Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and efficacy of 28-day inhaled chf 6001 dpi in copd patients

Conditions: COPD

Summary: phase iia study in copd patients aimed to evaluate the safety, tolerability ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in blood, and on pulmonary function) and on pharmacokinetics of chf 6001 (a pde4 inhibitor) after 28-days of daily inhaled dosing.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained prior to any study-related procedures. 2. male or female aged between 40 and 70 years inclusive. 3. current or past smoker of at least 10 pack/years 4. bmi in the range of 18-35 kg/m2 5. gold stage 2 and 3 copd subjects 6. a history of chronic bronchitis defined as chronic cough and sputum production 7. at screening, subjects must be able to produce an adequate induced sputum sample 8. female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential using two acceptable methods of contraception for the duration of the study and for the following three months exclusion criteria: 1. female subjects: pregnant or lactating women 2. past or current history of asthma 3. history of clinically significant hypotensive episodes 4. history or symptoms of significant cardiovascular disease 5. history or symptoms of significant neurological disease 6. unstable concurrent disease 7. an abnormal and clinically significant 12-lead ecg 8. clinically relevant abnormal laboratory values 9. use of oral or systemic corticosteroids oral and/or nebulised beta2 agonists and/or antibiotics within 6 weeks preceding the screening visit 10. moderate or severe hepatic impairment (child-pugh b or c) 11. intolerance/hypersensitivity or any contraindication to treatment with roflumilast, tiotropium bromide or salbutamol or any of the excipients contained in the formulations used in the study 12. chronic use of any other medication for treatment of lung disease like xanthines, antileukotrienes, systemic and inhaled corticosteroids, long acting beta2- agonists, roflumilast (other than the study drug) and cromoglycates 13. long term (at least 12 hours daily) use of oxygen therapy for chronic hypoxemia. 14. having received an investigational medicinal drug within 30 days prior to study entry 15. blood draws of 250 ml or more within 45 days prior to enrolment into the study. 16. known respiratory disorders other than copd. 17. history of alcohol dependency, or substance abuse 18. inability to comply with the study protocol for any other reason.
multiple dose safety study of pf-04802540 in subjects with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of pf-04802540 administered orally to subjects with schizophrenia.


Eligibility criteria:
inclusion criteria: * males or females of non-childbearing capacity aged 18 to 55 years inclusive * dsm-iv diagnosis of schizophrenia, stable symptoms for at least 3 months * body mass index in the range of 18 to 40 kg/m2 and body weight\>45 kg. exclusion criteria: * evidence or history of a primary dsm iv axis i diagnosis other than schizophrenia. * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * any condition possibly affecting drug absorption (eg, gastrectomy).

Keywords: pf-04802540 multiple dose safety study
low dose radiotherapy for advanced hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa; Hidradenitis

Summary: to establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa. patients will receive radiotherapy treatment over one week and then they will be followed for the next three months.

this is a phase i clinical trial using a simon-two stage design to establish the safety of radiotherapy in the treatment of advanced hidradenitis suppurativa (hs). in the first six months, 6 patients will be enrolled, if the patients in the study do not meet the termination criteria, then the study will extend to a second stage. a maximum of 20 patients will be enrolled. patients will be treated with skin-directed radiotherapy, using a total prescription dose of 7.5 gy in five fractions of 1.5 gy over one week. patients will then be seen in the hs specialty clinic at montefiore medial center for at least three months. quality of life changes, immunohistochemical changes, and cutaneous discharge will also be evaluated during the study period.

Eligibility criteria:
inclusion criteria: * diagnosis of hidradenitis suppurativa made at the montefiore hidradenitis suppurativa treatment center, with hurley stage 2-3 (defined as recurrent abscesses or boils with diffuse or broad involvement, multiple interconnected sinus tracts in the whole area) * failed maximal medical therapy for hidradenitis suppurativa or ineligible for "standard" medical therapy or surgery * age \> 20 years * women of childbearing age: must have a negative pregnancy test within 72 hours prior to the start of study therapy and agree to an adequate method of contraception throughout treatment and for at least 4 weeks after study contraception. exclusion criteria: * pregnant women * individuals \< 20 years old

Keywords: hidradenitis suppurativa hs radiotherapy
different abbreviated mri for hepatocellular carcinoma diagnosis

Conditions: Hepatocellular Carcinoma (HCC)

