cyrilzakka/clinical-trials huggingface dataset:
Fibrosis, Valvular and Ventricular Function in Patients With TGA

The aim of this project is to better evaluate the systemic right ventricular (RV) function in patients with transposition of the great arteries (TGA).

Patients with TGA frequently develop supraventricular and ventricular arrhythmia, conduction problems, systemic atrioventricular valve (SAVV) regurgitation, and congestive heart failure (CHF), all at young age. However, there is variation in time of onset of these adverse events. We want to evaluate ventricular and valvular function at rest, markers of RV fibrosis and cardiac reserve.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a TGA
* Informed consent to participate. If the patient is under the age of 18, the assent of the patient and the permission of the parents to participate

Exclusion Criteria:

* Previous double-switch intervention
* Any medical contra-indication for cardiovascular magnetic resonance (CMR) imaging (e.g. pacemaker)
* The presence of exercise-induced arrhythmia, symptomatic myocardial ischemia, a resting systolic blood pressure \> 200 mm Hg and/or diastolic blood pressure \> 110 mm Hg, New York Heart Association (NYHA) class III or IV, or non-cardiac co-morbidity that could aggravate by exercise
* Additional exclusion criterion for delayed gadolinium enhancement CMR: any medical contra-indication for intravenous gadolinium
Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique

This study is proposed to explore the correlation between fatty content of fatty liver and the difference of CT attenuation value in men using dual-energy CT, and to set up a threshold for diagnosis of fatty liver.

This study is proposed to explore the correlation between fatty content of fatty liver and the difference of CT attenuation value in men using dual-energy CT, and to set up a threshold for diagnosis of fatty liver.

Eligibility Criteria:
Inclusion Criteria:

* hepatic tumor
* living liver donor

Exclusion Criteria:

* pregnancy
A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Negative rapid diagnostic test for influenza at baseline;
* Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).

Exclusion Criteria:

* Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
* Influenza vaccination in 6 weeks prior to randomization;
* Positive rapid diagnostic test for influenza;
* Solid organ transplant within 6 months of randomization;
* Antiviral treatment for influenza in 2 weeks prior to randomization.
InSpace™ System Over Rotator Cuff Repair in Comparison to Repair Alone.

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ in the study population in comparison to surgical RCT repair.

The effectiveness will be assessed by comparing the scores of the ASES, Constant and Quick DASH outcome questionnaires with respect to pain reduction, improvement of activity of daily living (ADL) and improvement of range of motion (ROM).

Eligibility Criteria:
Main Inclusion Criteria:

* Age 40 or older.
* Positive diagnostic MRI of the affected shoulder indicating full thickness large to massive RCT of at least 3cm in diameter (according to Cofield classification2) involving one or more tendons. (MRI can be done up to 6 months prior to randomization.)
* Persistent pain and functional disability of the affected shoulder for at least 3 months.

Main Exclusion Criteria :

* Known allergy to the balloon material (copolymer of PLA and -θ-caprolactone).
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of gleno-humeral instability
* Previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Partial-thickness tears of the rotator cuff
"Art Therapy" in Acute Psychiatry

Background: Given the complexity of this problem, psychiatric in-patients in the acute stage of their disease need different types of therapeutic programs to recover they mental health state. Usually they're submitted to systematic biological programs (namely psychopharmaceuticals), often considered a priority when compared to psychosocial programs. Among the different therapies that have been introduced in this context "art therapy", also named creative therapy, can constitute a treatment that complements the allopathic treatments, providing improvements in self-esteem and self-efficiency, distraction and relief from concerns and negative thoughts. Scientific evidence on the effects of psychosocial programs in the context of hospitalization of acute cases is scarce.

Aims: a) evaluate the effectiveness of a 3 session program of "art therapy" in changing emotional indicators, namely depression, anxiety, stress, and psychological well-being, in individuals with mental illness; b) analyze the meanings a person attributes to his creative self-expression.

