cyrilzakka/clinical-trials huggingface dataset:
Reliability of Posterior Shoulder Endurance Test in Overhead Athletes

The purpose of this study was to investigate the reliability of posterior shoulder endurance test in overhead athletes and to compare the endurance of posterior shoulder muscles between athletes with and without shoulder pain.

A total of 40 overhead athletes, 20 with shoulder pain and 20 with no shoulder pain, will be included in the study. Shoulder endurance will be measured as isometric and isotonic on both arms of athletes using the posterior shoulder endurance test. The measurements will be repeated after 3-7 days, and the test-retest reliability of the isotonic and isometric posterior shoulder endurance test will be investigated.

Eligibility Criteria:
Inclusion Criteria:

For all athletes:

* Being between the ages of 13-24,
* Participating to overhead sports (tennis, volleyball, handball, etc.),
* Training at least 2-3 hours a week,
* Active participation in training and competitions,
* To be able to complete all assessments in the study,

For athletes with shoulder pain:

* Shoulder pain is 3/10 or more in the Visual Analogue Scale.

For Athletes without shoulder pain:

* No shoulder pain (0/10 according to Visual Analog Scale)
* No history of a shoulder injury and/or shoulder symptoms requiring treatment for the past 1 year.
* Having 90/100 or higher results in Kerlan-Jobe Orthopedic Clinical Shoulder \& Elbow Score

Exclusion Criteria:

* Bilateral shoulder pain,
* Upper extremity fracture history,
* Surgical history of shoulder, cervical and thoracic region,
* Diagnosis of musculoskeletal disease in the cervical region, elbow, and wrist,
* Neck and shoulder pain with active/passive cervical spine movement,
* Frozen shoulder,
* Multidirectional joint hypermobility,
* Having a systemic musculoskeletal disease,
* Diagnosis of chest deformity and scoliosis.
Right-front Direction in Parabolic Flight

The goal of this study is to objectively determine the perceived direction of the right-front by the subjects in weightlessness. The direction of the right-front has not been investigated to date with the measurements of the position of the eyes. The investigators will compare the intersection of the horizontal and vertical saccadic trajectories (jerky) with the apparent direction of the right-front indicated by the subjects when they look right front in the dark (LOOK) and that they indicate when they determine whether a visual target through the right-front apparent (PERCEPTION). Then, the investigators will compare these measurements between normal gravity and microgravity hypergravity during parabolic flight.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged between 20-65 years
* Affiliates to a social security system
* Who are willing to take part in the study,
* Who gave written informed consent,
* Declared fit after a similar visit to a medical aeronautical medical fitness for the non-professional cabin crew in civil aviation. There will be no other aptitude tests for the selection of subjects.

Exclusion Criteria:

* People who participated in a biomedical research protocol for which the exclusion period is complete,
* pregnant women.
Iplasma IL6, Procalcitonin and VEGF and Dialysate Level in CAPD Patients

The aim of study was to evaluated the correlation between plasma levels, dialysate appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in CAPD patients.

This cross -sectional study measured IL-6, procalcitonin and VEGF level in plasma and overnight effluent. PSTR of small solutes was evaluated by standard peritoneal equilibration test (standard PET). Weekly Kt/V and creatinine clearance (CCr ) were evaluated in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Stable CAPD patients without previous history of peritonitis

Exclusion Criteria:

* HIV
* Other infections, tuberculosis or on immunosuppressive drugs,
* Autoimmune disease,
* Cancer
* Diagnosis of permanent ultrafiltration failure .
Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy

This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive Chinese HIV/AIDS patients.

This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.

500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 \< 250/μL, and by LPV/r when CD4 \> 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb \< 90/L or neutrophil count \< 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.

The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.

