cyrilzakka/clinical-trials huggingface dataset:
Beneficial Effects of Coenzyme Q10 Treatment on the Mitochondrial Dysfunction and Oxidative Stress Associated to Atherothrombosis Developement in Antiphospholipidid Syndrome Patients

The study will be performed on 50 APS (antiphospholipid Syndrome) patients, which will be randomized to receive either CoQ10 (200mg/day) or placebo for one month. Blood will be drawn at time 0 and at the end of the treatment. Studies will be conducted in plasma and purified leukocytes from APS. Design: 1) Study of endothelial function: 2) Analysis of changes operated on various prothrombotic/proinflammatory parameters and their associated intracellular signalling. 3) Analysis of mitochondrial ultra structure and activity; mitochondrial antioxidant system characterization; Expression levels and activity of transcription factors/proteins involved in oxidative stress (Foxo 3, NFkB, Nrf2), Quantification of CoQ10 (Coenzyme Q10). 4) Biomarkers of oxidative stress. 5) miRNAs microarrays, RT-PCR validation and correlation/association studies. 6) Induction of over-expression of miRNAs of interest; luciferase constructs. 7)Studies of methylation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who fulfilled Sidney criteria for APS (antiphospholipid Syndrome) (Miyakis S et al., J Thromb Haemost 2006; 4:295-306)
2. Age over 18 years
3. Written informed consent

Exclusion Criteria:

1. Acute Liver Disease.
2. Severe renal impairment
3. Acute arterial or venous thrombosis episode in the last 3 months
4. Pregnancy and breastfeeding
Wheelchair User Physical Activity Training Intervention to Enhance Cardiometabolic Health

The goal of the study is to improve cardiometabolic health outcomes for wheelchair users and identify strategies for achieving sufficient physical activity intensity during bouts of structured physical activity.

Wheelchair users have a higher risk for obesity and cardiometabolic health-related diseases compared to persons without a disability and remain one of the most sedentary populations in the United States. Engaging wheelchair users in physical activity levels following the current recommendations to achieve cardiometabolic health-related changes requires tailoring and supports in an accessible community environment, but it is unclear if a community-based physical activity intervention that also prioritizes intensity levels is best to improve cardiometabolic health. This project will determine the effects and implementation outcomes of a community-based, intensity-controlled aerobic and strength training intervention on the cardiometabolic health of wheelchair users and will significantly advance public health knowledge of how to engage wheelchair uses in physical activity to reverse or prevent cardiometabolic health-related disease.

The aims of the study are to:

1. Compare the effectiveness of the intensity-controlled physical activity training (IPAT) group to the education and access (EA) group for improving cardiometabolic-related health outcomes.
2. Identify barriers and facilitators to wheelchair users engaging in physical activity at a community-based accessible gym.
3. Examine the moderators (i.e., age, race, gender, duration of disability, wheelchair type, and physical function) and mediators (ie., self-efficacy, motivation, and barriers/facilitators) of the proposed intervention to understand for whom and how the intervention was effective.

A hybrid I RCT will be conducted. One hundred and ten individuals with a physical disability requiring the use of a wheelchair will be recruited. Each participant will be randomized into either a 14-week IPAT group (n=56) or a 14-week EA group (n=54). Participants' cardiomrespiratory, body composition, metabolic blood chemistries and strength will be assessed baseline (T1) and post intervention (T2).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Has a physical disability requiring the use of a wheelchair (includes manual wheelchairs, motorized wheelchairs, motor-assisted wheelchairs, and electric scooters)
* Community-dwelling
* Ability to independently move one or both upper extremities
* Has participated in no more than 60 minutes of moderate-intensity physical activity per week in the past month
* English-speaking
* Able to provide informed consent
* Willing to participate in two assessments and 40 intervention sessions

Exclusion Criteria:

* Determination by their physician to be medically unstable
* Has had cardiovascular complications within the past year or unstable heart disease
* Currently receiving medical treatment for an acute injury
* Presence of a stage IV pressure injury
* Currently pregnant or suspect pregnancy
Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome

Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders. It is estimated that 80% of SAS cases are not diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and insufficient availability of these exams. It would therefore be useful to carry out a screening test before directing the patient to a complete test.

Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula, oximetry, heart rate) but they generally record only one night and remain intrusive enough to perturb the sleep.

The Withings Sleep is a non-contact device, along with an airbag placed under the mattress, which allows screening of SAS from four signals: movement, breathing, heart rate and snoring. The objective of the present study is to validate the diagnostic performance of the Withings Sleep for the detection of SAS compared to PSG.


Eligibility Criteria:
Inclusion Criteria:

* adults, men or women, aged between 18 and 70
* patients referred for an overnight polysomnographic exam for a suspicion of sleep-disordered breathing

Exclusion Criteria:

* children less than 18 years of age
* patients treated with continuous positive airway pressure
* person not giving her consent
* vulnerable subject according to current regulation:
* pregnant woman, parturient or breastfeeding
* subject deprived of freedom by judicial, medical or administrative decision
* subject legally protected or unable to express his consent
* subject non-beneficiary of healthcare
* subject falling into more than one of the above categories
* subject in linguistic or psychic incapacity to express his consent
The Efficacy of Postoperative Analgesia of Gabapentin Plus Nefopam in the Spinal Surgery

The acute pain after spinal surgery is serious. The most pain is during 24 hours after surgery. The multimodal therapy is a method which is applied to treat the postoperative pain.

Morphine is main analgesic to treat postoperative pain. However, some the side-effects can occur to patients and there are associate with dosage. So, some analgesics usually combinate with morphine to postoperative analgesia, include gabapentin, celecoxib, ketamine, ...

Nefopam is a central analgesic. There are effect prevent hyperalgesia. The effect of the combination of gabapentin with nefopam to postoperative analgesia in spinal surgery hasn't been reported yet.

The gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery whether to increase the effect of postoperative analgesia.

The investigators hypothesized that the gabapentin oral with 600 mg combine with continuously intravenous nefopam with 65 µg/kg/hour during 24 hours after spinal surgery can decrease 40% of the consumption of morphine during 24 hours.

After enrolled, all participants will randomly assigned into the two groups. The intervention group (GAPA-group) will treated preoperative oral 600 mg of gabapentin. After general anesthesia, all participants of both groups will continuously transfused 65 µg/kg/hour of nefopam during 24 hours. After surgery, all cases will treated analgesia with morphine-PCA (2 mg of singe dose, 5 minutes of lockout time, and 6 mg of one hour).

The efficacy of postoperative analgesia will evaluated with the consumption of morphine during 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 70.
* Spinal selective surgery

Exclusion Criteria:

* Allergy one of drugs in study.
* Neurological disorder.
Pediatric Postoperative Analgesia With Quadratus Lumborum Block(QLB) And Dexamethasone As An Adjuvant To Bupivacaine.

Studying the post-operative analgesic effect of dexamethasone as an adjuvant to bupivacaine giving intravenously and locally with ultrasound guided quadratus lumborum block(QLB) in pediatrics undergoing abdominal surgeries

After obtaining written informed consent from parents or guardians of all patients, 90 patients (6-12 years old) scheduled for abdominal surgeries operations will be included. Patients will be randomly allocated into three groups, 30 patients in each group. Randomization will be based on computer-generated codes maintained in sequentially numbered opaque envelopes.

Anesthetic Technique:

Anesthesia will be induced with Sevoflurane plus fentanyl (0.5µg/kg) and tracheal intubation will be facilitated with Rocuronium (0.4 mg/kg). Anesthesia will be maintained with Sevoflurane (will be adjusted according to A line autoregressive index (AAI)) and Rocuronium (0.1 mg/kg/dose will be given on the basis of train-of-four neuromuscular monitoring). ECG, noninvasive blood pressure, heart rate, temperature, oxygen saturation, and exhaled CO2 (end tidal CO2) will be continuously monitored during the procedure.

• After induction of anesthesia and before skin incision, a QLB will be performed in all patients in the three groups.

The procedure will be done under ultrasound guidance using curved array transducer 5-2MHz (Sonosite ultrasound system). Echogenic needle, Sono Plex Stim cannula (PAJUNK) 22 gauge and 60 mm length will be used. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The QLB block will be performed by anterior approach. The linear probe will be attached in the area of the triangle of Petit in transverse orientation in lateral abdomen in between the iliac crest and the costal margin, near the posterior axillary line. The muscle planes will be identified until visualizing the quadratus lumborum muscle, at the same plane as the psoas major muscle and the erector spinae. The needle tip is placed at the anterolateral border of the QL at its junction of QL with transversalis fascia outside the anterior layer of the thoracolumbar fascia (TLF) and fascia transversalis, and the local anesthetic will be injected.

Anesthesia will be discontinued when the wound dressing applied, and muscle relaxant will be reversed using (50ug/kg) of neostigmine and atropine (0.02mg/kg) and extubating of the patient will be done. The patient will be transferred to the postoperative care unit (POCU).

