Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of valsartan plus hydrochlorothiazide in fixed dose combination in hypertensive patients not controlled by the free combination of an angiotensin receptor blocker plus hydrochlorothiazide

Conditions: Hypertension

Summary: recruiting in germany only: this study will evaluate the safety and efficacy of valsartan plus hctz in fixed dose combination in hypertensive patients not responding to treatment with the free combination of candesartan plus hctz. in an optional extension patients with uncontrolled bp at the end of the core study can be treated with valsartan plus hctz in fixed dose combination plus amlodipine 5 mg for additional 4 weeks.


Eligibility criteria:
inclusion criteria: 1. male or female patients (\>=18 years) 2. females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. intra-uterine device, hormonal contraceptives). 3. patients with moderate essential hypertension (who): exclusion criteria: 1. severe hypertension (who) 2. pregnant or nursing women 3. treated hypertensive patients with controlled hypertension under current therapy (msdbp \< 90 mmhg and mssbp \< 140 mmhg) 4. a history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure nyha ii - iv

Keywords: hypertension valsartan amlodipine hydrochlorothiazide
ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with health subjects

Conditions: Spondylitis, Ankylosing

Summary: * evaluate the correlation of ultrasound masei index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis. * evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables. * evaluate correlation between articular and enthesis ultrasound exam in this study. * compare patients and healthy individuals data, to calculate the roc curve to estimate predictor value of disease.


Eligibility criteria:
inclusion criteria: * ankylosing spondylitis by the modified new york criteria (1984)or asas classification (2009) * healthy people with no history of joint pain, inflammatory lumbar pain inflammatory disease, * 18 - 65 years old exclusion criteria: * fibromyalgia * corticosteroid injection in the last 3 months * previous surgery in joint or enthesis of study * peripheric neuropathy * diabetes mellitus * hypothyroidism * peripheric venous insufficiency (with edema or ocre dermatitis)

Keywords: ultrasound masei index clinical and ultrasound correlation enthesis ultrasound articular ultrasound ankylosing spondylitis ultrasound radiographic and ultrasound correlation
asian multicenter prospective study of ctdna sequencing

Conditions: Cervical Cancer; Ovarian Clear Cell Carcinoma; Nasopharyngeal Carcinoma; Ovarian Cancer; Endometrial Cancer; Triple Negative Breast Cancer

Summary: this study is a genetic analysis of aberrations in circulating tumor dna (ctdna) in patients in asian countries. this study protocol is divided into parts describing several subanalyses that differ in terms of cancer types, analytical methods, participating countries, and participating institutions.

ngs analysis will be performed on cfdna extracted from peripheral blood samples of target patients to determine the types and incidences of genetic abnormalities. patient information and gene abnormality data will be integrated, and the types and incidences of gene abnormalities by cancer type will be analyzed.

Eligibility criteria:
inclusion criteria: 1. age of 18 years or older at registration. 2. diagnosis of cancer which is targeted by each cohort. 3. metastatic and/or recurrent disease. exclusion criteria: 1. any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the esophagus, stomach, colon, or cervix. 2. ongoing chemotherapy. (chemotherapy-naïve patients or awaiting initiation of the next line of chemotherapy are eligible. there is no limit on the number of prior chemotherapies or on the time from completion of chemotherapy to registration). 3. ongoing radiation therapy. (there are no limits on the time from completion of radiation therapy to registration).

Keywords: ctdna solid tumor in asia
feasibility and efficacy of a remote tai chi program in older adults

Conditions: Aging

Summary: this project is designed to explore the feasibility and preliminary efficacy of a remote tai chi program on older adults' 24-hour movement behaviors (i.e., physical activity, sedentary behavior and sleep patterns).

this study employed a 26-week cross-over, randomized control trial design in which each participant was assigned to one of two condition (i.e., 10 participants/cohort, 2 cohorts/condition) sequences at baseline: 1) the tai chi intervention condition then the usual care condition; or 2) usual care condition then intervention condition. the intervention condition requested participants participate in remote tai chi program for 60 minutes/session 2 times/week beyond their usual care. the usual care condition asked participants to maintain regular activities without tai chi and not to change their regular activity routine. each condition lasted 12 weeks, with a 2-week washout separating treatments. the researchers monitored intervention fidelity via monthly follow-up phone calls.

