cyrilzakka/clinical-trials huggingface dataset:
The Hug-up Test: A New, Sensitive Diagnostic Test for Supraspinatus Tears

We developed a new test, the "hug-up test," wherein elevation is resisted as the palm is held on the opposite shoulder with the elbow held in maximal anterior translation. The purpose of this study was to describe the hug-up test and compare it with other conventional tests used for diagnosing supraspinatus tears.

The supraspinatus tendon is the most commonly affected tendon in rotator cuff tears. Early detection of a supraspinatus tear using an accurate physical examination is, therefore, important. However, the currently used physical tests for detecting supraspinatus tears are poor diagnostic indicators and involve a wide range of sensitivity and specificity values. Therefore, the aim of this study was to establish a new physical test for the diagnosis of supraspinatus tears and evaluate its accuracy in comparison with conventional tests.

Between November 2012 and January 2014, 200 consecutive patients undergoing shoulder arthroscopy were prospectively evaluated preoperatively. The hug-up test, empty can (EC) test, full can (FC) test, Neer impingement sign, and Hawkins-Kennedy impingement sign were used and compared statistically for their accuracy in terms of supraspinatus tears, with arthroscopic findings as the gold standard. Muscle strength was precisely quantified using an electronic digital tensiometer.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo an arthroscopic procedure for a diagnosis related to shoulder pain and/or weakness or dislocation by one of the senior authors from November 2012 to January 2014

Exclusion Criteria:

* Patients with a history of shoulder surgery, upper extremity fractures, and bilateral shoulder diseases.
An Oral p38 Inhibitor Investigating Safety, Efficacy, And PK In Subjects With Active Rheumatoid Arthritis

Investigating the safety and tolerability of a p38 inhibitor as monotherapy in subjects who have failed at least 1 DMARD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with RA and has failed at least 1 DMARD therapy

Exclusion Criteria:

* Any other inflammatory arthritis and any significant history of acute or chronic infection with immunomodulatory etiology.
GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient with Alveolar Soft Part Sarcoma

CLIC-YYC-GPNMB-01 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-01 has progressive metastatic alveolar soft part sarcoma (ASPS). The investigators propose to treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).


Eligibility Criteria:
Inclusion Criteria:

1. Completion of Informed Consent Form

Exclusion Criteria:

1. Any significant medical issue(s) that would, in the opinion of the Principal Investigator (PI), prevent this patient from being dosed.
Feasibility of an Automated Bidet Intervention to Decrease Caregiver Burden

This study evaluates the feasibility, including acceptability and preliminary efficacy, of an automated bidet intervention to make it easier for caregivers to assist with toileting.

Informal caregivers provide over 30 billion hours of care to older adults each year. They often assist with toileting tasks which are often identified as one of the most physically and emotionally demanding activities of daily living. Caregivers receive limited training and support which increases their risk for injury and burnout. One potential strategy to reduce or replace the physical support needed from a caregiver is the used of an automated bidet system. It remains unknown whether an automated bidet can be used successfully with older adults and their caregivers at home. The objective of this feasibility study was to assess the acceptability and preliminary efficacy of a toileting intervention using an automated bidet system and training by an occupational therapy practitioner (OT) to reduce the amount of physical assistance required from caregivers.

The investigators will recruit 10 informal caregivers and randomize them to the treatment or waitlist control group. Caregivers in the treatment group will receive the automated bidet right away while those in the waitlist control group will not receive any treatment during that time. After 30 days, both groups will participate in a post-test assessment visit. The waitlist control group will then be offered the intervention and invited to participate in a final session after 30 days to complete assessments and a process evaluation (30 days post follow-up).

Eligibility Criteria:
Inclusion Criteria:

* (1) provided unpaid care and lived with a care recipient aged 55 years or older
* (2) assisted with toileting for at least 6 months
* (3) did not have an automated bidet
* (4) had a working toilet and bathroom outlet, and (5) their care recipient was willing to participate

Exclusion Criteria:

* Caregivers scoring 10 or above on the Short Blessed Test, indicating possible cognitive impairment
Modification in Cortical Activation in Pseudophakic Patients With Visual Difficulties After a Multifocal Implantation

This study will highlight differences in cortical activation between asymptomatic and symptomatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Cataract surgery with an bilateral multifocal lens implant Restor

Symptomatic patients :

* Symptomatic bilateral visual difficulties for 3 months or more after the intervention which impact the daily activity

Asymptomatic patients :

* No visual complaint for 3 months or more after the intervention

Exclusion Criteria:

* Patients with ophthalmology disorders
* Contra indication for fMRI
Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor

In this experiment the investigators would like to assess if papain induces an itch sensation comparable to the itch sensation induced by cowhage and to confirm that the mechanism of action of papain follows the non-histaminergic pathway.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other addictive drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers, as well as systemic or topical steroids.
* Skin diseases
* Moles, scars or tattoos in the area to be treated or tested.
* Hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Evaluation of SODB® in Metabolic Adaptations in Overweight Women

The objective of this study is to evaluate the influence of a 3 months SODB® supplementation in adipose tissue modulations of overweight women, in comparison to a placebo.

