Kornimate/medical-research-clean huggingface dataset:
expanded access to convalescent plasma for the treatment of patients with covid-19

Conditions: COVID19

Summary: this expanded access program will provide access to investigational convalescent plasma for patients in acute care facilities infected with sars-cov-2 who have severe or life-threatening covid-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.


Eligibility criteria:
inclusion criteria: * age at least 18 years * laboratory confirmed diagnosis of infection with sars-cov-2 * admitted to an acute care facility for the treatment of covid-19 complications * severe or life threatening covid-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease * informed consent provided by the patient or healthcare proxy severe covid-19 is defined by one or more of the following: * dyspnea * respiratory frequency ≥ 30/min * blood oxygen saturation ≤ 93% * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300 * lung infiltrates \> 50% within 24 to 48 hours life-threatening covid-19 is defined as one or more of the following: * respiratory failure * septic shock * multiple organ dysfunction or failure exclusion criteria: * none
the work of being a patient with diabetes: data collection via a smartphone application

Conditions: Diabetes Mellitus, Type 2

Summary: this mixed methods study aims to answer the question: "what is the work of being a patient with type 2 diabetes mellitus?" .

this study will describe how much time persons with type 2 diabetes mellitus spend on health management and the burden they experience from these activities.

Eligibility criteria:
inclusion criteria: * receiving medical care at mayo clinic endocrine subspecialty clinic * diagnosis of type 2 diabetes exclusion criteria: * unable to provide consent * patients who reside in an extended care of intermediate care facility
biomarkers in tissue samples from patients with ductal breast carcinoma in situ

Conditions: Breast Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is studying biomarkers in tissue samples from patients with ductal breast carcinoma in situ.

objectives: * to validate the prognostic utility of a new ductal breast carcinoma in situ (dcis) genomic score and the oncotype dx recurrence score® assay in tissue samples from patients with dcis enrolled on clinical trial ecog-e5194. outline: rna extracted from archived tissue samples are analyzed for gene expression profile by oncotype dx recurrence score® assay (a reverse transcriptase-pcr-based assay).

Eligibility criteria:
disease characteristics: * diagnosis of ductal breast carcinoma in situ * enrolled on clinical trial ecog-e5194 * local surgery without radiotherapy * treated or not treated with tamoxifen * available tissue samples * hormone receptor status not specified patient characteristics: * menopausal status not specified prior concurrent therapy: * see disease characteristics

Keywords: ductal breast carcinoma in situ
cetuximab (erbitux) in combination with cisplatin or carboplatin and 5-fluorouracil in the first line treatment of subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck (extreme)

Conditions: Head and Neck Cancer

Summary: the purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with recurrent or metastatic head and neck cancer. overall survival will be taken as the primary measure of efficacy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (scchn) * recurrent and/or metastatic scchn, not suitable for local therapy exclusion criteria: * prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to study entry * surgery (excluding prior diagnostic biopsy), or irradiation within 4 weeks before study entry * nasopharyngeal carcinoma

Keywords: head and neck cancer
efficacy and tolerability of pantovigar® vegan in female subjects with diffuse hair loss

Conditions: Diffuse Hair Loss in Females

Summary: the objective of this study is to assess the hair growth efficacy of a food for special medicinal purposes (fsmp) pantovigar® vegan after 3 and 6 months of intake.


Eligibility criteria:
inclusion criteria: * diffuse hair loss * modified savin score i to iii * hair length of at least 2 cm exclusion criteria: * pathological hair loss (like alopecia areata, universalis or totalis; scarring alopecias; androgenic alopecia; inflammatory conditions of the scalp) * symptomatic diffuse alopecia due to pathological low iron concentration or thyroid gland disorder * acute telogen effluvium * recent or concomitant treatment with any drugs that may cause hair loss * concomitant diseases that can cause hair loss
care - quality improvement in cardiovascular secondary prevention in primary care, through delegation of consultations to the nurse.

Conditions: Cardiovascular Disease

Summary: quality improvement in primary care: delegation of check-ups to nurses in general practice


Eligibility criteria:
inclusion criteria: * patients in secondary prevention of cardiopathy (ischaemic heart disease, claudication intermittence, thrombotic apoplexy cerebri, diabetes) who are not followed in an outpatient department. exclusion criteria: * patients who suffer from diabetic nephropathy will be excluded * according to the general practitioners appraisal, patients who suffer from severe co morbidity can be excluded as well.

Keywords: quality development project primary care nurses cardiovascular disease secondary prevention follow-up
dopaminergic modulation of declarative memory

Conditions: Parkinson's Disease

Summary: the study investigates the effect of dopaminergic stimulation over declarative memory functions in parkinson's disease (pd) patients. at this aim, 20 pd patients will receive declarative memory tasks in two different conditions: after 12-18 hours of dopaminergic stimulation withdrawal ("off" condition) and after the first daily dose dopaminergic therapy ("on" condition). 20 healthy controls will also administered the two tasks in two conditions with the same inter-session delay as pd patients, but without taking drugs.

parkinson's disease (pd) is frequently accompanied by declarative memory deficits. it has been hypothesized that these latter could be related to dopaminergic depletion within the fronto-striatal network. however, the nature of this relationship is not clearly understood. in this study we aim to assess the role of daily dopaminergic stimulation on the retrieval processes needed to perform different cognitive tasks. a group of pd patients will be administered declarative memory task both "on" (standard medication intake) and "off" (12/18 hours after the last medication intake). a group of comparable normal controls will also present with the same cognitive task twice, without any drug assumption. understanding the effect of dopamine treatment on declarative memory processes will allow standard medication treatment to be adjusted in order to take into account both motor and cognitive features of parkinson's disease.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson disease made by a neurologist according to the london brain bank criteria. exclusion criteria: * disease duration ≥ 5 years; diagnosis of dementia based on clinical criteria and confirmed by a mini-mental state examination score \< 26; presence of other neurological and/or psychiatric illnesses in the patient's clinical history.
effect of using oxygen on the diaper dermatitis in infants

Conditions: Diaper Rash; Diaper Dermatitis

Summary: background: airing the diaper area has a positive effect on dermatitis. in addition, it is reported in the literature that oxygen is effective in wound care. the aim of our study is to investigate the effect of oxygen on infant diaper dermatitis. method: the study population consisted of infants will admit to the neonatal intensive care unit of a public hospital in istanbul between october 2022 and april 2023. sixty newborns who met the study criteria will randomly divide into two as the experimental (n=30) and control (n=30) groups. personal data form and diaper dermatitis observation form will be used to obtain the data. all babies' diapers will be changed 8 times a day. oxygen flow will be applied to the experimental group for one hour after each diaper change. the degree of diaper dermatitis will be evaluated every 24 hours.


Eligibility criteria:
inclusion criteria: * approved by the family for the study * born between 34-42. gestational weeks * no skin disease other than diaper dermatitis * no skin lesions of another disease other than dermatitis-related lesions in the gland area * newborns who has stable vital signs exclusion criteria: * having a skin disease other than diaper dermatitis * having a lesion on the skin due to another disease * having a known skin allergy * born before 34. gestational weeks * having a gastrointestinal disease

Keywords: infant diaper dermatitis diaper rash oxygen
reducing the abuse of opioids in drug users

Conditions: Opioid Abuse, Unspecified; Opioid Dependence

Summary: the consequences of prescription opioid abuse are serious and the number of deaths from unintended overdose have quadrupled over the last 15+ years. opioid analgesics remain among the most commonly abused class of substances in the united states. moreover, patients who take pain medications for legitimate reasons may develop an opioid use disorder (oud), with as many as 1 in 4 patients becoming dependent on their pain medications. because of changing access to prescription opioid analgesics due to an increasingly negative prescribing climate and changes in guidelines, patients often turn to heroin, with an estimated 1 in 15 pain patients trying heroin within 10 years. pain is a symptom that can be severely debilitating and needs to be treated adequately to improve the quality of life. clinicians, then, are in a proverbial "catch-22" situation whereby treating a patient's chronic pain also exposes them to medications with substantial abuse liability and overdose risk. in this proposal, a method aimed at reducing the abuse potential of prescription opioid medications, without altering their analgesic efficacy, is described. the study team hypothesize that this can be accomplished by administering a fixed-dose-combination of an opioid with an atypical antipsychotic drug, in the same pill or capsule.


Eligibility criteria:
inclusion criteria: * adult patients between 21 to 65 years of age, capable of understanding and providing consent in english, and capable of complying with the outcome instruments used. * recreational opioid use (i.e. defined as prescription opioid use for nontherapeutic purposes on at least 10 occasions within the previous year and at least once in the 12 weeks prior to screening) * reported tolerated doses to opioid medications exclusion criteria: * currently receiving pharmacotherapy for psychiatric disorder, current suicide risk, or past history of major psychiatric disorder such as bipolar disorder/psychosis * presence of dementia * current neuroleptic medication in past 30 days * pregnancy * positive drug urine test for barbiturates, benzodiazepines, methadone, and buprenorphine. * subjects with a prolonged qt interval greater than 430ms (i.e. qtc \>430ms) * subjects with a heart rate of less than 60 or greater than 100bpm will be assessed by a physician for symptomatic bradycardia/tachycardia and eligibility determined on a case-by-case basis * subjects with serum potassium and/or magnesium outside of normal range of our institutional laboratory within the past three months from time of screening. * subjects who appears intoxicated on the day of study visit by an on-site physician.
a study on exploring the abscopal effect induced by different radioimmunotherapy combination patterns in the treatment of non-small cell lung cancer with multiple metastases

Conditions: NSCLC Stage IV Without EGFR/ALK Mutation

Summary: it is planned to carry out a multicenter umbrella study to find the optimal organ combination and the best radioimmunotherapy combination pattern, so as to improve the survival of nsclc patients with multiple metastases. at the same time, by using multimodal omics data, machine learning will be employed to construct a prediction model for the abscopal effect, and explore the immunoregulation of organ-specific radiotherapy and biomarkers of the abscopal effect. the main objective is to find the optimal organ combination and the best radioimmunotherapy combination pattern.


Eligibility criteria:
inclusion criteria: * patient must meet all of the following inclusion criteria to be enrolled in this study: 1. non-small cell lung cancer diagnosed initially through pathological histology. 2. there are 3-6 metastatic lesions. 3. no brain metastasis or the lesions are stable. 4. negative for driver genes (including egfr, alk, ros, braf, met, ret genes. note: the above english terms are all gene names). 5. ecog (eastern cooperative oncology group) score: 0-1 point, with an expected, survival period of more than 3 months. 6. aged between 18 and 75 years old. 7. evaluated by pet-ct (including fdg and fmiso, not mandatory). 8. no contraindications for immunotherapy and radiotherapy. 9. the informed consent form has been signed. exclusion criteria: * patients with any of the following criteria are not eligible for enrollment in this study: 1. those with severe dysfunction of vital organs (heart, liver, kidney). 2. those accompanied by other malignant tumors. 3. those with uncontrolled heart diseases or having experienced a myocardial infarction within the past six months. 4. those with a history of mental illness. 5. and other situations in which the researchers deem it inappropriate for the subjects to participate in the study.
safety surveillance of vaxigriptetra® and efluelda® influenza vaccines in europe during the influenza season 2021/22

Conditions: Influenza (Healthy Volunteers)

Summary: the primary objective of the study is to estimate the reporting rate of suspected adverse drug reactions (adrs) occurring within 7 days following routine vaccination with vaxigriptetra® and efluelda®, respectively, during the northern hemisphere (nh) influenza season 2021/22. the secondary objectives of the study are: * to estimate the reporting rates of suspected adrs occurring within 7 days following routine vaccination with vaxigriptetra® according to the pre-defined age groups. * to estimate the reporting rates of serious suspected adrs after vaccination with vaxigriptetra®, and efluelda®, respectively, at any time following vaccination, within the enhanced passive safety surveillance (epss) period. * to compare vaccinees' reporting rates of suspected adrs observed during the nh influenza season 2021/22.

study duration per participant is maximum 2 months.

Eligibility criteria:
individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location, recommendations for the individual vaccines as well as national recommendations.
rct on nonoperative versus operative treatment for acute complete tears of the ulnar collateral ligament of the thumb

Conditions: Ulnar Collateral Ligament Sprain; Skier's Thumb

Summary: a complete rupture of the ulnar collateral ligament (ucl) of the thumb must heal in order to regain proper function of the thumb. guidelines recommend surgery for complete ucl ruptures, including stener lesions. this recommendation is based on expert opinion, anatomic theories and low quality retrospective case series. high quality studies comparing cast immobilization with operative treatment are lacking. research has shown that in about 9 out of 10 patients, a complete ucl rupture, including stener lesions, can also be treated with a cast alone for 6 weeks and no surgery is needed. we hypothesize that cast immobilization is non-inferior regarding functional outcome and carries concomitant lower costs compared with operative treatment for complete ucl ruptures, including stener lesions. the project aims to conduct a multicenter randomized controlled trial and cost-effectiveness analysis comparing operative and nonoperative treatment for complete ucl ruptures, including stener lesions. the project will take four years, from preparation to reporting of the results. in the following years, implementation will be achieved in collaboration with the dutch hand surgery committees (nvvh and nvpc), health insurance companies, and medical experts. research question is nonoperative treatment with splint immobilization non-inferior to immediate operative treatment regarding functional outcome and does it lead to lower costs in adult patients with an acute complete ucl rupture, including stener lesions?


Eligibility criteria:
inclusion criteria: * patients 18 years and older * dutch or english speaking patients * patients with an acute complete ucl rupture, with or without a stener lesion, diagnosed using physical examination, performed by the hand surgeon. when providing radically directed force to the proximal phalanx (radial deviation stress) as the thumb metacarpal is stabilized, criteria 1 and 2 must be present to confirm the diagnosis of a complete ucl rupture: * no firm endpoint in the mcp joint and * at least more than 35 degrees of laxity in the mcp joint (measured with the mcp joint in extension or in 30 degrees of flexion) or more than 15 degrees difference in laxity compared with the uninjured side. exclusion criteria: -
sequential low-dose decitabine with pd-1/cd28 cd19 car-t in relapsed or refractory b-cell lymphoma

Conditions: Objective Response Rate

Summary: to evaluate the efficacy and safety of cd19 pd-1/cd28-car-t sequential low-dose decitabine in the treatment of relapse or refractory b cell lymphoma.


Eligibility criteria:
inclusion criteria: * (1) age ≥ 18, upper limit 75, unlimited for men and women; (2) ecog score 0-3; (3) histologically confirmed diffuse large b-cell lymphoma (dlbcl) \[according to who 2008\]; (4) cd19 was positive (immunohistochemistry or flow cytometry). (5) the definition of refractory or relapse of dlbcl is: no complete remission after 2-line treatment; disease progression in any treatment process, or disease stabilization time equal to or less than 6 months; or disease progression or relapse within 12 months after hematopoietic stem cell transplantation; (6) the previous treatment of diffuse large b cell lymphoma must include rituximab (cd20 mab) and anthracycline; (7) there should be at least one measurable focus. it is required that any length of lymph node focus should be greater than 1.5cm or any length of extranodal focus should be greater than 1.0cm. pet-ct scan focuses should have uptake (suv is greater than liver blood pool); (8) the absolute value of neutrophils in peripheral blood ≥ 1000 / μ l, platelet ≥ 45000 / μ l; (9) heart, liver and kidney function: creatinine \< 1.5mg/dl; alt (alanine aminotransferase) / ast (aspartate aminotransferase) 2.5 times lower than the normal upper limit; total bilirubin \< 1.5mg/dl; heart ejection fraction (ef) ≥ 50%; (10) sufficient understanding ability and voluntary signing of informed consent; (11) those with fertility must be willing to use contraceptive methods; (12) according to the judgment of the researchers, the expected survival time is more than 4 months; (13) willing to follow visit schedule, administration plan, laboratory inspection and other test steps. exclusion criteria: * (1) history of other tumors; (2) hematopoietic stem cell transplantation was performed within 6 weeks; (3) any target car-t treatment was performed within 3 months before the car-t treatment; (4) previous use of any commercially available pd-1 mab; (5) cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection; (6) active autoimmune diseases; (7) uncontrollable infection of active bacteria and fungi; (8) hiv infection, syphilis infection; active hepatitis b or c: hepatitis b: hbv-dna ≥ 1000iu / ml; hepatitis c: hcv rna positive and liver function abnormal. (9) known central nervous system lymphoma.
retrospective study for description of the use of omalizumab in patients with difficult to control asthma

Conditions: Asthma

Summary: the purpose of this study is do describe the experience in the use of omalizumabe, in a real life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient clinics, and its efficacy and safety. the efficacy of omalizumab in the population observed will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations, emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma medication).

omalizumab is indicated in children over 6 years of age, with diagnosis of difficult to control asthma, presenting a component of atopy demonstrated preferably positive skin tests (prick test) or in vitro reactivity (rast) allergens common inhalants. patients must also present the total serum ige levels between 30 and 700ui/ml. children until 12 years the ige level is between 30 and 300 iu/ml.

Eligibility criteria:
inclusion criteria: patients on optimal asthma treatment, good compliance and no response to treatment according to asthma consensus (gina/naeep and the latinamerican consensus for difficult to treat asthma)

Keywords: difficult to control asthma omalizumabe