linjc16/ctgov huggingface dataset:
A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.

Official Title
-----------------
A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Dersalazine sodium
* Drug: Mesalazine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 65 inclusive Male, non-child-bearing female or fertile female with appropriate contraception. Mild to moderate confirmed active ulcerative colitis Able and willing to give informed consent Exclusion Criteria: Colitis of other cause Pregnancy, inadequate contraception for fertile female patients Liver or kidney disease, unstable cardiovascular disease, coagulation disorder. Other significant medical condition that preclude participation at investigator criteria Allergy or hypersensitivity to salicylates Previous or concomitant treatment for ulcerative colitis interfering with safety or activity assessments

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dersalazine<br> | Drug: Dersalazine sodium<br>* Dersalazine sodium 2400 mg daily<br>|
| Active Comparator: Mesalazine<br> | Drug: Mesalazine<br>* Mesalazine 2400 mg daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo matching active and experimental treatments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal |  | 7, 14, 21, 28, 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mayo index |  | 28 days |
Lupus Education Alliance Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the evaluate the effect of education-only vs. navigation interventions on COVID-19 testing and vaccination for people with systemic lupus erythematosus.

Official Title
-----------------
Lupus Education Alliance Program

Conditions
-----------------
COVID-19, Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Behavioral: Navigation
* Behavioral: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living with systemic lupus erythematosus (SLE), At least 18 years of age, Ability to speak and understand English, and Live, work, or seek care in Alabama or Louisiana

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a two-arm study in which participants are randomized to an experimental (navigator) or comparison (education only) group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Navigation<br>COVID education for people with lupus and tailored guidance in vaccination and testing for COVID and making appointments. | Behavioral: Navigation<br>* COVID education for people with lupus plus tailored guidance in ordering COVID tests and making testing and vaccination appointments.<br>|
| Active Comparator: Education<br>COVID education for people with lupus. | Behavioral: Education<br>* COVID education for people with lupus.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of COVID testing | Participant-reported COVID testing | 2 months | 
| Incidence of COVID-19 Vaccination | Participant-reported COVID vaccination | 2 months |
Effect of Pioglitazone on Insulin Resistance and Atherosclerosis in Renal Allograft Recipients Without Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to evaluate the effect of pioglitazone treatment on insulin secretion, insulin resistance, and progression of atherosclerosis in renal allograft recipients without preoperative history of diabetes.

Detailed Description
-----------------
This is a prospective, randomized, open-label study. The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months. After treatment, we estimated insulin sensitivity index for transplantation,first phase and second phase insulin secretion, secretion area under the curve,and carotid intima-media thickness.

Official Title
-----------------
A Randomized Controlled Trial of Pioglitazone on Insulin Resistance, Insulin Secretion and Atherosclerosis in Renal Allograft Recipients Without History of Diabetes

Conditions
-----------------
Kidney Transplantation, Insulin Resistance, Atherosclerosis

Intervention / Treatment
-----------------
* Drug: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Renal allograft recipients were eligible to participate in the study if they were aged ≥ 18 years, had no previous history of organ transplantation and were not currently using steroids or other immunosuppressants. Exclusion Criteria: Diabetes before transplantation Severe metabolic or infectious disease Hepatic disease Congestive heart failure (New York Heart Association II-IV) Cadaver donor kidney donor transplantation Unstable condition of the transplanted kidney

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pioglitazone<br>* The pioglitazone treatment group received 30mg pioglitazone at 2 weeks after renal transplantation for 12 months.<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Resistance and Insulin Secretion |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid intima-media thickness |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Transplantation, Thiazolidinediones, Insulin Resistance, Atherosclerosis
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this trail is to evaluate the performance of Genetron D842V PCR kit in GIST patients using real-time PCR method.

Detailed Description
-----------------
This trial follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron D842V PCR Kit and Sanger sequencing method. The results were determined independently according to the cutoff values or interpretation requirements provided by each method. The safety and effectiveness of this kit are confirmed and evaluated.