Eligibility criteria:
eligible participants met the following inclusion criteria: 1) aged 60 years or older; 2) basic english communication skills; 3) without cognitive impairments or physical/mental dis-abilities that might limit their ability to practice tc, 4) computer/smartphone with internet access; and 5) provided informed consent. participants who lacked the capacity to consent or had any medical condition that could make it potentially unsafe to be in an unsupervised physical space were excluded from the study.

Keywords: physical activity tai chi quality of life sedentary behaviors sleep 24-hour movement behaviors fear of falling psychosocial beliefs of physical activity subjective psychological well-being cognitive flexibility
comparative study of nxl104/ceftazidime versus comparator in adults with complicated urinary tract infections

Conditions: Complicated Urinary Tract Infection

Summary: the purpose of this study is to determine whether nxl104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.


Eligibility criteria:
inclusion criteria: * acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens exclusion criteria: * ileal loops or vesicoureteral reflux * complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess. * fungal urinary tract infection * permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry * history hypersensitivity to study medication
impact of hiv-1 and aging on mucosal vaccine responses

Conditions: HIV-1-infection; Human Immunodeficiency Virus; HIV/AIDS; HIV Infections

Summary: the purpose of this study is to learn more about both hiv-1 infection and advancing age, and their association with increased risk of serious infection and impaired response to the prevnar 13 vaccine.

after being informed about the study and potential risks, patients will be screened to determine eligibility for the study and consented. patients who meet eligibility requirements will be immunized with pcv 20. hiv-infected adults will be tested prior to and after vaccination by blood, nasal filter paper, and stool samples to characterize mucosal and systemic antibody responses . hiv-uninfected control adults will be tested at vaccination and post vaccination to characterize mucosal and systemic antibody responses .

Eligibility criteria:
inclusion criteria: * veterans only (accessibility to non-veterans pending) * age 21-45 or 55-75 years old * have not received pneumococcal vaccine prevnar pcv-13 * able to attend 2-3 study visits over 1 month hiv+: -undetectable viral load hiv negative controls: -no history or risks for hiv infection exclusion criteria: * spleen removed * chronic kidney disease (creatinine ≥ 2.0 mg/dl) * active liver disease * currently taking: corticosteroids (prednisone, medrol, etc), chemotherapy, immunosuppressive medication (cyclosporine, methotrexate, azathioprine, infliximab, adalimumab, rituximab, etanercept, etc), or illicit drugs (methamphetamine, cocaine, crack, or heroin)

Keywords: hiv streptococcus pneumoniae infection prevnar-13 pcv-13 pneumococcal vaccine pneumococcal vaccines streptococcus pneumoniae colonization
profile of newborn undergoing early stimulation in a neonatal intensive care unit

Conditions: Motor Skills Disorders

Summary: to describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation.

objective: to describe the profile of newborns undergoing early stimulation in a neonatal intensive care unit, characterizing the study population, according to its variables and neonatal risk factors, indications for treatment of early stimulation. methods: it was conducted a descriptive, cross-sectional and analytical study carried out in the general hospital dr. cesar calls, from july to december 2010. the sample consisted of 116 medical records of newborns indicated for the treatment of early stimulation, representing (9.2%). the study excluded seven infants who had some type of congenital malformation. it was used the following variables: weight, sex, gestational age, apgar score, diagnosis of respiratory distress syndrome and intracranial hemorrhage and the use of mechanical ventilation and cpap.

Eligibility criteria:
inclusion criteria: all cases of newborns who were admitted to the nicu and were referred for treatment of early stimulation exclusion criteria: all records relating to incomplete study variables and newborns who had a congenital malformation.

Keywords: newborns intensive care unit early stimulation
using generalized estimating equation analysis in a study of relaxation training in patients with insomnia.

Conditions: Sleep Disorder; Insomnia Type

Summary: background: the purpose of this study was to examine the improvement in insomnia patients using relaxation training, and to use the generalized estimating equation model (gee-i) to analyze the results of repeated measurements and observe the difference between the subjective perception and the objective measurement of sleep duration. methods: there were 24 subjects diagnosed as insomnia who completed the treatment course and 5 times evaluation. of the 24 subjects, 7 accepted the sleep electroencephalogram (eeg). relaxation training shortened the duration of sleep onset time and decreased the frequency of night awakening.

of 47 qualified subjects, 24 volunteers took part in this study after the researchers had explained the study process.the patients were asked to keep a sleep diary. in the diaries, they recorded the time they went to bed and fell asleep, the duration to sleep onset (from "go to the bed" to "fall asleep"), the frequency of night waking, the time of getting up, and any medication history. patients were instructed to perform the treatment in the evening, preferably just before bedtime, total time was 15 minutes.the patients recorded their sleep conditions every day and underwent relaxation training intervention for 4 weeks.

