Kornimate/medical-research-clean huggingface dataset:
post covid-19 respiratory mechanisms and the efficacy of a breathing exercise intervention for dysregulated breathing

Conditions: COVID-19; Respiratory Disease

Summary: a pilot study to investigate the efficacy of a breathing intervention for improving persistent breathlessness due to dysregulated breathing following covid-19 when compared to usual care.

pilot rct for upto 60 subjects across 2 arms intervention a 12 session/six week, twice a week online group-based intervention based on breathing techniques including yoga practice directed by a specialist. each group will aim for between 3- 6 participants. each online session will be circa 40-50 minutes in length. this will include an introduction and warm up; breathing practice including yogic breathing and a final cool down and relaxation. sessions will run at set times to ensure efficient use of resources but will try to accommodate different time points periods of the day when patients might be functioning best. comparator a six week non-intervention (usual care) period will be recruited to, allowing a comparison to the intervention. primary co-outcomes change in * breathlessness: chronic respiratory disease questionnaire-dyspnoea domain (crq-d) * functional measure: 5 repetition chair to stand (5rcts) secondary measures include other measures of breathlessness, function, adherence and completion (see full text for detail).

Eligibility criteria:
inclusion criteria: * either hospitalised or non-hospitalised with confirmed covid-19 acute infection. * received a comprehensive clinical respiratory assessment * persisting (\>12 weeks) self-reported breathlessness (on crq-d) following covid-19 and confirmed dysregulated breathing (nijmegen questionnaire score nq \>23) * age 18 - 80 years of age * ability to give informed consent * able to understand and speak english language exclusion criteria: * severe mood disturbance that limits engagement with the intervention and study outcomes * no access to online delivery and/or it illiterate * significant diagnosed myalgic encephalitis/fibromyalgia/chronic fatigue syndrome prior to developing covid-19 * severe asthma or other chronic lung disease prior to covid-19
mk0431 and pioglitazone co-administration factorial study in patients with type 2 diabetes mellitus (0431-102 am2)

Conditions: Type 2 Diabetes Mellitus

Summary: a study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patient is highly unlikely to conceive * patient meets one of the 3 categories is naïve to all antihyperglycemic agent (aha) therapies, or is non-naïve based upon the patient's current diet, medical regimen and screening a1c patient is currently not on aha with a screening a1c \>=7.5 % and =\ =7.0 % and =\<9.0 % exclusion criteria * patient has a history of type 1 diabetes mellitus or history of ketoacidosis or has c=peptide value of =\<0.8 ng/ml * patient has previously been treated with insulin, thiazolidinedione (tzd) (rosiglitazone or pioglitazone), any dipeptidyl peptidase-4 (dpp-4) inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any dpp-4 inhibitor or incretin mimetic * patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks * patient has undergone surgery within the prior 30 days or has major surgery planned during the study * patient has a medical history of active liver disease including chronic active hepatitis b or c or symptomatic gallbladder disease including primary biliary cirrhosis * patient has received treatment with an investigational product within 12 weeks prior to visit 1
enhancing independence using group-based community interventions for healthy aging in elders: the engage pilot study

Conditions: Mobility Limitation

Summary: this study will be conducted to determine the safety and feasibility of translating a physical activity intervention (life study) into a community setting. study outcomes include physical performance, safety, and feasibility of conducting the life pa intervention in a community setting.

older adults who lose their mobility experience a poorer quality of life, are less likely to remain independent in the community and have higher rates of chronic disease, falls and mortality. recent results from the lifestyle interventions and independence for elders (life) study demonstrated that a structured program of physical activity (pa) reduced the onset of major mobility disability in at-risk older adults by up to 28% over a 2.6 year period. despite the public health significance of this study, to-date no study has attempted to translate life pa to broader populations of at-risk older adults in community-based settings. to address this knowledge gap, and to aid the design of a larger pragmatic trial of life pa in community-based settings, the investigators conducted the enhancing independence using group-based community interventions for healthy aging in elders (engage) pilot study. the investigators examined the safety and feasibility of translating life pa into the existing infrastructure of a community-based senior center. the investigators also explored the preliminary real-world effectiveness of pa on physical performance and several other important health related outcomes for older persons, including cognitive function, quality of life, depressive symptoms and frequency of falling.

