linjc16/ctgov huggingface dataset:
Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).

Official Title
-----------------
A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12 Patients 18 years of age or older Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab Diagnosis of active RA defined by >= 5 swollen joints and one of the following: Positive RF One or more joint erosions present of x-ray HAQ score > 1 Exclusion Criteria: Patient has failed 2 or more biologics Patient who had previous treatment with cyclophosphamide and chlorambucil Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +< 500/mm3) History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix History of malignant lymphoma or leukemia regardless of treatment

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: adalimumab|40 mg every other week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Screening & Health Education in Barbershop Centers for Hypertension

Study Overview
=================
Brief Summary
-----------------
SALOON-HTN is a cross-sectional, descriptive, non-interventional, multicenter survey aiming to screen high blood pressure by measuring blood pressure in barbershops.

Detailed Description
-----------------
The survey is a screening project for hypertension, which will enroll subjects at the barbershops. The Metline Township (located at Bizerte Town, in the north of Tunisia) will be the geographical area of population enrollment. Barbershops hairdressers will be trained by a medical staff to measure the blood pressure by an ambulatory device. All subjects willing to participate in the survey will be asked to measure their blood pressure by after at least 5 minutes rest. Three measures will be performed by the Hairdressers, with an interval of 3 minutes between each measure. The mean of the last two measures will be considered. If the mean blood pressure level exceeds 135/85 mmHg the subject will be sent to a physician of his choice.

Official Title
-----------------
Screening & Health Education in Barbershop Centers for Hypertension

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Informed Consent to participate in the screening study Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Hypertension frequency | Number of subjects with systolic blood pressure above 135 mmHg and/or diastolic blood pressure above 85 mmHg | at inclusion | 
| Controlled Hypertensive patients | Number of subjects with known hypertension having systolic blood pressure below 135 mmHg and diastolic blood pressure below 85 mmHg | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Barbershop, Screening, Health Education, Cardiology, DACIMA Clinical Suite
Higher Enjoyment in Response to High Intensity Interval Training Versus Moderate Intensity Continuous Exercise

Study Overview
=================
Brief Summary
-----------------
Previous research is equivocal concerning if high intensity interval training is viewed as more aversive versus moderate exercise. Our data in active men and women showed that interval training is viewed as more enjoyable than higher volume moderate exercise.

Detailed Description
-----------------
Twelve men and women who were habitually active initially performed ramp exercise on a cycle ergometer to assess maximal oxygen uptake (VO2max) and peak power output (PPO), which was used to determine workload for the subsequent 2 bouts. They returned at least 48 h later at the same time of day to complete high intensity interval training (HIIT consisting of repeated 1 min bouts at 85 %PPO) or moderate intensity continuous training (MICT consisting of 25 min at 40 %PPO). During exercise, heart rate, oxygen uptake, perceived exertion, pleasure:displeasure, and blood lactate concentration were continuously assessed. Ten minutes post-exercise, physical activity enjoyment was measured. Data showed that despite higher oxygen uptake, heart rate, blood lactate concentration, and perceived exertion in HIIT, enjoyment was higher in HIIT versus MICT.

Official Title
-----------------
Enjoyment Responses to High Intensity Interval Training and Moderate Intensity Continuous Exercise

Conditions
-----------------
Exercise Training

Intervention / Treatment
-----------------
* Other: Exercise intensity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Habitually active, healthy, non-obese Exclusion Criteria: Sedentary, unhealthy, joint pain precluding tolerance to exercise

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active men and women<br>Healthy, active men and women ages 18-45 yr completed 1 bout of high intensity interval training and moderate intensity continuous training in a randomized, crossover design. | Other: Exercise intensity<br>* Participants were randomized to 1 or 2 exercise intensities, moderate or high (interval training).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity enjoyment score (PACES) | This is an 18-item categorical survey used to assess participants' enjoyment of the bout of physical activity that was just completed | This was measured 10 min post-exercise in all participants during the 3 mo of data collection. | 
| Oxygen uptake | Oxygen uptake (VO2) represents mitochondrial consumption of oxygen to drive cellular metabolism generating ATP to support muscular contraction. | Measured continuously during exercise during the 3 mo of data collection. |
PET-CT and Circulating Tumor Cells in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria.

