cyrilzakka/clinical-trials huggingface dataset:
Effectiveness Inspirational Muscle Training

The long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Therefore, of this research will be to compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.

The study will consist of a randomized controlled clinical trial conducted at the Intensive Care Unit of the University Hospital of UNIVASF. Will be included individuals of both sexes, aged 18 years or older, who are on invasive mechanical ventilation and who obtain the Free and Informed Consent Form, signed by the responsible family member. Subjects will be randomized into two groups (training and control). The inspiratory (MIP), expiratory (MEP) and peak expiratory flow pressures will be evaluated. The training group will perform respiratory muscle training, using the Powerbreath equipment, with initial loading of 40% of MIP, 7 days a week, 2 times a day. Morbidities that have repercussions on diaphragmatic contraction and end-stage disease will be used as exclusion criteria. The sample data will be analyzed through the SPSS 22.0 program. The significance level of the study will be set at 5% (p \<0.05).

Eligibility Criteria:
Inclusion Criteria:

* invasive mechanical ventilation
* patients hemodynamically stable
* without use of vasoactive drugs

Exclusion Criteria:

* spindle trauma
* neuromuscular diseases
* end-stage disease
* pneumothorax
* rib fracture
* diaphragmatic injury
* postoperative pulmonary surgeries
* abdominal disease
* morbidities that have repercussions on diaphragmatic contraction
* mechanical ventilation with FiO2 \> 60% and PEEP \> 10 cm H2O
Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus

Studies in patients with intracranial hypertension have shown a good relationship between optic nerve sheath diameter measured by retrobulbar ultrasound and invasively measured intracranial pressure. The aim of this study was to evaluate changes in optic nerve sheath diameter before and after drainage of cerebrospinal fluid in patients with hydrocephalus.


Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ-Ⅱ
2. aged between 1 and 19 year
3. hydrocephalus
4. general anesthesia for undergoing drainage of cerebrospinal fluid

Exclusion Criteria:

1. an anatomical or functional abnormality in optic nerve
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants

The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis (UC) or Crohn's disease (CD). This study will look at the PK, safety, and tolerability of vedolizumab following a single intravenous infusion of vedolizumab IV in healthy adult Chinese participants.

The study will enroll approximately 16 participants. All participants will be assigned to receive a single dose of vedolizumab IV 300 mg on Day 1.

This single center trial will be conducted in China. The overall time to participate in this study is approximately 7 months. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after single dose of study drug for a follow-up safety survey assessment.

Eligibility Criteria:
Inclusion Criteria:

1. The participant weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0 kilogram per square meter (kg/m\^2) inclusive at Screening.

Exclusion Criteria:

1. Has one or more positive response on the progressive multifocal leukoencephalopathy (PML) subjective symptoms checklist at Screening or before dosing on Day 1.
2. Has had a surgical procedure requiring general anesthesia within 30 days before the initial Screening Visit or is planning to undergo a surgery that requires general anesthesia during the study period (through Final Visit/Day 127).
3. For participants who are negative for hepatitis B surface antigen (HBsAg) but are positive for either surface antibodies and/or core antibodies, hepatitis B virus Deoxyribonucleic Acid (DNA) polymerase chain reaction will be performed and any result that meets or exceeds detection sensitivity will be excluded.
4. Has poor peripheral venous access.
5. Has a QT interval with Fridericia correction method (QTcF) greater than (\>) 430 millisecond (ms) (males) or \>450 ms (females) or PR outside the range 120 to 220 ms, confirmed with 1 repeat testing within a maximum of 5 minutes, at the Screening Visit or Check-in (Day -1).
Clinical Validation of an Immunocytochemistry Method Using MARS1

The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to validate the clinical usefulness of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer-related protein expressed only in bile duct cancer.

Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.

Clinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by a new staining method and compare with the results of the conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunocytochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)
* Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy
* Patients who underwent surgical treatment with biliary cancer
* Patients with bile duct stenosis

Exclusion Criteria:

* Minors under the age of 19, vulnerable subjects such as illiteracy
* Necrotic specimens
* Samples with non-diagnostic cytology results and insufficient cells for further evaluation
* Samples classified as neoplastic (benign or other)
* Patient with cholangitis in the bile duct
Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.

This is a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this study is to determine whether MY008211A compared to eculizumab is efficacious and safe for the treatment of PNH patients who were naive to complement inhibitor therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
2. Mean hemoglobin level \<100 g/L at screening.
3. LDH \> 1.5 x Upper Limit of Normal (ULN) at screening.
4. Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.

Exclusion Criteria:

1. Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
2. History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
3. Known or suspected hereditary complement deficiency.
4. Previous bone marrow or hematopoietic stem cell transplantation.
5. Previous splenectomy.
6. A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Study of the Pharmacokinetic Action of Amantadine and Ribavirin in Chronic Hepatitis C. CINAM

Peg interferon and ribavirin currently represent the standard approved association for treating patients infected with hepatitis C virus (HCV) . The adjunction of amantadine is expected to gain about 10 % of sustained virological response (SVR) . Unfortunately, about 50 % of the patients remain relapsers or virological non responders. The main predictive factors of SVR are HCV genotype and body weight (BW). The impact of the drug pharmacological properties, particularly those of ribavirin requires complementary studies. This drug has a large distribution volume and its concentrations display large inter-individual variability. Two studies performed in HCV patients found no correlation between ribavirin dose adjusted on BW and a single ribavirin time point serum concentration at steady state.

