Kornimate/medical-research-clean huggingface dataset:
influence of role-expectancy on patient reported outcomes among patients with migraine: a randomized clinical trial

Conditions: Role-expectancy on Patient Reported Outcomes

Summary: this study was preregistered 2019 under https://osf.io/nczhj. since jama requires a registration with clinicaltrials.gov, we post-register the study here with the identical informations from osf (see there) migraine is frequently associated with motion sickness, vestibular symptoms, and abnormal motion and visual processing. clinical symptoms and underlying brain mechanisms during self-motion visual stimulation were not yet investigated in this population. therefore the aim is to investigate the behavioral responses from a visually simulated roller coaster ride of patients with migraine and headache-free controls. in order to verify the effect of response bias, part of the patients with migraine will be informed that the study aims to investigate vestibular disorders instead of headache disorders and that they are invited as healthy controls.

we have a three group randomized controlled design. migraine patients from the headache outpatient clinic will randomly be assigned to get two different cover stories via a flyer with study information and through the physician from the outpatient clinic: 50% of patients will receive the information that they will take part to investigate migraine (by watching the visual stimulus (roller coaster video)). the other 50% will receive the information that they will take part as healthy controls for a headache unrelated study (by watching the visual stimulus (roller coaster video)). sex and age matched healthy controls will take part in the same experiment and get no additional information but that we investigate the perception of a visual stimulus (roller coaster video). the protocol for the intervention is standardized and identical for all participants. migraine patients will be randomly given the priming information and therefore their group allocation. physicians will allocate by pulling from a randomized equally sized stock of flyers (of which 50% inform for healthy controls and 50% for migraine patients). migraine patients for both migraine groups will be recruited and diagnosed by a neurologist from the uke headache outpatient clinic. healthy controls will be recruited via an internet platform for job advertisement. participants will be paid 10€ for participation. participants must be at least 18 years old and have signed the informed consent. they are excluded if they have 1. history of any neurological disease, 2. self-report of diagnosis of vestibular disease, 3. history of trauma or pathology of the cervical spine (e.g., whiplash associated disorder), 4. pregnancy, 5. other relevant musculoskeletal, systemic or psychiatric disease.

Eligibility criteria:
inclusion criteria: * migraine patients following ichd-3 criteria * headache free controls exclusion criteria: * any other headache or pain disorder * known somatic or psychiatric disorder * pregnacy or breast feeding * known vestibular disorder or whiplash injury

Keywords: migraine role expectation outcomes social role response bias subjective pain reporting
sofosbuvir + ribavirin for 12 or 16 weeks in treatment experienced subjects with chronic genotype 2 or 3 hcv infection (fusion)

Conditions: Chronic Hepatitis C

Summary: this study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (rbv) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis c virus (hcv) infection as assessed by the proportion of participants with sustained virologic response (svr) 12 weeks after discontinuation of therapy (svr12).


Eligibility criteria:
inclusion criteria: * infection with hcv genotype 2 or 3 * had cirrhosis determination * prior treatment failure * screening laboratory values within defined thresholds * subject had not been treated with any investigational drug or device within 30 days of the screening visit * use of highly effective contraception methods if female of childbearing potential or sexually active male exclusion criteria: * prior exposure to an direct-acting antiviral targeting the hcv nonstructural protein (ns)5b polymerase * pregnant or nursing female or male with pregnant female partner * current or prior history of clinical hepatic decompensation * history of clinically significant illness or any other major medical disorder that may have interfered with subject treatment, assessment or compliance with the protocol * excessive alcohol ingestion or significant drug abuse

Keywords: hcv genotype 2 (gt-2) hcv genotype 3 (gt-3) hcv sustained virologic response direct acting antiviral combination therapy treatment experienced gs-7977 ribavirin
renal impairment in type 2 diabetic subjects

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to assess the effect of dapagliflozin on renal glucose clearance in type 2 diabetic subjects with mild, moderate, and severe renal impairment compared to type 2 diabetic and healthy subjects with normal renal function


Eligibility criteria:
key inclusion criteria: * subjects in the following groups: group a: healthy subjects with normal renal function (clcr \> 80 ml/min) group b: diabetic subjects with normal renal function (clcr \> 80 ml/min) group c: diabetic subjects with mild renal impairment (clcr \> 50 - ≤80 ml/min) group d: diabetic subjects with moderate renal impairment (clcr ≥ 30 - ≤50 ml/min) group e: diabetic subjects with severe renal impairment (clcr \< 30 ml/min) (and not receiving dialysis) * men and wocbp, ages 18 to 79 years old standard exclusion criteria, plus: * history of diabetic ketoacidosis * hba\*1c \> 10% * serum albumin \< 2.0 gm/dl * potassium \ 6.0 meq/l
consent for obtaining additional tissue at the time of a diagnostic biopsy

Conditions: Lymphoma; Hodgkin Disease

Summary: this study is designed to collect tissue samples that may aid in the treatment and learning about various oncology diagnosis.

the purpose of this study is to provide a mechanism to obtain tissue specimens to be used for experimental studies before the exact histologic diagnosis is known.

