cyrilzakka/clinical-trials huggingface dataset:
Neurofeedback Training (NFT) on Sleep Quality and Cognitive Function Performance Among HIV-infected Persons

The purpose of this study is to evaluate the effects of NFT on sleep quality and cognitive-behavioral performance among HIV-infected patients, to use it as a reference for the construction of NFT as a clinical empirical treatment model for HIV-infected patients with sleep disturbance.

This study will aim to evaluate the effects of NFT on sleep quality and neurocognitive performance among HIV-infected persons with sleep disturbance. A double-blind clinical randomized parallel trial will be enrolled in HIV-infected persons with sleep disturbance. We will exclude subjects with OSA. Random sampling by using a computer, and then we will be divided subjects into 2 groups. 30 people will be drawn into the experimental group and control group (sham). Two groups will be treated with NFT three times a week for at least four weeks. The vague distribution of this study will be handled by SNOSE (Sequentially Numbered, Opaque, Sealed Envelopes). Double-blind subjects include subjects, family members, outcome appraisers, and technologists to ensure the integrity of randomized controlled trials and blind assignment. The outcome indicators are sleep quality and the Chinese Montreal cognitive assessment (MoCA). Treatment compliance, sample loss, and adverse event events will be monitored, and the analysis will be followed the principle of intention to treat. The pair student t or McNemar's test will use to test the effect of NFT on sleep quality and neurocognitive performances among HIV-infected persons.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected persons

Exclusion Criteria:

* Patients with central neural infections
* Pregnant women
* Drug or alcohol abuse
Bridging Therapy in Patients at High Risk for Stent Thrombosis Undergoing Surgery

Patients who have undergone placement of coronary stents require dual antiplatelet therapy with Plavix and aspirin to prevent the serious complication of in-stent thrombosis. Some of these patients will require surgery while on dual antiplatelet therapy. This poses a challenge because being on Plavix is associated with higher risks of perioperative bleeding, but stopping Plavix puts patients at increased risk for in-stent thrombosis.

Currently, the ACC/AHA guidelines recommend discontinuation of Plavix five days prior to surgery to prevent bleeding complications. However, there are no universal recommendations for preventing in-stent thrombosis. Some experts recommend the use glycoprotein IIb/IIIa inhibitors (short-acting antiplatelet agents) as "bridging therapy" during the high-risk perioperative period. Although these agents should be beneficial based on theory, there is currently no published data on their effectiveness for this purpose.

The current study proposes to evaluate the value of Aggrastat (a short-acting intravenous platelet glycoprotein IIb/IIIa inhibitor) in decreasing the risk of in-stent thrombosis without increasing the risk of perioperative bleeding.

A. D/C clopidogrel 5 days prior to surgery

B. Continue ASA (Increase dose to 325 mg until prohibitive bleeding risk)

C. Check baseline IIb/IIIa and P2Y12 via the Verify Now device prior to initiating tirofiban

D. Start Tirofiban 2 days prior to the procedure (Patient MUST be on a monitored bed)

* Load Tirofiban ONLY if P2Y12 (Verify Now Assay) platelet inhibition is \< 20% OTHERWISE initiate only the continuous infusion dose
* Creatinine clearance \> 30mL/min: Tirofiban 0.4 mcg/kg/min for 30 minutes, followed by continuous infusion at 0.1 mcg/kg/min
* Creatinine clearance \< 30mL/min: Tirofiban 0.2 mcg/kg/min for 30 minutes, followed by continuous infusion of 0.05 mcg/kg/min

E. Check steady state IIb/IIIa inhibitor verify now assay (\>8 hour after initiation)

F. Hold Tirofiban 12 hours prior to procedure

G. Check IIb/IIIa inhibitor verify now assay (10-12 hours after Tirofiban is discontinued)

H. CBC pre and post op

I. Reload clopidogrel\> 24 hours post op (300 mg X 1 then 75 mg daily) unless prohibitive bleeding risk

J. Reduce ASA to pre-procedure dose. Restart ASA, 24 hours port-op if it was D/C prior to procedure

K. Check P2Y12 via the Verify Now device post-loading dose of clopidogrel (test cannot be performed w/in 48 hours of the D/C of IIb/IIIa inhibitor (tirofiban)

Eligibility Criteria:
Inclusion Criteria:

* Patients' with BMS/DES on plavix prior to surgery who are in need of an elective procedures

Exclusion Criteria:

* Patients' with BMS/DES on NOT plavix prior to surgery who are in need of an elective procedures
Emulation of Randomized Clinical Trial in Cardiovascular Disease

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study from Korean National Health Insurance Service database. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice.

