Kornimate/medical-research-clean huggingface dataset:
priligy usage patterns in selected populations

Conditions: Sexual Dysfunction, Physiological

Summary: this study will use electronic health services databases to describe the usage patterns of dapoxetine hydrochloride (priligy) in germany and italy with a focus on describing the extent and proportion of patients with characteristics suggestive of the use of priligy within, versus outside of the intended use population.

this study will use anonymized (nameless) patient data from electronic health services databases in germany and italy to describe the proportion of priligy (dapoxetine hydrochloride) usage among those patients with characteristics suggestive of the use of priligy within versus outside (eg, those with contraindications) of the intended use (iu) population. this is an observational study; no investigational drug will be administered.

Eligibility criteria:
inclusion criteria: * received a prescription for priligy * treated by physicians who contributed data to the ims disease analyzer database for germany and thales database for italy exclusion criteria: * age not specified * sex not specified as "male * " fewer than 6 months (183 days) of history in the electronic health services databases before receiving the first prescription for priligy (at least 6 months of history in the database is not required for the patients of the german urologists).

Keywords: dapoxetine hydrochloride (priligy) premature ejaculation
effectiveness of epidermal growth factor-containing ointment on the solar lentigines

Conditions: Epidermal Growth Factor; Nd-yttrium Aluminum Garnet Laser; Hyperpigmentation; Post Inflammatory Hyperpigmentation

Summary: subjects were randomly assigned to groups for treatment with either an egf-containing ointment (the study group) or the vehicle alone (petrolatum; the control group). the egf ointment included recombinant human egf (1 μg/g). random numbers used for assignment to groups were provided by the randomization function of sas. the subjects received one session of laser treatment with a q-switched (qs) 532-nm nd:yttrium aluminum garnet (yag) laser of their solar lentigines after enrollment. . the end point of laser treatment for lentigines was immediate whitening. the subjects then applied the egf ointment or vehicle twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of solar lentigines that occurred after adulthood * age of 20 years or older. exclusion criteria: * uncontrolled systemic or chronic disease * hypersensitivity to the ingredients of the ointment * current use of skin whitening agents * a history of other laser treatments within the past 6 months * pregnancy * lactation.
clinical outcomes of c3 glomerulopathy and ic-mpgn in russia: hybrid retrospective - prospective study

Conditions: Kidney Diseases

Summary: the study is planned to study specificity of the clinical course and treatment outcomes of c3 glomerulopathy (c3g) and immune-complex membranoproliferative glomerulonephritis (ic-mpgn) in patients aged under 18 years and 18 years and older in the russian population in 2025-2028. the primary objective of the study is to estimate the frequency of complete or partial remission 12 months after morphological verification of the diagnosis. assessment of demographic, clinical and laboratory, morphological characteristics at diagnosis and their relationship with the disease outcomes, primarily the disease progression and development of chronic renal failure, will allow assessing the efficacy of treatment used in real clinical practice, disease prognosis and factors associated with unfavourable outcomes.


Eligibility criteria:
inclusion criteria: 1. willing to sign informed consent form. if the patient is under 18 years of age, the parent or legally acceptable representative of the child/adolescent who can participate in this study also signs the consent form. 2. diagnosis of primary c3g or ic-mpgn confirmed by the results of morphological and clinical studies. 3. the results of serum creatinine level, proteinuria determination obtained not earlier than 4 weeks before the kidney biopsy 4. index date (kidney biopsy) not earlier than march 2024 and not later than 11 months before signing the icf 5. the estimated baseline gfr (using the ckd-epi formula for persons aged over 18 years and the modified schwarz formula for children) or the measured gfr is ≥30 ml/min per 1.73 m2. exclusion criteria: 1. patients participating in a clinical trial with the investigational product. 2. patients with monoclonal gammopathies (myeloma, b-cell lymphoma/lymphocytic leukemia, lymphoplasmacytoma) 3. patients with systemic autoimmune diseases and vasculitis (systemic lupus erythematosus, systemic sclerosis, dermatomyositis, mixed connective tissue disease, sjogren syndrome, henoch-schönlein purpura, anca vasculitis, cryoglobulinemia) 4. patients with current or recent infections (viral hepatitis b, viral hepatitis c, infective endocarditis or sepsis, infected ventriculoatrial shunts, abscesses, meningococcal and other bacterial infections, protozoan infections) 5. patients with any clinically significant acute disease within 30 days prior to kidney biopsy 6. clinically significant concomitant kidney disease 7. treatment with pegcetacoplan other protocol-defined inclusion/exclusion criteria may apply.

