linjc16/ctgov huggingface dataset:
Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)

Study Overview
=================
Brief Summary
-----------------
This research study is designed to evaluate the effects of human umbilical cord mesenchymal stem cells (UC-MSCs), on Duchenne's muscular dystrophy (DMD). The potential muscle regenerative and anti-inflammatory properties of UC MSCs position them as a possible treatment option for DMD. Both of these properties could lead to potential benefits for a DMD patient.

Official Title
-----------------
Allogeneic Transplantation of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)

Conditions
-----------------
Duchenne's Muscular Dystrophy

Intervention / Treatment
-----------------
* Biological: Umbilical Cord Mesenchymal Stem Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duchenne's Muscular Dystrophy Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 31 Years

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

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: Mesenchymal Stem Cells<br>Umbilical Cord Mesenchymal Stem Cells | Biological: Umbilical Cord Mesenchymal Stem Cells<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | No occurrence of adverse events | 3 months after final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of weight |  | 3 months after final treatment | 
| Change of muscle diameter (circumferential measurements) from baseline |  | 3 months after final treatment | 
| Change from baseline of Pulmonary Maximum Expiratory Pressure |  | 3 months after final treatment | 
| Change from baseline of Pulmonary Forced Vital Capacity |  | 3 months after final treatment | 
| Maximum Change from baseline of Predicted Inspiratory Pressure % |  | 3 months after final treatment | 
| Change from baseline of Predicted Maximum Expiratory Pressure % |  | 3 months after final treatment | 
| Change from baseline of Predicted Forced Vital Capacity % |  | 3 months after final treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duchenne's, Mesenchymal, Stem Cells, Umbilical Cord, Muscular Dystrophy
Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular Surface

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to look at contact lens on the eye and its interaction with the eye during wearing.

Detailed Description
-----------------
The goal of this study is to characterize the edge of contact lenses and its interaction with ocular surface.

Official Title
-----------------
Characterization of the Edge of Soft Contact Lens and Its Interaction With Ocular Surface

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: self reported normal subjects Exclusion Criteria: any ocular diseases/conditions will not wear contact lenses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| difference characteristics with different contact lenses and different interactions with the eye |  | 10 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contact lens, normal
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

Official Title
-----------------
An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of Two Fixed Doses of SR58611A (175 mg q12/ 350 mg q12) in Outpatients With MDD

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: amibegron (SR58611A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR Patient meets criteria for a recurrent Major Depressive Episode (MDE) Patient meets severity assessments of depression specified by the study Exclusion Criteria: Patient is at immediate risk for suicidal behavior Patient is with a unstable medical condition Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months Patient has been treated with paroxetine (Paxil) within the previous 6 months Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amibegron (SR58611A)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total score of a depression rating scale at 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Clinical Trials, Major Depressive Disorder
PK/PD, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
An open label, multiple-dose, phase 1 clinical trial to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of PHP-201 topical eye drop in Korean and Japanese healthy subjects

Detailed Description
-----------------
Primary: The evaluation of pharmacokinetic properties of repeating PHP-201 topical eye drop Secondary: The evaluation of pharmacodynamic, safety and tolerability of repeating PHP-201 topical eye drop

Official Title
-----------------
An Open Label, Multiple-dose, Phase 1 Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PHP-201 Topical Eye Drop in Korean and Japanese Healthy Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: PHP-201 0.5% ophthalmic solution (topical eye drop)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fully informed about the purpose of the study BMI of 18.0 kg/m² or more and 27.0 kg/m² or less who are between 19 and 50 years of age No congenital or chronic disease and no medically symptomatic findings Exclusion Criteria: Clinically significant disease history or disease history that may affect the absorption, distribution, metabolism and excretion of the drug, or ophthalmic corneal surgery had BCVA worse than logMAR 0.2(20/30snellen) or IOP < 10mmHg or >21mmHg in either eye Abnormalities of clinical examination (SBP, DBP, pulse rate, AST, ALT, Total bilirubin, eGFR and Serum test, ECG) Allergy, drug hypersensitivity and substance abuse Forbidden drug and diet Blood donation and transfusion

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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: PHP-201 0.5%<br>PHP-201 0.5%, ophthalmic solution, topical eye drop, OU | Drug: PHP-201 0.5% ophthalmic solution (topical eye drop)<br>* D1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2 D6: PHP-201 0.5% topical eye drop OU TID<br>* Other names: PHP-201 5mg/ml;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration [Cmax] | Cmax of PHP-201 & Metabolite | 1week | 
| Time to Cmax[Tmax] | Tmax of PHP-201 & Metabolite | 1week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change of Intraocular pressure(IOP) | Mean Change from baseline IOP after 1week | 1week |
Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America

Study Overview
=================
Brief Summary
-----------------
The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.

