linjc16/ctgov huggingface dataset:
Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia

Study Overview
=================
Brief Summary
-----------------
In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine that provides good hemodynamic stability compared to conventional anesthetic agents. This study aims to investigate whether remimazolam reduces vasoactive agent use during cryo/radiofrequancy ablation under general anesthesia, compared to desflurane(RCT).

Official Title
-----------------
Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial

Conditions
-----------------
Remimazolam, Desflurane, Cryoablation, Arrhythmia, General Anesthesia

Intervention / Treatment
-----------------
* Drug: Remimazolam besylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: =or > 20 years Admission for General anesthesia for RFCA or cryoablation procedure Exclusion Criteria: No severe adverse effect history or hypersensitivity of benzodiazepines or its additives Acute alcoholic intoxication state Coma or shock state due to other condition than heart problem. Acute narrow-angle glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 105 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam<br>General anesthesia with remimazolam-remifentanil TIVA. | Drug: Remimazolam besylate<br>* Remimazolam besylate TIVA<br>|
| No Intervention: Desflurane<br>General anesthesia with maintaining with desflurane (induction:PPF, remifentanil CIV) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressor CIV | Vasopressor CIV or not | During anesthesia | 
| Hypotension event | Hypotension event | During and after anesthesia | 
| Vasopressor (total amount) | Norepinephrine equivalent dose | During anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction time | Induction dose administration LOC | Induction | 
| Recovery time | Reversal agent administration extubation | Recovery | 
| Adverse event | Adverse event (desaturation, vomiting, hypotension, bleeding, allergic or anaphylaxis, etc.) | During and after anesthesia ( 24hr) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remimazolam, Desflurane, Arrhythmia, Cryoablation,heart, Cardiovascular disease
Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available

Study Overview
=================
Brief Summary
-----------------
When only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. There is no randomized trial compared the day 3 to day 5 for this subgroup.

Detailed Description
-----------------
Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.

Official Title
-----------------
Transfer of Single Embryo on Day 3 or 5 When Only One Embryo Transfer

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Embryo transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile couple with only one embryo available for transfer Exclusion Criteria: ineligible for study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Day 3 transfer<br>Transfer on day 3 when only one embryo is available | Other: Embryo transfer<br>* Transfer of only one embryo<br>|
| Experimental: Day 5 transfer<br>Transfer on day 5 when only one embryo is available | Other: Embryo transfer<br>* Transfer of only one embryo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | within 20 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical pregnancy rate |  | One month | 
| clinical pregnancy |  | 7 weeks of gestation | 
| Embryo development after In vitro fertilization cycle |  | 6 days after in vitro fertilization |
Prevention of Postpartum Haemorrhage

Study Overview
=================
Brief Summary
-----------------
Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial

Detailed Description
-----------------
This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage & reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. & reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.

Official Title
-----------------
Tranexamic Acid for the Prevention of Postpartum Haemorrhage

Conditions
-----------------
Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Tranexamic acid injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women at high risk for postpartum hemorrhage after cesarean section Exclusion Criteria: women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study<br>Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) . | Drug: Tranexamic acid injection<br>* 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .<br>* Other names: Kapron, 500 mg/5ml;|
| No Intervention: Control<br>control group will not be given tranexamic acid | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | Estimation of blood loss | immediately after deliver | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | blood pressure | immediately after delivery | 
| pulse | pulse | immediately after delivery | 
| temperature | temperature | immeditely after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cesarean section, tranexamic acid, postpartum hemorrhage
Home and School Visits Intervention for Children With DM TYPE 1

Study Overview
=================
Brief Summary
-----------------
Home and school visits by multidisciplinary team will improve metabolic control in kids having insulin dependent diabetes mellitus

Official Title
-----------------
The Efficacy of Constructed Intervention by Home and School Visits on Glycemic Control in Children With Type I Diabetes

Conditions
-----------------
Diabetes Type 1

Intervention / Treatment
-----------------
* Other: Home and school visits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c ≥ 8% at baseline, and diabetes duration of at least 7 months. Exclusion Criteria: Patients during honeymoon period Patients and their parents who do not speak Hebrew or Arabic Patients who were not under any educational system Patients who had other severe chronic disorders

Ages Eligible for Study
-----------------
Minimum Age: 4 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Home and school visits<br> | Other: Home and school visits<br>* Each child in the intervention group received, in addition to the standard care at the diabetic clinic, home and school visits by a multidisciplinary team during one year.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBA1C |  | 2 YEARS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of DKA episodes |  | 2 YEARS | 
| Number of Hospitalizations |  | 2 years | 
| Hypoglycemia rate |  | 2 years |
Safety and Tolerability of Oat Containing Gluten-free Diet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of oats in gluten free diet.

Official Title
-----------------
SAFETY AND TOLERABILITY OF OAT CONTAINING GLUTEN-FREE DIET

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Pure, uncontaminated oats


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children over 4 years and adults with celiac disease (diagnosed according to current guidelines) Subject is able to fully participate in all aspects of this clinical trial Exclusion Criteria: Known intolerance to oats Serious underlying disease other than CD which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>This is a single-arm interventional study, in which each patient gets 50 grams/day of pure, uncontaminated oats | Dietary Supplement: Pure, uncontaminated oats<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in immunological activity of the disease measured by specific antibodies |  | After 6 weeks | 
| Change in patient symptoms assessed by validated questionnaire |  | After 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palatability of oat-containing gluten-free products is evaluated through a product liking questionnaire |  | After 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
celiac disease, oat, gluten free diet
SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register

Study Overview
=================
Brief Summary
-----------------
The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions: How often does SDB occur in HF? What forms of SDB occur and how are they treated? How does SDB develop over time? How does the heart failure therapy affect SDB? What is the treatment adherence of patients treated? Does SBD and its treatment affect the survival of heart failure patients?

