Kornimate/medical-research-clean huggingface dataset:
virtual walking and transcranial direct current stimulation for chronic neuropathic pain due to spinal cord injury

Conditions: Spinal Cord Injury; Chronic Neuropathic Pain

Summary: the goal of this feasibility study is to assess the feasibility of the combined treatment intervention "virtual walking (vw) and transcranial direct current stimulation (tdcs)" of neuropathic pain in patients with spinal cord injury. the main question aims to answer: • to assess the feasibility of combining vw and tdcs for longer-term use from the patients' point of view. participants will: receive a two week intervention in the swiss paraplegic centre in nottwil, where the participants undergo vw and tdcs for ten sessions, each lasting around 20 minutes. the participants keep a diary and a pain drawing of their symptoms and will fill out some questionnaires about their impression of feasibility, the pain intensity, chronicity, the impression of change, depression, anxiety, stress and adverse events. at the beginning and end of the study the participants will be interviewed about their expectations, hopes and the feasibility of the procedures from a participants point of view.


Eligibility criteria:
inclusion criteria: * age ≥ 18y, ≤ 75y * traumatic sci (\> 6 month after sci) with a sci severity grade ais a, b, c or d * at or below level spinal cord injury neuropathic pain on trunk or lower extremities according to the iscip classification (bryce et al., 2012) of at least 4/10 intensity on a nrs (langford et al., 2023) with in the last 7 days (widerströmnoga et al., 2023) * good communication in german to understand the instructions, assessments and to fill in questionnaires * adequate siting balance * ability to draw with a pencil * ability to swing arms exclusion criteria: * severe psychiatric disorder requiring psychiatric hospitalisation or mental disease that could interfere with their ability to participate * previous brain surgery * metal implants in the skull or brain, including cochlear implants, intracranial electrodes or a pacemaker (datta et al., 2010) * drugs that affect cortical excitability (mclaren et al., 2018): alcohol, amphetamines, theophylline (asthma treatment), chlorpromazine, clozapine, amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, gamma-hydroxybutyrate (ghb), ketamine, mdma, ecstasy phencyclidine * previous adverse effects of stimulation with tdcs * a scalp or skin condition (e.g. psoriasis or eczema) * history of epilepsy or seizure * pregnancy (anamnestic) * inability to give consent

Keywords: neuropathic pain chronic neuropathic pain spinal cord injury virtual walking transcranial direct current stimulation tdcs
efficacy of blue light treatment in patients with nonseasonal major depressive disorder

Conditions: Depression

Summary: to compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(mdd) in adults.

the current study aims to compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(mdd) in adults. 162 patients with nonseasonal mdd will be randomized into three groups (i.e. blue light, bright light or dim light). the treatment will be performed five times a week for the first two weeks. and for the next 2 weeks, the treatment for patients will be undertook three times a week. there will be 16 times in total. the investigators will assess nonseasonal mdd'symptom severity in the baseline, 1 week,2 week, 4 week,6 week and 8 week. through the study, 17-item hamilton depression rating scale (hamd17),14-item hamilton anxiety rating scale (hama14),quick inventory of depressive symptoms, self-rated version (qids-sr)，pittsburgh sleep quality index (psqi) , clinical global impression scale(cgi), quality of life, enjoyment and satisfaction questionnaire (q-les-q),morningness-eveningness questionnaire (meq),repeatable battery for the assessment of neuropsychological status(rbans),subjective fatigue symptom scale and semantic differential scale will be obtained. the patients will also get individual's data of heart rate and blood pressure.