Beneficial experimental results have already been obtained with SODB®. That is why, the investigators expect several effects of SODB® here. Indeed, this clinical study could show that SODB® is able to induce endogenous antioxidant defence, and then reduce oxidative stress generally observed in overweight adipose tissue.

Moreover, this study could evaluate the impact of a decrease in oxidative stress on the others overweight-induced disorders, such as insulin resistance, inflammation, fibrosis, lipolyse alterations.

Eligibility Criteria:
Inclusion Criteria:

* overweight women (IMC 25-30 kg/m2)
* stable weight (variation \<5% over the last 3 months)
* age between 25 and 50 years old
* cellulite grade ≥ 2
* women with genital activity
* regular menstrual cycles (28 ± 2 days over the last 3 months)
* women with efficient contraception (oral, intra-uterine, ligature trunks or other surgery) - same contraception over the last 3 months
* women having given her free, informed and express consent.
* affiliated with a social security insurance or beneficiary of such an insurance system.
* glycemia \< 1,26g/l
* Arterial blood pression \< 140/90 mm Hg or stable for at least 2 months
* LDL cholesterol \<1,90g/l
* triglycerides \<2,50g/l

Exclusion Criteria:

* untreated dyslipidemia
* unstable hypertension
* type 1 or 2 diabetes
* any history of bariatric surgery
* any history of unstable thyroidian diseases
* any troubles of hemostasis
* any allergy to utilized antiseptic, xylocaine, or to one of the compounds of the experimental or placebo product
* excessive coffee consumption (\> 6 cups/day)
* consumption of drinks containing xanthic bases (\> 0.5 l/day)
* consumption of drinks containing grapefruit juice (\> 0.5 l/day)
* consumption of drinks containing plants (\> 2 l/day)
* medication with draining, lipolytic, anorexigenic activity
* current or recent (in the previous month) antioxidant supplementation (vitamine A, C, E, beta-carotene, lutein, lycopene, selenium)
* recent (in the previous year) local anti-cellulite treatment
* thigh liposuction in the last 2 years
* under current anticoagulant treatment
* under current neuroleptic treatment
* under current corticotherapy (local or systemic) treatment
* under current diuretic treatment
* under current antiinflammatory treatment that cannot be interrupted
* under current treatment which interferes with autonomous nervous system and lipids metabolism
* triglycérides \> 2.50g/l
* LDL cholesterol \>1.90
* positive serology for hepatitis B, C and HIV
* consumption of more than 66g/day of alcohol
* venous fragility not allowing to support catheters during the visits.
* adult protected by the law
* any subject who participated to a clinical assay within the 3 months.
Corneal Densitometry Changes With Adenoviral SEI

Adenoviral Sub epithelial infiltrates (SEI) affect ocular function.They lead to reduced vision, photophobia, glare, halos, and foreign body sensation.

first group of patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.S econd group underwent transepithelial PTK for subepithelial infiltrates. Baseline and post-treatment full ophthalmic examination was done.

Eligibility Criteria:
Inclusion Criteria:

* adenoviral SEI

Exclusion Criteria:

* Other corneal diseases
Second Meal Effects of a Wholegrain Cereal Product on Blood Glucose Response

The aim of this study is to investigate second meal effects of a wholegrain cereal product on blood glucose response. The wholegrain cereal product will be consumed in the evening and blood glucose analyzed after a standardized breakfast meal the following morning.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, 35 to 65 years of age
2. BMI 18.5-29.9 kg/m2
3. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
4. Healthy as determined by medical history and information provided by the volunteer.
5. Willingness to complete questionnaires and follow instructions associated with the study and to complete all visits.
6. Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria:

