cyrilzakka/clinical-trials huggingface dataset:
Opioid Free vs Opioid Based Anesthesia for Laparoscopic Sleeve Gastrectomy

Opioid free anesthesia is an anesthetic technique, in which administration of multimodal analgesia and sympathicolytics provides hemodynamic stability without use of opioids. Such management may be beneficial to the obese patients undergoing laparoscopic sleeve gastrectomy. Our study aims to compare opioid free anesthesia in such patients with standard, short-acting opioid based.

The study has been approved by Bioethical Committee of Medical University of Warsaw. Informed written consent will be obtained from all patients. Sample size of 60 patients has been calculated based on the Altman normogram to obtain 30% reduction of postoperative opioid consumption with significance and power of 90%.

Consenting patients scheduled for laparoscopic sleeve gastrectomy will be randomly assigned to the computer generated list to receive opioid free or standard opioid based anesthesia.

Opioid free protocol includes administration of dexmedetomidine, lidocaine, ketamine, magnesium sulphate whereas standard group will receive remifentanil TCI Minto Model.

After the end of operation all of the patient will receive oxycodone and additional doses via PCA system for postoperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Sleeve gastrectomy in patients with BMI \> 40 or \>35 with comorbidities
* Written informed consent

Exclusion Criteria:

* Patient's refusal
* Known allergies to study medication
* Inability to comprehend or participate In pain scoring scale
* Inability to use intravenous patient controlled analgesia
* Changes of operation extent during procedure
* Revisional operations
Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH

Daily subcutaneous injections of rhGH can be burdensome for patients, leading to poor adherence and reduced growth outcomes. This has spurred the development of long-acting GH (LAGH) analogues that allow for weekly, biweekly, or monthly injections. Previous studies on LAGH analogues have demonstrated their non-inferiority compared to daily rhGH in terms of increasing growth velocity and improving body composition in children and adults with growth hormone deficiency (GHD), respectively, without significant and unexpected adverse events. Since 2020, three molecules have received approval from the Food and Drug Administration (FDA) for the treatment of pediatric GHD: lonapegsomatropin, somatrogon, and somapacitan. These LAGH analogues may offer better patient acceptance, improved tolerance, and greater therapeutic flexibility. However, these LAGH analogues could also be associated with potential clinical issues in terms of therapeutic monitoring, incidence and duration of side effects, and long-term safety due to a non-physiological GH profile. The introduction of these new LAGH products will require clinicians to identify optimal candidates for LAGH therapy and gain knowledge on monitoring and adjusting treatment.


Eligibility Criteria:
Inclusion Criteria:

* Belgian and Luxembourgish patients currently under rhGh treatment in its various official indications (as per the Belgian RIZIV/INAMI monitor : growth hormone deficiency, Turner Syndrome, chronic renal insufficiency, Prader-Willi syndrome, Small for gestational age, Noonan Syndrome, SHOX gene deficiency) and included in the BELGROW Registry
* Male -female
* 0-18 years
* Free written or e-consent and oral consent

Exclusion Criteria:

* No exclusion criteria
Parenting Mindfully Study II

This study will conduct a large Randomized Controlled Trial to test effects of a parenting mindfully (PM) intervention versus a parent education (PE) intervention for highly stressed parents of adolescents.

Parents of early adolescents who report experiencing stress will be randomly assigned to receive the 8 week PM or PE intervention. Before, during, and after the interventions, and at 6 month, 1 year, and 2 year follow-ups (into middle adolescence), the researchers will collect questionnaire, interview, and biological measures of parent stress, parenting, and adolescent substance use and psychological symptoms. At pre- and post-intervention, observed parenting and stress reactivity will be measured in a parent-adolescent interaction task. Some mothers will also complete fMRI sessions at pre- and post- examining emotion-related neurobiological mechanisms.

Eligibility Criteria:
Main Study Inclusion/Exclusion Criteria:

Inclusion Criteria:

1. Family with adolescent between 12-14 years;
2. High stress levels for at least one primary caregiver (referred to as "parents" throughout the application, but not required to be biological parents) on stress screener;
3. Adequate English proficiency to complete questionnaires for adolescent and at least one parent (because several of our questionnaires have not been validated for use in other languages)

Exclusion Criteria:

1. Diagnosis of intellectual disability for adolescent or psychosis for adolescent;
2. Current active suicidality that is untreated for parent or adolescent (We will refer participants with active suicidality for inpatient treatment. They will be eligible to participate in the study once stabilized),
3. Current SUDs that are untreated for parent except Tobacco Use Disorder (because participants must to be able to refrain from substances except nicotine/tobacco during the PAIT lab session day safely without withdrawal symptoms). We will refer parents with active SUDs to treatment. They will be eligible to participate in the study once stabilized and in treatment.
4. Lifetime SUD diagnosis for adolescent because an aim of the study is SUD prevention.

