Kornimate/medical-research-clean huggingface dataset:
male sexual experience and its impact on quality of life before and after their sexual partners undergo polypropylene mesh augmented pelvic floor reconstruction

Conditions: Sacral Colpopexy; Pelvic Organ Prolapse

Summary: the correction of the pelvic organ protrusion is aimed at restoring the pelvic floor functional status and ultimately improving the patient's quality of life. there are a few studies that have explored the effect of pelvic reconstructive surgery on female sexual function (1,2) but no studies have evaluated the male partner's sexual experience. the investigators intend to use a newly psychometrically validated questionnaire to capture this aspect. the sexual experience questionnaire (sex-q) is the first questionnaire to solely and exclusively combine functional and quality of life concepts (erection, individual satisfaction, and couple satisfaction domains) in a brief questionnaire, which allows a more focused and less burdensome evaluation of the sexual experience in men (3). another issue is the density of the mesh material and if it can be felt vaginally even if it is not eroded and to what degree this might bother the male partner during intercourse.


Eligibility criteria:
inclusion criteria: 1. sexually active couple at the time of pre-operative visit 2. female partner scheduled to undergo a mesh augmented repair exclusion criteria: 1. not sexually active 2. use of other graft material than polypropylene mesh 3. contraindications to surgery based on existing medical conditions 4. pregnancy 5. desire for pregnancy in the future

Keywords: uterine prolapse vaginal prolapse
the more & less study: a trial testing different treatment approaches to obesity in preschoolers

Conditions: Obesity

Summary: obesity has been shown to be resistant to treatment in adults, adolescents, and in school age children, but not during early childhood. yet knowledge on the effectiveness of early childhood treatment programs for obesity is still very limited, preventing the widespread implementation of such programs. the overarching purpose of this study is to evaluate the effectiveness of early treatment of childhood obesity. the investigators plan to perform a carefully-designed randomized controlled trial that will evaluate different treatment options offered to families with children with obesity, organized within the healthcare system and followed up for at least 1 year post-baseline. participants will be children aged 4-6 years (n=180) with obesity and their parents. this study will facilitate a close examination of key treatment components and mechanisms of change. results from this study will lead to better healthcare options for obesity treatment during childhood and ultimately to the prevention of obesity later in life from a public health perspective.

the proposed randomized controlled trial has four specific aims: specific aim #1: parenting or lifestyle? to determine the effectiveness of two obesity treatment conditions: 1) parent training (n=90) and 2) treatment as usual focused on lifestyle changes (n=90). the two treatment conditions will be evaluated with respect to child weight status (bmi sds; primary outcome), psychosocial and metabolic health, lifestyle choices, and family functioning (secondary outcomes). specific aim #2: optimal length of treatment and follow-up? to understand the influence of treatment duration we will compare the effectiveness of the parent training program administered for 10 wks only and for 10 wks plus additional booster sessions at 8-week intervals for the following year. all groups will be followed up for at least one year post-baseline. specific aim #3: to start at age 4,5 or 6? to assess the influence of child age at the start of treatment on the treatment outcomes. specific aim #4: mediators and moderators? to determine whether changes in targeted parenting skills (such as limit setting, monitoring and problem-solving) will mediate child obesity outcomes by examining all treatment groups. in addition, we will examine moderators of intervention effects (e.g. socioeconomic status (ses), parental weight status, and depression).

Eligibility criteria:
inclusion criteria: * age 4-6 years old * obesity as defined by international cut-offs (cole t. j. et al. bmj, 2000). exclusion criteria: * weight affecting diseases

Keywords: children obesity treatment family
to evaluate safety and pharmacokinetics of belinostat in patients who have mild, moderate and severe renal impairment.

Conditions: Relapsed/Refractory Solid Tumors/Hematological Malignancies

Summary: a phase i, open-label, nonrandomized study to determine the pk profile of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies in patients with renal impairment. eligible patients will be assigned to 1 of 4 cohorts (a, b, c or d) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose a for normal or mild renal impairment, and dose b for moderate or severe renal impairment.

