Kornimate/medical-research-clean huggingface dataset:
interdisciplinary team approach to stroke rehabilitation in home care

Conditions: Stroke

Summary: as the population ages and the number of stroke survivors increases, information is needed to determine the best way of providing home care services for rehabilitation to stroke survivors and their caregivers while containing health care costs. this project will address this area by developing and testing the effects and costs of a collaborative and specialized team approach to stroke rehabilitation by health professionals, in a home care setting, compared to usual home care services. the overall goal of this way of providing home care services is to improve the quality of life and function of stroke survivors and their caregivers and prevent future strokes, which will reduce the overall cost to the health care system.

stroke is the third leading cause of death in canada, and is considered to be the most common disabling chronic condition. approximately 40,000 to 50,000 people in canada experience a stroke each year and about 80% of these people survive. many of these people who survive a stroke never fully recover and are left with significant impairments and disabilities, and 12% to 25% will have another stroke within the first year. this results in a significant burden to individuals, families, and society as a whole. of every 100 people who are hospitalized for a stroke, 15-40 return home and require home care services for rehabilitation. stroke rehabilitation is one of the key components of stroke care. the goal of rehabilitation is to assist stroke survivors to reach his or her optimal level of physical, social, and emotional function. information gained from this study will be used to inform home care practice, policy decisions and the allocation of home care resources and make a national contribution to health care delivery reform.

Eligibility criteria:
inclusion criteria: * diagnosis of stroke or tia has been confirmed. * newly referred to and eligible for home care services (physiotherapy, speech language therapy, occupational therapy, nursing) through the toronto central ccac. * living at home in the community (outside of an institutional setting) up to 18-months post-stroke. * english speaking exclusion criteria: * refuse to give informed consent. * more than 18 months post-stroke at time of recruitment. * unable to read/write english and an appropriate translator is not available.

Keywords: stroke rehabilitation home care services effectiveness quantitative research interdisciplinary cost health services research, integrated
uterine filling pressure in hysteroscopy

Conditions: Fibroids

Summary: the aim of the study is to compare the outcomes of patients undergoing hysteroscopy with a myosure device with a pressure of 60 mmhg to those using the standard of 80 mmhg.

an a priori sample size calculation was completed. to achieve 80% power and an alpha of .05, the study team needed a sample size of 68 total with 34 participants in each group.the study will be a double-blind randomized control trial. patients will be recruited based on surgery type (hysteroscopy) and consented using a written consent by the research coordinator with sufficient time to ensure patient comprehension and allow for any questions. the consent process will happen in the pre-operative appointment. participants will then be randomized to either the standard of care of 80mmhg or the experimental pressure of 60 mmhg for uterine filling pressure via an automated randomization program. the physician performing the surgery and the patient will not know what group they are assigned to. the procedure involved in the study will be hysteroscopy. hysteroscopy is a procedure that is used to diagnose and sometimes treat intrauterine pathologies. in order to visualize the uterus, pressurized saline is used to distend the uterus. in this study, the specific hysteroscopic procedure will involve the removal of uterine fibroids with a myosure hysteroscopic morcellator device. these tissue samples will be collected and sent to pathology to be weighed. during the surgery, the surgeon will be able to request an adjustment pressure if visualization is not adequate. physicians will start with a pressure of 80mmhg. once physician is ready to introduce the myosure hysteroscopy device, the pressure level will then be randomized. during the procedure, monitoring will be done by anesthesia through the use of pulse oximetry and measurement of vitals during the monitored anesthesia care. there is also real-time monitoring of hysteroscopic fluid deficit via the fluid management system that is attached to the hysteroscopic pump. fluid deficit can also be confirmed by the nurse who manually counts the amount of fluid used during theprocedure. per policy, once a 2500ml deficit is reached, the procedure is terminated. after the surgery, the surgeon will fill out a questionnaire that measures the outcomes of surgeon satisfaction and visualization during the procedure. the other end points of procedure time, specimen weight, volume of normal saline used, any changes in pressure needed during the surgery, and whether the patient required lasix post-operatively will also be collected at this time.

Eligibility criteria:
inclusion criteria: * patients electing for operative or diagnostic hysteroscopy procedures for management of polyps and fibroids * age equal to or greater than 18 * ability to understand and willingness to sign consent form. we will include non-english speaking patients in this study exclusion criteria: * patients electing for operative and diagnostic hysteroscopy procedures with polyps and fibroids * patients under the age of 18
peritoneal 1.3-ß-d-glucan for the diagnosis of intra-abdominal candidiasis in critically ill patients (pbdg2)

Conditions: Intra Abdominal Infections; Candidiasis, Invasive; Peritoneal Candidiasis; Critically Ill

Summary: new rapid diagnostic strategies are warranted in intra-abdominal candidiasis (iac). a previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-beta-d-glucan ≤ 310pg/ml could rule out an iac. this strategy was independent of the patient underlying conditions and candida risk factors. this study aimed to confirm these results with a multicenter prospective study


Eligibility criteria:
inclusion criteria: * critically ill adult (\> 18 yrs old) admitted to icu for intra-abdominal infection requiring surgery and possible intra abdominal candidiasis exclusion criteria: * declinate to participate, * expected death within the first 24 hours
evaluation of long-term adverse effects of gastric bypass in omega

Conditions: Bypass Complication; Obesity

Summary: the omega gastric bypass (oagb) is developing worldwide as an alternative to the y gastric bypass (rygb). cases of nutrition deficiency after oagb, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. in its technology assessment report issued in september 2019 (has, 2019), the haute autorité de santé rules on the invalidity of oagb with a 200 cm biliary limb and the lack of sufficient data on the safety of oagb with a 150 cm biliary limb compared to rygb. the lack of long-term data on weight, resolution of comorbidities, quality of life, and endoscopic evaluation given the risk of lower esophageal cancer is also noted. the main objective of the study is to compare the incidence of serious adverse events related to surgery after oagb at 10 years, according to 2 types of loop: a realization with a 150-cm biliary loop (oagb ab150) versus a realization with a 200-cm biliary loop (oagb ab200).


Eligibility criteria:
inclusion criteria: * patients who received 10 ± 2 years ago (between 2009 and 2013) an oagb with a 150 or 200cm biliary limb. patients should be consecutive at each center. * patients fulfilling the criteria of indication for bariatric surgery at the time of their intervention according to the recommendations of the has (has, 2009) in an expert center. * patients agreeing to perform an endoscopic evaluation with biopsies at 10 years * patients who gave their consent * patients with health insurance coverage exclusion criteria: * contraindication to bariatric surgery defined according to has recommendations (has, 2009) * persons deprived of liberty, under guardianship, or under curatorship * patients included in a protocol with a conflict of interest with omega10.

Keywords: one anastomosis gastric bypass obesity bariatric surgery gerd long term
first-in-human (fih), single ascending dose (sad) study of fluoroethylnormemantine (fenm)

Conditions: PTSD; Alzheimer Disease; Brain Diseases; Neuro-Degenerative Disease; Major Depressive Disorder; Treatment Resistant Depression

Summary: the goal of this first-in-human (fih) trial is to learn about safety and pharmacokinetics (pk) in healthy adult volunteers. the main questions it aims to answer are: * what is the safety of single ascending doses of the fluoroethylnormemantine (fenm)? * what is the pk profile of single ascending doses of the fenm in human? * what is the preliminary exploratory time course of brain disease neurotrophic factor (bdnf) plasmatic levels of single ascending doses of the fenm? participants will receive one single oral dose of fenm.


Eligibility criteria:
inclusion criteria: * willing and able to sign written informed consent, * body mass index (bmi) of 17.5 to 30.5 kg/m2, a total body weight \>65 kg, * efficient contraceptive mean, * no major psychiatric disorder per the mini-international neuropsychiatric interview (mini) questionnaire, * normal laboratory tests results, arterial blood pressure/pulse rate, 12-lead electrocardiogram recording. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease including drug allergies, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality, * history of febrile illness within 5 days prior to administration, * any condition possibly affecting drug absorption, * using of prescription drugs, vaccine, routine or as needed consumption of medications or herbal supplements, * having positive serology, positive urine test for drugs of abuse, a general medical or psychological condition or behavior, including current substance dependence or abuse, * history of drug or alcohol abuse within 1 year before screening, * consuming currently of nicotine containing products, any food or any beverage containing grapefruit or grapefruit juice within 48 h prior to administration, * having blood donation or loss of significant amount of blood within 2 months prior to study.

Keywords: nmda ptsd alzheimer's disease brain diseases neuro-degenerative disease major depressive disorder treatment resistant depression
a trial of seasonal malaria chemoprevention plus azithromycin in african children

Conditions: Malaria; Respiratory Infections

Summary: the primary objective of this study is to determine whether addition of azithromycin (az) to seasonal malaria chemoprevention (smc) using sulphadoxine/pyrimethamine (sp) +amodiaquine (aq) will provide an additional reduction in deaths and severe illness in young african children. the secondary objectives include an assessment of the safety and cost-effectiveness of the addition of az to smc with sp+aq. this a double blind, randomised, placebo controlled trial. the unit of randomisation will be the household. children aged 3 - 59 months will be randomised to receive four cycles of either sp+aq+az or sp+aq+ placebo at monthly intervals during the peak malaria transmission season. study sites: hounde district in burkina faso and in bougouni district, mali. children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. children with a severe, chronic illness or known allergy to one of the study drugs will be excluded. primary endpoint: incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period secondary endpoints: 1. incidence of the primary endpoint during the whole study period 2. attendance at a study health centre with a nonmalaria febrile illness 3. attendance at a study health centre with malaria, 4. the prevalence of moderate anaemia at the end of each malaria transmission season, 5. nutritional status at the end of each malaria transmission season, 6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season, 7. prevalence of resistance markers to sp at the end of the study, sample size: 19,200 children (9600 in each country) will be enrolled.


Eligibility criteria:
inclusion criteria: * children of either sex aged 3-59 months of age at the start of each period of drug administration * parental consent is obtained. exclusion criteria: * a severe, chronic illness, * a known allergy to one of the study drugs. * hiv+ children on cotrimoxazole prophylaxis
hydraderm for androgenic alopecia

Conditions: Androgenic Alopecia

Summary: the study will be focused on evaluating the use of hydradermabrasion on the scalp. the study aims to assess the effect of this treatment on scalp health and hair growth.


Eligibility criteria:
inclusion criteria: * participants who can give voluntary, written informed consent to participate in this study and from whom consent has been obtained including hipaa authorization * participants who have androgenetic alopecia * healthy men and women, ages 18 - 65 years of age * participants who understand the study and can follow study instructions and are willing to attend the required study visits * participants who agree to be photographed for research purposes and their identity may not be concealed in these photographs. * participants who agree to continue their same treatment they are on at the baseline visit for androgenetic alopecia, for the entire duration of the study without plans to stop, change or add additional treatments. * participants who agree to use the same shampoo for the duration of the study exclusion criteria: * participants who have not had a change to hair loss treatment for 4 months prior to study enrollment * participants who have an active or known skin inflammation or infection within the treatment area. * participants who have an active or known acute skin allergies * participants who have any other scalp conditions including eczema, psoriasis, infection, or scars within the treatment area * participants of child-bearing potential who are not using an approved method of birth control (oral contraceptives, iud, contraceptive implant, barrier methods with spermicide or abstinence). females of non-childbearing potential are defined as post-menopausal (absence of menstrual bleeding for one year), hysterectomy, or bilateral oophorectomy. * participants who are pregnant, planning to become pregnant or breastfeeding. a urine pregnancy test will be done to rule out pregnancy. * immunosuppression * participants who are hiv+ / hepatitis b + / hepatitis c+ * participants who have been diagnosed or have a known history of any hematopathology disorders * participants who have been diagnosed or have a known history of haemostasis disorders * participants who have been diagnosed or have a known history of an autoimmune diseases * participants who are undergoing chemotherapy * participants with a history of any skin cancer on the scalp * participants who have had skin biopsy or procedure on scalp in last month * participants who have an implantable devices such as a deep brain stimulator in or other implantable device on or near treatment area * non-english speakers

Keywords: alopecia hair loss pattern hair loss hydradermabrasion female pattern hair loss male pattern hair loss dermatology
evaluation of clinical signs and symptoms of chronic heart failure in patients treated with candesartan cilexetil in croatia

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to determine whether treatment with candesartan cilexetil for at least 6 months in patients with chronic heart failure improves clinical signs and symptoms of chronic heart failure.


Eligibility criteria:
inclusion criteria: * patients with diagnosed chronic heart failure * patients treated for at least 6 months with candesartan cilexetil * signed informed consent exclusion criteria: * hypersensitivity to candesartan cilexetil * pregnancy / lactation * severe hepatic impairment

Keywords: chronic heart failure candesartan cilexetil clinical signs symptoms
qnnections: refinement and pilot trial of a suicide prevention intervention to increase social connection

Conditions: Suicidal Thoughts and Behaviors; Social Isolation

Summary: despite the high risk of suicide among lgbtq+ veterans, there is currently no suicide-focused intervention for this population. this study will refine and pilot qnnections, a novel group-based suicide prevention intervention that aims to increase social connection and functioning in this population. the project will involve veterans with lived experience in further refining qnnections, and then will examine feasibility and acceptability of qnnections and of study procedures in a pilot randomized clinical trial.