Note: We are recruiting for about 130 of the primary caregiver parents to be eligible in and interested in completing functional magnetic resonance imaging (fMRI) scans are pre and post-intervention. If we do not meet this number, we will restrict recruitment to those families with one parent who is interested in and eligible for fMRI.
Outpatient Nurse Monitoring Under the Prevention of Recurrent Suicidal

To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.

Main objective: To evaluate the impact of a specific nursing management (personalized and close, through consultation at the hospital, at home or by phone) monitoring in post-hospitalization, the suicide attempt of recurrence and suicidal crisis, in the year following a suicide attempt in patients suffering from a mood disorder (unipolar or bipolar) or reactive depression.

Secondary objectives:

Studying during the year following the suicide attempt index, the impact of this device on:

* The frequency and intensity of suicidal ideation
* the spontaneous use of emergency care
* the death rate from suicide and other causes
* the cumulative duration of hospitalization for suicidal behavior
* The patient's quality of life
* the number of patients lost to at the end of search

Studying patient compliance with intensive nursing monitoring program.

To study the role of the nurse to determine the factors that promote the construction of a therapeutic alliance.

Establish a mapping of needs and resources suicidal patient for nursing care in post-emergency.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from a mood disorder (unipolar or bipolar) or reactive depression whose reason for hospitalization in the Psychiatric Emergency Unit Post has attempted suicide

Exclusion Criteria:

* Patients with bipolar disorder, current episode manic in
* Patient Hospitalized full-time (for high suicide risk incompatible with an output of emergencies or clinical transfer) within 3-5 days of the TS
* Patient suffering from a somatic pathology associated with the prognosis is committed in the short term.
* Patients suffering from a neurodegenerative pathology of dementia or pre-dementia types.
* Homeless Patient
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults

This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.

Exclusion Criteria:

* Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
* History of or current persistent drug or alcohol abuse.
Integrative Treatment Methods in COVID-19

This study was conducted to examine the use of integrative treatment methods by individuals undergoing Covid-19. In this study, which was designed in the qualitative and phenomenological type, the criterion sampling method was used and 12 people were included in the sample.

This study was a qualitative type of phenomenological study conducted to examine the use of integrative treatment methods by individuals undergoing Covid-19. The study was completed with 12 people. The data were collected between July and October 2021. The interviews lasted for an average of 25-30 minutes. The data collected with the semi-structured interview form were analyzed by descriptive content analysis method after the interviews were over.

Eligibility Criteria:
Inclusion Criteria:

* individuals who underwent Covid-19 and used any of the integrative treatment methods
* agreed to participate in the study constituted the sample group.

Exclusion Criteria:

-
Pathogenic Species and Genotypes of Bacterial Diversity in Relation to the Severity of Dental Caries

The primary objective of this study is to estimate the distribution of pathogenic species and genotypes of bacterial diversity in 7 stages ICDAS (International Caries Detection and Assessment System) corresponding to the severity of dental caries among patients aged 3-45 years consulting in the Dentistry Departments of the Nîmes University Hospital and the Montpellier University Hospital.

Secondary objectives include:

* Compare the distribution of bacterial species in relation to stages of severity of caries
* Compare the results from plaque with those of saliva samples.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers aged 3 to 45 who come in to the hospital for a dental consultation
* Minors must have parental permission
* The patient must have given his/her informed and signed consent

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is pregnant, or breastfeeding
* The patient has been on antibiotics within the past two months
* Smokers
* Teeth under current care
* Parodontopathy
* Use of a mouthwash within the last week
* Insufficient numbers of healthy and/or teeth with carious lesions for carrying out the study
Semaglutide in CFRD

This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with cystic fibrosis related diabetes (CFRD).

The overall goal of this proposal is to collect pilot data for safety and feasibility metrics to support a future larger randomized controlled trial. In this study, we will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with CFRD. We hypothesize that weekly administration of the long-acting GLP-1RA semaglutide to overweight/obese CFRD patients will be safe and well tolerated.

Specific Aim 1: Collect pilot data on the safety and feasibility of weekly semaglutide therapy in overweight and obese patients with CFRD to support a future larger randomized controlled trial.

Hypothesis 1: Weekly therapy with GLP-1RA semaglutide will be safe and well tolerated in overweight/obese adults with CFRD.

Specific Aim 2: Collect preliminary data to examine the impact of semaglutide therapy on insulin secretion, glucagon and glucose levels as measured by oral glucose tolerance test (OGTT), and on glycemic outcomes as measured by continuous glucose monitoring (CGM) and HbA1c.

