Kornimate/medical-research-clean huggingface dataset:
resolute onyx china rct study

Conditions: Ischemic Heart Disease; Stenotic Coronary Lesion; Cardiovascular Diseases; Arteriosclerosis; Coronary Artery Disease

Summary: it is a randomized controlled trial to evaluate the safety and efficacy of the medtronic resolute onyx™ zotarolimus-eluting coronary stent system in comparison with the medtronic resolute integrity™ zotarolimus-eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (ptca) in china.

this study is a pre-market, prospective, multi-center, open-label, randomized controlled trial. subjects will be 1:1 randomized and followed through 5 years (screen, implant procedure(including post-procedure assessment),30-day, 6 months, 9 months (primary endpoint_lll), and annual assessments from 1-5 years).

Eligibility criteria:
key inclusion criteria: * the subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the ib of resolute onyx stent, and the ifu of resolute integrity stent * the subject requires treatment of up to 3 target lesions in up to 2 separate target vessels \[2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel(including its side branches)\] amenable to treatment with stents with diameter from 2.25 mm to 4.0 mm key exclusion criteria: * known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, p2y12 inhibitors, mtor inhibiting drugs such as zotarolimus, biolimus a9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. biolinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * pci of the target vessel within 9 months prior to the procedure * active bleeding * subjects with a life expectancy of less than 12 months * participation in another clinical study * pregnant, or lactating women

Keywords: major adverse cardiac events (mace) myocardial infarction (mi) late lumen loss (lll) target lesion revascularization (tlr) target vessel revascularization (tvr) target vessel failure (tvf) target lesion failure (tlf) stent thrombosis (st) the randomized controlled trial percutaneous coronary intervention (pci)
the effect of modified olfactory training on postoperative olfactory dysfunction in patients with crs

Conditions: Olfactory Dysfunction; Chronic Rhinosinusitis

Summary: the goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are: is it possible that the device can treat postoperative olfactory dysfunction in patients with chronic sinusitis? compared to the conventional device, how efficient is the modified olfactory training device for treating postoperative olfactory dysfunction in patients with chronic sinusitis?

endoscopic sinus surgery is an effective treatment for treating olfactory dysfunction related to chronic rhinosinusitis. however, recent studies have shown that most patients experience a return of olfactory function to preoperative levels within months to a year after surgery. clinically, olfactory training after endoscopic sinus surgery has been proven beneficial for the olfactory recovery. the improved olfactory training device, based on a nasal bidirectional drug delivery system, can increase the deposition rate in the olfactory fissure region and improve the efficiency of olfactory training. in this study, the investigators planned to recruit 213 patients and divided them into three groups for control group and olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on changes in cognitive function and the comparison of the outcomes of the three groups.

Eligibility criteria:
inclusion criteria: 1. a diagnosis of crssnp based on the european position paper on rhinosinusitis and nasal polyps 2020 (epos20). 2. the duration after endoscopic sinus surgery is 3months. 3. olfactory dysfunction confirmed with the sniffin's sticks psychophysical test (tdi score≦30.5) . 4. willingness to participate in this study and sign the informed consent form (icf). exclusion criteria: 1. patients with olfactory impairment due to traumatic, congenital, toxic/drug-induced causes, tumors, or post-upper respiratory infections. 2. lund-mackay olfactory cleft score \> 0. 3. patients with severe comorbidities, such as malignant tumors. 4. current or planned pregnancy prior to the end of study. 5. patients who are unable to complete the study or are unable to comply with the requirements of the study (such as inability to tolerate olfactory function testing and treatment, memory or behavioral abnormalities, depression, smoking, heavy alcohol use, previous delinquent behavior)

Keywords: olfactory dysfunction chronic rhinosinusitis endoscopic sinus surgery olfactory training
observational registry of treatment patterns in castrate-resistant prostate cancer (crpc) patients

Conditions: Prostatic Neoplasms

Summary: primary objective: * describe real-life survival of crpc patients who received first-line docetaxel and have disease progression secondary objective: * describe treatment patterns * describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others * describe economic and patient-reported outcomes


Eligibility criteria:
inclusion criteria: * patients with crpc progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy * patient who have given their written consent exclusion criteria: * current participation in a clinical trial for the second-line treatment of prostate cancer * patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity * patients having already started a second line treatment the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
pharmacokinetic and pharmacodynamic properties of biod-105 and biod-107 compared to humalog® in subjects with type 1 diabetes

Conditions: Diabetes Mellitus Type 1

Summary: the primary objective of this study is to assess the speed of absorption and onset of action of biod-105 and biod-107 and compare them to humalog®.

the secondary objectives of this study are to assess other pharmacokinetic characteristics of biod-105 and biod-107 and compare those to humalog®, to assess other pharmacodynamic characteristics of biod-105 and biod-107 and compare those to humalog®, and to evaluate the safety and tolerability of biod-105 and biod-107 compared to humalog®.

