cyrilzakka/clinical-trials huggingface dataset:
TD-6450 MAD Study in HCV Infected Subjects

This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.


Eligibility Criteria:
Inclusion Criteria:

* Subject is HCV antibody positive
* Subject is treatment naïve, with no history of exposure (single or multiple dose) to interferon, ribavirin or direct acting antivirals.
* Subject has had a liver biopsy within 3 years or Fibroscan evaluation within 6 months prior to Screening that clearly excludes cirrhosis. If not available prior to Screening, the absence of cirrhosis must be confirmed prior to subject enrollment using either Fibroscan or Fibrosure®.
* Subject is negative for hepatitis A (HAV), hepatitis B (HBV), and human immunodeficiency virus (HIV).

Exclusion Criteria:

* Subject has prior histological evidence of cirrhosis or current clinical evidence of cirrhosis in the opinion of the investigator.
* Subject has a history or evidence of non-hepatitis C chronic liver disease.
* Subject has an estimated creatinine clearance of \<80 ml/min if 18-60 years of age, inclusive; or \<70 ml/min if \>60 years of age, calculated using the Cockcroft-Gault equation.
Magnetic Resonance Imaging of Brain Development in Attention Deficit Hyperactivity Disorder

The primary purpose of this study is to investigate brain whether ADHD represents a disruption or a delay of brain development. Children and adolescents both with and without ADHD are asked to participate in several MRI sessions, two years apart. This will allow us to chart brain development over time, both in typical development and ADHD, and therefore to address whether ADHD represents a disruption or a delay of typical brain development.

Attention Deficit Hyperactivity Disorder (ADHD) is a common and impairing neuropsychiatric disorder of childhood, occurring in 3 to 5% of all school-age children. This disorder is associated with greater risks for low academic achievement, school dropouts, poor family and peer relations, aggression, substance abuse, driving accidents and chronic problems in adult adaptation. As such, it has an enormous impact on the utilization of medical and health care services, and the direct and indirect costs of this disorder are high. However, in a large number of children symptoms dissipate as they grow up and they go on to function normally and lead typical lives. This has lead to speculation that ADHD may not so much represent a disruption, as a delay of brain development. This aim of this study is to address this issue.

There is a growing body of research supporting the existence of deficits in brain anatomy associated with ADHD, with evidence of reductions in overall brain size, cortical gray matter and subcortical structures. However, reported effect sizes are small and results not always consistent. Anatomical MRI studies may be easily confounded, as brain development is complex and associated with both progressive and regressive changes in brain anatomy. In this study, we propose to combine longitudinal data from a large cohort of children and adolescents with state-of-the-art imaging methods (including diffusion tensor imaging and voxelbased morphometry) to investigate brain development in ADHD. This will allow us to address the question whether ADHD represents a disruption or a delay of brain development.

Eligibility Criteria:
Inclusion Criteria:

* Aged 6 - 18 years at initial MRI

Inclusion Criteria for Subjects with ADHD:

* DSM-IV (APA, 1994) diagnosis of ADHD, according to DISC interview
* Scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form(TRF)

Inclusion Criteria for Controls:

* No DSM-IV (APA, 1994) diagnosis, according to DISC interview
* No scores in the clinical range on the Child Behavior Checklist (CBCL) and Teacher Rating Form (TRF)

Exclusion Criteria:

* IQ \< 70
* Major illness of the cardiovascular, the endocrine, the pulmonal or the gastrointestinal system
* Presence of metal objects in or around the body (pacemaker, dental braces)
* History of or present neurological disorder
* For individuals over 12 years of age: legal incompetence, defined as the obvious inability to comprehend the information that is presented by the investigator and is outlined in the Information letter and on which the decision to participate in the study is to be based
Radiological Outcomes of Modified Extra-articular LCL

To assess radiological and functional outcomes of modified extra-articular lateral column lengthening procedure for correction of adult acquired flexible flatfoot deformity

Measurement of

1. Calcencal pitch : This angle is formed on a weight-bearing lateral foot radiograph between the calcaneal Inclination axis and the supporting horizontal surface(10), normal ranges of between 10-25° and 20-30 have Been proposed(11)
2. Meary's angle: It is the angle between a line drawn along the longitudinal axis of the talus (mid-talar axis) and the first metatarsal (first metatarsal axis) , typically', Meary's angle is 0°, with abnormal values considered angle \>4° convex upward: pes cavus , angle \<-4 convex downward: pes planus, It can be used to classify the severity of deformity
3. lateral talocalceneal angle : the angle between the calcaneal inclination axis and the mid-talar axis , The lateral talocalcaneal angle should normally measure between 25 and 40°, \>40° diagnoses flatfoot deformity(12)
4. Talonavicular coverage angle: it is the medial angle between ( talar head articular surface and Proximal navicular articular surface) ,Interpreting the talonavicular coverage angle (13)Normal: \<7,Adult Acquired flatfoot disease: \>7°