Eligibility criteria:
inclusion criteria: * meet criteria for major depressive episodes as determined by mini * hamd17≥17 * received antidepressive medication at stable dosages for at least 14 days exclusion criteria: * any axis i psychiatric disorder comorbidity * who have received formal psychological therapy, mect or rtms in 3 months * any current significant medical condition especially eye diseases * serious suicide risk * pregnant or breastfeeding women * depression with seasonal pattern * treatment-resistant depression * epilepsy in the past

Keywords: nonseasonal major depression disorder light therapy
a study to determine the safety and tolerability of escalating doses of ins365 ophthalmic solution

Conditions: Dry Eye Disease

Summary: the purpose of this study is to evaluate the safety and tolerability of ins365 ophthalmic solution when applied topically as eyedrops in patients with mild to moderate dry eye disease.


Eligibility criteria:
inclusion criteria: * best corrected visual acuity 20/40 in each eye * 2 out 5 specified symptoms * corneal fluorescein staining score greater than or equal to 3 out of 15 exclusion criteria: * unable to stop concomitant medications * have had intraocular surgery in previous 90 days * have excluded systemic or ocular disease * wear contact lenses and are not willing to remove them * have intraocular pressure greater than 22 mg hg
circulating microrna as biomarker of cardiotoxicity in breast cancer

Conditions: Breast Cancer

Summary: in the proposed project the investigators will asses whether changes in expression of selected circulating micrornas in serum could comprise a sensitive and specific biomarker of cardiotoxicity in cancer patients treated with anthracyclines based chemotherapy.

blood will be taken 1. before anthracycline based chemotherapy administration 2. at the middle of anthracycline treatment (before 3rd and/or 5th cycle of drugs infusion) 3. after anthracycline chemotherapy cessation 4. 6 months after chemotherapy cessation if an end point occurs 5. 12 months after chemotherapy cessation if an end point occurs echocardiography will be performed 1. before anthracycline based chemotherapy administration 2. after anthracycline based chemotherapy cessation 3. 6 months after anthracycline based chemotherapy cessation 4. 12 months after anthracycline based chemotherapy cessation if no end point was observed earlier the investigators will perform high-throughput mirna(microrna) expression profiling of serum samples - called training set. training set will consist of sera of 30 patients who has reached an end point. training set will be sequenced using next generation sequencing. training set will be used to derive a mirna signature capable of separating early cardiotoxicity patients from healthy ones. mirna signature will be validated using validation set.

Eligibility criteria:
inclusion criteria: * age 18-70 * stage i-iii tnm (tumor node metastases) exclusion criteria: * second or next cancer (except for basal cell skin cancer and cin) * previously treated with chemotherapy * previously treated with radiotherapy * acute myocardial infarction * heart failure * cardiomyopathy

Keywords: breast cancer anthracyclines cardiotoxicity circulating microrna biomarker serum anthracyclines based chemotherapy
an open, qualitative, prospective, multicenter trial of a novel transanal irrigation system in spinal cord injured patients.

Conditions: Neurogenic Bowel

Summary: this study is designed as an open, prospective, non-controlled, qualitative, multicentre study of a novel transanal irrigation system performed in a population of 150 subjects suffering from spinal cord injury and confirmed neurological bowel dysfunction. the study is expected to last for a total of 1 year (treatment period) with a planned 12- month recruitment period and three scheduled site visits.

this study will be conducted in multiple countries, all outside of the united states. the study is approved by oversight authorities in the united kingdom, germany, spain, sweden, denmark, norway, france, and italy

Eligibility criteria:
inclusion criteria: 1. provision of informed consent. 2. male or female aged 18 years or older. 3. patient with previously confirmed chronic spinal cord injury, either: 1. traumatic; at any level and any completeness of injury and asia grade classification, or 2. non-traumatic; due to infection, inflammation (i.e.; transverse myelitis or ischaemic myelitis), compromised blood supply, a post-ischemic state, etc. 4. at least 3 months post spinal cord injury at time of consent. 5. nbd score ≥10, confirmed at baseline . 6. only tai treatment - naïve patient (not having previously used any particular transanal irrigation system, e.g. peristeen®). 7. confirmed nbd refractory to conservative therapy and judged eligible for transanal irrigation as per standardised treatment pathway 18. 8. able to handle smartphone/tablet. exclusion criteria: 1. any confirmed or suspected diagnosis of anal or rectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions. 2. untreated rectal impaction. 3. any radiotherapy to the pelvis. 4. any current treatment with anticoagulants (not including aspirin or clopidogrel). 5. any current treatment with long-term systemic steroid medication (not including inhalation agents and/or local topical treatment). 6. current use of prokinetics. 7. any prior rectal or colonic surgery (not including anal procedures \>3 months ago, e.g. haemorrhoid excision). 8. anal, rectal and/or colonic endoscopic polypectomy within the previous 4 weeks. 9. overt or planned pregnancy. 10. ongoing symptomatic uti as judged by investigator. 11. diagnosed psychiatric illness, considered as unstable by the investigator. 12. diagnosed with ms. 13. involvement in the planning and conduct of the study (applies to both whc staff and staff at the study site). 14. previous enrolment in the present study. 15. simultaneous participation in another clinical study that may interfere with the present study.
safety study of a recombinant protein vaccine to treat esophageal cancer

Conditions: Esophageal Cancer

Summary: the purpose of this study is to determine the biological recommended dose of imf-001.

the prognosis of esophageal cancer is improved with the improvement of surgery, chemotherapy and radiation therapy. however, there are no standard therapies established for recurrent esophageal cancer. ny-eso-1 antigen is expressed in 33% of patients. ny-eso-1 protein is applicable without limitation by hla types, and injected as a complex with cholesteryl pullulan (chp), forming nano-particles (imf-001), it can activate both cd4+ and cd8+ t cells. in this phase 1 study, the safety and the biological recommended dose will be determined.

Eligibility criteria:
inclusion criteria: * radically unresectable stage iii/iv esophageal tumors that have failed the standard treatment (including chemotherapy and radiotherapy), recurrent metastasis after radical surgery and not responding to the standard treatments, or recurrent metastasis after radiotherapy before/after radical surgery. * primary esophageal tumors confirmed by pathological diagnosis * tumor cells expressing ny-eso-1 antigen (by tissue-immunostaining method or quantitative rt-pcr method) * performance status (ps) of 0, 1 or 2 (ecog scale) * life expectancy \>/= 4 months * no serious disorders with major organs (bone marrow, heart, lung, liver and kidney) and meets the following criteria: * wbc count \>/= 2.0 x 10 9/l * hemoglobin \>/=8.0g/dl * platelet count \>/=75 x 10 9/l * serum total bilirubin: \</=1.5 x uln (3 x uln if with liver mets) * ast and alt: \</=2.5 x uln (5x uln if with liver mets) * serum creatinine: \</=1.5x uln * agree to use birth control including condoms from the time of obtaining the consent to 6 months after the final administration of the study drug \[except females after menopause (1 year or more after the last menstruation and females/males after an operation for sterilization)\] * given written informed consent exclusion criteria: * hiv antibody positive * double cancer * history of autoimmune disease * history of severe anaphylaxis * active metastatic disease in the central nervous system (cns) within 4 weeks after treatment with an anti-tumor agent, systemically administered adrenocorticosteroids, immune suppressants or immune enhancers * pregnant or lactating * any other inadequacy for this study
improving adherence to interventions for hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Obesity

Summary: to develop effective strategies for enhancing adherence to therapeutic interventions designed to improve care for hypertensive minority populations.

