cyrilzakka/clinical-trials huggingface dataset:
Using HIV Risk Assessment Tool to Promote HIV Testing Among Men Who Have Sex With Men

The objective of the study is to evaluate the effectiveness of a HIV risk assessment tool to promote HIV testing and to reduce high risk sexual behaviors among men who have sex with men (MSM). It hypothesizes that the social media-based HIV risk assessment tool can increase 20% HIV testing proportion during the six months follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Male at birth.
* Having had homo-sexual behaviors (anal/oral) in the past 6 months before enrollment.
* An age of 18 years or older.
* Living in Beijing, China.
* Self-reporting HIV negative or unknown.
* Willingly participating into the baseline survey and the six months follow ups.
* Agreeing not to share the research link to others.
* Owning a mobile phone and having had downloaded the social networking Application Blued before enrollment.

Exclusion Criteria:

* Not accepting blood sampling within the study period.
* Reporting injecting drugs use in the past six months before enrollment.
* Being currently involved in other HIV behavioral interventions for MSM.
* Having a specific plan to leave from Beijing in the next 6 months.
* Self-reporting female.
* Other reasons the investigators deem make participation either detrimental to the participants or the study.
Laser Acupuncture for Pain Prevention in Neonates

Pain prevention and/or therapy in neonates is still a challenge. It is widely accepted that early pain experience can have a tremendous impact on the pain memory. We want to investigate if a simple, fast method, that is nearly devoid of side effects can lead to a significant alleviation of pain sensation in neonates. Acupuncture has been shown to be effective in various painful conditions. Trials on acupuncture in children are rare. Trials on acupuncture in neonates are lacking so far. Our hypothesis is that neonates in the active laser group experience less pain than those in the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Neonates with no obvious underlying disease (genetic (e.g. M. Down), metabolic)and not under pain medication

Exclusion Criteria:

* Older than 28 days
Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Doses of AZD2066 in Japanese Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Furthermore, the study has been expanded to include two additional panels with increment of dose during the multiple dosing period (12 days) in order to obtain sufficient information on safety and tolerability of multiple dosing of AZD2066 in Japanese subjects at higher levels of exposure. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent
* Healthy Japanese males as judged by the investigator
* Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

Exclusion Criteria:

* History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
* Intake of medicine (except occasional paracetamol) within first 2 weeks before first administration of study drug.
Evaluation of Pcv-aCO2 in the Fluid Treatment of Abdominal Tumor Patients After Surgery

This research will confirm that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic effect of these patients.

1. Confirmed that Pcv-aCO2 is suitable for the guidance of early fluid therapy and the evaluation of the prognosis of patients with abnormal hemodynamics after abdominal tumor surgery, and is expected to be a new monitoring index to improve the therapeutic efficacy of this kind of patients.
2. Pcv-aCO2 effectively reflected the improvement of tissue and organ microcirculation disorder through the individual goal target treatment to guide the fluid resuscitation in the hemodynamic instability patients.
3. Research of the correlation between Pcv-aCO2 and the organ function in patients with abnormal hemodynamics after operation.

Eligibility Criteria:
Inclusion Criteria:

1. Acute physiology and chronic health score system II (APACHE II) score ≥10；
2. Hemodynamic abnormalities post-operation (a. systolic blood pressure\<90mmHg, or descent by basic blood pressure for more than 40mmHg. b. pulse pressure \<20mmHg, c. urine volume \<0.5ml/Kg/hr, d. heart rate \>100 / min, e.Central Venous Pressure(CVP) \<5mmHg, f. blood lactic acid \>2.7mmol/L, meet any one above).
3. Age ≥ 18 years, which is expected to stay in ICU for 5 days or longer;
4. Patients themselves or their authorized clients agree to participate in clinical trials and signed informed consent.

Exclusion Criteria:

1. age \<18 years;
2. without improvement in respiratory system disease or chronic obstructive pulmonary disease with Forced expiratory volume in one second (FEV1) \<50%;
3. lobectomy and pneumonectomy;
4. death within 24 after treatment;
5. patients with severe organ dysfunction;
6. pregnant or lactating women;
7. the patients did not sign informed consent;
8. any factors that may be expected to increase the risk of patients or other factors that may interfere with the results of clinical trials.
Determinant of Repeat Revascularization After Percutaneous Coronary Intervention

To determine factors associated with repeat revascularization among adults aged 25 years and above within 5 years of first Percutaneous Coronary Intervention (PCI) at a tertiary care hospital.

