cyrilzakka/clinical-trials huggingface dataset:
Rubinstein-Taybi Syndrome: Functional Imaging and Therapeutic Trial

An exploratory phase 2 therapeutic trial in children from 6 to 21, RTS carriers, randomized to be treated either with sodium valproate with the usual pediatric dosage (30 mg/kg/j), or by placebo for one year.

The investigator would like to include children because they could best profit from it due to their neuronal plasticity as CBP and EP300 take effect through neuronal and synaptic plasticity.

The therapeutic effect of sodium valproate in RTS patients will be assessed thanks to a clinical approach (learning and memory neuropsychological evaluation, fine motor skills assessment by pointing), to a biological approach (histone acetylation functional tests), and to imaging (morphological and functional MRI).

Such a multidisciplinary approach has never been presented for this syndrome; it should enable us identifying specific cognitive and motor deficits and their association thanks to imaging markers. Assessing the various aspects of motor skills, i.e. primary (movements, standing at ease position, immobility) and complex motor skills (actions and behaviours, motor aspects of feelings and language expressions) is an integral part of the clinical examination in psychiatrics.

The main interest of a functional capacity analysis is to be used as an index allowing the assessment of the nervous system's global capacities and the study of the connections between cognitive functions and motor skills Main objective: Evaluate long term memory with subtest "point location" - CMS and "image recognition" RBMT A patient is said to be responder if after one year his or her test result increase for one point at least one of the two tests : a increase of one point to "point location" or "image recognition".

Double-blind phase 2 clinical trial, designed as a one-step Fleming design but with a control group. Rubival is a two-parallel group randomized trial:

* a placebo group of 20 patients
* a group of 40 patients taking sodium valproate (HDAC inhibitor) with an oral dosage of 30 mg/kg/jour

Eligibility Criteria:
Inclusion Criteria:

* Children over 6 and under 21
* RTS confirmed by a genetic study with a CBP gene or EP300 gene mutation
* Sufficient cognitive capacities for neuropsychological evaluation
* Free and informed consent of the parents or guardians
* Children affiliated to or benefiting of the French social welfare system

Exclusion Criteria:

* Contraindication to sodium valproate
* Women of reproductive age without effective contraception means
* Case history of sodium valproate treatment
* Monotherapy treatment for epilepsy with Lamictal with a dosage superior to 5 mg/kg/j
* Family history of severe hepatitis including drug
* Acute or chronic hepatitis
* Pregnancy
Registry to Evaluate Chinese Real-World Clinical Outcomes in Patients With AF Using the WATCHMAN Left Atrial Appendage Closure Technology

The aim of the registry is to evaluate Chinese real-World clinical outcomes in patients With AF using the WATCHMAN left Atrial appendage closure technology


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years of age or above;
2. Patient is eligible for a WATCHMAN device according to current international and local guide-lines and per physician discretion;
3. Patient is willing and capable of providing informed consent to participate in all procedures associated with receiving a WATCHMAN device at an approved clinical investigational center.

Exclusion Criteria:

1. Patient is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments.
2. Patient is a woman of childbearing potential who is, or plans on becoming, pregnant during the duration of follow-up assessments required as part of the WATCHMAN procedure.
3. Patient is unable or not willing to complete follow-up visits and examination as required as part of the WATCHMAN procedure.
Clarithromycin is an Adjunct to Scaling and Root Planing

The present study was done to evaluate the effect of clarithromycin as an adjunct to scaling and root planning at baseline, three months and six months intervals . Clinical, microbiological and immunological parameters were taken. Clinical parameters include gingival index , probing depth and clinical attachment level. In the present study, improved clinical and microbiological outcomes were attained using adjunctive clarithromycin, including GI, PD reduction, CAL gain and reductions in the frequency of detection of C-reactive protein, Pg, Aa. These results together with the recommended easy dosage and limited side effects make the use of this antibiotic in the treatment of periodontitis patients but only for a shorter period of time.

Background \& Objectives: Along with conventional non-surgical periodontal therapy (NSPT) systemic antimicrobials may provide more effective treatment for chronic periodontitis by targeting tissue-invasive bacteria. The aim of this study was to evaluate the adjunctive effects of oral clarithromycin (CLM) to nonsurgical periodontal therapy for chronic periodontitis.

