linjc16/ctgov huggingface dataset:
Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives

Study Overview
=================
Brief Summary
-----------------
To study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment.

Official Title
-----------------
Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives

Conditions
-----------------
Obesity, Hypertension

Intervention / Treatment
-----------------
* Drug: sibutramine
* Drug: sibutramine
* Drug: verapamil/trandolapril
* Drug: metoprolol/HCT
* Drug: felodipine/ramipril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated essential hypertension. Obesity: BMI 27-35 kg/m2 Exclusion Criteria: Secondary hypertension. Stage 3 hypertension. Secondary obesity; BMI > 35kg/m2. CAD; MI within past 6 months; NYHA stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis. Kidney failure. Liver failure. Hyperthyroidism. Unstable DM. Carcinoma. Severe chronic infectious disease. Alcohol or drug abuse. Pregnancy. Epilepsy. Psychosis or treatment with antidepressants or major tranquilizers

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>verapamil/trandolapril | Drug: sibutramine<br>* 8-wks, sibutramine, 10 mg, capsules, once daily<br>* Other names: Reductil;Drug: sibutramine<br>* 8-wks, sibutramine, 15 mg, capsules, once daily<br>* Other names: Reductil;Drug: verapamil/trandolapril<br>* 2 wk Run-in phase, antihypertensive therapy only<br>|
| Active Comparator: 2<br>metoprolol/HCT | Drug: sibutramine<br>* 8-wks, sibutramine, 10 mg, capsules, once daily<br>* Other names: Reductil;Drug: sibutramine<br>* 8-wks, sibutramine, 15 mg, capsules, once daily<br>* Other names: Reductil;Drug: metoprolol/HCT<br>* 2 wk Run-in phase, antihypertensive therapy only<br>|
| Active Comparator: 3<br>felodipine/ramipril | Drug: sibutramine<br>* 8-wks, sibutramine, 10 mg, capsules, once daily<br>* Other names: Reductil;Drug: sibutramine<br>* 8-wks, sibutramine, 15 mg, capsules, once daily<br>* Other names: Reductil;Drug: felodipine/ramipril<br>* 2 wk Run-in phase, antihypertensive therapy only<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | Duration of Study | 
| Diastolic Blood Pressure |  | Duration of Study |
Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy

Study Overview
=================
Brief Summary
-----------------
Babies born to mothers with pregestational diabetes will be screened with parental consent for sacral agenesis

Detailed Description
-----------------
Parent/s of babies born to mothers with pregestational diabetes who have normal clinical examination and have no radiographs showing a normal sacrum will be approached for a spinal US

Official Title
-----------------
Screening for Sacral Agenesis in Offspring of Mothers With Diabetes in Pregnancy

Conditions
-----------------
Infant of Diabetic Mother, Sacral Agenesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants born to mothers with pregestational diabetes Normal spinal examination Exclusion Criteria: Infants born to mothers with pregestational diabetes Abnormal spinal examination such as a sacral dimple Radiograph with abnormal sacrum Spanish speaking parents
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 |
| --- | --- | --- |
| Babies with sacral agenesis identified with screening of asymptomatic babies with a spinal ultrasound | All babies who have tethered cord on spinal US will be referred to neurosurgery | 12 months |
To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery

Study Overview
=================
Brief Summary
-----------------
This is a study to investigate the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery . This will include enrolment of 400 patient undergoing open heart surgery .

Official Title
-----------------
Unrecognised Obstructive Sleep Apnoea In Cardiac Surgery Patient In The Asian Population

Conditions
-----------------
Obstructive Sleep Apnoea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults male and female , aged 45 years old and above undergoing open heart surgery that requires hospital stays of more than 5 days Exclusion Criteria: previous diagnosis and treatment of OSA or any sleep related breathing disorder. unwilling or physically unavailable for polysomnography before surgery. Patient undergoing MAZE procedure . Patient with severe COPD

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- | --- |
| Incidence of Obstructive Sleep Apnoea | To look at the incidence of Obstructive Sleep Apnoea in Patient undergoing open heart Surgery . | 2 years |
Liver Enzymes and Fluid Balance Following Colorectal Surgery

Study Overview
=================
Brief Summary
-----------------
The use of epidural anesthesia and postoperative analgesia influences fluid balance following colorectal surgery. Markers such as BNP (brain natriuretic peptide) and liver function enzymes can estimate intravascular fluid load and predict outcome after colorectal surgery.

