cyrilzakka/clinical-trials huggingface dataset:
Open Lung Strategy in Critically Ill Morbid Obese Patients

The goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.

Obese patients under mechanical ventilation are more likely to develop atelectasis as a consequence of the increased abdominal weight. Atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support.

In a previous study we demonstrated the efficacy of the application of titrated PEEP levels following a recruitment maneuver in obese patients, i.e. improvement in respiratory mechanics and gas exchanges without negative hemodynamic effects.

The application of lung and heat imaging will allow us to quantitatively describe:

* Increase in aerated lung tissue (reduction of atelectasis)
* Reduction of over-inflation of the ventilated regions
* Recoupling of ventilation and perfusion
* Improvement in right heart function by reduction of right heart afterload

Eligibility Criteria:
Inclusion Criteria:

* ICU admitted requiring intubation and mechanical ventilation
* BMI ≥ 35 kg/m2
* Waist circumference \> 88 cm (for women)
* Waist circumference \> 102 cm (for men)

Exclusion Criteria:

* Known presence of esophageal varices
* Recent esophageal trauma or surgery
* Severe thrombocytopenia (Platelets count ≤ 5,000/mm3)
* Severe coagulopathy (INR ≥ 4)
* Presence or history of pneumothorax
* Pregnancy
* Patients with poor oxygenation index (PaO2/FiO2\< 100 mmHg with at least 10 cmH2O of PEEP)
* Pacemaker and/or internal cardiac defibrillator
* Hemodynamic parameters: systolic blood pressure (SBP) \<100 mmHg and \>180 mmHg, or if SBP is between 100-180 mmHg on high dose of IV continuous infusion norepinephrine (\>20 μg per minute), or dobutamine (\>10 μg per minute), or dopamine (\>10 μg per Kg per minute), or epinephrine (\>10 μg per minute).
Quantification of the Differences in the Diagnostic Relationships Between Centric Occlusion Versus Maximum Intercuspation in Adult Orthodontic Patients : A Cross-sectional Study

The aim of the study is to quantify the differences in the diagnostic relationships between Centric occlusion versus maximum intercuspation in adult orthodontic patients with Cetric relation recoded using both conventional method utilizing semi-adjustable articulator and face bow record in addition to digital method proposed by Radu et al for finding and recording CR using a dental intraoral scanner with a leaf gauge

Study design Cross-sectional study PICO Components P: Adult orthodontic patient I: Centric occlusion C: Maximum intercuspation

O: -orthodontic relations:

Molar relation Canine relation Incisor relation Overjet Overbite Midline discrepancy

Eligibility Criteria:
Inclusion Criteria:

orthodontic patient having full permanent dentition

Exclusion Criteria:

* patients who had undergone previous orthodontic treatment, and syndromic patients, retained primary teeth , teeth heavily restored
Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

The purpose of this study is to determine if there are significant differences in the side effects related to memory, repetition and recall among these three drugs when used in a pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of migraine with and without aura or chronic daily headache as defined by IHS
* subjects must between the age of 8-17 (inclusive)

Exclusion Criteria:

* diagnosis of tension-type headache or cluster headache
Effectiveness of Nutritional Program Among Diabetic Patients

Dyslipidemia is very common in type 2 diabetes mellitus affecting around 72%-85% of diabetic patients.The exact mechanism of lipoprotein abnormalities in diabetes is not very well understood. Insulin resistance, rather than hyperglycemia, has been implicated in the pathogenesis of diabetic dyslipidemia because lipoprotein changes including an increase in triglycerides (TG), increase in VLDL particles, small dense LDL particles and a decrease in HDL level have been shown in patients with impaired fasting glucose and impaired glucose tolerance and T2DM

Hypertriglyceridaemia(HTG) occurs due to both increased production and decreased clearance, and it is the most common abnormality of diabetic dyslipidemia. Insulin resistance causes increased production of VLDL . In addition to increased secretion of VLDL, there is decreased clearance of VLDL due to decreased hepatic uptake and impaired activity of lipoprotein lipase.Management of dyslipidemia in patients with diabetes is an important step in the prevention of cardiovascular disease, the most common cause of death in the diabetic population. Diabetic dyslipidemia treatments can be divided into non-pharmacological and pharmacological. Non-pharmacological treatment includes ; medical nutrition therapy, weight loss, and physical activity. Diabetic patients should increase the intake of plant stanols/sterols, viscous fiber (legumes, citrus, oats), n-3 fatty acids and decrease the intake of saturated and trans-fatty acids. American Diabetes Association recommends the Mediterranean diet or DASH (Dietary Approaches to Stop Hypertension).

