linjc16/ctgov huggingface dataset:
Oral Water Ingestion in Heart Transplant Patients

Study Overview
=================
Brief Summary
-----------------
In this study the investigators propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. The investigators will test the hypothesis that water ingestion will increase the systemic vascular resistance.

Detailed Description
-----------------
In this study we propose to assess the hemodynamic response to the ingestion of 16 fl oz of water. We will test the hypothesis that water ingestion will increase the systemic vascular resistance. This study will occur in patients status post cardiac transplantation during their clinical right heart catheterizations. Invasive hemodynamics including cardiac outputs and plasma norepinephrine levels will be measured before and 30 min after the water ingestion.

Official Title
-----------------
Acute Hemodynamic Effects of Oral Water in a Stable Cardiac Transplant Population

Conditions
-----------------
Blood Pressure, Cardiac Transplantation

Intervention / Treatment
-----------------
* Dietary Supplement: water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: s/p cardiac transplantation scheduled for clinical right heart catheterization age > 18 years Exclusion Criteria: significant tricuspid regurgitation inability to safely swallow 500 ml of water other major medical comorbidities such as advanced renal disease where water ingestion may be harmful to patient

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>water ingestion | Dietary Supplement: water<br>* water 500 ml x 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in total vascular resistance |  | 40 min (before to 30 min after water ingestion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure |  | 40 min | 
| heart rate |  | 40 min | 
| plasma norepinephrine |  | 40 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
water, blood pressure, vascular resistance, cardiac transplantation
cliniMACs HUD for T Cell Depletion

Study Overview
=================
Brief Summary
-----------------
This protocol is designed to enable access to related or unrelated CD34 cells manufactured using the CliniMACS (Miltenyi) under the HUD designation for patients needing T cell depleted allogeneic grafts for hematopoietic stem cell transplant (HSCT). This will include patients with inherited immunodeficiency disorders as well as patients with malignancies, bone marrow failure, and other rare diseases amenable to HSCT. Finally, patients with poor graft function and Graft Versus Host Disease(GVHD) after a previous HSCT may require a boost of T-cell depleted donor Peripheral Blood Stem Cell (PBSCs) or bone marrow cells that are CD34 selected using the CliniMACS device ENROLLMENT BY INVITATION ONLY

Official Title
-----------------
cliniMACs HUD for T Cell Depletion

Conditions
-----------------
x Linked Combined Immunodeficiency

Intervention / Treatment
-----------------
* Device: CliniMACs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: severe combined immune deficiency need for stem cell boost Exclusion Criteria: n/a

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CliniMACs|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, and activity of extended treatment with NGM282 in patients with Primary Biliary Cirrhosis.

Official Title
-----------------
A Phase 2, Multi-Center Study to Evaluate Three Doses of NGM282 Administered for 24 Weeks in Patients With Primary Biliary Cirrhosis (PBC) Who Have Completed Study 13-0103

Conditions
-----------------
Primary Biliary Cirrhosis

Intervention / Treatment
-----------------
* Biological: NGM282


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of NGM 13-0103 Males or females, between 18 and 75 years of age, inclusive PBC Diagnosis consistent with AASLD and EASL guidelines Stable dose of UDCA Exclusion Criteria: Chronic liver disease of a non-PBC etiology Evidence of clinically significant hepatic decompensation

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM282 Dose 1<br>NGM282 Dose 1 | Biological: NGM282<br>* NGM282<br>|
| Experimental: NGM282 Dose 2<br>NGM282 Dose 2 | Biological: NGM282<br>* NGM282<br>|
| Experimental: NGM282 Dose 3<br>NGM282 Dose 3 | Biological: NGM282<br>* NGM282<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in plasma ALP from Baseline to Week 12 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in bilirubin, ALT, AST, and GGT from Baseline to Week 12 and Week 24 |  | 12 weeks and 24 weeks |
Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.

Official Title
-----------------
Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular Inflammation and Pain Associated With Cataract Surgery.

