cyrilzakka/clinical-trials huggingface dataset:
Improvement of Insulin Resistance With Traditional Chinese Treatment in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy of Traditional Chinese Treatment(TCT) on insulin sensitivity and other related factors in type 2 diabetes by using an double-blind, randomized, parallel control and prospective study This traditional compound Chinese herb preparation is referred to this study, with three kinds of plants: 50 mg of Coptis Chinensis, 30 mg of Astragalus mambranesceus and 120 mg of Lonicera Japonica, all of which are selected by The Chinese Academy of Medical Sciences among those traditionally considered effective and safe in the treatment of diabetes.

Patients enrolled were randomized into TCT group and placebo group administrated with TCT and placebo respectively. Glucose disposal rate (GDR), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1C and other metabolic components were assessed at baseline and end point


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed type 2 diabetes poorly controlled by diet only for one month
2. Obese with a BMI of 23-35 kg/m2

Exclusion Criteria:

1. Those patients used any drugs for treatment of diabetes
2. Patients with evidence of cardiac, hepatic, renal, other chronic diseases or acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma
3. Women who were pregnant or planned pregnant.
Iron Stores and Skeletal Muscle Metabolism in Chronic Heart Failure

Iron deficiency may contribute to exercise intolerance by altering mitochondrial oxidative capacity in skeletal muscle. Functional iron deficiency is common in heart failure patients, but the relationship to exercise intolerance and mitochondrial oxidative capacity is unknown. This is a pilot study to determine the feasibility of the use of specialized 31P-MRS and MRI techniques for measurement of skeletal muscle bioenergetics in patients with heart failure with and without functional iron deficiency.

This study will obtain pilot feasibility data to explore the relationship between blood biomarkers of functional iron deficiency and skeletal muscle mitochondrial oxidative capacity with 31P-magnetic resonance spectroscopy (MRS) and imaging in heart failure patients.

Twenty (20) subjects will be recruited from the clinical practice of the NYU Advanced Cardiac Therapeutics group at NYU Langone Medical Center.

Twenty (20) subjects will be recruited from the practice of the NYU Advanced Cardiac Therapeutics group at NYU Langone Medical Center. The study will require a maximum of four (4) visits over a period of five (5) weeks. Eligibility for Visits 2-4 will be determined by the screening criteria in Visit 1. It is anticipated that 50% of the screened subjects at Visit 1 will be eligible to participate in Visit 2. Eligibility for participation in Visits 3 and 4 will be determined by the results of the iron biomarkers obtained at Visit 2. We anticipate that 50% of the subjects at Visit 2 will be eligible to participate in Visits 3 and 4. Only subject with functional iron deficiency will participate in Visits 3 and 4. There is no clinical care component for this study.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent
* Age 21-80 years
* Chronic heart failure \>3 months with NYHA Class I-III symptoms

Exclusion Criteria:

* Presence of implantable defibrillator, permanent pacemaker not designed for safe use in 3T MRI stud
* Metallic implant or implants that are deemed not suitable for MRI scan on 3T
* Aneurysm clips, cochlear implants, presence of shrapnel in strategic locations, and metal in the eye
* Known claustrophobia or any other history of intolerance of MRI procedure
* Treated diabetes mellitus or hemoglobin A1c (HbA1c) \>6.5%
* Any hospitalization \<60 days
* Myocardial infarction or stroke \< 6 months
* Estimated glomerular filtration rate \<30 ml/min
* Weight \<50 or \>120 kg
* Systolic blood pressure \<90 mmHg or \> 160 mmHg
* Heart rate \<50 or \>100 beats per minute
* Resting oxygen saturation on room air \<92%
* Hemoglobin \<11 g/dl
* Serum phosphate below normal range (\<2.4 mg/dl)
* Liver function tests (AST, ALT, Alk Phos, or Total Bilirubin) \>twice upper limit of normal range
* Pregnancy or current breastfeeding
* Exercise limitation primarily due to valvular heart disease, lung disease, neuromuscular disease, or joint disease
* History of asthma
* History of anaphylaxis
* Known history of intolerance to any formulation of intravenous iron
Dasatinib Added to Gemcitabine for Subjects With Locally-advanced Pancreatic Cancer

The purpose of this study is to determine whether patients with locally advanced pancreatic cancer who receive dasatinib added to standard of care (gemcitabine) live longer, compared to patients who receive standard of care (gemcitabine) plus placebo; i.e. gemcitabine alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic documentation of unresectable adenocarcinoma of the pancreas.
* Recovery from toxicity of previous procedures to establish the diagnosis. ECOG PS 0 or 1.
* Adequate organ function.

