cyrilzakka/clinical-trials huggingface dataset:
Oxidative and Antioxidant Indices to HIIT and Aloe Vera Supplementation in Patients With T2DM

Diabetes is a prevalent metabolic disease that leads to increased blood sugar levels due to insulin shortage or resistance. Type 2 diabetes is often linked to obesity, which can increase insulin resistance. Meteorin-like protein (METRNL) is a new secreted protein that affects insulin sensitivity and has been found to be negatively related to serum glucose levels in people with diabetes.

Oxidative stress in diabetics can stimulate the production of inflammatory mediators, increasing the activity of the antioxidant system. Aloe vera, a widely used plant, has been used for treating diabetes, wound healing, tumors, and inflammatory bowel disease. It has anti-inflammatory, antioxidant, neuroprotective, antidepressant, and memory-enhancing effects.

Exercise can improve diabetic patients' conditions by increasing the expression of GLUT4 protein and skeletal muscle. High-intensity interval training has been shown to increase the expression of the METORIN gene in human subjects and decrease MDA in type 2 diabetic patients. However, no studies have examined the simultaneous effect of exercise and Aloe vera on diabetes indicators.

The present study aims to investigate the response of METRNL and some oxidative and antioxidant plasma indicators to high-intensity interval training and Aloe vera supplementation in type 2 diabetic men. The findings indicate that exercise and consumption of plants with anti-inflammatory and antioxidant properties can be effective in modulating the pathological effects of diabetes and increasing insulin sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who have been diagnosed with T2DM at least 3 months prior to the start of the study according to standard criteria
* Inactive participants according to the International Physical Activity Questionnaire (IPAQ)
* Participants receiving stable medical therapy for T2DM, excluding those on exogenous insulin therapy
* Participants who were free from injuries or chronic health conditions that could limit their ability to safely participate in an intense exercise program were included in the study

Exclusion Criteria:

* Fasting glucose above 270 mg / dL
* Exogenous insulin
* History of diabetic complications (the final stage of proliferative diabetic retinopathy, or subsequent overt nephropathy, diabetic ketoacidosis, or severe diabetic neuropathy)
* Hereditary glucose and galactose malabsorption
Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19

In patients with COVID-19, severe hypoxemic respiratory failure (SRF) leading to invasive mechanical ventilation (IMV), raises the mortality rate substantially. Thus, the management of patients with SRF to avoid intubation and intensive care admission is a challenging and crucial issue.

This study describes, as rescue/compassionate treatment, a therapeutic protocol based on the multi-mechanistic nature of severe COVID-19, using the combination of inhaled DNase, Baricitinib and Tocilizumab on top of standard of care (SOC) consisting of heparin and dexamethasone. COVID-19 patients with SRF who were treated with SOC, SOC plus Anakinra (ANA), and SOC plus Tocilizumab (TOCI) will be studied as comparators. Primary endpoint will be the reduction of the in-hospital mortality rate, whereas secondary endpoints concern intubation rate, days of hospitalization and overall survival as derived from the last follow-up visit, either in-office or remote.

This is a non-randomized, open-label, study, conducted in the First Department of Internal Medicine, University Hospital of Alexandroupolis, Greece.


Eligibility Criteria:
Inclusion Criteria:

1. adult patients ≥18 years old, of any gender
2. positive polymerase-chain-reaction (PCR) test for SARS-CoV-2 RNA in nasopharyngeal swab
3. pulmonary infiltrates suggestive of COVID-19
4. severe respiratory failure (SRF) as defined by PaO2/FiO2\<100 mm Hg
5. written informed consent from the patients or legal representatives for the current compassionate therapeutic protocol.

Exclusion Criteria:

1. need for intubation/IMV during the first 24 hours after the initiation of treatment
2. multi-organ failure,
3. systemic co-infection
4. SRF due to cardiac failure or fluid overload
5. glomerular filtration rate (GFR) \<30 ml/min/1.73 m2)
6. any stage IV solid tumor or immunosuppression due to hematological disorders
7. any immunosuppressive therapy and/or chemotherapy during the last 30 days
8. low patient's functional performance as defined by a Palliative Performance Scale (PPS) score ≤30%
9. pregnancy.
A Comparison Between GUMMETAL and SS Orthodontic Wires in Space Closure

When there is space present between our teeth orthodontically we have the ability to close them through many methods. Using braces as our treatment modality this study will be investigating how efficient a new orthodontic wire is in closing tooth space. This new material is trade-named GUMMETAL and claims to have many benefits to treating patients orthodontically. We will be exploring its efficiency in space closure compared to an industry standard (stainless steel). We predict that the stainless-steel orthodontic wire will be more efficient at space closure than the new GUMMETAL wires.

This will be a randomized pilot split-mouth clinical trial of patients with spaces ≥ 3mm distal to the maxillary canines in need of closure through sliding mechanics. The sample consists of adolescent patients regardless of Angle's molar malocclusion who are receiving comprehensive full fixed appliance orthodontic treatment. Preformed conjoint archwires half being GUMMETAL and the other half SS, will be utilized. Each patient will have one side of the maxilla randomly allocated into the SS or GUMMETAL treatment group. The study will follow a split-mouth design to reduce the confounding variables from patient to patient on space closure mechanics. The maxillary arch in each subject will be randomized into a SS side or GM side using a random number generator. Spaces will be measured at; T0 is initial records, T1 is initiation of space closure, T2 will be 4 weeks after the initiation of space closure, T3 is another 4 weeks of space closure evaluation and T4 will be the final evaluation of space closure after 4 weeks from T3, via 3D intraoral scans of maxillary arches. Space measurement and calculations will utilize 3Shape software to measure the distance of canine movement based off the distal surface. Sliding mechanics will be activated through NiTi coil springs from the maxillary canines to the maxillary molars. The force will be standardized to 150 gms and will be measured each visit. The same provider will activate the NiTi coil spring for retraction, along with data collection. Superimposition of scans will be utilized to assess outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Full permanent dentition (except third molars)
* Good general and oral health
* Bilateral spaces 3 \>/= mm distal to the maxillary canines
* Normal and hypodivergent growth pattern
* Any dental malocclusion
* Good Oral Hygiene

Exclusion Criteria:

* Systemic diseases or syndrome
* Abnormalities in teeth size and/or shape
* Previous orthodontic treatment
* Anti-inflammatory medication
* Craniofacial anomalies
* Hyperdivergent growth pattern
* Periodontal disease / attachment loss exceeding 25% of root length
* Significant pre or in-treatment root resorption
2D Strain of Right Ventricle in Peroperative of Cardiac Surgery

Evaluation of the right ventricle (RV) deformation (strain) with 2D speckle tracking technics obtained by echocardiographies (TEE) in peroperative period of cardiac surgery .

TEE is performed for each patient of cardiac surgery during the operation time .

This new evaluation parameter of RV could be a good tool to assess the early RV dysfunction after cardiac surgery.

Monitoring of 2D strain of right ventricle free wall by TEE in perioperative of cardiac surgery :

In preoperative time After sternotomy After surgery Inclusions of patients elected for aortic valve surgery without coronary diseases or previous RV dysfunction.

Comparison with others echocardiographic parameters of RV evaluation Association with right ventricle insufficiency after cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* patient eligible for aortic valve surgery

Exclusion criteria:

* previous right ventricle dysfunction
* severe coronary disease
Evaluation and Treatment of People With Eye Diseases

This study will evaluate and provide standard treatments for people with various eye conditions. It will provide a resource for enrollment into new research protocols throughout the Eye Institute and will allow institute specialists the opportunity to maintain their expertise and gain additional knowledge of the course of various eye disorders. The information obtained will allow for the evaluation of standard treatments and may lead to ideas for future research.

People with diagnosed or undiagnosed eye disease and first-degree relatives of people with a genetic or developmental eye disease may be eligible for this study. Participants are evaluated and treated in the National Eye Institute. Blood or other tissue samples (e.g., urine, stool, hair, saliva or cheek swab) may be collected for future laboratory studies.

The National Eye Institute (NEI) is conducting a study to evaluate and provide standard treatment to participants with various diagnosed and undiagnosed ocular conditions.

Objectives: The primary objective of this protocol is to provide a reservoir of patients for enrollment into new research protocols throughout the NEI laboratories. Evaluating and treating participants will allow the NEI specialists to maintain their expertise and gain additional knowledge of the course of various eye disorders. The information obtained will allow for the evaluation of standard treatments of the studied eye diseases. This understanding may lead to ideas for future protocols. In some cases, blood or other biologic samples (including tear fluid, urine, saliva, hair, stool or a cheek swab) will be obtained for future laboratory studies.

Study Population: The number of participants to be enrolled has no logical upper limit, but will be set to 5,000 patients with ocular diseases and their unaffected first-degree relatives.

Design: This is an observational natural history study of multiple ocular diseases and their progression and physiology.

