Kornimate/medical-research-clean huggingface dataset:
a comparison of duloxetine hydrochloride, marketed comparator, and placebo in the treatment of generalized anxiety disorder

Conditions: Anxiety Disorder

Summary: this is a clinical trial assessing duloxetine and comparator to placebo in patients who have generalized anxiety disorder.


Eligibility criteria:
inclusion criteria: * male and female outpatients at least 18 years of age, presenting with generalized anxiety disorder (gad). exclusion criteria: * any current and primary diagnostic and statistical manual of mental disorders, fourth edition (dsm-iv) axis i diagnosis other than gad. patients diagnosed with major depressive disorder within the past 6 months -or- patients diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year -or- obsessive-compulsive disorder, bipolar affective disorder, psychosis factitious disorder, or somatoform disorders during their lifetime * the presence of an axis ii disorder or history of antisocial behavior, which in the judgement of the investigator would interfere with compliance with study protocol * have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine * history of alcohol or any psychoactive substance abuse or dependence (as defined in the dsm-iv-tr) within the past 6 months
quality of life in patients with refractory angina

Conditions: Refractory Ischemia

Summary: the health and well being of patients with refractory angina will be assessed using validated questionnaires (sf-36 and seattle angina questionnaire \[saq\]) at baseline and one year.


Eligibility criteria:
inclusion criteria: * in the optimist clinic with documented refractory angina * have consented to participate in the optimist long-term follow-up database exclusion criteria: * decline to participate or are unwilling to give written consent

Keywords: angina health related quality of life
bethanechol for eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis (EoE)

Summary: the primary goals of this study are to ease the symptoms of patients with eosinophilic esophagitis (eoe) and to test the effectiveness of the drug bethanechol in relieving those symptoms.


Eligibility criteria:
inclusion criteria: * male or female * age 18-75 * symptoms associated with eoe such as dysphagia, heartburn, vomiting, abdominal pain, food impaction * subject has signed informed consent for the administration of bethanechol that informs the patient of potential adverse events * clinically or pathologically proven eoe exclusion criteria: * known allergy to bethanechol * asthma * pregnant or breast-feeding women * severe neurological problems * severe diabetes * achalasia * known allergy to lidocaine or other local anesthetic * hypothyroidism * peptic ulcer * pronounced bradycardia or hypotension * vasomotor instability * coronary artery disease * epilepsy * parkinsonism * weakened gastrointestinal or bladder wall * mechanical obstruction of the gastrointestinal tract or bladder neck * urinary bladder surgery in the 6 months prior to the study * gastrointestinal resection and anastomosis * spastic gastrointestinal disturbances * acute inflammatory lesions of the gastrointestinal tract * peritonitis * marked vagotonia
comparison of bowel preparation in virtual colonoscopy (vc) - patient experience

Conditions: Colorectal Cancer

Summary: the study will compare patient's experience between those taking a standard bowel cleansing regimen with minimal laxative tagging regimen of senna and gastrofin. additionally comparing any possible reduction in diagnostic accuracy that may ensue from an increased quantity of retained faecal residue.

bowel cleansing with high dose laxative is the standard bowel preparation prior to whole colon investigations but such regimens are associated with considerable patient discomfort and inconvenience, potentially affecting compliance rates \[1-3\]. unlike existing whole colon investigations (conventional colonoscopy and barium enema), reduced laxative regimens can be successfully used with vc, with the aim of improving patient experience, whilst maintaining diagnostic accuracy. these regimens utilize faecal tagging; a method of labeling residual faeces and fluid with radiodense liquids, such as iodine or barium based fluids, which are taken orally by the patient. once faecal residue and fluid is labeled in this way, it can easily be discriminated from true pathology (which remains 'untagged'). we are proposing to compare different bowel preparation regimens, and ascertain patient experience of the different regimes, while monitoring diagnostic accuracy of the 2 different regiments.

Eligibility criteria:
inclusion criteria: * patients with symptoms attributable to colorectal cancer exclusion criteria: * patients with known colorectal cancer referred for staging vc * patients who take laxatives regularly or with previous inadequate colonic examination due to excessive faecal residue * patients deemed too frail to undergo full bowel preparation

Keywords: colorectal cancer bowel preparation regimen patients with symptoms attributable to colorectal cancer
a prospective active-reference study of gaboxadol in primary insomnia

Conditions: Primary Insomnia

Summary: to evaluate the efficacy safety and tolerability of gaboxadol in primary insomnia

to compare the hypnotic efficacy and safety of different dose levels of gaboxadol with placebo in non-elderly patients with primary insomnia over two weeks of treatment

Eligibility criteria:
inclusion criteria: * diagnosis of primary insomnia

Keywords: primary insomnia
effectiveness and safety of convalescent plasma in patients with high-risk covid-19

Conditions: Sars-CoV2; Covid-19

Summary: the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) has affected the global population with significant morbidity and mortality. one of the main concerns is the management of the patients since there is no specific treatment for this condition. therefore, in sars-cov-2 patients the compassionate use of off-label therapies has been initiated; such as the use of plasma from convalescent patients. this treatment has been used in other pandemics like sars-cov-1, h5n1, h1n1, ebola, among others. this study is a phase ii/iii randomized clinical trial to assess the effectiveness and safety of convalescent plasma administration in patients with high-risk sars-cov-2.

this is a phase ii/iii randomized clinical trial to assess the effectiveness and safety of anti-sars-cov-2 convalescent plasma in i) hospitalized adult patients with high-risk of progression sars-cov-2 infection and ii) patients in intensive care unit (icu). compatible abo plasma from convalescent patients will be administered at a dose of 400 ml divided into two doses intravenously. outcomes will be measured as follows: \* group of patients with critical illness: primary outcomes (effectiveness and safety): * mortality * safety: presence of adverse events secondary outcomes: * intensive care unit length of stay * evolution of clinical and paraclinical aspects. * group of patients at high risk of progression: primary outcomes (effectiveness and safety): * mortality * safety: presence of adverse events * admission to icu in 30 days * mechanical ventilation requirement secondary outcomes: * hospital/intensive care unit length of stay * evolution of clinical and paraclinical aspects.

Eligibility criteria:
inclusion criteria: all patients * patients diagnosed with covid-19 infection by rt-pcr technique * patients ≥ 18 years of age * patients in standard care according to the national guide * onset of symptoms ≤ 14 days * signature of informed consent report patients at high risk of progression, defined by all of the following: * score greater than 9 on the call scale * pao2 / fio2 ≤ 200 (parameters adjusted to the height of bogotá, colombia) * x-ray or ct compatible with pneumonia * hospitalized patients critically ill patients, defined by any of the following: * mechanical ventilation requeriment * patients in intensive care unit or intermediate care unit * ventilatory failure, septic shock, dysfunction or multi-organ failure exclusion criteria: * negative rt-pcr result from secretion 48 hours prior to study recruitment * history of allergic reaction to blood or plasma in patients with a known history of iga deficiency * patients participating in other clinical trial * history of allergy to blood products * history of confirmed infection and that required antibiotic or antifungal treatment 30 days prior to recruitment * pregnant women

Keywords: covid-19 serotherapy mortality safety
premom: pregnancy remote monitoring

Conditions: Pregnancies, Cardiovascular Complications

Summary: multiple cardiovascular adaptations happen during pregnancy. when gestational hypertensive disorders (ghd) occurs, these adaptations are abnormal. approximately 5 - 8 % of all pregnant women develop ghd. ghd is an pregnancy complication which is characterized by an elevated blood pressure (≥ 140/90 mm hg) and sometimes the appearance of proteinuria (≥3 g/ 24 hours) after twenty weeks of pregnancy. when this remains uncured, ghd can have severe complications for both mother and child. for this reason, a close follow-up of women with a high risk for developing this condition is recommended. this to detect and threat ghd early. patients can be included when they are at least 10 weeks pregnant. every pregnant women receives two devices to control daily here parameters in her home environment: a blood pressure monitor and an activity tracker. the women will be asked to perform two blood pressure measurements a day and to wear the activity tracker day and night. this data will be send by bluetooth and wi-fi to the investigator in the hospital. also will the women be asked to measure once a week her weight and send this to the hospital. name of the device measurement protocol blood pressure monitor blood pressure, heart rate twice a day (morning and evening) activity tracker activity- and sleep pattern day and night weight scale (not remote) weight once a week (morning) the investigator controls daily the incoming measurements and consults the responsible gyneacologist when events (= abnormal blood pressure or weight measurement) occurs. depending on the decisions of the gyneacologist, following actions can be performed: * further observations * extra monitor * adjustments to the medication scheme * performing an 24 hours urine collection * admission to the prenatal observation ward when results are missing, the investigator contacts the women to ask of this measurement is due to personal or technical causes. the purpose of this study part is to detect early signs of pe. when patients gave birth, the data about the delivery (duration of labour, complications, mode of delivery, date of delivery, complications, parameters of the mother, specialties) and the neonate (gestational age, date and hour of birth, apgar score, birth weight, length, complications and admission to the neonatal intensive care) will be collected. these data will be compared to the data of women who were admitted to the hospital for ghd, but who doesn't receive remote monitoring devices.


Eligibility criteria:
inclusion criteria: * \> 10 weeks of gestation, in the possession of a smartphone exclusion criteria: * congenital malformations of the fetus
teriflunomide vs. placebo during gluten challenge in celiac disease

Conditions: Celiac Disease

Summary: the investigators will see if the drug teriflunomide (which is in use in other immune disorder (multiple sclerosis)) can inhibit the immune activation in celiac disease patients during a 3 day gluten challenge. this will be measured in a blood sample.

this is a controlled, double-blind, randomised, singlecentre, placebo-controlled, phase iia proof-of-concept study on effects of the drug on activation and efflux of gluten specific t cells using hla-dq:gluten tetramers. the study will be conducted with two treatment groups in the form of a 2:1 parallel group comparison and will serve to compare oral treatment with 14 mg/d teriflunomide vs. placebo in subjects with well-controlled coeliac disease undergoing gluten challenge. the screening period will be up to 8 weeks, followed by a 7-day run-in treatment period with a loading dose of teriflunomide followed by a 6 day therapeutic maintenance dose, an initial 4-week treatment-free follow-up period and a 6 month closing follow-up.

Eligibility criteria:
inclusion criteria: * patient aged 18-80 * willingness to comply with the study procedures and having signed informed, written consent * previous diagnosis of coeliac disease according to established guidelines based on positive serology (endomysium test, iga-tg2 and/or iggdgp) and a duodenal biopsy showing villous atrophy graded as marsh 3 * positive gene test for hla-dq2.5 * adherence to gluten-free diet exclusion criteria: * known intolerance to ingredients of teriflunomide or placebo tablets * known intolerance to gluten challenge * known intolerance to cholestyramine * duration of gluten free diet shorter than six months * positive serology (iga-tg2 below upper level of normal) at screening visit * pregnancy or breast-feeding * not willing to comply with proper pregnancy control (in females) * concomitant medication that interferes with immune activation (e.g. steroids, calcineurin inhibitors, biological treatment for inflammatory bowel disease or other immune disorders, further list is given below) * any other medical condition that in the opinion of the principal investigator makes the individual unsuitable for participation

Keywords: immunotherapy gluten challenge teriflunomide
micafungin salvage mono-therapy in invasive aspergillosis

Conditions: Invasive Aspergillosis

Summary: to evaluate the efficacy and safety of micafungin in patients with proven invasive aspergillosis and who are refractory or intolerant to previous systemic antifungal therapy. to compare the efficacy and safety of the micafungin therapy with the active control arm

this is a phase ii, multicentre, prospective, active-controlled, open-label, 2:1 randomised and parallel group clinical study. patients will be stratified according to the baseline infection status and the baseline neutropenic status: * intolerant to previous antifungal therapy * refractory to previous antifungal therapy; progression of infection * refractory to previous antifungal therapy; failure to improve in case, criteria for both intolerant and refractory are fulfilled at the same time the patient will be considered as refractory. * neutropenic (absolute neutrophil count (anc \< 500 cells/mm3) * non neutropenic (anc \>= 500 cells/mm3)

Eligibility criteria:
inclusion criteria: * adult patients with hsct, acute leukaemia or myelodysplastic syndrome, with proven (probable only in case of pulmonary aspergillosis) invasive aspergillosis and refractory or intolerant to amphotericin b or voriconazole products exclusion criteria: * patients with allergic bronchopulmonary aspergillosis, chronic pulmonary aspergillosis, aspergilloma, sinus aspergillosis or external otitis; patient with previous salvage therapy for the current episode of fungal infection

Keywords: invasive aspergillosis salvage therapy micafungin
a light exposure tracker designed to improve circadian rhythms - aim 1

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: the purpose of this research study is to investigate the relationship between light and circadian rhythms. twenty healthy older adults will be recruited to participate in a randomized, cross-over study, where an active lighting intervention designed to maintain entrainment and a control intervention designed not to entrain will be tested.


Eligibility criteria:
inclusion criteria: * healthy adults over the age of 55 * score of 25 or greater on moca exclusion criteria: * severe sleep apnea * restless leg syndrome * obstructing cataracts * macular degeneration * diabetic retinopathy * glaucoma * use of sleep medications * brain disease
evaluation of the diagnostic performance of specialized fetal cardiac ultrasound in the cpdpn - arc alpin network

Conditions: Heart Defects, Congenital; Ultrasonography, Prenatal

Summary: to evaluate the diagnostic performance of antenatal echocardiography with regard to the main diagnosis of heart disease made by cardio-pediatricians at the couple-child hospital in grenoble according to the acc-chd classification, in pregnant women who have had a fetal heart ultrasound between 2015 and 2019. \*acc-chd : anatomic and clinical classification of congenital heart defects

this work is in line with the desire of the pluridisciplinary center for pre-natal diagnosis (cpdpn) of the arc alpin network, to assess their professional practices regarding the prenatal diagnosis of heart disease over the last five years from 2015 to 2019, and so identify areas for improving their care. within the arc-alpin network, pregnant women for whom an abnormality is detected in the fetus during the screening ultrasound, then benefit from a diagnostic ultrasound, to confirm the detected abnormality. then, the patient's file will be studied within the cpdpn of the alpine arc, and the patient will then be referred to a doctor specializing in the diagnosed fetal pathology. the latter will prescribe additional examinations to characterize as much as possible the diagnosed pathology, in order to develop a course of action to be taken, and to establish a prognosis for this fetus (specialized ultrasound, mri, amniocentesis, etc.) as part of the diagnosis of fetal heart disease, the woman will be referred to cardio-pediatricians at the couple enfant hospital in grenoble, who will perform a so-called specialized 2nd line ultrasound in order to clarify the diagnosis, to develop a course of action to take, and establish a prognosis for this unborn child. we therefore want to study the diagnostic performance of specialized 2nd line fetal cardiac ultrasound in the cpdpn network of the alpin arc, by comparing the diagnosis established following the 2nd line fetal echocardiography with the reference examination (test of reference) which is the postnatal cardiac ultrasound.

Eligibility criteria:
inclusion criteria: * pregnant women who have had a fetal heart ultrasound performed by a cardiac pediatrician at the hopital couple enfant in grenoble between 2015 and 2019. exclusion criteria: - no

Keywords: heart defects, congenital / diagnostic imaging
xarelto [spaf] post-marketing surveillance in japan

Conditions: Brain Ischemia

Summary: this study is a regulatory post-marketing surveillance in japan, and it is a local prospective and observational study of patients who have received xarelto for spaf. the objective of this study is to assess safety and effectiveness of xarelto using in real clinical practice. a total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. an annual follow-up survey will be conducted for 5 years at the longest after standard observational period.


