Kornimate/medical-research-clean huggingface dataset:
a relative bioavailability and food-effect study of the fixed dose combination of gsk3640254 and dolutegravir (dtg) in healthy participants

Conditions: HIV Infections

Summary: this is a two part study to compare the relative bioavailability (ba) of 2 fixed dose combinations (fdcs) of gsk3640254/dtg with gsk3640254 and dtg administered together as single agents (part 1) and to assess the effect of food on the pharmacokinetic (pk) of the selected fdc of gsk3640254/dtg (part 2).


Eligibility criteria:
inclusion criteria: * participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent. * participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ecg). * participants capable of giving signed informed consent. exclusion criteria: * current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones). * a pre-existing condition interfering with normal gastro intestinal anatomy or motility (for example \[e.g.\], gastroesophageal reflux disease, gastric ulcers, gastritis) or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention. * prior cholecystectomy surgery (prior appendectomy is acceptable). * clinically significant illness, including viral syndromes within 3 weeks of dosing. * participant with known or suspected active coronavirus disease (covid)-19 infection or contact with an individual with known covid-19, within 14 days of study enrollment. * current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational covid vaccine) or any other type of medical research. * prior exposure to gsk3640254 or prior intolerance to dtg in this or another clinical study. * any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered columbia suicide severity rating scale (c-ssrs). * any significant arrhythmia or ecg finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular block, or conduction abnormality) which, in the opinion of the investigator or viiv healthcare (vh)/glaxosmithkline (gsk) medical monitor, will interfere with the safety for the individual participant.

Keywords: dolutegravir gsk3640254 fixed dose combinations bioavailability
patient positioning during colonoscopy: effects on safety and diagnostic outcome

Conditions: Sedation Problems; Breathing Complications

Summary: the purpose of this study is to determine the effects of patient positioning during colonoscopy on patient safety and diagnostic outcome.

sedative drugs are widely-used during endoscopic procedures. the administration of these drugs contain the potential hazard of breathing and cardiac complications. moreover it is well-known that the dorsal position is in some ways associated to breathing problems while patients are asleep. we assume this also to be true related to short anesthesia during colonoscopy. patient positioning may therefore have a positive effect on the safety during colonoscopy by reducing the absolute time that sedated patients spend in a supine position. we compiled a randomized trial which compares the appearance of breathing and cardiovascular complications by performing colonoscopy either in a dorsal or in a left lateral position.

Eligibility criteria:
inclusion criteria: * colonoscopy indicated exclusion criteria: * patient denies sedation * prior saturation \< 90% * prior heart rate \< 50 bpm * prior blood pressure \< 90 mmhg

Keywords: sedation endoscopy patient positioning hypoxemia
prevalence of spontaneous pneumothorax in bhd

Conditions: Spontaneous Pneumothorax

Summary: to assess the prevalence of bhd (birt-hogg-dubé syndrome) among patients with spontaneous pneumothorax. patients who were treated for primary spontaneous pneumothorax in rijnstate hospital are to be included. patients will receive a questionnaire. when given consent, the investigators will invite them for a one-time visit to the out-patient clinic. patients will be asked for a blood sample to determine pathogenic flcn (folliculin) mutations and a pulmonary ct scan for evaluation of presence of lung cysts.

based on the results of the pilot study in vumc \*free university medical center), in which 3 out of 40 tested patients had a pathological flcn mutation, the investigators decided to extend the study to a second center; rijnstate hospital arnhem. in this hospital a retrospective search was performed; patients who were treated for primary spontaneous pneumothorax were included. in the dossiers the investigators searched for medical history, pneumothorax side and recurrence, diagnostic imaging, treatment, co-morbidity, complications of treatment, skin abnormalities, kidney disease, smoking behavior, medication, and familial incidence of pneumothorax and other diseases. patients will receive a letter with explanation of the research and a questionnaire in which the investigators ask them their about the medical status, co-morbidity, pneumothorax (number and side), smoking behavior, use of drugs, familial incidence of pneumothorax and other diseases. the population will be formed out of patients who have returned the fully filled in questionnaire and who have given permission to receive information for further research. this further information will consist of an information letter on bhd syndrome and a consent form for a one-time visit to the out-patient clinic of rijnstate hospital. investigators expect that about 200 patients will return the fully filled in questionnaire and give their consent for further research. in a one-time visit in out-patient clinic, there will be given personal information on bhd syndrome and there will be performed physical examination for finding fibrofolliculomas. a pulmonary ct scan for evaluation of presence of lung cysts will be performed. two samples of venous blood will be collected to access information on dna diagnostics for pathogenic flcn mutations. these are associated with the bhd syndrome. this last diagnostic testing will be performed in vumc (vrije universiteit medisch centrum or free university medical centre).

