Kornimate/medical-research-clean huggingface dataset:
consumer health it tools: impact on experience, access, and outcomes for patients with complex chronic conditions

Conditions: Chronic Disease; Patient Outcome Assessment; Electronic Health Records

Summary: patient use of health it tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient access to care, change the way healthcare is delivered, and affect patient clinical outcomes. this study will examine the impact of implementation and use of consumer health it tools on patient-reported access to care, utilization of medical care services, and clinical outcomes.


Eligibility criteria:
inclusion criteria: * patients with chronic conditions * patient had at least 10-month membership in 2005 exclusion criteria: * patients less than age 18

Keywords: patient outcome assessment electronic health records
incretin physiology and beta-cell function before and after weight-loss

Conditions: Obesity

Summary: to evaluate the impact of laparoscopic adjustable gastric banding (lagb) on beta-cell function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones (glucagon-like peptide-1 (glp-1) and glucose-dependent insulinotropic polypeptide (gip)) in morbidly obese patients and to describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.

morbid obesity represents a serious health issue in western countries, with a rising incidence and a strong association with increased mortality and serious co-morbidities, such as diabetes. surgical interventions, such as laparoscopic gastric banding have been developed with the aim of providing a laparoscopic placed device that is safe and effective in generating substantial weight loss. by investigation of the incretin effect, the secretion of gip and glp-1, the insulin response and sensitivity and the beta-cell responsiveness to glucose in 10 obese patients without type 2 diabetes before and after laparoscopic gastric banding the aim of this project is describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.

Eligibility criteria:
inclusion criteria: * caucasians without type 2 diabetes mellitus * normal ogtt (75 g of glucose) according to who's criteria * patients fulfilling the criteria for laparoscopic gastric banding * normal hemoglobin * informed consent exclusion criteria: * liver disease (alat \> 2 x normal level) * nephropathy (s-creatinin \> 130 µm or albuminuria) * relatives (parents/siblings) with t2dm * medical treatment witch cannot be stopped for 12 hours

Keywords: incretin effect gastric banding glucagon glucagon-like peptide 1 gastric inhibitory peptide glucose intestinal peptide insulin c-peptide
a clinical trial to evaluate safety of vosoritide in at-risk infants with achondroplasia

Conditions: Achondroplasia

Summary: study 111-209 is a phase 2 randomized, open-label clinical trial of bmn 111 in infants and young children with a diagnosis of achondroplasia at a heightened risk of requiring cervicomedullary decompression surgery


Eligibility criteria:
inclusion criteria: * parent(s) or guardian(s) willing and able to provide signed informed consent after the nature of the study has been explained and prior to performance of any research related procedure. * have ach, documented by genetic testing. * are willing and able to perform all study procedures as physically possible. * age 0 to ≤ 12 months, at study entry (day 1). given that any potential impact of vosoritide therapy on the foramen magnum is dependent on treating as early as possible and as long as possible while the synchondroses at the base of the skull are still open. for subjects \> 6 months of age at enrollment, a discussion between the investigator and the medical monitor should occur with the goal of limiting the number of subjects in the range of \> 6 months to ≤ 12 months of age. * parent(s) or caregiver(s) are willing to administer daily injections to the subject and complete the required training. * have evidence of cmc that "may" require surgical intervention exclusion criteria: * have hypochondroplasia or short-stature condition other than achondroplasia (eg, trisomy 21, pseudoachondroplasia, etc). * have cmc that either does not require surgical intervention (for example foramen magnum narrowing with preservation of the cerebrospinal fluid space) or does require immediate surgical intervention . * have any of the following: untreated congenital hypothyroidism or maternal history of hyperthyroidism, insulin-requiring neonatal diabetes mellitus, autoimmune inflammatory disease, inflammatory bowel disease, autonomic neuropathy. * have a history of any of the following:renal insufficiency, chronic anemia,baseline systolic blood pressure below age and gender specified normal range or recurrent symptomatic hypotension (defined as episodes of low blood pressure generally accompanied by symptoms eg, pallor, cyanosis, irritability, poor feeding) and cardiac or vascular disease. * have a clinically significant finding or arrhythmia that indicates abnormal cardiac function or conduction or qtc-f ≥ 450 msec on screening ecg. * have been treated with growth hormone, insulin-like growth factor 1, or anabolic steroids in the 6 months prior to screening, or long-term treatment (\> 3 months) at any time. * have ever had prior cervicomedullary decompression surgery. * have had a fracture of the long bones or spine within 6 months prior to screening.

