cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cocoa on Platelet Function Profiles in Patients

The effects of chocolate on cardiovascular health are still a matter of debate. It can potentially favor cardiovascular health through the antioxidative effects of cocoa ingredients, such as polyphenols (present in dark but not white chocolate).

Epidemiologic studies have shown inverse associations between dietary polyphenols (present in dark chocolate and cocoa) and mortality from coronary heart disease. However, the basis for this protective association is uncertain. Food polyphenols such as in cocoa reportedly have antioxidant properties and decrease platelet function in vitro. The goal of the present study was to investigate whether the beneficial antioxidant effect of polyphenol-rich cocoa can induce an improvement of endothelial and platelet function in patients with stable coronary artery disease with known platelet hyperreactivity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with stable coronary artery disease.
2. Patients \> 18y of age.

Exclusion Criteria:

1. Patients with T2DM.
2. Patients who already ingest any cocoa-based products.
Effect of Benoxinate Hydrochloride Eye Drops on The Premature Infant Pain Profile Score During Retinopathy of Prematurity Screening

Aims: To evaluate the effects of topical Benoxinate HCL eye drops on the Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.

Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.

Aims: To evaluate the effects of topical Benoxinate HCL eye drops on Premature Infant Pain Profile (PIPP) scores in infants undergoing Retinopathy of Prematurity (ROP) screening.

Methods: A randomized prospective double-masked cross-over trial was conducted on preterm infants screened for ROP at least twice. Dilated fundus examination was done in Group A infants using the tear substitute eye drops and the second using the Benoxinate HCL drops and the reversed order of drops for Group B. Video recording of the pulse oximeter monitor, the face and the body of the infant were analyzed by a single neonatology consultant for Premature Infant Pain Profile (PIPP) scoring 1 minute before, during the examination of the first eye, 1 minute and 5 minutes after the conclusion of the examination of the second eye. The sound of the ophthalmologist on the video recordings indicating the time of the lid speculum insertion, the shining of the indirect ophthalmoscope light without indentation and the scleral indentation would aid in assessing the differences of the PIPP indicators during each step of the examination.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with GA ≤34 weeks and/or with birth weight ≤2000 g
* Preterm infants with larger GA or birth weight who were at increased risk of ROP according to the attending neonatologist
* Infants were believed to require at least 2 ROP screenings

Exclusion Criteria:

* Infants on muscle relaxants, analgesics, sedatives, or exogenous steroids
* Infants who required mechanical ventilation or continuous positive airway pressure at the first examination
Evaluation of Adherent Invasive E. Coli Eradication in Adult Crohn Disease

The primary objective of this trial is to assess whether a 12-week treatment with Ciprofloxacin and Rifaximin is superior to placebo to obtain endoscopic remission in adherent-invasive E. coli (AIEC)-colonized patients with ileal Crohn disease (CD), with or without involvement of the caecum or the right colon.


Eligibility Criteria:
Inclusion Criteria:

* CD of the ileum, with or without involvement of the caecum or the right colon
* Colonoscopy showing active lesions defined by a CDEISm score \>6
* Informed consent to participate in this study
* Prescription of steroid treatments : Budesonide, Prednisone (or Prednisolone) independently from entry in study
* Patients who respond to budesonide (initial dose 9 mg/d) or prednisone or prednisolone (initial dose 40 mg/d), defined as a 70 points decrease in CDAI between the pre-inclusion and the inclusion visit,
* Patients colonized with AIEC on initial ileal biopsies.

Exclusion Criteria:

