linjc16/ctgov huggingface dataset:
Use of Anticoagulant, and Associated Factors of Anticoagulant Refusal Atrial Fibrillation Patients

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation is a clinically significant cardiac arrhythmia that increases the risk of stroke by 3 to 4 times. Oral anticoagulation has been shown to mitigate stroke risk by two-thirds among patients with AF and is widely recommended in optimizing AF management.Direct oral anticoagulants have also been demonstrated to be superior to warfarin with respect to the risk of fatal bleeding and stroke prevention. However, the previous study finding highlighted a great gap between current guidelines and the clinical management of AF .Nonetheless, the decision for anticoagulant use is not straightforward.It is worth to investigate the updated prevalence of anticoagulant use, the reasons for not receiving anticoagulant, and the factors independently associated with anticoagulant refusal in patients with non-valvular atrial fibrillation.

Official Title
-----------------
Prevalence of Use of Anticoagulant, and Associated Factors of Anticoagulant Refusal in Non-valvular Atrial Fibrillation Patients---- A Study in Hong Kong General Out-patient Clinic

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis as atrial fibrillation aged ≧18 years able to given consent Exclusion Criteria: Unable/unwillingness to sign informed consent to study mechanical heart valve moderate-to-severe mitral stenosis Transient atrial fibrillation from reversible cause (e.g., during respiratory tract infection or bronchospasm) pregnancy hospitalization within 1 month prior to inclusion in the study.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of anticoagulant use in non-valvular atrial fibrillation patients | calculate the prevalence of anticoagulant use in non-valvular atrial fibrillation patients | August 2019 to March 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of the refusal of anticoagulant use | calculate the rate of refusal of anticoagulant use in the eligible non-valvular atrial fibrillation patients | August 2019 to March 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anticoagulants
Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.

Official Title
-----------------
Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement

Conditions
-----------------
Orthodontic Pain

Intervention / Treatment
-----------------
* Drug: Acetaminophen
* Drug: Avicel (placebo)
* Drug: Ibuprofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Orthodontic treatment requires banding of posterior teeth Orthodontic treatment requires the placement of two or more separators Able to swallow analgesic pills English speaking Age 9-17 Minimum weight requirement of 88 pounds Exclusion Criteria: Orthodontic appliances are present in the mouth Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems) Antibiotics or analgesics are currently in use History of systemic disease exists (arthritis, diabetes, cystic fibrosis) Significant cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetaminophen<br> | Drug: Acetaminophen<br> <br> |
| Experimental: Ibuprofen<br> | Drug: Ibuprofen<br> <br> |
| Placebo Comparator: Avicel<br> | Drug: Avicel (placebo)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain/discomfort levels reported on Visual Analogue Scales |  | Assessments conducted at six intervals during a 24 hour period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, orthodontic, acetaminophen, ibuprofen, separator
Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

Study Overview
=================
Brief Summary
-----------------
The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.

Detailed Description
-----------------
To describe platelet activity among PAD subjects undergoing vascular surgery. To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events. To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.

Official Title
-----------------
Platelet Activity in Vascular Surgery

Conditions
-----------------
Peripheral Vascular Disease, Peripheral Artery Disease, Carotid Stenosis, Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Amputation, Wound, Embolism and Thrombosis, Aortic Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing non emergent vascular surgery Use of aspirin within 48 hours prior to surgery Age > 21 years of age Able and willing to provide written informed consent for the study Exclusion Criteria: Use of any anticoagulant (Coumadin, heparin) within 24 hours to surgery Use of any Nonsteroidal Antiinflammatory Drug (NSAID) (such as ibuprofen, naproxen, etc.) within 72 hours Thrombocytopenia (platelet count<100) or Thrombocytosis (platelet count>500), Anemia (hemoglobin<9), Severe kidney disease (CrCl<30ml/min), Any known hemorrhagic diathesis.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Platelet Activity | The main outcome measures are platelet activity, coagulation markers, platelet mapping and profiling. | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Events | Thrombotic and Bleeding events | Two-years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amputation, Peripheral Artery Disease, Endarterectomy (Carotid), Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracic, Platelet Activity, Thrombin, Transcriptomics
Safety and Effectiveness of CPI-1189 in HIV-Infected Males on Combination Anti-HIV Drug Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe to give multiple doses of CPI-1189 to HIV-infected, otherwise healthy, males. The study will also look at how CPI-1189 affects the levels of HIV, T cells (cells in the body that help fight infection), and three anti-HIV drugs (zidovudine, lamivudine, and indinavir) in the blood. Advanced HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down.

