cyrilzakka/clinical-trials huggingface dataset:
Physiological Effects of Creatine Supplementation in Active Males

This study was designed to examine how different forms of creatine impact active males.

This study examined the effects of different formulations of creatine nitrate on muscle creatine content, body composition, anaerobic exercise capacity, bench press performance and clinical chemistry panels in recreationally active males.

Eligibility Criteria:
Inclusion Criteria:

* participants are apparently healthy and recreationally active males between the ages of 18 and 40;
* participants will need to have at least six months immediate prior history of resistance training on the bench press and leg press or squat;

Exclusion Criteria:

* participants have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease;
* participants are currently using prescription medications;
* participants have a history of smoking;
* participants drink excessively (i.e., 12 drinks per week or more);
* participants have a recent history of creatine supplementation within six weeks of the start of supplementation;
Monoamine Contributions to Neurocircuitry in Eating Disorders

This study will use brain imaging technologies to measure several neurotransmitters (serotonin and dopamine) that contribute to our abilities to respond to reward or inhibit our impulses, and which are known to be altered in the brain of people with anorexia nervosa (AN) and bulimia nervosa (BN). Because palatable food stimulates dopamine secretion, we propose to use a challenge with brain imaging that will stimulate dopamine release which we hypothesize will generate anxiety rather than pleasure in AN, and will help explain why AN restrict eating in order to reduce anxiety. This study will help to understand the unique puzzling symptoms in eating disorders and contribute to finding better methods for identifying effective treatments for these often relapsing and sometimes chronic disorders.

Alterations of serotonin (5-HT) and dopamine (DA) activity may contribute to extremes of appetitive behaviours in anorexia nervosa (AN) and bulimia nervosa (BN), through effects on inhibitory and reward neural pathways. To avoid the confounding effects of malnutrition, and because they have behaviours and neural circuit alterations relevant for this study, we will study 25 recovered (REC) restricting-type AN, 25 REC bulimic-type AN (AN-BN), 25 REC BN, and 25 control women (CW). This 5 year study, of women 18 to 45 years old, will employ positron emission tomography (PET) imaging with radioligands for the 5-HT transporter (\[11C\]DASB) and DA D2/D3 receptors (\[11C\]raclopride).

Eligibility Criteria:
Inclusion

* history of Diagnostic and Statistical Manual (DSM-IV) diagnosis of anorexia or bulimia.
* AN women have history of average body weight (ABW) below 85% for height.
* AN-BN subjects have history of ABW below 85% ABW.
* AN-BN subjects have history of binging/purging behaviors during a period of low weight.
* Subjects must be right-handed.
* Subjects have been recovered for 12 months or more.

Exclusion

* Diagnosis of alcohol or drug abuse or dependence in the 3 months.
* Alcohol or substance use within 30 days.
* Current diagnosis of an Axis I disorder.
* Organic brain syndromes, dementia, psychotic disorders, or mental retardation.
* Neurological or medical disorders such as seizure disorder, renal disease, diabetes, thyroid disease, EKG indicative of electrolyte imbalance
* BN subjects whose purging methods were the use of laxatives, diuretics
* Use of psychoactive medication in the 3 months.
* Pregnancy or lactation.
* Tobacco use in the 3 months.
Pilot Study of Atorvastatin in Children With Chronic Hyperlipidemia Secondary to Nephrotic Syndrome

OBJECTIVES:

I. Determine the effect of atorvastatin on the plasma levels of lipids, Lp(a), and apoproteins for treating hyperlipidemia in children with nephrotic syndrome in whom proteinuria and hyperlipidemia persist after other appropriate measures to treat their primary disease have been exhausted.

II. Determine the safety and tolerability of atorvastatin in these patients.

III. Provide preliminary data for a future investigation into the potential effect that lowering cholesterol levels may have on the rate of progression of renal insufficiency in such patients.

PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled, multicenter study.

After 3 months of low cholesterol diet, patients are randomized to receive atorvastatin tablets daily (arm I) or placebo tablets daily (arm II) for 3 months. Arm I patients receive increasing doses of atorvastatin every 4 weeks until individual maximum tolerated doses (MTDs) are determined.

After 3 months of treatment, all patients are given atorvastatin in a 6-9 month open label extended evaluation. Arm I patients receive atorvastatin for an additional 6 months and arm II patients receive atorvastatin for 9 months with increasing doses of atorvastatin every 4 weeks for the first 3 months until MTDs are determined.