* Ileal stenosis that cannot be crossed by the endoscope,
* Infliximab treatment received less than 8 weeks before inclusion in this study,
* Adalimumab treatment received less than 4 weeks before inclusion in this study,
* Vedolizumab treatment received less than 8 weeks before inclusion in the study,
* Hypersensitivity to Ciprofloxacin, to other quinolones, or to any of the excipients (cellulose microcrystalline, crospovidone, maize starch, magnesium stearate, silica colloidal anhydrous,, hypromellose titanium dioxide E171, macrogol 4000,),
* Tizanidine, Probenecid, Theophylline, Xanthine derivatives, Phenytoin, oral anticoagulants, and Ropinirole treatment,
* Hypersensitivity to Rifaximin, or to any excipients (sodium starch glycolate type A, glycerol distearate, colloidal anhydrous silica, talc, microcrystalline cellulose, hypromellose, titanium dioxide, disodium edentate, propylene glycol, red iron oxide E172),
* Previous extensive ileal surgery (≥ 1 meter as measured on the pathology and/or surgical report),
* Short bowel syndrome,
* Need for an intestinal resection for fistula, abscess or intestinal obstruction,
* Renal failure (creatinine clearance\<30 mL/min/1.73m2),
* Liver failure (V factor\<50%),
* Past history of epilepsy,
* No health insurance,
* Pregnant or lactating women,
* Refusal to have a double effective contraception,
* Patients already included in a biomedical research other than an observational study (e.g: registry, cohort).
Evaluation of the Mobility of the Digital Flexor Tendons

To study flexor tendon excursion in the hand after surgery by dynamic MRI

The study of the movement of the digital flexor tendon operated on MRI could lead to a better understanding of the biomechanics of this tendon after surgery, to objectively assess the repair of the tendon and the recovery of its mobility. The visualization of the aspect and the movement of this operated tendon would make it possible to adapt the rehabilitation for each patient and to prevent the occurrence of complications which limit functional recovery and source of handicap.

The analysis of the imaging in patients evolving would establish useful criteria the surgeon to judge the evolution of the operated tendon.

The first step consists in evaluating the feasibility of the acquisition of dynamic sequences in MRI and the possibility of observing the movement of the flexor tendon operated during the mobilization of the finger, and comparing the biomechanical data obtained with those of the nonoperated tendons and experimental models.

Eligibility Criteria:
Inclusion Criteria:

* flexor tendon injury in zone 2
* treatment by surgery
* insufficient functional outcome after surgery
* MRI requested by surgeon

Exclusion Criteria:

* pregnancy
* MRI contraindications
* previous surgery on the hand
* rheumatic disorder
Project VALOR: Veteran Stress and Wellbeing

This study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior veterans as the move into their second year post-Army. Up to 350 veterans drawn from The Network Study (Dept of Defense; Award number: W81XWH1920001) will be recruited with the intention of drawing a final sample of 300. Study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.

The combination of alcohol use and negative emotional states is a particularly toxic combination for suicide risk. The current study examines changes in alcohol/drug use/misuse and depression as veterans transition further into their post-Army environment and offers a personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and depression in this population.

The study's objectives are to empirically quantify the form of changes that occur with respect to alcohol use and depression as veterans move into their second year post-Army; to identify stable individual risk factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in stressors and normative contexts over time) that may be associated with differential temporal patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e., depression); and lastly, to determine whether a simple, internet-delivered brief intervention shown can reduce risky behavior in the veteran population.

Eligibility Criteria:
Inclusion Criteria:

* Is US Army veteran who participated in The Network Study (Dept of Defense; Award number: W81XWH1920001)
* Seeks/engages in civilian employment
* Lives in US

Exclusion Criteria:

* Retired with no plans to seek civilian employment
* Living outside of the US
* Separated from the National Guard or Reserves
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT

The purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.

A Phase 1, Open-label trial where up to 10 participants will enroll in the trial after parent REACT protocol EOS visit completion. Participants may undergo a biopsy to manufacture REACT if additional biopsy tissue is required. Participants will receive 2 REACT injections separated by 6 months. All participants will be followed for 12 months post last supplemental REACT injection.

Eligibility Criteria:
Inclusion Criteria:

1. The participant has received REACT in a previous trial for treatment of chronic kidney disease and completed their parent protocol follow up period.
2. The participant is male or female, 30 to 80 years of age on the date of informed consent.
3. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 14 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.
4. The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary.

Exclusion Criteria:

1. The participant has a history of renal transplantation.
2. The participant has received dialysis for more than 30 days.
3. The participant has received any other investigational products after completion of REACT injections within 3 months of screening.
4. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than 5,000 mg/g.
5. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to screening.
Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.

