Kornimate/medical-research-clean huggingface dataset:
changes in hormonal profile and body mass index in women with polycystic ovary syndrome after probiotic intake

Conditions: PCOS

Summary: changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.

50 women with pcos , diagnosed based on rotterdam eshre criteria,were assigned to two groups - the probiotics one and the placebo one. women from the probiotics group were given sanprobi® barrier capsules. they were taking probiotics for 12 weeks. the placebo group received identical-looking capsules filled mainly with maize starch and maltodextrins. the study concentrates on analysing specific hormones before and after the intervention (giving the probiotics or a placebo to the patients). the serum samples were obtained on days 3-5 (early follicular phase) of menstrual cycle. in the laboratory studies, the following hormones were measured before and after 12-week intervention: testosterone, androstenedione, 17-hydroxyprogesterone (17(oh)p); follicle stimulating hormone (fsh), luteinising hormone (lh); estradiol (e2), prolactin (prl), thyroid stimulating hormone (tsh), thyroxine (t4) and sex hormone binding globulin (shbg). the weight and height were measured before and after 12-week intervention. bmi was also calculated.

Eligibility criteria:
inclusion criteria: * women with pcos, diagnosed based on rotterdam eshre criteria exclusion criteria: * the patients with comorbidities such as diabetes mellitus type i and ii, heart diseas-es, liver diseases, hypertension, hypothyroidism should be excluded from the study

Keywords: pcos probiotics hormones bmi
truncated and extended forms of amyloid beta peptides in alzheimer's disease: genesis, toxicity and identification as biological markers

Conditions: Alzheimer Disease

Summary: beta amyloid immunoreactivity is probably due to a significant number of ab catabolites corresponding to n-terminally truncated and cterminally truncated or extended forms which display distinct propensity to aggregation. very few things are known concerning the mechanisms and proteases by which they are generated. furthermore, the link between truncation and toxicity has not been delineated. finally, little is known concerning ab fragments in biological fluids and whether they could be seen as early biomarkers and thereby, as putative targets for ad diagnostic. the present project will allow to examine the human biological samples and to identify various cohorts after complete clinical evaluation.


Eligibility criteria:
inclusion criteria: * 1) coming subjects to see patients in cmrr for a complaint mnésique 2) introducing a score in tiny mental the upper test (mmse) in 28/30 without error in under score of the recall of the 3 words 3) introducing a score of 10/10 in the test of the 5 words of b2c 4) introducing a score in the ladder cdr (clinical dementia rating) equal to 0 5) having given a lit consent 6) being affiliated member or beneficiary of the regime of french national health and pensions organization exclusion criteria: * major, all the vulnerable persons under 18 under tutelage, under legal guardianship, deprived of freedom, hospitalized in a health establishment or social for quite other reason that searches it * record of neurological or psychiatric pathology and inability for sensory reasons to perform a cognitive balance sheet
a study evaluating hypotension and autonomic nervous system dysfunction in multiple myeloma (mm) patients

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine whether the orthostatic hypotension reported among subjects during bortezomib-containing regimen is caused by a dysfunction of the autonomic nervous system (ans).

1. to gather pilot data on the incidence of autonomic dysfunction in patients with multiple myeloma prior to treatment with bortezomib. 2. to characterize the changes in the ans including the fluctuations in blood pressure (hypotension /hypertension) associated with bortezomib. 3. to determine the duration of the ans dysfunction if present. this is not a treatment study, only an evaluation of the autonomic nervous system (ans) among subjects receiving antimyeloma therapy which includes bortezomib (velcade).

Eligibility criteria:
inclusion criteria: * subjects with active multiple myeloma who are scheduled to be treated with bortezomib-containing regimens. * subjects must have signed an irb-approved informed consent indicating their understanding of the proposed treatment and understanding that the protocol has been approved by the irb. exclusion criteria: * subjects with unstable cardiovascular disease. recent (\< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrhythmias. * subjects unable to perform the valsalva maneuver such as patients with clinically significant aortic stenosis, glaucoma or retinopathy. * subjects receiving selective serotonin reuptake inhibitors.
a clinical study to evaluate the safety and immunogenicity of inactivated poliomyelitis vaccine in healthy infants

Conditions: Poliomyelitis

Summary: the purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on sabin strain (lbvc) in healthy infants to select optimal dose of lbvc as well as to demonstrate the lot-to-lot consistency and non-inferiority of lbvc.


