linjc16/ctgov huggingface dataset:
Risk Factors of Outcomes Associated With Disease Progression in Patients With Atrial Fibrillation and Heart Failure (HF) Who Are Receiving a Direct Oral Anticoagulant (Rivaroxaban)

Study Overview
=================
Brief Summary
-----------------
Evaluation of the risk factors associated with Heart Failure (HF) worsening (measured by hospitalizations and emergency visits because of HF exacerbations) in Spanish patients with Atrial Fibrilation and HF treated with rivaroxaban.

Official Title
-----------------
Risk Factors of Outcomes Associated With Disease Progression in Patients With Atrial Fibrillation and Heart Failure (HF) Who Are Receiving a Direct Oral Anticoagulant (Rivaroxaban)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males and females aged 18 years or older. Patients with a diagnosis of nonvalvular Atrial Fibrilation (AF). Patients with a diagnosis of chronic Heart Failure, New York Heart Association (NYHA) class I-IV HF with preserved Ejection Fraction (HFpEF), HF with reduced EF (HFrEF) or HF with mid-range EF (HFmrEF). Patients receiving antithrombotic treatment because of AF, with rivaroxaban since at least 4 months before entering the study. Patients who have been given appropriate information about the study objectives and procedures and with the mental and physical capacity to give their informed consent to participate in the study. Exclusion Criteria: Patients participating in a research program which involves some intervention beyond clinical practice. Patients who started rivaroxaban after the start of the inclusion period. Patients with significate mitral stenosis or other heart valvular diseases that requires or have needed specific treatment (prosthesis or valvuloplasty). Patients with severe cognitive impairment.

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 |
| --- | --- |
| Rivaroxaban<br>Adult patients diagnosed with Atrial Fibrilation and Heart Failure who started treatment with rivaroxaban at least 4 months prior to inclusion | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* As prescribed by the treating physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from the baseline visit to the first hospitalization or admission to emergency services due to a Heart Failure exacerbation |  | Up to 24 months or early termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Date of death |  | Up to 24 months or early termination | 
| Date of all hospitalizations or admissions to emergency service | due to a HF exacerbation or all cause | Up to 24 months or early termination |
Emotional Processing in Multiple Sclerosis / Clinically Isolated Syndrome: A Neuropsychological fMRI-study

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective non-interventional neuropsychological one visit study involving functional MRI (fMRI) is to ascertain emotional processing in patients with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) compared to healthy control subjects. In different experiments, the modulation of cognitive and motor responses by visual emotional information and the ability to discriminate visual emotional stimuli will be tested using experimental behavioral paradigms. Furthermore, functional connectivity and - using fMRI - activations of brain regions known to be involved with emotional processing will be evaluated.

Conditions
-----------------
Multiple Sclerosis (MS), Clinically Isolated Syndrome (CIS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years and ≤ 85 years Right handed For patients: Diagnosis of CIS or diagnosis of MS since ≤5 years Exclusion Criteria: Cognitive deficits as determined by a MMSE Score < 25/30 Depression as determined by a HADS-D Score > 7 Anxiety as determined by a HADS-A Score > 7 Physical disabilities interfering with the study procedures or impacting outcome measures Clinically significant diseases within 7 days prior to the study evaluations Contraindications against cranial MRI without contrast

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 84 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MS / CIS<br> | |
| Healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional modulation of motor response time | Δ ([Response time following neutral stimuli] - [Response time following emotional stimuli]) | 1 day | 
| Emotional memory performance | %-correct recognized emotional and neutral stimuli | 1 day | 
| Emotional experience | Subjective valence and arousal ratings of emotional and neutral stimuli | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD-fMRI brain responses during emotional processing |  | 1 day | 
| Expanded Disability Status Scale (EDSS) |  | 1 day | 
| Multiple Sclerosis Functional Composite (MSFC) |  | 1 day | 
| Short Form Health Survey (SF-36) |  | 1 day | 
| Satisfaction With Life Scale (SWLS) |  | 1 day | 
| Paced Auditory Serial Addition Test (PASAT) |  | 1 day | 
| Serial Reaction Time (SRT) Task |  | 1 day | 
| Symbol Digit Modalities Test (SDMT) |  | 1 day | 
| Beck depression inventory BDI-2 |  | 1 day | 
| Positive and Negative Affect Schedule (PANAS) |  | 1 day |
Effect of Preoperative Recombinant Human Erythropoietin on Transfusion Risk in Valvular Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The administration of rhEPO on the one day before cardiac surgery will be effective to decrease the bleeding due to the surgery.