Matched case-control study design was employed to determine the association between re-peat revascularization and its determinants in patients within 5 years of undergoing index PCI. The case was defined as a patient who had undergone repeat revascularization within 5 years of undergoing index PCI. Control was defined as a patient who had not undergone repeat revascularization within 5 years of undergoing index PCI.

The retrospective study was carried out with the approval of the Ethical Review Committee of the tertiary care hospital where the study was carried out. A waiver of informed consent was granted as this was a retrospective study and all patients were discharged from the hospital.

A minimum of 120 cases with matched 240 controls were required in 1:2 case to control ratio. This sample size was essential to achieve the power of 80% for an anticipated matched odds ratio of 2 with the hypothesized correlation of 0.2 using a two-sided hypothesis test with a significance level of 0.05.

The outcome of the study was the Repeat revascularization status. There are different types of repeat revascularization according to the site and lesion to which intervention has been provided. Any type of repeat revascularization was considered and enrolled as a case in this study5.

Covariates included in the study were divided into patient characteristics (gender, age, health coverage, BMI, smoking status), comorbidity status (Hypertension, Diabetes Mellitus, Hyperlipidaemia, valvular disease), clinical characteristics (Creatinine level, Systolic Blood Pressure, Diastolic Blood Pressure, HbA1c, Cholesterol level, other technical factors related to the index PCI) and medication status (Beta-blocker, ACE Inhibitor, Statin).

Eligibility Criteria:
Inclusion Criteria for Cases:

* Aged 25 years and older
* Undergone repeat revascularization within 5 years of undergoing index PCI (from 2011 to 2017).

Exclusion Criteria for Cases:

* If suffering from any hypercoagulable disorder
* Revascularization procedure was per-formed outside the study setting
* Staged PCI within 3 weeks or planned PCI within 6 months of Index PCI.

Inclusion Criteria for Controls:

* Patients aged 25 years and older
* Undergone PCI once from the year 2011 to 2017.

Exclusion Criteria for Controls:

* If suffering from any hypercoagulable disorder.
Study of QRH-882260 Heptapeptide Application in the Colon

A Phase 1B study of the efficacy of a topically-administered 7-amino acid peptide labeled with a near-infrared fluorophore Cy5 for detecting neoplastic areas of the colon is proposed. The study will test the efficacy of administering this agent (QRH-882260 Heptapeptide) to human subjects undergoing clinically-indicated colonoscopy for endoscopic resection of known colonic adenomas or for surveillance biopsies of known dysplasia in the setting of irritable bowel disease (IBD). Up to 120 evaluable subjects will be enrolled.

Subjects will be recruited around scheduled standard of care procedures. The endoscopists performing the procedures are all endoscopists credentialed at the University of Michigan to do these procedures. Urine for dipstick pregnancy testing (if applicable) will be collected before the procedure, along with medical information. Vital signs are routinely monitored throughout the clinical procedure and are available in the electronic medical record. The endoscopy will proceed per the University of Michigan Health System (UMHS) standard of care. The endoscopist performing the clinical procedure will evaluate the potential risk (if any) for the subject to continue with the procedure or study. Five mL of the reconstituted QRH-882260 Heptapeptide (\~100 μM) will be sprayed onto the site of interest through a catheter in the endoscope. Five minutes after QRH-882260 Heptapeptide application, the unbound peptide will be washed off using the endogator irrigator and the residual liquid will be suctioned. Pictures with white-light and fluorescence will be taken with the scanning fiber based molecular imaging endoscopic probe inserted via the instrument channel of the standard endoscope before the QRH-882260 Heptapeptide application, immediately after application and then again after the QRH-882260 Heptapeptide will be washed off. The area of interest identified will be resected/biopsied per discretion of the endoscopist per clinical care. All specimens taken are for clinical care only (not research use) and will be sent for routine histology per UMHS standard of care.


