cyrilzakka/clinical-trials huggingface dataset:
Egg Study With Peripheral Arterial Disease

The current research study has the potential to generate data that would provide solid clinical endpoints as to the impact of including eggs in a regular diet in individuals with peripheral arterial disease. Any one of three potential outcomes may be observed as a result of this study, and they are predicted as follows: 1) Egg consumption does not lead to a deterioration of indices of cardiovascular health; 2) Egg consumption improves indices of cardiovascular health; 3) Egg consumption worsens the indices of cardiovascular health.

Given the hypotheses proposed, if either of the first two predictions prove to be positive, they will help encourage directive efforts to be made toward effective nutrition messages for egg consumption in the peripheral arterial disease and the healthy population. If the last prediction is positive, while least favourable, it will still establish important information to assist the industry in their efforts toward establishing population-specific nutrition messaging.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of peripheral arterial disease including those with claudication as defined by an ankle brachial index of ≤ 0.90 or asymptomatic carotid stenosis of \> 50%; or who have had a previous intervention for peripheral arterial disease;
2. Male or female, \> 40 years of age;
3. Willing to comply with the protocol requirements;
4. Willing to provide informed consent;
5. Stable medication profile with no changes anticipated for the duration of the proposed study schedule (8 weeks);
6. Participants having completed the Flax Study are eligible to participate if their completion has been more than 3 months.

Exclusion Criteria:

1. Renal failure requiring dialysis;
2. Diabetes, requiring diabetic medication; Participants with diabetes who do not require diabetic medication and have good glycemic control will be eligible for participation in the study. Participant with elevated fasting blood glucose levels and glycated hemoglobin above 'standard of care' at baseline will not proceed with the study;
3. Hyperlipidemia as defined by a cholesterol of \>4.1 mmol/L (as per the National Cholesterol Education Program Adult Treatment Panel III, (NCEP ATP III) guidelines;
4. Hormone replacement therapy;
5. Inability to adhere to a regular diet;
6. Habitual egg intake of 5 or more eggs per week;
7. History of gastrointestinal reactions or allergies to eggs;
8. Daily consumption of omega-3 supplements.
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3

To evaluate the anti-HIV activity, safety, and tolerance of adefovir dipivoxil ( bis-POM PMEA ) in combination with standard antiretroviral therapy for 48 weeks.

Patients are randomized to receive either adefovir dipivoxil or placebo daily for 24 weeks, after which all patients will receive open-label drug for an additional 24 weeks. Study drug is administered in combination with a current antiretroviral regimen for the entire 48 weeks. Patients are followed every 4 weeks during the first 24 weeks of study, then every 8 weeks during the last 24 weeks.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection with HIV RNA titer \>= 2500 copies/ml (2.5 KEq/ml) plasma.
* CD4 count \>= 200 cells/mm3.
* No new AIDS-defining event within the past 2 months.
* Life expectancy at least 1 year.
* Consent of parent or guardian if less than 18 years old.
* Tolerated antiretroviral therapy for the past 2 months.

NOTE:

* Kaposi's sarcoma is permitted provided patient has not received systemic therapy within the past month.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active, serious infections other than HIV that require parenteral antibiotic or antiviral therapy.
* Gastrointestinal malabsorption syndrome or chronic nausea or vomiting that would preclude oral medication.
* Malignancy other than Kaposi's sarcoma or basal cell carcinoma.

Concurrent Medication:

Excluded:

* Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons.
* Isoniazid.
* Rifampin.
* Investigational agents (unless approved by sponsor).
* Systemic chemotherapeutic agents.

Prior Medication:

Excluded:

* Parenteral antibiotic or antiviral therapy for another active, serious infection within the past 2 weeks.
* Immunomodulating agents such as systemic corticosteroids, IL-2, or interferons within the past month.
* Systemic therapy for KS within the past month.

Required:

* Antiretroviral regimen other than study drug.

