Kornimate/medical-research-clean huggingface dataset:
assessing and addressing follow-up care needs that will facilitate care transitions for cancer survivors

Conditions: Stage I Lung Cancer; Stage II Lung Cancer; Stage III Lung Cancer; Stage IV Lung Cancer

Summary: this clinical trial evaluates whether a shared response plan (sharedcare) improves follow-up care for lung cancer survivors. as the number of cancer survivors increases, there is a new need for high-quality chronic illness care. high-quality chronic illness care can be difficult to deliver and involves working with the patient to be certain they have what they need to be actively involved with their care to meet their needs. sharedcare allows the patient to work with a navigator to review identified distress and social needs. the patient and navigator discuss the needs and develop a shared response plan to address the needs in ways that consider the patient's current behaviors, beliefs, and motivation. the plan also establishes specific patient goals, anticipates barriers, and establishes how the navigator will follow-up on the needs and adjust care and assistance when needed. using a shared response plan may improve follow-up care for lung cancer survivors.

primary objective: pilot and qualitatively assess the acceptability of sharedcare through semi- structured interviews secondary objectives: * describe quantitative assessments of intervention acceptability, appropriateness, and feasibility. * describe survivor level of unmet needs13 using a validated measure to collect data before and/or after completion of the sharedcare intervention. * track clinical referrals and other actions made as a result of patient responses on the electronic distress screening (eds) and the percentage of referrals that have been "completed" (i.e. those referrals where a patient completed the relevant medical or social needs-related visit). * track recruitment, assessment completion, and any related adverse events. outline: patients receive a sharedcare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. patients also receive standard of care automated referrals on study. two weeks following the initial call, patients receive a second sharedcare call with a navigator to follow-up on the shared response plan. after completion of study intervention, patients are followed up 4 weeks after initial call.

Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed study disease. a pathology report should be referenced/available (stages i-iv lung cancer) * ability to understand and the willingness to sign an institutional review board (irb)-approved informed consent document * ≥ 18 years of age * within two years of lung cancer diagnosis * able to understand, read and write english exclusion criteria: does not meet the above inclusion criteria
hyaluronic acid-containing artificial tears in post-cataract surgery dry eye disease

Conditions: Dry Eye Disease; Cataract

Summary: to compare the effects of hydroxypropyl guar (hpg)/hyaluronic acid (ha)- and carboxymethylcellulose (cmc)/ha-based lubricant eye drops on subjective and objective outcomes in dry eye disease (ded) patients after cataract surgery.

this is a prospective, open-label, assessor-masked, interventional, randomized controlled study. a total of 70 post-cataract surgery dry-eye subjects are planned to be enrolled after eligibility confirmation at week 1 post-operative (post-op). the subjects will then be randomized in a 1:1 ratio to either hpg/ha (systane hydration® ) or cmc/ha (optive fusion®) group. from week 1 to 3 (1st to 4th week post-op), the hpg/ha group will receive systane hydration® preservative-free lubricant eye drops whereas the cmc/ha group will receive optive fusion® lubricant eye drops (unit dose). both groups will receive 1-2 drops of artificial tears 4 times daily for 3 weeks. there are three visits scheduled in this study, i.e., screening, week 1, and week 3. the subjects will return to the study sites during these visits for efficacy and safety assessments.

Eligibility criteria:
inclusion criteria: 1. male or female patients of any race, 20 years or older who are scheduled for unilateral cataract surgery. 2. ded patients whose symptoms and signs are aggravated at baseline assessment after cataract surgery will be eligible for this study. postoperative dry eye diagnosis criteria at baseline assessment: 1. osdi score \>14.8\* (\*eligible subject mandatory required); 2. positive cfs\* (\*eligible subject mandatory required); 3. schirmer's test score ≤10 mm in 5 minutes (min) (without anesthesia); 4. tbut ≤5 seconds (sec) exclusion criteria: 1. patients with allergy to any of the study medications, conjunctival allergy or infectious disease, history of ocular chemical or thermal burn, stevens-johnson syndrome or ocular pemphigoid, glaucoma or ocular hypertension, eyelid or lacrimal disease, any ocular operation within 3 months, graft-versus-host disease (gvhd), non-dry-eye ocular inflammation, trauma, or presence of uncontrolled systemic disease. 2. before enrollment, corneal contact lens wear, history of severe systemic disease, or other conditions in the investigator's opinion precluded enrollment. 3. patients will be withdrawn from the study if they experience complications during surgery, or post-surgical ocular hypertension, endophthalmitis, or infectious keratitis.

