cyrilzakka/clinical-trials huggingface dataset:
16-week Flexible vs. 8-week Semaglutide Titration

Semaglutide is a Glucagon Like Peptide 1 (GLP-1) receptor agonist recently approved in Israel to improve glycemic control in patients with type 2 diabetes mellitus. Semaglutide is currently administered as a weekly subcutaneous injection.Treatment with semaglutide is associated with the occurrence of gastrointestinal adverse events (GI-AEs) commonly observed during GLP-1 receptor agonist treatment. The most common adverse reactions, reported in ≥5% of patients treated with semaglutide are nausea, vomiting, diarrhea, abdominal pain and constipation.

In this trial we plan to explore the effect of a slower titration regimen of semaglutide vs. the current label-recommended dose escalation regimen on the occurrence of GI-AEs.


Eligibility Criteria:
Inclusion Criteria:

* Have personally signed and dated the informed consent form indicating that he/she has been informed of all pertinent aspects of the trial.
* Be willing and able to comply with the scheduled visits and other study procedures.
* Meet one of the following categories:

  1. The subject is a male.
  2. The subject is a female who is not of reproductive potential, defined as a female who either: (1) is postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.
  3. The subject is a female who is of reproductive potential and agrees to avoid becoming pregnant: while receiving study drug and for 60 days after the last dose of study drug by complying with one of the following: (1) practice abstinence† from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity. Acceptable methods of contraception are‡:

Single method (one of the following is acceptable):

* non-hormonal intrauterine device (IUD)
* vasectomy of a female subject's male partner

Combination method (requires use of two of the following):

* diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)
* cervical cap with spermicide (nulliparous women only)
* contraceptive sponge (nulliparous women only)
* male condom or female condom (cannot be used together)

Exclusion Criteria:

* Has a known contraindication to use of GLP-1 agonists.
* Has been treated with a GLP-1 agonist in the last 30 days.
* Has a history of type 1 diabetes mellitus
* Has a medical history of untreated active proliferative retinopathy.
* Has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or blinded investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
HIFEM for Arms, Lower Limbs, and Oblique Muscles

Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.

This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily signed informed consent form
* BMI ≤ 30 kg/m2
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
* Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Cardiac pacemakers
* Implanted defibrillators, implanted neurostimulators
* Electronic implants
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Application in the head area
* Application in the heart area
* Malignant tumor
* Injured or otherwise impaired muscles
* Fever
* Pregnancy
* Sensitivity or allergy to latex
* Breastfeeding
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation
* Scars, open lesions and wounds at the treatment area
* Unrepaired abdominal hernia
* Patients after Cesarean section delivery
The Purpose of the Study is to Investigate if a Smartphone App Combined With Internet Based Cognitive Behavioural Therapy (ICBT) Leads to Improved Symtoms in Depressive Adults on Antidepressive Medicine, Compared to a Wait-list Control Condition

The purpose of the study is to investigate if a smartphone app combined with internet delivered cognitive behavioural therapy (ICBT) leads to improved symptoms in depressive adults on antidepressive mediation. The participants in the treatment group will get access to a smartphone app based on CBT-principles for 9 weeks. They will also get access to an internet platform with extra treatment material based on CBT and receive therapist support on demand. Participants will be recruited in Sweden with nationwide recruitment.

This study is a randomized controlled trial with the aim to investigate if an smartphone app in combination with ICBT can help adults (+18) on antidepressant medication who still suffers from depressive symptoms. Participants will either be randomized to a treatment phase for 9 weeks or to a wait-list control. The treatment primarily contains the installation and usage of a smartphone app where the participants can engage in a serious mobile game based on CBT-principles. They will receive access to a secure internet platform where they can find general guidelines about the app, and extra treatment modules (to use if needed). They will receive support on demand from a therapist during the whole treatment period.

Primary outcome measure is depressive symptoms (measured on the MADRAS scale). Secondary outcome measures will include measures of anxiety and quality of life. Pre-treatment measurement, post-treatment measurement, weekly measure, and 24 \& 36 months follow up is planned to be collected through an online survey.

Eligibility Criteria:
Inclusion Criteria:

* Ongoing drug treatment with an antidepressant mediated by an established care contact in (primary) care.
* 18 years or older.
* Be able to speak, read and write Swedish.
* Have access to a computer, tablet or other device with internet connection and smartphone to download the app.

