cyrilzakka/clinical-trials huggingface dataset:
Portable EMG-triggered Hand Robot for Individuals After Stroke

This is an interventional pilot study investigating the feasibility of using the hand of hope (HOH) device for individuals with decreased hand function after stroke.

The HOH will be used to provide hand training for patients with decreased hand ability after stroke. The HOH is a light-weight, non-invasive, portable hand robot that provides physical assistance when a patient activates the muscles that open and close the hand. The HOH works by detecting surface EMG muscle activity and therefore requires active participation from the patient throughout the session. Video games linked to the HOH device are specifically designed to work on opening and closing the hand facilitating mass practice and high repetition needed for improving strength and range of motion of muscles.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of stroke \> 6 months ago
2. Presence of some active range of motion (AROM) in the affected hand, measured by a score of at least 1 on the Box and Block test.
3. Intact sensation in the affected hand
4. Full passive range of motion (PROM) in mass flexion and extension of the hand
5. MAS score \< 3 for finger flexors and intrinsics
6. MAS score \< 3 for finger extensors
7. Visual tracking is intact in all directions
8. Patient must be otherwise medically stable in the opinion of the principal investigator

Exclusion Criteria:

1. Patient is receiving active occupational or physical therapy for the affected arm
2. Patient has joint contractures that prevent proper fit into the HOH device
3. Patient has other concurrent neurological or orthopedic diagnoses that affect motor ability of the arm such as Parkinson's or Multiple Sclerosis, or arthritis
4. It has been less than 3 months since last botulinum toxin injection in the affected arm
ConquerFear-Group: A Psychological Intervention for Fear of Cancer Recurrence

The primary aim of this randomized controlled trial is to evaluate the effect of ConquerFear-Group (CF-G), compared with a control condition (CC), on Fear of Cancer Recurrence (FCR). Secondary aims are to explore the effect of CF-G on emotion regulation and additional psychological outcomes, and to explore mediating effects of emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion. In addition, treatment expectancy, participation in other treatments after completion of the intervention of the study and demographic and clinical variables will be explored as moderators.

A randomized controlled trial testing the efficacy of ConquerFear-Group (CF-G) on breast cancer survivors with clinical levels of Fear of Cancer Recurrence (FCR), compared with a control condition (CC), will be conducted.

The aims are to:

1. Evaluate the efficacy of CF-G on FCR,
2. Explore the effects on the secondary outcomes of emotion regulation, general distress, health-related QoL, survivors' unmet needs, mindfulness, metacognitions, intervention satisfaction, negative effects of intervention, and sleep.
3. Explore emotion regulation, metacognitions, working alliance, patient adherence, and group cohesion will be explored as possible mediators.\*
4. Explore treatment expectancy, participation in other treatments after completion of the CF-G or the CC and demographic and clinical variables as possible moderators.

Primary hypothesis:

CF-G will yield larger reductions in FCR than CC at post treatment, and the effect will be maintained through the follow-up period.

Secondary hypotheses:

CF-G will demonstrate a larger improvement in measures of emotion regulation than CC following the intervention period.

Changes in emotion regulation during treatment will mediate the effect of CF-G on FCR.\* Changes in metacognitions during treatment will mediate the effect of CF-G on FCR.\* CF-G will yield larger reductions in general distress, health-related QoL, survivors' unmet needs than CC, and CF-G will yield larger improvements in metacognitions, mindfulness, and sleep than CC following the intervention period.

\*The prerequesties for conducting for mediation analysis were not fulfilled. Consequently, these analyses were abandoned. Data can be obtained upon request.

Eligibility Criteria:
Inclusion Criteria:

1. Eligible patients have a confirmed past diagnosis of stage 1-3 breast cancer,
2. have been treated with curative intent,
3. have completed all hospital-based adjuvant treatments 3 months to 5 years prior to study entry,
4. are disease free,
5. scores in the clinical range (≥22) on the Short Form of the Fear of Cancer Recurrence Inventory (FCRI-SF),
6. are able to read and write Danish,
7. are over the age of 18 years, and
8. are able to give informed consent.

Exclusion Criteria:

1. self-reported current major depression,
2. currently receiving psychological treatment from a therapist not involved in the study,
3. self-reported active psychotic illness or other severe psychiatric conditions.
Role of Systemic Inflammation in Increase of Cardio-vascular Risk in Chronic Obstructive Pulmonary Disease

The purpose is to study the correlation between systemic inflammation (serum levels of CRP, IL-1beta, IL-6 and TNF-alpha) or hyperhomocysteinemia and the increase of mortality, in a representative cohort of patients with chronic obstructive pulmonary disease (COPD).

