cyrilzakka/clinical-trials huggingface dataset:
Cocoa Flavanols and Exercise Capacity

The purpose of this study is to characterize the potential improvement of cocoa flavanols on exercise capacity in highly trained cyclist. A placebo-controlled double-blinded randomized control study will be performed in 13 highly trained cyclist (crossover design). Participants will perform a baseline exercise testing on an ergometer. They will receive either a flavanol-poor or flavanol rich cocoa drink twice daily for one week before a second and third exercise testing is performed. The order of drinks is randomized and balanced (high-flavanol--\>low-flavanol drink or low-flavanol drink--\>high-flavanol drink)

13 participants (highly-trained cyclist, accustomed to exercise testing on ergometers will be enrolled (VO2max\>50 ml/kg, FMD \>5%, non-smokers, no medication, no diseases, age 20-36, male).

Baseline Testing:

Participants will perform a baseline testing consisting of an ergometric test with a step-wise increase of workload until exhaustion to determine lactate anaerobic threshold and cardio-pulmonary exercise capacity. Vascular function is monitored by Doppler Ultrasound.

In a second test, participants will perform a time trial (goal: as fast as possible)

Flavanol intervention Participants will twice daily receive either a flavanol-poor cocoa drink (13mg/dl)or a flavanol-rich cocoa drink (596mg/dl) over a period of 7 days. Order is randomized and balanced. Subjects will crossover to the second arm after a washout period of 7 days.

Testing performed on baseline day is repeated after the intake of both drinks

In a subgroup of n=6 participants, we will test whether the blood pressure cuff maneuver used for FMD will itself modify nitrite levels. For this the manuever will be completed 4 times and compared to n=6 untreated controls. in another subgroup 6 participants will receive 4times the maneuver but reperfusion will be limited by means of an ultrasound probe.

Eligibility Criteria:
Inclusion Criteria:

* highly trained cyclists (VO2 peak \> 50 ml/kg bodyweight)
* refrain from cocoa ingestion during trial
* training continued throughout testing
* \> 20 years
* male

Exclusion Criteria:

* \> 36 years
* poor endothelial function
* acute infection
* any chronic heart or pulmonary disease
* arrhythmias
* acute or chronic renal failure
* smokers
* cardio-vascular risk factors : diabetes mellitus, hypertension, hyperlipidemia
* intake of nutrition supplements (l-arginine, creatinine)
* intake of WADA listed doping substances
The Effects of Mindfulness-Based Stress Reduction Program for Family or Caregivers of Children With Motor Disabilities

The present study aims to investigate the effect of a mindfulness-based program on perceived stress, severity of anxiety, parents'/caregivers' quality of life and their children, cortisol and IL-6 blood concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Not having attended previously a mindfulness course
* A score equal to or greater than 23 points at the PSS.
* \>18 years old
* Children \<18y with motor/physical disability due to a Neurological disorder.
* Spanish/Catalan speaking

Exclusion Criteria:

* Currently using drugs or any kind of medication related to stress, depression, anxiety or sleeping pills, such as steroid medicines.
* Regular meditation practice (once a week in the past 12 months)
* Diagnose of hypertension stage 2
* Pregnancy in the case of mothers
* Present hyperthyroidism
* Primary adrenal insufficiency syndromes such as Cushing syndrome or Addison disease
* Present any kind of infection or inflammation process, different from the interestingly to the present study that could differ the results
The Specific Elastance in Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS) Patients

The investigators aim to study the specific elastance in ALI/ARDS patients during invasive mechanical ventilation.

In sedated and paralyzed ALI/ARDS patients, we studied the specific elastance and also, we compared the specific elastance to healthy subjects during invasive mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Stable ALI/ARDS patients during invasive mechanical ventilation

Exclusion Criteria:

* Hemodynamic failure, pneumothorax
Comparison Using a VLS Using GlideRite Stylet Versus TCI Articulating Introducer in Predictive Difficult Intubation

This study will assess the feasibility of using the TCI Articulating Device with video-laryngoscope in predictive, difficult airway, endotracheal intubation cases. It is meant to show the use of this device is equivalent to using the GlideRite Rigid Stylet with video-laryngoscope.