Method: This is a pre-experimental, prospective study, with a pre test-post test design without control group, with a mixed approach (quantitative and qualitative). The study was performed in the psychiatry unit (Psiquiatria B), in the Centro Hospitalar e Universitário de Coimbra - Portugal. The target population was composed by men (older than 18), hospitalized in this ward. The exclusion criteria were: individuals with active psychotic symptomology, in manic phase and/or refusing to participate. The instruments used to collect information were: Depression, Anxiety and Stress Scale \[DASS-21\]; Ryff Scales of Psychological Well-Being (SPWB - 18 item version) and a semi-structured interview.

Data collection and the development of this study occurred in the following manner:

* Initial evaluation to verify the sample selection criteria in the first 48 hours after patient hospitalization;
* Obtain informed consent for the application of instruments and participation in the "art therapy" intervention program;
* Application of instruments (DASS-21 and SPWB-18 item version) before intervention;
* Development of the program applied as a group, during three weeks, one session a week, each lasting approximately 90 minutes and assisted by a specialist in plastic expression. Each session was held in an occupational therapy room, including all the material deemed necessary for the execution of some of the techniques introduced by the technician. After each session, a semi-structured interview was conducted with each participant in order to analyze the meanings attributed.
* In the end of the program, the same instruments were reapplied.


Eligibility Criteria:
Inclusion Criteria:

* men (older than 18), hospitalized in a psychiatric unit;
* capable of communicating and understanding communication;
* acceptance and commitment to participate in the study;
* signature of study informed consent.

Exclusion Criteria:

* individuals with active psychotic symptomology, in manic phase and/or refusing to participate.
Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex

The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by tDCS will be assessed using both laser stimuli and cold pressor test. In patients the assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular cortex). In patients, three separate conditions (two active and one sham) will be tested in randomised order. In healthy subjects, two other conditions are added to control for attention and distraction confounders.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects aged from 18 to 70 years, male or female, with social security protection, fully informed and having given their written consent.
* patients aged from 18 to 80 years, male or female, with social security protection , fully informed and having given their written consent.
* pharmacoresistant neuropathic pain during at least one year,
* without any change of the pharmacological treatment since at least one month

Exclusion Criteria:

In healthy subjects only:

* history of chronic pain
* analgesic medication within 24h before stimulation

For patients only: new analgesic treatment within 1 month before consent

for both:

* drug addiction, headache, epilepsy
* ferromagnetic intracranial device
* implanted stimulator
* recent neurosurgery and open wound of the scalp.
* absence of contraceptive method for women of childbearing age
National Bank Alzheimer

The Alzheimer's disease (MY) is a major problem of public health. The French National Database Alzheimer ( BNA) registers(records) all the medical acts made by units of memory(report) and of independent specialists in France.

In 2008, the national Plan Alzheimer 2008 - 2012 had for objective to strengthen the search(research) on the Alzheimer's disease (MY) and for related disorders(confusions), to promote an early diagnosis and to improve at the same time the management of the patients and to support careers(quarries). A specific part(party) of this plan gave rise to the creation of the French national database Alzheimer ( BNA) to supply epidemiological data as well as indicators of activity. Since 2009 The information collected(taken in) in the BNA consists of a set(group) limited by data (CIMA of information minimum Corpus Alzheimer) concerning the demographic, clinical and diagnostic data defined by national consensus. The number of variables is limited to facilitate and to improve the participation in this national database. The participants are the Centers Report (CM)((LECTURE)) and Center Memory(Report) of Resources and Search(Research) (CMRR) and independent specialists. In 2015 more than 500 Centers send CIMA to the BNA.

The plan Disease Neurodegenerative 2014 - 2019 wishes to pursue and to amplify the BNA.


Eligibility Criteria:
Inclusion Criteria:

* patients consulting in French Memory Centres

Exclusion Criteria:

-
Evaluation of the Effect Induced by Repeated Administration of Topical Local Anaesthetic (EMLA) on Itch

In this experiment, the investigators would like to study if the repeated application of local cuaneous anaesthetic EMLA cream will reduce itch induced by small needles from the plant mucuna pruriens (also known as cowhage) and histamine (an itch proving substance formed in the body).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other drugs
* Previous or current neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate
* Current use of medications that may affect the trial
* Skin diseases
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
* Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type.
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters

This is a randomized, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via PIVC's may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>19 years old

Exclusion Criteria:

* Not a good candidates for direct-to-media (DTM) technique
Hospital Wearable Defibrillator Inpatient Study

This study will obtain device-human interaction evaluations for the HWD1000 within the controlled environment of the hospital as well as establish that the safety profile is similar to outpatient wearable cardioverter-defibrillators use.

