linjc16/ctgov huggingface dataset:
Patient-Centered Acupuncture for Pain (PCAP)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to find out if acupuncture can improve the management of pain in cancer patients when used as part of a treatment plan that includes conventional pain medications. The investigators will enroll 36 cancer patients at Abramson Cancer Center and Penn Cancer Network sites. Participants will be enrolled in either the Conventional Pain Management group or Integrative Pain Management group.

Official Title
-----------------
Patient-Centered Integration of Acupuncture to Decrease Pain for Cancer Survivors

Conditions
-----------------
Cancer Survivors

Intervention / Treatment
-----------------
* Behavioral: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women or men age 18 years or older Primary diagnosis of cancer with history of stage I, II, or III cancer Finished primary cancer treatments (surgery, chemotherapy, radiotherapy) Have a Karnofsky score of 60 or greater Can understand written English Have worst pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week Have been taking pain medications daily Have had at least 15 days with pain in the preceding 30 days. Exclusion Criteria: Women or men with metastatic (stage IV) cancer Unstable and progressive medical conditions as judged by the PIs or designated research nurse at the community hospitals (e.g., progressive cancer, uncontrolled heart failure) that may require hospitalization in the next 12 weeks Planned surgical procedures in the next 12 weeks Patients currently in a pain crisis as judged by the PI or designated research nurse that may warrant acute titration of medications or hospitalization Women who are pregnant or breastfeeding Unwillingness to adhere to study related procedures.

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 |
| --- | --- |
| Cancer survivors<br> | Behavioral: Survey<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 12 weeks |
A Study of Iguratimod in Patients With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate the safety and efficacy of Iguratimod in patients with active Rheumatoid Arthritis.

Detailed Description
-----------------
This is a multi-center, open, single arm study.

Official Title
-----------------
A Phase IV Study of Iguratimod in Patients With Active Rheumatoid Arthritis (RA)

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

Intervention / Treatment
-----------------
* Drug: Iguratimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a diagnosis of RA Subjects who have active RA at the time of screening Subjects who haven't used any antirheumatic drugs or have used antirheumatic drugs for more than 3 months at the time of screening Written informed consent Exclusion Criteria: Subjects with serious cardiovascular, renal, hematologic or endocrine diseases Pregnant or lactating women ALT>1.5×ULN, AST>1.5×ULN, Cr>135umol/L WBC<4×109/L，HGB<85g/L，PLT<100×109/L Subjects with uncontrolled infection Patients with active gastrointestinal diseases (such as gastric ulcer, etc.) Allergic to any of the study drugs History of alcoholism Subjects receiving live vaccines within 3 months prior to study entry Subjects participating in other clinical study within 3 months prior to study entry

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: Iguratimod<br> | Drug: Iguratimod<br>* taken orally, 2 tablets/day (bid)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients meeting the American College of Rheumatology 20% response criteria (ACR20) |  | week 24 | 
| Incidence of adverse events |  | up to 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients meeting the American College of Rheumatology 50% response criteria (ACR50) |  | week 24 | 
| Percentage of patients meeting the American College of Rheumatology 70% response criteria (ACR70) |  | week 24 | 
| Change from baseline in Disease Activity Score 28 (DAS28) |  | week 24 | 
| Change from baseline in Health Assessment Questionnaire (HAQ) |  | week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Iguratimod
Long-term Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients who has history of FURESTEM-CD injection at least once.

Detailed Description
-----------------
This study is an extended study of KSTHD_FURESTEM-CD phase 1 / 2a clinical trials in patients with moderate active Crohn's disease who had received at least once a FURESTEM-CD injection. The purpose of this clinical trial is to evaluate long-term safety and efficacy in patients for approximately 36 months (144 weeks).

Official Title
-----------------
Extension Study, An Open-labelled, Multi Center, Comparative Phase I/IIa Clinical Trials to Evaluate the Efficacy and Safety of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Biological: stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who has history of FURESTEM-CD Inj. injection at least once. patients who understand and voluntarily sign an informed consent form. Exclusion Criteria: any other condition which the Principle Investigator judges would make subject unsuitable for study participation.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: stem cells|IV infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all kinds of adverse events which occur during the clinical sutdy | Safety outcome | 114 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of patients who is applicable to CDAI<150 | Efficacy outcome | 114 weeks | 
| ratio of patients who reduce CDAI over 70 as contrasted witd baseline(V7) | Efficacy outcome | 114 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
crohn's disease, stem cell therapy, inflammatory bowel disease, hUCB-MSC, UCB-MSC, Umbilical cord Blood, Rheumatoid Arthritis, RA, Stem cell, Cell therapy, Furestem, Mesenchymal stem cell, MSC
Evaluation of the Outcomes and Performances of the Application of Augmented Reality in Operative Digestive Endoscopy