Eligibility Criteria:
Inclusion Criteria:

Subject meets at least one of the following criteria:

* At increased risk for colorectal cancer (CRC) and colonic polyps
* Known colonic adenomas scheduled for colonic resection
* Scheduled for outpatient colonoscopy for follow up surveillance of IBD with known dysplasia or who are at high risk for high grade dysplasia
* Subject is scheduled for outpatient colonoscopy in the Medical Procedures Unit at UMHS
* Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Standard practice guidelines for safely proceeding with the procedure will be sufficient for the study
* Age 18 to 100 years
* Willing and able to sign informed consent

Exclusion Criteria:

Subjects with known allergy or negative reaction to Cy5 (a near-infrared fluorophore) or derivatives

* Subjects on active chemotherapy or radiation treatment
* Pregnant or trying to conceive
Effectiveness of a Hydrophobic Dressing for Microorganisms' Colonization and Infection Control of Vascular Ulcers

This study will determine the effectiveness of CUTIMED® hydrophobic dressings against AQUACEL® silver dressings in bacterial colonization of vascular ulcers.

Chronic wounds with torpid evolution are a real challenge for health services today. In the case of venous ulcers, it is estimated that more than 80% of these wounds may be colonized or infected by bacteria, which is associated with its chronification by delaying the healing process.

The most widespread therapeutic strategy in routine clinical practice is the use of silver dressings, due to its high antimicrobial power, although the effectiveness of these in venous ulcers is not supported by solid evidence. In addition, there are some uncertainties about the possible adverse effects of systemic absorption of silver molecules, as well as bacterial resistance to silver and the high cost associated with prolonged treatments.

In this sense, a novel method to deal with this problem is the use of dressings with high hydrophobic power, such as CUTIMED®.

Eligibility Criteria:
Inclusion Criteria:

Adult patients with chronic venous vascular ulcer located in lower limbs with signs of critical colonization, according to the criteria of Lazareth and Moore, which imply the presence of at least 3 of the following five:

1. Severe pain during dressing change
2. Perilesional edema.
3. Local edema.
4. Unpleasant smell.
5. Abundant pus
6. Microbial colonization higher than 100000 CFUs

Exclusion Criteria:

* Patients younger than 18 years old.
* Venous ulcer with signs of infection which requires antibiotic therapy
* Venous ulcers that do not meet Lazareth and Moore criteria
* Arterial ulcers.
* Patients with type I or type II diabetes.
* Patients with immunosuppression of any etiology or in immunosuppressive treatment or with NSAIDs.
* Patients with rheumatoid arthritis in the acute phase.
* Patients with dermatitis prior to the appearance of the ulcer.
* Patients with neuropathy or lack of sensitivity of any etiology.
* Patients who, for local or systemic clinical reasons, will need to initiate antibiotic therapy.
Family Intervention for Obese Children Using Portion Control Strategy for Weight Control

Obesity in children is a serious disease that is associated with increased mortality and decreased life expectancy. A simple tool used to assist in controlling portions (and therefore calorie intake) at mealtime would be of benefit in promoting weight maintenance and/or loss. The purpose of this study is to assess the efficacy of a family intervention using a portion control tool to help control weight in obese children. The investigators hypothesize that the use of portion control tools by the parents and child will result in a greater decrease in the child's BMI over a 6 month period compared with the control group.

This study is a randomized controlled trial designed to assess the efficacy of a portion control tool to help improve body mass index in obese children over a 6 months period. This study will also assess whether this weight control strategy results in improvement of blood pressure, waist circumference, and biomarkers of obesity including plasma visfatin, adiponectin, fasting lipid profile and apolipoprotein B, liver function tests and fasting insulin and glucose. Both the intervention and the control group will receive a one hour session of standard dietary counseling from a registered dietician at baseline regarding healthy eating habits, appropriate portion sizes and the Canada Food Guide. The duration of this study will be 6 months. Baseline measurements will be taken at the initial visit and again at 3 months and 6 months. Each participants' height and weight will be measured, and BMI will be calculated. Waist circumference and blood pressure will also be measured. A blood sample will be drawn at baseline and 6 months for a fasting lipid profile, fasting insulin, and glucose levels. Measurement of plasma visfatin and adiponectin levels using ELISA will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* age 8 years old to 16 years old
* BMI greater than or equal to the 85th percentile for age and gender

