linjc16/ctgov huggingface dataset:
ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.

Official Title
-----------------
Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety & Tolerability of Two Doses of ACT-128800, an Oral S1P1 Receptor Agonist, Administered up to Twenty-eight Weeks in Patients With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: ACT-128800
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males and females aged 18 to 60 years (inclusive) with moderate to severe chronic plaque psoriasis who require systemic treatment. Exclusion Criteria: Patients with other forms of psoriasis and patients who are currently treated for autoimmune disorders other than psoriasis. Systemic or topical treatments for psoriasis other than emollients. Ongoing bacterial, viral or fungal infections. History or presence of malignancy. Additional inclusion and exclusion criteria apply with respect to medical conditions and concomitant treatments which could affect patients' risk from participating in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Investigational drug - Dose 1<br> | Drug: ACT-128800<br>* ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily<br>|
| Experimental: Investigational drug - Dose 2<br> | Drug: ACT-128800<br>* ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily<br>|
| Placebo Comparator: Matching placebo<br> | Drug: Placebo<br>* ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. |  | Baseline to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Clear or Almost clear on PGA at Week 16. |  | Baseline to week 16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, chronic plaque psoriasis, Moderate to severe chronic plaque psoriasis
Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.

Study Overview
=================
Brief Summary
-----------------
With 18F-FDG PET, we have few atlases of normality allowing the realization of objective quantitative analyses. An atlas of normality is a probabilistic atlas of normal FDG uptake from a representative set of brain PET images of healthy subjects. This type of atlas is essential for intra- and inter-individual comparisons. Accurate quantitative analysis of brain 18F-FDG PET images acquired on a hybrid PET system has been shown to require an institutional normal database for statistical analyzes (Akdemir et al., JNM 2017 and Della Rosa et al Neuroinformatics, 2014).

Detailed Description
-----------------
This is a prospective, monocentric, non-randomized study, with no direct individual benefit since it involved healthy volunteers.

Official Title
-----------------
Creation of a Probabilistic Atlas of Normal Cerebral Uptake of 18F-FDG in PET/MRI.

Conditions
-----------------
Brain Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: brain PET-MRI with 18F-FDG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 20 to 50 Absence of any history or cardiovascular, neurological or psychiatric deficit Signed the informed consent Exclusion Criteria: Contraindication to the realization of an MRI or PET and to the injection of 18F-FDG People using a pacemaker or insulin pump People wearing a metal prosthesis or an intracerebral clip People with intraocular metal splinters People with a pathology considered incompatible for the production of the atlas according to the investigator Pregnant women and breastfeeding women Subject in period of exclusion.

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Healthy volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 18F-FDG injection<br>Health volunteers with 18-F-FDG injection | Diagnostic Test: brain PET-MRI with 18F-FDG<br>* Realisation of a brain PET-MRI with 18F-FDG in 39 healthy volunteers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation, from a representative set of brain PET-MRI images of healthy subjects, of a probabilistic atlas of normal FDG uptake in healthy volunteers | Evaluation of tracer activity at the cerebral level on the acquisition images | 30 minutes after 18F-FDG injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FDG PET, PET-MRI, atlas, brain
Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.

Official Title
-----------------
A Phase II Study of Genexol-PM and Cisplatin as Induction Chemotherapy in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Conditions
-----------------
Locally Advanced Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: genexolPM + cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: locally advanced head and neck squamous cell carcinoma oral cavity, oropharynx, hypopharynx, larynx measurable lesion unresectable age 18 or more ECOG 0 or 1 Exclusion Criteria: distant metastasis pregnancy prior chemotherapy or radiation therapy 2ndary malignancy other unfit medical condition

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: genexolPM + cisplatin<br> | Drug: genexolPM + cisplatin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | RECIST | every 2 cycles, 6wk later after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional control rate | NCI CTCAE | every 3wk (every cycle) | 
| Quality of life | EORTC Q30; performance scale(activities) pain adverse event(appetite, sleep and so on) | every 3wk (every cycle) | 
| safety | NCI CTCAE v3.0; disease or syndrome, pathologic funtion, sign or symptom, imjury or poisoning, anatomical abnormality, mental or behavioral dysfunction Neutropenia, leucopenia, thrombocytopenia, hepatotoxicity, renal toxicity | every 3wk (every cycle) |
Growth Hormone for Osteoporosis Pseudoglioma Syndrome

Study Overview
=================
Brief Summary
-----------------
Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. We have found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.

