cyrilzakka/clinical-trials huggingface dataset:
IN-US-276-1340: Pre-Exposure Prophylaxis to Prevent HIV Acquisition in US Women: A Demonstration Project

The overall aim of this study is to assess attitudes toward PrEP, feasibility of Truvada PrEP procurement through the established access procedures, and adherence to Truvada PrEP among US women at risk for HIV acquisition.

Study Design:

This is a 24 week prospective pilot study assessing attitudes toward and feasibility of using Truvada PrEP in a population of women at risk for HIV acquisition.At this site 31 HIV- uninfected women desiring PrEP will be enrolled at each site (confirm number). We will have to consent about 50 women which includes screen failures.The study will assess attitudes towards and adherence to PrEP with questionnaires at weeks 12 and 24. Tenofovir levels procured at week 12 and 24 week of PrEP will be used to assess adherence to PrEP.

Primary objectives:

1. Describe attitudes toward PrEP among a population of women at risk for HIV acquisition, living in HIV prevalent areas.
2. Assess feasibility of Truvada procurement through the established Gilead access program
3. Evaluate adherence at week 12 and week 24 using dried blood spots

Secondary objective:

1. Describe HIV incidence
2. Describe associations of positive and negative attitudes toward PrEP with acceptance of PrEP and subsequent adherence
3. Assess adherence at weeks 12 and 24
4. Evaluate the relationship between PrEP adherence and sexual activity
5. Compare geographic areas with respect to PrEP attitudes
6. Mentor junior investigators at each site.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 64 years old
* Able to give consent
* "At risk" for HIV as defined by any of the following:

  1. unprotected sex (in past 6 months) with 1 or more men of unknown HIV status
  2. evaluated for an STI within 6 months prior to screening
  3. sex in last 6 months with an HIV-infected partner
  4. IDU with report of using previously used or shared needles in past 6 months or has been in a methadone, buprenorphine, or suboxone treatment program in past 6 months or engaging in high-risk sexual behaviors
  5. individuals engaging in transactional sex (i.e sex for money, drugs, or housing)
  6. Infrequently uses condoms during sex with 1 or more partners of unknown HIV status who are known to be at substantial risk of HIV infection (IDU or bisexual male partner)
* CrCl ≥ 60 ml/min
* HIV- uninfected women desiring PrEP

Exclusion Criteria:

* Active alcohol or drug use or dependence which may interfere with adherence to study requirements
* HIV-infected at screening or enrollment
* Estimated CrCl \< 60 mL/min
* Past participation in an HIV vaccine study
* Positive Hepatitis B surface antigen test
* Underlying medical condition with survival unlikely during follow-up period
* Any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives
* Pregnant or breast feeding
* Actively trying to achieve pregnancy
Effects of Hypoxic-hyperoxic Preconditioning in Cardio-surgical Patients

Coronary artery bypass grafting (CABG) with cardiopulmonary bypass is a common surgical therapy for patients suffering from coronary artery diseases. The heart is subjected to a long period of ischemia due to the occlusion of the aorta. The heavy burden of myocardial ischemia-reperfusion injury (IRI) thus induces cardiomyocyte death, which can paradoxically reduce the beneficial effect of CABG. Preconditioning by moderate hypoxia or hyperoxia serves as an effective drug-free method to increase the organism's resistance to negative effects, including IRI.

It has been firmly established that the diminished oxygen delivery to the tissues in response to hypoxia is countered by a combination of the increased regional blood flow and the enhanced functional capillary density in the microcirculation. In experimental studies, exposure to hyperoxia for a limited time before ischemia induces a low-grade systemic oxidative stress evokes a preconditioning-like effect on the myocardium and reduces the infarction area by 20%, and the number of arrhythmias after ischemia-reperfusion. One hundred twenty patients were randomly assigned into two equal groups: hypoxic-hyperoxic preconditioning before the surgery (HHP group) and the control group (without preconditioning). Safety control of the preconditioning procedure included ECG monitoring, invasive blood pressure, cardiac output, pulse oximetry, capnography, cerebral oximetry, measurement of anaerobic threshold; acid-base status and metabolic state of arterial and venous blood were assessed once every 10 min during the preconditioning procedure; oxygen balance parameters were calculated. Seventy-two hours before the surgery, an anaerobic threshold was determined to establish a safe oxygen concentration in the respiratory gas mixture during the hypoxic preconditioning phase from 10 to 14%, followed by 75-80% oxygen concentration during the hyperoxic phase.

