cyrilzakka/clinical-trials huggingface dataset:
Oral Melatonin VS Nebulized Dexmedetomidine Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation in Hypertensive Patients

The aim of this study is to compare the efficacy of oral melatonin versus nebulized dexmedetomidine in attenuating the hemodynamic response to direct laryngoscopy and endotracheal intubation in controlled hypertensive patients prepared for general anesthesia

Laryngoscopy and endotracheal intubation are associated with sympathetic stimulation and induce hemodynamic changes with consequent increase in heart rate (HR) and blood pressure (BP) which may lead to myocardial infarction, cardiac arrhythmias, cardiac failure and cerebrovascular accidents in patients with underlying cardiovascular or cerebrovascular diseases.

Dexmedetomidine is a centrally acting α-2 adrenergic agonist with sedative, hypnotic, analgesic, anxiolytic, anti-sialagogue, antinociceptive and sympatholytic action. Premedication with dexmedetomidine through intravenous, intramuscular and intranasal route has been shown to effectively attenuate hemodynamic response to laryngoscopy and endotracheal intubation. Nebulization provides an alternative route of dexmedetomidine premedication with high bioavailability through both nasal (65%) and oral mucosa (82%) and avoids a venipuncture as a prerequisite. Recent studies have shown nebulization as a novel route of dexmedetomidine administration for attenuation of hemodynamic response to endotracheal intubation.

Melatonin is a natural substance produced mainly in the pineal gland of all mammals and vertebrates. It is rapidly distributed and eliminated after intravenous administration. After oral administration, plasma concentration peaks after 60 min and is then eliminated. It exerts its hypnotic effects through the activation of the Melatonin receptors type I and II (MT1, MT2). It has shown potent analgesic effects in a dose dependent manner in experimental studies. It may induce relaxation of the arterial wall smooth muscle by increasing nitric oxide levels. Therefore, premedication with sublingual/oral Melatonin is associated with pre-operative anxiolysis and sedation without impairment of orientation, psychomotor skills, or impact on quality of recovery, moreover, it attenuates the hemodynamic stress response to laryngoscopy and tracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* Age (40-60) years of both genders.
* Controlled hypertensive patients.
* Categorized as ASA physical status II.
* Planning to do an elective surgery under General Anesthesia.

Exclusion Criteria:

* Patient refusal to participate in the study.
* Patient with expected difficult intubation.
* Body Mass Index (BMI) \> 30 kg/m2.
* History of allergy to the drugs of the study.
* Patients with Heart rate\<50 or Heart block.
* End stage renal and hepatic disease.
* Patients on beta blocker, oral hypoglycemics, anti-depressants, anti-convulsants, anti- psychotics and thyroid medications.
* Pregnant or lactating females.
Predictive Value of Intraoperative Ventilatory Leak Flow in Prolonged Alveolar Air Leak After Lung Resection Surgery

After lung resection surgery, patients usually receive a postoperative pleural drain. Prolongated alveolar air leak (PAAL) is a frequent complication after lung surgery (6 to 26% of patients), defined by the European Society of Thoracic Surgeons (ESTS) as a duration of drainage greater than or equal to five days. PAAL is most often due to prolongated bubbling of the drain. Prolonged drainage is a leading cause of prolongated hospital stay, increasing care costs.

The risk of prolongated drainage can not be predicted with sufficient accuracy. Existing risk scores for PAAL do not take into account the intraoperative ventilatory leakage (IVL). IVL is a parameter displayed on the ventilator (anaesthetic machine that make the patient breathing during surgical procedure). There is new evidences suggesting that IVL could predict the risk of PAAL after lung resection surgery, but these data have to be supplemented by a well conducted prospective study.


Eligibility Criteria:
Inclusion criteria:

* To be 18 years old or older
* To be of French nationality or native from an European country affiliated to the French health care system
* To be scheduled for pulmonary resection surgery by videothoracoscopy or thoracotomy in the center of the study

Exclusion criteria:

* Patient minor, or major under legal protection, or enable to give consent
* Refusal or consent withdrawal
* No pulmonary resection or no pleural drain at the end of the surgical procedure (decided by the surgical team)
* Postoperative pleural fistula
Comparative Study Between Millard and Tennison Randall Techniques in Complete and Incomplete Cleft Lip Repair.

"the investigators will compare the quantitative and qualitative (functional and aesthetic outcomes) of these two surgical approaches for repair of the unilateral cleft lip using an evaluation protocol developed many years ago by the research council of Operation Smile, a non- profit organization based in Virginia Beach, USA. Operation Smile delivers charity management of cleft lip and palate cases in many different developing countries around the world. Under this protocol, a dual rating system has been developed with two scores: one preoperative score concerning the severity of cleft and one score for the postoperative results.