study design: a phase i, open-label, nonrandomized study to determine safety and pharmacokinetics of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies and to determine the pk profiles in patients with renal impairment. eligible patients will be assigned to 1 of 4 cohorts (a, b, c or d) based on their level of renal function (normal, mild, moderate, or severe renal impairment) and receive belinostat dose a for normal or mild renal impairment, and dose b for moderate or severe renal impairment. enrollment into all cohorts will occur simultaneously rather than sequentially except in the following instance: before any patient is enrolled in cohort d, safety will be assessed for at least 1 patient in cohort c through the end of cycle 6. if the patient in cohort c experiences a toxicity that is at least grade 3 in severity, cohort d will proceed at a reduced starting dose. belinostat will be administered via a 30-minute intravenous (iv) infusion once daily on days 1 to 5 of a 21-day cycle (for up to 6 cycles). clinical safety will be monitored in each patient, and up to two dose reductions from the starting dose (not less than 250mg/m\^2) is allowed based on pre-defined criteria. if a patient cannot tolerate the reduced dose due to grade 3 or 4 toxicity, belinostat administration must be discontinued. dose escalation is not allowed. blood samples for pk analysis will be collected from day 1 to day 3, and urine samples for pk analysis will be collected from day 1 to day 4.

Eligibility criteria:
inclusion criteria: 1. patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists. 2. patient must have received at least 1 prior therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening. 3. patient has either normal or impaired renal functions. 4. patient has adequate hematological and hepatic functions. exclusion criteria: 1. patient has acute or progressive renal impairment related to disease or any other cause (eg, toxicity, obstructive uropathy due to retroperitoneal disease, proteinuria, nephrotic syndrome), or requires dialysis. 2. patient has acute hbv or hcv 3. patient has known human immunodeficiency virus (hiv) positive diagnosis. 4. patient has had previous exposure to belinostat.

Keywords: relapsed/refractory solid tumors beleodaq renal impairment belinostat hematological malignancies
canakinumab in the treatment of acute gout flares and prevention of new flares in patients unable to use non-steroidal anti-inflammatory drugs (nsaids) and/or colchicines including a 12 week extension and a 1 year open-label extension study.

Conditions: Acute Gout

Summary: the purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (nsaids) and/ or colchicine are contraindicated, not tolerated, or ineffective. the efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide. the purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study cacz885h2357. the purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.


Eligibility criteria:
core study: inclusion criteria: * meeting the american college of rheumatology (acr) 1977 preliminary criteria for the classification of acute arthritis of primary gout * onset of current acute gout flare within 5 days prior to study entry * baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (vas) * history of ≥ 3 gout flares within the 12 months prior to study entry * contraindication, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (nsaid) and/or colchicine exclusion criteria: * rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis * presence of severe renal function impairment * use of specified pain relief medications or biologics (corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, il-blocker, and tumor necrosis factor inhibitor within specified periods prior to study entry * live vaccinations within 3 months prior to randomization * requirement for administration of antibiotics against latent tuberculosis (tb) * refractory heart failure (stage d) * unstable cardiac arrhythmias or unstable symptomatic coronary ischemia * any active or recurrent bacterial, fungal, or viral infection extension study 1: inclusion: - completion of the core study. a patient was defined as completing the core study if they completed the study up to and including visit 7. exclusion: - continuation in this extension study was considered inappropriate by the treating physician. extension study 2: inclusion criteria: * completion of the first extension study cacz885h2357e1. a patient was defined as completing the first extension study if they completed the study up to and including visit 10). exclusion criteria: -continuation in this second extension study was considered inappropriate by the treating physician. other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.

Keywords: frequent flares gout anti-interleukin-1β monoclonal antibody
post-authorization safety study in type 2 diabetic patients in saudi arabia treated with empagliflozin to assess the incidence of ketoacidosis, severe complications of urinary tract infection, volume depletion, and dehydration

Conditions: Diabetes Mellitus, Type 2

Summary: the objectives of this study are to assess the risk of ketoacidosis, severe urinary tract infections, volume depletion, and dehydration associated in patients with t2dm initiating empagliflozin compared to patient initiating a dipeptidyl peptidase-4 (dpp-4) inhibitors over a 12-month period of follow-up, including the month of ramadan


Eligibility criteria:
inclusion criteria: * patients who have signed informed consent form. * the patients will be at least 18 years old at index date, diagnosed with type 2 diabetes mellitus (t2dm) in saudi arabia, and who will initiate empagliflozin or dipeptidyl-peptidase 4 (dpp4) inhibitors treatment according to the local label and at the discretion of the treating physician during the study period, who have not used other sodium/glucose co-transporter 2 (sglt2) or dpp4 inhibitors during the previous 12 months. exclusion criteria: * known hypersensitivity to empagliflozin, the comparator dpp-4 inhibitors or any of their excipients * patients for whom empagliflozin or the comparator dpp-4 inhibitor is contraindicated according saudi food and drug authority (sfda) approved label * patients prescribed fixed-dose combinations of sglt2 inhibitors with dpp-4 inhibitors will be excluded. * the same inclusion and exclusion criteria will be applied to the comparator group, which will include new users of dpp-4 inhibitors.
real world observational study of poteligeo in adult patients with mf and ss (prosper)