The hypoxic-hyperoxic preconditioning with individual parameters selection based on the anaerobic threshold in patients with coronary artery diseases before the main stage of cardiac surgery with a cardiopulmonary bypass should reduce the duration of mechanical ventilation, catecholamine support, and frequency of perioperative complications.

Eligibility Criteria:
Inclusion Criteria:

* the need for coronary artery bypass grafting (CABG)

Exclusion Criteria:

* age over 75 years
* emergency surgery
* diabetes mellitus
* exacerbation of a chronic disease 1 week before surgery
* any oncological disease at the time of the examination
Short Term Outcomes From Minimally Invasive Surgery for the Treatment of Atrial Fibrillation

The purpose of this study is to assess the efficacy of minimally invasive surgery for atrial fibrillation.

Patients who are undergoing or who have undergone minimally invasive surgery for atrial fibrillation will be followed prospectively. At 6 to 9 months, 1 and two years post surgery follow-up subjects will receive a trans-telephonic monitor to wear for approximately 1 month, and will submit transmissions on a daily basis. Episodes of atrial fibrillation will be documented during this time. The overall efficacy of the procedure will be assessed based on the freedom from atrial fibrillation at the time of transtelephonic monitoring.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* paroxysmal, persistent, or permanent atrial fibrillation

Exclusion Criteria:

* concomitant heart surgery requiring open thoracotomy
Dexmedetomidine and Fentanyl Versus Midazolam and Remifentanil for Sedation in Patients Undergoing Ablation Procedures

To evaluate the safety and efficacy of dexmedetomidine and compare this to a current technique commonly used at TGH for sedation in patients undergoing ablation procedures for atrial fibrillation (AF) and atrial flutter.

The investigators hypothesise that dexmedetomidine will be at least equivalent to, or more so, in terms of effectiveness and safety, when compared to midazolam and remifentanil for sedation during ablation procedures.

The role of ablation for chronic persistent AF has been debated amongst cardiologists for some time, and there is increasing evidence that ablation may be superior to medical management. As populations age, the rate of AF is likely to increase and therefore the numbers of ablations performed for this arrhythmia will also be expected to increase.

Ablation procedures can vary in length from one to more than 6 hours in duration and require the patient to keep still so as not to influence the mapping procedure.

Options for anaesthesia care include a general anaesthetic or sedation. Several studies have evaluated the safety of sedation for ablation, using combinations of fentanyl, midazolam and propofol. These demonstrate that the ablation procedures are well tolerated under deep sedation.

Dexmedetomidine is an attractive potential agent for this role due to its favourable respiratory pharmacodynamics and good sedation profile. Dexmedetomidine is a short acting relatively specific alpha-2 receptor agonist (alpha 2: alpha 1 = 1300:1). It has been shown to have very little effect on respiratory parameters, even at high doses.In addition, it may offer some analgesic properties and therefore minimise the need for narcotic based agents. the investigators will compare dexmedetomidine infusion and fentanyl bolus with remifentanil infusion midazolam bolus.

Eligibility Criteria:
Inclusion Criteria:

* patients listed for an ablation procedure for treatment of atrial fibrillation or flutter at TGH requiring sedation provided by an anesthetist
* Valid consent

Exclusion Criteria:

* Baseline HR \<40
* Baseline SBP \< 80mmHg
* Baseline SBP \> 180mmHg
* Second or third degree heart block unless pacemaker in situ
* Uncontrolled heart failure/severe LV dysfunction (Ejection fraction \< 40%)
* Severe hepatic dysfunction (Transaminases greater than 2 times the upper limit of normal)
* Renal dysfunction: estimated GFR \< 30ml/min, or requiring dialysis
* Allergy to any of the study drugs (dexmedetomidine, remifentanil, fentanyl, midazolam)
* Cognitive impairment precluding ability to tolerate sedation and comply with assessment methods
* Requirement for general anaesthetic for the procedure
* Pregnancy or breast feeding mothers
* Chronic use or addiction to opioids
* \< 18 years of age
Development and Evaluation of a Web-based Diet Quality Screener for Vegans - BELGIUM

