cyrilzakka/clinical-trials huggingface dataset:
Adenoma Detection Rate of 3D Colonoscopy

Adenoma detection rate (ADR) has been the most important quality indicator on colonoscopy because ADR was reversely related with CRC incidence and mortality. Several image enhanced technologies, such as narrow-band imaging (NBI) or linked colour imaging (LCI) had been proved to have ability to increase the ADR. 3D techonology, however, has not been validated on colonoscopy performance. Therefore, current study was to compare the ADR between new 3D colonoscopy and conventional 2D colonoscopy.

An accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC.

To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC). Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy or add-on device such as Cap-assisted endoscopy. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI or iSCAN.

3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors and shortened the procedure time during performing gastric endoscopic submucosal dissection(ESD). However, few is known that whether 3D colonoscopy could enhance the adenoma detection, especially for non-polypoid lesion detection, during colonoscopy examination. Therefore, this prospective, randomized control study is aim to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 or above
* Indication for colonoscopy, including screening, surveillance, symptomatic, etc

Exclusion Criteria:

* Poor and inadequate bowel preparation
* Incomplete study because of obstructive lesion, including cancer, stenosis, etc.
* Failure of cecal intubation, difficult insertion
* Inflammatory bowel disease
* Hereditary polyposis, (FAP, Lynch syndrome, hyperplastic polyposis, etc.)
Is There Any Correlation Between Plasmatic Zonulin and Expression of Intestinal Tight Junction Proteins in IBS Patients?

Increased intestinal permeability is one of the main pathophysiological mechanisms involved in irritable bowel syndrome. The expression of some intestinal tight junction proteins is decreased mostly in IBS-diarrhoea patients. This decrease is correlated with increased intestinal permeability. Currently, no test used in clinical practice could assess intestinal permeability.

We hypothesis plasmatic zonulin could reflect intestinal permeability in IBS patients.

The goal of our study is to look for a correlation between plasmatic zonulin and increased colonic permeability (assessed by the expression of intestinal tight junction proteins by western blot) in IBS patients and to look for a role of intestinal low-grade inflammation and microbiota.

Population :

IBS patients with diarrhoea or IBS with constipation or mixed with worsening of symptoms

Outcomes measures :

Plasmatic zonulin (ELISA kit) Occludin expression in colonic biopsies (western blot)

Eligibility Criteria:
Inclusion Criteria:

* IBS-Diarrhoea, IBS-constipation or alternating with recent worsening of symptoms, according to Rome III criteria
* Effective contraception since 1 month for women in childbearing age

Exclusion Criteria:

* Patients with organic and/or inflammatory digestive disease
* IBS with constipation or alternating without clinical warning sign
* Treatment such as anti-inflammatory, probiotic in the last three months
* Severe renal failure
* Hypersensitivity to Normacol
* Patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments
* Anal pathology (anal fissure, hemorrhoidal thrombosis)
* Pregnant or breastfeeding women
* Person with administrative or judicial decision or under legal protection measure
* Patient participating in another trial in the last two weeks
Efficacy and Feasibility of an Intermittent Weight Loss Program.

The goal of the study is to measure the effect of an approach including phases of active weight loss broken by weight stabilisation periods (named intermittent weight loss) on the metabolic profile.

First, the intermittent weight loss approach will contribute to create an artificial transitory steady state during the weight loss treatment that will help to minimize the adverse effects of the standard approach on muscle mass and resting metabolic rate. Second, despite a comparable fat mass loss, the intermittent weight loss approach will improve the metabolic profile to a greater degree compared to the standard approach. Finally, the intermittent weight loss approach will be associated with less weight regain after the treatment since the beneficial effect on muscle mass and metabolic rate.

Excessive levels of body fat are associated with metabolic disturbances predictive of an increased risk of coronary heart disease (CAD). It is presently unclear as to the magnitude of weight loss needed to accrue metabolic benefits. Despite the effectiveness of weight loss to reduce obesity levels, studies have shown that only minor decreases in body weight (5-10%) are needed to clinically improve CAD risk factors. Our data suggested that a 10% reduction in body weight is as effective in improving the metabolic profile as a 20% decrease in body weight. Thus, the question are : " Is it possible to further improve the metabolic profile over that 5-10% weight loss threshold?" and "Could several 5-10% body weight loss (intermittent weight loss approach) have additive effects on the metabolic profile?". We would like to follow-up on these observation to better understand 1) the association between weight loss and improvements in the metabolic profile and 2) why minor decreases in body composition and body fat distribution are as effective as more important reduction.

Eligibility Criteria:
Inclusion Criteria:

* Women who had stopped menstruating for more than 1 year
* Waist circumference \> 90 cm
* Sedentary (\< 2 times a week of structured exercise)
* Non-smokers
* Low to moderate alcohol consumers (\< 2 drinks per day).

Exclusion Criteria:

* We excluded subjects with the following conditions based on medical history and physical examination and on laboratory testing of kidney and liver functions, serum TSH, fasting glucose and lipid profile, and 75g-OGTT
* Cardiovascular disease, peripheral vascular disease or stroke
* Diabetes
* Moderate to severe hypertension (resting blood pressure \> 170/100 mm Hg);
* Body weight fluctuation \> 5 kg in the previous 6 months
* Thyroid or pituitary disease
* Hormonal replacement therapy at any time during the previous 6 months
* Medication that could affect the metabolic profile
Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Objective(s):

The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR \< 1.0 BPM during spontaneous breathing.

Eligibility Criteria:
Inclusion Criteria:

* The subject is at least 18 years old;
* The subject has given written informed consent to participate in the study;
* The subject is both willing and able to comply with study procedures.

Exclusion Criteria:

* The subject has a history of or current atrial fibrillation;
* The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as \>3 per 30 seconds;
* The subject has an implanted pacemaker;
* The subject has had any relevant injury at the sensor location site (self-reported);
* The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination);
* The subject is currently or trying to get pregnant (self-reported); and/or
* The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.
Evaluation of Treatment Outcome of Lower Incisors Crowding Using Clear Aligners With Laser Acceleration .

The present study will be performed to evaluate the effect of low-level laser therapy (LLLT) on the rate of orthodontic tooth movement through the correction of lower incisors crowding using clear aligners

This study will employ a two-arm parallel randomized clinical trial design with an allocation ratio of 1:1. The study will include participants aged 16 to 23 years with mild to moderate anterior lower crowding and Class I Angle malocclusion, presenting with a full set of teeth excluding wisdom teeth. Eligible participants will be randomly assigned to either the intervention group, receiving LLLT in addition to clear aligner therapy, or the control group, receiving clear aligner therapy alone.

Intervention:

The intervention group will undergo LLLT using the Biolase Epic X device, calibrated to 0.2 W power, 0.16 J energy, and 0.8 seconds pulse duration per point. The laser will be applied to five points on the buccal surface (cervical mesial, distal, middle root, apical mesial, and distal) and four points on the lingual surface (cervical mesial, distal, middle root, and middle apical) of the target tooth. LLLT sessions will be conducted weekly over seven sessions.

Eligibility Criteria:
Inclusion Criteria:

1. A well-behaved, compliant, and motivated patient.
2. Patients from 16 to 23 years old .
3. Patients with mild to moderate anterior lower crowding.
4. Full complement of teeth (except for wisdom teeth).
5. Class I Angle malocclusion .

Exclusion Criteria:

1. Patients with missed anterior teeth .
2. Class II or III Malocclusion (dental or skeletal ) .
3. Any systemic diseases that may interfere with assigned treatment plan .
4. Periodontal affection especially at lower anterior teeth .
Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD 2010 guideline
* Current or ex-smokers who have a smoking history of at least 10 pack years
* Qualifying FEV1 at Visit 2 (day -7)

Exclusion Criteria:

* Patients with a history of asthma or a history of high blood eosinophil count (\>600/mm³)
* Patients with concomitant pulmonary disease
* Patients with lung lobectomy or lung volume reduction or lung transplantation
* Patients with α-1 antitrypsin deficiency
* Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during run-in period

Other protocol-defined inclusion/exclusion criteria may apply.
A Prospective Comparison of Ultrasound-Guided Percutaneous Platelet-Rich Plasma Injection

The purpose of this study is to determine the effectiveness of various treatment soft tendinosis also known as tendinitis.

Currently there are three treatments that are considered standard of care; rest, tenotomy and tenotomy with injections of platelet-rich plasma (PRP). Tenotomy is performed by passing a needle through the abnormal tendon repeatedly until the needle has passed through all areas of the abnormal tendon with softening of the tendon. Tenotomy with PRP injections is performed in the same manner but includes an injection of platelet-rich plasma (PRP) into the tendon. This study will evaluate the effectiveness of tenotomy versus PRP treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with a diagnosis of tendinosis of the hip.
* Adult subjects who have been referred to Dr. Jacobson for the treatment of tendinosis by tenotomy.

