Kornimate/medical-research-clean huggingface dataset:
self-care in parkinson's disease: a study on patients and caregivers/self-care in the patient-caregiver dyad with parkinson's disease: a descriptive observational study

Conditions: Parkinson Disease (PD); Self-Care Ability

Summary: this descriptive observational study will involve dyads of parkinson disease patients and their caregivers. participants will be recruited from the parkinson's disease and movement disorders centre of asst gaetano pini-cto. validated questionnaires, such as the whoqol-bref, the self-care of chronic illness inventory version 2, and the caregiver self-efficacy in contributing to self-care scale, will be administered. the study will also include semi-structured interviews to gather qualitative data on the patients' and caregivers' perceptions of self-care. a non-probabilistic convenience sampling method will be used, with the inclusion of both patients at any disease stage and their primary caregivers. the sample size will range 311 dyads with 5% margin of error.

the primary objective of this study is to describe the proportion of self-care maintenance in the population with parkinson's disease and their respective caregivers. gaining an in-depth understanding of the phenomenon in its experiential and perceptual components, as well as the meanings attributed to it, is essential for developing and validating a new tool capable of assessing and measuring self-care in parkinson's disease. the secondary objectives are (a) to describe the proportions of self-care monitoring and management in the population with parkinson's disease and their respective caregivers; (b) to explore the meaning attributed by patients with parkinson's disease to self-care in its three dimensions: self-care maintenance, monitoring, and management; (c) to describe the attitudes and self-care behaviours adopted by patients with parkinson's disease across different disease stages; (d) to explore the meaning attributed by caregivers of patients with parkinson's disease to self-care in its three dimensions: self-care maintenance, monitoring, and management; (e) to describe the attitudes and self-care behaviours adopted by caregivers of patients with parkinson's disease across different disease stages; (f) to identify the dimensions of self-care and the constructs that should be represented within the items of the new instrument, the parkinson's disease self-care questionnaire (pdsc-q).

Eligibility criteria:
inclusion criteria: * spatial-temporal orientation * identifying as the primary caregiver of the person * understanding of the italian language * consent to participate in the study * informal caregiver exclusion criteria: * secondary forms of parkinson's disease * subjects with cognitive impairments, assessed with the mini mental state examination; score lower than 24/30 subjects who do not understand written and spoken italian subjects who did not provide consent to participate in the study

Keywords: malattia di parkinson self-care nurse
pulmonary vein isolation to reduce future risk of atrial fibrillation in patients undergoing typical flutter

Conditions: Typical Atrial Flutter; Risk Factors With Future Development of Atrial Flutter

Summary: the purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (af) and thromboembolic complications including cerebrovascular events (cve) in patients with typical atrial flutter (aflt) undergoing cavo-tricuspid isthmus (cti) ablation alone versus cti ablation combined with pulmonary vein isolation (pvi).

typical atrial flutter (aflt) is a common cardiac arrhythmia. studies have demonstrated the safety and superiority of ablation procedure over antiarrhythmic drug (aad) therapy. long term freedom from typical aflt has been consistently shown after successful ablation, but up to 30% of these patients can experience new onset of a different arrhythmia i.e., atrial fibrillation (af). af results from triggers in the back of the left upper chamber in the heart (left atrium - la). these triggers typically arise from in and around the opening of the 4 veins (pulmonary veins - pvs) that bring blood from the lungs into the heart. the highest incidence of af in patients undergoing ablation for typical aflt was observed where the follow-up duration exceeded a year after the aflt ablation. this would suggest that af development in patients undergoing typical aflt ablation is progressive and inevitable.

Eligibility criteria:
inclusion criteria: all patients with typical aflt confirmed by a 12-lead ecg that are referred for ablation and manifest ≥ 2 risk factors associated with future development of af will be eligible to participate in the study. risk factors for predicting future occurrence of af will include: 1. prior remote history of af (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation), 2. la size \> 4.0 cm, 3. left ventricular ejection fraction (lvef) ≤ 50%, 4. hypertension, and/or 5) obstructive sleep apnea. exclusion criteria: 1. subjects with documented ≥ 2 af episodes within the preceding 6 months of enrollment, 2. inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and 3. failure to provide informed consent.