1. Elevated fasting blood glucose (above 6.1 mmol/L at fasting on visit 1, 2, 3 or 4)
2. Women who are pregnant or breast feeding
3. Any medical condition(s) or medication(s) known to significantly affect glucose metabolism. Significance to be assessed by the QI
4. Use of medication, over-the-counter medication, natural health products or dietary supplements/probiotics that may affect glucose metabolism is prohibited during this study. Significance to be assessed by the QI. Participants who are taking allowed prescribed medications must agree to maintain their current method and dosing regimen during the course of the study unless other is recommended by their physician.
5. Known Type I or Type II diabetes, including women who previously have had gestational diabetes.
6. Use of antibiotics within 2 weeks of enrollment
7. Metabolic diseases and/or chronic gastrointestinal diseases (IBS, Crohns etc.)
8. Allergy to ingredients included in investigational product, reference, or standardized meal
9. Participants restricted to a vegetarian or vegan diet
10. Intolerance to gluten
11. Individuals who are averse to venous catheterization or capillary blood sampling
12. Currently active smokers (or using other tobacco products, and e-cigarettes)
13. Unstable medical conditions as determined by QI
14. Participation in other clinical research trials
15. Individuals who are cognitively impaired and/or who are unable to give informed consent
16. Acute infection
17. Any other condition which in the QI's opinion may adversely affect the individual's ability to complete the study or its measures or which may pose significant risk to the individual

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Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.

Measuring sympathetic skin response or heart rate variability can provide an objective biomarker of bladder sensation and its modulation by drug with potential to treat overactive bladder.

Evaluation of the link between bladder sensation and changes in skin electrical conductance and heart rate.

Eligibility Criteria:
Inclusion Criteria:

* Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non lactating

Exclusion Criteria:

* History of lower urinary tract pathology
* Excessive alcohol and tobacco consumption
* Treatment with investigational drug in the last 30 days
* Abnormal ECG trace
* Conditions that would contraindicate the use of tolterodine or any other anti muscarinic agent
Point-of-Care Immunoassay for Detection of Bacterial Sinusitis

This study is conducted to evaluate the performance of a rapid, point-of-care in vitro diagnostic device (Sinu-Test®) for the qualitative detection of the three most common pathogens responsible for causing bacterial sinusitis.

Mucous specimens will be collected from patients displaying symptoms of acute bacterial sinusitis enrolled by primary care and/or otolaryngology clinics in the United States. Health care professionals not having endoscopy certification will collect specimens using the Entvantage sample collection device. Health care professionals with nasal endoscopy certification or specialty training will collect comparator specimens using an endoscope. Untrained operators with a range of education and training (primary care physician, otolaryngologist, physician assistant, nurse practitioner, registered nurse or other healthcare professional), will perform the Sinu-Test® lateral flow assay in an outpatient setting. Mucous samples will be tested for the presence of 3 bacterial pathogens responsible for sinusitis using the Sinu-Test® in the clinic and by a composite comparator method comprised of standard quantitative bacterial culture with identification (matrix-assisted laser desorption/ionization-Time of Flight (MALDI-TOF) mass spectrometry instrument) and semiquantitative real-time polymerase chain reaction (real-time PCR) of the residual culture sample and the Sinu-Test® residual swab performed by a central laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Meets definition of acute sinusitis by Infectious Disease Society of America (2012)

Exclusion Criteria:

* Chronic sinusitis
* Cystic fibrosis
* Patients treated with antibiotics currently or within the previous 30 days.
* Subjects with a prior history of sinus surgery will be excluded due to the modification of sinonasal anatomy.
* Primary immunodeficiencies, as self-reported

  * Combined variable immunodeficiency
  * Immunodeficiency with reduced immunoglobulin G (IgG) and immunoglobulin A (IgA)-bearing cells
  * Kartagener Syndrome (ciliary dyskinesia)
  * Agammaglobulinemia
  * Sickle cell disease
* Acquired immunodeficiencies, as self-reported

  * Chemotherapy
  * Radiation therapy
  * Transplantation
  * Asplenia
  * HIV
  * Poorly controlled Diabetes mellitus
* Cognitive impairment resulting in the inability to provide informed consent.
* Special groups, such as children under the age of 18, and men and women who are in prison will not participate in this study.
Falls Prevention in Acute Care Hospital

The aim of this study is to evaluate the effect of a multifactorial falls prevention program in an acute internal medicine ward.


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to internal medicine ward

Exclusion Criteria:

* none
FGF21 and Fructose Challenge in Humans

The primary aim of this study is to examine the effect of acute ingestion of fructose on serum FGF21 levels. Subjects in this study will be lean volunteers and individuals with metabolic syndrome.

Participation in this study involves fasting overnight, drinking a sweet beverage, and several blood draws through an IV line. Each subject may drink up to 10 different sweet beverages, separated by 2 weeks.

