Kornimate/medical-research-clean huggingface dataset:
a dose escalation study of blu-5937 in unexplained or refractory chronic cough

Conditions: Chronic Refractory Cough

Summary: this is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose escalation study of blu-5937 in subjects with unexplained or refractory chronic cough

this study will have two 16-day treatment periods (four escalating doses or matching placebo at four days interval) separated by a 10 to 14-day washout period. there will be a 14-day follow-up period.

Eligibility criteria:
inclusion criteria: * unexplained or refractory chronic cough for at least one year * chest radiograph or ct thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the chronic cough * cough count of ≥ 10 per hour (awake cough count) at screening * score of ≥ 40mm on the cough severity vas at screening * women of child-bearing potential must have a negative serum pregnancy test at screening * women of child-bearing potential must use a highly effective contraception method from screening through the follow-up visit * male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control exclusion criteria: * current smoker or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history * diagnosis of copd, bronchiectasis, idiopathic pulmonary fibrosis * treatment with an ace-inhibitor as the potential cause of a subject's cough, or requiring treatment with an ace-inhibitor during the study, or within 12 weeks prior to the screening visit * fev1/fvc \< 60% * history of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the baseline visit * history of concurrent malignancy or recurrence of malignancy within 2 years prior to screening * history of a diagnosis of drug or alcohol dependency or abuse within the last 3 years * clinically significant abnormal electrocardiogram (ecg) or laboratory tests at screening * other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results

Keywords: unexplained or refractory chronic cough, p2x3 antagonists
assessment of alcon's ocular image quantification system

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study was to evaluate ocular responses with different allergen provocation methods.

subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the environmental exposure chamber (eec) for a 3-hour exposure to a known concentration of the allergen. after waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour conjunctival allergen provocation test (capt) was performed with an escalating concentration of the allergen. subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Eligibility criteria:
inclusion criteria: * history of allergic conjunctivitis; * active signs and symptoms of ocular allergies; * other protocol-defined inclusion criteria may apply. exclusion criteria: * history of dry eye; * presence of ocular infection; * presence of severe or serious ocular conditions; * symptoms of allergic conjunctivitis; * use of topical or systemic ocular medications as specified in protocol; * ocular surgery or laser surgery within 6 months of study start; * unwilling to discontinue contact lens wear 72 hours prior to visit 1 and during study period; * other protocol-defined exclusion criteria may apply.

Keywords: allergic conjunctivitis
burden of ischemic stroke and intake of oral anticoagulants in patients with atrial fibrillation in the uk primary care

Conditions: Atrial Fibrillation

Summary: this study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial fibrillation) in a uk general population using the health improvement network (thin) database. the main aim of the study is to estimate in how many patients atrial fibrillation was diagnosed at the moment of stroke and to describe whether these patients received oac at the time of the stroke. in addition, researchers want to learn about the relative risk of ischemic stroke when such patients did not continue oac treatment.

the primary objectives of the study are to determine the incidence of ischemic stroke in patients registered in the british primary care thin database and to investigate the oac exposure, oac treatment patterns and the relative risk of having an ischemic stroke in relation to oac treatment for a subgroup of patients, who were diagnosed with non-valvular atrial fibrillation (nvaf) prior to ischemic stroke. secondary objectives are to determine the number of patients having nvaf diagnosed at the time of ischemic stroke and within 1 and 12 months after ischemic stroke; to describe cardiovascular risk factors for ischemic stroke and pharmacological treatments before and 12 months after ischemic stroke, and to estimate the case-fatality at 1 and 12 months after the occurrence of ischemic stroke.

Eligibility criteria:
inclusion criteria: * occurrence of an ischemic stroke that lead to hospitalization between 01-jul-2016 to 30-jun-2018 and concerned adults registered in the thin database * subgroup: patients with diagnosed nvaf prior or at the time of ischemic stroke exclusion criteria: * none

Keywords: ischemic stroke non-valvular atrial fibrillation (nvaf) oral anticoagulants (oac) vitamin k antagonists (nka) non-vitamin k antagonist oral anticoagulants (noac) discontinuation
cognitive behavior therapy for adolescents with bulimia

Conditions: Bulimia Nervosa

Summary: we are interested in studying two different psychological treatments for eating disorders for adolescents (ages 12-18). the study is designed to help adolescents who are having problems with binge eating and/or purging. the treatment consists of 14 sessions of approximately one-hour each over about three months.

interested adolescents will have a phone screen and then come in for an in-person psychiatric evaluation. if eligible and interested, they will be randomly assigned to 4 months of outpatient treatment (free of charge) that is either 1) cognitive-behavioral therapy or 2) supportive psychotherapy.

