Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of pf-06818883 in healthy subjects

Conditions: Healthy

Summary: safety, tolerability and pharmacokinetics of pf-06818883


Eligibility criteria:
inclusion criteria: * healthy female subjects of nonchildbearing potential and/or male subjects * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study * subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * any condition possibly affecting the placement of an intravenous drug administration line. * a confirmed positive urine drug screen * history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day * treatment with an investigational drug within 30 days (or as determined by the local requirement) * screening supine blood pressure \>140 mm hg (systolic) or \<90 mm hg (diastolic), following at least 5 minutes of supine rest * screening supine 12-lead ecg demonstrating qtc \>450 msec or a qrs interval \>120 msec. * blood donation (excluding plasma donations) of approximately 1 pint (500 ml) or more within 60 days prior to dosing. * history of sensitivity to heparin or heparin-induced thrombocytopenia * history of human immunodeficiency virus (hiv), hepatitis b or c; positive testing for hiv, hepatitis b surface antigen (hepbsag), hepatitis b core antibody (hepbcab) or hepatitis c antibody (hcvab). * other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product

Keywords: acute neuroinflammatory
ceramic modular dual mobility in primary total hip arthroplasty (tha)

Conditions: Coxarthrosis; Primary

Summary: a randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary tha in a cementless acetabular cup

the aim of this study is to show in a randomized controlled trial that cobalt and chromium ion serum levels are comparable to the metal ion levels in patients with standard articulation with metal head. the metal on polyethylene articulation is accepted as standard articulation since many decades, and which is currently in the czech republic the most used combination. most studies which focused on the topic of metal ion release from modular dual mobility systems do not present results of a control group with standard articulation hip implants.

Eligibility criteria:
inclusion criteria: * primary coxarthrosis patients indicated for cementless total hip arthroplasty * written informed patient consent exclusion criteria: * hip trauma or revision surgery * rheumatoid or neurologic disease * bmi \>35 * ongoing oncologic therapy * preoperatively elevated co or cr serum levels \>1.0 µg/l * patients with other joint implants, or anticipated need for another joint replacement surgery within the study period * acetabular cup size \<52 expected * patients not able to mentally or physically comply with the study demands and follow-up visits * patients \<18 years at surgery * pregnancy

Keywords: dual mobility cup total hip arthroplasty
evaluation of the neurological and psychiatric adverse events of dolutegravir and bictegravir in real life

Conditions: HIV+ Patients

Summary: the neurological and psychiatric adverse effects of antiretroviral drugs is a concern for clinicians and people living with hiv. in addition, clinical trials conducted prior to market authorization often have stric inclusion and exclusion criteria in terms of age, co-morbidity or co-medication, and the patients included in the studies are not always representative of the population for whom the drugs will be prescribed in real life. we propose a prospective cohort study to assess the occurrence of neurological and psychiatric adverse events in hiv+ patients starting an association with dolutegravir or bictegravir. patients will be included on the day dolutegravir or bictegravir is prescribed. neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hiv-infected * initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir exclusion criteria: * intolerance to dolutegravir or bictegravir * addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles ("poppers") and occasional recreational cannabis * alcohol consumption \>10 standard drinks/week * active hcv coinfection * pregnant or breastfeeding woman

Keywords: dolutegravir dictegravir neurological disorder psychiatric disorder hiv integrase inhibitors adverse drug event
study of the product qgc001 as a single dose and multiple doses administered orally to healthy adult subjects

Conditions: Essential Hypertension

Summary: 1qg2 is a phase 1 study aiming to assess the safety and tolerability of ascending single/multiple oral doses (sad \& mad) in healthy young subjects, the preliminary food interaction and the effect of qgc001 on blood pressure and heart rate, but also to determine pharmacokinetic preliminary profiles of qgc001 and its metabolite ec33 and pharmacodynamic preliminary profiles of qgc001 and its metabolite ec33 especially effects on the renin-angiotensin-aldosterone and copeptin systems.


