Kornimate/medical-research-clean huggingface dataset:
ventricular arrhythmias incidence according to sleep apnea syndrome in implantable cardioverter-defibrillator (icd) patients

Conditions: Sleep Apnoea

Summary: the purpose of this study is to report the incidence of ventricular arrhythmias correlated to the sas and to focus on the interest of diagnosing sleep-disorders breathing in icd patients. this diagnosis will be assessed by an ambulatory nasal pressure recording with portable multi-channel recorder associated to a complete sas related symptoms questionnaire.this clinical trial will be the first step to gather information about the suspected sleep relation between ventricular arrhythmias and sleep breathing disorders, in order to improve the management and treatment of such arrhythmias in next generation of defibrillators which will integrate a minute ventilation sensor able to monitor breathing.


Eligibility criteria:
inclusion criteria: * patients who are at risk of sudden death due to ventricular arrhythmia and who satisfy at least one of the following criteria are eligible for enrolment: * class i indications for icd * survival of at least one episode of cardiac arrest due to vt or vf not due to a transient or reversible cause, or presumed to be due to vf when electrophysiological testing is precluded by other medical conditions; or * spontaneous sustained ventricular tachycardia, or * syncope of undetermined origin with clinically relevant haemodynamically significant sustained vt or vf induced at electrophysiological study when drug therapy is ineffective, not tolerated or not preferred, or * class iia indication for icd * non-sustained vt with coronary disease, prior myocardial infarction, left ventricular dysfunction (≤ 40%) and inducible vf or sustained vt at electrophysiological study. * with prior myocardial infarction and lvef less than 30 % (without prior life-threatening arrhythmia or sustained vt). * patients candidate for cardiac resynchronization therapy (crt) need to be in functional class iii or iv of the nyha classification. patients will be included only after having granted their informed consent to participate in the study, preceded by the delivery of appropriate information exclusion criteria: * vt/vf is associated with drug toxicity, electrolyte imbalance, hypoxia, electrocution or other reversible cause; * vt/vf occurred during the acute phase of infarction (\< 1 week) or during an unstable ischemic phase; * incessant vt/vf; * implanted pacemaker that is not going to be explanted or otherwise disabled; * inability or refusal to provided informed consent * tricuspid valvular disease or tricuspid mechanical heart valve (lead contraindication); * unable to understand the purpose and plan of the study; * geographically unstable or not available for follow-up as defined in the investigational plan; * reduced life expectancy (≤ 1 year) for other than cardiovascular reasons; * patient participating in another clinical study; * patient of minor age (\< 18 years); * pregnancy (women of childbearing potential are required to have a negative pregnancy test within seven days prior to enrollment).
mbsr and nlp, postpartum breastfeeding and depression

Conditions: Breastfeeding, Exclusive; Fatigue; Sleep; Postpartum Depression

Summary: the postnatal period is a risky period in which mothers experience regressive and progressive changes and rapid biopsychosocial changes. since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes that occur in this period.

the postnatal period is a risky period in which retrogressive and progressive changes and rapid biopsychosocial changes occur in mothers. since this process affects not only the mother but also the family, mothers are under intense stress due to adaptation to the changes occurring in this period. studies have reported that the most common physical problems in the early postpartum period after caesarean section are pain in the incision area, difficulty in caring for the baby alone, activity intolerance, fatigue, insomnia, breastfeeding problems (such as nipple or lack of milk), mastitis and abdominal tension/gas. as important as it is to reduce postpartum symptoms after caesarean section, it is also important to support and maintain breastfeeding. however, postpartum symptoms such as pain, fatigue and negative effects of anaesthesia after caesarean section negatively affect the breastfeeding process and lead to a delay in the onset of lactation. when the literature was examined, no study was found that examined the effects of mindfulness-based stress reduction programme and neurolinguistic programme on fatigue, sleep quality, lactation and depression in the postpartum long term.

