Kornimate/medical-research-clean huggingface dataset:
treatment of functional abdominal distension by non-instrumental biofeedback

Conditions: Irritable Bowel Syndrome; Dyspepsia; Functional Bloating

Summary: background. abdominal distention is produced by an abnormal somatic postural tone. the authors developed an original biofeedback technique based on electromyography-guided control of abdominothoracic muscular activity. in a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. however, the technique is technically complex and unpractical. aim. to prove the efficacy of a non-instrumental biofeedback technique for the treatment of abdominal distension. selection criteria. visible abdominal distension after meal ingestion; patients are able to identify the offending meal. intervention. patients will be randomized into biofeedback in placebo groups. three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period. biofeedback: patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. placebo: sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.


Eligibility criteria:
inclusion criteria: * episodes of visible abdominal distension triggered by meal ingestion * patients are able to identify the offending foodstuff exclusion criteria: * organic cause detected by clinical work-up * constipation * abdominal distension not confirmed by the 7-day clinical questionnaires or after the probe meal in the pre-intervention evaluation
prospective covid-19 cohort study, dominican republic

Conditions: SARS-CoV-2 Infection; Covid19

Summary: this project will build on an existing cdc funded cooperative agreement in the dominican republic with the brigham and women's hospital (2018-2023) that includes (i) prospective covid-19 and afi surveillance at two health facilities and (ii) a nationally representative cross-sectional community-based serological survey of approximately 7,000 healthy adults and children targeting sars-cov-2 and other afi pathogens to be conducted between april and june 2021. this linked study will establish a nested cohort of 2,000 participants enrolled in the national serological survey and prospectively monitor them for covid-19 symptoms, conduct serial serological testing, implement molecular surveillance for sars-cov-2 and sequencing for variants of concern, implement and evaluate wash mitigation measures, and monitor uptake and perceptions of covid-19 vaccines.


Eligibility criteria:
inclusion criteria: * previously enrolled in a linked national community-based seroepidemiological study in the dominican republic * agreed and consented to be recontacted to participate in additional research studies at the time of enrollment in #1 * ≥2 years of age * agree to participate exclusion criteria: * ward of the state
blood pressure telemonitoring and goal blood pressure in diabetes

Conditions: Diabetes; Hypertension

Summary: does home telemonitoring increase the number of diabetes patients at goal blood pressure in a primary care practice?

this is a randomized control trial, two arms with block randomization. primary care patients with diabetes and elevated blood pressure randomized to intervention or control. intervention arm: home telemonitoring using the ideal life blood pressure cuff and telephone or internet transmission device to transmit blood pressure information to the primary care manager team with otherwise normal care manager care. control arm: omron (off the shelf) home blood pressure monitor (no transmission of data) and usual care. we will be comparing blood pressure control between groups and provider contacts.

Eligibility criteria:
inclusion criteria: * age 18-75 (inclusive * blood pressure in hypertensive range (systolic \>= 140 or diastolic \>=90 * diabetes exclusion criteria: * pregnancy * lack of computer with internet access or phone line * lack of english language literacy * arm size to large or small for cuff

Keywords: diabetes
creation of a digital heart failure registry using a novel mobile health platform: hugo-hf

Conditions: Heart Failure

Summary: the investigators goal is to create a digital registry that allows for seamless integration of patient reported outcomes, electronic health record data, and pharmacy information into data collection. the investigators will accomplish this using a novel patient centered mobile health platform called hugo that will allow them to engage patients in an entirely novel manner.

heart failure is the most common cause of mortality and morbidity in the united states and in western europe. it is a complex and chronic illness, and patient journeys vary considerably. however, to date, guidance about how to best treat patients has relied on large clinical international trials that do not represent contemporary patients and only include snapshots of the syndrome-at times when the patients interact with the health care system. additionally, patient participation in clinical research in the us is extremely low, approximated at 3% in cancer and far lower for disease states such as heart failure. one of the key reasons for this is a lack of patient engagement and trust in the research enterprise, especially among the elderly and minorities, groups that are disproportionally impacted by heart failure. to address this, the investigators plan to test a novel patient-powered, smartphone-based mobile health platform (called hugo) developed at yale school of medicine for real-world surveillance of patient reported outcomes in heart failure patients treated at 3 major academic medical centers. participants will then be queried about specific symptoms and health conditions at enrollment and prespecified time points for 2 years. the subgroup of participants who own devices that track their activity data will have the option of syncing them to this mobile health platform to provide additional insights into their health and health outcomes. additionally, participants will have the option to learn about opportunities to participate in heart failure clinical research. this digital registry will also allow seamless integration of patient reported outcomes, electronic health record (ehr) data, and pharmacy information into data collection. overall, the aim for this study is to create a digital registry using a novel patient centered mobile health platform of heart failure patients across large health care systems that allows investigators to engage patients in an entirely novel manner.