Exclusion Criteria:

* Evidence of metastatic disease.
* Previous radiotherapy or chemoradiotherapy.
* History of or current pleural effusion.
* History of significant cardiovascular disease.
* Clinically significant bleeding disorder or coagulopathy.
* Concomitant medication with strong CYP 3A4 inhibitor.
Does Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function

The hypothesis of the current proposal is that chronic pioglitazone therapy will result in improved endothelial function, decreased inflammation, and preservation of renal function in patients with CKD but without diabetes.

Despite continued improvements in the outcomes of patients with cardiovascular disease, similar improvements have not been seen in patients with chronic kidney disease (CKD). CKD constitutes one of the highest risk populations for cardiovascular disease. When the creatinine clearance is ≤ 60 ml/min the risk for cardiovascular events is greater than that of diabetes. However, few studies have focused on the prevention or treatment of coronary artery disease (CAD) in CKD patients.

The development of endothelial dysfunction and increased inflammation appear to be critical in the development of atherosclerosis and cardiovascular disease. The broad long-term objective of this grant proposal is to determine unique therapies to reduce endothelial dysfunction and inflammation, and thereby help to prevent cardiovascular disease and preserve renal function in patients with CKD. Thiazolidinediones such as pioglitazone appear to improve endothelial function and decrease inflammation, an effect that may be present in patients with or without diabetes.

To address this hypothesis the following Specific Aims are proposed:

1. To determine the effects of chronic pioglitazone therapy on endothelial function in non-diabetic patients with CKD (creatinine clearance ≤ 60 ml/ min, but not on dialysis)
2. To determine the effects chronic pioglitazone therapy on inflammation and oxidative stress in non-diabetic patients with CKD
3. To determine the effects chronic pioglitazone therapy on progression of renal disease in non-diabetic patients with CKD

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years.
* Creatinine clearance ≤ 60 ml/min by the Cockcroft-Gault equation
* Patients not anticipated to go on dialysis or have renal transplantation in the next 6 months
* Ability to provide informed consent
* Life expectancy greater than 12 months

Exclusion Criteria:

* Diabetes mellitus or a fasting blood glucose ≥ 110 mg/dL
* Acute renal failure
* Class 3 or 4 heart failure
* Liver failure, ascites, or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) two times the upper limit of normal
* Hemoglobin less than 9 mg/dL
* Multiple myeloma
* Premenopausal women not using at least 1 form of birth control
* Pregnant or nursing women
* Prisoners
* Known allergy to pioglitazone
Retrospective Database Review at LTC and SNFs

The goal of this observational study is to compare the differences in wound outcomes when the MolecuLight imaging procedure is used in combination with standard of care wound assessment in long term care and skilled nursing facilities. The main outcome studied is healing of ulcers after 12-weeks, along with other outcomes such as occurrence of infection, complications, and antimicrobial use. Medical records from the past were reviewed, where patients receiving the MolecuLight procedure were compared to those who did not.


Eligibility Criteria:
Inclusion Criteria:

* Were first treated by Wound Care Plus LLC during time periods from Jan 2019-Feb 2020 (standard of care cohort) and May 2021-Mar 2022 (Moleculight cohort)
* Received at least one debridement, as indicated by CPT codes 11042, 11045, 97597, and/or 97598, during the study admission period
* Were treated by a Wound Care Plus LLC provider for at least 4 calendar weeks during the study period
* Were treated in a SNF or LTC setting during the study admission period
* Were covered by Medicare of Missouri during the study admission period
* Had at least one chronic ulcer with ICD-10 diagnosis codes L89, L97, L98, or L97/L98 in combination with E11 during the study admission period
* MolecuLight cohort ONLY: at least one MolecuLight imaging procedure during the study admission period, indicated by CPT code 0598T

Exclusion Criteria:

* Did not receive at least one debridement, as indicated by CPT codes 11042, 11045, 97597, and/or 97598, during the study admission period
* Received care from Wound Care Plus LLC for less than 4 calendar weeks during the study admission period
* Were not treated in a SNF or LTC setting during the study admission period
* Were not covered by Medicare of Missouri during the study admission period
* Did not have a chronic ulcer with ICD-10 diagnosis codes L89, L97, L98, or L97/L98 in combination with E11 during the study admission period
* MolecuLight cohort ONLY: did not receive a MolecuLight imaging procedure during the study admission period, indicated by CPT code 0598T
Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection

The purpose of the study is to confirm if BACTEK-R (MV130) provides clinical benefit in subject with mild pneumonia (CURB-65≤2) by COVID-19 admitted to the Hospital.

