Kornimate/medical-research-clean huggingface dataset:
patient satisfaction study of single-use autoinjector for the delivery of pre-filled avonex syringe

Conditions: Multiple Sclerosis

Summary: determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled avonex syringe.


Eligibility criteria:
inclusion criteria: * must be using liquid avonex® to treat ms. in addition, the subject must be on liquid avonex® for 12 weeks prior to the screening visit. * must have a bmi of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at screening. * must be able to physically demonstrate use of the device and be able to self-administer all injections. * must be english speaking. * must be able to understand and comply with the protocol. exclusion criteria: * abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (wbc) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (alt) aspartate transaminase (ast), prothrombin time (pt). * known sensitivity to dry natural rubber. * treatment with other agents to treat ms symptoms or underlying disease as specified in the protocol. * history of severe allergic or anaphylactic reactions. * history of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study. * serious local infection other inclusion and exclusion criteria apply as per biogen idec protocol

Keywords: multiple sclerosis interferon beta-1a avonex liquid avonex
development and testing of a mobile app to scale delivery of cognitive-behavioral therapy for avoidant/restrictive food intake disorder

Conditions: Avoidant/Restrictive Food Intake Disorder (ARFID)

Summary: avoidant/restrictive food intake disorder (arfid) is a serious and impairing eating disorder - occurring in up to 4% of adults - for which most individuals do not have access to treatment. the proposed study aims to develop and test a mobile app to scale delivery of cognitive-behavioral therapy for arfid. knowledge gained will contribute to the development of a clinically accessible, scalable, inexpensive treatment for arfid, a highly impairing disorder for which there are significant barriers to care access.


Eligibility criteria:
inclusion criteria: 1. current avoidant/restrictive food intake disorder based on dsm-5 criteria 2. must not have completed face-to-face cbt-ar at the eating disorders clinical and research program at massachusetts general hospital 3. ability to speak, write, and understand english 4. residence in the united states 5. access to an internet-connected smartphone device exclusion criteria: 1. underweight status (i.e., bmi \< 18.5 kg/m2) 2. complete lack of oral intake or dependence on supplemental feeding 3. feeding or eating disorder other than arfid 4. any comorbid clinically significant disorder that would require attention beyond the study treatment 6. medical instability requiring inpatient care according to the american psychiatric association 2023 treatment guidelines for eating disorders 7. medical history of intellectual disability 8. illiteracy
evaluation of four treatment modalities in prostate cancer with low or "early intermediate" risk

Conditions: Prostate Cancer

Summary: 4arms preference based study to compare four therapy options in prostate cancer with low or early intermediate risk

the study will compare four possible therapy options for treatment of newly diagnosed prostate cancer with low or "early intermediate" risk according to the patients preferences. the following hypotheses will be tested: * radiation is not relevantly worse compared to prostatectomy with regard to time to prostate cancer-related deaths * permanent seed implantation therapy not inferior to prostatectomy with regard to time to prostate cancer-related deaths. * active surveillance does not lead to a significant decrease of time to prostate cancer-related deaths compared to prostatectomy. that for patients with newly diagnosed prostate cancer will be randomized into one of the four treatment arms. randomization may be limited to at least two of the four treatment arms if a patient refuses one or two of the four treatment arms according to his own preference.

Eligibility criteria:
inclusion criteria: * newly diagnosed, biopsy proven adenocarcinoma of the prostate (ultrasound guided biopsy by standardized protocol) * men aged 18-75 years * recruitment within 3 months after histological confirmation * localized prostata cancer \<= ct2a, nx or n0 m0 * psa \<= 10 ng / ml * gleason score \<= 7a (3 +4) * ecog performance status 0 or 1 * \<= 30% positive biopsy cores with largest contiguous tumor length \<= 5 mm * ipss score \< 18 * urine flow (qmax):\> 15 ml / s exclusion criteria: * unifocal gleason 6 cancer \<1mm * history of treatment for bph e.g. turp, hifu or cryotherapy * history of radiation therapy to the pelvis * life expectancy \<10 years * asa \>= 4 * post-void residual urine \> 50 ml * prostate volume on transrectal ultrasound \> 60 cm3 * large median prostate lobe visualized on transrectal ultrasound * chronic intestinal inflammatory disease covering the rectum * other active malignancy within the past 5 years (except for superficial basal cell carcinoma or non muscle infiltrating bladder carcinoma) * contraindications for prostatectomy, radiation therapy or active surveillance * patients refusing written informed consent
study of glaucoma treatment with food additives