Eligibility Criteria:
Inclusion Criteria:

* 1-clinical diagosis of type2diabetes 2-clinical diagnosis of hyperlpidemia 3-must be helpful patient 4-age below 70year

Exclusion Criteria:

1-insulin dependant diabetes 2- pregnancy 3-heart disease 4- renal disease. 5-pregnancy

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Ultrasound-Guided Extrafascial Versus Intrafascial Interscalene Brachial Plexus Block in Shoulder Arthroscopy

The aim of the study is to compare the diaphragmatic excursion and postoperative analgesia in the extrafascial versus intrafascial Interscalene brachial plexus block in patients undergoing shoulder arthroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes aged (21-60years) with American Society of Anesthesiologists (ASA) physical status I/II scheduled for shoulder arthroscopy

Exclusion Criteria:

1. Patient refusal.
2. Pre-existing (obstructive or restrictive) pulmonary disease.
3. Bleeding disorders (coagulopathy).
4. Mental dysfunction.
5. History of allergy to local anesthetics.
6. Pregnancy
7. Body mass index (BMI) \>40
QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* Smoking history of at least 10 pack years
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2009)
* Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) \>40% and \< 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<70%

Exclusion Criteria:

* Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
* Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer (within last 5 years)
* Patients with a history of certain cardiovascular co-morbid conditions
Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients

Retrospective, observationnal study. Evaluation of the association between plasmatic SARS-CoV-2 RNA and day 60 mortality in ICU adult COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* in ICU hospitalization
* COVID-19 related pneumonia confirmed by PCR

Exclusion Criteria:

* plasmatic SARS-COV-2 RNA quantification not available
* patient's refusal to participate
Implementation of the Hybrid Treatment in Clinical Care. A SCED.

In society today, mental health problems, specifically stress-, anxiety- and depressive disorders, are a primary cause of long-term sick leave, leading to significant societal costs and suffering. One important issue hindering implementation of successful treatments is that there is a marked co-occurrence between these problems and somatic health problems, such as different types of pain. An important key to solving this problem is to develop a more integrated conceptualization of, and treatment model for, these patients' health problems. Specifically, one way to understand the co-occurrence between mental and somatic health problems is offered by the 'transdiagnostic' perspective. The aim of this project is to implement and evaluate the effectiveness of a transdiagnostic emotion-focused treatment protocol in clinical context. The treatment addresses comorbid mental (stress, anxiety- and depressive) and somatic health (pain) problems and targets core emotion regulation processes that are hypothesized to maintain and exacerbate these problems.


Eligibility Criteria:
Inclusion Criteria:

* \> 11 points on the anxiety or depression subscale, Hospital Anxiety and Depression scale
* somatic health problems (pain \> 3 months) with functional impairment (\>3 on question 2 of the Multidimensional Pain Inventory, MPI, OR \> 20 points on question 21-24 of the Örebro Musculoskeletal Pain Questionnaire, ÖMPQ)

Exclusion Criteria:

* severe psychiatric problems requiring immediate other treatment
* current psychological treatment
* recently started psychopharmacological treatment for anxiety or depression (\<3 months prior to planned treatment)
* insufficient mastery of the Swedish language
Disposal of Oral Fructose During Exercise

There is evidence that total carbohydrate oxidation during exercise is higher after ingestion of fructose:glucose mixture than after ingestion of equimolar amounts of glucose alone. This may possible contribute to improve performance, provided that the extra carbohydrate oxidation induced by fructose:glucose co-ingestion occurs in skeletal muscle. The present study aims at assessing the hypothesis that, during exercise, a substantial portion of oral fructose is converted into lactate prior to oxidation To identify the major pathways of fructose disposal, 7 healthy endurance trained male volunteers will be studied. For each participant the following measurement will be performed

* a measurement of maximal oxygen consumption (VO2 max) on an ergometric bicycle
* a 2 hour exercise protocol with oral administration of a glucose drink. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body lactate oxidation
* a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g every hour) mixture. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body lactate oxidation
* a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g every hour) mixture with fructose labelled with 13C6 fructose to evaluate exogenous fructose metabolic fate and oxidation. 6,6-2H2 glucose (0.44 µmol/kg/min) will be infused to calculate glucose kinetics. Fructose conversion into lactate and glucose will be evaluated by monitoring the systemic appearance of plasma 13C-labelled lactate and 13C-labelled glucose. Total exogenous fructose oxidation will be measured by monitoring 13CO2 production.

Based on these measurements, semi-quantitative estimates of total fructose oxidation, fructose conversion into glucose, fructose conversion into lactate, and oxidation of fructose-derived lactate will be obtained


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 35 years
* males
* good physical health
* weekly cycling training sessions (\> 3 sessions/week)

Exclusion Criteria:

* diabetes or glucose intolerance
* past history of heart disease
* alcohol intake \> 30 g/day
* smokers
* drug consumption
A Clinical Trial of Tolcapone in Obsessive Compulsive Disorder

The primary aim of the present study is to examine the efficacy and safety of tolcapone in adults with moderate to severe OCD.

