Kornimate/medical-research-clean huggingface dataset:
observational follow-up extension study of aff002 and aff004a in patients with alzheimer's disease

Conditions: Alzheimer´s Disease

Summary: this study examines the long term safety follow-up of first patients vaccinated with ad02.

patients who have received ad02 during aff002 and aff004a will be observed.

Eligibility criteria:
inclusion criteria: * participation in aff002 and aff004a exclusion criteria: * no vaccination with ad02

Keywords: vaccination follow-up
observational study gemigliptin in patients aged ≥ 65 years with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to evaluate safety and effectiveness of treatment with gemigliptin for 24 weeks in korean patients aged ≥ 65 years with type 2 diabetes mellitus in routine clinical settings


Eligibility criteria:
inclusion criteria: * patients who have been started on gemigliptin in accordance with the approved label and who have signed on the consent form exclusion criteria: * patients with previous exposure to gemigliptin and current participation in clinical trials
identifying landmark factors of anal fistulas

Conditions: Anal Fistulas; Anal Fistula

Summary: the goal of this observational study is to understand the effects of anatomical factors, etiology, and complexity of anal fistula on the prognosis of patients undergoing anal fistula surgery within one year post-operation.the main question it aims to answer is: which factors are indicative of the prognosis of anal fistula surgery? which factors are landmark factors of anal fistulas? participants who have already undergone anal fistula surgery at our hospital will receive outpatient and telephone follow-up to assess their prognosis.

the search function of the electronic medical record system and surgical records were used to screen patients. for the enrolled patients, the electronic medical record system, imaging report query system, medical order system, outpatient follow-up and telephone follow-up were used to collect data data were entered into excel 2021 (microsoft corp., redmond, wa, usa) and checked for errors before conducting statistical analyses using r software (version 4.2.2; the r foundation, vienna, austria).

Eligibility criteria:
inclusion criteria: * patients diagnosed with an anal fistula through clinical and radiological examinations; surgeries performed by physicians at our hospital who had at least a title of associate chief physician, with operative records completed after surgery; patients with complete clinical data; and patients who completed post-operative outpatient follow-up and agreed to participate in telephone follow-up surveys. exclusion criteria: * patients who were assessed clinically as unable to tolerate surgery; patients who refused surgical treatment; and patients who failed to complete the outpatient follow-up, refused telephone follow-up, or were lost to follow-up.

Keywords: anal fistula perianal and rectal spaces surgery
prescription digital therapeutic for the treatment of insomnia

Conditions: Insomnia Chronic

Summary: this will be a prospective multi-center controlled trial of 100 patients conducted to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (pdt) device delivering cognitive behavioral therapy for insomnia using a novel patient-centered data-sharing platform with linkage to fitbit for 61 weeks

this is a multi-center, randomized, controlled trial to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (pdt) device delivering cognitive behavioral therapy for insomnia (i.e., somryst, herein called pear-003b) using a novel patient-centered data sharing platform (called hugo), with linkage to fitbit (inspire 2), among 100 patients with chronic insomnia. half of the patients with insomnia will receive the pear-003b digital therapeutic with linkage to the hugo platform and fitbit (inspire 2) and half of the patients with insomnia will not receive the pdt but will receive a fitbit and be enrolled in the hugo platform. the treatment duration will be 9 weeks with a 21-, 35-, and 61-week follow-up. all patients will be evaluated at baseline, as well as prompted to complete additional assessments at weeks 9, 21, 35, and 61. the pear-003b intervention will deliver cbt-i via mobile devices as 6 treatment core modules over 9 weeks. additionally, the hugo platform will be used to collect patient-generated engagement data, healthcare utilization outcomes, and patient activity/clinical outcomes. these real-world data points and trends collected as part of this pilot investigation will help inform a future larger healthcare effectiveness and outcomes research study.

