Kornimate/medical-research-clean huggingface dataset:
serranator point force registry

Conditions: Peripheral Artery Disease (PAD); Dysfunctional AV Fistula; Dysfunctional AV Graft

Summary: the objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the serranator® in treatment of peripheral artery disease (pad), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario. the data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.


Eligibility criteria:
inclusion criteria: * subjects intended to be treated with serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae. * subjects presenting with claudication or critical limb-threatening ischemia (clti) by rutherford clinical category 3, 4, 5, or 6 of the target limb. * age of subject is \> 18. * subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form. exclusion criteria: * subjects with any medical condition that would make him/her an inappropriate candidate for treatment with serranator® as per instructions for use (ifu) or investigator's opinion. * subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
ambien cr vs. placebo for treatment of insomnia associated with anxiety when used concomitantly with escitalopram (lexapro)

Conditions: Insomnia

Summary: a comparison of zolpidem tartrate extended-release (ambien cr)vs. placebo in the treatment of insomnia associated with generalized anxiety disorder (gad) when used concomitantly with escitalopram (lexapro - antidepressant).


Eligibility criteria:
inclusion criteria: 1. male or female between the ages of 21and 64 years, inclusive; 2. women must use a medically acceptable form of contraception during the entire study period, or: be surgically sterilized, post-menopausal, agree to use double-barrier contraception throughout the study period, or must have a negative urine pregnancy test prior to randomization; 3. must meet the diagnostic requirements of generalized anxiety disorder as defined by the diagnostic and statistical manual of mental disorders; 4. score at least 18 on the hamilton rating scale for anxiety (ham-a) 5. must be either newly diagnosed or show symptoms of relapse during a period of no drug therapy for anxiety. 6. subject must experience sleep disturbances at least three nights per week, for at least one month prior to study entry, based on historical data. 7. subject must be stabilized on all long-term medication therapy for at least one month prior to study entry. exclusion 1. history of post-traumatic stress disorder; 2. concomitant major depressive disorder or bipolar disorder; 3. any abnormal pre-study laboratory values that require clinical intervention 4. shift work or requirement for a regular change in sleep schedule by at least six hours within the previous month. 5. pregnant or breastfeeding 6. history of drug addiction, alcoholism, or drug abuse 7. currently using a benzodiazepine or ssri or more than 2 days of use within the 28 days preceding randomization. 8. a positive urine drug screen for compounds that would interfere with the assessment of a hypnotic. 9. use of prescription and non-prescription sedative drugs; 10. prior failure to respond to escitalopram therapy for anxiety 11. the presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebrovascular disease or malignancy. 12. history of sleep apnea 13. history of myasthenia gravis 14. known hypersensitivity and/or allergy to or previous adverse experience with zolpidem or escitalopram or any of their excipients 15. subject is currently participating in another clinical trial (or within 28 days of screening).
web-based insulin titration - an efficacy study

Conditions: Diabetes Mellitus, Type 2

Summary: the main objective of the study is to determine whether an intensive web-based titration system, called pandit (patient assisting net-based diabetes insulin titration), is effective in improving glycaemic control in patients with diabetes mellitus type 2 using a basal insulin, compared to standard care.


Eligibility criteria:
inclusion criteria: * male or female between 18 and 80 years * type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months * once daily basal insulin therapy usage * no restriction on hba1c or fpg * bmi \< 40 kg/m2 * ability to read and understand the dutch language * familiarity with the internet and use of a mobile phone * ability and willingness to adhere to the protocol * ability and willingness to use a web-based insulin self-titration system * confirmed written consent exclusion criteria: * type 1 diabetes * use of systemic corticosteroid in the last three months * recurrent severe hypoglycaemia or hypoglycaemic unawareness * active proliferative diabetic retinopathy * any clinically significant disease or disorder * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * working in night shifts
efficacy of celecoxib vs placebo to prevent pain in a paced walk

Conditions: Knee Osteoarthritis

Summary: a paced 20-minute walk is a reproducible model for acute pain in knee osteoarthritis

this is a randomizd, placbo-controlled, crossover trial comparing a single dose of celecoxib to placebo measuring the time to onset of acute pain in a paced 20-minute walk. 40 subjects will be enrolled

Eligibility criteria:
inclusion criteria: knee osteoarthritis by acr clinical criteria pain of at least 40 mm by vas at baseline - exclusion criteria: non-pregant, non-lactating able to stop active arthritis medication for washout cardiovascular risk factors abnormal ekg -

Keywords: pain osteoarthritis
efficacy and safety of sarilumab and adalimumab monotherapy in patients with rheumatoid arthritis (saril-ra-monarch)

