes in the Body After 8 Weeks of Following a Mediterranean Diet | Post diet waist circumference | 8 weeks |
Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab

Study Overview
=================
Brief Summary
-----------------
The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.

Official Title
-----------------
Daratumumab Subcutaneous Pre-approval Access Study

Intervention / Treatment
-----------------
* Drug: Daratumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daratumumab|Daratumumab 1800 milligram (mg) will be administered as a fixed dose by subcutaneous (SC) injection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics

Study Overview
=================
Brief Summary
-----------------
To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.

Official Title
-----------------
A Non-interventional Study Evaluating Well-being/Quality of Life in Schizophrenic Patients Treated With Seroquel XR® (Quetiapine) and Other Atypical Antipsychotics.A 9-month, Observational, Multicentric Prospective Study.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia Treatment with one atypical antipsychotic* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit. Patient takes an AAP according to local SPC and current medical practice The patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write Exclusion Criteria: Treatment with an additional AAP or AP to the initial prescribed AAP within the 2-8 weeks before the patient is included in the study Since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'AAP are excluded. Previous enrolment or treatment in the present NIS Known allergy to the prescribed AAP or any of its substances

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics. |  | At baseline (Visit 1), and after  3 months,  6 months,  9 months after V1, or at premature discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive And Negative Syndrome Scale-PANSS-8score |  | At baseline (Visit 1), and after  3 months,  6 months,  9 months after V1, or at premature discontinuation | 
| Global Assessment of Functioning 'GAF' scale |  | At baseline (Visit 1), and after  3 months,  6 months,  9 months after V1, or at premature discontinuation | 
| Disease insight; G-12 item of PANSS |  | At baseline (Visit 1), and after  3 months,  6 months,  9 months after V1, or at premature discontinuation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, remission, subjective well-being and effectiveness, Quality of Life
Evaluation of the Addition of an Interdental Cleaning Device to Manual Brushing on Gingival Health

Study Overview
=================
Brief Summary
-----------------
This study evaluates the addition of an interdental cleaning device paired with a manual toothbrush compared to using a manual toothbrush only. Plaque removal, reduction of gingival bleeding and reduction of gingival inflammation.

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Device: Interdental cleaning device
* Device: Manual Tooth brush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 25 and 70 years of age Able to provide written informed consent prior to participation Agree to not participate in any other oral/dental products clinical study for the study duration Good general health and be a non-smoker A minimum of 50% bleeding on probing sites A minimum pre-brushing plaque score of 0.6 A minimum of 1.75 gingivitis score Have no probing depths greater than 5 mm A minimum of 20 teeth (not including 3rd molars) No partial dentures, orthodontic brackets, wires or other appliances Agree to refrain from the use of any non-study dental device or oral care product for the study duration Agree to return for the scheduled visits and follow study procedures Agree to delay dental prophylaxis until study completion Have a minimum pre-brushing plaque score of 0.6 Have a minimum of 1.75 gingivitis score Exclusion Criteria: Probing depth greater than 5 mm Systemic disease (ex. Diabetes, autoimmune disease) Advanced periodontitis Taking medication that can influence gingival health such as seizure meds, calcium channel blockers, Cyclosporine, anticoagulants Orthodontic appliances or removable partial dentures Pregnant at time of study Use of antibiotics within 6 months of study

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interdental device<br>Water Flosser | Device: Interdental cleaning device<br>* Water Flosser<br>Device: Manual Tooth brush<br>* Control<br>|
| Other: Toothbrush<br>Control | Device: Manual Tooth brush<br>* Control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of gingival bleeding |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of gingival inflammation |  | 4 weeks | 
| Reduction in dental plaque |  | 4 weeks |
Genetic Mechanisms in Human Hypertension Renin-angiotensin-aldosterone System (RAAS) Inhibition Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop an approach to provide personalized medicine to individuals who have hypertension (high blood pressure). The investigators plan to use people's genetic characteristics (traits) to determine what medication they should use to lower their blood pressure most effectively. The investigators will give individuals one of two medications to treat hypertension (lisinopril or atenolol). The investigators believe that depending on the individuals genetic background one medication will work better in lowering their blood pressure.

Official Title
-----------------
Genetic Mechanisms in Human Hypertension RAAS Inhibition Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Lisinopril, Atenolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female hypertensive participants who were previously studied in SCOR program. Exclusion Criteria: Diabetes Taking other medications beside thyroid or estrogen supplements.

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: Lisinopril, Atenolol<br> | Drug: Lisinopril, Atenolol<br>* once a day for 14 weeks<br>* Other names: Prinivil, Zestril (Lisinopril);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One type of blood pressure medication will better treat individuals with certain genetic backgrounds. |  | 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High blood pressure
Hyperoxic Oxidative Stress During Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
Our aim is to compare the effects of 80% and 40% Fraction of inspired oxygen on oxidative stress, antioxidant response (in plasma and bronchoalveolar lavage), extubation quality, preanesthetic and postanesthetic expiration tidal volumes.

Official Title
-----------------
Comparing the Effect of Hyperoxic and Conventional Fraction of Inspired Oxygen on Oxidative Stress During Abdominal Surgery.

Conditions
-----------------
Response to Hyperoxia

Intervention / Treatment
-----------------
* Other: Fraction of inspired oxygen 40%
* Other: Fraction of inspired oxygen 80%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing abdominal surgery, between 20-60 years old, with American Society of Anesthesiology score I or II Exclusion Criteria: Patients with Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, muscle-bone diseases, inflammatory bowel diseases and patients with malnutrition. Patients will be recruited through general surgery service of our hospital

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 40% oxygen<br>Patients in this group will be ventilated with fraction of inspired oxygen 40% during the surgery. | Other: Fraction of inspired oxygen 40%<br> <br> |
| Active Comparator: 80% oxygen<br>Patients in this group will be ventilated with a fraction of inspired oxygen 80% during the surgery. | Other: Fraction of inspired oxygen 80%<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidant and antioxidant response | As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in plasma and bronchoalveolar lavage after intubation and prior to extubation will be evaluated | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamics | The secondary outcome was evaluating the effects of different inspired oxygen fractions on hemodynamics. | 4 hours |