cyrilzakka/clinical-trials huggingface dataset:
Universal Familial Hypercholesterolemia Screening in Children

30 million individuals globally with undiagnosed familial hypercholesterolemia (FH) are at a substantial cardiovascular disease (CVD) risk, which could be normalized by early diagnosis and treatment. Effective screening strategies are urgently needed, but the data on universal FH screening (uFHs) is scarce.

The investigators aim to assess the overall performance of the uFHs program in Slovenia and to compare the common elements to the pilot uFHs program in Lower Saxony (LS; Germany).

The study will include pediatric patients (or their siblings and parents in Slovenian cohort) undergoing the universal hypercholesterolemia screening; those with elevated cholesterol at universal cholesterol screening at primary care level are referred to the lipidology specialist at the UMC Ljubljana (Slovenia) or Kinderkrankenhaus auf der Bult (Lower Saxony, Germany). For those with elevated cholesterol levels, the familial hypercholesterolemia genetic diagnostics is done centrally in UMC Ljubljana.

Only those will be included from whom a signed informed consent by themselves or by their parents/guardians will be obtained prior to the genetic diagnosis of familial hypercholesterolemia.

Eligibility Criteria:
Inclusion Criteria:

* Elevated total cholesterol (cohort 1) or LDL-cholesterol (cohort 2) at universal screening program in children.
* Completed FH genetic analysis (cohort 3).
* Parent or sibling of child with confirmed familial hypercholesterolemia (cohort 4).

Exclusion Criteria:

* Children with hypercholesterolemia not referred through the screening program.
* FH genetic analysis not completed.
A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery

The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia orthopedic surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of reflux esophagitis
3. Subjects with a history of mental illness
4. Subjects with poor blood pressure control
5. Transcutaneous oxygen saturation (SpO2) \<90%
6. Random blood glucose ≥11.1mmol/L
7. Subjects with abnormal liver function
8. allergies to opioids and other medications that may be used during the trial
Compassionate Use of Omegaven IV Fat Emulsion

The purpose of the study is to provide use of Omegaven in children with life threatening Total Parenteral Nutrition (TPN) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. This is a compassionate use protocol.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of life threatening PNALD
* Dependent on Parenteral Nutrition for caloric needs
* Expected to require PN for at least another 30 days
* Other causes of liver disease have been excluded
* GI/Liver service is involved in patient care
* Standard therapies for the treatment of PNALD must have been utilized prior to initiating omegaven.
* Inpatient at Morgan Stanley Children's Hospital of NewYork Presbyterian Hospital
* Must be at least 2 months of age

Exclusion Criteria:

* Not inpatient
* Younger than 2 months of age
* Expected to be weaned off of parenteral nutrition within 30 days
* have other documented causes of liver disease
* have signs of proven severe advanced liver disease
* Allergy to seafood, egg protein and/or previous allergy to Omegaven
* active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent MI, cholestasis due to any reason other than PNALD, active new infection at time of initiation of Omegaven, hemodynamic instability or if unable to tolerate the necessary laboratory monitoring
* must not be enrolled in another clinical trial involving an investigational agent (unless approved by the designated physicians).
* Parent or legal guardian must be willing to provide consent.
Chewing Capability Study for Infants and Toddlers

The main objective of the study is to conduct a pilot study on the characterization of the mastication abilities of infants and toddlers using different commercial cereal based products in order to gain knowledge and be able to plan future studies.


Eligibility Criteria:
Inclusion Criteria:

* Born at term (37+ weeks)
* Familiar with solid foods
* No known history of food allergies
* Child must be within 2 weeks of the targeted age group for 9 months, within 1 month for 12 months, within 2 months for 18 and 24 months, and within 3 months for 36 months for this study.
* English must be the primary language of the participant and family.
* Having obtained his/her caregiver's or legal representative's informed consent.

Exclusion Criteria:

* History of speech/language, cognitive, or physical impairments as indicated on the self-reported medical history questionnaire completed by caregiver or legal guardian
* Any previously undiagnosed speech/language or cognitive impairment detected by the Investigator. In the case a subject is identified as being at risk for a communication or feeding impairment, the caregiver will be notified and provided with a list of local speech-language pathology providers who could perform a formal assessment
* History of poor weight gain/ weight loss, food allergies, difficulties with sucking, difficulties with chewing and/ or swallowing, frequent drooling (for age groups 18, 24, and 36 months), frequent choking, gastro-esophageal reflux, frequent spitting up/ vomiting (for age groups 18, 24, and 36 months) or irritability after feedings/ eating
* Latex allergies
* Currently participating in or having participated in a similar clinical trial related to food/diet within the last 9 months
* Caregiver must not be under the age of 18 years old.
Efficacy and Safety of Extracorporeal Biofeedback

Stress urinary incontinence is the most common type of female incontinence. The efficacy of pelvic floor muscle training with biofeedback has been already proved in many studies. But intravaginal probe is one of the limitation. So, the purpose of this study is to assess the efficacy and safety of extracorporeal biofeedback device with pelvic floor muscle training.