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients(6-12 years)
* ASA physical status I,II
* Abdominal surgery

Exclusion Criteria:

* Parents refusal or legal guardian's refusal
* Allergy to bupivacaine or dexamethasone
* Contraindications to regional techniques
* Failed QLB
* Infection on site of procedure
Study of the Consumption of a Food Supplement in a Group of Healthy People

Bioactive supplements might display relevant therapeutic properties according to validated molecular effects. Herein, the effect of a supplement based on diterpenes from Rosmarinus Officinalis L. and alkylglycerols with proven properties against signaling pathways involved in tumorigenesis is evaluated. The biological and molecular effects of this supplement, mainly based on expected effects on immune and genetic modulatory properties is investigated. For this purpose, 60 healthy volunteers were enrolled in a six week, double-blind, randomized and parallel pilot study with two study arms -rosemary and alkylglycerol containing capsules and control capsules. The study includes the analysis of (1) immunological parameters (ex vivo cytokine profile of LPS stimulated PBMC and PBMC phenotyping by cluster differentiation (CD) markers), (2) regulation of the expression of genes linked to immuno-modulation, inflammation, oxidative stress response and cancer, and (3) the analysis of correlation of selected genetic variants (SNPs) with the differential responses among individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 55 years
* Adequate understanding of the study.
* Willingness to complete the entire treatment.

Exclusion Criteria:

* BMI \>30
* Diagnosis of type 2 diabetes mellitus (T2D), hypertension, dyslipidemia or other cardiometabolic disorders
* Impaired cognitive function;
* Diagnosed hepatic, renal, or cardiovascular disease
* Subjects with primary immunodeficiency disorders, consumption of drugs with influence on the immune system, splenectomy.
* Presence of other pathologies like asthma, food allergies, Crohn's, myasthenia gravis, lupus
* Consumption of vitamins, minerals, supplements of antioxidant extracts or protein supplements in the 2 weeks prior to the start of the study
* Subjects treated with drugs affecting the lipid or glycemic profile during the previous 30 days
* Consumption of anticoagulants or antiplatelet agents, cyclosporine, acetylsalicylic acid, antihistamines or sedatives
* Hypersensitivity to rosemary, to its components or other members of the family of lipped plants or to soybean as excipient of the capsules
* Allergy or hypersensitivity to fish
* Habitual smoking or high consumption alcohol
* Pregnant or lactating women
* High-intensity physical exercise.
Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)

In this second phase of the multicenter study the investigators are going to evaluate the use of three different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these three videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As the gold standard, a standard Macintosh blade is being used for comparison.

The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480 patients.


Eligibility Criteria:
Inclusion Criteria:

* elective surgery with general anesthesia requiring intubation
* \>18 years old
* ASA I-III

Exclusion Criteria:

* known or presumed difficult airway
* risk of pulmonary aspiration
* refusing to participate
Hand Dexterity and Anthropometric Measurement

This study aims to investigate the relationship between hand and finger lengths, hand width, and dexterity. The main question it aims to answer is:

1-Is there a relationship between anthropometric measurements of the hand and manual dexterity?

The hand is capable of performing complex specialized tasks that require dexterity, manipulation, and tactile sensitivity.(Polat, 2023) Hand performance on a task is a combination of different skills, including grip muscle strength, movement, tactile feedback, and motor coordination. (Imamura, Rissanen, Kinnunen, \& Rintamäki, 1998). To achieve these, the hand is equipped with mechanical and sensory abilities.(Dianat, Haslegrave, \& Stedmon, 2012) Dexterity is a motor skill determined by the range of motion of the hands and fingers, as well as the ability to manipulate. It is a combination of reaction time, touch sensation, nerve conduction, grip strength and mobility. While finger dexterity is related to the fine motor skills required to move relatively small objects, manual dexterity includes the gross motor skills required to hold relatively large objects.(Roman et al., 2023) The most common dexterity tests reported in the literature include the Box-Block Test, Purdue Pegboard Test, Jebsen Taylor Test, 9-Hole Peg Test (NHPT), and Roeder Manipulative Ability Test.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers were included if they were 18 years of age or older and did not have any communication disorders

Exclusion Criteria:

* not having undergone any upper extremity surgery and not having a systemic disease
A Study to Evaluate the Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 \[NCT05620823\] or INCB 54707-302 \[NCT05620836\]).


Eligibility Criteria:
Inclusion Criteria:

* Completion of the study treatment period of the originating parent study (INCB 54707-301 or INCB 54707-302).
* Agreement to use contraception.
* Willing and able to comply with the study protocol and procedures.
* Further inclusion criteria apply.

