Kornimate/medical-research-clean huggingface dataset:
fecal microbiota transplantation for health improvement (tfm3)

Conditions: Ulcerative Colitis; Irritable Bowel Syndrome; Crohn Disease; Irritable Bowel

Summary: search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.

objectives of the study: 1. to select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms. 2. to select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control. 3. create a bank of fecal samples of healthy donors; 4. conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers; 5. analyze the efficacy of therapy with tfm on the sample of patients; 6. analyze the effect of autologous, heterologous tfm and placebo on healthy volunteers; 7. analyze long-term effects in patients within 6 months after the tpm. the study is expected to include 50 patients, 35 healthy volunteers and healthy feces donors the study is scheduled to begin in may 2018, the supposed completion of the study is december 2020

Eligibility criteria:
inclusion criteria: * the age of patients - from 18 to 75 years, both sexes; * patients with: * antibiotic-associated colitis, * inflammatory bowel diseases (ulcerative colitis, crohn's disease), * diseases caused by c. difficile infection, * a syndrome of impaired intestinal absorption, * irritable bowel syndrome, * celiac disease (severe form), * metabolic syndrome, including diabetes mellitus type ii, * atopic dermatitis with damage to the mucous membrane of the colon, * hepatitis of various etiologies, * cirrhosis of the liver of various etiologies * pancreatitis of various etiologies, * absence of contraindications to gastroscopy * informed consent of the patient for the transplant procedure exclusion criteria: * the presence of a concomitant chronic infectious or neoplastic disease in the patient * patients with a proven allergy to foods not excluded from the donor's diet * absence of the patient for one or more intermediate stages of the examination. * informed refusal to continue therapy
vinorelbine/gemcitabine versus vinorelbine/cisplatin in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.for each randomisation arm, 100 patients will be included. the trial was performed as a 2-stage phase ii study according to the optimal design by simon with overall response rate as the primary objective. study design: arm a vinorelbine 25 mg/m2 d1, 8;gemcitabine 1000 mg/m2 d1, 8 q 3 weeks arm b vinorelbine 25 mg/m2 d1, 8;cisplatin 25 mg/m2 d1, 2,3 q 3 weeks


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic breast cancer * all patients were required to give written informed consent * to have received a previous treatment with anthracyclines and taxanes * previous radiotherapy is allowed, whenever the radiated area is not the only disease location * at least 4 weeks since the last previous antineoplastic treatment * patients must have recovered from all previous toxicities * karnofsky performance status \>= 70% * adequate hematological, renal, cardiac and hepatic function * life expectancy of at least 12 weeks * patients able to comply and to receive an adequate follow-up exclusion criteria: * only bone metastases * active infection * previous treatment with one of the study drugs * application of other cytotoxic chemotherapy * insufficient renal function (creatinine clearance \< 60ml/min) * clinically unstable brain metastasis * pregnancy or lactation * other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin) * abnormal liver function (bilirubin \> 2.0-fold upper normal limit (unl); alanine aminotransferase and aspartate aminotransferase \>2.5-fold unl). in patients with hepatic metastasis, a value of alanine aminotransferase and aspartate aminotransferase of up to 5-fold unl is permitted * males * second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma
investigation of ferritin in critically ill patients with hemophagocytic lymphohistiocytosis

Conditions: Hemophagocytic Lymphohistiocytosis (HLH); Macrophage Activation Syndrome (MAS); Hemophagocytic Syndromes

Summary: retrospective analysis of ferritin, outcome and hlh-criteria in critically ill patients.

the study is a retrospective register study of critically ill patients from charité - universitätsmedizin berlin during 2000 and 2016 that had at least one measurement of plasma ferritin. outcome, underlying diagnoses and hlh-2004 criteria (henter ji et al. 2007) will be analyzed and the hscore of these patients will be calculated (fardet l et al. 2014). all recorded data of the specific admission term in icu will be used for the analysis. no follow-up of the patients after discharge will be performed in this study. the study does not involve any randomization or any drug testing. update 2019: we expanded our database for the years until 2018 and also for the surgical and medical icus of the charité - universitätsmedizin berlin (from 256 to 2623 patients). update 2022: a systematic literature search will be performed to find suitable validation cohorts for multicenter validation of optimized hlh diagnostic criteria, which are calculated based on our data (new secondary endpoint).

