cyrilzakka/clinical-trials huggingface dataset:
Tolerance to Electrostimulation in COPD Patients

The study was designed to test the following hypothesis

Patients with high cardio-respiratory response to electrostimulation (ES), high perception of pain during ES and high ES-induced muscle fatigue, have low tolerance to ES (more difficulties to increase intensity during training).

Background: Muscle electrostimulation (ES) appears as a promising alternative to general physical reconditioning in advanced COPD and its feasibility has been confirmed in this population. However, patients are not equal in tolerance to ES. Certain patients are not able to increase ES intensity during training, limiting its benefits. Furthermore, little is known about the effect of one ES training session on cardio-respiratory response, muscle fatigue and systemic inflammation in COPD patients.

Objective: To evaluate the tolerance to ES in COPD patients and to identify the physiological parameters involved in ES tolerance.

Method: We propose to conduct a prospective study including 21 COPD patients of different pulmonary severity (7 in each group of GOLD II, III and IV). Patients will be evaluated 3 times: at day 1, day 2 and day 9. In the first session, patients will be initiated to ES and evaluated in walking distance. In the second session, patients will become autonomous with ES and they will be evaluated in muscle strength and body composition. In the third session, cardio-respiratory measurements will be performed during ES and patients will be evaluated in muscle strength and systemic inflammation (blood sampling) before and after ES. Between the 2d and the 3d sessions, patients will have to perform 5 ES sessions at home (from day 3 to day 8). Tolerance (symptoms assessed with visual analogical scale (VAS)) and intensity of ES will be measured during each ES session.

Planning analysis: The main outcome will be the change in ES intensity between session 2 and 3 (delta intensity). The other end-points will be minute ventilation, heart rate, VO2 and SaO2 during ES, but also change in ES tolerance (VAS) during ES at equal ES intensity, leg muscle fatigue after ES, body composition and changes in plasmatic proteins after ES. Simple and multiple regressions analysis will be done between delta intensity and 1/cardio-respiratory response during ES, 2/muscle fatigue after ES, 3/body composition, 4/perception of pain at session 2 (VAS), 5/changes in plasmatic proteins after ES.

Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with COPD.
* 40 years-old and older
* Currently or previously smoking with a smoking history of at least 10 pack-years
* Subject understands and is able to read and write French or English

Exclusion Criteria:

* absence of neuromuscular pathology
* absence of vascular pathology
* absence of dermatosis on legs
Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)

Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of either sex, 14-65 years of age;
2. Diagnosis of Nephrotic syndrome with hypoalbuminemia (\<3.0g/dl) and heavy proteinuria (\> 3.5g/24hr);
3. Provision of written informed consent by subject or guardian;
4. Refractory nephrotic syndrome:

Steroid resistant: Persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; Steroid dependent: NS recurs when steroid dosage decease.Twice within 6 months, and 3 times within 1 year.

Exclusion Criteria:

1. Inability or unwillingness to provide written informed consent ;
2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids;
3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
4. Pregnancy, nursing or use of a non-reliable method of contraception;
5. Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
6. Previous kidney transplant or planted transplant;
7. Scr \> 4mg/dl (353umol/L);
8. Active hepatitis, with liver dysfunction;
9. Diagnosed DM;
10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1

The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if \<75 kg, 1200 mg/d if \>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Cirrhosis due to Hepatitis C virus (HCV) presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of care. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and ledipasvir (LDV) 90 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks only for HCV genotype 1 patients. The current recommendation for cirrhotics (genotype 1) is SOF/LDV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/LDV/RBV the investigators decided to treat 50 HCV genotype 1 cirrhotics with this combination for 12 weeks. Patients with MELD score \> 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Eligibility Criteria:
Inclusion Criteria:

* Positive qualitative hepatitis C RNA polymerase chain reaction assay on two occasions at least 6 months apart

Exclusion Criteria:

* Renal failure \[estimated glomerular filtration rate (eGFR) \< 30 cc/min\],
* Model or End stage Liver Disease (MELD) score \> 20,
* Child's class C (score \> 12),
* Heart rate \< 50/min,
* Taking amiodarone
The RAPID COVID-19 TRIAGE Algorithm

This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada. Phase I of this study will determine the best route for the swabs (nasal, throat, or both), and to determine if this POC test results are comparable to the standard core-lab test results.