Eligibility criteria:
inclusion criteria: * healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment * born at full term of pregnancy (gestational age ≥37 weeks) * body weight ≥ 3.2 kg at the time of screening * born to hiv negative mother * the parents or legally acceptable representative (lar) able to understand and comply with planned study procedures * signed informed consent by subject's parents or legally acceptable representative (lar) exclusion criteria: * previously received any polio vaccines (opv or ipv) * history of previous or concurrent vaccinations other than hepb, bcg, dtp, hib, rotavirus vaccine and pcv * history of bleeding disorder contraindicating intramuscular injection. * experienced fever ≥ 38 °c/ 100.4 °f within the past 3 days prior to the screening * receipt of immunoglobulin or blood-derived product since birth * history of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin b, etc.) * known or suspected immune disorder, or received immunosuppressive therapy * history of poliomyelitis * history of any neurological disorders or seizures * known or suspected febrile, acute or progressive illness * household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis * participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study * infants whose families are planning to leave the area of the study site before the end of the study period * infants who is considered unsuitable for the clinical study by the investigator
an open-label study to evaluate the efficacy of high-dose gammaplex in children on the autism spectrum

Conditions: Autism; Autistic Disorder; Asperger's Disorder; PDD; Pervasive Developmental Disorder

Summary: if autism is the consequence of a chronic inflammatory process preventing the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. igiv treatment has been known to suppress inflammation and has been used in the treatment of inflammatory conditions and autoimmune diseases.

we have come to believe that an immature immune system with abnormal signaling and altered apoptotic pathways may result in a process of neuroinflammation with a clinical presentation of autism spectrum disorder. if autism spectrum disorders are the consequence of a chronic inflammatory process that prevents the infant brain from forming the proper neural connections, then treatment that reduces inflammation might have a positive impact on autism. we believe that there is a correlation between immunological abnormalities and the development of the autism.

Eligibility criteria:
inclusion criteria: * the subject is between the ages of or equal to 4 and 12 years of age, of either gender, and belonging to any ethnic group. * the subject has a diagnosis, for a minimum of 6 months prior to screening, of either autistic disorder, asperger disorder, or pervasive developmental disorder (pdd). * normal physical test results. * immunological lab results showing reduced levels of activated cd40l or abnormal lymphocyte stimulation, or t or b cell dysfunction (hypgammaglobulinemia, primary immunodeficiency (pidd), or common variable immune deficiency (cvid). exclusion criteria: * a diagnosis of isolated iga deficiency * allergic reactions to blood products

Keywords: autism autism spectrum autism children
sleep duration required to restore performance during chronic sleep restriction

Conditions: Sleep; Sleep Deprivation; Insufficient Sleep Syndrome

Summary: the purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase.

the purpose of this study is to test the hypothesis that sleep and performance depend on length of time awake, length of time asleep, the amount of sleep over several sleep episodes, and circadian phase. inpatient sleep and performance data will be collected from healthy volunteers.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * prescription medications

Keywords: inpatients health normalcy circadian rhythm
vagal nerve stimulation for gastroparesis

Conditions: Gastroparesis

Summary: this study is investigating a new form of treatment for a digestive disorder called gastroparesis. gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction. the vagal nerve is a large nerve originating from the brain that regulates digestive function. patients with gastroparesis have what is a called a low vagal tone which results in gastrointestinal motility problems and inflammation; therefore, investigators hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce inflammation and gastrointestinal motility problems in gastroparesis patients. investigators will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of vagal nerve stimulation (vns) treatment. there are 6 research visits visit 1 and visit 2 may take up to 8 weeks (screening/baseline) visit 3 and visit 4 will take 4 weeks (vns treatment) visit 5 and 6 will take approximately 4 weeks (vns followup/washout) consequently, it is possible that if a patient were to be at the farthest ends of visit windows, they could potentially be in the study for approx 16 weeks. visit 1 and 2 may be less than 8 weeks which would shorten the patient's overall involvement in the study. the treatment phase of the study will always be 4 weeks with an additional 4 week washout phase. use of the vns device takes 4 weeks. endoscopy and blood work are taken before and after the treatment period.


Eligibility criteria:
inclusion criteria: 1. male or female. 2. age 21-65 years old. 3. established diagnosis of functional dyspepsia, idiopathic or diabetic gastroparesis as per aga (american gastroenterology association) guidelines. 4. patient is capable of giving informed consent and undergo upper endoscopy. 5. patient is on stable doses of other medications for gastroparesis for preceding 4 weeks prior to enrollment (baseline measures). exclusion criteria 1. surgical-related gastroparesis 2. extrinsic myopathy or neuropathy causing gastroparesis. 3. use of narcotic pain medications in the preceding 2 weeks of study enrollment. 4. patients with enteric feeding tubes or requiring parenteral nutrition (patients with g-tubes who are stable for 3 months and not using the g-tube for venting may be eligible. patient with j-tubes are not eligible. 5. patients with severe flare requiring hospitalization. 6. untreated significant depression or suicidal thoughts. 7. pregnant or breast-feeding women. 8. history of gastric pacemaker implantation. 9. patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, or gastric bypass. 10. patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology. 11. patients with primary pulmonary disorders that affect the spirulina breath test. 12. patients with implantable electronic devices. 13. patients with carotid artery atherosclerosis.
tpc vs pf as induction chemotherapy combined with ccrt for stage iva-b nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to compare the survival and toxicity of tpc (taxol, ddp and capecitabine ) vs pf (cisplatin and 5-fluorouracil) as induction chemotherapy combined with concurrent chemoradiotherapy (ccrt) for stage iva-b nasopharyngeal carcinoma patients in endemic area.

this is a prospective, parallel, randomized, open labeled, multicenter phase iii clinical trial to compare the survival and toxicity of tpc vs pf as induction chemotherapy combined with ccrt for stage iva-b nasopharyngeal carcinoma patients in endemic area.the primary endpoint is failure free survival (ffs）.the secondary endpoints are overall survival(os）,progression-free survival（pfs）, local-regionally relapse free survival(lrfs), distant metastasis free survival（dmfs)and toxicities.

Eligibility criteria:
inclusion criteria: * who ii or iii pathological type * stage ⅳa or ⅳb (uicc 7th edition) * no anticancer treatment before * no malignant history * both gender, 18-60 years old * enough liver function: tbil≤uln；ast/alt≤2.5×uln；alp≤5×uln * enough kidney function: clcr≥80 ml/min * enough hemo: anc≥2×109/l, plt≥100×109/l and hb≥9g/dl * no sever heart, lung disfunction * ps≤2 exclusion criteria: * previous anticancer treatment * distant metastasis * pregnant or breasting female * can not access to followup * enrolled in other therapeutic clinical trial * sever infection and internal disease * sever disfunction of heart, lung, kidney, liver, etc * tbil\>uln；ast/alt\>2.5×uln；alp\>5×uln * with factors that will affect the administration, distribution,metabolism or evacuation. * using immunosuppressive agents after organ transplantation * other malignant history

Keywords: nasopharyngeal carcinoma induction chemotherapy
dignity therapy/life plan in patients with pancreatic or advanced lung cancer

Conditions: Pancreatic Cancer; Non-Small-Cell Lung Cancer

Summary: this study will evaluate feasibility and acceptability of providing the dignity therapy/life plan intervention to pancreatic or advanced lung cancer patients presenting for treatment in the outpatient medical oncology setting. investigators hypothesize that providing dignity therapy to this population will be feasible.


Eligibility criteria:
inclusion criteria: * age \>18 * undergoing chemotherapy for pancreatic adenocarcinoma or advanced nsclc (pancreatic arm closed) * english-speaking * cognitively intact, per clinician judgment, as documented in electronic medical record (emr) exclusion criteria: * currently receiving hospice or palliative care services * concurrent diagnosis of delirium or dementia, per medical record * diagnosis of major depression disorder, acute anxiety disorder or schizophrenia per medical record * participating in other psychosocial intervention research studies.

Keywords: pancreatic cancer dignity therapy palliative care advanced lung cancer non-small-cell lung cancer
pilot project on interdisciplinary therapy of obesity

Conditions: Obesity; Weight Loss

Summary: obese individuals that undergo major intervention such as a low-calorie formula diet program or bariatric surgery with the result of substantial weight loss (\> 10%) are included and followed-up for at least 3 years. weight changes and excess weight loss as well as measures of quality of life are monitored. in addition, biomaterials will be collected from these individuals every 6 months for measurement of parameters related to obesity-associated gastrointestinal (gi) impairments such as change in gi hormone levels, change in gi microbiota, or enhanced bacterial translocation. moreover, micronutrient and metabolomics analysis will be performed. this project allows comparison of non-surgical and surgical intervention and enables to asses the anticipated relationship between obesity and the gi tract in humans in the future.

a database and a biomaterial bank will be established to assess, if the role of the gut for the development of obesity and obesity-related diseases such as fatty liver are of relevance in humans, e.g. for classification of afflicted individuals regarding risk or outcome after intervention. during 3 years, the investigators will include 480 obese individuals (4 cohorts of 120 individuals) who undergo a treatment program (either surgical or non-surgical), and follow them up for at least 3 years. every 6 months, a visit is planned at the obesity center where the initial intervention has been performed. within the visits, anthropometry (body mass index (bmi), excess body weight (ebw), bioelectrical impedance analysis (bia)), quality of life (sf36 score, impact of weight on quality of life (iwqol) questionnaire), and sample collection for laboratory analyses (inflammatory markers, hormones, flora composition, micronutrients, metabolomics etc.) will be performed. patients will be recruited from 3 centers in germany. the long-term expectation from this model project is to find gastrointestinal parameters allowing to predict outcome and sustainability of different intervention strategies. in addition, intervention programs will be compared regarding long-term outcome and quality of life changes.

Eligibility criteria:
inclusion criteria: * adults (18-65 years at time of inclusion) * obesity defined as bmi \> 30 kg/m2 * obesity treatment (multidisciplinary life style intervention with lcd or bariatric surgery) resulting in an estimated body weight loss of \>10% of the initial body weight within 6 month exclusion criteria: * body weight loss after intervention \< 10% * follow-up period \< 1 year or number of consultations within 3 years \< 3

Keywords: obesity therapy metabolic syndrome gastrointestinal tract microbiota metabolomics micronutrients outcome sustainability
11c-trimethoprim pet/ct imaging to evaluate biodistribution and kinetics in human subjects

Conditions: Bacterial Infections

Summary: patients with suspected bacterial infection at the time screening are eligible for this study. patients may participate in this study if they are at least 18 years of age, and most participants will be receiving care at the clinical practices of the university of pennsylvania. up to 30 subjects will participate in two different imaging cohorts. the biodistribution cohort will include up to 5 patients referred from orthopedics who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution \[11c\]trimethoprim pet/ct scans over a period of approximately 2 ½ hours. the dynamic cohort will include up to 25 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans imaging post injection of \[11c\]trimethoprim. some subjects who may be selected clinically to undergo surgical or antibiotic treatment may undergo a second therapy may also undergo an optional second \[11c\]trimethoprim pet/ct after the initiation of therapy to collect pilot data on the changes in \[11c\]trimethoprim biodistribution and uptake with therapy, the timing of this scan may vary depending on the type of treatment the patient is receiving. patients will also undergo baseline lab tests complete blood count (cbc), c-reactive protein (crp), erythrocyte sedimentation rate (esr) and blood cultures. if these tests are done as part of clinical standard of care they will not need to be repeated for this study.


Eligibility criteria:
inclusion criteria: 1. inclusion criteria at least 18 years of age 2. known or suspected bacterial infection. 3. participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. exclusion criteria: 1. antibiotic therapy with trimethoprim within 48h of the baseline pet/ct scan. 2. inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. serious or unstable medical or psychological comorbidities that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. 4. females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
a study of effectiveness and safety of the first-line nivolumab plus ipilimumab with or without chemotherapy for advanced/recurrent non-small cell lung cancer in japan

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this observational study is to assess the effectiveness and safety of nivolumab plus ipilimumab with or without chemotherapy as first-line treatment for participants with untreated advanced or recurrent nsclc in the real world setting in japan.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histologically confirmed advanced or recurrent nsclc * participants who have received or scheduled to administrate nivolumab plus ipilimumab with or without chemotherapy as first-line treatment from the date of approval of nivolumab plus ipilimumab with or without chemotherapy to november 30, 2021. 1. pemetrexed plus cisplatin or carboplatin for participants with non- squamous histology and paclitaxel plus carboplatin for participants with squamous histology are only acceptable combinations of chemotherapy. exclusion criteria: * in participants with non-squamous histology, participants who are confirmed to be positive for egfr gene mutation or alk fusion gene for which egfr tyrosine kinase inhibitor or alk tyrosine kinase inhibitor is indicated. * participants who had antineoplastic treatment as first-line treatment of advanced or recurrent nsclc prior to initiation of nivolumab plus ipilimumab with or without chemotherapy. however, participants who correspond to a) or b) below will be included in this study. 1. prior perioperative chemotherapy or stage iii chemoradiotherapy or durvalumab combination chemoradiotherapy. 2. participants who are received or have received bisphosphonates or denosumab for bone metastasis * participants who initiated treatment with nivolumab plus ipilimumab and added chemotherapy from the second course onwards. * participants who received investigational anti-tumor drug in clinical trial after being diagnosed with nsclc * other participants who are judged by the investigators to be inappropriate for enrollment in this study other protocol-defined inclusion/exclusion criteria apply

Keywords: bms-936558 ono-4538 nivolumab ipilimumab retrospective observational