linjc16/ctgov huggingface dataset:
Effect of Product Related Factors on Platelet Concentrate Transfusion Response in Patients With Hematologic Malignacies

Study Overview
=================
Brief Summary
-----------------
Platelet concentrates (PCs) characteristics, such as storage duration, ABO compatibility, dose and source, may have an impact on transfusion responses and outcomes. Because of the relative scarcity of PCs the selection of a specific PC for issue to the patient remains a challenging process. Regulatory agencies do not fully address these characteristics in their recommendations for prophylactic transfusions. The aim of the study was to analyse the effect of product-related factors in a real life setting, in order to determine which ones are the most relevant when selecting PCs for patients in prophylactic conditions. Two different endpoints are studied: the corrected count increment and the platelet transfusion time intervals.

Official Title
-----------------
Analyse de l'Effet Des caractéristiques de concentrés Plaquettaires Sur le Rendement Transfusionnel Chez Les Patients Ayant Une hémopathie Maligne et bénéficiant de Transfusions Plaquettaires à Titre Prophylactique

Conditions
-----------------
Lymphocytic Leukemia, Hodgkin Disease, Lymphoma, Multiple Myeloma

Intervention / Treatment
-----------------
* Other: Platelet concentrate transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inpatients in the hematology department between January 2001 and December 2012 Hematologic malignancy At least one platelet transfusion (with platelet count ≤ 25 G/L) Age 18 and over at time of first transfusion Exclusion Criteria: More than one hematologic malignancy Non-malignant haematological disorder

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

| Intervention/Treatment |
| --- |
|Other: Platelet concentrate transfusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected count increment | Platelet increment corrected for platelet dose and body surface area | 24 hours post transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion interval | Time interval to following platelet transfusion in days | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet Transfusion
A Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.

Official Title
-----------------
VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System

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

Intervention / Treatment
-----------------
* Device: VytronUS Ablation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 to 70 years old. Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug. Exclusion Criteria: Prior pulmonary vein isolation Presence of intracardiac thrombus Indication of inaccessible pulmonary or cardiac anatomy Myocardial infarction, PCI, or cardiac surgery in prior three months Moderate to severe valvular disease or prior valve replacement NYHA Class IV LVEF < 40% Previous stroke or TIA Serum creatinine > 2.5mg/dL or allergy to intravenous contrast agents Existing bleeding diathesis or history of complications with anticoagulation therapy Women who are nursing, pregnant, or trying to become pregnant Subjects unwilling or unable to provide consent Participation in a drug or device trial that would prevent completion of required study procedures Active implantable devices Major organ system disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VytronUS Ablation System<br>Treatment with the VytronUS Ablation System. | Device: VytronUS Ablation System<br>* Pulmonary vein isolation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device or procedure related adverse events. |  | Three months post procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary vein isolation. |  | Three months post procedure. |
Envarsus XR in African American Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect data prospectively on African American patients who are taking the immunosuppressant Envarsus post kidney transplant. We are looking to see if African American renal transplant recipients that receive Envarsus will have less tubular injury and calcenurin inhibitor toxicity compared with patients that receive tacrolimus IR. African americans have the higher rates of CYP3A5 which is associated with the need of higher tacrolimus dose to achieve an adequate level and this many times is associated with signs and symptoms of tacrolimus toxicity such as tremors, headaches and neuropathies. The retrospective cohort will be African American patients that will be matched by age, gender, type of kidney transplant (living vs deceased) and level of sensitization

Official Title
-----------------
Envarsus XR in African American Renal Transplant Recipients

