linjc16/ctgov huggingface dataset:
Drug-Drug Interaction Study Between DWC20155 / DWC20156 and DWC20162 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
A randomized, open label, crossover study to explore drug-drug interactions between DWC20155 / DWC20156 and DWC20162 in Healthy Volunteers

Official Title
-----------------
A Randomized, Open-label, Crossover Study to Explore Drug-drug Interactions Between DWC20155 / DWC20156 and DWC20162 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Co-administration of DWC20155/DWC20156
* Drug: DWC20162


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Accepts healthy volunteers Exclusion Criteria: Who has allergy to investigational product

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study effect of DWC20162 on DWC20155/DWC20156 PK<br>To study effect of DWC20162 on DWC20155/DWC20156 PK | Drug: Co-administration of DWC20155/DWC20156<br> <br> Drug: DWC20162<br> <br> |
| Experimental: Study effect of DWC20155/DWC20156 on DWC20162 PK<br>To study effect of DWC20155/DWC20156 on DWC20162 PK | Drug: Co-administration of DWC20155/DWC20156<br> <br> Drug: DWC20162<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) |  | 0   24 hours | 
| Area under the time versus plasma concentration curve (AUC) |  | 0   24 hours |
Study To Evaluate Long Term Treatment Effect Of Diapep277® In Patients Who Have Completed Study 901 And Study 910** (Extension To 901)

Study Overview
=================
Brief Summary
-----------------
Open label study to evaluate long term treatment effect of diapep277.

Conditions
-----------------
Giving a Vaccination in Three Months

Intervention / Treatment
-----------------
* Other: vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. patient that completed 901 and 910 study. Exclusion Criteria: 1. cpeptide<0.2

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

Design Details

Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| c peptide reserve |  |  |
A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals

Study Overview
=================
Brief Summary
-----------------
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia 、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children acute hot diseases in many Chinese hospitals. The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Detailed Description
-----------------
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice. In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Xiyanping injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015. Eligibility criteria Patients who will use Xiyanping injection in selected hospitals.

Official Title
-----------------
A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China

Conditions
-----------------
Bacillary Dysentery, Viral Pneumonia, Bronchitis, Infantile Diarrhea, Virus Hepatitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Xiyanping injection from 2012 to 2014
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 participants with adverse events; incidence of Xiyanping'ADRs and identify factors that contributed to the occurrence of the adverse reaction |  | The registry procedure will last 3 years only for patients using Xiyanping. |
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.

Official Title
-----------------
FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients

Conditions
-----------------
Myasthenia Gravis

Intervention / Treatment
-----------------
* Drug: tacrolimus
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed as myasthenia gravis Those whose MG symptoms are well-controlled by the treatment with prednisone Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain Exclusion Criteria: Those who have thymoma or the history of thymoma (Masaoka stage III or IV) Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug. Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug. Pancreatitis or diabetes Serum creatinine≦1.5mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 64 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: 1<br> | Drug: tacrolimus<br>* oral<br>* Other names: FK506;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.] |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of steroid therapy (mg) |  | 6 Months | 
| QMG score;MG-ADL |  | 6 Months | 
| Success rate of achievement to the targeted steroid dose |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Myasthenia Gravis
Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty

Study Overview
=================
Brief Summary
-----------------
Medial upper eyelid pad of fat bulge is a common problem. medial fat pad preservation might be a good adjutant to upper eyelid blepharoplasty

Detailed Description
-----------------
Blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery or orbitoglabellar groove

Official Title
-----------------
Patient Satisfaction After Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty

Conditions
-----------------
Eyelid Diseases

Intervention / Treatment
-----------------
* Procedure: medial fat preservation upper blepharoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: upper eyelid medial pad of fat bulge Exclusion Criteria: Other eyelid diseases and previous eyelid surgery

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 |
| --- | --- |
| Group A<br>blepharoplasty with repositioning of the nasal fat pad to the central arcus marginalis of the superior orbital rim during surgery. | Procedure: medial fat preservation upper blepharoplasty<br>* medial fat preservation upper blepharoplasty increasing volumetric upper eyelid skin fold<br>|
| Group B<br>blepharoplasty with repositioning of the nasal fat pad to orbitoglabellar groove during surgery. | Procedure: medial fat preservation upper blepharoplasty<br>* medial fat preservation upper blepharoplasty increasing volumetric upper eyelid skin fold<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global aesthetic improvement scale | calculate scale score (1-5);score 1:exceptional improvement and score 5 :worsened patient | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upper eyelid pad fat, blepharoplasty
Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl when used long-term to relieve breakthrough pain in opioid tolerant cancer patients.

Official Title
-----------------
Multi-center Study Evaluating OraVescent Fentanyl Citrate for the Treatment of Breakthrough Pain in Opioid Tolerant Cancer Patients

Conditions
-----------------
Pain, Cancer

Intervention / Treatment
-----------------
* Drug: OraVescent fentanyl (OVF)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of a malignant solid tumor or hematological malignancy causing cancer related pain Currently taking around the clock opioid therapy for pain Experience on average, 1-4 breakthrough pain episodes per day Exclusion Criteria: Opioid or fentanyl intolerance Sleep apnea or active brain metastases with increased intracranial pressure COPD (chronic obstructive pulmonary disease); cardiopulmonary disease; heart disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: OraVescent fentanyl (OVF)|nan|

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
-----------------
cancer, pain, Breakthrough Pain in cancer patients
Golf, Physical Rehabilitation, and Movement Disorders

Study Overview
=================
Brief Summary
-----------------
The importance of physical activity for individuals with movement disorders, including Parkinson disease and Essential tremor, has been established. Barriers including patient engagement continue to limit effectiveness. Golf requires skills found challenging to individuals with movement disorders. This study seeks to assess the feasibility and effectiveness of an outpatient-based rehabilitation program incorporating golf skills and activities on functional measures and quality of life.

