cyrilzakka/clinical-trials huggingface dataset:
Biological Adaptations of Strength Training.

A two-trial repeated measures design will be employed in this investigation. Both the control trial and the exercise trial will last for 3 months. During a week before the start of the study, participants will complete dietary recalls and record their habitual physical activity using accelerometers. Thereafter, body composition, ultrasound imaging of the muscle and liver, biochemical and hematological markers were measured. This range of measurements will be repeated the ended each month for both trials. Control trial succeeds exercise trial. An exercise intervention program will take place in the second trial, three times a week.

A sample size of 30 volunteers, aged 35-45 years, will participate in the present study. Of them, 15 will be normal weight and 15 will suffer from fatty liver disease (BMI 29-35 kg/m2, waist size \>102 cm). The exclusion criteria will be a) medication, b) musculoskeletal problems that will prevent participation in the training program, c) known condition or medical condition preventing participation in the program e.g. hypertension, d) BMI\> 35kg / m2, (e) a severe family medical history up to first degree relatives with cardiovascular disease and / or diabetes at the age of less than 65 for women and less than 55 years for men and (f) smoking. After informing and receiving a questionnaire and medical history, volunteers will sign for their participation in the survey.

A two-trial repeated measures design will be applied in this investigation. Both control and exercise trials will last for 3 months. During the week preceding the commencement of the study, participants will complete dietary recalls and will have their habitual physical activity monitored, by utilizing accelerometers. Thereafter, body composition, ultrasound imaging of muscle and liver, biochemical and hematological markers will be measured. The same measurements will be repeated at the end of each month, in both trials. Control trial will be executed prior to exercise trial. An exercise intervention program, combining strength and cardiovascular exercises performed three times a week, will take place in the exercise trial.

Eligibility Criteria:
Inclusion Criteria:

* no use of medication
* free of musculoskeletal limitations
* absence of a known condition or medical condition preventing participation in the program (e.g. hypertension)
* absence of a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men
* non-smokers

Exclusion Criteria:

* use of medication
* musculoskeletal limitations that will prevent participation in the training program
* known condition or medical condition preventing participation in the program (e.g. hypertension)
* a severe family medical history up to first degree relatives with cardiovascular disease and /or diabetes at the age of less than 65 for women and less than 55 years for men
* smoking
Prospective Cohort of Patients With Intracerebral Hemorrhage

The investigators designed a multicentral, observational, prospective cohort study to provide cortical data for risk stratification and biomarkers on early outcomes, complications, long-term neurological function, and cognitive status of spontaneous intracerebral hemorrhage patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with spontaneous intracerebral hemorrhage (ICH) through skull radiologic scans (CT or MRI);
* Underwent no surgical intervention;

Exclusion Criteria:

* Secondary intracerebral hemorrhage (with leading cause, e.g., Moyamoya disease, arteriovenous malformation, intracranial aneurysm, tumor, brain trauma)
* Pre-stroke life expectancy \&lt; 1 year for severe comorbidities (e.g., Progressive malignant tumor, severe chronic heart failure \[NYHA: III-IV\], severe chronic obstructive pulmonary disease \[III-IV\], chronic kidney disease requiring hemodialysis)
* Severe dependency or incorporation to interview (e.g., pre-stroke mRS\&gt;3, severe dementia, intractable mental disease)
* Unsuitable for inclusion in the study in the opinion of the investigator
Milestones of Adjustment Post-Psychosis

This nested design clinical outcome study of psychiatric case manager education on disease state, psychopharmacology of schizophrenia, relapse, motivational interviewing, and the process of psychological adjustment post-psychosis (Milestones of Adjustment Post-Psychosis Recovery Model-MAPP) will test the following hypotheses:

1. Medication non-adherence in patients with schizophrenia assigned to case managers who receive MAPP training will decrease from their pre-study rate and from the reported national average after one year enrollment compared to consumers not enrolled in the MAPP arm of the study.
2. Consumers in the MAPP intervention will have higher Quality of Life Enjoyment and Satisfaction Questionnaire (Q-Les-Q (53) scores than consumers not enrolled in the MAPP at quarterly measures.
3. Consumers enrolled in the MAPP intervention arm of the study will successfully complete the first two phases of the MAPP Recovery Model in one year.
4. Consumers in the MAPP intervention arm will have greater symptom reductions at quarterly data points compared to consumers not enrolled in the MAPP intervention arm.

