cyrilzakka/clinical-trials huggingface dataset:
Vascular Pathophysiology in Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a medical problem whose importance is increasing in recognition and awareness. The National Commission on Sleep Disorders estimates that 15 million Americans have OSA, many of whom remain undiagnosed (24). OSA is associated with the development of hypertension and other cardiovascular diseases (1,2). Patients with OSA, like those with congestive heart failure, hypertension, hypercholesterolemia and diabetes, exhibit impaired EDV (25-32). OSA is also associated with impairments in endothelium-dependent cerebral blood flow responses, which may be a risk factor for stroke (33). Impaired EDV is a result of reduced production or inadequate action of nitric oxide. Since EDV worsens with disease progression and improves with disease treatment, it serves as a prognostic marker of vascular function (34-37). In OSA, hypoxia and neurohumoral disturbances increase generation of reactive oxygen species (ROS) that neutralize nitric oxide and impair endothelium-dependent responses (9,10,38). One source of ROS in endothelial cells is the enzyme xanthine oxidase (38). XO is an enzyme present in the vascular endothelium that significantly contributes to generation of ROS in congestive heart failure, hypercholesterolemia and diabetes (13-17). Inhibition of XO improves endothelium-dependent resistance vessel responses in these populations (13-17), but it is unknown if XO significantly contributes to oxidative stress and endothelial dysfunction in OSA. The central hypothesis of this application is that inhibition of XO with allopurinol will reduce oxidative stress and generation of ROS, thereby improving nitric oxide bioavailability and EDV in OSA. Our hypothesis has been formulated on the basis that patients with OSA experience repeated hypoxemia that increases activity of XO and other enzymes, thus increasing the generation of ROS that negatively impact EDV. Hypoxia is detrimental to vascular homeostasis since it increases generation of ROS through direct mechanisms and via activation of XO.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Sleep Disordered Breathing:
* Significant obstructive sleep apnea as verified by complete overnight polysomnography with apnea-hypopnea index (AHI) \> 10 events per hour.
* Fasting total cholesterol \< 240 mg/dL
* Fasting blood glucose \< 120 mg/dL
* Control subjects:
* Free of sleep disordered breathing verified by complete overnight polysomnography or oxygen desaturation screening (AHI \< 5 events per hour)
* Fasting total cholesterol \< 240 mg/dL
* Fasting blood glucose \< 120 mg/dL

Exclusion Criteria:

* Presence of any cardiovascular diseases or medical conditions that will affect vascular responses (other than sleep apnea)
* Subject taking any vasoactive medications, willing to stop taking vitamins or supplements for study participation
* Current smokers
* History of adverse reaction to allopurinol, acetylcholine, nitroprusside, verapamil or lidocaine
Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery

The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.

This study will be a prospective randomized single-blinded clinical trial.

Patients undergoing shoulder arthroscopy who meet the inclusion criteria will be invited to participate in this study. A total of 120 patients will be recruited to participate.

Patients will be randomized via a 1:1 ratio to either the Interscalene block with the addition of buprenorphine, clonidine, dexamethasone group or Interscalene block alone group

The null hypothesis of this research study is that there will be no significant difference in morphine requirements between the Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients undergoing shoulder arthroscopy
* Patients willing to participate and sign informed consent

Exclusion Criteria:

* Severe COPD/other contraindication to general anesthesia
* Patient with a weight of less than 60 kg
* Dementia, not alert or oriented to person, place, or time
* Chronic pain patient with daily opioid use at home.
* Patient with allergy to local anesthetics
* Patient refusal
* Total shoulder arthroplasty
* Concomitant pain in different area from operative site.
* Pregnancy
* Patient with active infection on the injection sites for the blocks
* Patients unable or willing to understand or comply with the study protocol
A 2-week Clinical Comparison of SYSTANE® Ultra to Sensitive Eyes Rewetting Drops in Contact Lens Wearing Patients.

To evaluate safety with the use of Systane Ultra in contact lens wearers. A comparison to a currently marketed contact lens rewetting drop will be included as a control.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be between 18 and 65 years of age.
* Provide written Informed Consent.
* Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality, or a Rigid Gas Permeable (RGP) contact Lens
* Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
* Sodium fluorescein (NaFl) corneal staining score sum of \< 2 in both eyes (NEI scoring system).
* Must be willing to maintain pre-enrollment systemic medication regimens during the study.
* Must be available for study visits and to fill out study questionnaires.