Conditions
-----------------
Renal Transplant Recipients

Intervention / Treatment
-----------------
* Drug: ENVARSUS®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African American race Adult renal transplant recipients (>18 y/o) Previous adverse reaction or contraindication to the use of tacrolimus Exclusion Criteria: Non African American race Less than 18 y/o (pediatric patients) Recipients of liver and small bowel transplants Adverse reaction to tacrolimus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Envarsus<br>Open Label; Envarsus XR started at the time of transplant. Initial dosing of 0.17mg/kg. Target trough level of 8-10 ng/mL | Drug: ENVARSUS®<br>* ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant<br>* Other names: Extended Release Tacrolimus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint is to Determine the Rate of Calcineurin Inhibitor Toxicity as Measured by Surveillance Kidney Biopsies. | Data not collected - study terminated prematurely when PI left institution. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Function After Transplantation | Data not collected - study terminated prematurely when PI left institution. | 1 year |
Temsirolimus (Torisel) Drug Use Investigation (Regulatory Post Marketing Commitment Plan)

Study Overview
=================
Brief Summary
-----------------
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing: Confirmation of efficacy and safety for medical practice use. Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items). Investigation of the incidence status and the risk factors for interstitial lung diseases.

Detailed Description
-----------------
Implemented as a Drug Use Investigation by Central Registration System

Official Title
-----------------
Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Temsirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma). Exclusion Criteria: Patients not administered Torisel. Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.

Ages Eligible for Study
-----------------
Maximum Age: 99 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 |
| --- | --- |
| Temsirolimus<br>Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma) | Drug: Temsirolimus<br>* The usual adult dosage is temsirolimus 25 mg once weekly, to be administered via gradual intravenous infusion over 30 60 minutes. The dosage is to be appropriately reduced according to patients' status.<br>* Other names: Torisel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events |  | 24 weeks | 
| Adverse events not expected from Japanese Package Insert |  | 24 weeks | 
| Investigation of the incidence status and the risk factors for interstitial lung diseases |  | 24 weeks | 
| Response rate (Responsive cases: CR, PR, PD, SD) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items) |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Torisel, Regulatory Post Marketing Commitment Plan
A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
to prospectively assess the health-related quality of life (HRQOL) changes during the first year after different treatment modalities for localized prostate cancer.

Detailed Description
-----------------
Quality of life is of great concern to patients considering treatment options for prostate cancer. Patients with clinically localized prostate cancer treated with active surveillance, radical prostatectomy, external radiotherapy and high intensity focused ultrasound were included. All men completed the questionnaires of Functional Assessment of Cancer Therapy-Prostate (FACT-P) (version 4), International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF) before treatment and 1, 3, 6, 12 months after treatment.

Official Title
-----------------
A Prospective Quality of Life Study in Men With Clinically Localized Prostate Carcinoma Treated With Different Treatment Modalities

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with clinically localized prostate cancer Exclusion Criteria: patients with another malignancies

Ages Eligible for Study
-----------------
Minimum Age: 43 Years
Maximum Age: 82 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>active surveillance | |
| 2<br>radical prostatectomy | |
| 3<br>external beam radiotherapy | |
| 4<br>high intensity focused ultrasound | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life changes over time |  | 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary symptom score and erectile function over time |  | 12 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quality of life, localized prostate cancer, FACT-P
A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline for the Maintenance of Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is a comparison of abstinence maintenance in subjects randomized to double-blind varenicline or placebo from Weeks 13 -24 in subjects who responded to an intial 12-week open label course of varenicline, with post-treatment follow-up of smoking status to Week 52.

Official Title
-----------------
A 52-Week Multicenter Study Evaluating the Safety and Efficacy of Varenicline ( CP-526,555) for the Maintenance of Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline (CP-526,555)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: Subjects with clinically significant cardiovascular disease in the past 6 months.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: varenicline (CP-526,555)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence Weeks 13 -24. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence Weeks 13-52 |  |  | 
| Long term quit rate at Week 52 |  |  | 
| 7-day Point Prevalence of abstinence at Weeks 24, 52 |  |  | 
| 4-week Point Prevalence of abstinence at Week 52 |  |  | 
| Time to first cigarette post randomization |  |  |
Kinetic Analysis Due to Foot Dysfunction

Study Overview
=================
Brief Summary
-----------------
The aim of the current study is to examine the biomechanical changes of gait kinetics in patients with either partial foot amputation or peripheral neuropathy

Official Title
-----------------
Analysis of Gait Kinetics in Patients With Foot Dysfunction Either Physiological or Anatomical