Eligibility criteria:
inclusion criteria: * treated in rijnstate hospital for primary spontaneous pneumothorax * informed consent exclusion criteria: * secondary or iatrogenic pneumothorax

Keywords: spontaneous pneumothorax familial pneumothorax birt-hogg-dube syndrome prevalence flcn mutation lung cysts bhd inherited disease genetic disease primary pneumothorax cat scan ct scan
study of difluprednate in the treatment of inflammation following ocular surgery (st-601a-002b)

Conditions: Inflammation

Summary: the purpose of this phase iii study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.


Eligibility criteria:
inclusion criteria: * unilateral ocular surgery in the day prior to study enrollment. * anterior chamber cell grade ≥ "2" on the day after surgery (day 1). * aged 2 years or older on the day of consent. * negative urine pregnancy test on day 1 for postmenarchal subjects; negative urine pregnancy test for premenarchal subjects at the investigator's discretion. * provide signed written consent prior to entering the study or signed written consent from parent or legal guardian if subject is a minor and signed assent from minor subject, if appropriate. presurgical exclusion criteria: * systemic administration of any corticosteroid in the 2 weeks prior to study enrollment. * periocular injection in the study eye of any corticosteroid solution within 4 weeks prior to instillation of the study drug, or of any corticosteroid depot within 2 months prior to instillation of the study drug. * instillation of any topical ocular corticosteroid or nsaid within 24 hours prior to instillation of the study drug or during the course of the study, with the exception of presurgical administration of a topical nsaid to prevent miosis. * any history of glaucoma or ocular hypertension in the study eye. * history or presence of endogenous uveitis. * any current corneal abrasion or ulceration. * any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease. * allergy to similar drugs, such as other corticosteroids. * history of steroid-related iop increase. * scheduled surgery on the contralateral eye during the treatment period. * unwilling to discontinue use of contact lenses during the study period. * pregnancy or lactation. * participation in any study of an investigational topical or systemic new drug or device within 30 days prior to screening, or at any time during the study. * prior participation in the study described in this protocol. * unable or unwilling to give signed informed consent prior to participation in any study related procedures. postsurgical exclusion criteria: * ocular hemorrhage which interferes with evaluation of postsurgery inflammation. * injection of gas into the vitreous body during surgery. * presence of iop ≥24 mm hg on day 1 after surgery.
sympathetic mechanisms in obesity-crossover design

Conditions: Obesity; Hypertension

Summary: we will study obese hypertensive subjects in a randomized, crossover study to determine if two weeks sympathetic blockade improves endogenous glucose production. subjects will be studied on 3 different occasions after two weeks of receiving either placebo, amlodipine (vasodilator arm) or moxonidine (study arm). the order of the studies will be determined using computer-generated randomization. patients will be blinded as to which treatment they are receiving on each day. an investigator blinded to the treatment assignment will perform the analysis of the data.


Eligibility criteria:
inclusion criteria: * males and females of all races between 18 and 65 years of age * hypertension defined by two or more properly measured seated blood pressure readings \>130/85 mmhg or currently on antihypertensive medication. * obesity will be defined as having a body mass index (bmi) ≥ 30 kg/m2. * able and willing to provide informed consent. exclusion criteria: * pregnancy or breast feeding * current smokers or history of heavy smoking (\>2 packs/day) * history of alcohol or drug abuse * previous allergic reaction to study medications * type i diabetes. * cardiovascular disease other than hypertension such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (lv hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy * history of serious cerebrovascular disease such as cerebral hemorrhage, stroke, or transient ischemic attack * history or presence of immunological or hematological disorders * impaired renal function * treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month) * treatment with any investigational drug in the 1 month preceding the study * inability to give, or withdraw, informed consent * other factors which in the investigator's opinion would prevent the subject from completing the protocol (i.e., clinically significant abnormalities on clinical, mental examination or laboratory testing or inability to comply with protocol, inability to find iv access)
sleep disturbances as a non-traditional risk factor in chronic kidney disease- university of illinois

Conditions: Chronic Kidney Disease

Summary: this study will help determine the relationship between impaired sleep and chronic kidney disease, specifically to determine if sleep disturbances are a risk factor for worsening kidney function.


Eligibility criteria:
inclusion criteria: * ckd subjects will be participants in a larger study, cric, at the university of illinois, chicago * 30 healthy controls age and gender matched to 30 ckd subjects, regular bedtimes of at least 6h/night, sedentary lifestyle exclusion criteria: * diabetes * current or previous dialysis for more than 1 month * uncontrolled hypertension * heart failure * liver disease * hiv * hemoglobin \< 10.5 g/dl * treatment with eprocrit, epogen, or aranesp * bone or organ transplant, * use of immunosuppressive drugs within past 6 months * current oral contraceptive use * current pregnancy * chemotherapy for malignancy within past 2 years

Keywords: sleep ckd kidney psg polysomnography decreased sleep time decreased sleep quality
early rehabilitation of copd patients in icu

Conditions: Chronic Obstructive Pulmonary Disease; Acute Respiratory Failure

Summary: twenty per cent of the intensive care patients mechanically ventilated suffer from chronic obstructive pulmonary disease (copd). these patients stay longer in intensive care which is more costly and they are more prone to nosocomial infection.in addition, they are longer bedridden and they develop muscular weakness.prolonged inactivity results in respiratory and skeletal muscle weakness which curtails simple daily activity.the principal purpose of this study is to compare two types of muscular rehabilitation (electrical stimulation of the thigh and/or cycloergometer training) to classic passive mobilization of the leg.the second purpose is to analyse the effects of each type of rehabilitation on muscular fiber (structural and functional analysis) by muscular biopsies.two hundred forty copd patients admitted in the intensive care unit for acute respiratory failure will be randomized in 4: 1 fashion to receive passive mobilization of the legs(group 1, n=60), electrical stimulation of the thigh (group 2, n=60), cycloergometer training (group 3, n=60) or electrical stimulation of the thigh and cycloergometer training(group 4, n=60).the rehabilitation program will last 4 weeks with 5 sessions per week.in each group of patients, muscular biopsies will be done under local anaesthesia at the beginning and end of the rehabilitation programme and when they are discharged from the service.


Eligibility criteria:
inclusion criteria: * patient older than 18 years of age * chronic obstructive pulmonary disease * intubated with mechanical ventilation * patients without sedation or catecholamine * 2 previous spontaneous breathing trial at 24 hour intervals with t-piece having been unsuccessful * conscious and cooperative state * ability for the patient to sit in a armchair exclusion criteria: * non chronic obstructive pulmonary disease * lack of patient involvement * minor patients * patients under guardianship * unconscious and non cooperative state * patients unable to ride in a wheelchair * patients not affiliated with a social security system * patients under justice safeguard * patients under curator ship

Keywords: copd: chronic obstructive pulmonary disease and acute respiratory failure
a study to explore clinical characteristics and prognoses of n2 patients with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: a study to compare patient survivals in the n2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases

a multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the n2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.

Eligibility criteria:
inclusion criteria: * patients with surgeries from 2014 to 2017; * pathologically diagnosed patients with non-small cell lung cancer; * age \> 18 years old; * patients with chest surgeries before hospitalization; * patients with n2 lymph nodes (+) after surgeries who received lymphadenectomy (group 10 and 11 lymph nodes); exclusion criteria: - patients with radiotherapies, chemotherapies and biological therapies for tumors

Keywords: chinese, real-world evidences, nsclc, lymph skip metastases
mehri turki webbed neck classification

Conditions: Turner Syndrome; Pterygium Colli; Web Neck; Klippel-Feil Syndrome

Summary: this study aims to identify all types of congenital neck deformities called " webbed neck ". through a literature survey, the researcher selected 27 articles describing the surgical treatment of the webbed neck, but without considering the varieties of this deformity. for this reason, the researcher studied all the reported cases from which she developed a classification containing 4 types of webbed necks allowing the use of the most suitable technique to enhance the surgical outcomes.

through a literature survey of 27 selected articles (from pubmed database and clarivate web of science). the publication years ranged from 1937 to 2020 and the number of patients reported to have undergone surgery was 78 patients. the webbed neck is a noticeable congenital deformity mainly observed in turner syndrome. it consists of a bilateral fold extending from the mastoid to the acromion with several distinctions as described in mehri turki's webbed neck classification as follows: type 1: the fold is maintained by a fibrotic band and the posterior skin is abnormally hairy with a low hairline placement. type 2: there is no fibrotic band and the hair abnormality exists as in type 1 type 3: there is a fibrotic band and a low posterior hairline but the posterior skin is hairless type 4: the fold is maintained by a fibrotic band without hair abnormality it appears that according to the type of webbed neck, the surgical approach and surgical steps and technique will be adapted to what will be corrected. this classification is therefore crucial to guide surgeons towards the most suitable technique allowing the best results.

Eligibility criteria:
inclusion criteria: * articles with a detailed description of the surgical technique * articles reporting post-operative results * articles written in english or french exclusion criteria: * articles with incomplete descriptions of the webbed neck * articles without iconography

Keywords: webbed neck classification surgical technique
daily il-2 for steroid-refractory chronic graft-versus-host-disease

Conditions: Chronic Graft-versus-host Disease

Summary: chronic gvhd is a medical condition that may occur after a bone marrow, stem cell or cord blood transplant. the donor's immune system may recognize the your body (the host) as foreign and attempt to 'reject' it. this process is known as graft-versus-host-disease. it is thought that il-2 may help control chronic gvhd by stopping the donor's immune system from 'rejecting' your body. in this research study, we are looking to see how il-2 can be used in combination with steroids to treat cgvhd.

you will give yourself or be given il-2 daily through an injection under your skin. you should rotate the injection site, if possible. you will do this once every day for 12 weeks. you will then have 4 weeks off of il-2. during the first 6 weeks of il-2, you will continue to take steroids without changing the dose your doctor has set for you while you are on il-2. after 6 weeks of il-2 therapy, your doctor may reduce the amount of steroids you take. while you are on study, a member of the study team will examine you to evaluate your cgvhd. these assessments may include examination of your skin, joints/muscles, eyes, mouth, lungs and gastrointestinal system. you will have clinic visits for evaluation of toxicity and clinical benefit approximately every 4 weeks. you will also have immunologic assays approximately every 8 weeks. immunologic assays will measure the effect of il-2 on immune cells. you will be on the study for about 16 weeks. you may continue on study treatment for longer if you experience a clinical benefit.

Eligibility criteria:
inclusion criteria: * recipient of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens * steroid refractory cgvhd with systemic therapy onset within the prior 6 months * no more than 2 prior lines of cgvhd therapy * estimated life expectancy \> 3 months * adequate organ function exclusion criteria: * ongoing prednisone requirement \> 1 mg/kg/day (or equivalent) * concurrent use of calcineurin-inhibitors plus sirolimus * history of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura * active malignant relapse * active uncontrolled infection * uncontrolled cardiac angina or symptomatic congestive heart failure * organ transplant (allograft) recipient * hiv-positive on combination antiretroviral therapy * active hepatitis b or c * pregnant or breast-feeding

Keywords: stem cell transplant gvhd bone marrow transplant cord blood transplant regulatory t cell interleukin
dietary intervention and adults with intellectual disabilities

Conditions: Intellectual Disabilities Nutritional; Intellectual Disability

Summary: goal the overall aim of the study is to improve the health of persons with intellectual disabilities

purpose there are two main purposes of the study the first is to study the diet and heath of persons with intellectual disabilities. the second is to increase their knowledge on nutrition and health and that of service providers in municipalities housing facilities and to test, in an intervention, the effects of a method for weight reduction in adult persons with intellectual disabilities with overweight and obesity. physical activity is also an important factor in weight reduction, but this study focuses only on nutrition, to obtain new information on this one factor in weight reduction. a combined study with many changes in a short period of time is very challenging for the group in question. the vision is that results from this study will lead to improved health promotive and preventive services in the municipality in the future, to adult persons with intellectual disabilities and that this study also can have effects on services also for other groups, such as those with the fields of psychiatry and drug problems.

Eligibility criteria:
inclusion criteria: * mild intellectual disability and overweight * moderate intellectual disability and overweight exclusion criteria: * metabolic diseases * hypertension * diabetes