cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Alpha-Lipoic Acid in Diabetic Cardiomyopathy

The heart has the ability to respond to different patho-physiological conditions by adapting its energy metabolism. In diabetic subjects, the myocardium uses only fatty acids as a substrate. This is the cause of diabetic cardiomyopathy (DCM). The activation of the transcription factor PPARβ/δ allows a good use of fatty acids. The staff have demonstrated that alpha lipoic acid (AαL), a molecule with antioxidant properties present in food supplements and in certain foods (broccoli, cabbage, offal...), induces the expression of PPARβ/δ in skeletal muscle and thus increases the activity of this transcription factor.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adult age ≥ 18 years
* patient with diagnosed type 2 diabetes (history of pathological hyperglycemia according to WHO and HbA1c standards \>7% or ongoing treatment with oral antidiabetic agents).
* Patients with stable cardiomyopathy (no hospitalization in cardiology in the month before inclusion) with a left ventricular ejection fraction (LVEF) \<50%.
* patient who has signed an informed consent form
* For women of childbearing age: effective contraception followed for at least 3 months before the start of the study and agreeing to keep it for the duration of the study.
* affiliation to a social security scheme.

Exclusion Criteria:

subjects:

* With a coronary event in the year before inclusion.
* With symptoms of cardiac ischemia at inclusion.
* Pregnant or breastfeeding woman
* Severe renal insufficiency
* Using antioxidant molecules in the 6 months prior to inclusion.
* Using drugs that can activate PPARs (Fibrates, Telmisartan, Enalaprilat).
* Using anti-inflammatory drugs.
* Suffering from acute infectious diseases and inflammatory diseases.
* Hypersensitivity or a history of hypersensitivity reaction to gadoteric acid, meglumine or any drug containing gadolinium.

Non-inclusion criteria related to MRI:

* with an implanted vascular stent less than 6 weeks before the examination;
* carrier of an implanted biomedical device deemed "not safe" or "unsafe" in the list: http://www.mrisafety.com/TheList_search.asp;
* Beneficiary of an acquisition procedure that does not respect the conditions required by "conditional" use in a subject carrying an implanted biomedical material considered "conditional" in the list: http://www.mrisafety.com/TheList_search.asp;
* carrier of a ferromagnetic intraocular or intracranial foreign body close to the nerve structures;
* carrying biomedical equipment such as a cardiac, neural or sensory pacemaker (cochlear implant) or a ventricular bypass valve without medical and paramedical supervision trained to perform MRI in these subjects;
Enavogliflozin vs. Pioglitazone on Glucose and Atherosclerosis

The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients with a glycated hemoglobin (HbA1c) level of 7.0 - 10.5% at screening
* Males or females aged 20-80 years
* Individuals who have been taking Metformin (≥ 500mg) with or without a DPP-4 inhibitor (such as Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Gemigliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin) for at least the past 3 months
* Body mass index ≥ 23 kg/m²
* Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²

Exclusion Criteria:

* Patients with Type 1 Diabetes, Gestational Diabetes, or secondary diabetes due to other causes
* Patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit
* Pregnant or breastfeeding patients, or patients not using contraception. Patients with chronic Hepatitis B or C (excluding healthy carriers of Hepatitis B), or liver disease (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 3 times the upper limit of normal)
* Patients with heart failure or a history of heart failure
* Individuals with a history of cancer within the past 5 years (excluding those adequately treated for squamous cell carcinoma or thyroid cancer)
* Patients who have participated in another clinical study within the last 30 days
* Alcohol addiction
* Patients for whom the use of Enavogliflozin or Pioglitazone is contraindicated
* Patients taking other oral hypoglycemic agents or insulin or other investigational drugs
* Patients deemed unsuitable for the study based on the investigator's judgment
Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial)

The study is a large randomized controlled trial to assess the efficacy and safety of neonatal vitamin A supplementation administered to neonates once orally either on the day of birth or in the next 2 days in improving infant survival in the first 6 months of life.

The study is an individually randomized trial conducted in two districts in the state of Haryana.

Community informants report births to the enrolment team. At enrolment, the team explains the study to the family and in those willing, written consent is obtained from the parents of the infant. The infant is given the dose of vitamin A/placebo and a form containing baseline socioeconomic characteristics and information on feeding practices of the infant and mother is filled.

After enrollment, each infant is visited by the enrollment team at hospital or home 1 day and 3 days after supplementation to document any illnesses in the baby. Newborns with illnesses are referred/escorted to the nearest health facility for management.