Secondary purposes are:

1. To confirm the increase of cardiovascular mortality and the importance of cardiovascular morbidity in patients with COPD,
2. To establish the role of various genetic polymorphisms in the correlation between systemic inflammation and cardiovascular disorders observed in COPD,
3. To search for acceleration of aging of cardiovascular system evaluated with carotid intima-media thickness when systemic inflammation markers are increased,
4. To study the correlation between COPD risk factors (tobacco and other food factors), change of respiratory functional data and cardiovascular morbi-mortality. In this study cardiovascular morbi-mortality is defined by following disorders: ischemic cardiopathy, left-sided heart failure, cardiac arrhythmia and cerebrovascular accident. Diagnosis is confirmed with standard techniques and independently of this study. Results of clinical examination, ECG, echocardiography and /or brain scanner will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Actual or past active smoking of at least 20 packets/year
* FEV1/FVC \< 70%

Exclusion Criteria:

* Co-morbidity except essential arterial hypertension controlled by treatment, stable coronary disease, type 2 diabetes and/or degenerative arthropathy (non-inflammatory rheumatic disorder)
* Acute disorder during 8 weeks before inclusion, especially COPD worsening
* Long-term corticosteroid or non-steroid anti-inflammatory treatment
Development of a Personalised Therapeutic Approach for Cancer Patients With Resting Hypermetabolism

Half of all cancer patients show an increase in resting energy expenditure. The causes of hypermetabolism have only recently been investigated in cancerology. One established cause is inflammation, but other causes have yet to be identified.

The interest in hypermetabolism is due to the fact that it appears early, before the onset of clinical deterioration (weight loss, sarcopenia, altered performance status) and that it correlates with patient morbidity and mortality. Like the other parameters that make up cachexia, it is both a predictor of toxicity and reduced efficacy of anti-tumour treatments and a prognostic factor, regardless of the tumour.

A therapeutic goal is to correct hypermetabolism for two reasons:

* avoid progression to clinical cachexia, which is an independent cause of morbidity and mortality
* increase the efficacy of anti-PD1/PDL1 immunotherapies. This new class of therapy has revolutionised the therapeutic management of many cancers but is less effective in cases of inflammation and/or altered performance status and/or hypermetabolism.

Investigator hypothesises that it is possible to develop a patient-specific treatment to correct hypermetabolism, depending on the predominant clinical or biological cause.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with solid malignancy (any possible primary tumor), stage IV (M1), progressive or stable
* Without treatment or with anti-tumour treatment
* WHO performance status ≤ 2
* Person affiliated or benefiting from a social security scheme
* Having signed a consent to participate in the study
* Patient with hypermetabolism at the inclusion visit

Exclusion Criteria:

* Patient agitated, or unable to understand or tolerate wearing a mask for 20 minutes
* No active tumour disease (complete remission or ongoing tumour response)
* Care plan that does not allow for two calorimetry sessions 1 month apart
* Pregnant, breastfeeding or parturient woman
* Person deprived of liberty by judicial or administrative decision
* Person subject to forced psychiatric care
* Person subject to a legal protection measure
* Inclusion in another interventional study
Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear

The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric contact lens currently available in market, specifically with regards to the comfort and vision after two weeks of use.

Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.

Eligibility Criteria:
Inclusion Criteria: Prior to being considered eligible to participate in this study, subjects MUST

1. be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
2. be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy.
3. have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
4. be able and willing to adhere to the instructions set forth in the protocol.
5. agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
6. have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
7. have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
8. be in good general health, based on his/her knowledge.
9. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion Criteria:

1. The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
2. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
3. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
4. Slit lamp findings that would contraindicate contact lens wear such as:

   * Pathological dry eye or associated findings
   * Pterygium or corneal scars within the visual axis
   * Neovascularization \>1mm in from the limbus
   * History of giant papillary conjunctivitis (GPC) worse than Grade 2
   * Anterior uveitis or iritis (past or present)
   * Seborrhoeic eczema, seborrhoeic conjunctivitis
5. A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
6. A known history of corneal hypoesthesia (reduced corneal sensitivity.)
7. Aphakia, keratoconus or a highly irregular cornea.
8. Current pregnancy or lactation (to the best of the subject's knowledge).
9. Active participation in another clinical study at any time during this study.
Prostatic Urethral Lift in Subject With Acute Urinary Retention

Assess feasibility and safety of the Prostatic Urethra Lift (PUL) procedure in patients with acute urinary retention secondary to benign prostatic hyperplasia (BPH).

