Kornimate/medical-research-clean huggingface dataset:
program intensive habilitation (pih) for young children with early brain damage

Conditions: Brain Injuries; Cerebral Palsy; Motor Skills Disorders; Empowerment; Parent-Child Relations; Parenting

Summary: by longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.

evidence-based knowledge about the effects of intensive training programs for children with severe early brain damage is limited since research on this topic has methodological weaknesses and shows conflicting results. as intensive training programs require extensive efforts from the child, parents and professionals and represent major costs, the importance of scientifically proven effects is considerable. this research project aims to measure the effects of an intensive habilitation program for young children with severe early brain damage on the child's adaptive, motor, language and social functioning and on parental empowerment, family functioning and stress. in this randomized controlled trial (rct) 90 children will be divided into an intervention group participating in a norwegian developed program of intensified habilitation of 12 months duration and a control group, who will receive "services as usual" during the same time period. between-group analyses will then be performed. due to a stepped wedge design, the control participants will then be offered training in year two of participation. within-group analysis of results before and after training will then be performed for all participants. standardized measures with high responsiveness in documenting intervention effectiveness will be used as primary outcome measures. intensive training groups will be offered in all health regions in norway and if successful be implemented as standard clinical practice.

Eligibility criteria:
inclusion criteria: * age 2 - 6 years at the start of the program * a diagnosis of severe cerebral palsy or similar motor disability of non-progressive etiology (gmfcs level iv-v), * being able to participate in group sessions * having parents who want to take an active part in their child's training * least one of the parents must speak fluent norwegian or english. exclusion criteria: * children with progressive disorders * co-morbidity like autism spectrum disorder, severe visual and hearing impairments or intractable epilepsy that worsen with physical activity.

Keywords: brain injury cerebral palsy motor disability gmfcs level pedi-cat family empowerment scale parenting stress index
evaluation of the potentiating effect of tdcs on opioid analgesia of pain threshold in humans

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the potential additive effect of tdcs compared to placebo-sham in opioid analgesia on pain thresholds in nociceptive experimental model in healthy volunteers .

pain is a prevalent symptom in medicine and the role of various opioids is valuable in the treatment of moderate to severe pain. several technologies of brain stimulation , including transcranial direct current stimulation ( tdcs) are emerging as therapeutic options for many pain conditions. the effect of tdcs was demonstrated in sensory perception , decreasing the threshold for acute pain in healthy volunteers and in various chronic pain conditions . there is evidence about the use of tdcs with the participation through many mechanisms in cortical modulation , including the regulation of neurotransmitters, including opioids. in the context of neurostimulation, opioidergic system and cortical pain modulation, emerge the hypothesis of a possible potentiating effect of tdcs on clinical application of opioid analgesia.

Eligibility criteria:
inclusion criteria: * male * healthy * without medication * sign the informed consent exclusion criteria: * patients who did not understand the portuguese * acute or chronic pain conditions * medical or psychiatric disorders * history of sleep disorders (apnea, hypersomnia, somnambulism...) * history of alcohol or substance abuse * neurological disorder * use of anti-inflammatory drugs, steroids and non-steroids, opioid and non-opioid analgesics, psychiatric medications, anticonvulsants, alpha and beta blockers * traumatic brain injury * neurosurgery * metallic implant in the brain

Keywords: tdcs opioid pain pain threshold
folinic acid for prevention of pemetrexed-induced toxicity

Conditions: NSCLC; Mesothelioma; Thymoma

Summary: objective the main objective is to evaluate the haematological toxicity in patients who use pemetrexed with and without rescue therapy with folinic acid. primary endpoint difference between treatment groups in neutrophil count (\*109/l) at day 8-10 after administration of pemetrexed (nadir). secondary endpoints the grade neutropenia (according to the ctcae version 5, 2017) at day 8-10, the homocysteine plasma levels at baseline (predictor for developing toxicity), the efficacy of chemotherapy treatment based on response ct after cycle 2 and 4 and the incidence of discontinuation, dose delays and dose reductions of pemetrexed. trial design the flex-trial is a multi-centre, open label, double arm, randomized trial to compare neutropenia in patients with and without folinic acid rescue therapy where subjects are participating for 4 treatment cycles. population in total 50 patients (25 in each arm), \>18 years with stage iv non-small cell lung cancer (nsclc) or mesothelioma treated with pemetrexed (in combination with other chemo- or immunotherapy) are eligible for inclusion. interventions follow-up will take place during the first 4 cycles of chemotherapy with pemetrexed. patients in the intervention-arm will receive oral folinic acid orally 4 times 45mg / day for 3 days, starting 24 hours after the administration of pemetrexed.


