Kornimate/medical-research-clean huggingface dataset:
a 12 week, multicenter, open label evaluation of caregiver preference, safety and tolerability of exelon® patch (rivastigmine transdermal) in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study is designed to evaluate caregiver preference for exelon® patch (target patch size 10 cm²) treatment in patients with alzheimer's disease (mmse 10-26) who were under cholinesterase inhibitor treatment and experienced adverse event/s in a community setting.


Eligibility criteria:
inclusion criteria: * probable alzheimer's disease according to the nincds-adrda and dsm-iv criteria. * mmse score of \>10 and \<26. * patients who were under che inhibitor treatment and experienced adverse events. * residing with someone in the communities throughout the study or if, living alone, in contact with the responsible caregiver every day, primary caregiver willing to accept responsibility for supervising the treatment and condition of the patient. exclusion criteria: * involved in other clinical trials or treated by experimental drug within the previous 4 weeks. * current diagnosis of an active skin lesion that would prevent accurate assessment of the adhesion and potential skin irritation of the patch. * history of allergy to topical products containing any of the constitution of the patches. * patients with evidence of severe or unstable physical illness, i.e., acute and severe asthmatic conditions, severe or unstable cardiovascular disorders, etc. * patients with bradycardia (bpm less than 50) or sick sinus syndrome or conduction defects (sino-atrial block, second degree a-v blocks). * patients with body weight less than 40 kg. other protocol-defined inclusion/exclusion criteria may apply

Keywords: alzheimer's disease rivastigmine transdermal caregiver preference
safety of one dose of meningococcal acwy conjugate vaccine in subjects 2 years of age and older

Conditions: Meningococcal Disease

Summary: a multicenter, single arm, postmarketing surveillance study. this study is a postlicensure requirement of the philippine food and drug administration (fda) to provide continued safety evaluation of menacwy-crm in philippine individuals 2 years of age and older, receiving menacwy-crm vaccination according to routine clinical practice and prescribing information.


Eligibility criteria:
inclusion criteria: individuals eligible for enrolment in this study are those: 1. who are of any gender, from the age of 2 and older, and to whom/whose parents or legally acceptable representatives the nature of the study has been described and the subject/subject's parent/legally acceptable representative has provided written informed consent. 2. who the investigator believes that the subject and/or his or her parent/legal representative can and will comply with the requirements of the protocol. 3. who are in good health as determined by clinical judgment of the investigator. exclusion criteria: individuals not eligible to be enrolled in the study are those: 1. who are unwilling or unable to give written informed consent or assent to participate in the study. 2. who are perceived to be unreliable or unavailable for the duration of the study period. 3. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). 4. who have received any investigational or non-registered product (drug or vaccine) within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study. 5. who have received or who are planning to receive any vaccines (other than routine childhood vaccines) within 30 days before and after administration of study vaccine. (exception: influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination) 6. who have behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study. 7. who are pregnant or breast feeding (female subjects of appropriate age) or who plan to become pregnant during the course of the study. 8. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, hiv infection or aids, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition), who have epilepsy or any progressive neurological disease or history of guillain-barre syndrome. 9. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components. 10. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 11. who are included in study personnel or close family members of personnel conducting this study.

Keywords: neisseria meningitidis, conjugate vaccine, phase iv clinical trial
postmortem evaluation of adrenal and other endocrine tumors in patients with sudden death

Conditions: Primary Aldosteronism; Adrenal Cushing Syndrome; Pheochromocytoma; Endocrine Neoplasia

Summary: sudden cardiac death is a leading cause of mortality and remains a major public health burden worldwide. cardiac arrest due to coronary heart disease explains a large proportion of the cases, but if autopsy is not performed the exact underlying cause remains obscure in many adults who face sudden death outside heath care organizations. the investigators aim to find proof that primary aldosteronism is a risk factor for sudden death and to characterize the prevalence of adrenal pathology in sudden death of undetermined cause in a case-control study. in addition, the study aims to characterize the prevalence of other adrenal pathology i.e. silent adenomas, cortisol-producing adenomas and pheochromocytomas in sudden death. the investigators also seek evidence that other endocrine hormone overproduction-causing diseases are more prevalent in persons with sudden death compared with those experiencing traumatic or suicidal death sudden death.


