Kornimate/medical-research-clean huggingface dataset:
internet-based treatment of depression: comparing guided with unguided self-help

Conditions: Depression

Summary: the study is a randomized controlled trial and to compare the benefits of a 10-week web-based unguided self-help treatment with the same intervention complemented with weekly therapist support via e-mail. a waiting-list control group will be included. the beck depression inventory (bdi-ii) will be used as the primary outcome measure. secondary outcomes include general psychopathology, interpersonal problems, and quality of life.

depression is a major health problem associated with significant disability and economic costs. although depression can be treated effectively with several psychological and pharmacological treatment options, many sufferers still seek or receive inadequate therapy or no therapy at all. internet-based treatments may help to serve this demand, being accessible anytime and anywhere making it easier for underserved populations and people living in remote areas to receive treatment. the present study aims to assess the efficacy of an internet-based cbt intervention for depression (deprexis), directly comparing the benefits of a low intensity therapist-guided with an unguided self-help version. a waiting-list control group will be included. individuals meeting the diagnostic criteria of major depression or dysthymia will be randomly assigned to one of the three conditions. while unguided self-help will not include any contact with a therapist or the study team during the treatment, guided self-help will include a weekly scheduled e-mail feedback by a therapist and the possibility to ask questions via e-mail. while in an earlier study deprexis was assessed as an add-on to tau, this study will examine the efficacy of the program when delivered as a stand-alone intervention (i.e., only individuals who currently do not receive psychotherapy will be included). moreover, this study will include a structured diagnostic interview at pretreatment. only participants fulfilling the criteria of a depressive disorder (major depression or dysthymia) will be included in the trial. participants will be recruited in switzerland and germany via articles in national and regional newspapers and a national television interview. all questionnaires will be administered via the internet. the 21-item bdi-ii will be used as the main outcome measure. secondary outcome measures will include the brief symptom inventory (53-item bsi), the inventory of interpersonal problems (64-item iip), and the whoqol-bref.

Eligibility criteria:
inclusion criteria: * access to the internet * informed consent to participate * bdi-ii score \> 13 * if prescribed, constant dosage of medication (depression/anxiety) for 1 month prior and during study exclusion criteria: * suicide item of bdi ≥ 2 * other psychological treatment during this study
acute defibrillation performance of a novel can-less shock pathway

Conditions: Tachycardia

Summary: evaluate the operation of the implantable subcutaneous string defibrillator (issd) system in patients who require an implantable cardioverter defibrillator (icd) using an emulator.

the purpose of this study is to evaluate the operation, safety, and feasibility of the issd system in patients who require an icd. an issd emulator will be briefly implanted and tested during the standard implantation procedure of an icd, and then entirely removed. the emulator is not a powered medical device. this acute intra-operative protocol will test the ability of the issd to appropriately convert tachyarrhythmia.

Eligibility criteria:
inclusion criteria: * subjects meeting class 1, 2a or 2b indication for icd implantation * age \>18 * 32 \> body mass index (bmi) \> 25 * 190 \> height \> 165 cm * 120 \> waist size \> 90 cm exclusion criteria: * any condition that precludes the subject's ability to comply with the study requirements, including completion of the study * female who is pregnant or breastfeeding; * female who is of childbearing age who does not use reliable contraception methods (e.g. contraceptive pills, intra-uterine device, estrogen-containing plasters) or had a positive pregnancy test * an acute infection requiring antibiotics two weeks prior to surgery * participation in any other investigational study in the time icd implantation is planned, unless there is written consent from the study sponsor; * use of the antiarrhythmic drug amiodarone (cordarone, sedacoron, adenosine or other drugs) in the last 6 months before participation in the clinical trial; * existence of large permanent electrodes (e.g. epicardial electrodes), more than 3 permanent endocardial electrodes or any other metal object implanted in the upper part of your body; * any of the following cardiac diseases: protracted new york heart association (nyha) class iii or iv heart failure , left ventricular ejection fraction (lvef) \< 20% or an enlarged or hypertrophied heart * pulmonary hypertension patient, either with a history of moderate or severe pulmonary hypertension or by estimated pulmonary pressure above 45 (by cardiac echo test). * chronic obstructive pulmonary disease (copd) patient that have been hospitalized in the last 12 months for copd related reasons, require oxygen support or steroid based therapeutic support. * subjects with severely impaired kidney function as measured by a cockcroft-gault glomerular filtration rate (gfr) with an estimated gfr ≤ 29. * subjects with prior abdominal surgery in the upper abdomen, previous upper abdominal trauma or anatomical deformities of the chest or upper abdomen * subjects with known bleeding diathesis.
placebo controlled, randomized, double-blind, multi-center study to investigate the efficacy and tolerability of bay58-2667