Based on the mechanism of action and our previous pilot data, the primary aim of the present study is to examine the efficacy and safety of 8-week treatment with tolcapone vs. placebo in adults with moderate to severe OCD, as indicated by a score of at least 21 on the Yale Brown Obsessive Compulsive Scale (YBOCS), a scale of illness severity, at the baseline visit. We hypothesize that tolcapone will significantly improve symptoms of OCD compared to placebo.

A secondary aim of the proposed study is to examine the cognitive effects of tolcapone in OCD, by conducting objective neuropsychological tasks pre- and post-pharmacological trial. The rationale for this approach is that: dopamine plays a key role in cognition; cognitive effects of tolcapone are likely to be relevant in explaining symptomatic effects; and cognitive dysfunction constitutes an important treatment target in OCD that is not generally ameliorated by current first-line interventions. We hypothesize that any symptomatic benefit with tolcapone would also be associated with improvement in executive functions including cognitive flexibility.

Another secondary aim of the proposed study is to evaluate whether the single nucleotide polymorphism (SNP) Val-158-Met polymorphism significantly relates to changes in symptoms and cognition observed with tolcapone. Prior data indicate cognitive effects of tolcapone are affected by this SNP. We hypothesize that the val/val COMT variant will be associated with significantly higher tolcapone-related improvements in cognition and symptoms, since this is linked to lower cortical dopamine function.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women age 18-65 years
2. Primary diagnosis of OCD
3. YBOCS score of at least 21 at baseline (moderate or higher severity)
4. Ability to understand and sign the consent form

Exclusion Criteria:

1. Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination
2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
3. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
4. History of psychosis or bipolar disorder based on DSM-5 criteria
5. Alcohol/substance use disorder and/or illegal substance use based on urine toxicology
6. Initiation of psychological interventions within 3 months of screening (those who are continuing with CBT will be included)
7. Use of any new psychotropic medication within 3 months of study entry (stable doses of psychotropics will be allowed)
8. Major cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
9. Abnormal liver function tests at baseline
10. MADRS \>30 at baseline
Association of Non-alcoholic Fatty Liver Disease and Diabetes Mellitus

This study will evaluate the association of non-alcoholic fatty liver disease and diabetes mellitus. Patients presenting in our clinic with Diabetes mellitus type 1 or 2 will receive the following examination:

* Transient Elastography and Controlled Attenuation Parameter using the FibroScan
* blood examination including biochemical markers The statistically calculated sample size needed is 340 patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years and older
* Written informed consent
* Diabetes mellitus type 1 or 2

Exclusion Criteria:

* Patients with mental diseases
* Pregnancy or lactation
* Ascites
* Continued alcohol consumption (\> 21 drinks/week for male and \> 14 drinks/week for female patients)
* Chronic liver disease (viral hepatitis, autoimmune hepatitis, PBC, PSC, hemochromatosis, M Wilson)
* Hepatocellular carcinoma/ Liver metastasis
Multicentre Randomised Study Comparing a Taurolidine Lock and a Standard Saline Lock in Paediatric Oncology

Interest of a Taurolidine lock at each catheter closure in the primary prevention of catheter-related endoluminal infection in paediatric oncology.

Multicentric, controlled, randomized and double-blind label study.

The patient will be followed according to the type of pathology and the respective treatment protocol either Taurolock or physiological serum at each time cathter will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Patient less than or equal to 21 years of age at inclusion.
2. Patient for whom a central catheter is planned to be inserted\*, excluding a non-tunneled femoral or cervical external catheter or a peripherally inserted central catheter (as PICC line). \*1st catheter placement or placement following a relapse (this placement must take place at least one month after previous catheter removal).
3. Patient treated for a cancer.
4. Patient with regular follow-up in the inclusion center.
5. Informed consent signed by the patient if adult or by legal representatives if minor.
6. Patient benefiting from a social security coverage.
7. Time between the date of catheter placement and the planned date for the first solution lock injection less than 6 weeks.

Exclusion Criteria:

1. Patient with retinoblastoma.
2. Allografted patient.
3. Patient with a life expectancy of less than 6 months.
4. Patient refusing to participate in the protocol.
5. Patient already receiving a central venous catheter-related infection prevention lock (ILCVC).
6. Patient with known allergy to citrate or (cyclo)-Taurolidine.
7. Patient taking other drugs with a known contraindication with citrate or (cyclo)-Taurolidine.
8. Patient with an external femoral catheter.
9. Patient with a PICCLINE-type peripheral venous inserted central catheter.
10. Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
11. Patient under guardianship and curatorship.
Effectiveness of the Oxford-AstraZeneca COVID-19 Vaccine as a 2nd Booster, the REFORCO-Brazil Study

This study will address specific questions concerning the additional protection of the AZ COVID-19 vaccine as a second booster dose in preventing severe COVID-19 outcomes (hospitalisation, ICU admission etc) and will provide data to inform COVID-19 vaccine booster dose recommendations.