Conditions: Glaucomatous Neuropathy

Summary: the purpose of this study is to determine if certain food additives are effective in the treatment of glaucoma, improving and reversing the progress of the disease.

glaucomatous neuropathy is a condition that worsens with time causing atrophy of the optic nerve and narrowing of the visual field which may culminate in blindness. the treatment tested in the trial employs certain food additives intended to reverse this pathology.

Eligibility criteria:
inclusion criteria: * stable open angle glaucoma - with equilibrated eye internal pressure * above the age of 50 years and have severe damage that does not progress to the vision field in the upper and lower half. scoring of the vision field will be made according to the agis study instructions. exclusion criteria: * eye diseases excluding past cataract operation * allergy to one of the components in the preparation * deterioration in the vision field in the last year * kidney diseases, gastrointestinal (g.i.) tract, liver diseases, coagulation problems and thyroid diseases * persons who take steroids * diabetics or unbalanced hyperglycemia * autoimmune diseases * hypertension (not responding to treatment) * psychiatric treatment with drugs, psychiatric pathologies * pregnancy * ability to take more than 3 pills per day regularly * smoking
application of high resolution optical coherence tomography in skin disease: amyloidosis and differential diagnosis

Conditions: Amyloidosis

Summary: amyloidosis is caused by the misfolding protein accumulated in tissue, which affects the function of the organs. in addition to the primary cutaneous amyloidosis, a skin lesion may also appear in another classification - systemic amyloidosis. physicians can confirm diagnosis of the above classification by skin biopsy. primary cutaneous amyloidosis is common in asia and south america. in taiwan, 80 people are diagnosed with primary cutaneous amyloidosis in every 100,000 people. among the disease, macular amyloidosis and lichen amyloidosis are the most common subtypes. primary cutaneous amyloidosis can cause severe itching, pigmentation, and skin keratosis, and further affect the social behavior of patients. the etiology of primary cutaneous amyloidosis is currently unclear, possibly due to genetic variations or viral infection. typical primary cutaneous amyloidosis can be diagnosed by clinical manifestations, however, if the location or appearance of a lesion is atypical, the disease will be indistinguishable from other pigmented diseases, and further need a biopsy. if physicians can use a rapider and more accurate assistance tool to evaluate disease first, it will improve the accuracy of clinical diagnosis, relieve patient of suffering from biopsy, and further use medical resources more effectively. optical coherence tomography (oct) is a kind of optical imaging medical system. it generates images by detecting the variations in refractive indexes of the various components in soft tissues. apollo medical optics, ltd. (amo)'s oct device (apollovue™ s100 image system, viper1-s003) acquires real-time in vivo skin tissue tomograms with cellular resolution which provides a non-invasive, non-radioactive and rapid image acquisition. in this study, amo's oct will be used to observe features in tomograms of primary cutaneous amyloidosis and that of other indistinguishable diseases, compare the correspondence of tomograms with pathological sections, induct features in tomograms specific to primary cutaneous amyloidosis and other indistinguishable diseases, and further establish an oct database of primary cutaneous amyloidosis.