Eligibility criteria:
inclusion criteria: consecutive patients with out-of-hospital, sudden death exclusion criteria: 1. estimated time from death to refrigerator more than 24-48 hours and in the refrigerator time more than 7 days (susceptibility to excessive tissue breakdown) 2. terminal disease 3. institutionalized patients
insulin like growth factor-1 against oxidative stress in vitiligo

Conditions: Vitiligo

Summary: insulin like growth factor has a protective role on melanocytes against the oxidative stress. the aim is to investigate this effect in vitiligo patients.


Eligibility criteria:
inclusion criteria: * non-segmental vitiligo exclusion criteria: 1. pregnant or lactating females 2. smokers 3. patients with any endocrinal disease known to affect gh or igf-1 as diabetes (by measuring hba1c) and thyroid disturbance (by measuring tsh) 4. patients with liver disease (by measuring ast, alt and ggt) 5. obese patients (by measuring bmi) 6. patients with history of ischemic heart disease (known medical history of angina or myocardial infarction or history of recurrent chest pain, left shoulder pain, shortness of breath or fatigue on the ordinary effort or less than the ordinary effort ) 7. patients with history of peripheral arterial disease (known medical history of peripheral arterial thrombosis or history of recurrent claudications) 8. patients with history of cerebero-vascular disease (known medical history of transient ischemic attacks or stroke) 9. patients who received systemic treatment for vitiligo during the previous six months or topical treatment during the previous two months
pilates method on the upper limbs functionality

Conditions: Breast Neoplasm Female

Summary: introduction: breast cancer is one of the pathologies affecting women worldwide, with a high mortality rate of 14,206 per 100,000 women per year. however, pilates was used as a therapeutic treatment for women who underwent a modified radical mastectomy, being associated with the alterations when in the postoperative sequels. objective: to evaluate the pilates method in the functionality of women submitted to modified radical mastectomy. method: this is a quantitative clinical trial, in the form of women included in the project, to undergo a physical therapy rehabilitation program through the pilates method for 2 months, where they were evaluated before and after the procedure for measurement and comparison obtained. conclusion: in this way, the pilates method is presented as an instrument used for the rehabilitation of mastectomized women.


Eligibility criteria:
inclusion criteria: * female subjects, between 30 and 65 years, with a diagnosis of breast cancer, who underwent radical-mastectomy surgery and who had after 30 postoperative days exclusion criteria: * women who present alterations in healing, severe pain, who have another type of treatment, people who lack more than three times in the research, quitters, people with relapses and who do not tolerate the treatment protocol.

Keywords: breast cancer. exercise therapy modified radical mastectomy
effectivity of inspiratory muscle trainer in the chronic obstructive pulmonary disease rehabilitation program

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study aimed to reveal the role of inspiratory muscles exercise using inspiratory muscle trainer (imt), which is a form of weight training. the pre- and post study of this experiment were conducted in chronic obstructive pulmonary disease (copd) outpatient clinic during the period of september 2017 until april 2018. patients were recruited by consecutive sampling. inclusion criteria were stable copd patient with the global initiative for chronic obstructive lung disease (gold) criteria a-d, who has never received prior exercise for pulmonary rehabilitation, and willing to participate in the study. the exclusion criteria included any problem with extremities and cardiovascular disease. patients underwent an interview about their medical history, tested spirometry using carefusion®, and the inspiratory muscle strength was assessed using micro rpm carefusion®. the st george respiratory questionnaire (sgrq) was used to assess the health status and the 6-minute walking test (6mwt) was conducted to assess functional capacity. subject exercised using inspiratory muscle trainer (philips respironic®) for eight weeks.

intervention is given using inspiratory muscle trainer philips respironic®. impact on inspiratory muscles strength, health status, and functional capacity are observed. muscle strength is evaluated using micro rpm (respiratory pressure meter) carefusion®. health status is evaluated using st. george's respiratory questionnaire (sgrq), while functional capacity is evaluated by the 6-minute walk test (6mwt). patients were recruited by consecutive sampling. this study was granted ethical approval from the institutional review board (irb) of the faculty of medicine universitas indonesia subjects exercised using inspiratory muscle trainer (philips respironic®) for 8 weeks. inspiratory muscles strength (maximal inspiratory pressure, mip) and 6mwt were done at the beginning for basic data and were re-evaluated during the second, fourth, sixth and eighth week (last week). questionnaire (sgrq) was done at the initial and end of research. training dose with imt was determined by inspiratory muscle strength result and adjusted in every evaluation visit. the subject was expected to do exercise twice daily for 15 minutes each session with 30-70% intensity from determined mip score. exercise is monitored and noted in a logbook.