Eligibility criteria:
in order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. ≥18 years old 2. eligible for treatment with pemetrexed-based chemotherapy based on indication. 3. ecog performance score of 0-2. 4. subject is able and willing to sign the informed consent form a potential subject who meets any of the following criteria will be excluded from participation in this study: 1. contraindications for treatment with folinic acid in line with the smpc. 1. hypersensitivity to the active substance or to any of the excipients. 2. anaemia caused by vitamin b12 deficiency. 2. the presence of clinically relevant drug-drug interactions, according to the current smpc of folinic acid.
prevalence of obstructive sleep apnoea and reduction of promoters in af

Conditions: Atrial Fibrillation; Osa Syndrome

Summary: this study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. this is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. therefore it is important to understand its prevalence (how many patients with atrial fibrillation are affected by it). also, obesity and sleep disorders are often associated, therefore the evolution of atrial fibrillation is studied in patients who also have obesity and have lost weight compared with patients who did not loose any weight or are not obese. as medications or therapy are not changed, this is an observational study.


Eligibility criteria:
inclusion criteria primary outcome: * 1 episode of atrial fibrillation in the previous year inclusion criteria secondary outcome: * bmi \> o = 27kg/m2 * ahi \>30 o con 15\<ahi\<30 associated with other symptoms (sleeplessness, uncontrolled hypertension and cerebral events) exclusion criteria: * ejection fraction \<50% * hfpef not related to atrial fibrillation. * coronary artery disease * valvular cardiomyopathy * patient already in treatment for sleep apnoea * hyperthyroidism
study to evaluate the immunogenicity and the safety of an adjuvanted influenza vaccine candidate

Conditions: Influenza

Summary: the purpose of this study is to evaluate the immunogenicity and the safety of the candidate vaccine compared to fluarix™ administered intramuscularly in elderly aged 60 years and above


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and wil comply with the requirements of the protocol should be enrolled in the study. * a male or female 60 years or older at the time of the first vaccination. * free of obvious health problems exclusion criteria: * use of non-registered products * administration of immune-modifying drugs. * administration of vaccine 30 days before enrolment in study. * immunosuppressive or immunodeficient condition. * hypersensitivity to a previous dose of influenza vaccine * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality. * history of confirmed influenza infection within the last 12 months. * acute disease at the time of enrolment/vaccination. * history of allergy or reactions likely to be exacerbated by any component of the vaccine

Keywords: influenza vaccine prophylaxis influenza vaccine
a study of the safety and efficacy of a new treatment for macular edema resulting from branch retinal vein occlusion

Conditions: Macular Degeneration; Macular Edema; Branch Retinal Vein Occlusion

Summary: this study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone for the treatment of macular edema associated with branch retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * macular edema resulting from branch retinal vein condition * the criteria for visual acuity and macular thickness are met exclusion criteria: * history of glaucoma * diabetic retinopathy * known steroid-responder * use of systemic steroids * use of warfarin/heparin

Keywords: eye diseases
coffee consumption and nash in the french population.

Conditions: Non Alcoholic Steatohepatitis

Summary: the aim of our study is to evaluate the effect of coffee consumption on the risk of severe liver fibrosis in french patients with nash.


Eligibility criteria:
inclusion criteria: any newly diagnosed case of nash histologically proven graded according to saf criteria or metabolic syndrome defined by the idf 2005 criteria: * waist size\> 94cm (men) or\> 80cm (women) * and the presence of at least two of the following criteria: * blood pressure: systolic ≥ 130mmhg or diastolic ≥ 85 mmhg or antihypertensive treatment * triglycerides ≥ 1.5g / l or lipid-lowering therapy * hdl cholesterol \<0.4 g / l (men) or \<0.5 g / l (women) or lipid-lowering therapy * fasting blood glucose:\> 1 g / l or type 2 diabetes and hepatic steatosis diagnosed on liver imaging and liver fibrosis (diagnosed with a fibroscan\> 6 kpa) exclusion criteria: * age \<18 years * viral hepatitis and other chronic liver diseases * alcohol consumption\> 20g / day for women, 30g / day for men * liver biopsy or fibroscan dating more than 6 months before inclusion. * history of bariatric surgery * serious psychiatric pathology (psychosis, dementia, severe depression) and patients under legal protection (tutelage, guardianship) * solid cancer or progressive hematology or \<2 years (except basal cell carcinoma or localized squamous cell carcinoma) * severe and terminal chronic renal insufficiency (estimated gfr \<30ml / min) * recent myocardial infarction \<6 months
transcranial magnetic stimulation for mal de debarquement syndrome

