cyrilzakka/clinical-trials huggingface dataset:
Second-Generation Antipsychotic Treatment Indication Effectiveness And Tolerability In Youth (Satiety) Study

The purpose of this study is to get a better understanding of the side effect burden and identify predictors of psychotic, mood and aggressive disorders in children and adolescents. The study's primary aim is to identify genetic risk factors for weight gain and metabolic abnormalities.

Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAPs (second generation antipsychotics) during 4 visits over 12 weeks. Participants will also be evaluated at month 6, 9, and 12. This study does not involve treatment for participants. Treatment of subjects enrolled in this study will be determined by their clinician and will remain unaffected by participation in this observational minimal risk study.

All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25mg to 6mg daily for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between the ages of 3 and 19 (at the time of consent)
2. Clinical diagnosis of psychotic disorders (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified and prodromal schizophrenia (as defined by the Scale of Prodromal Symptoms (SOPS: Miller 1996)), mood disorder (i.e., bipolar disorder, major depressive disorder, depressive disorder not otherwise specified, mood disorder not otherwise specified) or an autism spectrum disorder.
3. Subjects who are considered for treatment with second generation antipsychotics (SGAPs) by a physician who has evaluated him/her
4. Subjects who are either A) antipsychotic naïve and have started an SGA within the past 2 weeks , B) have started a new antipsychotic within the past 2 weeks (specifically within 2 weeks of their first blood draw), or

Exclusion Criteria:

1. Individuals younger than 3 years or older than 19 years and 11 months (at the time of consent)
2. Personal history of or comorbid eating disorders
3. Active hyper-/hypothyroidism
4. Pregnancy
5. Severe medical disorder (i.e., AIDS, cancer, sepsis, etc.).
Amino Acid Infusion in Kidney Transplant Recipients

The study addresses the impact of amino acid infusion in the early post-transplant period on graft function and the incidence of post-transplant complications.

Background and Rationale: Delayed graft function (DGF) remains a significant challenge in kidney transplantation, particularly in recipients of deceased donor organs. DGF, often defined as the need for dialysis within the first post-transplant week, is associated with poorer long-term graft survival and increased immunological risk. Ischemia-reperfusion injury (IRI) plays a crucial role in the pathogenesis of DGF, contributing to oxidative stress, inflammation, and endothelial dysfunction. Strategies to mitigate IRI and enhance early graft recovery are highly sought after.

Amino acids play a critical role in cellular metabolism, protein synthesis, and immunomodulation. Prior research suggests that amino acid supplementation may improve nitrogen balance, enhance mitochondrial function, and reduce oxidative stress, potentially benefiting graft recovery. However, there is limited clinical evidence assessing whether perioperative amino acid administration improves graft function in kidney transplant recipients. The AID-KT study aims to evaluate the impact of intravenous amino acid infusion on early graft function following kidney transplantation.

Study Design: AID-KT is a prospective, interventional cohort study with a retrospective control group. The intervention group will receive intravenous amino acid (AA) supplementation at a dose of 1g/kg body weight daily for three days post-transplant. The historical control group consists of kidney transplant recipients from previous years who did not receive amino acid infusion. The study will evaluate graft function, metabolic response, and patient outcomes over a 12-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) undergoing deceased or living donor kidney transplantation
* First-time kidney transplant recipients
* No known allergy or contraindication to amino acids
* Stable hemodynamic status post-transplant
* Signed informed consent

Exclusion Criteria:

* Patients requiring immediate dialysis post-transplant
* Multi-organ transplant recipients
* Severe hepatic dysfunction (Child-Pugh C)
* Uncontrolled infection or sepsis
* Malignancy within the past 5 years (except non-melanoma skin cancer)
* Prior participation in conflicting clinical trials
RAAS Inhibitor Drugs in Dialysis Patients

Hypertensive haemodialysis patients are at high risk for cardiovascular events. This study was undertaken to ascertain whether the upstream of aliskirne, a direct renin inhibitor improves mortality and cardiovascular outcomes in these high-risk population.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease stage 5
* undergoing maintenance haemodialysis for a minimum of 3 months
* existing arterial hypertension or
* history of arterial hypertension or
* resting blood pressure ≥140/90 mmHg or
* antihypertensive medication
* man and female
* 18 years and older.