Exclusion Criteria:

* Has modified their systemic medications within 30 days prior to enrollment.
* Has a history of allergy to any study product ingredients
* Is unwilling or unable to meet the study visit timeline.
* Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
* Is currently using any topical eye medications (not including rewetting drops, artificial tear products or Restasis).
Closing -TB GAPs - for People Living with HIV: TB Guidance for Adaptable Patient-Centered Service

Tuberculosis (TB) is the world's leading infectious cause of mortality and responsible for 1/3 of deaths in people living with human immunodeficiency virus (PLHIV). Children and adolescents living with HIV (CALHIV) are disproportionately affected due to inadequate preventive services, large case detection gaps, treatment and adherence challenges, and knowledge gaps. This project will generate evidence to inform interventions targeting several of these weaknesses in the TB/HIV cascade of care.

Early detection and treatment of TB improve outcomes in people living with HIV (PLHIV). A key challenge in the detection of HIV-associated TB has been the implementation of screening that identifies the correct population for diagnostic testing. Increasing evidence demonstrates the poor performance of recommended symptom screens and diagnostic approaches. Hence, the investigators aim to define a more accurate TB screening and testing strategy among PLHIV (Objective 1 and Objective 2).

TB preventive treatment (TPT) averts HIV-associated TB. Nevertheless, among PLHIV, TPT initiation and completion rates are sub-optimal and effective delivery strategies are not defined. As such, the investigators aim to identify the most effective TPT delivery strategy through shared decision making and by integrating approaches proven to be effective at improving HIV treatment adherence (Objective 3).

Although evidence demonstrates that isoniazid preventive therapy (IPT) is cost-effective in young children living in TB/HIV high burden settings, the cost-effectiveness of newer short-course TPT has primarily been studied in the context of a TB low-burden, high-income setting. The investigators aim to generate evidence to fill this knowledge gap and inform policy for PLHIV living in TB/HIV high burden settings (Objective 4).

This study is supported by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling an anticipated $5,000,000 over five years with 100 percent funded by CDC/HHS.


Eligibility Criteria:
OBJECTIVES 1 and 2:

Inclusion Criteria:

* HIV positive or HIV exposed and presumptively positive while awaiting confirmatory testing in infants

Exclusion Criteria:

* do not provide informed consent or assent as appropriate or are currently being treated for TB

OBJECTIVE 3:

Inclusion Criteria:

* negative TB symptom screen OR for whom TB disease has been ruled out in accordance with WHO Guidelines in adults and according to consensus definitions for child TB

Exclusion Criteria:

* do not provide informed consent or assent as appropriate or are currently being treated for TB
Dealing With Anxiety: A Cognitive Behavioural Program for Diabetes

This study was designed to assess whether a cognitive behavior therapy (CBT) program for diabetes clinic patients was acceptable, improved quality of life and produced measurable change in levels of depression, anxiety and stress.

Having co-morbid anxiety or depression makes it difficult to carry out the activities for diabetes selfcare. Psychological interventions have been shown to result in improvements in HbA1C and depression. Reports on psychosocial outcomes are conflicting and there are no studies of quality of life. Our diabetes outpatient population has a higher prevalence of anxiety and depression compared to the general public and this led to the development of a group CBT intervention designed to reduce anxiety as a co-morbidity of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Consenting attendees of the Hunter Area Diabetes Services RNH Diabetes Outpatient Clinic

Exclusion Criteria:

* Accessibility problems including:

  * limited English
  * developmental disability
  * physical immobility
  * geographical distance
  * extreme age/frailty
Analysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing

This single-arm, multi-center, prospective study will assess the coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and determinants thereof (transit time, Pa, Pd) in patients before and after intracoronary nitroglycerine.

This will be a single arm, multi-center, prospective interventional study. We will approach, consent, and enroll patients referred to the cardiac catheterization laboratory for coronary angiography for the indication of angina without obstructive coronary artery disease (CAD; lesions \<50%, fractional flow reserve (FFR) \>0.80, or non-hyperemic pressure index (RFR) \<0.89). Patients will undergo invasive assessment with CRT first without IC nitrates followed by a dose of 200-500 mcg of intracoronary nitrates and repeat CRT.

Approximately 50 patients undergoing coronary angiography for evaluation of ANOCA or INOCA will be consented for this study.

The primary outcome will be comparing the variables assessed by CRT with the primary outcome being CFR before and after nitroglycerin administration.

The secondary outcomes will be IMR, Pd, Pa, RRR, and transit times before and after nitrates.

These variables will be compared to one another using paired t-tests and generalized estimating equations.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or older
2. Patient being evaluated for ANOCA or INOCA
3. Clinical suspicion for angina
4. Patient should be able to comply with the protocol.
5. Provide written informed consent before study participation.