Eligibility criteria:
inclusion criteria: * 19-35 years old * caesarean section * primiparous * breastfeeding women exclusion criteria: * women who refused to participate in the research.

Keywords: breastfeeding fatigue sleep postpartum depression
a modified baveno classification of obstructive sleep apnoea based on sleepiness and cardiovascular scores

Conditions: Obstructive Sleep Apnea (OSA)

Summary: the goal of this observational study is to evaluate a new classification system for obstructive sleep apnoea in patients with newly diagnosed obstructive sleep apnoea and monitor for long-term objective and subjective improvement.


Eligibility criteria:
inclusion criteria 1. adult patient ≥40 years at the time of signed informed consent 2. diagnosis of predominant obstructive sleep apnoea with a total apnoea-hypopnoea index of ≥5 /h based on a diagnostic sleep study (polysomnography or polygraphy, as per local standard). predominant obstructive sleep apnoea defined as ≥70% of respiratory events classified as obstructive. 3. signed and dated written informed consent in accordance with ich-gcp and applicable local regulations exclusion criteria 1. \>30% central respiratory events (apnoeas and hypopnoeas) within the diagnostic sleep study 2. established sleep apnoea treatment within the last 12 months before study inclusion (positive airway pressure, mandibular advancement device, positional therapy) 3. use, or need for chronic use, of any non-invasive positive pressure ventilation device 4. participation in an interventional study and/or receiving investigational treatment(s) 5. significant disease or condition, which, in the opinion of the investigator, may interfere with study procedures or cause concern regarding the patient's ability to participate in the study 6. patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the patient an unreliable trial participant)
iperia/sentus qp study

Conditions: Heart Failure; Tachyarrhythmia

Summary: the objective of this study is to confirm the safety and efficacy of the new sentus otw qp lv lead and iperia icd family. the study focuses on the safety and efficacy of the qp device system.


Eligibility criteria:
inclusion criteria: * patient is able to understand the nature of the study and provides written informed consent. * patient meets a standard indication for crt-d (sentus qp group) or icd therapy. * patient is able and willing to complete the planned follow-up visits at the investigational site. * patient accepts the home monitoring® concept. * age is ≥ 18 years. * sentus qp group only: patient is a candidate for a new (de novo) implant or an upgrade from an existing icd or pacemaker utilizing a biotronik sentus qp lead exclusion criteria: * patient has a standard contraindication for crt-d (sentus qp group) or icd therapy. * sentus qp group only: currently implanted with an endocardial or epicardial lv lead or had prior attempt to place a lv lead. * sentus qp group only: cardiac surgery procedure (coronary bypass graft, valve surgery, or ablation) that is planned to occur within 3 months after implantation. * patient is expected to receive ventricular assist device or heart transplantation within the next 3 months. * patient is pregnant or breastfeeding. * life expectancy of less than 3 months * participating in another cardiac clinical investigation with active treatment arm.

Keywords: heart failure iperia icd family sentus qp left ventricular lead quadripolar crt-d system
a rct of the efficacy of vonoprazan 20mg qd in the treatment of helicobacter pylori infection

Conditions: Vonoprazan; Helicobacter Pylori Infection; Proton Pump Inhibitor

Summary: the treatment of helicobacter pylori is very important. the routine treatment is quadruple therapy. in recent years, double therapy has appeared and the curative effect is fair. however, antacid generally uses proton pump inhibitor. the proton pump inhibitor needs double dose to achieve good antacid curative effect. the effect of vonoprazan used for inhibiting gastric acid is better than proton pump inhibitor. at present, many studies use vonoprazan instead of common proton pump inhibitor, but almost all use double dose of vonoprazan. in the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 20mg qd of vonoprazan. therefore, in this study, 20mg qd of vonoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of vonoprazan on helicobacter pylori.

the treatment of helicobacter pylori is very important. the routine treatment is quadruple therapy. in recent years, double therapy has appeared and the curative effect is fair. however, antacid generally uses proton pump inhibitor. the proton pump inhibitor needs double dose to achieve good antacid curative effect. the effect of vonoprazan used for inhibiting gastric acid is better than proton pump inhibitor. at present, many studies use vonoprazan instead of common proton pump inhibitor, but almost all use double dose of vonoprazan. in the previous study, we found that the effect of double dose of proton pump inhibitor can be achieved with 20mg qd of vonoprazan. therefore, in this study, 20mg qd of vonoprazan was used to replace the double dose of proton pump inhibitor to observe the antibacterial effect of vonoprazan on helicobacter pylori.