Exclusion Criteria:

* patients currently taking a weight loss medication
* gastrointestinal disorder
* psychiatric illness under the care of a psychiatrist
* Cushing's syndrome
* hypothalamic or genetic etiology of obesity
* uncontrolled or untreated thyroid disease
* current diagnosis of cancer
* history of an eating disorder such as bulimia or anorexia nervosa
* surgery in the past 3 months
* surgery planned in the ensuing 6 months
* any chronic illness that could affect weight status
In Vivo Glycocalyx as Predictor of Complications After Cardiac Surgery

Cardiac surgery has been described as altering endothelium structure and function, notably because of the use of cardiac-pulmonary bypass (CPB). Among the endothelial structure, glycocalyx, the thin layer recovering the endothelial surface, may be altered by the inflammatory process and probably the modification of flow during CPB. Endothelial and glycocalyx integrity are essential for vascular function and glycocalyx destruction is associated with organ failure and mortality. On the other hand, a chronic alteration of glycocalyx is observed in many diseases such as diabetes, hypertension or chronic kidney failure, all pathologies frequently observed in patients benefiting grom cardiac surgery.

Thus the preoperative alteration of glycocalyx may be associated with postoperative organ failure.


Eligibility Criteria:
Inclusion Criteria:

* all patients benefiting from a cardiac surgery with cardio-pulmonary bypass

Exclusion Criteria:

* impossibility to carry out the measurement by glycocheck device
* refusal to participate
Effects of IASTM vs. Foam Rolling on Knee and Hip Range of Motion in Soccer Players

The aim of this study is:

To compare the acute and long-term affects of instrument assisted soft tissue mobilization (IASTM) vs foam rolling on knee and hip flexibility and performance in soccer players.

The objective of this study is to compare the acute and long-term affects of instrument assisted soft tissue mobilization vs foam rolling on knee and hip flexibility and performance in soccer players. This is a randomized controlled trial, in which participants will be randomly divided into two groups: group-A and group-B. Group-A will receive intervention IASTM while Group-B will receive foam rolling as intervention. Intervention will be carried out for 8 weeks. Assessment of the range of motions for hip and knee joints will be carried out at baseline, immediately after the session, after four weeks and after five (5) months. The secondary measures of performance used in the study are sit and reach test, 100m sprint speed test, Illinois agility run test.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with normal BMI
* Players with at least one year of playing professional soccer and taking at least three training sessions/matches per week.

Exclusion Criteria:

* Players with any pathological conditions affecting any of the system.
* Suffering from recent acute unhealed MSK injury/Trauma.
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment

A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms

This is a multi-center observational study. Treatment and follow-up visits will be done as per standard of care.

The purpose of this study is to demonstrate that use of the FRED/FRED Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 1, 6 and 12 month post procedure.

100 patients will be enrolled over an 18-month recruitment period. All patients will be followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patient older than 18 years old
2. Patient harboring an unruptured intracranial aneurysm:

   * for which endovascular treatment is indicated
   * for which use of FRED or FRED Jr has been deemed appropriate
   * being the only one to require treatment over the period of the study
   * and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized
3. Patient with a modified Rankin Scale (mRS) ≤ 2
4. Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form

Exclusion Criteria:

1. Patient has suffered an ICH within the 30 days prior to the procedure.
2. The aneurysm to be treated is associated with an cAVM
3. The aneurysm to be treated is a dissecting or blister-like aneurysm
4. The aneurysm to be treated or any other aneurysm is in the posterior circulation
5. The aneurysm to be treated has a stenosis of its parent artery
6. Patient has another aneurysm previously treated with a stent or a flow diverter

   * on the same parent vessel at any time (except in the case of the proximal carotid if the treatment occurred more than 3 months prior to the procedure)
   * on a different parent vessel, less than 3 months prior to the procedure
7. Patient has another aneurysm requiring treatment within the study period
8. Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium
9. Patient with a contra-indication to antiplatelet or heparin
10. Pregnancy or child breastfeeding
11. Patient unable or unlikely to complete required follow up
12. Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
13. Treatment with a flow diverter other than FRED/FRED Jr or in addition to FRED/FRED Jr is planned.