Kornimate/medical-research-clean huggingface dataset:
development of a questionnaire on patients' perception of their oncology care pathway (onco-prems)

Conditions: Cancer

Summary: healthcare systems are evolving, giving increasing prominence to the patient-centered model, accompanied by objective and perceived outcomes. prems (patient reported experience measures) are used to assess how patients feel about their experience of care. prems enable patients to take an active role in their own care, and enable healthcare establishments to identify areas for improvement that can be incorporated into their quality processes. in oncology, the collection of patient-perceived quality regarding their care pathway would enable better coordination of their care. while a few initiatives have emerged in the field of prems, the development of a reliable questionnaire assessing patient perception of their care pathway in oncology remains a challenge.

the aims of the study are to constitute a questionnaire to assess patients' perceptions of their oncology care pathway and to perform its psychometric validation.

Eligibility criteria:
inclusion criteria: * cancer patient * regardless of location or stage * fluent in french * aged more than 18 years old * agreeing to take part in the study exclusion criteria: * with an estimated life expectancy of less than 3 months * in remission, untreated or without follow-up for more than 12 months * protected by law

Keywords: oncology oncology care pathway patients' perception questionnaire psychometric validation
assessment of novel sound changing principles in hearing instruments to determine their application - 2019_33

Conditions: Hearing Loss

Summary: participants will complete a listening task in a simulated reverberant environment. participants are seated and instructed to look at a fixation cross while a sentence is played. sentences are varied with respect to their speech rate. while listening to the sentences participant's pupil dilation is measured by means of pupillometry which is a non-invasive physiological measurement. participants are asked to repeat back the sentences loud. at fixed intervals, subjective ratings are collected by asking participants to move an on-screen slider using a game controller. two hearing aid programs will be compared, one intended for speech perception in quiet and the other to reduce reverberation in reverberant environments. the study is designed as factorial, with 2 speech rates, 2 room simulations and 2 hearing aid programs. the same conditions will be re-tested once after a minimum of one day. a pilot study will determine appropriate speech rates by applying a different factorial, with 4 speech rates, 2 room simulations and 1 hearing aid program. participants complete all conditions (within-subjects) in one experimental sessions that lasts around 1 hour.


Eligibility criteria:
inclusion criteria: * healthy outer ear (without previous surgical procedures) * ability to fill in a questionnaire conscientiously * informed consent as documented by signature * mild-moderate/severe (n2-n4) hearing loss exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * known central hearing disorders
retention and re-engagement in treatment for addiction following serious injection related infections (retain)

Conditions: Opioid Use Disorder; Bloodstream Infection; Osteomyelitis; Endocarditis; Septic Arthritis; Epidural Abscess

Summary: this project is a pilot study of an adapted intervention of an existing opioid use disorder (oud) treatment retention intervention called recovery management checkups (rmc). this intervention has been adapted to better fit the experiences and unique issues of those that have been hospitalized with serious injection related infections (siri) based on the findings from a prior qualitative study from the principal investigator. this project plans to test the adapted intervention within a smaller group of participants to assess feasibility, acceptability, and calculate early findings of intervention efficacy. hospitalizations for siris are a unique entry point for patients to start their recovery journey with medications for oud (moud), but many people do not remain on long-term treatment, despite evidence that indicates mouds reduce death and re-hospitalization after siris. the study objectives are to: * assess the implementation feasibility of the adapted rmc model for patients with siri and oud. * establish preliminary estimates of intervention efficacy. * make further adaptions to the intervention that will reduce both known and unknown barriers to care and increase effectiveness in future larger scale trials. findings from this pilot study will result in further intervention refinement to better fit the target population, and serve as the basis for a larger randomized control trial that will have aims focused on more in-depth analysis of the efficacy of this program


Eligibility criteria:
inclusion criteria: * between 18 and 65 years of age * able to provide informed consent * admitted to boston medical center on any inpatient unit for an active serious injection related infection (siri) such as endocarditis, osteomyelitis, bacteremia, septic arthritis, epidural abscess or other serious infection in which two weeks or more of antibiotics are recommended exclusion criteria: * not able to give informed consent * cognitive ability (defined through research assistant (ra) determination) * inability to complete assessments in english or spanish (defined through ra determination). * exclusion for any reason under pi discretion * unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future. * in police custody or expecting incarceration

Keywords: recovery management checkups (rmc) serious injection related infections (siri) medications for oud (moud) re-hospitalizations
a study to evaluate paritaprevir with ritonavir (abt-450/r) when given together with ombitasvir and with and without ribavirin (rbv) in treatment-naïve participants with genotype 1, 2 or 3 chronic hepatitis c virus (hcv)