background: the study was in response to a demonstration and education initiative, "improving hypertensive care for inner city minorities", which was reviewed and approved by the clinical applications and prevention advisory committee in april 1992 and by the national heart, lung, and blood advisory council in may 1992. the request for applications was released in october 1992. design narrative: an aggressive hypertension intervention project (hip) was developed in the hypertension research section of king/drew medical center in south-central los angeles. the private chuer clinic (located in the same cachement area) subcontracted with the drew university center in a community coalition consisting of several large health advocacy organizations. all subjects were randomized into usual care (controls) or interventional care (experimental) at the initiation of the hip. the cornerstone of the aggressive intervention was the development of a computerized patient tracking system and the introduction into the clinic of several educational activities including a) exit interviews; b) home visits; c) support group sessions, and d) community health seminars/fairs. community health workers performed the bulk of the patient tracking and educational intervention field work. outcome measures of pre and post-study blood pressure, renal function, body weight change, and all-cause mortality were compared between experimental and controls at two, three and four years into the study. quality-of-life questionnaires were obtained pre- and post-study and analyzed for new insights into needs assessment, awareness of hypertension, attitudes towards treatment, compliance with drug therapy, and effectiveness of various educational interventions employed in the study. concurrent efforts to reduce co-morbid risk factors such as obesity, cigarette smoking, excessive alcohol consumption and stress were assessed as secondary outcomes. the hip hoped to demonstrate cost-effective innovations for the adaptation of these medical center-targeted strategies to community physicians and health clinics of the inner city. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
multihole or epidural catheter for local anesthetic in the wound

Conditions: Postoperative Pain; Hip Arthroplasty

Summary: postoperative administration of local anesthetics is effective for postoperative pain management across surgical specialties but the optimal type of catheter (single, few or multiholed catheters) has not been determined. this study investigates wound spread of a radioactive isotope (technetium) administered in different types of catheters after total hip arthroplasty.


Eligibility criteria:
inclusion criteria: * operation with total hip arthroplasty exclusion criteria: * allergies to drugs administered

Keywords: total hip arthroplasty
risk of ischaemic stroke after pulmonary embolism in patients with and without patent foramen ovale

Conditions: Foramen Ovale, Patent

Summary: stroke's risk is increased in patients with pulmonary embolism and pfo compared to patients without pfo. does this increased risk persist years after pulmonary embolism ?

324 patients included in epic-fop study (2009 to 2015) were followed annually to collect data about the recurrence of vte, cardiovascular events and treatments.

Eligibility criteria:
inclusion criteria: * patients included in epic-fop study exclusion criteria: * refusal to participate

Keywords: foramen ovale, patent stroke pulmonary embolism
the munich knee questionnaire - development and validation

Conditions: Knee Injury

Summary: the purpose of this study is to develop and validate a new pro measurement tool for the knee joint, the so-called munich knee questionnaire (mkq), allowing for a qualitative self-assessment of the knee injury and osteoarthritis outcome score (koos), the international knee documentation committee (ikdc), the lysholm knee score, the western ontario meniscal evaluation tool (womet) and the tegner score.

a systematic review of the literature was performed to identify valid and commonly used instruments regarding follow-up examinations in the field of knee surgery. pubmed.gov was searched for knee-specific terms (knee, surgery, joint, lower extremity) combined with psychometric (follow-up, validity, reliability, responsiveness) and instrument-specific terms (self-reported, patient-based, measurement tool, outcome measure, questionnaire). hence, the koos, ikdc, lysholm, womet and tegner score were identified as frequent used and valid measurement tools in the evaluation of knee joint function. after analysing each single question of these questionnaires for coincidences regarding measurement of specific knee function, the identified items were condensed to one single question for each specific item. typical functional abilities (flexion/extension) were depicted as photographs. thus, one single questionnaire with a total of 33 questions divided in five subscales (symptoms, pain, work and activities of daily life, sports and recreational activities, physical function and knee related quality of life), was created.

Eligibility criteria:
inclusion criteria: * all patients presenting with knee pain exclusion criteria: * no exclusion

Keywords: assessment
effects of the administration of ornithine phenylacetate in patients with cirrhosis and upper gastrointestinal bleeding

Conditions: Gastrointestinal Bleeding; Cirrhosis

Summary: the main objective is to evaluate the effectiveness of the experimental drug to reduce plasma ammonia concentration at a dose that is safe and well tolerated. ammonia usually rises significantly in the hours after gastrointestinal bleeding in patients with cirrhosis of the liver. this increase in the concentration of ammonia facilitates the development of hepatic encephalopathy. the study will be divided in two parts: part a: open-label, dose-escalating, single cohort study. the goal of this phase is to confirm the tolerance and safety of the dose of op that is being proposed for the study according to the results of phase i and phase ii studies in healthy subjects and stable outpatients with cirrhosis. part b: multi-center (2 university hospitals), double-blind, randomized, parallel-group trial. assignment of treatment will be done according to a list (one at each study site) of random numbers in blocks that will be concealed until the end of the study. the control group will be assigned to placebo on a 1:1 ratio. the placebo and treatment will be masked.