Eligibility criteria:
inclusion criteria: * • age between 22-64 years * english-speaking (both reading and writing in english required) * diagnosis of chronic insomnia * participant is willing and able to give consent and participate in study * participant has an email account or is willing to create one and a smartphone able to download the necessary applications * participant is willing and able to use the pdt, the hugo data sharing platform and the syncable devices (e.g. fitbit) * participant has primary care at ynhh or mayo clinic exclusion criteria: * pregnancy * shift work or family/other commitments that interfere with establishment of regular night-time sleep patterns, and if wake/sleep time is outside the ranges of 4:00h - 10:00h (wake time) and 20:00h - 02:00h (bed time) * absence of a reliable internet access and smartphone * a reported diagnosis of psychosis, schizophrenia or bipolar disorder, or any medical disorders contraindicated with sleep restriction * current involvement in a non-medication treatment program for insomnia (participants are still eligible if they are taking traditional sleep medications) * those with untreated co-existing sleep conditions (e.g. sleep apnea) * those who have failed cbt for insomnia in the past

Keywords: insomnia cbt-i
g1t38, a cdk 4/6 inhibitor, in combination with osimertinib in egfr-mutant non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung; Lung Cancer; Non-small Cell Lung Cancer

Summary: this was a study to investigate the potential clinical benefit of g1t38 as an oral therapy in combination with osimertinib in patients with egfr mutation-positive metastatic non-small cell lung cancer. the study was an open-label design, planned to consist of 2 parts: a safety, pharmacokinetic, and dose-finding portion (part 1), and a randomized portion (part 2). both parts were to include 3 study phases: screening phase, treatment phase, and survival follow-up phase. the treatment phase began on the day of first dose with study treatment and completes at the post-treatment visit. approximately, 144 patients were planned to be enrolled in the study.

part 2, the phase 2 part of the study, was not conducted due to changes in corporate strategy. there were no safety signals identified in phase 1/part 1 that would have precluded the conduct of part 2. as a result, 30 out of the planned 144 patients were enrolled. all tumor assessments were conducted by the investigators or site radiologist. in order to reduce the burden to the patients, data of overall survival (os) were no longer required (since 29 january 2020). no os analysis was conducted for part 1 due to limited data in part 1. pk data for cohorts 4 (150 bid) and 5 (200 bid) were not analyzed as they were deemed unnecessary, as the pk data from cohorts 1-3 were sufficient to achieve the secondary study objective of assessing the effect of osimertinib on pk parameters of g1t38.

Eligibility criteria:
inclusion criteria: * confirmed egfr mutation for non-small cell lung cancer associated with egfr tki sensitivity * for part 2, egfr t790m mutation-positive tumor status * left ventricular ejection fraction (lvef) ≥ institution's lower limit of the reference range * for part 1, evaluable or measurable disease as defined by recist, version 1.1 * for part 2, measurable disease as defined by recist, version 1.1 * ecog performance status 0 to 1 * adequate organ function exclusion criteria: * prior treatment with egfr tki within 9 days of first study dose * for part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced nsclc * for part 2, prior treatment with osimertinib or other t790m active egfr tki * for part 2, prior chemotherapy for advanced nsclc * active uncontrolled/symptomatic cns metastases, carcinomatous meningitis, or leptomeningeal disease * investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose * concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow * prior hematopoietic stem cell or bone marrow transplantation

Keywords: lung cancer non-small cell lung cancer cdk 4/6 inhibitor egfr-positive egfr mutation- positive t790m egfr mutant lerociclib
autologous dendritic cell therapy for hormone-refractory metastatic prostate cancer

Conditions: Prostatic Cancer

Summary: this is an open label, phase i/iia trial of immunotherapy with creavax-pc as treatment in men with hormone-refractory metastatic prostate cancer.

creavax-pc consisted of antigen (psa, pap and klh) primed dendritic cell is an investigational product designed to activate a man's immune response, so they can detect prostate cancer cells and initiate an immune response against prostate cancer antigens. if patients decide to participate and are eligible, they will be enrolled in the study and will receive active product (creavax-pc). in detail, patients will receive creavax-pc injection at intervals of 3 weeks, maximum 6 times during 21 weeks. psa increase rate is a primary evaluation variables and tumor suppression effect is secondary evaluation variables. we also evaluate time to progression, overall survival and immune response.

