linjc16/ctgov huggingface dataset:
Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Study Overview
=================
Brief Summary
-----------------
Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites. Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites. The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).

Official Title
-----------------
Satavaptan in the Prevention of Ascites Recurrence: a Double-blind, Randomised, Parallel-group Comparison of Satavaptan at 5 to 10 mg Daily Versus Placebo With Concomitant Diuretics in Patients With Recurrent Ascites Due to Cirrhosis of the Liver.

Conditions
-----------------
Ascites, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Satavaptan
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with cirrhosis of the liver. Participants with recurrent ascites having undergone both of the following: therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of > 4 litres of fluid. at least one other therapeutic paracentesis in the previous 3 months. Exclusion Criteria: Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt. Known hepatocellular carcinoma. Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma. Participants previously exposed to satavaptan in the past 12 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 |
| --- | --- |
| Experimental: Satavaptan<br> | Drug: Satavaptan<br>* oral administration once daily<br>* Other names: SR121463B;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* oral administration once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and time of recurrences of therapeutic paracenteses |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomisation to first recurrence of ascites |  | study period | 
| Increase in ascites |  | over 12 weeks |
Registry of Participants With Generalized Myasthenia Gravis Treated With Alexion C5 Inhibition Therapies (C5ITs)

Study Overview
=================
Brief Summary
-----------------
Long-term, multicenter, multinational, observational, registry of patients with gMG that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT) such as eculizumab (Soliris®) and ravulizumab (Ultomiris®).

Detailed Description
-----------------
At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participants' medical history and gMG disease treatment history. Following enrollment, prospective data collection will be performed using data obtained as part of the routine clinical care and through patient-reported outcome methods in use. Data will be collected using an electronic data capture system. The duration of data collection for the Registry will be up to 5 years from the day of enrollment.

Official Title
-----------------
Long-Term, Observational, Global Registry of Patients With Generalized Myasthenia Gravis Who Have Received Treatment With Complement C5 Inhibition Therapies (C5ITs)

Conditions
-----------------
Generalized Myasthenia Gravis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with a diagnosis of gMG who are treated with Alexion C5IT at the time of enrollment, including patients previously treated with Soliris or Ultomiris and withdrawn from treatment. Capable of giving signed informed consent, which includes compliance with the protocol requirements and restrictions. Participants must have myasthenia gravis historical data, such as MG-ADL and MGFA class, available to be enrolled in the Registry. Exclusion Criteria: 1. Participants currently enrolled in an Alexion-sponsored interventional clinical study for treatment of gMG cannot be enrolled in the Alexion gMG Registry while enrolled/participating in the clinical study for gMG therapy.

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 |
| --- | --- | --- |
| Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score | The MG-ADL is an eight-item patient-reported outcome measure assessing MG symptoms and functional activities related to activities of daily living.48 Each of the items is scored from 0 (normal) to 3 (most severe), providing a total MG-ADL score ranging from 0 to 24, where higher scores indicate greater severity of symptoms. | Approximately 5 years from enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gMG, Soliris, Ultomiris, Alexion C5 Inhibition Therapy, Alexion C5IT, Patient Registry, Generalized Myasthenia Gravis, Alexion Registry
Pharmacokinetics of Tacrolimus in Children

Study Overview
=================
Brief Summary
-----------------
the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.

Official Title
-----------------
Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome

Conditions
-----------------
Nephrotic Syndrome

Intervention / Treatment
-----------------
* Drug: Tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients have been diagnosed with nephrotic syndrome; age range: 1 month to 18 years old tacrolimus used as part of regular treatment Exclusion Criteria: expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tacrolimus<br> | Drug: Tacrolimus<br>* Tacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of plasma concentration of Tacrolimus | To detect the plasma concentrations of Tacrolimus after oral administration | at 1,2,3,6,9,12 hours after oral administration |
Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate whether the dural puncture epidural technique (group B) improves sacral block anesthesia during vaginal surgeries compared with the conventional epidural technique (group A).