Conditions: Mal de Debarquement Syndrome

Summary: the goal of this study is to determine whether external neuromodulation using repetitive transcranial magnetic stimulation (rtms) can reduce the perception of self-motion that is experienced by individuals with mal de debarquement syndrome (mdds). mal de debarquement is translated as the "sickness of disembarkment," and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive motion. treatment for mdds is limited and morbidity is high. the goal of the study is to determine whether rtms can suppress the rocking dizziness of mdds.

participants will maintain web-based diaries of their symptoms for two weeks prior to treatment with rtms. up to 20 treatments with rtms with either anatomically or functionally determined targets will be administered. post treatment diaries will continue for up to 12 weeks after rtms administration.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years old 2. willing and capable of interacting with the informed consent process 3. primary disorder being a persistent rocking dizziness triggered by passive motion such as from water, land, or air travel and with no other central nervous system or peripheral vestibular disorder determined after appropriate evaluation. exclusion criteria: 1. subjects who cannot comply with study conditions. 2. active psychiatric condition such as mania or psychosis 3. unstable medical condition 4. implanted metal anywhere in the body (infusion pumps, pacemakers, metal or shrapnel in the body, deep brain stimulators, aneurysm clips, metal prostheses, joints, rods or plates). dental fillings are acceptable. 5. personal history of seizures or a first-degree relative with epilepsy 6. medications known to lower seizure threshold such as: typical (high-potency) neuroleptics and tricyclic antidepressants: subjects who take one or a combination of the following drugs will be excluded: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine. clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine (including mdma, ecstasy), phencyclidine (pcp, angel's dust), ketamine, gamma-hydroxybutyrate (ghb), theophylline, haloperidol, fluphenazine, bupropion. 7. pregnancy or planning to become pregnant during study enrollment.

Keywords: mdds tms fmri eeg
monotherapy versus placebo over 7 days-non-nucleoside reverse transcriptase inhibitor-experienced hiv1 infected adults

Conditions: HIV Infections

Summary: to investigate safety, tolerability and antiviral activity in non-nucleoside reverse transcriptase inhibitor (nnrti)-experienced hiv-1 infected patients


Eligibility criteria:
inclusion criteria: * cd4 cell count greater than or equal to 200 cells/mm3. * hiv-1 rna \>2000 copies/ml. * must have history of nnrti treatment with subsequent failure and documented evidence of an nnrti-associated mutation or a phenotype displaying reduced activity to efavirenz, nevirapine or delavirdine. * normal resting 12-lead electrocardiogram. exclusion criteria: * any history of seizure, cns toxoplasmosis infection, or any cns (central nervous system) lesion. * chronic diarrhea (\>3 loose stools/day). * an active cdc category c disease (1993), except cutaneous kaposi's sarcoma (ks) not requiring systemic therapy during the trial. * less than 4 weeks since stopping anti-retroviral therapy (art) therapy prior to day 1. * any acute laboratory abnormality. * positive for hcv antibody or hepbsag. * active infections requiring therapy in the previous 4 weeks.

Keywords: gw695634g gw695634x gw678248x pharmacokinetics nnrti hiv
aspecct: a study of panitumumab efficacy and safety compared to cetuximab in patients with kras wild-type metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (os) for chemorefractory metastatic colorectal cancer (mcrc) among patients with wild-type kirsten rat sarcoma-2 virus (kras) tumors.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum, metastatic disease * wild-type kras tumor status * eastern cooperative oncology group (ecog) score of 0, 1 or 2 * must have failed a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease * must have previously received a thymidylate synthase inhibitor (eg, fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) at any point for treatment of colorectal cancer (crc) * adequate hematologic, renal, hepatic and metabolic function exclusion criteria: * symptomatic brain metastases requiring treatment * prior anti-epidermal growth factor receptor (egfr) antibody therapy (eg, panitumumab or cetuximab) or treatment with small molecule egfr inhibitors (eg, gefitinib, erlotinib, lapatinib) * antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy), or investigational agent or therapy ≤ 30 days before randomization. * clinically significant cardiovascular disease * active infection requiring systemic treatment or any uncontrolled infection ≤14 days prior to randomization