Keywords: dwarfism bone diseases bone diseases, developmental ach natriuretic peptide, c-type musculoskeletal diseases
prospective study on hiv-related hodgkin lymphoma

Conditions: HIV-associated Hodgkin Lymphoma

Summary: standard therapy for hiv-related hodgkin lymphoma (hiv-hl) has not been defined. this trial was initiated to investigate a risk adapted treatment strategy in patients (pts) with hiv-hl as established in hiv-negative patients with hl. treatment schedule: * early stage favorable hodgkin lymphoma (hl): 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (abvd) plus 30 gy involved field (if) radiation * early stage unfavorable hl: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (beacopp)-baseline or 4 cycles of abvd plus 30 gy if radiation * advanced hl: 8 cycles of beacopp-baseline. beacopp should be replaced by abvd in pts with far advanced hiv-infection. after the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 gy of irradiation. * primary outcome measure: tolerability, treatment-related mortality * secondary outcome measure: complete remission rate, progression-free survival (pfs), overall survival (os).


Eligibility criteria:
inclusion criteria: * age 18 - 75 years * proven infection with hiv 1 (elisa and western blot) * histology-proven newly diagnosed hodgkin lymphoma * written, informed consent. exclusion criteria: * severe cardiac, hepatic or pulmonary insufficiency * severe renal insufficiency (creatinine \> 2,0 mg/dl) not caused by lymphoma * bone marrow failure, not caused by lymphoma or haart (neutrophils \< 1000/µl, platelets \< 70.000/µl) * uncontrolled infection * uncontrolled drug addiction or psychiatric disease * pregnancy or lactation period * prior chemotherapy of hodgkin lymphoma * life expectancy \< 6 weeks * hiv-related wasting-syndrome * active secondary malignancy with cervix carcinoma in situ, basalioma and kaposi's sarcoma being excepted
calcimimetics in hypophosphatemic rickets

Conditions: Familial Hypophosphatemic Rickets

Summary: currently, large oral doses of phosphate and 1,25(oh)2d (calcitriol) are the standard treatment of patients with familial hypophosphatemic rickets (xlh). while this therapy is effective in healing the rickets, it is often limited by development of complications due to the high dose of medications required to achieve cure. among them are the development of calcifications in the kidneys and secondary hyperparathyroidism (hpt) which in some patients may cause complications like high blood calcium level, high blood pressure and damage to the kidney. a drug to treat secondary hyperparathyroidism was just developed. in a short term study we found that it might help the treatment of xlh, by allowing the use of lower doses of the both phosphate and calcitriol. in the present study we will learn if indeed the addition of this new medicine (cinacalcet) to the long-term treatment will allow the use of lower doses of both phosphate and calcitriol and consequently lower the risk of complications.


Eligibility criteria:
inclusion criteria: 1. patients with xlh 2. age 5-21 years old 3. from the renal and endocrinology clinics who have been in a stable clinical, biochemical and radiological condition for the preceding 9 months 4. who have not received cinacalcet before exclusion criteria: 1. treatment with growth hormone 2. inability to swallow pills. 3. an orthopedic surgery or braces in the past 9 months, or scheduled within 9 months of start. 4. pregnancy 5. history of seizure disorder 6. abnormal liver functions (which may change the drug's auc)

