Kornimate/medical-research-clean huggingface dataset:
add-on dextromethorphan in bipolar disorders

Conditions: Bipolar Disorder

Summary: dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and having protective effect against inflammation-related neuron damage. these anti-inflammatory and neuroprotective effects of dextromethorphan would suggest potential clinical benefits of dextromethorphan add-on therapy to valproate for bipolar disorder patients. this hypothesis was based on the findings that the mood stabilizers have been reported to be neuroprotective through the release of neurotrophic factors such as gdnf from astroglia. thus, the combination treatment of mood stabilizers and dextromethorphan might improve the therapeutic efficacy for bipolar disorder patients.


Eligibility criteria:
inclusion criteria: 1. male or female patient aged ≧18 and ≦65 years. 2. a diagnosis of bipolar i or ii disorder according to dsm-iv criteria made by a specialist in psychiatry. 3. a total of hdrs score at least 18 or ymrs score at least 14 at screen. 4. signed informed consent by patient or legal representative 5. patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study. exclusion criteria: 1. women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study. 2. females who are pregnant or nursing. 3. patient has received dextromethorphan, or other selective cyclo- oxygenase 2 (cox-2) inhibitors, or other anti-inflammatory medication within 1 week prior to first dose of double-blind medication. 4. axis-i dsm-iv diagnosis other than bipolar i or ii disorder. 5. current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation. 6. history of intolerance to valproate or dextromethorphan or other cox-2 inhibitors. 7. history of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by dextromethorphan. 8. patient has received electroconvulsive therapy (ect) within 4 weeks prior to first dose of doubleblind medication. 9. diagnosis of or treatment for esophageal, gastric, pyloric channel, or duodenal ulceration or related complications (bleeding and/or perforation) within 30 days prior to receiving first dose of double-blind medication. 10. inclusion in another bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study. 11. increase in total sgot, sgpt, bun and creatinine by more than 3x uln (upper limit of normal). 12. history of idiopathic or drug-induced agranulocytosis. 13. substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by dsm-iv criteria.
impact of cardiac rehabilitation on acute heart failure patients with cognitive impairment

Conditions: Heart Failure, Systolic; Morality; Cognitive Impairment

Summary: in heart failure patients, neuropsychological disorders have been prospectively linked to frequent hospitalizations, recurrent cardiac events, and mortality. cognitive dysfunction is also a frequent comorbidity in heart failure (hf) patients. the benefit of cardiac rehabilitation between patients with cognitive dysfunction and patients without cognitive dysfunction is unknown. investigators hypothesize that patients with cognitive dysfunction benefit more from cardiac rehabilitation programs than patients without cognitive dysfunction.

investigators retrospectively reviewed hf patients discharged from acute hf hospitalizations between march 2015 and may 2021 at the heart failure center, kaohsiung chang gung memorial hospital. cognitive function was assessed with the luria-nebraska neuropsychological battery-screening test (lnnb-s) chinese version by an experienced psychologist. participants may have cognitive impairment when their lnnb-s \>=10. a heart failure disease management program was delivered to all patients before discharge, including an hf specialist nurse education program, dietitian consultation, physiatrist consultation, and psychologist consultation and assessment. participants were advised to receive phase ii cardiac rehabilitation (cr) after the cardiopulmonary exercise test (cpet) within one month. moderate continuous aerobic exercise training was prescribed individually according to the cpet result. participants who received at least one exercise session of phase ii cr were considered as receiving cr. other participants were considered non-receiving cr. kaplan-meier curves and log-rank test were constructed to compare the composite endpoint and all-causes mortality in four groups (group a: candidates without cognitive impairment and receiving cr. group b: candidates without cognitive impairment and not-receiving cr. group c: candidates with cognitive impairment and receiving cr. group d: candidates with cognitive impairment and not-receiving cr.)

Eligibility criteria:
inclusion criteria: * acute hf patients with reduced ejection fraction (left ventricular ejection fraction, lvef \<=40%) and discharged alive from the hospital. * completed cognitive and psychological functional assessment. * aged \>= 20 years of age, male or female. * received heart failure disease management coordinated by an hf specialist nurse as described before. exclusion criteria: * estimated survival time \< 6 months. * long-term bedridden for more than 3 months. * terminal heart status. 4. cannot cooperate with all functional studies.

Keywords: acute heart failure cognitive screening cardiac rehabilitation cardiopulmonary exercise test adverse outcomes
vitamin d and grass pollen specific immunotherapy

Conditions: Allergic Rhinoconjunctivitis

Summary: allergen-specific immunotherapy is the only causal therapy of immunoglobulin e-induced allergies like allergic rhinoconjunctivitis. despite progress during the last decades it is limited by a long treatment time and high non-responder frequency. based on experimental and epidemiological evidences we hypothesize that vitamin d can act as an effective immunomodulatory adjuvant to overcome these limitations.