Materials and Methods: 30 patients were categorized into two groups: test group - Base line scaling and root planing(SRP) was done. Clarithromycin tablet 500 mg( Clarino-500) was given for a period of 7 days orally two times per day. control group -only SRP done . Clinical parameters were recorded at baseline , 3 months, and six months interval .They included gingival index (GI), probing depth (PD), and clinical attachment level (CAL). Also microbial analysis of subgingival plaque samples was done at baseline, 3months and six months interval to estimate the levels of Pg and Aa bacteria using culture methods. Immunological parameter like estimation of C-Reactive protein was done in both groups at baseline 3 months and 6 months period. tests were used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients age ranged between 30- 50 years with chronic periodontitis
* Patients with Probing Depth (PD)- \>5mm, Clinical Attachment Level( CAL)- \>3mm
* Systemically healthy individuals

Exclusion Criteria:

* Patients below the age of 30 years
* Patients who have undergone periodontal therapy 3 months prior to study
* Active /passive smokers
* Any antibiotic use 3 months prior to study
* Pregnant women and lactating mothers
* Un co- operative/ retarded patients
* Drug allergy/ other allergies
* Any systemic diseases
Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)

The purpose of this study is to test the effectiveness of a community health worker intervention to expand access to hearing health care among older adults facing health disparities.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age: 50 years
* Audiometrically-confirmed hearing loss
* Availability of a communication partner to attend the program with the participant
* Be Spanish speaking and able to sign written informed consent

Exclusion Criteria:

* Cognitive impairment
Morbidity, Mortality and Gender Differences in Patients With Pacemakers

Previous publications suggest gender difference in outcome parameters after pacemaker implantation. Aim of this study is to investigate gender differences in patients with pacemaker. Implanted devices, indication for implantation and pacemaker follow up data of patients will be included. Survival data including cause of death will be documented. Prevalent comorbidities and relevant laboratory data will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* All patients registered in the pacemaker database of the Department of Cardiology at the Medical University Vienna. Patients get registered when clinical follow up of an implanted Pacemaker is done.

Exclusion Criteria:

* For survival analysis: No valid match of first name AND surname AND date of birth with patients' insurance data.
* For analysis of comorbidities: Not a single documented diagnose was found in our electronic clinic-wide patients' information system.
EffIcacy Between Arthrocentesis With High Versus Low Molecular Weight Hyaluronic Acid in Treatment of TMJ Disorders

The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.

The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.

, 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.

3-The presence of absence of clicking and cracking in jaw .

Eligibility Criteria:
Inclusion Criteria:

* Pain or tenderness of the jaw
* Pain in one or both of the temporomandibular joints
* Aching pain in and around your ear
* Difficulty chewing or pain while chewing
* Aching facial pain
* Locking of the joint,

Exclusion Criteria:

* Muscular TMJ disorders
* Bleeding tendency
Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit protheses and mobilise. Current treatment options are limited and existing painkillers have significant side effects. Nevertheless there is some evidence that pre-emptive analgesia (pain relief provided prior to the surgery) has additional benefits after the surgery (Ypsilantis \& Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is applied directly onto the skin. It works by desensitising to pain receptors in the skin (Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot, randomised controlled study of 30 patients undergoing lower limb amputation who will have Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks post-operatively with regular assessment of pain scores, quality of life and wound healing.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients \>18 years old undergoing lower limb amputation

Exclusion Criteria:

Traumatic amputation Severe active sepsis in non-viable limb Illness necessitating urgent surgery \<24 hours after admission to hospital Hypersensitivity to Qutenza, Emla or any of the excipients Broken skin or active ulceration at the site of application Severe uncontrolled hypertension (systolic BP \>200) Proven cardiac event during the preceding 3 months Women who are pregnant or breast feeding Lack of capacity or inability to provide informed consent Declines participation in the study
Does B Vitamin Supplementation Decrease Homocysteine Concentrations in Newborns

The purpose of this study is to determine whether supplementation with folinic acid, a B vitamin, lowers the concentrations of total homocysteine in newborns. Increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. These increased concentrations can easily and safely be lowered by folic acid in adults.

The incidence of cerebrovascular accidents (CVA) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear. Elevated homocysteine concentrations are shown to be associated with an increased risk for CVA in newborns. We want to study the possible homocysteine lowering effect of folinic acid in newborns.