Eligibility Criteria:
Inclusion Criteria:

* - PCI with MI (I21) admission
* Age more than 40 or less than 80 years old
* Aspirin and Clopidogrel/Prasugrel/Ticagrelor prescription with more than 2 days at discharge

Exclusion Criteria:

* - Previous use of a PPI, an H2-receptor antagonist, sucralfate, or misoprostol within 30 days before admission
* Preexisting cancer within a year before admission
* History of RBC transfusion
* RBC transfusion in admission
* Cardiogenic Shock
* Length of stay more than 14 days
* OAC prescription with more than 2 days at discharge
* H2 prescription with more than 2 days at discharge
Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products

The primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).

The objective of the study is to determine if the MIRASOL Pathogen Reduction Technology (PRT) System for Platelets device performs safely and maintains adequate platelet performance in a clinical setting. This will be achieved by comparing the platelet corrected count increment measured 1 hour post transfusion and the incidence of serious adverse events in response to the infusion of platelet concentrates treated with the device (test product) versus untreated (reference product) in thrombocytopenic subjects requiring platelet transfusions. The performance, safety, and tolerability profile of the device will be further assessed by monitoring and comparing the incidence of discontinuations due to adverse events in relation to platelet transfusion up to 4 weeks after transfusion, including the incidence of transfusion associated infections, and the number and time between transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of age of 16 years or older
* Women of Child Bearing Potential not pregnant
* Subject must have signed and dated the Informed Consent form
* Hospitalized, thrombocytopenic subjects and expected to receive at least two platelets transfusion

Exclusion Criteria:

* History of any hypersensitivity reaction to riboflavin or metabolites
* History of refractoriness to platelet transfusions
* Positive lymphocytotoxic antibody test
* Active bleeding
* Splenomegaly
* Acute or chronic Disseminated Intravascular Coagulation
* History or diagnosis of Immune/Idiopathic Thrombocytopenic Purpura, Thrombotic Thrombocytopenia Purpura, or Haemolytic Uremic Syndrome
* History or diagnosis of an autoimmune disease affecting haemostasis
* History of solid organ transplants
* Evidence of occlusive venous disease
* Clinical signs of infection at the time of inclusion
* Pregnant or lactating females
* Chronic alcohol misuse
* Use of prohibited medications
Post-Traumatic Stress Disorder (PTSD) Symptom Study

The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with stressful life events; and (3) change in PTSD symptoms associated with perceived social support.

The primary goals for this investigation are to quantify: (1) fluctuations in PTSD symptom reports when assessed at bi-weekly intervals; (2) change in PTSD symptoms associated with stressful life events; and (3) change in PTSD symptoms associated with perceived social support.

Despite increased sophistication in measurement of PTSD, little is known about the long-term longitudinal course of this disorder or the fluctuation of symptoms over time. Because previous studies have focused on the development and persistence of symptoms immediately following a stressor, the course of the chronic disorder has been largely unexplored. Although there is evidence of both persistence and fluctuation of PTSD symptom presentation in Vietnam veterans, little is known about how much and in what ways symptoms change over time. This investigation will increase understanding of the nature and extent of symptom fluctuation as well as the longitudinal course of PTSD as first steps in determining which variables affect that course and how clinicians might intervene to alter it.

Aversive life events may constitute one factor that influences the course of chronic PTSD. Researchers and clinicians have frequently hypothesized that stressful life events account for much of the variability in course of chronic PTSD; individuals with PTSD may have a compromised ability to cope with stressors, and such events may worsen existing symptoms. Social support is another variable thought to affect the course of post-trauma symptomatology. Support from other persons has been shown to both promote psychological health in general and to protect against psychological deterioration in times of stress. This investigation will examine aversive life events and perceived social support to determine their relationships over time to symptoms of PTSD.

Eligibility Criteria:
Inclusion Criteria:

1. Vietnam vets who served in combat
2. Diagnosis of current or lifetime PTSD

Excluded if severe psychosis, current diagnosis of acute substance dependence, if no stable residence in past 6 months

Exclusion Criteria:

Actively psychosis, currently suicidal or homicidal, without telephone access, or had experienced substance or alcohol abuse or dependence within the previous six months.
The Effect of Tea on Vascular Function and Insulin Sensitivity

The aim of this research is to explore changes in peripheral/cerebrovascular function and insulin sensitivity after a 7-day combination of physical activity reduction (-50% steps per day) and overfeeding (+50% kcal per day, comprising 65% fat) in healthy male volunteers, and examine whether daily intake of tea can prevent such changes.