Eligibility criteria:
inclusion criteria: * males and females age ≥ 65 and ≤89 years * community dwelling * short physical performance battery ≤ 9 * no participation in a structured physical activity program within the previous 3 months * willingness to be randomized and participate for 24 weeks * written permission from primary care physician * having obtained his/her informed consent exclusion criteria: * acute or terminal illness * modified mini-mental state examination score \<80(\<76 if african american)\* * myocardial infarction in the previous 6 months * symptomatic coronary artery disease * upper or lower extremity fracture in the previous 6 months * resting blood pressure \>180/100 mmhg * unable to communicate due to severe hearing loss or speech disorder * severe visual impairment that may preclude participation in the study assessments or interventions * non-english speaking
efficacy and safety of modified anti-tubercular regimens in treatment of tuberculosis in patients with underlying compensated and decompensated chronic liver disease

Conditions: Chronic Liver Disease With Tuberclosis

Summary: during the study: * subject is required to visit every week for the first 2 months and then every month till completion of study or as and when required * the usual symptomatic and supportive treatment of chronic liver disease, including use of antiviral, will be given to all patients. * effort will be made to avoid use of other hepatotoxic drug(s) during anti-tubercular treatment. * liver function tests (lft) will be done weekly during first 2 months then at one month interval or as when required. * the treatment efficacy of anti-tubercular treatment (att) will be made on the basis of clinical, biochemical, microbiological and imaging parameters at months 2, 4, 7 and 9. patients not improving at 4 weeks after initiation of treatment will be shifted to alternative regimens and will be excluded from the study.


Eligibility criteria:
inclusion criteria: * males or females subjects aged 18-75 years. * subjects with chronic liver disease (cirrhosis) * pulmonary or extra-pulmonary tuberculosis. * serum alt≤5times upper limit and serum bilirubin ≤3 mg/dl. * consent and willingness to follow-up exclusion criteria: * serum alt\>5times upper limit and serum bilirubin \>3 mg/dl. * renal failure (serum creatinine\>2mg/dl). * presence of hepatocellular carcinoma * alcoholic cirrhotic who continue to drink alcohol. * prior history of att (anti tubercular treatment) with documented hepatotoxicity. * known hypersensitivity to levofloxacin, other quinolones
intrathecal clonidine addiction for combined spinal epidural analgesia during labor

Conditions: Labor Pain

Summary: the study aims to evaluate the impact of the addition of 20 mcg of intrathecal clonidine in combined spinalepidural for labor analgesia on the local anesthetic consumption, on labor performance and on maternal fetal well-being.


Eligibility criteria:
inclusion criteria: * written maternal informed consent * singleton pregnancy * gestational age ≥ 37 weeks, * asa i * bmi \< 30 * fetus in cephalic presentation exclusion criteria: * suspect or certainty of fetal malformation, * presence of conditions such as preeclampsia, multiparity, preterm labor * history of adverse reaction to α-2 adrenergic agonists * nicotine addiction * chronic use of opioid

Keywords: clonidine, spinal injections
study of the absolute oral bioavailability of dapagliflozin in healthy subjects

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.


Eligibility criteria:
inclusion criteria: * healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ecg), and clinical laboratory evaluations will be eligible to participate in the study exclusion criteria: * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations * participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility * exposure to significant radiation within 12 months prior to admission to the clinical facility
analysis of volatile organic compounds in exhaled air and sweat: interest in rapid screening for covid-19 infection.

Conditions: Covid19

Summary: in the context of the actual pandemia of the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) which requires a better diagnostic strategy for the management of patients. the study of volatile organic compounds (voc) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. the analysis of voc can be done either by the technique of the mass spectrometry which allows the identification of each voc in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the voc without identifying them. the voc have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases. moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of sars-cov-2 infection with a specificity greater than 90%; this olfactory signature corresponds to vocs detectable by the flair of dogs (nosaïs-covid19 study). validation of the diagnostic value of voc analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a sars-cov-2 infection warrants the performance of this clinical study.


Eligibility criteria:
inclusion criteria: * subject included in the foch hospital : * patients managed at the foch hospital with rt-pcr screening for sars-cov-2 infection * healthy volunteers among the hospital staff, asymptomatic, for whom an rt-pcr sars-cov-2 is indicated or recommended. * healthy hospital volunteers vaccinated against covid (full vaccination schedule completed) * at least 18 years of age; * fluency in the french language; * have signed a consent form; * be affiliated with a health insurance plan. exclusion criteria: * pregnant woman * patient deprived of liberty by judicial or administrative decision
a randomized study of a short duration therapy for candidemia

Conditions: CANDIDEMIA

Summary: scientific justification candidemia is a major public health problem. in france, the 30-day mortality of candidemia varies from 30% to 50% depending on the need for intensive care and it has not decreased in 30 years. the duration of treatment for candidemia was set at a minimum of 14 days after the last positive blood culture following the rex trial (1) comparing the efficacy of fluconazole vs amphotericin b where the minimum duration of treatment was imposed. the risk of a too short treatment is the absence of control of the candidemia with secondary dissemination, in particular cardiac and ophthalmic. a retrospective study looking at the risk of ophthalmologic complications after candidemia found among the 21/78 treated for less than 14 days, only one case of late endophthalmitis in a patient who had only been treated for 48 hours. in addition, the prolonged duration of antifungals exposes the risk of selection of more resistant strains with a modification of the flora, with the possibility of acquiring resistance as early as 8 days of treatment with caspofungin, and has a greater liver toxicity. there is no prospective study on the direct impact of antifungal agents (type of antifungal agent and duration) on the mycobiota.


Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years old) * with an uncomplicated candidemia defined by the absence of secondary sites requiring prolonged treatment: endocarditis, ophthalmologic involvement, thrombosed catheter, arthritis, meningitis, candida abscess that cannot be drained, pyelonephritis. * without expected aplasia duration greater than 7 days * being apyretic and having a 1st negative blood culture after diagnosis * removal of the vascular catheter if present * written informed consent from the patients or his/her relatives * patients with less than 7 days of aplasia predictable exclusion criteria: * presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or the presence of secondary sites of candidemia requiring prolonged treatment * patients with more than 7 days of aplasia * candida strain resistant to the antifungal used * pregnancy, breastfeeding * hypersensitivity or previous severe adverse drug reaction to the antifungal treatments. * unwilling, in the judgment of the investigator, to comply with the protocol * patient under legal guardianship or without healthcare coverage * women with childbearing potential not using adequate contraception
observational study on the incidence of nsf in renal impaired patients following dotarem administration

Conditions: Renal Insufficiency

Summary: the main purpose of this study is to prospectively estimate the incidence of nephrogenic systemic fibrosis (nsf) in patients with moderate to severe renal impairment after administration of dotarem®

all patients will be followed up during 2 years after dotarem® administration to collect data on any suspected nsf or nsf-related symptoms

Eligibility criteria:
inclusion criteria: * patients with moderate to severe and end stage renal impairment or dialysis, scheduled for a contrast-enhanced magnetic resonance imaging (mri) with dotarem exclusion criteria: * patient who has received a gadolinium based contrast agent (gbca) within the past 12 months prior to inclusion in this study except if the gbca received is dotarem
assessment of endometrial pattern and sub-endometrial vascularity in icsi outcome

Conditions: Infertility

Summary: despite constant progress in in vitro fertilization (ivf) techniques and ovarian stimulation, pregnancy and embryo implantation rates remain modest . the phenomenon of embryo implantation depends both on the embryo itself and on endometrial receptivity

a favorable uterine medium is necessary for embryo implantation, but endometrial receptivity can be negatively affected by ovarian stimulation . study of endometrial receptivity is especially limited in the context of ivf cycles . biopsy of the endometrium cannot be considered during the treatment, and this has encouraged the development and use of ultrasonography and doppler-like non-invasive methods to evaluate ovarian response to the stimulation and uterine receptivity .

Eligibility criteria:
inclusion criteria: - maternal age from 20 to 40 years. women with bmi range from 20 - 35 women diagnosed with primary infertility exclusion criteria: maternal chronic medical disorder (diabetes mellitus or hypertension). women diagnosed with autoimmune diseases or antiphospholipid syndrome
low-dose atropine for the prevention of myopia progression in danish children

Conditions: Myopia

Summary: myopia (nearsightedness) is increasing in prevalence throughout the world. it is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. there is a direct association between the degree of myopia and the risk of complications. myopia develops in childhood and during adolescence. to prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. low-dose atropine eye drops have been shown to reduce myopia progression by 50% in asian populations but its effect in non-asian populations is unknown. the aim of this study is to investigate if low-dose atropine can reduce myopia progression in danish children and teenagers. the study is an investigator initiated randomized clinical trial conducted as a collaboration between three danish eye departments covering all of denmark.

the main hypotheses tested in this study are: * 0.01% atropine one drop nightly reduces the progression of childhood myopia in danish children. * 0.01% atropine one drop nightly is safe and with no significant side effects. * a 6-month loading dose of 0.1% atropine followed by a 0.01% atropine maintenance dose is superior to single 0.01% atropine. * 0.1% atropine one drop nightly is safe and has tolerable side effects. * the rebound effect after stopping both atropine regimens is limited. * choroidal thickness is a predictor for the progression of childhood myopia.

Eligibility criteria:
inclusion criteria: * children aged ≥6-\<9 years: myopia ≤-1 (spherical power) in at least one eye * children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye * cylinder less than 1.5 diopters exclusion criteria: * myopia related to retinal dystrophies * collagen syndroms (ehlers-danlos syndrome, marfan syndrome and stickler syndrome) * other ocular pathology (e.g., amblyopia, strabismus) * previous eye surgery * previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses * known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study * non-compliance to eye examinations * serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays
13 valent pneumococcal conjugate vaccine - follow-on study

Conditions: Pneumococcal Disease

Summary: this is a follow-on, multi-centre, open-label, clinical trial. the purpose of this trial is to investigate the concentrations of serotype-specific antibodies to igg included in pcv13 in children who have received either the pcv7 or pcv13 primary immunisation at 2, 4 and 12 months of age. we intend to recruit all interested participants who completed the wyeth-sponsored pcv13 infant trial study (6096a1-007) at selected study sites (i.e. those that recruited the majority of the children in the original study). the study will start in march 2010, at which time the eldest participants in the 6096a1-007 study will be approximately 42 months of age. there will be two visits per participant, 1 month apart from each other. at visit one, all participants will have a blood test and receive a dose of pcv13. at visit 2, all participants will have a blood test and will be offered the remaining pre-school booster vaccinations unless they have already received them.


Eligibility criteria:
inclusion criteria: 1. participant completed the wyeth-sponsored pcv13 infant trial study (6096a1-007) at one of the study sites participating in this follow-on study. 2. aged 39-46 months (inclusive) at time of enrolment. 3. available for entire study period and whose parent/legal guardian can be reached by telephone. 4. healthy children as determined by medical history, physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator. 5. parent/legal guardian must be able to complete all relevant study procedures during study participation. exclusion criteria: 1. has received further doses of pneumococcal vaccination with licensed or investigational pneumococcal vaccine other than those given as part of the wyeth-sponsored pcv13 infant trial study (6096a1-007). 2. a previous anaphylactic reaction to any vaccine or vaccine-related component. 3. contraindication to vaccination with pneumococcal conjugate vaccine. 4. bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection. 5. known or suspected immune deficiency or suppression. 6. history of culture-proven invasive disease caused by s pneumoniae. 7. major known congenital malformation or serious chronic disorder. 8. significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. 9. receipt of blood products or gamma-globulin (including hepatitis b immunoglobulin and monoclonal antibodies; eg, synagisb). 10. participation in another investigational study other than the wyeth-sponsored pcv13 infant trial study (6096a1-007). participation in purely observational studies is acceptable. 11. child who is a direct descendant (child, grandchild) of the study site personnel.

Keywords: 7 valent pneumococcal conjugate vaccine 13 valent pneumococcal conjugate vaccine pcv13 pcv7
long term f/u studies at y5&6 to demonstrate the equivalence of 2 vaccination schedules of combined hepatitis a & b vaccine

Conditions: Hepatitis B; Hepatitis A

Summary: to evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.

open, randomised, long-term antibody persistence studies, conducted in 2 centers. immune persistence was compared between subjects who received two doses of gsk biologicals combined hepatitis a and hepatitis b vaccine at either 0, 6 month schedule or 0, 12 month schedule. these long-term follow-up studies involved taking blood samples at approximately 5 and 6 years after the primary vaccination of combined hepatitis a and b vaccine, to assess antibody persistence and a retrospective safety follow-up.

Eligibility criteria:
inclusion criteria: * subjects who received gsk biologicals' combined hepatitis a and b vaccine in the primary study (hab-082). subjects were aged 12 to 15 years at the time of the first vaccination.