Conditions: Congestive Heart Failure

Summary: the purpose of this study is to assess a dose titration scheme, of a new drug (bay58-2667) given intravenously, to evaluate if this is safe and can help to improve the well-being, symptoms (e.g. breathing) and outcome of decompensated heart failure. patients living with chronic heart failure have a risk of increased number of hospitalisations because of worsening of their condition (decompensated heart failure). the current treatment of acute heart failure consists of oxygen and medical treatment with vasodilators and positive inotropic agents (drugs, which should strengthen the pump function of the heart) which have their limitations. therefore there is a need for new drugs in treatment of acute heat failure.


Eligibility criteria:
inclusion criteria: * patients with decompensated chronic congestive heart failure, nyha functional class iii-iv, either ischemic or non-ischemic, requiring hospitalization, and with clinical indication for parenteral pharmacotherapy and invasive hemodynamic monitoring (i.e indwelling swan-ganz pulmonary artery catheter) and pcwp \>/= 18 mmhg. * patients must have the clinical diagnosis of chf made at least 3 month prior to enrollment. * male or female patients, age 18 years or more. exclusion criteria: * females of child-bearing potential. * acute de-novo heart failure. * acute myocardial infarction and/or myocardial infarction within 30 days. * valvular heart disease requiring surgical intervention during the course of the study.

Keywords: acute decompensated heart failure double blind study, bay58-2667 soluble guanylate cyclase activator
endobronchial ultrasound needle aspiration with and without suction

Conditions: Mediastinal Lymphadenopathy; Hilar Lymphadenopathy; Lymphoma; Lung Neoplasms; Sarcoidosis; Tuberculosis; EGF-R Positive Non-Small Cell Lung Cancer; PDL1 Gene Mutation; ALK Translocation; ROS1 Gene Mutation

Summary: the main purpose of the present study is to compare the diagnostic yield of different aspiration techniques in ultrasound-guided transbronchial needle aspiration (ebus-tbna) in the diagnosis of hilar/mediastinal adenopathy

the role of ultrasound-guided transbronchial needle aspiration (ebus-tbna) for the diagnosis of hilar/mediastinal adenopathy is well established. however, different aspiration techniques are available and it's not clear if there's a significant difference between suction vs no suction aspiration. of great interest is the role of different aspiration techniques in ebus-tbna in determining the diagnostic yield for histopathological evaluation, including molecular biology and pd-l1 amplification assessment in lung cancer diagnosis. in this context, no comparative studies between suction and no suction aspiration have been performed; moreover, considering only suction techniques, no studies evaluated if there's a difference between aspiration with ebus dedicated syringe and manual aspiration through cameco syringe. it is very important for clinical practice to definitively assess the non inferiority of no suction techniques in ebus-tbna in terms of diagnostic yield, and to provide information regarding the quality of histologic sample to define the best diagnostic strategy. the study is focused on a minimum of 306 patients who have at least one hilar/mediastinal lymph node \> 1 cm on ct scan or hypermetabolic on fdg-pet in at least one approachable lymph nodal station for which a diagnostic cyto-histological assessment is required for clinical purpose. patients will be randomized 1:1:1 (no suction : passive suction with ebus dedicated syringe : manual suction with cameco syringe) by a computer-generated random-allocation system to undergo ebus-tbna with one of the three different aspiration techniques. the pathologist provides a final diagnosis and, as secondary endpoint, a qualitative assessment of the sample quality using both a binary and a semi-quantitative score.