Eligibility criteria:
inclusion criteria: * caucasian, male healthy subjects of 18 to 45 years of age (inclusive). * body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening. * subjects will sign and date an informed consent form before any study-specific screening procedure is performed. * healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ecg readings. * non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay. * have a high probability for compliance with and completion of the study. exclusion criteria: * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy. * acute disease state within 7 days before study day 1. * history of drug abuse within 1 year before study day 1. * history of alcoholism within 1 year before day 1. consumption of more than 50 g of ethanol per day. * positive serologic findings for human immunodeficiency virus antibodies, hepatitis b surface antigen, and/or hepatitis c virus antibodies. * positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, mdma) * history of any clinically important drug allergy. * prohibited treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration. * consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1. * use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen \[paracetamol\], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration. * donation of blood (i.e. 450 ml) within 90 days before study day 1.
laparoscopic sacrocolpopexy versus pops in the management of pelvic prolapse

Conditions: Pelvic Organ Prolapse

Summary: this is the first study comparing the laparoscopic sacropexy with pelvic organs prolapse suspension (pops) to treat pelvic organ prolapse. this prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.


Eligibility criteria:
inclusion criteria: * patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence exclusion criteria: * age \> 70 years * severe cardiovascular or respiratory disease * pregnancy * previous surgical procedure for pop correction
the effect of prebiotic b-gos on the immune function, metabolism and gut microbiota of elderly people

Conditions: Immunosenescence

Summary: the purpose of this study is to determine the effects of prebiotic b-gos on the immune function, metabolism and gut microbiota of elderly people


Eligibility criteria:
inclusion criteria: * aged between 65 and 80 years of age. * in good general health * the volunteer has given written informed consent to participate and is willing to participate in the entire study. exclusion criteria: * history or evidence of disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years. * family history of colorectal cancer in under 50's * consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks. * former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study (please note sensory evaluations are still permitted). * undergone surgical resection of any part of the bowel. * history of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma). * smoker * lactose intolerant * allergic to gluten * currently prescribed immunosuppressive drugs. participants will be required to withdraw should they begin taking any of the ineligible medication. * intention to use regularly other medication which affects gastrointestinal motility and/or perception. * history of alcohol or drug misuse. * suffer from any major conditions involving the following: head, ears, eyes, nose and throat dermatological/connective tissue coeliac disease neurological lymphatic urogenital/rectal gastroenterological abdominal respiratory cardiovascular incontinence
bioequivalence study of cephalexin tablets 1g

Conditions: Infections, Respiratory Tract

Summary: the objective of this study was to confirm if two formulations of cephalexin tablets are bioequivalent. test product was ceporex® (1 g cephalexin; glaxosmithkline) and reference product keflex® (1 g cephalexin; eli lilly). the single dosage was one tablet. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 26 healthy volunteers, both genders, adults between 18-40 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: free will participation according to mexican regulation, helsinki declaration, and good clinical practice. healthy, between 18 and 40 years. body mass index between 19 and 27 in good health by complete medical history and laboratory tests. blood pressure 130-90/ 90-60 mm hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, hepatitis b and c antigens, hiv, urinalysis, anti-doping, pregnancy, electrocardiogram) - exclusion criteria: alteration of vital signs not complying with inclusion criteria history of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. those suffering from muscular trauma 21 days before the beginning of the study. requirement of any kind of medication during the course of the study, except study medication. history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study. hospitalization for any cause in the seven months before the beginning of the study. administration of investigational drugs in the 60 days before the study. allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study. blood donation or loss =\> 450 ml in the 60 days before the beginning of the study. history of drug or alcohol abuse. positive pregnancy test. special diet requirement, for instance vegetarian diet. inability to understand nature, aims, and possible consequences of the study. evidence of non-cooperative attitude during the study. -

Keywords: pharmacokinetics bioequivalence mexico cephalexin
biomarker analysis of stress

Conditions: Sepsis

Summary: physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. the stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. the ability of different forms of stress to alter physiological processes (body functions) will be assessed by monitoring the blood profile of cell numbers and functions as well as the plasma protein content. it is anticipated that the pattern of blood changes will reflect the types of stress and the degree to which body functions could be altered by the stress.

blood will be collected from patients with an ongoing infection that has lead to sepsis (systemic inflammation) as a index of major stress. the blood will be analyzed for the types of proteins that could alter immune system functions and affect organ functions, including cardiovascular effects due to blood vessel changes. this will be followed by analysis of stress effects on mice and mice that have been generated with human immune cells. the ability of stress to alter blood patterns will also be examined in mice with genetic modification of metallothionein expression, which is believe to influence oxidative stress.

Eligibility criteria:
inclusion criteria: * patients at wadsworth center with sepsis

Keywords: stress
tumour registry breast cancer

Conditions: Breast Cancer

Summary: the registry aims to collect and analyse information on the antineoplastic treatment of breast cancer in daily routine practice of office-based and clinic-based medical oncologists in germany.

the tmk is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of breast cancer in germany. the registry will follow patients for up to five years. it will identify common therapeutic sequences and changes in the treatment of the disease. at inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. during the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented. the impact of nutrition (manut) and physical activity (manut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (matox) and the multiple patient-reported outcomes (malife).

Eligibility criteria:
inclusion criteria: * breast cancer * 18 years and older * antineoplastic or antihormonal treatment exclusion criteria: * no breast cancer * below 18 years * no antineoplastic or antihormonal treatment

Keywords: breast cancer advanced breast cancer epidemiology registry health services research germany palliative treatment adjuvant drug therapy nutrition assessment physical activity
a study of molecular residual, dynamic monitoring and recurrence of stage iii driver mutated nsclc

Conditions: Non Small Cell Lung Cancer

Summary: the goal of this prospective, observational study is to explore the value of dynamic monitoring of minimal residual lesions in driver mutated stage iii nsclc for disease recurrence and prognosis assessment. the main question it aims to answer is: 1) whether mrd(minimal residual disease) status can predict recurrence events in stage iii driven-mutant nsclc in advance

non-small cell lung cancer in stage iii (iiia, iiiib, iiic) has a low survival rate, and the 5-year survival rate of stage iii patients is less than 30%. in clinical studies of non-small cell lung cancer operable stage iii driver gene mutations, postoperative targeted adjuvant therapy improves patient survival relative to postoperative chemotherapy. the tumor patients still have residual malignant tumor cells in vivo during or after treatment, and minimal residual foci are released during cell necrosis or apoptosis. early the domestic large lung cancer mrd((minimal residual disease)) prospective research results, for the first time through the dynamic monitoring of mrd high negative predictive value defined the potential cure population, found that postoperative mrd negative population could not benefit from adjuvant therapy, clarify the existence of preoperative non-shedding tumor does not affect postoperative mrd monitoring, and exploring the stage ii / iii mrd turn high risk of postoperative lung cancer. therefore, for nearly 70% of patients with driver gene-positive non-small-cell lung cancer, detecting clear driver gene mutations in the peripheral blood is expected to stratify the risk of recurrence/progression.

Eligibility criteria:
inclusion criteria: 1. patients with stage iii non-small cell lung cancer were confirmed by imaging and histological biopsy 2. age≥ 18 3. ecog ps:0-1 4. tumor molecular testing by ebus or biopsy confirmed positive for one or more of the following driver genes:egfr\\alk\\ros1\\ret\\kras\\pik3ca\\braf\\her2\\met 5. patients who met and agreed to surgery or radical chemoradiotherapy, and the remaining samples after cutting tissue sections did not affect the possible further clinical treatment of the subject 6. provide 20 ml peripheral blood samples periodically 7. the subjects volunteered to join the study, and signed the informed consent form, with good compliance, and actively cooperated with the hospital for routine clinical diagnosis and treatment follow-up exclusion criteria: 1. patients with other malignancies within 5 years 2. according to the investigator, the patient also had other diseases that may affect the follow-up and short-term survival 3. the subject had other factors that may lead to the termination of the study, such as other serious diseases (including mental illness), serious laboratory abnormalities, and family or social factors that affected the safety of the subject, or the collection of data and samples
a study of the efficacy, safety and tolerability profile of csl limited's influenza virus vaccine (csl's ivv) administered intramuscularly in healthy adults

Conditions: Influenza

Summary: this study will assess the efficacy, safety and tolerability profile of csl's influenza vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.


Eligibility criteria:
inclusion criteria: * healthy males and females aged ≥ 18 to \< 65 years at the time of vaccination * non pregnant/ non lactating females exclusion criteria: * hypersensitivity to influenza vaccine or allergy to any components of the study vaccines * vaccination against influenza in the previous 6 months * acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality * known history of guillain-barré syndrome; * clinical signs of active infection and/or an oral temperature of ≥ 37.8 oc. * history of neurological disorders or seizures * confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder * current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids * administration of immunoglobulins and/or any blood products; * participation in a clinical trial or use of an investigational compound; * vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior; * participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.