Eligibility criteria:
inclusion criteria: * 1) histological confirmed prostatic carcinoma patient * 2) hormone non-respondence ex1) although treatment psa ≥ 5ng/ml ex2) psa level were measured two times ex3) prior one year radiology were processed * 3) just 18 years over * 4) has a score ≤1 on the ecog performance scale * 5) expected survival life time ≥ 6month * 6) adequate bone marrow function hemoglobin ≥ 10.0g/dl , leukocyte count ≥ 4,000/mm3 thrombocyte ≥ 100,000/mm3 * 7) adequate blood coagulation function pt(inr) \< 1.5, aptt\< 1.5 x control * 8) adequate kidney function normal blood upper level creatinine ≤ 1.5 times * 9) adequate liver function normal blood upper level ast/alt ≤ 1.5 times * 10) autoimmune antibody system don't have disorder ex) anti-nuclear antibody, anti-thyroglobulin antibody negativity * 11) person who didn't treat prior 6 weeks operation, radiotherapy treatment,immunotherapy or chemotherapy * 12) patient who voluntarily participated clinical trial and confirmed a written consent exclusion criteria: * 1) having other malignancy or previous history of malignancy * 2) brain metastases patient * 3) having autoimmune disease or its history * 4) pyrexia, rigor, leukocytosis infectious disease * 5) hbsag, anti-hcv, hiv positive patient * 6) myocardial infarction, cardiac insufficiency, other severe heart disease and non-controlled hypertension * 7) severe and active medical disease * 8) mental history disease or epilepsy * 9) patients participated other clinical trial within 4 weeks * 10) patients impossible to participate this trial by investigator's decision * 11) patients who received immunosuppressant such as steroid, cyclosporin a, azathioprine within 6 weeks

Keywords: prostate cancer psa hormone refractory prostatic cancer
impact of a physical activity program on bone mineral density in children and adolescents with chronic inflammatory bowel disease

Conditions: Crohn's Enteritis; Crohn Disease; Ulcerative Colitis; Chronic; Colitis (Noninfective)

Summary: muscle and physical activity play an important role in in growth, development and bone health in healthy children, especially during puberty. children with inflammatory bowel disease (ibd) have lower level and intensity of physical compared to a control group. several studies have shown that children with ibd have a lower bone mineral density (bmd) than general population, due to risk factors such as corticosteroid use, disease intensity, inflammation, malnutrition and a vitamin d deficiency. this low bmd is associated with an increased risk of fracture. a recent observational study found a positive and significant correlation between bmd in ibd patients and time spent in moderate to vigorous physical activity for one week (unpublished data).the present study aims to show a benefit of an adapted physical activity program on bmd in children and adolescents with ibd.


Eligibility criteria:
inclusion criteria: * patient with ibd (crohn's disease, ulcerative colitis or unclassified chronic colitis) since at least 6 months. * computer and internet access at home. * consent to adhere to a physical activity program. * assent of the child to participation in the research protocol. * informed consent of parents or legal guardian. * patient benefiting from national health. exclusion criteria: * at time of inclusion, acute intercurrent events which may lead to a decrease in physical activity (according to the judgment of the investigator) as fractures, recent arthritis, ano-perineal lesions, severe dermatological lesions. * chronic, acute or intermittent diseases (other than ibd) that may lead to a decrease in physical activity. * refusal of the child to participate to the protocol. * refusal of one of the child's parents to participate in the protocol. * predictable lack of compliance to study procedures (especially to the physical activity program). * child with visual impairment. * participation in another interventional study. * pregnant or lactating women. * patient under protection of justice.

