Kornimate/medical-research-clean huggingface dataset:
glaucoma hfa / oct specificity study

Conditions: Glaucoma

Summary: study consists of five visits over a one to three month time period.

each visit consists of optical coherence tomography (oct) scanning (4 scans ) and two hfa (humphrey field analyzer) visual fields of the study eye only.

Eligibility criteria:
inclusion criteria: * adult males or females 40 to 80 years old * able and willing to attend the required study visits * able and willing to provide consent and follow study instructions in english * a diagnosis by the principal investigator or co-investigator of glaucoma, pre-perimetric glaucoma or glaucoma suspect * subjects must have experience in threshold automated perimetry, having performed a previous sita (swedish interactive thresholding algorithm) threshold test within one year of enrolling to the study * ability to fixate that allows obtaining acceptable visual fields and oct scans in the study eye exclusion criteria: * • best-corrected visual acuity less than 20/40 (study eye only) on a snellen chart or on a snellen equivalent acuity chart * spherical refraction outside -12.00 to +5.00 diopters (d) or cylinder correction outside 3.00 d (study eye only) * amblyopia (either eye) * narrow irido-corneal angles or a diagnosis of narrow angle glaucoma * previous or current eye disease in the study eye, serious eye trauma or intraocular surgery (except cataracts with lens implants), or the presence of ocular findings that could affect the visual field, other than glaucoma * cataract surgery in the study eye within six (6) months of first visit * dx of any optic neuropathy other than glaucoma * vitreoretinal traction or epiretinal membrane in the study eye * diagnosis or history of any systemic disease / condition / treatment which is likely to affect the visual field outcome in the study eye other than glaucoma * history of diabetes, leukemia, aids, uncontrolled systemic high blood pressure, dementia or multiple sclerosis * any disease that is likely to progress within the 3 month time period that might have visual field implications * a life threatening or debilitating disease * participation in any study involving a non-fda approved investigational drug (ind) within the past month, or ongoing participation in a study with a non-fda approved or cleared investigational device (ide) * concomitant use of hydrochloroquine and/or chloroquine
exploration of health literacy in diabetes in reunion island and france

Conditions: Diabetes type1; Diabetes Type 2; Diabetes, Gestational

Summary: the goal of this observational study is to identify the health literacy profile of diabetic patients in reunion island and france in order to obtain information to improve access to information, therapeutic education and to health service. the main question\[s\] it aims to answer \[is/are\]: participants will complete the health literacy questionnaire (hlq) once.


Eligibility criteria:
inclusion criteria: patient with type 1, 2 or gestational diabetes taken care in hospital exclusion criteria: * patient unable to understand and respect study procedures * patient with cognitive disorder * patient with serious acute complication due to diabetes within 15 days before inclusion * stroke history with neurologic consequences * other specific types of diabetes : chronic calcific pancreatitis, iatrogenic, other secondary diabetes, rare monogenic or genetic diabetes due to insulin resistance
reinforcement-based treatment for pregnant drug abusers

Conditions: Drug Use Disorders During Pregnancy

Summary: objectives: this project is a stage ii behavioral development study designed to answer remaining critical questions necessary before disseminating reinforcement based treatment (rbt) to the larger treatment community. these questions focus on the levels of intensity of rbt most efficacious for substance-using pregnant patients. design: the proposed study utilizes a novel approach to conducting a controlled clinical trial, the sequential multiple assignment randomized trial (smart) design. participants (n=220) will first be randomized at treatment outset into either treatment-as-usual rbt or a reduced intensity rbt. all participants will receive a subsequent randomization based upon an assessment of their initial two weeks of treatment compliance. early-non-compliant participants will be randomized to receive either the same or an increased level of rbt treatment intensity while early-compliant participants will be randomized to receive either the same or decreased level of treatment intensity and scope. primary outcome measures include treatment completion, and maternal heroin, cocaine, and other illicit substance use. secondary outcome measures include maternal measures of hiv risk behavior, and psychosocial functioning and neonatal measures of length of hospitalization, and birth outcomes. significance: the proposed project's innovation includes: the novelty rbt, use of a cutting-edge smart model, application of advanced statistical techniques and inclusion of a cost-effectiveness approach. the proposed project's significance is exceedingly high, as it will lay the foundation for later stage iii studies focused on dissemination of stepped care treatment programs for drug-addicted pregnant women that can be implemented not only in comprehensive care clinics but in diverse community settings that provide services to such women.


