cyrilzakka/clinical-trials huggingface dataset:
Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake

The aim of the study is to assess gastro-intestinal tolerance, palatability, compliance, and use of a high caloric, high protein oral nutritional supplement (ONS) in elderly people


Eligibility Criteria:
Inclusion Criteria:

1. Sex: male/female
2. Age: 65 years or older
3. Body-mass index (BMI): ≥ 16.0 kg/m² and ≤ 30.0 kg/m²
4. Subjects with an indication for ONS of approx. 400 kcal per day for at least 7 days
5. Written informed consent

Exclusion Criteria:

1. Existing gastrointestinal diseases or pathological findings, which do not allow enteral nutrition
2. Subjects with galactosaemia or similar metabolic disorders
3. Subjects with severely impaired gastrointestinal function or complete failure
4. Subjects with insulin-requiring diabetes
5. Subjects with acute diarrhoea (defined as ≥ 3 loose or watery stools per day)
6. Subjects reporting frequent occurrence of migraine attacks
7. Subjects with acute or (current) chronic diseases, which might lead to impaired gustatory sense (e.g. sinusitis, anosmia)
8. Existing mouth abnormalities, which cause impaired gustatory sense
9. Subjects who report impaired gustatory sense (e.g. due to intake of concomitant medication)
10. Subjects passing through chemotherapy (last cycle \< 2 months ago)
11. Known allergic reactions or intolerance to any ingredient used or to constituents of the ONS
12. Subjects with severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical study by the investigator
13. Consumption of any additional ONS, enteral nutrition via tube or parenteral nutrition
14. Subjects with need of a special diet contradicting the intake of the ONS
15. History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders
16. Subjects with dysphagia or with high aspiration risk
17. Enrolment in another clinical study
18. Administration of any investigational medicinal product during the last month prior to individual enrolment of the subject
19. Subjects who are not able to self-report GI-problems and compliance
20. Subjects who report a general dislike of the ONS flavour
21. Subjects for whom a hospitalisation for rehabilitation or surgery during the study is planned
22. Subjects suspected or known not to follow instructions
23. Subjects unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical study
Affective and Cognitive Responses to Acute Bouts of Physical Activity and Mindfulness Training

The purpose of the present study is to investigate the benefits of mindfulness training during an acute bout of physical activity. We will compare the combination of mindfulness training and physical activity to mindfulness training alone and physical activity alone in three 20 minute sessions.

We will investigate whether mindfulness training during a single bout (20 minutes) of physical activity influences ratings of perceived exertion, feeling states and physiological response (blood pressure and heart rate) during physical activity. Changes in affect and cognitive function pre- and post- physical activity bout will also be assessed. The effects of mindfulness training during an acute bout of physical activity will be compared to mindfulness training alone and acute physical activity alone. This research will contribute to larger questions of how to increase rates of physical activity in the general population and make physical activity more enjoyable.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in spoken and written English
* Have access to internet to complete baseline and post-study assessments

Exclusion Criteria:

* Respiratory, joint, or cardiovascular problems precluding physical activity participation
* Fail the Physical Activity Readiness Questionnaire (PAR-Q) and are unable to obtain physician consent to participate
Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke

The objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.

As for transcranial direct current stimulation a HDC kit (ATES/EB NEURO, Firenze, Italy) will be used as device. It is a new device generation of stimulator able to provide an effective stimulation pattern.

As robotic device the InMotion wrist robot (Interactive Motion Technologies Inc., Watertown, MA, USA) will be used. It is an end-effector robotic device able to assist as needed the wrist movements.

Eligibility Criteria:
Inclusion Criteria:

1. persons affected by first supratentorial stroke, whose onset time is 25±7 days;
2. upper limb hemiparesis;
3. cognitive and speech abilities sufficient to understand instructions and to provide informed consent;
4. absence of intense pain due to passive wrist mobilization assessed by VAS \< 3 (range 0-10);
5. ability to provide written informed consent.

Exclusion Criteria:

1. previous epilepsy seizures;
2. severe electroencephalographic anomalies;
3. previous neurosurgery interventions involving metallic elements placement;
4. ongoing anticonvulsant drugs treatment
5. inability to keep sitting posture;
6. severe sensory deficits;
7. general clinical complication preventing delivery of rehabilitation treatment.
Effect of Infraclavicular and Interscalen Block on Oxygenitaon of the Forearm

to research the oxygenitaon effects of infraclavicular and interscalene blocks on the forearm.