Summary: abbreviated mri (amri) could improve the diagnostic performance of hepatocellular carcinoma (hcc), but it lacks analysis in different subgroups and effective validation. the investigators aimed to compare and validate the diagnostic performance of different amri protocols in diagnosing early-stage hcc.

this retrospective study enrolled untreated patients at risk for developing hcc who underwent gadoxetic acid-enhanced mri from three independent cohorts from january 2020 to december 2022. three amri protocols were extracted from the complete liver mri protocol, including non-contrast (nc-amri), hepatobiliary phase (hbp-amri); and dynamic contrast-enhanced (dce-amri). two readers at each cohort independently interpreted each amri based on ancillary and main features from the liver imaging reporting and data system (li-rads) version 2018. for dce-amri, two established algorithms were employed: modified li-rads (dce-amrim) and li-rads v2018 (dce-amriv2018). non-hccs were ascertained based on histologic and clinical follow-up data, while early-stage hccs were confirmed post-operatively. patient-level performance metrics were compared using bootstrap resampling and generalized estimating equations.

Eligibility criteria:
inclusion criteria: * no previous history of hcc treatment * no history of any other underlying malignancy besides hcc. exclusion criteria: * for hcc group: (a) without preoperative mri within 3 months; (b) without postoperative pathological confirmation; (c) liver cirrhosis without histopathologic proof or radiologic evidence; (d) the size of hcc smaller than 1cm; (e) outside of milan criteria; and (f) suboptimal imaging quality. * for non-hcc group: 1) lost follow-up, 2) insufficient follow-up period, or 3) suboptimal imaging quality.
progressive muscle relaxation and deep breathing exercises

Conditions: Progressive Muscle Relaxation; Deep Breath; COPD

Summary: the population of the study was composed of 186 patients whose cells were assigned to atatürk university hospital educational diseases polyclinic between april and june 2023, and whose cells were found to have copd according to the chronic obstructive pulmonary disease initiative by the physician. a total of 140 patients approved the inclusion criteria and agreed to participate in the study. priori power analysis was performed for sampling determination. in the power analysis, cohen's medium effect size reference method was chosen. as a result of the power analysis, it was determined that it should be done with a total of 90 patients, 30 patients in each group, two experimental groups and the control group (α=0.05, power=0.8, and effect expectation=0.65). in case of data loss, this number plus approximately 20% reserve allocation included 36 patients in each group. however, the study was completed with a total of 96 patients, including pmr(n=31), db(n=32) and 33 control subjects.

the pmr exercise, which includes the systematic relaxation of the main muscle groups of the body aimed at physical and psychological relaxation, was applied twice a day, every weekday, for eight weeks. pmr exercises and these exercises were given to the patients individually. the training for the implementation of the exercises was given by face-to-face interview method. during the training process, "muscle relaxation exercises practice guide" and "relaxation exercises audio recordings", which were prepared by the researcher and included relaxation exercises, were used. deep breath exercises training was given to the patients in this group individually by face-to-face interview. during the application, the importance of deep and comfortable breathing was explained and correct breathing technique was taught. informing and application training took an average of 20-25 minutes for each patient. the patients were told to do the 10-minute application at home 3 times a day for 8 weeks. they were called once a week and asked whether they continued the practice and whether they had any difficulties during the exercises.

Eligibility criteria:
inclusion criteria: * not having any physical problems * conscious * fully oriented * not have an acute exacerbation attack in the past month exclusion criteria: * having a hearing problem, * inability to practice relaxation exercises regularly, * wanting to leave the study * neurological diseases, * those with comorbidities such as acute myocardial infarction or cancer,
clarithromycin modified release observational study for evaluation of treatment, tolerability & recovery time in saudi & egyptian clinical settings (closer)

Conditions: Respiratory Tract Infection

Summary: the objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.


Eligibility criteria:
inclusion criteria: * adults, equal to or more than 18 years years of age * patients with respiratory tract infections, including any of the following: * acute tracheitis, acute tracheobronchitis * acute sinusitis * chronic sinusitis * acute tonsillopharyngitis * acute bronchitis * mild community-acquired pneumonia * acute exacerbation of chronic bronchitis exclusion criteria: * known hypersensitivity to or previously intolerant of macrolides. * illness severe enough to warrant hospitalization or parenteral therapy. * concomitant use of any of the following medications: * drugs metabolized by cyp3a isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine. * drugs metabolized by other isozymes within cyp450 system: phenytoin, theophylline and valproate. * colchicine, digoxin, some antiretrovirals: zidovudine and ritonavir. * severe immunodeficiency and chronic disease conditions. * renal or hepatic impairment (creatinine clearance under 30 ml/min, aspartate aminotransferase (ast), alanine aminotransferase (alt) and gamma-glutamyltransferase (ggt) equal or more than 3x higher level in comparison with the norm). * mental condition rendering the subject unable to understand the nature of the study.