theoretical and empirical research consistently identifies perceived burdensomeness and thwarted belongingness as suicide-specific risk factors. this proposal refines and pilots qnnections, a novel suicide prevention intervention which aims to increase social connection and functioning through improving belongingness and reducing burdensomeness. phase i (1.5 years) focuses on intervention refinement of qnnections with a veteran advisory board (n = 8) and expert mentors. in its current form, qnnections is a 10-week group-based intervention intended to augment veterans affairs (va) suicide prevention efforts, using a cognitive behavioral framework to target social disconnection. after refinement by mentors and veterans with lived experience, a pilot open trial (n = 10) will engage veterans and gather acceptability data. following refinement from phase 1, phase 2 (3.5 years) includes a pilot randomized feasibility and acceptability trial (n = 48), with participants randomized to qnnections (10 group sessions, safety plan, referrals) or an enhanced usual care condition that contains elements of standard va suicide prevention (safety plan, referrals). veteran participants in both phases will complete quantitative assessments at baseline, mid-treatment, post-treatment, and ten-week follow-up. qualitative data collection will occur at post-treatment. the focus is feasibility and acceptability of qnnections and of study procedures.

Eligibility criteria:
inclusion criteria: * veterans who report past-month active suicidal ideation (c-ssrs \[columbia-suicide severity rating scale\] -- or past-3-month suicidal behavior; * lgbtq+ or other minoritized gender or sexual identity; * have a mental health point-of-contact (e.g., suicide prevention coordinator, mental health treatment coordinator); * willing to complete or update safety plan. exclusion criteria: * cannot provide informed consent; * imminent psychiatric hospitalization; * current or planned participation in residential/intensive outpatient program that would interfere study participation; * in a conservatorship; and * has participated in any previous parts of the study.

Keywords: suicide social isolation
safety and feasibility of early active rehabilitation in children after concussion

Conditions: Post-Concussion Symptoms; Concussion

Summary: it has been suggested that activity immediately following concussion is detrimental to recovery and may lead to long term impairments. the animal model has shown that exercise too soon can lead to neurometabolic energy imbalances within the brain. however, there is also evidence to suggest that prolonged inactivity has negative consequences that may contribute to prolongation of symptoms. determining the ideal timeframe in which to initiate an active rehabilitation protocol for patients who are slow to recovery is an important factor in concussion management.


Eligibility criteria:
inclusion criteria: * referred to the mtbi clinic of the mch for atypical recovery (defined as the presence of symptoms with little improvement at 10 days post-injury preventing them from entering standard return to activities protocols) exclusion criteria: * co-morbidity preventing children from participating in intervention
the physical exercise and prostate cancer study

Conditions: Prostate Cancer

Summary: the purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. it is hypothesized a beneficial effect of the intervention on physical and psychological health in patients with prostate cancer treated with androgen deprivation.


Eligibility criteria:
inclusion criteria: * newly diagnosed locally advanced prostate cancer (clinical stage t2 and t3) * referred to rh and uus for radiotherapy * \< 75 years * capable of reading and writing norwegian * treating oncologist must approve of the subjects' participation * living within approximately 1 hour from oslo by car or public transportation exclusion criteria: * routinely resistance training with manuals * medication for osteoporosis (i.e. bisphosphonates) * conditions of a severity that contraindicate exercise without adjusted actions * mentally incompetent conditions * conditions of a severity that complicates the ability to participate in a supervised training program

Keywords: exercise prostatic neoplasm androgen deprivation
efficacy and safety of peg-interferon alpha-2a plus ribavirin in genotype 1 chronic hepatitis c participants co-infected with human immunodeficiency virus

Conditions: Hepatitis C, Chronic

Summary: this randomized, multi-center, phase iv, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (peg-ifn-alpha-2a) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with genotype 1 chronic hepatitis c (chc), co-infected with human immunodeficiency virus type 1 (hiv-1).


Eligibility criteria:
inclusion criteria: * serological evidence of chronic hepatitis c infection by anti-hepatitis c virus (hcv) test * detectable hcv-ribonucleic acid (rna) plasma level testing by roche amplicor hcv (\<50 international units per milliliter \[iu/ml\]) (qualitative test) * chronic liver disease consistent with infection of chc * compensated liver disease (child-pugh grade a) * serological evidence of infection by hiv-1 test, anti-hiv-1 or hiv-1 rna detection * negative pregnancy urine or blood test (for women in childbearing age); additionally, all men and women of childbearing potential must agree to use two effective forms of contraception during the treatment and during the 6 months after the end of treatment exclusion criteria: * pregnant or nursing women and male partners of pregnant women * prior therapy with interferon (ifn) or ribavirin and any investigational medication less than or equal to (\</=) 6 weeks before the first dose of the study drug * history or other evidence of a medical condition associated with chronic liver disease further than hcv * active opportunistic infection associated with hiv and / or cancer requiring systemic therapy * history of any other significant illness which in the investigator's opinion, could result in the participant's inability to meet the protocol requirements