Eligibility criteria:
inclusion criteria: * written informed consent * relative vitamin d deficiency * clinical relevant grass pollen allergy * positive intradermal test with grass pollen * forced expiratory volume at one second (fev1) \> 70% exclusion criteria: * current specific immunotherapy * instable allergic asthma * pregnancy and lactation * treatment with immunomodulators or immunosuppressive drugs * sarcoidosis, chronic diseases, malignancy

Keywords: vitamin d sit grass pollen allergic rhinoconjunctivitis
copd breathing record study 2

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of this study is to collect capnometric (tidal breathing co2) data using tidalsense's n-tidal c data collector device. the data collected will be examined for correlation with currently accepted assessment techniques for copd (spirometry, vital signs and pulse oximetry) and the patient's clinical condition (stable, worsening, improving). the patient numbers and study duration have been determined by power calculations to provide a statistically significant sample size, based on expected number of exacerbations (mild, moderate and severe) from the patient cohort. the data will also be examined to assess the predictive possibility of a non-invasive self-care personal co2 monitoring device to identify copd exacerbations.

study design: this is an uncontrolled, non-randomised, un-blinded longitudinal observational data collection study with the n-tidal c data collector device in patients with copd. patients will be identified from the cambridge copd centre. this unit sees patients following emergency admissions, gp referrals and has a regional referral base for complex copd. patients' medical records will be reviewed and classified according to gold criteria. those patients who are classified as copd with appropriate inclusion criteria (below) will be invited to participate. patients who give informed consent will be screened for the study. the n-tidal c data collector device will be explained to the patients and they will be trained how to use it. all patients will complete a short daily diary record. patients will undergo a clinical assessment of copd during screening at addenbrooke's hospital. all patients will be assessed five times: at the start, 2 weeks, 10 weeks, 18 weeks and at the end of the 26 week study period. a brief follow-up telephone review will be conducted approximately 2 weeks after the end of the monitoring period. at each assessment, capnometry measurements will be taken in addition to vital signs and pulse oximetry. the study will not interfere with routine management of the patient's condition.

Eligibility criteria:
inclusion criteria: 1. aged 40 years and over. 2. diagnosis of copd (primary) and at least one moderate exacerbation within 12 months of the start of the study period. 3. able to provide signed informed consent. exclusion criteria: 1. patients who, in the opinion of the investigator, are unlikely to comply with the requirements of the study, use the device correctly or keep the diary records; 2. diagnosis of neuromuscular disorders or kyphoscoliosis; 3. diagnosis of other respiratory disorders that, in the opinion of the investigator, would impact the conduct of the study e.g. clinically significant bronchiectasis, asthma; 4. patients who have experienced an exacerbation of their copd that has required treatment with antibiotics and/or oral corticosteroids within 2 weeks prior to the study start.

Keywords: capnography diagnosis breathlessness exacerbations device
quality of life and participation of the adult with spinal muscular atrophy in france

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy is a hereditary motorneuron disease caused by a mutation of the smn1 gene, which is at the origin of a progressive limb and axial motor deficiency. it concerns 1200 individuals in france, including 700 adults in 2018. the main objective of this study is to assess the quality of life of sma patients in france. the secondary objectives are, in one hand, to compare the quality of life of sma patients to a population of neuromuscular diseases patients. and on the other hand to evaluate the determinants of participation and the impact of participation on quality of life in adult sma patients.


Eligibility criteria:
inclusion criteria: * patient with sma type 1, 2, 3 or 4 * ≥ 18 years old * giving informed consent to participate to the study * patients from the study of dany et al "construction of a quality of life questionnaire for slowly progressive neuromuscular disease" (2015) exclusion criteria: * patients who do not complete ≥ 80% of the questionnaire)-
evaluating the impact of single dose tiotropium on allergen-induced early asthmatic response

Conditions: Asthma Bronchiale

Summary: evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced ear assessed as the maximal % fall in fev1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.


