Kornimate/medical-research-clean huggingface dataset:
qtern (saxagliptin/dapagliflozin fdc) regulatory post-marketing surveillance

Conditions: Type 2 Diabetes Mellitus

Summary: this is a local, prospective, non-interventional, regulatory post-marketing surveillance study. adult patients with type 2 diabetes mellitus who are initiating qtern as indicated by the mfds will be included. 600 patients are followed up 12 weeks and at least 60 patients of the 600 patients are followed up 24 weeks. patients will be treated as part of routine practice at korean healthcare centers by accredited physicians. in this study, patients will receive qtern as indicated in the locally approved prescribing information.

as part of a post approval commitment, the mfds has requested a post-marketing surveillance program to characterize safety in patients who are treated with qtern for t2dm by physicians in the normal clinical practice setting. this study is designed to confirm assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of qtern under conditions of routine daily medical practice in korea. the primary objective of this study is : descriptive analysis of the proportion of adverse events (aes) and serious adverse events (saes) in patients who are treated with qtern for type 2 diabetes mellitus by physicians in the normal clinical practice setting over a period of 12 and 24 weeks. the secondary objectives of this study are: to follow the changes of the hemoglobin a1c (hba1c), fasting plasma glucose (fpg), 2-hr post-prandial glucose (ppg-2hr), blood pressure, abdominal circumference and body weight and self-reported data in this cohort of patients from baseline to completion of the study. to evaluate the safety and tolerability of qtern in patients with type 2 diabetes mellitus based on conducted laboratory test. (laboratory tests are not mandatory because of the non-interventional nature of this study)

Eligibility criteria:
inclusion criteria: 1. patients aged 19 years and older 2. patients with t2dm eligible for treatment with qtern as indicated in the locally approved prescribing information 3. patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: 1. patients treated with qtern outside of the locally approved prescription information in korea 2. patients with contraindications for the use of qtern (as described in the korean prescription information)
allergy and asthma following children who were fed supplemented infant formula

Conditions: Allergy; Asthma

Summary: long-term cognitive outcome study of children who participated in randomized trials of lcp-supplemented formula during infancy.


Eligibility criteria:
inclusion criteria: * children previously randomized in a clinical study consuming lcp-supplemented infant formula exclusion criteria: * children who did not previously participate in a randomized clinical study consuming lcp-supplemented infant formula
efficacy of cognitive training in subjective memory impairment

Conditions: Memory Loss

Summary: this study evaluates the efficacy of cognitive training in subjects with subjective memory impairment. the first group will receive cognitive training and lifestyle modification in combination, the second group will receive only lifestyle modification, and the third group will receive no intervention.

subjective memory impairment is currently thought to be a risky state of progression to alzheimer's disease. this study aims to confirm whether cognitive training in subjective memory impairment would show improvement in the subjective and objective cognition. we include subjects with normal cognition but complained subjective feeling of memory decline and conduct cognitive training programs combined with lifestyle modifications for 3 months. we evaluate the neuropsychological tests and questionnaires about subjective improvement after 3 months of interventions.

Eligibility criteria:
inclusion criteria: * subjects who showed normal range (above 16percentile of norm) in all domains of detailed neuropsychological tests battery named seoul neuropsychological screening battery (snsb) * clinical dementia rating (cdr) score of 0 * subjects with at least 3 years of formal education exclusion criteria: * subjects with mild cognitive impairment or dementia * subjects who was diagnosed as any neurological disorders such as epilepsy, stroke, hemorrhage, hydrocephalus, parkinson's disease or brain tumor * subjects with uncontrolled severe medical conditions according to investigator's opinion

Keywords: subjective memory impairment cognitive training
results of manual therapy on pulmonary parameters

Conditions: Respiratory Disease

Summary: the main objective of this study is to evaluate the effectiveness of different manual techniques included traditionally on respiratory physical therapy

randomized controlled trial. participants are classified in two groups and they are assessed using pulmonary functions parameters and thoracic and spinal movements. there are two interventions: placebo and a manual technique. participants will be assessed again at the end of the study.

