cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Medasense Pain Monitor Performances

In this study, the performances of Medasense's non-invasive pain monitoring is compared with standard pain related indicators, such as heart rate, galvanic skin response, etc. , and with a subjective pain level assessment. The subjective pain level is assessed by the anesthesiologist when the patient is under general anesthesia and by the patient and a nurse in post anesthetic care unit (PACU).

The study is based on recording and analyzing the subject's physiological signals, while recording painful events, medication dosing and different clinical signs.

Pain is an unpleasant sensation, ranging from slight discomfort to intense suffering. Since pain is a subjective phenomenon, it has frequently defied objective, quantitative measurements. Today, in order to measure pain, subjective uni-dimensional scales are used to quantify pain. One of the most common scale used to rate a patient's pain intensity is the visual analog scale (VAS), usually scored from 0 to 100. Hitherto, those scales are based on the subjective evaluation of pain by the patient.

During anesthesia the patient cannot communicate and therefore the verbal or other report is impossible. Therefore, due to misrepresentation of the existence or extent of pain, care providers may fail to estimate the correct measure of pain and give too much or too little medication. A scoring system of pain level is therefore needed. That is the problem Medasense's system tries to approach.

In this study investigators intend to test and analyze the performances of Medasense pain monitor by comparing its results with standard pain related indicators and with subjective patient's pain level assessment. The patient's pain level will be assessed by the anesthesiologist during surgery based on known pain stimuli, medications administered and clinical signs, and by the PACU nurse and patient's reports, when the patient is in recovery.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-2
* Elective surgery under general anesthesia
* Baseline blood pressure \< (170\\100 mmHg), heart rate \< 100 bpm

Exclusion Criteria:

* Pregnancy or lactation
* History of severe cardiac arrhythmias
* Presence of any neuromuscular or neurological disease
* Use of central nervous system (CNS) -active medications
* Abuse of alcohol or illicit drugs
* History of mental retardation or any mental disease
* Any severe lung, liver, renal disease and uncontrolled diabetes mellitus
* Use of a α or β-adrenergic antagonist or anticholinergics
* Allergy to any of the drugs to be used during surgery
* Use of regional anesthesia
Effectiveness Study of GSK Biologicals' Rotarix TM Vaccine in Hospitalized Children

The purpose of this study is to assess vaccine effectiveness of Rotarix in preventing rotavirus severe gastroenteritis among hospitalized infants, in Belgium.


Eligibility Criteria:
Inclusion Criteria:

For confirmed cases:

* A male or female child born after 01 October 2006 and at least 14 weeks of age at the time of hospital admission.
* Child admitted at the study hospital for SGE during the study period.
* Onset of SGE ≤ 14 days prior to admission.
* Written informed consent obtained and signed from the parent or guardian of the child.
* Stool samples collected during the first 48 hours of hospitalisation and then tested positive for RV by PCR.

For controls:

* A male or female child born after 01 October 2006 and at least 14 weeks of age at the time of the hospital admission or visit to the hospital outpatient clinic.
* Hospitalised or visiting the hospital outpatient clinic for non-GE causes at the same hospital during the same time-period, as the probable case.
* Born within ±2 weeks from the date of birth of the case. If the list of children born within ±2 weeks is exhausted, then the range will be extended to ±4 weeks. In case a suitable control is not found even then, the range will be extended to ±6 weeks.
* Written informed consent obtained and signed from the parent or guardian of the child.

Exclusion Criteria:

For cases:

* Child has previously participated as a case or a control in this study, either in the same hospital or in another study hospital.
* Onset of SGE \>48 hours after admission to the hospital (nosocomial infections).
* Child with a condition where rotavirus vaccination would be contraindicated.