Official Title
-----------------
SchlaHF-XF- Register. Sleep Disordered Breathing in Heart Failure Register

Conditions
-----------------
Heart Failure (HF)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnose chronic heart failure, at least 3 months prior to diagnosis Age 18 years Signed informed consent Exclusion Criteria: Existing Positive Airway Pressure (PAP) therapy or long-term oxygen therapy Lack of capacity to consent minors persons who are housed on judicial or administrative order in an institution pregnant and lactating women

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 |
| --- | --- |
| Heart Failure patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of heart failure patients with sleep disordered breathing (apnea hypopnoea index >5) | Assess the changes in prevalence of SDB in HF from baseline to 5 years | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to sleep disordered breathing treatment | Assess changes in sleep disordered breathing when exposed to treatment from baseline to 5 years | 5 years | 
| Number of heart failure patients with sleep disordered breathing (apnea hypopnea index >5) when exposed to Heart Failure treatment | Assess changes in SDB when the patient is treated with heart failure therapy | 5 years | 
| Number of patients adherent to sleep disordered breathing treatment as measured by device reported usage hours | Assess adherence rates to treatment | 5 years | 
| Number of deaths of patients with HF and sleep disordered breathing (apnea hypopnoea index >5) who are treated for sleep disordered breathing | Assess survival rates of HF patients who are treated for sleep disordered breathing | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic heart failure, Positive Airway Pressure, Heart failure, Sleep disordered breathing, Sleep apnea
A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg

Official Title
-----------------
An Eight Week, Multicenter Study to Evaluate Efficacy and Safety of the Triple Combo of Aliskiren /Valsartan/HCTZ (300/320/25 mg), Compared to the Double Combos of Aliskiren/HCTZ (300/25 mg) or Valsartan/HCTZ (320/25 mg) in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg

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

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential hypertension Patients who are eligible and able to participate in the study Exclusion Criteria Severe hypertension History or evidence of a secondary form of hypertension Other protocol-defined exclusion criteria may apply.

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

| Intervention/Treatment |
| --- |
|Drug: aliskiren|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diastolic blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks |  |  | 
| Change from baseline in standing blood pressure after 4 weeks and 8 weeks |  |  | 
| Achieve blood pressure control target of < 140/90 mmHg after 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, aliskiren, blood pressure, valsartan, HCTZ
Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA

Study Overview
=================
Brief Summary
-----------------
As we have previously reported, the primary cause of hip OA with accompanying joint pain might be bone alterations which can be microfracture. In order to prove it, it is planned that conservative treatment will be performed on the hip OA patients with accompanying joint pain for the first year. For the second year, if the patients still have joint pain, they will do non-weght bearing walk.

Official Title
-----------------
Non-weight Bearing in Hip Joint With Accompanying Joint Pain Might Not Progress Radiographic OA

Conditions
-----------------
Hip OA

Intervention / Treatment
-----------------
* Procedure: To MRI-detecting bone signal changes in radiographic hip OA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hip OA, Joint pain Exclusion Criteria: Obvious radipgraphic fracture in hip joint,
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone Signal Changes<br> | Procedure: To MRI-detecting bone signal changes in radiographic hip OA<br>* To examine whether or not non-weight bearing reduced OA progression<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Signal Changes on the Hip MRI |  | 1 - 2 years |
Long-Term Tetrahydrobiopterin Treatment in PKU Patients of 0-18 Years - Study on Phenylalanine Tolerance and Safety

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to confirm the efficacy and safety of BH4 in the treatment of hyperphenylalaninemia caused by phenylalanine hydroxylase deficiency in patients responsive to BH4. The primary objective is to assess the effect of BH4 on phenylalanine tolerance compared to placebo under optimal blood phenylalanine control and to demonstrate safety in 12 months long-term treatment. Additionally population PK will be assessed.

Official Title
-----------------
Double-Blind, Placebo Controlled, Multicentre Study With an Open Label Extension to Evaluate the Efficacy and Safety of Tetrahydrobiopterin (BH4) in Children and Adolescents With Hyperphenylalaninemia Caused by Phenylalanine Hydroxylase Deficiency

Conditions
-----------------
Phenylalanine Hydroxylase Deficiencies

Intervention / Treatment
-----------------
* Drug: tetrahydrobiopterin (BH4)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male patients, aged 0-18 years Phenylalanine-4-hydroxylase (PAH) deficiency shown by mutation analysis Blood phenylalanine concentration in the target range under dietary treatment Written consent of a parent or legal representative Assumed availability within the period of study participation Patients/parents willing and able to follow the recommended diet Use of an effective method of contraception in female patients of child bearing potential Exclusion Criteria: BH4-deficiency due to genetic disorders in biosynthesis or recycling of BH4 History or current evidence of poor diet compliance History or current evidence of clinically relevant allergic or idiosyncratic reactions to drugs or food History of allergic reactions to BH4 or its excipients Positive pregnancy test (ß-HCG in serum) and lactating females Participation in other drug trials within the last 30 days before start for the study

Ages Eligible for Study
-----------------
Maximum 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

| Intervention/Treatment |
| --- |
|Drug: tetrahydrobiopterin (BH4)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dietary phenylalanine tolerance |  |  | 
| safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
phenylketonuria, phenylalanine hydroxylase deficiency, BH4, responsive, tetrahydrobiopterin, newborns, infants, children, adolescents