Kornimate/medical-research-clean huggingface dataset:
cognitive multi-sensory rehabilitation on upper limb function and fatigue in stroke

Conditions: Stroke; Ischemic

Summary: this interventional study aims to investigate the therapeutic efficacy of cognitive multi-sensory rehabilitation (cmr) on upper limb function and fatigue in chronic stroke patients. the main question is: • does cognitive multi-sensory rehabilitation significantly affect upper limb function and fatigue in stroke patients? participants will be assigned into two groups. they will receive 12 sessions of study group cmr and traditional physical therapy and control group traditional physical therapy rehabilitation. cmr 40 minutes immediately followed by 20 minutes of selected physical therapy program, three sessions per week for four weeks.

about 70% of people with stroke are unable to use their affected hand efficiently in activities of daily living. further, post-stroke fatigue affects up to 92% of post-stroke patients. post-stroke fatigue is a multifaceted motor and cognitive process, in which the patient experiences tiredness and lack of energy that develops during physical or mental activity which may persist for years. post-stroke fatigue impacts the mental/physical functions of the patient through decreased energy, and thus, is a significant barrier to recovery. preliminary evidence indicates sensory rehabilitation may enhance motor recovery in people with stroke. cognitive multisensory rehabilitation (cmr) is a therapist-guided sensorimotor rehabilitation approach, that targets the patients' ability to solve sensory discrimination exercises, where the patient compares the sensations felt by the hand to the shapes observed with the eyes. cognitive processes are encouraged by asking the patient to determine the limb movement or its position, how the movement was felt in the body, how the limb moved in relation to other parts of the body, and to spatial parameters in the environment. because cmr integrates cognitive processes with sensory and motor tasks, it may be a novel method to address post-stroke fatigue, and it may increase connectivity in sensory and motor areas of the brain.

Eligibility criteria:
inclusion criteria: * age between 45 and 65 years. * 6-18 months after ischemic stroke * living in the community (i.e., not in a long-term care home). * medically stable. * normal score in the montreal cognitive assessment (moca: 25 to 30, maximum score = 30). * spasticity of upper limb muscles ranged from (grade 1:2) according to the modified ashworth scale. exclusion criteria: * severe spasticity (modified ashworth scale score of 4) * any medical condition that hinders full participation, * another neurological diagnosis beyond stroke including cognitive impairment, or * upper extremity pain \> 4/10 on the numeric pain rating scale (maximum 10/10).

Keywords: cmr stroke upper limb function fatigue
auditory-cognitive training to optimize outcomes for older ci users

Conditions: Hearing Loss; Deafness

Summary: the proposed study will investigate whether an auditory brain training program can improve cochlear implant (ci) outcomes in older post-lingually deafened ci users. the study will evaluate the potential benefit of training on speech recognition performance, psychosocial and cognitive function.

optimizing speech recognition and cognitive outcomes for older cochlear implant users with auditory-brain training is evaluating the performance of older cochlear implant users completing a customized auditory-cognitive brain training program. the goal is to determine the effectiveness of training based on speech recognition, neural responses, cognitive, and psychosocial function. successful training could result in improved outcomes for communication and cognition, new client-centered care models, and better consumer access to effective training. specifically, investigators will assess two training programs to determine whether participants can improve speech understanding and speed, attention and memory, and communication in daily life. thirty participants will be randomly assigned to one of two treatment groups: auditory-brain training or non-auditory brain training. participants will complete two hours of training online at home or office. participants will meet virtually with a clinician weekly to discuss progress.the study will help determine the best training methods for older adult cochlear implant users.

Eligibility criteria:
inclusion criteria: * 60 years of age and over; * between 3 months and 3 years post cochlear implant activation; * passing score an cognitive screener (callahan et al, 2002); * speech recognition scores on azbio between 10% and 85%. exclusion criteria: * single-sided deafness * non-fluent english

Keywords: older adult auditory training speech recognition cognitive function quality of life post-lingual cochlear implant electrophysiologic response
birth outcomes in eswatini after transition to dolutegravir-based treatment

Conditions: Neural Tube Defects; Congenital Abnormalities; Teratogens

Summary: the goal of this observational study is to assess the birth outcomes of hiv-positive women delivering in hospitals in eswatini who are receiving dolutegravir (dtg) or other anti-retroviral (arv) drug regimens. the main question the study aims to answer is, what is the proportion of neural tube defects among live and stillborn infants delivered by: * hiv-positive women on dtg at conception * hiv-negative women * hiv-positive women on non-dtg arv at conception participants will be interviewed for information on hiv testing and antiretroviral therapy history, other medical history of selected conditions (e.g., diabetes, malaria, tb) and potential birth defect exposures. photographs will be taken of the infants. data on mothers' pregnancy history, birth outcomes, and hiv and arv information (as applicable) will be collected from patient records.