52 psychiatric case managers will receive manualized training in the disease state of schizophrenia, psychotropic medications, motivational interviewing, and relapse prevention. After randomization, 26 case managers will receive additional manualized training in the process of post-psychotic adjustment. Outcomes of 130 consumers (5 per case manager) related to medication adherence, relapse rates, symptom intensity, and quality of life will be evaluated at quarterly intervals over a two-year period. Outcomes of 130 consumers related to medication adherence, relapse rates, symptom intensity, quality of life, and progression through the phases of postpsychotic adjustment (MAPP-Milestones of Adjustment Post-Psychosis Recovery Model) will be evaluated at quarterly intervals via rating scales over a two-year period and the two groups compared.

Eligibility Criteria:
Inclusion Criteria:Case Managers

* Voluntary basis-includes willingness to administer study tools quarterly for two years to at least five consumers from their assigned caseloads and to keep a log of their activities and reactions.

Inclusion Criteria for consumer subjects: 130 in each treatment arm

1. A diagnosis of a schizophrenia spectrum disorder as defined by DSMIV TR (63)
2. Males and females at least 21 years of age assigned to case managers
3. Able to understand the requirements of the study

Exclusion Criteria:Case Managers

* None, all case managers are eligible for the study

Exclusion Criteria: Consumers

* Any DSM-IV Axis I disorder not defined in the inclusion criteria
Reduction of Postoperative Wound Infections by Antiseptica?

Wound infections are a frequent complication in abdominal surgery. The investigators hypothesize that the antiseptic solution 0.04 % polyhexanide (serasept) may reduce occurrence of postoperative wound infections compared to NaCL (saline) solution in a prospective randomized setting.

Invstigator initiated monocenter randomized controlled trial. Intraoperative irrigation of subcutaneous tissue with NaCl (saline) solution or antiseptic solution 0.04 % polyhexanide (Serasept) in elective abdominal surgery. Primary endpoint: SSI 30 days postoperatively according to CDC criteria.

Eligibility Criteria:
Inclusion Criteria: - planned laparotomy for visceral surgery

Exclusion Criteria:

* Age under 18 years
* allergy against polihexanid
* laparoscopic surgery
* emergency surgery
* lack of understanding of the trial
Dose-Escalating Study of Propiverine Hydrochloride in Children Suffering From Overactive Bladder

The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.


Eligibility Criteria:
Main Inclusion Criteria:

* Micturition Frequency ≥6 micturitions during awake period
* Urge Incontinence Episodes ≥1/week
* Urgency Episodes ≥1/day

Main Exclusion Criteria:

* Contraindication to anticholinergic therapy
* Repeated measurement of Post Void Residual ≥20 mL
* Nocturnal Enuresis
* Clinically significant cardiovascular, hepatic, renal, gastrointestinal or hematological disease, psychiatric disorder or diabetes insipidus
* Anatomical abnormalities of the urinary tract
Eruption Status of Primary Teeth in Low Birth Weight Children in Comparison to Normal Birth Weight Childern

determine the status of eruption of primary teeth and physical growth in children aged from 6 to 36 months with low birth weight in comparison to normal birth weight

Timing of eruption of primary teeth is an urgent question for every mother especially in low birth weight children. Although, the timing of eruption of primary teeth and their sequence of eruption shown to be under the genetic control , pre-natal maternal conditions, early childhood metabolic and nutritional factors along with socioeconomic states have been associated with the timing of eruption of primary teeth.

Many factors may affect the timing of eruption. Literature showed that factors like gender, race and physical growth may influence emergence of tooth in child mouth but there is scarce information on Egyptian children .

Eligibility Criteria:
Inclusion Criteria:

* Healthy children.
* Children aged from 6 to 36 month.

Exclusion Criteria:

* Refusal of participation from the parents.
* Medically compromised children.
* Major illness.
* The child had special needs.
* Any systemic disease.
* Any congenital deformity that may affect teeth eruption.
Mother-to-infant Bonding and Prematurity Are Associated With Sensory Processing at 12 Months of Age

Establishing a strong bond between mother and infant is crucial for fostering healthy relationships in the future. This research sought to investigate the correlation between mother-to-infant bonding and sensory processing, as well as the connection between prematurity and sensory processing in 12-month-old infants.

At the age of four months, mothers will utilize the Mother-Infant Attachment Scale (MIBS) to evaluate the bonding between themselves and their infants. Subsequently, at 12 months old, the sensory processing abilities of the infants will be assessed using the Test of Sensory Functions in Infants (TSFI). The study will encompass both preterm and term-born children.

