cyrilzakka/clinical-trials huggingface dataset:
Sucrose Practices for Pain in Neonates

Recent studies show that babies in hospital undergo an average of 4 to 5 painful procedures, such as heel lances, every day. Sucrose (sugar water) has been shown to be effective for reducing pain during invasive procedures and is a standard of care for painful procedures. The purpose of this study is to see what is the least amount of sucrose that can be given to a baby to reduce pain during procedures.

Infants in the NICU receive an average of 4 - 5 painful procedures daily for diagnostic and therapeutic purposes; less than half receive interventions to manage pain. Both immediate and long term effects of unmanaged pain in these vulnerable infants have been reported, including impaired brain development. To ensure optimal outcomes for hospitalized infants in NICUs, there is a crucial need to minimize procedural pain and its associated consequences. Multiple clinical trials have identified sucrose as an effective strategy for reducing procedural pain in infants. Despite its inclusion in neonatal pain guidelines, standards, and consensus statements sucrose has been inconsistently used. The under-utilization of sucrose may be explained by knowledge gaps in relation to the minimally effective dose and the influence of concurrent opioid analgesia, as well as the short and long-term effects of repeated administration. Once infants in the NICU are determined to be eligible for the study and parents consent, infants will be randomized to one of 3 dose of sucrose and their pain will be assessed using a validated pain assessment measure.

Eligibility Criteria:
Inclusion Criteria:

* Infants 24 to 42 weeks gestational age (GA) at birth, admitted to the Neonatal Intensive Care Unit (NICU), and scheduled to receive a heel lance will be eligible. Parents will be approached for participation within the first 2 weeks of the infant's life. Infants will be eligible for Trial 1, the non-opioid trial, if they have not received any opioids within 24 hours prior to the heel lance. Infants will be eligible for Trial 2, the opioid trial, if they are currently receiving an opioid infusion. Furthermore, observation of the procedures will be timed to ensure that no additional sucrose doses are provided within the previous 4 hours.

Exclusion Criteria:

* Infants will be excluded if they have a contraindication for sucrose administration (e.g., unable to swallow, pharmacologically muscle relaxed, or heavily sedated) due to safety concerns and/or inability to assess pain accurately (e.g., unable to clearly view the infant's face).
Effects of Creatine and Rehabilitation Programin Athletes With Patellar Tendinopathy

The aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.

Nutrition could play an important role in the rehabilitation from sport injuries. This afirmation is based on studies that analyze the impact of different dietary supplements along immobilization periods, stablishing that creatine, leucine and omega-3 fatty acid supplementation could ameliorate muscle loss, while creatine could potentiate the hypertrophy along the rehabilitation process. For this reason, the aim of this study are to analyze the effect of creatine ingestion in pain, histological properties of the tendon, body composition, strength and vertical jump performance in athletes with patellar tendinopathy that follow a physical rehabilitation program that include eccentric exercise combined with stretching and extracorporeal shock wave therapy.

Eligibility Criteria:
Inclusion Criteria:

* Athletes diagnosed with patellar tendinopathy by sport medicine doctor.
* Age (\>18 years and \<49 years).
* To be federated in a sport modality that involves high repetitive impact in the knee; iii) to train more than 3 sessions weekly.
* Not having undergone knee surgery.
* Not having undergone any infiltration of analgesics or platelet-rich plasma during the last year.
* Not intake any sport performance supplement in the previous year;
* Smoker person.

Exclusion Criteria:

* Not being diagnosed with patellar tendinopathy by a doctor
* Age (\<18 years and \> 50 years).
* Involved in a sport modality without high repetitive impacts during sports activity.
CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries

The overall purpose of this is study to provide continued access to the ReCell device following completion of protocol CTP001-6, and allow for collection of supplementary clinical outcome data for the ReCell device when used as an adjunct to meshed grafts in subjects with acute thermal burn injuries who require skin grafting for closure of burn injuries.


Eligibility Criteria:
Inclusion Criteria:

1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
2. The area of total burn injury is 5-50% TBSA inclusive.
3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
4. The subject is at least 5 years of age.
5. The subject (or family, for those under 18 years of age) is willing and able to complete all follow-up evaluations required by the study protocol.
6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

Exclusion Criteria:

1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
2. The subject is unable to follow the protocol.
3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
5. Life expectancy is less than 1year.
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy

This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).


Eligibility Criteria:
Inclusion Criteria:

* Currently participating in study VX17-659-105 (NCT03447262)

Exclusion Criteria:

* History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator
* Current participation in an investigational drug trial (other than study VX17-659-105)

Other protocol defined Inclusion/Exclusion criteria may apply.
Cutaneous and Mucosal Manifestations of Neurofribromatosis Type 2 in Children Under 15

.Neurofibromatosis type 2 is an inherently autosomal dominant genetic disease, but cases of mosaicism or de novo mutation are not uncommon. the prevalence is estimated at 1 / 60,000. the clinical presentation is based on the appearance of tumors in the central and peripheral nervous system. The current average age of diagnosis is around 25 to 30 years depending on the studies. Currently, the diagnostic criteria are based on the ENT, neurological and opthalmological manifestations of the disease. Cutaneous manifestations have been described in these patients. Except now, mucocutaneous manifestations of the disease are not taken into account for depisatage or diagnosis.

