Kornimate/medical-research-clean huggingface dataset:
an escalating dose study to evaluate the safety, tolerability and pharmacokinetics of lnk 754 in elderly volunteers and in subjects with mild alzheimer's disease

Conditions: Mild Alzheimer's Disease

Summary: to evaluate the safety, tolerability, multiple dose plasma pharmacokinetics (pk) of lnk-754 in male and female elderly volunteers after dosing with lnk-754 for 7 days and in subjects with mild alzheimer's disease after dosing with lnk-754 for 28 days.


Eligibility criteria:
inclusion criteria: part a and part b: 1. males or females aged 60 years or older. females must be surgically sterilized or postmenopausal for at least two years. males must be actively practicing double-barrier contraception (condom plus spermicide), unless they have had a vasectomy, or their partner(s) meet the above criteria for females. 2. voluntarily consent to participate in this study and provide written informed consent prior to start of any study-specific procedures. 3. be prepared to adhere to the protocol requirements and be willing and able to remain in the study unit for the entire duration of the confinement period. they must also be willing to return for the end-of-study visit one week after the last dosing. part a only: 4. subjects must be generally healthy, but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. subjects may be included with clinical deviations from normal limits in medical history, physical examination, vital sign measurements, ecg, or laboratory test results that are associated with stable, well controlled chronic illness. subjects with concomitant diseases or using concomitant medication will be allowed to participate provided a stable condition and stable treatment for 1 month (30 days) prior to administration of the first dose of study medication. inclusion of each subject will be reviewed with the link medical monitor prior to enrollment in the trial. part b only: 5. subjects with mild alzheimer's disease, as defined by dsm-iv. 6. subjects with a score of ≥ 18-26 on the mini-mental state examination (mmse). 7. subjects with a clinical dementia rating (cdr) total score of 0.5 or 1.0 (possible or mild dementia). 8. subjects with a rosen-modified hachinski ischemic score of ≤ 4. exclusion criteria: part a and part b: 1. any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease, as determined by medical history, physical examination or laboratory tests. 2. subjects who have positive serologic findings for human immunodeficiency virus (hiv) antibodies, hepatitis b surface antigen (hbsag), and/or hepatitis c virus (hcv) antibodies. 3. subjects who have received any experimental drugs or devices within 30 days prior to dosing or who wish to receive any experimental drug within 30 days after completing the study. 4. subjects unable to understand the protocol requirements, instructions and study related restrictions, the nature, scope and possible consequences of the clinical study.

Keywords: healthy elderly volunteers
extracorporeal co2 removal in acute exacerbation of copd not responding to non-invasive ventilation

Conditions: COPD Exacerbation Acute

Summary: background: acute exacerbation of chronic obstructive pulmonary disease (ae-copd) has a gold standard treatment: non-invasive ventilation (niv). however, this treatment sometime fails, and an invasive mechanical ventilation (imv) is required. the extracorporeal co₂ removal (ecco₂r) device can be an alternative to intubation. the aim of the study is to evaluate ecco₂r efficiency and safety and enlighten ecco₂r benefit/risk compared to imv. methods: successive ae-copd patients for whom niv failed were retrospectively analyzed during two periods: before and after the ecco₂r device implementation in our icu in 2015. we considered the before period as standard of care and patients were treated with imv. the ecco₂r device was a pump-driven veno-venous system (xenios ag).

the study compare 2 strategies for copd patients not responding to non invasive ventilation: the gold standard which is mechanical ventilation and a new technique which is extracorporeal co2 removal. this technique have been implemented in februrary 2015 in our intensive care unit so we choose to compare patients' outcome before and after the arriving of this device.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * no improvement or worsening of respiratory acidosis after more than one hour of non invasive ventilation treatment * and non improvement of respiratory distress signs * and ph \ 45 mmhg exclusion criteria: * patients not eligible for endotracheal intubation because of ethical limitations

Keywords: extracorporeal carbon-dioxide removal ecco2r acute exacerbation chronic obstructive pulmonary disease mechanical ventilation
simplicity: studying impacts on malabsorption with liprotamase in cystic fibrosis

Conditions: Exocrine Pancreatic Insufficiency; Cystic Fibrosis

Summary: liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. the purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, liprotamase powder for oral solution, in cystic fibrosis patients with exocrine pancreatic insufficiency (epi).