The primary objective of this study is to assess the construct validity and criterion validity for associations of the VEGANScreener with nutrient intakes from reference methods and associations with biomarkers of dietary intake. The investigators hypothesize that the screener is a valid tool to assess diet quality in the vegan population. The study will assess construct validity by testing whether the measure relates as it should to other measures (e.g., age, gender, education, socioeconomic status differences).

The investigators will assess concurrent and predictive validity (types of criterion validity) by evaluating associations and agreement between 'gold standards', such as diet records, biomarkers, and multi-metabolite signatures of intake. The investigators will examine associations of vegan diet quality with biomarkers of nutritional status, biomarkers of disease, and anthropometric measures and hypothesize that a higher diet quality in vegans is associated with a more favourable profile among vegans, for example, a lower blood pressure. This study is part of the European VEGANScreener Consortium.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported vegans (≥2 years on a vegan diet; vegan diet defined as not consuming any dietary animal products more often than once/month, honey excluded)
2. Self-reported omnivores. Consuming on average daily (at least 5 times/week) meat/meat products.
3. Age 18 to 65 years (1:1 ratio 18-35,99 and 36-65)
4. Males and females (1:1 ratio)

Exclusion Criteria:

1. Self-identified pescatarians (excluding all meat, except for fish/seafood) and reductarians/flexitarians (intentionally reducing intake of animal-based products)
2. History of a disease known to affect intermediary metabolism (e.g., any diabetes on treatment, i.e. medication or lifestyle recommendations, thyreopathies, cancer etc.)
3. BMI\>30 kg/m2
4. History of disease of intestinal integrity (i.e., inflammatory bowel disease, chronic pancreatitis, other malabsorption, etc.).
5. Pregnant or breastfeeding females.
the Effect of Oral Vasopressors for Liberation From IV Vasopressors in Spinal Shock

the study is developed to evaluate the effect of use of oral vasopressors (midodrine versus minirin) on weaning ICU patients from IV vasopressors (noradrenaline) and compare between them for efficacy in shortage the duration of IV vasopressor and has low complications and side effects.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 - 60 years.
* Patients of both genders.
* Patients diagnosed by spinal shock and they are in the recovery stage .

Exclusion Criteria:

* Patient refusal.
* Anuric or oliguric patients or patients with chronic kidney disease.
* Patients with allergy to medication included in the study.
Mental Health and Its Correlates Among Chinese Adolescents Exposed to the Novel Coronavirus Disease 2019

Background: Direct exposure to public health emergencies is associated with increased mental disorders. It is less clear about the prevalence of common mental disorders and its correlates in Chinese adolescents after experiencing public health emergencies.

Objective: This longitudinal study aims to estimate the prevalence of common mental disorders (i.e. depression, anxiety, and post-traumatic stress disorder) and its correlates in a sample of Chinese adolescents after experience a public health emergency, namely the novel coronavirus disease 2019 (COVID-19).

Method: This study intends to recruit 3,428 Chinese adolescent students from high and middle schools in the baseline survey. This study will track these recruited participants every 6 months via three-wave follow-up (i.e. 6-month, 12-month, and 18-month follow-ups). The demographics (e.g. age, gender, education, family background, and residence) and psychosocial factors (i.e. exposure to traumatic events, religious belief, social media exposure, loneliness, and perceived social support) associated with common mental disorders (i.e. depression, anxiety, and post-traumatic stress disorder) will be investigated in this sample population. Furthermore, a hardcopy self-report questionnaire will be disturbed to all participants. Additionally, the cross-sectional analyses will be first conducted to estimate the prevalence of mental disorders and their correlates in data of baseline survey. After obtaining the longitudinal data, the relative risk, incident rate ratios, latent class analysis, and structural equation model may be performed in this study. Missing data will be solved by the multiple imputations. Data analysis tools included the Stata 16.0 and Mplus 8.4.