Conditions: Rheumatoid Arthritis

Summary: primary objective: to demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (das28)-erythrocyte sedimentation rate (esr) in participants with active rheumatoid arthritis (ra) who were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (mtx), or after at least 12 weeks of continued treatment with mtx, were determined to be inadequate responders. secondary objectives: to demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy in participants with active ra who were either intolerant of, or considered inappropriate candidates for continued treatment with mtx, or after at least 12 weeks of continued treatment with mtx, were determined to be inadequate responders, with respect to: * reduction of signs and symptoms of ra. * improvement in quality of life assessed by participant reported outcome questionnaires. assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity) throughout the study.

total study duration was up to 310 weeks: up to a 4 week screening period, 24 week randomized double-blind treatment phase, 276-week open-label extension, and 6 weeks post-treatment final study visit.

Eligibility criteria:
inclusion criteria: * diagnosis of ra greater than or equal to (\>=)3 months duration. * american college of rheumatology (acr) class i-iii functional status. * active ra was defined as: at least 6 of 66 swollen joints and 8 of 68 tender joints, high sensitivity c-reactive protein (hs-crp) \>=8 mg/l or esr \>=28 millimeter per hour (mm/h), and das28-esr greater than (\>) 5.1. * participants as per investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with mtx, or after at least 12 weeks of continued treatment with mtx, or inadequate responders treated with an adequate mtx dose for at least 12 weeks. exclusion criteria: * age \<18 years or the legal age of consent in the country of the study site, whichever was higher. * current treatment with disease-modifying antirheumatic drug (dmards)/immunosuppressive agents including mtx, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (randomization visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (randomization visit) or leflunomide within 8 weeks prior to the randomization visit, or 4 weeks after cholestyramine washout. * treatment with any prior biologic agent, including anti-interleukin 6 (il-6), il-6 receptor (il-6r) antagonists, and prior treatment with a janus kinase inhibitor. * use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
prevalence of covid-19 (coronavirus disease 19) in pregnant women on labor in a public hospital in chile (coronavirus disease covid-19 pandemic in chile)

Conditions: Pregnancy; Covid19; Labor (Obstetrics)--Complications; Demography

Summary: this study aim is to assess the prevalence of sars-cov-2 in unselected pregnant women on labour (or a predictable delivery during next 24 hours), their outcome and sociodemographic conditions.

this is a cross sectional study conducted in hospital san juan de dios, santiago of chile. this hospital attends nearly 4500 births every year. when the covid-19 pandemia came to chile, there was no possibility to assess the seroconversion for sars-cov2. currently, it remains unclear the seroprevalence of sars-cov-2 in pregnant near to delivery in our country, also its correlation with clinical, perinatal outcomes and sociodemographic characteristics. the project will evaluate these features, collecting nasopharyngeal swab serology in a systematic manner in unselected pregnant women on labor (or a predictable delivery during next 24 hours). maternal information including clinical data, obstetric history, comorbidities and sociodemographic characteristics acquired from medical records will be correlated to the seroconversion.

Eligibility criteria:
inclusion criteria: * pregnant women on labor or preterm labor. * pregnant women who underwent programmed or emergence cesarean exclusion criteria: * stillbirth * refusal to participate in the study

Keywords: pregnancy labor covid-19 sars-cov2 sociodemographic
brodalumab (amg 827) in adults with moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: the study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe crohn's disease. participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that doesn't have any drug in it) and neither the doctor nor the patient will know what treatment is being given.


Eligibility criteria:
inclusion criteria: * diagnosed with ileal, ileo-colonic, or colonic crohn's disease for a minimum of 6 months prior to initiating study drug * moderately to severely active crohn's disease, as defined by a cdai score \>250 and \< 450 at baseline * evidence of active inflammation exclusion criteria: * short bowel syndrome * stricture with obstructive symptoms within 3 months * bowel surgery within 3 months * ileostomy and/or colostomy * any gastric or intestinal pouch * ulcerative colitis * evidence of an infected abscess * bowel perforation or evidence of noninflammatory obstruction during the 6 months * stool positive for c. difficile toxin at screening * presence of active infection requiring treatment * serious infection within 8 weeks * significant concurrent medical conditions * pregnant or breast feeding * significant laboratory abnormalities * any anti-tumor necrosis factor (tnf) agent within 2 months * steroid enemas within 2 weeks * tysabri (natalizumab) within 1 year * biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 3 months * cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),thalidomide or tacrolimus within 2 months