Exclusion Criteria:

1. Existing coronary artery disease
2. Previous percutaneous interventions within the coronaries
3. Current use (within 48 hours) of long-acting nitrate therapies
4. Current use (within 48 hours) of PDE-5 inhibitors (sildenafil, tadalafil)
5. Any other condition or co-morbidity which, in the opinion of the investigator or operator, may pose a significant hazard to the subject if he or she is enrolled in the study.
6. Children below 18 years, prisoners, pregnant people and patients who are unable to provide consent are excluded.
Lower Limb Venous Insufficiency and the Effect of Radiofrequency Treatment Versus Open Surgery

200 patients with insufficient great saphenous veins will be randomized to either radiofrequency ablation or high ligation/stripping (open surgery). They will be examined according to standardized examination protocol Venous Clinical Severity Score (VCSS), with duplex ultrasound and plethysmography pre- and postoperatively (1-month, 1-, 3 and 5 years). They are to fill questionnaires EuroQol 5 Dimensions (EQ-5D) and disease specific Aberdeen Varicose Vein Questionnaire (AVVQ).


Eligibility Criteria:
Inclusion Criteria:

* Insufficient great saphenous vein
* Possible to treat with both radiofrequency ablation and high ligation/stripping
* Clinical Etiological Anatomical Pathophysiological score (CEAP) C2-C6

Exclusion Criteria:

* Previous intervention in the affected leg
* Insufficient accessory branch origin close to the great saphenous vein estuary in the femoral vein.
* Small saphenous vein insufficiency with diameter \>6 mm and/or flow \>100ml/min
* Patient that is not able to perform plethysmography
Rivastigmine for the Prevention of Postoperative Delirium in Patients Undergoing Cardiac Surgery

The purpose of this study is to determine whether Rivastigmine is effective for the prevention of postoperative delirium in patients undergoing cardiac surgery.

Postoperative delirium is a frequent complication after cardiac surgery. In the literature an incidence ranging from 0 - 72 % is reported. The aetiology of this complication is multifactorial. A decline in cerebral cholinergic transmission as well as perioperative cerebral hypoperfusion or a systemic inflammatory response triggered by the extracorporeal circulation have been suspected. Advanced age is the most important patient-related risk factor. A perioperative delirium is an extremely unpleasant experience for the affected patients. Equally important is the fact that a delirium is associated with a prolonged length of stay on the intensive care unit and in hospital. Furthermore, patients who develop delirium have an increased six-month mortality. Recently successful treatment and prevention of the delirium with cholinesterase inhibitors such as rivastigmine have been reported.

The proposed study will test the hypothesis that prophylactically administered rivastigmine is able to prevent or at least reduce the symptoms of the postoperative delirium in elderly patients undergoing elective cardiac surgery with extracorporeal circulation.

This study is designed as a double blind randomised placebo controlled trial. Half the patients will receive placebo. The other half will receive rivastigmine 1.5m-1.5mg-1.5mg (oral solution), starting on the evening preceding the operation and for the first seven days postoperatively. Patients in both groups who develop delirium will be treated with a rescue medication consisting of lorazepam and haloperidol.

Measurements will include the incidence of delirium assessed using the Confusion Assessment Method (CAM). The severity of symptoms will by characterised by the Mini Mental Score and clock drawing. Further measurements will include the prescribed doses of rescue medication, the length of stay on intensive care and in hospital, the time of extracorporeal circulation, and laboratory parameters such as CRP, albumin, lymphocyte count, vitamin B12 and folic acid levels. Side effects of rivastigmine will be quantified.

The primary endpoint of this study is the incidence of delirium. Secondary endpoints will be the severity of delirium, the used doses of rescue medication, and length of stay (intensive care and hospital).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery with use of extracorporeal circulation
* Aged 65 or more

Exclusion Criteria:

* "redo" procedures
* anticipated use of succinylcholine during operation
* contraindications to rivastigmine
* preoperative mini mental score \< 15
Convalescent Plasma in Pediatric COVID-19

COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.

COVID19 is an emerging infection with no current approved treatment or prevention. COVID-19 is increasingly affecting children but convalescent plasma (CP) has not been adequately studied in children to date. The study will determine safety of convalescent plasma for pediatric patients with severe, or at high risk for severe, COVID-19 disease.

Eligibility Criteria:
Inclusion Criteria:

* Aged 0 to 22 years of age
* SARS-CoV-2 infection documented by RNA RT-PCR detection
* Admitted to an acute care facility
* Ability of patient or guardian to provide consent and assent (if applicable); if patient is intubated assent may be waived

Exclusion Criteria:

* Pregnancy/ breast feeding
* Medical condition that increases the risk of plasma infusion
* Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).