Eligibility criteria:
inclusion criteria: * stable copd patient with gold criteria a-d, * never got exercise for pulmonary rehabilitation before, * willing to participate in the study by signing the written informed consent. exclusion criteria: * any problem with extremities, * cardiovascular disease

Keywords: inspiratory muscle trainer pulmonary rehabilitation copd st george respiratory questionnaire 6-minute walking test
gastric and duodenal microbiota in dyspeptic subjects

Conditions: Microbial Colonization; Gastritis

Summary: the composition of gastric microbiota is determined by the status of helicobacter pylori infection. in subjects who have never been infected by h. pylori, gastric microbiota includes various bacteria, creating ideal microbial diversity. this ideal microbial diversity is destroyed by h. pylori infection at low intragastric ph. since it is difficult for most bacteria to proliferate within an acidic stomach, relative h. pylori abundance gives rise to microbial dysbiosis. conversely, unideal microbial diversity is often observed in infected individuals with impaired gastric secretory ability at hypochlorhydric condition. bacteria producing carcinogenic n-nitrosamine compounds are often detected in individuals with past or chronic h. pylori infection at high intragastric ph. nonetheless, microbial imbalance that occurs in the earlier phase before gastric carcinognenesis is uncertain.

dominant colonization of a specific microbiota leading to dysbiosis may lead to inflammation of the mucosa. we hypothesized that the degree of inflammation depend on the composition of microbiota. this study was aimed to define gastric and duodenal microbiota leading to abnormal histopathology. we further tried to elucidate whether the composition of duodenal microbiota is altered by gastric microbiota. among the dyspeptic subjects who visited for upper gastrointestinal (ugi) endoscopy, subjects with drug intake (antibiotics, ppis, laxatives, antidepressants, statins, metformin) within 3 months will be excluded. three biopsies will performed at the greater curvature side of the mid-antrum, greater curvature side of the mid-body, and at the duodenum, respectively. next generation sequencing analysis will be performed for 16s rrna variable regions using the biopsied samples. primary study endpoint is 16s rrna sequencing findings of gastric and duodenal microbiota. secondary endpoints are microbiota linked with higher degrees of inflammation, activity, atrophy and intestinal metaplasia based on the updated sydney classification. furthermore, correlation between the microbiota and endoscopy finding will be analyzed.

Eligibility criteria:
inclusion criteria: * dyspeptic subjects who visited for evaluation including upper gastrointestinal endoscopy and biopsies * age \>20 years old exclusion criteria: * underlying disease(s) that requires managements * recent intake of drug(s) * history of gastrectomy

Keywords: helicobacter pylori dyspepsia
a phase 3, multicenter study to evaluate the efficacy and safety of mod-4023 in adults with growth hormone deficiency

Conditions: Adult Growth Hormone Deficiency

Summary: this will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with ghd to assess the safety and efficacy of a long-acting, once weekly injection of modified hgh (mod-4023).


Eligibility criteria:
inclusion criteria: * men and women between the age of 23 to 70 years old at screening, inclusive * ghd subjects as defined in the consensus guidelines for the diagnosis and treatment of adults with gh deficiency ii (2007). * no r-hgh replacement therapy or use of gh secretagogues for at least 9 months with any registered or investigational r-hgh or gh secretagogue product. * the igf-i level at screening ≤-1 sds of the age and sex normal ranges according to the central laboratory measurements * subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months * subject had a dxa screening and the results are interpretable according to the study plan. exclusion criteria: * women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation) * evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous mri to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth). * history of any cancer. exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. patients with ghd attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record. * signs of intracranial hypertension at screening * heart insufficiency, nyha class \> 2 (appendix b) * history of overt diabetes mellitus (including currently treated, well-controlled dm) defined according to the american diabetes association (ada) criteriaa. a history of gestational diabetes, resolved after childbirth, is not exclusionary. * history of acromegaly
multi-institutional analysis of survival and recurrence patterns of different pathological regression types after neoadjuvant chemoradiotherapy or radiotherapy for esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the goal of this multicenter retrospective cohort study is to evaluate the impact of different pathological regression types on survival and recurrence patterns, with a particular focus on ypt0n+ patients in patients with esophageal squamous cell carcinoma. the main questions it aims to answer are the survival and recurrence patterns among the different pathological regression types in patients with esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed potentially resectable escc, clinical stage t1-4n0-1m0 (stage i-iii) according to the american joint committee on cancer 6th edition staging criteria. exclusion criteria: * incomplete surgical resection, two-dimensional radiotherapy, and incomplete clinical data.
a study of iressa treatment beyond progression in addition to chemotherapy versus chemotherapy alone