Eligibility criteria:
inclusion criteria: * age ≥ 18years; * presence of at least one hilar/mediastinal adenopathy \>1 cm on short axis assessed by contrast-enhanced ct scan and/or hypermetabolic adenopathy assessed by fdg-pet; * ability to give an informed consent exclusion criteria: * coagulopathy or bleeding diathesis that cannot be corrected; * severe refractory hypoxemia; * unstable hemodynamic status; * inability to give an informed consent
effect of glutaraldehyde on dentin hypersensitivity after non-surgical periodontal treatment

Conditions: Dentin Sensitivity

Summary: this randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin hypersensitivity reduction after non-surgical periodontal treatment, and its durability after 15 and 30 days. desensitizing treatment. additionally, investigate the impact of these treatments on health-related quality of life. the investigators selected patients who, after scraping and planing procedures, presented at least 2 teeth meeting the following inclusion criteria: presence of gingival recession without or with a periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile stimulus. and evaporative. subjects were randomized into 3 groups: placebo group (gp) - placebo gel application followed by placebo solution (distilled water); gpg- placebo gel application followed by application 5% aqueous glutaraldehyde solution; gsg - application of 37% phosphoric acid followed by 5% aqueous glutaraldehyde solution. the sensitivity of the dental elements was evaluated by pain stimuli (tactile and evaporative) with the aid of a visual analog scale (vas). a questionnaire was applied to patients with the objective of capturing psychosocial experiences, prior to treatment and one month after its completion, to assess the impact of desensitizing treatment on health-related quality of life. data will be collected and appropriate statistical tests will be applied.


Eligibility criteria:
inclusion criteria: - presence of gingival recession without or with periodontal pocket up to 5mm probing depth, which presented painful sensitivity response to tactile and evaporative stimuli. exclusion criteria: * systemic diseases; * pulpitis; * carious lesions; * presence of restorations in selected teeth; * cracked enamel; * noncarious cervical lesions; * use of medication with analgesics and/or anti-inflammatories; * pregnant or lactating women; * desensitizing treatment and periodontal treatment received during three months prior to study recruitment.

Keywords: clinical trials dentin sensitivity glutaraldehyde desensitizing agents
study of cdi-31244 in combination with sofosbuvir (sof) and velpatasvir (vel)

Conditions: Chronic Hepatitis C

Summary: open label phase 2a study of two week treatment with cdi-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis c (hcv) genotype 1 (gt1) infection

the study is open label and has one treatment group. eligible hcv gt1 subjects will self administer orally 400 mg of cdi-31244 and fixed dose combination of sofosbuvir and velpatasvir for 14 days. after 14 days the subjects will continue the treatment for another 4 weeks on the fixed dose combination sofosbuvir and velpatasvir. the subjects will be followed up until 24 weeks after the last dose of sofosbuvir and velpatasvir to determine if sustained virologic response at 12 (svr12) and 24 (svr24) weeks after treatment have been achieved.

Eligibility criteria:
key inclusion criteria: documented chronic hcv gt 1 infection; serum hcv rna \>1,000 iu/ml during screening; absence of advanced fibrosis or cirrhosis key exclusion criteria: nursing or pregnant women; active hepatitis b infection; human immunodeficiency virus (hiv) infection; history of use of any hcv direct-acting antiviral therapy

Keywords: hcv gt1
high-power short-duration radiofrequency ablation in patients with typical atrial flutter