The aim of this study is to explore the impact of a 7-day 'unhealthy' lifestyle that combines physical activity reduction (-50% steps per day) and overfeeding (+50% kcal per day, comprising 65% fat) on peripheral (conduit artery and skin microvessels) and cerebrovascular function and insulin sensitivity in healthy male participants. Moreover, the investigators will explore whether the detrimental impact of this lifestyle can be mitigated by daily tea consumption (equivalent to 6 cups/day). To explore this hypothesis, the investigators will perform measurements of these parameters before and after 7-days of reduced physical activity and overfeeding, with and without the combination of daily tea ingestion.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-55 years
* Male
* Habitually active (\>8,000 steps/day)
* Healthy

Exclusion Criteria:

* Smokers
* Medical history of cardiovascular/metabolic disease
* Family history of cardiovascular disease (first degree relatives)
* On medication known to influence the cardiovascular system
* BMI of \<18 or \>30 kg/m2
* Known food allergies or special dietary requirements
* Vaccination (\<1 week) due to induced systemic inflammatory reaction
Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients

This is local prospective multicenter observational non-interventional local study. Primary study objective is investigate and describe prescription pattern of neurologists in secondary stroke or non-CNS (non-Central Nervous System) systemic embolism prevention in patients with AF (Atrial fibrillation) and prior stroke or TIA (Transient Ischemic attack) who treat with rivaroxaban at an initial visit and three follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥ 18 years old who start treatment with rivaroxaban
* Non-valvular Atrial Fibrillation is documented in patients' file
* Prior TIA/Stroke history
* TIA - more than 72 hours after documented TIA
* more than 2 weeks after non-hemorrhagic stroke
* Written informed consent

Exclusion Criteria:

* Contraindications for use of Xarelto® in accordance with approved product label
* Previous thromboprophylaxis treatment with anticoagulants prior toby reason of stroke / TIA prevention
* Any reasons of medical and non-medical character, which in the opinion of the physician can hamper patient participation in NIS
Characterizing Upper Airway Collapse to Guide Patient Selection for Oral Appliance Therapy for Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is characterized by collapse of one or more pharyngeal structures during sleep (velum, tongue base, lateral walls, epiglottis). Structure-specific therapies for OSA have emerged as alternatives to positive airway pressure (PAP). Oral appliance (OA) therapy is increasingly being indicated for OSA treatment, although a complete response occurs in approximately 50% of patients. In general, OA devices are designed to maintain the mandible and/or tongue in a protruded posture during sleep, preventing upper airway obstruction. Limited studies in awake or sedated patients have demonstrated the effects of mandibular advancement on aspects of pharyngeal structure and function. The objective of the proposed research is to fully characterize upper airway collapse in OSA patients during natural sleep and use this information to understand why some patients appear to exhibit a large improvement in pharyngeal collapsibility whereas others do not.

OSA patients will undergo a baseline sleep endoscopy study to identify the site of pharyngeal collapse. Subsequently, they will undergo two clinical polysomnographies (PSGs) to measure the effect of an oral appliance (a site specific therapy) on upper airway collapsibility and sleep apnea severity. During the first hour of each clinical PSG, the passive pharyngeal collapsibility will be determined using the standard 5-breath continuous positive airway pressure (CPAP) drop method. During the remainder of the night, patients will be monitored to determine sleep apnea severity (apnea-hypopnea index). These measurements will allow the investigators to determine which pharyngeal collapsing site responds best (both in terms of collapsibility and AHI) to mandibular advancement with an oral appliance. Patients who have their own oral appliance will be recruited. In addition, patients without an oral appliance will be provided with a temporary oral appliance for the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Obstructive Sleep Apnea

Exclusion Criteria:

* Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
* Any medication known to influence breathing, sleep/arousal or muscle physiology
* Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
* Claustrophobia
* Inability to sleep supine
* Periodontal disease and/or insufficient number of teeth
* Allergy to lidocaine or oxymetazoline hydrochloride
* For women: Pregnancy
Pharmacologic Optimization of Voriconazole

The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to the current standard of care.

Patients with haematological malignancies and chemotherapy-induced prolonged neutropenia are at risk for severe bacterial and fungal infections. These opportunistic infections can result in prolonged hospital stay, increases costs and greater mortality. Voriconazole has now been recommended as the first line agent for invasive pulmonary aspergillosis. Retrospective observational studies of voriconazole serum concentration suggest that serum concentration correlate with toxicity and clinical response. These observations were however made in small series of patients and data were collected retrospectively. These inherent methodological flaws make it impossible to draw definite conclusions about the effect of voriconazole serum level monitoring on the outcome of IA, and therefore considered insufficient proof to recommend voriconazole concentration determination in blood as standard of care. The impact that so called serum concentration guided dosing of voriconazole will have on treatment success can only be evaluated through a prospective randomized clinical trial.