One of the common congenital malformations in the head and neck is cleft lips. The prevalence of cleft lip is about 1:1000 of live birth; it also more common in boys and tends to present on the left side with a 6:3:1 ratio of left to right to bilateral. Many facial malformations, including cleft lip, are linked with environmental, maternal, and genetic factors, such as exposure to teratogen drugs, including isotretinoin, alcohol, or anticonvulsants. Similarly, some habits or diseases during pregnancy increase the risk of the cleft lip as smoking, pregestational and gestational diabetes, and specific nutritional deficiencies. The treatment begins soon after the child's birth and continues until adulthood. The purpose of cleft treatment is aesthetic and functional rehabilitation. Surgical repair is important for facial growth preservation, normal speech formation and development of proper dentition. The less number of interventions, the less the scaring results and hence, growth retardation Nowadays, the most commonly used techniques in managing unilateral cleft lip (UCL) are Millard's rotation advancement and Tennison Randall's triangular flap repairs. This study aimed to use anthropometric analysis by anthropometric measurements taken pre and post operation to evaluate the quantitative assessment of the modified Millard technique compared with the Tennison Randall technique in UCL repair.

Eligibility Criteria:
Inclusion Criteria:

* Patients are generally fit
* Patients with unilateral with or without cleft palate
* Patients with compliance for follow up.

Exclusion Criteria:

* Syndromic cases.
* Patients are generally unfit.
* Secondary cleft lip.
* Age less than 3 months, more than 4 years
* Bilateral cleft lip.
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy

The main purpose of this study is to test the safety and tolerability of different, increasing doses of an experimental medication called HT-100 in boys and young men with Duchenne muscular dystrophy (DMD). The study medication, HT-100, is a medicine that may help promote healthy muscle regeneration, diminish inflammation and the resulting damage to muscle, and decrease the scar tissue that forms in the muscles of children with DMD. In this study, pharmacokinetic sampling, or measurements of the amount of HT-100 in the bloodstream will also be taken.


Eligibility Criteria:
Main Inclusion Criteria:

* Ambulatory or non-ambulatory
* Diagnosis of DMD with confirmation of minimal to no dystrophin
* Corticosteroid naive or on therapy for at least 12 months (stable dose and regimen)

Main Exclusion Criteria:

* Recent, substantial change in use of cardiac medications or medications affecting muscle function
* Inability to undergo magnetic resonance imaging (MRI)
* Significantly compromised cardio-respiratory function
* Prior treatment with another investigational product in past 6 months
Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer

This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors. The study design consists of a dose-escalation stage and dose-expansion stage. Study participation will consist of a 28-day screening period, a treatment period, and a safety follow-up period 90-days after the last dose.

Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-7354 safety and tolerability in patients with relapsed and/or refractory solid tumors. The dose expansion serial biopsy cohort will assess the intra-tumoral PD changes related to the activity of IGM-7354.

IGM-7354 will be administered intravenously (IV).

Eligibility Criteria:
Key Inclusion Criteria:

* Age \> 18 years at time of signing ICF
* ECOG Performance Status of 0 or 1
* Histologic or cytologic documentation of incurable, locally advanced or metastatic solid tumors for which standard therapies are not available, are no longer effective, are not tolerated, or have been declined by the participant
* Participants with either measurable or evaluable disease
* Adequate organ function
* At least 2 weeks prior to Day 1 or 5 half-lives, whichever is shorter, must have elapsed from the use of anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy
* Participants must be willing to have pre-treatment and on-treatment tumor biopsies for biomarker evaluation

Key Exclusion Criteria:

* Inability to comply with study and follow-up procedures
* Prior IL-15, IL-2, synthetic IL-2, or IL-2v based therapy
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Palliative radiation to bone metastases within 2 weeks prior to Day 1
* Major surgical procedure within 4 weeks prior to Day 1
* Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* Diagnosis of immunodeficiency
* Current Grade \>1 toxicity from prior therapy. Participants with current Grade 2 chronic toxicities that are well-controlled by medications may be enrolled after discussion with medical monitor
Emotion Recognition in Benign Epilepsy of Childhood With Centro-Temporal Spikes (BECTS)

The social processes depend on complex cognitive mechanisms, which involve mainly the frontal and temporal lobe regions. Patients with early onset frontal and temporal lobe lesions might later develop important deficits in social integration. Accordingly, children with early onset temporal lobe epilepsy (TLE) demonstrate altered emotion recognition.

Study design: Multicentre, Case-control study.