Keywords: familial hypophosphatemic rickets cinacalcet hyperparathyroidism
impact of vitamin c supplementation on hospital outcomes in children undergoing corrective heart surgery for congenital heart diseases

Conditions: Congenital Heart Disease (CHD)

Summary: vitamin c will be given before admission in the immediate preoperative preceding 7 days (the dose 30 -45 mg per day ) in oral drops preparations inflammatory markers including crp , tlc ,pni , gps nlr will be checked on admission and on discharge and compared between cases and controls hospital length stay will also be compared between the two groups


Eligibility criteria:
inclusion criteria: * children in the first two years who will be for corrective surgery for heart diseases congenital heart diseases * pediatric patients whose parents or caregivers agree to be enrolled in the study. * risk adjustment for congenital heart surgery -1 (rachs-1) for evaluation of mortality in children undergoing cardiac surgery : the first two categories (thiagarajan and c. laussen 2015) exclusion criteria: * pediatric patients with associated comorbid conditions.
study of the safety and efficacy of mln1202 in patients in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this was a phase 2a study of mln1202 to determine safety, tolerability and initial efficacy in patients with relapsing-remitting multiple sclerosis (rrms). it was conducted in 2 dose cohorts enrolling a total of 50 patients. efficacy was assessed by comparing the numbers of new gadolinium-enhancing brain lesions during the screening and treatment periods.


Eligibility criteria:
inclusion criteria: each patient was to have met all of the following inclusion criteria to be enrolled in the study: * 18 years of age or older * diagnosis of relapsing-remitting multiple sclerosis (rrms) * an expanded disability status score (edcc) of 0 to 5.5, inclusive * be willing and able to comply with the protocol for the duration of the study period * be willing to use adequate "double-barrier" contraceptive methods for the duration of the study period * if female, must be neither pregnant or breast-feeding * written informed consent * to be enrolled in the treatment phase of the study each patient must have a total of at least 2 new gadolinium-diethylenetriamine pentaacetic acid (gd)-enhancing lesions seen over the series of 3 pretreatment magnetic resonance imaging (mri)s. exclusion criteria: patients meeting any of the following exclusion criteria were not to be enrolled in the study: * diagnosis of primary progressive multiple sclerosis (ppms) or secondary progressive multiple sclerosis (spms) * received any investigational drug or experimental procedure within 3 months prior to study day 0 * if the patient has received disease-modifying treatments they must be discontinued prior to study day 0 as follows: 1. cyclophosphamide or mitoxantrone- 6 months prior 2. interferons, glatiramer acetate and azathioprine- 12 weeks prior 3. methotrexate, iv immunoglobulin, cyclosporin, plasma exchange or corticosteroids- 8 weeks prior * never have been exposed to tysabri® (natalizumab)or any other vla-4 (α4β1)antagonist * have an active infection or be considered to be at high risk for developing an infection * have a history of hepatitis b, c or human immunodeficiency virus (hiv) * have a chest x-ray within 6 months of study day 0 with clinically significant findings or abnormalities * have inadequate renal or hepatic function * have a known history of cancer, except for distant history (\>10 years) of carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin * received any live, attenuated vaccinations within 30 days prior to study day 0 * have a history of illicit drug or alcohol abuse within 5 years of study day 0 * have a history of hypersensitivity to prior monoclonal antibody (mab) treatment * have a history of allergy or sensitivity to gd * have a history that would preclude serial mri scans
influence of painphysiolgy education on the pain inhibition in fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to investigate whether education about the neurophysiology of pain is able to improve central pain inhibition in patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * diagnose fibromyalgia * widespread pain * dutch speaking
characteristics of neonatal covid-19 in turkey

Conditions: COVID-19; Neonatal Disease; Healthy

Summary: the investigators aimed to investigate the clinical and epidemiological characteristics of neonates who will be born to covid-19 positive mothers in turkey. it is a multicentric prospective cohort study designed and destined only in turkey. the investigators are planning to admit more than 20 neonatal intensive care units into the survey; nevertheless, the total number may change according to the prevalence of covid-19 in neonates. the investigators will also inquire into vertical transmission by collecting cord blood, placental, and postnatal serum samples to test for covid-19 pcr and covid-19 ig m and igg values from the neonates.

the patients will be recruited by a secure database of "trials network" with individualized accounts. plexus corporation will hold data monitoring and primary analysis.