Eligibility criteria:
inclusion criteria: 1. treatment entry at or before 34 weeks ega with singleton fetus. 2. evidence of opioid, cocaine and/or other primary illicit substance use. exclusion criteria: 1. severe medical or psychiatric concomitant condition interfering with treatment or needing hospitalization. 2. age 17 years or younger. 3. geographical constraints. these women are admitted only for a residential detoxification and often have plans to obtain aftercare in an outpatient or residential facility in closer proximity to their home. thus, this greater distance from cap increases the likelihood that these women will not return to cap and will not deliver in a hospital that functions under similar protocols that operate in baltimore city for treating drug-exposed neonates.

Keywords: pregnancy, opioid, cocaine, alcohol, benzodiazepines, neonate
a study of recombinant human erythropoietin in anemic cancer patients undergoing chemotherapy

Conditions: Chemotherapy Induced Anemia

Summary: to evaluate the effectiveness and safety in randomized, double-blind, parallel-group study in anemic cancer patients undergoing chemotherapy


Eligibility criteria:
inclusion criteria: * cancer patients exclusion criteria: * a history of myocardial, cerebral or pulmonary infarction * severe hypertension beyond control by drugs
individualization of dosage of irinotecan in the folfiri according to the genetic polymorphism of ugt1a1 in the first line treatment of metastatic colorectal cancer

Conditions: First Line Metastatic Colorectal Cancer

Summary: this prospective, non randomized multicenter phase ii study, will determine the feasibility of individualized dose of irinotecan with the ugt1a1 polymorphism, in patients with metastatic colorectal cancer treated with folfiri.


Eligibility criteria:
inclusion criteria: * colorectal cancer histologically or cytologically proven * indication of treatment according to the folfiri + / - bevacizumab or cetuximab or panitumumab * age\> 18 years * presence of at least one measurable target by recist * life expectancy\> 3 months * satisfactory biological functions (renal, hepatic and hematologic) * affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the act of august 9, 2004 * patient has signed, after informing the informed consent form exclusion criteria: * patients of childbearing age and not using effective contraception during treatment and for at least three months after the end of treatment with irinotecan and at least six months after the end of treatment with bevacizumab, cetuximab or panitumumab and patient pregnant or nursing * patient with another pathology deemed incompatible with the entry in the protocol * prior treatment in metastatic * patients taking antiepileptic * allergic reaction or intolerance to irinotecan * heart failure , kidney , bone marrow , liver or respiratory * higher bilirubin 1.5 times the upper limit of normal * significant psychiatric or neurological abnormality * infectious syndrome requiring treatment with antibiotics or antiviral long-term * patients with chronic inflammatory bowel disease and / or bowel obstruction * contraindication association st. john's wort and yellow fever vaccine * against heart indication 5-fu * concurrent treatment with a drug test , participation in a clinical trial within \<30 days * patient refused to sign the consent
long-term follow-up of phase 1 clinical trial of cs10br05(cs10br05-msa101)

Conditions: Multiple System Atrophy

Summary: the study purpose is conducting follow-up surveillance for the incidence of adverse events and efficacy of subjects participated in phase 1 trial to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells (cs10br05) in subjects with multiple system atrophy until 60 months from administering investigational product (ip).

