linjc16/ctgov huggingface dataset:
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy for cervical ripening in labor induction between titrated and conventional oral misoprostol

Official Title
-----------------
The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol

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

Intervention / Treatment
-----------------
* Drug: misoprostol
* Drug: misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years old or more singleton pregnancy at 37 weeks gestation or more cephalic presentation reassuring fetal heart rate pattern admission for labor induction due to medical or obstetrical conditions bishop score less than 6 giving consent and having signed the consent form for this study Exclusion Criteria: parity more than 3 estimated fetal weight more than 3,500 grams non-reassuring fetal heart rate pattern having contraindication for vaginal delivery previous uterine scar suspected abruptio placenta with non-reassuring fetal heart rate pattern abnormal bleeding per vagina, except bloody show PROM having underlying cardiac, hepatic, or renal diseases having history of allergy to misoprostol or prostaglandin analogues cervical dilatation 3 centimeters or more uterine contraction 3 times or more in 10 minute

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional oral misoprostol<br>misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 centimeters | Drug: misoprostol<br>* misoprostol 50 micrograms oral every 4 hours until cervical dilatation 3 cm<br>* Other names: cytotec;|
| Experimental: titrated oral misoprostol<br>misoprostol 20 micrograms oral every hour until cervical dilatation 3 centimeters | Drug: misoprostol<br>* misoprostol 20 micrograms oral every hours until cervical dilatation 3 cm<br>* Other names: cytotec;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of cervical ripening in labor induction |  | 12 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of vaginal delivery |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Efficacy, Cervical ripening/Labor induction, Titrated oral misoprostol/Conventional oral misoprostol, Term pregnancy
Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)

Study Overview
=================
Brief Summary
-----------------
This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.

Official Title
-----------------
A Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behavioural Therapy (CBT) for Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: Active tDCS + CBT
* Device: Sham tDCS + CBT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants will be ≥ 18 years old. Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration. MADRS score ≥ 20 at study entry. Exclusion Criteria: Participant is unable to give informed consent. DSM-IV diagnosis of psychotic disorder (lifetime). Bipolar disorder diagnosis and not on a mood stabiliser. Eating disorder (current or within past year). Obsessive compulsive disorder (lifetime). Post-traumatic stress disorder (current or within past year). Mental retardation. Drug or alcohol abuse or dependence (preceding 3 months). Inadequate response to ECT (current episode of depression). Rapid clinical response required, e.g., high suicide risk, inanition or psychosis. Clinically defined neurological disorder or insult. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. Pregnancy. Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication. Change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial. Participant becomes hypomanic or manic, as defined by DSM-IV.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS<br> | Device: Active tDCS + CBT<br> <br> |
| Sham Comparator: Sham tDCS<br> | Device: Sham tDCS + CBT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale for Depression (MADRS) |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression and Anxiety Stress Scale |  | 3 weeks |
Effects of DASH Diet on Corticosteroids Medication Use

Study Overview
=================
Brief Summary
-----------------
To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use.

Detailed Description
-----------------
Objective: To determine the effects of the Dietary Approaches to Stop Hypertension (DASH) diet on the metabolic side effects of corticosteroids medications use. Design: A randomized clinical trial was undertaken in 60 patients on corticosteroid therapy for 10 weeks. Patients were randomly assigned to a DASH or control diet. Fasting blood sample were measured to determine blood glucose and lipid profile. Blood pressure and anthropometric measurements were measured based on the standard guidelines.

Official Title
-----------------
Phase 3 Study of Beneficiary Effects of Dietary Approaches to Stop Hypertension (DASH) on the Metabolic Aeffects of Corticosteroids Medications Use

Conditions
-----------------
Nutritional and Metabolic Disease

Intervention / Treatment
-----------------
* Other: nutrition intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were on corticosteroid therapy Exclusion Criteria: refuse to follow the visits