Keywords: inflammatory bowel disease physical activity bone mineral density pediatric
whole lung imrt in children and adults with synovial sarcoma and lung metastases

Conditions: Synovial Sarcoma; Single or Multiple Lung Metastases

Summary: the purpose of this study is to find out what effects, good and/or bad, radiation has on the lungs has on the patient and on synovial sarcoma which has spread to the lungs. the standard treatment for synovial sarcoma which has spread to the lungs is chemotherapy with or without surgery to remove the tumors in the lungs. however, tumors often come back in the lungs after chemotherapy and/or surgery. since synovial sarcoma is known to be sensitive to radiation, this study is looking at whether radiation therapy which is targeted to the entire lung can further reduce the chances of the cancer returning. this type of radiation is commonly used in other types of sarcoma to treat the cancer once it has spread to the lungs and it may be very useful in synovial sarcoma as well. in this study, a special type of radiation will be used, called intensity modulated radiation therapy (imrt). with imrt the radiation beams are more customized to focus more radiation on the tumor cells while delivering less radiation to areas like the heart. the goal of this study is also to measure pulmonary toxicity and see if imrt is feasible and has less toxicity.


Eligibility criteria:
inclusion criteria: * patients with synovial sarcoma confirmed by mskcc pathological review * patients with single or multiple lung metastases at diagnosis or that develop over the course of treatment. after completion of all chemotherapy, lung metastases or must be ≤ 2cm. * age ≥12 months of age * karnofsky performance status (kps) must be ≥ 70 for patients ≥ 16 years of age and lansky performance status must be ≥ 70 for patients \< 16 years of age. * normal cardiac function * no active coronary artery disease; * no new york heart association class ii, iii or iv disease; * no arrhythmia requiring treatment. * baseline echocardiogram with a shortening fraction of ≥27% or an ejection fraction ≥ 50%. * female patients of childbearing potential must have a negative pregnancy test within 14 days of radiation start. * female patients who are lactating must agree to stop breast-feeding. * sexually active patients of childbearing potential must agree to use effective contraception. exclusion criteria: * patients with a history of prior radiation therapy to the thorax. * patients requiring a field size \>40 cm as imrt cannot be performed at extended ssds. * patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study.

Keywords: whole lung imrt 14-075
orthomolecular therapy and asthma in children

Conditions: Asthma

Summary: the purpose of this study is 1. to pilot the research methodology for a randomized trial on an orthomolecular treatment regime versus placebo as add-on therapy for children with asthma; 2. to obtain a preliminary estimate of the effectiveness of an orthomolecular treatment regime for allowing tapering of inhaled corticosteroids in clinically stable asthmatic children. the obtained estimate will allow sample size calculations for a full-scale randomized trial; and 3. to obtain preliminary information about the safety and tolerability of an orthomolecular treatment regime.

an orthomolecular treatment approach that combines supplements has, to date, not been tested, although it is commonly used by naturopathic practitioners to treat respiratory problems in individual children. a well-designed controlled trial is needed to determine if this approach is effective. this smaller study should establish guidelines for a large trial to follow. this proposed research is particularly important, as the trend to use natural treatments may encourage non-compliance with conventional medical treatments, leading to poor asthma control.

Eligibility criteria:
inclusion criteria: * male or female aged 7 to 18 years * mild to moderate asthma diagnosed by a respirologist * use of budesonide at a dose of 200-800 µg/d (or equivalent corticosteroid therapy) for ≥3 months * stable asthma, defined as no significant change in the regular asthma medication and no acute asthma exacerbation requiring corticosteroid rescue for at least 3 months before enrollment in the run-in phase. asthma symptoms must be under good control * baseline forced expiratory volume at 1 second (fev-1) \>= 70% of the predicted normal value. * possible participants treated with orthomolecular therapies within the previous year will require a wash out period of 7 days prior to enrolment in the trial. (vitamin c \> 200mg, vitamin e \>50iu, vitamin b12 \> 100µg, magnesium \> 200mg, selenium \> 50µg, omega-3 \> 300mg, quercetin \> 3mg, vitamin b6 \> 75mg will all be considered orthomolecular doses). exclusion criteria: * known hypersensitivity to any component of the orthomolecular therapy or placebo. * acute infectious sinusitis or respiratory tract infection or active lung disease other than allergic asthma within 1 month or any other significant systemic disease within 3 months of the study entry visit.

