Kornimate/medical-research-clean huggingface dataset:
effect of the consumption of a fermented milk enriched with plant sterols

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in midly hypercholesterolemic people not treated by statins.


Eligibility criteria:
inclusion criteria: * male/female subject, * aged from 21 to 75 years, * bmi between 19 and 30 kg/m2, * ldl-cholesterol plasma level between 130 and 190 mg/dl without statin monotherapy, * stabilized hypercholesterolemia, * accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (ncep-atp iii guidelines), * used to consume dairy products, * effective contraceptive methods used for female subjects, * having given written consent to take part in the study exclusion criteria: * subject with plasma triglycerides (tg) levels ≥ 350 mg/dl, * having experienced any cardiovascular event in the last 6 months, * taking any hypocholesterolemic treatment, * diabetic subject (type i and type ii), * smoking strictly more than 10 cigarettes / day, * heavy alcohol intake (\> 40 g / day for men ; \> 30 g / day for women), * presenting known allergy or hypersensitivity to milk proteins, * known soy allergy, * refusing to stop the consumption of plant sterols-enriched products (other than the studied product), * receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, * receiving a transplant and under immunosuppressor treatment, * currently involved in a clinical trial or in an exclusion period following participation in another clinical trial, * in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject, * with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product, * for female subject: pregnancy, breast feeding or intention to be pregnant during the study or subject likely to change her contraceptive method during the study

Keywords: plant sterol hypercholesterolemia diet dairy isoprostanes midly hypercholesterolemic subjects
probiotics alleviate functional constipation in adults

Conditions: Constipation

Summary: to investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function, immunity, and gut microbiota.


Eligibility criteria:
inclusion criteria: 1. chinese adults aged 18-70 who meet the following rome-iv diagnostic criteria for functional constipation: i. if the following symptoms started at least 6 months ago and have been present for the past 3 months with two or more of the following: 1. straining during more than 25% of defecations 2. lumpy or hard stools (bristol stool form scale 1-2) more than 25% of defecations 3. sensation of incomplete evacuation more than 25% of defecations 4. sensation of anorectal obstruction/blockage more than 25% of defecations 5. manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor) 6. fewer than three sbm per week ii loose stools are rarely present without the use of laxatives iii. insufficient criteria for irritable bowel syndrome. 2. able to complete the study according to the requirements of the trial protocol; 3. patients who have signed the informed consent form; 4. research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures. only those who meet all the above conditions can be selected for the study. - exclusion criteria: 1. the use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment. 2. regular use of a high-fiber diet, as measured by the recommended food score (rfs); 3. regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea. 4. currently have, or have had in the past 2 years, any gastrointestinal conditions such as: crohn's disease, celiac disease, ulcerative colitis, malignant tumor of the colon. 5. medical history of cardiovascular, liver, or renal diseases; alcoholics. 6. hypersensitivity to probiotics or the ingredients used in this study. 7. pregnancy or breastfeeding. 8. participation in another clinical trial in the 3 months before enrollment. all participants provided written informed consent. -
a new clinical pathway for personalized management of borderline resectable and locally advanced pancreatic cancer

Conditions: Locally Advanced Pancreatic Cancer; Borderline Resectable Pancreatic Cancer; Pancreatectomy; Chemotherapy Effect

Summary: norpact-3 is a nationwide, norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. eligible patients are treated with primary chemotherapy possibly followed by surgical exploration and resection. all norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. the assignment of the medical intervention is not at the discretion of the investigator, but follow the national norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up. the primary aim is a national resection rate of 50% in brpc and 15% in lapc in patients initiating primary chemotherapy, with adequate overall survival and morbidity/mortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival \>20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (clavien dindo grade 3) ≤40%).


Eligibility criteria:
inclusion criteria: * borderline resectable or locally advanced adenocarcinoma of the pancreas (nccn, version 2, 2021) (appendix 3) * nx, m0 (uicc 8th version, 2016) * cytological or histological confirmation of adenocarcinoma * age \>18 year * considered able to receive primary chemotherapy and possible surgery * written informed consent exclusion criteria: * co-morbidity or performance status precluding primary chemotherapy * co-morbidity or performance status precluding pancreatectomy * female patients in child-bearing age not using adequate contraception, pregnant or lactating women * mental or physical disorders that could interfere with treatment of with the provision of informed consent * any reason why, in the opinion of the investigator, the patient should not participate