Keywords: respiratory tract infection clarithromycin recovery
mnemonic strategy versus spaced retrieval training in those with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: this study compared two active cognitive interventions to evaluate whether one improved memory more than the other in patients with mild cognitive impairment. participants were randomized to either memory strategy training or spaced retrieval training and completed memory tests before and after 3 training sessions. participants returned 1 month after treatment to see how well they remembered the learned information. brain scans (functional mri) were collected before and after the interventions to see if training changed the way brain regions were functioning.

individuals with mci were randomized to 3 sessions of mnemonic strategy or spaced retrieval training that focused on object location associations. across these training sessions, each group received 9 training trials for each of the 45 trained stimuli. task-fmri was acquired before and after training. memory was again evaluated 1 month after the last training session. the primary outcome measure was memory for the "trained" stimuli while secondary outcome was accuracy for novel stimuli acquired outside of the mri environment.

Eligibility criteria:
inclusion criteria: -diagnosis of mci according to petersen (2004) criteria, right handed exclusion criteria: * diagnosis of other neurological condition, * active drug/alcohol abuse/dependence, * moderate-severe depression or other axis i diagnoses.

Keywords: mci cognitive training memory training dementia alzheimer's disease
safety and efficacy of sofosbuvir plus velpatasvir with or without ribavirin in treatment-experienced subjects with chronic hcv infection

Conditions: Hepatitis C

Summary: the primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (sof) + velpatasvir (vel; gs-5816) with or without ribavirin (rbv) in treatment-naive adults with chronic genotype (gt) 1 or 3 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 18 kg/m\^2 * hcv rna ≥ 10000 iu/ml at screening * prior treatment failure to a regimen including interferon with or without rbv * hcv genotype 1 or 3 * chronic hcv infection * cirrhosis determination * use of highly effective contraception methods if female of childbearing potential or sexually active male exclusion criteria: * current or prior history of clinically significant illness other than hcv * screening ecg with clinically significant abnormalities * prior exposure to hcv specific direct acting antiviral agent * pregnant or nursing female or male with pregnant female partner * chronic liver disease of non-hcv etiology * hepatitis b * active drug abuse * use of any prohibited concomitant medications

Keywords: hepatitis genotype 1 genotype 3 treatment experienced
prevalence of primary aldosteronism in atrial fibrillation

Conditions: Atrial Fibrillation; Primary Aldosteronism

Summary: this is an observational prospective cross-sectional study, investigating the prevalence of primary aldosteronism in patients with atrial fibrillation.


Eligibility criteria:
inclusion criteria: * established diagnosis of atrial fibrillation with a standard surface ecg tracing of at least 30 seconds (either paroxysmal or persistent or permanent). exclusion criteria: * diagnosis of primary aldosteronism * diagnosis of heart failure, treated with mineralocorticoid receptor antagonists * inability to be subjected to any confirmatory tests for primary aldosteronism * acute vascular event (acute coronary syndrome, stroke, acute peripheral vascular event) within last 6 months * renal replacement therapy * incompetence of unwillingness to provide written informed consent

Keywords: atrial fibrillation primary aldosteronism
surgical treatment of hip fractures under peripheral regional anesthesia

Conditions: Hip Fractures

Summary: the study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique.

the study investigates whether treatment of proximal femoral fractures is possible using a peripheral regional anesthesia technique. after positioning on the non-fractured side, a double injection technique is used (dual guidance concept: nerve stimulation and sonography). the injections are performed parasacrally (blockade of the sacral plexus under the piriformis muscle) and lumbar paravertebrally (psoas compartment block and transmuscular quadratus lumborum block). per block 20 ml ropivacaine 0.375% is administered (total dose: 225mg ropivacaine). the study examines the success rate (rate of successfully performed nerve blockade; need for supplemental medication: sufentanil and/or propofol; conversion rate to general anesthesia), circulatory stability (need for application of ephedrine or norepinephrine) and side effects.