Exclusion Criteria:

* recent myocardial infarction (less than 3 months)
* atrial fibrillation/atrial flutter
* hypotension with systolic blood pressure of \<90 mmHg
* high-grade aortic stenosis
* left ventricular ejection fration \<50%
* known allergy to aliskiren
* severe disorders of liver function
Remifentanil and Propofol Versus Fentanyl and Midazolam for Sedation During Therapeutic Hypothermia. A Randomised, Controlled Trial

The aim of this study is to increase knowledge about drug properties and effects during therapeutic hypothermia. The primary end point of this study is the time from termination of sedation to extubation in patients treated with therapeutic hypothermia, after treatment with the combination remifentanil and propofol versus that of fentanyl and midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Treatment with therapeutic hypothermia following cardiac arrest (33-34°C) and analgesia/sedation required
* Patients must be 18 years or older
* Inclusion must be approved by the attending physician

Exclusion Criteria:

* Pregnant women
* Cardiovascular unstable patients in a deteriorating circulatory status which require multiple other therapeutic measures that makes participation practically impossible
* Liver or renal failure defined as sequential organ failure assessment (SOFA)-score 3 or 4
* History of drug allergies, or contraindications for the study drugs
* Patients using a scheduled dose of any of the study drugs.
* Patients with a known substance abuse of opioids or benzodiazepines
Dupilumab and Milk OIT for the Treatment of Cow's Milk Allergy

This is a phase 2, multicenter, randomized, double-blind, parallel group, 2 arm study in approximately 40 subjects aged 4 to 50 years, inclusive, who are allergic to cow's milk. The primary objective is to assess whether dupilumab as an adjunct to milk oral immunotherapy (OIT) compared to placebo improves the safety of milk OIT and rates of desensitization, defined as an increase in the proportion of subjects who pass a double-blind placebo-controlled food challenge (DBPCFC) to at least 2040 mg cumulative milk protein at week 18.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 50 years (inclusive)
* Clinical history of allergy to cow's milk or milk-containing foods
* Serum IgE to milk of \>4 kUA/L within the last 12 months and/or a SPT to milk ≥6 mm compared to a negative control
* Experience clinical reaction at or before 444 mg cumulative protein dose of cow's milk protein on Screening DBPCFC
* No clinical reaction observed during the placebo (oat) Screening DBPCFC
* Subjects with other known food allergies must agree to eliminate these other food items from their diet so as not to confound the safety and efficacy data from the study
* Use of effective birth control by female participants of childbearing potential

Exclusion Criteria:

* Any previous exposure to dupilumab
* Known hypersensitivity to dupilumab or any of its excipients
* Known hypersensitivity to epinephrine or any of its excipients
* Allergy to oat (placebo in DBPCFC)
* History of severe anaphylaxis to cow's milk, defined as neurological compromise or requiring intubation
* Recent history of frequent severe, life-threatening episodes of anaphylaxis or anaphylactic shock as defined as 3 or more episodes of anaphylaxis within the past year
* Inability to tolerate biological (antibody) therapies
* Body weight \<5 kg at the time of screening
* History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology
* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
* History of a mast cell disorder
* Established diagnosis of a primary immunodeficiency disorder
* Severe asthma or mild or moderate asthma if uncontrolled or difficult to control
* Current participation or within the last 4 months in any other interventional study
* Use of medication such as beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
* Pregnant or breastfeeding women
A Study to Explore the Routes of Elimination of MDV3100

A study to investigate the excretion routes of radio-labelled MDV3100.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index within 18.5 to 30.0kg/m2
* Regular defecation pattern (minimum once per 2 days).
* Subject must be non-fertile, i.e., surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies as defined in the protocol.

Exclusion Criteria:

* Known or suspected hypersensitivity to MDV3100, or any components of the formulation used.
* Any of the liver function tests above the upper limit of normal. A retest to confirm the result may be performed once.
* Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug (excluding non-active hay fever).
* Abnormal pulse and/or blood pressure measurements at the pre-study visit as follows: Pulse \<40 or \>90 bpm; mean systolic blood pressure \>140 mmHg ; mean diastolic blood pressure \>90 mmHg (blood pressure measurements taken in triplicate after subject has been resting in supine position for 5 min; pulse will be measured automatically).
* A QTc interval of \> 430 ms after repeated measurements (consistently after duplicate measurements), a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
* Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day).
* Regular use of any inducer of metabolism (e.g., barbiturates, rifampin) in the 3 months prior to admission to the Clinical Unit.
* Positive serology test for HBsAg, anti HAV (IgM), anti-HCV or anti-HIV 1+2.
* Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton (excluding spinal column)), during work or during participation in a clinical study in the previous year.
The Effect Of Virtual Reality Glasses On The Behavior Of Children With Autism Spectrum Disorder

The aim of this study is to determine whether the use of virtual reality glasses showing an immersive video simulation of the dental visit will help decrease anxiety at future appointments by decreasing the element of surprise and increasing the patient's familiarity and comfort level with a specific dental practice environment.

