cyrilzakka/clinical-trials huggingface dataset:
Pre-exposure Prophylaxis Adherence Intervention for MSM

Following formative work, the proposed study is an open-label, pilot, randomized, two arm trial where subjects will receive pre-exposure prophylaxis (PrEP) for 6 months and either a cognitive-behavioral based adherence intervention or health education with supportive counseling.


Eligibility Criteria:
Inclusion Criteria:

* male sex at birth
* being 18 years old or older
* testing HIV-negative at screening
* evidence of high risk for HIV acquisition defined by having unprotected anal sex (insertive or receptive) with an HIV-positive male partner OR at least a total of three episodes of unprotected anal sex with at least two partners in the last three months
* medically cleared to take the study drug (ambulatory performance \>=60 on Karnofsky scale, adequate renal function, negative glucose and protein in urine, adequate hepatic function, adequate hematologic function)
* able to understand and speak English (for consenting and counseling).

Exclusion Criteria:

* participants who are not able to consent due to psychiatric or cognitive concerns
* those who have already been prescribed PrEP
* having a history of or current medical conditions that would preclude taking the study drug (e.g., previously diagnosed active and serious infections, acute or chronic hepatitis B, history of pathological bone fractures not related to trauma)
* receiving ongoing therapy with ART, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion, or other investigational agents
* receiving or possibly receiving antiretroviral drugs for an anti-HIV vaccine in a clinical trial
* active alcohol or drug use that would interfere with study participation
* having other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures
Glucose in Dialysis Water in Non-diabetics

The purposes are

1. to measure the effect of dialysis with glucose on blood pressure, pulse rate, plasma concentration of glucose, plasma concentrations of glucagon, growth hormone, renin, angiotensin II, endothelin and body temperature, and
2. to analysis the relationship between changes in blood pressure on the one hand and changes in vasoactive hormones on the other

Measurement of hormones and blood pressure during dialysis treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years,
2. Both men and women,
3. Dialysis treatment for at least three months

Exclusion Criteria:

1. Heart failure,
2. Chronic liver disease,
3. Diabetes mellitus,
4. Malignant disease,
5. Nephrotic syndrome,
6. Lack of compliance, 7 Unwillingness to participate
Age and Sleep Apnea Syndrome

By clinical record review, this retrospective study aims to compare the different age groups of patients with obstructive sleep apnea, who were diagnosed and treated in Taipei Veterans General Hospital, Taiwan.

This retrospective study aims to compare the characteristics of patients with obstructive sleep apnea (OSA). Patients with sleep problem and received a prior polysomnography at Taipei Veterans General Hospital during Jan. 1, 2016 to Dec. 31, 2017 will be enrolled. Obstructive sleep apnea (OSA) is defined by an apnea-hypopnea index(AHI) at least 5/hr with compatible symptoms. Their clinical record will be reviewed and data including demography, polysomnography, comorbidities and details related to upper airway structure will be collected. The charactereistics would be compared with Student's t tests, Mann-Whitney U tests, or Chi square tests if appropriated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with sleep complaints and received PSG in sleep center in Taipei Veterans General Hospital

Exclusion Criteria:

* Patients who ever received treatment for OSA
* Patients cannot tolerate PSG examination
* Patients cannot complete the questionnaires before and after PSG examination
The Effect of Foot Massage in Patients Undergoing Hemodialysis

Hemodialysis patients were divided into experimental and control groups. Foot massage was applied to the patients in the experimental group. Foot massage was not applied to the patients in the control group and routine nursing care was provided. Pre-test, mid-test and post-test sleep quality and fatigue level scores of the patients were determined.

An experimental study design was used to conduct this research on 73 hemodialysis patients treated in a hemodialysis unit. The aim of this study is to investigate how foot massage applied to hemodialysis patients affects sleep quality and fatigue level.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria were determined as follows:

  * Having a PSQI score of 5 points and above
  * Receiving HD treatment for at least 6 months
  * Having no neuropathy d) Using no sleeping pills
  * Having no communication problem
  * Having full orientation and no psychiatric problems
  * Having no conditions in the lower extremities and feet that would preclude massaging (no open wounds on the skin, orthopaedic and joint problems, oedema, abscess, infection, thrombophlebitis, deep vein thrombosis, thrombocytopenia, etc.)
  * Having no history of allergy to the oil used for massage.