Detailed Description
-----------------
Late-stage HIV infection can cause AIDS dementia (brain damage due to HIV leading to losses of memory and muscle control). CPI-1189 may be able to postpone AIDS dementia or slow it down. In this randomized, double-blind study, 48 HIV-infected, otherwise healthy, male volunteers receive either multiple-dose CPI-1189 or placebo by mouth for 15 consecutive days. Each dosing group begins 6 weeks following the start of the preceding group. Volunteers enter the study site the night before dosing on Days 1 and 15 and remain at the study site for 72 hours following dosing. Throughout the study, volunteers have physical exams and donate samples of blood, urine, cerebrospinal fluid, and sperm.

Official Title
-----------------
Multiple Ascending Dose Pharmacokinetics of CPI-1189 (LU 02-584) in Fasted, HIV Infected, Male Volunteers on Combined Reverse Transcriptase and Protease Inhibitor Therapy

Conditions
-----------------
AIDS Dementia Complex, HIV Infections

Intervention / Treatment
-----------------
* Drug: CPI-1189


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are an HIV-positive man who is otherwise in good health. Are 18-50 years old. Have a CD4 count of 75-500 cells/mm3. Are currently taking zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CPI-1189|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
-----------------
Dose-Response Relationship, Drug, Drug Therapy, Combination, AIDS Dementia Complex, Zidovudine, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors
Effect of Oral Rufinamide and Oxcarbazepine on Nerve Excitability, Hyperalgesia, Allodynia and Flare Reaction Compared to Placebo. A Monocenter, Randomized, Double-blind, Cross-over Study

Study Overview
=================
Brief Summary
-----------------
Untersuchungen über die Wirkmechanismen von Antiepileptika haben gezeigt, dass durch eine Blockierung von spannungsabhängigen Natrium-Kanälen im Nervensystem die Schmerzübertragung moduliert werden kann. Verschiedene Antiepileptika werden in der chronischen Schmerztherapie schon lange angewendet (z.B. Oxcarbazepinum, Trileptal ® bei Trigeminusneuralgie oder diabetischer Polyneuropathie). In unserer Untersuchung wollen wir zwei in der Schweiz zugelassene Antiepileptika bezüglich ihrer Wirkung auf das Schmerzempfinden untersuchen. Eines dieser Medikamente, Trileptal® (Wirkstoff: Oxcarbazepinum), wird schon häufig bei chronischen Schmerzzuständen eingesetzt. Das zweite Medikament, Inovelon® (Wirkstoff: Rufinamid) ist seit mehr als einem Jahr in der Schweiz zugelassen und wird klinisch vor allem in der Behandlung von besonderen Epilepsieformen im Kindesalter eingesetzt. Wir erwarten, dass auch nach Gabe von Inovelon® die Schmerzleitung in den Nervenzellen verändert und die lokalen Schmerzreaktionen in der Haut vermindert werden. Trial with medicinal product

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Rufinamid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male Age: 18-65 years Weight: 50 - 100 kg Height: 155 - 195 cm Signed and dated informed consent Exclusion criteria: Contraindications to the class of drugs under study Intellectually or mental impaired subjects Known hypersensitivity to class of drugs or the investigational product Drug abuse Known peripheral neuropathies Diabetes mellitus Chronic alcohol consumption Congestive heart disease Participants of other studies during study period and 30 days prior to study begin Smoker Abnormal electrocardiogram Any regular concomitant medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rufinamid|Effect of oral rufinamide and oxcarbazepine on nerve excitability, hyperalgesia, allodynia and flare reaction compared to placebo.|

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
-----------------
gesunde Probanden
BPA Levels Relationship With IVF/ICSI Outcomes in Low Ovarian Reserve

Study Overview
=================
Brief Summary
-----------------
The relationship between BPA elevation in urine, blood, and follicle fluid and embryo quality, IVF/ICSI outcomes.