Keywords: glomerulopathy
effect of camel milk on chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: camel milk as the new modality for treatment of chronic hepatitis c. the purpose of this study is to evaluate effectiveness and safety of camel milk in combination with peginterferon alfa-2a and ribavirin in genotype 2,3 chronic hepatitis c virus .

the investigators enrolled 40 patients into the study. group 1(intervention ) : received pegasys( peginterferon ) one subcutaneous injection containing 0.5 ml solution with180 mcg per week plus copegus( ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks. group 2 ( control ): received pegasys( peginterferon ) one subcutaneous injection containing 0.5 ml solution with180 mcg per week plus copegus( ribavirin ) tablets (body-weight adjusted dose: \< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12 weeks. follow up period is 1,2,3 months after treatment. the patients are visited every 4 weeks with biochemistry lab tests. the patients are checked with quantitative hcv rna (ribonucleic acid) on the first months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the third month after treatment completion for sustained response rate. the patients with undetectable hcv rna are considered as responders.

Eligibility criteria:
inclusion criteria: * hcv (hepatitis c virus ) rna positive * age age groups (18 to 70 years) exclusion criteria: * ongoing pregnancy or breast feeding * hx of hcc(hepatocellular carcinoma ) * hx of alcoholic liver disease * hx of bleeding from esophageal varices * hx of hemochromatosis * hx of autoimmune hepatitis * hx of suicidal attempt * hx of cerebrovascular dis * hx of severe retinopathy * hx of severe psoriasis * hx of scleroderma * hx of metabolic liver disease * hx of sle(systemic lupus erythematosus )

Keywords: hepatitis c ,chronic hepatitis c ,camel milk
refinement of suicide risk management intervention

Conditions: Structured Interview; Narrative Assessment; Safety Plan; Crisis Response Plan

Summary: participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. we will use sex (m, f) and history of suicide attempts (never, 1, and multiple) as our randomization strata. participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of suicide ideation * history of suicide attempts exclusion criteria: * geographic location outside the u.s.
study of pf-03084014 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic adenocarcinoma not previously treated with anticancer therapies

Conditions: Metastatic Cancer Pancreas

Summary: this study consists of a phase 1b portion aimed to determine the maximum tolerated dose and the safety profile of pf-03084014 in combination with gemcitabine and nab-paclitaxel followed by a phase 2 portion to evaluate the efficacy of the triple combination in terms of overall survival in patients with metastatic pancreatic ductal adenocarcinoma not previously treated with anticancer therapies.


Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosis of metastatic ductal adenocarcinoma of the pancreas. * no prior radiotherapy, surgery chemotherapy or investigational therapy for metastatic disease. prior adjuvant therapy with 5-fu or gemcitabine (± gemcitabine post radiation) administered as radiosensitizer allowed, provided at least 6 months have elapsed between the last dose and study registration * tumor tissue available (archival 6 months old or de novo biopsy) * measurable disease as per recist 1.1 * performance status (ecog) 0 or 1 exclusion criteria: * symptomatic brain metastases requiring steroids * prior therapy with gamma secretase inhibitors or other notch pathway inhibitor * major surgery within 4 weeks of registration in the current study * known hypersensitivity to gemcitabine or nab-paclitaxel or any of the excipients * current or anticipated need for food or drugs that are strong/moderate cyp3a4 inhibitors or inducers * diagnosis of any second malignancy within 3 years prior to registration
pharmacokinetics of morphine and oxycodone in frail elderly undergoing cardiac surgery

Conditions: Opioid Use; Side Effect of Drug; Postoperative Pain

Summary: * single centre observational cohort study. * 20 older patients undergoing cardiac surgery who receive standard of care pain treatment. * postoperative icu: blood sampling to determine morphine and metabolite (m3g, m6g, noroxycodone and oxymorphone) pharmacokinetics * after icu discharge on general ward: blood sampling to determine morphine, oxycodone and metabolite (m3g, m6g, noroxycodone and oxymorphone) pharmacokinetics * during study monitoring of pain scores, total opioid consumption, side effects (e.g. nausea, vomiting, pruritus), sedation and delirium scores.

postoperative pain after cardiac surgery in elderly patients is common and leads to postoperative complications. opioids play an important role in treatment of postoperative pain after cardiac surgery. in frail elderly after cardiac surgery however dosing schemes for opioids are still unknown, potentially leading to inadequate treatment of pain and/or safety issues. * single center observational cohort study * the study population includes frail patients ≥70 years undergoing elective cardiac surgery. * primary endpoints of this study is the concentration of morphine, oxycodone and metabolites in blood over time on behalf of pharmacokinetic modelling. * secondary endpoints of this study are the pharmacodynamic parameters of morphine, oxycodone and metabolites (m3g, m6g, noroxycodone and oxymorphone) in blood in frail patients; such as pain scores, postoperative opioid consumption, vital signs, side effects of opioids and the influence of covariates such as frailty, serum creatinine, glomerular filtration rate (gfr) on the pharmacokinetics and pharmacodynamics of morphine and oxycodone.

