cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers

Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)


Eligibility Criteria:
Inclusion Criteria:

* Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG, clinical laboratory tests:

  * No finding deviating from normal and of clinical relevance
  * No evidence of a clinically relevant concomitant disease
* Age ≥ 21 and ≤ 65 years
* Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and the local legislation
* Able to communicate well with the investigator and to comply with study requirements

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 14 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on trial days Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
* History of frequent headaches
* History of gastro-intestinal ulcer disease

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device (IUD)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Amputee Gait Training Using Virtual Reality and Real-Time Feedback

The purpose of this repeated measures design gait training study is to develop and quantitatively assess the effectiveness of a virtual reality training environment using real-time feedback for modification of pelvic motion during gait.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral traumatic trans-tibial or transfemoral amputation
* Independent ambulation without an assistive device for a minimum of three months
* Ability to ambulate continuously for a minimum of 15 minutes
* Trans-femoral participants must use an ischial containment socket
* VAS Pain scores on the involved side of less than 4/10
* Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.

Exclusion Criteria:

* Blindness
* TBI-Glascow Coma Scale score of 12 or lower at the time of injury
* Cardiac or pulmonary problems limiting physical activity
* PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.
Impact of Cardiac Resynchronization Therapy on Right Ventricular Function in Left Ventricular Assist Device Patients

Left Ventricular Assist Devices (LVAD) are mechanical heart pumps that are increasingly being implanted in patients with severe heart failure which have failed medical therapy. In patients with LVADs, right ventricular failure, which is not supported by the LVAD pump, is a major problem that affects quality-of-life and survival. Cardiac Resynchronization Therapy (CRT) aims to restore the synchronized contraction of the heart and has proven to be beneficial for improving ejection fraction of both right and left ventricle as well as quality of life in selected heart failure patients. The role of CRT in patients with LVADs is unknown. We hypothesize that CRT can exert a beneficial impact on right ventricular function in LVAD patients and improve their quality-of-life.

The specific questions that this study aims to answer are:

1. What are the effects of CRT on the function of the non-supported right ventricle in patients with an implanted LVAD?
2. Can the effects of CRT on cardiac function positively impact quality-of-life and exercise capacity in LVAD recipients?

In this study patients with a previously implanted CRT device, who later receives an LVAD, will be randomly assigned to have the CRT turned off (CRT-off) or on (CRT-on). The patients will be followed for an 8-week period, and then switched over to the opposite CRT status. The total participation in this study will last for 16 ± 1 weeks, and will involve 3 clinic visits of approximately 3 hour duration (initial visit, 8 week visit, and 16 week final visit), plus 2 quick checks of the pacemaker/defibrillator in-between the visits. Heart function will be assessed with comprehensive echocardiographic studies during the CRT "on" and CRT "off" periods. Quality-of-life and exercise capacity will be assessed with a standardized questionnaire and a 6-Minute Walk Test.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients with previously implanted Bi-Ventricular pacemaker / defibrillator, and continuous flow LVAD (Heart Mate II® or HeartWare®)
* The LVAD must be implanted between 8 weeks and 18 months prior to enrollment
* Patients should be at least 3 weeks post discharge from the LVAD implant hospitalization

Exclusion Criteria:

* Severe decompensated right ventricular failure defined as requiring any of the following:

  * Hospitalization for heart failure within last 30 days
  * Need for inotropic infusion for \> 48h within the last 14 days
  * Increase of \> 100% diuretic dose within last 14 days
* Severe aortic regurgitation documented by echocardiography or cardiac catheterization
* Stage IV or greater kidney disease (GFR \< 30 mL/min/1.73 m2)
* Active infection (not including controlled chronic driveline infection on suppressive antibiotic therapy)
* Biventricular pacing \< 90 % of time due to uncontrolled arrhythmias
* LVAD malfunction
* Inability to follow study protocol
* Non-functional LV lead (i.e. high capture threshold that cannot be corrected with programming changes)
High Dose Simplified Folfiri in Advanced Colorectal Cancer: a Multicentre Phase II Study

A multicentre phase II study to evaluate the results of high dose simplified folfiri in advanced colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Documented progressive metastatic disease
* Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to response evaluation criteria in solid tumours (RECIST)
* WHO performance status of 0 or 1
* Adequate laboratory values of haematology, liverfunction and renal function
* No previous chemotherapy for metastatic colorectal cancer

Exclusion Criteria:

* Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except curatively treated cancer free of disease for more than 10 years.
* Bowel obstruction or sub-obstruction. Crohn's disease, or ulcerative colitis.
* Other severe illness or medical condition such as unstable cardiac disease under treatment, myocardial infarction within 6 months before inclusion.
* Active uncontrolled infection
* Other concomitant anticancer agent
Individual Metabolism and Physiology Signature Study

To determine if consumption of different diet plans that both are nutritionally-adequate and provide energy to maintain body weight, alters fasting insulin concentrations, shifts other common clinical markers of metabolic disease risk, and affects metabolomic profiles that reflect glucose, lipid, and amino acid metabolism.

Western Human Nutrition Research Center (WHNRC) scientists have observed rapid and substantial improvements in metabolic health indices in non-diabetic obese persons who undergo a weight-maintenance diet including prepared meals that were aligned with current dietary recommendations, including those of the Institute of Medicine and the United States Department of Agriculture (USDA) and Department of Health and Human Services (DHHS) Dietary Guidelines for Americans. For instance, marked reductions and often normalization of hyperinsulinemia were observed within days of provision of a controlled nutrient-dense high quality diet, and LDL was reduced by 20-30% or more within 2 weeks or possibly earlier. This indicates that change in diet alone would benefit many at-risk persons with respect to normalizing metabolic parameters and disease risk markers. Yet, surprisingly little formal research has focused on how a high quality, weight maintaining diet impacts health over a short-term period in at-risk individuals. The overall objective of this study is to determine if a nutrient-adequate diet closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans elicits a superior metabolic profile in persons at-risk for metabolic disease, compared to a nutrient-adequate containing foods closely aligned with the National Health and Nutrition Examination Survey (NHANES) "What We Eat In America" report. Further, the investigation will include effect modification of stress-related cortisol measures on change in cardiometabolic risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal by self-report
* Body Mass Index 25-39.9 kg/m2
* Fasting glucose ≥100 and \<126 mg/dL and/or
* Oral Glucose Tolerance Test (OGTT) 2-hour glucose ≥140 and \<199 mg/dL and/or
* Quantitative insulin sensitivity check index (QUICKI) score \<0.315 and/or
* Homeostasis Model Assessment (HOMA) \>3.67, or log HOMA \>0.085 and/or
* Glycated Hemoglobin HbA1c ≥5.7 and \<6.5fasting glucose ≥100 and \<126 mg/dL and/or
* Fasting triglyceride concentrations \>150 mg/dL and/or
* LDL cholesterol \>100 mg/dL and/or
* HDL cholesterol \<40 mg/dL.

Exclusion Criteria:

* BMI \<25 and \>39.9 kg/m2
* Presence of any metabolic diseases, by self-report
* Gastrointestinal disorders by self-report
* Presence of cancer or other serious chronic disease by self-report
* Current use of prescribed or over the counter weight loss medications
* Pregnant
* Lactating
* Current use of tobacco
* Moderate or strenuous physical activity \>30 min/day, 5 or more days per week
* Weight change \>5% of body weight during the previous 6 months
* Dietary restrictions that would interfere with consuming the intervention foods
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.


Eligibility Criteria:
Inclusion criteria:

Male or female recipients of a full-size liver allograft, aged 18 to 65 years.

Exclusion criteria:

Patients with thrombocytopenia (platelets \<50,000/mm³), with an absolute neutrophil count of \<1,000/mm³ or leucopenia (leucocytes \<2000/mm³), with anemia with Hb \< 6g/dl at time of randomization

Patients with uncontrolled hypercholesterolemia (\>350mg/dL; \>9mmol/L) or hypertriglyceridemia (\>750 mg/dL; \>8.5 mmol/L) at time of randomization

History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC
FluAlert: Influenza Vaccine Alerts for Providers in the Electronic Health Record

Childhood influenza coverage rates are far below rates for the other childhood vaccinations. Increasing influenza vaccine coverage rates is important not only for the health of the child, but for that of the child's household and community. Yet,influenza vaccine delivery rates at pediatric clinics are low, even when the vaccine is available. The proposed project will take advantage of existing health information technology to tailor, implement and evaluate influenza vaccine alerts in the electronic health record (EHR) for pediatric providers to help improve health care decision making.