Conditions: Mycosis Fungoides and Sézary Syndrome

Summary: this is a prospective, observational, non-interventional, international, multi-center, mixed methods study that will involve the integration of quantitative and qualitative data in patients with mf/ss treated with poteligeo.

the prosper study aims to collect information about the experiences of patients with mf/ss receiving poteligeo and of their caregivers in real-world clinical practice. the objective of this study is to generate patient-level data to provide insights into real world clinical practice and an understanding of treatment decisions, as well as to collect patient reported outcomes (pro) data, enriched with qualitative data on disease and treatment experience and burden, to demonstrate the full impact of treatment and the relevant patient experience in real-world clinical practice. the study will be conducted 6 countries, including north america, united arab emirates and countries in europe, at 19 sites known to treat and follow-up patients with mf/ss. patients will be followed for up to 50 weeks from study enrollment.

Eligibility criteria:
inclusion criteria: 1. patient aged ≥18 years 2. confirmed diagnosis of mf/ss 3. disease staging at enrollment has been completed 4. about to commence primary treatment with poteligeo® as per reimbursed indication 5. patient is willing and able to complete the symptom diary and pros. 6. patient is willing and able to provide written informed consent to participate in the study in a manner approved by institutional review board(irb)/ independent ethics committee (iec) and local regulations exclusion criteria: 1. patient unable to participate in all aspects of the study and/or does not agree to the collection of data from medical records 2. patient currently participating in an interventional clinical trial
comparison of vortioxetine and desvenlafaxine in adult patients suffering from depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to compare the efficacy of vortioxetine versus desvenlafaxine after 8 weeks of treatment in patients that have tried one available treatment without getting the full benefit

the study will consist of a screening period of up to 14 days before the baseline visit, followed by an 8-week treatment period with vortioxetine or desvenlafaxine. a safety follow-up visit will be performed approximately 4 weeks after the primary outcome/withdrawal visit. at baseline, patients will be equally randomised (1:1) to 1 of the 2 treatment groups for an 8-week, double-blind treatment period.

Eligibility criteria:
inclusion criteria: * the patient has a primary diagnosis of single or recurrent mdd, diagnosed according to dsm-5®. the current mde must be confirmed using the mini international neuropsychiatric interview (mini). * the patient has a madrs total score ≥24 at screening and baseline. * the patient has had the current mde for ≥3 months and \< 12 months. * the patient has been treated with an ssri as monotherapy (citalopram, escitalopram, paroxetine, sertraline) for at least 6 weeks at licensed dose for the current mde with a partial response and is a candidate for a switch in the investigator's opinion. * the patient wants to switch antidepressant treatment. exclusion criteria: * the patient has any other disorder for which the treatment takes priority over treatment of mdd or is likely to interfere with study treatment or impair treatment compliance. other in- and exclusion criteria may apply
acute neuroendocrine response to intravenous infusion of diclofenac sodium

Conditions: Hypopituitarism

Summary: the effects of acute administration of non-steroidal anti-inflammatory drugs (nsaids) on the neuroendocrine regulation of hydro-electrolytic metabolism are not precisely known to date. although the mechanism by which nsaids favor the antidiuretic action of vasopressin (avp) in the kidney has been partially elucidated, their influence on the mechanisms responsible for regulating its secretion are less known. the interactions between nsaids and natriuretic peptides are also not entirely certain. the present pharmacological research study therefore aims to investigate, in a cohort of healthy subjects, the acute effects of intravenous infusion of diclofenac sodium on the neuroendocrine regulation systems of water and salt balance (i.e. the antidiuretic axis and the system of natriuretic peptides).


Eligibility criteria:
inclusion criteria: - any adult healthy subject (with age 20-50 years old) not meeting any of the exclusion criteria listed below exclusion criteria: * bmi \ 25 kg/m2 * any active pharmacological treatment * pregnancy or breastfeeding * history of polyuria/polydipsia syndrome * history of dysionia * history of peptic disease * history of gastrointestinal bleeding * history of kidney disease * history of heart disease * history of asthma * known allergy to nsaids * any current acute medical condition
effect of cpap on respiratory load in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: both intrinsic positive end expiratory pressure (peepi) and dynamic hyperinflation are considered as inspiratory loads which increase work of breathing in patients with copd. the application of extrinsic positive end expiratory pressure (peepe) supplied by cpap has been claimed to reduce inspiratory load based on change in esophageal pressure which could be significantly affected by change in lung volume and airflow. the investigator hypothesized that cpap could increase respiratory load because it increases lung volume.

