cyrilzakka/clinical-trials huggingface dataset:
Effects of Cocoa Procyanidins on Vascular Function

There is a question regarding the role of higher flavanol oligomers (procyanidins) and of intestinal flavanol metabolites i.e. valerolactones, in the context of flavanol intake-related vascular effects. Only flavanol monomers, and to a certain degree dimers, are absorbed in the small intestine and enter circulation. Higher oligomers (procyanidins) are not absorbed and are catabolized by the colonic microflora. The catabolites enter the circulation. Phenolic acids and valerolactones represent a significant proportion of these catabolites, reaching peak concentrations in the order of 6-10 h post ingestion. The vascular effects of these colonic microbiome-derived flavanol derivatives have not been studied so far. The purpose of the study is to determine the timecourse of endothelial function along with flavanol catabolites \& metabolites during acute, sustained, and acute on sustained ingestion of procyanidins as compared to previously used flavanol interventions, and flavanol free control.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects (no clinical signs or symptoms of cardiovascular disease)
* \>18 years, \<35 years

Exclusion Criteria:

* cardiovascular disease
* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* C-reactive protein \> 1 mg/dl
* malignant disease
Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy

The study aim of this study is to evaluate the effect of proton therapy on quality of life and long-term normal tissue toxicities of the pediatric cancer patients. Based on these results, the predictive model of long-term normal tissue toxicities, survival, and quality of life could be recognized. Risk-adapted treatment strategy based on the predictive model in pediatric cancer patients could be established.


Eligibility Criteria:
Inclusion Criteria:

* less than 18 years of age
* patient who is planned to receive proton therapy at Samsung Medical Center
* Informed consent

Exclusion Criteria:

* Refuse to participate this cohort study
Intraperitoneal Pressure Measurements in Children

Pediatric peritoneal dialysis is prescribed according to the type of dialysis, the volume infused and the dialysis time. The measurement of intraperitoneal pressure (IPP) is an important and easy indicator to perform. A IPP greater than 18 cmH20 has been correlated with pain and dyspnea, a IPP greater than 14 has been correlated with a higher risk of peritonitis and a IPP greater than 13 was correlated with higher mortality and a switch on hemodialysis. These data suggest the importance of routine IPP measurement. Few data are available in the pediatric population.


Eligibility Criteria:
Inclusion criteria:

* Minor subject (\<18 years old)
* In stable peritoneal dialysis for more than 3 months
* Subject having had at least 3 IPP measurements
* At least 3 months after surgery to insert a peritoneal dialysis catheter
* Subject (and / or his parental authority) not having expressed, after being informed, his opposition to the reuse of his data for the purposes of this research.

Exclusion criteria:

- -Subject (or his parents) having expressed his (their) opposition to participating in the stud
Benefits of High Flow Nasal Cannula Oxygen for Preoxygenation During Intubation in Non Severely Hypoxemic Patients

The aim of this study is to determine whether High Flow nasal cannula (HFNC) oxygen is more efficient than the standard High Flow face mask (HFFM) for preoxygenation before orotracheal intubation after crash induction in non severely hypoxemic patients

This study will be designed as followed : patients will be randomized in 2 groups : High Flow nasal cannula "HFNC" or standard High Flow face mask "HFFM".

Patients randomized in "HFNC" group will receive a four minutes preoxygenation period with Nasal High Flow Therapy (60 L/mn , fraction of inspired oxygen (FI02) = 100%) before orotracheal intubation under laryngoscopy after crash induction. After induction and during laryngoscopy, HFNC will be maintained in an attempt to achieve apneic oxygenation.

Patients randomized in "HFFM" group will received a four minutes preoxygenation period with standard face mask (15 L/mn) before orotracheal intubation under laryngoscopy after crash induction. After induction, HFFM will be removed, enabling laryngoscopic vision

Eligibility Criteria:
Inclusion Criteria:

* Adults older than 18 years regardless of the gender
* Requiring orotracheal intubation in intensive care unit
* "No severely hypoxemic respiratory failure" defined as Oxygen Pression (Pa02)/FI02 \> 200 mmHg measured in the 4 hours before inclusion

Exclusion Criteria:

* Not the first Intubation during this stay in intensive care unit
* Contraindication to oro-tracheal intubation
* Intubation without anaesthesic rapid sequence induction
* Intubation during cardiac arrest
* Real emergency (as asphyxia) with immediate intubation needed (without time enough for randomization)
* Nasopharyngeal obstacle with contraindication to use Optiflow device
* Patients with a documented Cormack IV exposition before inclusion
* Protected adult
* Pregnancy or breastfeeding
* Lack of consent
* Patient already enrolled in another study that could interfere with the primary objective of this study
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction

Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.