Conditions: Typical Atrial Flutter; Catheter Ablation

Summary: the aim of cavotricuspid isthmus (cti) dependent flutter ablation is the bidirectional conduction block of cti. the probability of achieving a permanent bidirectional block at the cti depends, mainly, on the ablation energy applied and the quality of the obtained lesion. among the factors that determine the lesion's quality those which have the bigger impact are catheter stability, contact force, power and duration of energy application and the temperature reached at depth.this is a multicenter 1:1 randomized, blinded (open for the operator) study. two cti ablation strategies are compared: 1) conventional treatment branch which consists of individual 25-40 w applications of unlimited duration until achieving in each application the minimum value of one of the currently accepted and used lesion markers (ablation index \>500 at the anterior half of the cti and \>400 at the posterior half with de carto 3 system; 2) experimental treatment branch consistent of cti block using individual high power (90w) short duration (4 seconds) point-by-point applications. the main objective of this study is assessing the non-inferiority of the efficacy and safety of high-power short-duration ablation in patients undergoing typical atrial flutter ablation. secondary objectives include the comparison of total radiofrequency time, number of applications, number of steam pops, percentage of reconnections, procedure duration, pain during the procedure and time to atrial flutter recurrence.


Eligibility criteria:
inclusion criteria: * patients with cavotricuspid isthmus dependent flutter referred to ablation * patients clinically and hemodynamically stable. * patients who give informed consent. exclusion criteria: * refusal to participate in the register or inability to understand the informed consent. * age under 18. * patients who have already undergone previous flutter ablation procedures.

Keywords: typical atrial flutter cavotricuspid isthmus cavotricuspid isthmus high-power short-duration
identification of risk phenotypes for sarcopenia using dxa wbc, anthropometric and ma among young adults

Conditions: Sarcopenia

Summary: this cross-sectional study aims to identify risk phenotypes for sarcopenia among young adults using dual-energy x-ray absorptiometry (dxa) for whole-body composition analysis, along with anthropometric and musculoskeletal assessments. sarcopenia, characterized by the loss of muscle mass and strength, is a growing concern, particularly among the aging population.

however, early identification in young adults can allow for preventive strategies to improve long-term health outcomes. this study, involving 221 participants aged 15 to 35, focuses on assessing the correlation between dxa-derived body composition, musculoskeletal fitness, and anthropometric measurements with sarcopenia risk. primary outcome measures include dxa imaging and dynamometry for body composition and strength evaluation, while secondary outcomes focus on detailed anthropometric and musculoskeletal analyses. by addressing early risk factors in younger populations, this research hopes to enhance understanding of sarcopenia's development and support early intervention strategies. data collection is conducted at the center of nuclear medicine in lahore, pakistan.

Eligibility criteria:
inclusion criteria: * young adults ( between 15-35) (7) exclusion criteria: * elderly patients * children below the age of 18 years * diagnosed malignancy * diagnosed patients * diseased individuals such as chronic illness and malignancies
comparison of stationary breast tomosynthesis and 2-d digital mammography in patients with known breast lesions

Conditions: Breast Neoplasms

Summary: the goal of the study is to compare the radiologist confidence level in evaluating patients with known breast lesions using a carbon nanotube x-ray based stationary breast tomosynthesis imaging device. the comparison will be made against conventional mammography acquired as a part of a standard clinical workup. one hundred patients who are to have a clinical surgical breast biopsy will be recruited for the study. a reader study will be performed to evaluate the roc characteristics of the system.


Eligibility criteria:
inclusion criteria: * women at least 18 years old. * scheduled for breast biopsy of at least one breast lesion. * lesion detected on mammogram. * symptomatic by patient self-report, patient self-breast exam or clinical exam. * able to provide informed consent. exclusion criteria: * male. (it is uncommon for men to present for imaging and the overwhelming majority of findings are non-cancerous and do not lead to biopsy; male breast cancer represents \<1% of newly diagnosed breast cancer) * less than 18 years of age. * patient unable to give consent. * institutionalized subject (prisoner or nursing home patient). * any woman who is pregnant or has reason to believe she is pregnant or any woman who is lactating

Keywords: breast cancer
healthy brain and child development study - covid-19 supplement

Conditions: Child Development; Prenatal Infection; Prenatal Stress; Covid19

Summary: the purpose of this study is to advance the scientific understanding of how a prenatal covid-19 infection and associated psychological distress influences infant neurodevelopment. this project will aim to shed light on how families and child development are impacted by the current covid-19 pandemic and will work to better support these families and children as they grow.