Discussion: This longitudinal study will better help to understand the prevalence changes of mental disorders among Chinese adolescents following the COVID-19. These findings have the potential to provide empirical evidence about the burden of mental disease and key drivers of Chinese adolescents following the COVID-19, which can benefit the formation of public policy and mental health intervention programming. This study will close the gaps that a lack of epidemiological studies about the mental disorder prevalence and related risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. age range: 10-19;
2. full-time students in these targets high or middle schools;
3. nationality: China;
4. exposure context: COVID-19;
5. able to adequately understand the content of consent form and questionnaire;

(d) able to sufficiently state the purpose of the research and acknowledge the potential risks and benefits based on the questionnaire
Green Banana Peel Extract for Stasis Dermatitis Treatment

To develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis.

Objective: to develop and evaluate a pharmaceutical formula based on green banana peel extract for the treatment of stasis dermatitis. Methods: it will be a clinical, interventional, longitudinal study, random sampling, Sample will have 20 patients divided into two groups. In the Control Group, a moisturizing cream with SPF 30 sunscreen plus a pharmaceutical formulation without green banana peel extract will be used, and in the Study Group, in addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used. Patients will undergo treatment for 90 days, applying the formulation twice a day, evaluated every 45 days through clinical, photographic and Chromatic Palette evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stasis dermatitis.
* Patients aged 18 years or over and 60 years or less.
* Patients who agree to participate in the study. -

Exclusion Criteria:

* Patients who have other types of hyperchromia in the legs.
* Patients known to have an allergic reaction to bananas.
* Patients who give up, for any reason, to continue treatment.
Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of CJ-12406 in Healthy Male Subjects

Study objectives

* To evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of CJ-12406 in healthy male subjects.
* To evaluate the pharmacodynamics of CJ-12406 after multiple oral administrations to healthy male subjects.
* To evaluate the effect of food on the pharmacokinetic of a single oral dose of CJ-12406 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male volunteers in the age between 20 and 45 years old
2. Subjects with no history of any significant chronic disease
3. The weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
5. Available for the entire study period
6. Willing to adhere to protocol requirements and sign a informed consent form
7. Multiple escalation study; H. pylori positive, as determined by the urea breath test

Exclusion Criteria:

1. History of clinically significant allergies including drug allergies
2. History of clinically significant hepatic, renal, gastrointestinal, pulmonary, ,musculoskeletal, endocrine, psychiatric, hematologic, oncologic, neurologic or cardiovascular disease
3. Symptom of an acute illness within 4 weeks prior to drug administration
4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
5. Treatments or symptoms of symptomatic GERD, gastric ulcer, duodenal ulcer, functional dyspepsia, irritable bowel syndrome within 3 months prior to drug administration
6. Clinical laboratory test values are outside the accepted normal range

   * AST or ALT \>1.25 times to normal range
   * Creatinine clearance \<80 mL/min
   * 12-lead ECG; PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec
7. Clinically significant vital signs

   * Hypotension (SBP ≤ 89 mmHg)
   * Hypertension (SBP ≥ 141 mmHg or DBP ≥ 91 mmHg)
   * Tachycardia (≥ 101 beats/min)
8. History of drug and alcohol abuse(alcohol \> 30 g/day)
9. Subjects who have ever smoke within 3 months prior to drug administration
10. Positive urine screen for drugs and cotinine
11. Use of any other medication, including herbal products, within the 2 weeks before dosing
12. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
13. Donated blood within 60 days prior to dosing
14. Participated in a previous clinical trial within 90 days prior to dosing
15. Subjects considered as unsuitable based on medical judgement by investigators
The Effects of the Inspiratory Muscle Plus Aerobic Training Compare to Aerobic Training Alone in Heart Failure Patients.

This study aims to compare effects of inspiratory muscle training added by aerobic training to aerobic training alone in heart failure patients with inspiratory muscle weakness. To do so, strength and endurance of inspiratory muscles, functional capacity, quality of life, heart rate variability and sleep apnea evaluations will be conducted in patients with heart failure.