Keywords: typical aflutter (aflt) cti ablation atrial fibrillation (af) pvi
hydroxychloroquine (hcq) for recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss; Miscarriage

Summary: recurrent pregnancy loss (rpl) affects 5% of couples trying to achieve parenthood. most cases of rpl are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. this leads to significant patient and provider frustration and emotional stress. hydroxychloroquine (hcq) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (sle). this use has shown that hcq is very safe in pregnancy. hcq has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained rpl. although some providers are already prescribing hcq for unexplained rpl, a randomized controlled trial is necessary to determine the true efficacy and safety of this treatment. this study has the potential to establish support for a new treatment option for unexplained rpl.


Eligibility criteria:
inclusion criteria: * women ages 18 and older * planning conception and have experienced 2 or more unexplained pregnancy losses prior to 20 weeks gestation and no more than one live birth exclusion criteria: * documented antiphospholipd antibodies * uterine malformation or parental chromosomal abnormality * known lupus or other medical conditions that require treatment with hydroxychloroquine outside of this study protocol * any medical contraindications to hydroxychloroquine or aspirin therapy, including liver or kidney disease, pregestational diabetes or known retinopathy
efficacy and safety study of gb-0998 for treatment of generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: this randomized controlled, multi-center study will carry out to assess the efficacy of gb-0998 compared to plasmapheresis in the treatment of the generalized myasthenia gravis based on the changes in quantitative myasthenia gravis score (qmg score) as primary endpoint, and in addition, to assess the safety of gb-0998


Eligibility criteria:
inclusion criteria: * patients diagnosed as generalized myasthenia gravis * patients who are not controlled by current therapy and need plasmapheresis therapy * patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent * patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment exclusion criteria: * patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment * patients who had undergone thymectomy within 24 weeks prior to enrollment * patients with 3 points item in bulbar symptom of mg-adl scale * patients with severe hepatic disorder, severe renal disorder or severe heat disorder * patients who have received treatment of malignant tumors * patients who have the anamnesis of shock or hypersensitivity to this drug * patients who have been diagnosed as hereditary fructose intolerance * patients who have the anamnesis of cerebral infarction or symptom of these diseases * patients who have been diagnosed as iga deficiency in their past history * pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant * patients who were administered other investigational drug within 12 weeks before consent

Keywords: myasthenia gravis
zepatier in patients with substance use

Conditions: Hepatitis C; Hiv; Coinfection, HIV; Substance Use Disorders

Summary: the goal of this study is to assess hepatitis c virus (hcv) treatment with zepatier (elbasvir/grazoprevir) in hcv monoinfected and human immunodeficiency virus (hiv)-hcv co-infected, hcv treatment-naïve or peginterferon/ribavirin-experienced patients with hcv genotype 1a, without baseline ns5a resistance, 1b, or 4 and substance use in urban, multidisciplinary specialty clinics.

previously, people who use substances and those without liver fibrosis or cirrhosis were excluded from receiving direct-acting antiviral (daa) treatment due to illinois medicaid restrictions. these sobriety and staging restrictions were recently lifted. however, due to these previous stringent requirements for sobriety, many patients were not able to be treated for hcv. this created a data gap for real-world outcomes of hcv treatment in people who use substances. this study presents a unique opportunity to provide patients with hepatitis c treatment and obtain much needed data on the use of elbasvir/grazoprevir in patients with substance use and other underrepresented comorbidities. additionally, this study will determine if our current standard of care for the treatment of hcv is effective for patients with substance use.

Eligibility criteria:
inclusion criteria: * adults (at least 18 years of age or older) * chronic hcv (hcv antibody positive with detectable hcv-rna) * hcv genotypes 1a, without the presence of baseline ns5a resistance (specifically, polymorphisms at amino acid positions 28, 30, 31, or 93), 1b, or 4 * hcv treatment-naïve or peginterferon/ribavirin-experienced * managed by the ui health infectious diseases clinic or liver clinic * recent or current substance use (per self-report or electronic medical record (emr) data within 90 days of the screening visit, with or without positive baseline urine toxicology), inclusive of one or more of the following: opiate substitution therapy; prescription medication misuse (including: opiates, sedatives, tranquilizers, hypnotics, and psychostimulants); illicit substances; injection drug use; alcohol exclusion criteria: * incarcerated * pregnant or breastfeeding * decompensated liver disease (child-pugh b or c) * albumin below 3 g/dl * platelet count below 75,000 * unwilling to commit to treatment and/or monitoring * poor venous access inhibiting laboratory collection * any condition considered by the investigators to be a contraindication to study participation * hepatitis b virus (hbv) surface antigen (hbsag) positive