Exclusion Criteria:

* Severe psychiatric or somatic problems that make participation difficult or impossible
* Ongoing abuse (via Audit and during interview)
* Acute suicidality
* Other ongoing psychological treatment or planned investigation.
* Planned dose change of medicine or change of medicine during pre-measurement.
Effects of Etomidate on Postoperative Circadian Rhythm Changes of Salivary Cortisol in Children

Etomidate is an unique drug used for induction of general anesthesia and sedation. Adrenal cortical inhibition by etomidate has received much attention. However wether the circadian rhythm and pulse secretion pattern of cortisol in children are the same as that in adults is not known. Moreover, the effect of etomidate on circadian rhythm changes and clinical outcomes has never been carefully studied in children undergoing surgery. Our hypothesis is that etomidate can relieve the changes of circadian rhythm of salivary cortisol in children for 24-48 hours，and this does not make clinical outcomes worse postoperatively.

* Sample size assessment: Using formula to calculate the total number is 30.
* Statistical analysis: ANOVA
* Reporting for adverse events: During the period of study, if there is any severe adverse event happening, such as severe infection, severe low cortisol concentration threatening the patient's life we will stop the trial.

Eligibility Criteria:
Inclusion Criteria:

* 3-12 years old who are plan to undergo surgery

Exclusion Criteria:

* endocrine disease, blood infusion, having fever, ulcer or bleeding in the oral cavity
Prevention of Gastrostomy-Related Wound Infection by Vancomycin in Carriers of Methicillin-Resistant Staphylococcus Aureus.

The aim of this study is to determine whether vancomycin with cefazoline is superior to vancomycin with placebo in preventing gastrostomy-related wound infection in carriers of methicillin-resistant staphylococcus aureus (MRSA).

Percutaneous endoscopic gastrostomy (PEG) provides an enteral route for long-term nutrition in patients unable to swallow. Peristomal wound infection occurs in 5 - 30 % of patients. Systematic antibiotic prophylaxis by cephalosporins or ampicillin/clavulanic acid has been shown to prevent this complication efficiently.

MRSA-positive patients have been suggested to be at higher risk of PEG-related wound infection due to MRSA. However, recommendations about vancomycin-prophylaxis before surgical procedures have not been extended to PEG insertion. This might be due to the fact that the exact route of contamination is unknown. It is assumed that contamination occurs when gastrostomy tubes are passed through the oropharynx. However, oropharyngeal carriage appears less frequent than nasopharyngeal or cutaneous carriage. Furthermore, patients who receive PEG are particularly vulnerable to vancomycin toxicity because of older age and multiple comorbidities.

The aim of this study is to compare the rate of infectious complications after PEG insertion in patients colonized with MRSA who received either standard intravenous antibiotic prophylaxis associated with vancomycin or standard prophylaxis with placebo.

Eligibility Criteria:
Inclusion Criteria:

* PEG insertion in a patient with a swab positive for MRSA during the 4 weeks preceding PEG insertion

Exclusion Criteria:

* Age \< 18 years
* No informed consent obtained either from the patient or from his legal representative
* Contraindication to the administration of cefazolin or of vancomycin
* Systemic administration of antibiotics effective against MRSA during the week prior to the procedure
* Technique of PEG insertion different from the standard pull technique proposed by the physician in charge and the gastroenterologist
* Patients requiring antibiotic prophylaxis of endocarditis
Primebrain Stimulation

Background : Brain vulnerability is particularly marked in preterm neonates and has long-term consequences. Unlike lesions affecting other organs, those that affect the brain can currently not 'be repaired' by producing new cells. However, exeprience-driven brain plasticity allows the brain to reorganise its connections to compensate (at least partially) the effects of an injury.

Purpose : To evaluate the influence of Primebrain stimulation programme administred by parents until 6 months post-term on motor and neurophysiological development of infants born \<32 weeks' gestation or with birth weight \<1500 g.

Preterm and very low birth weight infants are at risk for neurodevelopmental disorders, including cerebral palsy, sensory impairment and intellectual disability. Several early intervention approaches have been designed in the hope of optimising neurological development in this context. These programmes show high variety in the type of intervention, frequency of sessions and total duration of the intervention, as well as the duration of follow-up. Depending on studies, there is an inconstant benefit on cognitive and behavioural development in the first 2 years and preschool age. According to the most recent studies, it seems important that the intervention takes into account parental mental health, focuses on parent-child interactions and lasts sufficiently long.

This prospective randomized-controlled clinical study has been designed to evaluate the effects of an additional parent-administed programme to the usual care in this developmental risk population,.