objective: to assess the effect of cpap on respiratory load and lung volume in stable copd. methods: patients with copd were recruited to breath under the atmosphere pressure and different levels of cpap (4, 6, 8 and 10 cm h2o). diaphragm emg, esophageal pressure (pes) and transdiaphragmatic pressure (pdi) were recorded using balloon esophageal electrode catheter (yinghui, guangzhou, china). end inspiratory lung volume (eilv) was measured directly from a pneumotachograph combined with a three way valve under the different cpap levels. sensation of breathing difficulty was also assessed. in an additional study, the effect of airflow on pressure was investigated by a physical mode.

Eligibility criteria:
inclusion criteria: 1. willing to participate after informed consent 2. males and females, any race and aged 40-80 years 3. gold ii-iv copd (post-bronchodilator fev1 \< 80 % of the predicted normal, and a post-bronchodilator fev1/fvc \< 0.70) exclusion criteria: 1. patients recovering from acute exacerbation less than 4 weeks. 2. patients with concomitant pulmonary disease (e.g. lung fibrosis, interstitial lung disorder).

Keywords: copd cpap diaphragm emg
concurrent neoadjuvant chemoradiotherapy plus trastuzumab in the treatment of siewert ii ，iii of human epidermal growth factor receptor-2(her-2) positive gastroesophageal junction adenocarcinoma： a randomized, controlled clinical study

Conditions: Gastroesophageal Junction Adenocarcinoma

Summary: the purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for siewert ii ，iii of locally advanced her-2 positive adenocarcinoma at gastroesophageal junction


Eligibility criteria:
inclusion criteria: * age:18 to 60 years old (man or female); * confirmed to siewert ii , iii of locally advanced adenocarcinoma at gastroesophageal junction. the her-2 positive was detected by immunohistochemistry or fluorescence in situhybridization(fish); * patients with stage for ⅲ by endorectal ultrasonography( eus), computed tomography(ct) (or positron emission tomography(pet )-ct) and laparoscopic (according to the eighth edition of american joint committee on cancer (ajcc) ); * patients are diagnosed as potentially resectable by multidisciplinary team, no surgical contraindications, and expected to be surgical resection; * eastern cooperative oncology group (ecog) performance status of 0-1; * major organ function has to meet the following criteria: hb≥80g/l; anc≥1.5×109/l; plt≥90×109/l; alanine transaminase (alt) and aspartate transaminase(ast)≤2.5×uln, but\<≤5×uln if the transferase elevation is due to liver metastases； total bilirubin(tbil)\<1.5×uln； serum creatinine ≤1.5×uln;serum albumin ≥ 30g / l * life expectancy greater than or equal to 6 months; * participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up. exclusion criteria: * allergic to trastuzumab, capecitabine and oxaliplatin; * severe diseases such as liver and kidney，myocardial infarction, symptomatic congestive heart failure (chf) (nyha classes ii-iv), unstable angina or serious cardiac arrhythmia，which affect the situation of chemotherapy or surgery * a variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc); * patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); has melena and hematemesis in two months; * coagulant function abnormality (international normalized ratio(inr) \> 1.5 uln, activated partial thromboplastin time(aptt ) \> 1.5 uln), with bleeding tendency; * pregnant or lactating women; * patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ); * history of psychiatric drugs abuse and can't quit or patients with mental disorders; * less than 4 weeks from the last clinical trial; * the researchers think inappropriate.
differences in exhaled breath by using ion mobility spectrometry (ims) in subjects tested for sars-cov-2 infection (covid-19 disease)

Conditions: SARS (Severe Acute Respiratory Syndrome); Covid19

Summary: breath gas analysis is the evaluation of exhaled breath. it aims to evaluate the volatile organic compounds (vocs) in exhaled breath. in this feasibility study it is intended to find specific peaks/pattern in exhaled breath indicating an infection with sars-cov-2 (severe acute respiratory syndrome coronavirus 2).


Eligibility criteria:
inclusion criteria: * pcr (= polymerase chain reaction) testing for sars cov-2 will be/has been performed in a timely manner of sampling exhaled breath or pcr test for sars-cov-2 was performed within 96 hours, but preferably within 48 hours before sampling exhaled breath and pcr test result is already available * subject must be able to comply with study-specific procedures, e.g.is able to comply with breathing commands exclusion criteria: * previous (history) sars-cov-2 infection, independent of the current episode * participation in a therapeutic study prior to breath analysis which could influence the result of the breath analysis