cyrilzakka/clinical-trials huggingface dataset:
Use of Phenylbutyrate Therapy for Patients With Pyruvate Dehydrogenase Complex Deficiency.

In this study phenylbutyrate is used for patients with pyruvate dehydrogenase complex deficiency. The aim of the study is to investigate the safety and efficacy of therapy.

The Investigator will evaluate the safety and efficacy of a 4-weeks treatment with sodium phenylbutyrate in patients with pyruvate dehydrogenase complex deficiency. Efficacy will be evaluated based on biochemical endpoints (blood lactate and pyruvate).

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be older than 3 months old and younger than 18 years old.
2. Clinical diagnosis of PDC deficiency confirmed by DNA testing showing a missense mutation in the PDHA1 gene.
3. Lactate concentration ≥ 2.5 mmol/l or ≥ 2 mmol/l, respectively in venous or arterial blood samples.
4. Provision of signed and dated informed consent form by the parents/legal guardians of the patient
5. Negative pregnancy test for women of childbearing potential, and agree to use effective form of contraception until 6 weeks post treatment.

Exclusion Criteria:

1. Frameshift or nonsense mutations of the PDHA1 gene.
2. Defects affecting any gene encoding PDC subunits other than PDHA1
3. Secondary forms of lactic acidosis (e.g. impaired oxygenation or circulation).
4. Tracheostomy or requirement for artificial ventilation.
5. Hyperlactatemia or organic acidosis associated with other metabolic disorders (e.g. biotinidase deficiency, primary disorders of gluconeogenesis, organic acidurias, primary defects of fatty acids oxidation)
6. Evidence of hepatic insufficiency, renal insufficiency, edema with sodium retention, cardiac arrhythmia, congenital heart defects, hypertension, blood dyscrasia, symptomatic pancreatitis, or inflammatory bowel disease.
7. Any clinical condition or medications known to significantly affect renal clearance.
8. Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study.
9. Known allergic reactions to components of the study agent.
10. Treatment with another investigational drug or other intervention (including DCA) or participation in a clinical study with an investigational drug within 6 months prior to enrolment.
11. Pregnancy or lactation.
Regulatory Nebilet PMS

An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information

An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Nebivolol administered in Korean patients according to the prescribing information

Nebivolol will be administered to Hypertension or Chronic heart failure (CHF) patients as described the prescribing information of Nebivolol by physician's decision.

Eligibility Criteria:
All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:

* Subjects with indication in the prescribing information
* Subjects administrated Nebivolol by physician's decision
* Subjects with no contraindication according to the prescribing information
A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects

This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2

Exclusion Criteria:

* Subjects with evidence or history of clinically significant urologic diseases
* A positive urine drug screen
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method
Measuring Smoking Behaviors While Using Varenicline

This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. The primary hypothesis for the study is to observe decreases in smoking topography, an objective measure of smoking behavior or puffing, on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We will also examine puffing and nicotine cigarette choices during lab visits at baseline, and Days 7 and 21. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus potentially increasing the efficacy of varenicline.

Eligibility Criteria:
Inclusion Criteria:

* self report minimum 10 daily cigarettes
* self report smoking every day past 5 years
* between the ages 21-65
* self report intention to try to quit smoking in the next 6 months

Exclusion Criteria:

* self reported use of any nicotine-containing products other than non-menthol cigarettes
* self reported history or current treatment of substance abuse (other than nicotine dependence)
* self reported alcohol use greater than 25 standard drinks per week;
* currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
* self reported history or current diagnosis of any Axis 1 disorders except past depression
* self reported serious or unstable disease within past year
* self reported history of epilepsy or seizure disorder;
* self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
* self reported kidney function impairment
* any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
* less than 5 years of daily smoking
* any medical condition or concomitant medication that could compromise participant safety or treatment
* provide a baseline carbon monoxide (CO) reading \< 10 ppm
* self reported use of non filtered cigarettes
* inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician
Vasospasm in Pediatric Traumatic Brain Injury

The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic brain injury (TBI) patients who have experienced a mild to severe head injury.


Eligibility Criteria:
Inclusion Criteria:

1. admission to Duke University Children's Hospital;
2. age 5 days to 15 years;
3. a diagnosis of a TBI with a GCS 3-15;
4. capable of adequate TCD ultrasound examination;
5. and presence of intravenous or arterial access (blood) and/or an EVD for cerebrospinal fluid (CSF) and/or Foley catheter/ability to void unassisted (urine) biomarker collection unless they are excluded based on the exclusion criteria.