Eligibility criteria:
inclusion criteria: * current or prior dsm iv diagnosis of bulimia nervosa or sub-threshold bulimia nervosa (those who meet all dsm-iv criteria for bn, but engage in subjective binge-eating episodes and binge/purge at a frequency of at least once per week for 3 months, whereas meeting full dsm-iv criteria for bn requires binge eating and purging twice per week for 3 months) * major depression exclusion criteria: * diagnosis of bipolar disorder, current psychosis, drug or alcohol abuse in past 3 months, acute suicidal risk, major depression producing significant functional impairment, significant medical illness, weight outside of normal weight range.

Keywords: bulimia nervosa, ednos, adolescents
´sit less, move more' at work: mhealth intervention on office employees with diabetes type 2.

Conditions: Diabetes Mellitus, Type II

Summary: the objective of the study is measuring the impact of a ´sit less, move more' mhealth intervention at work on the glycaemic control and anthropometric profile of office employees with diabetes type 2 (dt2) at short, mid and long term.

a double-blind randomized controlled trial. seven primary care centers from spain (n=5 catalonia, n=2 madrid), 2 hospitals (n=1 catalonia, n=1 madrid) and 2 companies (occupational health services; n=1 public, n=1 private) will participate in the study. in each center, physicians, nurses, endocrinologists and occupational physicians will recruit patients with dt2 who spend at least 55% of their working hours doing desk-based tasks (ospaq) and have a cellphone. following the consort statement (2010), volunteers will be randomized into a control (cg) or intervention group (ig) by the research team using a computer program to generate the random sequence. 184 individuals are needed in each group. main variables: fasting glucose levels, hba1c, weight, height, bmi, waist circumference. occupational sitting time and sitting time breaks will be measured using activpal devices. other variables: physical activity (ipaq short), quality of life (euroqool), presenteeism (wlq), triglycerides, total cholesterol (ldl and hdl), blood pressure and sociodemographic variables. intervention: a mhealth program (13 wks) will progressively replace occupational sitting time with light physical activities. participants from the cg will receive usual care. multivariate analysis will assess changes over time (post intervention and at 6 months follow up) in the dependent variables; looking at differences between groups. intention to treat will be applied.

Eligibility criteria:
inclusion criteria: * dm2 diagnosed office employees according to international criteria. * doing sedentary tasks during at least a 55% of their daily work schedule (according to the occupational sedentary and physical activity questionnaire: ospaq \>55%). * having a cellphone . * having a minimum work contract of 18.5 hours per week. * being able to get up from the chair or to walk by themselves (without any help). exclusion criteria: * not having a cellphone. * having some pathology/disability/injury which changes their ability and capacity to walk or getting up from the chair. * doing less than a 55% of the daily tasks in a sitting position according to the ospaq questionnaire.

Keywords: mhealth physical activity glucose, blood glycated hemoglobin a1c health-related quality of life quality of life triglycerides hdl cholesterol ldl cholesterol blood pressure, arterial presenteeism sitting time sedentary behaviour workplace
study of zemplar iv in patients with end stage chronic kidney disease, undergoing haemodialysis

Conditions: Parathyroid Hormone

Summary: this is the post-marketing study conducted in two countries: croatia and serbia. in both countries zemplar (paricalcitol) is the first injectable form of any vitamin d receptor (vdr) activator available for chronic kidney disease patients on hemodialysis. the evaluation of outcomes of vdr activator treatments in clinical practice is a major challenge in the management of this patient population. the aim of this post-marketing observational study is to obtain further data on the outcomes of zemplar injection administration during routine clinical use.

this study is a non-interventional, observational study in which zemplar® injection is prescribed in the usual manner in accordance with the terms of the local summary of product characteristics (smpc) with regards to dose, population and indication. the study population consists of participants receiving hemodialysis in whom the diagnosis of secondary hyperparathyroidism has been established, and who are not adequately controlled with the oral vdr activator (calcitriol or alfacalcidol). participants will be included via consecutive sampling. to be included, participants should have a clinical indication to initiate treatment with zemplar® injection due to: (1) a diagnosis of secondary hyperparathyroidism and (2) because they require a change in treatment for secondary hyperparathyroidism (e.g. due to a lack of effectiveness of the previous treatment). each participant will be observed during his/her zemplar® injection treatment regimen for a maximum period of 12 months.

Eligibility criteria:
inclusion criteria: * subject is more than 18 years of age and diagnosed with secondary hyperparathyroidism and has a pretreatment ipth \> 300 pg/ml, receiving chronic hemodialysis. * subject for which treatment with zemplar injection is indicated clinically according to the criteria of participating investigator. exclusion criteria: * subject has a corrected serum calcium \>10.5 mg/dl, serum phosphorus \> 6.5 mg/dl or subjects with corrected ca x p\>65. * subject has known hypersensitivity and/or toxicity to vitamin d metabolites and/or other product ingredients, or has participated in clinical study within the last month

Keywords: paricalcitol iv vitamin d secondary hyperparathyroidism hemodialysis
evaluation of the effect on pain of attentional diversion associated with hypnotic induction by virtual reality (vrh) in perioperative prostate biopsies under local anesthesia:

Conditions: Prostate Biopsy

Summary: the primary objective of the study is to prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, either transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset. the study was sized based on a mean pain reduction of 1.5 points on a numerical scale (0-10 nas), with an estimate of procedure-related pain of 4.0 on the nas scale.

prospective comparison of pain during the procedure assessed in patients treated for prostate biopsies under local anesthesia with or without a virtual reality headset.no additional examination will be performed in addition to the conventional management of a biopsy except for the fitting of the headset for patients randomized to the "with virtual reality headset" group. patients will be randomized on the same day of the procedure into one of the two study groups. a single follow-up visit will be performed postoperatively 1 month after surgery.

Eligibility criteria:
inclusion criteria: * adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route * patient having signed informed consent exclusion criteria: * patient suffering from blindness or any other visual handicap that contraindicates the use of the headset * deaf or hard of hearing patients * patients suffering from epilepsy and/or mental deficiency, and/or disorders of higher functions * psychotic patients * claustrophobic patients or those who cannot tolerate a mask over their eyes * refusal of local anesthesia * protected person (art. l1121-5 to l1121-8 of the csp)

Keywords: sedation pain hypnosis virtual reality
different ribavirin dosages and different duration of treatment in combination with peginterferon in patients with genotype 2 and 3 (write)

Conditions: Chronic Hepatitis

Summary: write study aim at identifying the effectiveness of an innovative individualized schedule of treatment as compared to standard regimen in patients with chronic hcv genotype 2 and 3.

the investigators are going to compare weight-based dosages of ribavirin, in combination with peginterferon alpha-2a, with standard fixed dosages of 800 mg. patients will be evaluated at week 4 with an assay of sensitivity of 15 iu/ml. patients with week 4 response will discontinue treatment at week 12 in both arms. patients with hcv rna still detectable at week 4 and receiving 1000-1200 mg of ribavirin in arm a will discontinue treatment at week 24, whereas patients with hcv rna still detectable at week 4 and receiving 800 mg of ribavirin in arm b will be treated till week 48. a standard treatment arm (c) including patients treated for 24 weeks with peginterferon alpha-2a and fixed 800 mg ribavirin dosage will be used as control arm.

Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis c virus (hcv) infection (both hcvab and hcv rna positive) * patients with hcv genotype 2 or 3 * age 18-70 years * naïve patients or previously treated only with standard interferon monotherapy * female patients of childbearing age who agree to avoid pregnancy during the period of treatment and 24 weeks after the end of treatment exclusion criteria: * previous treatment with ribavirin * cirrhosis (child pugh b and c) * evidence of hepatocellular carcinoma * pregnancy * retinopathy class i or ii * alcohol consumption \> 40 gr/day * chronic cardiac or respiratory diseases * hiv or hbsag or hdv positivity * hemoglobin \< 8.5 gr/dl * wbc \< 3.500/mm3 * plt \< 80.000/mm3

Keywords: genotypes 2 and 3 combination treatment individualized treatment
budi (bariatric urodynamic improvement)

Conditions: Urinary Incontinence; Obesity; Urodynamics; Quality of Life

Summary: in the population of obese women, the prevalence of urinary incontinence (ui) is around 70%. it was shown in the literature that weight loss by bariatric surgery allowed a significant improvement in the symptoms and impact on the quality of life of the iu. however, no prognostic factor for recovery has yet been identified and the pathophysiological mechanisms underpinning this improvement are not fully elucidated. the main objective of this study is to highlight the urodynamic changes associated with the improvement of the symptom and quality of life scores in a population of incontinent obese women before and after bariatric surgery.


