Kornimate/medical-research-clean huggingface dataset:
the clinical effects of modified trs treatment

Conditions: Tinnitus, Subjective

Summary: objective tinnitus is one of the most common acoustic disorders by affecting 5-43% people around the world, and tinnitus is harmful to social and individuals, inducing to annoyance, irritability, anxiety, depression, insomnia and concentration difficulties. many efforts have been made to help tinnitus suffers, however, the curative means are still in absence. this study aims to introduce a novel sound therapy for tinnitus and to evaluate the efficacy of modified tinnitus relieving sound treatment in comparison with unmodified music which served as a control. methods and analysis a randomized, triple-blinded, controlled, clinical trial will be carried out. 68 patients with subjective tinnitus will be recruited and randomized into two groups in 1:1 ratio. the primary outcomes will be tinnitus handicapped inventory (thi), hospital anxiety and distress scale (hads), and visual analogue scale (vas) for tinnitus; the secondary outcome measures will be athens insomnia scale (ais), tinnitus loudness matched by sensation level (lm, sl), and minimum masking level (mml). assessment will be performed at baseline and at 1, 3, 9, and 12 months post-randomization. the sound stimulus will be persistent until 9 months after randomization, and be interdictory in the last three months.


Eligibility criteria:
inclusion criteria: 1. adults aged between 18 to 80 years old; 2. diagnosed with subjective tinnitus; 3. chronic tinnitus: tinnitus course ≥3 months; 4. be able to understand and communicate with mandarin； 5. the average pure tone threshold (0.5, 1, 2khz) ≤ 55db hl of the worse ear; 6. subjects are able to understand the purpose of the study, volunteer to participate and cooperate with the instructors to complete the experiment, and be willing to sign the informed consent. exclusion criteria: 1. pulsatile tinnitus and objective tinnitus； 2. having significant health issues that affect or prevent participation or continue with the follow-up; 3. diseases requiring other medical intervention first (eg, infections, tumors, otosclerosis, meniere's disease, the acute stage of sudden sensorineural hearing loss); 4. people with severe hyperacusis, severe anxiety, depression and other psychiatric disorders； 5. currently participating in other research projects that may affect tinnitus； 6. subjects who are not considered suitable for this clinical trial by the researchers.

Keywords: subjective tinnitus tinnitus relieving sound clinical effects
post-marketing surveillance of gliadel 7.7mg implant (all-case observational study)

Conditions: Malignant Glioma

Summary: post-marketing surveillance to investigate the clinical safety and effectiveness in patients of all implantation of gliadel with malignant glioma in the actual medical setting.


Eligibility criteria:
inclusion criteria: * all-patient of gliadel implantation exclusion criteria: * none

Keywords: malignant glioma glioblastoma multiforme
feasibility of technology-based ssip in prostate cancer patients

Conditions: Prostate Cancer; Psychosocial Stressor

Summary: the goal of this pilot study is to assess the perceived usability of a smartphone application called wings targeting psychosocial distress and well-being in prostate cancer patients and their social network. the main questions it aims to answer are: * how do prostate cancer patients and their social network rate the usability of the technology-based social-support intervention program smartphone application? * do symptoms of prostate cancer patients improve after using the wings smartphone application? * does the burden of prostate cancer patients social network decrease after using the wings smartphone application? participants will be asked to use the wings smartphone application over the period of eight to twelve weeks and fill in questionnaires before, during, and after this time.

there is still little knowledge about how smartphone apps can improve the quality of life in prostate cancer patients. hence, the investigators are interested in finding out whether the simplified access to information and planning of activities increases the perceived social support in prostate cancer patients and ultimately improves their quality of life. the duration of the study is approximately three months per participant. the wings smartphone application can be used from home and questionnaires can be completed online. participants are therefore not required to be present at the university hospital basel during the entire course of the present study. the investigators plan to recruit a total of 30 prostate cancer patients at the university hospital basel and 0-10 supporters (family members and friends) per prostate cancer patient. all study participants will have access to the regular treatment services of the university hospital basel.

