cyrilzakka/clinical-trials huggingface dataset:
An Efficacy, Safety, and Tolerability Study of Canagliflozin (JNJ-28431754) in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of JNJ-28431754 compared with placebo in patients with type 2 diabetes.

Type 2 diabetes mellitus is a metabolic disorder that is characterized by decreased secretion of insulin by the pancreas and resistance to the action of insulin in various tissues (muscle, liver, and adipose), which results in impaired glucose uptake. Chronic hyperglycemia leads to progressive impairment of insulin secretion and to insulin resistance of peripheral tissues in diabetes (so-called glucose toxicity), which further worsens control of blood glucose. In addition, chronic hyperglycemia is a major risk factor for complications, including heart disease, retinopathy, nephropathy, and neuropathy. Although numerous treatments have been developed for the treatment of diabetes and individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients with diabetes. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter, dose-ranging study to determine the efficacy, safety and tolerability of JNJ-28431754 taken orally over 12 weeks, compared with placebo, in the treatment of Type 2 diabetes mellitus. The primary clinical hypothesis is that JNJ-28431754 is superior to placebo as measured by the change in hemoglobin A1c from baseline through Week 12 in the treatment of type 2 diabetes mellitus. Subject safety will be monitored throughout the study using spontaneous adverse event reporting, clinical laboratory tests (hematology, serum chemistry, urinalysis); severe and serious hypoglycemic episodes, assessment of urinary albumin excretion and markers of proximal renal tubular function; pregnancy tests; electrocardiograms (ECGs); vital sign measurements; physical examinations, assessment of calcium and phosphate homeostasis, bone formation and resorption markers, and hormones regulating calcium and phosphorus homeostasis; and vaginal and urine sample collection for fungal and bacterial culture in subjects with symptoms consistent with vulvovaginal candidiasis (VVC) or urinary tract infection (UTI).

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of type 2 diabetes mellitus
* Hemoglobin A1c levels \>=7% and \<=10.5%
* taking a stable daily dose of metformin
* Body mass index (BMI) 25 to 45 kg/m2 except those of Asian descent who must have a BMI of 24 to 45 kg/m2
* Stable body weight
* Serum creatinine \<=1.5 mg/dL (132.6 umol/L) for men and \<=1.4 mg/dL (123.76 umol/L) for women

Exclusion Criteria:

* Patients must not have prior exposure or known contraindication or suspected hypersensitivity to canagliflozin (JNJ-28431754)
* Known contraindication or suspected hypersensitivity to sitagliptin or metformin
* A history of diabetic ketoacidosis or type 1 diabetes mellitus
* History of pancreas or beta-cell transplantation
* History of active proliferative diabetic retinopathy
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Type 1 diabetes for at least 5 years
* Urine albumin to creatinine ratio 30-5000 mg/g on first morning void
* eGFR 30-89 ml/min/1.73m2 at time of screening
* Blood pressure \<140/90 mm Hg prior to randomization
* Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks
* BMI \< 40 kg/m2 (FMDBA measurements can be inaccurate in severely obese patients).
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization
* Sedentary or recreationally active (≤2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)
* Able to provide consent

Exclusion Criteria:

* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
* Uncontrolled hypertension
* Factors judged to limit adherence to interventions
* Anticipated initiation of dialysis or kidney transplantation within 6 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Allergy to aspirin
* Severe hepatic impairment (Child-Pugh Class C)
* History of major psychiatric disorder
* Use of inhaled or systemic corticosteroids or long-acting beta agonists (higher risk of neuropsychiatric reaction)
* Penicillin allergy
* Iodine allergy
* Shellfish allergy
* Current use of phenobarbital, rifampin or carbamazepine
Sedation During Spinal Anesthesia

Patients during spinal anesthesia should be sedated.

Spinal anesthesia offers a number of advantages to both the patient and the physician. However, patients are often reluctant to remain awake during a procedure. Sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.Therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged from 18 to 50 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities.

Exclusion Criteria:

* Age: younger than 18 or older than 50.
* Psychatric or neurological disorders.
* Cardiovascular disorders.
* Coagulation disorders.
* Contraindications to neuraxial block (allergy to L.A, peripheral neuropathy, prior spine surgery).
Precision Nutrition

Determine the relationship between relevant genotypes and nutrient plasma levels, with the aim to normalize such levels using a nutritional intervention.

(Original text in Romanian language: Caracterizarea precisa a relatiei dintre variatiile genetice si nivelul de nutrienti din sange/plasma/ser, in scopul de a defini modul in care aportul alimentar poate normaliza aceste nivele.)

1. Define plasma levels prediction formulas for each involved nutrient, based on relevant genotypes;
2. Characterize the roles that food intakes may have in the alteriations of such plasma levels, depending on genotype structure;
3. Based on clinical data, create predictive equations using dependent variables (genotypes) in order to define optima nutrient intakes;
4. (Secondary aim): compare the efficacy of a nutrigenetic-based intervention with a non-nutrigenetic intervention (classical approach).

(Original text in Romanian language:

1. Definirea unor formule de predictie a nivelelor din sange, in functie de variatiile genetice;
2. Caracterizarea rolului pe care aportul alimentar de nutrienti il are in modularea acestor valori, in contextul variatiilor genetice.
3. Gasirea unor formule de predictie in care variabilele independente (variatii genetice si combinatii ale acestora) sa defineasca necesarul de nutrienti pentru a normaliza valorile sangvine ale acestor nutrienti.
4. (Obiectiv secundar): compararea eficacitatii unei interventii nutrigenetice fata de o interventie clasica nutritionala (non-nutrigenetica).)

Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* any pathology
Bone Marrow-Derived Autologous Stem Cells for the Treatment of Duchenne Muscular Dystrophy

This study is single arm, single center trial to study the safety and efficacy of bone marrow-derived autologous specific populations of stem cells and mesenchymal stem cells for the treatment of Duchenne Muscular Dystrophy (DMD).

Duchenne muscular dystrophy (DMD) is a genetically determined X-linked disease. The manifestation of muscle weakness typically starts around the age of 4-5 in males and deteriorates fast. Typically muscle loss occurs first in the upper legs and pelvis followed by muscles of the upper arms. It is caused by a mutation in the gene for the protein dystrophin. Dystrophin is crucial to maintain the muscle fiber cell membrane.

Currently, there is no cure for muscular dystrophy. Corrective surgery, braces, and physical therapy may help with some of the symptoms. Assisted ventilation might be required in patients with weakness of breathing muscles. Medications prescribed include steroids to slow muscle degeneration, anti-convulsants to control seizures and muscle activity, and immunosuppressants to delay damage to muscle cells.

For decades, research has been conducted to find an effective therapy for Duchenne muscular dystrophy (DMD). Stem cell based therapy is considered to be one of the most promising methods for treating muscular dystrophies.

Stem cell based therapies for the treatment of Duchenne muscular dystrophy (DMD) can proceed via two strategies. The first is autologous stem cell transfer involving cells from a patient with Duchenne muscular dystrophy (DMD) that are genetically altered in vitro to restore dystrophin expression and are subsequently re-implanted. The second is allogenic stem cell transfer, containing cells from an individual with functional dystrophin, which are transplanted into a dystrophic patient.

Herein, the investigators describe a method for the treatment of Duchenne muscular dystrophy (DMD) using autologous bone marrow derived specific populations of stem cells and mesenchymal stem cells transplanted in patients with Duchenne muscular dystrophy (DMD).

Eligibility Criteria:
Inclusion Criteria:

* Age group of 3-25 years
* Duchenne muscular dystrophy diagnosed on the basis of clinical presentation

Exclusion Criteria:

* Respiratory Distress
* Acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus malignancies
* Acute medical conditions such as respiratory infections, fever, hemoglobin less than 8 bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* Pregnancy or breastfeeding
Manual Dexterity Control After Cerebellar Stimulation

This study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. In order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed.

Cerebrovascular accidents (CVA) are the first cause of acquired disability in France. Despite rehabilitation interventions, a great proportion of patients suffers from motor disability in the upper limb. Recently, several studies have shown that post CVA patients exhibit great neural plasticity as a direct consequence of their condition.

Interestingly, the transcranial direct current stimulation (tDCS) is a non-invasive electro stimulation technique that allows for a modulation of cerebral activity. It has been shown that when applied to the cerebellum, tDCS increases learning performances of healthy subjects. Yet, motor rehabilitation after a CVA highly relies on motor (re)learning. The cerebellar tDCS thus appear as a promising method to enhance the performance of post-CVA motor learning and consequently the benefits of post-CVA rehabilitation.