Conditions
-----------------
Pain, Inflammation, Cataract

Intervention / Treatment
-----------------
* Drug: Bromfenac Ophthalmic Solution
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female at least 18 years of age who are scheduled for unilateral cataract surgery Exclusion Criteria: Have known hypersensitivity to bromfenac or to any component of the investigational product

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: Bromfenac Ophthalmic Solution<br>Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. | Drug: Bromfenac Ophthalmic Solution<br>* Sterile ophthalmic solution<br>|
| Placebo Comparator: Placebo<br>One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. | Drug: Placebo<br>* Sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Inflammation | The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15. | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Pain | The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of None on the pain scale of the Ocular Comfort Grading Assessment in the subject diary. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery
Frequency of ICAM-1 Polymorphisms in Obese Subjects

Study Overview
=================
Brief Summary
-----------------
The genetic contribution to the development of obesity is now well recognized. However obesity is a polygenic disease and thus many genes are likely to be involved. This study aims to investigate the possible association between specific variants of the gene coding for the Intercellular Adhesion Molecule-1 (ICAM-1)and the development of severe obesity in an Italian population

Detailed Description
-----------------
Severely obese subjects referred to our institution will be evaluated. For the aim of the study, a venous blood sample will be obtained from these subjects and from a group of normal weight volunteers. Genomic DNA will be extracted from the blood samples and analysed by standard molecular biology techniques.The allelic and genotype frequencies of the two ICAM-1 variants will be calculated in the obese and control groups. The statistical significance of possible differences will be determined

Official Title
-----------------
Study of the Association Between ICAM-1 Polymorphisms and Severe Obesity

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obesity Exclusion Criteria: Associated inflammatory diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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
-----------------
ICAM-1, Obesity, Gene variants
Effect of NN5401 in Japanese Subjects With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese subjects with type 1 diabetes. Each subject will be randomised to one of the two possible treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic insulin aspart 30 followed by NN5401).

Official Title
-----------------
A Trial Investigating the Pharmacodynamic Properties of NN5401 in Japanese Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: insulin degludec/insulin aspart
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Japanese subject Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months Body mass index (BMI): 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Loss of more than 400 mL blood (inclusive) in total with in the last 12 weeks or more than 200 mL blood (inclusive) in total within the last 4 weeks prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes (not inclusive 5) or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDegAsp<br> | Drug: insulin degludec/insulin aspart<br>* Single dose of 0.5 U/kg body weight injected s.c. (under the skin)<br>|
| Active Comparator: BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* Single dose of 0.5 U/kg body weight injected s.c. (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Glucose Infusion Rate curve after a single dose |  | From 4-12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin aspart concentration-time curve after a single dose |  | From 0-12 hours |
Revival Active Program for Adolescents With Depression

Study Overview
=================
Brief Summary
-----------------
Active play and sports has shown to be effective intervention in managing depression. Extending the support with Mind body therapy, Revival Active Program was designed as an early intervention for adolescents. To measure the efficacy and feasibility of the community based revival active play intervention for adolescent depression, present pilot study was undertaken.

Official Title
-----------------
Impact of Revival Active Program on Adolescents With Depression: A Pilot Study

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Other: Revival Active Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosed with depression as per the DSM IV-TR criteria Parents willing to give written informed consent Exclusion Criteria: Physical limitation for active sports Co-morbid mental health diagnosis high risk of self harm/ suicide history of self harm or harming someone else

Ages Eligible for Study
-----------------
Minimum Age: 10 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revival Active Program<br>Revival Program included supervised play group, twice a week followed by home practice. | Other: Revival Active Program<br>* Program comprised of physical activities, group play, mind games, reasoning and discussion on sleeted topics, breath work and relaxation techniques, 60 minutes all together.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Children Depression Inventory-II was used to assess depression level | Changes from baseline depression at 8-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Efficacy for Children | Emotional, social and academic self efficacy was assessed using Self-Efficacy Questionnaire for Children | Changes from baseline self -efficacy at 8-week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Revival Active Program
Eye Drop Use in Glaucoma Patients Through Patient Surveys and Video Observations

Study Overview
=================
Brief Summary
-----------------
This study will be used to evaluate how patients put eye drops in their eyes and any problems that may arise from this activity. The information gathered will help identify common problems patients are having with putting in their eye medications. Then doctors can be better informed about the issues and provide better advice to their patients to overcome these problems.