Exclusion Criteria:

* the presence of previously diagnosed significant neurodevelopmental delay,
* a diagnosis of non-traumatic intracranial hemorrhage and
* parents/legal guardians who do not speak or understand English.
Evaluating the Efficacy of the Management of an Online Program of Cognitive Behavioral Therapy for Primary Insomnia

The purpose of this study is to evaluate the effectiveness of the management of chronic primary insomnia patients by a computer program guidance of behavioral and cognitive therapies for insomnia (BCT-I).

Chronic insomnia is a common sleep disorder (prevalence = 10%) and a risk identified on the physical and mental health. Currently, the treatment involves the prescription of drug treatments by general practitioners, which may be unsuitable for the medium term. It is better to turn to Behavioral and Cognitive Therapies for Insomnia (BCT-I) in the case of primary chronic insomnia. The objective of this study is to evaluate the effectiveness of a computer program guidance BCT-I in patients with chronic primary insomnia. This biomedical research psychotherapeutic assessment will be randomized, controlled versus psychoeducation and conducted in 46 patients with chronic primary insomnia (defined according to Diagnostic and Statistical Manual-5) for which a supported by BCT-I is indicated.

The 46 patients will be randomized into two groups. The subjects in Group 1 will be supported by BCT-I online. And the subjects in group 2 will receive psychoeducation. All patients will be followed by the research team for three months, during which 3 visits (V0 = pre-selection; V1 = visit of randomization and start of the program; V2 = 3 months follow-up visit and end of the study) will be performed in the University Hospital Sleep Disorder Unit of Montpellier. Patients in Group 1 will conduct BCT-I online at home therapy. Patients in group 2 will receive a structured 45-minute session information insomnia (psychoeducation = work performed daily by clinicians in charge of insomnia problems) to the visit 1. All patients in the study will be equipped 2 sensors for the registration of sleep data.

The primary endpoint will be based on the severity of insomnia measured by the ISI after the last online psychotherapy session (3 months) between the 2 groups of patients (BCT-I online and without treatment - psychoeducation ). The analyse efficacity to be conducted by intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 65
* disorder diagnosis of chronic insomnia (according to Diagnostic and Statistical Manual-5)
* sleep efficiency \<80%
* Index severe insomnia: ISI\> 14/28
* have a computer at home
* Practicing internet regularly in everyday life
* have a personal email address

Exclusion Criteria:

* Clinically suffer from insomnia comorbid linked to other sleep disorders
* Presenting an unbalanced psychiatric disorder
* Have Score Beck Depression Inventory (BDI-II) \>29
* Have neurological disorders
* Have severe medical conditions that can affect the quality of sleep
* Have Hypnotic, Anxiolytic, antidepressants Treatment \> 2
* Have antipsychotics, opioids, anticonvulsants, anti-parkinson treatment
* Having a disorder of substance use (alcohol, drugs) in the last 6 months
* Having undertaken a meridian trance journey (± 3H) in the preceding month or during the study period
* Already be treated with CBT-I
The Effect of Haptonomy Applied to Pregnant Women

Introduction: Stress experienced during pregnancy can increase fear of childbirth, cause negative perinatal outcomes, and adversely affect the maternal-infant attachment process. This study was conducted to determine the effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment.

Methods: The population of the randomized controlled experimental study consisted of 72 primiparous pregnant women within the gestational weeks 22-28 who presented to the Obstetrics and Gynecology Polyclinic of a state hospital in Turkey for check-up (36 experimental subjects, 36 control subjects).

Background: Stress experienced during pregnancy can increase fear of childbirth, cause negative perinatal outcomes, and adversely affect the maternal-infant attachment process.

Aim: This study was conducted to determine the effect of haptonomy applied to pregnant women on perceived stress, fear of childbirth, and prenatal attachment.

Methods: The population of the randomized controlled experimental study consisted of 72 primiparous pregnant women within the gestational weeks 22-28 who presented to the Obstetrics and Gynecology Polyclinic of a state hospital in Turkey for check-up (36 experimental subjects, 36 control subjects). A home visit was made to the experimental group, and haptonomy was applied for at least 30 minutes, once a week, for 7 weeks (with the researcher for 3 weeks, with the husband by providing the training brochure and video that will help the practice for the next 4 weeks). The control group did not receive any treatment. Data were collected at the first, third, and seventh weeks using the Pregnancy Description form, the Perceived Stress Scale (PSS), the Wijma Delivery Expectancy/Experience Questionnaire version A (W-DEQ-A), and the Prenatal Attachment Inventory (PAI). Number and percentage distribution, chi-square test, t test, Mann-Whitney U test, repeated measures, two-way analysis of variance, Friedman test, and Cohen d test were used in the evaluation of the data.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous pregnant women who were married,
* aged 18 years and over,
* literate,
* living in the city center,
* not having any health problems in themselves and their infants,
* with spontaneous pregnancy at 22-28 weeks of gestation,
* without perception and communication problems,
* and who agreed to participate in the study were included in the study.

