Kornimate/medical-research-clean huggingface dataset:
cognitive impairment in parkinson's disease categorised in accordance to motor symptoms

Conditions: Parkinson's Disease

Summary: background: approximately 40% of patients with parkinson's disease (pd) have cognitive impairments. there is a lack of consensus as to the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the type and severity of cognitive impairment. this discrepancy can in part be caused by the lack of distinction between patients with different motor symptoms and disease severity. objective: to identify the extent to which psychiatric symptoms, depression, age at disease onset, disease duration, and medication is related to the severity and type of cognitive dysfunction in patients with idiopathic pd categorized according to motor symptoms and disease severity. methods: the population of patients with pd in the old county of aarhus is described on the background of medical records, and stratified in accordance to age, sex and cardinal symptoms. through proportional allocation a sample of a minimum of 50 patients with pd is drawn from the population. the patients and 30 healthy matched controls will undergo comprehensive neuropsychological assessment including tests of language, memory, executive function, and visuospatial function. furthermore, all participants will be screened for depression (geriatric depression scale) and psychiatric symptoms (neuropsychiatric inventory and symptom checklist). the patients will be categorized in accordance with their motor symptoms via cluster analysis for the purpose of analyzing the effect of psychiatric symptoms, depression, and age of disease onset, disease duration, and medication on cognition.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's in accordance to uk parkinson's disease society brain bank clinical diagnostic criteria, * born and raised in denmark , * \>50 years exclusion criteria: * cerebrovascular disease, * dementia not caused by parkinson's disease, * metabolism anomaly, * abuse of drugs, medication or alcohol, * history of head injuries, * severe psychiatric disorder, excluding depression, * resident outside the region of aarhus h) dbs -

Keywords: neuropsychology cognitive impairment motor disorder parkinson's disease
phase 1b/2 platform study of select immunotherapy combinations in participants with advanced non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: this is a phase 1b/2 study evaluating the anti-pd1 antibody, cemiplimab, in combination with either s095018 (anti-tim3 antibody), s095024 (anti-cd73 antibody), or s095029 (anti-nkg2a antibody) in adult participants with previously untreated advanced/metastatic non-small cell lung cancer (nsclc) with high pd-l1 expression. the study includes two parts: part a, the combination-therapy safety lead-in phase to determine the recommended dose for expansion (rde) for s095018, s095024, and s095029 in combination with cemiplimab and part b, the randomized dose expansion phase to assess the efficacy of s095018, s095024, or s095029 in combination with cemiplimab. study treatment will be administered for a maximum of 108 weeks, or until confirmed disease progression per irecist and/ or until meeting other treatment discontinuation criteria.


Eligibility criteria:
inclusion criteria: * adult patient aged ≥ 18 years * written informed consent * histologically (squamous or non-squamous) or cytologically documented locally advanced nsclc not eligible for surgical resection and/or definitive chemoradiation, or metastatic nsclc * no prior systemic treatment for locally advanced or metastatic nsclc * high tumor cell pd-l1 expression \[tumor proportion score (tps) ≥50%\] based on documented status as determined by an approved test * eastern cooperative oncology group (ecog) performance status of 0 or 1 * measurable disease as determined by recist v1.1 exclusion criteria: * tumors harboring driver mutations/genetic aberrations for which targeted therapies are approved as frontline treatment (e.g. egfr mutation, alk fusion oncogene, ros1 aberrations) * prior immune checkpoint inhibitor therapy * active brain metastases * participants with active and uncontrolled hepatitis b virus (hbv) or hepatitis c virus (hcv) infection * uncontrolled hiv infection. participants with hiv who have controlled infection (undetectable viral load and cd4 count above 350 either spontaneously or on a stable antiviral regimen) are allowed to enroll * active, known or suspected autoimmune disease or immune deficiency * history of hypersensitivity reactions to any ingredient of the investigational medicinal product (imp) and other monoclonal antibody (mabs) and/or their excipients * history of interstitial lung disease, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis or active pneumonitis ≥ grade 2 * history of inflammatory bowel disease or colitis ≥ grade 2 * history of hemophagocytic lymphohistiocytosis. * systemic chronic steroid therapy (\>10mg/d prednisone or equivalent) * active infection, including infection requiring systemic antibiotic therapy * pregnant or breast-feeding (lactating) women * participants with a history of allogeneic organ transplantation (e.g., stem cell or solid organ transplant) * any medical condition that would in the investigator's judgement prevent the participant's participation in the clinical study