Eligibility criteria:
inclusion criteria: * age (years) at least 18 years * no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity as determined by the principal investigator) * baseline fev1 ≥ 65% of predicted normal at visit 1 * evidence of atopy to an allergen suitable for inhalation challenge following skin prick testing such as house dust mite, grass, cat or horse * fall in fev1 of ≥ 20% at a dose of methacholine ≤ 600mcg (methacholine pd20) at visit 1 * positive response to allergen inhalation challenge (fall in fev1 of ≥ 15% after inhalation of allergen at a dilution 1:32 or more dillute. * absence of respiratory infection for at least 4 weeks prior to visit 1 * absence of significant worsening of asthma that requires health care intervention or prolonged change in medication due to allergen exposure (or other trigger) for at least 4 weeks prior to visit 1 * women of child-bearing potential shall not be pregnant or lactating * non-smoker (cigarettes, vaping); ex-smoker with \<10 pack year history allowed; cannabis use will be evaluated on a case-by-case basis * if on as needed budesonide/formoterol therapy, no reported use within 3 weeks prior to allergen challenge exclusion criteria: * smoker \>10 pack year history

Keywords: asthma tiotropium early asthmatic response
golidocitinib plus chop in newly diagnosed ptcl

Conditions: Peripheral T-cell Lymphoma

Summary: this is single-arm phase i/ii study designed to evaluate the safety and efficacy of golcadotinib in combination with the chop regimen for patients with newly diagnosed peripheral t-cell lymphoma (ptcl). the study adopts a two-stage design, consisting of a phase i and a phase ii parts. in the phase i study, a standard "3+3" design will be used. the primary endpoints of the phase i study are the maximum tolerated dose (mtd) and the recommended phase ii dose (rp2d). the primary endpoint of the phase ii study is the complete response rate (crr) of the golcadotinib combined with chop regimen.


Eligibility criteria:
inclusion criteria: * age between 18 and 70 years; * histopathologically confirmed diagnosis of ptcl of one of the following subtypes: (1) peripheral t-cell lymphoma, not otherwise specified (ptcl-nos); (2) angioimmunoblastic t-cell lymphoma (aitl); (3) anaplastic large cell lymphoma (alcl); or (4) other ptcl subtypes considered eligible by the investigator; * patients must have at least one measurable lesion according to the lugano 2014 criteria: for lymph node lesions, the measurable lymph node must have a long diameter \>1.5 cm; for non-lymph node lesions, the measurable extranodal lesion must have a long diameter \>1.0 cm; * ecog performance status score of 0-3; * adequate bone marrow function: absolute neutrophil count (anc) ≥1.5×10\^9/l, platelet count (plt) ≥75×10\^9/l, and hemoglobin (hgb) ≥90 g/l (for patients with bone marrow involvement, anc can be relaxed to ≥1.0×10\^9/l, plt to ≥50×10\^9/l, and hgb to ≥75 g/l); * adequate organ function: alanine aminotransferase (alt) \<3 times the upper limit of normal (uln), total serum bilirubin (tbil) ≤1.5 times uln, creatinine clearance ≥50 ml/min, and left ventricular ejection fraction (lvef) ≥50% as determined by echocardiography. exclusion criteria: * extranodal nk/t-cell lymphoma; * history of acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmias, or significant qt interval prolongation (men \>450 ms, women \>470 ms) within the past 6 months; * uncontrolled active infection; * anc ≤0.5×10\^9/l, lymphocyte count ≤0.4×10\^9/l, plt ≤75×10\^9/l, alt ≥3 times the uln, or creatinine clearance ≤50 ml/min; * presence of primary or secondary central nervous system (cns) lymphoma at the time of enrollment; * pregnant or breastfeeding women; * patients who have received any investigational drug or radiotherapy within the past 4 weeks; * individuals deemed unsuitable for participation by the investigator;
a pilot study to increase utilization of gdmt in patients with hfref

Conditions: Heart Failure

Summary: the purpose of this study is to test a clinical decision support (cds) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (gdmt) in patients with heart failure and reduced ejection fraction (hfref).

the purpose of our study is to test whether home blood pressure monitoring (hbpm) with clinical-decision support (cds) will optimize the use of gdmt in patients with hfref. hbpm allows cardiologists and nps to monitor patients outside the clinical setting so that gdmt can be safely initiated and up-titrated. the cds employs hbpm and electronic medical record (emr) data to implement the acc/aha hf guidelines and provides cardiologists and nps with gdmt recommendations.

Eligibility criteria:
inclusion criteria: * diagnosis of hfref (left ejection fraction \< 40%, assessed by transthoracic echo, cardiac mri, cardiac spect) within the past year. * new york heart association (nyha) class ii-iii at most recent screening assessment. * gdmt composite score of less than or equal to 50% at baseline exclusion criteria: * previous contraindication to beta blockers, ace inhibitors, and/or arb. * baseline creatinine \> 2 mg/dl or potassium level at baseline \> 5 meq/l or egfr \<30 ml/min/1.73 m2. * baseline systolic blood pressure \< 100 mmhg. * concomitant use of ace, arb, and/or arni * polycystic kidney disease * history of angioedema * history of or currently on a transplant list * left ventricular assist device * uncontrolled asthma * severe copd * cirrhosis * currently receiving hospice or comfort care * patient not proficient with written and spoken english * patient has diminished decision making capability * history of non-compliance
the impact of lifestyle on sperm telomere length and telomerase activity in men undergoing ivf treatments