Currently, testing for COVID-19 is carried out with swabs and blood tests that are sent to hospital laboratories for analysis. With the current technology, the turnaround time for test results may take any where from 8 hours up to several days for confirmation of whether you have COVID-19. This delay in diagnosis may delay care, prevent other testing modalities, consume isolation beds and deplete the valuable personal protective equipment (PPE) needed while providing treatment for patients with COVID-19.

Using a new, Health Canada approved technology, we can conduct the virus genetic testing at the bedside with a nostril and throat swab, with results in under 45 minutes. This new "point-of-care (POC)" technology, if proven accurate, may help future patients receive faster and more definitive treatment. At the same time, it might help health care teams to preserve resources and optimize care for patients (example: triage use of intensive care or isolation unit beds, determine need for PPE, get quarantined staff back to front line to help with care if they are non-carriers).

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 yo referred to the cardiology, internal medicine, ICU, CICU, CSICU or RACE teams who have tested positive for COVID-19.

Exclusion Criteria:

* Patients in whom conventional COVID-19 testing would not have otherwise been instituted or in whom immediate test results would not alter short-term treatment, Patients with pre-existing wishes for DNR.
The Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia

Primary objective: To examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. The investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male
* Diagnosed with choroideremia and in good health
* Willing to allow his general practitioner and consultant, if appropriate, to be notified of participation in the study
* Over age of 18 years

Exclusion Criteria:

* Female
* Significant health disease, disorder, or medication, which, in the opinion of the investigator, would put the patient at risk if he were to take simvastatin
* Already taking simvastatin or another statin
Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain

This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.


Eligibility Criteria:
Inclusion Criteria:

* Enroll subjects in this study if they meet the following inclusion criteria:
* Are at least 18 years of age or older
* Are able to give written informed consent and are willing to comply with the protocol requirements
* Are scheduled to undergo MRI
* Are willing to undergo two MRI procedures within 14 days
* Have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by:
* clinical/neurological symptomatology;
* diagnostic testing, such as CT or previous MRI examinations; or
* have had recent surgery within 6 months and are to be evaluated for recurrence.

Exclusion Criteria:

* Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed.
* Are pregnant or lactating females. Exclude the possibility of pregnancy:
* by testing on site at the institution (serum or urine bHCG) within 24 h prior to the start of each investigational product administration
* by history (i.e., tubal ligation or hysterectomy)
* post menopausal with a minimum of 1 year without menses
* Have any known allergy to one or more of the ingredients in the investigational product, or have a history of hypersensitivity to any metals
* Have congestive heart failure (class IV according to the classification of the New York Heart Association
* Have suffered a stroke within a year
* Have received or are scheduled to receive any other contrast medium in the 24 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h following Exam 2
* Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 h post-administration of the second investigational product.
* Have moderate-to-severe renal impairment, defined as a GFR/eGFR \< 60 mL/min.
* Have been previously entered into this study
* Have received or are scheduled for one of the following:
* Surgery within three weeks prior to the first examination or between the two examinations
* Initiation of steroid therapy between the two examinations
* Radiosurgery between the two examinations
* Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field.
* Are suffering from severe claustrophobia
* Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

The purpose of this study is to investigate the accuracy of second generation colon capsule (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using conventional endoscopy as the gold standard.