Keywords: non-small cell lung carcinoma
home-based interventions for adolescents with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: adolescents with t1d and chronic poor metabolic control are at high risk for short and long-term diabetes complications and are heavy users of both medical resources and health care dollars. the purpose of the proposed study is to collaborate with a community agency to develop and test an intervention, fit families, that uses the core components of a previously successful home-based family treatment, but that can delivered by lower cost community health workers. if successful, fit families could improve health outcomes in a vulnerable population at high risk for diabetes complications, and could be translated to real-world treatment settings.

the proposed study is a planning grant in which mst will be adapted for delivery by community health workers and will be conducted in collaboration with chass, a community agency providing health care to underserved residents of detroit with diabetes. the new intervention, fit families (ff), will be tested in a pilot randomized controlled trial in order to evaluate ff feasibility, finalize outcome measures, estimate intervention effect sizes on health outcomes (i.e., youth adherence, glycemic control, quality of life) and determine potential cost savings associated with reduced hospital admissions. these steps will allow for finalization of intervention content and other trial parameters in preparation for a larger r18 dissemination trial. the design for the proposed study is a randomized, controlled trial using a sample of 60 adolescents. half will be randomly assigned to the treatment intervention, fit families plus standard medical care, and the other half will be assigned to standard medical care alone. families who are randomized to ff receive intensive, home-based family therapy delivered by a community health worker (chw) for approximately six months.

Eligibility criteria:
inclusion criteria: * a current hemoglobin a1c(hba1c) of \>9.0% * an average hba1c of \>9.0% during the past year * reside in the metro detroit tri-county area * diagnosed with type 1 diabetes for at least one year * aged 10-17 * patient of children's hospital of michigan diabetes clinic exclusion criteria: * severe mental impairment/thought disorder * active suicidality * active homicidality * diabetes secondary to another comorbid medical condition and/or medical management differing substantially from that of most children with diabetes.

Keywords: insulin dependent diabetes mellitus family therapy adolescents regimen adherence metabolic control
comparison of the acute effects of focused and radial eswt on pain and balance performance in individuals with plantar fasciitis: a randomized clinical trial

Conditions: Plantar Fascitis; Pain

Summary: this study aimed to compare the acute effects of focused and radial eswt on pain and balance performance in individuals with plantar fasciitis.

this study aimed to compare the acute effects of focused and radial eswt on pain and balance performance in individuals with plantar fasciitis. the study included 40 individuals (27 females and 13 males) aged between 18 and 63 years, presenting with plantar fasciitis (pf). extracorporeal shockwave therapy (eswt) was administered once a week for four weeks. the participants were randomly assigned to two groups (f-eswt and r-eswt). pain levels were assessed using the visual analogue scale, while static and dynamic balance were evaluated using the biodex balance system.

Eligibility criteria:
inclusion criteria: unilateral or bilateral tenderness in the medial tubercle of calcaneus and heel pain in the first few steps in the morning, which gets worse with increased activity, absence of any known systemic disease, absence of any surgical procedure to lower extremity, absence of any treatment for pf in the last 6 months, 18-65 years, and consent to participate in the study. exclusion criteria: pregnancy, pacemaker, receiving anticoagulant therapy, uncontrolled cardiovascular disease, tumor, acute infection, nerve root compression, local dermatological or neurological problems, diabetes mellitus, taking anti-inflammatory drugs during treatment, or incomplete follow-up.

Keywords: balance pain plantar fasciitis stability
mechanisms of refractory hypertension (reserpine)

Conditions: Refractory Hypertension

Summary: the study is deigned to determine if refractory hypertension is attributable to heightened sympathetic tone by quantifying the antihypertensive benefit of reserpine, a sympatholytic agent, in patients failing other classes of antihypertensive agents.

patients with refractory hypertension, defined as uncontrolled office blood pressure despite use of 5 or more antihypertensive agents, including a thiazide diuretic and spironolactone. after withdrawal from other centrally-acting agents if needed, enrolled patients will be randomized to open-label reserpine 0.1 mg daily for 4 weeks. twenty-four hour ambulatory blood pressure monitoring will be done at baseline, after the initial 4-week treatment period. all other antihypertensive medications will remain unchanged during the 4-week treatment period. the primary endpoint will be change in 24-hr ambulatory systolic blood pressure.