In Brazil, second COVID-19 boosters became available to specific risk groups in early 2022. By June 2022, immunocompromised individuals aged 12 years and above, individuals aged 50 years and above, and healthcare workers were eligible for a second booster. The vaccines available for second booster doses in Brazil are produced by AstraZeneca (AZ), Janssen, Pfizer and Sinovac.

While several studies have estimated absolute vaccine effectiveness (aVE) or relative vaccine effectiveness (rVE) of second boosters of mRNA COVID-19 vaccines, only a single study has, to date, estimated aVE of AZ vaccine as a second booster dose, and no studies have estimated rVE for AZ vaccine as a second booster dose. As the pandemic progresses, more individuals are choosing to become vaccinated (and boosted) against COVID-19 and thus there is greater need to evaluate the additional protection offered by a second booster dose amongst individuals previously administered a first booster. This is particularly important in the context of waning protection of a first booster dose.

The primary objective is to estimate relative vaccine effectiveness (rVE) against COVID-19 hospitalization of the AZ COVID-19 vaccine as a second booster dose relative to a first booster dose only, of any COVID-19 vaccine, administered at least four months ago.

This study will also evaluate rVE of other vaccines used in Brazil as a second booster doses. The study will further evaluate rVE of all vaccines (including the AZ-COVID-19 vaccine) as a first booster dose relative to a complete primary series only, of any COVID-19 vaccine administered at least four months ago."

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for SARS between 01 January 2022 and 31 December 2022 (Population A) or hospitalised for SARS between 01 August 2021 and 31 December 2022 (Population B).
* Eligible for a second COVID-19 vaccine booster dose at the time of SARS hospitalization (i.e., aged 50+ or aged 18+ and either a HCW or with an IC) for second booster objectives \[Population A\] OR eligible for a first COVID-19 vaccine booster dose at the time of SARS hospitalisation (i.e., aged 18+) for first booster objectives \[Population B\].
* Results available for a RT-PCR and/or antigen test for SARS-CoV-2 conducted on a sample taken up to 14 days after symptom onset.
* Individuals have required matching variables (e.g. age and sex).

Exclusion Criteria:

* Hospitalized for COVID-19 within 3 months prior to date of current hospital admission for SARS
* Nosocomially-acquired infection (where SARS case is flagged as nosocomial and/or where symptom onset date is after hospitalisation date)
COVID-19 Immunity Assessment

The purpose of this study is to collect blood specimens from individuals post infection or post vaccination over time to assess COVID19 Immunity.

The DxTerity COVID-19 Immunity Assessment Collection Mailer Kit contains the DxCollect MicroCollection Device (MCD) Serology fingerstick blood collection device packaged as a home collection kit, designed for collection and shipment of fingerstick blood back to DxTerity CLIA (Clinical Laboratory Improvements Amendment) certified laboratory for testing.

The clinical performance of the collection device for use with anti-SARS-CoV-2 antibody tests will be evaluated for use with cPASS™ anti-SARS-CoV-2 neutralizing antibody detection kit (EUA 201427).

The samples may also be used for assessing immunity or protection post COVID-19 vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥13 years old.
* Not vaccinated and were previously positive for COVID-19 OR are vaccinated for COVID-19.
* Provides test report to demonstrate prior COVID-19 positive result (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
* Provides informed consent and completed questionnaire.
* Able to register the collection kit on the DxTerity portal.
* Able to collect and ship blood samples back to DxTerity.

Exclusion Criteria:

* Unable to provide COVID-19 positive test report (only applicable to unvaccinated subjects who were previously positive for COVID-19, not applicable for COVID-19 vaccinated subjects).
* Unable to complete informed consent and/or questionnaire.
* Unable to complete the study activities in a timely manner.
Impact of Defecation Posture on Ease of First Bowel Movement Following Posterior Repair

This study will determine if defecation posture, when using a defecation posture modification device (DPMD), improves ease with first bowel movement following pelvic reconstructive surgery, specifically posterior repair.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery by one of the sub investigators including a posterior compartment repair

Exclusion Criteria:

* Anyone currently using a defecation posture modification device
* Unwillingness or unable to participate in the study
* Presence of ileostomy/colostomy
* Wheelchair bound
* Device may pose fall or safety hazard risk to patient
* Patients weighing over 250 lbs, as per device manufacturer guidelines
* Inability to understand English
* Pregnant women