cyrilzakka/clinical-trials huggingface dataset:
Bioavailability Study of Sirolimus Tablets 2 mg Under Fed Condition

This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy, adult,human subjects under Fed conditions.

Open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose, oral bioequivalence study of Sirolimus tablets 2 mg under Fed conditions.

Eligibility Criteria:
Inclusion Criteria:

i. Provide written informed consent

ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg

iii. Having a body mass index between 18.0 and 24.9 (both inclusive), calculated as weight in Kg/height in m2

iv. Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance)

v. Female Subjects

* Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence
* Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

Exclusion Criteria:

i. Incapable of understanding the informed consent

ii. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg

iii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg

iv. Oral temperature is below 95.0°F or above 98.6°F

v. Pulse rate below 50/min or above 100/min

vi. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs

vii. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function

viii. Consumption of grapefruit for the past ten days prior to the check-in, in each period

ix. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period

x. Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period

xi. Difficulty in abstaining from xanthene containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period

xii. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing

xiii. Clinically significant abnormalities and / or with significant diseases

xiv. Confirmed positive in alcohol screening

xv. Confirmed positive in selected drug of abuse

xvi. Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study

xvii. Confirmed positive in urine pregnancy test

xviii. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study
The "Virtual" Multicenter Spontaneous Coronary Artery Dissection (SCAD) Registry

The primary goal of this project is to describe the clinical and physiologic characteristics of Spontaneous Coronary Artery Dissections (SCAD) in order to increase awareness, understanding, treatment and prevention of a potentially fatal cardiovascular event.

This study will be a retrospective and prospective review of medical course and current health of men and women with SCAD.

Spontaneous Coronary Artery Dissection (SCAD) is a relatively rare and poorly understood condition that has been reported to affect more women than men. The coronary arteries consist of three layers, and dissection occurs when two of these layers separate, enabling blood to flow into the space between the layers. As the blood accumulates, this can cause obstruction to normal blood flow within the heart, leading to chest pain, heart attack and even sudden death.

The medical community has much to learn about treatment and prevention of this potentially fatal cardiovascular event. Mayo Clinic is conducting two studies of SCAD. This study consists of building a database/registry of patients with SCAD (whether they have been patients at Mayo Clinic or not) to identify patterns of SCAD incidence, causes and associations that could guide future research. With participant consent, Mayo Clinic staff will request a copy of the original coronary angiogram when SCAD was diagnosed to confirm the diagnosis and determine eligibility. If eligible, study coordinators will contact the participant to provide more information about the studies and request a signed informed consent document.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have been cared for at Mayo Clinic with a diagnosis of SCAD
* SCAD in women who are pregnant or within 12 months postpartum at the time of SCAD
* SCAD in individuals who self-identify as a member of a racial or ethnic group that is currently underrepresented in the registry. This would include anyone who identifies as: Black/African American, Asian, American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, and any race with Hispanic ethnicity
* SCAD in a man
* SCAD in persons younger than 30 years of age
* SCAD within the past 2 weeks (acute)
* SCAD patient enrolling into any other Mayo Clinic SCAD Research Study
* SCAD in individuals who have a relative that has had a SCAD event

Persons with history of SCAD who are interested in participating in the study but do not meet the updated inclusion criteria will not be enrolled at this time. However, they will be given the option to share their contact information in order to be invited to future Mayo Clinic SCAD studies.
Effect of Lumbrical Stretching on Carpal Tunnel Syndrome

Symptoms of CTS occur when any condition decreases the size of the carpal canal or increases the volume of the structures within the carpal canal, compressing the median nerve. One cause of the symptoms of CTS is the incursion of the lumbrical muscles of the hand into the carpal canal. Individuals with CTS tend to have tight lumbrical muscles which increase this incursion, thereby increasing CTS symptoms. An intervention designed to reduce the incursion of the lumbrical muscles should have an effect on the symptoms of CTS.

The purpose of this study is to systematically examine the effect of an intensive lumbrical muscle intervention, splinting to prevent lumbrical muscle incursion and lumbrical muscle exercises, on the symptoms of CTS. This project will be a randomized clinical trial to evaluate the effectiveness of a home program targeting the lumbrical muscles. One hundred and twenty subjects will be assigned to one of 4 groups: Group 1 will receive a home program of lumbrical muscle stretches combined with a lumbrical positioning splint; Group 2 will receive a home program of lumbrical muscle stretches combined with a night wrist cock-up splint; Group 3 will receive a home program of general stretches combined with a lumbrical positioning splint; and Group 4 will receive a home program of general stretches combined with a night wrist cock-up splint. After 1 month, 3 months, and 6 months the groups will be compared to determine if there is a significant reduction in symptoms between the groups.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 yo
* Clinical symptoms of Carpal tunnel syndrome (CTS)
* Positive Tinel's, Phalen's, or Durkin's test
* Absence of thenar atrophy
* 2 pt discrimination of 5mm or less

Exclusion Criteria:

* Persons needing immediate CTS surgery
* Pregnancy
* Compressive neuropathy in the ipsilateral arm
* Diabetes
* prior CTS release
* Non-English speaking
Changes in Attention Level Due to Isometric Exercises and Level Three Progression Eccentric Movements