For this purpose, we designed a prospective stratified cluster randomized cross-over trial of therapeutic drug monitoring in patients with haematological disease who have developed IA. The order of periods (TDM or standard of care, each 12 months) will be randomized per centre. During the TDM episode, the voriconazole dosage will be adjusted to achieve trough blood concentrations in a predefined window of 2-5 mg/L. A sample size of n=192 is needed to detect a 20% absolute reduction in the number of treatment failures (40% to 20 %) compared to control.

Eligibility Criteria:
Inclusion Criteria:

* are at least 18 years of age
* have received chemotherapy for haematological malignancies or have received a hematopoietic stem cell transplant
* proven, probable or possible invasive fungal disease according to the EORTC/MSG criteria
* treatment with voriconazole

Exclusion Criteria:

* allergic to voriconazole or its excipients
* age below 18 years
The Effects of Vitamin D on Glycemic Control and Proinflammatory Markers in Adolescents With T1DM

The investigators are conducting a prospective cross-over study to evaluate the effects of vitamin D supplementation on diabetes control and the pro-inflammatory markers involved in microvascular complications in adolescents with Type 1 Diabetes. The investigators expect to see a significant improvement in glycemic control and a reduction of serum pro-inflammatory markers in adolescents with Type 1 Diabetes and vitamin D deficiency or insufficiency, who are treated with vitamin D.


Eligibility Criteria:
Inclusion Criteria:

1. Between 13 to 21 years of age, with at least Tanner stage 4 sexual maturity for males or post-menarchal females, and T1DM for at least 1 year. To ensure that inclusion criteria for sexual maturity are met, a physical exam for research purposes will be performed.
2. HbA1c between 7 to 9%
3. Adequate renal function (serum creatinine \< 1.5 mg/dL in males and \< 1.2 mg/dL in females) and adequate liver function (AST and ALT \< 2.5 times the upper limit of normal)
4. Vitamin D insufficiency or deficiency (25-OH vit D level \< 30ng/mL) which will be determined on initial screening labs after consenting subjects.

Exclusion Criteria:

1. Less than 13 or greater than 21 years of age
2. Less than Tanner stage 4 sexual maturity for males or pre-menarche
3. HbA1c less than 7% or greater than 9%
4. T1DM for less than 1 year
5. Vitamin D sufficient (25-OH vit D level \> 30 ng/mL)
6. Currently taking any medication that can interfere with vitamin D synthesis or metabolism, including but not limited to Orlistat, Phenobarbital, Dilantin, Anti-tuberculosis drugs
7. Currently taking any medication other than insulin that alters blood glucose levels, including but not limited to systemic glucocorticoids
8. Inadequate renal function (serum creatinine \> 1.5mg/dL in males and \> 1.2mg/dL in females) or inadequate liver function (AST and ALT \> 2.5 times the upper limit of normal)
9. Evidence of malabsorption or short gut.
A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC

This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.

This investigation will include a minimum of 40 sample sets from unique patients.

This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia, lymphoma, and/or other blood cell disorders.

This investigation will include a minimum of 40 sample sets from unique patients.

The primary aim of this study is to demonstrate the agreement between capillary blood collected using the Tasso device and venous blood collected in a K2EDTA (dipotassium ethylenediaminetetraacetic acid) tube according to established sampling procedures for quantification of WBC and ANC as part of a standard CBC panel with 5-part differential.

The secondary aim of the study is to demonstrate the agreement between Tasso device and venous samples for the measurement of additional analytes evaluated as part of a standard CBC panel with 5-part differential, including PLTs, HGB, RBC, Hct, MCV, lymphocytes, monocytes, eosinophils, and basophils.

An exploratory aim of this research is to evaluate patient acceptance of the Tasso device in a diseased population.

Adverse Events (AEs) occurring up to 24 hours after use of the Tasso device will be evaluated.

Patient response to using the Tasso device will be collected via simple survey.

Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written (or electronic) informed consent prior to study entry
2. At least 18 years of age
3. Requiring a CBC blood test as part of the patient's standard of care
4. Have abnormal laboratory results of either leukopenia, leukocytosis or neutropenia.
5. Normal skin integrity and healthy skin appearance around the capillary collection site (upper arm/shoulder area on at least one side)

Exclusion Criteria:

1. Unable to give full and free consent to participate in a study due to limited capacity or risk of undue influence or coercion (including but not limited to children, prisoners, individuals with diminished decision-making capacity, illiterate or educationally disadvantaged populations) or any other individual who is unable to give full and free consent in the judgement of the investigator
2. At the determination of the treating physician, unsuitable for enrollment due to severe immunocompromised status or other comorbidities.