For controls:

* Child has participated in the past as a case or control in this study, either in the same hospital or in another study hospital.
* Child who has symptoms of GE/ SGE during current hospital stay/ visit to the hospital outpatient clinic or on the day of interview of his/her parent or guardian.
* Child with a condition where rotavirus vaccination would be contraindicated.
A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma


Eligibility Criteria:
Inclusion Criteria:

* At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the Europe: Male or female between 18 and 70 years of age, inclusive.
* Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Grade 2 (6-15 cells) or Grade 3 (16-30 cells) in the study eye that are without any treatment or with Stable Medical Therapy requiring further treatment.
* Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eye using Early Treatment Diabetic Retinopathy Study (ETDRS).

Exclusion Criteria:

* Pregnant or breastfeeding females or females.
* History of or active significant ocular disease in either eye.
* Uncontrolled intraocular pressure (IOP; defined as \>27mmHg) or narrow angle glaucoma in either eye and/or are at risk of angle closure with dilating.
* Poor posterior view due to limitation of dilation or media opacity that limits ability to examine the posterior segment.
* Cancer or melanoma that is actively treated with immunotherapy.
* Certain clinically significant systemic diseases or conditions.
* Receiving specific medication/interventions as specified per protocol.
Characterization of Hepatopathy in Turner Syndrome: Analysis of Determinants

The present study is therefore aimed at investigating the prevalence of hepatic alterations (laboratory and imaging) in adult patients with TS and generating hypothesissto the possible etiopathogenetic factors most involved, as well as evaluating the correlation between biochemical and structural abnormalities.

Thus, the study could provide relevant etiopathogenetic and prognostic results on the development of hepatopathy in TS patients.

The study is an observational retrospective cohort type; patients with TS in longitudinal monitoring at the U.O.C. of Endocrinology and Diabetes Prevention and Care, DIMEC, of IRCCS Policlinico S. Orsola of Bologna will be enrolled. The diagnosis of TS was made for most patients by the Pediatrics unit of Policlinico S. Orsola; in rare cases it was performed in adulthood by our operating unit or at another center; in all cases, the diagnosis was made by karyotype analysis on peripheral blood.

The patients, as per clinical practice, underwent clinical evaluation with measurement of anthropometric parameters; an evaluation of the patients' medical history will be performed, paying attention to possible diagnosis of metabolic comorbidities and autoimmune diseases. Complete information regarding the history of menstrual cycles and replacement therapies used will also be collected. Finally, laboratory investigations are planned.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Turner syndrome made by karyotype analysis on peripheral blood.
* Age 18 years or older
* Written informed consent obtained

Exclusion Criteria:

* TS patients on therapy with drugs responsible for significant liver enzyme alterations (liver function alteration, LFA).
Assessment of FibbroScan in Diagnosing MASLD Among the Chinese Population With Obesity

The non-invasive evaluation of liver steatosis and fibrosis with FibroScan is a routinely procedure in clinical practice for people with obesity. However, there are still considerable uncertainties regarding the potential influence of confounding factors and the optimal application of cut-off values for obesity.

The goal of this observational study is to learn about the optimal application of cut-off values of for Chinese people with obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older who provided written informed consent
2. Patients who schedule to undergo bariatric surgery and a liver biopsy (LB) for the investigation of suspected MASLD
3. Patients who schedule to undergo FibroScan examination

Exclusion Criteria:

1. Patients with ascites or pregnant women
2. Patients with any active implantable medical device (such as a pacemaker or defibrillator)
3. Patients who have undergone liver transplantation
4. Patients with cardiac failure and/or significant valvular disease
5. Patients with haemochromatosis
6. Patients who have refused to undergo LB or blood tests
7. Patients with a confirmed diagnosis of active malignancy, or other terminal disease
8. Patients participating in another clinical trial within the preceding 30 days
Cereal-based Products Fortified With Legumes and Effects on Glycemic Control and Appetite Regulation

Legumes are rich source of proteins and dietary fibers which are associated with satiety and amelioration of postprandial glycemic response. The purpose of the study is to examine the effects of cereal-based products fortified with legumes on appetite regulation and body weight management.

