cyrilzakka/clinical-trials huggingface dataset:
Effects of Motor Imagery on Motor Learning and Motor Retention in Octogenarian.

Aging is associated with impairments in cognitive function, particularly motor learning and memorizing, impacting functional capacities. Older adults are still able to learn new skills but at a slower rate, and they forget quickly the new-learned skill because of an alteration in motor memory. Motor imagery, which is a mental simulation of an action without actual execution, has been demonstrated to improve performance in young adults and stabilize performance after a short break in older adults. However, in very old adults (\>80 years old) for whom the decline in motor and cognitive functions is greater, it is unknown whether motor imagery training during a short break is still efficient. Previous studies on old adults were performed on upper limb muscles. Because aging differentially affects upper and lower limb muscles, the present study will aim to explore the effects of motor imagery on motor memorizing in both upper and lower limb muscles.

The primary purpose is to evaluate the effectiveness of motor imagery to improve the performance of very old people (\> 80 years) through learning a task of the upper limbs.

Eligibility Criteria:
Inclusion Criteria:

* Being part of the Proof cohort
* Signed written consent form
* Affiliated to social security

Exclusion Criteria:

* Pathology or chirurgical intervention causing locomotor disorder
* Neurological or psychic pathology
* Use psychotropic drugs
* Mini-Mental State Examination (MMSE) \< 20
Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.

The objective of this study is to compare the efficacy and safety of combined administration of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB in patients with Grade I or II essential hypertension.

This study is a randomized, double-blind, multicenter, phase 2/3 study to evaluate the efficacy and safety of combined administration of TAK-536CCB and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB or Hydrochlorothiazide in patients with grade I or II essential hypertension.

This study consists of a 4-week single-blind placebo run-in period and a 10-week double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Grade I or II essential hypertension.
2. An office sitting systolic blood pressure of ≥ 150 and \< 180 mmHg, and an office sitting diastolic blood pressure of ≥ 95 and \< 110 mmHg during the placebo run-in period at Week -2 and Week 0.
3. Male or female aged 20 years or older at the time of providing informed consent.
4. Outpatient.

Exclusion Criteria:

1. Secondary hypertension, grade III hypertension or malignant hypertension.
2. An office sitting systolic blood pressure of ≥160 mmHg or sitting diastolic blood pressure of ≥100 mmHg recorded while on combined therapy with 3 or more antihypertensives within 4 weeks prior to the initiation of the placebo run-in period and at Week -4.

3 Evident white coat hypertension or white coat phenomenon. 4. Day-night reversed lifestyle, such as night-time workers. 5. Sleep apnea syndrome requiring treatment. 6. Have any of the cardiovascular disease or symptoms listed below:

* Heart disease: myocardial infarction (within 24 weeks before the placebo run-in period), coronary arterial revascularization (within 24 weeks before the placebo run-in period), severe valvular disease, atrial fibrillation, or following diseases which require medication: angina pectoris, congested heart failure, or arrhythmia.
* Cerebrovascular disease: cerebral infarction, cerebral hemorrhage (within 24 weeks before the placebo run-in period), or transient ischemic attack (within 24 weeks before the placebo run-in period).
* Vascular diseases: peripheral arterial disease with intermittent claudication, artery dissection, aneurysm
* Advanced hypertensive retinopathy: bleeding, exudation, or papilledema (within 24 weeks before the placebo run-in period).

  7. Clinically significant hepatic disorder. 8. Clinically significant renal impairment. 9. Significantly low or high Potassium or Sodium levels. 10. Complicated by gout, or had a past history of gout within 24 weeks prior to the initiation of the placebo run-in period, or complicated by hyperuricemia requiring medication.

  11. Diabetic subject on insulin treatment or poorly controlled type 2 diabetes mellitus.

  12. Have a malignant tumor.
MicroNet-covered Stent System for Stroke Prevention in All Comer Carotid Revascularization

All-comer study of unselected patients suitable for carotid artery revascularization to evaluate the feasibility, efficacy and safety of first line endovascular revasculariztion using MicroNet covered stent (CGuard™) in the treatment of consecutive symptomatic and increased-stroke-risk asymptomatic carotid lesions that require revascularization by Neurovascular Team decision.