Conditions: Hepatitis C Virus

Summary: the purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of abt-450/r when given together with abt-267 and with and without rbv in treatment-naïve participants with genotype 1, 2 or 3 chronic hcv infection.

this was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for hcv genotype 1, 2, and 3. the study consisted of 2 phases, a treatment phase and a post-treatment phase. the treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of abt-450/r dosed in combination with abt-267 with and without rbv for up to 12 weeks. the post-treatment phase was designed to monitor and evaluate sustained virologic response (svr) 12, svr 24, and the evolution and persistence of viral resistance to abt-267 and abt-450 in hcv genotype 1-, 2-, and 3-infected participants who have been exposed to abt-267 and abt-450/r. arms 1 and 2 were enrolled sequentially.

Eligibility criteria:
inclusion criteria: * participants who had a body mass index 18 to \< 35 kg/m\^2. * females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control. * males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study. * participants were in a condition of general good health, other than the hcv infection. * participants had a chronic hcv genotype 1, 2, or 3 infection for at least 6 months, a plasma hcv rna \> 50,000 iu/ml, and fibrotest score \<= 0.72 and aspartate aminotransferase (ast) to platelet ratio index \<= 2, fibroscan® result of \< 9.6 kilopascal (kpa), or absence of cirrhosis based on a liver biopsy. exclusion criteria: * positive drug screen * previous use of anti-hcv agents * history of cardiac disease * history of uncontrolled diabetes or diabetes requiring insulin * abnormal laboratory results * females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/rbv or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/rbv * positive test result for hepatitis b surface antigen (hbsag) or anti-human immunodeficiency virus (hiv) antibody (ab). negative hiv status was to be confirmed at screening.

Keywords: genotype 1 genotype 2 genotype 3 hepatitis c virus abt-450/r ribavirin abt-267 ombitasvir paritaprevir
comparison of the effects of instrument assisted soft tissue mobilization techniques low back pain

Conditions: Chronic Low-back Pain

Summary: the aim of this study is to determine whether the effectiveness of instrument-assisted soft tissue mobilization technique is different from passive prone lying when performed with a functional exercise in individuals with chronic nonspecific low back pain.

individuals participating in the study will first be divided into two groups by randomization. while iastm (instrument assisted soft tissue mobilization techniques) will be applied to one group in the prone position, iastm will be applied to the other group with functional exercise. the pain, mobility, flexibility, disability and endurance parameters of the individuals assigned to the groups after randomization will be determined just before the application, immediately after the 1st application and immediately after the 6th application. the study will last for a total of 6 sessions, with two sessions per week for 3 weeks.

Eligibility criteria:
inclusion criteria: * being diagnosed with non-specific low back pain by a specialist physician * 18-45 years old * having 3 or more pains on vas for the last 3 months. * those who do not use analgesic drugs * not taking physiotherapy for the last 6 months. exclusion criteria: * those with orthopedic, neurological, psychiatric and systemic diseases (such as fracture, osteoporosis, scoliosis, kyphosis, stenosis, cauda equina, myositis ossificans, severe nerve compressions, rheumatoid arthritis, cancer) * those with a history of spinal surgery * pregnant and lactating * open wound, infection, serious kidney disease * those who have limited hip joint movements

Keywords: iastm chronic pain flexibility disability mobility muscular endurance
prone flexed position in percutanous nephrolithotomy

Conditions: Renal Stones

Summary: prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. a randomized controlled trial.

patients meeting the inclusion criteria will be randomly allocated to 2 groups: 1. 1st group will undergo prone-flexed pcnl. 2. 2nd group will undergo prone pcnl. iii. recruitment of participants patients appointed for an outpatient diagnostic cystoscopy will be reviewed for the inclusion and exclusion criteria. legible patients will be asked to participate in the study and to sign the informed consent form. iv. randomisation randomization will be performed using computer generated random tables using stratified blocked randomization in 1:1 ratio. v. study procedure preoperative evaluations included 1. detailed medical history 2. physical examination 3. routine blood examination 4. urinalysis \& urine cytology 5. renal and liver function tests 6. coagulation profile 8. computed tomography of the abdomen and pelvis operative technique prone-flexed positioning i. retrograde access will be obtained ii. the patient is repositioned prone with adequate padding under the pressure points of the head, chest, knees, and feet. iii. the table is flexed 30 degrees at the level of the patient's mid lumbar region to open the space between the 12th rib and the posterior iliac crest dropping the gluteal muscles from the working plane. ancillary intervention patients will receive a 20-ml infiltration of 0.25% bupivacaine. under fluoroscopic guidance, the local analgesic was infiltrated with a 22-gauge spinal needle (10-cm length) along the nephrostomy tract at the 3, 6, 9, and 12 o'clock positions (5 ml in each tract), including the muscles, subcutaneous tissue, and skin. patients will receive 1 g tranexamic acid at induction followed by three further doses of 500 mg over the next 24 h.