The study is a multi-centre, prospective evaluation of PUL and retrospective review of invasive surgery as potential comparator. The study is intended to be conducted at up to 5 different centres in the United Kingdom to enrol up to 50 subjects. Subject follow-up visits are at post-procedure, 6 weeks, 3 months, 6 months and 12 months.

Eligibility Criteria:
UroLift System Procedure Arm

Inclusion Criteria:

1. Male gender
2. Diagnosis of symptomatic BPH
3. Age ≥ 50 years
4. Prostate volume ≤ 100 cc per ultrasound (US)
5. Acute urinary retention with at least one failed trial without catheter (TWOC) while on alpha blocker

Exclusion Criteria:

1. An obstructive or protruding median lobe of the prostate
2. Previous BPH surgical procedure
3. Previous pelvic surgery
4. Urethral conditions that prevents insertion and delivery of device system into bladder
5. Retention volume of \>1500 mL
6. Has not had prostate cancer excluded
7. History of prostate or bladder cancer
8. Biopsy of the prostate within the 6 weeks prior to Index Procedure
9. History of neurogenic or atonic bladder
10. Acute or chronic renal failure
11. Known coagulopathies or subject on anticoagulants within 3 days of index procedure (excluding up to 100mg ASA)
12. Known bladder stones within the prior 3 months or treatment within 12 months
13. Prostatitis requiring treatment (antibiotics) within the last year
14. Other co-morbidities that could impact the study results

    * severe cardiac arrhythmias uncontrolled by medications or pacemaker
    * congestive heart failure New York Heart Association (NYHA) III or IV
    * history of uncontrolled diabetes mellitus
    * significant respiratory disease in which hospitalisation may be required
    * known immunosuppression (i.e. AIDS, post-transplant, undergoing chemotherapy)
15. Life expectancy estimated to be less than 5 years
16. Desire to maintain fertility post procedure
17. Unable or unwilling to complete all required questionnaires and follow up assessments
18. Unable or unwilling to sign informed consent form
19. Currently enroled in any other clinical research trial that has not completed the primary endpoint
Comparison of the Effects of Face-to-Face and Internet-Based BBAT in Fibromyalgia Syndrome

The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.

H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.

H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.

The aim of our study is to compare the effects of face-to-face and internet-based BBAT in patients diagnosed with Fibromyalgia Syndrome.

H0: Face-to-face and internet-based BBAT have superiority over each other in patients diagnosed with Fibromyalgia Syndrome.

H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based BBAT have no superiority over each other.

Goals:

1. Investigation of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome.
2. Comparison of the effects of face-to-face and internet-based BBAT on functional disability, pressure pain threshold, body awareness, posture, pain intensity, trunk position sense, postural control, balance, sleep quality, quality of life and inflammation level in patients diagnosed with Fibromyalgia Syndrome

Eligibility Criteria:
Inclusion Criteria:

1. To be between the ages of 18-65
2. Being diagnosed with FMS according to ACR 2016 criteria
3. To be diagnosed with FMS at least 6 months before the study
4. Reported pain intensity \> 4 (Visual Analog Scale 0-10),
5. Individuals that do not have barriers to basic body awareness therapy.

Exclusion Criteria:

1. Pregnancy or intention to become pregnant within the study period.
2. Substance and alcohol abuse, major psychiatric disorder (preventing compliance), uncontrolled hypertension, diabetes, congestive heart failure, or other serious chronic medical condition that puts the patient at risk for the clinician to expose the patient to potentially serious consequences of their illness
3. Those who have malignancy and those receiving chemotherapy and radiotherapy causing malignancy
4. Those who have suffered from any musculoskeletal, neurological, rheumatological disorder or any condition that may interfere with evaluations (advanced respiratory or orthopedic problems such as fractures, sprains or strains, or spinal surgery) in the past 12 months -
Use of Bevacizumab in Trabeculectomy Surgery

When a patient with glaucoma who has a pressure that is too high and causing damage to their vision, despite receiving the maximum amount of medication that can be tolerated, the decision is made to have glaucoma surgery. Trabeculectomy is the most common form of glaucoma surgery used to treat open angle glaucoma. During trabeculectomy, an opening is created in the eye and partially covered with a flap of tissue. This new opening allows fluid to drain out of the eye bypassing the clogged drainage channels that are malfunctioning in patients with glaucoma. Studies have found that trabeculectomy significantly reduces vision loss and lowers eye pressure.