Conditions: Male Infertility

Summary: this aim of this study is to determine the impact of lifestyle on telomere length and telomerase enzyme activity on sperm cells of men undergoing ivf treatments.

following approval of the study by the hospital ethical committee (helsinki), semen samples and blood will be collected from infertile individuals referred to our ivf unit at hillel yaffe medical center. informed written consent will be obtained from each participant. standard semen analysis will be carried out according to world health organization protocol. an aliquot of semen sample will be used for assessment of sperm motility, concentration, and morphology by using computer-aided sperm analysis (casa) and the remaining sample will be used for assessment of sperm telomere lengths and telomerase activity. genomic dna will be extracted from the remaining washed sperm and peripheral blood. sperm telomere length will be determined by real-time polymerase chain reaction (qrt-pcr) and telomerase activity will be determined by trap assay (telomeric repeat amplification protocol).

Eligibility criteria:
inclusion criteria: * infertile couple exclusion criteria: * chronic disease * azoospermia
study of ibrutinib in combination with bortezomib and dexamethasone in subjects with relapsed/relapsed and refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase 2 open-label study to evaluate the efficacy and safety of ibrutinib in combination with bortezomib and dexamethasone for patients with relapsed or relapsed and refractory multiple myeloma.

bruton's tyrosine kinase (btk) is an enzyme that is present in hematopoeitic cells other than t cells and is necessary for downstream signal transduction from various hematopoietic receptors including the b cell receptor as well as some fc, chemokine and adhesion receptors, and is crucial for both b cell development and osteoclastogenesis. although down-regulated in normal plasma cells, btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. ibrutinib is a potent and specific inhibitor of btk currently in phase 2 and 3 clinical trials. the current study is designed and intended to determine the safety and efficacy of ibrutinib in combination with bortezomib and dexamethasone in subjects with relapsed/relapsed and refractory multiple myeloma.

Eligibility criteria:
inclusion criteria: * subjects with multiple myeloma (mm) who have received 1-3 prior lines of therapy and have demonstrated disease progression since the completion of the most recent treatment regimen. (subjects may have received prior bortezomib exposure if it does not meet the exclusion criteria for prior proteasome inhibitor use) * measurable disease defined by at least one of the following: * serum monoclonal protein (spep) ≥1 g/dl (for subjects with immunoglobulin a (iga), immunoglobulin d (igd), immunoglobulin e (ige) or immunoglobulin m (igm) multiple myeloma spep ≥0.5 g/dl) * urine monoclonal protein (upep) ≥200 mg by 24 hour urine electrophoresis * adequate hematologic, hepatic and renal function * eastern cooperative oncology group (ecog) performance status of ≤2 exclusion criteria: * subject must not have primary refractory disease * refractory or non-responsive to prior proteasome inhibitor (pi) therapy (bortezomib or carfilzomib) * peripheral neuropathy grade ≥2 or grade 1 with pain at screening * plasma cell leukemia, primary amyloidosis, or poems syndrome * unable to swallow capsules or disease significantly affecting gastrointestinal function * requires treatment with strong cyp3a inhibitors * women who are pregnant or breast feeding

Keywords: bruton's tyrosine kinase bortezomib dexamethasone ibrutinib
effect of pulsatile hormone administration on insulin action

Conditions: Insulin Sensitivity

Summary: in humans, insulin is secreted in pulses from the pancreatic beta-cells, and these oscillations help to maintain fasting plasma glucose levels within a narrow normal range. given the fluctuations in insulin concentrations, oscillations enhance precision of control. the hyperinsulinemic euglycemic clamp test (clamp) involves a continuous infusion of insulin and is the gold standard for measuring insulin sensitivity. in this study, insulin sensitivity measured using the standard clamp will be compared with a clamp in which the same total amount of insulin as the standard clamp is infused every five minutes instead of continuously.

participants with obesity and insulin resistance completing a randomized, controlled, two-arm parallel trial (motivate) will be enrolled in this cross-sectional study. twelve participants from the motivate study will return within two weeks to complete two clamp tests within a week of each other. at these clamps, the insulin will be infused continuously at a dose of 40mu/m2/min during the first clamp test and the same total amount of insulin will be infused every five minutes at the second clamp. the day following the clamps, participants will return to the clinic in a fasted state and blood will be drawn for measurement of glucose and insulin.

Eligibility criteria:
inclusion criteria: * completion of the motivate study (nct05649176) exclusion criteria: * non-completion of the end-of-study hyperinsulinemic euglycemic clamp test of the motivate study