Eligibility criteria:
inclusion criteria: * subjects who are having a tissue procedure done as part of their standard oncology work-up will be eligible to be consented on this study. exclusion criteria: * none.

Keywords: lymphoma hodgkin disease
the efficacy of pantoprazole treatment in patients with functional dyspepsia

Conditions: Nonulcer Dyspepsia

Summary: the aim of our study is to evaluate the effectiveness of proton pump inhibitor (ppi) treatment in patients with functional dyspepsia.


Eligibility criteria:
inclusion criteria: * aged 18-45 years with symptoms of dyspepsia, * no evidence of organic disease. exclusion criteria: * patients with alarm symptoms, * severe concomitant illness, * pregnancy or lactation, * alcohol or drug abuse, * use of aspirin or other non-steroidal anti-inflammatory drugs antibiotics, h2 receptor blockers, bismuth, or proton pump inhibitors in the preceding two weeks
intestinal microbiota and vitamin k levels in pxe patients (improve study)

Conditions: Pseudoxanthoma Elasticum

Summary: this study aims to demonstrate a potential association between gut microbiota composition, plasma levels of various forms of vitamin k, and severity of clinical manifestations of pseudoxanthoma elasticum (pxe).

vitamin k deficiency contributes to pathological calcification which underlies the clinical picture of pseudoxanthoma elasticum (pxe), an inherited autosomal recessive disease. a substantial proportion of vitamin k, namely the k2 form (menaquinones), is produced by gut microbiota. in healthy volunteers fecal levels of the major menaquinone producers, escherichia coli and bacteroides species, are approximately 5 and 9 log10 cfu/g dry weight respectively. there is however a lack of data on gut microbiota in pxe patients. the objective of our project is to demonstrate a potential association between gut microbiota composition, plasma levels of various forms of vitamin k and severity of clinical manifestations in pxe patients. this study will be performed as research surrounding bio collection "clinical and biological exploration of pxe patients" kept at the center of biological resources of angers university hospital (bio collection n° dc 20116-14-67, authorization to transfer n° 2016-27-99). fecal samples, plasma samples and clinical data will be collected from patients diagnosed with pxe who will be monitored at the angers university hospital referral center (france) in 2019-2020. clinical severity of pxe will be assessed using modified phenodex score. gut microbiota will be analyzed using metagenomic sequencing. plasma vitamin k species and fecal excretion of menaquinones will be assessed using hplc. plasma dp-ucmgp (circulating biomarker of vitamin k status) and serum pivka-ii (protein induced by vitamin k absence-ii) will be assessed using immunoassay. results will be compared to healthy age- and gender-matched controls from the pre-existing biofortis database.

Eligibility criteria:
inclusion criteria: * patients with phenotypically and genetically (abcc6) proven pxe * aged over 18 years * written consent obtained for angers university hospital (france) pxe bio-collection exclusion criteria: * patients under the age of 18 * patients unwilling to participate in the study, or unable to sign the bio-collection consent form

Keywords: pxe calcification gla proteins gut microbiota vitamin k2 menaquinones taxonomic meta-sequencing
perceptions of their own body and of the body of their child among young mothers with anorexia nervosa

Conditions: Anorexia Nervosa; Eating Disorders

Summary: the bodybabe studies aims to evaluate the perceptions that young mothers with anorexia nervosa (active or in remission) have of their own body and of the body of their child. the evaluations are carried out with self-assessment questionnaires and silhouette scales at three time points: d0 (during the stay at the maternity hospital), d15 (15 days after delivery) and m9 (9 months after delivery). the output expected from this study is to validate a questionnaire to help healthcare providers to adapt their care of women with anorexia nervosa during the pregnancy and the post-partum period.