Enrolled infants are visited when aged 29 days, 3, 6 and 12 months to document vital status and hospitalizations since the last visit. Information on feeding practices, immunization, maternal intake of vitamin A rich foods and supplements, and intake of any supplement containing vitamin A by the infant is recorded at these visits. Subgroup analyses includes the effect of vitamin A supplementation in LBW and non LBW infants, male and female infants, immunized and unimmunized infants, infants of families in the poorest and richest quintiles and by vitamin A intake of mothers. For all deaths, verbal autopsy interviews are conducted.

Blood specimens are obtained in a subsample of infants at 2 weeks and 3 months of age and in a subsample of mothers at 3 months of age.

Quality control activities include independent and supervised checks and are conducted for a subsample by a separate team.

A DSMB has been constituted for the study. All deaths occurring within 72 hours of supplementation will be reported to the SAS ERC and to the WHO Coordinating Unit.

At the recent DSMB meeting in February 2012, the DSMB recommended an increase in sample size to 45,000 instead of the earlier estimate of 40,200 because of somewhat lower than expected mortality rates. This increase in sample size is expected to preserve the specified power of 0.85 and the corresponding level of precision anticipated at the design stage.

Similar trials are being funded by the World Health Organization (Geneva) in Ghana and Tanzania.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate
* All births in the study area that are contacted by enrolment team within the eligible age window

Exclusion Criteria:

* Unable to feed on offering feeds, as reported by the mother
* Mother does not intend to stay in the study area for at least 6 months
Study To Establish The Effects Of PF-04457845 On Sleep In Healthy Volunteers

PF-04457845 has been shown to temporarily decrease the dream (REM) period of sleep in rats, which suggests that PF-04457845 is active in rat's brains. This study is designed to see whether this is also the case in man.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) between 17.5 and 30.5 kg/m2
* Total body weight \>50 kg

Exclusion Criteria:

* History of any active sleep disorder
* History of any sleep or circadian rhythm sleep disorder including RLS, narcolepsy, sleep apnea, phase advance or delay syndromes within the past 5 years
* Currently on or planning to be involved in night or rotating shift work or traveling across more than four time zones in 14 days prior to screening
The Use of Tranexamic Acid (TXA) Intravenously, to Reduce Blood Loss in Proximal Femur Surgery

The use of Tranexamic Acid (TXA) intravenously, to Reduce Blood Loss in proximal femur surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 60, who came to the orthopedic department for proximal femur fracture surgery
* Sound judgment

Exclusion Criteria:

* Known hypersensitivity to Tranexamic Acid or component solution provided
* Subarachnoid hemorrhage
* Acquired color blindness
* Myocardial infarction in 12 months before admission
* Unstable angina
* Known clotting disorders (Thromboembolic disease in the past, elongated PT and PTT, hypercoagulability),
* Kidney or liver failure
* Another situation prostate resection , pathologic fractures according to anamnesis or by imaging
* Oncology patients
* Patients on anticoagulation
* Patients undergoing vascular intervention ( coronary or peripheral ), which was inserted Supporter requires a Dual antiplatelet therapy
Dopaminergic Enhancement of Learning and Memory in Aphasia

The purpose of this study is to determine whether levodopa, in combination with a high frequency language training, is effective in boosting naming performance in patients with aphasia.

Our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether daily administration of levodopa, coupled with several hours of language training every day, will significantly improve naming abilities in patients with aphasia as compared to placebo administration. We furthermore examine with magnetic resonance imaging which brain regions need to be functionally intact for a dopaminergic improvement of language therapy.

Eligibility Criteria:
Inclusion Criteria for patients with aphasia:

* Unilateral cerebrovascular accident (stroke) in the territory of the arteria media
* Time post onset: \> 6 months
* Aphasia with anomia
* Age between 18-75 years
* Premorbid right-handedness
* Primary language: German

Exclusion Criteria for patients and healthy controls:

* Known allergy to levodopa or tartrazine
* History of medication/drug abuse
* Acute nicotine withdrawal or \> 15 cigarettes per day
* \> 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
* \> 50 grams of alcohol per day
* Severe hypertonia (systole \>180 mm Hg)
* Severe arteriosclerosis
* Diabetes, asthma, or glaucoma
* Severe hearing disability
* Evidence for severe hippocampal damage
* Premorbid depression or psychosis
* Medication with dopamine agonists or antagonists
* Parkinsonian symptoms
* Changes in anticonvulsive medication during the week prior to study enrollment
Mortality in Non-cystic Fibrosis Bronchiectasis