Emotion recognition is a first step for the development of the capacity to judge the thoughts, intentions, and desires of others. In infants, the capacity to identify, distinguish, and interpret emotions is limited, but these processes are developing rapidly and innately during the first years of life, on the same neural bases as those described in adulthood. Children with BECTS show altered social behavior. In fact, deficit in social cognition could derive from brain dysfunction in the frontotemporal regions primarily affected in BECTS, since these regions are also viewed as playing an important role in social cognition and development of social skills.

The investigators hypothesized that children with BECTS might have altered social cognitive skills and underlying neural networks.

Eligibility Criteria:
Inclusion Criteria:

* children diagnosed with active BECTS (e.g. having at least one seizure with epileptiform abnormalities at EEG)
* treated or not with anti-epileptic drugs; age range between 6 and 11
* infants who have not presented an epileptic seizure within 48 hours before the psychodiagnostic evaluation
* patients with a sleep EEG recording; MMSPE (Mini Mental State Pediatric Examination) ≥23.3

Exclusion Criteria:

* mental retardation
* presence of other neurological or severe neuropsychiatric disorders
* atypical EEG pattern (awake or asleep)
A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2

The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)


Eligibility Criteria:
Key Inclusion Criteria:

* Capable and willing to provide written informed consent or assent
* Documented diagnosis of PH1 or PH2, confirmed by genotyping
* Must meet the 24 hour urine oxalate excretion requirements
* Less than 20% variation between the two 24-hour urinary creatinine excretion values derived from the two 24-hour urine collections in the screening period
* Estimated GFR at screening ≥ 30 mL/min normalized to 1.73 m2 BSA

Key Exclusion Criteria:

* Renal or hepatic transplantation (prior or planned within the study period)
* Currently on dialysis or anticipated requirement for dialysis during the study period
* Plasma oxalate \>30 µmol/L
* Documented evidence of clinical manifestations of systemic oxalosis (including pre-existing retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations)
* Use of an RNA interference (RNAi) drug within the last 6 months
* Participation in any clinical study in which you received an investigational medicinal product (IMP) within 4 months before Screening
* Liver function test (LFT) abnormalities: Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5 times upper limit of normal (ULN) for age and gender
* Inability or unwillingness to comply with study procedures
Characterization of Sweat Gland Function in Patients With Recessively Inherited Hypohidrotic Ectodermal Dysplasia

Hypohidrotic ectodermal dysplasia (HED) is a complex genetic disorder characterized by lack of sweat glands, sparse hair, and missing or malformed teeth. Inability to sweat may result in episodes of severe hyperthermia and cause sudden infant death. To assess sweat gland function in HED patients, the investigators will first quantify gland pores in a defined area of the palm and then stimulate the glands by pilocarpine followed by sweat collection in a special capillary for volume determination. This will be combined with non-invasive skin conductance measurement prior and subsequent to stimulation of the sympathetic nervous system. The data should provide a basis for genotype-phenotype correlation.


Eligibility Criteria:
Inclusion Criteria:

* for patients: hypohidrotic ectodermal dysplasia caused by mutations in the genes EDA or EDAR
* written informed consent

Exclusion Criteria:

* febrile disease
* pregnancy or breastfeeding
* implantable electronic devices, e.g. pacemaker
* hypersensitivity to self-adhesive electrodes
Periarterial Injection Versus Multiple Periveural Injection

In the transarterial technique for axillary brachial plexus block, the axillary artery is intentionally punctured to indicate placement of the needle within the neurovascular sheath; local anesthetic is then injected deep and superficial to the axillary artery.

To lessen the risk for hematoma and intravascular injection, several modifications, such as the multi-injection perineural technique, have become popular. These techniques require a high degree of technical skill and multiple needle passes, and also carry potential for injury. In this study, the investigators will compare an ultrasound-guided equivalent of the transarterial technique (periarterial injections) to a commonly used multi-injection perineural technique.

Eligibility Criteria:
1. Inclusion criteria:

   - Patients (ASA physical status I-III) scheduled to undergo hand or wrist surgery under axillary brachial plexus block
2. Exclusion criteria:

   * Patients with pre-existing neuropathy
   * Patients with allergy to local anesthetics
   * Patients with prior surgery in the ipsilateral axilla
   * Pregnant patients
   * Patients with difficulties in communication
Functional Connectivity Measurement After Severe Traumatic Brain Injury

To compare functional connectivity after severe traumatic brain injury (TBI) between a group of post-comatose TBI with restored consciousness and a group of post-comatose TBI with persistant disorder of consciousness at admission in rehabilitation

Recovery of consciousness can be impaired in severe traumatic brain injury (TBI). Prognostic factors are sparse and mostly clinical (mainly the initial Glasgow coma scale GCS) (1). Functional magnetic resonance imaging (fMRI) could allow a better understanding of functional recovery. Graph method has been applied to fMRI signal analysis in disorder of consciousness (DOC) due to post-anoxic encephalopathy. Comatose state was characterized by dramatic change in local connectivity (hub location) without significant change in global connectivity (2). The present study aims at describing functional connectivity in DOC following severe TBI. We will record resting state fMRI in TBI patients in two clinical conditions: conscious state versus DOC state.