Inclusion criteria for infusion:

* Severe COVID-19 disease, OR
* Moderate disease with a risk of progression to severe or life threatening disease, OR
* Severely immunocompromised patient with any illness attributed to COVID-19 disease requiring inpatient care.

Exclusion to infusion:

* Pregnancy/ breast feeding
* Medical condition that increases the risk of plasma infusion
* Contraindication to transfusion (severe volume overload, history of anaphylaxis to blood products).
The TRAIN Study: A Concussion Prevention Strategy in Middle Schools

Purpose: The purpose of this study is to evaluate the effectiveness of a theory-driven intervention (TRAIN concussion education) to improve parental concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy.

Participants: 180 parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years.

Procedures: The study is a single-blind (participants) randomized control trial. The investigators will randomize eligible parents into two groups: (1) control (standard concussion education); and treatment (standard concussion education AND TRAIN concussion education) to evaluate the effectiveness of the TRAIN concussion education intervention.

A convenience sample of participants will be recruited from parents of United States middle school aged children whose children have been engaged in organized sports within the past 2 years. Interested parents will contact study stuff, who will ensure eligibility criteria are met.

Upon this, and completing the written informed consent process, participants will be assigned a unique identifier and randomized (simple) without replacement to one of the two study arms (control vs. treatment), using a predetermined random number generator in Excel.

Participants in the control group will receive standard concussion education materials focused on concussion prevention in youth sport. Participants in the treatment group will receive the same standard concussion education materials AND the TRAIN concussion education module. The TRAIN education module is grounded in a theoretical structure inclusive of the original intervention tenants of the Popular Opinion Leader (POL) and Diffusion of Innovations frameworks, and within the context of the socioecological model.

Participants will complete a self-administered online pre-test survey, which includes assessments of concussion-related attitudes, beliefs, intentions, confidence in knowledge, and self-efficacy. After completion of the pre-test survey, participants will complete their assigned intervention (TRAIN concussion education module + standard concussion education materials versus standard concussion education materials only).

Upon completion of their assigned intervention, participants will complete the online survey again to obtain post-test measures (post-test survey). Participants will also be scheduled to complete individual semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* Adult with a child/children enrolled in a United States middle school
* Adult whose child has participated in organized sports in the past 2 years

Exclusion Criteria:

• Adult without a child/children enrolled in a United States middle school
Low Energy Availability and Recovery from Resistance Exercise

This research project will determine how restricting Calories to lose weight affects your ability to recover between weightlifting exercise sessions.


Eligibility Criteria:
Inclusion Criteria:

* 3 years of resistance training experience

Exclusion Criteria:

* 1+ American College of Sports Medicine sign(s) or symptom(s) of cardiovascular, metabolic or renal disease(s)
* musculoskeletal disorder(s)
* lactose intolerance; soy or dairy allergies
KinesioTaping on Knee Joint Position Sense

The aim of this study is to evaluate the effect of kinesio tape (Neuromuscular bands) application on knee joint position sense. The investigators intend to evaluate, trough the use of an isokinetic dynamometer, the sensation of active and passive joint position sense of the knee joint, before, during and after the application of kinesio tape in different periods, and to verify if there is any noticeable change. The guiding question is presented as the following: "Does the application of kinesio tape influence the knee joint position sense in healthy young adults?".

The hypothesis of this study is represented as follows:

H1: Kinesio tape application improves knee joint position sensation in healthy young adults.

H0: Kinesio tape application has no influence on knee joint sensation and position in healthy young adults.

As mentioned before, the aim of this study is to evaluate the effect of kinesio tape (Neuromuscular bands) application on knee joint position sense. After explaining the objectives and procedures of the study, the subjects will sign an informed consent. Afterwards, the sample subjects will be randomly divided into two groups, the experimental group and the control group. Joint position sense will be measured at four different times in the control group and at 6 different times in the experimental group. In the first moment of data collection, anthropometric data of the participants will be measured, namely weight and height, and a sociodemographic questionnaire will be completed. Then, the identification of the dominant side of the individual will be carried out, through the step test, in which we ask the individual to climb a step 3 times and through the ball kick test. All subjects will always have to carry out measurements in shorts and t-shirts, completely barefoot. The intervention, in the experimental group, will consist of the application of neuromuscular bands on the dominant lower limb. No intervention will be performed in the control group. A physical therapist will be in charge of applying the neuromuscular bands to the participants and another physical therapist will take measurements of joint position sense.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Individuals from 18 to 35 years old

Exclusion Criteria:

* Musculoskeletal condition in the dominant lower limb 3 months before the beggining of the study;
* Central and Periferical Nervous System alteration;\~
* Pain In the dominant lower limb;
* History of fracture on the dominant lower limb;
* Adverse reactions to ahesive materials;