Eligibility Criteria:
Inclusion Criteria:

* Medical (medical doctor/nurse practitioner (MD/NP)) or nursing providers (registered nurse, licensed practical nurse (RN/LPN)) at participating practices
* Parents of a child 6 months - 18 years who is a patient at one of the participating ACN practice
* Parents fluent in English or Spanish
* Children 6 months- 18 years with visit to participating practice during influenza season
Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression

This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors.

Based on previous work with other computerized CBT (cCBT) interventions (e.g., cCBT-D), which has found that cCBT has similar effectiveness to traditional CBT, members of the team along with Veterans Health Administration (VHA) leaders have developed computerized cCBT-SP and cCBT-D courses that will be ready for safety, feasibility, and acceptability testing. If proven to be feasible, safe, and effective, these courses could be made available to all Veterans, at no cost to users.

Eligibility Criteria:
Cohort A - cCBT-SP Program

Inclusion Criteria:

1. Veterans between the ages of 18 and 65
2. Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA Care
3. Recent suicidal ideation (past month; C-SSRS Screener -Yes to Item 2) and history of lifetime suicidal behavior (lifetime, C-SSRS Screener - Yes to Item 6)
4. Reliable access to a computer/tablet and the internet
5. Ability to provide informed consent

Exclusion Criteria:

1. Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
2. Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
3. Severe cognitive impairment, as determined by screening or electronic medical record
4. Currently enrolled in/participating in another mental health-related intervention research study

Cohort B - cCBT-D Program

Inclusion Criteria:

1. Veterans between the ages of 18 and 65
2. Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA care
3. Mild to moderate depressive symptoms, as determined by the PHQ-9, (score of 5-14)
4. Reliable access to a computer/tablet and the internet
5. Ability to provide informed consent

Exclusion Criteria:

1. PHQ-9 score below 4 or 15 and above
2. Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record
3. Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record
4. Severe cognitive impairment, as determined by screening or electronic medical record
5. Currently enrolled in/participating in other intervention research study
Flap Sliding to Treat Post-LASIK Striae

This study assessed the efficacy and safety of a simple, noninvasive "flap sliding" technique for managing flap striae following laser in situ keratomileusis (LASIK). Included eyes underwent flap sliding 1-2 days after surgery, which involved using a cellulose sponge to gently slide the flap perpendicular to the striae. The flap was not lifted during the procedure. Thirteen of 14 eyes were successfully managed with flap sliding. Uncorrected distance visual acuity (DVA) improved in all patients 1 day after flap sliding, with 11 eyes having a corrected DVA of 20/25 or better. Complications following flap sliding occurred in 2 eyes. We believe that our study makes a significant contribution to the literature because it demonstrates a simple, noninvasive technique for managing flap striae that develop during early post-LASIK epithelial healing.


Eligibility Criteria:
Inclusion Criteria:

Significant flap striae in the visual zone within 2 days following microkeratome LASIK.

Exclusion Criteria:

* striae 2 days after surgery
* visually insignificant striae
MASTER I - Microvolt T Wave Alternans Testing for Risk Stratification of Post MI Patients

The purpose of the study is to determine the usefulness of microvolt T wave alternans (MTWA) testing of patients that have had a heart attack and have decreased pumping ability of the lower chamber of their heart. MTWA testing is a non-invasive test used to detect the likelihood of developing abnormally fast rhythms in the lower chambers of the heart. The objective of the study is to prove that if a patient has a negative MTWA test, they will be less likely to develop abnormally fast and dangerous rhythms in the lower chambers of the heart. The results of the study will help doctors to determine which patients would benefit the most from having an Implantable Cardioverter Defibrillator (ICD) implanted.


Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for an ICD with a history of heart attacks
* LVEF \<= 0.30 as measured by a radionuclide study, angiography or quantitative echocardiography within 3 months prior to enrollment

Exclusion Criteria:

* Patients with electrocardiographically documented sustained ventricular tachycardia, ventricular fibrillation or prior cardiac arrest (Class I indications)
* Patients who have undergone an electrophysiologic study with ventricular stimulation or a MTWA test within 1 year prior to enrollment
* Patients with medical conditions that preclude the testing required by the Investigational Plan or limit study participation
* Patients unable to complete MTWA testing requirements due to current atrial fibrillation or flutter
* Patients unable to exercise and for which alternative modalities (pacing or pharmacological stress) used for MTWA testing are not available
* Patients who have experienced an MI within 1 month prior to enrollment
* Patients with advanced cerebrovascular disease per physician's assessment
* Patients classified as NYHA Class IV at time of enrollment
* Patients who have undergone cardiac revascularization within 3 months prior to enrollment or are scheduled for cardiac revascularization at the time of enrollment
* Patients with a life expectancy of less than 1 year
* Patients with prior ICD
* Patients unable to complete follow-up visits at the study center
* Patients who are enrolled or intend to participate in another clinical study that would compete with the study objectives (assessment will be the responsibility of the Clinical Trial Leader with guidance from the Executive Committee)
Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: -DALFEN Study

Pediatric patients with febrile neutropenia coming to Department of Medical Oncology with low risk features (culture awaited), will be started on intravenous antibiotics (Inj Cefoperazone+ Sulbactam ± Amikacin) on outpatient basis. Those patients will be reassessed for randomization once they fulfill all inclusion criteria and get afebrile for at least 24 hours. Antibiotics will be stopped in Arm-A and oral antibiotics, in place of intravenous antibiotics, will be started in Arm-B. The patients will be followed-up till ANC≥ 500, or reappearance of fever within follow-up of ≤ 10 days.


Eligibility Criteria:
Inclusion Criteria:

* All pediatric febrile neutropenia patients treated on outpatient basis
* Age 3 years - 18 years
* Fulfilling low risk criteria ( Hematological malignancies in remission, No identifiable focus of infection, No Pneumonia/ mucositis / GI sepsis / Nausea-vomiting/ neurologic-mental status changes/ Central Venous Catheter (CVC) related infection, Anticipated Absolute Neutrophil Count (ANC) recovery ≤ 10 days, No organ dysfunction, Hemodynamically stable, Culture negative )
* Afebrile for at least 24 hours, on intra-venous antibiotics

Exclusion Criteria:

* Bone marrow involvement in solid tumor
* Already enrolled once, in previous episode
* On antibiotics prophylaxis
* Retroviral positive patients
* Patient undergone stem cell transplant
Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis

Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner surface of the heart), which may include one or more heart valves. Epidemiologic pattern has changed during the last 20 years whereas the incidence was unchanged. However, the mortality increase despite recent diagnosis and therapeutic advances.

Only few investigations consider the prognostic and the therapeutic medical care according to the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery, (ii) patients secondary addressed to a referent center with cardiac surgery, (iii) patients for which the totality medical care are performed in non-referent health center. In addition, epidemiologic studies concern only a part of IE, not including most of the time the patients hospitalized in non-referent center.

The aim of the study was to determine the prognosis of threated patients according to the clinical care pathway. Secondary objectives was (i) to evaluate the application of European recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and surgical practice, (ii) to compare the epidemiologic profile according to the type of center.

For this, 300 patients addressed in the 22 French participating centers for a possible or certain IE according to Duke Criteria were prospectively included during 3 years.

Patient data (clinical, demographical, biological, microbiological, echocardiographic and evolutive data) were collected at the admission, during hospitalization, at discharge and one-year follow up.


Eligibility Criteria:
Inclusion Criteria:

- adult with infective endocarditis episode according to Duke Criteria

Exclusion Criteria:

* Patients with a new episode of infective endocarditis that led to its prior inclusion in the study