Eligibility criteria:
inclusion criteria: * for part a: males or females ≥7 years of age * for part b: males or females 28 days to \<7 years * diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride * low fecal elastase * fair-to-good nutritional status exclusion criteria: * history or diagnosis of fibrosing colonopathy * distal intestinal obstruction syndrome in 6 months prior to screening * receiving enteral tube feedings * chronic diarrheal illness unrelated to pancreatic insufficiency * liver abnormalities, or liver or lung transplant, or significant bowel resection

Keywords: exocrine pancreatic insufficiency cystic fibrosis liprotamase pancreatic enzyme replacement therapy (pert)
recurrent high grade glioma treated by litt

Conditions: Recurrent High Grade Glioma

Summary: this clinical trial aims to investigate the efficiency and safety of laser interstitial thermal therapy (litt) in recurrent high-grade glioma (rhgg) patients. the main questions it aims to answer are: * the litt would increase the progression-free survival and overall survival of rhgg patients compared to other treatments. * the litt is safe and applicable to rhgg patients participants will be randomized to the intervention group (litt) or control group at a ratio of 2:1. the intervention group patients will receive litt. the control group will be treated with any other treatment. the primary outcome of this trial is progression-free survival. the estimated sample size is 135, 90 in the litt group and 45 in the control group.


Eligibility criteria:
inclusion criteria: 1. aged 18 years old or above; 2. patients with previous pathological diagnosis of 2021 world health organization classification of central nervous system tumors (who cns5) grade 3 or 4 glioma and received standard treatment; 3. meet any of the following: 1. meets the disease progression criteria in the response evaluation of neuro-oncology (rano 2.0) criteria; 2. at least one image other than t1 contrast indicates progression; 3. pathology shows progression or recurrence; 4. other progress determined by the clinical events committee (cec); 4. all tumor lesions are located supratentorial and the maximum cross-sectional short-axis length in the t1 contrast is ≤30 mm; 5. karnofsky score (kps) ≥ 60 and the patient can tolerate the intervention; 6. the subjects or their agent can understand the purpose of the trial, show sufficient compliance with the trial protocol, and sign the informed consent form. exclusion criteria: 1. patients may benefit from other treatments or may not benefit from this trial; 2. no more than three months since the patient underwent craniotomy; 3. mri contrast cannot be performed; 4. severe coagulation disorder; 5. women who are pregnant, lactating, or planning to become pregnant within 6 months; 6. participated in any other clinical trials of drugs or medical devices within 3 months; 7. combined diseases that may interfere with treatment or prognosis assessment; 8. refuse or unlikely to complete follow-up assessment; 9. other circumstances in which the researcher deems it inappropriate to participate in this clinical trial.

Keywords: laser interstitial thermal therapy recurrent high grade glioma
determining clinical profile of parkinson's disease among egyptian population

Conditions: Parkinson's Disease

Summary: parkinson's disease is the second most common neurodegenerative disease affecting about 1-3% of population above 60 years. recently, non-motor symptoms are getting more attention in pd management. the pattern of pd onset and clinical course differ from one population to another. many studies have been conducted to determine the clinical profile of pd in populations worldwide. however, no similar studies have been conducted in egypt. therefore, the investigators will conduct a nation-wide, collaborative, cross sectional study to determine the pattern of parkinson's disease onset, clinical course, and non-motor symptoms among egyptian population.


Eligibility criteria:
inclusion criteria: * patients who meet the parkinson's disease criteria of united kingdom brain bank within the study centres. exclusion criteria: * patients with vascular parkinsonism (history of stroke) * patients with treatment induced parkinsonism * patients with history of dopaminergic neurotoxin (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)
effect of brainphyt high dose on cognitive function in healthy older individuals

Conditions: Age-associated Memory Impairment

Summary: the purpose of this study is to evaluate if brainphyt, a microalgae based ingredient may affect cognitive function parameters in older healthy individuals with evidence of age-related cognitive decline. in a double blind, randomized manner, 40 free living males and females between 55 to 75 years with age-associated memory decline will ingest brainphyt supplement or placebo for 12 weeks. cognitive function battery will be realized after 4 and 12 weeks of supplementation.


Eligibility criteria:
inclusion criteria: * be able to give written informed consent and to consume the investigational product daily for the duration of the study. * healthy males and females aged ≥ 55 and ≤ 75 years old. * body-mass index between 18.5 and 35.0 kg/m2 * is free-living (living in a private home, alone or with family, and able to maintain their health and hygiene without assistance). * have age-associated memory impairment (aami) based on the following national institute of mental health criteria, specified as scoring: 1. absence of dementia as determined by a score of \>24 on the mini mental state examination (mmse). 2. ≤29 or ≤9 on the vpa i and ii portions of the wechsler memory scale iv, respectively 3. a score on the mac-q of ≥25. * is in general good health, as determined by the investigator * ability to comply and understand the cognitive function practice tests * willing to maintain their habitual diet and exercise routines. * willing to maintain consistent sleep duration the evening before study visits. exclusion criteria: * use of medications or supplements known to alter cognitive function within past 2 weeks * abnormal clinical laboratory test that may affect study outcome. * history or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, biliary, gastrointestinal, pancreatic, or neurological disorders (including sleep disorders, head injuries, alzheimer's disease, parkinson's disease, stroke, inflammatory brain disease * history or presence of cancer, except nonmelanoma skin cancer * uncontrolled hypertension/diabetes * history of depression within past 24 months or use of psychotropic medications within 1 month of screening * planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study. * history within previous 12 months of alcohol or substance abuse. * history of heavy smoking (\>1 pack/day) within past 3 months

Keywords: elderly microalgae cognitive function inflammation
healey als platform trial - regimen b verdiperstat

Conditions: Amyotrophic Lateral Sclerosis

Summary: the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. regimen b will evaluate the safety and efficacy of a single study drug, verdiperstat, in participants with als.

the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. this trial is designed as a perpetual platform trial. this means that there is a single master protocol dictating the conduct of the trial. the healey als platform trial master protocol is registered as nct04297683. once a participant enrolls into the master protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. all participants will have an equal chance of being randomized to any currently enrolling regimen. if a participant is randomized to regimen b - verdiperstat, the participant will complete a screening visit to assess additional regimen b eligibility criteria. once regimen b eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active verdiperstat or matching placebo. regimen b will enroll by invitation as participants may not choose to enroll in regimen b. participants must first enroll into the master protocol and be eligible to participate in the master protocol before being able to be randomly assigned to regimen b. for a list of enrolling sites, please see the healey als platform trial master protocol under nct04297683.

Eligibility criteria:
inclusion criteria: * no additional inclusion criteria beyond the inclusion criteria specified in the master protocol (nct nct04297683). exclusion criteria: * the following exclusion criteria are in addition to the exclusion criteria specified in the master protocol (nct nct04297683). 1. participants who are taking strong inhibitors of cyp1a2 (i.e., ciprofloxacin, enoxacin, fluvoxamine, zafirlukast) for chronic/long-term use defined as more than two weeks. 2. participants who are taking strong inhibitors of cyp3a4 (i.e., conivaptan, itraconazole, ketoconazole, posaconazole, troleandomycin, voriconazole, clarithromycin, diltiazem, idelalisib, nefazodone, and certain antiviral agents \[cobicistat, danoprevir, ritonavir, elvitegravir, indinavir, lopinavir, paritaprevir, ombitasavir, dasabuvir, saquinavir, tipranavir, nelfinavir\]) for chronic/long-term use defined as more than two weeks. note: topical antifungal use is not exclusionary. participants should not consume large quantities of grapefruit juice (more than 8oz per day) on a regular basis.

Keywords: als placebo-controlled double-blind regimen specific appendix lou gehrig's disease verdiperstat biohaven pharmaceuticals
gut microbiota in chronic gi diseases

Conditions: Microbiota

Summary: the study involves characterizing the microbiota of patients with ibs, functional diarrhea, ibd, severe motility disorders and celiac disease. this will be complemented by a translational phase of human-mouse hybrid experiments in which germ-free mice will be colonized with feces from these patients with different gi disease and non-disease controls and we will compare symptoms, microbiota composition and histological changes in the gut and in the brain of the mice.

a complex community of microbes collectively referred to as microbiota, inhabit the human body. the intestinal microbiota is a diverse and dynamic ecosystem, which has developed a mutualistic relationship with its host and plays a crucial role in the development of the host's innate and adaptive immune responses. this ecosystem serves the host by protecting against pathogens, harvesting otherwise inaccessible nutrients, aiding in neutralization of drugs and carcinogens, and affecting the metabolism of lipids. gut bacteria modulate intestinal motility, barrier function and visceral perception. a better understanding of the role of microbiota in the proposed gi diseases will have profound impact in the characterization of future biomarkers and has also potential treatment implications. as the microbiota may be disturbed in the mentioned gi conditions, a possible treatment approach could be to correct dysbiosis either by the administration of an antibiotic or a preparation of 'beneficial' bacteria (probiotics) according to each bacteria profile. general objective the objective of this study is to identify different patterns of intestinal microbiota in patients diagnosed with inflammatory bowel disease, microscopic colitis, functional diarrhea, severe motility disorders, celiac disease and irritable bowel syndrome and to compare it with non-disease controls, by assessing data (questionnaires) and samples (stool, blood and tissue) from single time point (endoscopy/colonoscopy appointment).

Eligibility criteria:
inclusion criteria: * diagnosis of ibd, active celiac disease (attg positive + endoscopic view and histological findings compatible), ibs (rome iv criteria or physician diagnosis) severe motility disorders (severe constipation, severe functional dyspepsia) gluten sensitivity (ibs diarrhea predominant with positive anti gliadin antibodies and negative attg), functional diarrhea (rome iv criteria), anal fissure and/or fistula or non-disease control individual or 1st degree family member of celiac patient. * willingness to participate * signed informed consent exclusion criteria: * antibiotics in the last month * probiotics in the previous month

Keywords: microbiota chronic gastrointestinal disorders colonization metabolites
olive leaf extracts in the control of cardiovascular risk

Conditions: Diabetes Mellitus, Type 2; Hypertension

Summary: this study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the chu fb monastir and diabetology consultation, jemmal hospital). patients over 18 years of age with: 1. arterial hypertension (hypertension). 2. or diabetes. 3. or one or more other cardiovascular risk factors (aha, esc) or risk of cardiovascular disease\> 20% according to the framingham scale (apart from hypertension and diabetes were included.

this study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the gr2 study) and 2 external consultations (endocrinology of the chu fb monastir and diabetology consultation, jemmal hospital). all the population will benifit of a biological assessment which include: * complete lipid profile, blood sugar, creatinine * hba1c (if the patient is diabetic). * inflammatory assessment: reactive protein c three populations will be randomized: 1. the population of patients with hypertension. 2. the population with diabetes. 3. the population of patients with other risk factors with a framingham\> 20% in each study population, the patient will be assigned to one of two treatments (atherolive or placebo). the study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months. the placebo will be prescribed identically. for patients in the hypertension group: a blood pressure or glycemic holter will be carried out for 24 hours respectively and diabetics. the raw data (hourly averages) are stored on a computer . for diabetic patients: continuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. these patients will be equipped with an ipro continuous glycemic monitoring for other patients (framingham\> 20%) for this group, the initial assessment will also include a specific assessment. assessment of endothelial function by the digital plethysmography method to measure flow-mediated dilation (fmd or flow-mediated dilation expressed by the rhi) and specific biological assesement ( willebrand factor, homocystein )

Eligibility criteria:
inclusion criteria: * patients over 18 years of age with: 1. arterial hypertension (hypertension). 2. or diabetes. 3. or one or more other cardiovascular risk factors (aha, esc) or risk of cardiovascular disease\> 20% according to the framingham scale (apart from hypertension and diabetes. criteria exclusion: -. exclusion criteria: none.

Keywords: diabetes hypertension atherolive
treatment of nafld with two different diets

Conditions: NAFLD

Summary: the impact of popular diets on liver-related health is unclear. in this randomized, controlled trial, patients with nafld will be randomized to one of two popular diets or a placebo diet.

subjects will include patients with mri-verified nafld, with no concurrent liver diseases. randomization will be done to either a control diet, the 5:2 diet or a low-carb-high-fat diet. the subjects will follow the diet for three months, after which a new mri is performed. main outcomes measure is reduction in liver fat.

Eligibility criteria:
inclusion criteria: * known nafld exclusion criteria: * other forms of liver disease * bolus insulin treatment * cirrhosis

Keywords: reduction of liver fat
study to evaluate the safety, tolerability and pharmacokinetics of repeated doses of pf-04958242 in healthy volunteers

Conditions: Schizophrenia

Summary: this study aims to assess the safety, tolerability, and pharmacokinetics of pf-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.

this study was previously posted by pfizer, inc. sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non-child bearing potential body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * history of seizures or of a condition with risk of seizures * pregnant or nursing females, and females of child bearing potential

Keywords: pf-04958242 multiple dose safety schizophrenia