Study Overview
=================
Brief Summary
-----------------
Virtual reality obtained by the fusion of images can be applied to several fields of medicine leading to the so called augmented reality. Since 2017 investigators have been using a new digital angiographic system (Discovery IGS 40, General Electrics), where fluoroscopy can be fused with pre-procedural CT o MRI. Specifically the present study aimed at verifying the advantages that fusion imaging could bring in EUS-guided drainage of post-pancreatitis fluid collection (PFC), i.e. pseudocysts or WON, in terms of more appropriate visualization, drainage approach and time needed for resolution.

Detailed Description
-----------------
17 drainages performed with traditional radiology (group 1) were retrospectively compared with 14 ones achieved with the fusion approach (group 2). The two population were homogenous for age, sex, pancreatitis etiology and indication for drainage whereas PFCs of group 2 were larger (663 cm3 vs 437 cm3), more frequently WON than pseudocysts and were treated more precociously. As for procedure, in the group 2, thanks to fusion imaging, endoscopists didn't need ever contrast media - that was pivotal with traditional radiology - to adequately define lesion morphology. LAMS (Axios) stents were placed mainly in group 2, while in group 1 other types of stent were used.

Official Title
-----------------
Fusion Radiology in Interventional Endoscopy (FRIEnd) Approach for Pancreatic Fluid Collections

Conditions
-----------------
Pseudocyst, Walled Off Cavity

Intervention / Treatment
-----------------
* Device: fusion imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with post-pancreatitis PCF endoscopically drained Exclusion Criteria: refuse to sign the 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 |
| --- | --- |
| 1<br>Patients with pancreatic fluid collection treated with traditional EUS-drainage | |
| 2<br>Patients with pancreatic fluid collection treated with fusion imaging | Device: fusion imaging<br>* To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and radiological resolution of the PFC | complete emtying of the PFC tighter with resolution of patients' symptomps | 12 months | 
| time of radiological resolution | time taken for the complete emtying of the PFC | 12 months |
Integrated Intervention for Substance Abusers With Depressive Disorders

Study Overview
=================
Brief Summary
-----------------
This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications.

Detailed Description
-----------------
This study is a randomized clinical trial comparing outcomes of Integrated Cognitive Behavioral Treatment plus standard medications for veterans with both substance use disorders, depressive disorders versus the most commonly administered form of therapy for substance use disorders and depression, Twelve Step Facilitation (AA/NA model) group treatment plus medications. Follow-up assessments were conducted at quarterly intervals for one year following treatment.

Official Title
-----------------
Integrated Intervention for Substance Abusers With Depressive Disorders

Conditions
-----------------
Substance-Related Disorders, Depressive Disorder

Intervention / Treatment
-----------------
* Behavioral: Twelve Step Facilitation
* Behavioral: Integrated Cognitive Behavioral Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Veterans age 18 and older with alcohol, cannabinol, and/or stimulant dependence and independent mood disorders will be included. Exclusion Criteria: Psychotic disorders

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Twelve Step Facilitation | Behavioral: Twelve Step Facilitation<br>* Twelve Step Facilitation Therapy involves focusing on topics from 12-Step programs which support sobriety goals and personal growth.<br>|
| Experimental: Arm 2<br>Integrated Cognitive Behavioral Treatment | Behavioral: Integrated Cognitive Behavioral Treatment<br>* Integrated Cognitive Behavioral Treatment involves focusing on thoughts, activities, and interactions with people related to depressive symptoms and/or substance use.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Scale, Timeline Follow-back (substance measure) |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mood Disorders, Substance-Related Disorders
Cost-effectiveness of Tele-expertise for Premature Infants for Retinopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether telemedicine would be as effective as having a pediatrics ophthalmologist on site for screening examination of retinopathy in premature infants and would be cost-effective.