A multi-center prospective study of hospitalized patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period, wearing the HWD1000 hospital wearable defibrillator in order to evaluate caregiver and patient interactions with the device. In addition, ECG signal quality will be reviewed to confirm the HWD1000 safety profile.

Eligibility Criteria:
Inclusion Criteria:

Patients whom a physician deems at risk of sudden cardiac arrest during the hospitalization period (patients will be monitored using the hospital's telemetry system). Specific inclusion criteria are:

* Hospitalized patients having continuous independent ECG monitoring.
* Patients at risk of sudden cardiac arrest during the hospitalization period as determined by the investigating physician.
* Patient ≥18 years of age (over the legal age of providing consent).

Exclusion Criteria:

* Patients with an active implantable cardioverter-defibrillator.
* Patients with an active unipolar pacemaker.
* Patients with physical or mental conditions preventing them from interacting with or wearing the device as determined by the investigating physician.
* Patients having an advanced directive prohibiting resuscitation.
* Patients having bandages or other clinical condition preventing the HWD use.
* Patients unable to consent.
* Patients having recently experienced an arrhythmic storm.
* Patients prone to paroxysmal supraventricular tachycardia.
Gabapentin as Preanesthetic Medication to Fast Procedures in Pediatric´s Oncology

This study is a clinical trial, prospective, randomized and double-blinded. Placebo, Gabapentin syrup at 15 mg/kg, and Gabapentin syrup at 30 mg/kg were administered to reduce agitation before and after in children submitted procedures (myelogram or lumbar puncture) among 1 and 6 years.

Gabapentin syrup at 15 mg/kg and at 30 mg/kg was administered to reduce the agitation before and after oncologic procedures (myelogram or lumbar puncture) in children among 1 and 6 years. Three groups were compared: the control group received placebo, the other two groups received gabapentin at 15mg/kg or at 30mg/kg. All patients received the same protocols (anesthesia and analgesia). Anesthesia protocol used was induction with sevoflurane 8% plus N2O 50% and oxygen, maintenance with sevoflurane 4%. We provided local analgesia with 5% lidocaine creme before the procedure. If it was required, dipyrone 10mg/kg every 6 hours was given as rescue analgesia. To prevent post-operative vomit, ondasentron 0,1mg/kg was administered when intrathecal chemotherapy. The mYPAS scale was used to evaluate preoperative anxiety at several moments: at basal, at after 1-hour administration, at separation from parents, and at induction. The PAED scale was applied after 30 minutes of procedure to evaluate postoperative agitation. The CHIPPS scale was used to assess postoperative pain. The frequency of vomits was recorded for 8 hours after the procedure finished.

Eligibility Criteria:
Inclusion Criteria:

* Cancer or under investigation for cancer.
* Children between 1 and 6 years.
* Previously submitted to oncologic procedures, e.g. myelogram or puncture lumbar.

Exclusion Criteria:

* Cardiac disease.
* Pulmonary disease.
* Renal disease.
* Neurological disease.
* Any allergies.
* Refusal of parents, caregivers or patients to participate in the study.
New-onset Heart Blocks After Noncardiac Surgery: a Retrospective Study of More Than 280,000 Patients

This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.

Objective: This study aimed to investigate new-onset heart blocks after noncardiac surgery, identify risk factors, and develop a prediction model.

Methods: A retrospective cohort study included 281,497 patients aged 18 or older who underwent noncardiac surgery at a single center between Jan 2008 and Aug 2019. The main outcome was postoperative new-onset heart blocks within one year, including atrioventricular and bundle blocks. Prognostic impact was assessed using Kaplan-Meier survival curves and time-dependent Cox regression analysis. Perioperative data was used for machine learning models (logistic regression, support vector machine, random forest, decision tree). Model performance was measured using the area under the receiver operating characteristic curve (AUC).