Eligibility criteria:
inclusion criteria: * all subjects had been diagnosed as having primary insomnia or insomnia related to medical and psychiatric comorbid diagnoses using the d diagnostic and statistical manual of mental disorders, fifth edition (dsm-v) diagnostic criteria. exclusion criteria: * patients who had comorbid serious medical illnesses, and pregnant and lactating women were excluded.

Keywords: insomnia relaxation training generalized estimating equation
phase i study of bms-188667 (ctla4ig) in patients with psoriasis vulgaris

Conditions: Psoriasis Vulgaris

Summary: the purpose of this clinical research study is to determine the safety, pharmacokinetics, immunogenicity in humans, the recovery time required from the biologic effects and the optimal biologic dose range of bms188667 (ctla4ig)


Eligibility criteria:
inclusion criteria: * men or women who received adequate counseling and were judged reliabel in their use of contraceptive measures. * diagnosis and documentation of stable psoriasis vulgaris of at least 6 months duration. * psoriasis vulgaris total body surface area involvement between 10% and 49% (overall disease severity score \[odss\]of 4-7 inclusive). * failure of toxicity or inefficacy of at least one standard antipsoriatic therapy including topical treatment, etretinate, phototherapy, or methotrexate. exclusion criteria: * treatment with: a) retinoids within 2 years, b) cyclosporin a, systemic corticosteroids, methotrexate, or an investigational agent within 16 weeks, c) any phototherapy or photochemotherapy within 4 weeks d) any topical psoriasis treatment other than emollients within 2 weeks prior to enrollment. * no clinical response to a prior adequate therapeutic trial of cyclosporin a * prolonged exposure to the sun within 4 weeks prior to the first dose. * guttate, erythrodermic, or pustular psoriasis. * spontaneously improving or rapidly deteriorating psoriasis vulgaris.
evaluation of sensitization to peach and/or cypress in potato sensitized patients in a large cohort

Conditions: Allergic Rhinitis

Summary: the aim of the study will be to investigate the prevalence of of sensitization to peach and/or cypress in potato sensitized patients, based on the collection of medical data from patient records consulting in the allergy unit of the arnaud de villeneuve hospital. some gibberellin-regulated protein (grp) in fruits and pollens have been identified as allergen, and peach grp (peamaclein) has recently emerged as a relevant food allergen in cypress pollen-hypersensitive patients. multiple fruit allergies might be related to cross-reactivity between grps. peamaclein shares 82% identity with snakin-1 from potato. thus, because of this hight homology the investigators want to determine the prevalence of cosensitization between these 3 allergens potato, peach and cypress.


Eligibility criteria:
inclusion criteria: * patients evaluated at the montpellier university hospital, allergy unit * children and adult with positive skin prick test to potato from february 2013 to december 2015 exclusion criteria: * patients under legal protection * patients under guardianship or under curatorship * patients not capable of understanding french

Keywords: cypress gibberellin-regulated protein peach potato rhinitis
phase 2 study of vinblastine in children with recurrent or refractory low grade glioma

Conditions: Glioma

Summary: this study is examining whether vinblastine is an effective drug to shrink low grade glioma brain tumors in children, and what the side effects are.


Eligibility criteria:
inclusion criteria: * \< 21 years of age at original diagnosis * histological verification of low grade glioma (glial tumors, neuronal tumors or chiasmatic-hypothalamic tumor) at original diagnosis * evidence of tumor recurrence or progression by mri or contrast ct * karnofsky and lansky performance status of 0,1 or 2 * life expectancy of greater than or equal to 2 months * adequate organ and bone marrow function within 7 days of starting treatment with vinblastine * absolute neutrophil count (anc)\> 1000/ul * platelet count \> 100,000/ul (transfusion independent) * serum creatinine \< 1.5 x normal for age * written informed consent signed by subject and/or subject's parent/legal guardian exclusion criteria: * not recovered from the acute toxic effects of all prior chemotherapy, immunotherapy or radiotherapy * chemotherapy within 2 weeks of entry in study (4 weeks if prior nitrosourea was used) * less than 7 days since the completion of therapy with a biologic agent * less than 2 months since cranial/spinal radiation * receiving a stable dose of dexamethasone for less than one week

Keywords: glioma brain tumour cancer pediatrics vinblastine sulfate
study to compare differing dosing regimens of isv-303 (bromfenac in durasite) to xibrom and vehicle in post cataract surgery volunteers

Conditions: Ocular Inflammation

Summary: the purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of isv-303 compared to vehicle and xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.