Eligibility criteria:
inclusion criteria: * subjects with respiratory conditions * must be able to do spirometry exclusion criteria: * subjects with acute processes in their pathologies

Keywords: manual therapy respiratory disease thoracic movement
a randomized, open-label, comparative 3-way treatment crossover study of 24-hour intragastric ph profile of once daily oral administration of esomeprazole 40mg, lansoprazole 30mg, and pantoprazole 40mg at steady state in nsaid-using patients

Conditions: Heartburn; Upper Abdominal Pain; Nausea; Acid Regurgitation

Summary: this study looks at controlling intragastric ph following administration of esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg taken orally, once daily in patients taking either non-selective or cyclooxygenase-2 (cox-2) selective nonsteroidal anti-inflammatory drugs (nsaids).


Eligibility criteria:
inclusion criteria: * a medical diagnosis of a condition that requires daily nonsteroidal anti-inflammatory drugs (nsaid) treatment for at least 5 days per week for 1 month prior to entering the study and during the study. * some patients will need to undergo an upper endoscopy at screening. exclusion criteria: * signs of clinically significant (gi) bleeding (e.g., melena, frank hematochezia) at the time of the baseline egd or within 3 days prior to randomization. * history of gastric or esophageal surgery (including but not limited to nissen fundoplication, bariatric surgery (e.g. gastric stapling or roux-en-y gastric bypass), vagotomy, or billroth operation). * many further exclusion criteria, please refer to the investigator site.

Keywords: nexium esomeprazole lansoprazole pantoprazole nonsteroidal anti-inflammatory drugs (nsaids)
psychoeducational intervention against support groups for caregivers

Conditions: Dementia

Summary: background: to explore the effectiveness of a psychoeducational intervention against support groups and the usual care in caregivers. providing care involves major changes in the lives of caregivers, with far-reaching repercussions. there is evidence that acting upon its mediator variables reduces its effects. methods: a randomised controlled trial will be carried out. the study will be conducted at the faculty of psychology of the university of salamanca (usal) in spain. family caregivers of people with dementia will participate in this study. the participants will be divided into three groups: the intervention group (ig), which will undergo a psychoeducational intervention programme, the support group (sg) (control group - placebo), which will undergo a support group intervention programme, and the control group-waiting lists (cg), which will only be assessed at the different measurements points, and after the end of the programme they will be offered the intervention of the experimental group. the programme (ig) will comprise eight sessions over a period of two months. all participants will be assessed at the outset and conclusion of the study, as well as after three and six months, during which time data regarding their socio-demographic characteristics and responses to the different scales will be collected. both mediator and negative outcome variables will be assessed. discussion: effective interventions need to be developed to improve the biopsychosocial state of caregivers. the presented psychoeducational intervention may help family caregivers because it could be more effective than others. the psychoeducational intervention has the aim of improving quality of life, problem-solving and social skills, leisure time, self-efficacy and social support of caregivers; and decreasing their depressive symptomology, dysfunctional thoughts, burden and stress.


Eligibility criteria:
inclusion criteria: * be the main caregiver of a family member with dementia, either as a spouse or as an offspring. * no previous involvement in studies/programmes like this one. * the family member lives at home (not institutionalised). exclusion criteria: * not be the main caregiver of a family member with dementia, either as a spouse or as an offspring. * previous involvement in studies/programmes like this one. * the family member not lives at home (the family member is institutionalised).

Keywords: dementia effectiveness family caregiver psychoeducational intervention support groups
low molecular weight heparin and aspirin in the treatment of recurrent pregnancy loss: a rct

Conditions: Recurrent Pregnancy Loss; Antiphospholipid Antibody Syndrome

Summary: to compare the livebirth rate of women with recurrent pregnancy loss and autoantibodies randomized to either low molecular weight heparin plus aspirin versus aspirin alone.

previous studies of these therapeutic regimens in the population of recurrent pregnancy loss and autoantibodies, have not provided conclusive evidence of their efficacy due to small sample size and/or weak study design. we undertook a rct of low molecular weight heparin plus aspirin versus aspirin alone to investigate if the low molecular weight heparin treatment resulted in an increased rate of livebirths as compared to treatment with aspirin alone.

Eligibility criteria:
inclusion criteria: * history of two or more unexplained consecutive pregnancy losses prior to 32 weeks * presence of one of the panel of autoantibodies/thrombophilia markers * confirmed pregnancy exclusion criteria: * sle * known peptic ulcer disease * sensitivity to asa or heparin * previous thrombotic event * geographic distance from clinic * failure to consent

Keywords: recurrent pregnancy loss lupus anticoagulant anti cardiolipin antibodies thrombophilia low molecular weight heparin aspirin randomized clinical trial
stella trial: transperitoneal vs. extraperitoneal approach for laparoscopic staging of endometrial/ovarian cancer

Conditions: Endometrial Neoplasms; Ovarian Neoplasms

Summary: the purpose of this study is to determine whether the extraperitoneal approach is better than the transperitoneal approach for laparoscopic aortic lymphadenectomy for the surgical staging of endometrial or ovarian cancer.