Eligibility Criteria:
Inclusion Criteria:

* Women with stress urinary incontinence
* Standard pad test \> 2gram

Exclusion Criteria:

Women with:

* Mixed urinary incontinence of which urgency incontinence is dominant
* True incontinence
* Overflow incontinence
* Treatment within 14 days preceding screening, or expected to initiate treatment during the study with electrostimulation, bladder training
* Treatment within 7 days preceding screening, or expected to initiate treatment during the study with OAB medication or other medication which affect bladder function
* Pelvic organ prolapse which the stage is at least 2
* Proven urinary tract infection during screening period
* Pacemaker
* Pregnant women
* Neurogenic voiding dysfunction
Efficacy and Safety Evaluation of Prebiotics Combined With Quadruple Probiotics in Improving Functional Constipation.

In this study, we will evaluate the efficacy of prebiotics combined with quadruple probiotics in the treatment of functional constipation through an open RCT study. The experimental group received lifestyle guidance and combined intervention of prebiotics and quadruple probiotics at the same time. The patients took the combination of prebiotics and probiotics twice a day during the treatment period. The control group received only lifestyle instruction. At the same time, to evaluate the safety of probiotics combined with quadruple probiotics in the treatment of functional constipation, and provide a new treatment plan for clinical treatment of functional constipation.

The purpose of this study is to analyze the intestinal microecology of patients with functional constipation before and after treatment through intestinal microecological intervention, mainly using the combination of probiotics and prebiotics. We will record the patient's stool diary, including bowel movements, stool quality, bowel time, defecation difficulty, emptying sensation, manual operation and medication. At the same time, we will use the Bristol Fecal Traits Scale (BSFS) and the Constipation Patient Self-Rating Scale (PAC-SYM) and Constipation Patient Quality of Life Scale (PAC-QOL) scores completed weekly. In addition, we will monitor indicators of inflammation (IL-1β, IL-6, TNF-alpha) and intestinal barrier function (LPS), neurotransmitter (serotonin, acetylcholine)) to assess constipation improvement in patients with functional constipation.

Eligibility Criteria:
Inclusion Criteria:

1. Age: between 18 and 60 years old
2. Functional constipation was diagnosed using Rome IV criteria.
3. No other relevant medications that may affect the gut microbiota before the start of the experiment
4. Ability to participate
5. Consent to participate in the study

Exclusion Criteria:

1. Organic constipation (such as intestinal obstruction, bowel cancer, etc.)
2. Outlet obstructive constipation
3. Previous abdominal, rectal, or perianal surgery except cholecystectomy, appendectomy, tubal ligation, and cesarean section
4. Patients with constipation-oriented irritable bowel syndrome (IBS-C) or functional abdominal pain syndrome who meet Rome IV criteria
5. a serious mental illness or any medical condition related to it
6. Diseases of the small or large intestine, such as ulcerative colitis and Crohn's disease
7. There are serious important organs such as respiratory, heart, liver, kidney and other functional insufficiency
8. Use probiotics, prebiotics and/or Biostime within 1 month
Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis

Systemic sclerosis is an autoimmune disease characterized by skin lesions and visceral responsible for significant morbidity. Microcirculatory disorders and tissue fibrosis are excessive severity of the disease. This condition can affect the hands with a major functional consequence severely impairing the quality of life of patients.

Adipose tissue is used in plastic surgery for over a century for the filling of depressions in the skin. In addition to the volume effect, a trophic effect on the surrounding tissue was noted. It is shown that the stromal vascular fraction is responsible for this regenerative effect.

In a previous study the investigators have demonstrated in a mouse model that the subcutaneous adipose tissue provides a trophic effect on SSc skin lesions by reducing the fibrosis of the dermis and providing a pro angiogenic.