Eligibility Criteria:
Inclusion Criteria:

preterm children with a gestational age \<34 weeks Term children with a gestational age between 37 and 41 weeks

Exclusion Criteria:

* infants with chromosomal defects, metabolic or neuromuscular disease,
* hydrocephalus, cerebral palsy, congenital heart disease,
Oral Health and Endometriosis: A Cohort Study

A survey has been conducted thanks to a questionnaire composed of 45 questions. The study group was composed of 4079 women affected by endometriosis, recruited from dedicated communities present on the social network Facebook. The questionnaire investigated about: the endometriosis status, the kind of therapy, the presence of any sign and symptoms in the oral cavity, the presence of periodontal problems, the self-perception of the oral health status, the presence of other autoimmune diseases and oral hygiene and the eating habits, physical activity practiced, the life quality.

The questions were structured thanks to the collaboration of expert health professionals: gynecologist, dentist, dental hygienist, physiotherapist, dietician, psychologist to obtain targeted information on endometriosis, on the type of therapy, on any signs and symptoms in the oral cavity (perception health status, presence of periodontal problems), to investigate oral hygiene and dietary habits, physical activity, quality of life, the presence of other immune-based diseases. In the final part of the questionnaire there was a section in which women were free to tell their stories.

Eligibility Criteria:
Inclusion Criteria:

* The only inclusion criterion was being at least 18 years old

Exclusion Criteria:

* • Pregnancy.

  * Administration of antibiotics in the last 15 days prior to entry into the study or indications for antibiotic prophylaxis.
  * Orthodontic Appliances.
  * Immunological diseases or use of drugs that can affect oral tissues (phenytoin, cyclosporine), nifedipine, chronic use of nonsteroidal anti-inflammatory drugs.
  * Refusal to participate in the study.
Progressive Metabolic Adaptations to Low Intensity Exercise Training and Weight Loss

the investigators first aim is to determine the effect of low intensity exercise (without weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days without exercise in obese adults. the investigators second aim is to determine the effect of combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle lipid metabolism, and factors regulating these processes in skeletal muscle.

Although a single 40 minute session of exercise at a low exercise intensity will not improve insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training program (without weight-loss) will be similar to that measured after 2 weeks of training. the investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and pro-inflammatory activation will be markedly improved after 10% weight loss when measured the day after exercise. the investigators would expect the improvements in Insulin sensitivity, accumulation of fatty acid intermediates, and markers of inflammatory stress will be significantly attenuated when measured 3 days after the most recent exercise session, but beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared with before weight loss.


Eligibility Criteria:
Inclusion Criteria:

* body mass index \[BMI\]: 30-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)

Exclusion Criteria:

* Hematocrit ≤ 34%; Fasting plasma glucose concentration ≥ 125 mg/dL; Weight instability ≥ ±5 lbs in past month; Taking medications known to affect lipid and/or glucose metabolism; evidence and/or history of cardiovascular or frank metabolic diseases; pregnancy or actively breast feeding
Comparison of Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block

Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery.

Design: A prospective randomized controlled study. Participants: Adult patients undergoing elective video-assisted thoracoscopic surgery.

Interventions: Preoperative SAPB or ESPB implementation.

Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) classification I-II scheduled for elective VATS

Exclusion Criteria:

* Patients who did not give consent
* Local anaesthetic allergy
* Known or suspected coagulopathy
* İnfection at the injection site
* History of thoracic surgery
* Severe cardiovascular disease
* Hepatic or renal insufficiency (glomerular filtration rate \<15 ml/min/1.73 m2)
* Severe neurological or psychiatric disorders
* Chronic opioid use
Cerebral Oxygen Saturation Monitoring In Cardiac Surgery (COSMICS)

Neurological dysfunction continues to be one of the complications of considerable concern in patients undergoing cardiac surgery. It was previously reported in the literature, that cerebral oxygen desaturation during cardiac surgery was associated with an increased incidence of cognitive impairment. This study aims to determine whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with predetermined intervention protocol to optimize cerebral oxygenation.

Despite all the progress over the last decades regarding the improvement of the perioperative care of patients with heart disease and the development of new surgical techniques, neurological dysfunction continues to be one of the complications of the greatest concern in patients undergoing cardiac surgery with cardiopulmonary bypass. Brain injury can manifest itself through permanent or temporary injury, contributing to the increase in-hospital mortality, in the length of stay in intensive care, in the length of hospital stay, to a higher incidence of motor dysfunction requiring rehabilitation, and consequently, to reduced quality of life.

Even though the causes of brain injury are multifactorial, perioperative cerebral hypoperfusion, tissue hypoxia, and thromboembolic events are among the main factors related to neurological dysfunction.

Several clinical studies have indicated an association between cerebral desaturation and the increase of neurological complications. Cerebral oximetry monitoring using near-infrared spectroscopy (NIRS) is a non-invasive technique used to estimate regional cerebral oxygen saturation (rSO2) and has been associated with diminishing the incidence of neurological complications.