Official Title
-----------------
Dural Puncture Epidural Technique Versus Conventional Epidural Technique During Vaginal Surgeries

Conditions
-----------------
Dural Puncture Epidural Technique

Intervention / Treatment
-----------------
* Procedure: Conventional epidural
* Procedure: Dural puncture epidural


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age (25- 55) years. Height (150 -170) cm. Exclusion Criteria: Patient refusal. Hypersensitivity to local anesthetic drugs. Bleeding disorders and coagulopathy. Severe mitral or aortic stenosis. Local or systemic sepsis. Uncooperative patients. Sever spinal deformity. Blood or CSF in the epidural catheter during the procedure. Failure of the block and need for general anesthesia.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br>Women who received the conventional epidural technique (group A). Intervention: Procedure: Conventional epidural | Procedure: Conventional epidural<br>* In this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space.<br>|
| Active Comparator: Group B<br>Women who received the dural puncture epidural technique (group B). Intervention: Procedure: Dural puncture epidural | Procedure: Dural puncture epidural<br>* In this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of onset of anesthesia to T10 |  | During surgery | 
| Time for complete motor block |  | During surgery | 
| Time for first rescue analgesia will be required during surgery |  | During surgery |
Health Mobile Cognitive Stimulation in Alcohol Use Disorder

Study Overview
=================
Brief Summary
-----------------
The consequences of alcohol dependence are severe and may range from physical diseases to neuropsychological deficits in several cognitive domains. Alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex. To assess these deficits and the application of a novel approach of cognitive stimulation to alcoholics, we have carried out a neuropsychological intervention program with mobile health technology. Patients diagnosed with alcohol dependence syndrome were submitted to cognitive stimulation during four weeks in a three-day/week basis.

Official Title
-----------------
Executive Functioning in Patients With Alcohol Use Disorder Following a Mobile Health Cognitive Stimulation Approach: a Randomized Controlled Trial

Conditions
-----------------
Alcohol-Induced Disorders, Nervous System, Alcohol Dependence

Intervention / Treatment
-----------------
* Other: Mobile health cognitive stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients that scored higher than the cutoff values for their age on the Mini Mental Examination Test and with no clinical scores on the Symptoms Checklist Revised were included in the study. Exclusion Criteria: Patients with dependency from substances other than alcohol or with history of previous neurological disorders were excluded from the study. Patients were also screened for minimal computer literacy; no patients were excluded due to lack of this criterion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Mobile health cognitive stimulation<br>Experimental group | Other: Mobile health cognitive stimulation<br> <br> |
| No Intervention: Treatment-as-usual<br>This group consists of treatment-as-usual for alcohol abstinence according to the Minnesota Model. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the results of Frontal Assessment Battery - FAB | The participants were assessed in Frontal Lobe Cognitive Functioning (Retention, Attention and Calculation, Language and Visual-spatial abilities)at the beginning of the rehabilitation and after 10 rehabilitation sessions, which had the approximate duration of one month. | Before cognitive rehabilitation - After cognitive rehabilitation (1month - after 10 sessions) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol Dependence, Cognitive Therapy, Executive Function, Mobile Health, Recovery of Function, Rehabilitation
Effect of Feet and Calf Heating on Glucose Tolerance and Heart Rate Variability

Study Overview
=================
Brief Summary
-----------------
Determine the effect of feet and calf heating on glucose tolerance and heart rate variability relative to thermoneutral control. Heat will be administered using hot water (40 degrees celsius).

Official Title
-----------------
Effect of Feet and Calf Heating on Glucose Tolerance and Heart Rate Variability

Conditions
-----------------
Postprandial Hyperglycemia, Heart Rate Variability

Intervention / Treatment
-----------------
* Other: Heat to ankle
* Other: Heat to calf


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone within specified age range Exclusion Criteria: Anyone outside specified age range

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Thermoneutral<br>thermoneutral condition | |
| Experimental: Feet heated<br>Hot water up to ankles | Other: Heat to ankle<br>* Heat administered via hot water to ankle level<br>|
| Experimental: Calf heated<br>Hot water up to top of calves | Other: Heat to calf<br>* Heat administered via hot water to calf level<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Glucose |  | 30 minute | 
| Blood Glucose |  | 60 minute | 
| Blood Glucose |  | 90 minute | 
| Blood Glucose |  | 120 minute | 
| Heart Rate Variability |  | 30 min | 
| Heart Rate Variability |  | 60 min | 
| Heart Rate Variability |  | 90 min | 
| Heart Rate Variability |  | 120 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure |  | 30 min | 
| Blood Pressure |  | 60 min | 
| Blood Pressure |  | 90 min | 
| Blood Pressure |  | 120 min | 
| Tympanic Temperature |  | 30 min | 
| Tympanic Temperature |  | 60 min | 
| Tympanic Temperature |  | 90 min | 
| Tympanic Temperature |  | 120 min |
Uterine Artery Embolization for Symptomatic Fibroids

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, efficacy , quality of life and patient satisfaction of uterine artery embolization for the treatment of symptomatic uterine fibroids. It will provide useful information in the development od guidelines in patient selection, procedural management and subsequent follow up.

