linjc16/ctgov huggingface dataset:
Mechanisms of Refractory Hypertension (Reserpine)

Study Overview
=================
Brief Summary
-----------------
The study is deigned to determine if refractory hypertension is attributable to heightened sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic agent, in patients failing other classes of antihypertensive agents.

Detailed Description
-----------------
Patients with refractory hypertension, defined as uncontrolled office blood pressure despite use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone. After withdrawal from other centrally-acting agents if needed, enrolled patients will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. Twenty-four hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week treatment period. All other antihypertensive medications will remain unchanged during the 4-week treatment period. The primary endpoint will be change in 24-hr ambulatory systolic blood pressure.

Official Title
-----------------
Mechanisms of Refractory Hypertension (Reserpine)

Conditions
-----------------
Refractory Hypertension

Intervention / Treatment
-----------------
* Drug: Reserpine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone Exclusion Criteria: congestive heart failure (EF 40%) chronic kidney disease (GFR <40 ml/min/1.73 mm) stroke and/or myocardial infarction or acute CHF exacerbation within last 3 months ongoing depression active peptic ulcer disease bradycardia <50 beats per minute 2nd or 3rd degree heart block known intolerance of reserpine use of digoxin or tricycle antidepressants

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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
Interventional Model Description: Open-label, dose titration study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reserpine<br>Subjects will receive open-label reserpine 0.1 mg daily for 4 weeks. | Drug: Reserpine<br>* Open label reserpine 0.1 mg pill orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Ambulatory Systolic Blood Pressure | Twenty-four hour ambulatory systolic blood pressure | Baseline and 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, sympathetic tone, resperpine
Vitamin D Status and Muscle Function

Study Overview
=================
Brief Summary
-----------------
People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due to low sun exposure and the risk may be even more pronounced among elite swimmers since indoor training further reduces sun exposure. In light of this, the investigators want to examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength.

Detailed Description
-----------------
To examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength, twenty-nine swimmers, 12 female and 17 male (16-24 years) residing at latitude 55-56°N were included to the trial conducted in March-April. Blood samples were analysed for serum 25-hydroxyvitamin D (s-25(OH)D) and hand-grip strength was measured as marker of muscle strength. Subjects´ vitamin D and calcium intake were assessed by food frequency questionnaire and sun exposure and training status by questionnaires.

Official Title
-----------------
Vitamin D Status and Muscle Function Among Adolescent and Young Swimmers.

Conditions
-----------------
Vitamin D Status, Muscle Function

Intervention / Treatment
-----------------
* Other: Screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 16-35 years Top atlets, conducting: Hard physical activity Indoor elitesport min. 10 hours a week Healthy, without use of any medications Eat fish max 2 times per week Exclusion Criteria: Use of corticosteroids Illness Use of supplements Use of solarium Donation of blood within the last 3 months Having spent time below the latitude of 42° north from September through April

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 Years

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 |
| --- | --- |
| Swimmers<br>Screening of elite athletes | Other: Screening<br>* Screening of elite swimmers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25-hydroxyvitamin D (s-25(OH)D) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food frequency questionnaire |  | One week | 
| Hand-grip strength |  | 2 months |
Use of Clarithromycin in Mustard-Induced Bronchiolitis

Study Overview
=================
Brief Summary
-----------------
We looked for the effectiveness of low-dose long-term prescription of clarithromycin in mustard-induced chronic pulmonary lesions, especially bronchiolitis obliterans

Official Title
-----------------
Phase III, Randomized, Double Blind Study of Low Dose Long Term Clarithromycin Versus Placebo in Treatment of Chronic Pulmonary Lesions Due to Sulfur Mustard

Conditions
-----------------
Bronchiolitis Obliterans, Acute Obliterating Bronchiolitis