The goal of this observational study is to provide optimal monitoring and support when initiating ETI treatment in eligible persons with cystic fibrosis (aged 12 y +) and to document on a daily basis, from 72 hours before the start of treatment and then for 14 days i) i) FEV1 changes (home spirometry), ii) ii) respiratory symptoms changes, iii) any possible side effects. Through a dedicated electronic platform, these data will be monitored every day by the medical team, which will be fully available for any questions or concerns patients may have.


Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis diagnosis
* At least 12 years old
* Carrier of at least one copy of F508del mutation
* Ability to perform reliable and reproducible spirometry
* Medical and psychological stability
* written consent
* owning a smartphone

Exclusion Criteria:

* Lung transplant
* FEV1 \> 120 % pr (%GLI) at the inclusion test
* Pulmonary exacerbation
Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)

The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.

Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. Although research indicates that the majority are not treated for ADHD while in substance treatment, we do not know whether concurrent pharmacotherapy for ADHD will improve treatment outcomes. This Clinical Trials Network (CTN) study will evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH), relative to placebo, in treating ADHD and decreasing substance use in adolescents (13-18 years old) with ADHD and a substance use disorder. Approximately 300 participants will be recruited at 11 sites and randomly assigned to either OROS-MPH or matching placebo for a 16-week treatment period, during which all participants will receive individual cognitive-behavioral therapy as a standardized treatment for substance abuse.

Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual for Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for ADHD
* Meet DSM-IV diagnostic criteria for at least one non-nicotine substance use disorder
* Has a DSM-IV ADHD Symptom Checklist score ≥ 22 derived from the adolescent-completed checklist

Exclusion Criteria:

* Serious medical illness
* History of tic disorder
* Pregnant or breastfeeding
* Meet DSM-IV criteria for current or life-time psychotic disorder
* Meet DSM-IV criteria for current or life-time bipolar disorder
* Requires/or prescribed other concurrent psychotropic medication
* Taking any medications that may produce interactions with OROS-MPH
* Opiate dependence
* Methamphetamine abuse or dependence
* Suicidal risk
* Enrolled in an inpatient, residential, day treatment, or outpatient substance abuse program within 28 days prior to signing consent
SomPsyNet - Prevention of Psychosocial Distress Consequences in Somatic Medicine: a Model for Collaborative Care

This study is to evaluate the impact of the "stepped and collaborative care model" (SCCM) on health-related quality of life in somatic hospital patients with psychosocial distress.

Given the burden of psychosocial distress, the public health relevance, and the current standard of health care, new approaches to a model of care for patients with mental-somatic multimorbidity are urgently needed. SomPsyNet is a comprehensive healthcare project for patients from somatic hospitals that promotes the prevention of psychosocial distress by establishing a stepped and collaborative care network in Basel-Stadt, Switzerland and may therefore help to counteract against the described lack of care.

SomPsyNet is a "stepped and collaborative care model" (SCCM) including a Psychosomatic-psychiatric consultation and liaison Service (CL Service) and post hospital intervention supported by a collaborative network structure. It aims to identify patients with psychosocial distress at an early stage during their hospital stay in a standardized way.

Implementation of the SCCM within this study using the stepped-wedge cluster randomized trial (SW-CRT) design will take place in phases:

* SomPsyNet phase 0: treatment as usual (TAU) in combination with the baseline and follow-up survey in a distressed focus sample.
* SomPsyNet phase 1: TAU in combination with the baseline survey, implementation of screening questions stage 1 ('baseline distress information from professionals', without consequence) in hospital routine and follow-up survey in a distressed focus sample.
* SomPsyNet phase 2 refers to the implementation of the SCCM: baseline survey, assessment of screening questions stage 1 (with consequence), screening questions stage 2 (with consequence) and if necessary psychosomatic-psychiatric consultation and liaison service including if applicable post hospital intervention and a follow-up survey in a distressed focus sample.