Keywords: hcv hiv-hcv coinfection daa elbasvir/grazoprevir
using healthcare financing and digital technology to improve hypertension prevention and control in tanzania

Conditions: Hypertension; Diabetes

Summary: the aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in tanzania. the investigators will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called stop-ncds) and; (b) assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized stop-ncds strategy. the investigators will select and/or adapt intervention components making up the optimized stop-ncds strategy. using a hybrid clinical-effectiveness implementation design, the investigators will conduct a study in 2 sequential phases: 1) a clinical-effectiveness phase in which the investigators evaluate the effect of our combined strategies (task-sharing and weltel) versus usual care, on rates of systolic bp reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of cvd risks and prevention, and, other features of health provider ncd prevention activities. 2) a post-implementation phase in which the investigators use the re-aim framework to evaluate changes in the adoption and maintenance of our combined strategies in participating ichf health facilities across kilimanjaro region. the investigators will use the weltel communication and patient management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. it allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. deployment of weltel will allow for integration of ncd prevention targeted health services to all adult ichf members across differing life stages and ncd risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change.


Eligibility criteria:
inclusion criteria: * all adults with uncontrolled htn who receive care through ichf membership and are able to provide informed consent. exclusion criteria: * adults with controlled htn or those without a diagnosis of htn * unable or unwilling to provide informed consent

Keywords: hypertension diabetes ncd management ncd prevention mhealth healthcare financing
efficacy of lactobacillus reuteri dsm 17938 for the treatment of acute gastroenteritis in children

Conditions: Acute Gastroenteritis

Summary: acute gastroenteritis (age) is one of the most common diseases among children. oral rehydration therapy is the key treatment. according to the 2014 guidelines developed by the espghan probiotics may be considered in the management of children with age in addition to rehydration therapy. considering that evidence on l reuteri remains limited, the investigators aim to assess the efficacy of l reuteri dsm 17938 for the treatment of age in children. children vaccinated and not vaccinated against rotavirus will be evaluated separately. two independent reports (rotavirus-vaccinated and non-vaccinated children) are planned.


Eligibility criteria:
inclusion criteria: 1. acute gastroenteritis (age) defined as a change in stool consistency to loose or liquid form (according to the bristol stool form (bsf) scale or in the case of infants, the amsterdam stool form (asf) scale) and/or an increase in the frequency of evacuations (typically ≥3 in 24 h), lasting for no longer than 5 days. 2. age: older than 1 month and younger than 60 months. 3. a caregiver must provide written informed consent. exclusion criteria: 1. use of antibiotics within two weeks prior to enrolment. 2. use of gelatine tannate, diosmectite, probiotics, racecadotril, or zinc (including zinc containing ors) within a week prior to enrolment (a single dose is allowed). 3. breast feeding (\>50%) 4. chronic diarrhoeal gastrointestinal disease (e.g., inflammatory bowel disease, cystic fibrosis, coeliac disease, food allergy) 5. immunodeficiency 6. malnutrition (weight/height/length under 3rd percentile) (who child growth standards will be used)
identification of mutations responsible for rare familial skin diseases by next generation sequencing

Conditions: Familial Lipomatosis; Very Rare Dermatologic Diseases

Summary: the primary purpose of the protocol is to use next generation sequencing to identify pathogenic variants in genes involved in very rare skin diseases. the secondary purpose will be to study the genotype-phenotype correlation in order to re-evaluate the classification of these disorders. this work could help in the understanding of the physiopathology of very rare skin disorders.


Eligibility criteria:
inclusion criteria: * patients affected by familial lipomatosis * patients with rare dermatologic disease without molecular diagnosis * written informed consent is obtained from the patient and his/her family exclusion criteria: * the patient does not want to participate to the protocol * the patient is already included in another study using next generation sequencing technologies

Keywords: exome sequencing skin disease familial lipomatosis
floating for chronic pain

Conditions: Chronic Pain Syndrome

Summary: in recent years there has been a novel approach for the treatment of chronic pain: floatation rest (restricted environmental stimulation therapy). floating is a therapeutic approach, in which patients float in a specialized pool or tank on water that contains high concentrations of epsom salt (magnesium sulfate). water is kept at skin temperature (35-36°c) and the pool or tank is shielded to provide almost complete darkness and silence. this therapeutic approach has proven to be effective in alleviating chronic pain. due to the difficulties associated with designing a credible placebo control there have been no randomized controlled trials (rcts) with patients blinding so far. such blinding, however, is crucial, to assess the true therapeutic effect of the intervention. the investigators will conduct the first patient blinded rct of floatation rest for chronic pain with a credible placebo control for floating and a no-treatment group.