Keywords: ileal crohn's disease ileo-colonic crohn's disease colonic chron's disease
sunphenon in progressive forms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the investigators hypothesize that an oral sunphenon egcg (epigallocatechin-gallat, egcg) treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more effective than an oral placebo treatment regarding following parameters: increase in brain atrophy, number of new t2-lesions in the cerebral magnetic resonance tomography, reduction of the naa/cr-ratio in mr-spectroscopy, progression of disability such as cognitive disorders in patients with ms.

the hypotheses of our study are: sunphenon egcg has an antiinflammatoric effect due to its impact on the t-cell-proliferation and the inhibition of the activity of nf-kb. sunphenon egcg has a neuroprotective effect due to its antioxidative potence as a radical scavenger. a 30 month treatment with sunphenon egcg is safe and well-tolerated.

Eligibility criteria:
inclusion criteria: * primary or secondary chronic progressive multiple sclerosis (ms) * edss 3-8 * age 18-65 exclusion criteria: * relapsing-remitting ms * immunodulatoric or immunosuppressive therapy * pretreatment with mitoxantron, natalizumab, rituximab, azathioprin \<2 month before screening * pretreatment with glairameracetat or beta-interferons \<4 weeks before screening * signs of hepatic dysfunction * active ulcus ventriculi or duodeni * neoplasias if not cured \>1 year before screening

Keywords: primary or secondary chronic-progressive sunphenon egcg brain atrophy t2 lesions
quality of life in patients with allergic rhinitis: clinical trial with bilastine or loratadine

Conditions: Allergic Rhinitis

Summary: the purpose of this study was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg.

this was a prospective randomized double-blinded study, in which patients were recruited from august 2013 until august 2014. outpatients attended in 4 otolaryngology clinics from criciúma, state of santa catarina, brazil were invited to participate of the study. they were aged between 18 and 63 years. seventy-three patient were included, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for ten days. the primary outcome was quality of life, assessed by the modified rhinoconjunctivitis quality of life questionnaire (rqlqm), which was applied at baseline and after 10 days of treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of allergic rhinitis (a typical history of rhinitis symptoms: coryza, sneezing, nasal obstruction, nasal itching, and eye symptoms, and hypersensitivity tests for specific ige measured by radioallergosorbent test (rast) or skin tests * patients classified as with intermittent rhinitis (symptoms during less than 4 days per week) or persistent rhinitis (symptoms during more than 4 days per week) of moderate to severe intensity (annoyance impairing the quality and quantity of sleep and interfering with daily activities) exclusion criteria: * pregnancy or breast-feeding; * non-allergic rhinitis (vasomotor, infectious or drug-induced); * known hypersensitivity to antihistamines; * clinical disorders that might affect the assessment; * nasal diseases that could lead to complete blockage or one of the nostrils blockage, such as tumors or septal deviation; * therapy with immunotherapy; * use of antihistamines or disodium cromoglycate within the past four weeks; * use of topical or systemic corticosteroids, immunosuppressants or any investigational drug within the last two weeks; * use of topical antihistamines or nasal decongestants within the last 48 hours; * use of deposit steroid within the last month.

Keywords: quality of life allergic rhinitis bilastine loratadine clinical trial
parent behavioral training for disruptive behaviors in tourette syndrome

Conditions: Tourette Syndrome; Behavioral Problem

Summary: this is a randomized controlled trial to assess the efficacy of a parent training program to control disruptive behaviors in children with tourette syndrome.

disruptive behaviors occur in 80% of children with tourette syndrome, and can be more disabling than the tics themselves. the aim of this study is to assess the efficacy of a parent training program to control disruptive behaviors in children with tourette syndrome. in addition, social cognition will be examined in all the participants to analyze its relationship with the severity of disruptive behavior and the treatment response. 42 children with tourette syndrome and moderate disruptive behaviors will be randomly assigned to a 10-week parent training program or a 10-week supportive therapy. clinical response will be evaluated after the intervention period, and three and six months later.

Eligibility criteria:
inclusion criteria: * fulfill dsm-5 diagnostic criteria for tourette's disorder * moderate disruptive behaviors (home situations questionnaire score \>3) exclusion criteria: * lifetime history of global learning disability, autism spectrum disorder, psychosis, bipolar disorder or organic brain disorder. * previous parent training with qualified therapist within the last 12 months prior to assessment * simultaneous individual treatment for disruptive behaviors. * initiation or adjustment of any psychotropic medication within the last 6 weeks prior to assessment

Keywords: tourette syndrome
prevalence of gastroesophageal reflux disease in primary care patients with upper gastrointestinal symptoms

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to provide data on the gastroesophageal reflux disease (gerd) prevalence as percentage of patients with upper gastrointestinal (gi) symptoms that are identified with gerd using the gerd-q questionnaire.