Eligibility criteria:
inclusion criteria: * patients diagnosed with suspected primary cutaneous amyloidosis and other indistinguishable diseases * patients with no open wounds exclusion criteria: * patients with a transcutaneous infectious disease * patients under the age of 20 * vulnerable populations, including: pregnant women, handicapped, and homelessness * patient cannot cooperate in examination

Keywords: optical coherence tomography (oct) amyloidosis pigmented diseases skin diseases dermatology pathology h&e stain
picaros - acalabrutinib rwe on 1l cll in spain

Conditions: Chronic Lymphocytic Leukemia

Summary: this is a multicenter non-interventional study (nis) on patients with cll who have been treated with acalabrutinib for the first time within the year before the first site initiation visit in spain

this is a multicenter, non-interventional study (nis) based on ambispective (including retrospective and/or prospective) real-world data collection of patients with cll who have been treated with acalabrutinib for the first time within the year before the first site initiation visit, from approximately 50 hospitals in spain. patients who had already initiated acalabrutinib therapy will be identified by the investigators and offered to participate in the study. the start of acalabrutinib treatment (index date) must be prior to the first site initiation visit. therefore, the clinical decision of starting patient on acalabrutinib has independently occurred prior to the patient inclusion into this study. patients' eligibility for study inclusion is regardless of their current status of acalabrutinib therapy, for example, patients already deceased or discontinued therapy are still eligible to be included into this study. patient data will be collected both retrospectively and/or prospectively up to 3.5 years from the first site initiation visit. for patients who received acalabrutinib therapy and have deceased, only retrospective medical chart review will be conducted.

Eligibility criteria:
inclusion criteria: * age ≥18 years old at starting acalabrutinib treatment. * diagnosis of cll. * start of acalabrutinib treatment (index date) in treatment-naïve cll patients or those switching in first-line between first-generation btk inhibitor to acalabrutinib due to intolerance in absence of progression according to routine clinical practice within the year before the first site initiation visit. decision to administer acalabrutinib must be made and documented prior to inclusion into the study and must follow local clinical practice. * informed consent (for alive patients). exclusion criteria: * enrolled in any clinical trial during acalabrutinib treatment. * patients who are unable to understand the study and its questionnaires due to insufficient knowledge of the spanish language or their health status.

Keywords: observational chronic lymphocytic leukemia acalabrutinib
effects of adherence therapy on medication adherence in patients with schizophrenia spectrum disorder

Conditions: Motivational Interviewing; Schizophrenia Spectrum Disorder; Medication Adherence

Summary: this study will explore the effect of adherence therapy(at) on medication adherence in patients with schizophrenia spectrum disorder.

a single-blind, randomized controlled trial with a repeated-measures, two parallel groups design will be conducted for 120 participants with schizophrenia spectrum in regional hospital in northern taiwan. after baseline data collection finished, the blocked randomization will be employed to assign participants to two groups. the experimental group will participate in a eight session course of adherence therapy. the control group received routine care. the data will be collected for baseline(t0) and after 4 session interim analysis(t1；9-12 weeks) and 8 session after intervention(t2；21-28 weeks). a structured questionnaire will use to collect data on the medication adherence rating scale, schedule for the assessment of insight, internalized stigma of mental illness scale, self-appraisal of illness questionnaire and positive and negative syndrome scale. data analysis will employ statistical package for the social sciences 20.0 with generalized estimating equations approach to examine effects of adherence therapy and routine care on medication adherence.

Eligibility criteria:
inclusion criteria: * aged 20-64 * were chinese speaking or taiwanese speaking; * diagnosed with schizophrenia or schizoaffective disorder * recent history of non-adherence to antipsychotic medication. 1. non-adherence to medication was defined as a recent history of cessation of psychiatric admission for more than one month at a time 2. the patient recently (half year) relapse of mental illness 3. family and health care worker state that the patient has taken irregular medication * demonstrated cognitive understanding of the research plan and provided consent. exclusion criteria: * discharged from hospital for at least 3 months * no intellectual disability, organic brain diseases or cognitive impairment * no alcohol or sub-stance abuse problems * were not attending medication management program .

Keywords: adherence therapy insight medication adherence motivational interviewing schizophrenia spectrum disorder symptom severity randomized controlled trial
new tools for the diagnosis, prognosis and treatment follow-up in chagas disease

Conditions: Chagas Disease

Summary: chagas disease is endemic to latin america, and is of emerging importance in non-endemic countries because migration of people infected with t. cruzi. current methods for diagnosis of t. cruzi infection are not ideal. existing drugs for treatment are very limited, produce severe side-effects, and their effectiveness cannot be properly evaluated. reliable biomarkers for prognosis, early diagnosis and effectiveness of treatment will be investigated.


Eligibility criteria:
inclusion criteria: * patients from endemic areas (latin america) * older than 18 years old and younger than 50 * with serological confirmation of chagas disease infection with two different techniques * indeterminate or initial cardiac form * no previously treated for chagas disease exclusion criteria: * co-morbidity: previous cardiac disease from other aetiology (ischemic, alcoholic or hypertensive), active inflammatory or immunology diseases for another agent. hepatic disfunction * pregnancy or lactation
post - activation potentiation after plyometric and heavy resistance exercise in soccer players

Conditions: Soccer

Summary: the main purpose of this study will be comparison of acute effects of plyometric and heavy resistance exercise on post-activation potentiation

this is a single-center, randomized, crossover study. collegiate soccer players will be enrolled in this study. the study will be performed in 3 separate sessions.in the first session, participants will be familiarized with the experimental conditions and 1rm will be calculated. participants will then be randomized to receive either heavy resistance or plyometric exercise first in the second session and then will be crossed over to receive the opposite intervention in the third session. the objective of the study is to compare the acute effects of plyometric and heavy resistance exercise on post - activation potentiation by measuring physical performance and blood lactate level.

Eligibility criteria:
inclusion criteria: * collegiate soccer players aged 18 - 26 years * participants must have at least 2 years of playing experience * participants should be involved in sport-specific training on at least 2 occasions per week and play competitively once per week exclusion criteria: * lower extremity reconstructive surgery in last 24 months or unresolved musculoskeletal disorder which would prohibit subject to participate in the sport. * participants who are consuming (or had consumed) growth hormone, anabolic steroids or any kind of performance enhancing drugs.
regorafenib in metastatic colorectal cancer : a cohort study in the real-life setting

Conditions: Metastatic Colorectal Cancer

Summary: this is a largest cohort study aimed to estimate the overall survival of patients been treated with regorafenib for metastatic colorectal cancer (mcrc) within the frame of a french compassionate program.

regorafenib (reg) is a multi-kinase inhibitor with survival benefits in patients with pretreated mcrc, as demonstrated in the phase iii correct study. as a result, reg has been made available for medical practice use in the us, and in the europe. however, prescribing conditions in the real-life setting are known to be less stringent than selection criteria in clinical trials. the regorafenib in metastatic colorectal cancer: a french compassionate program (rebecca) is an ambispective cohort study designed to elucidate safety and effectiveness outcomes associated with reg as used in clinical practice for mcrc who have been previously treated with, or are not considered candidates for, available therapies. patients were identified from the database of the french atu (temporary authorization for use), approved by the french health authorities to provide early access to innovative, not yet approved medicinal products such as reg. baseline patient and tumor characteristics, reg dosing and dose-intensity, reg-related adverse events, pre- and post reg treatments, predictors of events, and effectiveness data (pfs, os) were collected from patients who agreed, and whom physicians accepted to collaborate on the rebecca cohort.

Eligibility criteria:
inclusion criteria : * patient ≥ 18 years old * with a colorectal cancer metastatic histologically proven * have met the criteria defined in the monograph atu (temporary authorization for use) validated by french health authorities and for which the request for access to treatment has been validated, that is in patients with mcrc as used in clinical practice for mcrc who have been previously treated with, or are not considered candidates for, available therapies. * patients who received at least one dose on reg exclusion criteria : * opposed to the study * patient does not meet the inclusion criteria * patient deprived of liberty or under guardianship

Keywords: regorafenib, cohort, metastatic colorectal cancer
fetal myelomeningocele repair with maternal bmi between 35.0 and 40.0

