cyrilzakka/clinical-trials huggingface dataset:
Efficacy of L-carnitine Versus Placebo in the Treatment of Fatigue in Multiple Sclerosis

The objective of this study is to evaluate the efficacy of L-carnitine versus placebo in the treatment of fatigue in multiple sclerosis patients. This study will randomize 60 patients in a cross-over design. This study is sponsored by academic French health institutions.

Fatigue is one of the most frequent disabling symptom in Multiple Sclerosis (MS). L-Carnitine is currently used in the symptomatic treatment of fatigue after chemotherapy in patients with cancers. It is also empirically used by numerous MS centers in the treatment of fatigue. However, this practice is not evidence-based (Cochrane review 2010). This study will evaluate the efficacy of L-carnitine versus placebo in the treatment of fatigue in MS patients in a randomized double blind national multicenter cross-over trial.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* Relapsing remitting (RR) secondary progressive (SP) or primary progressive multiple sclerosis according to McDonald 2005 (Polman) MS diagnostic criteria.
* Affected of fatigue for more than 3 months with global score on Modified Fatigue Impact Scale (MFIS)\>45.
* Indication of treatment of fatigue to the appreciation of the neurologist.
* Expanded Disability Status Scale (EDSS) not exceeding 6.0.
* Information and comprehensive agreement signed by patient and the investigator.
* Subject affiliated to health insurance coverage.

Exclusion Criteria:

* Patients with serious unstable disease :

  * recurrent or serious relapses
  * rapidly ongoing disability impairment in the preceding 6 months
  * serious or non stabilized depression
* Patients starting a new disease modifying therapy, immunosuppression or antidepressant therapy less than 3 months ago or not stabilized.
* Patients with a treatment of fatigue or of other condition that may interfere with fatigue evaluation to the appreciation of the neurologist.
* Energy drinks consumption or toxicomania.
* All other reasons to the opinion of the neurologist that may impair study management, especially patient compliance, neuro-psychological disorders that may input questionnaires filling.
* Person under protection of the law.
* Participation in other clinical trials (allowing for exceptions, after recommendation from the scientific council).
Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive)
* Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with varying degrees of Renal Disease)
* Normal renal function with eGFR ≥90 mL/min/1.73m2 (Cohort 1), or renal insufficiency with eGFR 60 to \<90 mL/min/1.73m2 (Cohort 2), 30 to \<60 mL/min/1.73m2 (Cohort 3), or \<30 mL/min/1.73m2 (Cohort 4), calculated using Modification of Diet in Renal Disease (MDRD). Subjects with ESRD must be receiving hemodialysis at least 3 times per week for at least 3 months at Screening (Cohort 5 only)
* Non-smoker for at least 1 month prior to screening for the study
* Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food
* Other inclusion criteria per protocol

Key Exclusion Criteria:

* Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
* Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec
* Hemoglobin (HB), hematocrit (HCT), white blood cell count (WBC), or platelet count less than the lower limit of normal range of the reference laboratory (Cohort 1). HB \<8.5 gm/dL, WBC ≤3,000 cells/μL or platelet count ≤100,000 cells/μL (Cohorts 2-5)
* Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 X the upper limit of normal (ULN) for the reference laboratory
* Recent history (within 6 months) of known or suspected Clostridium difficile infection
* History of chronic liver disease, cirrhosis, or biliary disease
* History of seizure disorder except childhood history of febrile seizures
* Positive urine drug/alcohol testing
* Positive testing for human immunodeficiency virus1/2 (HIV 1/2), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies
* History of substance abuse or alcohol abuse
* Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
* Other exclusion criteria per protocol
Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography

Recent advances in technology have resulted in the development of scanners that can image the heart blood vessels within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. Further advances in technology allow the visualisation of both the blood vessels and the supply of blood to the heart muscle. Here we propose to assess the latest and most powerful computed tomography scanner and compare it to magnetic resonance and conventional coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* referred for invasive coronary angiography because of suspected coronary heart disease

Exclusion Criteria:

* inability or unwillingness to undergo computed tomography or magnetic resonance imaging
* renal failure (serum creatinine \>200 micromol/L or estimated glomerular filtration rate \<30 mL/min)
* hepatic failure
* allergy to iodinated contrast or gadolinium
* pregnancy
* contraindication to adenosine infusion
* inability to give informed consent
* inability to perform fractional flow reserve during invasive coronary angiography
Erector Spinae Plane Block With Ropivacaine for Major Upper Abdominal Surgery

Prospective, single-centre, randomized, controlled, open-label, evaluator-blinded, superiority trial.