Official Title
-----------------
Short and Long Term Outcomes of Uterine Artery Embolization.

Conditions
-----------------
Uterine Fibroids, Menorrhagia, Adenomyosis

Intervention / Treatment
-----------------
* Procedure: Uterine Artery Embolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms related to the pressence of uterine fibroids serious enough to consider surgical options Confirmation of fibroids by endovaginal and transabdominal ultrasound Exclusion Criteria: Pedunculated fibroids Desire for fertility Carcinoma of pelvic organs Previous pelvic irradiation Bleeding diathesis and vasculitis History of allergiy to contrst medium

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Uterine Artery Embolization|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders

Study Overview
=================
Brief Summary
-----------------
The specific aim of this study is to evaluate the effect of surgically-induced weight reduction, as achieved by laparoscopic gastric banding or sleeve gastrectomy, on pelvic floor disorders such as stress urinary incontinence, overactive bladder, anal incontinence, and pelvic organ prolapse in severely, morbidly and super-obese women using a prospective, observational study design.

Official Title
-----------------
A Prospective Cohort Study of the Impact of Surgically-Induced Weight Loss on Pelvic Floor Disorders

Conditions
-----------------
Pelvic Floor Disorders

Intervention / Treatment
-----------------
* Procedure: LapBand


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical eligibility met by Center for the Treatment Obesity criteria morbid obesity (BMI > 40 kg/m2) or severe obesity (BMI > 33 kg/m2) in presence of NIH co-morbidities willing to participate in study, including completion of self-reported questionnaires Exclusion Criteria: pregnancy or planned pregnancy recent pregnancy or pelvic surgery age < 21 years known neurologic disease or pelvic pathology

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laparoscopic adjustable gastric banding<br>100 obese women undergoing laparoscopic adjustable gastric banding | Procedure: LapBand<br>* Prospective observation study of 100 obese women undergoing laparoscopic gastric banding to determine impact of weight loss on pelvic floor disorders<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of pelvic floor disorders ascertained by Epidemiology of Prolapse and Incontinence Questionnaire |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly incontinence episodes and pad use ascertained by incontinence diary |  | 12 months | 
| Quality of life impact ascertained by validated measures (PFIQ, PFDI, FISI, and PGI-I) |  | 12 months | 
| Sexual function ascertained by validated measure (PISQ) |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pelvic floor disorders, weight loss
Adherence With Iron Sprinkles Among High-Risk Infants

Study Overview
=================
Brief Summary
-----------------
Compared with iron drops, iron sprinkles supplied for 3 months to high-risk children beginning at age 5-7 months will increase adherence and reduce the rates of anemia and iron deficiency.

Detailed Description
-----------------
Iron deficiency is the most common known nutrient deficiency and cause of anemia in childhood. It is associated with numerous adverse health effects, particularly delayed mental and motor development, that may be irreversible. Despite advances of iron nutrition, the prevalence of iron deficiency remains high among low-income infants and toddlers. Previous studies suggest adherence with iron containing drops is low. Adherence to iron sprinkles among children as tested in studies in less developed countries appears high. Comparison: Children randomized to ferrous sulfate drops will be compared with children randomized to ferrous fumarate sprinkles.

Official Title
-----------------
Adherence With Iron Sprinkles Among High-Risk Infants

Conditions
-----------------
Anemia, Iron Deficiency

Intervention / Treatment
-----------------
* Drug: Ferrous sulphate drops with vitamins A, D, and C
* Drug: Ferrous fumarate sprinkles with vitamins and minerals


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants Age 5-7 months Presenting for 6 months well-child care Caregiver speaks English or Spanish Exclusion Criteria: Pre-existing medical conditions with potential relation to iron deficiency or anemia (e.g., hemoglobinopathies, gastrointestinal disorders resulting in malabsorption, chronic renal disease, gestational age at birth of less than 36 weeks, and HIV infection) Inability to speak English or Spanish Use of vitamin or iron supplements in the previous three months

Ages Eligible for Study
-----------------
Minimum Age: 5 Months
Maximum Age: 7 Months

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Ferrous sulphate drops with vitamins A, D, and C|nan|
|Drug: Ferrous fumarate sprinkles with vitamins and minerals|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| full adherence, use of iron supplements 6-7 days/week for 3 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iron deficiency at 9 months of age |  |  | 
| anemia at 9 months of age |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adherence, Supplements, Iron, Iron deficiency, Anemia, Vitamins, Minerals