Intervention / Treatment
-----------------
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: His/her own will to participate Documented chemical exposure Clinical, spirometric and radiological findings were compatible with BO on High Resolution Computed Tomography (HRCT) Exclusion Criteria: any drug reactions during the trial history of sensitivity to macrolides diarrhea, gray stool, jaundice, eosinophilia, acute cholestatic hepatitis, pruritis, dark urine, abdominal pain, osteomatosis, depression, taste change, behavioural changes, early fatigue, odynophagia, glossitis , dizziness co-adminstration of: terfenadine, theophylline, carbamazepine, ergotamine, dihydroergotamine, warfarin, cisapride, digoxin, triazolam, phenytoin, steroids, any immunosuppressive, any systemic antibiotics using drugs that he/she cannot discontinue using drugs with potential interaction subject will to exit from the trial history of lobe resection of lung history of exacerbation in the last month prior to the beginning of trial continuous need to oxygen use of corticosteroids in last week prior to the trial beginning Radiographic evidence of pneumonia, active tuberculosis, lung carcinoma, or an infection that necessitated the use of an antibiotic exacerbating of subjects creatinine srum level more than normal increasing ALT, AST levels total bilirubin more twice than normal subjects who did not use their drugs properly
Sexes Eligible for Study
-----------------
Male

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: Clarithromycin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

Study Overview
=================
Brief Summary
-----------------
This is a trial to investigate the effectiveness and safety of [S,S]-Reboxetine in relieving chronic peripheral pain suffered by patients with diabetes. Some evidence for the effectiveness of [S,S]- Reboxetine in relieving chronic pain has been seen in 3 completed trials.

Official Title
-----------------
A Randomized, Double-Blind Placebo Controlled Trial Of [S,S]-Reboxetine In Patients With Chronic Painful Diabetic Peripheral Neuropathy.

Conditions
-----------------
Diabetic Neuropathies

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: [S,S]-Reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female of any race at least 18 years of age Diagnosis of painful, distal, symmetrical, sensory-motor polyneuropathy, which is due to diabetes, for at least 1 year Patients at Visit 1 must have a score ≥40 mm on the Pain Visual Analogue Scale Exclusion Criteria: Patients with significant hepatic impairment Neurological disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathic pain Any pain or other condition that may confound assessment or self-evaluation of the pain due to diabetic neuropathy Amputations other than toes A current or recent diagnosis (past 6 months) or episode of major depressive disorder and/or uncontrolled depression History of transient ischemic attack or stroke Myocardial infarction or unstable angina within the past three months

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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral tablet once a day dosing for 10 weeks.<br>|
| Experimental: 2<br> | Drug: [S,S]-Reboxetine<br>* Oral tablet once a day dosing for 10 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in weekly average pain score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rates (patients with a 30% reduction from baseline in weekly average pain score and patients with a 50% reduction from baseline in weekly average pain score) |  | 8 weeks | 
| Change from baseline in weekly average sleep interference scale |  | 8 weeks | 
| Change from baseline in the total score and each dimension of the Neuropathic Pain Symptom Inventory |  | 8 weeks | 
| Modified Brief Pain Inventory-Short Form |  | 8 weeks |
Saliva and Dental Calculus in Handicapped People

Study Overview
=================
Brief Summary
-----------------
This is an evaluation of potential differences in saliva composition and dental calculus composition between orally fed and tube fed individuals in an institutional environment.

Official Title
-----------------
The Relationship Between Saliva and Dental Calculus in a Population of Institutionalized Handicapped Persons

Conditions
-----------------
Disabled Persons

Intervention / Treatment
-----------------
* Procedure: saliva sampling + dental calculus collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: handicapped (mentally and/or physically) persons in an institute older than 5 years of age both sexes full medical records available Exclusion Criteria: healthy individuals disabled individuals not staying in an institution

Ages Eligible for Study
-----------------
Minimum Age: 5 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

| Intervention/Treatment |
| --- |
|Procedure: saliva sampling + dental calculus collection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva composition and dental calculus composition |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Handicapped individuals
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Study Overview
=================
Brief Summary
-----------------
Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively. These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms

Official Title
-----------------
Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound

Conditions
-----------------
Prolapse of the Uterus

Intervention / Treatment
-----------------
* Other: perineal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years of female sex Patient with double laparoscopic promontofixation without associated hysterectomy Exclusion Criteria: History of hysterectomy Anterior cure (before index intervention) of prolapse with placement of prosthetic material.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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: Perineal ultrasound to visualize the strips and their position<br> | Other: perineal ultrasound<br>* Ultrasound measurement of the size and position of the prostheses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the reproducibility study of intra and interobserver measurements of the size of promontofixation prostheses |  | 10 minutes | 
| Evaluate the reproducibility study of intra and interobserver measurements position of promontofixation prostheses |  | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect the position of the strips |  | 20 minutes | 
| Collect the symptoms of the patients |  | 20 minutes |
Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Study Overview
=================
Brief Summary
-----------------
Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years. The investigators' primary hypothesis is that time from end of medication to extubation will be shorter with dexmedetomidine sedation.

Official Title
-----------------
A Prospective, Double-blind Study of Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Conditions
-----------------
Sedation

Intervention / Treatment
-----------------
* Drug: dexmedetomidine
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent from parents age between 2 and 18 years anticipated need of respirator treatment for more than 24 hrs included in study within 48 hrs of admission to intensive care unit (ICU) Exclusion Criteria: severe, unstable circulatory failure severe intracranial or spinal trauma with circulatory instability sever bradycardia or atrioventricular (A-V) block liver failure less than 50% chance of anticipated survival known allergy to study drugs

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: midazolam<br> | Drug: Midazolam<br>* Midazolam is given as major sedative drug<br>|
| Experimental: dexmedetomidin<br> | Drug: dexmedetomidine<br>* Dexemedethomidine is given as major sedative drug<br>* Other names: Midazolam is given as major sedative drug;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from end of sedation to extubation |  | 1-24 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
To see if sedation with dexmedetomidine results in faster emergence after end of intensive care treatment in children, treatment
Magnetic Resonance Imaging (MRI) of Appendicitis in Children

Study Overview
=================
Brief Summary
-----------------
Study to find out if MRI can diagnose appendicitis in children as well as or better than CT scan and/or ultrasound scan performed at the same time. No additional contrast material or sedation will be used to perform the MRI.

Official Title
-----------------
Magnetic Resonance Evaluation of Appendicitis in Children Aged 8-18

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Device: MRI of the abdomen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 8-18 years, referred from emergency department for suspected appendicitis and receiving either CT scan or ultrasound of the abdomen for diagnosis Exclusion Criteria: Failure to pass MRI metal screening. Claustrophobia or need for sedation due to inability to hold still.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Only one arm<br>All patients enrolled will receive an MRI of the abdomen with detailed views of the appendix | Device: MRI of the abdomen<br>* Multiple MRI pulse sequences of the abdomen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Sensitivity/Specificity and Accuracy of Appendiceal MRI Comparedsurgical Findings or Clinical Follow-up | Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) | during diagnostic procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Appendicitis, Children, Magnetic Resonance Imaging
Hepatitis C in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients.

Official Title
-----------------
Hepatitis C in Renal Transplant Recipients - Safety and Efficacy of a Conversion of Immunosuppression to High-dose Cyclosporine A and Its Impact on Hepatitis C Virus-replication, Parameters of Liver Function and Glucose Tolerance. An Open Label Trial.

Conditions
-----------------
Chronic Hepatitis C-virus Infection, Renal Transplantation

Intervention / Treatment
-----------------
* Drug: tacrolimus-cyclosporine A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent prior renal transplantation current tacrolimus-based immunosuppressive regimen hepatitis C-infection age 18-70 years Exclusion Criteria: current hemodialysis or peritoneal dialysis pregnancy or breastfeeding known contraindication for cyclosporine A-treatment

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tacrolimus-cyclosporine A<br>conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients | Drug: tacrolimus-cyclosporine A<br>* conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Hepatitis C-virus load at 12 weeks |  | one day before and 4, 8 and 12 weeks after the conversion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in oral glucose insulin sensitivity (OGIS) index at 12 weeks |  | one day before and 12 weeks after the conversion | 
| change in serum hepcidin levels at 12 weeks |  | one day before and 12 weeks after the conversion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic hepatitis C-virus infection, renal transplantation, glucose tolerance, immunosuppression