Exclusion Criteria:

* pregnancy
* risk of bleeding due to anticoagulant medication
* presence of malignancy
* steroid injection less than 3 months before enrollment
Rapamycin in Relapsed Acute Lymphoblastic Leukemia

This is a research study designed to look at the biological effects of two drugs on leukemia cells. In this study, we are comparing the effects of drugs called corticosteroids when used alone or with another drug called rapamycin. Rapamycin is a drug that prevents the body's immune system from working normally. It has been used for many years after kidney transplants to prevent rejection of the organ. Recent work suggests that rapamycin may also help treat leukemia and other cancers.

* Participants will be randomized into two groups; one group will receive corticosteroid alone, and the other group will receive rapamycin and corticosteroid.
* The length of treatment will be 5 days, during which time we will collect blood samples to measure the biologic effects of these drugs. Because these drugs will be given for a short period of time only, this study is not designed to treat or cure the participants leukemia. After the 5-day period, participants may resume other cancer-directed therapies.

Eligibility Criteria:
Inclusion Criteria:

* Documented acute lymphoblastic leukemia (L1 or L2 subtypes)
* First or subsequent relapse
* 365 days of age or older
* Greater than 7 days from any chemotherapy or immunotherapy, with the exception of intrathecal chemotherapy
* Absolute peripheral leukemia blast count of 1000 cells/ul or greater
* Patient (or parent/guardian if patient is less than 18 years of age) must sign informed consent

Exclusion Criteria:

* Burkitts leukemia (acute lymphoblastic leukemia L3 subtype)
* Uncontrolled active infection
* Pregnancy or mothers who are nursing
* Patient currently taking rapamycin
* Patients with significant liver dysfunction as outlined in protocol
* Severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into the study
* Active psychiatric disease, substance abuse, or mental illness that would interfere with cooperation with the requirements of the trial
Train Your Brain - Executive Function

The purpose of this research is to test if playing games designed to improve an individual's executive function can change their views about the types of foods they eat. Executive function is a set of mental processes that people use every day to make decisions - such as what kinds of foods they choose to eat and when and where they eat those foods.

The purpose of this study is to determine whether executive function (EF) training concurrently improves attitudes, perceptions, and consumption of nutrient-dense foods (i.e., fruits, vegetables) while worsening the same of nutrient-poor foods. In effect, the aim is to test whether EF training can promote the substitution of nutrient-poor foods with fruits and vegetables (FV), as the Dietary Guidelines for Americans (DGA) recommends regular consumption of FV as part of a healthy dietary pattern. Given the health benefits associated with consuming FV, EF training that effectively promotes increased FV intake may benefit health. For example, FV consumption is associated with the reduced risk of all-cause mortality, cardiovascular disease, diabetes, cancer, and eye and skin health. Moreover, FV consumption is associated with better mental and cognitive health.

Eligibility Criteria:
Inclusion Criteria:

* BMI 23-38 kg/m2
* US citizenship
* Not currently dieting to lose weight and no weight loss or gain of \>2 kg over the past 3 months
* No tobacco or e-cigarette use
* Not pregnant or lactating or planning to become pregnant while participating in the study

Exclusion Criteria:

* Not a US citizen
* Currently dieting to lose weight
* Weight loss of \>2 kg over the past 3 months
* Tobacco or e-cigarette use
* Pregnant or lactating or planning to become pregnant while participating in the study
* A history of bariatric surgery
* Diagnosis of major medical or psychiatric condition that would interfere with participation, including not being physically able to play the games, or a current eating disorder
Mechanisms Underlying Cardiovascular Consequences Associated With COVID-19 and Long COVID

AIM 1. Characterize cardiovascular phenotypes of long COVID by cardiopulmonary, meta-bolic, and cardiac mechanical/physiological responses to exercise and microvascular vasomotor function.

AIM 2. Identify intercellular signaling between immune cells and cardiac cells associated with microvascular phenotypes of long COVID.