Detailed Description
-----------------
To determine if measuring both tumor metabolic response (via FDG-PET scan) & circulating tumor cells (CirTC) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (CRC) who are undergoing first-line oxaliplatin-based chemotherapy. To determine if a new method of assessing drug response (measuring tumor metabolic response via FDG-PET & CirTC at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'Response Evaluation Criteria in Solid Tumors' - RECIST).

Official Title
-----------------
Identifying an Early Indicator of Drug Efficacy in Patients With Advanced Colorectal Cancer - a Prospective Evaluation of Circulating Tumor Cells, Positron-emission Tomography Scan and RECIST Criteria

Conditions
-----------------
Colorectal Cancer, Metastasis

Intervention / Treatment
-----------------
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic colorectal cancer patients not received prior drug treatment for metastatic CRC Age >= 18 years (ECOG) performance status of 0-2 Measurable tumor sites by RECIST criteria Adequate bone marrow, renal & hepatic functions Exclusion Criteria: Patients with diabetes mellitus presence of hyperglycemia Pregnant or lactating patients

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 |
| --- | --- |
| metastatic colorectal cancer<br> | Drug: Chemotherapy<br>* The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 4 years | 
| Progression-free survival |  | 4 years | 
| serum carcinoembryonic antigen (CEA) level |  | 4 years | 
| Circulating tumor cells level changes at 4 weeks after chemotherapy |  | 2 years | 
| RECIST-based tumor response at 10 weeks after chemotherapy |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Identifying an early indicator of drug efficacy
Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to compare the utility of etomidate and midazolam in helping patients to relax when there was a need for the placement of a ventilation tube by medics who were transporting patients to a hospital in an ambulance.

Detailed Description
-----------------
Study Objective: The objective of this study was to compare the utility of etomidate and midazolam for sedative facilitated intubation (SFI), without paralytics, in pre-hospital adult patients. Methods: This prospective, double-blind, randomized trial was conducted with two ground pre-hospital Advanced Life Support (ALS) units. All patients age 18 or over transported by the two participating systems requiring pre-hospital SFI were eligible for participation. The ambulances were stocked with blinded numbered syringes, each containing either 7mg of midazolam or 20mg of etomidate. Contact with the Medic Command physician was not required and no paralytics were used. If sedation was not achieved with the study drug, medics could request additional sedation from a Medical command physician; only midazolam or diazepam were available outside of the study.

Official Title
-----------------
Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Drug: Etomidate (20mg) or Midazolam (7mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Under the study protocol, all patients age 18 or over transported by the two participating ALS systems, requiring pre-hospital Sedation Facilitated Intubation, were eligible for participation. Exclusion Criteria: Exclusion criteria were pregnancy and age less than 18.

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etomidate (20mg) or Midazolam (7mg)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Special Survey for Paediatric Subjects

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Japan. The aim of this study is to collect safety and efficacy data when using NovoRapid® (insulin aspart) in children with type 1 and type 2 diabetes under normal clinical practice conditions.

Official Title
-----------------
Special Survey for Paediatric Subjects

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Requiring insulin therapy No treatment history of NovoRapid® (insulin aspart)

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| Insulin Aspart<br> | Drug: insulin aspart<br>* Injected subcutaneously (s.c., under the skin). Prescribed by physician as a result of normal clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycaemic events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 
| Physicial examination |  |  | 
| Adverse events |  |  |
FGF-1 for Topical Administration for the Treatment of Diabetic or Venous Stasis Ulcers

Study Overview
=================
Brief Summary
-----------------
FGF-1 is being used for the treatment of patients with diabetic or venous stasis ulcers. Procedure includes topical administration of FGF-1 or placebo and evaluation of safety, pharmacokinetics, and wound improvement.