Eligibility criteria:
inclusion criteria: * infants born to mothers with covid-19 infection exclusion criteria: * if pcr values of mother negative, even though the clinic is preferable for covid-19, the infant will not be recruited.

Keywords: vertical transmission
serotonin-norepinephrine reuptake inhibitors and acute kidney injury

Conditions: Depression; Acute Kidney Injury

Summary: the purpose of this study is to determine if there is an excess risk of acute kidney injury (aki) with serotonin-norepinephrine reuptake inhibitors (snris) as compared to selective serotonin reuptake inhibitors (ssris), two classes of medication used for the treatment of depression.

we plan to conduct retrospective population-based cohort studies within eight administrative databases from canada, the united states, and the united kingdom. within each cohort, a nested case-control analysis will be performed to estimate incidence rate ratios (rr) of aki associated with snris compared to ssris using conditional logistic regression, with adjustment for high-dimensional propensity scores at baseline. the overall effect across sites will then be estimated using meta-analytic methods.

Eligibility criteria:
inclusion criteria: * a first prescription of an antidepressant of the snri or ssri class of any dose between january 1, 1997 and march 31, 2010. exclusion criteria: * they were \<12 years old at the time of cohort entry. * they had less than 1 year of information in the database prior to the date of cohort entry. * they had a prescription of an snri or ssri in the year before the date of cohort entry. * they had a prescription for both an snri and an ssri on the day of cohort entry. * they had a history of chronic kidney disease (including kidney transplantation and dialysis) or aki in the year preceding cohort entry. * the subject was previously included in the cohort.

Keywords: antidepressants acute kidney injury snri renal failure duloxetine cnodes
frequency and characteristics of pruritus in patients with monoclonal gammopathy

Conditions: Pruritus; Monoclonal Gammopathy

Summary: pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is called pruritus sine materia. the causes of pruritus sine materia are various: haematological (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure, dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when no cause is found. gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy (mgus, multiple myeloma, waldenström disease). however, there is very little data on the frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this pruritus. so the aim of this study is to compare the frequency of pruritus between patients with monoclonal gammapathy and controls


Eligibility criteria:
inclusion criteria for case : major patient realized serum protein electrophoresis between 2014 and 2017 hematology follow-up at brest chr positive monoclonal gammopathy non-opposition formulated inclusion criteria for control : major patient realized serum protein electrophoresis between 2014 and 2017 hematology follow-up at brest chr negative gammopathy non-opposition formulated exclusion criteria: minor patient major protected patient with another haemopathy secreting a monoclonal immunoglobulin (lymphoma, llc ...) physical or mental incapacity refusal to participe
closure method study following tonsillectomy in children

Conditions: Tonsillectomy; Children

Summary: this is a children's study evaluating the effects of a tonsillectomy with tonsillar fossae closure compared to without closure of the operative wound.

this is a children's study. patients experience significant postoperative pain, activity limitation and sometimes other significant postoperative complications. we are going to compare the effects of closing the tonsil wound versus non-closure. a daily journal will be kept (by the patient's parent or legal guardian)to log in measures of morbidity. postoperative telephone calls will be made and scripted questions will be asked regarding any tonsillar hemorrhage requiring medical re-evaluation, and dehydration requiring medical re-evaluation. the patients will also be examined in the clinic at 10-14 days postoperatively to determine if the fossa remained closed or dehisced.

Eligibility criteria:
inclusion criteria: * normal children between that ages of five to ten requiring a tonsillectomy exclusion criteria: * children older than ten years of age. * those children with identified syndromes, cleft palates and velopharyngeal insufficiency will not be eligible.