Eligibility criteria:
inclusion criteria: * large renal or upper ureteral calculi or both, exclusion criteria: * (1) age \ 40) (6) non opaque renal stones. (7)refuse to complete study requirements (8)untreated uti (9)atypical bowel interposition by ct (10)tumour in the presumptive access tract area or potential malignant kidney tumour
targeting collagen vii antibodies with iv igg in dystrophic epidermolysis bullosa

Conditions: Epidermolysis Bullosa; Epidermolysis Bullosa Acquisita; Dystrophic Epidermolysis Bullosa; Recessive Dystrophic Epidermolysis Bullosa

Summary: the study objective is to see if iv igg treatment in recessive dystrophic epidermolysis bullosa (rdeb) skin in conjunction with vyjuvek treatment improves wound healing and affects the levels of c7 and hsv-1 antibody levels in serum. fewer wounds, more rapidly healing wounds, and decreased c7 and hsv-1 antibodies could improve quality of life.


Eligibility criteria:
inclusion criteria: 1. diagnosis of generalized recessive dystrophic epidermolysis bullosa (rdeb) demonstrated by col7a1 mutations. 2. diagnosis of eba demonstrated by the presence of levels of serum c7 antibodies above the normal elisa range 3. baseline skin blistering greater than 5% total body surface area 4. 1 wound at least 20 cm\^2 able to be entirely treated with vyjuvek weekly 5. 1 wound at least 20 cm\^2 that has never been treated with vyjuvek 6. ongoing vyjuvek treatment. exclusion criteria: 1. history of thrombotic event(s) 2. history of cardiac failure 3. history of renal failure 4. iga deficiency

Keywords: epidermolysis bullosa epidermolysis bullosa acquisita dystrophic epidermolysis bullosa recessive dystrophic epidermolysis bullosa collagen 7 c7 col7 eb eba deb rdeb antibodies collagen vii iv igg igg ivigg c7 antibodies collagen 7 antibodies collagen vii antibodies vyjuvek b-vec
an observational retrospective cohort study being conducted in women with atopic dermatitis exposed to ruxolitinib cream versus topical corticosteroids during pregnancy: a us claims database analysis

Conditions: Pregnancy Related; Atopic Dermatitis

Summary: this study is to assess infant outcomes of women with ad who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with ad who were exposed to a topical corticosteroid (tcs) during pregnancy.


Eligibility criteria:
inclusion criteria: * women aged 14 years or older at pregnancy outcome. * pregnancy following fda approval of ruxolitinib cream for ad on 21 sep 2021. * at least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a tcs (tcs-exposed cohort). * a diagnosis of ad prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a tcs (tcs-exposed cohort) from 6 months before the estimated date of conception. * continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy. * for infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). a 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias. exclusion criteria: • one or more pharmacy claims for oral ruxolitinib or other jak inhibitors in the exposure window for a given outcome.

Keywords: ruxolitinib atopic dermatitis pruritus eczema topical therapy jak inhibitor
zr-89 cimzia pet imaging rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a single center exploratory imaging study investigating the initial application of zirconium-89 deferoxamine b certolizumab pegol (89zr-dfo-czp) pet in patients with rheumatoid arthritis. patients with active symptoms of ra or signs on physical exam will be invited to participate for pet imaging.