Exclusion Criteria:

Exclusion criteria were determined as follows:

* Receiving less than 6 months of HD treatment
* Having communication problem
* Suffering from neuropathy
* Having incomplete orientation and any psychiatric problem
* Having a PSQI score below 5
* Having conditions in the lower extremities and feet that would preclude massaging (open wounds on the skin, orthopaedic and joint problems, oedema, abscess, infection, thrombophlebitis, deep vein thrombosis, thrombocytopenia, etc.) and having a history of allergy to the oil used for massage
Magnetic Resonance Diagnosis of Pulmonary Embolism

* The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in patients with clinically suspected acute pulmonary embolism
* Thoracic CT angiography (CTA) will serve as reference standard
* Result of MRI will not interfere with patients' management
* Untreated patients with negative CTA will have 3-month follow-up to verify they were free of thrombose-embolic disease

Background In patients with clinically suspected pulmonary embolism (PE)°with a contraindication to thoracic CT angiography, there is a need for an alternative diagnostic procedure. MRI has not been fully evaluated in this field; moreover, recent technological advances make it necessary to re-evaluate its performance for PE diagnosis.

Design Prospective monocentric study

* Patients with clinically suspected acute pulmonary embolism will undergo thoracic magnetic resonance imaging if inclusion criteria are fulfilled.
* A non-inclusion register will be establish for patients fulfilling the inclusion criteria , not included because MRI was not available (off-hours presentation , another patients already included in the protocol on the same day )

Estimated enrolment : 280 (based on a 25% prevalence of PE in our institution and an expected 80% sensitivity of MRI) Study start date: June 2007 Estimated study completion date: 17 months later (40 to 50 presentations for PE suspicion each month, 20 inclusions expected per month)

Magnetic Resonance imaging: performed on a 1.5 Tesla unit with 3 different sequences

* Unenhanced Steady State Free Precession (SSFP) sequences
* Perfusion imaging following Gadolinium injection at a rate of 5 c/s and a dose of 0.1mmol/kg
* Magnetic resonance angiography following an injection of 0.1mmol/kg of gadolinium at 3ml/s MRI studies will be interpreted secondarily by 2 independent radiologists, blinded to CTA results and clinical probability.

Two different readings will be performed, one global reading and one reading of each sequence separately, displayed in a random order (access base)

Objectives

* to evaluate MRI performance for PE diagnosis globally
* to evaluate the diagnostic value for each sequence (especially the negative predictive value of a normal perfusion sequence)
* to evaluate inter-observer agreement

MRI and CTA have to be performed within 24 hours

Eligibility Criteria:
Inclusion Criteria:

* Clinically suspected acute pulmonary embolism
* 18 years old or more
* D-dimers more than 500 or high clinical probability of pulmonary embolism according to the revised Geneva score
* Thoracic CT angiography performed within 24 hours
* Informed consent

Exclusion Criteria:

* - Contraindication to MRI (pace maker, claustrophobia, any implanted ferromagnetic foreign body)
* Obese patients too large to fit in MRI unit
* Allergy to gadolinium-containing contrast agent or to iodinated contrast media
* Renal insufficiency (clearance less than 30 ml/mn)
* Anticoagulation at a curative dose started more than 48 hours prior to MRI
* Life expectancy less than 3 months
* Pregnancy
Peri-articular Tranexamic Acid Injection in Total Knee Arthroplasty

This study evaluates the peri-articular tranexamic acid injection in total knee arthroplasty which is an alternative route of administration for blood loss reduction. Half of participants will receive intravenous tranexamic acid injection, while the other half will receive peri-articular tranexamic acid injection during total knee arthroplasty.

Intravenous tranexamic acid (IV TXA) is one of the most effective agents in use for reducing blood loss following total knee arthroplasty (TKA) but its safety regarding venous thromboembolic events (VTEs) remains in question. The direct, local application of TXA may reduce systemic toxicity whilst maintaining good or better bleeding control compared to IV TXA. The topical application of TXA via Hemovac drains has been reported previously with good results. However, there are no data on peri-articular TXA injections during TKA.