To research the oxygenation effects of infraclavicular and interscalen blocks on the forearm by comparing the blood flow (BF) values using the USG, Perfusion index (PI) and Near infrared spectroscopy (NIRS) values using the massimo device.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18-65
* ASA Score I-III
* undergoing elective or emergency arm, elbow and forearm surgery

Exclusion Criteria:

* Patient's refusal for Brachial Plexus Blockage
* Patients who had any neurological disorders preventing the evaluation of the sensory block in the upper extremity,
* Infection in the area to be blocked with ICB or ISB,
* Non-cooperated patients
* Patients with coagulopathy,
* Morbidly obese patients
* Patients with diabetes mellitus
* Patients with hypertension
* Patients with peripheral artery disease
* Patients with allergy to the drugsto be used
* Patients who had trauma in the area scheduled for the block
* Paitens who had deterioration of anatomical integrity because of previous surgery
* Pregnant women
* Patients whose block failed
Single-Sided Deafness in the Medicare Population

The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.

The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older at the time of implantation
* Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
* Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz
* Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less
* Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
* Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
* Fluent in English

Exclusion Criteria:

* Duration of profound hearing loss of 10 years or more
* Sudden onset of hearing loss within six months of implantation
* Evidence of non-functional cochlear nerve or other retrocochlear hearing loss
* Evidence of severe cochlear malformation (i.e., common cavity or ossification)
* External or middle ear infection
* Suspected cognitive concern
* Other medical contraindication for surgery or anesthesia
Impact/Interest of a Collective Prevention Intervention in Sexual and Emotional Health

Main objective To measure the effects of a group prevention intervention on the sexual and affective knowledge of high school students in the Basse-Normandie region.

Secondary objective Take stock of what is known about the sexual and emotional health of teenagers.

With the average age at first sexual intercourse in France being 17.6 for girls and 17.2 for boys, according to the 2010 health barometer, sexuality education and prevention seem essential at this age, and upstream.

An Australian qualitative study of young men aged 18 to 24 revealed that the main obstacles to discussing sexual health in general practice included the possibility of embarrassment and the fact that the subject was private. Most said they would only talk to their doctor about a sexual problem if it was very important or urgent: if not, they would prefer to wait for the doctor to initiate the subject.

Sexual health prevention initiatives are therefore essential outside the general practitioner's office, and have been shown to be effective in high schools. This is why the PSLA de la Grâce de Dieu has initiated sexual and emotional health prevention initiatives for students at a high school in Caen.

It therefore seemed interesting to assess these students' knowledge of sexual and emotional health before the PSLA's intervention in the amphitheatre with the students, and then after the intervention, in order to find out whether this large-scale prevention action had an impact on these students' knowledge, in the short and medium term.

Eligibility Criteria:
Inclusion Criteria:

* school students in the 2023-2024 school year

Exclusion Criteria:

* A newsletter was sent to the school's head teachers, the students' parents and the students themselves, informing them of the possible use of the data for research purposes, and the possibility of objecting. The principal teachers provided information on the non-obligation to respond during the distribution of the questionnaires. Students who did not respond to the questionnaire were therefore not included.
The Effects of a Music Therapist Designed Listening Program on Intraoperative Vitrectomy

This will be a prospective, randomized controlled trial with patients randomly assigned to either the experimental or control group. The experimental group will be exposed to the independent variable (IV) and the control group will not be exposed to the IV. The IV will be a music therapist- designed listening program during surgery. A total of 60 patients will be consecutively enrolled and undergo block randomization to either a music listening group or a control group (no music). Trained medical research personnel will assist with various parts of the study and will be defined as those individuals who have completed and are up-to-date on the Collaborative Institutional Training Initiative (CITI) training. These individuals will consist of a board certified music therapist, practicing ophthalmologists, and physicians-in-training.

This prospective trial will block randomize a consecutive cohort of patients undergoing routine vitrectomy surgery at an university hospital to a designed listening program during surgery or to nothing in order to determine whether music listening during surgery can measurably result in decreased patient pain assessed by the Wong-Baker Faces Pain scale. Secondary outcome measures will be blood pressure, need for anxiety medication, postoperative pain medication, and patient overall experience.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria will consist of patients already scheduled for elective vitrectomy surgery at a tertiary academic university hospital.