Eligibility criteria:
inclusion criteria: * diagnosis of endometrial cancer confirmed by histopathological analysis (endometrial biopsy) requiring surgical staging according to figo (the international federation of gynecology and obstetrics) recommendations * diagnosis of ovarian cancer confirmed by histopathological analysis after an initial cystectomy or oophorectomy without suspicion of neoplasia thus requiring additional surgical staging according to figo recommendations exclusion criteria: * diagnosis of advanced endometrial cancer based on findings on imaging techniques (ct, mri and/or pet) * diagnosis of advanced endometrial or ovarian cancer based on intraoperative findings (e.g. peritoneal carcinomatosis at initial laparoscopy) * patients who underwent previous aortic lymphadenectomy * patients who received previous pelvic and/or aortic radiotherapy

Keywords: extraperitoneal transperitoneal laparoscopic aortic lymphadenectomy endometrial ovarian cancer ovarian cancer surgical staging
effect of estradiol pretreatment on antagonist icsi cycles

Conditions: Female Infertility

Summary: depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual follicle stimulating hormone (fsh) elevation that occurs during the late luteal phase, the aim of this work is to study the effect of estradiol pretreatment on follicular synchronization and intracytoplasmic sperm injection (icsi) outcome in antagonist cycles

gonadotropin-releasing hormone antagonist (gnrh-ant) cycles are characterized by higher patient acceptability with more attention being directed to the potential effect of steroid pretreatment to program antagonist protocol cycles, as marked size discrepancies of growing follicles reflect incoordinated maturation of follicular-oocyte complexes and complicates clinical criteria for human chorionic gonadotropin (hcg) administration. this phenomenon is associated with fewer mature oocytes and resulting embryos, which limits sufficient embryo selection for embryo transfer. indeed, the large number of available embryos represented an important prognostic factor of invitro-fertilization (ivf) outcome, particularly in poor prognosis patients, possibly by increasing the probability that at least one good-quality embryo will be selected for embryo transfer. during coh, a better understanding of follicular development has resulted in the improvement of strategies for ovarian stimulation. this approach represents a potential and more physiological alternative to gnrh agonist or oral contraceptive pills pre-treatment in a trial to synchronize multi-follicular development and improve controlled ovarian hyperstimulation (coh) results. the present study is a randomized controlled trial that investigated whether e2 pre-treatment during the luteal phase affects developmental characteristics of growing follicles during coh. it depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual fsh elevation that occurs during the late luteal phase, thus testing for detection of the effect of luteal estradiol on follicular synchronization and its effect on icsi outcome.

Eligibility criteria:
inclusion criteria: 1. women age 20-37 years. 2. anti-mullerian (amh) level greater than 1.2 ng/ml. 3. body mass index between 18 and 29 kg/m2. 4. undergoing a first or second icsi cycles. exclusion criteria: 1. endometriosis. 2. uterine disorders such as fibroids and uterine anomalies. 3. antral follicular counts (afc) less than 10. 4. azoospermic males.
relationship of proprioception, reaction time and the gait and balance parameters after stroke

Conditions: Stroke

Summary: the aim of this observational study is to analyze how impaired proprioception affects the gait, reaction time, balance and functioning of stroke patients. research questions: * are there correlations between the deficit of proprioception and reaction time and the parameters of gait and balance as well as the functional state of stroke patients? * are there relationships between factors such as proprioception, reaction time, balance, functional status and gait, and time since stroke, the hemisphere where the stroke occurred, and gender? * are there differences in proprioception deficits and reaction times between the lower limbs in stroke survivors? participants will be assessed once using standard functional clinical tests and the rehabilitation devices. researchers will compare stroke patients and healthy volunteers to see, if there are differences in proprioception deficits, reaction time and balance.

for this prospective observational study, 50 ischemic - stroke survivors (study group) and 50 healthy volunteers matched for age and gender (control group) will be recruited. study procedures will be performed in the morning including one-time functional assessment of proprioception, gait, balance and reaction time using standard clinical tests (timed up and go test, sit to stand test, 10m walk test, wisconsin scale, berg scale, ashworth scale, brunstrom scale, barthel scale, rankin scale and fac) and rehabilitation devices (luna emg - proprioception assessment, pablo - gait parameters assessment, omego plus - proprioception assessment, alfa stabilometric platform - balance and reaction time assessment).