Detailed Description
-----------------
Patients meeting eligibility criteria will be randomized to receive topical administration of either FGF-1 or placebo. Patients will be evaluated at days 1 and 7, post-treatment for safety, pharmacokinetics, and wound healing.

Official Title
-----------------
A Phase 1, Open Label, Single Dose, Dose Response, Pilot Study to Evaluate the Safety and Tolerability of Human Fibroblast Growth Factor-1 (FGF-1) in Patients With Diabetic or Venous Stasis Ulcers

Conditions
-----------------
Chronic Wounds, Diabetes, Venous Stasis Ulcers

Intervention / Treatment
-----------------
* Drug: FGF-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility Criteria: Informed consent Female patients post-menopausal, sterilized, or on adequate birth control Full-thickness lower extremity diabetic or venous statis ulcers of specific target size and of at least 8 weeks but no more than 1 year duration Target ulcer freshly debrided at screening or within two weeks prior to screening Adequate blood supply defined by transcutaneous oxygen pressure > 20 mmHG and ABI greater than or equal to 0.4 Compliance with non-weight bearing regimen in diabetic patients Compliance with wound care regimen

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FGF-1|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic wounds, Diabetes, Ulcers, Arterial bypass, Angioplasty, Diabetic ulcers
CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)

Study Overview
=================
Brief Summary
-----------------
The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.

Official Title
-----------------
CD123/CLL1 CAR-T Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia

Conditions
-----------------
Relapsed/Refractory AML

Intervention / Treatment
-----------------
* Biological: CD123/CLL1 CAR-T Cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Aged < 70 years Patients with relapsed/refractory AML Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70% Exclusion Criteria: Pregnant or lactating females. Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.

Ages Eligible for Study
-----------------
Maximum Age: 70 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: Arm 1<br>CD123/CLL1 CAR-T Cells treat | Biological: CD123/CLL1 CAR-T Cells<br>* CD123/CLL1 CAR-T Cell Therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukemia free survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events that are related to treatment |  | 1 year |
Islide-Establishing a Clinical Dermatopathology Online Discourse System

Study Overview
=================
Brief Summary
-----------------
The trend is changed by a large number of low-cost computers, large-capacity computing power, and the rapid advent of network bandwidth. From the Internet to the WWW to Web2.0, the technology in addition brings impact on economic, social, and technological, but also on medical education about knowledge delivery globally and learning patterns. Currently, many scholars start to take the affection of social network seriously. In the medical field, ECGpedia is the typical successful example. There are more than 250,000 members from 188 different countries in the website. On the other hand, the effect of data computing and transition improve the development of Gigapixel image presentation. For example, users can zoom in and zoom out on GoogleMap. The research team has being worked on this kind of search engine on pathology and anatomy slides in past three years. For education purpose, students can observe slides by using a virtual microscope directly. This research will target on establishing a Clinical Dermatopathology Online Discourse System (iSlide). It will combine a virtual microscope platform and a biopsy diagnosis eLearning System. This survey will be focused on evaluating of this platform. The object is all interns in dermatopathology department at Wan Fang Hospital this semester. All the new physicians can learn from experienced experts. Users who have questions can search for help from others via this website. They can get assistance by thinking procedure learning model -scheme inductive and pattern recognition. In doing so, clinicians and pathologists can discuss with each other through this system. It also can improve the education and research development in this field.

Official Title
-----------------
Islide-Establishing a Clinical Dermatopathology Online Discourse System

Conditions
-----------------
Biopsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All interns in dermatology department of Wan Fang Hospital this semester. Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 20 Months

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
-----------------
Online Discourse, e-Learning, Biopsy, Virtual Pathologic Section