Official Title
-----------------
Clinical Evaluation of Genetron D842V PCR Kit in GIST Patients

Conditions
-----------------
GIST, Gastrointestinal Stromal Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Paraffin-embedded tissue samples from patients clinically diagnosed with gastrointestinal stromal tumor (GIST), and a small number of other cancers or benign lesions in the gastrointestinal site were included as interference samples. The sample should have corresponding basic clinical information, including: the patient's unique traceability number, age, gender, pathological diagnosis results, etc. The sample is a formalin-fixed paraffin-embedded gastrointestinal stromal tumor tissue sample, and each sample can provide 5 paraffin sections or 5 paraffin rolls with a thickness of at least 5 µm. The content of tumor cells meets the requirements of assessment reagents and comparison methods. Exclusion Criteria: The investigator considers that it is not appropriate to continue the clinical trial, such as the samples that are not prepared according to the required steps. Samples that cannot complete the entire testing process. Patients with incomplete sample information.
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 |
| --- | --- | --- |
| Ct Value (Ct Values From PCR Reaction) | the number of PCR cycles where the amplification signal starts to be observed | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPV | the ratio of true positive in all positive cases | 3 months | 
| NPV | the ratio of true negative in all negative cases | 3 months | 
| Consistency (the Overall Ratio of True Positive and True Negative) | The overall consistency ratio of true positive and true negative, i.e. (true positive+true negative)/total number of cases | 3 months | 
| Kappa coefficient | Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the Genetron D842V PCR kit and sanger sequencing method. | 3 months |
Edible Oils in the Treatment of Constipation of Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the effect of olive oil and flaxseed oil in the treatment of constipation of patients undergoing hemodialysis.

Official Title
-----------------
Double-blind Randomized Trial on the Effect of Olive Oil and Flaxseed Oil on Constipation of Hemodialysis Patients

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Other: Mineral oil
* Dietary Supplement: Olive oil
* Dietary Supplement: Flaxseed oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Constipated patients by Rome III criteria Hemodialysis > 3 months Exclusion Criteria: Diagnosis of gastrointestinal disease other than constipation Previous intolerance to the oils used in the study Cognitive limitations

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mineral oil<br>4ml daily (adjusted as needed), for 4 weeks | Other: Mineral oil<br>* 4 ml daily (adjusted as needed), for 4 weeks<br>|
| Active Comparator: Olive oil<br>4ml daily (adjusted as needed), for 4 weeks | Dietary Supplement: Olive oil<br>* 4 ml daily (adjusted as needed), for 4 weeks<br>|
| Active Comparator: Flaxseed oil<br>4 ml daily (adjusted as needed), for 4 weeks | Dietary Supplement: Flaxseed oil<br>* 4 ml daily (adjusted as needed), for 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of constipation symptoms | Constipation was diagnosed by the Rome III criterion. The diagnosis consists in the presence, for at least three months, of two or more of the following symptoms: fewer than three evacuations per week, straining on evacuation, lumpy or hard stools, incomplete evacuation, anorectal obstruction and use of manual maneuvers to facilitate evacuation. Each symptom is scored as: 0=never or rarely, 1=sometimes, 2=often, 3=most of the time and 4=always. In the present study, the frequency of the symptoms was considered as a continuous variable and, a final score ranging from 0 to 24 was calculated. Lowest scores were indicative of fewer symptoms of constipation. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Constipation, Rome III criteria, Hemodialysis
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.

Official Title
-----------------
Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross

Conditions
-----------------
Dengue

Intervention / Treatment
-----------------
* Device: Procleix Dengue Virus Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Donor must meet all the blood collection sites' standard eligibility requirements. Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Treatment<br> | Device: Procleix Dengue Virus Assay<br>* in vitro diagnostic assay<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. |  | Approximately three years |
A Capacitance and Transepidermal Water Loss Test to Determine the Ability of Sunscreen to Moisturize Skin

Study Overview
=================
Brief Summary
-----------------
To evaluate the ability of 2 Helioblock SX Cream formulations to moisturize skin using capacitance and transepidermal water loss methodology