Keywords: hyaluronic acid hydroxypropyl guar carboxymethylcellulose
safety and efficacy in adult subjects with acute migraines

Conditions: Migraine, With or Without Aura

Summary: the purpose of this study is to compare the efficacy of bhv-3000 (rimegepant) versus placebo in subjects with acute migraines


Eligibility criteria:
key inclusion criteria: 1. patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the international classification of headache disorder, 3rd edition, beta version\[1\] including the following: * not more than 8 attacks of moderate or severe intensity per month within last 3 months * consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the screening visit and maintains this requirement during the screening period 2. less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the screening visit and maintains this requirement during the screening period 3. patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry. 4. patients with contraindications for use of triptans may be included provided they meet all other study entry criteria. key exclusion criteria: 1. patient history of hiv disease 2. patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. patients with myocardial infarction (mi), acute coronary syndrome (acs),percutaneous coronary intervention (pci), cardiac surgery, stroke or transient ischemic attack (tia) during the 6 months prior to screening. 3. uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled) 4. patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the investigator's opinion, might interfere with study assessments 5. patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption. 6. the patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitisb or c, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (ae) or interfere with assessments of safety or efficacy during the course ofthe trial 7. history of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met dsm-v criteria for any significant substance use disorder within thepast 12 months from the date of the screening visit.
treatment of c. difficile infection with fecal microbiota transplantation (fmt)

Conditions: Clostridium Difficile Infection

Summary: the purpose of this study is to treat children with severe, moderate, resistant or relapsing c. difficile infection and to determine the changes in the intestinal microbiome (all of the bacteria living in the intestines) in children receiving fmt for c. difficile infection. data will be collected throughout the fmt procedure to determine effectiveness and to help standardize this procedure. stool samples will be collected to look at the different bacteria that are in the intestines before and after fmt.


Eligibility criteria:
recipient inclusion criteria 1. older than 18 months of age 2. fmt procedure has been decided by the treating gastroenterologist and was based on: 1. recurrent or relapsing cdi and: * failure of standard medical therapy with metronidazole, vancomycin and fidaxomicin (over age 18 years. fidaxomicin is not approved for \<18years and insurance authorization may not be possible). * at least 2 episodes of cdi requiring hospitalization 2. moderate cdi not responding to vancomycin for at least a week. 3. severe cdi with no response to vancomycin after 4 hours. 3. english speaking recipient exclusion criteria 1. lack of informed consent/assent. 2. not eligible for fmt procedure
sodium restriction by behavioral intervention

Conditions: IgA Nephropathy

Summary: the aim of this study is to evaluate the effects and efficacy of dietary sodium restriction by mean of a new healthcare approach in patients with immunoglobulin a nephropathy. the test persons in the intervention group are actively supported to adhere to a restricted sodium diet with a structured education program in combination with regular sodium excretion monitoring.

patients in the intervention group receive regular sodium-restriction education by a dietician, which entails introducing food types and cooking skills, quantifying salt intake with a special spoon and recording detailed interactive food diary. sodium excretion was measured using one 24-hour urine collection regularly to assess dietary compliance and enable feedback. the test persons with sodium excretion higher than 90mmol/24h will receive intensive education. test persons in the control group receive standard care. after 2 weeks in study, all test persons visit the outpatient clinic for measurements and data collection. within 3 months of total study duration, data collection and measurements take place at the end of every month. at each timepoint blood and 24-hourly urine is collected, test persons fill out questionnaires.

Eligibility criteria:
inclusion criteria: * female or male patients\>14 years of age and \<70 years of age * diagnosed immunoglobulin a nephropathy with biopsy; * egfr\>30ml/min per 1.73m2 using chronic kidney disease epidemiology collaboration formula * proteinuria \>1 g per day * urinary sodium excretion \>200 mmol per day within one month * systolic blood pressure higher than 140 mmhg or diastolic blood pressure higher than 90 mmhg, or a well-controlled blood pressure by treatment with antihypertensives including renin-angiotensin-aldosterone system-blockade (ace-inhibitor or arb) * written informed consent exclusion criteria: * be treated with diuretics * blood pressure \> 180 mmhg systolic or \> 125 mmhg diastolic without medical treatment * have undergone renal transplantation * with acute kidney injury (rifle criteria) \< 6 months ago * cardiovascular or cerebrovascular event (myocardial infarction, cerebral hemorrhage or infarction) \< 6 months ago * with progressive malignancy or pregnancy * with contraindications of raas blockers * unwilling or unable to meet the requirements of the protocol
study of sgn-40, lenalidomide, and dexamethasone in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase i, open-label, multi-dose trial to define the mtd and tolerability of a regimen including lenalidomide, dexamethasone, and intravenous sgn-40 in patients with relapsed multiple myeloma.


Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma. * received at least one prior systemic therapy other than single-agent corticosteroids. * measurable disease of monoclonal protein greater than or equal to 0.5 gram/dl in plasma or 0.5 gram/24 hr urine collection, or greater than 10 mg/dl free light chain (flc) in serum as determined by serum flc assay and provided the serum flc ratio is abnormal. exclusion criteria: * received an allogenic stem cell transplant. * previous intolerance of lenalidomide or dexamethasone. * primary invasive malignancy (other than multiple myeloma) within the last 3 years.

Keywords: antigens, cd40 antibodies, monoclonal combined modality therapy multiple myeloma blood coagulation disorders hematologic diseases hemorrhagic disorders hemostatic disorders immunoproliferative disorders lymphoproliferative disorders paraproteinemias vascular diseases antibody-dependent cell cytotoxicity
cardiac and thoracic imaging in pediatric patients with evidence of systemic inflammation covid19 linked

Conditions: COVID-19 Infection

Summary: to perform comprehensive cardiac and thoracic non invasive imaging assessment by mri and/or ct scan including cardiac functional evaluation and myocardial tissue characterization of covid_19 related disease in pediatric patients with cardiac involvement.


Eligibility criteria:
inclusion criteria: 1. patient with cardiac mri or cardiac ct scan or thoracic ct scan admitted for acute inflammatory syndrome and cardiac compromise 2. patient with pcr or antibodies test for covid 19 (positive of negative) 3. patient or parents of minor patients informed about collection of personal data for the study exclusion criteria: * patient or parents refusing personal data collection

Keywords: covid-19 infection children acute myocarditis kawasaki-like-syndrome
novel autologou car-t therapy for relapsed/refractory b cell lymphoma

Conditions: B Cell Lymphoma

Summary: it's a single arm, open label prospective study, in which the safety and efficacy of autologous car-t are evaluated in refractory/relapsed b cell lymphoma patients. abbreviation: car-t: chimeric antigen receptor t-cell immunotherapy.


Eligibility criteria:
inclusion criteria: 1. age≥18 years, male or female; 2. karnofsky≥60%； 3. b cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years). 4. patients with cr2 or cr3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons. 5. patients have had more than 2 combined chemotherapy regimens; 6. creatinin \<2.5mg/dl；alt/ast level \<3 times of the maximum of normal range; bilirubin\<3mg/dl； 7. proper venous condition for leukapheresis, no contraindication for leukapheresis; 8. patient that could understand and is willing to sign the written consent; 9. fertile female patient should be willing to take contraceptive measures. 10. patient that is willing to follow up till at least 2 months after t cell re-transfusion. exclusion criteria: 1. patients who need ≥15mg prednisone daily due to any cause; 2. patients with autoimmune disease and need immunosuppressor treatment; 3. serum creatinin\>2.5 mg/dl；serum ast \>5 times of normal maximum; bilirubin \>3 mg/dl; 4. fev1\<2 l，diffusion capacity for carbon monoxide of lung (dlco) \<40%； 5. cardiovascular abnormalities that fulfill any of the following: nyha level iii or iv congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction\<35%； 6. patients with hiv infection, active hepatitis b or hepatitis c infection; 7. patients that have previously received gene therapy of any kind; 8. obvious clinical encephalopathy or novel neuron function damage; 9. patients with active infection; 10. patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment; 11. patients who had allergic history to agents of the similar structure as car-t;
a clinical investigation of the m2a-magnum™ hip system

Conditions: Osteoarthritis, Hip; Arthritis; Rheumatoid Arthritis; Joint Disease; Bone Disease

Summary: the purpose of this prospective clinical data collection is to document the performance and clinical outcomes of the m2a-magnum™ hip system

this is a 10 year prospective data collection documenting the function and survivorship of the m2a-magnum™ hip system. patients are required to come in for preoperative, operative, one year follow-up, three year follow-up, five year follow-up, and ten year follow-up exams. this product was fda cleared in 2004.

Eligibility criteria:
inclusion criteria: * non-inflammatory degenerative joint disease including: avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, leg perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, traumatic arthritis * rheumatoid arthritis * correction of functional deformity * treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * revision of previously failed total hip arthroplasty exclusion criteria: absolute contraindications include: * infection, sepsis, and osteomyelitis relative contraindications include: * uncooperative patient or patient with neurologic disorders that are incapable of following directions * osteoporosis * metabolic disorders which may impair bone formation * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * vascular insufficiency, muscular atrophy, or neuromuscular disease

Keywords: total knee replacement total knee arthroplasty hip arthritis
alexithymia frequency and interhemispheric transfer in patients with a first demyelinating event

Conditions: Multiple Sclerosis

Summary: prevalence of alexithymia in multiple sclerosis (ms) is closed to 50% but is unknown in clinically isolated syndrome (cis).the present study sought to characterize alexithymia in cis patients and his link between psycho behavioral and cognitive disturbances. in this context, the objectives of the present study were to (a ) define the prevalence of alexithymia in cis patients, (b ) to study this relation between psycho behavioral and cognitive disorders frequently encountered in ms.

the aim to recruit 40 cis patients with at least two subclinical lesions on brain mri. patients are tested only one month at least after steroids intake and after 6 weeks at least after any relapse. the control group include 40 right -handed participants; each of them are matched for age, gender, and education level with a cis patient. the parameters to be evaluated are: the prevalence of alexithymia is assessed by the toronto alexithymia scale tas-20, a self-reported scale. the tas-20 total score corresponds to global level of alexithymia, as the sum of these three subdomains: 1.difficulties in identifying feelings (dif); 2. difficulties in describing feelings (ddf); 3. externally oriented thinking (eot). standard neurological examination is performed by a neurologist using the kurtzke expanded disability status scale (edss ). the standardized neuropsychological battery, named bccogsep, is administrated. the bccogsep is made of eight tests commonly impaired in ms. fourteen scores were obtained and a score was considered impaired when it was inferior to 5th percentile range compared to the normal range. the number of impaired scores are considered and a cognitive impairment is considered when 4 scores are superior or equal to percentile 5th. for psychobehavioral assessments, the investigators estimated (a) depression (according to the beck depression inventory; bdi (30)) and anxiety (according to the state-trait anxiety inventory (31)); (b) apathy (according to the lille apathy rating scale (32)); (c) empathy (according to interpersonal reactivity index; iri).

Eligibility criteria:
inclusion criteria: * right-handed patient * at least 1 month after steroid intake * without severe neurological impairment * without psychiatric disorder exclusion criteria: * patients with steroids in the last month * patients with psychotropic drugs started in the last month * patients with immunotherapies * patients having contra indications for mri * pregnancy or breast feeding

Keywords: cognition alexithymia
sleep apnea, arrhythmias and cardiac reverse remodeling in heart failure patients

Conditions: Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)

Summary: prospective, international, non-randomized, multicentre, clinical investigation (phase iv). the aim of the study is to investigate the correlation between hf, severe sbd, and af in crt-p patients at 6 months.

the primary objective is to estimate the change in severity of sleep breathing disorders (sbd) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up. the main secondary objective is to assess the prevalence, type and evolution of the sbd, co-morbidities and major adverse cardiac events in each subgroup of hf patients (based on the etiology), up to 12 months follow-up period. predictors of the clinical outcomes will be investigated.

Eligibility criteria:
inclusion criteria: * patient successfully\* implanted (de-novo implant, upgrade or replacement) with a livanova crt-p device, according to the latest applicable crt guidelines and ifu * signed and dated informed consent * the subject will be available for postoperative follow-up beyond one year exclusion criteria: * chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study) * already included in another clinical study that could confound the results of this study * not available to attend routine follow-up visits * not able to understand the aim of the study and its procedures * minor age (according to local regulation) * drug / alcohol addiction or abuse * known pregnancy * under guardianship