multiple system atrophy is a neurodegenerative disease of the central nervous system which is accompanied by signs of autonomic imbalance (orthostatic hypotension, urinary problems and erectile dysfunction), parkinson's symptoms (movement decreases and limb tremors) and cerebellar ataxia symptoms (grogginess and incorrect pronunciation). it shows signs similar to parkinson's disease, however, it doesn't show improvement of symptoms by dopaminergic drugs and occurs at any age. the purpose is conducting follow-up surveillance for the incidence of adverse events and efficacy of subjects participated in phase 1 trial to evaluate the safety and tolerability of autologous bone marrow-derived mesenchymal stem cells (cs10br05) in subjects with multiple system atrophy until 60 months from administering investigational product (ip). because it is the following observational study for subjects participated in phase 1 trial, there is no additional administration of the investigational product in the study. if the subjects who participated in phase 1 trial voluntarily consent in writing to take part in this observational study, the subjects visit the institution according to the protocol that designed the follow-up visits every 3 months (visit 1, visit 2) until 6 months from administration of investigational product and since then 6 months later (visit 3), every 12 months (visit 4\~7) to observe the incidence of adverse events and efficacy. as a result of evaluating severity of ae divided into subjective, objective in accordance with the ctcae (version 4.0) standards.

Eligibility criteria:
inclusion criteria: * subjects who participated in the phase 1 clinical trial(protocol no.: cs10br05- msa101) at 3 months after administering investigational product * subjects who give a written, signed and dated informed consent spontaneously exclusion criteria: * subjects who decided as inappropriate cases to participate in the observational study by investigator

Keywords: mesenchymal stem cell cell therapy multiple system atrophy neuroprotection cs10br05 long-term safety study
optimal length for nasal mid-turbinate and nasopharyngeal swabs

Conditions: Covid19

Summary: this study aim to explore the optimal swap insertion length for mid-turbinate and nasopharyngeal samples. our clinical trial took place at a covid-19 test center in copenhagen. participants consisted of voluntary citizens who were at the test center for a nasopharyngeal antigen quicktest. an endoscopic examination was performed simultaneous with the swap to measure the length from the vestibulum nasi to the posterior wall of the nasopharynx and the mid-turbinate.


Eligibility criteria:
inclusion criteria: * referred for covid-19 testing exclusion criteria: * nose patology
a comparison of two different treatment approaches for adolescents with osgood schlatter

Conditions: Osgood-Schlatter Disease; Apophysitis; Osteochondrosis; Tibia; Physeal Injury

Summary: the most common growth-related injury is osgood schlatter, which affects up to 1 in 5 physically active adolescents. it can cause long-term pain and potential discontinuation of sports and physical activity, with sequela well into adulthood. no effective conservative treatments have been documented, and clinical practice is characterized by a wealth of conflicting advice and modalities. a novel treatment approach has shown promising results in a small single-cohort study. therefore, this study aims to compare this novel treatment with usual care in 10-16-year-old adolescents with osgood schlatter. this single-center pragmatic, double-blinded, randomized, controlled superiority trial, will have a two-group parallel arm design. participants will undergo 3 months of treatment, followed by 2 months of self-management with self-reported knee function (koos-child 'sport/rec') at 5 months as the primary endpoint. this trial comparing a novel treatment with usual care for adolescents with osgood schlatter could result in an evidence-based treatment ready for implementation in clinical practice, benefitting patients outcomes and clinicians.


Eligibility criteria:
inclusion criteria: * tenderness on palpation of the tibial tuberosity or pain during resisted isometric knee extensions * insidious onset of pain or swelling of the tibial tuberosity for ≥6 weeks * provoked by at least 2 of the following positions or activities; prolonged sitting or kneeling, squatting, running, hopping/jumping, stair walking or during multidirectional sports * clinical diagnosis of osgood schlatter * markedly reduced sports participation or severely affected by pain during sports participation exclusion criteria: * other primary pathology or complaints from other structures of the knee * other injuries, complaints or illnesses that may cause disability, or specifically restricts levels of physical activity or sports participation * previous surgery in the lower extremities or lumbar spine * congenital deformities, device implants og cysts og tumors of the knee * participants not willing to cease concomitant treatment * participants and their parents not able to understand and communicate in written and verbal danish