Eligibility criteria:
inclusion criteria: * male and female patients * at least one measurement of plasma ferritin exclusion criteria: -age below 18 years

Keywords: ferritin hemophagocytic lymphohistiocytosis (hlh) critically ill patients intensive care unit (icu) outcome diagnosis
researchers at uc san diego are learning about the benefits of human milk and how it influences infant and child health

Conditions: Breastfeeding; COVID-19 Infection; COVID-19 Vaccine; Remdesivir; Antibiotics

Summary: the purpose of the ucsd human milk biorepository is to establish and maintain a repository of breast milk samples that can be used to learn more about how breast milk influences infant and child health.

participants in this study will participate in the following: 1. provide a milk sample: if participants agree, the investigators will ask participants to express 50ml (about 2 ounces) of milk. the investigators will take as much as participants wish to donate, or as little as one teaspoon. 2. answer questions about participant's health: future researchers may need to know if participants have any health problems, or about any treatments participants have had while breastfeeding. the investigators will ask participants for some contact information, health habits, and family's health history. 3. fill out online questionnaires about participant's eating habits and mood: the investigators will ask the participant to answer an online questionnaire about how often participants eat certain foods. the investigators will also have the participant answer some questions about the participant's mood and how the participant has been feeling recently. the questionnaires can be completed on a tablet at the visit, or the investigators may send an email with a link to fill it out online. these questionnaires take about 30 minutes altogether. 4. the investigators will store the participant's sample and information in the human milk biorepository: the investigators will keep the participant's milk and health information in the human milk biorepository. there is no limit on the length of time we will keep the milk and information. the investigators will keep them as long as they are useful, unless the participant asks to remove them. 5. the investigators will let researchers use the stored materials for approved research studies: researchers can apply to study the samples and information stored in the human milk biorepository. 6. if the participant agrees, the investigators may contact the participant with information about other research studies.

Eligibility criteria:
inclusion criteria: * women who are 18 years old or older * breastfeeding * producing sufficient breast milk to donate an excess to the biorepository exclusion criteria: * women under 18 years old

Keywords: breastfeeding covid-19 infection covid-19 vaccine remdesivir antibiotics
prospective randomized trial comparing robotic versus open radical prostatectomy

Conditions: Prostatic Neoplasms; Adenocarcinoma

Summary: to date, no study has prospectively compared open versus robotic radical prostatectomy in a randomized fashion for patients with prostate cancer. for patients with newly diagnosed prostate cancer who choose surgical management, the choice of surgical approach is often limited to surgeon preference and experience. this study will prospectively randomize patients with localized prostate cancer who are candidates for surgical management to open versus robotic radical prostatectomy.


Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the prostate * deemed a surgical candidate for a bilateral nerve bundle preservation * potent * continent of urine * surgical candidate for both open and robotic nerve-sparing radical prostatectomy * age \>18 exclusion criteria: * previous treatment of prostate cancer (radiation, hormones, etc.)
tace+tilelizumab+sorafenib in the treatment of bclc stage c hcc

Conditions: BCLC Stage C Hepatocellular Carcinoma

Summary: according to the bclc staging system treatment recommendation, systemic treatment is recommended for patients in bclc stage c, and tace and systemic treatment are recommended for patients in this stage. studies have shown that tace combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and pd-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. therefore, in order to improve the survival benefit of bclc stage c liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of tace combined with sorafenib and tislelizumab in the treatment of bclc stage c liver cancer patients.


Eligibility criteria:
inclusion criteria: * age ≥18 years * child-pugh score≤ 7 * hcc diagnosed by biopsy or by the noninvasive criteria of the chinese liver cancer guideline 2019 * the primary hcc being in bclc c stage according to nccn guideline * no previous systemic therapy for hcc exclusion criteria: * diffuse hcc * uncontrolled ascites of hepatic encephalopathy * prior liver transplantation * positive for human immunodeficiency virus * active gastric or duodenal ulcer * other uncontrolled comorbidities or malignancy

Keywords: bclc stage c hepatocellular carcinoma transarterial chemoembolization sorafenib tilelizumab
to compare the efficacy and safety of perrigo's product to an fda approved product for the treatment of glaucoma or ocular hypertension in both eyes

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: to compare the efficacy and safety of perrigo's product to an fda approved product in the treatment of primary open angle glaucoma or ocular hypertension in both eyes.


Eligibility criteria:
inclusion criteria: 1. male or nonpregnant females aged at least 18 years with chronic open angle glaucoma or ocular hypertension in both eyes 2. subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. 3. adequate wash-out period prior to baseline of any ocular hypotensive medication. 4. baseline (day 0/hour 0) pressure ≥ 22 mm hg and ≤ 34 mm hg in each eye and any asymmetry of pressure between the eyes no greater than 5 mm hg. 5. baseline best corrected visual acuity equivalent to 20/200 or better in each eye exclusion criteria: 1. females who are pregnant, breast feeding, or planning a pregnancy. 2. females of childbearing potential who do not agree to utilize an adequate form of contraception 3. current, or past history of, severe hepatic or renal impairment 4. current, or history within two months prior to baseline of, significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye 5. current corneal abnormalities that would prevent accurate readings with the goldmann applanation tonometer 6. functionally significant visual field loss 7. contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy 8. use at any time prior to baseline of an intraocular corticosteroid implant 9. use within one week prior to baseline of contact lens 10. use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid 11. use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy 12. use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid 13. having undergone within six months prior to baseline any other intraocular surgery (e.g., cataract surgery) 14. having undergone within twelve months prior to baseline refractive surgery, filtering surgery, or laser surgery for pressure reduction
collecting recorded videos of colonoscopy screening tests

Conditions: Colon Polyp

Summary: the study shall mainly help to better evaluate the performance the apds device and secondly it may help to assess the potential of the future alpha version of the device to be a useful and effective for the detection of colon polyps.

primary objectives • to evaluate, in objective way, the usability of the future alpha version of the apds device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of colonoscopy screening tests of the general population. secondary objectives • when the apds would be ready for field installation (beta version), to install it in the gastroenterology institute of the medical center, in order to evaluate, as part of a continuation study, the physicians satisfaction from the apds performance.

Eligibility criteria:
inclusion criteria: subjects must meet all the criteria related to regular colonoscopy according to the standard of care at the gastroenterolgy department of the selected center. in addation, the following criteria have to be met to be eligible for the study: 1. able to read, understand and provide written informed consent; 2. females or males - older than 18 years old exclusion criteria: any of the following colonoscopy related exclusion criteria will exclude the subject from the study: * bleeding disorder or unacceptable risk of bleeding * terminal illness or life threatening malignancy
safety and immunogenicity of glaxosmithkline biologicals meningococcal group b vaccine when administered concomitantly with glaxosmithkline biologicals menacwy conjugate vaccine to healthy infants

Conditions: Infections, Meningococcal

Summary: the purpose of this trial is to evaluate the immunogenicity, the safety and the tolerability of rmenb+omv nz and menacwy vaccines in healthy infants, when concomitantly administered at 3, 5, 7 and 13 months of age, compared to either alone.


Eligibility criteria:
inclusion criteria: 1. healthy 3-month old infants (85-119 days, inclusive) at time of visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained. 2. available for all the visits scheduled in the study. 3. in good health as determined by medical history, physical examination and clinical judgment of the investigator. exclusion criteria: 1. history of any previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) at the time of enrollment. 2. previous known or suspected disease caused by n. meningitidis. 3. household contact with and/or intimate exposure to an individual with laboratory confirmed n. meningitidis infection or colonization. 4. history of severe allergic reaction after previous vaccinations, or hypersensitivity to any component of the vaccine. 5. known or suspected autoimmune disease or impairment/alteration of the immune system resulting from, for ex-ample: * chronic administration of immunosuppressants or other immune-modifying drugs since birth (3 months prior). (for corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day or ≥ 10 mcg/day for children below 2 years. inhaled and topical steroids are allowed), * immune deficiency disorder, or known hiv infection. 6. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation since birth. 7. history of any progressive or severe neurologic disorder, or seizure disorder or guillan barré syndrome (exception: one self-limited febrile seizure is acceptable). 8. history of any bleeding disorder considered as a contraindication to intramuscular injection or blood draw. 9. child's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study. 10. receipt of any investigational or non-registered product since birth (3 month prior) or are expected to receive during the study period. 11. family members or household members of site research staff. 12. any clinically-significant chronic or progressive disease according to judgment of the investigator (pulmonary, cardiovascular, renal, hepatic or endocrine functional abnormality) or a congenital anomaly/known cytogenic disorder (e.g., down's syndrome). 13. history or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.

Keywords: central nervous system diseases nervous system diseases meningitis
a study of roxadustat for the treatment of anemia in participants with chronic kidney disease and not receiving dialysis

Conditions: CKD Anemia

Summary: the purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

there is a screening period of up to 6 weeks, a variable treatment period for individual participants. in order to complete the treatment period simultaneously for all study participants, the minimum treatment duration may be less than 52 weeks, with a maximum treatment duration of up to 3 years after the last participant is randomized, and a post-treatment follow-up period of 4 weeks. participants who prematurely discontinued from treatment will be expected to complete the early termination (et) and end of study (eos) visits. such participants will be considered non-completers, but they will be expected to participate in long-term follow-up (ltfu) for cardiovascular events (cv) of interest, vital status, and hospitalizations until overall study closure unless the participant withdrew consent for this ltfu data collection. participants were randomized in a 2:1 ratio to receive either roxadustat or placebo in a double-blind manner.

Eligibility criteria:
inclusion criteria: * chronic kidney disease stages 3, 4, or 5 and not receiving dialysis * anemia qualified by measurements of hemoglobin values during screening * additional blood work must be in a safe range for study entry * body weight 45 to 160 kilograms (kg) * willingness to use contraception if of child-bearing potential exclusion criteria: * treatment with an erythropoiesis-stimulating agent (esa) within 12 weeks prior to study participation * more than 1 dose of intravenous iron within 12 weeks prior to study participation * blood transfusion within 8 weeks prior to study participation * active infection * chronic liver disease * severe congestive heart failure, recent heart attack, stroke, seizure, or blood clot * uncontrolled blood pressure within 2 weeks prior to study participation * renal cell carcinoma * history of malignancy, including multiple myeloma or other myelodysplastic syndrome * chronic inflammatory disease that could impact red blood cell production * any prior organ transplant or a scheduled organ transplantation * anticipated elective surgery that is expected to lead to significant blood loss or anticipated elective heart procedure * gastrointestinal bleeding * any prior treatment with roxadustat or a hypoxia-inducible factor prolyl hydroxylase inhibitor (hif-phi) * recent use of an investigational drug or treatment, or participation in an investigational study

Keywords: anemia chronic kidney disease (ckd) non-dialysis hemoglobin (hb) end-stage renal disease erythropoeitin asp1517 erythropoeisis stimulating-agent azd9941
theta burst transcranial magnetic stimulation as treatment for auditory verbal hallucinations

Conditions: Schizophrenia; Psychotic Disorders

Summary: auditory verbal hallucinations (avh) are a characterising symptom of schizophrenia. in the majority of patients, these avh respond well to antipsychotic medication. yet, a significant minority continues to experience frequent avh despite optimal pharmacotherapy. the number of alternative treatment options for this medication resistant group is currently low and most of them focus on coping with the hallucinations. transcranial magnetic stimulation (tms), in contrast, is a non-invasive technique of influencing cortical excitability. this technique has the potential to actually decrease the frequency and severity of medication resistant hallucinations. several previous studies have assessed efficacy of low frequency rtms, with contradicting results. a previous large study by the investigators group could not demonstrate efficacy of low frequency rtms. a new stimulation protocol using theta burst rtms (tbs) could provide a more effective therapeutic option. objective: the present study aims to examine the efficacy of tbs on the severity of avh. study design: the objectives are tested in a randomized double blind placebo-controlled trail. study population: 60 patients with the diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or psychosis not otherwise specified with frequent auditory verbal hallucinations will be included. intervention: the participant will receive either 10 tbs treatments or 10 placebo treatments consisting of 900 pulses each with a 30 minute interval on the left temporoparietal area, distributed over 5 treatment days. stimulation will be at 80% of the motor threshold. main study parameters/endpoints: the main study parameter is the change in the severity of the avh. the secondary study parameter is the number and severity of adverse events.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis not otherwise specified. * age 18+ years. * frequent auditory verbal hallucinations (cut-off at \>once an hour). * written informed consent. exclusion criteria: * metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing, cardiac pacemaker, medicinal pumps) * history of seizures * increased intracranial pressure due to infarcts or trauma. * history of eye trauma with a metal object or professional metal workers * patients who are coercively treated at a psychiatric ward (based on a judicial ruling) * patients who are represented by a legal ward or under legal custody * in female patients, there should be no possibility for pregnancy as determined with a pregnancy test * changes in the prescribed medication in a period of 2 weeks prior to participation

Keywords: auditory verbal hallucinations transcranial magnetic stimulation theta burst frequency