Kornimate/medical-research-clean huggingface dataset:
women's isoflavone soy health (wish) trial

Conditions: Atherosclerosis

Summary: the purpose of this study is to determine whether soy supplementation can reduce hardening of the arteries and cognitive decline in postmenopausal women.

heart disease is the leading cause of death among women in the united states. atherosclerosis, a primary cause of heart disease, accounts for more than 485,000 heart attacks and 370,000 strokes each year in american women. data indicate that a woman's risk of suffering from an atherosclerosis-related cardiovascular event significantly increases after menopause; this risk may be due to reduced estrogen production associated with menopause. soy isoflavones are plant compounds that are structurally similar to human estrogen. evidence suggests that soy supplements may provide the same protection against heart disease as estrogen in postmenopausal women. this study will determine the effects of soy supplementation on subclinical atherosclerosis progression and cognitive decline in postmenopausal women. in this double-blinded, placebo-controlled trial, a total of 350 postmenopausal women were randomly assigned to receive either soy protein supplementation or placebo twice daily for 2.7 years. the initial 2.5-year treatment period was increased to 3 years. the active product, given as two divided doses, was 25 g soy protein containing 85 mg aglycone weight naturally-occurring isoflavones (150 mg total isoflavone) of genistein 45 mg aglycone weight (80 mg total weight), daidzein 35 mg aglycone weight (60 mg total weight), and glycitein 5 mg aglycone weight (10 mg total weight). the primary trial end point was the rate of change in the right distal common carotid artery intima-media thickness (cimt) by ultrasonography. participants underwent ultrasonography at baseline and every six months along with laboratory determinations and clinical measurements. cognitive assessments were completed at baseline and the final follow-up visit (2.5 years).

Eligibility criteria:
inclusion criteria: * postmenopausal, defined as no vaginal bleeding for at least 1 year and serum estradiol level lower than 20 pg/ml exclusion criteria: * signs, symptoms or personal history of cardiovascular disease * diabetes mellitus or fasting serum glucose of 126 mg/dl or greater * fasting plasma triglyceride of 500 mg/dl or greater * serum creatinine greater than 2.0 mg/dl * uncontrolled hypertension * untreated thyroid disease * life expectancy less than 5 years * current use of hormone replacement therapy (hrt) * soy, nut, or related food allergies * more than 5 alcohol drinks per day or substance abuse

Keywords: atherosclerosis cardiovascular diseases carotid artery intima-media thickness (cimt) cognition complementary and alternative medicine daidzein genistein glycitein intervention isoflavones menopause prevention postmenopausal randomized controlled study soy soy protein subclinical vascular disease ultrasonography women
effect of acceptance and commitment therapy on psychotic severity

Conditions: Psychosis; Emotion Regulation; Recovery

Summary: our study aims to assess the efficacy of acceptance and commitment therapy on psychotic severity among inpatients with primary psychosis: a randomized controlled trial.

current study was an open label, two-arm, parallel, randomized controlled trial, evaluating the efficiency of acceptance and commitment therapy (act) added to treatment as usual (tau) as opposed to treatment as usual (tau) alone on patients with schizophrenia. the study adheres to the rules for writing clinical trials: "the consolidated standards of reporting trials" (consort) statement

Eligibility criteria:
inclusion criteria participants' criteria of inclusion involved those patients who were 1. current psychiatric hospitalization; 2. dsm-5 diagnosis of a primary psychotic disorder; (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder, brief psychotic disorder, and unspeciﬁed psychotic disorder, this diagnosis was confirmed by a psychiatrist 3. 18 years or older; 4. ability to talk, read and write in arabic; and 5. willingness to participate in the study that was scheduled for seven weeks. exclusion criteria patients were excluded if they 1. had a comorbid learning disability or organic brain disorder; 2. psychosis related to a general medical condition or substance-induced psychotic disorder; 3. were considered mentally unstable; or 4. unfit to participate in the study by their therapist, and/or had newly had (been receiving) psycho-education or somewhat designed psychosocial intervention.

Keywords: psychosis emotional regulation recovery
a combination of two currently approved drugs to enhance the treatment of schizophrenia

Conditions: Schizophrenia

Summary: study of a medication for the treatment of schizophrenia in patients who are already taking abilify, risperdal, seroquel, zyprexa


Eligibility criteria:
inclusion criteria: * must have a clinical diagnosis of schizophrenia * must be at least 18 years of age and not older than 55 years of age * must have been stable on a dose of abilify, risperdal, seroquel, or zyprexa for the past 8 weeks * women of childbearing potential must be using a medically accepted means of contraception * must be able to swallow capsules exclusion criteria: * has serious health problems other than schizophrenia * takes an antidepressant for depression * takes insulin for diabetes * have a history of alcohol or drug dependence (except for nicotine and caffeine) within the past 6 months
yoga for rheumatoid arthritis

Conditions: Rheumatoid Arthritis; Osteoarthritis

Summary: the purpose of this study is to evaluate the impact of yoga on inflammatory arthritis and knee osteoarthritis.

yoga is a set of ancient indian theories and practices, focusing on unifying mind, body, and spirit, and promoting strength, balance, and flexibility. the physical aspect of yoga includes poses, breathing techniques, and relaxation. inflammatory arthritis, a chronic disease characterized by inflammation of the lining of the joints, can cause long-term joint damage, resulting in chronic pain, loss of function, and disability. the primary objective of this study is to learn how people with inflammatory arthritis and knee osteoarthritis respond to an exercise program of yoga. to accomplish this, 30 persons with inflammatory arthritis or knee osteoarthritis will be randomly assigned to one of two groups. group one will begin an immediate 8-week program of yoga classes consisting of 60-minute sessions, twice a week. group two, or the "waitlist" control group, will receive 8 weeks of arthritis education followed by the same 8-week yoga program as group one. participants also will have blood drawn, and complete various tests. the yoga classes will be taught by an experienced, certified yoga instructor, and are designed especially for the needs of people with inflammatory arthritis and knee osteoarthritis. this study will provide important data on integrating mind-body activities into the treatment of inflammatory arthritis and knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * age 18+ (ra only upper age limit 70) * confirmed or probable oa (using pre-specified criteria) or rheumatoid arthritis (participation approved by rheumatologist) * currently sedentary (physically active for 20 min \< 3times/week) exclusion criteria: * inability to ambulate without use of assistive device * uncontrolled high blood pressure or existing heart condition * co-morbid inflammatory condition with overlapping symptoms (i.e., fibromyalgia) * surgery within 6 months

Keywords: inflammatory arthritis rheumatoid arthritis knee osteoarthritis arthritis yoga
evaluate the long term safety and efficacy of dwp16001 add-on to metformin in patients with t2dm inadequately controlled on metformin

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: a multi-center, open-label, extension study to evaluate the long term safety and efficacy of dwp16001 add-on to metformin in patients with type 2 diabetes mellitus inadequately controlled on metformin


Eligibility criteria:
inclusion criteria: * participated in the prior phase 3 study (protocol no: dw_dwp16001302) for meeting the inclusion criteria and completed the study * voluntarily decided to participate in the extension study and provided a written consent on the consent form exclusion criteria: * withdrawn from the prior phase 3 study (protocol no: dw_dwp16001302) or expected of having safety issue if taking part in the study in the judgment of the investigator * subjects with the following diseases or signs: * diabetic ketoacidosis * moderate to severe renal impairment (estimated glomerular filtration rate \[egfr\] \< 60 ml/min/1.73 m2 * females who are pregnant or breast-feeding, or subjects who do not agree to the use of appropriate contraceptive methods throughout the study subjects must agree to one of the following appropriate contraceptive methods for subjects or their partners: ① either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or ② a physical barrier method combined with either systemic hormonal contraceptives or spermicide, or ③ use of male condom combined with either cervical cap or diaphragm determined to be ineligible for the study by the investigator, besides the above
prucalopride in paediatric subjects, with functional faecal retention

Conditions: Constipation

Summary: the purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (r108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (ffr) for 8 weeks. hypothesis: pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile. safety and tolerability profile are expected to resemble the adult profile.

this is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years) with ffr were administered prucalopride in oral solution once daily for 8 weeks. subjects who entered this extension trial had completed pru-usa-12, a single-dose pharmacokinetic trial, usually within the previous week. evaluations for efficacy, safety and tolerability were performed, and plasma samples for analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks. the initial dosage of prucalopride oral solution was 0.02 mg/kg/day. dependent on the subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to 0.03 mg/kg/day.

Eligibility criteria:
inclusion criteria: * subject completed the pru-usa-12 pharmacokinetic trial * subject bowels had been "cleaned-out" (ie, any faecal impactions removed) * written informed consent, signed by the subject's legal guardian and by the investigator * subject assent documented in the form of a note-to-file in the subject's source documentation exclusion criteria: • no exclusion criteria
tao-towards optimal (neo)adjuvant systemic therapy of stage iii triple-negative breast cancer

Conditions: Breast Cancer

Summary: this prospective, national, multi-centre study will include patients with stage iii triple-negative breast cancer (tnbc) who are planned to start with standard (neo)adjuvant systemic treatment. the study will gather clinico-pathological, treatment and follow-up information of participating patients through dutch databases. participating patients will be asked to complete cancer specific and more generic quality of life questionnaires at seven time points during and after their anticancer treatment in a mobile application. for all patients who have consented to additional blood collection, to assess the course of dynamic ctdna during (neo)adjuvant chemotherapy and its relation with outcome, two tubes will be collected at four different time points.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * histologically confirmed adenocarcinoma of the breast * assumed clinical or pathological stage iii (tnm) breast cancer * breast tumor must be: * her2-negative: i.e. either score 0 or 1 at immunohistochemistry or score 2 at immunohistochemistry and negative at in situ hybridization (ish, cish or fish) * hormone receptor negative i.e. an estrogen receptor (er) of \<10% and progesterone receptor (pr) of \<10%.; or in case of a histological grade iii tumor an er of \<50% and a pr of \<50%. * patients are planned to receive the complete standard of care in the netherlands; neo-adjuvant chemotherapy according to local practise * participating patients have to be able to use a mobile phone, tablet, laptop and/or computer and understand the dutch language exclusion criteria: * evidence of distant metastases. staging examinations should have been performed according to dutch national guidelines. * patients who are only treated systemically in the adjuvant setting * participation in another clinical study with an treatment intervention during the course of this study.

Keywords: stage iii triple negative neo adjuvant treatment quality of life
pityriasis lichenoides chronica, role of streptococcal infection and azithromycin

Conditions: Pityriasis Lichenoides

Summary: primary outcome: the primary outcome at end of study (eos) is to compare the therapeutic efficacy of azithromycin in the treatment of pityriasis lichenoides chronica (plc) with that of a well-documented line of therapy namely narrow band ultra violet b (nbuvb). secondary outcomes: 1. to identify the possibility of streptococcal throat infection as a possible underlying etiology in plc.


Eligibility criteria:
inclusion criteria: 1. patients with classic papular eruption of plc (scaly erythematous papules with mica-like scales) with diagnosis documented histopathologically with or without associated hypopigmented lesions 2. age: \> 6 years 3. both sexes. exclusion criteria: 1. patients presenting with only hypopigmented macules whom their skin biopsy revealed plc. 2. patients with hypopigmented lesions that reveal mycosis fungoides pathologically. 3. patients with plc associated with classic mf. 4. patients with known absolute contraindications to nb-uvb. 5. patients with impaired liver and/or kidney functions. 6. patients with history of any heart disease. 7. patients with known hypersensitivity to azithromycin -
the effect of intubation method on outcome of cervical spine surgery

Conditions: Cervical Pain

Summary: the specific aim of this study is to demonstrate that inserting a breathing tube using a standard laryngoscope with the patient fully anesthetized is a safe and effective means of securing the airway in a patient with cervical spine disk herniation or stenosis. the two groups compared are composed of those who are intubated with direct laryngoscopy and those who are intubated with a fiberoptic scope.


Eligibility criteria:
inclusion criteria: * over 18 years of age for cervical disk herniation or cervical spine surgery by either drs snow or lavyne from 1998-2006. exclusion criteria: * unstable (broken) cervical spine
automated chest compression in cardiac arrest

Conditions: Cardiac Arrest

Summary: to evaluate the effect of use of automated chest compression device on blood pressure in patients presenting with cardiac arrest. higher systolic, diastolic and mean blood pressures are expected.

the protocol compares arterial pressures produced by an automated self-adjusting load-distributing band device (autopulse™ 100, zoll®) with those of manual cardiopulmonary resuscitation in refractory out-of-hospital cardiac arrest. each patient will receive first manual compressions and then automated resuscitation. patients presenting with cardiac arrest are treated following standard advanced life support guidelines. they are intubated and ventilated, received epinephrine and defibrillation if appropriate. manuel chest compressions are continued. an arterial catheter is placed to monitor hemodynamics continuously as we usually do in this case. patients are included at this stage. three blood pressure values (every 1 minutes) are recorded. then, the automated band device is started up without any pause, following our procedure for refractory cardiac arrest. three blood pressure values are recorded again, during automated cardiopulmonary resuscitation.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * refractory cardiac arrest exclusion criteria: * defective invasive arterial blood pressure monitoring

Keywords: cardiac arrest cardiopulmonary resuscitation
impact of a multidimensional intervention in elderly patients with pneumonia

Conditions: Community-acquired Pneumonia; Healthcare-associated Pneumonia

Summary: the hypothesis of this study is that long-term outcome in elderly patients admitted with the diagnosis of community-acquired pneumonia (cap) or healthcare-associated pneumonia (hcap) would improve with a multidimensional intervention including assessment of co-morbidities, nutritional, functional and cognitive status and immunization.

detailed description published in "revista española de geriatría y gerontología" (see citation and link)

Eligibility criteria:
inclusion criteria: * elderly patients (aged 65 years and over), of either sex, not dependent for basic activities of daily living (barthel index ≥60 points). * diagnosed with community-acquired pneumonia at the emergency department or day hospitals at "hospital de la santa creu i santa pau" * admitted to hospital. exclusion criteria: * derived from other acute care hospitals. * patients with hiv infection. * neutrophil counter\<1000/mm3 * transplanted patients. * barthel index\<60 points. * terminal disease. * no signed informed consent.

Keywords: pneumonia intervention studies aged aged, 80 and over geriatric assessment
study to evaluate the safety of cb-280 in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a phase 1b multiple ascending dose escalation study to evaluate the safety and tolerability of arginase inhibitor cb-280 in subjects with cystic fibrosis.

study cx-280-202 is a phase 1b, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of cb-280 in adult subjects with cystic fibrosis and chronic infection with pseudomonas aeruginosa. the study will evaluate the safety, pharmacokinetics, pharmacodynamics, and biological activity of cb-280 in approximately 32 adult patients with cystic fibrosis. there are four planned sequential dose escalation cohorts of 8 subjects each, randomized 6:2 to receive cb-280 or matched placebo at doses of 50 mg, 100 mg, 200 mg, or 400 mg administered twice daily for 14 days. intermediate dose levels may be evaluated based on emerging safety data at the planned dose levels.

Eligibility criteria:
inclusion criteria: 1. written informed consent in accordance with federal, local, and institutional guidelines 2. confirmed diagnosis of cystic fibrosis 3. male or female subjects ≥ 18 years on the date of informed consent 4. percent predicted fev1 of 40-90% at screening per global lung function initiative (gli) equation 5. clinically stable with no significant changes in health status within 28 days prior to day 1 6. chronic lung infection with p. aeruginosa defined as at least one positive culture in the last two years and more than 50% of cultures positive since then 7. stable cystic fibrosis medication regimen for at least 28 days inclusive of cftr modulators prior to day 1 8. hemoglobin \> 10 g/dl at screening 9. glomerular filtration rate \> 50 ml/min/1.73 m2 at screening 10. normal liver function at screening exclusion criteria: 1. history of any comorbidity that, in the opinion of the investigator, might pose an additional risk in administering study drug to the subject or confound the results of the study 2. lung infection with organisms associated with a more rapid decline in pulmonary status (including, but not limited to, burkholderia cenocepacia, burkholderia dolosa, and mycobacterium abscessus) 3. unable to receive study medication per os (po) 4. females who are pregnant, have a positive pregnancy test at screening, or are nursing (lactating) other protocol defined inclusion/exclusion criteria may apply.

Keywords: arginase inhibitor cb-280
mhealth alibird: a digital health care model

Conditions: Thoracic Neoplasms

Summary: the aim of this pilot study was to evaluate the feasibility and acceptability of the alibird platform, a new mobile health (mhealth) application prototype design for personalized and remote support on the follow-up of cancer patients. the alibird platform is a mhealth intervention that tracks pros, improving symptom control and allowing real-time feedback, and provides personalized recommendations and educational content, promoting empowerment and encourage healthy lifestyle behaviors in patients with thoracic neoplasms in active treatment.

the investigators have developed an innovative mhealth platform that provides personalized recommendations based on patient reported outcomes (pros) records and the study of patient´s nutrigenomics and gut microbiome. the usability of the alibird mhealth platform prototype is being tested in a 28-week pilot study carried out at infanta sofía hospital. a small group of stage iv thoracic neoplasms patients (n=20) were asked to participate. all the participants gave informed consent.

Eligibility criteria:
inclusion criteria: * patients diagnosed with thoracic neoplasms, histologically or cytologically confirmed. * \< 18 years. * eastern cooperative oncology group (ecog) performance status ≤ 2. * patients receiving cancer treatment: chemotherapy, chemotherapy-immunotherapy, immunotherapy or biological therapy. * patients with internet access and intermediate level in the use of technology (smartphone, mobile applications, wearable) * signed informed consent. exclusion criteria: * patients with symptomatic brain metastases. * patients with neurological impairment, dementia or psychiatric disorders. * patients unable to follow the protocol due to psychological, social or geographic reasons.

Keywords: active treatment