Eligibility criteria:
inclusion criteria: * able and willing to give written consent * male; * ≥ 18 years of age; * sufficient knowledge of german language; * confirmed diagnosis of prostate carcinoma; * successfully completed prostatectomy with "da vinci®" method; * willingness to use the wings-ip1 smartphone application (technology-based ssip); * in possession of a smartphone on which the wings-ip1 smartphone application v1.0 can be installed (required operating systems: ios 12.1 or newer, android 7.0 or newer); * access to the internet with smartphone; * ability to operate a smartphone; exclusion criteria: * previous enrolment in the current investigation; * current diagnosis of severe mental disorder, namely bipolar disorder, schizophrenia, personality disorder; * simultaneous participation in any other clinical trial, hospital program, or psychosocial intervention targeting similar concepts (e.g., mental wellbeing, social support, sexuality, etc.); * receiving any current treatment for mental disorder (psychotherapy and/or medication) apart from already existing long-lasting therapies (≥ 6 months);

Keywords: prostate cancer social support mental health psychosocial intervention pilot study
the effect of anakinra on insulin secretion

Conditions: Glucose Intolerance; Impaired Insulin Secretion; Diabetes Mellitus Type 2

Summary: rationale: once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. recent findings suggest that interleukin-1 (il-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus. objective: to determine whether blocking il-1β by recombinant human il-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.


Eligibility criteria:
inclusion criteria: * impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/l) and/or hba1c levels of 5.7-6.4% * bmi \>25 kg/m2 * age 40-70 years exclusion criteria: * known diabetes mellitus * fasting plasma glucose ≥ 7.0 mmol/l or hba1c ≥ 6.5% * immunodeficiency or immunosuppressive treatment (including tnfα blocking agents and corticosteroids) * use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed) * signs of current infection (fever, c-reactive protein \>30 mmol/l, treatment with antibiotics, previous or current diagnosis of tuberculosis) * a history of recurrent infections * pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required) * liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range * renal disease defined as mdrd \< 60 ml/min/1.73m2 * neutropenia \< 2x 109/l * inability to understand the nature and extent of the trial and the procedures required. * any medical condition that might interfere with the current study protocol * participation in a drug trial within 60 days prior to the first dose
investigating genetic status in patients presenting to clinic

Conditions: Dementia, Frontotemporal; Alzheimer Dementia (AD); Lewy Body Dementia (LBD)

Summary: the causes of neurodegenerative dementias such as frontotemporal dementia, lewy body disease and alzheimer's disease are still largely unknown. while the contribution of some genetic mutations and polymorphisms is associated with autosomal dominant patterns of inheritance of these dementias, in many cases, the specific causative mutation in these families is not yet identified. further, in many patients, polygenic risk is thought to give rise to pathophysiologic changes, but which specific genes affect risk are largely yet unknown. by examining genotypes in patients that present to our cognitive neurology and alzheimer's research clinic with suspected or confirmed neurodegenerative dementia, or have a history of a familial dementia, we aim to help identify and characterize genetic mutations or polymorphisms that give rise to neurodegenerative diseases.


Eligibility criteria:
inclusion criteria: * persons presenting to the cognitive clinic with a neurodegenerative disorder (for example, ad, ftd, lbd, alsp, and related conditions); * biological family members of someone diagnosed with a neurodegenerative disorder, presenting to clinic; * age 18+ years old; * consenting to a blood draw. exclusion criteria: • persons declining / unwilling / not able to have a blood draw.

Keywords: neurodegenerative disorders
greens-based crossover trial to improve epigenetic aging in adults

Conditions: Aging

Summary: the primary purpose of this study is to assess changes in epigenetic markers of aging and physiological parameters in overweight older adults consuming a mixed greens-based supplement over a 30-day period in a randomized crossover design.

investigators will recruit 20 overweight/obese but otherwise healthy participants aged 50-65. participants will be randomized to consume the greens-based supplement each morning for the first 30 days or second 30 days of the study. usual diet, physical activity, and sleep patterns will be encouraged and monitored during the duration of the study. phlebotomy will be conducted at baseline, 30-day crossover, and 60-day follow-up to assess dna methylation in peripheral blood mononuclear cells. visceral and total body fat, stool microbiome composition, and actigraphy will also be assessed.

Eligibility criteria:
inclusion criteria: * men and women of any ethnicity (women must be postmenopausal) * body mass index \> 30 kg/m\^2 * low habitual dark green leafy vegetable consumption * willing to adhere to study protocol and measures * willing to communicate via smartphone technology * able to read, write and speak english exclusion criteria: * overt cardiometabolic diseases such heart attack, stroke, diabetes, insulin resistance and non-alcoholic fatty liver disease, etc. * diagnosis of a transient ischemic attack in the 6 months prior to screening * diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision * food allergies

Keywords: epigenetic aging microbiome quality of life overweight and obesity
efficacy and safety of the fixed dose combination of glimepiride+metformin in type 2 diabetic patients inadequately controlled