Conditions: Myelomeningocele; Pregnancy

Summary: inclusion and exclusion criteria for fetal repair of mmc was established by the management of myelomeningocele study (moms trial) and these criteria are the standard of care throughout the united states. these criteria state exclusion for hypertension and diabetes which are known co-morbidities for obesity. investigators plan to expand one exclusion criteria for open fetal repair surgery. currently, an exclusion factor is a maternal bmi of 35.0 and greater.investigators will maintain all other inclusion and exclusion criteria (including excluding for hypertension and diabetes) with the exception of expanding the bmi to include mothers with a bmi of 35.0 to 40.0. co-morbidities of the research group will be compared to the comorbidities of the mothers published in the moms trial.

the moms trial proved prenatal repair of myelomeningocele was an advantage over postnatal repair for the fetus/neonate/child and is the standard of care for maternal/fetal dyads who meet the inclusion exclusion criteria. investigators plan to maintain all inclusion exclusion criteria for open fetal repair surgery of myelomeningocele with one exception, the expansion of the maternal bmi to 40.0. this population of mothers with a bmi of 35.0 to 40.0 have not been studied. the morbidities of these mothers will be compared to morbidities of mothers with a bmi less than or equal to 34.9 currently in the scientific literature.

Eligibility criteria:
inclusion criteria: * maternal bmi 35.0 to 40.0 * no maternal documented co-morbidities * fetal mmc begins between thoracic 1 and sacral 1, on the spinal column. * evidence of fetal hindbrain herniation (hindbrain is being pulled down the spinal column). * a gestational age is between 19 weeks 0 days and 26 weeks with evidence of placental membrane fusion. * documented normal fetal karyotype. exclusion criteria: * history of maternal alloimmunization problem * kell sensitization * risk of preterm birth * history of spontaneous preterm birth * cervix \<20mm in length * presence of cerclage * placental problem * history of placental abruption * placental previa * body-mass index of 40.1 or more * maternal contraindication to surgery * insulin-dependent pregestational diabetes * hypertension or preeclampsia * hiv, hepatitis-b, or hepatitis-c positive * other medical condition of risk to mother * uterine problem * previous hysterotomy in the active uterine segment * severe fibroids * uterine malformation (bicornuate, arcuate, unicornuate, didelphys) * no support person for periprocedural period * inadequate support at home for pregnancy * inadequate understanding of risks and benefits of fetal surgery * inability to comply with medical restrictions, follow up after fetal surgery * multiple gestation pregnancy (twins, triplets, etc.) * a fetal anomaly unrelated to myelomeningocele (heart defect, lung lesions) * severe fetal kyphosis \>30 degrees (curvature of the back)

Keywords: fetal surgery open fetal surgery elevated bmi body mass index spina bifida
24-hour intraocular pressure (iop) and blood pressure control in glaucoma and ocular hypertension patients

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to compare the short-term mean 24-hour intraocular pressure control, 24-hour blood pressure effect and safety of latanoprost/timolol fixed combination given once in the evening with placebo once in the morning versus timolol maleate 0.5% given twice daily in patients with ocular hypertension and primary open-angle glaucoma.


Eligibility criteria:
inclusion criteria: * poag * oht exclusion criteria: * advanced glaucoma * arterial hypertension
evaluation of blood flow characteristics in glaucoma using optical coherence tomography angiography (oct-a).

Conditions: Glaucoma

Summary: the investigators aim to evaluate the efficacy of the new optical coherence tomography based angiography (oct-a) softwares in the diagnosis and management of glaucoma.


Eligibility criteria:
inclusion criteria: * diagnosis of open angle glaucoma (oag) including pseudo-exfoliative and pigmentary glaucoma. * documented glaucomatous visual field damage (in the previous 12 months with mean defect (md) \> 2.0 db) * structural and/or functional glaucomatous damage * have given written informed consent, prior to any investigational procedures exclusion criteria: * patients with allergy to corneal anesthetic * patients not able to understand the character and individual consequences of the investigation * participation in other clinical research within the last 4 weeks * other diseases that may cause visual field loss or optic disc abnormalities * refractive error of \> +3.00d or \< -7.00d