linjc16/ctgov huggingface dataset:
Antiretroviral Adherence Evaluation in HIV Pregnant and Postpartum Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare adherence to antiretroviral therapy during pregnancy and postpartum, and to record adherence barriers and facilitators.

Detailed Description
-----------------
Data of all consecutive pregnant women included in the adherence enhancing program of the Pharmacy, Department of ambulatory care & community medicine, are collected. In this program, adherence is measured and enhanced by electronic monitoring, pill count, motivational interviewing and interdisciplinary collaboration. Electronic monitoring data are collected during pregnancy and postpartum, and compared. Barriers and facilitators are collected using interview's marks.

Official Title
-----------------
Retrospective Study: Evaluation of Antiretroviral Adherence During Pregnancy and Postpartum Using Electronic Monitoring Data

Conditions
-----------------
HIV Infection, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Women HIV-positive Antiretroviral medication delivered in electronical monitors Exclusion Criteria: Monitored period during pregnancy < 1 month

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

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

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 |
| --- | --- | --- |
| Change in patient adherence during pregnancy and postpartum | By electronic drug monitoring, pill count and subject interviews' marks | before delivery (1 to 9 month) and postpartum (6 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence barriers and facilitators | Data recorded in subject's interview marks | pregnancy and postpartum (6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Pregnancy, Postpartum, Women, Medication Adherence
Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors

Study Overview
=================
Brief Summary
-----------------
Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other factors (genetic, psychological) could have a major and independent role in the development of the post operative pain.The main objective of this study is to identify genetic and psychological profile (cognitive and emotional) of patients who develop chronic pain after lung surgery.

Official Title
-----------------
Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Procedure: Lung surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing lung resection surgery. 18 years and older (without superior limit); Affiliated to french securité sociale Exclusion Criteria: Emergency procedure litigation or search for compensation; Previous intervention in the same region; Peripheral neurological pathology (polyneuropathy) or central (brain damage, multiple sclerosis …) that may interfere with the evaluation of the post-operative pain Participation in another biomedical research protocol if there is an incompatibility with the present protocol. mental disability vulnerable person within the meaning of French law, poor understanding of French.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung Surgery<br> | Procedure: Lung surgery<br>* Genetic analysis and questionnaires<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with chronic pain 4 months after surgery |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung surgery
Airway Resistance Measurement in Children 3 to 6 Years of Age

Study Overview
=================
Brief Summary
-----------------
In preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (Rint) and plethysmographic measure of specific airway resistance (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to be better for discriminating airway obstruction. These two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.

Official Title
-----------------
Interrupter Technique and Plethysmography Airway Resistance Measurement: Comparison of These Two Techniques for the Diagnosis of Airway Obstruction Diagnosis and Bronchodilation Response in Children 3 to 6 Years of Age

Conditions
-----------------
Airway Obstruction

Intervention / Treatment
-----------------
* Other: airway resistance measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Child 3 to 6 years aged Exclusion Criteria: Height below 90 centimeters Opposition to participation

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: airway resistance measurement<br>interruption and plethysmography techniques airway resistance measurement at each routine visit | Other: airway resistance measurement<br>* assessment of airway resistance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway resistance measure by interruption technique (Rint) | Rint is performed using Spiroteq Dyn'R during a 100 ms occlusion and calculated using the linear back extrapolation method | Day one | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of bronchodilator response | Bronchodilator response is assessed with Rint and sRaw measurement | Day one |
Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease

Study Overview
=================
Brief Summary
-----------------
The investigators conducted a prospective multi-center study assessing the effect of direct bypass and indrect bypass in treatment of hemorrhagic moyamoya disease.

Official Title
-----------------
Direct Bypass Versus Indirect Bypass in Treatment of Adults Hemorrhagic Moyamoya Disease:a Prospective Multi-center Cohort Study

Conditions
-----------------
Moyamoya Disease

Intervention / Treatment
-----------------
* Other: bypass surgery and indrect bypass surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cerebral digital subtraction contrast angiography (DSA) revealed severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate moyamoya collaterals patients had experienced at least one intracranial hemorrhage which was verified by computed tomography (CT) scanning, magnetic resonance imaging MRI), or lumbar puncture. Patients requiring surgery Exclusion Criteria: Patient whose initial onset was marked by ischemia but subsequently suffered from intracranial hemorrhage patients refused to participate in the study

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: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: group 1 direct bypass<br>direct bypass : patients recieve direct bypass treatment | Other: bypass surgery and indrect bypass surgery<br>* bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes<br>|
| Other: group 2 indirect bypass<br>indirect bypass: patients recieve indirect bypass treatment | Other: bypass surgery and indrect bypass surgery<br>* bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rebleeding events |  | 5-10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischemic events |  | 5-10 years | 
| postoperative compilications |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bypass, hemorrhagic moyamoya disease, indirect bypass
Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of transcervical double balloon catheters versus controlled release dinoprostone vaginal inserts for pre-induction cervical ripening in term women with unfavourable cervices.

Official Title
-----------------
Double Balloon Catheter Versus Vaginal PGE2 for Pre-induction Cervical Ripening: a Randomized Study.

