Kornimate/medical-research-clean huggingface dataset:
impact of vertigoheel® on patients suffering from bilateral vestibulopathy and functional dizziness

Conditions: Vertigo; Functional Dizziness; Bilateral Vestibulopathy

Summary: in this study the researcher observe how vertigo symptoms change during two months of treatment with the natural medicinal product vertigoheel©. adult patients suffering from vertigo symptoms can participate if they are diagnosed with bilateral vestibulopathy (bvp) or functional dizziness (fd) and assigned to vertigoheel treatment. participating patients receive an examination at study start and after 2 months of vertigoheel treatment. the study focuses on patient reported outcomes assessed by questionnaires. vertigo symptoms are assessed by the dizziness handicap inventory questionnaire. patients' quality of life is assessed by a questionnaire. body sway is assessed by static posturography. fd patients are additionally tested for depressive and anxiety symptoms by questionnaires. bvp patients are additionally tested for vestibular function by video head impulse test and caloric testing. adverse events and other observations related to safety (physical examination and vital signs) are evaluated. vertigo is a common symptom with significant adverse effects on patients' quality of life. regardless of the exact cause of vertigo attacks, it is important to reduce the frequency, intensity, and duration of vertigo attacks with an effective medication that has no or minimal adverse effect. vertigoheel®, a natural medicinal product consisting of four ponderable active ingredients, is approved in germany as treatment for vertigo of various origins. however, no systematic data are available for vertigoheel® regarding patient-reported outcomes in bvp and fd as the most accepted endpoint in vertigo studies.


Eligibility criteria:
inclusion criteria: * treatment with vertigoheel® has been chosen by the physician independently of including the patient in this non-interventional study. * bilateral vestibulopathy or functional dizziness according to the current diagnostic criteria of the bárány society * symptoms for \> 3 months of moderate to severe intensity according to the dizziness handicap inventory \[0 (minimum score) -100 (maximum score)\] between 30 to 90 points. * ≥18 years of age * legally competent male or female outpatient. * signed informed consent. * not pregnant (as proven by negative pregnancy test in case of woman of childbearing potential before first study drug administration) or breast-feeding. exclusion criteria: * having taken within the last 2 months or currently taking vertigoheel®. * debilitating acute or chronic illness (i.e. psychiatric illnesses). * history of sensitivity to any component of the study drug under observation. * unwilling or unable to comply with all the requirements of the study protocol. * any relationship of dependence with the sponsor or with the investigator.

Keywords: real world evidence non-interventional study patient reported outcome
evaluation of clinical decision support system for intracranial hemorrhage using brain ct images

Conditions: Intracranial Hemorrhages

Summary: chs is a software that has been pre-learned based on a intracranial haemorrhage diagnosis model using brain ct images, and clinical decision support system for diagnosing intracranial haemorrhage by automatically analyzing brain ct images by assisting the medical team. the specific aims of this study are to evaluate efficacy of chs for intracranial haemorrhage compared to the sensitivity and specificity levels of predicate device which is currently approved to triage intracranial haemorrhage.


Eligibility criteria:
inclusion criteria: * adults over 19 years old * brain ct acquired * abnormal cohort: a patient diagnosed with intracranial haemorrhage after a brain ct scan * normal cohort: a normal person or a patient not diagnosed with intracranial haemorrhage after a brain ct scan exclusion criteria: * patients with brain tumor or cerebral toxoplasmosis * patients with brain abscess or brain calcification * poor or incomplete brain ct image quality
progesterone in expectantly managed early-onset preeclampsia

Conditions: Preeclampsia

Summary: preeclampsia is a disorder of widespread vascular endothelial malfunction and vasospasm that occurs after 20 weeks' gestation and can present as late as 4-6 weeks postpartum

currently there is no effective treatment for early-onset preeclampsia except for early delivery of the fetus along with the placenta. progesterone supplementation in the form of 17-alpha-hydroxyprogesterone caproate (17-ohpc) is currently used obstetrically to prevent recurrent preterm birth in patients with pregnancies not complicated by preeclampsia. previous studies reported that patients with severe pe had significantly lower serum progesterone concentrations than gestational age- and race-matched non-preeclamptics. moreover, supplementation of placental ischemic rats with 17-ohpc decreased blood pressure, inflammatory cytokines, and et-1 within 24 hours of treatment