Detailed Description
-----------------
Osteoporosis pseudoglioma (OPPG) syndrome is a rare autosomal recessive condition of childhood osteoporosis and congenital blindness for which new treatments are needed. We have found that body fat is increased in OPPG and muscle mass is reduced. We hypothesize that growth hormone therapy will improve muscle mass and bone strength in OPPG.

Official Title
-----------------
Trial of Growth Hormone for Osteoporosis Pseudoglioma Syndrome

Conditions
-----------------
Osteoporosis Pseudoglioma Syndrome

Intervention / Treatment
-----------------
* Biological: Human recombinant growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoporosis pseudoglioma syndrome Age 4 years and above not on medication for osteoporosis Exclusion Criteria: pregnant Age under 4 yrs Active malignancy

Ages Eligible for Study
-----------------
Minimum Age: 4 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: Growth hormone therapy<br>Growth hormone treatment for 6 months | Biological: Human recombinant growth hormone<br>* growth hormone treatment for 6 months (daily, weight based)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone quality by pQCT | By pQCT: periosteal circumference, cortical density, trabecular density, section modulus | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat percent | Percent body fat by DXA | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoporosis pseudoglioma, OPPG, growth hormone, osteoporosis
Effectiveness of a Four-level Chinese Emergency Triage Scale in Mainland China

Study Overview
=================
Brief Summary
-----------------
Inter-rater reliability between experts and triage nurses was assessed in 484 emergency patients. The criterion-related validity was evaluated in other 30687 emergency patients, based on emergency department (ED) mortality, the length of stay in ED, the number of discharge, and hospitalization (intensive care/general ward).

Official Title
-----------------
The Reliability and Validity of a Four-level Chinese Emergency Triage Scale in Mainland China

Conditions
-----------------
Emergencies, Triage

Intervention / Treatment
-----------------
* Other: Four-level Chinese Emergency triage scale


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients, older than 14 years and admitted to the ED, were eligible for this study. Exclusion Criteria: Gynecologic and obstetric emergencies Patients, who left against medical advice or hadn't been aided by a doctor

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| emergency triage patients<br>triage Level I triage Level II triage Level III triage Level IV | Other: Four-level Chinese Emergency triage scale<br>* a four-level category system, i.e. life-threatening (Level I), emergent (Level II), urgent (Level III) and semi-urgent (Level IV) . This system contains critical indicators (cardiac arrest, shock, and apnea), high risk indicators (ACS and DKA), single objective indicators (SBP, RR, HR, and SpO2) and MEWS (synthesis indicator). According to patients' health care problems, patients are rated by nurses into one of the four mentioned levels.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-rater reliability | inter-rater reliability as the agreement between triage nurses and experts | 2019-10-1 | 
| emergency department (ED) mortality |  | 2019-12-31 | 
| the number of discharge |  | 2019-12-31 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of hospitalization |  | 2019-12-31 |
Rheumatoid Arthritis (DMARD) Intervention and UtilizationStudy

Study Overview
=================
Brief Summary
-----------------
The Rheumatoid Arthritis DMARD Intervention and Utilization Study (RADIUS 1) is designed to systematically collect and document use patterns, effectiveness, and safety of DMARD treatments currently used in the management of rheumatoid arthritis (RA). It is anticipated that study data may help improve the quality of information upon which clinical decisions are based.