Conditions
-----------------
Cervical Ripening, Labor Induction

Intervention / Treatment
-----------------
* Device: Double balloon catheter
* Drug: Dinoprostone 10 mg controlled-release vaginal insert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton gestation gestational age greater than 34 weeks cephalic presentation intact membranes Bishop score of ≤4 reactive fetal heart rate (FHR) pattern on admission Exclusion Criteria: any condition precluding vaginal delivery any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease previous cesarean section or other uterine incision

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dinoprostone Vaginal Insert<br> | Drug: Dinoprostone 10 mg controlled-release vaginal insert<br>* Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.<br>* Other names: PROPESS®, Ferring Pharmaceuticals;|
| Experimental: Double Balloon Catheter<br> | Device: Double balloon catheter<br>* The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred.<br>* Other names: COOK CERVICAL BALLOON, COOK UROLOGICAL INC. US;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal delivery within 24 hours |  | 24 hours from start of cervical ripening | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cesarean section rate |  | 48 hours from start of ripening | 
| Onset of active labor | Active labor is defined as at least 4 uterine contractions in a 30 minutes interval with a totally effaced cervix and a cervical dilatation ≥3 cm | 36 hours from start of ripening | 
| Uterine hyperstimulation |  | 12 hours (double ballon catheter arm) and 24 hours (dinoprostone vaginal insert arm) from start of ripening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical ripening, Induction of labor, Prostaglandins, Mechanical methods, Balloon catheter
Phase III/Seroquel SR Bipolar Depression Monotherapy - US

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression

Conditions
-----------------
Affective Psychosis, Bipolar, Depression, Bipolar, Manic-Depressive Psychosis, Psychoses, Manic-Depressive

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate (Seroquel) SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder Outpatient status at enrollment Exclusion Criteria: Patients with >8 mood episodes during the past 12 years Use of prohibited medications Substance or alcohol abuse or dependence Current suicide risk or suicide attempt within last 6 months.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate (Seroquel) SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in depression symptoms by final visit as measured by the MADRS total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, Bipolar Depression,, Manic Depression, Seroquel, Seroquel SR, quetiapine fumarate
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term

Official Title
-----------------
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes in Adults

Conditions
-----------------
Type II Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 20-65 years Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association) A normal or high C-peptide level (to exclude type 1 diabetes) (>.9ng/ml) A random plasma glucose of 200mg/dl or more with typical symptom of diabetes A fasting plasma glucose of 126mg/dl or more on more than one occasion BMI 22-34 KG/m2 Patients on oral hypoglycemic medications or insulin to control T2DM Inadequate control of diabetes as defined as HbA1c>7.5 No contraindication for surgery or General Anesthesia as determined by multidisciplinary surgical team Ability to understand and describe the mechanism of action of ricks and benefits of the operation Exclusion Criteria: Patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study Enrolled in another clinical study which involves and investigational drug Diagnosis type 1 diabetes Pregnancy (all female patients will have beta HCG) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method Previous gastric or esophageal surgery Immunosuppressive drugs including corticosteroids Coagulopathy (INR>1.5 or platelets<50,000/ul) Anemia (Hgb<10.0g/dl)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |
A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study aims to provide preliminary data on the feasibility and outcomes of a 12 week exercise program on the quality of life of men with hormone refractory prostate cancer receiving docetaxel-based chemotherapy.

Official Title
-----------------
A Pilot Study of Exercise in Patients With Docetaxel-Based Chemotherapy for Hormone Refractory Prostate Cancer

Conditions
-----------------
Prostatic Neoplasms, Neoplasm Metastasis, Palliative Care

Intervention / Treatment
-----------------
* Behavioral: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of prostate cancer receiving docetaxel-based chemotherapy at the CCI age 18 years or over approval of oncologist informed written consent Exclusion Criteria: life expectancy less than 6 months Karnofsky performance score less than 70 contraindications for exercise (e.g. uncontrolled cardiac, respiratory, hypertensive or psychiatric disorder) unable to understand, read, write and speak English unable or unwilling to attend supervised exercise sessions 3 times weekly unable or unwilling to complete outcome assessments

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

| Intervention/Treatment |
| --- |
|Behavioral: Exercise training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility (recruitment, adherence, safety) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  |  | 
| functional abilities |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, exercise therapy, activities of daily living, quality of life
Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia

Study Overview
=================
Brief Summary
-----------------
Study aims to compare two treatment modalities for treatment of transverse fractures of tibia. One is Intramedullary interlocking nail and the other is dynamic compression plate.

Detailed Description
-----------------
This study is a comparison of two devices used to teat transverse fractures of tibia and these include intra medullary rod popularly known as intra medullary nail and the second is a weight bearing device know as dynamic compression plate which is fixed with screws to diaphyseal segment of bone.

Official Title
-----------------
Comparison of Interlock Nailing Versus Dynamic Compression Plating in Transverse Fractures of Tibia

Conditions
-----------------
Transverse Fracture of Shaft of Tibia

Intervention / Treatment
-----------------
* Device: DCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients with closed transverse tibial fractures Exclusion Criteria: - Patients unsuitable for surgical intervention
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 |
| --- | --- |
| Active Comparator: group interlock<br>Intra medullary device used to treat tibial shaft fractures | Device: DCP<br>* Dynamic compression plating to compress the fracture Intramedullary device to share the load.<br>* Other names: Interlock nailing;|
| Active Comparator: group DCP (dynamic compression plate)<br>dynamic compression plate used to treat tibial shaft fractures | Device: DCP<br>* Dynamic compression plating to compress the fracture Intramedullary device to share the load.<br>* Other names: Interlock nailing;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight bearing | when patient started to fully bear weight on affected leg after intervention | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of union | time for union during which three cortices of the bone seem united radiologically | 12 weeks |