Consecutive patients with ulcerative colitis will be recruited. Second generation colon capsule endoscopy (C2) and conventional colonoscopy will be performed one after another on the same day. Colonic mucosal inflammation will be scaled by physicians who review C2 videos and those who perform conventional colonosocpies independently. Physicians who review C2 videos and colonoscopists will be blinded to the findings of colonoscopies and C2 videos, respectively.The accuracy of C2 in evaluating mucosal inflammation will be evaluated, using conventional endoscopy as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years
* suspected or known UC
* written informed consent

Exclusion Criteria:

* patients with severe UC according to Truelove and Witts' criteria
* current pregnancy/lactating
* patients with a pacemaker or other implanted electromedical device
* the presence of dysphagia
* patients at higher risk of capsule retention (including Crohn's disease, small bowel tumor, radiation enteropathy, previous intestinal surgery, acute abdominal pain without regular defecation)
* patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition)
* patients with an allergy to polyethylene glycol, sodium phosphate solution, metoclopramide or bisacodyl suppository
Embodied Virtual Reality Therapy for Functional Neurological Symptom/ Conversion Disorder

The purpose of this study is to design and test the safety and feasibility of virtual reality technologies and experiences of egocentric avatar embodiment in the application of physical and cognitive behavior therapy in functional neurological symptom/conversion disorder. Investigators hypothesize that patients will safely use and accept this modality of treatment and will show evidence of a decrease in symptom frequency.

This is a treatment development trial, participants randomly assigned to active treatment will be enrolled in embodied Virtual Reality therapy. The therapy will be based on principals of exposure and behavioral shaping therapies and mirror visual feedback therapy. The therapy will be delivered over 8 sessions and modified as indicated by clinical feedback. A fixed protocol will be developed with exact methods to be used to be determined. After a fixed protocol has been established, a treatment manual will be created to use in further controlled trials.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 years, who are diagnosed with functional neurologic symptom or conversion disorder. If diagnosis of seizure type then video EEG with diagnosis confirmed by board-certified neurologist with subspecialty training in epilepsy and clinical neurophysiology using the criteria of the International Classification of the Epilepsies is required. If diagnosis of motor type, documented and clinically established levels of diagnostic certainty (Williams,1995) confirmed by 2 neurologists is required.
* Participants must have at least one symptom per month in the month prior to enrollment
* Fluency in English spoken language

Exclusion Criteria:

* Nonfluency or inability to communicate in English spoken language
* Inability to participate or attend biweekly 30 minute session over 14 weeks
* Frank psychosis
* Active self harm urges
* Serious medical illness
* Active substance or alcohol use or dependence that could interfere with participation
* Diagnoses of mental retardation, dementia or delirium
* Pregnant women
Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691)

This trial will study the efficacy and safety of a fixed dose of asenapine in participants diagnosed with Bipolar 1 Disorder. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 5 mg or 10 mg twice daily \[BID\]) or placebo (BID) for 3 weeks. Throughout the trial, observations will be made on each participant at various times to assess the safety and effectiveness of the study treatment. The primary hypothesis is that there is at least one dose of asenapine that is superior to placebo in the change from baseline in manic symptoms (as measured by Young Mania Rating Scale \[YMRS\]) at Day 21 of the trial.


Eligibility Criteria:
Inclusion Criteria:

* Each participant must be at least 18 years of age
* Male, or a female who is not of child-bearing potential or who is non-pregnant, non-lactating, and is using a medically accepted method of contraception
* Each participant must have a current diagnosis of Bipolar I Disorder, current episode manic or mixed
* Each participant must be confirmed to be experiencing an acute manic or mixed bipolar 1 episode
* Each participant must have discontinued the use of all prohibited psychotropic medications

Exclusion Criteria:

* A participant must not have a primary Axis I disorder other than Bipolar 1 Disorder (i.e., an Axis 1 disorder other than Bipolar 1 Disorder that is primarily responsible for current symptoms and functional impairment)
* A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR™) criteria for substance abuse or dependence (excluding nicotine)
* A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (CSSRS).
This Study Is To Estimate The Time Course Of Pf-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers

The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
* Pregnant or nursing females.
Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis

The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.