Exclusion Criteria:

* Participation in the extension study could expose the participant to an undue safety risk.
* Women who are pregnant (or who are considering pregnancy) or breastfeeding.
* Further exclusion criteria apply.
PNF Stretching Compared to SMR on Hamstrings

The use of stretching techniques in the sports world is frequent and widely used for its many effects. One of the main benefits is the gain in flexibility, range of motion and facilitation of the sporting performance. Recently the use of self-myofascial release (SMR) has spread in sports practice both at elite and recreational level for its benefits being similar to those observed in stretching. The objective of the following study is to compare the results of the proprioceptive neuromuscular facilitation stretching with SMR on the hamstring muscle flexibility.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* hypermobility
* hamstring injury in the previous 6 months
* diagnosed orthopedic problems
* surgery in the lower limbs
* back pain
* spine surgery
* systemic or neurological disorders.
Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section

This is a randomized, multicenter, double blind, placebo controlled trial of betamethasone versus a placebo given prior to the mothers at term and near term gestation (\>34 and \<40 weeks of gestation) who are scheduled to undergo a planned Cesarean section. The study design is to determine the efficacy and safety of betamethasone in the prevention of breathing problems commonly seen in this population.

In infants born by elective Cesarean section, it is hypothesized that antenatal betamethasone treatment will reduce the risk of neonatal intensive care unit (NICU) admission from 11% to 8% and/or oxygen therapy +/- positive pressure ventilation (PPV) for \>30 minutes from 4.5% to 2.5%.

The purpose of this pilot study is to determine if antepartum betamethasone given to mothers undergoing elective cesarean section (ECS) delivery at term or near term gestation (\>34 and \< 40 weeks of gestation) is safe and feasible in reducing neonatal respiratory morbidity and the related admissions to neonatal intensive care units (NICU).

The data from this pilot study will be used to support a NIH application for a multicenter randomized trial to determine, if compared to placebo treatment, antenatal betamethasone initiated 2-7 days prior to an ECS results in decreased occurrence of respiratory morbidity and NICU admissions in the newborn.

The multicenter protocol was recently reviewed by the NICHD network for clinical trial. The reviewers were enthusiastic about the scientific merit and public health importance of the study but asked for a pilot study to determine feasibility before launching the national trial. Given the rise in the rate of CS deliveries, we project substantial health cost savings from this preventive strategy if it were found to be successful in reducing neonatal morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women \>/= 34 weeks gestation scheduled to undergo operative delivery within 48-72 hours after study enrollment

Exclusion Criteria:

* Known contraindication to the use of betamethasone in the mother
* Known lethal or non-lethal congenital anomaly diagnosed antenatally
* Spontaneous labor
* Premature rupture of membranes
The Effect of Eating Disorder on Occupational Balance in University Students

The aim of this study is to examine the effect of eating disorders on occupational balance in university students. Occupational balance levels will be compared in university students with and without eating disorders. The study will be finalized with the voluntary participation of 105 university students for both groups and 210 university students in total. The relationship between eating disorder tendencies and occupational balance in university students will be examined.

The population of the study will consist of voluntary students between the ages of 18-25 who continue their university education. In the power analysis performed to determine the sample size, it was determined in the G\*Power program, with 95% power (alpha = .05, two-way), the effect size was taken as Cohen's d = 0.5 by the guidelines provided by J. Cohen, and it was determined that at least 105 people in each group and 210 people in total were needed for the independent sample t-test.

Inclusion criteria:

* Volunteering to participate in the study,
* To be able to read and write Turkish,
* To be between the ages of 18-25 and studying at undergraduate level

Exclusion criteria:

* Any disability,
* Presence of a chronic disease

Individuals who volunteered to participate in the study will be evaluated with data collection forms filled in through questionnaires. Demographic information about the individuals (such as class, department, age, and gender) will be obtained with the sociodemographic information form. Data collection tools will be used by the researchers in face-to-face interviews with the participants and the data will be recorded anonymously.

It will be determined whether the participants have an eating disorder according to the results of the SCOFF Eating Disorders Scale. Participants with eating disorders will constitute the research group and participants without eating disorders will constitute the control group. Both groups will complete the Occupational Balance Questionnaire and their occupational balances will be compared. The study was planned to be terminated when there were at least 105 participants in each of the research and control groups for the endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* To be able to read and write Turkish,
* To be between the ages of 18-25 and studying at undergraduate level.

Exclusion Criteria:

* Having any disability,
* Presence of a chronic disease.