Eligibility Criteria:
Inclusion Criteria:

- 1) Age : adult ( age above 16 years old and below 65 years old

2) symptomatic flexible flat foot after failure of Conservative treatment

Exclusion Criteria:

* 1- Age: (\&amp;lt;16,\&amp;gt;65) years old 2 -Previous foot surgery 3- autoimmune disease
* 4 Uncontrolled blood sugar 5- Osteoprotic patient 6- Infection
Zynrelef vs Exparel: The Battle of Postoperative Pain Control After Robotic Sleeve Gastrectomy

The purpose of this study is to evaluate the use of an injectable combination of bupivacaine and meloxicam (Zynrelef) vs injectable liposomal bupivacaine (Exparel), two extended local anesthesia strategies currently approved by FDA and on the market for post-surgical pain control. The investigators plan on randomizing study participants to either Exparel or Zynrelef at the closure site of robotic sleeve gastrectomy and assessing their pain control postoperatively both in the hospital and at home. The investigators will measure the outcome of two drugs, Zynrelief, and Exparel on postoperative pain score -using the NRS pin score up to 72 hours after surgery. The total opioid use will be recorded in forms that will be used to measure pain score and total opioid use and will be collected to the Excel sheet. The cost of the drug will be calculated for internal use for Hospital purpose only.


Eligibility Criteria:
Inclusion Criteria:

1. Age range: 18-65 years old
2. Scheduled or being scheduled to undergo robotic sleeve gastrectomy by Dr. Goyal.
3. Is able to provide written informed consent.
4. Is able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

1. Positive urine drug screen prior to surgery
2. History of substance abuse in the past year-by self report
3. Patient with ongoing daily narcotic use at the time of surgery-by self report
4. Inability to understand informed consent or read English/Spanish
5. Pregnant or lactating patients
6. Prisoners
7. Patients with renal or hepatic failure
8. Bupivacaine use within 96 hours of operation
9. Patient intolerant of opiates, nonsteroidal anti-inflammatory drug s, acetaminophen, or Zynrelef and Exparel. Subjects in all cohorts must not have any contraindications to any of the protocol-specified drugs
10. Patient with a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-65
* Morning serum testosterone (T) \<300 ng/dL on two occasions

Exclusion Criteria:

* Significant intercurrent disease
* Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score \>15 or history of prostate cancer.
* Serum transaminases \>2 times upper limit of normal
* Serum bilirubin \>2.0 mg/dL
* Hematocrit \<35% or \>50%
* BMI \>36
* Untreated, obstructive sleep apnea.
Better Hips- Better Function

The focus of this project are elderly people who have experienced hip fracture and need at least two weeks rehabilitation after discharge from hospital. The aim is to increase the evidence-based knowledge base for planning and appropriate follow-up intervention for patients with hip fracture on short-term / rehabilitation stays. In this study the investigators want to explore whether training High Intensity Functional Exercises (HIFE) , of short duration ie a 2- 4 week program and frequent intervention ie 5 times per week has a significant positive effect on physical function, pain and quality of life. The main aim is to explore whether a high intensive strength and balance training program has better effect than a low intensive strength and balance training program on functional status measured by Short Physical Performance Battery (SPPB) in patients with hip fractures. Another aims is to explore whether this high intensive strength and balance training program has better effect than a 'low intensive strength and balance training program' on pain, endurance and quality of life measured respectively Numeric Pain Rating Scale (NPR), 6-minute walk test and SF-36. The study is a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Fractura colli femoris, pertrochantar or subtrochantar)
* Discharged from hospital within 3 weeks since surgery.
* Need of minimum two weeks rehabilitation
* Life expectancy of more than one month
* Able to walk at least 3 m with walking aid
* Willingness to participate
* Able to follow instructions
* 65 years or older

Exclusion Criteria:

-Other reasons for gait impairment than hip fracture
A Study of LY3200882 in Participants With Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as LY3200882 in participants with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* The participant must have histological or cytological evidence of cancer.
* Have adequate organ function.
* Have Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1.
* Are able to swallow capsules and tablets.