Determine the changes in attention level due to isometric exercises and level three progression eccentric movements. The attention level will be measured using a mental speed test (how quickly a subject can process information and make decisions based upon that information). Another outcome measure will be the ability of the subject to maintain balance

On Day 1, subjects will complete the mental speed test and will undergo CDP testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface (a 4" tall foam cushion of known mechanical properties) in a comfortable posture, feet shoulder width, with eyes open or closed, head straight and arms to the side and free to move, gazing forward, and breathing normally. These will constitute the baseline information. Subjects will be divided into two groups: a isometric group (performing the isometric exercises) and an eccentric group (performing the eccentric exercises). At the end of Day 1, the isometric group will perform the isometric exercises while the eccentric group will act as control (no exercise). On Day 2, subjects will complete the mental speed test and will undergo the CDP testing a second time. These will constitute the first follow-up information. At the end of Day 2, the eccentric group will perform the eccentric exercises while the isometric group will act as control (no exercise). Throughout Day 3, subjects will complete the mental speed test and undergo the CDP testing a third time. This will constitute the second and last follow-up information.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Any pathology preventing the subject to safely perform the isometric exercises (the clinician enrolling the subjects will make the decision)
Far Infrared Irradiation for Management and Treating of Parkinson's Disease (PD)

Parkinson's disease (PD) is a degenerative disorder of the central nervous system that often impairs the sufferer's motor skills and speech. This study will investigate the use of far infrared radiation to manage, control and treat PD.

Parkinson's disease belongs to a group of conditions called movement disorders. It is characterized by muscle rigidity, tremor, a slowing of physical movement and, in extreme cases, a loss of physical movement. The primary symptoms are the results of decreased stimulation of the motor cortex by the basal ganglia, normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. PD is both chronic and progressive.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have PD.

Eligibility Criteria:
Inclusion Criteria:

* People with Parkinson's Disease

Exclusion Criteria:

* None
Advance Care Planning for Critical Care - A Prelude to Breaking Barriers

Advance Care Planning (ACP) is a process of 'reflection and communication, in which a person with decision-making capacity makes decisions regarding their future health and/or personal care in the event that they become incapable of consenting to or refusing treatment' Most Canadians have not planned for end-of-life Care and are at risk of aggressive medical care that may not be compatible with their wishes. This study aims to systematically evaluate local barriers to making personal choices with regards to life support interventions that can be provided in the contemporary Intensive Care Unit.

HYPOTHESIS: The overarching hypothesis is that the average layperson lacks sufficient knowledge about the aggressive life support measures used routinely in contemporary Critical Care to make informed decisions for themselves and their loved ones. Considering that most Canadians have not even heard of the term Advance Care Planning, it is likely that there is a gap in their knowledge and expectations of Critical Care. Such a gap can be bridged through education - the only caveat being that the individual should be in full possession of their faculties and can make informed decisions. This point is critical.

Thus this study uses a mixed methods (qualitative and quantitative) research design to address the following questions: 1) What is the state of knowledge about Critical Care interventions among healthy elderly laypersons in London, Ontario? 2) What are the barriers to formulating ACPs? 3) What opportunities exist for increasing ACP in the healthy elderly population? The primary objective of this proposal is to assess public knowledge of Critical Care interventions (and their outcomes) from the perspective of making Advance Care Plans. Secondary Objectives are 1) To evaluate local barriers to Advance Care Planning 2) To determine effective modes of education for Advance Care Planning that could be used for the community and in our hospital setting.

Eligibility Criteria:
Inclusion Criteria:

* Members from the community who are i) \> 55 yrs of age, ii) living in London Middlesex community, iii) not housebound, iv) in apparent good health and iv) have the ability to make independent decisions for themselves

Exclusion Criteria:

* Factors that preclude a meaningful interview (such as cognitive impairment, aphasia, profound hearing impairment, language barriers) or anticipated emotional burden with the proposed topic.
Human Skin Safety Testing of a Mitopure Topical Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Volunteers

The objective of this study is to investigate the irritation and sensitization potential of multiple topically applied test articles (containing different concentrations of Mitopure), in a shared panel of healthy volunteers by means of repeated cutaneous patch applications under occlusion based on the modified Draize method


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females,18 years of age or older.
* Completed written informed consent.
* Female subject agrees to use an acceptable method of birth control (e.g. abstinence, condoms, hormonal birth control, IUD, tubal ligation, hysterectomy, bilateral oophorectomy, hysterectomy, post-menopausal for at least one year or male partner vasectomy).