This is a randomized, single blind placebo-controlled study in which the groups were selected from the cases presenting to the health post. The inclusion criteria were: age between 15 and 50 years, of either sex, diagnosis of cutaneous leishmaniasis of less than 60 days. The diagnostic criteria were the presence of a typical single cutaneous ulcer, localized on lower limbs, and a positive delayed type hypersensitivity test (DTH or Montenegro skin test) to Leishmania antigen.

Eligibility Criteria:
Inclusion Criteria:

* Age between 15 and 50 years
* Either gender
* Diagnosis of cutaneous leishmaniasis
* Less than 60 days of disease

Exclusion Criteria:

* Any history of prior anti-leishmania therapy
* Negative parasitology (aspirate/smear)or negative Montenegro test
* Pregnancy
* Age below 15 and above 50 years
* Other associated acute or chronic illnesses
* History of allergy to GM-CSF and/or antimony
* HIV, HTLV-1 infections or diabetes
* Administrative reasons:
* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedures
Magnetic Resonance Fingerprinting Guided Extended Resection in Glioblastomas

Magnetic resonance imaging, MRI, is a procedure that uses radio waves, a powerful magnet, and a computer to make a series of detailed pictures of areas inside the body. The goal of this study is to determine if MR fingerprinting, new way of acquiring MRI images, can help identify the extent of tumor spread in the brain, better than routine MRI images.

Glioblastomas (GBs) are aggressive malignant brain tumors with a median survival of less than 15 months . Infiltration of cancer beyond the tumor margins causes recurrence in nearly 100% of GBs; however, this cannot be measured by current imaging techniques . Availability of reliable and reproducible infiltration prediction maps at initial diagnosis will open new treatment opportunities such as targeted surgery or escalated radiation therapy (RT).

On clinical contrast enhanced (CE) magnetic resonance imaging (MRI) scans, a typical GB demonstrates an enhancing mass with central necrosis and an extensive surrounding, peritumoral region with bright signal on T2-weighted(w) and FLAIR (Fluid attenuation inversion recovery) images. This bright, peritumoral T2/FLAIR region is known to contain vasogenic edema and tumor infiltration, as it is well known that GBs infiltrate beyond the enhancing tumor margins.

Since there is a clear link between extent of tumor resection and survival the challenge for neurosurgeons is maximizing resection of tumor, while avoiding neurological injury. Typically, the central region of the tumor can be safely resected with minimal risk. The challenge lies in maximal safe resection along the tumor margins as it infiltrates normal brain. MR Fingerprinting is a quantitative imaging (QI) scan developed at CWRU that provides rapid quantification of multiple tissue properties, such as T1 and T2 relaxation maps, with high reproducibility and excellent tissue characterization. Our preliminary analysis of retrospective data of 60 GB participants with MRF+MRI scans with targeted 5-aminolevulenic acid (5-ALA) tissue sampling demonstrates an AUC of 0.8 for MRF/MRI model for GBM infiltration prediction in peritumoral region .

Eligibility Criteria:
Stage I:

Inclusion criteria:

* Age \> 18
* MR imaging findings suggestive of GB
* Maximal tumor diameter greater than 3 cm
* Ability to provide written informed consent
* Ability to undergo MRI scan
* Consideration for biopsy, subtotal or gross total resection.

Exclusion Criteria:

* Contraindications to MRI
* Contraindication to surgical treatment
* Prior treatment for glioblastoma

Stage II:

Inclusion Criteria:

* Age \> 18
* MR imaging findings suggestive of GB
* Maximal tumor diameter greater than 3 cm
* Ability to provide written informed consent
* Ability to undergo MRI scan
* Lesions amenable to gross total resection
* Presence of peritumoral FLAIR signal abnormality beyond the area of enhancement.

Exclusion Criteria:

* Inability to undergo MRI imaging
* Participants undergoing only stereotactic biopsy or less than gross total resection
* Participants undergoing LITT
* Inability to consent for the study
* Previously treated/ recurrent glioma.