Official Title
-----------------
Could the Consumption of Water From Plastic Bottles Affect the Embryo Grade and Clinical Pregnancy Rate Obtained With IVF/ICSI in Low Ovarian Reserve

Conditions
-----------------
Infertility Low Over Reserve, IVF, Infertility, Female

Intervention / Treatment
-----------------
* Other: BPA levels


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent IVF due to low ovarian reserve patients provided urine, blood, and follicle fluid (FF) samples on the oocyte retrieval day patients who did not smoke or use alcohol patients did not work in the plastic industry Exclusion Criteria: patients who underwent IVF due to unexplained infertility or tubal factor or male factor indications patients diagnosed with endometriosis patients with freeze-all cycles patients having previous ovarian surgery women with metabolic disease (such as hypertension or diabetes mellitus) patients with a known genetic problem (male or female)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BPA level<br>BPA (bisphenol A) in urine, blood and follicle fluid samples | Other: BPA levels<br>* BPA (bisphenol A) in urine, blood and follicle fluid samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to BPA | Concentrations of Bisphenol A (BPA) will be quantified in the urine, blood plasma, and follicular fluid (individual and pooled samples) by use of ELİSA test in women with low ovarian reserve | 6 month |
Efficacy of DNK333 in Patients With COPD and Cough

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients with COPD and cough.

Official Title
-----------------
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Clinical Efficacy, Tolerability and Safety of Two Weeks Treatment With DNK333 100 mg Bid in Patients With COPD and Cough.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: DNK333 100 mg twice daily
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate COPD Forced expiratory volume in 1 second (FEV1) ≥30% predicted FEV1/FVC (forced vital capacity) <70% Significant amount of cough and minimal amount of sputum production, both as judged by self reporting Exclusion criteria: Upper or lower airway infection within 4 weeks prior to screening COPD exacerbation within 4 weeks prior to screening Past history or current diagnosis of congestive heart failure, cirrhosis or hepatic failure History of lung cancer or pulmonary resection/thoracic radiotherapy Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 35 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: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DNK333<br> | Drug: DNK333 100 mg twice daily<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported cough |  | At 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity to capsaicin challenge |  | At 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic obstructive pulmonary disease, Cough, DNK333
Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine

Study Overview
=================
Brief Summary
-----------------
Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall survival?

Detailed Description
-----------------
Primary tumors of the spine are exceedingly rare and therefore the literature has been limited to case series of limited size and significant heterogeneity. These tumors comprise 11% of all Primary Musculoskeletal Tumors and 4.2% of all spine tumors. Of all primary spine tumors only 6% are malignant, but it is the malignant tumors that present the greatest therapeutic challenges. Through this multi-center retrospective cohort study performed at 13 spine oncology referral, data on at least 2.000 patients with specific primary benign and malignant spine tumors will be collected. This will provide power to determine the influence of many previously hypothesized variables on outcome. The purpose of this study is to determine clinical, imaging and treatment factors that influence patient survival, local recurrence rate, and peri-operative/post-operative morbidity. Most surgical options carry significant morbidity and consume vast resources. In contrast, there is emerging evidence that incomplete or oncologically inappropriate resection increases local recurrence rate and decreases overall survival. These data will be used to refine existing study questions regarding patient outcomes and to develop new study questions that will be assessed in the future using prospectively collected data.

Official Title
-----------------
Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine: A Multi-center Retrospective Cohort Study With a Cross-Sectional Survival Check

Conditions
-----------------
Spine Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Were admitted to one of the participating spine centers with a diagnosis of primary tumor of the spine and were treated surgically. At least one follow-up detectable in the medical charts Exclusion Criteria: metastatic tumor of the spine primary spinal cord tumor

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 |
| --- | --- |
| Surgical treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Average of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence |  | Average of 10 years |
Variation IGFBP7 Markers and TIMP2 Induced by Injection of Contrast Iodized Drug at the Intensive Care Patient

Study Overview
=================
Brief Summary
-----------------
Multicenter, prospective, uncontrolled study to evaluate variations in urinary concentrations of TIMP-2 and PCI IGFBP7 induced injection during a CT scan in intensive care patient.

Official Title
-----------------
Variation IGFBP7 Markers and TIMP2 Induced by Injection of Contrast Iodized Drug at the Intensive Care Patient

Conditions
-----------------
Emergency

Intervention / Treatment
-----------------
* Other: contrast product used to assess biomarkers variations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 years or more, Hospitalized in intensive care, Holders of a urinary catheter Patient receiving a first CT with intravenous injection of PCI during their ICU stay. Patient agreeing to participate in the research protocol Exclusion Criteria: Anuria Need to retain urine, whatever the reason (eg measurement of 24-hour proteinuria). Urine unanalyzable whatever reason (eg urinary washing with double current probe, injection is saline to measure bladder pressure.). Patient subjected to renal replacement Patient already included in the study for a previous injection of PCI in intensive care.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: contrast product used to assess biomarkers variations|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant increase in urinary concentrations of TIMP-2 and IGFBP7 defined as an increase of NephroCheck® test of more than 0.2 [ng / mL] 2/1000) after PCI injection |  | follow up: 5 days after injection |