Postprandial glycemic response as well as response of hormones related to appetite regulation after consumption of cereal-based products fortified with legumes will be evaluated. Apparently healthy subjects with normal body weight and overweight subjects will participate in the study (two protocols). Certain effects on metabolites related to the composition of the different products will be examined. The results of the study will help in the design of a long-term clinical trial regarding the effects of the functional products on body weight management in overweight subjects.

Eligibility Criteria:
Inclusion Criteria:

* normal exercise and dietary habits
* weight stable for at least 3 months before enrollment

Exclusion Criteria:

* pregnancy
* diabetes
* chronic medical illness
* use of nutritional supplements
* regular intense exercise
* alcohol consumption \>2 drinks per day
Pilot Study: Active Video Gaming to Facilitate Physical Activity and Quality of Life in Kidney Transplant Recipients

Background:

Renal transplant recipients have a greater risk of morbidity and mortality primarily due to cardiovascular disease when compared to the general population. Cardiovascular disease is responsible for 50% to 60% percent of deaths amongst renal transplant population and death from cardiovascular disease is a leading cause of functioning graft loss.

Physical activity is an effective form of secondary prevention in existing cardiovascular disease reducing all-cause mortality by 25%-30% and has demonstrated positive effects overall on quality of life and well-being. Transplant patients who participated in regular cardiovascular exercise have significant more positive scores on the SF-36 Health Status Questionnaire in comparison to inactive transplant recipients.

Active video gaming is evolving as an innovative method to increase physical activity. Active video gaming has supported physical activity in children and youth. There is however a paucity of literature examining interactive games as a means to facilitate physical activity and its impact on CVD and quality of life in the adult population nor any literature examining AVG and its impact on an adult surgical population.

This pilot study is designed to determine if Active Video Gaming is feasible and is able to lead to behavioral modifications and Quality of Life improvement.

Subject Selection:

This is a pilot study during which 10 patients who have undergone renal transplant will be selected to exercise with Active Video Gaming for a duration of 3 months. The program activity will begin 6 months post surgery.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant patient who want and are able to take part in this study

Exclusion Criteria:

* Cardiac or pulmonary dysfunction diagnosed through preoperative assessment.
* Any surgical complication incurred with transplantation.
* Peripheral vascular disease.
Ovarian Reserve After Cancer: Longitudinal Effects

Women of reproductive age who will receive treatment for cancer that includes chemotherapy may participate in a study measuring ovarian function over time. Eligible women are asked to complete a questionnaire, a menstrual diary, a brief physical examination, an ultrasound, and a blood test before, during and after cancer treatment.

A total of 7 study visits will be completed at 3 month intervals including 1 visit prior to treatment, and at least 2 visits after completion of treatment. Duration of study participation is 18-30 months, depending on length of treatment.

Review and Documentation of Cancer Therapy will be abstracted from the clinical oncology chart by the oncology offices caring for the patient. Treatment will be summarized in terms of chemotherapeutic type, duration and cumulative dose; total radiation dose and location; history and type of bone marrow transplantation; and any surgery. Any attempts at fertility preservation or use of gonadotropin releasing hormone agonist treatment during cancer therapy will be captured as well.

Eligibility Criteria:
Inclusion Criteria for exposed population:

* Postmenarchal females to be treated with chemotherapy
* between the ages of 11-35 years,
* with a uterus and at least one ovary

Inclusion Criteria for unexposed population:

* healthy postmenarchal females
* no prior or planned exposure to chemotherapy
* between the ages of 11-35,
* with a uterus and at least one ovary
* regular menstrual cycles (21-35 days)

Exclusion criteria for all subjects:

* positive pregnancy test at enrollment
* lactation within the previous 1 month,
* previous treatment with chemotherapy or radiation therapy with the exception of radioactive iodine for thyroid cancer.
* previous diagnosis of an illness associated with premature ovarian failure (Turner's syndrome, Fragile X permutation carrier)
* endocrine disorder associated with irregular menstrual cycles (Cushing's disease, Thyroid disease, hyper-prolactinemia, congenital adrenal hyperplasia).