In this study we analyzed the overall survival for all newly diagnosed patients with non-cystic fibrosis bronchiectasis from June 2006 onwards. The investigators wanted to confirm the known risk factors such as age, gender, smoking history and Pseudomonas aeruginosa and evaluate the impact on survival of etiology, number of different bacteriological species in retrospective and prospective sputa, azithromycin use and presence/development of pulmonary hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically significant and radiologically proven bronchiectasis
* Chest CT scan confirming the presence of bronchiectatic lesions and had symptoms of chronic productive cough
* Bronchiectasis was deemed to be present if there was one or more of the following criteria: a bronchoarterial ratio greater than 1, lack of tapering of the bronchi and visualization of bronchi within 1 cm of costal or paravertebral pleura or abutting the mediastinal pleura

Exclusion Criteria:

* diagnosis of cystic fibrosis
* underlying tumoral problem causing the bronchiectatic lesions (postradiotherapy, secondary immunodeficiency due to chemotherapy or postinfectious due to tumoral obstruction)
* patients with asymptomatic traction bronchiectasis caused by interstitial lung disease
Remote Monitoring and Social Support for Hypertension Management

A 3-arm randomized pilot trial aimed at comparing the effectiveness of different remote approaches to improving blood pressure (BP) control.

The investigators plan to leverage the Way to Health (WTH) platform to develop and evaluate a new HTN service-delivery model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN:

1. The investigators will assess the effects of monitoring blood pressure and medication adherence with feedback to the patient and to the clinical practice, as needed if out of control.
2. The investigators will also compare the impact of providing feedback to a social support partner with facilitated cheerleading.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 75 years old with HTN (ICD-10 code I10)
* Has had at least two office visits at Penn Family Care (PFC) within the past 12 months (at time of chart review), with at least two of the visits with BP readings exceeding HTN guidelines, including the last visit (150/90 or 140/90 if ages 21-59 yrs with CKD or diabetes)
* Must have a cellular phone with texting capabilities
* Must be prescribed at least one medication for hypertension

Exclusion Criteria:

* Has metastatic (Stage IV) blood or solid tumor cancer
* Has end stage renal disease
* Has congestive heart failure
* Has dementia
* Has liver cirrhosis
Docetaxel and Cisplatin in Treating Patients With Untreated Stage IIIA Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer.

OBJECTIVES:

* Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage IIIA non-small cell lung cancer.
* Determine the safety of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and cisplatin IV over 30 minutes on days 1 and 2. Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 24-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed stage IIIA non-small cell lung cancer (NSCLC) (T1-3, N2, M0)

  * Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes
* Measurable disease

  * Must be at least 20 mm in one dimension by conventional techniques or at least 10 mm by spiral CT scan
* No distant metastases
* No CNS involvement
* No pleural or pericardial effusion

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* AST/ALT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN

Renal:

* Creatinine no greater than 1.25 ULN
* Creatinine clearance at least 60 mL/min

Cardiovascular:

* No superior vena cava syndrome
* No uncontrolled congestive heart failure or angina
* No myocardial infarction within past year
* No uncontrolled hypertension or arrhythmia

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No concurrent active infection requiring IV antibiotic therapy
* No other prior malignancy in past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and hypernephroma
* No concurrent illness or medical condition which is a contraindication for corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus)
* No motor or sensory neurotoxicity of grade 2 or greater
* No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent immunotherapy

Chemotherapy:

* No prior chemotherapy for NSCLC
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy

Radiotherapy:

* No prior radiotherapy for NSCLC
* No concurrent radiotherapy

Surgery:

* No prior surgery for NSCLC

Other:

* At least 1 month since prior investigational agents
* No other concurrent experimental medications
CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).

The increasing incidence of Esophageal Adenocarcinoma (EAC) in several Western countries can be primarily ascribed to risk factors such as obesity, chronic gastroesophageal reflux, dietary habits and alcohol intake. Nevertheless, Barrett's Esophagus (BE), remains the main risk factor for EAC. Several studies supports the role played by the gut microbiota on the modulation of metabolic and immunological pathways. An abnormal state of the microbial ecosystem seems to be involved in the promotion and onset of various diseases, including cancer. Recent studies have shown that diet and lifestyle have an important modulatory role as protective or risk factors for oncological diseases. The World Cancer Research Fund (WCRF) and the American Institute for Cancer Research (AICR) released a review of the evidence that emerged from published studies in the field of nutrition and cancer prevention and summarized their findings into 10 recommendations. Several studies have also shown that a moderate caloric and/or protein restriction seems to be able to reduce the risk of neoplastic disease development. The primary aim of this study is to evaluate the impact of a lifestyle-oriented intervention on body weight, waist circumference, biomarkers associated with cancer risk, esophageal microbiota composition and adherence to cancer prevention recommendations after 24 months in overweight or obese BE patients.

