Kornimate/medical-research-clean huggingface dataset:
persons with disabilities generating quality metrics

Conditions: Physical Disability; Chronic Mental Disorder

Summary: no standard way exists to measure the quality of medical care or independent living long-term services and supports provided to persons with disabilities. this project will: provide a broader picture of how consumers with disabilities define care and care quality; measure the value of using consumers' expertise in developing, collecting, and assessing quality measures; and use this information to assist one care providers in improving care delivered to their enrollees

the aims of the project are as follows: 1. to work with persons with significant physical disabilities and serious and persistent mental illness to develop two new approaches to assess quality of care: approach #1: we will survey enrollees about their experiences in one care and their thoughts about the care they receive. this survey will also ask one care enrollees about how they manage their care and what self-direction means to them. the survey will be called the persons with disabilities quality survey (pdq-s), and it will be available in english and spanish versions. approach #2: enrollees in one care will provide information about their perceptions of care quality to a trained team of persons with disabilities who will report the information to one care care teams. the goal of the activity is to support quality improvement in one care through hearing the consumer's voice. this is called yes health - your experience: speak up for better health care. 2. we want to test how providing consumer informed and consumer directed quality information to one care providers affects one care quality. 3. we want to improve the ability of one care enrollees to manage their own health care and to recognize and report quality problems

Eligibility criteria:
inclusion criteria: * one care enrollee * permanent physical disability and/or serious mental illness * seen at designated practice site * english or spanish speaking exclusion criteria: * persons with an intellectual or a developmental disability
a national study of the chronic disease self-management program

Conditions: Diabetes Mellitus, Type 2; Chronic Disease

Summary: this survey will address important research, practice, and policy questions: how does chronic disease self-management program (cdsmp) impact participants' general health, their health behaviors, and their need for health care utilization? who benefits most from the cdsmp program? are predicted gains maintained over a six and twelve month period? can critical clinical changes be seen for those who are diabetic?

a national survey of participant outcomes is important for documenting how the cdsmp program is impacting people with chronic diseases and influencing health care outcomes. this study will help bridge the research to practice gap and further our knowledge about the outcomes of evidence?based programs that are widely disseminated. investigators hope to learn the answers to the following questions for english and spanish-speaking populations: 1. how does the cdsmp impact a person's general health? 2. does the cdsmp increase the use of healthful behaviors? 3. does the cdsmp impact health care utilization? 4. what are the characteristics of those who benefit from the cdsmp? 5. can these benefits be maintained over 6 and 12 month periods? 6. for people with type 2 diabetes, and hemoglobin a1c be impacted by the cdsmp?

Eligibility criteria:
inclusion criteria: * age 18 or over * has a chronic health condition * attending a chronic disease self-management workshop at a designated host site in the united states * speaks english or spanish * for blood test portion of study: have type 2 diabetes exclusion criteria: * do not meet inclusion criteria

Keywords: long term health problems chronic disease
itakos - italian observation, multicenter, prospective study of ofatumumab in rrms patients

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: study to evaluate the effectiveness of ofatumumab in italian rrms patients in the real-life setting.

prospective real-world data on ofatumumab is still very limited. for this reason, the main aim of this study is to investigate the impact of ofatumumab in a population of italian rrms patients in routine clinical practice to evaluate if ofatumumab is able in these conditions to provide relevant clinical benefits that comprehensively encompass anti-inflammatory activity (relapses), disability accumulation, cognitive impairment, fatigue symptoms and quality of life. this is an observational, multicenter, single-arm, prospective study. prospective data will be collected on patients newly treated with ofatumumab over an observational period of 12 months.

Eligibility criteria:
inclusion criteria: 1. male or female outpatients ≥18 years old. 2. patients diagnosed with rrms (mcdonald criteria 2017). 3. patients newly treated with ofatumumab, for whom the decision to start treatment with the drug has already been taken independently from study inclusion, based on clinical practice and according to the smpc and to aifa reimbursement criteria and who already successfully qualified for treatment with ofatumumab (i.e., passed the screening procedure mandated by the smpc and the risk management plan (rmp) for this treatment). 4. patient or a legal representative of the patient must provide written informed consent before any study assessment is performed. exclusion criteria: 1. patients outside the approved label of ofatumumab. 2. pregnant and lactating women. 3. patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on investigator's judgement. 4. patients cannot participate in this non-interventional study if they also participate in an interventional trial. 5. treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.