Eligibility Criteria:
Inclusion Criteria:

* patients above 18 yrs undergoing noncardiac surgery at the First Medical Center of the Chinese People's Liberation Army General Hospital (PLAGH) from January 1, 2008 to August 1, 2019.

Exclusion Criteria:

* surgical duration of less than 30 minutes
* incomplete data
Meal Handling of Advanced Closed Loop Insulin Delivery.

The study will Compare meal related glycemic indices following 2 types of meal announcement:

1. Conventional assessment of carb content plus carb equivalence of proteins and fat
2. Algorithm device optimal universal meal announce equivalent


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 20 to 70 years of age at time of screening
2. Subject's weight is between 50 and 120 kg
3. A clinical diagnosis of Type 1 diabetes as determined by the Investigator for a minimum of 36 months prior to enrollment
4. Subject has ongoing use of an insulin pump and rtCGM ≥ 6 months prior to screening
5. current use of 670G 4.0 pump
6. Subject has an A1C value ≤ 10.0% demonstrated at the time of enrollment.
7. Subject uses a rapid-acting analogue insulin in his/her pump
8. Patient is willing to undergo all study procedures
9. English proficiency
10. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units

Exclusion Criteria:

1. Female subject who has a positive serum pregnancy screening test, or who plans to become pregnant during the course of the study
2. Subject has unresolved adverse skin condition, or unable to tolerate tape adhesive, in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject has a history of hypoglycemic seizure or hypoglycemic coma within the past 12 months
4. Subjects currently taking adjunct therapy with SGLT2-inhibitors, Amylin.
5. Subject has a history of seizure disorder unrelated to diabetes within the past 12 months
6. Gastroparesis, uncontrolled thyroid disorder, Addison disease,. , Pituitary insufficiency
7. Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease within the past 6 months
8. Subject has a presence of a cardiac pacemaker or any other device that may be sensitive to radio frequency telemetry
9. Subject has any condition, including screening lab values that in the opinion of the Investigator may preclude him/her from participating in the study and completing study related procedures
10. Subject is actively participating in other investigational study (drug or device)
11. Subjects who consume alcohol daily
12. Use of CGM (other than per protocol) throughout the duration of the study
13. Use of Hydroxyurea medication
First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133

In this clinical trial we will test a new approach for decolonization of S. aureus.

As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned.


Eligibility Criteria:
Inclusion Criteria

* Must be ≥ 18 years at the time of signing the informedconsent.
* Understand and voluntarily sign an informed consent document prior to any study related
* assessments/procedures.
* Nasal colonization with methicillin-susceptible S. aureus (MSSA)
* Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment until end of study at D15

Exclusion Criteria

* Nasal colonization with methicillin-resistant S. aureus (MRSA)
* Nasal traumata including nose penetrating foreign bodies (e.g. piercings)
* Presence of any significant morbidity, e.g. Diabetes, cardiovascular disease
* Acute or known chronic diseases of the nose or the paranasal sinuses
* Acute or known chronic diseases of other parts of the respiratory tract
* Running nose due to other reasons (e.g. allergic diseases)7. Positive serological HIV, hepatitis A, B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
* Women during pregnancy and lactation.
* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
* Participation in other clinical trials or observation period of competing trials, in the 12 weeks prior to screening.
* Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test
* Systemic antibiotic treatment in the 12 weeks prior to screening.
* Intranasal eradication therapy in the 12 weeks prior to screening.
CPAP/PSV Preoxygenation in Obese Patients

The purpose of this study is to determine whether continuouse positive airway pressure (CPAP), during induction of anaesthesia in morbidly obese patients, result in higher levels of oxygen in the blood.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) \> 35 kg/m2
* scheduled to undergo elective gastric bypass surgery
* age ≥ 18 years
* ASA Physical Status Classification II-III

Exclusion Criteria:

* significant cardiopulmonary disease
* previous abdominal or thoracic surgery
* inability to comprehend the protocol.