Exclusion Criteria:

• Multiparity
PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

The purpose of the study is to evaluate the safety and effectiveness of the PULSTA Transcatheter Pulmonary Valve (TPV) System for the treatment of congenital or acquired pulmonary valve stenosis and/or regurgitation who require pulmonary valve replacement.

The PULSTA TPV is a self-expandable valve with flared-ends to adapt to the larger native right ventricular outflow tract (RVOT) and is using a relatively low profile delivery catheter from knitted nitinol wire backbone and trileaflets made from treated porcine pericardial tissue, and a delivery system, which provides access to the right ventricular outflow tract through blood vessels. Consecutive subject data should be collected at discharge, 1, 6 months, and 1-5 years post PULSTA TPV implantation.

Eligibility Criteria:
Inclusion Criteria:

* Body weight greater than or equal to 30 kilograms
* Pulmonary regurgitation moderate or severe pulmonary regurgitation or pulmonary valve stenosis with mean gradient \>35mmHg by echocardiography
* Main pulmonary artery trunk of ≥16 mm and ≤30 mm
* Patients willing to provide written informed consent and comply with follow-up evaluations.

Exclusion Criteria:

* Females of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant up until 6 months after TPV implantation
* Pre-existing mechanical valve in pulmonary position or require concomitant repair of other cardiac valves
* Obstruction of the central veins to be approached for the TPV implantation
* Coronary artery compression confirmed by angiography
* A known severe allergy to Nickel
* A known hypersensitivity to any anticoagulation therapy, contrast agent or a hemorrhagic disease
* Suspected active infectious disease (e.g. endocarditis, meningitis)
* Life expectancy of less than 6 months
Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate

This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.


Eligibility Criteria:
Inclusion Criteria:

* Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation
* Women ages 18 and older

Exclusion Criteria:

* Planned vaginal breech delivery
* Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
* Fetal death in utero
* Red cell isoimmunization
* Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
* Placenta previa or other known abnormal placentation (e.g. placenta accreta)
Mitigating Hunger and Food Insecurity Among Socioeconomically Disadvantaged Caregivers of Hospitalized Children

The Feed1st proposed program of research will promote health of informal caregivers with a hospitalized child by testing a self-management intervention that addresses the widely overlooked problem of caregiver hunger. As many as 54% of parents and other informal caregivers of hospitalized children struggle with insufficient food to nourish themselves and their family during and after a hospital stay. Hunger impairs caregiver physical and mental health by depleting energy for self-care, emotional self-regulation, and supportive interactions with the child, the family, and the formal caregiver team. The long-term objective of the Feed1st program is to alleviate hunger and food insecurity among families with hospitalized children. Established in partnership with nursing and chaplaincy leadership at our children's hospital and the Greater Chicago Food Depository, the Feed1st program currently operates self-serve food pantries on four inpatient units and the emergency department in our children's hospital on Chicago's South Side. Since 2010, Feed1st has provided nearly 8500 pounds of food to at least 4,000 individuals and 1500 households via the self-serve food pantries in the children's hospital. Over this same period, our team has also created a system for efficiently connecting families to community-based resources for hunger and other basic needs.


Eligibility Criteria:
Inclusion Criteria:

- 18 years of age or older and English speaking, the primary caregiver to a dependent child younger than age 18, have been screened for household food insecurity, reside in the 16 zip code primary service area geography,

Exclusion Criteria:

* Caregivers of children in the neonatal intensive care unit (NICU) will be excluded to minimize infectious risk to critically ill newborns and their caregivers.
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation

This study aims to evaluate possible predictors for the successful od external cephalic version (ECV), a procedure that is indicated in your case due to breech presentation of your baby and your desire to avoid cesarean section. Before the procedure, a detailed ultrasound scan will be performed to measure several parameters. After the procedure we will collect data about the duration, outcome and eventual complications of ECV.