Eligibility criteria:
inclusion criteria: * age\> 18 years * english speaking * diagnosis of heart failure * participant is willing and able to read and sign consent and participate in study * participant has an email account exclusion criteria: - unable to participate in registry

Keywords: heart failure heart transplant left ventricular assist device
hesperidin and diosmin effect on metabolic syndrome

Conditions: Metabolic Syndrome and Diabetic Neuropathy

Summary: the components of metabolic syndrome (mets), particularly obesity and dyslipidemia, are linked to peripheral neuropathy (pn) among patients with diabetes or even without diabetes. several studies revealed that complementary and herbal medicine could provide a potential for pn management and mets components. thus, designing clinical trials with interventions combinations to achieve a considerable improvement is highly recommended. hesperidin and diosmin, citrus-derived flavonoids, have been reported to possess anti-hyperlipidemic, anti-inflammatory, analgesic, antioxidant, antidiabetic, and anti-hypertensive effect with high tolerability and safety profile


Eligibility criteria:
inclusion criteria: type 2 diabetes adult patients who meet metabolic syndrome criteria and with diabetic neuropathy exclusion criteria: patients without any parameter of inclusion criteria
evaluation of the treatment of recurrent corneal erosions by anterior stromal puncture with nd: yag laser

Conditions: Recurrent Corneal Erosion; Trauma

Summary: to evaluate the clinical outcomes in patients with recurrent corneal erosions who received anterior stromal puncture by use of neodymium:yttrium-aluminum-garnet (nd:yag) laser.

participants: from 2000 to 2005, thirty-three eyes in 33 patients with unilaterally recurrent corneal erosions who showed poor response to conservative managements and were treated with nd:yag laser were studied. intervention: anterior corneal stromal puncture with nd:yag laser was performed in the loosened epithelium or epithelial defect area. the causes and frequency of corneal erosions and the spot numbers and total energy of the nd:yag laser were recorded. slit-lamp biomicroscopic examination, refraction, corneal topography, and times of laser were reviewed. a questionnaire regarding the preoperative and postoperative difference in the intensity of pain and frequency of corneal erosion was provided. main outcome measures: rate of recurrence and pain assessment by numerical rating scale.

Eligibility criteria:
inclusion criteria: * patients with recurrent corneal erosions who showed poor response to conservative managements and were treated with nd:yag laser. exclusion criteria: * slit-lamp biomicroscopic examination in both eyes of patient showed any evidence of anterior basement membrane dystrophy.

Keywords: nd: yag laser recurrent corneal erosions trauma anterior stromal puncture
a novel endoloop pre-test to treat gastroesophageal reflux

Conditions: GERD; Reflux Esophagitis

Summary: the purpose of this study was to evaluate the safety and efficacy of endoscopic endoloop pre-test for gastroesophageal reflux before anti-reflux surgery or endoscopic treatment. in the study, the investigators used the novel pre-test to narrow the gastric cardia to control symptoms temporarily to decide whether to undergo irreversible surgery or endoscopic treatment.thirty patients were enrolled and underwent endoscopic endoloop pre-test treatment. the primary outcome in this study was measured by the percent reduction in post-procedure gerd symptoms as evidenced by analysis of the gerd-hrql (health related quality of life) questionnaire. the secondary outcomes included improvement in esophageal 24-hr ph monitoring, improvement in quality of life questionnaires and safety. patient follow-up assessments were completed at 7 and 14 days post treatment.

gastroesophageal reflux disease (gerd) is a neuromuscular disorder with abnormal reflux of gastric contents into the esophagus.the most common symptoms are heartburn, dysphagia, and regurgitation.due to less invasion, several endoscopic treatments of gerd have been investigated, such as collagen or radio frequency delivery, and antireflux mucosectomy(arms).the disadvantages of these treatment included short-term effectiveness, increasing reflux and ulcer, and serious complications. a novel endoscopic endoloop pre-test treatment has been developed, offering a minimally reversible endoscopic treatment to predict whether the symptoms can be alleviated in order to ultimately decide whether to undergo irreversible surgery or endoscopic treatment, which can be performed in an outpatient setting.the aim of this study was to assess the feasibility and safety of the pre-test treatment.