This is a prospective, open-label, randomized pilot study to evaluate the efficacy and safety of BACTEK-R (MV130) in subject with mild pneumonia due to COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

1. - Subjects who voluntarily sign informed consent forms
2. - Both genders.
3. - Subjects aged between 18 and 70 years.
4. -Subjects capable of complying with the treatment
5. - Subjects admitted to hospital with non-severe pneumonia (CURB-65≤2) by COVID-19
6. - Confirmatory test for COVID-19 infection

Exclusion Criteria:

1. - Subjects who has not signed informed consent forms
2. - Subjects included in another clinical trial.
3. - Subjects under treatment with immunosuppressants.
4. - Subjects in treatment with another type of immunotherapy.
5. - Subjects who are or have been undergoing treatment with metformin.
6. - Subjects who are or have been treated with statins.
7. - Subjects who are or have been under treatment with sertraline.
8. - Pregnant women.
9. - Subjects who cannot offer cooperation and / or have serious psychiatric disorders.
10. -Subjects who are allergic to any of the components of BACTEK-R (MV130).
11. - Subjects with pathologies described in the Charlson index
Heart and Estrogen-Progestin Replacement Study (HERS)

The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.

A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.

Eligibility Criteria:
Inclusion Criteria:

* \<75 y.o.
* uterus present
* postmenopausal
* evidence of CHD
* signed consent

Exclusion Criteria:

* MI, CABG, mechanical revascularization within 6 months
* serum triglyceride \>300mg/dl
* used hormone therapy or estrogen vaginal cream in past 3 months
* history of DVT or pulmonary embolism
* history of breast cancer or mammogram suggestive of cancer
* history of endometrial cancer
* abnormal uterine bleeding
* pap smear abnormal
* SGOT more than 1.2 times normal
* Disease judged to be fatal within 4 yrs
* alcoholism, drug abuse
* NYHA Class IV congestive heart failure
* uncontrolled hypertension
* uncontrolled diabetes
* participation in any other investigational study
Pre-stroke Physical Activity in Patients With Stroke

The aim of this study is to explore the level of pre-stroke physical activity in patients with stroke and to investigate associations between physical activity and sociodemographic variables, e.g. history of stroke, co-morbidities and subtype of stroke.

Physical inactivity is a great risk factor for stroke; thus, the investigators hypothesise that patients hospitalised with stroke will present with a lower level of pre-stroke physical activity than recommended by World Health Organization (WHO) guidelines on physical activity for health. Additionally, the investigators expect to find an association between pre-stroke physical activity and specific sociodemographic variables, e.g. stroke subtype, and re-stroke.

Physical inactivity and low cardiorespiratory fitness are important risk factors for stroke. To design future secondary non-pharmacological prevention strategies in stroke, detailed information on current level of physical activity is essential.

In the Danish adult population, 28,8% do not adhere to the WHO guidelines on physical activity for health, with an increasing number (33%) in the population older than 55 years of age. Diverging results have been given on level of physical activity in patients with stroke which warrants further investigation.

Statistics: Descriptive statistics will be used to characterise the study population. To evaluate whether the participants adhere to recommendations on physical activity the proportion of participants adhering will be estimated. To evaluate the association between pre-stroke physical activity using MET-values (dependent variable) and sociodemographic variables (age, gender, previous event of stroke, subtypes of stroke, cardiovascular risk factors, living status and educational level) a multiple linear regression analysis will be performed. The aim is to include 120 participants in the multiple linear regression analyses. This is based on the number of variables (a maximum of seven). p \< 0.05 will be used as level of statistical significance. All tests will be two-sided. Data will be analysed using Microsoft Excel 2019 and Stata 17.

Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms of acute stroke, verified by a neurologist with diagnosis of stroke (intracerebral haemorrhage, cerebral infarction, "stroke, not specified as haemorrhage or infarction" or transient ischemic attack (TIA)).
* Acute/subacute stroke or TIA verified on MRI-scan or CT-scan.
* Able to speak, read and understand Danish.
* Able to provide informed consent, including being awake, alert and oriented (personal data, place, and time).

Exclusion Criteria:

* Aphasia that hinders responding to the PAS2.
* Cognitive deficits that hinder responding to the PAS2 (Mini-Mental State Examination-score (MMSE) ≤ 23, diagnosis of dementia at hospital admission).
Patient-centred Deprescribing of Psychotropic, Sedative and Anticholinergic Medication in Elderly Patients With Polypharmacy

The PARTNER study is a multicentre, two-arm, pragmatic cluster-randomised trial evaluating the impact of a focused and patient-centred cooperation between general practitioners (GPs) and community pharmacists (PARTNER intervention) on reductions in the use of psychotropic, sedative and anticholinergic potentially inappropriate medication (PSA-PIM) compared to a control intervention. The PARTNER intervention comprises (1) education for health care professionals, (2) an interprofessional workshop and case conference, (3) a pharmacy visit with brown bag/medication review and patient empowerment, (4) GP practice visit with shared decision making. The control intervention only comprises a pharmacy visit with brown bag review.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Patient is capable of giving consent
* GP contact in the quarter prior to inclusion
* Current use of ≥ 5 drugs, including ≥ 1 PSA-PIM (hypnotics, opioids, gabapentinoids, antipsychotics, antidepressants, anticholinergic urospasmolytics) with a treatment duration of ≥ 6 months
* Willingness to select a regular pharmacy for the study period
* Consent to data exchange between GP and community pharmacy

Exclusion Criteria:

* Terminal illness (life expectancy \< 6 months)
* Current treatment of pain associated with cancer
* Other serious physical illness or mental distress (e.g. bereavement) that makes participation in the study impossible (according to the GP's assessment)
* Psychiatric illness or addiction that makes participation in the study impossible (according to the GP's assessment)
* Unable to meet the requirements of the study (participation in telephone or written questionnaires, visits to the GP practice or community pharmacy, alone or with the help of caregivers for physical infirmity)
* Current participation in research projects on medication safety or geriatric medicine
Cytarabine (Ara-C) in Children With Acute Promyelocytic Leukemia (APL)

Several groups, especially the PETHEMA group (in their LPA96 and 99 trials), obtained low relapse rates in newly diagnosed Acute Promyelocytic Leukemia (APL) patients by combining ll-transretinoic acid (ATRA) and anthracyclines without Ara-C, suggesting that avoiding Ara-C in the chemotherapy of APL reduced treatment toxicity without increasing relapses. While the relapse rate for the children with white blood cell(WBC) counts greater than 10×109/L at presentation were higher than those WBC counts less than 10×109/L (31% and 3.5%,respectively) in the LPA96 and 99 trials. A recent adult randomized trial show that avoiding Ara-C leads to an increased risk of relapse in the APL patients with WBC counts less than 10×109/L. The role of the Ara-C remains controversial. And there are very limited data reported on children with APL so far.

Some studies suggest patients with high-risk disease should be treated with intensified doses of anthracycline, or intermediate/ high-dose Ara-C or As2O3 as an early consolidation, so as to decrease the risk of relapse.However, a higher cumulative dose of anthracycline may lead to cardiac toxicity, especially for children. In addition, containing Ara-C will led to more therapy-related toxicity. The benefit to add Ara-C to the schedules is questionable and remains a matter of investigation in children.

Eligibility Criteria:
Inclusion Criteria:

* Acute Promyelocytic Leukemia (APL)

Exclusion Criteria:

* \> 14
Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure \[LPP\] of neuropathic etiology.

Secondary objectives were:

* To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents,
* To investigate the number of Urinary Tract Infection (UTI) episodes,
* To investigate the pharmacokinetics of Alfuzosin (population kinetics).

The study consisted of 2 phases:

* a 12-week efficacy phase then,
* a 40-week safety extension phase.

All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets.

Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. The treatment was the same as in the 12-week efficacy phase.

All patients had a one-week follow-up period after the last dose intake.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to neuropathic bladder dysfunction.

Exclusion Criteria:

* Hydronephrosis of non-neuropathic etiology.
* Urological surgery in the last 4 months prior to the study.
* Urethral dilatation in the last 3 months prior to the baseline urodynamic assessment.
* α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment.
* Detrusor injections of botulinum toxin in the last 6 months.
* Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele).
* History of intolerance to α-blocker therapy.
* Orthostatic hypotension.
* History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.