Keywords: panitumumab vectibix colon cancer colorectal cancer rectal cancer cetuximab erbitux metastatic
a study of nivolumab combined with cabozantinib compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to determine whether nivolumab combined with cabozantinib is safe and effective compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histological confirmation of rcc with a clear-cell component, including participants who may also have sarcomatoid features * advanced (not amenable to curative surgery or radiation therapy) or metastatic (ajcc stage iv) rcc * no prior systemic therapy for rcc with the following exception: i) one prior adjuvant or neoadjuvant therapy for completely resectable rcc if such therapy did not include an agent that targets vegf or vegf receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy exclusion criteria: * any active cns metastases * any active, known or suspected autoimmune disease * any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization * participants who have received a live/attenuated vaccine within 30 days of first treatment other protocol defined inclusion/exclusion criteria could apply
diep flap surgery and intraabdominal pressure

Conditions: Intraabdominal Hypertension; Breast Neoplasms

Summary: aim: the primary aim of this study is to test if closure of the abdominal donor site increases the intraabdominal pressure (iap) in women undergoing secondary deep inferior epigastric perforator (diep) flap breast reconstruction. materials and method: by an unometer, attached to a standard catheter in the bladder, we measured the intravesical pressure as a surrogate marker for the iap, at baseline, immediate after- and 24 hours after abdominal skin closure, for 13 patients.


Eligibility criteria:
inclusion criteria: * females undergoing secondary diep flap breast reconstruction. * performance status 1-2 exclusion criteria: * performance status above 2. * untreated hypertension or atrial fibrillation performance status evalutated using american society of anaesthesiologists' (asa) classification of physical health.
selective d-dimer testing compared with uniform d-dimer testing in the diagnosis of deep vein thrombosis (select)

Conditions: Deep Vein Thrombosis

Summary: the purpose of this study is to compare two diagnostic interventions to improve the way d-dimer blood testing (mda d-dimer) is used to diagnose first time symptomatic deep vein thrombosis.

* limiting use of d-dimer testing to outpatients with a low or moderate clinical pretest probability (c-ptp)for deep vein thrombosis and using a d-dimer level of \< 1.0 µg feu/ml to exclude deep vein thrombosis in those with a low c-ptp, and a d-dimer level of \< 0.5 µg feu/ml to exclude deep vein thrombosis in those with a moderate c-ptp, is as safe and a more efficient way to diagnose dvt than: * performing d-dimer testing in all patients with suspected deep vein thrombosis with use of a single d-dimer value of \< 0.5 µg feu/ml to exclude thrombosis (current practice). all randomized patients, including those who are treated for deep vein thrombosis after initial testing, will be followed for a period of 3 months to monitor for signs and symptoms suggestive of deep vein thrombosis, pulmonary embolism, bleeds and death.

Eligibility criteria:
inclusion criteria: * age 18 and older * presenting with symptoms compatible with clinically suspected deep vein thrombosis exclusion criteria: * treatment with full dose anticoagulation for 24 hours or more. * other test for deep vein thrombosis already performed. * ongoing need for therapeutic anticoagulant therapy. * life expectancy less than 3 months. * absence of acute symptoms within 7 days of presentation. * presenting with symptoms of pulmonary embolism. * previous confirmed episode of deep vein thrombosis or pulmonary embolism. * current pregnancy. * geographic inaccessibility which precludes follow-up.

Keywords: deep vein thrombosis pulmonary embolism d-dimer testing
risk identification of the glucotab system in routine use

Conditions: Diabetes Mellitus

Summary: identification of risks of the glucotab system in routine use.

a study to identify risks in routine use of the glucotab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

Eligibility criteria:
inclusion criteria: * informed consent obtained after being advised of the nature of the study * type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay * diabetes therapy supported by glucotab system exclusion criteria: * type 1 diabetes mellitus * intravenous insulin therapy * hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy * gestational diabetes or pregnancy * known or suspected allergy to certain insulin types, named in the user manual * total parenteral nutrition (tpn) * any mental condition rendering the patient incapable of giving his consent