linjc16/ctgov huggingface dataset:
A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction

Study Overview
=================
Brief Summary
-----------------
Post surgical pain associated with ligament reconstruction may persist for few days after the surgical procedure. Arcoxia is a new anti-inflammatory and analgesic drug that alleviate pain through oral administration. This study will test the safety and efficacy of Arcoxia in the management of post-operational pain in patients receive the ligament reconstruction surgery.

Official Title
-----------------
A Randomized, Double Blind, Placebo-controlled Study to Assess the the Preemptive Benefit of Etoricoxib in Patients Receiving Anterior Cruciate Ligament Reconstruction

Conditions
-----------------
Post-operational Pain

Intervention / Treatment
-----------------
* Drug: Arcoxia(etoricoxib 90 mg/tablet)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age ranged from 16 35 who have anterior cruciate ligament injury and/or associated injuries are scheduled for ACL reconstruction surgery. Patient agrees to participate into this study and is willing to sign the patient informed consent form.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Etoricoxib 90mg | Drug: Arcoxia(etoricoxib 90 mg/tablet)<br>* Arcoxia(etoricoxib 90 mg/tablet) or placebo, #1, 3 days<br>|
| Placebo Comparator: 2<br>placebo | Drug: Arcoxia(etoricoxib 90 mg/tablet)<br>* Arcoxia(etoricoxib 90 mg/tablet) or placebo, #1, 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at rest at different timepoint after surgical procedures |  | From baseline(preoperation) to 3 days after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COX-2; post-operative ; sports injury; surgical pain
Perceptions and Barriers About Cessation of Smoking Among IBD Patients

Study Overview
=================
Brief Summary
-----------------
This study will investigate the perception of the relationship between smoking and inflammatory bowel disease by surveying inflammatory bowel disease patients. Afterward, the relationship between smoking and inflammatory bowel disease will be explained, and the smoking cessation rate will be investigated three months later.

Detailed Description
-----------------
A survey is conducted on patients with inflammatory bowel disease (IBD). Current smoking status, daily smoking amount, smoking period, perception of smoking effect on the induction of Crohn's disease (CD) or ulcerative colitis (UC), and perception of the effect of smoking on the course of CD or UC were investigated. Moreover, the intention to quit smoking is investigated. After the survey, information on the effects of smoking on CD or IBD is provided, and smoking cessation education is provided. After three months, the patients' smoking behavior was investigated, and the smoking cessation rate was investigated.

Official Title
-----------------
Perceptions and Barriers About Cessation of Smoking Among IBD Patients

Conditions
-----------------
Smoking, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Behavioral: smoking education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients previously diagnosed with inflammatory bowel disease or newly diagnosed with inflammatory bowel disease Exclusion Criteria: Those who do not agree to the survey or smoking cessation education

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: smoking education<br>smoking education | Behavioral: smoking education<br>* Educate on the relationship between inflammatory bowel disease and smoking and the necessity and importance of quitting smoking.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking cessation rate | Percentage of smokers who succeeded in quitting smoking | 3 month later |
A Study Evaluating Efficacy and Safety of YM150 Compared to Enoxaparin in Subjects Undergoing Hip Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of various doses of YM150 (the experimental drug) compared to enoxaparin in the prevention of venous thromboembolism in patients that are undergoing elective hip replacement surgery.

Official Title
-----------------
A Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Compare YM150 Bid and qd Doses and Enoxaparin for Prevention of Venous Thromboembolism in Subjects Undergoing Elective Hip Replacement Surgery

Conditions
-----------------
Venous Thromboembolism, Arthroplasty, Replacement, Hip

Intervention / Treatment
-----------------
* Drug: YM150
* Drug: enoxaparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is scheduled for elective hip replacement surgery Exclusion Criteria: Subject has active bleeding or any condition associated with increased risk of bleeding Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study Subject has had an MI or stroke within 3 months before planned hip replacement 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?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. YM150, Dose X, twice daily<br> | Drug: YM150<br>* oral<br>|
| Experimental: 2, YM150, Dose X, once daily<br> | Drug: YM150<br>* oral<br>|
| Experimental: 3. YM150, Dose Y, twice daily<br> | Drug: YM150<br>* oral<br>|
| Experimental: 4. YM150, Dose Y, once daily<br> | Drug: YM150<br>* oral<br>|
| Active Comparator: 5. Enoxaparin<br> | Drug: enoxaparin<br>* SC injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic Venous Thromboembolisms and death from all causes |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all Venous Thromboembolic events |  | Until day 12, during the treatment period, follow-up period and entire study period | 
| Incidence of Bleeding events |  | During the treatment period, follow-up period and entire study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elective hip replacement surgery, Venous Thromboembolism, Thrombosis, Anticoagulants, Prevention, YM150, Factor Xa
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

Study Overview
=================
Brief Summary
-----------------
To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.