Eligibility Criteria:
Inclusion Criteria:

* age between 18-65 years of either gender
* HIV-1 antibody seropositive detected by ELISA and confirmed by western blot
* CD4 cell count \< 500/ul
* Signed informed consent, with no condition that precludes follow-up for 2 years
* No plan to move out of the area during the trial
* antiretroviral therapy naive

Exclusion Criteria:

* patients in acute phase of HIV infection
* patients with ongoing opportunistic infection or AIDS-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion
* patients with the any of the following test results during screening for inclusion:

  * WBC count \< 2000/ul,
  * neutrophil count \< 1000/ul,
  * Hb \< 9g/dl,
  * platelet count \< 75000/ul,
  * serum creatinine \> 1.5 ULN,
  * transaminases or alkaline phosphatase \> 3 ULN,
  * total bilirubin \> 2 ULN,
  * serum creatinine kinase \> 2 ULN
* CCr \< 60ml/min
* Pregnancy and breastfeeding
* Intravenous drug user
* Severe neuropathy or mental disorder
* history of alcohol abuse and unable to withdrawal
* Severe peptic ulcer disease
* Non-Chinese nationality
Reducing Catheter-Related Bloodstream Infections in the ICU With a Chlorhexidine-Impregnated Sponge (BIOPATCH)

We proposed to perform a prospective randomized controlled trial to study the effect of the use of a commercially-available chlorhexidine-impregnated sponge (Biopatch) as part of central venous catheter care on catheter-related bloodstream infections among patients in two Barnes-Jewish Hospital ICUs.

At the time of the inception of this study, there were no published randomized controlled trial on the efficacy of the Biopatch in reducing bloodstream infections. Preliminary data has shown that the Biopatch decreases colonization of the catheter exit site and thereby decrease bloodstream infections but this was at that time only theoretical.

Eligibility Criteria:
Inclusion Criteria:

* patients who are admitted to the ICU with a central venous catheter (i.e. triple lumen catheters, quadruple lumen catheters, percutaneously inserted central catheters, arterial catheters, intraaortic balloon pumps, Swan-Ganz catheters).

Exclusion Criteria:

* patients who are not enrolled into the trial within 7 days of having the catheter being placed and patients who are allergic to chlorhexidine.
Effect of CER-001 on Atherosclerosis in Acute Coronary Syndrome (ACS) Patients - Efficacy and Safety: The CHI SQUARE Trial

Cardiovascular disease remains the most pressing healthcare issue for developed countries and is becoming so for developing countries. There are a number of chronic therapies available for long-term management of risk. Short term therapies for subjects with an acute event, such as an episode of acute coronary syndrome (ACS), are focused on reperfusion and removing thrombus but most subsequent events are caused by atherosclerotic plaque rupture at a different site. There are no approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. HDL has multiple actions that could lead to atherosclerotic plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature, improvement in endothelial function, protection against oxidative damage and reduction in inflammation. This study will assess the effects of CER-001, an ApoA-I-based HDL mimetic, on indices of atherosclerotic plaque progression and regression as assessed by intravascular ultrasound (IVUS) measurements in patients with (ACS).


Eligibility Criteria:
Inclusion Criteria:

* Male or female less than 75 years of age
* Acute coronary syndrome (acute chest pain and a diagnosis of ST segment elevation myocardial infarction, non-ST elevation myocardial infarction or unstable angina)
* Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation

Exclusion Criteria:

* Females of child-bearing potential
* Weight \>120 kg
* Angiographic evidence of \>50% stenosis of the left main artery
* Uncontrolled diabetes (HbA1C\>10%)
* Hypertriglyceridemia (\>500 mg/dL)
* Congestive heart failure (NYHA class III or IV)
* Ejection fraction \<35%
* Uncontrolled hypertension (SBP \>180 mm Hg)
* Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction
Bazedoxifene Post Approval Safety Study (PASS) in the European Union (EU)

This observational cohort study is being conducted to further characterize selected adverse events of interest among a patient population with osteoporosis who are prescribed bazedoxifene, raloxifene, or a bisphosphonate in usual clinical care outside of a randomized clinical trial setting. The study will compare the rates of the selected clinical events among the three treatment groups.

All women in the database meeting the inclusion criteria will be included in the study without any statistical sampling.