Required:

* Antiretroviral therapy for at least the past 2 months. Current alcohol or substance abuse that would interfere with compliance.
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Shoulder Function

Basic strength training for the neck/shoulder muscles can decrease intensity of neck/shoulder pain, but it is uncertain whether training should focus directly on the upper trapezius - which is most often tender - or on the lower compartments and serratus anterior.

We hypothesize that strengthening exercise for the lower and middle trapezius as well as the serratus anterior will decrease intensity of neck/shoulder pain among office workers


Eligibility Criteria:
Inclusion Criteria:

* employees
* more than 30 days with pain previous year
* pain intensity of at least 3 on a scale of 0-10

Exclusion Criteria:

* trauma
* life threatening disease
* pregnanacy
Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players

Fifth metatarsal stress fracture is a failure of a healthy metatarsal bone subject to repetitive microdamages. It has a high prevalence in soccer players and is classified as a high-risk stress fracture. Based on Torg classification, the treatment options may be conservative or surgical. The recent increase of evidences about Shock Wave Treatment in different bone pathologies, including stress fractures, suggests the possibility to use this conservative intervention option also in patients candidate for surgery. This randomized clinical trial included 18 soccer players diagnosed of proximal fifth metatarsal stress fracture, randomly matched in Surgery group and Shock Wave group. Patients of Surgery group were treated with intramedullary screw fixation; patients of Shock Wave group received 3 weekly sessions of Focused Shock Wave Treatment (F-ESWT), using an electrohydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses. Patients of both groups were followed monthly until their return to play (RTP) using radiography, Visual Analogue Scale (VAS), Tegner Activity Level Scale and AOFAS score.


Eligibility Criteria:
Inclusion Criteria:

* Male soccer players, aged over 18 years.
* Diagnosis of proximal fifth metatarsal stress fracture, according to clinical signs and symptoms and to radiologic findings
* Fracture occurred during soccer practice
* Informed consent signed

Exclusion Criteria:

* To be under 18 years old
* Traumatic fracture
* Fracture occurred out of soccer practice
* Patients with metatarsal shaft, neck or head fracture
* Patients with contraindication to receive surgical treatment
* Patients with contraindication to receive shock wave treatment
* Patients that refuse the informed consent
Behavioural Interventions for Postnatal Depression: a RCT Study

Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer as compared to Medical Officer alone

This was a two-group double-blind randomized controlled trial (RCT) conducted in six primary care clinics at Klang Valley, with 27 subjects in each arms. All post-partum women at 4 to 24 weeks, registered at these clinics, were screened using self-administered Edinburgh Postnatal Depression Scale for symptoms of depression. Those who scored 12 or more and/or positive for question on suicidal behaviour, were interviewed by trained Research Assistants using Mini International Neuropsychiatric Interview, a diagnostic interview tool. Those with mild to moderate depression were invited to join this study, while severe depressed cases were referred to the Family Medicine Specialist for appropriate management. Consented eligible women were randomized into either control group; managed by Medical Officers alone, or intervention group; managed by both Medical Officers and trained nurses. Medical officers were given standard refresher course on Postnatal Depression management based on Clinical Practice Guideline while nurses were trained using brief cognitive-behavioural therapy (CBT) module, which consists of 6 modules for 6 weekly sessions. Depression level and its severity were assessed using self-administered Beck's Depression Index (BDI) and Automatic Thought Questionnaire (ATQ), at Baseline, Week 3 and Week 6.

Eligibility Criteria:
Inclusion Criteria:

* postpartum 4-24 weeks
* registered with selected primary care clinics
* Edinburgh Postnatal Depression score: 12 or more; and Mini diagnostic interview:

positive (mild to moderate depression)

* consented to participate

Exclusion Criteria:

* severe depression or psychosis
Hypothermia's Impact on Pharmacology

The purpose of the study will help us understand the complex interaction between hypothermia (cooling) and pharmacogenetics (how specific genes effect how drugs are handled), and their impact on how routinely given sedation drug are broken down and used by the body when given to children after cardiac arrest (when heart stops pumping blood) and are critically ill.