Eligibility criteria:
inclusion criteria: * gestational age between 20+0 and 33+6 weeks. * singleton pregnancy. * willing to participate in the study and sign the informed consent. exclusion criteria: * maternal compromise requiring emergent delivery (ongoing placental abruption, dic, pulmonary edema). * fetal compromise requiring emergent delivery (fetal bradycardia, recurrent late fetal heart rate decelerations). * platelet count \< 100,000/microliter (thrombocytopenia) with evidence of hellp syndrome; * persistently abnormal hepatic enzyme concentrations (twice or more upper normal values); * severe fetal growth restriction (ultrasound-estimated fetal weight less than fifth percentile); * severe oligohydramnios (afi \< 5cm) * reversal of end diastolic flow(redf) in umbilical artery doppler testing; * eclampsia; * nonreassuring fetal status during daily testing (biophysical profile \<4/10 and/or recurrent variable or late decelerations); * intrauterine fetal death. * patient is unable or unwilling to give consent. * patients currently using progesterone for other indications.
fish oil and epo in breast cancer

Conditions: Breast Cancer

Summary: recent literature data suggest beneficial effects of dietary fats in patients with cancers, in particular polyunsaturated fatty acids (pufas). fish oil and evening primrose oil provide a high amount of pufas and a desirable n-6/n-3 pufas ratio.

breast cancer (bc) is leading cancer in women. as most of the cancers, it is characterized by inflammation and alternations in lipid and fatty acid metabolism. patients with bc have impaired fatty acid profiles, low level of pufas, and high n-6/n-3 pufas ratio. moreover, these changes are related to clinical outcome. fish oil is the richest source of anti-inflammatory n-3 pufas. evening primrose oil (epo) is rich in 18:3 n-6, the only n-6 fatty acid with an anti-inflammatory effect. dietary intake of fish oil or epo has been shown to decrease inflammation and improve pufas status in patients with cancers. however, it is not known what is the effect of combined epo and fish oil in bc patients. the study design is double-blind, controlled, randomized nutritional intervention. the participants are randomly assigned into intervention and control group before starting chemotherapy. all patients receive nutritional counseling to achieve a daily energy and protein intake according to recommended dietary allowances, with (intervention) or without (control) of milled seed mix.

Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer, * clinical stadium iii and iv, * patients able to understand requirements of the study and provide written informed consent- exclusion criteria: * previous radio- or chemotherapy * other serious chronic diseases * statin therapy * use of fat-based dietary supplements (such as fish oil, evening primrose oil etc) 3 months prior to study
internet-delivered cbt for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the aim of this study is to investigate the efficacy of a 10 week internet-delivered cbt treatment for patients diagnosed with ibs. the patients' work with the treatment and is supported through online contact with a therapist. approximately 86 patients will be included in the study and randomized to either condition. all included patients are assessed one week before the treatment starts. after 10 weeks (post treatment). follow-up assessments are conducted at 3 and 12 months follow-up after treatment. patients in treatment condition are hypothesized to experience significant reduction ibs symptoms, societal costs and quality of life compared to patients on waiting list.


Eligibility criteria:
inclusion criteria: * diagnosis of ibs given by physician * at screening fulfilling rome iii-criteria for ibs exclusion criteria: * severe depression * suicidal ideation * presence of unexplained ibs alarm symptoms

Keywords: cognitive behavior therapy internet cost-effectiveness irritable bowel syndrome
diet and exercise in pompe disease

Conditions: Pompe Disease; Glycogen Storage Disease Type II; Lysosomal Storage Diseases

Summary: this study examines the effects of individualized diet and exercise plans on muscle strength, quality of life and respiratory function in pompe disease. subjects will be given a diet and exercise plan based on their individual needs, which will be followed for 16 weeks. participants will also be provided with an activity tracker in order to track their exercise activities, access to an app that will allow them to input their daily food intake, and they will also come to the university of florida for exercise tests, respiratory tests and questionnaires.

pompe is a rare disease, which occurs in approximately 1 in 40,000 births. it is a progressive and often fatal neuromuscular disorder resulting from a mutation in the gene for acid alpha- glucosidase (gaa), an enzyme necessary for the degradation of glycogen. common symptoms include skeletal and smooth muscle myopathy, resulting in respiratory insufficiency, peripheral muscle weakness and generalized fatigue. the progressive myopathy in pompe disease seems to be influenced by increased muscle protein breakdown. the increased muscle protein breakdown leads to muscle wasting, weakness, increased resting energy expenditure and, consequently, increased fatigue. our hypothesis is that a high protein, low carbohydrate diet associated with regular physical exercise will improve respiratory and peripheral muscle functions in pompe disease. in this study, we will investigate the effects of 16 weeks of planned diet and exercise in adolescent and young adult (15-55 years old) individuals with pompe disease using an activity tracker. the participant will be asked to come to the university of florida 4 times throughout the study (screening, baseline, +/- 15 days of completing the diet and exercise plan and a follow up three months later) for exercise testing, quality of life questionnaires, respiratory function testing and blood draws.