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: rhEPO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The 90 patients who are planned to have the heart surgery during this study period.(minimum age 20) Exclusion Criteria: Uncontrolled hypertension(diastolic blood pressure(DBP)>100 mmHg), Hct > 45%, Plt. count)>450,000 There are no history of seizure, thrombus, cancer, acute hepatitis, alcoholism, peripheral blood vessel disease, pure red blood cell dysfunction, liver function failure, chronic multiple arthritis. No pregnancy, acute hyper parathyroidism.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Active Comparator: Venoferrum<br> | Drug: rhEPO<br>* recombinant human erythropoietin(rhEPO)<br>|
| Placebo Comparator: saline<br> | Drug: rhEPO<br>* recombinant human erythropoietin(rhEPO)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.

Official Title
-----------------
Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial

Conditions
-----------------
Renal Tolerance, Digestive Tolerance

Intervention / Treatment
-----------------
* Dietary Supplement: Phytalgic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 70 years old minimum Satisfying general health judged by principal investigator Pain and /or stifness associated with arthritis Regular used of analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs) Digestive tolerance biomarkers ASAT : Men < 150 UI/L - Women < 100 UI/L ALAT : Men < 180 UI/l - Women < 130 UI:l Gamma GT Men < 180 UI/l - Gamma GT Women < 100 UI/l Amylase < 250 UI/l Lipase < 750 UI/l Renal tolerance biomarker: Glomerular filtration rate (GFR)superior or equal to 60 mL /min / 1.73m3 - calculated with the Modification of the Diet in Renal Diseases formula Exclusion Criteria: Inflammatory arthritis Allergy to any constituents of the study drug Types 2 diabetes Not legally fit to participate Any treatment able to modify determined biological parameters

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 87 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soft capsules of Phytalgic<br>Phytalgic is a food supplement. Its galenic form is soft capsule. | Dietary Supplement: Phytalgic<br>* Volunteers have to take three soft capsules per day, one in the morning and two in the evening.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal tolerance by Glomerular filtration rate (GFR) determination; Digestive tolerance by Aspartate Amino transferase (ASAT), Alanine Amino Transferase (ALAT), gamma Glutamyl Transpeptidase (gamma GT), lipase and amylase determination |  | 168 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS) |  | 168 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glomerular filtration rate (GFR), Aspartate Amino Transferase (ASAT), Alanine Amino transferase (ALAT), gamma Glutamyl transpeptidase (gamma GT), Lipase, Amylase
Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture

Study Overview
=================
Brief Summary
-----------------
A prospective cohort study to compare the direct lateral and poster-lateral approach concerning abductor function. Patients admitted with a femoral neck fracture operated with a hemiarthroplasty through a direct lateral or a poster-lateral approach were screened for inclusion. Patients with altered mental status SPMSQ >7, pathological fractures, non-walkers were excluded. Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 1 year postoperatively by clinical examination. Sample size were estimated to 30 patient in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry, trochanteric tenderness measured with algometry and palptation.

Official Title
-----------------
Hip Abductor Strengths, Limping and Trochanteric Tenderness After Hip Arthroplasty Due to Femoral Neck Fracture: A Comparison Between the Lateral and Posterolateral Approaches

Conditions
-----------------
Femoral Neck Fracture, Trochanteric Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Displaced femoral neck fracture Walker Hemarthroplasty Preiffer test >7/10 Exclusion Criteria: Pathological fracture Non-walker Pfeiffer test <7/10 indicating mental alteration.

Ages Eligible for Study
-----------------
Minimum Age: 55 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 |
| --- | --- |
| Direct lateral approach<br>Total or hemiarthroplasty operated with direct-lateral approach. | |
| Postero-lateral approach<br>Total or hemiarthroplasty operated with postero-lateral approach. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trendelenburg Test | 30 seconds standing on the operated leg | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abductor strenght | Dynamometry | 1 year | 
| Trochanteric tenderness | Algometry | 1 year | 
| Trochanteric tenderness | Palptation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femoral neck fracture,surgical approach, limp, abductor strenght, trochanteric pain
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Compatibility

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the absence of irritation potential (primary dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Sweet Flower.