Eligibility criteria:
inclusion criteria: the research protocol will be proposed to all patients requiring bariatric surgery (gastric bypass or sleeve gastrectomy) and describing urinary incontinence according to the definition of the international continence society (ics) exclusion criteria: * minors under the age of 18 * pregnant or lactating women * women not speaking french (important to understand and respond to questionnaires) * women who have not given their written consent * neurological diseases, * patients who have benefited from urinary incontinence surgery, prolapse treatment or pelvic surgery at risk of urodynamic modifications (extensive resection of deep endometriosis, pelvic wound surgery, pelvic radiation therapy).
mycotic antimicrobial localized injection for treatment of corneal ulcers

Conditions: Corneal Ulcer; Fungal Keratitis

Summary: mycotic antimicrobial localized injection (malin) is a randomized, masked, two-arm clinical trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers. there is currently little evidence to guide the treatment of fungal keratitis beyond topical anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used as well. this study will provide evidence to guide the treatment of fungal keratitis in the future. the purpose of this study is to determine differences in microbiological cure for 3-day repeat cultures between different antifungal treatments. for this study, there will be 1:1 randomization to one of these two treatment groups: 1) topical natamycin plus intrastromal voriconazole injection or 2) topical natamycin alone.

the proposed study is a randomized controlled trial to determine whether intrastromal voriconazole improves outcomes in fungal keratitis. patients presenting to the aravind eye hospitals in pondicherry, india for treatment of fungal keratitis will be recruited for the proposed study. approximately 70 patients will be enrolled in the study. subjects presenting with fungal keratitis will be randomized to receive topical natamycin plus intrastromal voriconazole or to receive topical natamycin alone. subjects may also receive oral antifungals after day 3 at the discretion of the treating clinician. all study subjects will be followed for 3 months to evaluate response to treatment. investigators from the university of california, san francisco (ucsf) will assist aravind eye hospital with the study design, implementation, and analysis of the research, and will help fund the study. the investigators will visit aravind to help with the study implementation. ucsf will play an important role in this study by assisting with the study design, implementation, analysis, and funding.

Eligibility criteria:
inclusion criteria: * moderate to severe corneal ulcer that is smear positive for filamentous fungus * pinhole visual acuity worse than 20/70 in affected eye * basic understanding of the study as determined by the physician * commitment to return for follow up visits exclusion criteria: * gram stain positive for bacteria or evidence of other concomitant infection (i.e. herpes, acanthamoeba) * impending or frank perforation at recruitment * involvement of sclera at presentation * non-infectious or autoimmune keratitis * history of corneal transplantation or recent intraocular surgery * no light perception in the affected eye * pinhole visual acuity worse than 20/200 in the unaffected eye * pregnant women * participants who are decisionally and/or cognitively impaired

Keywords: cornea ulcer fungal keratitis
different surgical approaches for treatment of upj obstruction in children: prospective randomized clinical trial

Conditions: Urologic Diseases; Surgery

Summary: this study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (lp) for ureteropelvic junction obstruction (upjo) via retroperitoneal and transperitoneal approaches.

ureteropelvic junction obstruction (upjo) is the most common congenital abnormality of the kidney and is responsible for flank pain, recurrent urinary infections, hydronephrosis and the loss of renal function. until recently, open pyeloplasty (op) was the standard surgical treatment modality for upjo.however, with the development of laparoscopic devices and surgical technology, laparoscopic pyeloplasty (lp) has become a more beneficial choice for the patients with upjo than open surgery because of the advantages of excellent visualization, minimal trauma, rapid postoperative recovery, good cosmetic result, and a nearly successful rate compared with open pyeloplasty. the first lp in children was performed in 1995. it has gained popularity for older children. lp can be performed though retroperitoneal and transperitoneal approaches. which surgical method is better is still controversial.

Eligibility criteria:
inclusion criteria: * age above two years. * unilateral upjo. exclusion criteria: * age below two years. * bilateral upjo. * recurrent upjo. * malrotated kidneys and renal fusion anomalies.

Keywords: upj obstruction pediatric urology pyeloplasty