Eligibility criteria:
inclusion criteria: * scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment * meet the best corrected visual acuity score requirement * meet the iop requirement * additional inclusion criteria also apply exclusion criteria: * known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications * use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to day of surgery * additional exclusion criteria also apply
white blood cell spect/ct and diabetic foot osteomyelitis

Conditions: Diabetic Foot Osteomyelitis

Summary: osteomyelitis is a risk factor for lower extremity amputation in diabetic people. antibiotic therapy allows a remission in 60 to 80% of cases. however the optimal duration of antibiotic therapy remains controversy due to the absence of validated marker of osteomyelitis remission. we have previously shown that the negativity of white blood cell spect/ct (single photon emission computed tomography/computed tomography) imaging at the end of treatment allowed to predict remission of osteomyelitis at 1 year in all cases. a positive imaging was associated with recurrence in 70% of cases. the aim of our study was to evaluate prospectively the interest of white blood cell spect/ct to set the duration of antibiotic therapy.


Eligibility criteria:
inclusion criteria: * age \>18 years * diabetes * osteomyelitis defined by soft tissue infection and/or positive probe-to-bone test and suggestive signs of osteomyelitis on plain-x-ray exclusion criteria: - indication for acute surgical bone resection or amputation

Keywords: diabetic foot osteomyelitis antibiotic treatment white blood cell spect/ct
healthcare students' attitudes towards patients with chronic pain

Conditions: Attitude to the Patient With Chronic Pain; Attitude of Health Care Students

Summary: researchers studied the attitude towards patients with chronic pain, it is a very important issue for the literature. the prevalence of chronic pain is very high in the world, however, patients with chronic pain state at every opportunity that patients are not sufficiently understood and stigmatized by healthcare professionals. in this article, researchers studied the validity and reliability of the scale of the attitude of healthcare professionals towards their patients with chronic pain in students studying in the field of health (medicine, physical therapy and rehabilitation, nursing). researchers found that the healthcare professionals' attitudes towards patients with chronic pain scale was valid and reliable in healthcare students. thanks to this scale, students' attitudes towards patients with chronic pain will be measured, and an idea will be gained about the student's deficiency.


Eligibility criteria:
inclusion criteria: medicine, nursing, and physical therapy and rehabilitation students in their final year, with internet access, who want to participate in the study. exclusion criteria: medicine, nursing, and physical therapy and rehabilitation 1st, 2nd, and 3rd year undergraduate students not wanting to participate in the research

Keywords: nursing students healthcare students chronic pain attitude validity and reliability study
dexamethasone in supraclavicular brachial plexus block for anesthesia after pediatric hand/wrist surgery

Conditions: Wrist Disease; Hand Injuries and Disorders

Summary: effect of systematic dexamethasone on the duration of supraclavicular brachial plexus block for anesthesia after pediatric hand/wrist surgery

this study is proposed to explore the effect of systemic dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery. after hand and wrist surgery, children need good analgesia. peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. the safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. an effective adjuvant, such as dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect. there is considerable research where intravenous and perineural dexamethasone use has been compared in adults. however, there is a massive lack of research regarding children. in this study, investigators compare different doses of systemic dexamethasone. before the anesthesia, the patients receive dexamethasone intravenously. groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.2mg/kg. the investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively.

Eligibility criteria:
inclusion criteria: * children scheduled for hand/wrist surgery * body weight \> 5kg exclusion criteria: * infection at the site of the regional blockade * coagulation disorders * immunodeficiency * asa= or \>4 * steroid medication in regular use
dsp-3025 study of healthy male volunteers and seasonal allergic rhinitis male patients out of season

Conditions: Allergic Rhinitis; Healthy Volunteer

Summary: investigate safety/tolerability after a single dose intranasal administration of dsp-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg * no clinically relevant abnormal findings * history of cedar and/or japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only allergic rhinitis) exclusion criteria: * acute illness which requires medical intervention * definite or suspected personal history of adverse drug reactions or drug hypersensitivity * clinical relevant disease or disorder (past or present) * a history of asthma