After an initial baseline data collection visit to the dental clinic, patients will be placed in the virtual reality (VR) group or the no VR group. Caregivers in the VR group will be given VR glasses. They will be instructed how to access the video and use the glasses. The child/wearer of the glasses will feel immersed in the three-dimensional environment and be able to look around the room as they move down the hallways in the video. The caregiver will be encouraged to have the child wear the VR glasses as often as possible and record the number of times the video is watched. The caregiver will fill out a "records form" which will include the date and time the video was watched. Both groups will then return to the clinic for follow up data collection visit.

Eligibility Criteria:
Inclusion Criteria:

* Autism Spectrum Disorder (ASD)

Exclusion Criteria:

* No specific diagnosis of Autism Spectrum Disorder (ASD)
* Limited English Proficiency
* Existing patient of VCU Department of Pediatric Dentistry
* Parent/guardian determination that child would not be avle to tolerate immersive simulation with VR glasses
A Study of Effects of Selpercatinib (LY3527723) on Repaglinide in Healthy Participants

The main purpose of this study is to assess the effect of selpercatinib on how fast repaglinide gets into the blood stream and how long it takes the body to remove it when administered in healthy participants. Information about safety and tolerability will be collected. The study will last up to 12 days.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²) and had a minimum weight of at least 50 kg at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
* Hemoglobin (Hb) A1c value \< 6.5 % at screening and fasting glucose ≤ 126 mg/dL.
* Males who are capable of fathering a child must agree to use one of the following methods of contraception from the time of the dose administration through 6 months after the last dose
* Female of non-childbearing potential only or must have undergone sterilization procedures at least 6months prior to the first dosing

Exclusion Criteria:

* History or presence of diabetes or history of prior episode(s) of hypoglycemia.
* Estimated creatinine clearance \<90 mL/min at Screening or Check-in (Day -1, Period 1)
* Unable to refrain from or anticipates the use of any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements for 14 days prior to the first dosing and through EOT or ET. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee
Cushing's Disease Complications

This study aims at investigating the complications of Cushing's disease in "de novo" patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.

At inclusion the following will be investigated and recorded :

* demographic and personal medical history.
* Familial medical history related to osteoporosis, cardiovascular disorders and thromboembolism.
* Current medical treatment.
* Physical examination.
* Assessment of basal 24hrs urinary cortisol and salivary cortisol.

  - At baseline (i.e. before specific treatment of Cortisol excess):
* physical examination,
* routine biology,
* HbA1C, fasting glucose and oral glucose load,
* cholesterol, triglyceride, HDL \& LDL,
* coagulation and fibrinolysis investigation,
* 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
* EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US,
* ophthalmology examination,
* spine X-Ray, bone densitometry,
* QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).

Every year during a 3 years follow-up the following will be investigated :

* Current medical treatment.
* Physical examination.
* Assessment of basal routine biology,
* HbA1C, fasting glucose,
* cholesterol, triglyceride, HDL \& LDL,
* coagulation and fibrinolysis investigation,
* 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
* EKG, cardiac ultrasound, cardiac CT-scan (if abnormal initially), arterial and venous US,
* ophthalmology examination, bone densitometry,
* QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).

Eligibility Criteria:
Inclusion Criteria:

* Cushing's disease diagnosed by complementary explorations according to the National Program of Diagnosis and Care of the Cushing 's disease

Exclusion Criteria:

* other cause of Cushing's syndrome
* known inherited syndrome having for consequence an hormonal hypersecretion (NEM-1, complexe of carney, McCuneAlbright syndrome)
* patient does not understand french
* life expectancy of less than 6 months
* pregnant women
* dependent patient
Effects of Low-level Laser Therapy After Surgical Removal of Impacted Lower Third Molar

Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after surgical removal of impacted lower third molars (ILTM).

Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after surgical removal of impacted lower third molars (ILTM), including pain level, postoperative facial swelling, trismus and non-stimulated saliva secretory immunoglobulin A (sIgA).