during the stay at maternity hospital, healthcare providers will identify potential candidates for the study on a daily basis according to the following criteria : * bmi at the beginning of the pregnancy lower than 18,5 kg/m2 and/or * history of anorexia nervosa tools and methods the questionnaires used for the self-assessments are the following : * two questionnaires that evaluate the body satisfaction * the body shape questionnaire (bsq) * a questionnaire assessing the satisfaction of the mother regarding her baby's body shape (bodybabe questionnaire). * two silhouette scales * stunkard scale also called figure rating scale (frs)5 * infant body figure drawings * a questionnaire evaluating the severity of the eating disorders : eating attitude test (eat) * a questionnaire detecting depression symptoms during post-partum : edinburgh post-natal depression scale (epds)

Eligibility criteria:
inclusion criteria: * adult woman, understanding and reading french, delivering in the chu (centre hospitalier universitaire) clermont-ferrand maternity hospital between 01/15/2020 and 01/14/2021, and with active or in remission anorexia nervosa diagnosed according to dsm-5 criteria (diagnostic and statistical manual of mental disorders) * able to accept participating to the study * affiliated to the national healthcare system exclusion criteria: * delivery before 32 weeks of amenorrhea (significant prematurity and extreme prematurity) * death in utero or medically-motivated induced termination * infant death during labour or post-partum * refusal to participate

Keywords: mother anorexia nervosa body perception post-partum baby body
a study of ritonavir-boosted danoprevir in combination with pegasys (peginterferon alfa-2a) and copegus (ribavirin) in patients of asian origin with chronic hepatitis c genotype 1 with or without cirrhosis

Conditions: Hepatitis C, Chronic

Summary: this phase ii, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with pegasys (peginterferon alfa-2a) and copegus (ribavirin) in treatment-naïve patients of asian origin with chronic hepatitis c genotype 1. patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly pegasys 180 mcg subcutaneously and copegus 1000-1200 mg orally daily in divided doses. treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.


Eligibility criteria:
inclusion criteria: * adult patients of east asian or southeast asian origin, \>/= 18 years of age * presence of chronic genotype 1 hepatitis c infection * treatment-naïve exclusion criteria: * history or presence of decompensated liver disease * presence or history of non-hepatitis c chronic liver disease * positive for hepatitis b or hiv infection
health behaviors, surveillance, psychosocial factors, and family concerns

Conditions: Melanoma; Survivors; Psychological Factors

Summary: the purpose of this study is to examine the health behaviors of melanoma survivors. we want to know about their thoughts and concerns. melanoma is a type of skin cancer. the number of people being diagnosed with melanoma is growing. many people who are diagnosed with melanoma are young. little research has been done to find out how melanoma survivors feel years after they have been treated.

the rapidly rising incidence and mortality rates of melanoma, the most fatal form of skin cancer, are among the greatest increases of all preventable cancers over the past decade. however, because of recent advances in early detection, secondary prevention efforts, and treatment, the number of melanoma survivors is increasing. little research has been conducted on melanoma survivors and important opportunities exist for research in this understudied population. understanding recurrence and second primary cancer risk, cognitive characteristics, behaviors, surveillance patterns, economic sequelae, and family issues of melanoma survivors is imperative from a public health standpoint to promote the health and well-being of this cohort. the objectives of this study are to: 1) conduct focus groups to enhance our understanding of the behaviors of melanoma survivors, and 2) conduct a pilot survey study based on the results of the focus groups to further describe the behavioral and psychosocial issues in melanoma survivors. this will be among the first studies that explores behavioral and psychosocial issues in melanoma survivors. the study findings will inform a large-scale melanoma survivorship grant proposal to the national cancer institute or other federal/private sources of funding.

Eligibility criteria:
inclusion criteria: for the focus group recruitment (specific aim 1) - patients with melanoma (invasive primary cutaneous melanoma, stages 1-iii), who have been treated at mskcc from 1996-2005 for the survey group recruitment (specific aim 2): patients with melanoma (invasive primary cutaneous melanoma, stages 1-iii), who have been treated at mskcc from 2001-2011• ability to sign informed consent which indicates the psychosocial, behavioral, epidemiological nature of this study • age ≥ or = to 18 years and fluent in the english language exclusion criteria: * patients with intraepithelial (in situ) melanoma * patients with stage iv melanoma * patients with nodal or visceral melanoma without a documented primary lesion * patients with prior malignancies for the focus group recruitment (specific aim 1): (patients treated at mskcc from 1996-2005) who have a diagnosis \>10 years ago from treatment. for the survey group recruitment (specific aim 2): patients treated at mskcc from 2001-2011)who have a diagnosis \>10 years ago from treatment. * patients with a recent diagnosis of melanoma, \<12 months * patients who are one year or more post diagnosis and are still receiving treatment for their melanoma

Keywords: health behaviors surveillance 06-128
longitudinal study of cognition with niemann-pick disease, type c

Conditions: Niemann-Pick Disease, Type C

Summary: niemann-pick disease, type c (npc) is a rare neurodegenerative disorder with a wide clinical spectrum and variable age of onset. classically, children with npc demonstrate neurological dysfunction with cerebellar ataxia (an inability to coordinate balance, gait, extremity and eye movements), dysarthria (difficulty speaking), seizures, vertical gaze palsy (ability to move eyes in the same direction) motor impairment, dysphagia (trouble swallowing), psychotic episodes, and progressive dementia. there is no curative treatment for npc and it is a lethal disorder. the purpose of this protocol is to obtain both baseline and rate of progression data on a clinical and biochemical markers that may later be used as outcome measures in a clinical trial. specifically, this study will examine and characterize the longitudinal progression of neurocognitive symptoms of npc with the goal of identifying early markers of disease progression that may be utilized in later trials to evaluate treatment efficacy.


Eligibility criteria:
inclusion criteria: all individuals between the ages of 2 years and 99 with an established diagnosis of niemann-pick disease, type c (biochemical or molecular) will be considered for this study. patients with both niemann-pick disease, type c1 (npc1) and niemann-pick disease, type c2 (npc2) mutations are eligible to participate. exclusion criteria: participants with at least one of the following will not be eligible for this study: 1. individuals that cannot travel because of their medical condition or are too ill to be cared for at home, 2. individuals with stage 4 disease (non-ambulant with vegetative disturbances) 3. individuals will be excluded if english is not their primary language

Keywords: niemann-pick disease type c lysosomal disease
living kidney donor lost wages trial

Conditions: Kidney Diseases

Summary: this study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation.

live donor kidney transplantation (ldkt) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor kidney transplantation (kt). however, the annual number of ldkts has declined over the last decade, particularly among minority and low-income patients. the investigators hypothesize, and have preliminary data to support, that the financial impact on living donors (lds) is a major contributor to the ldkt decline and for persistent racial disparities in ldkt rates. many lds have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. in this study, the investigators will: (1) evaluate the effectiveness of offering reimbursement for ld lost wages on the ldkt rate; (2) examine whether offering reimbursement for ld lost wages reduces known racial disparities in ldkt; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for ld lost wages.

Eligibility criteria:
inclusion criteria: * for kt patients: * chronic kidney disease (ckd) stage 4/5 * approved for kidney transplant (kt) listing or active on kt waiting list * for patients listed at multiple centers: primary listing at beth israel deaconess medical center (bidmc) * for lds: * their kt candidate is enrolled in the trial exclusion criteria: * for kt patients: * kt candidate has a potential ld approved, with surgery scheduled * listed for multi-organ transplantation * temporarily unavailable (tu) status on kt waiting list * current enrollment in another study to increase ldkt likelihood * for lds: * not residing in the us

Keywords: ldkt live donor transplantation kidney transplantation
translation of basic research in cognitive science to hiv risk

Conditions: HIV/AIDS

Summary: a randomized trial was conducted at drug diversion educational programs with a sample of 343 adult drug offenders who volunteered for the study. the trial tested three different interventions on hiv testing and condom use, with a 3 month follow-up. the study translated consistent basic research showing strong effects of memory practice on memory for new material. one of the conditions involved extensive memory practice of action plans involving hiv testing and condom use. other conditions varied two active control interventions. results showed that the memory practice condition led to a substantially larger odds of hiv testing than did the two control conditions. condom use was also significantly more frequent in the memory practice condition than in one of the control conditions but was not significantly different from the second control condition.

this study translated basic research from several areas of cognitive science to a new intervention procedure designed to reduce hiv risk and increase screening for hiv and other infections. a randomized trial was conducted (n = 343) to test effects on testing for infection (hiv and hepatitis b/c) and condom use frequency in a sample of drug offenders at risk for infection. many populations of drug offenders are not currently receiving evidence-based prevention for hiv or hepatitis and are in need of effective interventions that can be used in existing drug programs. at three-month follow-up, the results revealed that the condition translating basic research on memory practice and integrative processing significantly increased the odds of infection testing as compared to two alternative conditions. this condition also significantly improved the extent of condom use, compared to a traditional health education condition. the results show promise for increased translation of basic research on memory to behavioral interventions on health and prevention science. such procedures can be effectively applied in a complex field setting in existing drug diversion programs.

Eligibility criteria:
inclusion criteria: * enrolled in drug diversion education program * minimum age 18 * understand english exclusion criteria: * under 18 * do not understand english * obviously intoxicated