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 35 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: diet intervention, DASH diet<br>intervention: nutrition intervention: DASH diet | Other: nutrition intervention<br>* DASH diet control diet<br>|
| No Intervention: not intervention, control diet<br>control weight loss diet | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the amount of weight reduction and change of blood pressure | weight (kg) body mass index (kg/m2) blood pressure (mmHg) | up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile, fasting blood glucose | measurement of LDL-C (mg/dl), HDL-C (mg/dl), triglyceride (mg/dl), total cholesterol (mg/dl), fasting blood glucose(mg/dl), by the analysis of blood samples and blood pressure(mmHg) and weight (kg), waist circumference (cm), body mass index (kg/m2). | 10 weeks |
Prospective Randomized Study of SILS Versus CLS for Rectal Cancer

Study Overview
=================
Brief Summary
-----------------
Background: Single-port laparoscopic surgery is emerging as a method to improve morbidity and cosmetic benefits of conventional laparoscopic surgery and minimize the surgical trauma. However, the feasibility of this procedure in rectal surgery has not been determined yet. The aim of this study is to evaluate our initial experience using single port access in laparoscopic rectal surgery. Design: randomized, prospective clinical study Patients: 40 patients

Official Title
-----------------
Prospective Randomized Study of Single Incision Laparoscopic Surgery Versus Conventional Laparoscopic Surgery for Rectal Cancer

Conditions
-----------------
Rectal Cancer, Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: Single Incision Laparoscopic Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years of age. ASA I-III. Tumor-location: maximum 15 cm from the anal verge. No involvement of neighbouring organs. No distant metastasis. Exclusion Criteria: Linguistic, physical or psychological barriers precluding oral and written consent. History of intestinal surgery (excl. appendectomy).

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: SILS-group<br>20 patients undergoing Single Incision Laparoscopic Surgery | Procedure: Single Incision Laparoscopic Surgery<br>* Single incision laparoscopic surgery for rectal cancer<br>|
| No Intervention: CLS-group<br>20 patients undergoing Conventional Laparoscopic Surgery for rectal cancer | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity | The purpose of this study is to compare 30-days postoperative morbidity between the two groups | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunology | to compare results of blood-samples (C-reactive protein, leucocyte-count and interleukin-6) 72 hours postoperatively between the two groups | 72 hours postoperatively | 
| postoperative outcome | to compare postoperative results (postoperative pain, time to bowel function, time to regain full diet and mobilisation) between the two groups. | 5 days postoperatively | 
| oncology | Comparison of the oncological results (quality of specimen, completeness of mesorectal fascia, circumferential resection margin, number of harvested lymphnodes, TNM-classification) between the two groups. | 30 days |
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

Study Overview
=================
Brief Summary
-----------------
This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

Official Title
-----------------
A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.

Conditions
-----------------
Anemia, Kidney Disease, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Chronic kidney disease, in pre-dialysis or dialysis Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics Exclusion Criteria: Anemia due to non-renal causes Pregnant or lactating women Uncontrolled hypertension Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines |  | 2 years | 
| Maintenance of target Hb range (10-12 g/dL) |  | 2 years | 
| Safety: Incidence of adverse events |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between baseline clinical variables and time on target Hb level |  | 2 years | 
| Dosing pattern in clinical practice, including dose adaptations |  | 2 years | 
| Frequency of visits and laboratory assessments |  | 2 years | 
| Effect of compliance to treatment on Hb levels |  | 2 years |
Deep Brain Stimulation for the Treatment of Obesity

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option for obesity.

Detailed Description
-----------------
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option in the management of severe, treatment refractory, morbid obesity.

Official Title
-----------------
Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 24 months post Roux-en-Y gastric bypass surgery without evidence of a sustained improvement in BMI after gastric bypass surgery for at least 6 months. Participant is willing to comply with all follow-up evaluations at the specified times Participant is able to provide informed consent Fluent in English Exclusion Criteria: Medical contraindications for general anesthesia, craniotomy, or DBS surgery Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas. Severe cardiovascular, pulmonary, renal, liver, hematological disease, severe coagulopathy, acute infectious process

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DBS Surgery<br>All patients enrolled will undergo DBS implantation in the targeted region to assess the safety of the procedure and the efficacy through weight loss. | Device: Deep Brain Stimulation Device<br>* Deep brain stimulation surgery<br>* Other names: Reclaim;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of excess weight loss | The primary outcome measure at the conclusion of the study will be percent of excess weight loss (EWL). | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, DBS
Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT)

Study Overview
=================
Brief Summary
-----------------
The first aim of this study is to test the effect of the case management on the evolution of therapeutic alliance in patients with first episode psychosis in comparison with traditional nursing. The second aim is to test the effect of case management on nurses' well-being in comparison with traditional nursing. The third objective aims to show if therapeutic alliance is associated with insight in patients and with clinical and demographic data.