Independent investigator initiated, academic, single arm, open-label, non-randomized, prospective, multicenter, multispecialty trial of CGuard™ routine use in all-comer population of consecutive patients with symptomatic or increased-stroke-risk asymptomatic carotid stenosis.

Increased-stroke-risk is defined as the following patient and/or lesion characteristics:

thrombus containing, documented progressive, irregular, ulcerated lesion; evidence of ipsilateral ischemic cerebral injury in MRI or CT imaging; contralateral stroke in relation to carotid stenosis; contralateral artery occlusion.

The main objective of this observational study is to evaluate (1) the periprocedural feasibility and efficacy of CGuard™ stent system in the treatment of carotid artery stenosis (2) long-term efficacy and safety of routine CGuard™ stent system use.

The study hypothesis is that the novel CGuard™ MicroNet® covered stent is safe and effective for a majority of consecutive patients considered to require carotid revascularization.

The multicenter arm of the project has a specific cohort descriptor: PARADIGM-EXTEND MC

Eligibility Criteria:
General Inclusion Criteria:

* Patient \> 18 years old qualified by NeuroVascular Team for carotid revascularization according to local standards of care
* Signed informed consent
* Agreement (routin un this group of patients) to clinical and ultrasonographis follow up.

Angiographic Inclusion Criteria:

* De-novo atherosclerotic lesions or neo-atherosclerosis
* Symptomatic patients (history of transient ischemic attack, ischaemic stroke or amaurosis fugax within 6 months from index procedure) with index artery stenosis ≥50% assessed in angiography with NASCET method or
* Asymptomatic patients with index artery stenosis ≥70-80% assessed in angiography with NASCET method

General Exclusion Criteria:

* Lack of NeuroVascular Team agreement on carotid revascularization indication
* Lack of signed informed consent
* Estimated life expectancy less than 1 year
* Chronic renal failure with serum creatinine level \> 3.0 mg/dL
* Myocardial Infarction within 72 hours prior to index procedure.
* Pregnant women
* Diagnosed coagulopathies
* History of contrast media allergy, not reacting to pharmacotherapy

Angiographic Exclusion Criteria:

* Index lesion occlusion
* Common carotid artery stent protruding to aortic arch
* Anatomical conditions restricting stent implantation
* Significant common carotid artery stenosis proximal to index lesion (unless treated)
Attitude and Perception Towards COVID-19 Pandemic

Assess response and attitude of general population living in Sharkia Governerate, Egypt as regard COVID-19 pandemic through arabic questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* General population within age range (16-70) and both sexes living in Sharkia Governerate, Egypt and accept to participate

Exclusion Criteria:

* below 16 or above 70 years
* refuse to participate
* duplicate answers
* incomplete answers
Safely and Efficacy of ClinOleic-based Lipid Parenteral Nutrition

Small studies suggest differences in efficacy and safety exist between olive oil-based and soybean oil-based parenteral nutrition regimens in hospitalized adult patients. A study in China suggested that olive oil-based parenteral nutrition provided effective nutrition, was well tolerated, was associated with fewer infections and conferred greater ease-of-use than soybean oil-based parenteral nutrition. The objectives of this study were to assess safety and efficacy of an ClinOleic-based lipid parenteral nutrition regimen compared with Structolipid-based lipid parenteral nutrition regimen in Chinese adults after pancreatectomy for whom oral or enteral nutrition was not possible, insufficient or contraindicated.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized ≤14 days before enrolment
* required parenteral nutrition
* had the capability to complete at least five days of study treatment;
* useable peripheral vein for parenteral nutrition;
* written informed consent.

Exclusion Criteria:

* A life expectancy of \<6 days;
* hypersensitivity to the study treatments;
* use of prohibited medications within 30 days before enrolment;
* serious clinically significant condition such as congestive heart failure or severe renal insufficiency;
* impaired hepatic function；
* history of human immunodeficiency virus infection;
* congenital abnormalities of amino acid metabolism;
* severe dyslipidemia;
* clinically significant abnormalities of plasma electrolytes;
* currently pregnant or lactating; prior enrolment in this clinical trial;
* participation in a clinical trial of any investigational drug or device concomitantly or within 30 days before enrolment in this clinical trial;
* unsuitable in the opinion of the Investigator.
An App-based Instructional Platform to Improve Eye Drop Recall

The goal of this interventional study is to assess whether an in-office, language-concordant instructional app improves drop regimen recall in a population of glaucoma patients who are on multi-drop regimens.

