linjc16/ctgov huggingface dataset:
Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

Study Overview
=================
Brief Summary
-----------------
Transjugular intrahepatic portosystemic shunt (TIPS) dysfunction is defined as a loss of decompression of the portal venous system due to occlusion or stenosis of the TIPS. Occlusion of the TIPS can either be due to thrombosis or hyperplasia of the intima. Thrombosis of the TIPS usually occurs early and can happen within 24 hours of TIPS creation. The frequency of this complication is on the order of 10%-15% when bare stents are used. Post-TIPS short-term low molecular weight heparin (LMWH) was used to prevent the early thrombosis formation. Weather post-TIPS LMWH was necessary when polytetrafluoroethylene-covered stent was used during TIPS creation was not answered. The present study was designed to evaluate the effect of short-term use of LMWH on early TIPS dysfunction.

Official Title
-----------------
Post-TIPS Short-term Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction

Conditions
-----------------
Liver Cirrhosis, Portal Hypertension

Intervention / Treatment
-----------------
* Drug: low molecular weight heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of liver cirrhosis Technical success of TIPS was achieved. Exclusion Criteria: Non-cirrhotic portal hypertension Portal vein thrombosis Budd-Chiari syndrome Pregnancy Contradictions to anticoagulation therapy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>After TIPS procedure was performed, low molecular weight heparin was given for three days. | Drug: low molecular weight heparin<br>* After TIPS procedure was performed, low molecular weight heparin was given for three days.<br>|
| No Intervention: control group<br>After TIPS procedure was performed, no low molecular weight heparin was given. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIPS patency rate | Analysis | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LMWH-related complication | Analysis | one month | 
| Mortality rate | Analysis | one year |
Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.

Detailed Description
-----------------
A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.

Official Title
-----------------
A Pilot Study for Comparative Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap®) in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

Conditions
-----------------
Minimal Change Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: from 18yrs to 80 yrs , man and women Minimal change disease is diagnosed by kidney biopsy On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0 On screening, the patient shows that the serum albumin is below 3.0g/dL the patient sign on the concent form Exclusion Criteria: the patient have experience to take tacrolimus or cyclosporin for 1 month If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day steroid dependent or steroid resistant or frequent relapse case uncontrolled hypertension pregnancy or anticipate pregnancy with 6 month hypersensitivity to tacrolimus or macrolide acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus<br> | Drug: Tacrolimus<br>* tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd<br>* Other names: Prograf;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission of proteinuria |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to remission, relapse rate, response failure rate |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minimal change disease, tacrolimus, corticosteroid
The TOGETHER Project - Heart

Study Overview
=================
Brief Summary
-----------------
The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.

Detailed Description
-----------------
The study will utilize peripheral blood assays collected at time points that are considered standard of care at most institutions. Subjects will have peripheral blood collected at 1 month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for cause time points. These samples will then be used for purposes of developing an RNA-seq based peripheral blood assay in adult heart transplant recipients.

Official Title
-----------------
The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients

Conditions
-----------------
Heart Transplant Rejection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment as study participants: Adult (≥18 years) solitary heart transplant recipient Patient is willing and able to provide informed written consent Exclusion Criteria: Patients who meet any of these criteria are not eligible for enrollment as study participants: Adult (<18 years) heart transplant recipient Patient refusal to enroll in the studyc3. Any simultaneous heart and extra organ transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had previous transplants may be included.

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 Transplant Recipients<br>Heart Transplant Recipients meeting the criteria for enrollment and consented will be followed post transplant for 1 year after enrollment into the study. Blood samples will be obtained at their 1, 3, 6, 12 months and any for cause heart biopsy's obtained. There will be no active intervention for recipients that are enrolled. Results from the samples will not be obtained in real time. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RNA-seq based peripheral blood assay in heart transplant recipients | Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart transplant
Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse

Study Overview
=================
Brief Summary
-----------------
Posttraumatic stress disorder (PTSD) is the most common disorder among childhood sexual abuse survivors and is associated with substantial psychosocial and medical problems, but evidence-based treatment for PTSD in adolescents is lacking. This study aims to examine the efficacy and effectiveness of prolonged exposure therapy for adolescents with client-centered therapy.

Official Title
-----------------
Comparing Behavioral Therapies for Treating Adolescents With Post-Traumatic Stress Disorder Related to Sexual Abuse

Conditions
-----------------
PTSD

Intervention / Treatment
-----------------
* Behavioral: Prolonged Exposure for Adolescents
* Behavioral: Client Centered Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female gender, age 13-18, and a primary DSM-IV-TR diagnosis of chronic or subthreshold PTSD related to sexual assault Exclusion Criteria: current suicidal ideation with intent, uncontrolled bipolar disorder, schizophrenia, other thought disorders, or conduct disorder, the presence of a pervasive developmental disorder, initiation of treatment with psychotropic medication within the previous 12 weeks, and current inpatient psychiatric treatment

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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: 1<br>Prolonged exposure for adolescents | Behavioral: Prolonged Exposure for Adolescents<br> <br> |
| Active Comparator: 2<br>Client centered therapy | Behavioral: Client Centered Therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on PTSD symptoms utilizing the Child PTSD Symptom Scale-Interview (CPSS-I) |  | Baseline, mid-treatment, post-treatment, 3-, 6-, and 12-month follow-ups | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, Cognitive Behavioral Treatment, Child Sexual Abuse
Study To Evaluate Upper Arm Autologous Fat Transfer

Study Overview
=================
Brief Summary
-----------------
The objective of this pilot study is to observe the utility of autologous transfer of fat collected using ultrasonic assisted liposuction into the upper arms with ultrasonic visualization.