Eligibility criteria:
patients aged ≥18 years with hp-positive first sterilization were included in this study. before treatment, the existence of helicobacter pylori can be confirmed by one or more of the following methods: rapid urease test, hp culture, 13c urea breath test, 14c urea breath test and stool hp antigen test. the main exclusion criteria include acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric or duodenal mucosal lesions, previous eradication treatment of helicobacter pylori, penicillin/furazolidone allergy, surgery that may affect gastric acid secretion (upper gastrointestinal resection or vagotomy), zollinger-ellison syndrome or other hypergastric acid secretion diseases, severe neurological, cardiovascular, pulmonary, liver, renal, metabolic, gastrointestinal, urological, etc. any fertile woman must use proper contraception. all subjects provided written informed consent before participating in the study.

Keywords: vonoprazan helicobacter pylori proton pump inhibitor
need for subcutaneous wound drains in ileostomy reversal

Conditions: Presence of Ileostomy

Summary: the purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal.


Eligibility criteria:
inclusion criteria: * elective open reversal of an protective ileostomy exclusion criteria: * age \< 18 years * missing suitability to comprehend patient information

Keywords: ileostomy reversal subcutaneous drain hospital stay postoperative wound infection patients with elective ileostomy reversal
i2transhealth: interdisciplinary, internet-based trans health care

Conditions: Gender Dysphoria; Gender Identity Disorder; Transsexualism; Gender Identity; Gender Incongruence

Summary: i2transhealth is a randomized controlled trial that investigates the outcomes of an internet-based health care approach for transgender and gender diverse (tgd) people. as a health services research project, i2transhealth aims at reducing the structural disadvantage for tgd people \[people with transsexualism (ts: icd-10), gender incongruence (gic: icd-11) and/or gender dysphoria (gd: dsm-5)\] living in areas lacking specialized transition-related treatment. located at the institute for sex research and in cooperation with the interdisciplinary transgender health care center hamburg (ithcch), both university medical center hamburg-eppendorf (uke), i2transhealth is an innovative intervention including video consultation and a 1:1 chat with clinical psychologists. by cooperating with the ithcch, general physicians and psychiatrists provide first and local access to the specialized treatment provided by the uke. in the intervention group, the study participants are invited to use the i2transhealth e-health platform including a video consultation hour every two weeks and a messenger between the video-meetings. in addition, they have the opportunity to receive medical support close to their home by licensed gps and psychiatrists according to their needs (especially in case of a somatic or mental health crisis). the waiting group participants will be able to go forward with transition-related care after four months of study participation, as part of regular care. the primary outcome measure is a reduced symptomatology for tgd people (bscl). secondary outcome parameters include quality of life and patient satisfaction as well as healthcare-related costs and cost-effectiveness. finally, based on a longitudinal design, it will be assessed if the physicians improve their tgd-related expertise by cooperating within the i2transhealth-network.


Eligibility criteria:
inclusion criteria: * age 18 years or older * gender different from their assigned sex at birth * resident at least 50 km outside hamburg * present themselves with treatment needs (ts/gd) to one of the participating physicians in the i2transhealth network, or direct contact with institute and/or e-health platform * receive the suspected diagnosis ts/gd during an initial interview in the uke * can operate the video chat cognitively, verbally and auditory * able to read, speak, and understand german * written informed consent after written and oral information exclusion criteria: * under 18 years of age * missing informed consent * unable to speak german * indication for inpatient treatment, e.g. due to acute psychotic symptoms (self-report, prodromal questionnaire, pq-b) or severe depressive symptoms (self-report, bdi-ii ≥ 29) * acute suicidal tendencies * decrease in intelligence (iq below 70) * acute drug intoxication * failure to meet technical requirements (no internet access, lack of it knowledge)
atorvastatin in myeloma

Conditions: Myeloma

Summary: the purpose of this trial is to study the effects of a medication already widely used to treat cardiovascular disease and diabetes, in reducing the progression of myeloma.