prenatal exposure to maternal illness and stress has been widely associated with adverse neurodevelopmental outcomes, including deficits in cognition and socioemotional development. the principal goal of this project utilizes magnetic resonance imaging (mri), electroencephalography (eeg), and a variety of behavioral measures to assess brain maturation and neurodevelopment among infants exposed prenatally to covid-19 and associated high levels of stress. the planned experiments are effective in identifying brain markers that may contribute to resiliency in young infants, determining measures of stress response in relation to a maternal covid-19 diagnosis, and characterizing the neurodevelopment of those infants born to mothers with a covid-19 infection. specific goals include: 1. to determine the prevalence of psychological distress in pregnant women with a confirmed covid-19 diagnosis and to examine the extent to which existing high risk environments play a role in the susceptibility of heightened psychological distress. 2. to examine the effects of prenatal distress and maternal illness/inflammation related to a maternal covid-19 diagnosis on early structural and functional brain development. 3. to characterize neural networks that may have been impacted by a maternal covid-19 infection and related stress during pregnancy. 4. to assess the early neurodevelopment outcomes of infants exposed to elevated prenatal stress related to a maternal covid-19 diagnosis during pregnancy.

Eligibility criteria:
inclusion criteria: * english or spanish- speaking of any ethnicity * women, aged 18 or older * women who received covid-19 diagnoses during pregnancy or women without any sars-cov-2 positive test during pregnancy, any suspected covid illness (even if not tested) or who received a negative covid-19 test result during pregnancy exclusion criteria: participants will be excluded if the child: * is born at less than 34 weeks or if birth weight is not appropriate for dates * has an identified genetic, metabolic, syndromic or progressive neurological disorder (e.g., down syndrome, rett syndrome, tuberous sclerosis, neurofibromatosis, fragile x syndrome) at birth or within the first year
use of a new phototherapy device (bbloo®) for the treatment of hyperbilirubinemia in the newborn infant

Conditions: Neonatal Hyperbilirubinemia

Summary: jaundice occurs in most newborn infants. most jaundice is benign, but because of the potential toxicity of bilirubin, newborn infants must be monitored to identify those who might develop severe hyperbilirubinemia an, in rare cases, acute bilirubin encephalopathy or kernicterus. jaundice is a commonly observed, usually harmless condition in newborn infants during the first week after birth. however, in some babies the amount of bilirubin pigment can increase to dangerous levels and require treatment. treatment of jaundice in newborn infants is done by placing them under phototherapy, a process of exposing their skin to light of a specific wavelength band. fluorescent tubes or halogen lamps have been used as light sources for phototherapy for many years. a light-emitting diode (led) is a newer type of light source which is power efficient, has a longer life and is portable with low heat production. several technologies and devices are developed around this led and specially a compact system. the purpose of this study is to evaluate efficacity of led phototherapy by comparing with conventional phototherapy (non-led) and satisfaction of the parents and the professional staff about comfort of this new technology. the newborn infant is placed in a sleeper with the device b' bloo ® which maintains him in position (lap or dorsal) allowing to pass the blue light. this one is generated by the module led and transmitted in the braid of optical fibers which takes place directly on the mattress of the cradle in which is placed the patient usually. the device is endowed with an hour counter to schedule the time of treatment. the energy illumination varies between 3 and 4 mw / cm ² for an average 3,6 mw / cm ².


Eligibility criteria:
inclusion criteria: * newborn infants ≥ 38 gestation weeks without or with risk factors of severe icterus (g6pd or pyruvate-kinase deficiency, red blood cells membrane defects, hemoglobinopathies, cephalohematoma or significant bruising, decreased breastfeeding) * newborn at 35 and 38 gestation weeks without risk factor of severe icterus (qs) * hyperbilirubinemia to deal according to the curves of indication of phototherapy of the app on 2004 * no opposition of parents exclusion criteria: * opposition of parents * newborn infants less than 33 weeks * newborn infants at 35 or more weeks of gestation with risk factors of severe icterus * jaundice in first 12 hours * hyperbilirubinemia \> 340 µmol/l whatever is the age