Eligibility Criteria:
Inclusion Criteria:

* adult patients with osteoarthritis in need of a TKA

Exclusion Criteria:

* inflammatory arthritis
* post-traumatic arthritis
* a history of or current venous thromboembolic disease
* any underlying disease of haemostasis
* cirrhosis
* chronic renal failure
* patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
* know allergy to TXA
* defective color vision
* preoperative hemoglobin \<10 g/dL
* platelet count \< 140,000 /uL3
Effects of Therapeutic Mobile Game on Anxiety

Participants with Social Anxiety Disorder (SAD) will use a digital therapeutic for 30 days, and will complete assessments measuring a broad range of anxiety and mood-related symptoms, with a focus on SAD symptoms, and metrics of functional impairment during this time. After the treatment period, participants will be followed at 6 month and 12 month after the completion of the study.

This study aims to assess the feasibility and efficacy of the digital therapeutic ABM-01 in adults ages 22-65 with SAD. Participants access ABM-01 on their mobile smart phone and complete treatment over a period of 30 days. Enrolled participants will be randomly assigned to one of two groups (Experimental Group and Placebo Control) and be assessed over five periods of time (Baseline Session, 30-Day Treatment Phase, Post-Treatment Session, 6-Month Follow Up Session, 12-Month Follow Up Session).

Participants will complete the 30-Day Treatment Phase as well as the five assessments remotely. During the treatment period, participants complete assessments social anxiety and generalized anxiety symptoms, as well as safety and medication use questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Adults 22-65 at the time of screening
* Meets DSM-5 diagnostic criteria for Social Anxiety Disorder
* Access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration.
* Currently residing in the United States

Exclusion Criteria:

* Risk of suicide or has attempted suicide within 24 months of the screening visit
* Moderate to severe substance use disorder
* Current co-morbid psychiatric diagnosis including PTSD, Schizophrenia, Bipolar Disorder I or II, Autism Spectrum Disorder, or Borderline Personality Disorder
* Currently pregnant or planning to become pregnant during the treatment period
Enhancing Transdiagnostic Mechanisms of Cognitive Dyscontrol

The proposed project aims to test the cognitive and neural effects of a cognitive training in a sample of individuals seeking treatment for anxiety, depression, or traumatic stress symptoms. Participants will be randomly assigned to a high dose, low dose, or assessment only condition. Participants will be compared on cognitive performance and brain response during cognitive tasks from baseline to post-treatment.

Mood, anxiety, and traumatic stress disorders are common psychiatric conditions - affecting over 40 million U.S. adults - and are leading causes of disability worldwide. People with these conditions are commonly plagued by difficulty controlling distressing personal thoughts and memories, collectively referred to as repetitive negative thinking symptoms. Models suggest that repetitive negative thinking is driven by executive functioning deficits, such that cognitive resources are insufficient to downregulate unwanted thoughts. Executive functioning deficits could be a promising treatment target but are not typically addressed with existing interventions. The long-term goal advanced by this project is to develop effective, mechanistic cognitive training programs that can improve cognition and reduce symptoms associated with mood, anxiety, and traumatic stress disorders. The objectives of this proposal are first to determine the optimal dose of a cognitive training program designed to improve executive functioning in this population using behavioral and neural outcomes. The central hypothesis is that repeated training exercises will enhance executive functioning and will lead to a reduction of repetitive negative thinking in mood, anxiety, and traumatic stress disorders. The project will randomize participants with depression, anxiety, and/or traumatic stress disorders to one of two doses of cognitive training or a no-treatment control condition. The investigators will examine executive functioning change with cognitive task performance and functional neuroimaging assessments.