Background:

Therapeutic hypothermia is used in the pediatric intensive care unit, and is being studied in the setting of pediatric cardiac arrest. Following cardiac arrest, multiple organ dysfunction syndrome, especially renal and hepatic dysfunction, is common and affects the metabolism and excretion of drugs. In addition, very little is known about the impact of hypothermia on a child's ability to metabolize medications. Dose adjustments may be required in the setting of hypothermia to avoid under-dosing and over-dosing of medications. Improper dosing and drug accumulation of sedatives and opiates can worsen existing neurologic, circulatory and respiratory failure. The measurement of the actual drug and metabolite concentrations in the body (pharmacokinetics) provides information on how a child metabolizes medications. In addition, variability in these concentrations after the administration of equal doses to different children may result from genetically driven differences in drug metabolizing systems (pharmacogenetics). Finally, these genetic differences may respond differently to hypothermia. Our overarching hypothesis is that morphine and midazolam disposition will be affected by temperature management even when accounting for potentially confounding quantifiable factors of organ dysfunction and genetic differences.

Objectives:

The objectives of this study, Hypothermia's Impact on Pharmacology 2, are

1. To estimate the impact of hypothermia on the variability in morphine and midazolam pharmacokinetics in children after cardiac arrest and
2. To estimate the impact of genetic factors on the variability in morphine and midazolam pharmacokinetics, specifically in the setting of hypothermia.

Sophisticated modeling and simulation techniques will be utilized to examine the highly dynamic changes in physiology associated with critical illness, drug disposition, pharmacogenetics and temperature modulation. The models created using this approach will be implemented to optimize the prospective treatment of these critically ill children.

Study Design:

Prospective pharmacokinetic study

Eligibility Criteria:
Inclusion Criteria:

* Be greater than or equal to three (3) kg
* Receiving or have received morphine and/or midazolam as part of clinical care
* Receiving hypothermia after any cardiac arrest
* Provide Informed Consent

Exclusion Criteria:

* Receiving renal replacement therapy \[example Continuous Veno-Venous Hemofiltration (CVVH), Continuous Veno-Venous Hemodialysis (CVVHD), and Continuous Veno-Venous Hemodiafiltration (CVVHDF)\]
* Receiving plasmapheresis
Immunoglobulin G4 and Immunoglobulin E Antibodies in a Population With Adverse Reactions to Foodstuffs-related Symptoms

The aim of this study is to analyze a population with symptoms associated with adverse reactions to foodstuffs (ARFS). To determine the levels of food-specific immunoglobulin G4 (IgG4) and immunoglobulin E (IgE) antibody reactions (AbR).

Volunteers with symptoms related with adverse reactions to foodstuffs (ARFS) and suspicion of having a food allergy or a food intolerance are enrolled in this study. A 50μl of capillary whole blood is analyzed and the levels of food-specific immunoglobulin G4 (IgG4) or immunoglobulin E (IgE) antibody reactions (AbR) are determined.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years of age)
* To present symptoms related to adverse reactions to foodstuffs (ARFS)

Exclusion Criteria:

* Antibiotic treatment
Clinical Study to Evaluate the STENTYS Xposition S for Treatment of Unprotected Left Main Coronary Artery Disease

Prospective, non-randomized, multi-center study assessing the long term safety and efficacy of the self expandable sirolimus eluting Xposition S stent in the treatment of unprotected left main coronary artery disease.

In the treatment of unprotected left main coronary artery (ULMCA) disease, previous mono-center studies have shown promising results with the previous generation of the self-expandable STENTYS stent (paclitaxel eluting stent, delivered via withdrawal of a sheath).