Keywords: primary chemotherapy resection rate borderline resectable pancreatic cancer locally advanced pancreatic cancer pancreatectomy chemotherapy effect fdg pet-ct ctdna
clinical study on the combined administration of 15-valent pneumococcal conjugate vaccine and diphtheria, tetanus, pertussis vaccine

Conditions: Streptococcus Pneumoniae Infections

Summary: this clinical study aims to evaluate the mutual influence of combined administration of 15-valent pneumococcal conjugate vaccine and diphtheria, tetanus, pertussis vaccine in the target population


Eligibility criteria:
inclusion criteria: * infants aged 3 months (90-119 days old), full-term (37-42 weeks pregnant), with a birth weight of ≥ 2.5kg; * the legal guardian provides informed consent and signs the informed consent form; * the legal guardian agrees to comply with the requirements of the clinical research protocol, is willing to accept a follow-up of 10 months, and has the ability to use thermometers, scales, and fill out diary cards; 4) have not received pneumococcal vaccine or pertussis vaccine, and have no history of receiving other live vaccines in the past 14 days or non live vaccines in the past 7 days; 5) underarm temperature ≤ 37.0 ℃. exclusion criteria: * a history of invasive diseases caused by streptococcus pneumoniae that has been confirmed through cultivation; * known to be allergic to any component of the experimental vaccine, especially those allergic to diphtheria toxoid, or those who previously have a fever of 39.5 ℃ or above after receiving vaccine; * history or family history of seizures, epilepsy, encephalopathy, and mental illness; * infants born with abnormal labor processes (difficult labor, instrumental delivery) or with a history of asphyxia or neurological organ damage; * a history of confirmed thrombocytopenia or other coagulation disorders may result in contraindications for subcutaneous injection; * injecting human normal immunoglobulin after birth; * known or suspected immunological dysfunction, receiving immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), such as continuous treatment with systemic corticosteroids (prednisone or similar drugs) for ≥ 14 days, human immunodeficiency virus (hiv) infection, etc; * having congenital malformations, severe malnutrition, developmental disorders, and genetic defects (such as favism); * currently suffering from serious chronic diseases, infectious diseases, active infections, liver diseases, kidney diseases, cardiovascular diseases, and malignant tumors; * severe asthma; * systemic rash, skin ringworm, skin suppuration or blisters; * currently or planning to participate in clinical trials of other drugs in the near future; researchers believe that any situation that may affect the evaluation of the study.

Keywords: 15-valent pneumococcal conjugate vaccine diphtheria, tetanus, pertussis vaccine
white matter integrity according to bdnf genotype after stroke

Conditions: Stroke

Summary: the aim of this study was to investigate differential plastic changes of fractional anisotropy (fa) in the corticospinal tract (cst), the intrahemispheric corticocortical tract from the primary motor cortex to ventral premotor cortex (m1pmv) and the corpus callosum (cc) from 2 weeks to 3 months after stroke according to bdnf genotype.

the aims of this study were to investigate plastic changes in the fractional anisotropy (fa) of three motor-related white matter fibers according to the bdnf genotype from 2 weeks to 3 months after stroke onset; one is a the majority of fibers from m1 to medullary oblongata (cst), another is the intrahemispheric connection from m1 to ventral premotor cortex (m1pmv), and the other is the interhemispheric connection between bilateral m1s (cc). there were also to investigate the relationships between motor impairment and tract-related fa of white matter tracts in each bdnf genotype

Eligibility criteria:
inclusion criteria: * diagnosed with first-ever hemispheric ischemic infarction with damage to the supratentorial area confirmed by brain mri within 2 weeks after stroke onset exclusion criteria: * any clinically significant or unstable medical disorder or neuropsychiatric comorbidity
anterior discectomy surgery with arthrodesis in degenerative spinal canal sténoses. (icasc)

Conditions: Lumbar Canal Stenosis

Summary: single-center retrospective study to characterize changes in the functional capacity of patients (change in oswestry desability index (odi)) undergoing anterior approach surgery for the management of symptomatic lumbar spinal stenosis between the pre-surgical period and the first assessment 6 months after surgery.


Eligibility criteria:
inclusion criteria: * anterior surgical management (alif or llif) * symptomatic lumbar degenerative pathology (l1-l2 to l5-s1), objectified on mri (schizas b, c, d) * period from june 2017 to december 2019 exclusion criteria: * traumatic sprains * history of decompression after the operated stage * operated from a later time at the same time * scolioses with cobb angles greater than 10° * patients under judicial protection * refusal to participate
correlation between cognitive function and relapse of schizophrenia regarding dose reduction

Conditions: Schizophrenia Relapse

Summary: to reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than 1000mg/day and to evaluate relationship between relapse and cognitive function.

we attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. the dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was discontinued if the subjects relapsed. the differences in baseline cognitive function were analyzed between the patients with no relapse and relapse groups.

Eligibility criteria:
inclusion criteria: * inpatients with a diagnosis of schizophrenia, and * those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg chlorpromazine eq./day. exclusion criteria: * mental retardation, * substance abuse or dependence, * a history of major head trauma, * serious medical or neurological disorders, or * depot antipsychotic injections within the previous 3 months and electroconvulsive therapy within the previous 6 months
acute clinical evaluation of multi-purpose solutions (mps) in soft contact lens wearers

Conditions: Myopia

Summary: the purpose of this study was to clinically evaluate lens care solutions used with soft contact lenses.

this study was conducted as a series of ten smaller studies in three countries using commercially available contact lens solutions per each country, ie, united kingdom, france, and the philippines. in each study, participants were assessed after use of up to 5 products (with one always being a control saline/blister pack solution) in randomized order in conjunction with one of the silicone hydrogel contact lenses. a total of 278 participants were enrolled in the 10 studies.

Eligibility criteria:
inclusion criteria: * have read, understood, signed, and dated the written informed consent. * be an adapted and successful soft contact lens wearer on a daily wear basis for at least two weeks. * vision correctable to at least 20/30 snellen. * other protocol-defined inclusion criteria may apply. exclusion criteria: * topical ocular medication use. * history of hypersensitivity to any component of the study contact lens care systems. * any slit-lamp finding of abnormal nature at the baseline visit assessment of each study period. * pregnant, lactating, or planning a pregnancy. * other protocol-defined exclusion criteria may apply.

Keywords: contact lens wear contact lens solution corneal staining
package of interventions after recovering from moderate acute malnutrition

Conditions: Malnutrition

Summary: children who recover from moderate acute malnutrition in malawi remain at high risk for relapse or death in the year following recovery. this cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. these children will be followed for a year following recovery to assess rates of relapse and mortality.


Eligibility criteria:
inclusion criteria: * recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (muac) of 11.5-12.4 cm exclusion criteria: * not permanent resident in vicinity of site * severe chronic illness * receiving other supplementary food or participating in other research

Keywords: moderate acute malnutrition
an observational study of presentation, treatment patterns, and outcomes in multiple myeloma participants

Conditions: Multiple Myeloma

Summary: the purpose of this study is to describe contemporary, real-world patterns of participant characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with newly diagnosed \[nd\] multiple myeloma (mm) and participants with relapsed/refractory \[r/r\] mm.

this is a prospective, non-interventional, observational study. this study will look at contemporary, real-world patterns of participant characteristics, clinical disease presentation, therapeutic regimen chosen, and clinical outcomes in participants with mm. participants will not be asked to change their routine clinical treatment. participants will have to complete patient reported outcomes (pros) surveys during on-site routine office visits. the study will enroll approximately 4200 participants. participants will be assigned to one of the following cohorts based upon the diagnosis of mm: * nd mm within 3 months from initiation of treatment * r/r mm who have received 1 to 3 prior lines of therapy this multi-center trial will be conducted worldwide. the overall time to participate in this study is up to 8 years. participants will be evaluated and followed-up for a period of at least 5 years, until death, are lost to follow-up, or the end of the study, whichever comes first.

Eligibility criteria:
inclusion criteria: is 18 years of age or older. is experiencing the following: 1. newly diagnosed mm within 3 months from initiation of treatment with documented month and year of diagnosis, criteria met for diagnosis, stage, and mm-directed treatment history, including duration, or 2. relapsed/refractory mm who have received 1 to 3 prior lines of therapy with documented data in the medical record regarding diagnosis (month and year), the regimens used in 1st, 2nd, and 3rd line as applicable, whether stem cell transplant was part of 1st, 2nd, and 3rd line of therapy, whether consolidation/maintenance was part of 1st, 2nd, and 3rd line of therapy, also whether investigational therapy/treated on a clinical trial was part of any of these regimens. is willing and able to sign informed consent to participate. is willing and able to complete patient-reported outcomes (pros) in accordance with local regulatory and data protection requirements. exclusion criteria: is reporting to a site in this study for a second opinion (consultation only) or participants whose frequency of consult and follow-up are not adequate for quarterly electronic case report form (ecrf) completion. has participated in another study (observational or interventional) that prohibits participation in this study.

Keywords: drug therapy
to demonstrate the relative bioavailability of diclofenac sodium 75 mg enteric-coated tablets under non-fasting conditions

Conditions: Inflammation

Summary: to demonstrate the relative bioavailability of diclofenac sodium 75 mg enteric-coated tablets under non-fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: anti-inflammatory
an extension study of xolair in moderate to severe, persistent asthma patients who completed study q2143g

Conditions: Asthma

Summary: this is a phase iiib, multicenter, open-label, extension study available to subjects who successfully complete study q2143g and have not participated in study q2195g. subjects should be registered via the ivrs (interactive voice response system) within 48 hours prior to their baseline visit. all subjects in this study will be treated with xolair for 24 weeks. subjects in the new treatment group may require additional visits for study drug injections (as frequently as every 2 weeks). data collection during these additional visits will be limited to the assessment of adverse events. the study will evaluate all serious and nonserious adverse events, laboratory assessments, data on asthma exacerbations, and concomitant medication usage.


Eligibility criteria:
inclusion criteria: * successful completion of the 24-week study period in study q2143g * signed informed consent (in the case of a minor, consent must be given by the child's parent or legally authorized representative) * for subjects who have never received xolair, a serum ige level \>=30 iu/ml and \ =20 kg and \<=150 kg * females of childbearing potential must, in the opinion of the investigator, be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study. exclusion criteria: * thrombocytopenia as evidenced by a platelet count of \<100,000/ul * pregnant or breastfeeding * significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrine or gastrointestinal disease) within the previous 3 months * history of neoplasia * any systemic condition requiring regular administration of an immunoglobulin * known hypersensitivity to any ingredients of xolair, including excipients (sucrose, histidine, polysorbate 20) * history of noncompliance with medical regimens * current participation in a study using an investigational new drug other than xolair * participation in study q2195g

Keywords: moderate persistent asthma severe persistent asthma
hipec combined with sintilimab for gastric cancer with peritoneal metastasis

Conditions: Gastric Cancer

Summary: to evaluate the safety and efficacy of hipec combined with sintilimab for gastric cancer patients with peritoneal metastasis.

peritoneal metastasis is the most common pattern of disease relapse and is attributed to the dismal prognosis of the gastric cancer. the national comprehensive cancer network (nccn) guidelines suggest that systemic chemotherapy is the first-line standard strategy, and chemotherapy combined with trastuzumab for patients with positive her-2. hipec can significantly improve survival in peritoneal metastasis from gastric cancer. pd-1/pd-l1 antibody has shown promising outcomes for unresectable or metastatic solid tumors. the present study aimed to evaluate the safety and efficacy of hipec combined with sintilimab (tyvyt®) in gastric cancer patients with peritoneal metastasis.

Eligibility criteria:
inclusion criteria: 1. advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology; 2. age 18-75 years, male or non pregnant female 3. ecog (eastern cooperative oncology group) : 0\~1； 4. negative for her-2 by ihc/fish； 5. peritoneal metastasis is confirmed by laparoscopic exploration, and the pci≤20； 6. untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy); 7. normal bone marrow, liver and kidney function indices before the recruitment: 8. expected survival≥ 12 week 9. signed the informed consent form, and blood and tissue samples can be obtained; exclusion criteria: 1. other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.); 2. previous systemic therapy for gastric cancer; 3. recurrent gastric cancer after surgery; 4. cardiopulmonary dysfunction; 5. immunosuppressive drugs(eg.corticosteroids) were used within 14 days before treatment, eg.corticosteroids, 6. there is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and those who do not need any intervention after adulthood can be included asthma requiring medical intervention with bronchodilator was not included.) 7. allergy to the drugs in this protocol； 8. patients with other diseases not suitable for inclusion, such as immune deficiency, active tuberculosis, hepatitis b (non-active hepatitis b surface antigen (hbsag) carriers, hepatitis b virus titer \<500iu/ml after treatment and with normal liver function can be included), hepatitis c virus positive; 9. a history of idiopathic pulmonary fibrosis, tissue pneumonia, drug pneumonia, idiopathic pneumonia, or r active pneumonia; 10. other patients who were considered unsuitable for inclusion by the researchers;

Keywords: gastric cancer peritoneal metastasis hipec pd1