Outcome Measures: No formal outcomes will be measured; however the clinical assessments of enrolled participants can be used to measure the response to standard treatment. In addition, DNA samples obtained may be used to identify and verify causative mutations, which may help establish pathogenic mechanisms and genotype-phenotype correlations.

Eligibility Criteria:
* INCLUSION CRITERIA:

Participants will be eligible if they:

* Have either a diagnosed or undiagnosed eye disease, OR are an unaffected first-degree relative of a participant with a genetic or developmental eye disease.
* Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children.

EXCLUSION CRITERIA:

Participants will not be eligible if they:

* Are unable or unwilling to give informed consent.
* Are unwilling or unable to be followed as clinically indicated.
* Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment.
Efficacy and Safety of BP1.4979 in Smoking Cessation

Clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of BP1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled CO (abstinent \< 10 ppm).

BP1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase I studies.

This is a multicenter,randomized, double blind, placebo controlled, phase IIb trial with parallel group to assess safety and efficacy of BP1.4979 in smoker.

Eligibility Criteria:
Main inclusion Criteria:

* a smoking history of at least 10 years
* subject smoking at least 15 cigarettes per day at the time being and for at least 30 days before selection.
* having already made at least 2 attempts to stop
* with no period of abstinence \> 3 months in the previous year
* FTND ≥ 7

Main exclusion Criteria:

* any significant psychiatric illness or mood disorder, assessed by the BDI
* HAD scale (A + D ≥ 19, the day of the selection and inclusion)
* AUDIT ≥ 8
* subject smoking cigars or pipes exclusively
* subject taking any antismoking medication and/ or Nicotine Replacement Therapy (NRT) in the previous month.
Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine

Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.

Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.

Eligibility Criteria:
Inclusion criteria:

The study will include 80 ASA physical status I, II patients with age between 18- 50 years old scheduled for elective myomectomy under general anesthesia

Exclusion criteria:

Patients who refused to participate, ASA physical status III, IV, patients younger than 18 years or \> 50 years old, BMI \> 30, history of epilepsy. Patients having a history of parenteral or oral analgesics within the last 24 hours before initiation of operation or those having allergy to study agents will be excluded.

-
Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.

It is known from extensive documentation that second victims in critical illness often are the care givers of the patients: family, friends or other persons. Although this has not been specifically studied in the very old patients, there is no reason to believe that this group will be different from other ICU patients. Even more so, in this very old age patient group there are seldom any older relatives. Partners, like wife/husband or other cohabitants, may be dead or themselves incapacitated. Many will be in institutional care. The closest care-givers will be middle-aged people such as children or others, if no partners are available.

The hypothesis is that critical illness can be a large stressor to care-givers of survivors in the VIP measured as the occurrence and severity of the usual problems like PTSD and depression. The investigators hypothesize that a low-threshold on-line support program decreases the magnitude of anxiety, depression and PTSD for care-givers of very old intensive care patients (VIP) after discharge.

Aims of the study

* Results from family/care givers experience: Degree of involvement with post-ICU care, impact on their own health (depression, PTSD, burden questionnaire)
* Effect of a simple intervention: on-line support and/or telephone advice on Return to pre-ICU frailty score (patients) and Occurrence of PTSD and depression in care-givers
* Information on 6 months' outcome (frailty and mortality) in very old survivors after ICU in different European countries
* Information on trajectories in the time after discharge: Dead/alive, home, nursing home, new hospital admissions, living with family/other care-givers, etc.

Eligibility Criteria:
Inclusion Criteria:

* Hospital survivors after any ICU admission

Exclusion Criteria:

* Imminent terminal care
Biological Nutrition Technique Which is Used in Initiation of Breastfeeding

Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy.

Material and Method: This randomized controlled study was conducted with 130 mothers who had a cesarean section in a public hospital located in Southeast Turkey (65 experimental, 65 control).

Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy.