Official Title
-----------------
Rheumatoid Arthritis Disease Modifying Anti-Rheumatic Drug (DMARD) Intervention and Utilization Study (RADIUS 1)

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

Intervention / Treatment
-----------------
* Drug: DMARD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfillment of the 1987 American Rheumatism Association criteria for RA Currently requiring a new DMARD (change or addition) Exclusion Criteria: Currently enrolled in a clinical trial with treatments or patient visits imposed by a protocol Nursing or pregnant women Patients with active infection

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 |
| --- | --- |
| Observation<br> | Drug: DMARD<br>* All subjects were required to initiate, add or change DMARD therapy at study entry.<br>|

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
-----------------
rheumatoid arthritis, RA, DMARD
Acupuncture to Prevent Postoperative Bowel Paralysis (Paralytic Ileus)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if acupuncture is effective in preventing prolonged postoperative paralysis of the gastrointestinal tract among patients undergoing colostomy/ileostomy closure.

Official Title
-----------------
Acupuncture to Prevent Postoperative Paralytic Ileus

Conditions
-----------------
Ileus, Neoplasms

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure Hospital admission must be same day as surgery Exclusion Criteria: Incapacitating disease Concurrent herbal or laxative use Use of Heparin or Coumadin Upper or lower extremity deformities Chronic constipation prior to cancer diagnosis History of cerebrovascular accident or spinal cord injury Chronic pain that has been treated with any form of major opioid or weak opioids (=/> 30mg/24 hours) Pacemaker or metal implants Concurrent alternative medicine/herbal use

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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupuncture|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
-----------------
Colostomy, Ileostomy
500mg Fulvestrant in HR+ MBC

Study Overview
=================
Brief Summary
-----------------
To study the real world use of 500mg Fulvestrant in HR+ MBC.

Detailed Description
-----------------
An observational, retrospective study of 500mg Fulvestrant in hormone receptor+/HER2- advanced breast cancer

Official Title
-----------------
An Observational, Retrospective Study of 500mg Fulvestrant in Hormone Receptor+/HER2- Advanced Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with ER/PR+，HER2- advanced breast cancer Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer. 3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015. 4.Available medical history Exclusion Criteria: Incomplete medical history HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fulvestrant<br>Fulvestrant 500mg per month (D1, D28, q28d), with a loading dose 500mg of first dose at D15 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 6 weeks |
Predictors of Lymphedema Following Breast Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study evaluate which factors play a role in lymphedema development among women who have had axillary surgery for breast cancer. Potential risk factors for women who have developed lymphedema will be compared to risk factors among women who have not developed lymphedema after breast cancer surgery.

Detailed Description
-----------------
Surgery for breast cancer includes removal of the breast tumor along with the axillary lymph nodes. The status of these nodes helps clinicians determine prognosis and guides treatment decisions. Unfortunately, a relatively common side effect following axillary lymph node dissection is upper-extremity lymphedema. The purpose of this study is to identify risk factors for lymphedema among women who have had axillary surgery for breast cancer. Specific aims include identifying risk factors for lymphedema and comparing quality of life (QOL) ratings for women who have and do not have lymphedema. A case-control study will be conducted with enrollment of 200 participants. Cases will be identified at their lymphedema consult in the physical therapy centers. Using the oncology registry, controls will include patients who have had breast cancer surgery and have not developed lymphedema. The severity of lymphedema and interference with daily life will be assessed with the Measure of Arm Symptom Survey (MASS), a patient-completed survey, and QOL will be collected with the SF-36. Treatment risk factors including previous surgery, radiotherapy and chemotherapy will be obtained from oncology registry data. This study will determine which factors play a role in lymphedema development.

Official Title
-----------------
Predictors of Lymphedema Following Breast Cancer Surgery

Conditions
-----------------
Lymphedema, Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of lymphedema Axillary node surgery by sentinel node or axillary node dissection No known metastatic disease in the axilla Able and willing to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients with lymphedema<br>Identification of risk factors for lymphedema in women who have had axillary surgery for breast cancer. | |
| Control patients without lymphedema<br>Controls matched on type of axillary surgery and surgery date for comparison in quality of life (QOL) ratings from women who have lymphedema. | |

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
-----------------
Breast cancer, Lymphedema, Quality of life