However, many people need another trabeculectomy or other glaucoma surgery because the surgery may fail either early or much later because the body closes the drain created by the surgeon. The surgery is also less likely to work in patients with darker pigmentation, children who have congenital glaucoma, people with difficult to control glaucoma with new blood vessels growing on the iris, diabetes or persons with prior eye surgery. As a result, the investigators need to find ways to improve the longterm survival of trabeculectomy surgery in all patients.

The usual treatment is to not have an injection of Bevacizumab on the third through fifth day after trabeculectomy surgery. Topical anaesthetic drops to numb the eye will be given, prior to being given the tested medicine. Once the eye has been anaesthetized, the medication will be injected into the potential space created during the glaucoma surgery, also called a bleb, using a standard small syringe. The patient will receive an injection of either 1.25mg (0.05ml) of Bevacizumab or Balanced Salt Solution (BSS) into the trabeculectomy bleb that had been created in the surgery. Participants will be randomly (by chance) placed in one of the 2 study groups. There will be a 50% chance of being placed in either group. There will be 60 people who will participate in this study at 2 centres throughout the Toronto region. The length of this study for participants is 12 months, and the entire study is expected to take about 18 months to complete.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* Patients with glaucoma that is inadequately controlled on maximal tolerated medical therapy and scheduled for trabeculectomy surgery (with/without combined cataract extraction)
* Decision makers fluent in English
* Decision makers able to understand and read consent form

Exclusion Criteria:

* Patients with active intraocular inflammation/uveitis or neovascular glaucoma
* History of previous trabeculectomy surgery or prior retinal detachment with scleral buckle placement in the surgical eye
* Aphakia in surgical eye
* Pregnant and nursing women
* Unable to fulfill inclusion criteria
* Refusal of consent
TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion

Utilisation of extended criteria donors due to critical organ shortage contributes to increased ischemia reperfusion injury as well as mortality following liver transplantation. Experimental data show protective effects on hepatic ischemia reperfusion injury (IRI) using the calcineurin inhibitor Tacrolimus applied intravenously or directly as a hepatic rinse. Moreover clinical data indicate a protective role of a Tacrolimus rinse in human liver transplantation when using normal, healthy grafts. The effects of Tacrolimus on hepatic injury in extended donor criteria (EDC) liver grafts remain unclear. Therefore, the aim of the present study is to examine the effects of a Tacrolimus ex vivo rinse (20 ng/ml) on cellular injury after transplantation of marginal liver grafts exhibiting 2 or more EDCs according to Eurotransplant's definition of EDC grafts.


Eligibility Criteria:
Inclusion Criteria:

Recipient:

Chronical terminal liver failure, age \> 18 years, first organ transplantation

Donor:

* donor age \> 65 Jahre
* macrovesicular steatosis \> 40% (macroscopy or biopsy)
* BMI \> 30
* sodium \>165 mmol/l
* ICU stay and ventilation \> 7 days
* cold ischemia time \> 13 hours
* AST \> 99 U/l
* ALT \> 105 U/l
* bilirubin \> 3 mg/dl (\> 51 µmol/l)
* application of epinephrine

Exclusion Criteria:

Donor:

• Hepatitis B- or Hepatitis C-infection

Recipient:

* Multi organ transplantation
* high urgency listing
* extrahepatic tumor disease
* pregnancy
Behavioral Exercise Intervention for Smoking Cessation

The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for smokers interested in quitting smoking. We expect that this project will contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers may have a valuable adjunct to more traditional smoking cessation approaches.


Eligibility Criteria:
Inclusion Criteria:

1. are between 18 and 65 years of age
2. are current smokers (i.e., smoking at least 10 cigarettes per day)
3. are sedentary, i.e., have not participated regularly in aerobic physical exercise (for at least 20 minutes per day, 3 days per week) for the past six months.

Exclusion Criteria:

1. current DSM-IV Axis I psychiatric disorder as assessed by SCID-NP
2. Substance abuse or dependence (excluding nicotine dependence) within the past 6 months
3. lifetime DSM-IV diagnosis of a bipolar disorder as assessed by the SCID-NP
4. lifetime history of a psychotic disorder or current psychotic symptoms as assessed by the SCID-NP
5. current suicidality or homicidality
6. marked organic impairment
7. physical disabilities or medical problems (such as a history of diabetes, hypertension, seizure disorder, coronary heart disease, valvular heart disease, and pulmonary disease) or use of medications (such as beta blockers) that would prevent or hinder participation in a program of moderate intensity exercise
8. current pregnancy of intent to become pregnant during the next 12 weeks, and i) current use of any pharmacotherapy, including transdermal nicotine replacement, for smoking cessation