Patients are followed every 6-8 weeks for one year.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Chronic hyperlipidemia with treatment-resistant nephrotic syndrome; Must have received at least 2 months of therapy with steroids on a daily or alternate basis

Primary nephropathy described as minimal change nephrotic syndrome, mesangioproliferative glomerulonephritis, IgM neuropathy, and focal segmental glomerulosclerosis

Glomerular filtration rate at least 30 mL/min

LDL cholesterol at least 160 mg/dL

--Prior/Concurrent Therapy--

No concurrent medications affecting or interacting with lipids or atorvastatin, with the exception of angiotensin converting enzyme inhibitors at discretion of referring physician, including: lipid-lowering medications, beta blockers, thiazides, fish oils, cyclosporine, Cytoxan, azathioprine, chlorambucil, and erythromycin

Concurrent prednisone and other corticosteroids allowed on a continual basis at a dose of no greater than 1 mg/kg every other day (maximum dose, no greater than 40 mg every other day); Concurrent acute courses of steroids no greater than 1 week for other unrelated conditions (e.g., asthma) also allowed

--Patient Characteristics--

Hepatic: ALT or AST less than 2 times normal

Renal: See Disease Characteristics; Creatine phosphokinase less than 3 times normal

Other: No history of familial hypercholesterolemia; No systemic disease such as systemic lupus, Schoenlein-Henoch purpura, Hodgkin's disease, polyarteritis nodosum, sickle cell disease, or HIV; Not pregnant; Effective contraception required of all adolescent patients
Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus

Primary Objective:

- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state

Secondary Objectives:

* To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments;
* To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c));
* To compare the occurrence of hypoglycemia between the 2 treatments;
* To assess the safety and tolerability of a new formulation of insulin glargine.

66 days

Eligibility Criteria:
Inclusion criteria :

* Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;

Exclusion criteria:

* Age \< 20 years at written informed consent;
* HbA1c \< 6.5% or \> 10.0% at screening
* Diabetes mellitus (DM) other than T1DM;
* Body Mass Index (BMI) \> 35.0 kg/m2 at screening visit
* Any contraindication to use of insulin glargine as defined in the Japanese Package Insert
* Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Effects of CPAP on Ventricular Function Modifications

To assess modifications of ventricular function induced by CPAP (Continuous Positive Airway Pressure).

There are still few studies on the effects of positive intra-thoracic pressure on ventricular function and spontaneous baroreflex sensitivity changes. Aim of the study is to evaluate, in patients with chronic heart failure with an ejection fraction \< 40%, the modifications of ventricular function induced by CPAP (Continuos Positive Airway Pressure) application. All the measurament will be made in basal condition (without CPAP) and with CPAP administration at 10 cmH2O via an oro-nasal mask.

Echocardiograpich evaluation: morphologic and hemodynamic evaluation is obtained with an echocardiographic exmination. Left ventricular measurement will be assessed in M-mode, under two dimensional guide) according to American Society of Echocardiography guidelines. Left ventricular ejection fraction will be assessed with Simpson method.

Right ventricle morphology will be evaluated categorizing dimensions in a) normal, b) mild enlargement, c) severely increased and d) reduced. Right ventricle area will also be quantified in tele-diastole and in meso-sistole in apical 4 chamber and parasternal short-axis.

Baroreflex control of heart rate was assessed by "sequence method" analysis of continuous blood pressure recordings obtained in basal condition and during CPAP. Data obtained by non invasive assessment of arterial pressure will be analized and values of arterial systolic, diastolic pressure and pulsatory period for each cardiac cicle will be registered.

Assessment via "sequence method" is founded on identification, every 10 minutes, on sequences characterized by a progressive increase both in pressure both in RR interval or, conversely, by a progressive reduction of pressure and RR interval evaluated on 4 or more cardiac cicles.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of heart failure
* Chronic heart failure
* Ejection fraction \< 40%

Exclusion Criteria:

* Age \< 18 years
* Permanent atrial fibrillation
* Infiltrative cardiomyopathy
* Mild/moderate chronic obstructive lung disease
* Chronic heart failure
* Diabetes mellitus
* Chronic kidney failure
A Study in Adults and Adolescents With Angelman Syndrome (STARS)

The purpose of the study is to assess the safety and tolerability of oral OV101 (gaboxadol) in adult and adolescent subjects with Angelman syndrome. In addition, several exploratory efficacy outcome measures will be investigated.

Two dosing schedules of OV101 (gaboxadol) giving as once daily or twice daily dose will be assessed against placebo.