Eligibility criteria:
inclusion criteria: * male or female subjects 15-55 years of age; * have a diagnosis of pompe disease, as defined by protein assay and/or dna sequence of the acid alpha-glucosidase gene, with present clinical symptoms of the disease; * be naïve to ert or receiving ert for at least eighteen months prior to beginning study; * be able to walk at least 40m in the 6 minute walk test. * willing to comply with study requirements exclusion criteria: * be pregnant; * be in the lower limit for pulmonary function; fvc \< 30% predicted; * be dependent on assisted ventilation; * be dependent on wheelchair; * have evidence of clinical heart failure; * have any contraindication to exercise
effect of interscalene block on ventilatory function

Conditions: Respiratory Depression; Anesthesia Morbidity; Block

Summary: interscalene block with local anesthetic impairs ventilation (unilateral diaphragmatic dysfunction). single injection of local anesthetic induced transitory dysfunction (\< 24h). the investigators hypothesized that continuous interscalene block would prolonged ventilatory impairment

unilateral pulmonary dysfunction occured after interscalene block due to phrenic nerve paralysis. this reduction induced vital capacity alteration and peek flow reduction.several studies analysed dysfunction recovery duration after single injection using short (lidocaine)or intermediate (ropivacaine, bupivacaine)local anesthetic drug. because continuous infusion prolonged block duration, phenic nerve may be also prolonged. however no study with continuous interscalene infusion have been performed for this dysfunction.

Eligibility criteria:
inclusion criteria: * surgery : scheduled for elective shoulder surgery * available for 1 month of follow up * physical status : 1, 2, 3 exclusion criteria: * body mass index \> 35 * contraindication for interscalene block (local sepsis, bleeding, allergy, peripheral neuropathy) * vital capacity less than 1.5 liters * cardiac or renal insufficiency * physical status \>3, pregnant, weigh less than 50 kg
intensive combination approach to rollback the epidemic in nigerian adolescents: uh3 phase

Conditions: Adolescent HIV Infection

Summary: combination interventions with mhealth and peer navigation components will be evaluated in a randomized, stepped wedge trial among youth in ibadan, lagos, sagamu, and jos, nigeria. study findings will demonstrate whether or not the combination interventions for hiv testing and linkage to care and for hiv treatment outcomes, which were found to be efficacious in our prior pilot ug3 trial, will remain efficacious if scaled as proposed in this uh3 trial, across multiple sites.

a randomized stepped wedge (cluster) trial will be conducted to investigate two combination interventions (each with mhealth + peer navigation components) among youth in ibadan, lagos, sagamu, and jos, nigeria. study 1 (testing and linkage to care) will test a combination intervention that targets hiv testing and linkage to care. study 2 (treatment intervention) will test a combination intervention that targets hiv treatment outcomes (retention, adherence and viral suppression).

Eligibility criteria:
inclusion criteria: * living with hiv infection * registered in the study clinics or their satellite clinics * on antiretroviral therapy (art) for at least 3 months * intention to remain a study clinic patient during the study observation and intervention period exclusion criteria: * inability to provide informed consent * youths who are 15 years old and not emancipated, who do not have parental consent
comparison of ariscat score and post-operative pulmonary complication rate in percutaneous nephrolithotomy

Conditions: Postoperative Complications; Nephrolithotomy, Percutaneous

Summary: postoperative pulmonary complications are relatively common in all age groups and are closely related to increased costs, morbidity and mortality in the postoperative period. in recent years, various risk indices have been developed for preoperative evaluation to predict postoperative pulmonary complications, such as the american society of anaesthesiologists physical status classification (asa), the assessment of respiratory risk in surgical patients in catalonia (ariscat). the ariscat score has demonstrated promising results in identifying patients at higher risk for pulmonary complications. the ariscat risk index is derived from multiple variables, including age, oxygen saturation, previous respiratory tract infections, anaemia, abdominal or thoracic surgery, operative time, and emergency surgery. the ariscat risk index is used to predict respiratory failure, bronchospasm, respiratory tract infections, atelectasis, pneumothorax, pleural effusion, and aspiration pneumonia. percutaneous nephrolithotomy (pnl) is a type of operation performed endoscopically in a prone position in cases of kidney stones that cannot be broken by extracorporeal shockwave lithotripsy (eswl) and/or cannot be removed by ureterocystoscopy. the prone position is one of the positions that limits lung capacity and respiratory function. the objective of this study was to assess the relationship between the ariscat score in patients undergoing pnl and the occurrence of pulmonary complications in the postoperative period.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i-iii patients * patients who undergone of percutaneous nephrolithotomy procedure exclusion criteria: * patients with any liver and/or kidney failure * obese patients (body mass index (bmi) 30 and above) * trauma patients * cancer patients * american society of anesthesiologists (asa) iv patients * cardiac arrhythmia, implanted pacemakers * a history of chronic pain
antenatal betamethasone compared to dexamethasone - "betacode trial"

Conditions: Respiratory Distress Syndrome; Intraventricular Hemorrhage; Neonatal Mortality