The intervention is carried out at home by parents coached by physiotherapist from term-age to 6 months of corrected age. The monitoring and evaluation period for all infants participating in the study ends at 24 months of corrected age and includes clinical, neurodevelopmental, parental stress and neurophysiological assessments using high density electroencephalography and recording of event-related potentials at term age, 3, 6, 12 ,18 and 24 months of corrected age (ActiveTwo, BioSemi).

Eligibility Criteria:
Inclusion Criteria:

* Infants born before 32 weeks of gestation or with a birth weight less than 1500 grams

Exclusion Criteria:

* Severe congenital malformation (cerebral, cardiac or within a syndrome)
* Neurodevelopmental genetic syndrome
* Cytomegalovirus, rubella or toxoplasmosis congenital infection
* Neonatal hypothyroidism
* Peripheral neurological disorder or congenital muscular disorder
* Neurodegenerative disorder
Gastroesophageal Reflux and Cardiorespiratory Problems

Cardiorespiratory and gastroesophageal reflux events often coexist in infants in Neonatal Intensive Care Unit (NICU) thus leading to drugs over-prescription and delayed discharge.

Through cardiorespiratory and pH-impedance monitoring this study aims to evaluate the temporal association between gastroesophageal reflux (GER) and cardiorespiratory (CR) events in a large number of infants with gastroesophageal reflux disease (GERD) and CR symptoms and, whether this association is significant, to clarify the impact of GER on CR events.

This is an observational retrospective study to describe the association between cardiorespiratory (CR) and gastroesophageal reflux (GER) events in infants who underwent synchronized 24h Multichannel Intraluminal Impedance/pH-metry (MII/pH) and CR monitoring for GER disease symptoms and CR events. Data are collected from medical records and database of the University Neonatal Intensive Care Unit of the Sant'Anna-Regina Margherita Children Hospital (Turin).

The symptom association probability (SAP) index is used to identify those infants with significant associations between GER and CR events. In the group of infants with a positive SAP index the differences in reflux characteristics are compared according to whether a reflux preceded or followed a cardiorespiratory event (30 s time window).

Eligibility Criteria:
Inclusion Criteria:

* synchronized MII-pH and cardio-respiratory monitoring lasting more than 12 hours, excluding meal periods;
* exclusive enteral feeding
* parents' informed consent

Exclusion Criteria:

* infectious, genetic, metabolic and neurological diseases
* ventilatory support and/or oxygen supplementation at the time of MII-pH/CR monitoring
* pharmacological therapies with effects on GER or apnoea during the week before MII-pH/CR monitoring
Use of Semen TEX101 to Improve Sperm Retrieval Rates for Men With Non-obstructive Azoospermia

The investigators hypothesize that sperm production varies with time in men with no sperm in semen (non-obstructive azoospermia, NOA) and that the semen protein, TEX101, is able to monitor these changes. The investigators further hypothesize that TEX101 levels may be used to predict the optimum time for microsurgical testicular sperm extraction (mTESE) to provide the highest successful rates of sperm retrieval.

This is a non-randomized pilot study. All men with NOA, who may or may not consider having mTESE, will be approached to enter this study.

Recruited men will have a semen test performed at the initial visit (time 0) to measure semen TEX101 levels using an ELISA assay.

For men who are not considering a mTESE to retrieve sperm, the TEX101 semen levels will be measured monthly for three months to determine the variability of semen TEX101.

For men who are considering a mTESE in an attempt to retrieve sperm, the mTESE procedure to retrieve sperm will be booked. If the level of TEX101 is detectable at time 0, then the men will have semen testing monthly. If the TEX101 is persistently detectable then the men will have surgery at the time originally scheduled. If the TEX101 drops on any subsequent test to be undetectable, then the semen testing for TEX101 will continue monthly for a maximum of 3 additional months. If the TEX101 remains undetectable for all tests, the men will have the mTESE at the end of the additional 3 months. If the TEX101 is detectable on a subsequent test, then the men will undergo an immediate mTESE (\< 2 weeks).

If the initial TEX101 is undetectable, then the men will have monthly semen testing for TEX101 for a maximum of 3 additional tests. If the TEX101 remains persistently undetectable, then a mTESE will be performed as originally booked. If the TEX101 is detected on a subsequent test, then an immediate mTESE (\< 2 weeks) is performed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with NOA by standard clinical means with a minimum of 2 semen tests confirming that the man is azoospermic
* Ability to understand the study and consent
* Ability to deliver semen samples

Exclusion Criteria:

* Men do not have NOA
* Cannot understand the study and consent
* Cannot provide semen samples
Flutamide In the Prevention of Prostate Cancer in Patients With Neoplasia of the Prostate

RATIONALE: Chemoprevention therapy is the use of certain drugs such as flutamide to try to prevent the development of cancer. Flutamide may be effective in the prevention of prostate cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of flutamide in preventing prostate cancer in patients who have neoplasia of the prostate.