Official Title
-----------------
Pilot Study To Evaluate Upper Arm Autologous Fat Transfer

Conditions
-----------------
Cosmetic and Circumferential Change After Fat Transfer

Intervention / Treatment
-----------------
* Procedure: Autologous fat transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is male. Is between 20 and 50 years of age, inclusive, on the day of enrolment. Is to undergo abdominal liposuction. Wishes to undergo autologous fat transfer to the upper arms. Exclusion Criteria: Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study. Undergoing body contouring for reconstruction following injury or disease. Deemed inappropriate candidates for the surgical procedures for any reason. Are unwilling to undergo the study procedures or participate fully in all follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autologous fat transfer<br> | Procedure: Autologous fat transfer<br>* Autologous fat transfer from abdomen to upper arms<br>|

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
-----------------
fat, transfer, autologous fat transfer, bicep
Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).

Official Title
-----------------
Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis

Conditions
-----------------
Inflammation, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: NNC0114-0006
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of RA, meeting the 2010 ACR-EULAR (American College of Rheumatology-European League Against Rheumatism) or the 1987 ACR classification criteria, made at least 4 months prior to trial drug administration Active RA, characterised by a DAS28-CRP equal to or above 4.5 and at least 5 tender and 5 swollen joints Methotrexate (MTX) treatment for at least 16 weeks (dose equal to or above 7.5 mg/week and equal to or below 25 mg/week) at a stable dose for at least 6 weeks prior to dosing Female subjects not pregnant and not nursing Exclusion Criteria: Subjects with chronic inflammatory autoimmune disease other than RA Any active or ongoing chronic infectious disease requiring systemic anti-infectious treatment within 4 weeks prior to randomisation Body mass index (BMI) below 18.0 or above 35.0 kg/m^2

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0114-0006<br> | Drug: NNC0114-0006<br>* Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. The trial comprises dose escalation up to four dose levels. Progression to next dose will be based on safety evaluation.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | From first administration of trial product (week 1) and up until week 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum levels of total IL-21 from first administration of trial product |  | Week 1, week 27 | 
| Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP) |  | From week 1 to week 9 (8 weeks after initiation of treatment) |
Performance of Non-Invasive Monitors During ANH

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the responsiveness of the standard minimally invasive hemodynamic monitors used in the operating room to known changes in the intravascular volume status that occur during blood removal and volume replacement with three different standard fluids used during ANH.

Official Title
-----------------
The Evaluation of Minimally Invasive Hemodynamic Monitors for the Assessment of Volume Responsiveness to Various Standard Replacement Fluids During Acute Normovolemic Hemodilution

Conditions
-----------------
Baseline, Hemodilution

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those surgical procedures where ANH is included in the surgical plan and consent is obtained Exclusion Criteria: Severe or symptomatic COPD, emphysema, renal, hepatic or coronary artery disease as defined by the American College of Cardiology (Cannon et al., 2001). Esophageal pathology (diverticulum, hiatal hernia, esophageal cancer, esophageal surgery), which introduces risks associated with the placement of the esophageal Doppler. Ascites. BMI >35 Pregnancy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac output | Metrics: Cardiac output stroke volume Stroke volume: variation | Baseline (Supine) Volume Replaced (S/P ANH) |
Dietary Therapy in Children With Refractory Epilepsy

Study Overview
=================
Brief Summary
-----------------
In children aged 1yr -18 years with refractory epilepsy Modified Atkins diet as add on to ongoing AED therapy would not be inferior compared to ketogenic diet ** in terms of seizure reduction from baseline seizure frequency at 6 months

Detailed Description
-----------------
Primary objective: To compare the efficacy of Modified Atkins diet compared to Ketogenic diet * in children aged 1 year to 18 years of age with refractory epilepsy on anti epileptic drugs at 6 months of diet intake in terms of percentage of seizure reduction from base line. Secondary objective: Proportion of patients who achieve > 50% seizure reduction from baseline after 6 months in both groups To evaluate the nature of adverse events in both the groups

Official Title
-----------------
Efficacy of Modified Atkins Diet Versus Ketogenic Diet in Children With Refractory Epilepsy Aged 1 Year to 18 Years: a Randomized Controlled Trial

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: Ketogenic diet (2.5 to 4:1)
* Other: Modified Atkin's diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 1-18 years with refractory epilepsy* Willing to come for regular follow up No motivational or psychosocial issues in the family which would preclude compliance with the diet Exclusion Criteria Surgically remediable cause for refractory epilepsy Suspected mitochondrial disorder or diagnosed with a disorder in which high fat diet is contraindicated Previously received ketogenic diet or modified Atkins diet Chronic systemic disease like chronic kidney disease, chronic liver disease, heart disease (congenital and acquired) and chronic respiratory illness

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ketogenic diet<br>ketogenic diet (2.5 to 4:1) | Other: Ketogenic diet (2.5 to 4:1)<br>* Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given<br>|
| Active Comparator: Modifid Atkin's diet<br>Modified Atkin's Diet | Other: Modified Atkin's diet<br>* 1:1 fixed ketogenic ratio Modified atkins diet will be given<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of seizure reduction at 6 months ( sz frequency / wk average of 4 wks) from base line | To develop an optimal dietary therapy for management of refractory epilepsy in children and adolescents | Baseline and 6 months |