Exclusion Criteria:

* Exclusion criteria consist of: patients with deafness or unilateral or bilateral severe hearing loss, unwillingness or inability to complete post-surgical surveys, previous vitrectomy surgeries, diagnosed anxiety disorder (claustrophobia, etc.), and/or chronic narcotic or substance abuse.
Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea

The investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (CDSS) not only to detect the presence of sleep apnea but also to predict its severity. The CDSS is based on deploying an artificial neural network (ANN) derived from anthropomorphic and clinical characteristics.

The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be diagnosed with the use of ANN without undergoing a sleep study, and that empiric management with auto-CPAP has similar outcomes to those who undergo a formal sleep study.


Eligibility Criteria:
Inclusion Criteria:

* Must be an adult (≥18 years old)
* Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider.

Exclusion Criteria:

* Pregnancy or breast feeding
* Patients with severe congestive heart failure (eg, NYHA Class IV, ejection fraction \< 35%).
* Patients with end-stage renal disease on hemodialysis
* Patients with CVA, Parkinson, neuromuscular degenerative disease.
* Patient on narcotics.
* Patients with severe lung disease requiring oxygen at night and/or during the day.
* Patient with predominant insomnia or sleep hygiene problems, and who are not considered for PSG by the sleep specialist.
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma

The small insulinoma can not be detected by the CT or MRI. We use 68Ga-NOTA-exendin-4 positron emission tomography/computed tomography (PET/CT) to detect the insulinoma for the patient diagnosed with endogenous hyperinsulinemic hypoglycaemia. And the diagnostic value will be performed. A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

The glucagon-like peptide-1 receptor (GLP-1R) is an emerging target due to its high expression in benign insulinomas. 68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The clinical use of 68Ga-NOTA-exendin-4 PET/CT in detecting insulinomas will be evaluated. And the comparation between PET diagnostic value and CT / MRI will be done.

Eligibility Criteria:
Inclusion Criteria:

* 1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent

Exclusion Criteria:

* 1. Breast feeding 2.Pregnancy or the wish to become pregnant within 6 months 3.Renal function: serum creatinine during 41-73umol/L 4.Any medical condition may significantly interfere with study compliance; 5.Known allergy
Hospital Workplace Nutrition Study

The purpose of this study is to evaluate the effects of a plant-based diet on body weight, blood pressure, and plasma lipid concentrations, as part of a hospital workplace program.

Using a randomized controlled trial design, participants will be randomly assigned to either a plant-based or a control diet for 12 weeks. T Before and after each intervention period, the investigators will measure participant body weight, blood pressure, and plasma lipid concentrations.

Eligibility Criteria:
Inclusion Criteria:

1. Employee of Sibley hospital
2. Male or female
3. Age at least 18 years
4. Have a BMI \>25 kg/m2
5. Ability and willingness to participate in all components of the study
6. A willingness to follow a plant-based diet for the duration of the study
7. A willingness to attend weekly classes for the duration of the study
8. A willingness to keep physical activity level consistent throughout the duration of the study

Exclusion Criteria:

1. Diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or Cushing's syndrome
2. Smoking during the past six months
3. Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
4. Current or unresolved past drug abuse
5. Pregnancy or plans to become pregnant in the next 12 weeks
6. Intention to leave hospital employment in the next 12 weeks
7. Unstable medical or psychiatric status
8. Evidence of an eating disorder
9. Lack of English fluency
10. Inability to maintain current medication regimen
Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia

The planned randomized, sham-controlled, double-blind, monocentric study aims to evaluate the effectiveness of intermittent Theta-Burst Stimulation (iTBS) on negative symptoms and cognitive deficits in schizophrenia. Both the cerebellar vermis and the left dorsolateral prefrontal cortex will be stimulated successively within the same session.

The goal of this trial is to learn if intermittent theta-burst stimulation (iTBS) of the cerebellum and the left dorsolateral prefrontal cortext (DLPFC) can treat negative symptoms and improve cognition in patients with schizophrenia. The main question it aims to answer is:

Does iTBS of the cerebellum and the left DLPFC improve negative symptoms in patients with schizophrenia? Researchers will compare iTBS to sham stimulation to see if iTBS improves negative symptoms.

Participants will:

* Receive 10 sessions of iTBS over the course of 2 weeks
* Undergo extensive examination before iTBS treatment, immediately after iTBS treatment and 4 weeks after iTBS treatment. The examination includes assessment of negative symptoms; psychometric assessment of cognition, social cognition, depressive symptoms; functional magnetic resonance imaging; assessment of eye movements; blood and saliva sampling; assessment of adverse events and stimulation associated sensations.