Keywords: adolescents sport physical activity knee load management strength training accelerometer ultrasound tibial tubercle handheld dynamometry handheld algometry usual care
nutrition in gastrointestinal tumors

Conditions: Pancreatic Cancer; Oesophageal Cancer; Colon Cancer; Liver Cancer; Rectal Cancer; Bile Duct Cancer; GIST, Malignant; Neuroendocrine Tumors; Small Intestine Cancer; Gastric Cancer

Summary: malnutrition and loss of muscle mass frequently occur in patients undergoing chemotherapy and can negatively effect therapy outcome. especially patients with cancer of the gastrointestinal tract are often affected by malnutrition. therefore, this study aims to examine changes in nutritional status of patients with cancer of the gastrointestinal tract during chemotherapy. findings of this study will help to improve nutritional treatment of patients undergoing chemotherapy.

malnutrition and sarcopenia are common complications in patients with malignant diseases of the gastrointestinal tract. during chemotherapy there is a high risk of further impairment of nutritional status due to anorexia, nausea, emesis and other gastrointestinal conditions that adversely impact food assimilation or absorption. findings on changes of nutritional status during chemotherapy are scarce but of paramount importance for adequate nutrition therapy. therefore, this study aims to provide a detailed description of changes in nutritional status of patients with a malignant condition of the gastrointestinal tract during chemotherapy.

Eligibility criteria:
inclusion criteria: * patients with initial diagnosis of a malignant condition of the gastrointestinal tract planned to receive cytostatic treatment. * ongoing cytostatic treatment of a known malignant condition of the gastrointestinal tract exclusion criteria: * pregnancy * history of any other malignant tumor disease * inability to provide consent
rna as prognostic biomarkers in patients with acute coronary syndrome

Conditions: Coronary Syndrome

Summary: identify circulating protein-coding (mrnas) or non-coding (ncrnas) transcripts (acs_signature) predictive of ventricular dysfunction in acs patients undergoing pci.

perform an observational, prospective study involving the evaluation of circulating biomarkers predictive of ventricular dysfunction (fe \<45%) in patients with acs. in particular, will be to verify whether there are circulating transcripts in peripheral blood, coding or not for proteins (mrnas or ncrnas), modulated differently in patients with acs (acs_signature) undergoing pci, distinguished on the basis of evolution towards ventricular dysfunction. the study will be based on whole genome transcriptomic analysis.

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. patients with acs (first episode), defined according to the guidelines of the european society of cardiology (esc) 2017 3. indication for percutaneous revascularization treatment 4. informed consent to study enrollment exclusion criteria: 1. severe valve disease or other conditions requiring cardiac surgery 2. previous cardiac surgery including coronary artery bypass grafts 3. total chronic occlusions 4. patients with known hypersensitivity or contraindication to any of the following drugs: * heparin * aspirin, * clopidogrel, * ticlopidine, * sirolimus, * everolimus. 5. any contraindication to drug-eluting stent implantation (des) 6. patients with a documented history of myocardial infarction; 7. left ventricular ejection fraction (lvef) \<30% before pci 8. patients in cardiogenic shock 9. patients with advanced st-segment elevation myocardial infarction (\> 48 h from onset of symptoms/q waves on electrocardiogram) or undergoing fibrinolysis; 10. patients with prior known cardiomyopathy with lvef \< 40% 11. patients with malignant neoplasm or systemic disease with quoad vitam prognosis less than 1 year; 12. patients with known active infectious diseases; 13. patients who are unable to express valid informed consent to the act of enlistment 14. pregnant women
prospective study of pregnancy in women with cystic fibrosis

Conditions: Pregnancy Related; Cystic Fibrosis

Summary: in this study, the investigators aim to evaluate changes in lung function in women with cystic fibrosis (cf) during pregnancy and for 2 years after pregnancy based on exposure to highly effective cystic fibrosis transmembrane conductance regulator (cftr) modulators.

advances in medical treatment, including the use of highly effective cftr modulators have greatly increased life expectancy in women with cf, but the effects of pregnancy on women with cf are yet unknown. it is anticipated that over 90% of the cf population will be on cftr modulators in the next few years. more knowledge about the effects of cftr modulators in pregnancy is needed. this is a prospective, multi-center, observational study to follow pregnant women with cf, conducted at 40 us sites. women are enrolled in the first trimester of pregnancy and assessed every 3 months during pregnancy and during the first year after delivery, then every 6 months for an additional year. changes in lung function over the course of pregnancy will be evaluated based on cumulative cftr modulator use while pregnant while accounting for other factors that may influence changes in pulmonary function: baseline lung function, genotype, history of exacerbations, and pre-existing co-morbid conditions.

Eligibility criteria:
inclusion criteria: * pregnant, intending to continue pregnancy, enrolled in the cystic fibrosis foundation patient registry (cffpr) exclusion criteria: * none

Keywords: pregnancy/obstetric health in women with cystic fibrosis pregnancy cftr modulators cystic fibrosis
casodex vs placebo in non-metastatic early prostate cancer

Conditions: Non-Metastatic Prostate Cancer

Summary: the purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of non-metastatic cancer of the prostate gland * patient to be 18 years and above exclusion criteria: * previous systemic therapy for prostate cancer * previous history of another form of cancer (not prostate) within 5 years of study start.

Keywords: androgen antagonists prostate neoplasms
reduced length of adt and arta with xrt in high-risk prostate cancer (relax): a randomised trial

Conditions: Prostate Carcinoma

Summary: aim of the study to improve the treatment of high-risk non-metastatic prostate cancer by comparing reduced duration of hormone therapy to the standard duration of two years, when combined with curative intent standard of care radiotherapy to prostate and pelvic nodes. the reduced duration will be intensified with addition of newer hormonal agents such as abiraterone or enzalutamide tablets, which have been shown to improve disease control in locally advanced prostate cancer. this is hoped to reduce the side effects of prolonged hormone therapy, while maintaining similar rates of disease control and survival. the effectiveness of both treatment approaches will be assessed in terms of cancer control, survival, and overall quality of life of patients. additionally, the study will examine the side effects associated with each treatment regimen, which could provide valuable insights into impact of treatment duration on patients. if a person decides not to participate, they will still receive the standard two years of hormonal therapy and radiation therapy outside the study. this ensures that all patients receive appropriate care regardless of their involvement in the research. participation is voluntary, and will not affect patient care.


Eligibility criteria:
inclusion criteria:- * patients with biopsy proven prostate adenocarcinoma, deemed suitable for curative- intent radiotherapy * clinicoradiological stage t1-t4n0m0 using psma-petct and mri * high risk or very high risk (as per nccn 2023): stage t3a + or gleason score 4+4 or 4+5 or psa 20 + * patient fit and able to receive adt for 2 years * patient fit and able to receive arta for 6 months * ecog performance status 0-2 * patient able and willing for informed consent and reliable for follow-up exclusion criteria:- * primary gleason pattern 5 (gleason score 5+4 or 5+5) * life expectancy deemed to be less than 2 years * uncontrolled comorbidities such as diabetes or hypertension causing ineligibility to receive arta * bulky primary disease with extensive infiltration into bladder/rectum/pelvic muscle * prior adt more than 3 months before screening or prior orchiectomy * prior prostatectomy * unsuitable for curative dose of radiotherapy (severe urinary obstructive symptoms, inflammatory bowel disease, prior pelvic radiotherapy etc.) * presence of adverse pathological variants (such as small cell histology) * unable or unwilling to consent and follow up

Keywords: prostate cancer prostate radiotherapy hormone therapy