The current study aims to promote the post CVA neural plasticity by using the tDCS in order to enhance motor learning of the upper limb.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Affiliated to the French health insurance or similar organisation
* Signed informed consent
* Clinical examination

For "Post-AVC patients" :

* at least 18 years old
* completed the Moberg Pick-up test with a minimum score of 20 secondes For "Young healthy" group
* 18 = or \> years = or \<30 For "Older healthy" group
* 50 \> or = years = or \< 80

Exclusion Criteria:

* Metallic implant in the head
* Pacemaker, or other electronic implanted devices
* Other central neurological disease
* Pregnancy, breast feeding
* Previous history of neurosurgery or seizures or 1st degree relative with history of seizures
* History of medical neurological or psychiatric disorders
* Participation to another study using cerebral stimulation
* History of bi-polar or recurring depressive disorders
* Planned carotid revascularization, severe caridac disease
* Kidney failure (transaminase \> 2 times normal value)
* Other invalidating condition or deficiency interfering with the study

For "Post-AVC patients" :

* NIHSS score \> 20
* Cerebellar ischemic CVA
Identification of Priority Clinical Variables in Rehabilitation of Lower Extremity Amputation

Background: Identifying which variables influence the personalized rehabilitation of patients with lower limb amputation and understanding their interrelationships optimizes resource allocation. This study aims to identify priority variables that influence clinical follow-up using hierarchical cluster analysis (HCA).

Methods: Data on 26 variables were collected from 70 patients diagnosed with lower limb amputation; (age, gender, body mass index(BMI), marital status, education, occupation, smoking and alcohol use, amputation - level/duration/lateral/etiology, prosthesis type, type of additional prosthesis, Kellgren Lawrence Classification(KLC) - right/left knee, Houghton Scale(HS), Timed-Up\&Go(TUG) Test, Trinity Amputation and Prosthesis Experience Scales(TAPES)-prosthesis satisfaction/psychosocial adjustment/activity limitation, Using the 12-item Short Form Health Questionnaire(SF-12)-physical score(PS)/mental score(MS), Locomotor Capabilities Index-5(LCI-5), Medicare Functional Classification Level(MFCL) and Falls Efficacy Scale(FES)). From the collected data, dendrograms were formed by using HCA with Ward linkage method.


Eligibility Criteria:
Inclusion Criteria:

1. having been diagnosis of lower limb amputation,
2. sufficient perceptual acuity to complete the tasks,
3. no head injury within the last 2 years, and
4. being a native Turkish speaker.

Exclusion Criteria:

1. being unable to complete the study,
2. having a history of severe psychiatric illness.
Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis

Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence remains high. The purpose of this study was to evaluate two lock solutions on reduction of PF and CRBSI: one, a lock solution combining of the tetracycline antibiotic minocycline with the anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other, trisodium citrate (C) versus H. M-EDTA and C were also evaluated as to their safety versus H.

Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients were blinded to treatment allocation. The primary end-point was a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding and lock solution-related adverse events were the primary safety end points. Logistic Regression was performed to evaluate differences in PF rates among the treatments (SPSS version 13.0, IBM, USA).

Based upon the pilot-study data, the clinical trials has being executed in order to verify whether the three lock solutions have the same performance or not.

Methods: 75 CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) will be randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations are M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients are blinded to treatment allocation. The primary end-point is a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI will be recorded. Poor Flow Rate (event/1,000 catheter-day) and CRBSI Rate (event/1,000 catheter-day) will be calculated in each arm. Bleeding and lock solution-related adverse events are also the primary safety end points and their rates (events/1,000 catheter-day) will be calculated. Logistic Regression will be performed to evaluate differences in PF, CRBSI, Bleeding and lock solution-related adverse events rates among the treatments (SPSS version 13.0, IBM, USA).

Eligibility Criteria:
Inclusion Criteria:

* male and female patients;
* patients with subclavian long term central venous catheter;
* patients on on high-efficiency hemodialysis (BFR= 350 ml; dialisate flow = 500 ml; 3 times; 4-hour sessions).