Eligibility Criteria:
Inclusion Criteria

1. Age 13- 49 years
2. Diagnosis of Angelman syndrome
3. Receiving a stable regimen of concomitant medications for at least 4 weeks prior to Baseline, and able to maintain these throughout the duration of the study
4. Has a caregiver capable of providing informed consent on behalf of the subject and able to attend scheduled study visits
5. Able to ingest study medication
6. Caregivers must agree not to post any subject or study information on social media

Exclusion Criteria

1. Unable to perform the study related safety and exploratory efficacy assessments, such as motor function
2. Poorly controlled seizure activity
3. Concomitant cardiovascular, respiratory, liver, renal, or hematologic diseases of a degree that would limit participation in the study
4. Pregnancy or women of child-bearing potential who are not using and acceptable method of contraception
5. Concomitant use of minocycline, levodopa, zolpidem, zaleplon, eszopiclone, ramelteon, and cannabinoid derivatives, or any other use of any investigational agent, device, and/or investigational procedure 4 weeks prior to Baseline and during the study
6. Allergy to OV101 or any excipients
7. At increased risk of harming self and/or others based on investigator assessment
8. Any condition or reason that in the opinion of the investigator makes the subject unsuitable for enrollment
9. Inability of subject or caregiver to comply with study requirements

Other protocol-defined inclusion/exclusion criteria may apply.
Mechanisms of Exercise Intolerance in Chronic Obstructive Pulmonary Disease

1: Is endothelium function impaired in COPD? Other chronic cardiovascular diseases are associated with endothelial dysfunction, and the endothelium plays an important role in regulating vascular tone, tissue blood flow, coagulation and the inflammation process. Although the specific causes of endothelial dysfunction remain unclear, physical inactivity, chronic systemic inflammation and smoking are all known to be associated with endothelial abnormality.

2. Is Muscular Sympathetic Nerve Activity (MSNA) increased in COPD? A balanced regulation of blood flow to skeletal muscles may be disturbed by pathophysiology and may therefore contribute to the exercise intolerance and skeletal muscle depletion seen in patients with COPD.Skeletal muscle blood flow is tightly regulated to match tissue oxygen demands and is thus adapted to meet energy requirements. During physical activity, the sympathetic nervous system is activated ("exercise pressor reflex"), resulting in increased ventilation, heart rate and a redistribution of cardiac output from inactive to active tissues. The redistribution of cardiac output to the body organs is heterogeneous. Blood flow to skeletal, respiratory and cardiac muscle increases as exercise intensity increases, whereas blood flow to gastrointestinal, renal and reproductive tissues decreases. As blood pressure during exercise remains largely unchanged, the redistribution of blood flow is caused by changes in vascular conductance. These conductance changes are caused by an overall vasoconstriction induced by the increased sympathetic outflow of noradrenaline (NA), and a vasodilation of vascular beds supplying the working skeletal -, cardiac- and respiratory muscle.


Eligibility Criteria:
Inclusion Criteria:

* Forced Expiratory Volume at on second/ Forced Vital Capacity fixed ratio \<0.70, - Forced Expiratory Volume at one second \<60% of predicted and Medical
* Research Council scale \> or equal to 3
* Arterial oxygen saturation at rest\> 90%,
* Body Mass Index \>18,
* Left Ventricle Ejection Fraction\> 45.

Exclusion Criteria:

* Unstable ischemic heart disease,
* severe heart valve failure,
* pulmonary emboli,
* severe heart failure,
* severe infections,
* musculoskeletal disorders,
* malignant disease,
* contraindicated medicine as anticoagulants.
Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

Prospective controlled study (Canadian Task Force II-2) : Comparison analysis regarding surgical outcomes, complications, overall survival (OS), disease free survival (DFS) and cancer specific survival between patients subjected to radical Hysterectomy either by open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).

Study Objective: To analyse the effect that the introduction of minimally invasive procedures has had on surgical and oncological outcomes when compared with conventional open radical hysterectomy (ORH) in a national reference cancer center Design: A prospective controlled study (Canadian Task Force II-2) Setting: A university teaching hospital Patients: All patients that underwent RH as primary treatment for cervical cancer in our institution between May 1999 and June 2016, with a total of 188 patients.

Interventions: Patients underwent an open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer.
* Subjected to Radical Hysterectomy.

Exclusion Criteria:

* Pregnant women in which a RH was performed at the time of caesarean section.
* Previous chemotherapy treatment
* Previous pelvic radiotherapy
The Recovery in Stroke Using PAP Study

The proposed study is a randomized controlled trial among an anicipated 180 participants with acute ischemic stroke and mod/severe OSA diagnosed by ambulatory polysomnography (PSG) comparing PAP treatment with usual care concerning the primary outcome of functional recovery.

This study has 4 aims: 3 main aims and an additional exploratory aim.

Specific aim 1: Test whether PAP treatment for OSA in ischemic stroke improves stroke severity, post-stroke symptoms, post-stroke functional recovery (primary outcome), and quality of life.

Specific aim 2: Determine whether acute vs. subacute initiation of PAP in ischemic stroke results in greater improvement in post-stroke outcomes (stroke severity, symptoms, stroke recovery, quality of life).

Specific Aim 3: Conduct in-depth qualitative interviews with 25-30 stroke patients, family members, and acute care providers to elicit their experience with PAP use, including factors that influence adherence.