Exclusion Criteria:

* Have moderate or severe cardiovascular disease.
* Have a serious concomitant systemic disorder.
* Have acute leukemia.
Anesthesia With Epinephrine in Diabetes Patients is Safe and Effective

The purpose of this study is to investigate the variation in blood glucose levels, hemodynamic effects and patient anxiety score during tooth extraction in type 2 diabetes mellitus with coronary disease patient under local anesthesia with lidocaine 2% with and without epinephrine.

This is a prospective randomized study including 70 diabetes with coronary disease patients that needed to be submitted to oral surgery. The study was double blind in relation to glycaemia measurements. Continuous monitoring of blood glucose levels for 24 hours was performed using the Minimed Continuous Monitoring System (CGMS, Medtronic). Patientes were randomized into two groups: 35 received 5.4 mL of 2% lidocaine and 35 received 5.4 mL of 2% lidocaine with 1:100,000 epinephrine. In addittion, hemodynamic effects (blood pressure and heart rate) and degree of anxiety were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes mellitus pharmacologically controlled (in use of insulin and/or hypoglycemic agents) Coronary disease -

Exclusion Criteria:

* Pregnant sepsis acute renal failure
Predictors of Mortality Among Ventilator Associated Pneumonia Patients

In this context, this study aims to explore the risk factors for mortality from VAP in respiratory ICU.

Pneumonia is the most common infection treated within ICUs and carries significant mortality risk . Ventilator-associated pneumonia (VAP) is a specific form of nosocomial pneumonia occurring in patients greater than 48 hours after intubation and the initiation of mechanical ventilation .

VAP is considered a leading cause of morbidity and mortality among intensive care unit infections. Despite various preventive measures, the incidence of VAP remains high .

In studies, VAP-related mortality is 14-70% . It is contemplated that there are independent risk factors, increasing VAP-related mortality .

However, the question of which factors are associated with early or late mortality in patients with VAP diagnosis, remains unanswered. Early identification and understanding of the etiology of VAP in the ICU is essential to prevent mortality and morbidity.

Eligibility Criteria:
Inclusion Criteria:This study will enroll:

1. adult participants over 18 years old who had undergone mechanical ventilation for longer than 48 hours.
2. Only the first episode of VAP for each patient will be included.

Exclusion Criteria:

1. Patients who are less than 18 years old.
2. Pneumonia diagnosed before mechanical ventilation.
Efficacy and Safety of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Phase III, Multicenter Study of the Efficacy and Safety of Adalimumab Treatment in Subjects with Moderate to Severe Chronic Plaque Psoriasis


Eligibility Criteria:
Inclusion Criteria:

* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
* Subject had a clinical diagnosis of psoriasis for at least 6 months, had moderate to severe plaque psoriasis.
* Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections

Exclusion Criteria:

* Subject had previously received anti-TNF therapy.
* Subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid UVB or PUVA phototherapy
* Subject cannot avoid excessive sun exposure
* Subject is taking or requires oral or injectable corticosteroids
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
To Study Generic Tacrolimus Ointment, 0.1% in the Treatment of Moderate to Severe Atopic Dermatitis (Inflammation of Skin: Itchy, Red, Swollen, and Cracked Skin)

This is a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Tacrolimus Ointment, 0.1% (Glenmark Pharmaceuticals, Ltd) to the Marketed Product Protopic® (tacrolimus) ointment, 0.1% (Astellas Pharma US, Inc.) in the Treatment of Moderate to Severe Atopic Dermatitis (AD).


Eligibility Criteria:
Key Inclusion Criteria:

1. Non-immunocompromised male or non-pregnant, non-lactating female, 18 years of age or older with a clinical diagnosis of moderate to severe AD.
2. Have confirmed diagnosis of atopic dermatitis for at least 3 months using the diagnostic features as described by Hanifin and Rajka
3. Have an IGA score of 3 (moderate) or 4 (severe).
4. Have an affected Body Surface Area (BSA) of at least 20% at baseline.
5. Treated with a bland emollient for at least 7 days.

Key Exclusion Criteria:

1. Active cutaneous bacterial or viral infection in any treatment area at baseline.
2. Sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline.
3. History of confounding skin conditions, e.g., psoriasis, rosacea, erythroderma, or ichthyosis.
4. History or presence of Netherton's Syndrome, immunological deficiencies or diseases, HIV, diabetes, malignancy, serious active or recurrent infection, clinically significant severe renal insufficiency or severe hepatic disorders.
5. Known allergy or hypersensitivity to tacrolimus or any other component of the Study products.
A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2010/2011 Influenza Virus Strains for the Northern Hemisphere

A study to assess whether the Northern Hemisphere 2010/2011 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male adults
* Aged ≥18 to ≤60 years or \>60 years on Day 1
* Written informed consent