Eligibility criteria:
inclusion criteria: * informed and voluntary consent of the patient, * first-time stroke, * hemiparesis, * time from stroke to 3 months, * age 30-75, * grade 3-5 in the functional ambulation category, * walking without orthopedic support. exclusion criteria: * lack of informed and voluntary consent of the patient, * second or subsequent stroke, * stroke of the brainstem and cerebellum, * epilepsy, * disorders of higher mental functions, * coexisting neurological, rheumatological, orthopedic diseases, * use of orthopedic supplies during locomotion.
phase i combination w/ epirubicin

Conditions: Metastatic Breast Cancer

Summary: tumor response information was obtained for all participants who received at least 2 cycles of study drug, underwent requisite baseline and on-treatment disease assessments and had at least one post-treatment assessment. tumor response assessment in evaluable participants was done according to the response evaluation criteria in solid tumors (recist) criteria.


Eligibility criteria:
inclusion criteria: * women ≥18 years * histologically or cytologically confirmed diagnosis of metastatic breast cancer * measurable or nonmeasurable disease defined by response evaluation criteria in solid tumors (recist) exclusion criteria: * number of prior chemotherapy lines of treatment in the metastatic setting ≥2
improving diabetes efforts across language and literacy (ideall)

Conditions: Diabetes

Summary: the ideall project (improving diabetes efforts across language and literacy) is a 3-arm randomized controlled trial to explore contextual factors at the patient, clinician, and organizational level of two patient self-management support strategies. a communication technology-based intervention (automated telephone diabetes management) and an interpersonally-oriented intervention (group medical visits)will be compared to usual care for their ability to improve diabetes outcomes among vulnerable populations in 4 safety-net health centers in the university of california, san francisco (ucsf) collaborative research network.

see above

Eligibility criteria:
inclusion criteria: * have type 2 diabetes * have a hba1c equal to or \> 8.0% * must speak english, spanish, or cantonese. exclusion criteria: * dementia * psychosis/schizophrenia * end stage renal disease

Keywords: disease management health literacy telephone care group medical visits type 2 diabetes access to care technology language barriers
to compare the efficacy of intralesional saline versus 35% trichloracetic acid (tca) peel in the treatment of atrophic acne scars

Conditions: Atrophic Acne Scar; Atrophic Acne Scarring

Summary: this study aimed to compare the efficacy of intradermal normal saline versus trichloroacetic acid (tca) in treating atrophic acne scars. atrophic acne scars are a common and disfiguring complication, with limited research on the use of normal saline.

acne vulgaris is a common skin problem affecting adolescents and adults. it is the eighth most common skin disease globally, having a prevalence ranging from 35%-85%, with notable variations across different regions and age groups.a randomized controlled trial was conducted at the dermatology department, sheikh zayed hospital, rahim yar khan, from 1st april 2023 to 31st october 2023. 126 patients were enrolled. scar grading was based on goodman and baron's qualitative scar classification. the observer scar assessment scale (osas) was used by dermatologists. patients rated their acne scars using the visual disease severity scale. photographs were taken for comparison. efficacy was defined as ≥50% improvement in the osas.

Eligibility criteria:
inclusion criteria: * age: 13-50 years * clinically diagnosed patients of atrophic acne scars on face * duration of more than 6 months * no history of any procedural intervention in past 3 months exclusion criteria: * history of keloid, active acne, local infection, skin allergies, hypertrophic scarring, photosensitivity, or history of any comorbidities * history of use of oral isotretinoin, ocps, steroids or immunosuppressants * pregnant or lactating females

Keywords: acne scars tca peel intralesional saline
brief physical activity program to increase physical fitness in elementary school children

Conditions: Childhood Obesity

Summary: the investigators hypothesized that the addition of 6 minutes of exercise during the school day would increase physical fitness in elementary school students as demonstrated by longer distances run in 2 minutes and a decrease in heart rate at the end of the exercise.

intervention group played music for 6 minutes each morning in addition to recess and physical activity classes. baseline fitness data and after-intervention data were compared.

Eligibility criteria:
inclusion criteria: * all students were invited to participate. exclusion criteria: * lack of parental consent