Eligibility Criteria:
Inclusion Criteria:

* had two impacted lower third molars symmetrically in the same position as the classifications of Pell- Gregory and Winter diagnosed by 2D panoramic radiography

Exclusion Criteria:

* Patients with systemic diseases such as cardiovascular disease, hypertension, diabetes mellitus, pregnant, local infections
* refused to participate in the study
* patients who did not follow-up visit would be excluded
Recognition of a Cardiac Arrest Within the EMS

This study aims to evaluate the average time taken by the Medical Regulation Assistants (MRA) to detect a cardiac arrest during the call to the EMS as well as the factors influencing this delay.

Its main objective is to evaluate the delay, in seconds, between the call being picked up and the recognition of a cardiac arrest by the medical regulation assistant at the EMS 95

In France, the incidence of cardiac arrest in adults is approximately 40,000 per year. It is a major cause of mortality with an average survival rate of 8%, as well as morbidity, particularly neurological morbidity for surviving patients. The majority of cardiac arrests occur at In France, the incidence of cardiac arrest in adults is approximately 40,000 per year. It is a major cause of mortality with an average survival rate of 8%, as well as morbidity, particularly neurological morbidity for surviving patients. The majority of cardiac arrests occur at home, in the presence of a witness.

In the event of a cardiac arrest, every minute counts. Studies have shown that the time between the patient's collapse and the start of ECM (External Cardiac Massage) is directly correlated to the survival rate after a cardiac arrest.

According to other studies, a maximum delay of 90 seconds between the call to the EMS and the recognition of the cardiac arrest would be the most optimal for the patient, but is it reached at the EMS 95? This study aims at evaluating the average time taken by the Assistants of Medical Regulation (ARM) to detect a cardiac arrest during the call to the EMS as well as the factors influencing this delay.

Its main objective is to evaluate the delay, in seconds, between the call pick-up and the recognition of a cardiac arrest by the medical regulation assistant at the EMS 95. This evaluation will be made in particular by determining the elements of language highlighting the cardiac arrest, those which lengthen the time of detection of the arrest and the delay of starting a procedure by the ARM. The study will be conducted within the EMS and will include a review of the current state of knowledge and experience of the MRAs. This study will be carried out within the EMS 95.

Eligibility Criteria:
Inclusion Criteria :

- Any call resulting in the detection of a cardiac arrest during ARM regulation: calls to 15 and calls transmitted by 18

Exclusion Criteria :

* Traumatic context
* Call involving cardiac arrest already identified as such by the caller or 18
* Call with criteria of proven death
* The caller does not speak French, the linguistic elements noted are not usable.
Lung Expansion Technics on Chest Wall Mechanics and Preventing Pulmonary Complication After Abdominal Surgery

The lung expansion techniques are widely used to prevent postoperative pulmonary complications. However, the effect of each technique on thoracoabdominal mechanics after abdominal surgery and if it influences the rate of postoperative pulmonary complications remains unknown. The investigators hypothesis is that the lung expansion technique that more increases lung volume after abdominal surgery, will be the most efficient in preventing postoperative pulmonary complication after abdominal surgery. The investigators objectives will be to compare the effect of different lung expansion techniques on lung volumes and activation of inspiratory muscle, and prevention of pulmonary complications in patients undergoing upper abdominal surgery. This study will involve 171 patients undergoing elective abdominal surgery. Patients will be randomly divided into 5 groups: no therapy group (n=35), continuous positive airway pressure (CPAP, n=34); volumetric incentive spirometry (VIS, n=34); flow oriented incentive spirometry (FIS, n=33) and deep breathing (DB, n=35). The thoracoabdominal mechanics will be assessed before and 3 days after surgery. Complications will be evaluated by a researcher who did not know to which group each patient belongs.

The assessments performed were thoracoabdominal kinematics (by optoelectronic pletysmography)and respiratory muscles activity (by surface electromyography). The follow pulmonary complications were considered: pneumonia, tracheobronchitis, atelectasis and acute respiratory failed

Eligibility Criteria:
Inclusion Criteria:

* candidates for elective upper abdominal surgery expected to last longer than 120 minutes
* absent of spine or thoracic deformity
* no previous lung parenchyma resection
* no tracheostomy
* able to understand and perform the maneuvers proposed.

Exclusion Criteria:

* cancellation of surgery
* mechanical ventilation for more than 24 hours in the postoperative period
* need for chest tube use
* postoperative cardiac complications
* surgical complication
* reoperation