As many as 40-60% of patients who recovered from mild or moderate acute COVID have reported what is now called long COVID - multiple, persistent or recurrent symptoms lasting 6-9 months (or longer) following initial illness.1-4 Fatigue, dyspnea, and chest pain are the most common symptoms. Others include palpitations, lightheadedness, and syncope. All these cardiovascular symptoms can be debilitating, resulting in worse quality of life and morbidity.5, 6 Treatment options are limited.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18, \< 75 yrs
* History of lab-confirmed COVID
* Symptomatic at \>12 wks post-acute COVID (cases)
* Recovered by 8wks post-acute COVID (controls)

Exclusion Criteria:

* Any history of critical illness
* Chronic kidney disease, Stage \>4
* Pre-COVID: HFrEF, CABG, arrhythmia; pulmonary hypertension, pulmonary embolus, interstitial lung disease (ILD), O2 dependence; dementia, stroke, autonomic dysfunction; coagulopathy
* Post-COVID: ILD, O2 dependence
Effect of Ventilation Mode on Lung Deposition of a Radiolabeled Aerosol During Mechanical Ventilation: Barometric Versus Volumetric

Controlling the respiratory pattern of mechanically ventilated patients in volume control mode is recommended during nebulization. No studies looked into conditions of nebulization during assisted mechanical ventilation to define the optimal nebulization technique and its effect on pulmonary deposition.

The aim of this study is to analyse the effect of ventilation mode (barometric versus volumetric) on deposition by planar scintigraphy during mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation
* Healthy lungs

Exclusion Criteria:

* Change of ventilation mode during nebulization
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia

OBJECTIVES:

I. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months.

Arm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6 weeks.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis

Received hydroxyurea for at least 6 months On a stable dose for at least 3 months Tolerating dose of at least 5 mg/kg/day

--Prior/Concurrent Therapy--

Chemotherapy:

* No other concurrent antisickling agent

Other: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole

--Patient Characteristics--

Hematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less than 11 g/dL

Hepatic: AST/ALT no greater than 100 units/L

Renal: Creatinine no greater than 1.5 mg/dL

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior adverse reaction to hydroxyurea or clotrimazole
* No recent or progressive neurologic dysfunction
Analysis of Cardiac Damage Post Infection With SARS-CoV-2 and Post Vaccination Against COVID-19

From May 2020 to May 2021, the investigators retrospectively evaluated clinical cardiac magnetic resonance (CMR) examinations performed in patients with suspected cardiac involvement post COVID-19. Between May 2021 and August 2021, the investigators evaluated patients with suspected cardiac disease after COVID-19 vaccination.

Hospital database for patients that underwent a clinical CMR examination between May 2020 and May 2021 for suspected cardiac pathology post COVID-19 were analyzed. For comparison, CMR examinations from January until August 2021 were searched for suspected cardiac pathology post COVID-19 vaccination. The study complies with the declaration of Helsinki and was approved by the ethics committee of the Charité-Universitätsmedizin Berlin (EA2/020/21).

CMR Imaging All scans were performed for clinical indications on either a Philips Ingenia 3.0 T scanner or a Philips Ambition 1.5 T scanner according to recent recommendations for CMR in patients post COVID-19. Protocols were adjusted to the clinical scenario but generally included standard CINE imaging, T2 STIR edema imaging, basal and medial short axis T2 mapping (T2-GraSE) and pre- and post-contrast T1 mapping (MOLLI), and Late-Enhancement-Imaging (mDIXON). Vasodilator stress with Regadenosone or Adenosine was performed in patients with clinically suspected myocardial ischemia. The Adenosine dose was 0.140 µg/kg/min, with an increase to 0.210 µg/kg/min in case of insufficient response. The Regadenosone dose was 200µg irrespective of weight, followed by Theophyllin reversal as needed (max. 200mg). The contrast agent was 0.1 mmol/kg Gadobutrol (Gadovist®, Bayer AG, Leverkusen, Germany).

CMR image analysis Image post-processing and measurements were performed according to recent recommendations using dedicated CMR post-processing software (IntelliSpace Portal V11.1, Philips, Best, The Netherlands). The diagnosis of 'probable myocarditis' was based on the updated Lake Louise Criteria requiring findings of myocardial damage (LGE) and edema (T2 STIR or T2 mapping) in a non-ischemic pattern (intramyocardial or subepicardial). Evidence of edema without myocardial damage was considered 'possible myocarditis' whereas myocardial damage without edema was considered 'subsided myocarditis.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac MRI for suspected cardiac Involvement after COVID-19 or COVID-19-vaccination

Exclusion Criteria:

* None