Eligibility Criteria:
Inclusion Criteria:

* severe TBI
* no general anesthesia since 7 days
* no neuroleptic nor hypnotic drug since 3 days
* medical criteria fulfilled to be discharged from ICU
* medical insurance

Exclusion Criteria:

* age \< 18
* contra indication to MRI
* consent refusal from the family
* neurological trouble before TBI
* patient protected by law
Experimental Peri-implant Mucositis in Humans

This is a pilot study. The investigators hypothesize that the peri-implant soft tissue response to de novo plaque accumulation is similar to that of normal gingival tissue in the same subjects.

The investigators propose to conduct a controlled clinical trial to evaluate peri-implant soft tissue response to de novo plaque accumulation in comparison to the response of gingival tissue in the same subjects


Eligibility Criteria:
Inclusion Criteria:

-Male and Female ³21 years of age.

Oral site specific inclusion criteria:

* 1) Presence of 2 implants in the maxillary or mandibular arch supporting fixed restorations in function for at least 1 year (Test)
* 2) Presence of 2 teeth in the corresponding position of the implant (Control); -3) Absence of active infections at both test and control sites
* 4) Absence of radiographic bone loss at both test and control sites
* 5) Pocket depth ≤4mm at both test and control sites
* 6) must give written informed consent.

Exclusion Criteria:

* 1) Treatment with antibiotics for any dental or medical condition within 1 month before screening
* 2) Systemic diseases that require chronic use of anti-inflammatory medications, antibiotics or anticoagulants
* 3) Ongoing medications for systemic conditions initiated \<3 months before the start of the study or the requirement to take prophylactic antibiotics for invasive dental procedures
* 4) Significant organ disease including impaired kidney function, heart murmur, rheumatic fever, bleeding disorder
* 5) Active infectious diseases such as hepatitis, tuberculosis and HIV
* 6) Clinically detectable caries and periodontal disease
* 7) Tobacco use of any kind
* 8) Use of medications affecting periodontal status (diphenylhydantoin, cyclosporine etc.)
* 9) No pregnancy or lactation or expectation to become pregnant within next 3 months.

Participants will be excluded from the study or analysis if any of the following occur during the study: 1) Changes in the patient medical status or medications that met the exclusion criteria; 2) Use of antimicrobial rinses; 3) Use of irrigating devices; 4) Subject noncompliance with stent wearing during the experimental mucositis/gingivitis phase and/or Vitamin C use; 5) Use of anti-inflammatory drugs or antibiotics; 6) allergic history to common toothpaste or mouth rinse ingredients.

Acute use of acetaminophen will be permitted.
Megestrol Acetate Plus LNG-IUS in Young Women With Endometrial Atypical Hyperplasia

To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate or LNG-IUS alone in patients with endometrial atypical hyperplasia.

After diagnosed of endometrial atypical hyperplasia (EAH) by hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids and anti-müllerian hormone(AMH) will be performed before treatment to evacuate their metabolic conditions.

Patients are randomized to 1 of 3 treatment groups. Patients will receive MA (megestrol acetate) 160 mg by mouth daily for at least 3 months on Arm I. Patients will receive LNG-IUS insertion on Arm II and MA 160 mg plus LNG-IUS insertion on Arm III. Then an hysteroscope will be used to evaluate the endometrial condition every 3 months, and the findings will be recorded. For patients with EAH, complete response (CR) is defined as the reversion of endometrial atypical hyperplasia to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the appearance of endometrial cancer in patients. Continuous therapies will be needed in PR, NR or PD.

After completion of study treatment, 2 months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Primarily have a confirmed diagnosis of endometrial atypical hyperplasia based upon hysteroscopy
* Have a desire for remaining reproductive function or uterus
* Need to be able to undergo correlative treatment and follow-up

Exclusion Criteria:

* Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
* Pregnancy or suspicion of pregnancy
* Have a history of EAH and have disease relapse during Merina insertion
* Under treatment of high-dose progestin therapy more than 3 months in recent 6 months
* Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
* Confirmed diagnosis of malignant tumor in genital system
* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
* Hypersensitivity or contradiction to any component of this product
* Ask for removal of the uterus or other conservative treatment
* Smoker(\>15 cigarettes a day)