Summary: antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality by specifically reducing the risk of respiratory distress syndrome, intraventricular hemorrhage and neonatal death among premature infants. no human randomized study has formally compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality. our objective was to compare betamethasone with dexamethasone in terms of effectiveness in reducing perinatal morbidities and mortality among preterm infants.

we conducted a double blind placebo-controlled randomized trial of antenatal betamethasone compared to dexamethasone among women at risk of preterm deliveries at stony brook university hospital from august 1, 2002 through july 31, 2004. we excluded women with clinical chorioamnionitis, major fetal structural anomalies, fetal chromosomal abnormalities, prior antenatal steroid exposure, and use of betamethasone or dexamethasone for other medical indications, quadruplets and higher order multiple gestation and those who declined enrollment. consenting women were randomly allocated to one of two groups by the pharmacy using computer generated random numbers. the statistical analysis was performed in accordance of the intention-to-treat principle. student t test, chi square and fisher exact test were used for analysis. a p value of \< .05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * women in preterm labor with intact membranes * women with preterm premature rupture of membranes * women been delivered for fetal and maternal indications * gestational age between 24 and 33 6/7 weeks'. exclusion criteria: * clinical chorioamnionitis * known major fetal structural anomalies, * known fetal chromosomal abnormalities, * prior antenatal steroid exposure, * quadruplets and higher order multiple gestation * women who declined enrollment.

Keywords: antenatal corticosteroids betamethasone dexamethasone premature
self-monitoring of blood glucose study#1: the ability of people with diabetes to use onetouch(r) ultrasmart(tm)

Conditions: Diabetes

Summary: insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing. effective presentation and data analysis are essential. we examined hba1c changes using the onetouch(r) ultrasmart(r) system (test group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (control group).


Eligibility criteria:
inclusion criteria: * male or female subjects with type 1 or type 2 insulin-treated diabetes mellitus with a baseline hba1c greater than or equal to 8.0%. * the lower age limit for pediatric subjects was at the discretion of the pediatric investigators and their institutional review board (irbs). * the upper age limit for pediatric subjects was 20 years (i.e., not having reached their 21st birthday on date of enrollment). * subjects must have monitored blood glucose at least 2 times per day. - subject's current blood glucose meter has download capability, however, the subject did not routinely use this capability on his/her own. exclusion criteria:
a trial investigating the pharmacokinetic and pharmacodynamic properties of faster-acting insulin aspart in subjects with type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: a trial investigating the pharmacokinetic and pharmacodynamic properties of faster-acting insulin aspart in subjects with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: * male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. the total number of subjects aged 65-75 years (both inclusive) must not exceed 25. * subjects diagnosed (clinically) with type 2 diabetes mellitus for at least 12 months (365 days) prior to the day of screening * hba1c below or equal to 9.5 % based on central laboratory analysis exclusion criteria: * smoker (defined as a subject who is smoking more than one cigarette or the equivalent per day) who is not able or willing to refrain from smoking and use of nicotine substitute products during the in-patient period * surgery or trauma with significant blood loss (more than 500 ml) within the last 90 days prior to screening
research study to compare semaglutide tablets with empagliflozin tablets taken once daily in people with type 2 diabetes and obesity

Conditions: Diabetes Mellitus, Type 2

Summary: this study compares the medicines semaglutide and empagliflozin in people with newly diagnosed type 2 diabetes and obesity. the study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine. participants will either get semaglutide tablets or empagliflozin tablets. which treatment participants get is decided by chance. participants will get one tablet per day for 2 years. the study will last for about 2 years and 8 weeks.


Eligibility criteria:
inclusion criteria: * male or female, age 18- less than (\<) 50 years at the time of signing informed consent. * diagnosed with type 2 diabetes mellitus less than or equal to (\<=) 365 days from the day of screening. * glycated haemoglobin (hba1c) of 7.0-9.5 percentage (%) (53-80 millimoles per milliliter \[mmol/mol\]) (both inclusive). * body mass index (bmi) greater than or equal to (\>=) 30.0 kilograms per meter square (kg/m\^2). * treatment naïve to any antidiabetic drug(s). however, for a subset of participants (≤25%) any metformin dose or formulations administered is allowed. exclusion criteria: * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria since diagnosed with type 2 diabetes mellitus. prior insulin treatment for gestational diabetes is allowed. * renal impairment measured as estimated glomerular filtration rate (egfr) value of less than (\<) 60 milliliter per minute per 1.73 meter square (1.7ml/min/1.73 m\^2) at screening. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * c-peptide less than (\<)1.5 nanograms per milliliter (ng/ml) at screening. * positive insulinoma associated-protein 2 (ia-2) antibodies or anti-glutamic acid decarboxylase (anti-gad) antibodies. * history of major surgical procedures involving the stomach or small intestine potentially affecting absorption of drugs and/or nutrients. * presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.