Eligibility criteria:
inclusion criteria: - adult with refractory hypertension defined as uncontrolled office blood pressure with use of 5 or more hypertensive agents, including a thiazide diuretic and spironolactone exclusion criteria: * congestive heart failure (ef 40%) * chronic kidney disease (gfr \<40 ml/min/1.73 mm) * stroke and/or myocardial infarction or acute chf exacerbation within last 3 months * ongoing depression * active peptic ulcer disease * bradycardia \<50 beats per minute * 2nd or 3rd degree heart block * known intolerance of reserpine * use of digoxin or tricycle antidepressants

Keywords: hypertension sympathetic tone resperpine
efficacy of non-invasive vagus nerve stimulation for treatment of low weight eating disorders

Conditions: Anorexia Nervosa

Summary: this project includes a 4-week randomized trial comparing pre-meal vagal nerve stimulation (tavns) to pre-meal sham stimulation. the aims will assess if tavns results in greater satisfaction, greater calorie consumption, less self-reported fullness, decrease in eating disorder symptoms, and less anxiety than sham stimulation.

the purpose of this research study is to determine the safety and ability of a device that will stimulate the vagus nerve (tavns), in 30 adolescents ages 14-17. this project will explore if stimulation has any effect on eating behaviors in individuals with eating disorders, such as anorexia nervosa. study measurements include eating behavior and other measures of behavior. these measurements will take place before and in response to the nerve stimulation during the course of a 4-week randomized trial. participants are assigned to one of two conditions: 1) vagal nerve stimulation (n=20; this group includes use of the vagus nerve stimulator with stimulation); and 2) sham stimulation (n=10; this group includes use of the vagus nerve stimulator with no stimulation). screening to determine eligibility includes physical measurements of height and weight, interview questions to determine inclusion/exclusion criteria and eating disorder diagnoses, and online redcap surveys. if eligible, participants will be scheduled for 5 study visits. procedures will include tavns, single item meals, check-ins during treatment in the eating and weight disorders program, and self-report questionnaires. clinic check-ins (3 days per week while in the clinic during the 4 week intervention) will include tavns stimulation or sham for 30 minutes. study visits (4 weekly study visits lasting 1 hour each) will include a single item meal test, self-report surveys, and adverse event assessment and documentation. the follow-up visit, lasting 1 hour, will take place 1 week after the final study visit and includes self-report surveys and adverse event assessment and documentation.

Eligibility criteria:
inclusion criteria: * ages 14-22 * engaged in standardized refeeding in the ewdp during the intervention (may include individuals with anorexia nervosa or avoidant/restrictive food intake disorder) * needing to gain at least 8 lbs during the refeeding period * english-speaking exclusion criteria: * pregnancy * gi disturbance or diagnosis (crohn's disease, diverticulitis, irritable bowel syndrome, gastric bezoar, or suspected or known gi obstruction) * gi surgery in the last 3 months * implanted or portable electro-mechanical device such as a pacemaker, defibrillator, or infusion pump * allergies to the ingredients in the shake provided * use of illicit substances including misuse, overuse, abuse, illegal use, or addiction to or dependence on * acute suicide risk/active suicidal ideation determined with the c-ssrs. "yes" to questions 1 or 2 in the suicidal ideation section or "yes" to any question in the suicidal behavior section will be exclusionary * psychiatric diagnoses of schizophrenia or bipolar disorder
efficacy and safety study of opc-1085el ophthalmic solution in subjects with glaucoma or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to determine the efficacy and safety of opc-1085el ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.


Eligibility criteria:
inclusion criteria: * subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension exclusion criteria: * subjects with ocular conditions as defined by the protocol
adalimumab in adult japanese subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in japanese subjects with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * participation and completion until week 24 of the prior adalimumab dose-ranging study. * females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion. * female subjects tested negative in pregnancy test (serum test) at week 24 in prior adalimumab study, if capable of pregnancy. exclusion criteria: * a subject who experienced any of the following during prior study: * advanced or poorly controlled diabetes * joint surgery (joint evaluated in this study) * a subject who has been prescribed excluded medications during prior study. * history of following during prior study: * clinically significant drug or alcohol abuse * intravenous (iv) drug abuse * active infection with listeria or tuberculosis (tb) * lymphoma, leukemia * and, any malignancy with the exception of successfully treated non-metastatic basal cell carcinoma of the skin. * a subject who has been administered a live vaccine during prior study, or subject scheduled to complete the administration of a live vaccine during the study period