The primary objective is to establish whether ESP ropivacaine reduces post-operative opioid use and improves pain rating post-operatively. The secondary objectives include adverse event incidence, time to ambulation and time to discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Adults who are scheduled to undergo major upper abdominal surgery (e.g. Pancreato-duodenal resection). If enrollment rates are insufficient, patients undergoing other major upper abdominal surgery will be enrolled (e.g in the supraumbilical area: liver resection, colon resection; Whipple procedure; gastrectomy).
2. Males or females 18-70 years of age
3. American Society of Anesthesiologists physical status class I,II, III
4. Signed informed consent

Exclusion Criteria:

1. Patients undergoing emergency surgery
2. Decompensated cardiovascular disease (e.g. left ventricular ejection fraction ≤40%), chronic heart failure, rhythm and conduction disorders, coagulopathies)
3. Comorbid obesity (BMI≥35kg/m2)
4. Anomalies of vertebral column
5. Use of anticoagulants and patients with hypocoagulable conditions
6. Pregnancy
7. Physician preference for therapeutic anticoagulation
8. Infection of skin at site of needle puncture
9. Known allergies to study drugs
The Relationship Between Social Memory Disorders and Sleep Spindles in Children With Autism Spectrum Disorder

Research background and project basis

Autism spectrum disorder (ASD) is a lifelong neurodevelopmental disorder characterized by social disorders and repetitive stereotypical behavior. Social memory impairment is a significant feature of ASD patients, and the specific pathogenesis of social memory impairment in ASD patients is currently unclear, and there are no objective indicators to measure social memory levels. Sleep spindle wave is a special brain wave in sleep that is closely related to memory consolidation. However, no one has yet studied the impact of sleep spindles on social memory.

Research purpose

Exploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with ASD.

The goal of this observational study is to exploring the correlation between sleep spindles and social memory in the population, providing reference for the auxiliary diagnosis of social memory disorders in children with autism spectrum disorders(ASD). The main question it aims to answer is the effect of sleep spindles on social memory. The study clinically recruited 30 children with ASD and 30 normal children. Participants will be asked to take face and car recognition memory tests which car recognition memory test as a control. After the two tasks, nighttime EEG recordings and subsequent spindle analysis will be recorded and performed.Then the correlation analysis between social memory levels and spindle levels would be conducted by machine learning model, so that researchers can infer the individual's social memory level through the level of spindles in the EEG.

Eligibility Criteria:
Inclusion Criteria:

* Children with ASD diagnosed through DSM-V (Healthy controls do not have this requirement)
* IQ score ≥ 75（WISC-IV，Wechsler Intelligence Scale for Children）
* Age: 6-18
* Not receiving psychotropic medication (Or stopping medication for at least 2 weeks before the experiment)

Exclusion Criteria:

* In addition to ASD, other mental illnesses are also combined
* Presence of a sleep disorder, sleep apnea, periodic leg movements during sleep, or atypical EEG patterns
* Left handed
A Pilot Study for Adaptation of Neospot Device for Health Care at Primary Health Facilities in Kenya

Neospot device is a 5-in-1 wearable vital signs monitor designed to measure temperature, blood pressure, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SPO2). We propose to study the experiences of patients and nurses regarding spot measurement of vital signs at the outpatient department in primary care facilities in Kenya. The study aims to investigate the capability, opportunity, and motivation of nurses to use the Neospot device for vital signs measurement in level 3 facilities in Kenya by validating the accuracy of the Neospot and assessing the experience of patients while using the Neospot, the study also aims to assess the experiences of nurses as they use the Neospot and determine how the Neospot affects their workflow.

This study intends to investigate the experiences of both nurses and patients in the use of a specific brand of such a device known as the 'neospot' device in various sub county, health centres in Kenya. The study also aims at finding out whether the device affects the rate and efficiency of how nurses work in these facilities.

The study will apply a cross sectional design, three facilities will be used as the sampling frame two urban facilities from Nairobi County and one peri urban rural facility from Kajiado county. The participants will be selected randomly. Data will be obtained from a total of 159 randomly selected patients, all the nurses who will be on duty will also be included as participants in the study and the team leaders will be interviewed as key informants for qualitative data. Quantitative data will be analysed using SPSS version 24 for descriptive and inferential statistics, NVIVO software will be used to analyse the qualitative data to determine the themes. Study Duration: Data collection, analysis and report writing will take 4 ½ months.