this is an observational study conducted at five high volume hospitals in eswatini, in which birth defect and other data will be collected at the time of delivery (or hospital admission for miscarriages and medical abortions) for all women. the overall aim of this study is to evaluate the birth outcomes of hiv-positive women who are receiving dtg or other arv drug regimens. the primary research objectives are to: 1) determine the proportion of neural tube defects among live and stillborn infants delivered by hiv-positive women on dtg at conception; 2) determine the proportion of neural tube defects among live and stillborn infants delivered by hiv-negative women; and 3) determine the proportion of neural tube defects among live and stillborn infants delivered by hiv-positive women on non-dtg art at conception. secondary objectives are to determine overall general prevalence of major external birth defects and other pregnancy outcomes and any associations with other factors (e.g., maternal age, gravida). data on mothers' pregnancy history, birth outcomes, and hiv and arv information (as applicable) are collected from patient charts, registers, reporting forms and databases for all women. women of live or stillborn infants with birth defects are consented for interviews capturing detailed history and exposure data and photographs of newborns' birth defects. data collection will be for approximately 24 months. blinded interview data and photographs are reviewed by a medical geneticist for confirmatory defect diagnosis. we will describe rates and 95% confidence intervals (ci) for birth defects among infants by maternal hiv and art status.

Eligibility criteria:
surveillance component includes all deliveries/admissions as defined in study population description. for a subset of the population recruited for additional data collection: inclusion criteria: * women whose live or stillborn infant has birth defect as identified by a midwife or other clinician at the study hospital * willing to provide informed consent exclusion criteria: * unable to provide informed consent
searching for the optimal tdcs target combined with peripheral electrical stimulation in chronic low back pain

Conditions: Chronic Pain; Low Back Pain

Summary: low back pain (lbp) has been associated with severe impairments, primarily related to activities of daily living, functional ability and quality of life. a multimodal approach to pain management, such as transcranial direct current stimulation (tdcs) and peripheral electrical stimulation (pes), may improve outcomes in chronic lbp. however, the optimal cerebral target for stimulation still remains controversial. this pilot trial aims to investigate whether active stimulation could promote additional gains to the pes results in lbp participants. the secondary objective is to investigate whether the stimulation of primary motor cortex and dorsolateral prefrontal cortex results in distinct clinical effects for the participants involved.

for this, a pilot, sham-controlled, double-blind, randomized clinical trial in accordance with the standard protocol items: recommendations for interventional trials (spirit) guidelines. sixty participants with chronic low back pain will be randomized into one of three tdcs groups associated with pes: motor primary cortex, dorsolateral prefrontal cortex and sham stimulation. each group will receive transcranial direct current stimulation at an intensity of 2 ma for 30 minutes daily for 10 consecutive days. participants will be assessed with a brief pain inventory (bpi), roland morris disability questionnaire (rmdq), medical outcomes study 36-item short - form health survey (sf-36) and electromyography at baseline, endpoint (after 10 sessions) and 1-month follow up. this study will help to clarify the additive effects of tdcs combined with peripheral electrical stimulation on pain relief, muscle function and improvement in quality of life. additionally, the investigators will provide data to identify optimal targets for management of chronic low back pain.

Eligibility criteria:
inclusion criteria: * age over 18 years; * diagnosis of chronic low back pain, lasting more than 6 months (the diagnosis of chronic lumbar pain will be based on clinical and neurophysiological criteria, according to the european guidelines on low back pain); * pain intensity of at least 4 in 10 in visual analogue scale (vas); * stable pharmacological treatment for at least one month before the study and throughout the study; exclusion criteria: * intense pain from another origin, such as neuropathic pain; * alcohol or substance abuse; * associated diseases of the peripheral or central nervous system; * contraindications for non-invasive brain stimulation.

Keywords: pes tdcs
brief psychological intervention for suicidal patients with borderline personality disorder in the emergency department

Conditions: Borderline Personality Disorder (BPD)

Summary: when in crisis, people with borderline personality disorder (bpd) frequently seek care in emergency departments (eds) often presenting with suicide and self-harm behaviour. there is no established evidence-based brief treatment for patients with bpd in ed settings, however a 4-session treatment for people with personality disorders in ed settings was tested in australia and showed promising results in reducing health care use and improving symptoms. a recent pilot feasibility randomized controlled trial (rct) comparing this 4-session treatment to treatment as usual was conducted at the centre for addiction and mental health and preliminary findings have shown that the treatment is feasible to deliver and acceptable to both patients and clinicians. the proposed fully powered rct will build on this pilot data to assess the efficacy of delivering this 4-session intervention in the ed for people with bpd who present with suicidal ideation or self-harm with the aim of reducing emergency health care use and improving bpd symptoms, functioning and quality of life.