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

a phase iii randomised, double blind, placebo controlled, parallel, multicentre study to assess the efficacy and safety of continuing iressa 250 mg in addition to chemotherapy versus chemotherapy alone in patients who have epidermal growth factor receptor (egfr) mutation positive locally advanced or metastatic non-small cell lung cancer (nsclc) and have progressed on first line iressa.

Eligibility criteria:
inclusion criteria: * male or female patients aged 18 years or older (for japan only- male or female patients aged 20 years or older) * cytological or histological confirmation of nsclc other than predominantly squamous cell histology with an activating egfr tk mutation as determined locally * patients with documented 'acquired resistance' on first line gefitinib * patients suitable to start cisplatin based pemetrexed combination chemotherapy. * provision of informed consent prior to any study specific procedures. exclusion criteria: * prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). palliative bone radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity). * past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease * other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer * any evidence of severe of uncontrolled systemic disease treatment with an investigational drug within 4 weeks before randomization

Keywords: non small cell lung cancer gefitinib pemetrexed treatment beyond progression
moderate bleeding in cardiac surgery post operative

Conditions: Heart Surgery

Summary: determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population. secondary objectives: to evaluate the kinetics of moderate sport and its impact on anemia and postoperative transfusion. to evaluate the prognostic impact of the spo moderate in terms of post-operative complications. determine predictors of moderate spo.

Eligibility criteria:
inclusion criteria: * patients in the postoperative intensive care in cardiac surgery exclusion criteria: * patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation.
the role of preoperative ureteral diameter measurements in predicting difficult access during retrograde intrarenal surgery: a retrospective analysis of 234 patients

Conditions: Kidney Stones; Retrograde Intrarenal Surgery; Difficult Ureteral Access Prediction

Summary: this study investigates the role of preoperative ureteral diameter measurements in predicting difficult access during retrograde intrarenal surgery (rirs) in patients with kidney stones. a retrospective analysis was conducted on 234 patients who underwent rirs, evaluating factors such as preoperative ureteral diameters (measured at distal, iliac, and upper ureteral levels via ct scans), stone size, patient demographics, operation duration, and surgical success rates. the findings aim to determine whether ureteral diameter measurements can serve as reliable predictors for surgical challenges, ultimately improving preoperative planning and patient outcomes.

this retrospective study evaluates the role of preoperative ureteral diameter measurements in predicting difficult access during retrograde intrarenal surgery (rirs) in patients with kidney stones. a total of 234 patients who underwent rirs were included in the analysis. preoperative computed tomography (ct) scans were used to measure ureteral diameters at three levels: distal ureter, iliac ureter, and upper ureter. the relationship between ureteral diameter and intraoperative access difficulty was assessed. the study also analyzed patient demographics (age, gender, bmi), stone characteristics (size, location), operative parameters (duration, access attempts), and outcomes (surgical success and complication rates). difficult access during rirs was defined based on the number of attempts required to achieve successful ureteral access, need for secondary procedures, or inability to complete the planned surgery. the primary aim was to determine whether preoperative ureteral diameter measurements can serve as predictive markers for challenging surgical access. secondary objectives included identifying other patient or stone-related factors contributing to access difficulty and evaluating their impact on surgical outcomes. the findings may assist clinicians in preoperative planning, improving patient selection for rirs, and optimizing intraoperative strategies to minimize complications and enhance procedural success rates.

Eligibility criteria:
inclusion criteria: patients aged 18 years or older. diagnosed with kidney stones (nephrolithiasis) requiring surgical intervention. underwent retrograde intrarenal surgery (rirs). available preoperative ct scans for ureteral diameter measurements. complete medical records, including demographic, clinical, and surgical data. exclusion criteria: history of open or laparoscopic renal surgery. presence of ureteral strictures or congenital anomalies. patients with incomplete or missing medical records. active urinary tract infection at the time of surgery. pregnant or lactating individuals.

Keywords: retrospective analysis of 234 patients undergoing retrograde intrarenal surgery (rirs).