Material and Method: This randomized controlled study was conducted with 130 mothers who had a cesarean section in a public hospital located in Southeast Turkey (65 experimental, 65 control). The mothers in the control group received routine hospital care. The mothers in the experimental group were taught the biological nurturing technique after the first breastfeeding and breastfeeding was provided according to the technique during the hospitalization. Pre-test data were obtained by applying LATCH and BSES-SF to the mothers in the experimental and control groups at the 1st hour after the first breastfeeding. LATCH was re-administered at the end of the 8th and 24th hour postpartum. Post-test data were obtained by administering LATCH and BSES at the end of the 48th hour postpartum.In statistical analysis; count, percentage distribution, arithmetic average, chi-square test, standard deviation, t-test in dependent and independent groups and ANOVA analysis in repeated measurements were used.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years and older,
* Having a full-term, single and healthy newborn,
* Having no known health problems
* Having no general anesthesia
* Implementation of planned cesarean delivery,
* Primiparous women who do not have a condition that prevents breastfeeding. Inclusion criteria of the research for infants

Exclusion Criteria:

• Women with a risky pregnancy diagnosis (such as preeclampsia, placenta previa, gestational diabetes)
Evaluation of Vitrase as a Spreading Agent

The purpose of this study is to determine whether Vitrase (hyaluronidase for injection) is effective as a spreading agent for other injected drugs prior to ocular surgery


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an ophthalmic surgical procedure

Exclusion Criteria:

* Documented history of hypersensitivity to hyaluronidase or any other ingredient in Vitrase
* Known history of hypersensitivity reaction to bee or wasp venom
* Needing enhanced absorption and dispersion of dopamine, alpha agonist drugs, furosemide, the benzodiazepines, or phenytoin
* Inflammation or apparent clinical signs of infection in the area where Vitrase was to be injected
Healing Process and Blood Sugar Level Following Local Anesthetic Infiltration With and Without Vasoconstrictor

Evaluating the healing of the extraction socket and the glycemic levels before, and after injection of local anesthesia with and without vasoconstrictor in diabetic patients


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria patients over 20 years and under 60 years of age
* DM controlled by medication
* Requiring a tooth extraction in the maxilla, with an indication of the intra-alveolar technique for periodontal reasons.
* Only participants that are willing to control and record blood glucose level throughout the study period.

Exclusion Criteria:

* Patients with any significant medical condition (besides DM)
* Alcoholic individuals
* Patients on drugs that affect the central nervous systems
* Patients who reported the use of drugs that might interfere with pain sensitivity
* Pregnant and lactating women
* Patients with hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain

We will conduct a 12-week, randomized open label study, comparing usual care (UC) antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in children and adolescents aged 13-18 years old. Patients will have 10 days or less lifetime antipsychotic exposure and be in clinical need for antipsychotic treatment for a pediatric psychiatric disorder with FDA indication for antipsychotic use, i.e., bipolar mania, schizophrenia-spectrum disorders, and irritability associated with autistic disorder. In addition, we will also include youth fulfilling research diagnostic criteria for severe mood dysregulation (SMD). Randomization will be stratified by high vs. low genetic risk for antipsychotic-induced weight gain based on MC4R genotype and the primary outcome will be weight change from baseline to endpoint between ZIP and UC antipsychotic treatment in each of the two genotype groups. As detailed below, other metabolic and cardiac safety parameters will also be measured and compared across treatments in each of the genotype groups.


Eligibility Criteria:
Inclusion Criteria:

* age 13-18 years
* English-speaking
* DSM diagnoses that have an FDA indication for SGA use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of early-onset schizophrenia spectrum disorders; bipolar I disorder mania (and BP-NOS); irritability associated with autism spectrum disorder, as well as severe mood dysregulation (SMD) according to Leibenluft et al. (2011) with an ABC-irritability score of \>/=18 Sexually active girls must agree to use two effective forms of birth control or be abstinent
* Participant has a primary caretaker who has known the child well for at least 6 months before study entry Primary caretaker is able to participate in study appointments
* Ability of child to participate in all aspects of the protocol per investigator clinical judgment.

Exclusion Criteria:

* Major neurological or medical illnesses that affect weight (e.g., unstable thyroid disease), require a prohibited systemic medication (e.g., diabetes mellitus \[insulin\], chronic renal failure \[steroids); Fasting glucose \> 125 mg/dL on 2 occasions during screening
* Any medication (other than currently prescribed psychotropic medications) that would significantly alter weight
* Antidepressants not allowed for at least 2 weeks in BP-I or BP-NOS patients
* DSM-IV diagnosis of anorexia or bulimia nervosa
* DSM-IV diagnosis of Substance Dependence disorder (other than tobacco dependence) within the past month
* Initial urine toxicology screen and follow-up screen indicate ongoing use of illicit substance
* Hypersensitivity to ZIP or UC antipsychotics
* Pregnant, breast feeding or unwilling to comply with contraceptive requirements
* Screening or baseline QTc \> 450 msec
* IQ \< 55
* Significant risk for dangerousness to self or to others
* Ongoing or previously undisclosed child abuse requiring new department of social service intervention.