Eligibility criteria:
inclusion criteria: * myeloma in remission exclusion criteria: * adverse events (aes) to statin, already on a statin, or contraindication to statin
accuracy, satisfaction and usability of a fgm system among children and adolescents attending a diabetes summer camp

Conditions: Type 1 Diabetes Mellitus

Summary: the aim of this study was to assess accuracy, satisfaction and usability of the fgm among children and adolescents with t1dm. the primary outcome was to assess the accuracy of the fgm system. secondary outcomes included satisfaction and usability of the device as well as assessment of sensor-related issues.

the aim of this study was to assess the accuracy, satisfaction and usability of a flash glucose monitoring system (fgm) in children and adolescents with type 1 diabetes mellitus (t1dm) and attending a 1-week diabetes summer camp, supervised by a multidisciplinary team of health care providers. the camp comprised a structured daily routine with five fixed meals: breakfast, lunch, afternoon snack, dinner and evening snack. capillary blood glucose (bg) values were measured in parallel with unmasked flash glucose measurements (fgm) using the fgm reader's built-in glucometer at breakfast, lunch and dinner. additional measurements were taken before snacks, between the meals or overnight and bg was measured only in cases of low (\ 15.0 mmol/l) fgm values or when symptoms were discordant with sensor readings. sensor-related issues were documented and a questionnaire assessing satisfaction and usability of the fgm was completed by patients and caregivers at study completion.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus, children and adolescents participating at the diabetes summer camp. exclusion criteria: * acute health condition (infectious disease), known allergy to medical adhesives or with a skin condition (e.g. atopic dermatitis)).

Keywords: flash glucose monitoring children adolescents
bacterial vaginosis screening at iud insertion

Conditions: BACTERIAL VAGINOSIS

Summary: a number of studies have shown a higher prevalence of bv among iud users.13,,14 none, however, have screened women prior to inserting the iud. no data exists detailing the status of the vaginal microflora and possible cervical infection prior to iud insertion. thus, no inference can be made about the possible influence of iud insertion and presence to the development of upper genital tract infection . consequently, with the current literature, it would be difficult to make an argument for screening and treatment for bv prior to iud insertion. this study will help us determine whether women with an iud develop a change in the normal bacteria that are present in the vagina, known as bacterial vaginosis (bv). in addition, in those women with bv, we are looking to see if they develop more significant problems with the iud, than those who do not have bv. overall, this will help us determine whether all women should be screened for bv prior to iud insertion.


Eligibility criteria:
inclusion criteria: * women between the ages of 18 and 48, who request to have an iud inserted, both for contraceptive and noncontraceptive indications, will be asked to participate in the study. exclusion criteria: * pregnancy * a previous history of ectopic pregnancy or pelvic inflammatory disease * hiv positive or immunocompromised * unable to understand english * unable to give informed consent

Keywords: bacterial vaginosis iud insertion
biomarker analysis in high pd-l1 expressing nsclc patients treated with pd-1/pd-l1 based therapy with or without the addition of platinum based chemotherapy

Conditions: NSCLC Stage IV; NSCLC, Stage IIIC

Summary: this observational study will explore the utility of the biodesix, inc. "pir" (primary immune response) test to predict outcomes in treatment-naïve advanced stage nsclc with pd-l1 tumor proportion score (tps) \> 50% and ecog performance status (ps) 0-2 nsclc patients who are treated with pd-1/pd-l1 based therapy with or without the addition of platinum based chemotherapy.