Eligibility criteria:
inclusion criteria * cirrhosis of the liver; diagnosed by clinical, laboratory or radiological findings. * upper gastrointestinal bleeding, as judged by clinical signs (hematemesis, melena, anemia) combined with endoscopic data. * bleeding that has been active within 24 hours prior to inclusion; signs of activity are defined by the presence of blood in the gastrointestinal tract and symptoms attributable to bleeding (hypotension, tachycardia, etc.). * age between 18 and 75 years. * informed consent by the patient. in case of inability to provide informed consent due to impaired mental status secondary to hepatic encephalopathy the informed consent should be provided by the next of kin and should be confirmed by the patient when he/she recovers from hepatic encephalopathy. * absence of exclusion criteria. exclusion criteria * terminal illness (e.g. advanced hepatocellular carcinoma). * need for mechanical ventilation. * renal impairment, defined by a creatinine \> 1.5 mg/dl or need of hemodialysis. * pregnant or breast-feeding. pre-menopausal women capable of bearing children should be following a reliable method of birth control and should have a negative result in a pregnancy test prior to inclusion. * known or suspected hypersensitivity or allergic reaction to ornithine or phenylacetate. * use of medications known to interfere with the clearance of either ornithine and/or phenylacetate, such as antibiotics of the penicillin group and probenicid. * use of medications that may induce hyperammonemia; such as haloperidol, valproic acid, and systemic corticosteroids. * history or known infection with human immunodeficiency virus (hiv). * neurological comorbidities that impair mental status and do not allow to adequately assess the presence or outcome of hepatic encephalopathy. * the presence in the electrocardiogram of a qtcf \>500 msec

Keywords: cirrhosis, gastrointestinal bleeding
mindfulness training for children with attention-deficit/hyperactivity disorder (adhd) and mindful parenting

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study evaluates the effectiveness of an 8-week mindfulness group training for children (8-16 years old) with adhd in combination with a parallel mindful parenting training for their parents. half of the participants will be randomly assigned to the mindfulness training in addition to care-as-usual (cau); the other half to cau-only. the hypothesis is that compared to care-as-usual only, the addition of the mindfulness training will improve self-control of youth with adhd.


Eligibility criteria:
inclusion criteria: * child has a clinical diagnosis of adhd according to the diagnostic and statistical manual of mental disorders; dsm-iv or dsm-5 system, and confirmed by a structured interview (the schedule for affective disorders and schizophrenia for school-age children (k-sads)). * child receives cau and has remaining adhd-symptoms (average score \> 1.0 on the investigator-rated dsm-5 items from the conners' adhd rating scale). * child is between 8 and 16 years old. * at least one parent is willing to participate. * adhd medication dose is stable, or there is an informed decision on not taking adhd medication. * psychiatric comorbidities are allowed except psychosis, bipolar illness, active suicidality, untreated posttraumatic stress disorder or substance use, provided adhd is the primary diagnosis in the child; similarly, psychopathology in the parents is allowed except psychosis, bipolar disorder, active suicidality, untreated posttraumatic stress disorder or substance use. * child and parent have an estimated intelligence quotient (iq) ≥ 80. * child and parent have adequate mastery of dutch language. exclusion criteria: * child or the participating parent(s) have participated in a mindfulness programme in the past year or ever in a mindful parenting training. * child or parent is participating in another intervention study.

Keywords: self-control well-being