Eligibility criteria:
inclusion criteria: * patients with upper gastrointestinal symptoms exclusion criteria: * history of oesophageal, gastric or duodenal surgery * current treatment with antiinflammatory drugs, including otc * current treatment with proton pump inhibitors ang h2-blockers

Keywords: gerd diagnosis gerd-q gerd patients' characteristics gerd
neuromodulation in patients with neuropathic pain and depression.

Conditions: Neuropathic Pain; Depression

Summary: high-frequency repetitive transcranial magnetic stimulation of the primary motor cortex has shown its effect on refractory neuropathic pain, and rtms of the dorsolateral prefrontal cortex is commonly used for treatment-resistant depression. the treatment for patients suffering from neuropathic pain and depression, concomitantly, still needs to be studied, as there are some specificities in both symptoms and brain functional mri.

this project is a cross-over study for these patients, including 4 sessions of either m1 or dlpfc rtms, a wash-out period, followed by 4 sessions of the other stimulation site, to assess the efficiency of a dlpfc rtms for neuropathic pain with a comorbid depression. besides pain intensity and quality, patient's mood, quality of life, and catastrophizing will be assessed.

Eligibility criteria:
inclusion criteria: * central or peripheral neuropathic pain * chronic pain (present for more than 6 months) with intensity greater than or equal to 4/10 on the numerical scale * pain present on a daily or near-daily basis (at least 4 days a week) * patient not completely relieved by recommended drug treatments for first- and second-line neuropathic pain * stable analgesic treatment (no new treatment or dosage adjustment) for at least one month, and will not need to be modified for the duration of the study. * patient with a depressive episode characterized according to dsm v criteria * indication for motor cortex rtms by a neurologist * patient can be followed for the entire duration of the study * patient having received informed consent to participate in the study, and having co-signed a consent form with the investigator * member or beneficiary of a social security scheme exclusion criteria: * industrial accident or litigation * contraindication to rtms or mri (seismotherapy treatment since the previous month; epilepsy and/or history of epilepsy; history of head trauma; neurosurgical lesion; intracranial hypertension; intracerebral metal clip; piercing; pacemaker; insulin pump; metal prosthesis; pregnant or breast-feeding woman; claustrophobia) * drug or psychoactive substance abuse * neuropathic pain in the context of a progressive pathology (hiv, cancer, systemic disease disease) * presence of other pain more severe than that justifying inclusion * patient unable to understand informed consent * patient unwilling or unable to stop treatments prohibited during the study * patient participating in another research protocol involving a drug within the 30 days prior to inclusion * patient deprived of liberty or under legal protection (guardianship, curatorship, safeguard of justice safeguard, family safeguard) * minor patient

Keywords: neuropathic pain depressive disorder transcranial magnetic stimulation neuromodulation pain relief
study of myobloc in the treatment of sialorrhea (drooling) in patients with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis; Sialorrhea

Summary: the purpose of this study is to determine the safety and efficacy of myobloc in als patients who are having excessive drooling. the primary goal of the study is to determine if the patient perceives a benefit from the myobloc in controlling excessive drooling.

the secondary goals of this study are to: * determine the safety of bilateral injections of myobloc into the parotid and submandibular glands as an effort to control sialorrhea; * determine by objective measures if the myobloc injection decreases the saliva produced; * determine caregiver perceived benefit from myobloc injection.

Eligibility criteria:
inclusion criteria: * diagnosis of probable or definite als based on current world federation of neurology criteria * between the ages of 21-85, inclusive * sialorrhea refractory to treatment with at least two anticholinergic medications or has been intolerant of anticholinergic medications due to side effects * capable of giving informed consent * must be able to attend all study visits exclusion criteria: * patient has any uncontrolled significant medical, psychiatric or neurological disease (other than als) over the past 30 days * history of ongoing substance abuse * history of non-compliance with treatment in other experimental protocols * cannot provide informed consent or comply with evaluation procedures * has received any form of botulinum toxin in the past for any indication * women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control * currently being treated with coumadin * forced vital capacity (fvc) \ 600cc, as patients with significant bulbar weakness may show a falsely low fvc due to bulbar muscle spasticity

Keywords: als lou gehrig's disease motor neuron disease amyotrophic lateral sclerosis sialorrhea hypersalivation excessive drooling myobloc botulinum toxin type b clostridium botulinum b toxin botulinum b toxin botulinum neurotoxin b neurobloc