Conditions
-----------------
Fluid Balance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing colorectal surgery Exclusion Criteria: Severe cardiac failure Severe renal failure Severe liver failure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| epidural<br> | |
| general anesthesia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver enzymes |  | 5 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BNP (brain natriuretic peptide) |  | 5 days |
Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

Study Overview
=================
Brief Summary
-----------------
To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium

Official Title
-----------------
Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

Conditions
-----------------
Pterygium, Primary

Intervention / Treatment
-----------------
* Procedure: Conjunctival autograft using fibrin glue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of primary pterygium Symptomatic pterygium Limbal invasion Exclusion Criteria: Secondary pterygium
Sexes Eligible for Study
-----------------
All

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

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 |
| --- | --- |
| Other: Fibrin glue<br> | Procedure: Conjunctival autograft using fibrin glue<br>* Conjunctival autograft using fibrin glue in pterygium surgery<br>* Other names: Pterygium surgery using fibrin glue;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of pterygium after its excision with the conjunctival autograft technique. |  | One, three and five months after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure. |  | One day, one week and one month after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pterygium, Autologous Transplantation, Conjunctiva, Fibrin Tissue Adhesive, Recurrence
Long Term Follow-Up After Patients Underwent Total Hip Replacement

Study Overview
=================
Brief Summary
-----------------
The investigators want to contact patients that underwent total hip replacement for the past ten years. The investigators will ask them about their daily living, functioning and quality of life.

Conditions
-----------------
Total Hip Replacement, Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. total hip replacement from 01.01.2002 Exclusion Criteria: 1. no

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 85 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 |
| --- | --- |
| total hip replacement, quality of life, functioning<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | quality of life will be assessed by the SF-12 questionnaire. We will compare between the results from the last visit to the current. | up to ten years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functioning | functioning will be assessed by the Harris Hip Score. We will compare between the results from the last visit to the current visit | up to ten years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, functioning
Impact of Infant Formula on Caregiver-perceived Intolerance

Study Overview
=================
Brief Summary
-----------------
Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms

Official Title
-----------------
Impact of Infant Formula on Caregiver-perceived Intolerance

Conditions
-----------------
Healthy Infants

Intervention / Treatment
-----------------
* Other: Routine infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infant Full-term (> 37 weeks gestation) Birth weight > 2500 and < 4500 g 14-60 days of age on enrollment Singleton birth Infant's mother has elected not to breastfeed prior to enrollment Infant exclusively formula-fed for at least 5 days prior to enrollment Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days Caregiver wishes to switch infant's formula Has not received solid foods Having obtained his/her legal representative's informed consent Exclusion Criteria: Known or suspected cow-milk allergy Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic) Has switched formula more than two times since hospital discharge Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu) Congenital illness or malformation that may affect infant feeding and/or growth Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment Receiving probiotic supplements Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen). Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.

Ages Eligible for Study
-----------------
Minimum Age: 14 Days
Maximum Age: 60 Days

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

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

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: Intervention<br>Routine infant formula | Other: Routine infant formula<br>* Routine infant formula with probiotic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant GI Symptom Burden | Study personnel will administer questionnaire | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Formula Intake | Caregivers will document on diary records | 24 hours | 
| Fussiness | Caregivers will document on diary records | 24 hours | 
| Formula Satisfaction Questionnaire | Study personnel will administer questionnaire | 3 weeks | 
| Adverse Events | Assessed throughout study | 24 hours and 3 weeks |
Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis (AS).