Eligibility criteria:
inclusion criteria: * current diagnosis of chronic pain disorder with somatic and psychological factors (german icd f45.41) * able and willing to give written informed consent exclusion criteria: * pregnant or nursing women (self report) * previous experience with floating * acute illnesses that may exacerbate or shadow the chronic pain condition (acute inflammation, major depression, active neoplasm, etc.) * history of alcohol and drug abuse * any clinically relevant abnormal findings in the clinical history, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study or the subject's ability to participate in the study. * any clinical condition that may prevent the subject from floating, such as: open injuries, contagious diseases (influenza, gi infections, athlete's foot), gerd, epilepsy, claustrophobia, schizophrenia, incontinence or acute skin disorders. * suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.

Keywords: somatic and psychological factors
cognitive rehabilitation for pd

Conditions: Parkinson's Disease

Summary: to investigate the effectiveness of a novel compensatory cognitive rehabilitation program for individuals with parkinson's disease (pd) and mild cognitive impairment (mci).

eligible study participants will be randomly assigned to one of two interventions: 1) cognitive rehabilitation (cognitive symptom management and rehabilitation therapy for parkinson's disease; cogsmart-pd) or 2) supportive care. interventions are held within a group format consisting of approximately 5 individuals with pd. groups will meet once per week for 1.5 hours over a 10-week period. neuropsychological testing will be administered pre- and post-intervention as well as 6- and 12-months after the intervention.

Eligibility criteria:
inclusion criteria: 1. diagnosis of parkinson's disease 2. mild cognitive impairment 3. over 40 years of age 4. fluent english speaker exclusion criteria: other neurological conditions (e.g., stroke) besides parkinson's disease

Keywords: parkinson's disease rehabilitation cognition
natural history study of children with metachromatic leukodystrophy

Conditions: Lipid Metabolism Disorders; Metachromatic Leukodystrophy (MLD); Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Demyelinating Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Sphingolipidoses; Hereditary Central Nervous System Demyelinating Diseases; Metabolic Inborn Brain Diseases; Lysosomal Storage Diseases; Metabolic Diseases; Sulfatidosis

Summary: the purpose of this study is evaluate the natural course of disease progression related to gross motor function in children with metachromatic leukodystrophy (mld).

metachromatic leukodystrophy (mld) is an inherited, autosomal recessive disorder of lipid metabolism characterized by deficient activity of the lysosomal enzyme, arylsulfatase a (asa). mld is a rare genetic disease that occurs in most parts of the world. the estimated overall incidence of the disease in the western world is approximately 1 in 100,000 live births. this study is a multicenter, observational, longitudinal study that plans to enroll up to 30 patients with onset of mld-related signs and symptoms prior to 30 months of age and who are less than 12 years of age. patients will participate in this study for approximately 114 weeks (screening through follow-up) and will be assessed at defined intervals for disease status.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of mld by both: * arylsulfatase a (asa) deficiency by assay in leukocytes and * elevated sulfatide in urine 2. appearance of the first symptoms of disease at or before 30 months of age. 3. a gmfm-88 total (percent) score greater than or equal to 40 at the screening examination. 4. the patient is less than 12 years of age at the time of enrollment. 5. the patient and his/her parent or legally authorized representative(s) must have the ability to comply with the clinical protocol. 6. patient's parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. study-related activities are any procedures that would not have been performed during normal management of the patient. exclusion criteria: 1. history of hematopoietic stem cell transplantation. 2. the patient has any known or suspected hypersensitivity to agents used for anesthesia or is thought to be at an unacceptably high risk for associated potential complications of airway compromise or other conditions. 3. any other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study. 4. the patient is enrolled in another clinical study that involves the use of any investigational product (drug or device) within 30 days prior to study enrollment or at any time during the study.