Kornimate/medical-research-clean huggingface dataset:
predicting ovarian response in artificial insemination with low stimulation

Conditions: Subfertility

Summary: this large prospective multi-center cohort study aims to identify patient's characteristics that significantly influence ovarian response to mild stimulation with a fixed dose of 75 iu recombinant fsh.

a multi-center, open-label, prospective cohorts study. patients with a regular indication for coh/iui (controlled ovarian stimulation/ intra uterine insemination) will be asked to participate. patient's characteristics will be documented including age, weight, bmi, smoking status, cycle day 2 3 or 4 fsh /estradiol levels, antral follicle count, and amh. amh and fsh/estradiol will be determined centrally after completion of inclusion of all patients in the study. all patients will receive a fixed 75 iu recfsh per day conform normal stimulation protocol starting from cycle day 3, 4 or 5 after exclusion of ovarian cysts by ultrasound. ovarian response will be documented by ultrasound only. once the dominant follicle(s) reach a mean diameter of 16-18 mm, hcg (5000iu or 250 mcg) will be applied and insemination will be scheduled 36-42 hours later. cancellation criteria will be defined according to the national guidelines provided by the nvog (7).

Eligibility criteria:
inclusion criteria: * couples with unexplained or mild male subfertility (1-3) and a spontaneous chance of conception below 40% (hunault score). * unexplained subfertility including minimal to mild endometriosis (afs grade 1 or 2) is defined as the failure to conceive after at least one year of unprotected intercourse whereas the standard fertility work-up was unable to detect any factors that might influence fertility negatively. * semen analysis should be normal according to the who guidelines (8), * ovulation should be documented (by bbt charts, ovulation detection by ultrasound or normal luteal progesterone values), * tubal patency should be confirmed (hsg, laparoscopy or fertiloscopy) and when a postcoital test was performed a cervical factor should have been excluded. * mild male subfertility is defined as abnormal semen parameters according to the who (8) but an average total motile sperm account before processing of at least 10 million. exclusion criteria: * hunault score ≥ 40% * endometriosis afs grade 3 or 4 * contra-indications for the use of gonadotrophins (cysts larger than 2 cm, allergy for gonadotrophins) * total motile sperm count after sperm processing below 1 million * women aged younger than eighteen years or older than 45 years. * previous treatment with coh/iui for treating current subfertility * unable to speak or read the dutch language

Keywords: subfertility, iui, rec fsh, fsh, e2, amh
study of oxycyte in severe closed head injury

Conditions: Traumatic Brain Injury

Summary: brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. laboratory studies in animals and clinical trials have shown that increasing oxygen in the brain results in better brain oxygen consumption, less cell death, and better functional outcome. this study will test the hypothesis that oxycyte is an effective way to increase brain oxygen levels in severe head injury.

decreased brain oxygen in severe brain injuries appears to be implicated in poor functional outcome and death. animal and clinical studies have shown that increasing brain oxygen in such patients improves functional outcome, and oxycyte has been shown to be an effective means of delivering oxygen to tissues, including the brain. this study is an eight patient proof of concept study to test the effects of oxygen delivery with oxycyte in patients with a severe traumatic head injury with a glasgow coma scale (gcs) score of 3 to 9. subjects diagnosed with a severe head injury (gcs 3-9) who receive a brain oxygen monitor and microdialysis catheter, will undergo baseline monitoring for 4 hours. in the first 4 subjects the fi02 on the ventilator will be increased to 50% for a 4 hour stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of oxycyte. the fi02 will remain at 50% for 24 hours. in the second 4 subjects the fi02 on the ventilator will be increased to 100% for a 4 hour stabilization period and this will be followed by a single intravenous infusion of 3ml/kg of oxycyte. the fi02 will remain at 100% for 24 hours. subjects will be enrolled, treated, and then monitored by licox 02 monitor before and after infusion of pfc, and then for at least 48 hours following the discontinuation of oxycyte.

Eligibility criteria:
inclusion criteria: * severe closed head injury patients or gcs 3-9 patients who receive brain oxygen monitoring * ventriculostomy/icp monitor * at least one reactive pupil * no known life threatening disease prior to trauma * age 18-70 years old * consent for microdialysis/brain 02 monitoring * legal family representative present that can give informed consent for perfluorocarbon administration exclusion criteria: * no motor response * both pupils fixed and dilated * no consent available * allergy to egg proteins * coagulopathy * major liver injury * major pulmonary injury

Keywords: oxycyte perfluorocarbon oxygen carrier brain oxygen tension
preventive effect of egf cream for cutaneous adverse event of egfr inhibitors

Conditions: Drug-Related Side Effects and Adverse Reactions; Epidermal Growth Factor

Summary: the purpose of this study is to evaluate the preventive efficacy of topical egf cream for dermatologic adverse events related to egfr inhibitors.

epidermal growth factor receptor(egfr) is involved in cell proliferation and is overexpressed or abnormally activated in malignant tumors originating from the colon, breast, ovary, pancreas, and lung. egfr tyrosine kinase inhibitor(tki), gefitinib, erlotinib, and afatinib have been for the treatment of cancer associated with egfr gene mutation. in addition, monoclonal antibodies to egfr, such as cetuximab and panitumumab, have been used as a chemotherapy for rectal cancer without ras gene mutation and advanced head and neck cancer. the incidence of cutaneous toxicity of egfr inhibitors is reported to be 75-80%. clinical features include acneform folliculitis, xerosis, paronychia, and itching. of these, about 10% of patients with grade 3 or greater have a detrimental effect on quality of life and adherence to treatment, resulting in impaired therapeutic results. there have been many attempts to prevent or treat such skin toxicity. however, there has been no scientifically proven treatment until now. there is a growing interest in the role of egf emulsifiers in the treatment of skin adverse effects of egfr inhibitors, as a result of studies that improve acne significantly compared to placebo. the purpose of this study is to evaluate the preventive efficacy of egf cream in the treatment of skin adverse effects in patients with malignant tumors treated with egfr inhibitor (tki or monoclonal antibody).

Eligibility criteria:
inclusion criteria: * over 20 years old * patients scheduled to receive egfr inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) as malignant tumors * patients who can understand and follow the protocol * patients who spontaneously agreed to the study exclusion criteria: * patients with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks of other skin disorders * patients with existing acne history * breastfeeding or pregnant women * patients who are deemed unsuitable for the examination by the researcher's judgment

Keywords: epidermal growth factor
the effects of yogurt on gut microbiome and metabolism in h. pylori.

Conditions: Probiotic; Gut Microbiota; Helicobacter Pylori Infection; Insulin Resistance

Summary: helicobacter pylori is a common pathogen causing upper gastrointestinal diseases including gastric ulcer and gastric cancer. recent epidemiological findings have also shown that it is also related to colon cancer, metabolic syndrome, gut dysbiosis, glycemic control and insulin resistance. the aim of this study is to investigate whether the gut microbiota and insulin resistance of patients with h. pylori infection are abnormal. in addition, whether drinking fermented milk product with probiotic reduces helicobacter pylori, improves gut microbiota, and increases butyrate-producing bacteria and insulin resistance.


Eligibility criteria:
inclusion criteria: 1. age between 20 to 70 years old with positive helicobacter pylori gastric c13 urea breath test (δubt\>10%). 2. negative gastric helicobacter (δubt\<2%) matching age, gender, and body mass index. exclusion criteria: 1. unhealthy habits or poor health status, including habitual smoking, alcoholism, polypharmacy or drug abuses. 2. patients with acute diseases, such as respiratory tract infection, acute gastroenteritis. 3. in the past three months, those who have had dyspepsia but have not undergone gastroscopy, or have a history of active gastrointestinal ulcers and gastrointestinal bleeding. 4. those who have had gastrointestinal cancer or have undergone gastrointestinal surgery. 5. those who are unwilling to delay receiving anti-h. pylori therapy. 6. newly diagnosed cancer (except basal cell carcinoma) or cancer treatment in the past 5 years. 7. people who have had cardiovascular disease, respiratory disease, autoimmune disease, mental disease or other chronic diseases that are not well controlled, such as myocardial infarction or stroke, chronic obstructive pulmonary disease, inflammatory bowel disease, schizophrenia. 8. diabetes and those who are or need to take drugs. 9. those who have used the following drugs in the past month: antibiotics, nsaids, obesity drugs, steroid therapy, proton pump inhibitors, bismuth agents. 10. in the past month, regularly consume the following foods (at least 2 times a week): probiotics, prebiotics, or any foods containing probiotics, dairy products (yogurt, cheese), chinese medicine, kimchi, miso, honey, cranberry, spicy food. 11. fecal occult blood positive, unexplained iron-deficiency anemia, weight increase or decrease by more than 5% within six months. 12. abnormal liver function index (ast, alt or alp greater than 2 times the upper limit of normal), abnormal renal function index (egfr less than 45 ml/min). 13. pregnant or breast-feeding women.
a school-based intervention project to increase completion of upper secondary school in norway

Conditions: Drop Out; Absence; Academic Achievement/Average Grade; Mental Health

Summary: drop out from upper secondary school represents a risk for the future health and wellbeing of young people. strengthening of psychosocial aspects of the learning environment may be an effective strategy to promote completion of upper secondary school. the complete study is a school based cluster randomized controlled trial (rct) evaluating two school-based interventions, namely the dream school program (dsp) and the mental health support team (mhst) among 1st grade upper secondary school students in four counties in norway. the interventions aim to improve psychosocial learning environments and subsequently school achievements and decrease drop-out and absence. specifically, the complete study will 1. evaluate whether the dsp alone 1. increases completion 2. increases presence 3. improves school achievements 4. improves mental health and wellbeing 2. evaluate whether the dsp and the mhst combined 1. increase completion 2. increase presence 3. improve school achievements 4. improve mental health and wellbeing the complete study will also evaluate the effect of the dsp and mhst combined and the dsp alone against secondary outcomes of school satisfaction and loneliness. 3. evaluate through a process evaluation whether the interventions were implemented in line with guidelines for each of the interventions, and whether the degree of program fidelity has influenced the effect of the interventions on the primary and secondary outcomes.


Eligibility criteria:
inclusion criteria: * school inclusion criteria: not been or currently involved in either of the dream school program or the mental health support team or similar programs or research projects * student inclusion criteria: student enrolled at any of the included schools. exclusion criteria: * schools previously or currently involved in either of the dream school program or the mental health support team or similar programs or research projects. * student exclusion criteria: students with special needs or who are illiterate in norwegian are excluded from the survey assessment, but included in the interventions.

Keywords: randomized controlled trial drop out upper secondary school psychosocial learning environments
moisturizing effect of two dexpanthenol formulations

Conditions: Skin Abnormalities

Summary: the study focuses to prove the equivalent moisturizing effect of two different dexpanthenol formulations


Eligibility criteria:
inclusion criteria: * healthy subjects * phototype: i to iv according to fitzpatrick scale * subjects with dry skin on their forearms exclusion criteria: * pregnant or nursing women * subjects registered as being in exclusion period in the french health minister file of subjects * subjects with hypersensitivity to one of the test products

Keywords: dry skin dexpanthenol moisturizing effect
efficacy and utility of cxbladder tests in hematuria patients

Conditions: Hematuria; Urothelial Carcinoma

Summary: prospective observational study to validate the performance characteristics and clinical utility of cxbladder tests in a veterans affairs cohort.

non-invasive, voided urine sample used for both cxbladder molecular tests, voided urine sample may be used for standard of care testing. retrospective analysis of data after study completion ensures a de-phasing of study sample analysis from clinical decision making; patient treatment and management. the study aims to sequentially recruit up to 1000 patients presenting for assessment of hematuria (microscopic or macroscopic) by cystoscopy across multiple veterans affairs sites

Eligibility criteria:
inclusion criteria: * patient is undergoing investigation of recent confirmed hematuria (by either flexible or rigid cystoscopy/turbt), including hematuria patients referred due to suspicious/positive imaging, in order to determine the presence of urothelial carcinoma. * able to provide a voided urine sample of the required minimum volume * able to give written consent * able and willing to comply with study requirements * aged 18 years or older exclusion criteria: * prior history of bladder malignancy, prostate or renal cell carcinoma * prior genitourinary manipulation (flexible or rigid cystoscopy / catheterisation, urethral dilation) in the 14 days before urine collection * previous alkylating based chemotherapy * known pregnancy.
the combination of tacrolimus and high-dose dexamethasone as first-line treatment in adult immune thrombocytopenia

Conditions: ITP; Immune Thrombocytopenia

Summary: randomized, open-label, multicenter study to compare the efficacy and safety of combination of high-dose dexamethasone and tacrolimus versus high-dose dexamethasone for the first-line treatment of adults with primary immune thrombocytopenia (itp).

the investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with itp in china. patients were randomized to tacrolimuis plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. platelet count, bleeding and other symptoms were evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: 1. confirmed newly-diagnosed, treatment-naive itp; 2. platelet counts \<30×109/l ; 3. platelet counts \< 50×109/l and significant bleeding symptoms (who bleeding scale 2 or above); 4. willing and able to sign written informed consent. exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit; 2. received first-line and second-line itp-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ; 3. current hiv infection or hepatitis b virus or hepatitis c virus infections; 4. active infection; 5. maligancy; 6. severe medical condition (lung, hepatic or renal disorder) other than chronic itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia); 7. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy 8. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test; 9. patients who are deemed unsuitable for the study by the investigator.
beacon: a study evaluating the safety and efficacy of beam-101 in patients with severe sickle cell disease

Conditions: Sickle Cell Disease

Summary: this is an open-label, single-arm, multicenter, phase 1/2 study evaluating the safety and efficacy of the administration of autologous base edited cd34+ hspcs (beam-101) in patients with severe scd


Eligibility criteria:
key inclusion criteria include: 1. age ≥18 years to ≤35 years for the initial sentinel cohort; for subsequent enrollment patients from ≥12 years up to ≤35 years may be enrolled only upon approval by fda. 2. documented diagnosis of sickle cell disease with βs/βs, βs/β0, or βs/β+ genotypes. 3. severe scd defined by the occurrence of at least 4 severe vocs in the 24 months prior to screening despite receiving hydroxyurea or other supportive care measures key exclusion criteria include: 1. hbf levels \>20%, obtained at the time of screening on or off hydroxyurea therapy 2. previous receipt of an autologous or allogeneic hsct or solid organ transplantation 3. available and willing matched sibling donor 4. definitive diagnosis of moyamoya syndrome based on screening brain mra 5. history of overt stroke

Keywords: gene editing sickle cell severe sickle cell
evaluation of an integrated care project

Conditions: Asthma; Allergic Rhinitis; Atopic Eczema; Migraine; Headache; Depression

Summary: the purpose of the study is to investigate the effectiveness and cost-effectiveness of the integrated care program of a statutory health insurance offering additional homeopathic treatment to their members

the german statutory health insurance 'techniker krankenkasse' offers an integrated additional homeopathic treatment. to date, this offer has not been evaluated. therefore we aim to investigate the effectiveness as well as the cost-effectiveness of this program in adolescents (12-17 years) and adults with various chronic diseases. in an observational study we plan to compare patients participating in the integrated care project with matched insured persons from the techniker krankenkasse that do not participate in this program. matching will be based on gender, age and diagnosis. regarding the diagnosis, we plan to include adolescents with: asthma, allergic rhinitis and atopic eczema; and adults with asthma, allergic rhinitis and atopic migraine, headache and depression. to measure effectiveness, patients have to complete diagnosis-specific questionnaires at baseline and 3, 6 and 12 months. the primary outcome for each diagnosis is measured with diagnosis-specific questionnaire at 6 months. secondary outcomes include quality of life (sf-12) at 3, 6 and 12 months as well as the diagnosis-specific questionnaires at 3 and 12 months.

Eligibility criteria:
inclusion criteria: * newly registered for the integrated care program * insured for at least 1 year at the techniker krankenkasse * having access to the internet and e-mails at least once a week * adults with any of the following diagnoses: asthma, allergic rhinitis, atopic eczema, migraine, tension headache, depression * adolescents with any of the following diagnoses: asthma, allergic rhinitis, atopic eczema * informed written consent exclusion criteria: * participation in a disease-management program * participation in an intervention study * cancer diagnosis * current usage of a complementary therapy (control group only)

Keywords: comparative effectiveness research health economic evaluation
yellow fever vaccination under low dose methotrexate therapy

Conditions: Rheumatic; Dermatologic Disorders

Summary: travelers (n = 30, 15 taking low-dose methotrexate (mtx), 15 healthy controls (hc), seeking travel advice in one of the following swiss travel centers (aarau, basel, bern, geneva, lausanne, zurich) and who have an indication for yellow fever (yf) vaccination according to the swiss federal office of public health's vaccination recommendations are invited to participate in this study. after signing the consent form (i) yf viremia and (ii) anti-yf antibody production in patients taking low-dose mtx and hc will be compared after yf vaccination. it will be analyzed whether the percentage of people with protective antibodies differs between the two groups and (iii) vaccine side effects will be compared between the groups.

the study will be conducted in the form of a multi-center open-label prospective observational controlled pilot study. 15 patients under low dose methotrexate treatment and 15 healthy controls with an indication for yellow fever vaccination will be included. the study duration will be 28 days for each subject and will consist of 6 clinical visits on days 0, 3, 7, 10, 14 and 28. yf antibodies will be measured on days 0, 7, 10, 14 and 28; viremia will be measured on days 3, 7, 10, 14 and 28.

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * indication for yellow fever vaccination according to swiss foph recommendations * individuals under low dose mtx (≤20mg/week) therapy or healthy individuals * male and female travelers ≥18 years to \<60 years of age exclusion criteria: * contraindications on ethical grounds * women who are pregnant or breast feeding * contraindication against yellow fever vaccination (e.g. hypersensitivity against vaccine ingredient) * current treatment with other immunosuppressive agent apart from low dose methotrexate * alemtuzumab or rituximab in the last year * tnf-blocking therapy in past three months * immunocompromising condition in healthy control * other immunocompromising condition than mtx treatment itself and the underlying disease in patients under mtx * previous yellow fever vaccination * no indication for yellow fever vaccination according to swiss travel vaccination recommendations * known or suspected non-compliance, drug or alcohol abuse * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Keywords: methotrexate therapy