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing Spondylitis

Conditions
-----------------
Ankylosing Spondylitis

Intervention / Treatment
-----------------
* Drug: Etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis. Active AS, defined by average of visual analog scale (VAS) of ≥ 30 for duration and intensity of morning stiffness and at least 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100). Exclusion Criteria: Complete ankylosis (fusion) of spine. Previous treatment with etanercept, antibody to Tumor Necrosis Factor α (TNFα), or other TNFα inhibitors or other biologic agents. Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study. Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline. Dose of NSAID changed within 2 weeks of baseline evaluation. Dose of prednisone >10 mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Etanercept|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly. |  |  |
Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare the analgesic-treated children with analgesic prior to the treatment and to compare the postoperative analgesic needs of children undergoing dental treatment under general anesthesia.

Detailed Description
-----------------
The investigator's study included patients who were admitted to Inonu University and Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry in 2019 and decided to perform dental treatment under general anesthesia. Patients 1 to 7 years of age with dental treatment between February 28 and June 1, 2019 will be included. Patients who underwent analgesic 15 minutes after the induction of general anesthesia from the patients, and those who made painkillers 15 minutes before the end of the treatment will constitute the control group. Paracetamol 15 mg / kg IV will be given in 50 ml of saline. The demographic data of the children to be included in the study such as age, gender, type of dental intervention, duration of operation, postoperative pain scores, recovery times will be recorded and compared.

Official Title
-----------------
Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia in Children

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: Preemptive Analgesics
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be treated under general anesthesia No systemic disease To have at least one painful dental procedure in the upper and lower jaw (pulpectomy, pulpotomy Exclusion Criteria: Patients with mental or physical disabilities of any disease Patients who have not undergone painful dental intervention under general anesthesia

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group Control<br>Analgesic application15 minutes before the end of the treatment will constitute the control group. | Drug: Control<br>* Analgesic application15 minutes before the end of the treatment<br>* Other names: Preventive analgesic;|
| Group preemptive<br>Patients who underwent analgesic 15 minutes after the induction of general anesthesia . | Drug: Preemptive Analgesics<br>* Analgesic application15 minutes before the treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative dental pain | Wong-Baker faces Scale is validated for children aged 3 to 7 years, includes six cartoon faces corresponding to scores 0-5 (0=no hurt, 1= hurts a little bit, 2= hurts a little more, 3=hurts even more, 4= hurts a whole lot, 5=hurts worst). | An average of 24 hours postoperatively |
A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various countries in order to obtain country-specific data.

Official Title
-----------------
A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: etonogestrel implant (Implanon)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible subjects are healthy premenopausal women requiring a long-term method of contraception, with a body mass index between 18 and 29 kg/m2, who are willing to give voluntary written informed consent. Subjects must have regular cycles with a usual length between 24 and 35 days. Exclusion Criteria: Male Postmenopause Infertile Under 18; Over 40

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Healthy premenopausal women requiring a long-term method of contraception | Drug: etonogestrel implant (Implanon)<br>* subdermal etonogestrel implant<br>* Other names: Org 3236;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy |  | Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years. | 
| (Serious) adverse events |  | Continuous, recorded at visits conducted every 3 months for the entire trial duration of 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability (satisfaction questionnaire) |  | Every 3 months, for the entire duration of the trial |
Association Between Peripheral Artery Stiffness and Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
Arterial pulse wave velocity (PWV) is strongly correlated with atherosclerosis, and the PWV of carotid or femoral artery could predict the severity of arterial atherosclerosis. Because the measurement of PWV is noninvasive, it would serve as a good clinical and screen marker to evaluate the extent of atherosclerosis. The study uses self-made PWV measurement device to investigate the correlation of the PWV in the high cardiovascular risk population, and compare it with normal population.

Conditions
-----------------
Arteriosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a high risk for cardiovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulse wave velocity, cardiovascular disease