The purpose of this study would be to identify the different cutaneous and mucosal manifestations in a pediatric population under 15 years of age, and to analyze whether this might be of interest in early detection of the disease in association with other symptoms.


Eligibility Criteria:
Inclusion Criteria:

* age up to 15 years
* diagnosis of neurofibromatosis type 2

Exclusion Criteria:

* refusal to participate in the study
* informed consent that can not be obtained because of a disability or difficulties with a - language barrier
Evaluation of Analgesia by PENG Block Versus Intra-Articular Infiltration in Prosthetic Hip Surgery (API)

The main objective of this study is to compare the effectiveness of the ultrasound-guided PENG block technique compared to intra-articular infiltration on postoperative morphine consumption during hip prosthetic surgery via the anterior minimally invasive approach under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, over 18 years old.
* Patient scheduled for anterior hip prosthesis.
* Affiliated patient or beneficiary of a social security scheme.
* Patient having been informed and having signed a free and informed consent.

Exclusion Criteria:

* Patient with a contraindication to local anesthesia.
* Patient with a high level of dependence, defined by level 1 or 2 of the Iso-Ressources Group (GIR).
* Patient participating in another clinical study.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of freedom by judicial or administrative decision.
* Pregnant, breastfeeding or parturient woman.
* Patient hospitalized without consent.
Bethanechol for Eosinophilic Esophagitis

The primary goals of this study are to ease the symptoms of patients with Eosinophilic Esophagitis (EoE) and to test the effectiveness of the drug bethanechol in relieving those symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age 18-75
* Symptoms associated with EoE such as dysphagia, heartburn, vomiting, abdominal pain, food impaction
* Subject has signed informed consent for the administration of bethanechol that informs the patient of potential adverse events
* Clinically or pathologically proven EoE

Exclusion Criteria:

* Known allergy to bethanechol
* Asthma
* Pregnant or breast-feeding women
* Severe neurological problems
* Severe diabetes
* Achalasia
* Known allergy to lidocaine or other local anesthetic
* Hypothyroidism
* Peptic ulcer
* Pronounced bradycardia or hypotension
* Vasomotor instability
* Coronary artery disease
* Epilepsy
* Parkinsonism
* Weakened gastrointestinal or bladder wall
* Mechanical obstruction of the gastrointestinal tract or bladder neck
* Urinary bladder surgery in the 6 months prior to the study
* Gastrointestinal resection and anastomosis
* Spastic gastrointestinal disturbances
* Acute inflammatory lesions of the gastrointestinal tract
* Peritonitis
* Marked vagotonia
A Study to Compare Two Formulations of LY3819469 in Healthy Participants

The main purpose of this study is to assess two formulations of LY3819469 based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3819469 will also be evaluated.

Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening and follow-up periods.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation
* Have a body mass index (BMI) in the range of 18.5 to 35.0 kilogram per square meter (kg/m²), inclusive at the time of screening
* Are male or women not of childbearing potential

Exclusion Criteria:

* Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that could affect interpretation of study data
* Have any abnormality in the 12-lead electrocardiogram (ECG)
* Are heavy alcohol drinkers or heavy cigarette smokers
* Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives, or 30 days, whichever is longer, should have passed prior to CRU admission
* Have lost or donated blood of more than 450 mililitres (mL) within 3 months
Pharmacokinetic Profile and Safety of Fluticasone Propionate and Albuterol Sulfate in Combination When Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old

The primary objectives of this study are:

* To determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 (Fp and ABS multidose dry powder inhaler with e-module \[Fp/ABS eMDPI\]) in participants with asthma
* To compare the PK profiles of Fp for 2 different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI)
* To compare the PK profiles of ABS between the 2 different strengths of TEV-56248

The secondary objective is:

• To evaluate the safety of a single dose of TEV-56248 and a single dose of Fp MDPI

The planned duration for this trial is approximately 1.5 to 3 months. The trial includes a 14-day screening period, 3 treatment periods (2 days each), and a follow up visit 7 days after end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Participant has a diagnosis of asthma as defined by the Global Initiative for Asthma guidelines (GINA 2023), which has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in asthma medication) for at least 30 days before the Screening Visit
* Has persistent asthma, with a forced expiratory value (FEV1) that is greater than or equal to 80% of the value predicted for age, height, sex, and race at the Screening Visit
* Demonstrate acceptable inhalation technique with the training inhaler
* Able to stop (as judged by the Investigator) his or her rescue medication, for approximately 6 hours before the Screening Visit and for approximately 4 hours before training sessions in periods 1-3
* Has body mass index (BMI) within the 3rd and 97th percentiles for the participant's age and gender. The participant must have a weight of ≥18 kilograms (kg)
* Able to achieve a peak inspiratory flow (PIF) rate of at least 60 liters per minute (L/min) on an inhaler training device