Keywords: rheumatoid arthritis
mri in evaluating the effect of efaproxiral on the brain in patients with recurrent or progressive glioma enrolled on clinical trial nabtt-9806

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: diagnostic procedures, such as mri, may help doctors learn how efaproxiral works in the brain and help plan the best treatment. purpose: this clinical trial is using mri to evaluate the effect of efaproxiral on the brain in patients with recurrent or progressive glioma receiving treatment on clinical trial nabtt-9806.

objectives: * determine whether efaproxiral has a measurable effect on the brain as shown by t2 and/or t2\* mri in patients with recurrent or progressive malignant glioma enrolled on nabtt-9806. * determine predicted oxygenation changes based on observed t2 mri changes in these patients. * determine the effects of this drug on t2 and t2\* mri relaxation times of normal areas of the brain in these patients. * determine baseline oxygen extraction ratios in tumors of patients treated with this drug. * determine whether administration of this drug reveals any new tumor- or non-tumor-related abnormalities on t2 and t2\* mri in these patients. outline: this is an open-label, multicenter, pilot study. patients receive efaproxiral and carmustine on clinical trial nabtt-9806. during any one course of treatment on that study, patients undergo mri before oxygen administration (baseline), before efaproxiral infusion, and then every 5 minutes until 1 hour after efaproxiral and carmustine treatment. data is evaluated for extent and intensity of t2/t2\* changes and oxygen concentration changes in both abnormal and normal brain. projected accrual: a total of 15-48 patients will be accrued for this study within 12-24 months.

Eligibility criteria:
disease characteristics: * recurrent or progressive glioma * currently enrolled on clinical trial nabtt-9806 patient characteristics: * no severe claustrophobia * no cardiac pacemaker * no mri-incompatible metallic implant prior concurrent therapy: * not specified

Keywords: adult anaplastic oligodendroglioma adult giant cell glioblastoma adult anaplastic astrocytoma recurrent adult brain tumor adult glioblastoma adult gliosarcoma
efficacy of aerosal® in the treatment of inverse psoriasis and sebopsoriasis

Conditions: Inverse Psoriasis; Sebopsoriasis

Summary: the purpose of this study is to evaluate the efficacy of aerosal® compared to placebo in the prognosis of inverse psoriasis or sebopsoriasis present for at least one year


Eligibility criteria:
inclusion criteria: * inverse psoriasis or sebopsoriasis lasting from at one year * at least 1% of total body surface area involvement suspension for more than 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporin, systemic steroids), psoralen plus ultraviolet a irradiation (puva) or ultraviolet b phototherapy (uvb) exclusion criteria: * patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure * iodine allergy * women who are pregnant or planning to become pregnant during the study

Keywords: psoriasis salt sodium chloride
effect of an oral supplement enriched in amino acids and the leucine metabolite b-hydroxy b-methylbutyrate (hmb)

Conditions: Pressure Ulcers

Summary: the focus of this study is to look at the role of nutrition in the healing of pressure ulcers. the purpose of this study is to test whether the rate of healing of pressure ulcers is increased in those patients receiving a nutritional supplement of amino acids and the leucine metabolite, b-hydroxy-b-methylbutyrate is enhanced when compared to control patients receiving a supplement containing only one of the proteins in the experimental supplement

patients who have pressure ulcers stage ii or greater will be randomized to receiving one of two nutritional supplements. one supplement contains arginine and the other contains both arginine,glutamine and leucine metabolites. pressure ulcers will be measured at study entry and measured biweekly using a standardized tool (push) until the trial is completed or the pressure ulcer has healed. inclusion criteria include: * stage ii or greater pressure ulcer * patient consent * patients who can drink supplement or receive it by tube * patients who are 21 years old or greater exclusion criteria include: * patients with infected wounds * patients with cellulitis, sepsis or osteomyelitis * patients with end-organ failure * patients with poorly controlled diabetes mellitus (hba1c\>10) * patients who cannot tolerate oral or tube feeding

Eligibility criteria:
inclusion criteria: 1. patients with stage ii pressure ulcer or greater 2. patients who consent to participate 3. patients who can ingest the supplement either orally or per feeding tube 4. patients who are 21 years of age or older exclusion criteria: 1. patients with infected wounds 2. patients with cellulitis, sepsis or osteomyelitis 3. patients with end-organ failure 4. patients with poorly controlled diabetes mellitus (hba1c\>10) 5. patients who cannot tolerate oral or bolus tube feedings