Conditions
-----------------
Amputation, Neuropathy;Peripheral

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partial foot amputees who didnt receive physiotherapy and dont use prosthesis. patients with PN grade (1-2) Age 40-65y Both sexes. Walking independently however, no walking aids were used during the testing procedures Exclusion Criteria: Foot amputation levels more proximal than tarso metatarsal joint. Less than 4 months after partial foot amputation. Foot amputees who use prosthesis or suffer from phantom pain. Active foot problems; ulcer, infection, or gangrene. Patients with PN who received physiotherapy or injections like Puerarin Major surgeries in lower limb that could affect either gait or balance like ACL, hip/knee arthroplasty Spine problems that could affect either gait or balance History of ankle sprain. Pathologies such as skin diseases, inflammatory diseases, congenital diseases, or neurological diseases rather than PN. Fractures or dislocations. Symptomatic degenerative changes that require medications. BMI over 35. Inability of walking independently

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A: PFA<br>partial foot amputation secondary to peripheral neuropathy | |
| B: PN<br>peripheral neuropathy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRF | Ground Reaction Force | 5 minutes | 
| Planter Pressure | Peak Planter Pressure | 3 minutes | 
| Planter Pressure distribution | Planter Pressure distribution | 4 minutes | 
| Foot surface area | Foot surface area | 6 minutes |
SonR Based Stimulation-VECtor OPTimisation in CRT Patients

Study Overview
=================
Brief Summary
-----------------
The primary aim of the present study is to investigate whether the optimisation of LVSV in addition to the optimisation of AV-D and VV-D when using the device-based sensor technology mentioned above results in an improved clinical outcome of CRT. Moreover, noninvasive measurements are intended to evaluate hemodynamic differences between the different stimulation configurations using the Finapres® method.

Official Title
-----------------
Effect of SonR Based Stimulation-VECtor OPTimisation in Patients With Chronically Implanted Cardiac Resynchronization Devices

Conditions
-----------------
Cardiac Resynchronization Therapy

Intervention / Treatment
-----------------
* Device: Vector optimisation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for CRT-D implantation according to guidelines at the time of implantation Implanted CRT-D system with SonR sensor technology Sinus rhythm NYHA class II-IV Age ≥ 18 years Written informed consent to participate in the study Exclusion Criteria: Patients having received a CRT system without SonR sensor technology Patients with an insufficient SonR signal Confirmed pregnancy Age < 18 years Life expectancy < 1 year Atrial fibrillation / atrial flutter at the time of enrollment Unability to give informed consent Participation in another clinical study with active therapeutic arm Regular follow-up at the study site from enrolment to 12 months follow up not guaranteed

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

| Intervention/Treatment |
| --- |
|Device: Vector optimisation|Evaluation of hemodynamically best LV Stimulation vector and device programming according to measurements|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NT-proBNP decrease (-15%) |  | 12 months | 
| VO2max (+ ≥0.7 ml/min/kg) |  | 12 months | 
| NYHA class (improvement by ≥ 1 class) |  | 12 months | 
| QOL (MLHF), score reduction (-15) |  | 12 months |
Bioavailability of Oxymorphone Hydrochloride 40 mg Extended Release Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the relative bioequivalence of oxymorphone hydrochloride extended release tablets (Sandoz) with Opana extended release oxymorphone hydrochloride tablets.

Official Title
-----------------
A Study to Evaluate the Relative Bioavaility of Oxymorphone Hydrochloride 40 mg Extended-Release Tablets(Sandoz, Inc. Compared to Opana ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 40 mg (Edo Pharmaceuticals Inc.) in Healthy Volunteers Under Non-fasted COnditions

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: oxymorphone hydrochloride
* Drug: Opana


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on physical exam, nonmedical history or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C Treatment for drug or alcohol abuse Allergy to opiates

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oxymorphone hydrochloride 40 mg extended release tablets (Sandoz) | Drug: oxymorphone hydrochloride<br> <br> |
| Active Comparator: 2<br>Opana 40 mg extended release tablets | Drug: Opana<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence according to US FDA guidelines |  | Two weeks |