Eligibility Criteria:
Inclusion Criteria:

* Female
* At least one prescription for bazedoxifene, raloxifene, or any bisphosphonate during the study inclusion period (index prescription);
* A recoded diagnosis code of osteoporosis on or within 60 days prior to the index prescription date;
* Age \>=45 at the date of the index prescription; and
* At least 6-months of follow-up data in the electronic medical record system prior to the date of the index prescription

Exclusion Criteria:

* There is no exclusion criteria. All women in the database who meet the inclusion criteria will be studied.
Eliminating Risk of Preventable Adverse Drug Events at the Hospital-community Interface of Care

This initiative aims to decrease the risk of medication errors at the hospital-community interface as well as health system utilization following hospital discharge by implementing a pharmacist-led medication reconciliation in the patients' home within 72 hours of hospital discharge.

The goals of this initiative are to decrease the risk for medication errors at the hospital community interface of care, thus decreasing preventable adverse drug events and preventable drug-related health system utilization following hospital discharge. This initiative has four objectives that aim to:

1. Develop and test a community-based medication reconciliation process/intervention.
2. Design and conduct a randomized controlled trial to examine the impact of the intervention on post-discharge health services utilization by comparing a set of outcome variables between intervention and non-intervention groups.
3. Design a risk prediction model that helps identify patients discharged from in-patient care with the highest level of need for the intervention.
4. Determine whether a community-based medication reconciliation process/intervention adds risk reduction value to individuals who have undergone an in-hospital medication reconciliation.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending the WestView Health Centre Medicine/Family Health Unit with at least one medication at discharge.

Exclusion Criteria:

* First Nations persons
* Residents of continuing care or assisted living facilities
* Persons not residing in the Edmonton, AB, Canada region
* Persons who obtain a score of 19 or less on the Mini Mental State Examination (MMSE)
CrossFit Exercise to Improve Glucose Control for Overweight and Obese Adults

The purpose of this study was to examine the differences in glucose control, fitness, and body composition between a standard aerobic and resistance exercise training program and a shorter-duration, high-intensity CrossFit training program in overweight and obese physically inactive adults.

Hypotheses:

1. Both groups would improve glucose control, with the CrossFit group improving significantly more than the aerobic and resistance training group.
2. Both groups would improve fitness, with the CrossFit group improving significantly more than the aerobic and resistance training group.
3. Both groups would demonstrate decreases in body fat percentage and fat mass and increases in lean body mass, with the CrossFit group improving significantly more than the aerobic and resistance training group.

Overweight or obese participants will take part in an 8-week exercise intervention after clearance from a doctor, that is expected to improve glucose control, fitness (Eurofit and peak aerobic capacity), and body composition (body fat percentage, fat mass, and lean body mass). After stratification by age and body mass index, participants will be randomized to either a standard aerobic and resistance training exercise program or a relatively higher intensity, shorter duration CrossFit exercise program.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) of 25 - \< 40, physically inactive (i.e., not participating in any structured exercise programs for the past 2 months and not exceeding 30 total minutes of physical activity per week)

Exclusion Criteria:

* current smoker, pregnant, taking blood glucose altering medications, heart disease, type 1 or 2 diabetes mellitus, total cholesterol 200 mg/dL or higher
The Effect of Clopidogrel on Coated-Platelets in Patients Undergoing Cardiac Catheterization

This study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. We hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.

Platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. The change in the percentage of platelets that are coated platelets will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention

Exclusion Criteria:

* Acute coronary syndrome
* Unable to tolerate clopidogrel
Intravascular Ultrasound Prediction of Myocardial Size and Coronary Computed Tomography-Derived Ischemic Burden for Coronary Lesion

The aims of this study are 1) to identify IVUS determinants of the CAMS-derived myocardial territories subtended to the diseased vessels, 2) to find IVUS determinant for the extent of CAMS-derived myocardial size, and 3) to develop the mathematical model that integrates the IVUS information about myocardial territory and stenosis severity and predicts the extent of CAMS-derived myocardial size.