Multi-Centered, Prospective, Randomized, Control Trial

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring oral endotracheal intubation
* Age 18 years or older
* Group A Criteria (need only one of the following criteria)

  1. History of difficult intubation
  2. History of head/neck radiation and prior oral cavity, pharyngeal, or laryngeal surgery

Group B Criteria (need three or more of the following)

1. Thyromental distance \<6 cm (Defined as distance measured from the thyroid notch to the tip of the jaw with the head extended and the mouth closed)
2. Sternomental distance \< 12 cm (Defined as distance measured as the straight line between the upper border of the manubrium sterni and the bony point of the mentum with the head in full extension and the mouth closed
3. Oropharyngeal view: modified Mallampati scale of 3 or 4
4. Mouth opening \< 4 cm
5. Protruding upper teeth (severe overbite)
6. History of radiation to the neck
7. Limited neck movement: inability to extend and flex neck \>90° from full extension to full flexion or presence of cervical spine pathologies and fractures (e.g., C-collar in place)
8. Body Mass Index (BMI) \>35 kg/m2
9. Neck circumference .\> 40 cm in females and 43 cm in males measured at the thyroid cartilage
10. Obstructive sleep apnea diagnoses or a STOP BANG score 6 and above

Exclusion Criteria:

Any patient under the age of 18 Full stomach, Untreated hiatal hernia Uncontrolled gastroesophageal reflux disease Known tracheal narrowing
Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus

Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus


Eligibility Criteria:
Inclusion Criteria:

* contact lens intolerance
* corneal thickness \> 450 micrometers
* Keratometry \< 56 diopters
* Astigmatism \< 6 diopters

Exclusion Criteria:

* corneal thickness \< 450 micrometers
* Keratometry \> 56 diopters
* Astigmatism \> 6 diopters
A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation

This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary agreement to provide written informed consent.
* Predicted survival ≥ 12 weeks.
* According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC.
* Is willing and able to provide an adequate archival tumor tissue sample
* Has relapsed from or is refractory to standard treatment and had received both platinum-based therapy and immunotherapy.
* Measurable lesion according to RECIST 1.1.
* Documented HER2 exon 20 insertion mutation.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Adequate organ function.
* For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, the blood pregnancy test within 7 days of study enrollment must be negative and must be non-lactating. Male subjects: Patients who should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study.
* Willing and able to follow trial and follow-up procedures.

Exclusion Criteria:

* No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation.
* Patient has had previous treatment with HER2-targeted therapy prior to study participation.
* History of major surgery within 4 weeks of planned start of trial treatment.
* Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
* Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
* NYHA Class III heart failure.
* Suffering from active infection requiring systemic treatment.
* Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD.
* Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
MGC Health COVID-19 & Flu A+B Home Multi Test Usability Study

The purpose of this study is to evaluate the usability of the MGC Health COVID-19 \& Flu A+B Home Multi Test in home use.

The MGC Health COVID-19 \& Flu A+B Home Multi Test is a lateral flow immunochromatographic antibody assay intended for the simultaneous qualitative detection and differentiation of the nucleocapsid antigen from SARS-CoV-2, influenza A and/or influenza B directly from anterior nasal swab specimens obtained from individuals, who are suspected of respiratory viral infection within five (5) days of symptom onset. This test is intended for non-prescription home use with self-collected direct anterior nares swab samples from individuals ages 14 years and older or adult lay user collected anterior nares swab samples from individuals aged 2 to 13 years.

The objective of the study is to determine the usability of the MGC Health COVID-19 \& Flu A+B Home Multi Test in a simulated home use environment.

This is an open label study to evaluate the usability of the MGC Health COVID-19 \& Flu A+B Home Multi Test using information from the Quick Reference Instructions (QRI).

Eligibility Criteria:
Inclusion Criteria:

* An Institutional Review Board (IRB) approved informed consent / assent, if applicable, is signed and dated prior to any study related activities.
* Male and female subjects 2 years of age and older.
* Subject is willing to provide a self-collected nasal swab sample. (If the subject is under the age of 14, an adult lay user will collect the sample.)
* Subject agrees to complete all aspects of the study.

Exclusion Criteria:

* Subject has a visual impairment that cannot be restored with glasses or contact lenses.
* Subject has prior medical or laboratory training.
* Subject uses home diagnostics, e.g., glucose meters, HIV tests.
* Subject has prior knowledge of their current COVID-19 or flu infection status.
Drug-drug Interaction Study Between Edaravone and 2-Aminoethanesulfonic Acid in Compound Edaravone Injection

An experiment to evaluate the drug-drug interaction of formula edaravone and formula 2-aminoethanesulfonic acid in compound edaravone injection.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 years old (including upper and lower limits);
2. Weight ≥50 kg, body mass index (BMI) between 18-28 kg / m2 (including upper and lower limits);
3. Understand and sign the informed consent voluntarily, and volunteer to participate in this research.

Exclusion Criteria:

1. A history of diseases of the heart, liver, lung, kidney, digestive tract, blood, or neuropsychiatric system judged by the investigator as clinically significant;
2. A comprehensive physical examination, neurological examination, laboratory examination, ECG examination, or cognitive assessment indicates that the subject has an abnormality that the researcher has determined to be clinically significant;
3. Have taken any drug within two weeks before the study administration, and the researcher believes that this situation may affect the evaluation results of this study;
4. There is a history of food or drug allergy or allergies that the researcher judges to be clinically significant;
5. Those with positive results of serological examination (HBsAg, anti-HCV, anti-HIV, TP-Ab);
6. A history of alcohol or drug abuse that the investigator believes may affect the evaluation results of this study within one year before the study administration;
7. Cannot quit smoking or drinking during the study period or the carbon monoxide breath test\> 7 ppm during the screening period CO breath test, so if the subject's CO breath is\> 7ppm, but the urine cotinine test is negative, it means that the CO breath test result may be false positive, the subject can be enrolled;
8. As a subject who has participated in any drug clinical trial within 3 months before the first administration of the study;
9. Those who donated blood or blood products ≥400 mL or 2 units within three months of the study;
10. Do not agree to avoid the use of tobacco, alcohol or caffeinated beverages, or vigorous exercise, or other factors that affect drug absorption, distribution, metabolism, excretion, etc. during the 24 hours before and during the test;
11. Pregnant or lactating women, or those who tested positive for serum HCG before the test administration, or those who were unable or unwilling to take researcher-approved contraception during the study according to the researcher's instructions;
12. Subjects with poor compliance or unable to comply with the relevant provisions of the research protocol due to personal reasons, the investigator judges that the subjects are not suitable to participate in this clinical study.
Virtual Reality Laparoscopy Training

The use of virtual reality simulation training in obstetrics and gynecology has not been widely studied. The investigators hypothesized that residents randomized to the trainer would not perform differently when compared with those who are not randomized. Residents in Obstetrics and gynecology are randomized to a 4 month training course on our simulator. They are objectively evaluated performing various laparoscopy tasks prior to and after the course.


Eligibility Criteria:
Inclusion Criteria:

* Resident in OB/Gyn at TriHealth

Exclusion Criteria:

* None
Effect of Cross Frequency tACS on Cognitive Control

Investigation of frequency specific transcranial alternating current stimulation on cognitive control signals in frontal cortex

Previous evidence suggests that there are specific frequency bands associated with different aspects of cognitive control. In specific delta (2-4Hz) and beta (15-30Hz) are associated with increased levels of abstraction for learned rules; and theta (5-8Hz) and gamma (30-50Hz) has been associated with increased set-size or number of learned rules. Here we aim to find causal evidence in support of these previous correlational findings by applying cross-frequency transcranial alternating current stimulation (tACS) in the specific frequency bands previously shown to be task-relevant. In a crossover design, we stimulate subjects with either delta-beta or theta-gamma tACS during performance of a hierarchical cognitive control task that manipulates the level of abstraction and set-size of rules that must be learned in order to make the correct button press.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 35 years
* Able to provide informed consent
* Willing to comply with all study procedures and be available for the duration of the study Speak and understand English

Exclusion Criteria:

* Attention Deficit Hyperactivity Disorder (currently under treatment)
* Neurological disorders and conditions, including, but not limited to:
* History of epilepsy
* Seizures (except childhood febrile seizures and electroconvulsive therapy induced seizures) Dementia
* History of stroke
* Parkinson's disease
* Multiple sclerosis
* Cerebral aneurysm
* Brain tumors
* Medical or neurological illness or treatment for a medical disorder that could interfere with study participation (e.g., unstable cardiac disease, malignancy)
* Prior brain surgery
* Any brain devices/implants, including cochlear implants and aneurysm clips
* History or current traumatic brain injury
* (For females) Pregnancy or breast feeding
* Personal or family history of mental/psychiatric disorder (e.g., anxiety, major depressive disorder, schizophrenia, etc.)
* Positive urine test for the following: Marijuana (THC), Cocaine (COC), Phencyclidine (PCP), Amphetamine (AMP), Ecstasy (MDMA), Methamphetamine (Mamp), Opiates (OPI), Oxycodone (OXY), Methadone (MTD), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Tricyclic Antidepressants (TCA), Propoxyphene (PPX)
* Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
Energy Expenditure in Patients With Crohn's Disease