Hypothesis 2a: Treatment with semaglutide will lower glucose levels, and increase insulin and C-peptide area under the curve (AUC) during the OGTT as compared to baseline.

Hypothesis 2b: Treatment with semaglutide will improve glycemic control as indicated by time in range on CGM and HbA1c

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects 18 years or older with CFRD and on insulin treatment
* BMI \>26 kg/m2
* Diagnosis of pancreatic insufficiency (based on treatment with pancreatic enzyme replacement therapy)
* A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Oral, injectable, or implanted hormonal contraceptives 3. Intrauterine device 4. Tubal ligation

Exclusion Criteria:

* personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2 (MEN2)
* acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
* gastrointestinal(GI) symptom exacerbation defined by current nausea/vomiting or diarrhea at the baseline assessment
* history of chronic GI problems requiring hospitalization in the 1 year prior to baseline
* history of clinically symptomatic pancreatitis
* history of clinically significant gastroparesis
* history of eating disorders
* less than 24 weeks since start of a new CFTR corrector/modulator therapy
* pregnancy or lactation
* severe CF liver disease
* chronic kidney disease
* history of suicide attempts or active suicidal ideation
* Non-English speakers and those unable to read in English
The Effect of the Mode of Delivery to the Pelvic Floor Function

The childbirth is one of the risk factors for pelvic organ prolapse. In order to prevent the pelvic organ prolapse, the physicians do not routinely advice any exercises after deliveries. The investigators wondered if the mode of deliveries such as ceserean section, vaginal route delivery with episiotomy or vaginal route delivery without episiotomy effect the pelvic floor function differently or not. In order to evaluate this, the investigators are planning to measure the muscle tonus in primiparous women.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous women 5-10 years after birth

Exclusion Criteria:

* Multiparous women Women with connective tissue disorders
Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery

The purpose of this study is to assess shoulder pain at rest (average over the last 24 hours) assessed by visual analogue scale from 0 to 100mm on Day 1.

This is an interventional, comparative, controlled, randomized, single-blind study (the patient will be blinded to the result of the randomization, unlike the investigator) and single-center.

Comparative prospective cohort study of laparoscopic surgery with the addition of specific non-surgical interventions aimed at preventing postoperative shoulder pain (use of local intraperitoneal anesthetics, alveolar recruitment maneuver and compression maneuver abdominal) versus without specific interventions aimed at preventing post-operative shoulder pain.

All patients will benefit from Transversus Abdominis Plane block with multimodal analgesia provided in the usual setting of laparoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Celiosurgery including a Transversus Abdominis Plane block with multimodal analgesia;
* Planned laparoscopic surgery for gallbladder, inguinal hernia, umbilical hernia, incisional hernia repair, adnexectomy, oophorectomy, endometriosis, tube ligation;
* Affiliation to the social security scheme;
* Signed informed consent

Exclusion Criteria:

* Celiosurgery such as colectomy, bariatric surgery, hysterectomy, prostatectomy, nephrectomy;
* Surgical emergency;
* History of chronic obstructive pulmonary disease;
* Weight less than 50 kg;
* Consumption of preoperative opioids;
* Antidepressant treatment and/or anxiolytic treatment;
* Conversion by laparotomy;
* Intraperitoneal sepsis;
* Major intraoperative complication (hemorrhage, anaphylaxis, etc.);
* Other surgical or medical interventions planned during the study;
* Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
* Inability to understand information related to the study;
* Woman who is pregnant or likely to be pregnant (of childbearing age, without effective contraception) or currently breastfeeding;
* Patient deprived of liberty or under guardianship or curatorship or unable to give consent.
Comparison Between the SBK Microkeratome Versus Femtosecond Laser in Flap Creation During LASIK Surgery for Myopia

LASIK is the most commonly performed refractive surgery worldwide. It has been shown to be safe and effective procedure with predictable results over long term follow ups. With the advancement of technology, sub-Bowman keratomileusis allows thin flap of approximately 100 microns thickness thus preserving thicker stromal bed as compared to conventional LASIK. The femtosecond laser corneal flap has th advantage of producing a flap of uniform thickness, adjustable flap diameter, relatively few complications. The disadvantages of this procedure is the high cost of surgery, development of bubbles in the corneal layer and anterior chamber which may affect pupil trackingduring the procedure. Despite the emergence of femtosecond laser-assisted flap creation, mechanical microkeratomes remain the preferred choice in the majority of developing countries. Recent studies have shown that SBK corneal flap has the same advantages as femtosecond laser flap regarding flap uniformity, regularity, and accuracy with less suction time and cost, but with its specific complications as well.