Methods and analysis: Patients are randomly divided into two arms, a control arm (CA) and an interventional arm (IA). The CA receives information about a correct lifestyle to prevent cancer.

The IA is involved in the two-year program of moderate caloric and protein restriction.

At the time of enrollment, anthropometric measurements will be recorded for each patient and they will be randomized to IA or CA. Blood samples will be obtained from each patient and blood glucose will be determined. Serum metabolic biomarkers will be measured in each serum sample and total proteins will be extracted from fresh frozen esophageal biopsy and will be analyzed to evaluate the insulin signal pathway.

To assess esophageal microbiota profiling, total genomic DNA (gDNA) will be extracted from matched fresh frozen biopsy.

In order to determine a score of adherence to cancer prevention recommendations, participants will be asked to complete a self-administrated questionnaire reflecting WCRF/AICR recommendations.

All the measurements will also occur at the end point, after two years from the enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of Barrett's esophagus without dysplasia or cancer aged ≥ 18 years with BMI ≥ 25.0 kg/m\^2
* Willingness and ability to perform supervised Nordic walking session twice a month and self-planned physical activity at least 3 times a week
* Signed informed consent

Exclusion Criteria:

* No histological confirmation of Barrett's esophagus
* Cancer diagnosis within one year before trial begins
* Presence of insulin-dependent diabetes
* Denied informed consent
Connect-Home: Alzheimer's Disease and Related Dementias

This study is a parallel arm, cluster randomized trial (CRT) to test the efficacy of Connect-Home ADRD, a transitional care intervention focusing on Skilled Nursing Facility (SNF) patients with Alzheimer's disease and dementias and their caregivers during transitions from SNFs to home, assisted, living, and long-term care. The primary hypothesis is that the intervention will reduce caregiver strain (Aim 1) and patient neuropsychiatric symptoms (Aim 2).

Connect-Home ADRD is a Donabedian-guided intervention that introduces new structure and processes to support Skilled Nursing Facility (SNF) staff delivery of transitional care for transitions to home, assisted living, or long-term care, and post-discharge transitional care by the Dementia Caregiving Specialist (DCS).

The research objective is to test the efficacy of Connect-Home ADRD, a transitional care intervention, targeting Skilled Nursing Facility (SNF) patients with Alzheimer's disease and related dementias (ADRD) and their primary caregivers who discharge home and other settings of care. The study will be set in 12 North Carolina SNFs and in the patient's discharge destination (during intervention periods only). Using a cluster-randomized trial design, twelve SNFs will be randomly allocated to an intervention group (N=6 SNFs) and to a control group (N=6 SNFs) by a study statistician masked to SNF identity. 360 dyads of SNF patients with ADRD and caregivers will be enrolled in 12 SNFs.

Eligibility Criteria:
Inclusion Criteria:

Patients:

* Ability to speak English
* Goal of discharge to home, assisted living, or long-term care
* Diagnosis of dementia
* Having a caregiver willing to participate

Caregivers:

* Ability to speak English
* Legally authorized representative (LAR) who also provides support for the person with ADRD

Inclusion criteria for SNFs:

* Location within 120 miles of UNC-Chapel Hill
* Admission of at least 75 SNF patients per year

Exclusion Criteria:

Patients:

* Planned hospital readmission for procedures or treatments within 30 days post enrollment.

Caregivers:

* LAR is a court-appointed guardian.
Efficacy Study of Lucentis in the Treatment of Retinoblastoma

This study will evaluate the clinical efficacy of intravitreal injections of Ranibizumab (Lucentis) together with chemotherapy in the treatment of Retinoblastoma as compared to chemotherapy alone.

This study will be a phase II open label interventional case series. Patients with retinoblastoma will be randomized to receive chemotherapy with or without intravitreal ranibizumab at a dose of 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 6 months. Patients will be followed for 24 months .

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Definite characteristic signs of retinoblastoma,Group D base on Intraocular International Retinoblastoma classify, IIRC.

Exclusion Criteria:

* History of surgical intervention for retinoblastoma in the study eye.
* Any previous disease in the study eye.
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals).
* Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)