this is an observational, multicenter study designed to assess biomarkers (serum and plasma) as predictive of early progression in 390 treatment-naive patients with advanced stage non-small cell lung cancer (nsclc) and pd-l1 tps ≥50% treated with two standard of care (soc) regimens, platinum based pd-1/pd-l1 regimen with monotherapy (single agent pd-1/pd-l1 therapy). prior to enrollment, tumor specimens will be tested for pd-l1 expression according to participating centers' standard operating procedures. patients will be treated, according to physician choice, with platinum-based pd-1/pd-l1 regimen versus single agent pd-1/pd-l1 regimen. for each treatment cohort of 195 patients, enrollment will proceed in sub-cohorts to ensure a population with 20% ecog ps2 patients and a total of 40 squamous cell carcinoma patients per treatment arm. patients will receive one of the following standard-of-care (soc) treatment regimens at the discretion of the treating investigator: * pd-1/pd-l1 therapy * platinum doublet-based chemotherapy plus pd-1/pd-l1 combination tumor assessment will follow recist v1.1. blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. the biomarker analysis will be performed retrospectively. remaining serum and plasma will be stored for subsequent exploratory studies and will be available to the investigators in the alcmi network per alcmi standard operating procedures. additionally, pathology reports including pd-l1 results and next generation sequencing results, from any clia laboratory, will be collected.

Eligibility criteria:
inclusion criteria: * treatment naïve for their stage iiic/iv ajcc 8 non-small cell lung cancer with a tumor biopsy pd-l1 tps \> 50% * intent to treat with pd-1/pd-l1 or pd-1/pd-l1 plus pemetrexed/carboplatin or paclitaxel/nab-paclitaxel/carboplatin * ecog ps 0-2 * ability to consent to participate in the study exclusion criteria: * ability to understand the requirements of the protocol or to provide informed consent is impaired or is unwilling to comply with the protocol requirements
the effects of reducing stomach acid on post-tonsillectomy pain

Conditions: Post-tonsillectomy Pain; Post-tonsillectomy Activity; Post-tonsillectomy Hydration

Summary: this study was designed to determine whether post-operative pain following a tonsillectomy can be reduced by adding an antacid-like medication to the medications taken after surgery. it is hypothesized that even a small amount of stomach acid backing up and entering the mouth can increase post-tonsillectomy pain. therefore, the use of an antacid-like medication should help to decrease pain and reduce the amount of narcotic medication required for pain control.

this study has been limited to children and adolescents ages 5-18 who are undergoing tonsillectomy for an indication of obstructive sleep disturbance (snoring, choking/gasping or pauses in breathing during sleep.) study participants will be randomized to two groups: study medication (lansoprazole) or an inactive substance(placebo). participants will be asked to do all of the following: 1. take the study medication twice a day for 14 days. 2. keep a log book which will include: * record the medications and amount of each medication taken each day for 14 days. this includes pain medication and the study drug. * record your child's activity level daily for 14 days. * collect your child's urine one time daily and test it using special medicated strips to monitor their daily liquid intake for 14 days. 3. meet with a research assistant or study physician 14-21 days after the study to collect the log book and perform a post-operative examination.

Eligibility criteria:
inclusion criteria: * all healthy children ages 5-18 years scheduled for tonsillectomy and /or adenotonsillectomy for sleep disturbance secondary to airway obstruction at children's hospital boston exclusion criteria: * patients on any medications other than the study drug (lansoprazole or placebo), amoxicillin®, and acetaminophen with or without codeine * an underlying medical condition which would necessitate an alteration in the anesthetic regimen * patients allergic to any of the medications in the protocol * history of chronic tonsillitis * history of chronic pain conditions * history of active gastro-esophageal reflux disease * surgery in addition to tonsillectomy/adenotonsillectomy (except for myringotomy) * cognitive/developmental disorders * inability to use a self-report pain scale

Keywords: tonsillectomy pain