Eligibility criteria:
inclusion criteria: 1. must be deemed to have capacity to provide informed consent; 2. must sign and date the informed consent form; 3. stated willingness to comply with all study procedures; 4. aged 16 or older; 5. presenting to ed with self-harm and/or suicidal ideation; 6. meeting criteria for bpd on the international personality disorders examination (ipde). 7. endorsing a score of 1 or greater on the suicide ideation attributes scale (sidas). exclusion criteria: 1. meeting dsm-5 criteria for severe substance use disorder, schizophrenia spectrum disorder or bipolar disorder i mania based on the structured clinical interview for dsm-5 (scid-5); 2. iq \< 70 based on the test of premorbid functioning (topf).

Keywords: brief intervention brief treatment treatment intervention gold card
co-administration of cabergoline and gliclazide improve glycemic parameters and lipid profile in t2dm patients

Conditions: Diabetes

Summary: evaluation of the glycemic efficacy of cabergoline on diabetic patients

type 2 diabetes mellitus (dm) is a progressive metabolic disorder that is associated with basal hyperinsulinemia, insulin resistance and impaired insulin release. glycemic control is a fundamental part of the management of type 2 dm and difficult to achieve. different antidiabetic agents can handle diabetic metabolic abnormalities. the development of antidiabetic agentswith novel mechanisms of action is highly desirable. cabergoline, a long acting d2 agonist, is expected to play a role in the glycemic control.

Eligibility criteria:
inclusion criteria: * diabetic patients. exclusion criteria: * other drugs administration
safety and pharmacokinetics of cbx129801 in patients with type 1 diabetes

Conditions: Type 1 Diabetes; Diabetes Mellitus; Peripheral Diabetic Neuropathy

Summary: the purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of cbx129801 (long-acting synthetic c-peptide) in type 1 diabetes patients.

this study will be conducted in two parts (part 1 and part 2). part 1 will be conducted in three sequential dose cohorts with dose level escalated for each successive cohort. in part 2 of the study, a dose regimen determined from the pharmacokinetic data from part 1 will be administered in up to 40 additional subjects to achieve a target plasma concentration range that represents the most commonly observed physiological c-peptide levels in healthy, non-diabetic individuals.

Eligibility criteria:
key inclusion criteria: * give informed consent * aged 18 to 55 years (part 1), ages 18 to 65 years (part 2) * stable type 1 diabetes mellitus (t1dm) for a minimum of 5 years * body mass index of 18-35 kg/m2 * be c-peptide deficient (assessed by fasting concentration level) * normal renal function (assessed by serum creatinine) * be in good general health (besides t1dm) * have abnormal sural nerve conduction velocity observed bilaterally (part 2 only) key exclusion criteria: * any significant cardiovascular, hematological, renal, hepatic, pulmonary, endocrine (except for diabetes mellitus), central nervous, or gastrointestinal condition or disease * unstable glucose control * have had a islet cell, kidney, and/or pancreas transplant * blood loss or blood donation within 56 days * drug or alcohol abuse (within 2 years) or recreational drug use (within 3 months) * history or positive test result for hepatitis b, c, and/or hiv * treatment with medication for peripheral neuropathy within 30 days
effects of exogenous ketones in healthy young adults

Conditions: Healthy Young Adults

Summary: exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and maintaining normal blood glucose levels. the purpose of this study is to determine the effects and safety of supplementing with exogenous ketones for 6-weeks in healthy college-aged males and females. the results of this proposed study will determine whether exogenous ketone supplementation can be useful in promoting better body composition, energy levels, and blood cholesterol, glucose, and insulin levels.

a total of 22 subjects, male and female, were randomized to either a ketone salt group or a placebo group. both the participants and investigators were blinded, as the supplements were coded by an external lab. data was collected at baseline and again in 6-weeks. participants consumed 2 servings of the assigned supplement daily for 6 weeks. measures included body composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel, complete blood count, and lipid panel), and a urinalysis. also, blood ketone levels were assessed before and periodically after consuming the supplemental drink (30 and 60 minutes post drink). these measures were performed at both baseline and 6-weeks later.

Eligibility criteria:
inclusion criteria: * healthy (no known conditions) exclusion criteria: * chronic smoker pregnant

Keywords: exogenous ketone salts ketosis safety comprehensive metabolic panel complete blood count lipid panel insulin
my ms toolkit + coaching: a guided web-based symptom self-management program for people with ms

Conditions: Multiple Sclerosis

Summary: my ms toolkit is a web-based symptom self-management program for persons with multiple sclerosis (ms). this study is evaluating various aspects of my ms toolkit plus coaching and how it impacts symptom self-management in multiple sclerosis. the research team believe that the toolkit will be feasible, acceptable, and beneficial to participants.

study participants will be asked to use a newly developed web-based symptom self-management program, called the my ms toolkit, for 8 weeks. the my ms toolkit includes 8 modules that describe symptom self-management strategies. participants will explore the my ms toolkit, following the prompts and guides built into the program, and meet with a study coach weekly for 15 to 30-minute telephone-delivered coaching sessions. participants are encouraged to practice and apply the skills learned. the study can be done from participants' homes using a reliable internet-connected device. no travel is required.