The aim of this study is to investigate the pharmacokinetic-pharmacodynamic relationships of ribavirin in hepatitis C patient

The study is conducted in naive patients infected with genotype non 2 non 3 administered peginterferon alpha 2-a (40KD) weekly, and ribavirin with dose adjusted on BW (\< 75 kg 1000 mg/day, \>75 kg 1200 mg/day) for the first three months with adjunction of amantadine 200 mg daily for the following 9 months.

Plasma concentration profiles of ribavirin were studied after the first dose (D0) and at W12. At each period, blood samples were collected pre-dose and 30 minutes, 1, 1.5, 2, 3, 4, 6, 8, and 10 hours post-dosing. Ribavirin concentrations were measured using liquid chromatography-tandem mass spectrometry and ribavirin area under the concentration-timcurves (AUC0-10h) were derived from plasma concentrations profiles using the linear trapezoidal rule.

Virological follow-up was performed at W2, W4, W6, W8, W12, W24 and W72. Early virological response was defined by undetectable viral load at W12.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \>18 years of age and \<65 years of age
* Génotype non2 non3
* Chronic liver disease consistent with chronic hepatitis C infection on a biopsy (obtained within the past 24 months) as judged by a local pathologist (Metavir \>A1and \>F1)
* Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug

Exclusion Criteria:

* Women with ongoing pregnancy or breast feeding
* IFN or ribavirin therapy at any previous time
* Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, anti-HIV Ab
* History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* Serum creatinine level \>1.5 times the upper limit of normal at screening
* History of severe psychiatric disease, especially depression
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone

To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor, in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how much of the HbA1c response is attributable to nocturnal coverage will be explored.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 70 years, inclusive;
2. Males and females of non-childbearing potential;
3. Diagnosis of type 2 diabetes mellitus according; and
4. On a stable dose of metformin monotherapy at randomization (can be on other oral therapies or naive at study entry

Exclusion Criteria:

1. History of type 1 diabetes mellitus or history of diabetic ketoacidosis or persistent hypoglycemia;
2. History or presence of alcoholism or drug abuse
3. Typical consumption of ≥10 drinks of alcohol weekly;
4. Presence of any of the following conditions:

   * Significant renal impairment (glomerular filtration rate \<60 mL/min \[to be calculated by the central laboratory\]);
   * Diabetic retinopathy;
   * Diabetic gastroparesis;
   * Active liver disease (other than asymptomatic nonalcoholic fatty liver disease), cirrhosis, or symptomatic gallbladder disease;
5. Uncontrolled high blood pressure;
6. History or evidence of cardiovascular or pulmonary disease
7. Must meet other laboratory and Medical History clinical criteria. Please contact recruitment center for referrals
Wearable Technology to Assess Gait Function in SMA and DMD

The purpose of this project is to devise instrumented insoles capable of accurately measuring gait at each footfall, over multiple hours in any environment. To achieve high accuracy, the investigators will develop a new learning-based calibration framework. Features will be tested in controlled lab settings 39 during a single visit in people with SMA (13), DMD (13) and healthy controls (13) and in 15 participants in real-life environments.

Spinal muscular atrophy (SMA) and Duchenne muscular dystrophy (DMD) are genetic disorders that often result in progressive weakness and impaired function. Results from this study will help characterize how gait is affected in SMA and DMD. This novel device can serve as a more affordable and versatile measurement instrument for neuromuscular disorders that affect gait and balance. All participants will be observed and measured while wearing the instrumented insoles in the lab and in real-life environments.

Eligibility Criteria:
Inclusion Criteria:

1. One of the following categories:

   * Genetic confirmation of spinal muscular atrophy
   * Genetic confirmation of Duchenne or Becker muscular dystrophy or evidence on muscle biopsy with a clinical presentation consistent with DMD/BMD
   * Healthy individuals.
2. Able to walk independently at least 25 meters

Exclusion Criteria:

1. Unable to walk 25 meters independently.
2. Use of investigational medications intended for the treatment of SMA or DMD/BMD within 30 days prior to study entry.
NHANES 2003-2014 and Sugar-sweetened Beverages in Children

The study uses data from the NHANES surveys to evaluate trends in SSB intakes among US children. The goal was to determine whether recent declines in intake may have been less marked in the more vulnerable groups with a persistently high burden of obesity, including race/ethnic minorities and low-income groups.

Recent studies suggest sugar-sweetened beverage (SSB) consumption has been declining among US children 2-18y. However, most studies focus on changes in mean intake and little is known about trends in the high SSB consumers who are most at risk of excess weight gain. There is also limited understanding of whether and how these changes over time may have influenced disparities in intake among vulnerable groups of children with persistently high levels of obesity, including children from low-income households, and several race-/ethnic minorities.