Objectives and means:

This is a clinical study evaluating an innovative cell therapy procedure. The objective of this study was to evaluate the effects of injection of autologous stromal vascular fraction of adipose origin according to the system Celution ® (Cytori Therapeutics, Inc.., United Kingdom) in digital in patients with scleroderma cutaneous hands.

Eleven patients with scleroderma with the hands will be included in the study. Due to the nature of the orphan disease, a longitudinal study be conducted, where each patient will have own control.

The evaluation will be pre and post operative for a period of six months. This evaluation will be based on clinical criteria (trophic balance, functional) and laboratory (capillaroscopy, Doppler ultrasound of the arteries of the forearm, laser-Doppler tissue).

Project schedule and implementation phases:

The project will run over a period of twelve months. Patients will be followed for a period of six months. Analyzes clinical, paraclinical, and exploitation of results will be achieved over a period of six months.

Expected Results: This study will validate the functional and trophic effects of reinjection of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients with scleroderma.

Conclusion: This innovative cell therapy could represent an alternative treatment for patients with scleroderma in check, intolerant or insufficiently relieved by medical treatment currently available in the scleroderma hand


Eligibility Criteria:
Inclusion Criteria:

* Men and women of more than 18 years old wishing a therapeutic alternative.
* Functional Disability of the hand authenticated by a functional index of the hand of Cochin upper to 20.

Exclusion Criteria:

* Persons participating simultaneously in another biomedical search(research)
* Minors
* Pregnant or breast-feeding Women
* Major Persons protected by the law (under guardianship or guardianship)
* Persons staying in a sanitary or social establishment
* Persons in emergency situation
* Private persons of freedom
Detection of Chemotherapy Induced Cardiotoxicity

To identify patients that are at risk of heart damage after receiving chemotherapy (adriamycin).

To identify patients at risk of development of heart damage after receiving chemotherapy by obtaining the genetic profile of those who show: elevation of troponin, left ventricular systolic and diastolic dysfunction, and pro-oxidant stress markers.

Eligibility Criteria:
Inclusion Criteria:

* undergoing anthracycline and/or trastuzumab therapy for the first time

Exclusion Criteria:

* abnormal ventricular ejection fraction
* past history of, or active cardiac disease including: MI, CHF, angina, arrhythmia requiring medication, valvular disease, uncontrolled systemic hypertension
Comparison of Outcome of Post Burn Flexion Contracture Release Under Tourniquet Verses Tumescent Technique in Children

Post burn flexion contractures are common in pediatric age group. Release of contracture and coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem. This procedure is routinely done under tourniquet control because bloodless operative field is essential to visualize important neurovascular structures in hand.

Use of tumescent technique without a tourniquet is gaining acceptance because it avoids complications associated with tourniquet use, maintains a blood less surgical field and decreases operative time. Furthermore use of tumescent anesthesia often results in better surgical outcomes.

Although the benefits of tumescent technique used in wide awake hand surgery are well documented, epinephrine at a concentration of 1:1 000,00 has also been used as a replacement for pneumatic tourniquet for release of hand contracture in infants and adults under general anesthesia. Thus epinephrine 1:1,000,00 in saline solution can be a potential replacement for a tourniquet in hand surgeries done under general anesthesia.

Post burn flexion contractures are common in pediatric age group. Release of contracture and coverage with full thickness skin graft (FTSG) is a widely used procedure for this problem. This procedure is routinely done under tourniquet control because bloodless operative field is essential to visualize important neurovascular structures in hand.

Use of tumescent technique without a tourniquet is gaining acceptance because it avoids complications associated with tourniquet use, maintains a blood less surgical field and decreases operative time. Furthermore use of tumescent anesthesia often results in better surgical outcomes.

Although the benefits of tumescent technique used in wide awake hand surgery are well documented, epinephrine at a concentration of 1:1 000,000 has also been used as a replacement for pneumatic tourniquet for release of hand contracture in infants and adults under general anesthesia. Thus epinephrine 1:1,000,000 in saline solution can be a potential replacement for a tourniquet in hand surgeries done under general anesthesia.