Eligibility criteria:
inclusion criteria: * multiple sclerosis * have access to a reliable, internet-connected device (e.g. computer, tablet). (note: this study is conducted electronically and is not location dependent.) * one or more of the following: 1. moderate/moderately severe depressive symptoms 2. chronic pain 3. presence of significant fatigue symptoms * read, speak and understand english. exclusion criteria: * significant cognitive impairment * current psychotherapy for symptoms

Keywords: self-management web-based program
management of women with an incomplete miscarriage

Conditions: Miscarriage

Summary: miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, that is, before the fetal viability. the clinical signs of miscarriage are usually vaginal bleeding associated abdominal pain and cramping . the miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. if a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. however; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus. from many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold standard management' for miscarriage to remove the retained placental tissue. it is quickly performed and removed almost all the retained products of conception. however, the routine surgical evacuation of the uterus associated with higher rate of morbidity and mortality and should be limited for special indications. many studies compared the effectiveness of medical treatment compared to surgery in management of incomplete abortion. there is only one study compared the curettage with expectant management in those women after medical therapy.however; none of them, looked at the effectiveness of the second chance of medical treatment in management of incomplete abortion in trial to avoid the surgical intervention after failure of previous medical treatment. so we think that the immediate evacuation using surgical intervention is truly unnecessary in most cases of failed medical abortion and the patients may get benefit from another trial of medical treatment.


Eligibility criteria:
inclusion criteria: 1. women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation. 2. no known allergy to misoprostol. 3. women who will be haemodynamically stable. 4. good access to emergency facilities. exclusion 1. women with signs of severe infection ( fever \> 38°) 2. women with severe vaginal bleeding 3. women known to have allergy to prostaglandins 4. severe abdominal pain requiring immediate intervention
the safety and effectiveness of hyperimmune anti-hiv intravenous immunoglobulin (hvig) plus zidovudine in hiv-infected infants

Conditions: HIV Infections

Summary: to determine the safety and tolerance of hyperimmune anti-hiv intravenous immunoglobulin (hivig) and of zidovudine (azt) in infants with established hiv infection; to get preliminary evidence for the effectiveness of this type of treatment in preventing the advance of disease in hiv infected infants. hivig may be an effective agent that either alone or in combination with azt will prevent progression of clinical disease.

hivig may be an effective agent that either alone or in combination with azt will prevent progression of clinical disease. participants are randomized to receive either oral azt or hivig. patients may receive treatment for a maximum of 48 weeks. patients are evaluated during treatment at weeks 2, 4, and every 4 weeks thereafter. infants who are receiving hivig initially are treated with the appropriate age-adjusted dose of oral azt in addition to hivig if they meet clinical disease progression criteria. all participants who have completed 48 weeks of treatment or who are discontinued from treatment are followed every 3 months for an additional 48 weeks. this follow-up may be conducted over the telephone.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * recommended: * standard immunizations. should repeat mmr 3 months after discontinuing study. * benadryl and/or aspirin. * pneumocystis carinii pneumonia prophylaxis. * systemic ketoconazole and acyclovir, or oral nystatin for acute therapy. * aerosol ribavirin for short-term treatment of rsv. concurrent treatment: allowed: * blood transfusion. patients must have the following: * parent or guardian available to give written informed consent. * protocol requires prior institutional review board (irb) approval before any subject is entered into study. prior medication: allowed: * gammaglobulin, intravenous (iv) or intramuscular (im). * immunoglobulin, iv (ivig). * maternal antiretroviral treatment during pregnancy. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * symptomatic of any class p-2 symptoms (except lymphadenopathy at time of study entry. * presence of serious acute infection requiring parenteral treatment at time of study entry. concurrent medication: excluded: * prophylaxis for oral candidiasis or otitis media or other infections. * immunoglobulin therapy (except single dose or for hypogammaglobulinemia). * ketoconazole, acyclovir, or nystatin for prophylaxis. patients with the following are excluded: * symptomatic of any class p-2 symptoms (except lymphadenopathy at time of study entry. * presence of serious acute infection requiring parenteral treatment at time of study entry. prior medication: excluded: * antiretroviral treatment or experimental treatment within 2 weeks of entry.

Keywords: drug therapy, combination zidovudine