This analysis of six cycles of US National Health and Nutrition Examination Survey (NHANES) dietary surveillance data from 2003-2014 examined shifts over time in SSB intake at both the median and 90th percentile among US children. The study evaluated the extent to which disparities in intake of total SSBs, as well as major SSB subtypes (regular sodas, fruit drinks and other), may have persisted in vulnerable groups, for both median and "heavy" intake. The analysis presents data for three age groups: 2-5y, 6-11y and 12-18y by gender, and focus on three race-ethnic groups: Non-Hispanic White, Non-Hispanic Black, and Mexican-American. Household income is used as the primary socioeconomic status variable.

Eligibility Criteria:
Inclusion Criteria:

* All U.S. children aged 2-18y in US NHANES diet surveys from 2003-2014

Exclusion Criteria:

* missing socio-economic data: parental education or household income as a percentage of the Federal Poverty Level; n=1841
* missing or implausible dietary data, defined as: energy intake of zero kcal or more than four standard deviations beyond individual estimated energy requirements, or no report on whether data represents usual intake (more, same or less than usual); n=236
Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation

After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood.

The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.

Special attention will be paid to the epidemiology of virus infections behind one year post transplant. Very limited data are available on this issue and there is suspicion that tacrolimus patients suffer more hard with viruses like CMV, EBV, BKV. These viruses can induce graft nephropathy and threat to the life of the recipient.

Eligibility Criteria:
Inclusion Criteria:

* first kidney allograft recipients
* alemtuzumab induction

Exclusion Criteria:

* CNI intolerance
Functional Significance of Complexity Measures in the Sensory-motor Behavior

The main objective of this study is to compare between groups the level of complexity of the estimated sensorimotor performance through multi-fractal (minmaxMF-DFA) exponents.

The secondary objectives of this study are to compare the level of complexity of the estimated sensorimotor performance using the(A) mono-fractal exhibitors (the αDFA values) and the (B) coefficient of variation (CV) between groups.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The subject does not practice music intensively (\<1h / day on average)

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, or under guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The subject regularly practices music
* The subject is suffering from a neurodegenerative disease of the central or peripheral nervous system which may affect the sensorimotor control of rhythmic movements of the upper limb
* The subject has had a recent trauma of the upper limb
* The subject is suffering from uncorrected visual and hearing impairment
Efficacy and Safety of Melatonin and Clonazepam for IRBD

This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.

This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril).

Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.

Eligibility Criteria:
Inclusion Criteria:

* REM sleep behavior disorder (ICSD-3 criteria)

Exclusion Criteria:

* Neurological disorder including epilepsy or stroke
* History of psychiatric illness
* Neurodegenerative disease including dementia or parkinsonism.
* Medication affecting sleep within 1 month
* Intake of melatonin or clonazepam within 1 week.
* Unable to complete questionnaires
Early Maladaptative Schemas Among Euthymic Patients With Bipolar Disorder in the Versailles FondaMental Advanced Centers of Expertise for Bipolar Disorders Cohort

Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality.

The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months.

The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.

Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality. However, few studies have explored EMS in bipolar disorders, despite EMS therapy is a promising tool for the psychotherapy of BD.

This study will use the data collected at the Versailles Expert Center for Bipolar disorder, in the local FACE-BD registry. These data will be collected at the inclusion, 12 months and 24 months later. They included an extensive neuropsychological battery and an extensive evaluation of the clinical characteristics of bipolar disorder. EMS will be measured with the Young Schema Questionnaire Short Form 3.

The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months.

The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

- bipolar disorder according to DSM IV-R (structured clinical interview)

Exclusion Criteria:

* major depressive or manic or hypomanic during the evaluation
* Montgomery Åsberg Depression Rating Scale ⩽10
* Young Mania Rating Scale ⩽12
Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function

Each year, only one third of patients registered on the waiting list receive a kidney transplant. Numerous paths are being explored with the aim of reversing this shortage. The first is to increase the number of organs by developing harvesting from donors in a state of brain-death (BD) termed "expanded criteria donors" or from patients deceased from circulatory arrest.

Another fundamental factor is to insure the success of the transplant by limiting the dysfunction of donor kidneys, marked by a delayed graft function (DFG).

The development of techniques to insure correct perfusion of harvested organs, and the optimization of reanimation and intensive care of brain-dead donors constitute important factors in DGF reduction.

Therapeutic Hypothermia could to be an attractive care strategy for BD patients.


Eligibility Criteria:
Inclusion Criteria:

* For donors: legal determination of death by neurologic criteria/deceased organ donor/no medical contre-indication to donation/Information given to the authorizing surrogate/ Pregnant women.

  * For transplant recipients : age 18 years or greater /information given and no opposition signed by recipients.

Exclusion Criteria:

* For donors: no legal determination of death by neurologic criteria/not a deceased organ donor/ medical contre-indication to donation/ no Information given to the authorizing surrogate.
* For transplant recipients: age \<18 years / no information given and/or opposition signed by recipients.