The study thus seeks to determine whether iTBS of the fronto-cerebellar network might improve negative symptoms and cognition by altering the network's functional activity. Additionally, it will investigate whether a pro-inflammatory cytokine profile could affect iTBS outcomes and whether inflammatory markers could be affected by iTBS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia (ICD-10: F20.-)
* Age: 18-65 years
* Ability to give informed consent
* Signed informed consent form

Exclusion Criteria:

* Any electronic implants
* Non-MRI-compatible metal implants (e.g., pacemaker, cochlear implant, insulin pump, metal fragment injuries, work in the metal-processing industry)
* Non-TMS-compatible metal implants (compatible items include: earrings, piercings, dental fillings, crowns, implants)
* Claustrophobia
* Epilepsy
* History of traumatic brain injury within the last 3 months
* History of stroke
* Active central nervous system (CNS) infection
* History of CNS infection within the last 3 months
* Pregnancy
* Current drug, medication, or alcohol abuse
* Simultaneous participation in another clinical trial
* Planned changes in psychopharmacological medication within the next 2 weeks
* Severe physical illnesses that could endanger the patient, affect the examinations or make the MRI scanning cause additional burden
Efficiency of Deep Transcranial Magnetic Stimulation on Patients With Mild Cognitive Impairment

This is a first feasibility study in order to test if deep Transcranial Magnetic Stimulation (TMS) treatment with high frequency (10Hz) will improve the symptoms of patient MCI (Mild Cognitive impairment). The hypothesis of the study is that high frequency treatment with deep TMS will improve the daily functioning of patients who suffers from MCI.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women 50-80 years of age.
2. Self reporting of the patient about memory deterioration, without any damage of daily lify functioning.
3. Scored of one standard deviation below the average (according to standardization of age and years of schooling) in the memory index and Mindstream test, without any major damage of other cognitive function)
4. score \>= 24 in MMSE (Mini Mental State Examination) test.
5. Preserved Cognitive and executive functioning, without dementia according to DSM -IV
6. Lack of other reason for memory deterioration like acute affect disorder or other neurological disorders, according to the doctor diagnosis.
7. Score of maximum 0.5 in the Clinical Dementia Rating. in this test the score of the memory index will be 0.5 or 1, and not more then 1 point in two other index of this test.
8. Capable and willing to provide informed consent.

Exclusion Criteria:

1. Any other Axis I diagnosis as the primary diagnosis
2. Any medications that can cause a risk of seizure. for instance, anti psychotic medication, high dosage of anti depression medication
3. History of non tolerance for TMS treatment
4. Diagnosis of Severe personality disorder according to DSM-IV
5. current suicidal tendency
6. Uncontrolled hypertension
7. History of epilepsy, seizure, or heat convulsion
8. History of epilepsy or seizure in first degree relatives
9. History of head injury or stroke
10. History of metal implants in the head (except dental fillings)
11. History of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps
12. History of drug or alcohol abuse
13. Inadequate communication with examiner
14. Participation in another clinical study, either concurrent with this trial or in the 3 months preceding it
15. Inability to sign a consent form
16. Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse
Post-Operative Voiding After Gynecological Surgery Trial

To determine whether partially filling the bladder after outpatient gynaecological laparoscopy expedites time to first void and discharge. Methods: A single site, single-blinded, randomized control trial in which eligible patients undergo partial retrograde bladder filling immediately post-operatively compared to bladder drainage and foley catheter removal. Primary outcome is time to first void, secondary outcomes include time to discharge, post-operative complications and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Undergoing elective laparoscopy for a gynaecological indication
* Plan for same day discharge
* Able to provide informed consent

Exclusion Criteria:

* Pregnancy
* Undergoing procedure for pelvic organ prolapse, stress urinary incontinence, or nerve detrapment
* Prior hysterectomy, or incontinence/pelvic organ prolapse procedures
* Pre-existing voiding dysfunction
* Known recurrent urinary tract infections
* Known genito-urinary malformations
* Known for neuromuscular disorders such as multiple sclerosis
* Use of anticholinergic medication
* Intraoperative bladder related complications
* Need for discharge with indwelling foley catheter
* Patients requiring overnight admission for any reason