The TRUNC study aims at assessing at large scale the Xposition S in the treatment of ULMCA disease. The Xposition S is a sirolimus eluting stent, mounted on a balloon delivery system. The study aims at collecting clinical practice routine data from 200 patients.

Eligibility Criteria:
Main Inclusion Criteria:

* Subject ≥ 18 years old;
* Presence of coronary artery stenosis in the unprotected Left Main (LM) Coronary Artery which is indicated for PCI and Xposition S stent treatment
* Left Main Coronary Artery reference vessel diameter ranging from 2.5 mm to 6.0 mm;
* The subject is able to provide voluntary informed consent, willing to comply with all study requirements and sign the written informed consent.

Main Exclusion Criteria:

* Recent STEMI (\<1 month) ;
* SYNTAX score ≥ 33 ;
* Highly calcified lesions or excessive tortuosity at target lesion site;
* Subject unable to comply with dual antiplatelet therapy as recommended per guidelines;
* Planned cardiac surgery or valve intervention within the next 12 months.
* Participation to other investigational drug or device studies that have not reached their primary endpoint.
Multi-ingredient Supplement for Strength and Power

It has been suggested that high amounts of total serum testosterone levels correlate with higher lean body mass, lowered fat mass, greater muscle strength, and faster recovery. These suggestions drive athletes and body builders to find ways to raise their testosterone levels. Many athletes and bodybuilders look to alternative methods to anabolic steroids in order increase their testosterone levels without legal repercussions or physiological side effects. Herbs and other plant extracts have been introduced as a possible source to naturally boost testosterone levels. Research supporting the use of herbs and plant extracts has been shown to be equivocal. However, evidence in studies with hypogonadal men suggests that longjack root may naturally boost testosterone levels.

Onnit Labs, LLC has packaged this supplement (T+) which claims it can naturally boost testosterone and lower estrogen levels and subsequently improve performance. This product is a powder (11g) that is mixed with 16 oz of water and consumed 20 minutes prior to anaerobic workouts, such as high intensity weight training.

T+ is a multi-ingredient supplement that consists of vitamins B5 and B6, magnesium aspartic acid, mucuna pruriens, longjack root, nettle root, red clover luteolin, resveratrol, beta- alanine, branch chain amino acids, L- glutamine, Bioperine, and Fibersol 2.

The active ingredients purported to boost plasma testosterone levels are mucuna pruriens, longjack root, and magnesium aspartic acid. The active ingredients claimed to lower plasma estrogen concentrations are red clover, luteolin, resveratrol and nettle root. All other ingredients (Branch Chain Amino Acids and Beta-Alanine) have been documented to improve exercise performance.

It is hypothesized that there will not be any physiological changes after supplementation of T+. It is also hypothesized that performance will not be affected by the supplementation of T+.

The purpose of this study is to examine the physiological and performance effects of T+ on power athletes.

Eligibility Criteria:
Inclusion Criteria:

* Must be familiar with the three main powerlifting movements (squat, bench and deadlift)
* Must have one month training with a designated strength coach to understand the expectations of the strength coach and movement patterns for performance
* Have no pre-existing musculoskeletal disorders
* Participate in the three-week supplement wash out prior to beginning the experiment (except for basic protein supplements and multivitamins)

Exclusion Criteria:

* Female
Clinical Trial of Human Allogenic Culture-expanded Bone Marrow-derived Mesenchymal Stem Cells

This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from mesenchymal stem cells and delivered using the investigational Helix transendocardial delivery catheter as a therapy for ischemic HFrEF with reduced ejection fraction.

Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow-derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure. At present, several types of adult bone marrow derived stem cells hold great promise to treat heart failure. Allogenic culture-expanded bone marrow-derived human mesenchymal stem cells (MSC) are the subject of the current study as having potential to provide a safe and effective treatment for patients with ischemic heart failure. Mesenchymal stem cells are multipotent stromal cells that can differentiate into a variety of cell types, including osteoblasts (bone cells), chondrocytes (cartilage cells), myocytes (muscle cells) and adipocytes (fat cells which give rise to marrow adipose tissue). The CardiALLO cell therapy is an allogenic bone marrow-derived cell treatment which is delivered intramyocardially using the investigational Helix delivery catheter. The purpose of this study is to determine the safety, optimal dose and efficacy of CardiALLO cell therapy system in patients with ischemic heart failure with reduced ejection fraction (HFrEF). Phase I is designed to determine effective dose and Phase II is designed to evaluate effectiveness for improving clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* New York Heart Association (NYHA) Class II or III
* Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction
* Left ventricular ejection fraction between 20% and 40%
* On stable, guideline-directed medical and device therapy, as appropriate
* NTproBNP level of \>500 pg/ml.
* Have inflammation \> 2 mg/L as measured by high-sensitivity C-reactive protein (hs-CRP) test.

Exclusion Criteria:

* Other cardiovascular or medical history parameters, as appropriate, that may preclude safe administration of the study treatment.
Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer

To compare the efficacy and safety of prophylaxis of venous thromboembolism by Nadroparin during hospitalization to long-term usage in patients with advanced lung cancer treated by chemotherapy and/or radiotherapy.

This is a prospective, multi-center, randomized and controlled study. Advanced lung cancer patients without venous thromboembolism(VTE) are included. The selected patients were randomized into A and B groups. Group A: Nadroparin given during hospitalization, 0.4mL, subcutaneously, qid; Group B: Nadroparin given by long-term, 0.4mL, subcutaneously, qid. The incidence of VTE , the risks of bleeding and overall survival in two groups of patients are studied at different time points.

Eligibility Criteria:
Inclusion Criteria:

* Stage Ⅲ B and Ⅳ non-small cell lung cancer patients and inoperable small cell lung cancer patients
* Performance status score ≤ 2
* Chest CT with measurable lesions

Exclusion Criteria:

* Examination revealed any part of venous thromboembolism
* Chemotherapy regimens containing bevacizumab or Endostar
* Severe coagulopathy
* Active bleeding within two weeks
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates

Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in premature neonates. Secondary aim is to assess the effect of the age of transfused red blood cells on the biological markers of oxidative stress.

Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.

Eligibility Criteria:
Inclusion Criteria:

* Premature neonates ≤36 weeks in need for blood transfusion.

Exclusion Criteria:

* Critically ill neonates.(perinatal asphaxia,on high setting mechanical ventilation,different types of shock eg ;septic shock and major congenital anomalies)
* Extremely low birth weight neonates(\<1000gm birth weight )
* Recipient of blood transfusion before enrollment in the study.
* Neonates planned for exchange transfusion .
Implementation of the Hospital to Home (H2H) Heart Failure Initiative

This study determines if a community of practice of clinicians and quality improvement specialists can be used to implement a national quality initiative known as Hospital to Home (H2H). This quality initative is designed to reduced readmission rates for patients with heart failure or heart attack by improving the transition of care upon discharge.


Eligibility Criteria:
Inclusion Criteria:

* VA medical centers are the unit of randomization. A medical center will be included if had at least 20 patients discharged with a principal diagnosis of heart failure in 2008
Effect of Covid-19 Affliction on Psychological and Mental Health Among College Going Students: Cross-Sectional Survey

The study aims to study the effects of Novel corona virus (COVID-19) on the psychological and mental health of college going students. Online version of the Event Impact Scale - Revised will be used to filled by the students who got afflicted by the novel corona virus (COVID-19).

Objective : To study the impact on psychological and mental health of COVID-19 affliction among college going students

Methodology:

Study Design: Cross-sectional Mode of implementation: Online surveys Population : COVID positive College students Inclusion criteria: Students positive to corona tests Exclusion criteria: students negative to corona tests

Eligibility Criteria:
Inclusion Criteria: Students positive for COVID-19 test -

Exclusion Criteria: Students negative for COVID-19 test

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