Keywords: childhood asthma inhaled corticosteroids alternative medicine vitamins, minerals, and fish oil as add-on treatment
effect of intravenous versus intrathecal dexamethazone on postdural puncture headache

Conditions: Postdural Puncture Headache

Summary: this study will be conducted at ain shams university hospital in operating theatre after ethical committe approval number (ms 32/ 2020). it is a prospective randomized controlled study will be done on patients undergoing lower abdominal and lower limb surgeries under spinal anethesia,eligible patients will be randomized by computer system to one of two groups, either intravenous dexamethazzoe 8 mg with intrathecal heavy bupivacaine 0.5% or intrathecal 4mg dexamethazone with intrathecal heavy bupivacaine 0.5%. .

patients will be randomly divided into two equal groups: group 1: patients receive intrathecal 3 ml bupivacaine 0. 5% +1 ml normal saline + intravenous 8 mg dexamethazone in 10 ml saline. group 2: patients receive intrathecal 3 ml bupivacaine 0. 5% + 4 mg (1 ml) dexamethazone + intravenous 10 ml normal saline. upon patients' arrival into the operating room, peripheral oxygen saturation (spo2), ecg, pulse rate (pr), and systolic and diastolic blood pressures will be monitored one of the researchers and recorded every 5 minutes till the end of surgery. in a sitting position and with antiseptic techniques, 25 g quincke needle was inserted intrathecally at l3-l4 or l4-l5 interspace through midline approach. the study drugs were given by an anesthesiologist not not aware of the type of medications injected. subsequently, the patients were put in the supine position, and given oxygen 3 l/minutes by nasal prongs.

Eligibility criteria:
inclusion criteria: * patients asa i or ii undergoing lower limb surgeries under spinal anesthesia * patients asai or ii undergoing lower abdominal surgeries under spinal anesthesia. exclusion criteria: * emergency surgeries. * patients with uncompensated heart diseases. * patients with coagulopathy. * presence of infection at site of injection of spinal anesthesia.

Keywords: intravenous dexamethazone intrathecal dexamethazzone
the effect of vitamin c on preventing complex regional pain syndrome (crps type i) following ankle fracture

Conditions: Ankle Fracture

Summary: the use of prophylactic treatment with vitamin c may prevent complex regional pain syndrome (crps)

there are several studies similar in wrist fracture.

Eligibility criteria:
inclusion criteria: * ankle fracture within 3 weeks after the fracture exclusion criteria: * pregnant or lactating woman * open fracture * already treated with vitamin c * chronic renal failure

Keywords: vitamin c ascorbic acid ankle fracture crps rds crps prevention
methacholine, long-acting m-cholinolytic and beta2-agonist on the activity of beta-receptors in healthy volunteers

Conditions: Health, Subjective; Hyperreactivity, Bronchial

Summary: interventional open-labeled study in parallel groups is aimed to evaluate changes of beta receptors in healthy volunteers under the influence of inhaled metacholine, long-acting anticholinergics and beta-agonists using modified radioligand method.

long-acting beta2-agonists and anticholinergics are main drugs in therapy of chronic obstructive pulmonary disease . beta-agonists exert their bronchodilatory effects via β2 adrenoceptors located on airway smooth muscle cells. anticholinergics block mainly m3-cholinoreceptors located in the airways, thus inhibiting bronchoconstriction. metacholine blocks m2-cholinoreceptors thus inducing bronchoconstriction. it is known, that muscarine and beta-receptors interact with each other, but the detailed mechanism is unknown. for evaluating the binding activity of beta-receptors after inhalation of these drugs the modified radioligand method was used.

Eligibility criteria:
inclusion criteria: 1 provision of signed and dated informed consent form 2. healthy male or female, aged 18-60 years exclusion criteria: * participants unable to perform spirometry * exacerbation respiratory infection within the previous four weeks * hypersensitivity or allergy to formoterol, metacholine or tiotropium bromide * females who are currently pregnant and lactating * major surgery in the last 6 months * refusal to participate * currently participating in another clinical study

Keywords: beta-receptors metacholine formoterol tiotropium