Eligibility criteria:
inclusion criteria: * patients with typical symptoms of gerd with symptomatic response to ppi therapy for ≥ 3 months * patients considered for non-medical therapy, i.e. unwillingness to take life-long medication in medically-responding disease, suffering from medication side-effects or medically-intractable disease * pathological esophageal acid exposure after discontinuation of medical therapy, proven by ambulatory 24-hour ph-monitoring with \> 5% of time a ph \ 95% * written informed consent exclusion criteria: * 24 hr acid exposure study showing abnormal esophageal acid exposure \<4% * demeester score \<14.7 * hiatal hernia (\> 3 cm in length) * history of antireflux or esophageal/gastric surgery * severe psychiatric disease * barrett's esophagus with dysplasia * esophageal stenosis/malignancy * pregnancy or lactation * history of low therapeutic compliance * other severe comorbidity (including cardiopulmonary disease, portal hypertension, collagen diseases, morbid obesity, coagulation disorder) * use of anticoagulant or immunosuppressive drugs
genotyping directed salvage therapy in children who have failed dual nrtis

Conditions: HIV Infections

Summary: in hiv-nat 013 phase i study, genotyping was performed in 95 children on dual nrti which showed that almost all children had resistance to nrti. the hiv-nat 013 phase ii is a follow up study to evaluate treatment outcome after salvage therapy and the evolution of mutations.

the hiv-nat 013 study (conducted in 2003) evaluated prevalence and pattern of rt mutation in 95 children treated with dual nrti. the study showed almost all children to have some degree of nrti resistance and 40% with multi nrti resistance. the mutation reported was major mutation. after the study, the patients were managed based on the physician's judgment using genotyping results. the 95 patients in hiv-nat 013 are categorized into 3 groups. 1. no viral resistance 2. low grade resistance with or without clinical/ immunological failure 3. high grade resistance with or without clinical/ immunological failure. there are limited prospective studies evaluating outcome of decision regarding salvage therapy after genotyping results there are also new mutations that are not considered major mutation that may affect treatment outcome knowledge learned from this study will benefit thai children with nrti resistance by helping pediatricians better choose salvage treatment options

Eligibility criteria:
inclusion criteria: * all children from hiv-nat 013 phase i exclusion criteria: * no inform consent obtained

Keywords: hiv children genotypic resistance dual nrtis salvage therapy treatment outcome salvage therapy based on genotyping results treatment failure
effects of the örebro prevention program on youth drinking

Conditions: Youth Drinking

Summary: the örebro prevention program is a brief (6 x 30 minutes)program administered to parents of 13-16 year old youths in regular parental meetings. the program aims to encourage parents to maintain a restrictive attitude towards youth drinking throughout their children's teenage years, and thereby postpone and reduce youth drinking. a previous quasi-experimental study by the program developers showed a sustained alcohol-specific restrictivity among parents exposed to the program, and also a reduction on drinking measures among the youths of the exposed parents (koutakis, stattin \& kerr, 2008). this study aims to investigate whether these effects are sustained also when the program has gone into wide dissemination in sweden.


Eligibility criteria:
inclusion criteria: municipal schools in counties with local öpp program presenters, comprising grades 7-9, with at least two 7th grade classes in parallel, and with no previous experience of the örebro prevention program. - exclusion criteria: -

Keywords: örebro prevention program youth drinking
single focused shock wave in the release od delayed onset muscle soreness (doms)

Conditions: Musculoskeletal Pain; Athletic Injuries

Summary: the study is a single-center, double blinded, randomized controlled trial aimed to investigate the effects of focused extracorporeal shockwave therapy (feswt) on delayed onset muscle soreness (doms) of the non-dominant biceps brachialis muscle in healthy voluntary adults.

forty-five participants agreed to participate and signed a written informed consent. after enrollment, muscle soreness was induced and participants were subsequently randomized to receive either (1) focused extracorporeal shockwave therapy (verum), (2) sham shock wave (sham) or (3) no treatment (control). thereafter, treatments were administered once, only. measures were repeated after the treatment and at 24, 48 and 72 hours. main outcome parameter was the pain intensity at rest and in movement as assessed by visual analogue scale (vas) in the elbow region of the non-dominant arm. secondary outcome included the pressure pain threshold (ppt) over the biceps muscle belly, the maximum isometric voluntary force (mivf) of the elbow flexors and the assessing the impairment of activities of the daily living. participants were followed-up 72 hours after the induction of delayed onset muscle soreness.