Eligibility Criteria:
Inclusion Criteria:

* Age 20years or older
* Patients who have at least one epicardial coronary artery lesion (including isolated left main disease or side branch) with visually estimated diameter stenosis \>50% and take coronary angiography, CT angiography and IVUS
* Willing and able to provide informed written consent

Exclusion Criteria:

* In-stent restenosis
* Bypass graft
* Suspected coronary spasm even after sufficient nitrate injected
* Cases in which the IVUS imaging catheter failed to cross the lesion
* Poor quality IVUS or CT images
* Visible collateral flow on angiography
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:

To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).

This study investigates the inhibition of restenosis using the CVI Paclitaxel-coated PTA Catheter in the treatment of de-novo occluded/stenotic or re-occluded/ restenotic superficial femoral or popliteal arteries. The proposed clinical study will be a prospective, non-randomized, single arm, multi-center, pharmacokinetic study. The objective of the study is to describe the pharmacokinetics of paclitaxel in the blood delivered from the CVI Paclitaxel-coated PTA Catheter as a result of de novo occluded/restenotic or re-occluded/restenotic lesion(s).

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female greater than or equal to 18 years of age.
* Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Exclusion Criteria:

* Pregnant or lactating females.
* Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.
A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants

The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.


Eligibility Criteria:
Inclusion Criteria:

* Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Participant must be healthy on the basis of physical examination, medical history, and vital signs performed at screening
* Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
* Participant must have normal 12-lead electrocardiogram (ECG) and echocardiogram and must be healthy on the basis of clinical laboratory tests performed at screening
* Participant must be nonsmoker for at least 6 months prior to study drug administration

Exclusion Criteria:

* Participant with a history of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardia, and heart blocks
* Participant with unusual T wave morphology (such as bifid T wave) likely to interfere with QTc measurements
* Participant with a past history of: Sick sinus syndrome, Cardiac arrhythmia (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary, Risk factors associated with Torsade de Pointes (TdP) such as hypokalemia, Family history of short/long QT syndrome, Sudden unexplained death (including sudden infant death syndrome) in a first-degree relative (that is, sibling, offspring, or biological parent)
* Participant with any skin condition likely to interfere with ECG electrode placement or adhesion
* Participant with a breast implant or a history of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues
* Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
* Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days or within a period less than 10 times the drug's half-life, whichever is longer, before the planned administration of study drug, or is currently enrolled in an investigational study
* Participant has a history of human immunodeficiency virus (HIV)-1 or HIV-2 infection positive, or tests positive for HIV-1 or HIV-2 at screening
The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers

Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
2. Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
3. Mobile digital device with active data and text plan, able to receive email and text messages
4. Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days
5. Habitual soft contact lens prescription optimized over-refraction within ±0.25 D
6. 18-35 years of age
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
8. Vertex corrected refractive cylinder must be -0.75 or less.
9. Visual acuity best correctable to 20/25 or better for each eye
10. The subject must read and sign the Informed Consent form.

Exclusion Criteria:

1. A habitual wearer of any of the test lenses
2. Any active conditions that may prevent soft contact lens wear.
3. Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
4. Any doctor diagnosed, self-reported accommodative or binocular vision issues
5. History of issues of eye alignment or binocularity by self-report
A Randomized Trial for Suicidal Patients

Although suicide risk is highly prevalent among the patient population in mental health care, remarkably little research exists on effective treatments. Among a small set of novel approaches, CAMS is particularly promising. The investigators compare CAMS to TAU in a randomized controlled trial at four departments in Vestre Viken Hospital Trust, hypothesizing CAMS to be the superior approach. Primary outcome measures are suicidal ideation and suicide attempts, with secondary outcome measures including general symptoms of mental health problems. Changes in the outcome measures are compared between the two groups from baseline to 6 and 12 months after patients are included in the study. The study has the potential to impact the science of treating suicidal individuals and it could benefit the general public by establishing CAMS as an effective clinical approach for rapidly reducing suicide risk.


Eligibility Criteria:
Inclusion Criteria:

* Significant suicide ideation on Beck's Scale for Suicide Ideation (score 13 and above). Informed consent to participate.

Exclusion Criteria:

* Active psychosis, cognitive or physical impairment or other problems that preclude the ability to understand the study procedures and provide informed consent, non-Norwegian speaking subjects