Official Title
-----------------
Effectiveness and Cost-effectiveness of Tele-expertise for the Screening Examination of Premature Infants for Retinopathy of Prematurity

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Device: Infants hospitalized in health facilities performing Tele-expertise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Born before 32 WA or having a birth weight under 1500g Exclusion Criteria: Brain malformations
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed group, during Tele-expertise<br>Infants hospitalized in health facilities performing tele-expertise | Device: Infants hospitalized in health facilities performing Tele-expertise<br> <br> |
| Exposed group, Prior Tele-expertise<br>Infants hospitalized in health facilities performing Tele-expertise prior implementation of Tele-expertise | |
| Control group, Prior Tele-expertise<br> | |
| Control group, during Tele-expertise<br>Infants hospitalized in health facilities not performing Tele-expertise while the exposed group use Tele-expertise | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of premature infants being screened for retinopathy following recommendations | Proportion of premature infants being screened for retinopathy following recommendations (between 31 and 32 weeks of amenorrhea (WA) for infants born before 28 WA and during the fourth week of life for infants born after 28 WA) | 4 weeks in average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay before the first screening of retinopathy | For infants born at or after 28WA | 4 weeks in average | 
| Cost of telemedicine |  | 6 months after enrollment of the first patient |
Efficacy of Arch Insoles in the Dynamic Postural Control for the Elderly

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the ability of balance controlling and test the evaluation of clinical trials with different arch insoles. The investigators want to find out the difference and efficacy of arch insoles in the dynamic postural control for the elderly.

Official Title
-----------------
Efficacy of Arch Insoles in the Dynamic Postural Control for the Elderly

Conditions
-----------------
Balance; Distorted

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no cognition problem. (mini-mental state examination [MMSE] > 23) no sensory or motor problem no use drugs about balance control lower extremity without any traumatic injury Exclusion Criteria: Cognition impairment with specific neurological deficits resulting from neuropathy, neuromuscular disorders or spinal stenosis use drugs about balance control total joint arthroplasty

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental Group<br>the healthy elders | |
| Control Group<br>the elders who have fallen once | |

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
-----------------
the elders, falling, loss balance
Analysis of Methicillin Resistant Staphylococcus Aureus (MRSA) Obtained Through the Emergency Department in a Tertiary Care Hospital in Vancouver Canada From 2001-2005

Study Overview
=================
Brief Summary
-----------------
To analyze microbiological data from MRSA samples obtained through the emergency department from 2001-2005. There is a strong clinical suspicion that we are now seeing an outbreak of a new strain of MRSA and we plan to better characterize the Vancouver population and complete a chart review to assess specific associated factors.

Detailed Description
-----------------
Pulse field gel electrophoresis, SCC mec typing, antibiotic susceptibilities, presence of the Panton-Valentine Leukocidin gene will be carried out. Clinical manifestations and associated factors will be assessed via chart review. These include: recent antibiotic use, recent hospitalization, IV drug use, HIV status, number of co-morbidities identified, presence of soft tissue abscess, post operative status, presence of bacteremia, residence in Vancouver's downtown eastside (an area of particularly low socioeconomic status).

Official Title
-----------------
Analysis of Methicillin Resistant Staphylococcus Aureus (MRSA) Obtained Through the Emergency Department in a Tertiary Care Hospital in Vancouver Canada From 2001-2005

Conditions
-----------------
Infection With MRSA Bacteria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient had a microbiological sample submitted from the emergency department of the study hospital from 2001- 2005 which grew MRSA.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRSA, USA300, CMRSA-10, CMRSA-6, soft tissue abscesses
Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the outcomes of severe osteoporotic fractures hospitalized in France, the risk of incident severe fracture at 2 years and 5 years and the risk of mortality over 2 and 5 years.

Detailed Description
-----------------
In France, the burden of osteoporotic fractures has been studied using cross sectional data from the French hospital national database. The availability of fracture liaison service in the main French cities allows the recruitment of a high number of these targeted patients. A large national multicenter, longitudinal, prospective cohort of patients hospitalized for severe osteoporotic fracture, the CROSS cohort (Cohorte sur les Risques d'une OStéoporose Sévère), in order to update data on prognosis (refracture, mortality), epidemiology and of severe osteoporotic fractures.

Official Title
-----------------
Outcomes of Severe Osteoporotic Fractures Hospitalized in France: the CROSS Cohort

Conditions
-----------------
Severe Fragility Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged above 60 years, living in France and hospitalized for severe fragility fractures in response to low-energy trauma (e.g., a fall from standing height). Vertebral fractures have to be confirmed by an X ray examination. To be eligible for the study the patient has to be included and interviewed within 6 weeks of the fracture event. Informed and free consent given and form signed and dated Exclusion Criteria: Non severe fracture (for example wrist fracture), pathological fractures, high trauma fractures and per prosthetic fractures. Non registration with a social security scheme (holder or beneficiary).

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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 |
| --- | --- | --- |
| Number of new severe fracture over 2 years | To assess the incidence of new severe fracture over 2 years in patients hospitalized for a severe fracture | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new severe fracture over 5 years | To assess the incidence of new severe fracture over 5 years in patients hospitalized for a severe fracture | 5 years |