Detailed Description
-----------------
Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. Patients failing the low dose will be eligible to increase the dose to the higher dose. Treatment may continue indefinitely. After 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter.

Official Title
-----------------
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

Conditions
-----------------
HIV Infections, HIV Wasting Syndrome

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy. Prophylaxis or treatment for opportunistic infection. Patients must have: HIV-associated wasting. Prior Medication: Allowed: Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study.

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thalidomide|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
-----------------
Acquired Immunodeficiency Syndrome, Cachexia, Thalidomide
An Interview Study With Injured Workers Concerning Their Experiences With the Social Systems and Psychosocial Health Consequences

Study Overview
=================
Brief Summary
-----------------
Objective: In addition to physical discomforts, work-related injuries and illnesses often result in various forms of hardships, including economic hardship, labor conflicts and legal disputes. The physical and psychological health conditions are likely to be worsen when the social supporting systems are not well functioning. In this study, the investigators aim to conduct in-depth interviews with injured workers to study their experiences with the social systems, including employment protection system, workers' compensation system, health care system and other social welfare systems, and to explore how the systems may affect workers' physical and psychological health. Methods: Face-to-face interviews will be conducted with a semi-structured questionnaire. Subjects who had ever experienced work-related injuries or diseases (including muscular skeletal disorders and work-related cardiovascular or cerebrovascular diseases) over the past 3 years are invited. The investigators anticipate to recruit a total of 60 100 cases, whom will be recruited through the assistance of occupational physicians, occupational health centers, labor groups and unions. Interview time will be limited to 1 hour. Anticipated results and contribution: Findings of this study will help to advance our knowledge concerning the functions of current social systems and the hardships of workers who suffer from work-related injuries and diseases. Suggestions will be provided for the improvements of current systems. Keywords: work-related injury, occupational disease, workers' compensation, psychological, policy.

Official Title
-----------------
An Interview Study With Injured Workers Concerning Their Experiences With the Social

Conditions
-----------------
Psychological, Policy, Work-related Injury, Occupational Disease, Workers' Compensation

Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| self-rated mental health | using BSRS-5 scale | 12 months after occupational injury or diseases | 
| self-rated health | Self-rated health measured by a single question such as in general, would you say that your health is excellent, very good, good, fair, or poor? and a survey questionnaire in which participants assess different dimensions of their own health. This survey technique is commonly used in health research for its ease of use and its power in measuring health. | 12 months after occupational injury or diseases | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
work-related injury, occupational disease, workers' compensation, psychological, policy
Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multi-modality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury

Study Overview
=================
Brief Summary
-----------------
This is the proof of concept study with multi-modality approach (using intra-thecal bioactive peptides, stem cells, laser and transcranial IV laser and Median Nerve stimulation as adjuvants) in cases of brain death due to traumatic brain injury having diffuse axonal injury to document possibility of reversal of brain death (BD).

Official Title
-----------------
Non-randomized, Open-labeled, Interventional, Single Group, Proof of Concept Study With Multimodality Approach in Cases of Brain Death Due to Traumatic Brain Injury Having Diffuse Axonal Injury

Conditions
-----------------
Brain Death

Intervention / Treatment
-----------------
* Biological: BQ-A Peptide Extract
* Biological: Mesenchymal Stem Cells
* Device: Transcranial Laser Therapy
* Device: Median Nerve Stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals declared Brain dead from a traumatic brain injury having diffuse axonal injury on MRI Not willing for organ donation Written informed consent from the legally acceptable representative of the patient Exclusion Criteria: Metallic clips/ metal implants or intracranial implants in the brain. Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br> | Biological: BQ-A Peptide Extract<br>* BQ-A Peptide Extract<br>Biological: Mesenchymal Stem Cells<br>* Mesenchymal Stem Cells<br>Device: Transcranial Laser Therapy<br>* Transcranial Laser Therapy<br>Device: Median Nerve Stimulator<br>* Median Nerve Stimulator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of brain death as noted in clinical examination or EEG |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrospinal fluid (CSF) analysis of color consistency, cell counts, and microbial evaluation | To signify any signs of aseptic or bacterial meningitis | 15 days | 
| MRI analysis to analyze any changes in meninges | To signify any signs of aseptic or bacterial meningitis | 15 days | 
| Pulse |  | 15 days | 
| O2 saturation |  | 15 days | 
| Blood Pressure |  | 15 days | 
| Respiration changes |  | 15 days |
Pregnane X Receptor (PXR) Agonist Rifampicin Effects on Glucose, Lipid and Hormone Homeostasis