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (≥38.0 °C)
* Prior vaccination with an influenza vaccine in the past 330 days
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, cancer, HIV seropositivity)
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial
* Employee at the investigational site, or relative or spouse of the investigator
* Suspected non-compliance
Low Concentration ALA-PDT in Treatment of Skin Ulcer

Skin ulcer is a common disease with complicated etiopathogenes, which makes it hard to be cured. It has been reported that photodynamic therapy (PDT) can be used to treat skin ulcers which were caused by different diseases. However, PDT is an expensive treatment and patients always experience obvious pain during or after the treatment, which hinders the application of PDT in skin ulcer. Our previous study found that PDT using a low concentration of 5-Aminolevulinic acid (ALA) could promote the healing of skin ulcer without obvious adverse reactions, which suggests us that low concentration ALA-PDT might be an efficient and cost effective treatment in skin ulcer. To further investigate the use of low concentration ALA-PDT in skin ulcer, we plan to recruit patients with skin ulcers caused by different diseases, and divide these patients into different groups according to their causes of disease, and then treat them using low concentration ALA-PDT to observe the healing process of skin ulcer. This study could further optimize and promote the use of low concentration ALA-PDT in skin ulcer.


Eligibility Criteria:
Inclusion Criteria:

* chronic skin wounds that involved the dermis and did not heal in three months or did not exhibit a tendency toward healing

Exclusion Criteria:

* allergies to photosensitizers and their solvents, serious medical illnesses, such as severe heart disease, severe liver or kidney dysfunction, systemic infection or any concomitant infection that would require treatment with an additional antimicrobial agent, the use of topical or systemic antibiotics within one month prior to treatment. Pregnant or lactating women were also excluded.
Early Post Transplant Cardiac Allograft Vasculopathy

Heart transplantation is an effective life-saving treatment for patients with end-stage heart disease. After a transplant, the new heart may develop narrowing in the arteries, causing heart failure, heart attacks and abnormal heart rhythms. This condition is known as cardiac allograft vasculopathy (CAV). The disease is very common, affecting almost a third of heart transplant patients by 5 years after transplant. CAV is a serious problem that causes the new heart to fail and is one of the main causes of death after transplant. Early detection of CAV is important as treatment options are poor once the disease is established. Currently, available techniques to evaluate CAV are limited by poor ability to detect disease early. The current tests usually focus on the large heart arteries and do not examine the smaller arteries that are also affected.

The objective of this study is to determine whether early abnormalities of the heart arteries after heart transplantation can predict the development of CAV. We will use a combination of sophisticated imaging tools to examine in detail the early changes that occur in the arteries of a new heart. Heart transplant patients from the University of Ottawa Heart Institute and Toronto General Hospital will undergo a series of tests at 3 and 12 months after transplant. Statistical analyses will determine whether results from the above tests at 3 months predict the development of early CAV at 12 months after a heart transplant.

Eligibility Criteria:
Inclusion Criteria:

1. Heart transplant \<3 months.
2. Age ≥18 years.
3. Able and willing to provide informed consent.

Exclusion Criteria:

1. Contraindications to dipyridamole.
2. Contraindications to aminophylline.
3. Contraindications to nitroglycerin.
4. Contraindications to iodinated contrast.
5. Acute allograft rejection ≤1 month.
6. Uncontrolled heart failure or myocardial infarction ≤7 days.
7. Estimated glomerular filtration rate ≤30 mL/min.
8. Combined solid organ transplantation.
A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

People with Fabry disease have an alteration in their genetic material (DNA) which causes a deficiency of the a-galactosidase A enzyme. Fabrazyme is a drug that helps to breakdown and remove certain types of fatty substances called "glycolipids." These glycolipids are normally present within the body in most cells. In Fabry disease, glycolipids build up in various tissues such as the liver, kidney, skin, and blood vessels because a-galactosidase A is not present, or is present in small quantities. The build up of glycolipid ("globatriaosylceramide" or "GL-3") levels in these tissues in particular is thought to cause the clinical symptoms that are common to Fabry disease. This study will test the safety and efficacy of Fabrazyme in the treatment of patients with Fabry disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have successfully completed the previous double-blind study (AGAL-1-002-98)
* Patients must provide written informed consent prior to study participation
* Female patients must have a negative pregnancy test prior to each dosing and use a medically accepted method of contraception throughout the study

Exclusion criteria:

* Patient has undergone kidney transplant or is currently on dialysis
* Patient is pregnant or lactating
* Patient is unwilling to comply with the requirements of the protocol
* Patient has a clinically significant organic disease (with the exception of symptoms related to Fabry disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would preclude participation in the study