We will include newborns in our prospective randomized folinic acid intervention study from patients admitted to our Neonatal Intensive Care Unit. We will measure total homocysteine (tHcy) and folate concentrations at three time points. The intervention group will be treated with folinic acid (70 µg/kg/day) for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* admitted at our NICU

Exclusion Criteria:

* midline defects
* Extracorporeal membrane oxygenation (ECMO) treatment
* blood transfusion
* overt renal failure
Diagnostic Precision Study on Vibration Induced Nystagmus Test for SCDS by Ortofone B250 Skull Vibration Protocol

to study the videonystagmography response to a bone conducted vibration on the mastoid by B250 bone transducer in patients affected by vestibular loss, Menieres disease and Superior Semicircular Canal Dehiscence Syndrome vs healthy control subjects


Eligibility Criteria:
Inclusion Criteria:

Patients affected by certain vestibular disorders.

Exclusion Criteria:

Patients with vertigo and dizziness without certain diagnosis.
Influence of Hormone Therapy on Heart Attack Incidence in Men Undergoing Prostate Brachytherapy

The purpose of this study is to review cause of death in patients undergoing prostate brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing androgen deprivation therapy and whether or not this contributed to cardiovascular deaths, specifically myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Deceased anytime after prostate brachytherapy treatment

Exclusion Criteria:

* Patients whose cause of death was unable to be determined
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance

The present pilot study is aimed to obtain preliminary data on the effect of three ascending oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance. In addition, the assessment of drug exposure (PK assessment) will provide additional information on the dose-effect relationship, thus supporting the dose selection and dosing schedule in the future studies.

Feeding intolerance is a transient neuro-developmental phenomenon affecting 25% to 40% of infant and toddler, with a peak at 6 weeks of age. Feeding problems include mainly vomiting, slow feeding, refusal to eat and colic.

Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs and antiacids) are largely unsatisfactory.

Nepadutant is postulated to have a therapeutic effect in infant colic since it reverts exaggerated intestinal motility and sensitivity induced by different stimuli through the activation of neurokinin-2 receptors, without interferring on the on physiological gastrointestinal transit.

This phase IIa study is designed to test in each participant infant two out of three oral doses of nepadutant in order to measure its blood levels, safety and efficacy with each dose level to be given for 7 concecutive days.

The experimental clinical phase encompasses the following periods:

* Screening period (no study medication), lasting approximately 7 days prior to randomization
* Treatment period, lasting fourteen days (7 days fore each dose)with once daily administration
* A safety follow-up visit, approximately four weeks after start of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Infants with a clinical diagnosis of feeding intolerance.
* Age ≤ 6 months at the enrolment.
* Normal growth.
* Infants who can refrain from use of erythromycin, metoclopramide, antihistaminic drug, proton pump inhibitors (PPIs), antacids, antimuscarinic drugs, simethicone and dimethicone from 1 week prior randomization until end of study.

Exclusion Criteria:

* Any clinically relevant event (excluding those relevant to the condition under study) which has occurred within one week prior to randomization.
* Any pharmacological treatment starting within one week prior to randomization.
* Infants for whom a change in the diet (i.e. weaning) has been performed within one week prior to randomization or is planned during the study period.
The Cold Fluids Study

In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion criteria is; Pre-existing medical problems, Pregnancy (validated through a certified pregnancy test), Body mass index \>35 kg/m2, Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.

Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Primary outcome is

* The increase in MAP at 15 minutes after infusion of the fluid bolus. Secondary outcome is
* Time until return of MAP to baseline value after infusion.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-64

Exclusion Criteria:

* Pre-existing medical problems
* Pregnancy (validated through a certified pregnancy test)
* Body mass index \>35 kg/m2
* Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
Generalist Cohort of Migrant Patients Consultants in City Medicine

This innovative cross-sectional study, carried out in the city, will provide valuable prospective data that will make it possible to identify public health avenues for specific and adapted care both in the medical and social field of newcomers to our territory. Our study will characterize the impact of reforms of the conditions of access to State medical aid and universal health protection on access to care and the state of health of this population. . It will make it possible to participate in the advocacy in favor of access to healthcare for all and the city PASS, the only device allowing access to healthcare in the city for all newcomers regardless of their status.