Detailed Description
-----------------
Approximately 100 patients will take part in a one time procedure and survey as part of this project. After appropriate consent patients are asked to complete a short 2 page survey about themselves and their eye drops. Then a video recording will be made of the patient instilling eye drops in their habitual manner. The eye drops used will be sterile saline placed in either Travatan-like or Systane bottles to simulate the corresponding prescribed medication. The videos will be graded for instillation technique and combined with scoring of survey answers. Patients will be asked to instill the drops to their left eye with their dominant hand as we expect this to be most difficult. Patients with severe (>20/200) vision loss will instill drops into their better seeing eye.

Official Title
-----------------
Evaluation of Eye Drop Administration in Glaucoma Patients

Conditions
-----------------
Glaucoma, Dry Eye Syndrome, Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently using topical glaucoma medications
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
-----------------
eyedrops, compliance, glaucoma medications, adherence
Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease

Study Overview
=================
Brief Summary
-----------------
Measure the cytokines, transforming or neurotrophic factors in CSF and plasma as the pain markers and as a new therapeutic target for pain control.

Detailed Description
-----------------
The research protocol was approved by the Institutional Review Board (IRB) for the Protection of Human Subjects at National Cheng Kung University Hospital (NCKUH/B-ER-104-070). The study procedures were performed according to the rules of IRB and fully explained to the participants. Blood and CSF samples were collected and compared the difference in no pain group, acute pain group, and chronic pain group.

Official Title
-----------------
Investigating the Role of Brain-derived Neurotrophic Factor (BDNF) Between Pain and Other Neuronal Disease

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: pain evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: . Patients undergo spinal anesthesia . Over 20 years of age Patients who are competent to understand the study and provide written informed consent. Exclusion Criteria: Patients have the contraindication for spinal anesthesia (refuse spinal anesthesia, coagulopathy, severe aortic stenosis) Refuse participated in this study or pre-existent neurological disease. Patients with advanced tumor staging (stage 3 or 4).

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| no pain<br>pain evaluation for patients performed surgery without painful condition (bleeding or others) | Behavioral: pain evaluation<br>* collect CSF during spinal anesthesia<br>|
| acute pain<br>pain evaluation for patients performed surgery with painful condition within several days | Behavioral: pain evaluation<br>* collect CSF during spinal anesthesia<br>|
| chronic pain<br>pain evaluation for patients performed surgery with the painful condition for over months | Behavioral: pain evaluation<br>* collect CSF during spinal anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine measurement in cerebrospinal fluid | cytokine measurement ( via ELISA) in cerebrospinal fluid | through study completion, an average of 1 year | 
| cytokine measurement in blood | cytokine measurement (via ELISA) in blood | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain
Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.

Study Overview
=================
Brief Summary
-----------------
To determine the effect in the post operative period of early feeding (4 hours after surgery) vs. traditional management (feeding 12 hours after surgery) in uncomplicated cesarean section.

Official Title
-----------------
Early Oral Feeding Versus Traditional Postoperative Care After Uncomplicated Cesarean Section. A Randomized Controlled Trial.

Conditions
-----------------
Complications; Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Early feeding
* Procedure: Late feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cesarean section with regional anesthesia, regardless of gestational age. Exclusion Criteria: Use of magnesium sulphate General anesthesia Pre gestational or gestational diabetes Bowel injury during surgery
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Experimental: Early feeding<br>Early feeding (fluid diet), four hours after cesarean section. | Procedure: Early feeding<br>* Fluid diet four hours after cesarean section<br>|
| Active Comparator: Late feeding<br>Late feeding (fluid diet) 12 hours after cesarean section. | Procedure: Late feeding<br>* Fluid diet 12 hours after cesarean section<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adynamic ileus | Presence of signs of adynamic ileus (nausea, vomiting, abdominal distention) after feeding | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Level of pain, using a visual scale (12, 24, 48 and 72 hours after surgery) | 72 hours | 
| Satisfaction | Personal satisfaction, using a numeric scale (12, 24, 48 and 72 hours after surgery) | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean section, Early feeding