Additional exclusions for the unexposed population:

* a history of infertility, defined as at least 12 months of unprotected intercourse without conception
* polycystic ovary syndrome (PCOS)
RESTIT : Evaluation of Resorbable Osteosynthesis Devices Versus Titanium in Maxillofacial Surgery

Primary objective : To evaluate the quality of fractures setting and osteotomy of the facial massif osteosynthesised with resorbable device PLLA/PGA compared with usual Titanium plates.

Secondary objective :

* To evaluate the resorbable device ergonomy versus Titanium.
* To evaluate the clinical tolerance of resorbable device versus Titanium.

Hypothesis :

Osteosynthesis with resorbable device demonstrates a non inferiority success probability regarding the success observed in osteosynthesis with Titanium, with a less important probability of re-operation.

Study duration : 14 months for each patient.

Study treatment :

* Group I : Resorbable device PLLA/PGA.
* Group II : Titanium device.

Study visits :

- Screening visit - Baseline with randomization and surgery - Day1 - Day 21 - Day 45(Traumatology)/Day 90 (orthognatic) - Month 6,12 and 14.

Randomization : Stratification by centres, mono or bimaxillar surgery and traumatologic or orthognatic criteria.


Eligibility Criteria:
Inclusion Criteria:

* 18\<Age\<50.
* One or more fractures of facial massif requiring a surgical setting with osteosynthesis plates.
* One or more osteotomy of facial massif requiring a surgical setting with osteosynthesis plates.
* Orally and written informed patient. Patient willing to participate the study.
* Signed informed consent.

Exclusion Criteria:

* Any previous surgery at the same operative site.
* Patient suffering from chronic affection which could interfere with bone consolidation.
* Corticotherapy, immunosuppressive or anticonvulsant treatment or long term antibiotherapy.
* Nursing or pregnant female.
* Patient with a high risk of non compliance to sudy visits.
* Unconscious patient.
Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)

The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe® Mapping and Ablation System for treating patients with atrial fibrillation.

Upon successful enrolment, subjects will be scheduled for mapping and radiofrequency (RF) ablation. Cardiac CT imaging, echocardiography and baseline 12-lead ECG will be performed pre-procedure for screening and health assessment. During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by RF ablation to achieve pulmonary vein isolation (PVI). Additional lesions will be created as deemed appropriate by the investigator. Intracardiac electrogram mapping will be used to confirm PVI during the procedure. Echocardiography will be performed at discharge to assess cardiac function. Electrocardiograms by 12-lead ECG and 7-day Holter monitoring will be recorded at discharge, and 3, 6 and 12 months after treatment. Follow-up assessments will be performed at discharge, 7 days, and 1, 3, 6 and 12 months after treatment, to track freedom from documented AF and adverse events. Subject-reported AF symptomology and quality of life will also be assessed during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for ablation, with a documented history of symptomatic paroxysmal atrial fibrillation
* Between 18 and 80 years of age, inclusive

Exclusion Criteria:

* Patients who have contraindications to open heart surgery
* Patients from an Intensive Care Unit
* Patients requiring concurrent right atrial ablation or who have had previous left atrial ablation
* Previous cardiac procedure or known abnormalities that would interfere with device delivery, position, or treatment efficacy
* History of a documented thromboembolic event or bleeding abnormalities
* Contraindication to anticoagulation therapy
* Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
* Anatomy that would prevent safe and appropriate introduction or delivery of the Globe device into the patient
Non Invasive Diagnosis of Pneumocystis Pneumonia

Incidence and morbi-mortality of Pneumocystis pneumonia (PCP) are increasing. Early and fast diagnosis and treatment improve PCP prognosis. Biological diagnosis is based on the detection of Pneumocystis jirovecii, mainly by PCR, in broncho-alveolar lavage (BAL) obtained from bronchial fibroscopy. However this invasive exam is not always possible in emergency in suspected patient and others non invasive (sputa) and/or non-targeted (bronchial aspiration) are sent to the laboratory (25% of cases, data from the Grenoble University Hospital). Diagnosis performances of these non invasive/non-targeted samples are not clearly established.