Keywords: multiple sclerosis, relapsing-remitting, rrms, ofatumumab
bioequivalence study: 2 mg estradiol valerate (ev) and 3 mg dienogest (dng) without and with levomefolate calcium

Conditions: Pharmacology, Clinical

Summary: investigation of the bioequivalence (be) of estradiol valerate (ev) and dienogest (dng) after administration of one film-coated tablet containing 2 mg estradiol valerate, 3 mg dienogest and 0.451 mg levomefolate calcium as compared to one film-coated tablet containing 2 mg estradiol valerate,3 mg dienogest.investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 2 mg estradiol valerate, 3 mg dienogest and 0.451 mg levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium


Eligibility criteria:
inclusion criteria: * healthy postmenopausal women, age: 45-75 years with body mass index between ≥18 and ≤30 kg/m2. post-menopausal state revealed by: medical history, and hormone analyses in serum: estradiol ≤20 pg/ml and in women \<60 years old: follicle-stimulating hormone ≥ 40 iu/l at screening exclusion criteria: * contraindications for use of combined (estradiolvalerate/dienogest) contraceptive (e.g.history of venous/arterial thromboembolic disease) * regular intake of medication * clinically relevant findings (ecg, blood pressure, physical and gynaecological examination, laboratory examination) * smoking
a continuation trial for subjects with rheumatoid arthritis that have completed protocol lbra01

Conditions: Rheumatoid Arthritis

Summary: this is a continuation trial of lymphostat-b™ to evaluate the long-term safety in subjects with rheumatoid arthritis that completed study lbra01 and benefitted from treatment.

this is a multi-center, open label, continuation trial of lymphostat-b™ in rheumatoid arthritis (ra) subjects who achieved at least an acr20 response in the phase 2 study lbra01 (nct00071812).

Eligibility criteria:
primary inclusion criteria: 1. have completed the lbra01 trial. 2. have achieved at least an acr20 response at the end of lbra01. primary exclusion criteria: 1. have switched nsaids due to worsening ra disease activity, used more than 10 mg/day of oral prednisone, or were given a corticosteroid injection during the last 30 days of lbra01. 2. required a new dmard (not otherwise excluded in protocol lbra01) to replace an ineffective one, or an additional dmard (not to exceed 2 dmards in total) within the last 60 days of lbra01. 3. used prohibited medications during their participation in lbra01. these medications include the following: * other investigational agents. * biologic response modifiers * cyclophosphamide. * corticosteroid injections (except 1 injection of up to 40 mg of prednisone into an inflamed joint or intramuscularly every 6 months). * 2 new dmards. * 1 new dmard plus high dose prednisone \>10 mg/day.

Keywords: rheumatoid arthritis ra
reduced pain after bariatric surgery - gastric bypass

Conditions: Pain; Postoperative Pain; Acute Pain; Analgesia; Bariatric Surgery Candidate; Anesthesia

Summary: this study aims to analyze the effect of laparoscopic guided transversus abdominis plane (lg-tap) block compared to placebo for postoperative analgesia following laparoscopic gastric bypass. one group of participants received a (lg-tap) block with local anesthetic while the other group received (lg-tap) block with saline solution (placebo).


Eligibility criteria:
inclusion criteria: * elective laparoscopic gastric bypass * body mass index (bmi) \> 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type ii diabetes, dyslipidemia, hepatic steatosis, etc) * bmi \> 40 kg/m², even in the absence of comorbidities * asa physical status score \< 4 exclusion criteria: * asa physical status score ≥ 4 * patient's refusal or inability to sign the informed consent * allergies to any drug provided by the study protocol
effects of preoperative correction of anemia with intravenously iron in colorectal cancer patients.

Conditions: Colorectal Cancer; Anemia; Iron-deficiency

Summary: the aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery. the study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(iii)isomaltoside, non-anemic patients, and anemic patients treated with iron(iii)isomaltoside prior to surgery. propensity score matching will ensure identification of controls from a pool of patients treated at the department of surgery, zealand university hospital. the two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). group 3 will be the treatment group, with patients with anemia and treated with iron(iii)isomaltoside. the study period of cases undergoing i.v. treatment will be 1st of february 2017 to 31st of october 2019 with approximately 70 cases included


Eligibility criteria:
inclusion criteria: * undergoing curative intended surgery for colon or rectum cancer * uicc stage i-iii exclusion criteria: * neoadjuvant oncological treatment * acute / subacute surgery * palliative surgery * other pathology than adenocarcinoma

Keywords: anemia iron-deficiency anemia
safety and efficacy of an investigational drug in human immunodeficiency virus (hiv)-infected patients failing current antiretroviral therapies (0518-005)(completed)

Conditions: HIV Infections; Acquired Immunodeficiency Syndrome

Summary: this study will investigate the safety and efficacy of different doses of an investigational drug (mk0518) as a therapy for hiv-infected patients failing current antiretroviral therapies.


Eligibility criteria:
inclusion criteria: * patient must be hiv positive with human immunodeficiency virus (hiv) ribonucleic acid (rna) values that are within ranges required by the study * patient must be currently on antiretroviral therapy (art) exclusion criteria: * patient less than 18 years of age * additional exclusion criteria will be discussed and identified by the study doctor
ef5 in melanoma patients

Conditions: Melanoma

Summary: the purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the melanoma tumor microenvironment. the study is based around four cornerstone features of the pathologic microenvironment - hypoxia, reactive species (reactive oxygen and nitrogen species), hif-1 and vegf, which the investigators term the hrhv axis. patients with in-transit melanoma (ajcc stage iiib or iiic) (1) will be administered the hypoxia marker drug, ef5, 24 hr prior to isolated limb infusion (ili) or hyperthermic isolated limb perfusion (hilp). tumor biopsies will be performed just prior to ili or hilp, at the 30 minute time point during ili (or 60 minute time point during hilp), and 24 hours after ili or hilp. tissues obtained will be snap frozen and subsequently analyzed for ef5 binding. immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the hrhv axis will also be examined. the association of the markers with the presence of hypoxia, as determined by ef5 positivity, will be determined. data from this pilot study will be used to establish the prevalence of markers of the hrhv axis in melanoma. this information will be crucial for future human trials in which the hrhv axis is therapeutically targeted.


Eligibility criteria:
3.1. inclusion criteria * histologically confirmed ajcc stage iiib/iiic/iv extremity melanoma who are undergoing ili or hilp and have tumor available for biopsy (note: patients with only 1 in-transit lesion are not eligible) * age ≥18 * kps status ≥ 70 * bilirubin ≤ 1.5x normal * creatinine ≤ 1.8 ( -ef5 is primarily excreted via the kidney) * wbc \> 3000/mm3 and platelets \> 100,000/mm3 3.2. exclusion criteria * pregnancy or breast feeding. a negative serum pregnancy test is required of any women childbearing potential prior to enrollment. pregnant women are excluded from this study because ef5 is an agent with potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ef5, breastfeeding should be discontinued if the mother is given ef5. * allergy to iv contrast dye * history of grade iii or iv peripheral neuropathy as defined by the nci ctc (other 2-nitroimidazole compounds are neurotoxic) * previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy

Keywords: melanoma
a proof-of-concept trial of gla-se in patients with merkel cell carcinoma

Conditions: Merkel Cell Carcinoma

Summary: this is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of gla-se administration to patients with merkel cell carcinoma. ten patients will be treated. the goal is for gla-se to assist the patient's own immune system in attacking the cancer cells.

this is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of gla-se administration to patients with merkel cell carcinoma. ten patients with metastatic or locoregional disease will be treated. the goal is for gla-se to assist the patient's own immune system in attacking the cancer cells.

Eligibility criteria:
inclusion criteria: * biopsy-confirmed merkel cell carcinoma with metastatic or loco-regional disease. * patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable it injection. * ecog performance status score 0, 1 or 2 * ≥ 18 years of age * life expectancy of ≥ three months. * adequate neutrophil and platelet counts * adequate renal and hepatic function * willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy * use of effective contraception * signed informed consent document * members of all genders, races and ethnic groups are eligible for this trial exclusion criteria: * prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment * no concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents * active, untreated brain metastases * pregnant or nursing * use of any systemic immunosuppressive agents * immunosuppressed patients * uncontrolled depression or other major psychiatric disorder

Keywords: merkel cell carcinoma mcc
evaluation of an aerobic exercise program in migraine management

Conditions: Migraine

Summary: this trial assesses the impact of a supervised aerobic exercise program by a kinesiologist in patients with migraine. patients can be assigned to one of two groups 1)the exercise group or 2)non-exercise group. this is a important area to study because there is currently limited information regarding exercise and its impact on migraine frequency and severity. in many cases, migraine patients are disabled by their headaches and sometimes will not have a significant response to medications. as a result, it is important to study other non-pharmacological interventions. in this study, the investigators hope to show the benefits of exercise by a reduction in number of headache days per month as well as by improvement in quality of life, disability,depression,anxiety,and aerobic fitness.this study will not interfere with the usual treatment patients receive at our headache clinic and patients can remain on medications deemed necessary.


Eligibility criteria:
inclusion criteria: 1. patients must meet diagnostic criteria for migraine without aura, migraine with aura or chronic migraine. 2. patients must be 18-50 years of age. 3. individuals motivated to exercise and complete the study. - exclusion criteria: 1. patient has a headache on more than 25 days a month 2. patient is a medication over-user by international headache society (ihs) criteria 3. patient currently has a fitness program with regular aerobic exercise for 30 minutes three times a week or more. 4. known cardiovascular disease which contraindicates the exercise program 5. inability to complete the outcome measure questionnaires. -

Keywords: exercise fitness program
akershus university hospital retrospective cohort study of family based treatment

Conditions: Anorexia Nervosa; Atypical Anorexia Nervosa

Summary: the goal of this observational study is to compare short and long-term effects of manualised family based treatment for adolescent anorexia nervosa to those of non-manualised family therapy. the study will approach former patients who were treated before and after family based therapy was adopted in an outpatient clinic, and extract data from electronic health records and public registries.

a two-group retrospective exploratory cohort study with longitudinal follow-up comparing adolescents with anorexia nervosa treated with generic family therapy to those treated with the manualised family based treatment (fbt). the primary aim is to investigate whether adoption of fbt has led to faster normalisation of weight and lower rates of eating disorder in early adulthood. secondary aims are to investigate whether implementation of fbt has changed the time to discharge, heterogeneity of patient weight change across treatment, rates of adverse events, rates of readmission, patient experiences of the treatment, long term functional outcomes and mortality. data are extracted from patient health records, reported by participants and extracted from public registries.

Eligibility criteria:
inclusion criteria: • clinical diagnosis of f50.0 anorexia nervosa or f50.1 atypical anorexia nervosa according to the international classification of diseases-10. exclusion criteria: • patient was treated during the years 2018-2020 and fbt was never initiated according to patient health records.
safety, activity and cell kinetics of cyad-211 in patients with relapsed or refractory multiple myeloma

Conditions: Relapse/Refractory Multiple Myeloma

Summary: the purpose of the immunicy-1 study is to assess the safety, activity and cell kinetics of cyad-211 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen with fludarabine and/or cyclophosphamide

this study aims to determine the recommended dose of the allogeneic cyad-211 (anti-bcma car-t) cells after a non-myeloablative preconditioning chemotherapy in multiple myeloma (mm) patients with relapsed or refractory disease.

Eligibility criteria:
1. documented diagnosis of mm with relapsed or refractory disease to at least two prior mm treatment regimens which should include exposure to imid and pis either alone or in combination. 2. presence of measurable disease as per international myeloma working group (imwg) response criteria 3. eastern cooperative oncology group (ecog) below or equal 2 4. adequate hematologic, renal, hepatic, pulmonary, and cardiac function exclusion criteria: 1. history or presence of clinically relevant central nervous system (cns) tumor involvement. 2. autologous stem cell transplant within 12 weeks of registration or an allogeneic stem cell transplant within 6 months of starting study treatment. 3. any investigational agent within 3 weeks prior to the initiation of the non-myeloablative preconditioning chemotherapy). 4. prior systemic therapy for mm within 14 days prior to the initiation of the non-myeloablative preconditioning chemotherapy. 5. prior treatment with any bcma-targeted therapy and which has not achieved at least a partial response.
perfluorohexyloctane (nov03) for the treatment of signs and symptoms of dry eye disease (ded)

Conditions: Dry Eye Disease (DED)

Summary: this study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (nov03) at two different dosing regimens compared to saline solution in subjects with dry eye disease (ded).


Eligibility criteria:
inclusion criteria: * signed icf (informed consent form) * subject-reported history of drye eye disease (ded) in both eyes * ability and willingness to follow instructions, including participation in all study assessments and visits exclusion criteria: * women who are pregnant, nursing or planning pregnancy * unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control * clinically significant slit-lamp findings or abnormal lid anatomy at screening * ocular/peri-ocular malignancy * history of herpetic keratitis * active ocular allergies or ocular allergies that are expected to be active during the study * ongoing ocular or systemic infection * wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study * intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period * presence of uncontrolled systemic diseases * presence of known allergy and/or sensitivity to the study drug or saline components * use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening