linjc16/ctgov huggingface dataset:
MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal

Study Overview
=================
Brief Summary
-----------------
Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.

Official Title
-----------------
MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Corticosteroid withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who have received a kidney transplant during the MMF era Patients who have stable graft function indicated by a serum creatinine of < 1.8 mg/dl, or a calculated creatinine clearance of > 50 ml/minute Exclusion Criteria: Patients who have had > 1 rejection episode, Patients who have had a rejection episode within the past year; Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| No Intervention: 1<br>Remain on 3-drug standard of care immunosuppression including prednisone | |
| Experimental: 2<br>Corticosteroid withdrawal / prednisone taper over 14 weeks | Drug: Corticosteroid withdrawal<br>* prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Allograft rejection |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function as determined by serum creatinine |  | measure after 36 months | 
| Allograft Survival |  | 3 years | 
| Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH) | Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study. | Day 0 (pre-transplant) |
A Clinical Pharmacodynamic and Pharmacogenetic Study of OPB-51602 in Patients With Advanced Solid Tumours

Study Overview
=================
Brief Summary
-----------------
OPB-51602 is a novel oral small molecule STAT3 inhibitor developed by Otsuka Pharmaceutical Company, Ltd, and is currently undergoing clinical investigation at the National University Health System (NUHS), Singapore. The proposed correlative pharmacodynamic and pharmacogenetic biomarker study is initiated and funded by the investigators, and will be conducted in conjunction with the extension phase I protocol of OPB-51602 in patients with advanced solid tumours (Study code 266-09-801-01/ DSRB protocol B/09/514). All biomarker and pharmacogenetic samples will be collected, stored and analysed at the local laboratory of the study site (Cancer Science Institute, National University Health System, Singapore, Dr Boon-Cher Goh).

Conditions
-----------------
Advanced Solid Tumors

Intervention / Treatment
-----------------
* Other: Biomarker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Solid Tumor Exclusion Criteria: Non advanced solid tumor

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Advanced solid tumours<br> | Other: Biomarker<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibition of STAT3 phosphorylation in peripheral mononuclear blood cells (PBMCs)pharmacodynamic effect of OPB-51602 in surrogate tissue. | Analysis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify single nucleotide polymorphisms (SNPs) that correlate with OPB-51602 pharmacokinetics and pharmacodynamics | Analysis | 1 Year |
Dynasplint for Distal Radius Fracture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to examine the efficacy of dynamic splinting as a therapeutic modality in reducing contracture following surgical treatment of distal radius fractures.

Official Title
-----------------
Contracture Reduction Following Distal Radius Fracture Surgical Management

Conditions
-----------------
Distal Radius Fracture

Intervention / Treatment
-----------------
* Device: Wrist Extension Dynasplint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up Exclusion Criteria: Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium) Radial nerve entrapment Arthrodesis Traumatic dislocation of the distal ulna

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynasplint<br>Patients will be treated with the current standard of care and the Wrist Extension Dynasplint. | Device: Wrist Extension Dynasplint<br>* Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or Experimental group will add this therapy to their standard of care regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dependent variable will be change in maximal, active range of motion in extension and the independent variables will include DASH scores and measurements taken from radiographic imaging |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Distal Radius fracture
Pain Relief by Intra-Peritoneal Ropivacaine During Gynecological Laparoscopy

Study Overview
=================
Brief Summary
-----------------
In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecological laparoscopic surgery.

Official Title
-----------------
Pain Relief by Continuous Intra-Peritoneal Nebulization of Ropivacaine During Gynecological Laparoscopic Surgery

Conditions
-----------------
Laparoscopic Surgical Procedures

Intervention / Treatment
-----------------
* Drug: ropivacaine
* Device: Aeroneb Pro Nezulizer, Aerogen, Ireland


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective gynecologic laparoscopic surgery including unilateral or bilateral salpingo-oopherectomy or ovarian cystectomy. The patient is not participating in other medical study at present or in the last 30 days. The patient signed on an informed consent. Age 18 years and above. ASA (American Society of Anesthesiologists) physical status grade 1- 2. Exclusion Criteria: Allergy to Ropivacaine, other local anesthetics or other medications listed in the protocol. The patient is participating in other medical experiment at present or in the last 30 days. Acute Pelvic Inflammatory Disease. Coumadin or Aspirin treatment. ASA physical status grade 3-4. Age < 18 years. Significant arrythmias Analgesic treatment for chronic pain

Ages Eligible for Study
-----------------
Minimum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study<br>Receiving 10ml of 1% ropivacaine | Drug: ropivacaine<br>* 1% ropivacaine<br>* Other names: Narop;|
| Placebo Comparator: Control<br>Receiving 10ml of saline | Device: Aeroneb Pro Nezulizer, Aerogen, Ireland<br>* Aeroneb Pro Nezulizer, Aerogen, Ireland<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score |  | early post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ropivacaine, laparoscopy, intraperitoneal, nebulization, pain, local analgesic, gynecology
A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods

Study Overview
=================
Brief Summary
-----------------
This study will assess the continuation rates among women using oral contraceptive pills, Depo-Provera and Ortho Evra following a first trimester abortion.

Detailed Description
-----------------
Unintended pregnancy rates among women in the United States continue to surpass that of the rest of the developed world at great cost to society. Contraceptive failure has been attributed to poor compliance with contraceptive methods and results in unintended pregnancies. This study will evaluate the 3-month continuation rates among women using the oral contraceptive pill and Depo-Provera. It will also assess the continuation rates of Ortho Evra®, which has not previously been studied in the adolescent population. This study will provide information with regard to pregnancy rates and 3-month patterns of use of contraception among women seeking first-trimester abortion. It will also assess other factors contributing to successful contraception such as the use of emergency contraception and concomitant condom use. The results of this study will be used to inform the practice of providers who provide reproductive health care to women and add to the sparse body of literature available comparing the success of different contraceptive methods used by women.

Official Title
-----------------
A Comparison of Continuation Rates for Three Hormonal Contraceptive Methods (Oral Contraceptive Pills, Depo Provera and Ortho Evra) Among Women Seeking First Trimester Abortion.

Conditions
-----------------
Contraception

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 13-45 women presenting at the ambulatory surgery at Grady Memorial Hospital who want to use either oral contraceptive pills, ortho evra or depo provera? Exclusion Criteria: Leaving the Atlanta area within 6 months? Desires pregnancy within the next 6 months? Unable to provide contact information? Contraindications to hormonal contraceptive?

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Continuation Rates | We followed subjects to evaluate the continuation rates for subjects receiving oral contraceptive pills, Depo Provera and Ortho Evra. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
birth control, continuation, abortion, contraception
Oral Glucose Stimulation in Normal-weight and Obese Volunteers

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to examine gastric emptying and satiety hormones after oral glucose stimulation in 2 different concentrations in normal-weight and obese patients.

Official Title
-----------------
Oral Glucose in Normal-weight and Obese Volunteers

Conditions
-----------------
Endocrine System Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Glucose 25g
* Dietary Supplement: Glucose 10g


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy normal weight subjects with a body-mass index of 19.0-24.5 or healthy obese subjects with a body-mass index of > 30 Normal eating habits Age 18-40 years Stable body weight for at least three months Exclusion Criteria: Smoking Substance abuse Regular intake of medications (except for oral contraceptives) Medical or psychiatric illness Any abnormality detected during the screening procedure history of gastrointestinal disorders food allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucose 10g<br>10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube | Dietary Supplement: Glucose 10g<br> <br> |
| Active Comparator: Glucose 25g<br>25g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)via nasogastric tube | Dietary Supplement: Glucose 25g<br> <br> |
| Placebo Comparator: Placebo<br>intragastric tap water | Dietary Supplement: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of different oral glucose loads on secretion of satiation hormones | Plasma concentrations of glucose, insulin, glucagon, ghrelin, GLP-1, PYY and CCK are measured | 240min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of different oral glucose loads on gastric emptying | measured by C13 breath test | 240min. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ghrelin, glucagon-like peptide-1, peptide tyrosine tyrosine, stomach, small intestine, gastric emptying
Brain Effects of Sacral Neuromodulation

Study Overview
=================
Brief Summary
-----------------
Sacral neuromodulation (SNM) has become an accepted treatment for patients with refractory lower urinary tract dysfunction such as urgency frequency syndrome, urgency incontinence, non-obstructive chronic urinary retention and chronic pelvic pain syndrome. Modulation of central afferent activity is considered critical to this therapeutic effect but the neural mechanisms are poorly understood. We hypothesize that SNM has a significant effect on brain activity detectable by positron emission tomography (PET).

Official Title
-----------------
Brain Effects of Sacral Neuromodulation in Patients With Refractory Lower Urinary Tract Dysfunction

Conditions
-----------------
Urinary Tract Disease

Intervention / Treatment
-----------------
* Radiation: Baseline neuroimaging
* Radiation: Neuroimaging during sacral neuromodulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with refractory lower urinary tract dysfunction scheduled for sacral neuromodulation Exclusion Criteria: Pregnancy Age <18 years Claustrophobia

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: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A<br>Baseline neuroimaging | Radiation: Baseline neuroimaging<br>* Baseline neuroimaging using PET and MRI of the brain in patients before sacral neuromodulation<br>|
| Other: B<br>Neuroimaging during sacral neuromodulation | Radiation: Neuroimaging during sacral neuromodulation<br>* Neuroimaging during sacral neuromodulation using PET<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of sacral neuromodulation on brain activity |  | 2-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in brain activity effects of sacral neuromodulation (SNM) in patients with successful compared to failed SNM testing |  | immediately and 2-8 weeks after study inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory lower urinary tract dysfunction, Sacral neuromodulation, Brain effects, Neuroimaging, Neuromodulation
Methylphenidate and Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.

Detailed Description
-----------------
This study was set-up to examine the controversial issue whether or not it is safe to drive a car or not when treated with methylphenidate. On-the-road driving tests during normal traffic are conducted to determine the effects of methylphenidate versus placebo on driving ability of adult ADHD patients.In addition, two laboratory tests are conducted to examine memory functioning and inhibitory control.

Official Title
-----------------
A Double Blind, Placebo-Controlled Crossover Study to Determine the Effects of Methylphenidate on Driving Ability in Adult Patients With Attention-Deficit Hyperactivity Disorder

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult ADHD patient over 21 years old valid driver's license for at least 3 years treated with methylphenidate written informed consent Exclusion Criteria: use of illicit drugs use of drugs or having medical conditions known to affect driving ability

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving test:Standard Deviation of Lateral Position (SDLP, cm);i.e. the weaving of the car [single dose effects] |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other Driving test parameters: Standard Deviation of Speed, mean speed, mean lateral position. |  |  | 
| Memory test: immediate & delayed word recall, delayed recognition.[single dose effects] |  |  | 
| Continuous Performance test: RT, %errors [single dose effects] |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult