Kornimate/medical-research-clean huggingface dataset:
breath and air stacking on respiratory mechanics in tracheostomized patients

Conditions: Mechanical Ventilation; Lung Infection

Summary: the researchers hypothesized that the aid of the resuscitator by the technique air stacking increase lung volume, promoting increased lung compliance and improvement of the ventilatory pattern. in addition, air stacking does not depend on patient collaboration. the objective of this study was to compare the effects of breath stacking and air stacking techniques on respiratory mechanics and ventilatory pattern in patients admitted to the icu


Eligibility criteria:
inclusion criteria: * patients without mechanical ventilation for more than 72 hours * mucus hypersecretion (defined as the need for suctioning \< 2-h intervals) exclusion criteria: * bronchospasm. * pleural effusion or pneumothorax undrained. * bronchopleural or tracheoesophageal fistula. * neuromuscular disease.

Keywords: physical therapy modalities respiratory care units respiratory mechanics
part a: drug interaction study of sofosbuvir and antiretroviral therapy (art) combinations in hiv and hepatitis c virus (hcv) co-infected patients. part b: efficacy and safety of sofosbuvir for 12 weeks in hiv/hcv co-infected patients.

Conditions: Hepatitis C; HIV

Summary: this study consists of 2 parts, part a and part b. part a, the phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics of sofosbuvir (gs-7977; psi-7977) and its metabolites in participants with hiv and hepatitis c virus (hcv) coinfection. part b, the phase 2 treatment study, will investigate the efficacy and safety of sofosbuvir, pegylated interferon alpha (peg) and ribavirin (rbv) in participants with hiv/hcv coinfection.


Eligibility criteria:
inclusion criteria: * healthy according to medical history and physical examination with exception of hcv and hiv diagnoses * confirmation of chronic hcv infection * confirmation of chronic hiv-1 infection * on a stable protocol approved hiv antiretroviral (arv) regimen with undetectable hiv-rna * agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication * subjects must be naive to treatment for chronic hcv infection exclusion criteria: * known or suspected cirrhosis * history of any other clinically significant chronic liver disease * a history consistent with decompensated liver disease. * use of any prohibited medications as defined by the protocol * pregnant or nursing female or male with pregnant female partner * contraindication to peg or rbv therapy (for part b) * clinically relevant drug or alcohol abuse
fructose and lactose intolerance and malabsorption in functional gastrointestinal disorders

Conditions: Functional Gastrointestinal Disorders; Lactose Intolerance; Fructose Intolerance

Summary: background: the association of fructose and lactose intolerance and malabsorption with the symptoms of different functional gastrointestinal disorders (fgid) is unclear. the mechanisms behind the multi-organ symptoms remain unclear. both fgid and saccharide intolerances are common (\>10% of any given population). dietary modification based on intolerance diagnostics could provide an effective treatment for fgid, which are otherwise difficult to treat. aim: to investigate the prevalence and interrelationships of fructose and lactose intolerance (symptom induction) and malabsorption (breath test gas production) and their association with clinical gi as well as non-gi symptoms in fgid and the outcome of standard dietary intervention. mechanisms related to symptom genesis will be investigated using metabolomic analysis of plasma and urine by gas chromatography/time-of-flight mass spectrometry (gc/tofms). methods: fructose and lactose intolerance (defined by positive symptom index) and malabsorption (defined by increased hydrogen/methane) will be determined in successive male and female fgid patients in a single center using breath-testing. symptoms will be recorded using standardised questionnaires and the rome iii criteria. the prevalence of the intolerances in the different fgid subgroups and the associations between breath testing results, clinical symptoms and the outcome of dietary modification will be assessed. factors predictive of the outcome of dietary modulation will be screened for. gc/tofms will be used to assess the human and microbial metabolome in urine and plasma.


Eligibility criteria:
inclusion criteria: * patients with functional gi disorders according to rome 3 criteria * without evidence of organic disease by standardised testing in gi practice. exclusion criteria: * current or relevant history of organic disease.
clinical assessment of urinary antiseptics methenamine and methylthioninium in recurrent cystitis

Conditions: Urinary Tract Infections

Summary: this is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for three days, followed by three days of antibiotic therapy as determined by urine culture and antibiogram. this study aims to assess the efficacy and safety of each treatment.

this is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). after initial evaluations including urine culture and antibiogram, a total of 284 subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for six days. after three days of treatment, subjects will return to the study center and antibiotic therapy based on the results of the urine culture and antibiogram will be initiated for each subject, to be continued for the remaining three days of the treatment period. efficacy assessments will include the utisa (urinary tract infection symptoms assessment questionnaire) together with a global assessment by the investigator. safety assessments will include monitoring of adverse events and laboratory tests carried out at each of the three study visits.

Eligibility criteria:
inclusion criteria: * patients of both sexes, age ≥18 * clinical diagnosis of recurrent cystitis (≥ 2 episodes in the past 6 months) * female subject of reproductive age not pregnant, agrees to use birth control during study period * subject has read, understood, signed and dated informed consent document exclusion criteria: * history of nephritis or kidney stones * history of hepatic or gastrointestinal disease * diabetes * glaucoma * female subjects: pregnancy or breastfeeding * history of anatomical alterations contributing to recurring cystitis on imaging exams * hypersensitivity to any component of study drug
exercise oxygen kinetic and cardiac output in hypertrophic cardiomyopathy

Conditions: Cardiopulmonary Exercise Test; Hypertrophic Cardiomyopathy; Cardiac Output Measurement

Summary: fatigue and dyspnea that reduce exercise performance are common symptoms in patients with hypertrophic cardiomyopathy. since the cause of this functional limitation has not yet been described, this study aims to evaluate the cardiopulmonary parameters measured at cardiopulmonary exercise test in combination with those obtained by non-invasive measurement of cardiac output by impedance (physioflow) and echocardiography. these results will help to better define the mechanisms underlying limitation in these patients, also in relation to the degree of lvot obstruction. the aim of the present study is to assess the cardiopulmonary response to exercise in patients with hypertrophic cardiomyopathy, based on the degree of lvot obstruction, by adding non-invasive measurement of cardiac output by physioflow and echocardiographic parameters to the cardiopulmonary exercise test parameters associated with stroke volume and cardiac output (ie. vo2/wr, o2pulse) consecutive patients with a previous diagnosis of hypertrophic cardiomyopathy on optimised medical therapy will be enrolled to perform a cardiopulmonary exercise test with simultaneous measurement of cardiac output and an exercise echocardiogram for clinical routine.


Eligibility criteria:
inclusion criteria: * hypertrophic cardiomyopathy diagnosis exclusion criteria: * use of long-term oxygen therapy; * presence of comorbidities affecting the ability to perform cardiopulmonary exercise test or interfering with exercise performance; * concomitant at least moderate chronic obstructive pulmonary disease
somnomedics clinical validation trial

Conditions: Blood Pressure; Perioperative/Postoperative Complications

Summary: observational study in which pulse transit time (ptt) as a method and the device to register this data is compared with arterial blood pressure. the population is composed of pediatric and adult patients in anesthesia or intensive care in need of arterial blood pressure monitoring.

plan to enroll patients who accept the terms of the study consecutively. the population is composed by pediatric and adult patients in anesthesia and intensive care in need of close blood pressure monitoring. after informed consent from the patients themselves, patient and parents and sometimes only parents. the device measuring ptt is the prepared and calibrated with existing arterial blood pressure. data is then recorded via the storage capacity of the device and via videocamera. the videocamera is used to identify large disturbances in data registration. this is to identify confounding data and in the end calibrate the device to be more accurate. data from the ptt device and the camera is then downloaded to the study computer and to an external hard drive in order to create redundancy in data storage. data is then analysed to compare the difference between data recorded from the ptt device and arterial pressure respectively. aim is to be able to collect sufficient data to be able to decide wether to recommend or advice against clinical use. patient data is registered and then handled by our departmental clerk. data is stored for ten years.

Eligibility criteria:
inclusion criteria: * arterial line planned or existing exclusion criteria: * suspected major perioperative hemodynamic variation. * non existing consent.

Keywords: perioperative monitoring
acute effects of furosemide on hemodynamics and pulmonary congestion in acute decompensated heart failure.

Conditions: Acute Heart Failure

Summary: intravenous (iv) loop diuretics have been a key component in treating pulmonary edema since the 1960s and has a class 1 recommendation in the 2021 guidelines for acute heart failure. however, no randomized clinical trials have investigated loop diuretics versus other interventions for acute heart failure, and clinical knowledge of the hemodynamic effects of furosemide is based in studies from the 1970s. in this study, we aim to assess the acute effect of furosemide on cardiac filling pressures and pulmonary congestion. hypothesis: administration of furosemide induces a hyperacute (within 30 minutes) lowering of cardiac filling pressures and pulmonary congestion before significant diuresis occurs. design: a prospective, interventional study including 20 patients admitted due to a clinical diagnosis of acute heart failure with pulmonary congestion. intervention: 80 mg of furosemide is administered iv. measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content by reds\*, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. measurements are repeated at several time points until 6 hours have passed.

prospective observational study of the acute and subacute effects of furosemide in patients with acute heart failure. after inclusion, 80 mg of furosemide is administered iv. measurements include blood pressure, peripheral oxygen saturation, pulmonary fluid content, ultrasound examination of heart and lungs, and assessment of cardiac filling pressures with doppler and strain analysis. measurements are repeated at several time points until 6 hours have passed.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. clinical diagnosis of acute heart failure requiring hospitalization 3. systolic blood pressure ≥100 mmhg 4. oxygen saturation \<94% or need of oxygen 5. confirmed pulmonary congestion on x-ray or reds exclusion criteria: 1. more than 40 mg iv furosemide within the last three hours before randomization, including prehospital administration 2. ongoing ventricular taky- or brady-arrythmias or supraventricular arrhythmias with hr \> 180 or \< 40 bpm. 3. known chronic obstructive lung disease 4. pacemaker or icd on the right side 5. congenital heart malformations or intra-thoracic mass that would affect the right lung anatomy (e.g. dextrocardia, lung carcinoma) 6. wounds, burns, healing tissue, skin infection or recent skin graft or flap where the sensors should be attached to the skin 7. height less than 155 cm or higher than 200 cm 8. bmi of less than 18 or more than 38
specimen collection from pregnant women at increased risk for fetal aneuploidy

Conditions: Down Syndrome; Fetal Aneuploidy

Summary: the specimen collection is designed for the purpose of the development of a noninvasive prenatal test for t21.

to collect specimens for the purpose of developing a prenatal aneuploidy test. the test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (cvs) and/or genetic amniocentesis. the results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via cvs or genetic amniocentesis.

Eligibility criteria:
inclusion criteria: * pregnant between 10 and 22 weeks gestation * 18 years of age or older * provides signed and dated informed consent * subject is at increased risk for fetal aneuploidy * subject is willing to undergo a cvs and/or amniocentesis procedure for the purpose of genetic analysis * subject agrees to provide the genetic results of the invasive procedure exclusion criteria: * fetal demise at time of specimen sampling * previous sample donation under this protocol

Keywords: down syndrome fetal aneuploidy trisomy noninvasive screening test
intraoperative and postoperative outcomes of three ophthalmic viscosurgical devices during phacoemulsification

Conditions: Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery

Summary: ophthalmic viscosurgical devices (ovds) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including iol implantation. equally important is the ease of use, good visualisation and easy removal of the ovd from the eye. currently, 3 popularly used ovds as a single injection sufficing for surgery are: healon 5, discovisc, and celoftal (2% hydroxypropylmethylcellulose). whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. the aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three ovds


Eligibility criteria:
inclusion criteria: * age related, uncomplicated senile cataracts exclusion criteria: * presence of glaucoma, * shallow anterior chamber (acd \< 2.1mm), * pupillary dilatation \< 6mm, * extremely dense cataracts, * posterior polar cataract, * subluxated cataract, * white mature cataract, * diabetic retinopathy, * high myopia (defined as al \> 25mm), * uveitis, or * previous ocular trauma/surgery.
smart taiko-drum playing for older adults with cognitive frailty

Conditions: Cognitive Impairment; Frailty

Summary: the objective of this randomised controlled feasibility trial is to evaluate the feasibility of the smart taiko drum-playing intervention embedding the cognitive-motor dual-task training concept for older adults with cognitive frailty, and identify the preliminary efficacy of the intervention on cognitive and physical functions and frailty status.

1. study design: - randomized control trial 2. participants: - community-dwelling older adults with cognitive frailty 3. setting: - community centres for seniors 4. intervention * playing smart taiko three times/weeks x 16 weeks for 30 - 45 minutes each session * a smart taiko drumming system has been developed for older adults to play the drumming game with their preferred music genres. 5. waitlist-control group - will receive usual care 6. health outcomes that will be assessed three times at baseline, during (8th week) and immediate post-intervention (16th week) * cognitive functions * physical functions * mental health * physical frailty status * body composition 7. feasibility evaluation * recruitment * retention * satisfactory survey * compliance with the survey * safety * focus group intervention with participants

Eligibility criteria:
inclusion criteria: * with cognitive frailty * without a diagnosis of a neurological or psychiatric condition that could affect cognitive function * live independently or with partial assistance * with pre-frailty exclusion criteria: * with a significant sensory or motor impairment that would preclude participation in the intervention * are unable to understand or follow instructions due to language or hearing impairment * have already been in another cognitive or physical intervention programme within the past three months * are taking medications that could significantly affect cognitive or physical functions * with any medical condition or treatment that would contraindicate participation in the study.

Keywords: cognitive frailty motor-cognitive training drumming
periodontal plastic reconstruction of soft tissue dehiscences after the removal of localized gingival enlargements

Conditions: Localized Gingival Enlargement; Epulides; Recurrence; Periodontal; Lesion

Summary: non-inflammatory recessions and miller class i-ii-iii. mucogingival defects after elimination of localized gingival enlargements are frequently encountered challenges in the daily practice. in miller class ii-iii. recessions the lack of keratinized tissues often compromise the maintenance a proper oral hygiene, this can cause inflammation, which can result in further periodontal attachment loss. in the literature there are some approaches that aim at widening of keratinized tissues and root coverage at the same time, such as the subperiosteal envelope technique (set) (allen 1994) combined with a subepithelial connective tissue graft (sctg) or a partially epithelialized connective tissue graft (pe-sctg) (stimmelmayr 2011). in the eradication of localized gingival enlargement postoperative complications following surgical removal, such as recurrence and subsequent gingival recessions as well as loss of keratinized tissues are commonly observed. nevertheless, a state of the art comprehensive treatment approach has not been reported yet to overcome the above mentioned sequels. the aim of this study is to present a periodontal plastic surgical approach to definitively eliminate localized gingiva enlargements and to simultaneously correct consecutive miller class i ii-iii. recessions, esthetic disturbances. (ethical committee permission number: se rkeb: 185/2020.)


Eligibility criteria:
inclusion criteria: * patients older than 18 years * systematically healthy patients * localized gingival enlargement is present that involves maximum 3 teeth exclusion criteria: * pregnant women * medication intake that can potentially affect the oral mucosa and its healing * heavy smokers (\>=15)

Keywords: periodontal reconstructive surgery surgical excision surgical treatment localized gingival enlargement
study of peposertib in combination with capecitabine and rt in rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: the main purpose of the study was to define maximum tolerated dose (mtd), recommended phase ii dose (rp2d) safety and tolerability of peposertib in combination with capecitabine and radiotherapy (rt).


Eligibility criteria:
inclusion criteria: * participants who have an eastern cooperative oncology group performance status less than or equals to (\<=) 1 * participants who have histologically confirmed and localized resectable rectal cancer (stage 3) * participants who received induction chemotherapy are allowed to be enrolled to this study except this induction is resulting in clinical complete response (ccr) or tumor progression * participants who have lower edge of the tumor located in rectum * adequate hematological, hepatic and renal function as defined in the protocol * male participants if they agree to the following during the study intervention period and for at least 12 weeks after the last dose of study intervention * female participants are eligible if not pregnant or breastfeeding * other protocol defined inclusion criteria could apply exclusion criteria: * participants with history of any other significant medical disease or psychiatric conditions that might in the assessment of the investigator preclude safe participation in the study * participants with history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the study intervention * unstable cardiovascular function within 6 months prior to enrollment * hypertension uncontrolled by medication (ie, systolic blood pressure \>= 150 millimeter of mercury (mmhg) and diastolic blood pressure \>= 90 mmhg) * participants with history of other malignant disease within the past 5 years, other than successfully treated basal carcinoma of the skin or carcinoma in situ of the cervix * participants with known human immunodeficiency virus positivity, known active hepatitis (for example, hepatitis b virus or hepatitis c virus), current alcohol abuse, or cirrhosis * participants with ongoing active infection or treatment with a live attenuated vaccine within 4 weeks of dosing * participants with concomitant use of h2-blocker or proton pump inhibitors (ppis) (or unable to stop at least 5 days prior to the first treatment). note that calcium carbonate is acceptable * participation in any interventional clinical study within 28 days prior to screening or during participation in this study * other protocol defined exclusion criteria could apply.

Keywords: dna-pk inhibitor peposertib capecitabine