Pregnant women with a diagnosis of fetal breech presentation, desirous of an attempt of ECV after counseling and written consent and hospitalized for the procedure will be consecutively enrolled. The following anonymous data will be recorded:

* Demographic and anthropometric data (i.e., age (y), ethnicity, height (m), weight (kg), BMI);
* Parity
* Gestational Age (weeks + days)

Before ECV attempt, the following evaluations will be performed:

* Vaginal examination to evaluate the cervical dilatation and the level of presenting part (floating or not floating)
* Fetal transvaginal ultrasound reporting:

  * biometry (BPD, HC, AC, FL, EFW);
  * Occiput position (right, left);
  * Back position (anterior, posterior, right, left);
  * Breech variant (footling, frank, complete);
  * Fetal leg posture (extended, flexed)
  * Placental localization;
  * Amniotic Fluid Index (AFI);
  * Fore-bag of amniotic fluid;
  * Eventual presence of nuchal cords;
  * Fetal head ballottement (yes, no);
  * Occiput-spine angle (see Figure 1)

Then, all the participants will undergo a transabdominal ultrasound-guided ECV in a semi-sitting position by the same expert operator (B.C.). After the procedure, the following data will be collected:

* Success (yes, no)
* Duration of the procedure (min);
* Direction of fetal flip in case of success (frontside flip, backside flip)
* Pain perception in Numerical Rating Scale (NRS) (1-10);
* Reason for terminating the procedure (success, failure, pain, uterine contractions, non-reassuring fetal conditions)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 y.o.;
* Pregnant women with a diagnosis of fetal breech presentation eligible and desirous for ECV;
* Singleton;
* At term (≥ 37 weeks);
* Breech presentation;
* No previous uterine scars or other indications for elective C-section;
* Signed written informed consent to study participation.

Exclusion Criteria:

* Age \&lt;18 y.o.;
* Preterm gestational age;
* Multiple pregnancies;
* Indications for elective cesarean section;
* Incomplete obstetrical data;
* Refusal to provide informed consent.
* Desire to an elective C-Section
* Controindications for ECV or vaginal delivery (placental abruption, placenta previa, uterine malformations)
* Reduction of amniotic fluid (AFI \&lt;4 cm)
* Uterine contractions
* Vaginal bleeding
* Premature rupture of membranes
* Nonreassuring fetal heart rate patterns before the procedure.
Enhancing the Efficiency of EMLA Cream in Palatal Anesthesia for Children

The aim of this study is to Avoid traditional palatal local injections when extracting upper primary teeth through enhancing the efficiency of EMLA cream by using drug delivery systems (permeability enhancer (DMSO), oral patches and micro-needle patches) for palatine injection.

Group 1: Conventional local palatine injection (control group). Group 2: EMLA cream only. Group 3 :chemical permeability enhancer DMSO with EMLA cream. Group 4: Oral patches with EMLA Cream. Group 5: Micro-needle patches dissolved with EMLA Cream.

The insertion of the needle and the infusion of the anesthetic solution into the palate often uncomfortable for the children and their acceptance of dental treatment. Therefore, there is a need for studies to find ways to replace the palatine injection in the modern dentistry.

Effectiveness of Compound surfactant drugs (EMLA) have strong activity on the palatine tissues. Therefore, it will be chosen as an alternative to the traditional ones and will be enhanced by one of the drug delivery systems (physical/chemical).

Decreased permeability of the palatine mucosa is a major reason behind using drug delivery systems to reach an effective therapeutic level.

To our knowledge, this research will be the first which will be used a method of drug delivery systems to replace traditional palatal needle.

Eligibility Criteria:
Inclusion Criteria:

* no previous dental experience.
* Healthy children.
* Definitely positive or positive ratings of Frank scale
* Child did not receive any sedative or pain drugs during the last three.
* Presence of upper primary teeth, an indication for extraction

Exclusion Criteria:

* Presence of general diseases or health problems.
* Uncooperative children
* Children with congenital or idiopathic Methemoglobin
* Teeth with severe abscesses
The Relation Between MiR-125b-5p and Staging of Endometriosis

78 endometriosis patients presented with infertility were clinically examined and the diagnosis was assured by US imaging. The study also included 11 control fertile women free of gynecological problems as a control for lab tests. Patients and controls gave blood samples for lab investigations. All patients underwent diagnostic abdominal laparoscopy under general anesthesia for disease staging. Quantitative determination of expression levels of genes of microRNA-125b-5p and 203a was conducted using qRT-PCR.


Eligibility Criteria:
Inclusion Criteria:

* Patients who presented clinical pictures suggestive of EM disease

Exclusion Criteria:

* Patients with previous pelvic or abdominal surgery that may hinder the laparoscopic examination,
* patients who were suspicious of having malignancy elsewhere in the body region,
* pregnant women,
* patients who had diabetes mellitus,
* body mass index (BMI) of \>30 kg/m2, coagulopathies, and autoimmune disorders.