Official Title
-----------------
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Dermacyd PH_DETINBACK (Lactic Acid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Phototype Skin I,II, III e IV Integral skin test in the region; Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; Exclusion criteria: Lactation or gestation Use of Antiinflammatory and/or immunosuppression drugs Personnel history of atopy; History of sensitivity or irritation for topic products; Active cutaneous disease; Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dermacyd PH_DETINBACK (Lactic Acid) | Drug: Dermacyd PH_DETINBACK (Lactic Acid)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. |  | Throughout the study |
Vitamin D and Periodontitis

Study Overview
=================
Brief Summary
-----------------
Vitamin D has become important for periodontal disease due to play a role in autoimmunity, bone mineral metabolism and inflammation. Our aim was to investigate the relation between serum 25-hydroxy vitamin D levels, clinical periodontal parameters and blood serum biomarkers. The subjects were evaluated in 2 groups as chronic periodontitis (n= 30) and periodontally healthy subjects (n= 30). Periodontal parameters and fasting venous blood samples were taken from the subjects to assess each patient's periodontal status and for biochemical analyses (25-hydroxy vitamin D (25-OH vit D), osteoprotegerin (OPG), receptor activator of nuclear kappa B ligand (RANKL), C-telopeptide (CTx), tumor necrosis factor-α (TNF-α)).

Official Title
-----------------
Relationship of Bone Metabolism Biomarkers and Serum 25-Hydroxy Vitamin D in Patients With Chronic Periodontitis

Conditions
-----------------
Alveolar Bone Loss

Intervention / Treatment
-----------------
* Diagnostic Test: fasting venous blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: never-smokers no history of systemic disease no patients had been under periodontal therapy and medicine for at least 6 months before the study no pregnancy or lactation no alcohol or antioxidant vitamin consumption. Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Periodontally healthy subjects<br> | Diagnostic Test: fasting venous blood samples<br> <br> |
| Chronic periodontitis patients<br> | Diagnostic Test: fasting venous blood samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical parameters | serum TNF-α | Baseline | 
| Biochemical parameters | serum CTx | Baseline | 
| Biochemical parameters | serum RANKL | Baseline | 
| Biochemical parameters | serum OPG | Baseline | 
| Biochemical parameters | serum 25-OH vitamin D | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal parameters | The plaque index (PI) | Baseline | 
| Periodontal parameters | gingival index (GI) | Baseline | 
| Periodontal parameters | probing depth (PD) | Baseline | 
| Periodontal parameters | clinical attachment level (CAL) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
25-OH vitamin D, RANKL, Osteoprotogerin, TNF-α
Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery

Official Title
-----------------
Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study

Conditions
-----------------
Thromboembolism

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for elective primary total knee replacement surgery Legal minimum age requirement ( country-specific) Written informed consent has been obtained Exclusion Criteria: Documented history or considered to be at increased risk of venous thromboembolism Subjects considered to be at increased risk of bleeding: Known hemorrhagic disorder and/or coagulation disorder Thrombocytopenia Clinically important bleeding occurred within 3 months prior to the screening visit Acute bacterial endocarditis Severe hypertension Retinopathy Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose regimen 1 | Drug: YM150<br>* Oral<br>|
| Active Comparator: 2<br> | Drug: enoxaparin<br>* Sub cutaneous<br>|
| Experimental: 3<br>Dose regimen 2 | Drug: YM150<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment |  | 2 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous thromboembolism and/or bleeds |  | 2 Weeks | 
| Other safety assessments |  | 2 Weeks | 
| PK, PD variables |  | 2 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Factor Xa inhibitor, Thromboembolism, Arthroplasty, Knee Replacement, Prevention and Control
Aberrant Gene Expression Prostate Carcinoma

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to gain a better understanding of the molecular changes responsible for causing prostate cancer and that examination of tissue and blood samples will help in the development of improved screening and therapeutic approaches.

Detailed Description
-----------------
The goal of this study is to identify novel genetic elements that are aberantly expressed throughout prostatic neoplastic progression. The approaches proposed exploit the known familial arm of prostatic cancer, using established molecular genetic approaches, and extend these studies to sporadic prostatic cancer using a novel technique of differential display. Application of the latter technique to colon cancer in the American population establishes this tumor type as a high priority for scientific investigation and this study is part of an initiative to address this problem. Presently the studies in the field of prostate are under-represented. The collection of tissue samples from patients diagnosed with prostate cancer. Patients will also provide a blood sample at the time of their surgery and potentially post-op from 6 mos to 5 years. Samples will also be obtained from patients who's biopsy turns out to be non-prostate cancer. These samples will be obtained shortly following the biopsy out to 6 months after the biopsy.

Official Title
-----------------
Identification of Aberant Gene Expression in Human Prostatic Carcinoma

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed prostate cancer undergoing prostatectomy Suspicion of prostate cancer undergoing biopsy - negative biopsy Health volunteer (control group) - blood sample for PSA Exclusion Criteria: Patients not fitting the inclusion criteria
Sexes Eligible for Study
-----------------
Male

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

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
-----------------
prostate cancer