Eligibility criteria:
inclusion criteria: * healthy subjects * age 18+ * voluntariness exclusion criteria: * pain * pregnancy * musculoskeletal disease * systemic neurological disease * cancer * coagulation disorder * mental illness * drug addiction * allergy to the ultrasound gel * cardiac illness * vascular disease of the limbs or the central nervous system * regional scars * regional skin transplants or hypoesthesia * allergic or other forms of acute dermatitis * chronic intake of analgesic, neuroleptics, antidepressants, corticoids or alpha2-blockers * current state of delayed onset muscle soreness * extracorporeal shockwave therapy within last 2 weeks
pharmacokinetics of testosterone lotion in the treatment of hypogonadal males

Conditions: Hypogonadism

Summary: testosterone replacement treatment is the most effective way of treating hypogonadism in men. acrux has a proprietry testosterone replacement product - testosterone-md lotion, and this study will evaluate the efficacy and safety of this product.


Eligibility criteria:
inclusion criteria: * hypogonadal males between 18-70 years old with qualifying general medical health exclusion criteria: * disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy
abo-incompatible kidney transplants between robot-assisted vs. open surgery

Conditions: Kidney Transplantation

Summary: while robot-assisted kidney transplantation (rakt) offers potential benefits such as minimal postoperative pain, better cosmesis, fewer wound infections, and shorter hospital stay, its efficacy in abo-incompatible (abo-i) kt compared to open kt (okt) remains understudied. this study aims to compare abo-i kt outcomes between rakt and okt. the study utilized data from 29 abo-i rakt and 210 abo-i okt cases performed at asan medical center from october 2020 to february 2023. univariate and multivariate analyses were performed to evaluate factors associated with a composite of biopsy-proven acute rejection (bpar), de novo donor-specific antibodies (dsa), and overall graft failure.


Eligibility criteria:
inclusion criteria: * patient eligible for living donor abo incompatible kidney transplantation * presenting an isoagglutinin immunoglobulin g titer (anti-a-b) between 1/8 and 1/128 before operation * patient older than 18 years and young than 80 years * patient able to sign an informed consent form exclusion criteria: * patient with comorbidities or hypersensitivity that prevent desensitization protocols * women who are pregnant, or who may become pregnant or breastfeeding women * subjects under legal protection * subjects participating in another interventional research protocol or in an exclusion period from another interventional research protocolpatient affiliated with a social security scheme

Keywords: robot-assisted kidney transplantation abo incompatible biopsy-proven acute rejection immunologically high-risk patients
panobinostat or placebo with bortezomib and dexamethasone in patients with relapsed multiple myeloma

Conditions: Multiple Myeloma

Summary: panobinostat (lbh589) is a highly potent pan-deacetylase inhibitor (pan-daci), inclusive of hdac6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. combination of pan-dac and protease inhibition by co-treatment with panobinostat (pan) and bortezomib (btz) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. furthermore, clinical experience in advanced multiple myeloma (mm) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile. given the medical need for improved treatment strategies for patients with previously treated and relapsed mm, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group phase iii study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated mm whose disease has recurred or progressed.


Eligibility criteria:
inclusion criteria: 1. patient has a previous diagnosis of multiple myeloma. 2. patient requires retreatment for multiple myeloma 3. patient has measurable m component in serum or urine at study screening exclusion criteria: 1. patient who has progressed under all prior lines of anti mm therapy 2. patient who has been treated by bortezomib before, and did not reach at least a minor response under this therapy, or progressed under it or within 60 days of last dose 3. patient has shown intolerance to bortezomib or to dexamethasone or components of these drugs or has any contraindication to one or the other drug , following locally applicable prescribing information 4. patient received prior treatment with dac inhibitors including panobinostat 5. patient has impaired cardiac function, or a prolonged qtc interval at screening ecg 6. patient taking medications with relative risk of prolonging the qt interval or inducing torsade de pointes 7. female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: myeloma daci bortezomib combination panobinostat lbh589d relapsed velcade® combination,