Eligibility Criteria:
Inclusion Criteria:

* Participants between 18 and 70 years of age
* In stable condition
* Willing to give consent to participate in the study

Exclusion Criteria:

* Very ill and unstable patients who need emergency care
* Patients with medical conditions that are characterized by rapid changes in vital signs such as thyroid disorders
* Patients who have skin lesions on the forehead where the device is to be fixed
Weekly Dosing of Malarone ® for Prevention of Malaria

The purpose of this study is to determine whether Malarone ®, which is a drug approved to prevent malaria when taken daily, will still effectively prevent malaria if taken weekly.

In this study, two groups of volunteers will be exposed to malaria through the bites of infected mosquitoes. In one group, volunteers will be randomly assigned to one of 5 arms. Each of these arms will receive a different dose of Malarone®, a drug known to prevent malaria when taken daily. Each of these doses will be lower than the maximum approved dose of this medicine. The other group will not be treated with any drug that could prevent symptoms or infection.

After exposure, both groups will be monitored for a period of approximately 3 months to see if they develop symptoms of malaria. Any subjects who do so will be treated with appropriate medications. Subjects in both groups will have their blood checked regularly during this period for the presence of malaria parasites. At the completion of the study, results will be analyzed to determine whether any of the doses of Malarone might effectively prevent malaria if taken weekly rather than daily.

Eligibility Criteria:
Inclusion Criteria:

* A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening
* Free of clinically significant health problems
* Baseline ECG before entering into the study
* Available to participate for duration of study (approximately 4 months, not including screening period)
* If the participant is female, not pregnant or lactating and willing to use contraception to prevent pregnancy
* BMI between 19 and 30

Exclusion Criteria:

* History of malaria or travel to a malarious country within the previous 12 months
* History of participation in a study in which potential exposure to malaria or vaccination against malaria occurred.
* Planned travel to malarious areas during the study period.
* History of malaria chemoprophylaxis within 60 days prior to time of study entry.
* Chronic use of antibiotics with anti-malarial effects
* Chronic use (defined as more than 14 days)of immunosuppressants or other immune-modifying drugs within six months of study entry.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination, ECG or laboratory screening tests
* Significant unexplained anemia
* History of sickle cell disease or sickle cell trait
* Seropositive for hepatitis B or hepatitis C
* History of splenectomy
* Pregnant or lactating female, or female who intends to become pregnant during the study
* Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV
* History of a neuropsychiatric disorder (anxiety, depression, psychosis, schizophrenia)
* Chronic or active illicit and/or intravenous drug use
* History of allergy to atovaquone, proguanil or chloroquine
* History of psoriasis
* Concurrent participation in other research studies
• Comparison of Blood Culture Contamination Rates

In this study, blood culture contamination rates will be compared in patients who used povidine/iodine-alcohol and chlorhexidine/alcohol, which were applied before the blood culture was taken by randomized two methods routinely used in this study.

Detection of the pathogen in blood cultures as soon as possible reduces mortality significantly by providing timely initiation of treatment1. However, when skin antisepsis is not performed properly, an increase in the rate of contamination is observed. In this study, it was planned to compare the contamination rate of two antiseptics, povidine iodine/alcohol and Chlorhexidine/alcohol used as skin antisepsis, in the blood culture taken.

Full randomization" will be applied in the study. Multiples of 3 of the patients to be included in the study will be included in the "Chloraprep" group, the remaining patients and multiples of 2 will be included in the "povidine/iodine" group. . According to the number of samples determined for each institution, patients who came to the outpatient clinic during data collection and accepted to participate in the study will be randomly selected.

Eligibility Criteria:
Inclusion Criteria:

* patients who will be hospitalized at SBU Izmir Dr. Patients who are hospitalized in the Pediatric Infection Service of Behçet Uz Pediatrics and Surgery Training and Research Hospital, and who will require blood culture indications will participate in the study If they are willing to

Exclusion Criteria:

* The patents with central lines will be excluded.
* The patient who were transferred from ICU's will be excluded.
Effects of Parabolic Flight on Spatial Cognition and Hippocampal Plasticity

The main objective of this experiment is to assess the impact of parabolic flight on (1) spatial memory and orientation, (2) the changes in brain structure and function, and particularly the hippocampal formation, and (3) biochemical markers of stress and neuroplasticity.