Eligibility Criteria:
Inclusion criteria for lean subjects:

* Men and women ages 18-60
* BMI 19-25 kg/m2; 19-23 for Asian subjects
* Stable weight (variation \< 3 kg within 6 months of screening visit)
* Ability to give informed consent
* Ability to follow verbal and written instructions in English
* Use of medically approved form of contraception (monophasic oral contraception, intra uterine device, surgical sterilization or 2 combined barrier methods)

Specific exclusion criteria for lean subjects:

* Fasting blood glucose \>100; 2 hr OGTT blood glucose \>140
* Fasting triglycerides \>150

Inclusion criteria for metabolic syndrome subjects:

3 or more of the following (based on joint scientific statement by Alberti et al, 2009:

* Fasting triglycerides \>150 mg/dl (or on treatment for elevated triglycerides)
* HDL cholesterol \<40 mg/dl in men or \<50 mg/dl in women
* Blood pressure \> 130/85 (or antihypertensive treatment in a subject with history of hypertension)
* Fasting BG \>100
* Elevated waist circumference \*\* see below for race and ethnic specifications

Men Women

* Asian or Central, South or Native American \> 90 cm \> 80 cm
* Non-Asian, Non-Latino United States \> 102 cm \> 88 cm

General Exclusion criteria

* Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
* Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
* Uncontrolled hypertension (BP \> 160/100 mmHg on or off antihypertensive medication)
* Marijuana or intravenous drug use
* Recent weight loss (\> 3 kg within 6 months of the screening visit)
* Gastroparesis
* Inflammatory or irritable bowel disease
* Malignancy treated with chemotherapy within the past 3 years
* Depression or psychosis requiring hospitalization
* Renal insufficiency (creatinine clearance \< 40 ml/min)
* Transaminases \> 2x above the normal range
* Known liver disease
* Pregnancy within 6 months of the screening visit
* Lactation
* Failure to use medically approved contraceptive methods
* History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
* Change in dose of thyroid hormone or antithyroidal medication within 3 months of screening visit
* History of alcohol abuse within the past 5 years
* Fructose intolerance

Exclusionary medications:

* Oral steroids
* Metformin
* Weight loss medications including nonprescription supplements
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)

The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.

The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with Rutherford 3-6.The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.

Eligibility Criteria:
Inclusion Criteria:

* The patients volunteer to join the trial and sign the formal consent.
* The patients are ≥55 year-old and ≤75 year-old.
* The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
* The lesion of the femoral artery should be TASC B、C or D.
* The femoral-popliteal artery has never received bypass or endovascular therapy before.
* No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
* No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.
* No surgical contraindications;no infection in operation region.
* Be diagnosed with DM for at least 1 year.

Exclusion Criteria:

* Refuse random treatment.
* Previous operations on the superficial femoral artery.
* Acute lower extremity arterial thrombosis.
* Serious major organ failure.
* Allergic to the contrast agent or has contrast nephropathy.
* No clinical compliance or unfit to join the trial
Role of Delay and Antibiotics on Perforation Rate While Waiting Appendectomy

This study evaluates the effects of preoperative delay and antibiotics on perforation rate of appendix while waiting surgery for acute appendicitis. Patients with diagnosed acute appendicitis are randomized into two urgency groups: surgery within 8 hours or surgery within 24 hours. In addition, patients are randomized to either receive antibiotics while waiting or waiting without antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Acute appendicitis where surgery is planned. Diagnosis of appendicitis should be verified either by clinical diagnosis with Adult Appendicitis Score \>=16 or by diagnostic imaging (CT-scan, MRI or ultrasound) showing appendicitis. All patients with symptoms at least 3 days should undergo diagnostic imaging before inclusion.

Exclusion Criteria:

* Complicated appendicitis according to diagnostic imaging. The following findings indicate complicated appendicitis: extraluminal air or extraluminal fecalith; fluid collection, abscess or phlegmon next to appendix; non-enhancement appendiceal wall on contrast enhanced CT-scan.
* Plasma C-reactive protein \>=100
* Fever measured on emergency department over 38.5 degrees Celcius.
* Clinical generalized peritonitis or other reason that indicate immediate surgery
* Pregnancy, pregnancy test is taken from all fertile aged women before randomization
* Allergy to study antibiotics, or anaphylactic reaction after betalactam antibiotic or other contraindication for metronidazole or ongoing antibiotic treatment or patient is carrier of resistant bacteria. (This exclusion criteria are applicable only on randomization into antibiotic treatment arms)
* Missing written informed consent