Official Title
-----------------
Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America: Retrospective and Translational Multicenter Database

Conditions
-----------------
Recurrent/Metastatic Urothelial Cancers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age at least 18 years; Histological confirmation of urothelial carcinoma (include mixed urothelial histology); Diagnosis of recurrent or metastatic (Stage IV) urothelial carcinoma during the period of January 2016 to July 2018; Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records; Availability of tumor sample (FFPE/slides) from primary tumor or metastatic site at the time of registration. Exclusion Criteria: Synchronous tumors or history of other malignancy in the previous 3 years before study entry (exception to non-melanoma skin cancer or non-invasive cancers); Pure non-urothelial carcinoma histology.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiology | Overall survival (OS) will be defined from the date of treatment initiation to date of death from any cause. In case of patients that received palliative care only, OS will be defined from date of diagnosis of advanced disease to date of death from any cause. Patients who are alive will be censored at the date of last known contact. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socioeconomic chactacteristcs | Health Care Insurance (Public or Private) | 2 years | 
| Overall response | Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1 | 2 years | 
| Duration of response | Defined as the time from response to progression by RECIST v11.1 or death | 2 years | 
| PFS | Progression-free survival (PFS) will be defined from date of treatment initiation to date of disease progression or death from any cause, whichever occurs first in each line. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metastatic, recurrent, urothelial cancers, renal pelvis, ureter, bladder, urethra
Minimal Access Repair of Contralateral Hernias (MARCH Trial)

Study Overview
=================
Brief Summary
-----------------
Repair of unilateral inguinal hernia in infants. Laparoscopic repair, with closure of contralateral patent processus vaginalis if present, versus open repair

Conditions
-----------------
Unilateral Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: Repair of unilateral inguinal hernia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral inguinal hernia Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 1 Year

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 |
| --- | --- |
| Other: Laparoscopic repair<br>Laparoscopic repair, with closure of contralateral patent processus vaginalis | Procedure: Repair of unilateral inguinal hernia<br> <br> |
| Other: Open repair<br>Open repair | Procedure: Repair of unilateral inguinal hernia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of metachronous contralateral inguinal hernia |  | Until end of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of recurrent hernia |  | Until end of follow-up |
Effects of Abdominal Hot Compresses on Indocyanine Green Elimination in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
We investigated, whether abdominal hot compresses effect hepatic blood flow. Our hypothesis was, that the hot compresses might either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system increase hepatic blood flow.

Detailed Description
-----------------
Abdominal hot compresses are traditionally used by patients with liver diseases as self help. This study investigated the effect of abdominal hot compresses on hepatic blood flow measured by elimination of indocyanine green (ICG), a non-toxic green dye. It was presumed, that abdominal hot compresses increase hepatic blood flow either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system. In healthy volunteers ICG elimination was measured with and without hot compress at two investigations in a weekly interval. At each investigation ICG was injected as bolus after a rest period of 10 minutes. After the injection blood was taken in regular intervals for analysis of ICG concentration over a period of 40 minutes and half life was calculated. The time interval between the investigations was 8 days, the sequence was randomly assigned.

Official Title
-----------------
Effects of Abdominal Hot Compresses on Indocyanine Green Elimination - a Randomized Cross Over Study in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: abdominal hot compress


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers Exclusion Criteria: iodine allergy any acute or chronic disease [with exception of pollinosis because it is common] elevated levels of alanine amino transferase [ALT], aspartate amino transferase [AST], gamma glutamyltransferase [GGT] or bilirubin heat urticaria pregnancy alcohol intake >30 g/d any medication except contraceptives body mass index (BMI) >30 kg/m2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: abdominal hot compress|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indocyanine green half life |  | 40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate, blood pressure |  | 40 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy subjects
A Survey on Postoperative Pain (POP) Experience in Asian Patients.

Study Overview
=================
Brief Summary
-----------------
Pain management is becoming an important ethical responsibility of the medical profession and a focus of the health care system. However, there are limited literature evaluate the postoperative pain experience and management in our local setting.

Detailed Description
-----------------
We need to identify those patients who, from a demographic, psychology and surgical viewpoint, are more at risk of experiencing postoperative pain.

Official Title
-----------------
A Survey on Postoperative Pain (POP) Experience in Asian Patients.

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: operation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Adult with age ≥ 18 who undergo operation Exclusion Criteria: 1. Refused to give informed consent

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 |
| --- | --- |
| postoperative pain<br> | Procedure: operation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain experience | To determine patient's postoperative pain experience during and 2 weeks after discharge from hospital. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, postoperative
Dendritic Cells-Derived Exosomes in Human Sepsis

Study Overview
=================
Brief Summary
-----------------
The amount of peripheral blood exosomes has been confirmed to change in the endotoxin-induced infection. The primary objectives of this study are to compare the changes of peripheral blood dendritic cell-derived exosomes in the patients with sepsis and the healthy controls.

Detailed Description
-----------------
This is a prospective, single-centered, clinical cohort study.

Official Title
-----------------
A Cohort Study to Investigate the Impacts of Peripheral Blood Dendritic Cells-Derived Exosomes at Early Phase on the Prognosis in Human Sepsis

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Drug: Antibiotics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were selected with the diagnostic standard Sepsis 3.0. Healthy volunteers do not have serious illness. Exclusion Criteria: Patients or volunteers do not agree to provide written informed consent and / or can not be legally authorized to provide informed consent. Patients give up treatments. Patients or volunteers withdrew from the study.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sepsis group<br>The patients were admitted to the Jinling Hospital, who met the diagnosis of sepsis(Sepsis 3.0). | Drug: Antibiotics<br>* In the sepsis group, antibiotics were used when needed.<br>|
| Healthy control group<br>Healthy volunteers. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of dendritic cell-derived exosomes |  | The first 4 hour after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compositions of microRNA in the dendritic cell-derived exosomes |  | The first 4 hour after admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sepsis, exosomes, dendritic cell