Participants will be informed orally and via an information note written by the doctor during their first medical contact in France or during a follow-up visit within the municipal health center.

The health data comes from the participant's care file and some social data is extracted from the social information system, already existing and used by the reception agents responsible for the consultations. access to rights.

Inclusion visit :

This visit will take place during the first medical visit of eligible patients.

During this visit, the investigative team:

* Checks the inclusion and non-inclusion criteria;
* Gives clear oral and written information;
* Collect the patient's non-opposition;
* Performs the medico-social consultation in accordance with the management recommendations.

Follow-up visits Follow-up will be continued 12 months after the inclusion visit. The rhythm, as well as the nature of the follow-up visits for the patients included, will be defined by the information obtained during the inclusion visit, and will be determined by the doctor in charge of the patient.

For patients included retrospectively The inclusion visit will take place during a follow-up medico-social visit planned as part of the care in one of the participating the municipal health center.

During this visit, the investigative team:

* Checks the inclusion and non-inclusion criteria;
* Gives clear oral and written information;
* Collect the patient's non-opposition;
* Performs the medico-social consultation in accordance with the management recommendations

During the inclusion visit and medical follow-up visits, within the Municipal Health Centers, a consultation on access to rights will also be carried out in order to help patients put together their social file.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥ 18 years)
* Newly arrived migrants (foreigners born outside France, first arrival in France AND presence in the territory ≤ 1 year)
* 1st medical contact in town medicine in France

Exclusion Criteria:

* Refusal of participation
* Communication impossible due to the language barrier despite translation or interpreting (telephone or face-to-face)
Thyroid Function in Sick and Healthy Preterm Infants Admitted in NICU of Assiut University Children Hospital

Thyroid hormones are the cornerstones of a complex system that plays an important role in the growth and development of children, especially in the development of the nervous system and brain. Therefore, even minimal disruptions of this system can cause permanent damage.

Thyroid dysfunction is a common problem in pre-term infants. Hypothyroxinemia of prematurity within the first month of life may represent important prognostic information about morbidity and mortality. Thyroid hormone synthesis may be disrupted in co-morbid conditions . worsening the metabolism of premature infants and causing higher hormone levels compared to healthy infants.

The most common thyroid function disorder in premature infants is physiological hypothyroxinemia, followed by hypothyroidism of non-thyroidal causes. In pre-maturity, several factors can inhibit the conversion of peripheral T4 to T3, including hypoxemia, acidosis, infections, hypoglycemia, hypocalcemia and malnutrition . Some rare conditions include transient secondary/tertiary hypothyroidism, transient primary hypothyroidism and permanent primary hypothyroidism.

Thyroid dysfunction has been reported to be more common in infants with low birth weight due to inadequate intrauterine nutrition, hypoxia, and acidosis.In addition, a meta-analysis found that birth weight and gestation week age closely related to thyroid function tests. Plasma T4, FT4, T3, rT3, (thyroid stimulating hormone), and (thyroxin binding globulin) concentrations during the first 8 weeks after birth in infants of 28-30 weeks gestation and in infants of \<28 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* All preterm infants (\<37w gestational age) admitted to NICU unit of assiut university children hospital with various problems as : •respiratory distress

  * hypoxia
  * sepsis
  * necrotizing enterocolitis
  * receiving TPN (total parental nutrition)
  * infants presented with jaundice.
* Another group of healthy preterm of comparable gestational age not complaining from any problems coming to routine postnatal checkup and outpatient clinic of neonatal unit will be taken .

Exclusion Criteria:

* preterm infants with : • fetal congenital malformations.
Mealtime Anxiety in Eating Disorders

The goal of this observational study is to assess mealtime anxiety in patients with eating disorders receiving treatment at an in-patient unit. Anxiety wil be assessed using ecological momentary assessment (EMA). The main research question is:

• Does post meal activity reduce anxiety in patients with eating disorders?

Study participation will last for two weeks. Participants will be reporting current levels of anxiety/distress on an EMA mobile app during treatment as usual. During one of the two study participation weeks, the participants will perform post mealtime activity.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the Regional Department for Eating Disorders adult in-patient unit (\>16 years old) will be invited to participate.

Exclusion Criteria:

* Patients who receive tube feeding for all meals during the study period will be excluded.