Exclusion Criteria:

* Pregnancy or lactation.
* A current skin disease of any type apart from mild facial acne (e.g. eczema, psoriasis) or has tattoos or excessive hair at the patch sites that would interfere with patching/skin evaluations.
* Heavy alcohol consumption (i.e. more than 21 units per week or 8 units a day for men, more than 14 units per week or 4 units a day for women).
* Current use or history of repeated use of street drugs.
* A febrile illness lasting more than 24 hours in the six days prior to first patch application.
* Significant past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, locomotor or psychiatric disease.
* Currently taking asthma medication or antihistamines for hay fever.
* A history of multiple drug hypersensitivity.
* Concurrent medication likely to affect the response to the test articles or confuse the results of the study (e.g. Anti-allergy, glucocorticoid, aspirin, non- steroidal anti-inflammatory, asthma or hay fever medication).
* Known sensitivity to the test articles or their constituents including patch materials (for example tape/plaster adhesive).
* Current treatment by a physician for allergy unless physician consulted by Investigator and participation approved.
* Participation in a repeat insult patch test (RIPT) or follow-up work within the last month.
* Sensitisation or questionable sensitisation in a RIPT.
* Recent immunisation (less than 10 days prior to test patch application).
* A medical history indicating atopy.
Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

Hand recovery following cerebral stroke is complex and requires intensive training. The investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index \<3) were randomized. Patients in the Treatment group received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the Control group received conventional intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences between final and basal results were compared between groups.

Upper limb recovery, particularly that of the hand, is complex in patients with cerebral stroke and requires an intensive approach.

Regarding upper limb rehabilitation, several research groups have developed robotic devices to provide passive and/or active movements. Their use appears to reduce the motor deficit of the arm and affected hand and to improve hand function both at the wrist and fingers. Hence, the evidence supporting specific robot-assisted rehabilitation of the hand is very promising even if further study is required.In particular, evidence is limited about the benefit of passive exercises and mobilization of the hemiplegic upper limb following stroke, and further research is called for.

In this study the investigators used Gloreha, a new hand rehabilitation glove that provides computer-controlled, repetitive and passive mobilization of the fingers, with multi-sensory feedback. The purpose of the study was to evaluate in the rehabilitation of patients with ischemic or hemorrhagic stroke in the sub-acute phase: 1) the feasibility of this new neuromotor rehabilitation device 2) its efficacy in improving arm function abilities, and 3) the costs involved.

Post-stroke patients admitted for inpatient rehabilitation between May 2013 and January 2014 were screened for enrollment. Eligible patients were randomly assigned, following a simple randomization procedure (computerized random numbers) conducted independently of the study investigators, to Treatment group or Control group, on a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before, with Ashworth spasticity index \< 3.

Exclusion Criteria:

* orthopedic limitation (amputations, irreducible articular limitations, advanced osteoarthritis, active rheumatoid arthritis);
* peripheral nerve injury;
* uncontrolled inflammation;
* severe cognitive and behavioral disorders;
* neurodegenerative and neuromuscular diseases;
* Ashworth spasticity index ≥ 3.
Impact of the Excess Weight Loss on Mineralization Patterns of the Knee After Bariatric Operations

Evaluation of the subchondral mineralization plate after excess weight loss in patientes undergoing bariatric operation by means of CT-osteoabsorptiometry.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35
* need for bariatric operation
* knee pain (VAS \> 2)

Exclusion Criteria:

* malignancy
* poor compliance
* previous bariatric operation
* pregnancy
* lack of knee pain (VAC \< 2)
* previous knee operation
Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial (AMBIC)

Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein content of the ascitic fluid or a gastrointestinal bleeding. This trial will use the CLE (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.We aim to evaluate a new diagnostic tool (the confocal laser endoscopy(CLE) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a SBP (spontaneous bacterial peritonitis).The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis.

Defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (Child class A, B or C)


Eligibility Criteria:
Inclusion Criteria:

Adult individual (\>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy

Exclusion Criteria:

* Patients younger than \< 18, older than 80 years
* Pregnant or breastfeeding women
* Known allergy to fluorescein.
* Cardiac disease
* Asthma bronchiale
* Patients with inability or unwillingness to provide blood samples or samples of ascitic fluid.
* patients unable to give informed consent
* non-resident patients
* contraindication for an endoscopic examination
Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.

This project is composed of a phase I study with the purpose of evaluating adverse reactions and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29, with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of cutaneous leishmaniasis.

The phase I study was performed in 10 healthy subjects and 10 patients with CL. In healthy individuals (N=5) Sm29 was applied to healthy skin at a concentration of 5ug and in another 5 Sm29 was used at a dose of 10ug applied twice a day for 20 days. A phase I study was also carried out in 10 patients with CL to assess the occurrence of adverse reactions to Sm29 applied to the ulcerated lesion and to compare the use of two doses of Sm29. In 5 patients, Sm29 was used at a dose of 5ug and applied twice a day, and in 10 patients, a dose of 10ug of Sm29 was used, also applied twice a day. The 10 patients were also treated with glucantime at a dose of 20mg/kg/weight with a maximum dose of 1200mg/day intravenously for 20 days. Patients were evaluated on days 10, 20 and 30 for adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of cutaneous leishmaniasis (typical ulcerated lesion); 1 to 2 ulcers; ulcer size ranging from 10-40mm; disease duration between 20-90 days.

Exclusion Criteria:

* Diabetes; Cardiovascular or kidney disease; HIV seropositivity; use of immunosupressive drugs; pregnancy.