Official Title
-----------------
Impact of Case-management on Therapeutic Alliance With First Episode Psychosis Patients (CAMAT)

Conditions
-----------------
Psychotic Disorders

Intervention / Treatment
-----------------
* Behavioral: Case-management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 16 and 30 years First episode psychosis diagnosis according to DSM-5 criteria Exclusion Criteria: Lees of 16 years or more than 30 years Not fulfilling DSM-5 criteria for first episode psychosis Any treatment with the psychologist or the psychiatrist of the team

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case-management<br>Patients will meet the case-manager 5 times per month during 1h30 in community living | Behavioral: Case-management<br> <br> |
| traditional nursing<br>Patients will meet the case-manager 2 times per month during 1h00 in hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work alliance inventory |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birchwood insight scale |  | 6 months | 
| Scale to assess Unawareness of Mental Disorder |  | 6 months | 
| Well-being at work scale |  | 6 months |
Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation exists.

Detailed Description
-----------------
Sidestream Darkfield imaging is used to determine rectal microcirculatory flow in patients after postoperative cardiac surgery. At the same time PCO2 gap is established by monitoring rectal CO2 (tonometry) and arterial CO2 After initial enrollment and first analysis we also includes a control group with equal inclusion criteria for sublingual SDF imaging.

Official Title
-----------------
Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac surgery informed consent age > 18 Exclusion Criteria: pregnancy off pump procedure rectal fecal contamination

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 |
| --- | --- | --- |
| Relation between MFI (by SDF) and capno |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relevance of changes in flow and metabolism |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microcirculation, cardiac surgery, metabolism, capnometry
COL4A1 Gene Related Cerebra-retinal Angiopathy

Study Overview
=================
Brief Summary
-----------------
This prospective multicenter cohort study aims to define the clinical, radiological and mutational spectrum of the disease related to COL4A1 gene.

Detailed Description
-----------------
150 index patients (children or young adult) will be prospectively recruited over three years according to eligibility criteria. Relatives will be also recruited. Clinical, brain MRI-MRA and genetic testing (COL4A1 mutation screening) will be conducted for each included patient or asymptomatic relatives. 13 French investigating centres will be participating to the study.

Official Title
-----------------
COL4A1 Gene Related Cerebra-retinal Angiopathy : Clinical Spectrum From Children to Adult, Mutational Spectrum and Application to Routine Management of Affected Patients : a Prospective Cohort Study

Conditions
-----------------
Cerebra-retinal Angiopathy

Intervention / Treatment
-----------------
* Genetic: COL4A1 genetic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria for the index patient : Children and young adult (< 65 years) Intracranial hemorrhage of unknown etiology leukoencephalopathy Any associated signs (including retinal arteriolar tortuosity, intracranial aneurysm, porencephaly, Infantile Cerebral Palsy, juvenile cataract) Exclusion criteria: (for the index patient) Hypertension Diabetes Other (than COL4A1) genetic small vessel diseases of the brain
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COL4A1 genetic testing<br>COL4A1 genetic testing | Genetic: COL4A1 genetic testing<br>* genetic testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implication of COL4A1 gene (and other related genes) in intracranial haemorrhages of unknown etiology in children and young adults and in brain diffuse small vessel diseases of unknown etiology in young adults. |  | at 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the whole clinical, radiological and mutational spectrum of COL4A1 gene. |  | at 36 months | 
| To define any genotype-phenotype correlation in COL4A1 gene disease. |  | at 36 months | 
| Application of the results in daily clinical practice |  | at 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genetic, Cerebral angiopathy, Retinal angiopathy, COL4A1 gene, Infantile Cerebral Palsy, Congenital porencephaly, Congenital cataract, Leukoencephalopathy, COL4A1 gene related cerebra-retinal angiopathy