In this study, the investigators aimed to establish the diagnosis value of non-invasive and/or non-targeted respiratory samples (oral fluids, sputa and bronchial aspiration) for the PCP diagnosis, compared to the gold-standard (Pneumocystis PCR on BAL, beta-D-glucans testing on serum and radio-clinical records).


Eligibility Criteria:
Inclusion Criteria:

* Immunocompromised patient with (i) clinical and/or radiological suspicion of PCP, and (ii) bronchial fibroscopy with contributive BAL
* No immediate life-threatening conditions (estimated life expectancy \>12h)
* No PCP treatment or PCP treatment \< 48h
* Patient hospitalized in the Grenoble Alpes University Hospital with medical insurance
* Informed and written consent of the patient or its related

Exclusion Criteria:

* Pregnancy, breastfeeding
* Exclusion period of another clinical trial
* Deprivation of liberty
Effect of Mechanical Loading With PTH on Cortical Bone

Clinical trial to investigate effect of voluntary upper extremity loading in combination with anabolic osteoporosis therapy.


Eligibility Criteria:
Inclusion Criteria:

* women aged 45+
* postmenopausal
* osteoporotic with high risk of fracture

Exclusion Criteria:

* no significant previous use of bone health modifying treatments
A Clinical Study of Theta Burst Stimulation (cTBS) in the Treatment of Insomnia Disorder Targeting the Dentate Nucleus of the Cerebellum

Insomnia disorder (ID) is a significant public health problem worldwide, with nearly a third of the general population experiencing insomnia symptoms in their lifetime. Therefore, finding a safe, effective, and easy-to-use non-pharmacological method for treating ID is urgent. Repetitive transcranial magnetic stimulation (rTMS) has been used to varying degrees in many neurological and psychiatric diseases and has broad application prospects for treating ID.θ-burst stimulation is characterized by cluster stimulation.Continuous stimulation (cTBS) mainly has inhibitory effects on the cortex. The inhibition of motor-evoked potentials can last for 60 minutes, which is longer-lasting, has a lower stimulation intensity, and is shorter in duration than traditional rTMS. There are no reports on clinical studies of cTBS treatment for ID. So far, sleep research has mainly focused on the interconnections between the neocortex and subcortical structures, while cerebellar activity has been largely overlooked.The mechanism of rTMS treatment for insomnia with the cerebellum as the target is unclear. This study proposes to apply cTBS mode to the cerebellar dentate nucleus for rTMS treatment in patients with ID to explore its effectiveness and safety in improving insomnia disorder.


Eligibility Criteria:
Inclusion Criteria:

* All participants aged from 18 to 60 years old; all participants met diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V), and scored \>10 on PSQI , ≤14 on the Hamilton Anxiety Scale (HAMA), and ≤17 on the Hamilton Depression Scale (HAMD); no sleep-affecting drugs were taken 1 month before or during the trial (non-prescription sleep medication, benzodiazepines or hypnotics, ect.); patients can cooperate to complete the treatment and related examination items; all subjects signed informed-consent forms before enrolling in the trial.

Exclusion Criteria:

* The patient is unable to cooperate with the completion of treatment and examinations; there are other types of sleep disorders; a history of psychotropic drug or alcohol dependence or abuse in the last 2 years; have undertaken trans-meridian travel across more than two time zones or worked night shifts in the preceding one month or during the trial period; plan surgical treatment within 1 month before or during the trial; evidence of neurological or other physical diseases such as respiratory, cardiac, renal, hepatic, endocrinal diseases and other psychiatric diseases as assessed by clinical history, physical examination or routine laboratory tests; pregnancy or breastfeeding women; any contraindication for rTMS (including implanted metal and devices in the body, and history of epilepsy); concurrent other clinical trials; patient or family member withdraws informed-consent.