There is no consensus in the literature about its real benefit, mainly due to the absence of well-designed scientific studies that demonstrate that cerebral desaturation associated with intervention measures to improve rSO2, are related to the prevention of neurological dysfunction in adult cardiac surgery.

The study hypothesis evaluates whether continuous monitoring of cerebral oximetry improves the neurocognitive outcome in coronary artery bypass surgery when associated with early interventions to optimize rSO2.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 or older
* Elective coronary artery bypass graft surgery using cardiopulmonary bypass
* Preoperative cognitive assessment by means of Mini-Mental State Examination (MMSE) test, greater than or equal to 24
* Signed informed consent

Exclusion Criteria:

* Patients with focal neurologic deficit
* Carotid artery stenosis greater than 70%
* Patients with pre-existing cognitive dysfunction
* Patients with psychotic disorders
* History of allergy to adhesive part of the electrode
* History of craniofacial surgery
Protocol to Ease Acute Cephalalgia in Emergency-department

The purpose of this study is to determine if the use of a therapeutic and global protocol to relieve cephalalgia is helpful in the emergency department of Grenoble University Hospital.

Cephalalgia is a very common symptom that justifies daily appointment in emergency department.

Analgesic support, and especially use of oxygen and care of associated symptoms as nausea, photophobia or phonophobia, is very dependent on the physician.

The aim of this study is to evaluate the impact of a global analgesic protocol of cephalalgia in emergency department.

The investigators included 200 patients aged of 18 up to 55 years old coming in emergency department for headache. Pain (Visual analogic scale), nausea, photo or phonophobia are recorded each 15 minutes by the patient by using a self-assessment questionnaire. The final diagnosis is recorded by the physician in charge of patient, using International Headache Society criteria.

First 100 patients(group 1) receive usual care.

For the last 100 patients (group 2), physician in charge of patients are incited to use a formal protocol that include: putting the patient in a quiet spot, laying down on a stretcher, providing sound proof helmet and light blocking google, administering oxygen therapy 15 l/min during 15 min, and administering etiological headache adapted medication following learned society guidelines.

Comparison of the data of this 2 groups shall help us to see if the investigators actual analgesic support of cephalalgia is efficient, and if it can be improved by this global analgesic protocol.

Eligibility Criteria:
Inclusion Criteria:

* Complain about cephalalgia
* Age 28 to 55 years.

Exclusion Criteria:

* Fever \> 38,0 °C
* History of breath disease, long term use of oxygen therapy, chronic obstructive pulmonary disease, dyspnea
* History of cranial traumatism, heart attack, cerebrovascular accident \<3 month
* Inability to read or understand french.
* Pregnancy
Late Neutropenia in VLBW Preterm Babies

There are rare reports regarding late neutropenua in very low birth weight preterm infants.

The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants.

There are rare reports regarding late neutropenua in very low birth weight preterm infants.

The investigators wish to characterize it among our population, and assess its consequenses and the postnatal menagement of the infants.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infant with birth weight up to 1500 gram

Exclusion Criteria:

* Early neutroenia - neutrophil count \< 1500 at the first week
Fluid Responsiveness in Post-cardiac Surgery

the study aims to examine the validity of combined end-expiratory and end-inspiratory occlusion test and tidal volume challenge test for prediction of fluid responsiveness in immediate post-cardiac surgery patients

multiple studies prove that dynamic variables based on heart-lung interactions accurately can predict fluid responsiveness in mechanically ventilated patients, including pulse pressure variation (PPV) and stroke volume (SV) variation.

Furthermore, passive leg raising (PLR), end-expiratory occlusion test, and tidal volume challenge test, "Mini"-fluid challenge are currently available to assess fluid responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients on mechanical ventilation
* Patients ≥18 years of age
* patients undergoing cardiac surgery (coronary artery bypass graft, valve repair/ replacement, combined cardiac surgery)
* patients with normal systolic function of the left and right ventricle
* patient is mechanically ventilated with a protective lung strategy

Exclusion Criteria:

* Patients with Spontaneously breathing activity
* Patients undergoing emergent cardiac surgery.
* Patient with severe peripheral arterial occlusive disease
* Pregnant women
* Contraindication of passive leg raising test
* unstable post-operative course
* Post-operative complications such as uncontrolled bleeding, severe neurologic impairment, or accidental mechanical complications;
* presence of residual severe tricuspid or any valvular regurgitations
* low cardiac output, low ejection fractions (EF ≤45%)
* open chest,Pao2/Fio2 ≤ 200