Official Title
-----------------
An Outpatient Physical Therapy and Golf Program Designed for Individuals With Movement Disorders

Conditions
-----------------
Parkinson Disease, Movement Disorders

Intervention / Treatment
-----------------
* Other: Physical Therapy, Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of either PD, Parkinsonism, or ET. Subjects must also demonstrate functional deficits in at least one of the three categories (gait, transfers, balance) to be further assessed by the evaluating PT Exclusion Criteria: Subjects will be excluded if they are unable to maintain standing balance with an assistive device, if they are non-ambulatory even with a device, if pain does not allow for subject participation, and if they are unable to follow instructions due to an underlying attentional or cognitive deficit.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 105 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: Intervention of golf and rehab<br>2x/week x 6 weeks participation in a golf and PD rehab program | Other: Physical Therapy, Exercise<br>* Outpatient physical therapy intervention incorporating golf related assessment of skills and prescribed exercises including postural, balance, and club swing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional gait assessment | Scale that measures ambulation quality | Scale completed at baseline and at 6 weeks of treatment |
Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice

Study Overview
=================
Brief Summary
-----------------
Feasibility study to report on the impact of ACCESS of single-fraction radiation therapy on cancer patients with bone metastases enrolled in hospice care.

Detailed Description
-----------------
Hospice care for terminally ill patients with metastatic cancer improves quality of life, pain control, and potentially also survival when patients are enrolled early.1-3 However, hospice programs are often seen by patients and their caregivers as the last resort after exhaustion of all effective treatment options. The need to revoke active treatment (for all hospice patients with cancer outside of the VA system) discourages hospice enrollment. This study aims to understand and analyze barriers to access specifically for short course palliative radiation therapy in cancer patients enrolled in hospice.

Official Title
-----------------
Impact of Access to Single-Fraction Palliative Radiation Therapy in Cancer Patients Enrolled in Hospice

Conditions
-----------------
Cancer Metastatic

Intervention / Treatment
-----------------
* Radiation: Single-Fraction Palliative Radiation Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Solid Tumor Malignancies and Multiple Myeloma with Bone Metastases and Associated Bone Pain Enrolled in Hospice Exclusion Criteria: Decisionally-Impaired Subjects, Pregnant Women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Single-Fraction Palliative RT<br>Single-Fraction Palliative Radiation Therapy Adminstration | Radiation: Single-Fraction Palliative Radiation Therapy<br>* All subjects will be undergo single-fraction palliative radiation therapy who have cancer and associated bone metastases and symptomatic bone pain.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opioid Use for Pain Management | Opioid Dosage (mg/day) | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Quality of Life Measures | Questionnaires using Herth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale | During study completion | 
| Improved Activities of Daily Living | Questionnaires using Hearth Hope Index, Timed Up and Go, and Edmonton Symptom Assessment Scale | During study completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Patients Hospice Care, Palliative Radiation Therapy
Exploratory Study of Natural Killer Inflammatory Lymphocytes in Waste Per-operating of Tonsillectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to describe the frequency of the presence of cells Natural Killer (NK) expressing CD86 and HLA - DR in tonsils

Official Title
-----------------
Exploratory Study of Natural Killer Inflammatory Lymphocytes in Waste Per-operating of Tonsillectomy

Conditions
-----------------
Tonsillectomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with programmed tonsillectomy as part of the care Exclusion Criteria: patient opposition to use its waste of per-operating tonsillectomy for research purposes patient with immunosuppressive and/or corticoid treatment (> 1 mg/kg)
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 |
| --- | --- | --- |
| presence of lymphocytes NK expressing CD86 and HLA - DR | by immunostaining and detection by flow cytometry | inclusion |
Impact of Decision Aids on Bariatric Surgery Choice

Study Overview
=================
Brief Summary
-----------------
Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. These treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. Investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on obese patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. Investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.

Official Title
-----------------
Impact of Decision Aids on Bariatric Surgery Choice: A Randomized Controlled Trial

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Behavioral: Shared decision making with decision aids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity Body mass index (BMI) ≧ 37 kg / m2 Exclusion Criteria: Endocrine system abnormalities in patients Drug abuse or mental illness Major organ dysfunction and can accept surgery Patients cannot understand Chinese Age less than 20 years old or more than 70 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAs group<br>Shared decision making using decision aids | Behavioral: Shared decision making with decision aids<br>* For obese patients, we use shared decision making with decision aids to help them choose the suitable types of bariatric surgery.<br>|
| No Intervention: Control group<br>Standard oral explanation guided with booklets | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Total scores of decisional conflict scale | One week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision regret | Total scores of decision regret | 3 month after bariatric surgery |