Study Overview
=================
Brief Summary
-----------------
This clinical trial is designed to study the effects of rifampicin on the glucose, lipid and hormone homeostasis in healthy volunteers. The main hypothesis is that rifampicin lowers fasting glucose and enhances insulin sensitivity. The study is a randomized, placebo-controlled, open-label cross-over trial. Twelve subjects will be given 600 mg of rifampicin a day for a week compared to a one-week placebo arm. There is at least a 4-week wash-out between the arms. The main outcome measures are the changes in the fasting glucose and HOMA-IR-index (calculated based on fasting glucose and insulin).

Official Title
-----------------
PXR-agonisti Rifampisiinin Vaikutukset Glukoosi-, Lipidi- ja Hormonihomeostaasiin

Conditions
-----------------
Glucose Tolerance

Intervention / Treatment
-----------------
* Drug: Rifampicin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer Age 18-40 years Exclusion Criteria: Any continuous medication Any significant disease Allergy to rifampicin Pregnancy and breast feeding Fear of needles and previous difficult blood samplings Substance abuse Participation in another clinical drug trial within 1 month of enrollment Use of soft contact lenses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rifampicin<br> | Drug: Rifampicin<br> <br> * Other names: Rimapen, ATC J04AB02;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose |  |  |
Predictive Value of Pet Scan With Fdg Performed During Irradiation in Patients Treated for Oesaphagus Carcinoma

Study Overview
=================
Brief Summary
-----------------
The poor prognosis in the early-stage of oesophageal carcinoma cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments. FDG-PET is a medical imaging modality allowing the quantification of the tumour glucose consumption. Then, this exam is used for pathology staging, target volume definition for RT, and treatment efficiency few months after CRT. Our assumption is that an FDG-PET exam during the course of CRT might be predictive of the treatment efficiency few months later. In this study, we propose to perform 4 FDG-PET: first PET1 before chemo-radiotherapy, second PET2 during the chemo-radiotherapy (see RTEP1), third and fourth PET3 PET4 3month and 12 month after the end of radiotherapy. We will investigate the performances of FDG-PET performed during CRT for the prediction of the one-year patient heath outcome. If the predictive value of TEP2 is confirmed, we would be able to optimize the planning treatment during the course of the therapy.

Official Title
-----------------
Predictive Value of FDG-TEP During Exclusive Chemo-Radiotherapy (CRT) in Patients With Oesophageal Carcinoma Cancer on the One-Year Survival (RTEP3)

Conditions
-----------------
Oesophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Carcinoma épidermoïde of the oesophagus histologically proved, UICC Stage II B, III or IVa (TNM on 2002) Decision of treatment by radio concomitant chemotherapy (radiotherapy in classic spreading of 50Gy associated with a platinum chemotherapy. Exclusion Criteria: Presence of a second evolutionary cancer in the previous three years index of performance OMS > 2 Patients badly balanced diabetics

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positron-Emission Tomography, PET Scan, FDG, oesophageal cancer, chemo-Radiation Oncology, SUV
Bardet-Biedl Syndrome Study: Clinical and Genetic Epidemiology Study in Adults

Study Overview
=================
Brief Summary
-----------------
This study is based on the study of the natural history of a rare disorder: the Bardet-Biedl syndrome (BBS) (which is associated with retinitis pigmentosa, polydactyly, cognitive impairment, obesity, and kidney failure). The clinical, biological, and radiological features of adult patients are studied. In parallel, a molecular study is performed on the known genes to date (8 genes from BBS1 to BBS8) and to identify new genes involved. The parts of the study are combined in a phenotype-genotype correlation study.

Official Title
-----------------
Bardet-Biedl Syndrome: Clinical and Genetic Epidemiology Study in the Adults

Conditions
-----------------
Bardet-Biedl Syndrome, Orphan Diseases

Intervention / Treatment
-----------------
* Behavioral: clinical, biological, and radiological


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (age over 16 years old) At least 3 of the five major criteria (retinitis pigmentosa, obesity, polydactyly, cognitive impairment, and kidney disorder) and/or BBS mutations identified

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: clinical, biological, and radiological|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome evaluated end 2005 and 2006 |  |  | 
| Clinical results (natural history, phenotype-genotype correlations, genetic epidemiology, new genes identification |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study may lead to further clinical investigations according to the results (new protocol to be established) and to further molecular investigations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bardet-Biedl syndrome, retinitis pigmentosa, obesity, genes