Eligibility Criteria:
Inclusion Criteria:

* acute myocardial infarction (5-31 days)
* fulfill requirement I and/or II :

  * I first ECG heart rate \>= 90 bpm (within day 1-2 post MI) and LVEF \<= 40 % (within day 5-31 post-MI)
  * II \>= 1 episode of non-sustained ventricular tachycardia \>= 150 bpm (on Holter, within 5-31 days post-MI)

Exclusion Criteria:

* Patients with ventricular arrhythmia, requiring clinical therapy, before the index infarction or more than 48 h later
* Patients with therapy refractory heart failure (NYHA IV)
* Myocardial infarction older than 31 days
* First-ECG not available or was recorded more than 48 h after the symptom onset.
* Patients with indication for CABG operation before inclusion
* Patients with cerebral organic psycho syndrome
* Secondary diseases which clearly limit life expectancy
* Patient with right sided artificial heart valve
* Patients with poor compliance
* Patients who are participating in another study
* Unstable clinical condition
* Pregnancy
* No consent from patient
A Study of Sensitizing Potential of Diacerein 1% Ointment in Healthy Subjects

Single center, randomized, controlled, evaluator blinded, within-subject study to evaluate the sensitization potential of diacerein 1% ointment under occlusive conditions on normal skin of healthy volunteer subjects.

The study was designed to assess the sensitization potential of diacerein 1% ointment in comparison to vehicle ointment and 0.9% saline (negative irritant control) under occlusive patch conditions, at 3 randomly assigned, adjacent skin sites, 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total) for determining sensitization potential.

Eligibility Criteria:
Key Inclusion Criteria:

* Is a healthy male or female (to be confirmed by medical history);
* Is 18 years of age or older;
* In the case of a female of childbearing potential, is using two acceptable forms of birth control;
* In the case of a female of childbearing potential, has a negative urine pregnancy test (UPT) on Day 1 prior to randomization and are willing to submit to a UPT at the end of study (EOS);
* Is free of any systemic or dermatological disorder, which, in the opinion of the Investigator, will interfere with the study results or increase the risk of AEs;
* Is of any Fitzpatrick Skin Type or race, providing the skin pigmentation will allow discernment of erythema

Key Exclusion Criteria:

* Has any visible skin disease at the application site which, in the opinion of the Investigator, will interfere with the evaluation of the test site reaction;
* Is using systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;
* Is not willing to refrain from using systemic/topical anti-inflammatory analgesics such as aspirin (occasional use of acetaminophen will be permitted);
* Is using medication which, in the opinion of the Investigator, will interfere with the study results;
* Is unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study;
* Has psoriasis and/or active atopic dermatitis/eczema;
* Has a known sensitivity or allergy to constituents of the materials being evaluated; including diacerein, mineral oil, petrolatum, cetyl alcohol, D\&C Yellow #10 and/or ethyl paraben;
* Has damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
* Has received treatment for any type of internal cancer within 5 years prior to study entry;
* Has any known sensitivity to adhesives; and/or
* Has received any investigational drug(s) within 4 weeks prior to study entry
Investigation of Short Course, High Dose Primaquine Treatment for Liver Stages of Plasmodium Vivax Infection

This study specifically seeks to provide data on the safety, tolerability and pilot efficacy of short course, high dose primaquine treatment in Papua New Guinean children aged 5-10 years, in a cross-sectional study design. Community screened asymptomatic cases and/or cases of clinically diagnosed malaria admitted to the out-patient units of the health center, will be screened for Glucose-6-phosphate dehydrogenase deficiency (G6PD) and malaria illness by rapid diagnostic test and P. vivax infection confirmed by light microscopy. Following treatment with artemether-lumefantrine (Coartem), G6PD normal children will be enrolled into the study and followed for 2 months. Primaquine treatment will be allocated to study participants in a step-wise design; firstly receiving the current 14 day treatment regimen of 0.5 mg/kg total dose (n=40); secondly, a 7 day treatment regimen receiving a total dose of 1.0 mg/kg/day; then thirdly, receive 1.0 mg/kg twice daily dose (bd) for a total of 3.5 days, should the 7 day treatment prove to be safe and well tolerated. In addition to this dose-escalation study, the pharmacokinetic profiles of single doses of 0.5 mg/kg and 1.0 mg/kg will be determined using an intensive sampling protocol, in children aged 5-10 years. The pharmacokinetic profiles obtained by this sub-study will be essential for modeling the population pharmacokinetic data obtained from the dose-escalation study. As there is currently no data on the safety, tolerability and efficacy of primaquine in children, the present study will validate previous observation and contribute to the knowledge of primaquine as a treatment for liver stages of Plasmodium vivax infection.


Eligibility Criteria:
Inclusion Criteria:

* Permanent resident in study area
* Absence of history of hypersensitivity reactions to pre-treatment drugs
* Positive for P. vivax infections on blood smear or PCR
* Normal G6PD enzyme activity

Exclusion Criteria:

* Features of severe malaria
* Clinical evidence of nonmalarial illness
* Severe malnutrition (weight for age nutritional Z score \<60th percentile)
* Moderate to severe anemia (Hb \<8g/dL)
* Permanent disability which prevents or impedes study participation
PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia

This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.

To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks

Eligibility Criteria:
Inclusion Criteria:

1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
3. subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.

Exclusion Criteria:

1. Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
2. Subjects who are alcoholomania or independent of drug, or have drug abuse history;
3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;

Other protocol-defined inclusion and exclusion criteria may apply.
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.

The purpose of this study was to evaluate the efficacity and the safety of bumetanide/S95008 in the improvement of Autism Spectrum Disorder core symptoms.

The present study (CL3-95008-002) was performed in children from 2 to less than 7 years old presenting with ASD. A 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg BID were assessed versus placebo. This double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg twice daily in which long term safety was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients from 2 to less than 7
* Primary diagnosis of ASD as per Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria
* Criteria met for ASD on Autism Diagnostic Observation Schedule-Generic (ADOS-2) and Autism Diagnosis Interview Revised (ADI-R)
* CGI (Clinical Global Impression) - Severity rating Score ≥ 4
* Childhood Autism Rating Scale second edition (CARS2-ST or HF) total raw score ≥ 34
* Social responsiveness Scale second edition (SRS-2) total score ≥ 66 T-Score
* Absence of diagnosis of Fragile X or Rett Syndrome
* Absence of any clinically significant abnormality likely to interfere with the conduct of the study according to the judgment of the investigator.

Exclusion Criteria:

* Patients not able to follow the study assessments defined by the protocol, with the exception of self-rating questionnaires which will be assessed by parent/legal representative/caregiver for those patients unable to complete them
* Patients having a high suicidal risk according to the investigator judgement
* Chronic renal dysfunction
* Chronic cardiac dysfunction
* Patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural therapy
* Severe electrolyte imbalance that is likely to interfere with the study conduct or evaluation
Addressing Social Determinants of Health Among Metro Detroit Cancer Survivors

The goal of this screening study is to determine the feasibility of completing a social needs screening tool in participants who have a past or current cancer diagnosis and reside in Metro Detroit, Michigan. Main questions to answer are:

* Can we have a completion rate of at least 80% of participants filling out the screening tool?
* Can we determine procedures for patient referrals based on social needs
* Can we implement brief interventions based on food access and digital inclusion (ensuring everyone has access to the digital technologies they need to participate in society)

In part 1 of the study, Participants will be administered a social screening tool either in person or via telephone. Responses to the screening tool will be translated into diagnosis codes which identify non-medical factors that may influence a patient's health status. In part 2 of the study, participants will be referred to community-based resources based on their responses to the social needs screening tool. Follow up will be made via telephone call at 2, 4, 6 and 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* past or current cancer diagnosis
* reside in metropolitan Detroit (Wayne, Oakland, Macomb counties)
* English proficient
* Actively receiving care through one of Karmano's Cancer Institute's outpatient clinics OR post treatment survivors in the Detroit Research on Cancer Survivors (ROCS) longitudinal cohort study who have reported past food insecurity and agreed to be contacted for further research

Exclusion Criteria:

* none
Maintenance Electroconvulsive Therapy (ECT) Versus Aripiprazole in Clozapine-resistant Schizophrenia

The pharmacological treatment options in schizophrenia developing resistance to clozapine are limited. Few studies have found ECT as beneficial in TRS, including CRS. However, literature on the role of M-ECT in maintaining the therapeutic gains of acute ECT in CRS is lacking. The objective of the study is to compare the efficacy of M-ECT vs aripiprazole as an add-on to ongoing clozapine on the severity of symptom dimensions, cerebral perfusion, global functioning and cognitions in patients with CRS.


Eligibility Criteria:
Inclusion Criteria:

1. Patients clinically diagnosed with CRS (currently under clozapine)
2. Patients aged 18-60 years of either sex.
3. LAR giving voluntary written consent for participation in the study

Exclusion Criteria:

1. Patient already on ECT or aripiprazole.
2. History of psychoactive substance abuse or dependence.
3. Co-morbid psychiatric, major medical or neurological disorders.
4. History of organicity or significant head injury.
5. Pacemaker or metal in any body part, excluding the mouth. Pregnant and breastfeeding females.
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)

Hepatitis B Vaccine \[Recombinant\] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: \[1\] induce protection against the morbidity and mortality of acute hepatitis B virus infection, \[2\] reduce the incidence of chronic infection in vaccinated populations, and \[3\] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine \[Recombinant\] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine \[Recombinant\] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age)
* Born to mothers with documented negative test for HBsAg within 9 months prior to delivery

Exclusion Criteria:

* Infant born to mother with no prenatal care
* Known or suspected impairment of immunologic function
* Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.)
* Recent(\<72 hours) history of febrile illness \>/= 99.5 degrees F (\>/= 37.5 degrees C) axillary or \>/= 100.5 degrees F (\>/= 38.1 degrees C) rectal
* Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant
* Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study
* Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast)
* Any infant who cannot be adequately followed for study visits during the course of the clinical study
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Effect of Nutrition Education on Energy Availability, Body Composition, Eating Attitude and Sports Nutrition Knowledge

This study investigates the effects of a series of nutrition education sessions conducted by a registered dietitian on energy availability, various anthropometric measurements, eating attitudes, and sports nutrition knowledge in young female endurance athletes aged 15-18 years (football, basketball, volleyball) who engage in training for more than 10 hours per week (n=83).

Participants were randomly divided into two groups with 45 individuals receiving six physical nutrition education lectures, and the remaining 38 participants receiving no nutrition education. Participants completed the The low energy availability in females questionnaire (LEAF-Q), Eating Attitude Test (EAT-26) and Sports Nutrition Knowledge Questionnaire (SNKQ). Energy and nutrient intakes were evaluated thorough 3-day food records, while exercise energy expenditure was assessed using 3-day activity logs. All of the questionnaires were repeated after a 6-months period.

At baseline, the prevalence of LEA among athletes was determined to be 63.8%. In the intervention group, energy availability (EA) and SNKQ scores increased, and LEAF-Q scores decreased significantly (p \< 0.05). However, there was no significant change in EAT-26 scores between the two groups. Energy intake, weight, fat free mass and resting metabolic rate has been increased significantly in the intervention group (p \< 0,05). These findings suggest that nutrition education proves beneficial in enhancing dietary intake, positively influencing body composition and improving nutrition knowledge, ultimately contributing to increased energy availability in female athletes over the short term.

Eligibility Criteria:
Inclusion Criteria:

Non-contraceptive using Competitive female endurance athletes 14-18 years of age training minimum 6 hours a week not taking a break from sports for more than 3 months due to injury

Exclusion Criteria:

Pregnancy or planned pregnancy chronic diseases (e.g. diabetes, crohn's disease, thyroid dysfunction) Use of any medication that may disturb hormonal balance
Safety and Blood Level Study of Unit Dose Budesonide

The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers, aged 18-50 years
* BMI less than 30 kg/m2
* Non smoker (currently and \<10 pack years total if ex-smoker)

Exclusion Criteria:

* Any use of corticosteroid in previous 4 weeks
* Pregnancy/lactation
* Significant blood donation (or testing) in previous 8 weeks