Exclusion Criteria:

* pregnant; patients on oral coagulants; patients aged less than 18 years;
* patients aged more than 75 years
Aerobic Exercise on Ventilatory Efficiency in CAD Patients

The purpose of the present study was to test the hypothesis that patients with coronary artery disease with lower aerobic fitness exhibit greater responsiveness on improving ventilatory efficiency after aerobic exercise training.

Measurements of ventilatory efficiency during cardiorespiratory exercise testing typically expressed as the minute ventilation/ carbon dioxide production ratio have been validated to be useful in assessing the presence and severity of both heart and lung diseases. In this context, previous studies have showed ventilatory inefficiency in patients with coronary artery disease suggests abnormalities in the distribution of ventilation and perfusion in the lungs. In addition, a growing body of studies has demonstrated that lower ventilatory efficiency during exercise is considered an important predictor of risk mortality, hospitalization, and other outcomes than peak VO2.

Eligibility Criteria:
Inclusion Criteria:

* was stable coronary artery disease diagnosed by coronary angiography

Exclusion Criteria:

* unstable angina pectoris,
* complex ventricular arrhythmias,
* pulmonary congestion and
* orthopaedic or neurological limitations to exercise
[18F]MC225 PET to Evaluate Gender Differences in BBB P-gp Function

P-gp is one of the main efflux transporters at the blood-brain barrier and is responsible for the transport of a variety of neurotoxic substances, including pharmaceuticals. Multiple studies report gender differences in therapeutic outcomes, toxicity and side effects for many drug agents. P-gp plays an important role in the bio-availability, drug distribution, metabolism and elimination of pharmaceuticals labelled as P-gp substrates (e.g. the majority of antidepressants and antipsychotics). A difference in P-gp function was already reported in hepatic P-gp expression. The aim of the current study is to evaluate the influence of gender on cerebral P-gp function. Outcomes of this study can be of great importance in gender-based prescription of P-gp substrate pharmaceuticals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Use of medication with a known effect on the BBB P-glycoprotein transporter
* Any history of neurological or psychiatric conditions affecting the BBB P-glycoprotein function
Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy

Evaluation of the diagnostic performance of an algorithm developed to detect metabolic profiles specific of non-alcoholic steatohepatitis NASH and based on the reading of a blood sample's infrared spectra

The study is aimed at patients suffering from severe or morbid obesity and engaged in a bariatric surgery course. An additional blood sample will be taken upstream of the surgical procedure in the fasted subject. The metabolic fingerprint of the patient will be analyzed on serum from spectral data measured at most two hours after collection. The spectra obtained by the spectroscopy platform will be processed by algorithmic analysis to build the diagnostic test.

During the surgical procedure, a liver biopsy will be performed. The sample will be sent to the pathology laboratory for preparation and the slides will then be anonymized to be sent to a specialized laboratory for centralized reading by an expert pathologist. This expert will determine the diagnosis of non-alcoholic steatohepatitis (NASH) or non-NASH after microscopic analysis of the sample without having any information about the patient.

The two results obtained by the spectroscopic test and by means of the biopsy will then be compared to determine the diagnostic performance of the developped test (NASHMIR test).

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old;
* Patient able to read, write and understand the French language;
* Patient who has signed an informed consent form before carrying out any procedure related to the study;
* Patient supported in bariatric surgery;
* Patient affiliated to a social security scheme or comparable scheme

Exclusion Criteria:

* Patient who has already benefited from a bariatric surgery (ring, sleeve, bypass ..);
* Patient taking: corticosteroid for more than 2 months, amiodarone, methotrexate, tamoxifen, 5-fluorouracil, irinotecan, cisplatin, asparaginase, nucleoside reverse transcriptase inhibitors of HIV, tetracycline, valproic acid, perhexilline;
* Patient with excessive alcohol consumption (\> 210 g/week in men,\> 140 g/week in women) present or past;
* Patient with infection or coinfection present or passed with hepatitis B virus, hepatitis C virus or human immunodeficiency virus;
* Patient with known chronic liver disease (including hemochromatosis, autoimmune hepatitis ...);
* pregnant, parturient or nursing women;
* Patient deprived of liberty by judicial or administrative decision;
* Patient subject to a legal protection measure;