Eligibility Criteria:
Inclusion Criteria:

* patients from selected wards (i. e., somatic diseases treated at these wards from three somatic hospitals)

Exclusion Criteria:

* Inability to understand and speak German or any other language at which study is tailored at that point in time
* Inability to give informed consent by himself / herself
* Inability to follow the procedures of the study, e.g. due to severe medical / clinical limitations
* Need for immediate support as indicated by the risk of current suicidality or attempted suicide
* Oncological condition
* Already participated in the SomPsyNet project on the occasion of a previous hospitalization
* Confirmed current COVID-19 disease at time of screening for exclusion criteria
* Being hospitalized under the medical supervision of services of a ward that is not part of one of the SomPsyNet study clusters ('original ward'), but physically located in rooms of a ward contributing to one of the study clusters only because of lack of space in the original ward
Usefulness of Lidocaine in Oral and Maxillofacial Surgeries Under General Anesthesia for Pain Control After Operation

This will be a randomized double blinded clinical study conducted in patients undergoing oral and maxillofacial surgery under general anesthesia. Lidocaine group will receive intravenous bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the completion of surgery.Normal saline group will receive same amount of intravenous normal saline .The primary outcome will be postoperative pain using the NRS scale during first 24 hours and time to first analgesic request


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-60 years of age
* Patients of ASA (American Society of Anesthesiologists) Class I or Class II (I- healthy with no systemic disease, II- mild systemic disease with no functional limitation) who require oral and maxillofacial surgeries under general anesthesia

Exclusion Criteria:

* Refusal to give consent.
* Hypersensitivity or allergy to the study medication.
* ASA physical status III or more.
* Subjects with known severe hepatic or renal dysfunction or cardiac dysrhythmia or atrioventricular block.
* History of taking opioids or antiarrhythmic drugs within 1 week of surgery.
* History of drug or alcohol abuse
* History of psychiatric disorders.
* Patients requiring emergency surgery.
* Patients unable to comprehend pain assessment
The Effect of Cognitive Behavioral Therapy and Virtual Reality Use in Inured Athletes

In this study, which aimed to develop a Cognitive Behavioral Therapy (CBT) protocol enriched with Virtual Reality (VR) to address the psychological responses that arise after ACL surgery, and to examine the effectiveness of this protocol. The effectiveness of the protocol was assessed using pre-test, post-test, and two follow-up measurements with the Re-Injury Anxiety Inventory (RIAI), the Sport Injury Rehabilitation Adherence Scale (SIRAS), the Tampa Scale for Kinesiophobia (TSK), the Athletic Injury Self-Efficacy Questionnaire (AISEQ), the Return to Sport After Serious Injury Questionnaire (RSSIQ), and the Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI). Anxiety levels during VR exposure sessions were measured through biofeedback and the Subjective Units of Distress Scale (SUDS).

In this study, which aimed to develop a Cognitive Behavioral Therapy (CBT) protocol enriched with Virtual Reality (VR) to address the psychological responses that arise after ACL surgery, and to examine the effectiveness of this protocol. The protocol was developed in 5 stages and a randomized controlled trial was conducted with 36 athletes to test its effectiveness. The study consisted of 1 experimental and 2 control groups. One of the control group was a plasebo control group.The effectiveness of the protocol was assessed using pre-test, post-test, and follow-up measurements with the Re-Injury Anxiety Inventory (RIAI), the Sport Injury Rehabilitation Adherence Scale (SIRAS), the Tampa Scale for Kinesiophobia (TSK), the Athletic Injury Self-Efficacy Questionnaire (AISEQ), the Return to Sport After Serious Injury Questionnaire (RSSIQ), and the Anterior Cruciate Ligament Return to Sport Scale (ACL-RSI). Anxiety levels during VR exposure sessions were measured through biofeedback and the Subjective Units of Distress Scale (SUDS).

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Have had an ACL injury operation
* Be between the ages of 18 and 45
* To be a professional athlete in Turkish leagues
* Being an athlete in football, volleyball, and basketball

Exclusion Criteria:

* Having a discomfort that prevents participants from participating in VR sessions (panic attack, epilepsy, etc.)
* Having Motion Sickness Susceptibility (The athlete's score from the " Motion Sickness Susceptibility Questionnaire" will be decisive.)
* Having decided to quit sports even if participants will continue rehabilitation after the operation