Participants will be divided into two groups -- those who use the app and those who do not. The app will have narrated information regarding the drop regimen, a quiz to test understanding of the regimen, and will enable a graphical printout of the eye drops and schedule.

At one month, both groups will be assessed on their eye drop regimen recall.

Specific Aim: To investigate whether a language-concordant instructional application improves drop regimen recall in population of glaucoma patients at a 1-month follow-up period.

App features

1. Pictorial representation of drops (color-coded) and schedule.
2. Quiz to assess understanding of the regimen.
3. Narrated instructions (language-concordant) on how and when (frequency and eye laterality) to take each drop.
4. Graphical print-out of the regimen.

Study design

1. Study design: Randomized study, two groups: (1) patients that use the app, and (2) patients that do not use the app.
2. Study population:

   Inclusion criteria: patients with primary open-angle glaucoma on at least 2 eye drops

   Exclusion criteria: patients taking additional prescribed eye drops for other eye conditions; patients diagnosed within the last 3 months; patients unable to self-administer eye drops
3. Intervention: Use of an in-office app that has both graphical and verbal (language-concordant) instruction for how to use drops.
4. Main outcome measure: Ability to correctly identify drops/regimen

Eligibility Criteria:
Inclusion Criteria:

* patients with a diagnosis of glaucoma (any type)
* drop regimen of at least 2 pressure-lowering drops
* languages supported at this time: English, Spanish, Cantonese

Exclusion Criteria:

* concurrent eye conditions necessitating additional eye drops
* inability to self-administer eye drops
* inability to engage with app (either visual or other barrier)
Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive
* One (1) unidimensionally measurable lesion
* ECOG Performance Status of 0 or 1, no peripheral neuropathy \>Grade 1
* Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.
* Recovery in full from any previous surgical procedure
* No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease

Exclusion Criteria:

* Hypersensitivity to any of the 4 study drugs
* Concurrent immunotherapy or participation in any investigational drug study within 4 weeks
* Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft
* History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)
* Patient is a pregnant or lactating female
Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients

This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.


Eligibility Criteria:
Inclusion Criteria:

* Male \& Females aged 65 and older
* Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
* Patients must have had a colonoscopy within the past 5 years
* Patients must pass a balloon expulsion test at screening
* Patients must be able to comply and understand the use of a diary

Exclusion Criteria:

* Patients with a clinically significant medical condition that would interfere with the patient completing the trial
* Patients with loose stools at least once per week
* Patients with IBS
* Known allergies to the same class of drug and/or allergies to eggs
* Patients who require the use of manual maneuvers to have a bowel movement

Other protocol-defined inclusion/exclusion criteria may apply.
Intravaginal Vibratory Stimulus and Pelvic Floor Muscle Training

This is a randomized blinded trial with non-probabilistic sampling for convenience. Our goal is to compare PFMT with intravaginal vibratory stimulus versus PFMT alone on the treatment of female urinary incontinence.

This is a randomized blinded trial with non-probabilistic sampling for convenience. Our goal is to compare PFMT with intravaginal vibratory stimulus versus PFMT alone on the treatment of female urinary incontinence. Women with an indication for conservative treatment of urinary incontinence will be referred to the Pelvic Floor Physiotherapy Team by the Medical Team of the Ambulatory of Urogynecology and Obstetrics of the Hospital de Clínicas de Porto Alegre and those who are in compliance with the inclusion criteria proposed for the research will be invited to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* Women with urinary incontinence;
* Know how to perform a voluntary pelvic floor muscle contraction;
* Have not undergone pelvic floor muscle training in the last 6 months;
* Understand the instruments used in research.

Exclusion Criteria:

* Latex allergy;
* Neurological diseases;
* Pelvic organ prolapse \> grade 2;
* Pain during vaginal palpation and / or introduction of the vaginal probe;
* Vaginal atrophy;
Quality of Life After Hysterectomy (AdenoQOL)

Adenomyosis is a disease where ectopic endometrial-like glands affect the muscular wall of the uterus. About 70% of women affected by adenomyosis suffer from dysmenorrhea and menorrhagia. A levonorgestrel-releasing intrauterine device (LNG-IUD) is the first-choice treatment of adenomyosis, but is not always sufficiently effective in all women. Those women often end up removing the uterus (hysterectomy).