Conditions
-----------------
Dry Skin

Intervention / Treatment
-----------------
* Drug: Helioblock SX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy,male or female subjects 18 years to 55 years of age, with a minimum Stanfield score at baseline of 2 at the forearm sites intended to be assessed in the study Female subjects of childbearing potential using a reliable form of contraception during the course of the study(oral contraceptive pill, intrauterine device, bilateral tubal ligation, abstinence, or other reliable forms at the discretion of the Investigator.) or of non childbearing potential(i.e.,post-menopausal(one year without menstrual period), hysterectomy or bilateral ovariectomy) Subjects who have read, understood and signed an informed consent Subjects who are willing and capable of cooperating to the extent and degree required by the protocol Absence of any visible skin diseases which might be confused with a skin reaction from the test material Exclusion Criteria: Subjects with a condition, or in a situation, which in the Investigator's or Sub-Investigator's opinion, may suggest a significant hazard for the subject, may confound the study results, or may interfere with the subject's participation in the study. Subjects with known sensitivities to any of the study preparations or to other skin care products Subjects who have participated in a clinical research study, including consumer products studies, within the last 30 days prior to enrollment Subjects who are currently receiving medication(prescription or OTC) that in the opinion of the Investigator may interfere with the evaluations made in this study (e.g.vasoactive substances) Pregnant or nursing females or women who are planning to get pregnant during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Helioblock SX|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cardiac MR (CMR) in Cardiac Resynchronization Therapy Non-responders

Study Overview
=================
Brief Summary
-----------------
Cardiac MR (CMR) will be used to assess myocardial activation and hemodynamics in patients with CRT. Goals are to demonstrate that differences in Left ventricle (LV)- right ventricle (RV) pacing delays cause differences in myocardial activation differences in LV-RV pacing delays cause differences in LV/RV hemodynamics and to use these data to optimize CRT.

Detailed Description
-----------------
CMR will be performed in patients under CRT who are currently not responding to CRT. Different LV-RV delays will be programmed during CMR and LV function and different dyssynchrony parameters will be assessed. Results will be used to determine the optimal LV-RV delay, and CRT-devices will be reprogrammed accordingly. Improvement in NYHA-class/conversion to therapy responder will be determined clinically after 3 months.

Official Title
-----------------
Cardiac MR (CMR) in Cardiac Resynchronization Therapy (CRT) Non-responders: Therapy Optimization by Means of Tissue Characterization, Hemodynamic Analysis and Analysis of Myocardial Activation

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CRT reprogramming (Medtronic CRT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of CRT device CRT non responder Exclusion Criteria: pregnancy end-stage renal failure

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

| Intervention/Treatment |
| --- |
|Device: CRT reprogramming (Medtronic CRT)|CRT devices will be reprogrammed according to CMR analysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in NYHA-class |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of CMR in CRT-patients | pacing capture threshold, sensing and lead impedances will be monitored for significant and/or clinically relevant changes. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRT, heart failure, CMR, safety
Effects of Kinesiology Tape Tensions on Gastrocnemius and Soleus H-reflex Modulations

Study Overview
=================
Brief Summary
-----------------
Kinesio tape (KT) has been widely used in the areas of sports and physical therapy (Kase, 2003). The effect of KT tensions on H-reflex modulation has not been discussed in the literature. This study investigated the effect of different KT tensions on the H-reflex modulation in the gastrocnemius and the soleus muscles.

Official Title
-----------------
Effects of Kinesiology Tape Tensions on Gastrocnemius and Soleus H-reflex Modulations

Conditions
-----------------
Kinesiology Taping

Intervention / Treatment
-----------------
* Device: Kinesiology tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undertake regular exercise at least 3 times a week with accumulation of 150 min per week Age between 20 and 30 years old Exclusion Criteria: History of severe neuromuscular injury Current lower extremity injury Current neurological diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Kinesiology tape application to dominant leg during lying and standing positions | Device: Kinesiology tape<br>* Application for 0%, 50%, and 100% of maximal KT stretch to the calf muscle during lying and standing positions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| H-reflex and M-wave ratio | Electromyographic record | 30 min before kinesiology taping application | 
| H-reflex and M-wave ratio | Electromyographic record | During kinesiology taping application | 
| H-reflex and M-wave ratio | Electromyographic record | Immediately following kinesiology taping application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H-reflex modulation, motoneuronal excitability, Ia afferent inputs, posture, Kinesiology tape