Eligibility criteria:
inclusion criteria: * proximal femoral fracture * older then 18 years * written informed consent exclusion criteria: * local or systematic inflammation * allergy to ropivacaine * participate in other studies * body mass index over 35 * periprosthetic fractures

Keywords: regional anesthesia ultrasonography hip fractures lumbosacral plexus
reason evaluation of initial treatment failure in patients with cap

Conditions: Community-acquired Pneumonia

Summary: this research is to evaluate the effect of different antibiotics (moxifloxacin hydrochloride and sodium chloride injection vs. β-lactam antibiotics for injection +/- azithromycin for injection) on the early deterioration or progression (\<72 h of treatment) of community acquired pneumonia and to study the effect of the early deterioration or progression on the prognosis of community acquired pneumonia.


Eligibility criteria:
inclusion criteria: 1. age\>=18y. 2. diagnosed with cap. 3. need hospitalization. 4. receive moxifloxacin hydrochloride and sodium chloride injection or β-lactam antibiotics for injection +/- azithromycin for injection as initial treatment. 5. signed informed consent form. exclusion criteria: patients who meet any of the following criteria will not be included in the study: 1. pneumonia is aquired more than 48h after admission or the patient was admitted to hospital within 30 days prior to admission. 2. start antibiotic treatment before admission. 3. gestational period or suckling period. 4. admitted to icu. 5. immunocompromised patients. 6. pneumonia is the terminal event of a serious disease. 7. tuberculosis, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmanory eosinophilia, pulmonary vasculitis. 8. allergic to the antibiotics of the study.
responsiveness of exercise tests in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: pulmonary arterial hypertension (pah) is characterized by the progressive increase in pulmonary vascular resistance leading to shortness of breath and exercise intolerance. exercise capacity has been used as the primary endpoint in most recent randomized controlled trials evaluating pah-specific therapies as it correlates with functional class and survival in pah. exercise test is commonly assessed by the six-minute walk test (6mwt). however, there is commonly some discrepancy between significant clinical improvement and minor changes (generally \<10% from baseline) in 6wmt following therapy. because important clinical decisions are based on patients' functional capacity, a reproducible and sensitive exercise test is needed in pah. the aim of this study was to compare the reproducibility and the responsiveness of the 6mwt, the endurance shuttle walk test (eswt) and the cycle endurance test (cet) following pharmacological therapy in this disease.


Eligibility criteria:
inclusion criteria: * who functional class ii or iii * idiopathic pah, familial pah, or associated pah due to connective tissue disease patients * mean pulmonary artery pressure ≥25 mmhg at rest * pulmonary capillary wedge pressure ≤15 mmhg exclusion criteria: * prior use of phosphodiesterase type-5 inhibitors * unstable clinical condition over the last 4 months * recent syncope * who functional class iv * left ventricular ejection fraction \<40% * restrictive or obstructive lung disease * intrinsic musculoskeletal abnormality precluding exercise testing * patients with a pacemaker * treatment with systemic corticosteroids

Keywords: pulmonary hypertension pulmonary arterial hypertension exercise six-minute walk test sildenafil
effect evaluation of different blood products infusion on neonatal anemia

Conditions: Neonatal Anemia

Summary: the goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. the main questions it aims to answer are: * objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy. * to provide objective basis for clinical rational use of blood in the selection of blood products. participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators.


Eligibility criteria:
inclusion criteria: neonates with stable hemodynamics who need blood transfusion are comprehensively evaluated by neonatologists according to their clinical conditions (heart, respiratory status, postnatal age, pregnancy at birth), laboratory indicators, etc. diagnosis of neonatal septicemia: * the mother had chorioamnionitis infection or premature rupture of membranes (prom) ≥18 h. * the clinical diagnosis is that there are clinical abnormal manifestations, and any of the following conditions is met at the same time: ① blood non-specific examination ≥ 2 items are positive, ② cerebrospinal fluid examination is purulent meningitis change, and ③ pathogenic bacteria dna is detected in blood. * the diagnosis was confirmed as having clinical manifestations and positive blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture. exclusion criteria: * infants with necrotizing enterocolitis (nec) (current or previous). * feeding intolerance (defined as the decision of the treatment clinical team to suspend feeding / suspend feeding for at least 12 hours). * rbc transfusion in the past 72 hours; children who received ibuprofen / indomethacin / surgery 72 hours ago and / or severe congenital malformations such as congenital gastrointestinal tract, complex cardiopulmonary / fatal abnormalities or need emergency blood transfusion.