A sample comprising at least 30 individuals is necessary. These subjects will be randomized in two groups, one consisting of inspiratory muscle training plus aerobic training, whereas the other will consist of the aerobic training alone.

This prospective, randomized, controlled trial will include patients with the diagnosis of chronic heart failure attributable to left ventricular systolic dysfunction who will be recruited from the Heart Failure Clinic.

Entry criteria for the study are a previous history of symptomatic heart failure caused by left ventricular systolic dysfunction, inspiratory muscle weakness (PImax \< 70% of the predicted), and clinical stability, including no change in medications for the past three months.

Exclusion criteria will be unstable angina, myocardial infarction, or cardiac surgery within the previous three months, chronic metabolic, orthopedic, or infectious diseases, treatments with steroids, hormones, or cancer chemotherapy, history of exercise-induced asthma, chronic obstructive pulmonary disease and smokers will be not recruited.

The protocol was approved by the Committee for Ethics in Research of Hospital de Clinics de Porto Alegre and Ijuí University and all subjects are required to sign an informed consent form.

Variables will be measured by strength and endurance (progressive and constant load), 6-min walk test, cardiopulmonary exercise testing, quality of life questionnaire, evaluation of the heart rate variability and sleep apnea.

The inspiratory muscle training plus aerobic training will consist of cycle exercise (3 sessions/week) and inspiratory exercise by using Threshold equipment for 30 min, 7 times per week, whereas aerobic training group will perform only cycle exercise. Both treatments will last 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* previous history of symptomatic heart failure caused by left ventricular systolic dysfunction
* inspiratory muscle weakness (PImax \< 70% of the predicted)
* clinical stability, including no change in medications for the past three months

Exclusion Criteria:

* unstable angina
* myocardial infarction, or cardiac surgery within the previous three months
* chronic metabolic, orthopedic, or infectious diseases
* treatments with steroids, hormones, or cancer chemotherapy
* history of exercise-induced asthma, chronic obstructive pulmonary disease
* smokers
The Diagnostic Value of Shear Wave Elastography and Viscosity Imaging Techniques in Diabetic Peripheral Neuropathy

The main objective of this observational study is to evaluate the diagnostic value of multimodal ultrasound for diabetic peripheral neuropathy (DPN). The questions it aims to address are: (1) To compare the differences in various parameters between the DPN group, non-DPN group, and healthy control group; (2) To explore the diagnostic efficacy of each parameter for DPN and establish a combined model.


Eligibility Criteria:
Inclusion Criteria:Individuals aged 18 to 75 years without diabetes -

Exclusion Criteria:Individuals without peripheral neuropathy.

-
Vojta Therapy in Early Stroke Rehabilitation

Stroke is the major cause for permanent disability in adults. It is still unclear, which physiotherapeutic approaches are most effective. The Bobath-concept is one of the most widely used approaches in stroke rehabilitation within the western world, although several studies have failed to demonstrate superiority and showed partially even inferiority compared to other physiotherapy approaches. The Vojta therapy is based on a completely different approach - the reflex locomotion. However to date no study has been performed for stroke. We designed a randomized clinical trial (RCT) to compare Vojta and conventional physiotherapy in patients with acute ischemic (AIS) or hemorrhagic stroke (ICH). This RCT will be the first trial to investigate improvement of postural control due to Vojta therapy in early rehabilitation of stroke patients, which is a very new approach in stroke-rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years)
* CT or MRI proven acute ischemic (AIS) or hemorrhagic stroke (ICH) within 72h after onset of symptoms
* Severe hemiparesis (medical research council scale for muscle strength ≤2)
* premorbid modified Rankin Scale (mRS) ≤3
* maximal National Institute of Health Stroke Scale Score (NIHSS) 25
* Voluntary written consent by the patient

Exclusion Criteria:

* Severe cognitive impairment due to aphasia or dementia, prohibiting that physiotherapeutic challenges can be understood.
* Participation on another clinical trial
* Pregnancy