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: -to demonstrate the efficacy of a fixed combination of glimepiride + metformin in terms of hba1c reduction, during 24-week treatment period in patients with inadequately controlled type 2 diabetes mellitus. secondary objective: to assess the effects of the fixed combination of glimepiride and metformin at week 24 on: * percentage of patients reaching hba1c \<7% * percentage of patients reaching hba1c \<6.5%. * fasting plasma glucose (fpg) * safety and tolerability

the study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period and 3 days follow-up period with a last call phone visit.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus inadequately controlled despite a treatment with sulfonylurea (su) alone or metformin alone or a free combination of su and metformin prior to the study entry. * signed informed consent, obtained prior any study procedure exclusion criteria: * age \< legal age of adulthood * hba1c \< 7% or ≥ 11% * bmi \> 35 kg/m2 * treatment with a stable dose of maximally tolerated su alone or metformin alone or the free combination of su and metformin for less than 12 weeks prior to the screening visit. * patients who received any anti-diabetic drug other than su or metformin within 12 weeks prior to the screening visit. * diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake...) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
nurse-led integrated care in copd patients with a pulmonary exacerbation

Conditions: COPD Exacerbation

Summary: the aim of the study is to evaluate the effect and effectiveness of the nurse-led integrated care programme for the management of copd (chronic obstructive pulmonary disease) exacerbations on patients' quality of life, rehospitalisation and exacerbation rate, illness-related emotional distress, selected health behaviours and cost-utility at three months. furthermore, understanding barriers and facilitators to implementation success is of interest.


Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of copd (gold 1-4) * hospitalisation due to a copd exacerbation and decision to start with steroids and/or antibiotics (severe exacerbation) * age ≥ 18 exclusion criteria: * cognitive impairment (dementia, delirium) * not speaking german, french, italian, english, spanish, portuguese, serbian, tamil, hindi, turkish or slovakian

Keywords: integrated care self-management
remote monitoring to identify worsening heart failure the remoti-hf randomized clinical trial

Conditions: Heart Failure; Arrythmia

Summary: heart failure, characterized by high mortality and morbidity rates, frequent hospital admissions, and prolonged stays in cardiology wards, significantly impacts patients' quality of life. the remoti-hf is a single-center randomized controlled trial designed to assess the impact of remote monitoring, utilizing the heartlogic and triagehf algorithms, in patients with heart failure with implantable cardioverter defibrillator or cardiac resynchronization therapy. the primary endpoints include mortality, hospital admissions related to heart failure, and visits for worsening heart failure. moreover, we will explore the full capabilities of these algorithms, by analysing the association of physical activity, measured by the devices, with the same key outcomes. additionally, the research will explore the relationship between the absolute values provided by the algorithms and nt-probnp values.

patients will be randomized into two arms: one with the activation of the algorithm and the other with no active algorithm. the algorithm is programmed to alert our team upon detecting a patient at risk of worsening heart failure. when an alarm is triggered, the patient will receive a telephone call from the investigation team. subsequently, the patient may be scheduled for a hospital visit, or ambulatory medication adjustments can be made. for patients in whom the algorithm is deactivated, no such alarm mechanism will be in place. patients in both arms will undergo comparison based on relevant heart failure events, defined as follows: * all-cause mortality * hospital admission for heart failure * hospital visit for worsening heart failure * ventricular arrhythmias * atrial arrhythmias additionally, the study will explore the association between physical activity measured by the devices and these specified events. in addition to evaluating patient outcomes, a correlation analysis will be conducted to examine the relationship between the absolute value provided by the algorithm and absolute nt-probnp values. this analysis aims to assess the concordance and potential predictive value of the algorithm's output with established biomarkers, specifically nt-probnp, in the context of heart failure progression and severity (if possible).

Eligibility criteria:
inclusion criteria: * possession of an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt) device that is compatible with the heartlogic or triagehf algorithms. * left ventricular ejection fraction at the time of device implantation must be equal to or less than 35%. exclusion criteria: * younger than 18 years old or older than 85 years old. * unable to be contacted when out of the hospital. * presence of severe cognitive impairment. * currently on the heart transplant waiting list

Keywords: heart failure remote monitoring icd crt
study measuring differences in cognition due to sedative effects of risperidone and quetiapine in stable bipolar i outpatients

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine whether the sedating (causing sleepiness) effects of risperidone or quetiapine alter cognitive (person's ability to think, perceive, recognize, remember, judge, and reason) functioning in subjects with stable bipolar i disorder.

to compare the treatment effects of risperidone and quetiapine on cognitive function, using measures commonly believed to be affected by sedation and at doses typically used in clinical settings in stable bipolar i outpatients.one-half of patients are randomized to treatment sequence risperidone-quetiapine (r-q), and the other one-half to quetiapine-risperidone (q-r). patients randomized to r-q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing. after a 6 - 14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing. those randomized to q-r receive the same treatments, but in reverse order. patients randomized to r-q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing. after a 6-14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing. those randomized to q-r receive the same treatments, but in reverse order.