OBJECTIVES: I. Determine the ability of flutamide to reduce the incidence of prostate cancer in patients with high grade prostatic intraepithelial neoplasia. II. Determine the effect of this regimen on a series of endpoint biomarkers in these patients. III. Assess the quality of life of these patients.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to age (under 65 versus 65 and over), PSA (0-2.5 versus 2.6-4.0 versus 4.1-10 versus greater than 10 ng/mL), PIN (on one biopsy versus on two biopsies), and family history (prostate cancer in brother, father, or uncle versus no prostate cancer in these relatives). Patients are randomized to one of two treatment arms.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed high grade prostatic intraepithelial neoplasia Confirmed by second prostate biopsy within 180 days of first biopsy No prior or concurrent prostatic carcinoma No prior hormonal replacement or antiandrogen therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Greater than 5 years Hematopoietic: Not specified Hepatic: SGOT and alkaline phosphatase no greater than 2 times upper limit of normal No hepatitis B or C or liver cirrhosis Renal: Not specified Other: Fertile patients must use effective contraception No other prior malignancy in past 5 years except carcinoma in situ or nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: No prior radiotherapy Surgery: Not specified
Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills

The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural African American (AA) adults in South Carolina (SC) for assessing the usefulness of tablet-based resources in good diabetes self-management behaviors, and (2) to test a tablet-aided intervention for improving diabetes self-management behaviors

The proposed study will assess the feasibility of recruitment of African American adults residing in rural South Carolina who will assist with improving the usability of tablet computers. In addition, we will implement a pilot trial of the TABLETS (Tablet-Aided BehavioraL intervention Effect on Self-management skills) intervention for diabetes, using motivational strategies, among rural African Americans. The proposed project is designed to address 3 important issues: recruitment for a hard-to-reach population, utility of technology-enabled intervention, and development of a tablet-aided intervention tailored to understand best practices for diabetes self-management

Eligibility Criteria:
Inclusion Criteria:

* Age ≥45 years
* Clinical diagnosis of diabetes with HbA1c ≥8% and either diagnosis of hyperlipidemia with LDL \>100mg/dL or hypertension with BP \>140/80mmHg
* Self-identified as African American
* Residence in a 4G cellular service area
* Able to communicate in English

Exclusion Criteria:

* Cognitive impairment
* Active alcohol or drug abuse/dependency
* Acute decompensation of chronic conditions precluding participation
* Participation in other diabetes clinical trials
* A life expectancy \<6 months
A New 3D Geometrical Modelisation of Adolescent Idiopathic Scoliosis and Conception of a Personal Brace

Adolescent idiopathic scoliosis (AIS) involves complex tridimensional deformities of the spine. In case of progressive curve deformity, the use of spinal bracing remains the standard non operative treatment of moderate AIS. Most of the time, the different types of braces don't take into account the individual biomechanical properties of each patient's spine. Actually, it is essential to better understand the effect of the loads applied on the trunk and on the spine, and a 3D geometrical modelisation of these components is essential. Many studies have been publishing concerning the use of radiographs for the geometrical reconstruction of the spine, and more recently the EOS system. But even then, it is still necessary to obtain an important number of geometrical data and discretisation is still a long procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 years
* Pre menarchial for the girls
* Risser 0 et Risser 3 on X rays. Radiologic classification of spine maturity (ossification of the iliac crests). Five stages.
* Cobb angle ≥25° and \< 40°
* Information to the parents and child, and signed approval

Exclusion Criteria:

* No idiopathic scoliosis
* Previous brace treatment
* Immediate indication for surgery
* Previous thoracic surgery
Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation

The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery.


Eligibility Criteria:
Inclusion Criteria:

* Full term gestational period (37 weeks gestation or greater)
* minimum of 2.5kg or greater body weight
* diagnosis of single ventricle physiology, or complex congenital cyanotic heart disease requiring staged palliation surgery in the form of Norwood-type procedure, systemic-to-pulmonary artery shunt, or pulmonary artery banding.

Exclusion Criteria:

* Have diseases affecting other organs,
* have major congenital anomalies such as Hirschsprung disease, imperforate anus, CHARGE syndrome, or VACTERL association.