The objective of this study is to investigate the changes in crohn on resting energy expenditure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohn's disease
The Parenting Young Children Check-up: Proof-of-Concept Trial

The Parenting Young Children Check-up (PYCC) is a 3-part system for parents of children with Disruptive Behavior Problems (DBPs). First, at a pediatric visit, parents complete a screener for DBPs and, if reported, go through a tablet-based program to receive feedback and learn about the PYCC. Next, parents receive text messages to connect them to further parent training content. Third, parent training content is delivered via a web-based resource, which includes videos to teach parenting skills. In this proof-of-concept trial, the investigators will examine the acceptability of the tablet-based program and motivation of parents to engage in the PYCC and use the web-based resource.

At a pediatric visit, parents will be told about the research opportunity by a staff member before, during, or after their visit. There will be a flier for parents, which will be available for receptionists to include with in-take paperwork. If parents express openness to participating, a research assistant will meet with them, go over the consent form, and let them complete the screener. Parents will complete a demographics questionnaire and the DBP screener. If parents report elevated DBPs, then they will be eligible to further participate. If they are eligible and choose to participate, the research assistant will have them go through the tablet-based program. Next, they will complete a brief questionnaire asking for input on the PYCC. Each of these components will be completed in the Computerized Intervention Authoring System (CIAS). The brief questionnaire is intended to evaluate perceptions of 1) ease of use, 2) usefulness of the information, 3) likability, and 4) intentions to use the PYCC web-based resource. Items will be rated on a 0 (strongly disagree) to 4 (strongly agree) scale. Parents will also verbally answer 6 open-ended interview questions about the program and suggest improvements. Answers will be audio-recorded and transcribed. All participants (whether only completing the screening or both parts of the study) will receive a resource list as well as a list of URLs to access videos on the video-based content on PYCC website. An ID number will need to be entered to use the website and the investigators will track website use.

This data collection is not hypothesis driven. Rather, the intent is to gather mixed methods feedback from parents to shape the PYCC program.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above
* English speaking
* Parent to a child ages 2-5
* Report their child has elevated disruptive behavior problems on the Eyberg Child Behavior Inventory

Exclusion Criteria:

* Parent reports child has Autism Spectrum Disorder
* Parent reports child has an intellectual disability
* Parent reports child is receiving treatment for Oppositional Defiant Disorder or Attention Deficit Hyperactivity Disorder
RESOLUTE China Registry:

To document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a real-world patient population requiring stent implantation.

The Resolute stent is designed to support the approach of delivering drug to the coronary arterial tissue over a longer period of time than that offered by current approved DES products. This method of prolonged drug elution may address the need to control local vascular neointimal proliferation in patients with complex lesions for extended therapeutic effect. The purpose of this multi-center trial is to investigate the clinical safety and efficacy of the Endeavor Resolute drug-eluting stent in every-day patients, like stable and unstable patients with single or multi-vessel disease and/or complex lesions.

Patients should be treated according to normal hospital routine practice and in line with the applicable guidelines on percutaneous coronary interventions and the Instructions For Use of the device.

1800 patients will be enrolled from China at approximately 40 centers where Endeavor Resolute stent is commercially available.

Eligibility Criteria:
Inclusion Criteria:

Patient must meet all of the following criteria to be eligible for treatment in the trial:

1. Age ≥ 18 years or minimum age as required by local regulations
2. The patient is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the Instructions for Use of the Resolute stent and the Declaration of Helsinki
3. The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form
4. Intention to electively implant at least one Resolute stent
5. The patient is willing and able to cooperate with study procedures and required follow up visits

Exclusion Criteria:

Patients will be excluded from the trial if any of the following criteria are met:

1. Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, bivalirudin, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. Biolinx), zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative, or contrast media
2. Women with known pregnancy or who are lactating
3. High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
4. Currently participating in another trial that has not completed the primary endpoint or that clinically interferes with the current trial requirements
5. Planned surgery within 6 months of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
6. Previous enrollment in the Resolute China Registry