Eligibility criteria:
inclusion criteria: * patients with non-valvular atrial fibrillation (nvaf) for whom the decision to be treated with xarelto was made * patients without experience of using xarelto prior to the study exclusion criteria: * patients who are contraindicated based on the product label

Keywords: xarelto spaf
urdu version of fear avoidance belief questionnaire: reliability and validity study

Conditions: Low Back Pain

Summary: the study aims to translate and culturally adapt fear avoidance belief questionnaire into the urdu language and to investigate the reliability and validity in the pakistani population and check its correlation with visual analog scale , ronald morris questionnaire, quebec back pain disability scale and hospital anxiety and depression scale .

as per preceding commendation, fear avoidance belief questionnaire will be translated into urdu language from its english version and adapted culturally in pakistan. among low back pain population, fear avoidance belief questionnaire will be conducted in 180 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. for testing inter-observer reliability and intra-observer reliability of fear avoidance belief questionnaire, hospital anxiety and depression scale, ronald morris questionnaire, quebec pain rating scale and numeric pain rating scale will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. as for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. statistical package of social sciences software version 24 will be used for the purpose of data entry and analysis. internal consistency will be assessed by using an intra-class correlation coefficient. the fear avoidance belief questionnaire will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria:
inclusion criteria: * patients or the ones next to them who gave informed consent * participants with complain of low back pain for more than 3 months. * age at least above 18 years. exclusion criteria: * inability to understand or follow the instructions of the fear avoidance belief questionnaire. * any musculoskeletal pathologies * suffering from any cardiovascular pathologies * any history of tumor and cancer * any history of fracture * any histories of infections * any history of neurological disorders * having any spinal deformity

Keywords: fear avoidance belief questionnaire urdu version reliability validity low back pain
a study of bibw 2992 (afatinib) in patients with metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: this phase ii study is open to patients with metastatic colorectal cancer who have tried but failed chemotherapy regimens containing oxaliplatin and irinotecan. patients must not have received anti-egfr (epidermal growth factor receptor) treatment (for example, cetuximab, panitumumab) in the past. patients with wild-type kras (v-ki-ras2 kirsten rat sarcoma viral oncogene homolog) colorectal cancer will be randomised to receive either bibw 2992 or cetuximab. patients with kras mutated colorectal cancer will not be randomised, but will all receive bibw 2992. the main objectives of the study are: to compare the effectiveness of bibw 2992 with that of cetuximab in patients with kras wild type cancer, and to assess the effectiveness of bibw 2992 in patients with kras mutated cancer.


Eligibility criteria:
inclusion criteria: 1. patients with metastatic colorectal cancer who have failed both oxaliplatin- and irinotecan-based regimens 2. tumour sample available for kras (v-ki-ras2 kirsten rat sarcoma viral oncogene homolog) mutation testing and other biomarker analyses. exclusion criteria: 1. prior treatment with epidermal growth factor receptor (egfr) targeting small molecules or antibodies. 2. biological treatment (including bevacizumab or any other antiangiogenic agents) during the trial is not allowed. 3. known pre-existing interstitial lung disease. 4. planned major surgical procedures during the trial period.
enhancing gluteus maximus recruitment

Conditions: Muscular Weakness

Summary: can participants enhance gluteus maximus recruitment during a single-leg squat test following a neuromuscular training program?


Eligibility criteria:
inclusion criteria * female * healthy, active individuals * age 18-36 * walk without assistive device * able to run, jump, squat without difficulty * show evidence of hip muscle dysfunction on screening exam exclusion criteria * history of knee ligament injury, knee surgery, patella dislocation * knee pain traversing stairs, squatting or after prolonged sitting within 6 months of test * joint line tenderness suggestive of meniscus pathology * positive knee ligament stress tests

Keywords: knee hip muscle strength electromyography biomechanical phenomena