Exploratory aim: Evaluate whether polysomnographic measures have prognostic utility in understanding the variability in stroke recovery.

Eligibility Criteria:
Inclusion Criteria:

* Having an acute ischemic stroke with brain imaging within 48 hours of symptoms onset;
* Being within 5 days of neurologic symptoms onset;
* Moderate (15 =\< overall AHI \< 30) /severe (overall AHI \>= 30) OSA, thus with an obstructive apnea-hypopnea index AHI \>= 15.

Exclusion Criteria:

* Past use of prescribed PAP for OSA;
* Suspected sleep disorder other than OSA (e.g., narcolepsy) (because such patients should be referred for a formal PSG in a sleep laboratory);
* Life expectancy is less than 6 months (e.g., hospice patients);
* Patients who require mechanical ventilation (because such patients could not participate in the intervention protocol);
* Non-English language patients (because the intervention strategy involves forming a relationship between the patient and research staff);
* Central sleep apnea with \> 50% of respiratory events classified as central apnea;
* Resting oxygen saturation \< 90%.
* Inability to provide their own informed consent. To enhance the generalizability of our study, all stroke severity will be included. However, we will exclude patients who cannot provide their own consent. This is because patients will need to participate actively in the protocol with a behavioral intervention. An assessment of the patient's competence to provide consent will be made based on published recommendations.
Effects of Drugs on Stress Memories

There is evidence that cannabinoids, including delta-9-tetrahydrocannabinol (THC), reduce responses to acute stress and fear-related stimuli, but few studies have examined the effects of THC on memories of stressful experiences. The researchers hypothesize that THC will attenuate behavioral and physiological responses to negative valence stimuli, including memories of aversive experiences.

The current study will use a between subject, randomized, placebo-controlled design to assess the effects of low doses of delta-9-tetrahydrocannabinol (THC) on stress memories. Healthy male and female participants (N=48) will be randomly assigned to one of the three drug conditions (5 mg THC \[n=16\], 10 mg THC \[n=16\], or placebo \[n=16\]). Each subject will participate in 3 sessions. In the first session, they will undergo the TSST procedure. Researchers will obtain ratings of subjective distress, heart rate variability, and cortisol levels to assess response to the stressor for each individual. On the second session, one week later, participants will receive either THC or placebo and they will then be presented with TSST-related cues during a stress-memory retrieval session.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 y/o
* BMI 19-29 kg/m2
* some prior experience with cannabis (used at least 4 times, no adverse experiences, and current use no more than once a week)

Exclusion Criteria:

* Current severe substance use disorder
* history of psychosis or mania
* Lack of English fluency
* Current DSM IV Axis I disorder
* Abnormal EKG
* Daily use of medications outside of contraception,
* Women who are pregnant or trying to become pregnant
Evaluation of Efficacy and Safety of FOLFIRI Association Treatment in Patients 70 Years of Age and Older With Gastric Cancer

The number of patients over 70 years old with cancer is increasing in France. This population is heterogenous: physiological functions, presence of co-morbidities, and autonomy can vary a lot between subjects of the same age. Physicians hesitate to treat them with optimal doses because they are afraid of the risk of toxicity in spite of the benefits of treatment. Fifty eight percent of gastric cancers are diagnosed in patients over the age of 70 in France. FOLFIRI (irinotecan, leucovorin and fluorouracil) chemotherapy appears to be a promising treatment for digestive cancer. It increases the level of response and survival without major toxicity. It becomes necessary to evaluate patients, to propose adapted treatments for their conditions.

The principal objectives are to demonstrate the efficacy of treatment, safety, survival and to find out if geriatric assessment data can help to better predict chemotherapy toxicity. The researchers plan to accrue 43 patients diagnosed with locally advanced or metastatic gastric cancer. They will receive FOLFIRI and 4 geriatric evaluations: before treatment, day 1 cycle 2, day 1 cycle 4 and at the end of chemotherapy. These evaluations include tests of cognitive functions (MMS), nutritional status (MNA), co-morbidity (CIRS-G), mobility (Get up and Go), activities (ADL; IADL), quality of life (QLQ-C30), depression (GDS-15) and Lachs-Balducci screening.


Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or older
* Gastric cancer, locally advanced or metastatic
* No previous adjuvant treatment (surgery, radiotherapy, chemotherapy) in the last 6 months
* One measurable lesion
* ECOG \< 3
* Biology and biochemistry within normal limits
* Life expectancy \> 12 weeks

Exclusion Criteria:

* Other palliative chemotherapy for this cancer
* Other cancer in the last 5 years
* Previous treatment with irinotecan
* Atropine treatment not possible
* Concomitant cancer therapy except bone radiotherapy
* Metastases to brain or meninges with symptoms
* Other severe pathology uncontrolled
* Problem of compliance