this is a single center exploratory imaging study investigating the initial application of 89zr-dfo-czp pet in patients with rheumatoid arthritis. patients with active symptoms of rheumatoid arthritis (ra) or signs on physical exam will be invited to participate for pet imaging. study 1 is a dose finding study that will involve a single 89zr-dfo-czp pet scan acquired \~24 hours following a single administration of the radiopharmaceutical. the first 2 patients will receive 1 millicurie (mci) of 89zr-dfo-czp. subsequent groups of two patients will receive 0.5 mci decrease or increase dose (up to 2 mci) to determine the acceptable optimal imaging dose. after receiving the dose, participants will undergo 4 serial whole body pet scans between 2 hours and 120 hours after dose administration. several blood samples will also be collected over this time period, for dosimetry analysis.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old. 2. ability to read and understand written informed consent document. 3. patients with clinical diagnosis of rheumatoid arthritis. exclusion criteria: 1. for patients planning to be imaged on pet (positron emission tomography) / mri (magnetic resonance imaging) (pet/mr) scanner, exclusion criteria will include any contra-indication to mri, including permanent pacemaker, implantable metallic device/ prosthetic, aneurysm clip, non-removable piercing, or severe claustrophobia. 2. any medical condition that would compromise the imaging acquisition, in the opinion of the investigator. 3. patients who have had a study involving radiation within one year of enrolling in this study. 4. patients who are pregnant (female patients of childbearing age will be tested prior to injection of imaging agent - positive test will exclude from participating in the study). 5. patients who are breastfeeding. 6. patients who cannot confirm that they will use reliable contraceptive methods for 90 days. 7. patients treated with tnf-alpha inhibitor therapy. 8. females of child-bearing age (\<50 years old), until data from the dose-finding study has been reviewed by the ucsf radiation safety committee and explicit written permission has been provided by the ucsf radiation safety committee to open the window of potential female participants to ages 18 years and older.
prospective evaluation of biomarker profiles in idiopathic pulmonary fibrosis

Conditions: IPF

Summary: idiopathic pulmonary fibrosis (ipf) is a progressive, fatal, fibrotic disorder of the lung. the estimated prevalence is 30-80/100,000 in the united states with incidence estimates clearly rising. a major challenge in the care of patients with ipf is determining prognosis. the natural history of ipf is usually one of inexorable decline in lung function, ultimately resulting in death from respiratory failure. however, longitudinal physiologic decline in ipf is heterogeneous and difficult to predict in individual patients. while some patients with ipf may remain stable for years, in others the disease may progress rapidly over a relatively short time. we hypothesize that peripheral blood biomarkers based on extracellular matrix and matrix-modifying molecules will improve prognostication in patients with ipf.


Eligibility criteria:
inclusion criteria: 1. age 35-80 years, inclusive 2. diagnosis of ipf by hrct or surgical lung biopsy 3. able to understand and provide informed consent exclusion criteria: 1. ae-ipf during the prior year 2. environmental exposure (occupational, drug, etc.) felt to be the etiology of the interstitial disease. 3. diagnosis of collagen-vascular conditions according to published american college of rheumatology criteria. 4. significant airway obstruction (fev1/fvc ratio \ 200 ml or change in fvc ≥ 12% and absolute change \> 200 ml at baseline 5. partial pressure of arterial oxygen (pao2) \< 55 mm hg 6. evidence of active infection 7. listed for lung transplantation 8. myocardial infarction, coronary artery bypass, or angioplasty within 6 months 9. unstable angina pectoris or congestive heart failure requiring hospitalization or deteriorating within 6 months 10. uncontrolled arrhythmia or hypertension 11. known hiv, hepatitis c, cirrhosis, or chronic active hepatitis 12. active substance and/or alcohol abuse 13. if you are pregnant or breastfeeding 14. any condition other than ipf that is likely to result in your death within the next year 15. any condition that, in the judgment of the pi, might cause participation in the study to be detrimental to you or that the pi deems makes you a poor candidate

Keywords: idiopathic pulmonary fibrosis biomarkers forced vital capacity diffusion capacity for carbon monoxide prognosis
partners calciphylaxis biobank

Conditions: Calciphylaxis; Calcific Uremic Arteriolopathy; End Stage Renal Disease; Chronic Kidney Diseases

Summary: calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles. there are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. at present, there is no effective treatment. uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis. the partners calciphylaxis biorepository (pcb) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository.

calciphylaxis, a vascular calcification disorder, is a rare and serious disorder characterized by calcification of dermal arterioles. there are significant gaps in the understanding of the pathophysiology and risk factors for calciphylaxis. at present, there is no effective treatment. uncertain pathobiology, rare incidence and lack of collaborative approach have been some of the major limiting factors towards treating calciphylaxis. the partners calciphylaxis biorepository (pcb) aims to address these gaps within calciphylaxis research by utilizing existing and, when necessary, developing new infrastructure to support the consent of patients and the collection of dedicated samples for a calciphylaxis repository. this repository is working in collaboration with the partners biobank as they will still be receiving samples from the pcb and storing them and distributing them according to their own procedures.

Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years old 2. skin lesions consistent with calciphylaxis diagnosis as determined by the treating clinician 3. informed of the investigational nature of the study and sign written informed consent or are eligible for surrogate consent process based on impaired decision making exclusion criteria: 1. patients \<18 years of age 2. prisoners

Keywords: calciphylaxis warfarin dialysis