Keywords: tonsillectomy, tonsillar fossa, wound closure
a study of arv-766 given by mouth in men with metastatic prostate cancer

Conditions: Prostate Cancer Metastatic

Summary: a phase 1/2 study to evaluate the safety and efficacy of arv-766 given by mouth alone or in combination with abiraterone in men with metastatic prostate cancer.


Eligibility criteria:
inclusion criteria: part a,b,c and d: * histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate. * ongoing androgen deprivation therapy (adt) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration). * eastern cooperative oncology group (ecog) performance status of 0 or 1 part a: * progression on at least 2 prior approved systemic therapies for metastatic prostate cancer (at least one must be a second-generation androgen inhibitor, e.g., abiraterone, enzalutamide, darolutamide, apalutamide). * progressive mcrpc part b: * participants must have received at least one but no more than three prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone). * participants must have received no more than two prior chemotherapy regimens. * progressive mcrpc part c \& d: • metastatic castration resistant or sensitive prostate cancer with radiographic evidence of metastatic disease exclusion criteria: part a and b: * known symptomatic brain metastases requiring steroids (above physiologic replacement doses). * active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease, or previous gastric resection or lap band surgery. * radiation therapy within 4 weeks of first dose of study drug or prior irradiation to \>25% of the bone marrow. * receipt of an investigational drug(s) within 4 weeks prior to anticipated first dose * systemic anti-cancer therapy within 2 weeks of first dose of study drug (except agents to maintain castrate status). for bicalutamide, mitomycin c, or nitrosoureas the exclusion period must be 6 weeks and for abiraterone 4 weeks. part c and d • prior treatment with a second generation nha

Keywords: metastatic prostate cancer castrate-resistant prostate cancer mcrpc adenocarcinoma of prostate prostatic neoplasms genital neoplasms, male urogenital neoplasms castrate-sensitive mcspc adenocarcinoma of prostate
psychopathology of dissociative disorders

Conditions: Dissociative Disorders

Summary: the goal of the project is to investigate the prevalence of dissociative disorders in psychiatric inpatients in taiwan. relevant clinical issues, including common psychiatric comorbidity (e.g., positive psychotic symptoms), associated psychosocial factors (e.g., negative life events, perceived parenting style), and neuro-cognitive underpinning (e.g., executive functions) were also targeted. standardized interview schedules, self-report scales, and cognitive tasks will be applied. the investigators hypothesized that dissociative disorders would be associated with positive psychotic symptoms, a history of early interpersonal adversity, and enhanced executive functions.

though formally included in the diagnostic and statistic manual of mental disorders since 1980, dissociation had once been considered as a rare psychiatric disturbance. with standardized structured interview, however, recent empirical studies showed that in average 9 percent of participants in general population, 10 percent in psychiatric outpatients, and 15 percent in psychiatric inpatients receive the diagnosis of a dissociative disorder. in taiwan few attempts have been made for systematic investigation of dissociative disorders. little has been known about the characteristics, prevalence, and associated features of taiwanese patients with a dissociative disorder. the goal of the project is to investigate the prevalence of dissociative disorders in psychiatric inpatients in taiwan. relevant clinical issues, including common psychiatric comorbidity (e.g., positive psychotic symptoms), associated psychosocial factors (e.g., negative life events, perceived parenting style), and neuro-cognitive underpinning (e.g., executive functions) were also targeted. standardized interview schedules, self-report scales, and cognitive tasks will be applied and the assessment will be held by the licensed clinical psychologist who receive training on the assessment and treatment of dissociative disorders. the results may enhance the understanding about the clinical features of dissociative disorders in taiwan.

Eligibility criteria:
inclusion criteria: * being stable and appropriate for interviews exclusion criteria: * with organic syndromes * mentally retarded (fiq \<80) * cannot communicate in mandarin chinese

Keywords: dissociation psychosis trauma parenting executive functions