It is a prospective comparative non randomized interventional clinical study

Primary outcomes of this study include:

1. Comparison between the SBK microkeratome versus Femtosecond laser in flap creation during LASIK surgery for myopia using anterior segment OCT (AS-OCT) 1 month after surgery in each group of patients.
2. Measuring corneal flap diameter using (AS-OCT)

Secondary outcomes:

1. Measuring uncorrected and best corrected visual acuity after 1 day, 1 week, 1 month postoperative.
2. Recording any related complications in each group.

Eligibility Criteria:
Inclusion Criteria:

* Myopes (from -1 to -9), with astigmatism up to -4, normal corneal topography, central corneal thickness (CCT) more than 500 microns, and stable refraction for at least 12 months.

Exclusion Criteria:

* CCT less than 500 microns, any ocular pathologies, one eyed patients, history of systemic disease, intraoperative complications, and abnormal corneal topography.
Efficacy of Udenafil After Radical Resection for Sigmoid Colon and Rectal Cancer

The purpose of this study is to evaluate the efficacy of Udenafil (Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In this study, the efficacy of Udenafil will be evaluated in treatment for patient with chronic erectile dysfunction, which developed after radical resection for sigmoid and rectal cancer and continues 12 months after the surgery.

Post-pelvic surgery erectile dysfunction is of much interest to those performing sigmoid colon and rectal cancer surgery and their patients. Erectile dysfunction has been recognized to develop from damage to pelvic parasympathetic nerve, which are especially vulnerable during anterior rectal dissection. There may be also a contribution of psychological factors from the presence of stoma and fear of recurrent cancer. Recently, several studies reported that erectile dysfunction after rectal excision for rectal cancer was completely reversed or satisfactorily improved using oral erectile dysfunction drugs. Udenafil is a new phosphodiesterase type 5 (PDE 5) inhibitor for erectile dysfunction. Prior studies have also demonstrated a selectivity profile for udenafil that is similar to Sildenafil (viagra®) and tadalafil (Cialis®). But unlike tadalafil (Cialis®), it does not significantly inhibit the PDE11 isozyme and not produce significant myalgia. back pain, or leg pain.

This prospective, randomized study was designed to evaluate the efficacy of Udenafil treatment in treatment of erectile dysfunction after radical resection for sigmoid colon and rectal cancer. In order to conduct this study, enrolled patients will be randomly attributed to Udenafil group or placebo group.

Eligibility Criteria:
Inclusion Criteria:

* • Male patients between 19-70 years old in good general health

  * Patient willing to treat postoperative erectile dysfunction and participate in the study
  * Patient who understands and accepts to sign the informed consent form
  * Patient who received radical resection for sigmoid colon and rectal cancer. : erectile dysfunction was developed following operation, not preoperatively
  * Scores of IIEF-5 measured at 12 months after surgery is 16 or less

Exclusion Criteria:

* • Documented problem of preoperative erectile dysfunction

  * Past history of myocardial infarction, cerebrovascular disease
  * Under administration of nitrate
  * Liver dysfunction (SGOT or SGPT 100 IU/L or more)
  * Kidney dysfunction (serum Creatinine 3mg/dl or more)
Genotype-phenotype Correlations in Children and Adults With CTNNB1 Mutation

The aim of this study is to explore and define the correlations between genotype and phenotype in patients with CTNNB1 mutations as well as monitor and survey the natural history of the CTNNB1 syndrome.

CTNNB1 mutation is linked with autism and other neurodevelopmental disorders. So far, there have been 28 studies published describing 71 patients with this syndrome, which leaves much to be yet discovered. The goal of the study is to reach out to the community and include as many families of patients with CTNNB1 syndrome as possible to create a strong and reliable base of information. the investigators are specifically interested in the correlation between different genotypes and phenotypes and the natural course of the disease. The information gathered with this study will help understand CTNNB1 mutations as well as their effect on patient's overall health and wellbeing. The long-term goal is using this information to help create new treatment options, e.g. gene therapy.

The participants will be guided through a detailed questionnaire about the patient's history, prenatal and delivery risk factors, current medical issues and standardized questionnaires on a variety of subjects that constitute the patient's health and daily function. The investigators wil ask the participants to provide results of genetic testing and other diagnostic measures, thus providing the medical community as well as the families of the patients a reliable overview of the syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosed mutation in the CTNNB1 gene.
* Patients whose parents/caregivers were informed about the aims of the study and have signed the Informed consent form.

Exclusion Criteria:

* Patients who do not have a diagnosed mutation in the CTTNB1 gene.
* Patients whose caregivers have not signed the Informed consent form.