Eligibility Criteria:
Inclusion Criteria:

* age 21-55
* fluent in English
* diagnosis of mood, anxiety, or traumatic stress disorder
* clinically elevated repetitive negative thinking
* outpatient status
* 6-week stability if taking selective serotonin reuptake inhibitor (SSRI) medications

Exclusion Criteria:

* past year diagnosis of severe alcohol or moderate or greater substance use disorder
* lifetime history of psychotic or bipolar I disorder
* acute suicidality necessitating immediate clinical intervention
* neurodegenerative or neurodevelopmental disorders
* history of moderate or severe traumatic brain injury or other known neurological condition
* sensory deficits that would preclude completing tasks
* conditions unsafe for completing MRI scanning (e.g., metal in body)
* currently receiving psychosocial treatment
* currently receiving psychiatric pharmacotherapy, except SSRIs
Short-Term Efficacy of Triamcinolone Acetonide (Aristocort® C) in Subjects with Atopic Dermatitis

This study is a randomized, intraindividual study to evaluate the short-term efficacy of triamcinolone acetonide (Aristocort® C) in subjects with atopic dermatitis.

This study is being conducted to evaluate the short-term efficacy and effect of triamcinolone acetonide (Aristocort® C) on pruritus, skin biomarkers and skin parameters in subject with atopic dermatitis.

Approximately 20 subjects with atopic dermatitis will receive twice-daily topical application of triamcinolone acetonide (Aristocort® C) or vehicle in two different randomized areas for 3 days.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 years of age or older at the time of consent.
2. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.
3. Subject has at least a 6-month history of AD and had no significant flares in AD for at least 4 weeks before screening.
4. Subject has 2 applications areas (10 X 10 cm) with a lesional surface of at least 6 X 6 cm, preferably located on 2 distinct anatomical areas at Day 1.

Exclusion Criteria:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
2. Subject has clinically infected AD.
3. Subject has a Fitzpatrick's Skin Phototype ≥5.
4. Subject has a history of skin disease or presence of skin condition, other than AD, that would interfere with the study assessments in the opinion of the investigator.
5. Subject is known to have immune deficiency or is immunocompromised.
6. Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1.
7. Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
8. Subject has a known history of chronic infectious disease.
9. Subject has a known or suspected allergy to triamcinolone acetonide (Aristocort® C) or any component of the investigational product.
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer

Obtain PSMA-PET imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard).

Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).

Directly compare PSMA-PET performance for predicting extra-prostatic extension to standard-of-care assessments.

Assess quality of life changes from preoperative baseline.


Eligibility Criteria:
Inclusion Criteria:

* 1. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:

  1. \> 3 cores of Gleason 3+4 or
  2. NCCN unfavorable intermediate risk or
  3. NCCN high-risk or
  4. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).

Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI

Exclusion Criteria:

* 1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.

  2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).

  3. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Vascular Access Choice and Outcomes in the Elderly and Very Elderly With End Stage Renal Disease in China

The purpose of the study is to evaluate the clinical outcomes and cost-effectiveness of different vascular access(arteriovenous fistula, tunneled cuffed catheter and arteriovenous graft) in the elderly and very elderly with end-stage renal disease in China.


Eligibility Criteria:
Inclusion Criteria:

1. The elderly and very elderly with end stage renal disease.
2. Estimated glomerular filtration rate (eGFR) \<20ml/min\*1.73m2
3. All study subjects agree to participate in the study and provide written informed consent.

Exclusion Criteria:

1. Patients' life expectancy is less than 2 years.
2. Mental illness that makes the patients unable to complete the trial.
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients

To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).


Eligibility Criteria:
Inclusion Criteria:

* The patient is not a candidate for a native fistula.
* The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease.
* The patient has been on hemodialysis for ≥1 month.

Exclusion Criteria:

* The patient is scheduled for a different surgical procedure within 30 days post Index Procedure.
* The patient has a known hypercoagulable disorder or bleeding disorder.
* The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin.
The Relationship Between Brain Volume and Sensory Integration in Autistic and Attention Deficit Hyperactivity Disorder.

The relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study

Detect pattern of sensory disintegration in autistic and attention deficit hyperactivity disorder children and adolescence. Also detect relationship between changes in brain and sensory disintegration in each group.

Eligibility Criteria:
Inclusion Criteria .Diagnosis of Autism spectrum disorders /ADHD verified and confirmed on a clinical basis.

. Willing of the parents or the caregivers to participate in the study.

Exclusion Criteria:

.Children with intelligence quotient below 70. .Children with history or current substance use. .Children with medical or other neurological conditions. .Children with history of preterm labour (as brain volume lower than term delivery).

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