A preliminary study will be performed with the aims (1) to test during weightlessness hardware used to administer visuo-spatial testing and (2) to determine the optimal body posture for testing under microgravity conditions (i.e. body posture for which change in visuo-spatial testing induced by weightlessness is maximal).

The main criteria are:

* Structural and functional changes of brain evaluated by fMRI;
* Cognitive performance, and specifically spatial cognition using a series computer-based tasks.
* Key neurotrophins determined in venous blood samples The criteria used in the preliminary experiment is visuo-spatial performance evaluated with a computer-based test assessing spatial cognition.

The investigators hypothesize that hippocampal structure and function, and particularly the dentate gyrus, will be altered after parabolic flight compared to ground based controls. Specifically, the 3 tested hypotheses are:

* Parabolic flight induces changes in hippocampal structure;
* Weightlessness induces changes in cognitive performance, and specifically spatial cognition;
* There is a correlation between changes in hippocampal structure and changes in visuo-spatial memory performance.
* There is a correlation between changes in hippocampal structure and changes in key neurotrophins.

The hypothesis tested during the preliminary experiment is that body posture affects the changes in spatial cognition performance.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 67
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection.

Subjects will be staff member of the team or of other teams participating in the parabolic flight campaign.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Person with medical history of claustrophobia
* Person with contraindication to MRI
* Pregnant women
BI 2536 BS in Patients With Advanced Solid Tumours and Repeated Administration in Patients With Clinical Benefit

The primary objective of this study was to determine the maximum tolerated dose (MTD) of BI 2536 BS in patients with advanced solid tumours. Secondary objectives were the evaluation of safety, efficacy, and pharmacokinetics of BI 2536 BS


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who had failed conventional treatment, or for whom no therapy of proven efficacy exists, or who were not amenable to established forms of treatment
* Evaluable tumour deposits
* Age of 18 years or older
* Life expectancy of at least 6 months
* Written informed consent consistent with international conference of harmonization (ICH) - good clinical practice (GCP) and local legislation
* Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ≤ 2
* And full recovery from all therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies

Exclusion Criteria:

* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the trial protocol
* Pregnancy or breastfeeding
* Active infectious disease
* Known brain metastases
* Second malignancy requiring therapy
* Absolute neutrophil count less than 1500/mm3
* Platelet count less than 100 000/mm3
* Bilirubin greater than 1.5 mg/dL (\> 26 μmol/L, international system of units (SI) equivalent)
* Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
* Serum creatinine greater than 1.5 mg/dL (\> 132 μmol/L, SI unit equivalent)
* Sexually active women and men who are unwilling to use a medically acceptable method of contraception
* Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
* Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial
* Patients unable to comply with the trial protocol
* Or active alcohol or drug abuse
Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Alternative)

A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 or above
* Congestive Heart Failure with symptoms for more than 4 weeks before starting study
* Provision of informed consent

Exclusion Criteria:

* Current low blood pressure with symptoms
* Liver disease considered significant by the study doctor
* Pregnant or lactating females
ESCAPE Study : Validation of a Specific Tool Scoring Residents at Risk of Escaping/Elopement From Nursing Homes (ESCAPE)

Residents' escapes occur even if most of the nursing homes (NH) have set up specific devices to prevent from this risk. Therefore, the need to develop and validate a specific tool to assess the risk of escaping was obvious to the working group, aim at emphasizing patient centered-care by the nurses' staff and help to develop personalized devices.

Aim of the study: develop and validate a specific tool to score the risk of escaping in NH residents Study design: Observational prospective multicentered cohort study Nursing homes volunteer to participate Location: Provence Alpes Cotes d'Azur Region ( South East of France) Population: 4050 NH residents. Duration: two years, each resident included is followed up for one year Measures: Nursing homes characteristics, residents characteristics ( social and from medical record); Escape Scale (25 items with a Yes/no answer; filled up during a nurses staff meeting for each resident and every three months; 3 sub scales: resident environmental items, social items, and medical items.


Eligibility Criteria:
Inclusion Criteria:

* Every resident of Nursing home participating to the study
* Living in the NH for three months or more
* With a living prognosis longer than 3 Months

Exclusion Criteria:

* Prognosis less than three months
* Bedridden (not able to move alone from bed to chair)
* Nursing home short stay scheduled \< 3 months