Eligibility criteria:
inclusion criteria: * ≥70 years undergoing elective cardiac surgery. exclusion criteria: * patients undergoing transcatheter aortic valve replacement or mitral valve repair * contra-indication for morphine and/or oxycodone
acceptance and commitment therapy for problematic chemsex

Conditions: Hypersexuality; Compulsive Sexual Behavior; Sexualized Drug Use (Chemsex)

Summary: investigation of the efficacy of acceptance and commitment therapy (act) for the psychological treatment of problematic chemsex. as a pilot study, the intervention will be tested in a small group.

after being informed about the study, all patients giving written informed consent will be assessed to determine eligibility for study entry. patients who meet eligibility requirements will receive psychological intervention consisting in an 8-session individual on line-delivered act-based treatment. the participants will be assessed through self-report instruments before and after treatment and at 3 months follow-up. the pilot study will not include a control group.

Eligibility criteria:
inclusion criteria: * older than 18 years-old * spanish speaking * having used psychoactive substances to facilitate, maintain and/or improve sexual relations in the last year * significant score on the hbi inventory (of 53 or more) * clinically significant discomfort related to sexual practices * degree of interference in his/her life of sexual practices greater than or equal to 5 out of 10 * desire to improve/reduce excessive sexual behaviour exclusion criteria: * receiving psychological or psychopharmacological treatment * intellectual disability * substance dependence (use not associated with sex) * personality disorder or other serious or chronic mental disorder diagnosed

Keywords: sexuality risky sexual behavior
gene-by-stress interactions in intervention studies significance

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to identify gene variants that increase risk of cardiovascular disease (cvd) and type 2 diabetes, particularly genes related to stress factors.

in aim 3, 100 subjects who participated in previous studies will be recruited to test the ability of a 5htr2c agonist (lorcaserin) to increase and antagonist (ziprasidone) to reduce cortisol response to mental and metabolic stress in men carrying the rs6318 c allele and women in the rs6318 cc genotype of 5htr2c. lorcaserin is serotonin receptor agonist indicated for use as a weight loss drug. ziprasidone is an antipsychotic indicated for treatment of bipolar disorder. subjects will be treated with a single dose of each drug, 1 to 2 weeks apart, followed by a mental stress test and an oral glucose tolerance test with multiple blood draws. each subject will also receive a placebo drug during one of the study visits.

Eligibility criteria:
inclusion criteria: * men and women who have been enrolled in the strride, enhanced, and/or remit studies age 18 years or greater. * ability and willingness to provide informed consent. * individuals with specific genotypes as determined from our previous work on their samples through aim 1 of this project. exclusion criteria: * women who are known to be pregnant, intend to become pregnant, or breast-feeding will be excluded. women who are of child bearing potential (under age 55) will be informed that they will need to have their urine tested for pregnancy and that they should not participate in the research if they are not willing to have the investigators provide them with information on positive pregnancy test results. subjects will be informed that the pregnancy testing is not being performed for clinical purposes and that the testing is not a substitute for their regular medical care if they need to know whether or not they may be pregnant. * history of type ii diabetes mellitus. * history of prolonged qt interval. * participation in an investigational drug trial within the last 30 days. * already taking either ziprasidone or lorcaserin or any potential confounding medications, for example, other weight loss medications or psychotropic medications. * unwillingness to fast for at least 6 hours prior to the research study visit.
postmarketing surveillance study of atrovent® inhaletten® in chronic obstructive airways disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to obtain further information on the tolerability and efficacy of atrovent® inhaletten® in the treatment of chronic obstructive airways disease under conditions of daily practice


Eligibility criteria:
inclusion criteria: * primarily patients of both gender, older than 30 years,who suffer from chronic obstructive airways disease * only patients who had not been treated with atrovent® within the last year were to be considered for inclusion exclusion criteria: - contraindications listed in the instructions for use/summary of product characteristics for atrovent® inhaletten®
nefa (non esterified fatty acid) , adipose factors behind insulin sensitivity

Conditions: Obesity; Non-obese Controls

Summary: we want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).