Hysterectomy is clinically regarded to be an efficient and final treatment of adenomyosis, but pelvic pain may also prevail after removal of the uterus. This study aimes to investigate the short - and long-term impact of hysterectomy on quality of life (QOL) and sexual function in women with adenomyosis, and further to evaluate if there is any difference compared to women that are removing their uterus due to other benign gynecological conditions.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal status defined by having had menstruation within the last 12 months, or age \< 50 years if amenorrhea due to hormonal treatment
* Hysterectomy planned due to a benign condition
* Able to communicate in Norwegian or English
* Electronic consent given

Exclusion Criteria:

* Age \< 18 years, postmenopausal status or no menstrual bleeding for the last 12 months
* Hysterectomy as part of female-to-male transition
* Pelvic organ prolapse as an indication for hysterectomy
* Gynecological cancer suspected at the time of inclusion
* Not able to communicate in Norwegian or English
Using Lay Health Advisors to Improve Hypertension Management

Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension.

Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. Health providers generally lack the skills and resources to address social contextual factors (i.e. health and community services, social networks, social stressors, physical environment, and economic resources) that influence management of hypertension. Instead, providers tend to focus on adjusting antihypertensive medication prescriptions and exhorting patients to exercise and eat better. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension. Helping patients address these barriers may lead not only to improved blood pressure but also to increased survival, reduced organ damage, and decreased health care costs. This project may also serve as a model of healthcare delivery innovation that could be used to address other health disparity conditions.

Eligibility Criteria:
Inclusion Criteria:

* At least 2 outpatient blood pressures with systolic \>140 or diastolic \>90 mm Hg in last 6 months. Separate occurrences at least 1 day apart
* Age 18-59 years
* Non-diabetic
* Preserved kidney function (glomerular filtration rate \>60 ml/min)
* English speaking

Exclusion Criteria:

* Mentally incompetent
* Pregnant
* Terminal illness
* Active substance abuse
* Documented coronary, peripheral arterial, or cerebrovascular disease
Vitamin D and Disease Activity in Ulcerative Colitis

The purpose of this study is to test blood and tissue samples of people with Ulcerative Colitis (UC) to see what effects vitamin D may have on the immune system. This research is being done because it could lead to the development of new treatment for people with inflammatory Bowel Disease (IBD).

Patients with UC will be recruited and consented prior to colonoscopy or flexible sigmoidoscopy. All patients will be age 18 or older with a known history of UC that has been confirmed by biopsy and an extent of disease of at least 20cm proximal to the anus. Clinical data will be collected on the patient's age, disease duration, family history of IBD, smoking status and history, as well as current medications for IBD through a questionnaire. Data will also be collected regarding current vitamin D supplementation (if taking) and dose. Prior to the endoscopic procedure, peripheral blood will be drawn into two 10ml red top tubes. At the time of endoscopy, five standard size mucosal pinch biopsies will be obtained from 20cm proximal to the anus. . A bar-coded unique identifier label will be applied to each sample. One biopsy will be placed in formalin. Paraffin samples will be maintained at room temperature. Following to the endoscopic procedure, the patient's physician will complete a Mayo score based on the patients current symptoms and endoscopic disease severity. Comparison will be made between disease activity, serum serum 25 hydroxyvitamin D level, and mucosal expression of tight junction proteins as well as proinflammatory cytokines.

Eligibility Criteria:
Inclusion:

* Age 18 years old and over
* A diagnosis of ulcerative colitis that has been confirmed by biopsy and an extent of disease of at least 20cm proximal to the anus.

Exclusion:

* Age \<18 years old
* Diagnosis of Crohn's disease
* Diagnosis of ulcerative colitis with disease extent \<20cm proximal to the anus
In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus

In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

Comparisons:

A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.

D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.

Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.

Eligibility Criteria:
Inclusion Criteria:

* non-smokers, 18 to 50 years of age.
* Habitual use of \> 7 portions snus daily since minimum 1 year.
* Healthy according to the health declaration and interview.
* Written informed consent given.

Exclusion Criteria:

* Concurrent participation in another clinical trial.
* History of allergy.
* History of allergy.