To the investigators' knowledge no study has so far been done to compare the outcome of release of post burn flexion contractures under tumescent technique with general anesthesia or under tourniquet control with general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Children with post burn flexion contractures involving volar aspect of palm and fingers
* Possible to cover the defect with full thickness skin graft
* age range of 3 to 12 years.
* Patients of both genders

Exclusion Criteria:

* Children with recurrent post burn contractures.
* Children with any history of bleeding diathesis or coagulopathy.
* Children with any co-morbid condition making any contraindication of general anesthesia.
* Patients having previous history of vascular insufficiency like Raynaud's disease or phenomenon, severe peripheral vascular disease and peripheral neuropathy.
* The patient having allergic hypersensitivity to epinephrine, lidocaine.
Study of the Social and Psychological Consequences of ICU Hospitalization

Patients are admitted to intensive care for serious diseases (sepsis, ARDS ...) burdened with a high mortality rate. Invasive methods of resuscitation and the diseases treated can lead to serious sequelae. Follow-up studies of patients at hospital discharge report most often the quality of life using validated quantitative scales. A recent consensus of the American Society of resuscitation an update on the physical, cognitive and psychological sequelae of ICU hospitalization for the family and the patient, grouped under the term "post-intensive care syndrome." Social changes, emotional and professional are little studied and are not part of the information provided by the quality of life questionnaires. The investigators hypothesize that intensive care stay entails a profound effect on the lives of patients. This study will add additional data on a little known aspect of post resuscitation.

Primary objective :

To evaluate the social changes, emotional, professional a cohort of patients following ICU stay

Secondary objective:

Evaluate post traumatic stress disorder and quality of life of a cohort of patients following ICU stay

Methods :

Study design Study of bi-center cohort (ICUs of Saint Joseph and Bichat hospitals).

prospective follow the consequences of the intensive use of patient already included in the Outcomerea database using quality of life questionnaires, independence and post-traumatic stress and a questionnaire constructed for the study.

Patient selection in the database The database contains more than 10,000 visits. Investigators will select the patients in the two hospitals in the study. Then a second selection will be based on the inclusion criteria. The review of hospital records will not include patients with the first five criteria for non-inclusion. These patients appear in the flow chart

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted in ICU and who had at least one organ dysfunction (need at least 24 hours of mechanical ventilation) in two intensive care units

Exclusion Criteria:

* Patient Do not speak French
* Patient aphasic deaf
* Patient with xxistencing cognitive disorders
* Homeless
Biphasic Effects of Acute Alcohol Intoxication on Bystander Intervention

The goal of this experimental study is to examine the effect of alcohol, gender, and bystander attitudes on bystander barriers and sexual violence intervention among young adult men and women (age 21-20). The main questions it aims to answer are:

* Does alcohol intoxication and gender influence bystander barriers and sexual violence intervention?
* Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among men, compared to women?
* Does alcohol intoxication have a greater impact on bystander barriers and sexual violence intervention among those with higher, compared to lower, prosocial bystander attitudes?

Participants will be randomly assigned to one of two beverage conditions (alcohol or control beverage) and those assigned to alcohol will complete the study on either the ascending or descending alcohol limb. Participants will project themselves into a heat-of-the moment, risky sexual violence scenario that will assess bystander barriers and behavioral intentions. Researchers will compare those assigned to the alcohol and control beverage condition and men/women to see if this impacts bystander barriers and sexual violence intervention.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 21 and 30
* Report that on at least 3 days in the past year they have consumed an alcohol quantity on a single occasion that was equal or greater to the dose administered in the lab

Exclusion Criteria:

* Currently seeking treatment or in recovery for an alcohol or substance use disorder
* A medical condition or medication use in which alcohol consumption is medically contraindicated
* Pregnant, nursing, or has engaged in sexual intercourse without effective contraception in the past two weeks
* If the participant is less than six feet tall and weighs over 250 pounds or is over six feet tall and weighs over 300 pounds
Trial of Probiotics for Constipation in Parkinson's Disease

This is a double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics in the treatment of constipation in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 to 80 years old
* Provision of written informed consent
* Diagnosis of PD made by a Neurologist using UK Brain Bank Criteria
* Fulfils criteria for functional constipation according to the Rome IV Criteria during in the preceding 6 months with frequency of bowel movements less than 3 times per week

Exclusion Criteria:

* Ingestion of probiotics in the preceding 4 weeks
* Use of antibiotics in the preceding 4 weeks
* History of gastrointestinal disorders or surgery
* Known or suspected allergy to probiotics
* Comorbidities that prevent reliable completion of study assessments
* Prior functional neurosurgery for PD or treatment with apomorphine infusion
* Recent initiation of dopaminergic medications in the preceding 3 months
Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate

The present study evaluates the effects of bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791.

The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility Criteria:
Inclusion Criteria:

* Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
* They do not use substances with antibacterial action.

Exclusion Criteria:

* Taken antibiotics before 10 days of the intervention.
* Wear any jewellery on the hands