Eligibility criteria:
inclusion criteria: * subjects with bipolar i disorder in partial or full remission and deemed clinically stable exclusion criteria: * current use of benzodiazepines, prescription or herbal sleep agents * use of antihistamines * use of antipsychotic medications in the past 6 months * pregnant/breastfeeding females * females not using contraception * illicit drug users

Keywords: bipolar i disorder risperidone quetiapine sedation cognition
safety, tolerability, and efficacy of bvs857 in patients with spinal and bulbar muscular atrophy

Conditions: Spinal and Bulbar Muscular Atrophy

Summary: the purpose of this study was to determine if bvs857 is safe, tolerable and increases thigh muscle thickness in patients with spinal bulbar and muscular atrophy (sbma).


Eligibility criteria:
key inclusion criteria: * genetic diagnosis of sbma with symptomatic muscle weakness * able to complete 2 minute timed walk * serum igf-1 level less than or equal to 170 ng/ml key exclusion criteria: * medically treated diabetes mellitus or known history of hypoglycemia * history of bell's palsy * treatment with systemic steroids \> 10 mg/day (or equivalent dose); androgens or androgen reducing agents; systemic beta agonists; or other muscle anabolic drugs within the previous 3 months * history of cancer, other than non-melanomatous skin cancer * retinopathy * papilledema other protocol defined inclusion/exclusion criteria may apply
vitamin d, blood pressure, lipids, infection and depression

Conditions: Hypovitaminosis D

Summary: there are numerous indications for a relation between low serum levels of 25(oh)d and blood pressure, lipid levels, frequency of infections and tendency towards depression. whether it is a causal relationship it is not known, and can best be studied with a vitamin d intervention. the investigators hypothesis is that supplementation with a high dose vitamin d (40.000 iu per week) will have a beneficial effect on these parameters.


Eligibility criteria:
inclusion criteria: * men and women 30 - 75 years of age * low serum 25(oh)d levels exclusion criteria: * diabetes * other serious diseases * hypercalcemia

Keywords: vitamin d blood pressure lipids infection depression
coproporphyrine isomers and methotrexate elimination

Conditions: Central Nervous System Neoplasms; Lymphoma, Large B-Cell, Diffuse; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma

Summary: high dose methotrexate (mtx) is responsible of severe toxicity in patients in whom elimination from plasma is delayed. factors responsible for mtx accumulation are partly known but some patients still experience toxicity despite adequate measures being taken. our hypothesis is that renal tubular secretion may be impaired in these patients. this study aims at evaluating the performance of the ucp ratio (urinary ratio of coproporphyrins), a putative biomarker of tubular secretion, in predicting delayed mtx elimination.

mtx is a substrate of mrp2, a renal tubular transporter encoded by the abcc2 gene. it has been shown that single nucleotide polymorphisms (snps) on the abcc2 gene are associated with impairment of mtx elimination. mutations on the abcc2 gene are also responsible for the dubin-johnson syndrome, characterised by the absence of a functional mrp2 protein. apart from hyperbilirubinaemia, the main biological perturbation observed in this disease is a typical increase of the urinary ratio of coproporphyrins i (i+ iii) (ucp ratio). our hypothesis is that the ucp ratio could be used as a biomarker of mrp2's activity, thus predicting mtx elimination. one hundred patients treated with high dose mtx will be recruited in this prospective study. their ucp ratio will be measured before and after mtx administration and correlated with mtx clearance. a genetic analysis will be conducted to study the five more frequents snps of abcc2 in each patient.

Eligibility criteria:
inclusion criteria : * patients receiving hdmtx (≥1g/m2) for a primitive cerebral lymphoma, a large cell lymphoma, a lymphoblastic lymphoma, a burkitt's lymphoma or an acute lymphoblastic leukaemia, * over 18 years old, * signed informed consent. * affiliated to a medical assurance. * able to respect the protocol. * effective contraception for women. exclusion criteria : * renal failure, * liver failure, * hepatic cytolysis, * chronic respiratory deficiency, * pregnancy, * breast-feeding, * concomitant medication: phenytoin, probenecid, trimethoprim, phenylbutazone, salicylates, non steroid anti-inflammatory, yellow fever vaccine. * patient included in another study in the four weeks preceding his inclusion.

Keywords: biomarkers abc transporters mrp2 mtx pharmacokinetics