Eligibility criteria:
inclusion criteria obese: * bariatric surgery with laparoscopic gastric by-pass exclusion criteria obese: * diabetes mellitus typ 2 with insulin treatment and/or glitazones * oral or parenteral steroid treatment * complicated psychiatric disease * warfarin use inclusion criteria non-obese controls: * bmi under 30 exclusion criteria non-obese controls: * diabetes * oral or parenteral steroids treatment * complicated psychiatric disease * warfarins use
conventional bronchoscopy plus rose versus electromagnetic navigation (emn) plus rose in small peripheral lesions

Conditions: Lung Cancer; Secondary Lung Cancer; Benign Lung Lesions

Summary: the aim of this study is to evaluate if electromagnetic navigation (enb) in combination with rapid on site evaluation (rose) can improve diagnostic accuracy in those patients who fail to be diagnosed with conventional fluoroscopic assisted bronchoscopy (fbs) in combination with rose.


Eligibility criteria:
inclusion criteria: * presence of small peripheral lung lesions (\< 3 cm) in patient suitable for surgical procedure exclusion criteria: * patient with metastatic disease * patients unfit for surgical procedure

Keywords: fbs coin lesions enb rose
s-1 versus 5-fu bolus in metastatic pancreatic cancer patients previously treated with gemcitabine-based regimen

Conditions: Pancreatic Neoplasm; Neoplasm Metastasis

Summary: the primary objective of this study is to determine whether s-1 increases overall survival when compared to 5-fluorouracil (5-fu) in patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. the secondary objectives are to compare: progression free survival, overall response rate, clinical benefit and improvement in tumor related symptoms and also to assess overall safety and pharmacokinetics of s-1.


Eligibility criteria:
inclusion criteria: * cytologically or histologically confirmed evidence of adenocarcinoma of the exocrine pancreas * metastatic disease previously treated with a gemcitabine-based regimen exclusion criteria: * locally advanced disease * more than one prior chemotherapy-line for advanced pancreatic disease * prior treatment with fluoropyrimidines for advanced pancreatic cancer * eastern cooperative oncology group (ecog) performance status \>or= 2 * poor kidney, liver or bone marrow functions * any serious active disease or co-morbid condition, which in the opinion of the principle investigator, will interfere with the safety or with compliance with the study * unable to swallow capsules * hypersensitivity history to any of the constituents of the study medications or fluoropyrimidines * concurrent participation in another clinical trial or treatment with any other anticancer therapy the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: pancreatic cancer
effects of respiratory yoga training on heart rate variability and baroreflex of healthy elderly subjects

Conditions: Elderly Subjects; Respiration Exercises

Summary: the decreases of physiological capacities which take place with senescence include diminishing respiratory capacity as well as a reduction of heart rate variability and baroreflex sensibility. altogether, these alterations increase elderly people's frailty and have a negative impact over quality of life. since yoga (indian auto-discipline) has a wide range of respiratory exercises already investigated as components for non-pharmacological treatments for hypertension (situation in which heart rate variability is also diminished), the investigators hypothesis is that the training of respiratory exercises of yoga may have a significant positive effect on heart rate variability and baroreflex of health elderly subjects, increasing quality of life and reducing frailty. we included 30 health elderly subjects (both sexes, from 60 years-old onwards) divided into 2 randomized experimental groups: control (c) and respiration (r). each group underwent an entry evaluation, followed by a 4-months training period, after which they were re-evaluated. control consisted of 2 stretching classes per week, and respiration consisted of 2 respiratory exercises classes a week. both groups were instructed to perform the exercises at home twice a day, and to keep a record of each session in a log sheet. evaluations were: whoqol-old questionnaire for quality of life, 20 minutes of seated rest with heart rate, respiration and blood pressure acquired continuously for further spectral analysis.

heart rate variability was performed using the autoregressive model, and the baroreflex was calculated with the spontaneous approach, both with the softwares developed in milan by alberto porta in a non-invasive way. the frequency domain analysis of heart rate, respiration and systolic blood pressure were conducted, consisting of calculating the power spectral density with the minimum error predicted by akaike's algorithm. spectral power was then subdivided into two bands of physiological interest: low - (lf 0.03-0.15 hz) indicating predominant sympathetic modulation, and high - (hf 0.15-0.5 hz) frequency, indicating parasympathetic modulation of the heart. the fraction calculated dividing lf by hf (lf/hf ratio) provided information of sympathovagal balance to the heart. the spectral analysis of systolic blood pressure provided information of the vasomotor tone, and the integration of heart rate information with these data also provided information about the spontaneous baroreflex gain. other questionnaires used were: pittsburgh quality of sleep questionnaire, stress symptoms questionnaire by marilda lipp - validated in brazil, and beck's anxiety and depression inventories.

Eligibility criteria:
inclusion criteria: * health elderly subjects exclusion criteria: * use of beta-blockers * atrial fibrillation * previous training in respiratory exercises

Keywords: healthy elderly subjects respiratory yoga exercises heart rate variability baroreflex quality of life