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Participant has a history of a life-threatening asthma exacerbation that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures
* Has participated as a randomized participant in any investigational drug trial within 30 days (starting from the final follow-up visit of that trial) preceding the Screening Visit or plans to participate in another investigational drug trial at any time during this trial
* Known hypersensitivity to any corticosteroid, albuterol, or any of the ingredients in the investigational medicinal product
* Asthma exacerbation requiring systemic corticosteroids within 30 days of the Screening Visit, or has had any hospitalization for asthma within 2 months of the Screening Visit

NOTE- Additional criteria apply, please contact the investigator for more information
A Study to Learn About Study Medicine ALTA2618 in Adults With AKT1 E17K-Mutant Solid Tumors

The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

This is an open-label, multicenter, Phase 1/1b study of ALTA2618, a mutant-selective and orally bioavailable AKT1 E17K inhibitor, in adults with AKT1 E17K-mutant solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity of ALTA2618, and aims to find the best dose. The study consists of two parts: Part 1 - Dose Escalation and Part 1b - Dose Expansion.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy harboring AKT1 E17K mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test.
* Unresectable or metastatic disease
* Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage
* Evaluable or measurable disease per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function.

Exclusion Criteria:

* Prior treatment with PI3K and/or mTOR inhibitors
* Patients known to have KRAS, NRAS, HRAS, or BRAF genomic alterations in their tumor
* Known condition that prohibits ability to swallow or absorb an oral medication

Other inclusion/exclusion criteria may apply.
Optimized Treatment of Peginterferon Alfa 2a/2b in Treatment Experienced Patients With HBV Related Liver Fibrosis

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment experienced patients with HBV related liver fibrosis.

Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment experienced patients with HBV related liver fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year;
2. Age from 18 to 55 years old;
3. Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
4. Portal vein diameter ≤ 12 mm from liver ultrasound;
5. Receiving treatment of nucleoside/nucleotide analogues at the past one year;
6. Normal liver function;
7. Undetectable hepatitis b virus DNA.

Exclusion Criteria:

1. Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
2. Pregnancy or lactation;
3. Other active liver diseases；
4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
5. Severe diabetes, autoimmune diseases;
6. Other important organ dysfunctions;
7. Patients can not follow-up;
8. Investigator considering inappropriate.
A Study of Complete Molecular Response for Chronic Myeloid Leukemia in Chronic Phase Patients, Treated With Dasatinib

The purpose of this study is to evaluate complete molecular response of Dasatinib in patients for Philadelphia chromosome-positive chronic myeloid leukemia


Eligibility Criteria:
Inclusion Criteria:

* Chronic Myeloid Leukemia in the Chronic Phase
* 20 years old over
* ECOG performance status (PS) score 0-2
* Patients for major molecular response (MMR) with no CMR
* Adequate organ function (hepatic, renal and lung)
* Signed written informed consent

Exclusion Criteria:

* A case with the double cancer of the activity
* Women who are pregnant or breastfeeding
* The case of Pleural effusion clearly
* Patients with complications or a history of severe or uncontrolled cardiovascular failure following

  * have a Myocardial infarction within 6 months
  * have an Angina within 3 months
  * have a Congestive heart failure within 3 months
  * have a suspected congenital QT syndrome
  * have a QTc interval of more than 450msec at baseline
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
* Prior treatment with dasatinib
* Subjects with T315I, F317L and V299L BCR-ABL point mutations
Lantus in Prediabetes

To assess the safety, tolerability, and efficacy of Lantus® (insulin glargine) in prediabetes (IFG or IGT).


Eligibility Criteria:
Inclusion Criteria:

* Hyperglycemia (either IGT , IFG, or untreated type 2 diabetes)
* HbA1c \< 7.0%
* BMI \< 40kg/m2
* Able to perform moderate stationary bicycle exercise

Exclusion Criteria:

* Chronic pharmacologic treatment for hyperglycemia, past or present
* CAD
* serum creatinine \> 2.0mg/dL
* BP \> 180/105
* History of hypoglycemia unawareness
-Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms

The purpose of this study are:

1. to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism
2. to evaluate gender differences in the human pharmacology of MDMA
3. to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults, the recreational use of MDMA on at least ten occasions (two in the previous year), and the EM phenotype for CYP2D6 activity determined using dextromethorphan as a selective probe drug.
* Women had to present a regular menstrual cycle and not take oral contraceptives.

Exclusion Criteria:

* Daily consumption \>20 cigarettes and \>4 standard units of ethanol in men (\>2 in women)
* Regular ingestion of medication in the month preceding the study
* Presence of major psychiatric disorders
* History of abuse or drug dependence (except for nicotine dependence)
* Psychiatric adverse reactions after MDMA consumption.