Eligibility criteria:
inclusion criteria: subjects must present with the following: 1. body mass index: ≥ 18 - ≤ 28 kg/m2 2. diagnosed with type 1 diabetes mellitus for at least 1 year 3. insulin antibody less than or equal to 10 μu/ml at screening exclusion criteria: subjects presenting with any of the following will not be included in the study: 1. type 2 diabetes mellitus 2. serum c-peptide \> 1.0 ng/ml 3. hba1c \> 10.0% 4. history of hypersensitivity to any of the components in the study medication 5. treatment with any other investigational drug in the last 30 days before screening visit 6. regular smoking as assessed clinically by the investigator.
hepatitis b virus reactivation: a cautionary event after liver transplantation for patients with hepatocellular carcinoma

Conditions: Liver Transplant; Complications

Summary: highly active hepatitis b virus (hbv) is known to be associated with poor outcomes in patients with hepatocellular carcinoma (hcc). this study aims to investigate the relationship between hbv status and hcc recurrence after liver transplantation. the study retrospectively analyzed hcc patients undergoing liver transplantation in 2 centers between january 2015 and december 2020. we reviewed post-transplant hbv status and its association with outcomes.


Eligibility criteria:
inclusion criteria: * (1) preoperative diagnosis of hbv-related hcc and (2) pathologically confirmed hcc. exclusion criteria * (1) non-hbv-related hcc; (2) simultaneous presence of other tumors; (3) re-transplantation; (4) presence of portal vein tumor thrombus; and (5) a survival time of less than 90 days.
translation and validation of mpcosq in urdu language

Conditions: PCOS- Polycystic Ovary Syndrome

Summary: to translate and validate modifies polycystic ovary syndrome quality of life (mpcoq) questionnaire into urdu. to evaluate the reliability, validity and of urdu version of modified polycystic ovary syndrome quality of life questionnaire (mpcoq).

* all statistical analyses will be conducted using the statistical product and service solution version 21 software. * continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage. * in this study, factor structure of the (mpcoq) will be analyzed using the principal component factor analysis with varimax rotation. * intraclass correlation coefficient (icc) (95% confidence interval) will be used for test-retest value and cronbach's alpha will be used for internal consistency analysis. * measurement error will be determined by calculating the standard error of measurement (sem) and the smallest detectable change (sdc). independent t-test will be used to determine the differences between groups

Eligibility criteria:
inclusion criteria: * • age 18 - 30 * married * female patients diagnosed with pcos, having 2 of the following rotterdam diagnostic criteria: i. polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume \>10ml ii. clinical signs of hyperandrogenism (the hirsutism score based on the ferriman-gallwey score \>7 or obvious acne) iii. having an interval between menstrual periods \>35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days patients who are willing to participate exclusion criteria: * • non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia * female undergoing hormone replacement therapy * female with malignancies * any recent fractures, surgeries * patient with nephrological and neurological conditions * dementia or cognitive impairments
maternal adipose tissue and placental dysfunction programs the fetus for type 2 diabetes (placenta-dm)

Conditions: Obesity; Type 2 Diabetes

Summary: the purpose of this study is to discover the characteristics of pregnant women which increases risk for their babies to develop diabetes, later on in life.

obesity has been recently diagnosed in a younger population and currently in the united states more than two thirds of women of childbearing age are overweight or obese. these women will have children at high risk for developing obesity and type 2 diabetes (t2dm). there is an acute need for preventing these complications in children so that we can break the cycle of obesity and t2dm. numerous interventions have attempted but failed to improve outcomes in obese pregnancies by weight loss. clinicians do not currently have specific recommendation for identifying the obese mothers and risk and for the prevention of infant's complication in healthy obese pregnancies. the global objective of this study is to identify the relevant maternal phenotype at risk and the mechanism(s) of fetal environment predisposing the offspring for t2dm. this will enhance t2dm early screening and prevention. the global hypothesis is that dysfunctional adipose tissue secretes angiostatic and pro-inflammatory factors that lead to the formation of a dysfunctional placenta, which through a hypoxic and inflamed environment alters the epigenome to program the fetus for t2dm.

Eligibility criteria:
pregnant women inclusion criteria: * pregnant women undergoing planned cesarean section at 39 weeks of gestation due to: a) elective cesarean section; b) breach presentation c) repeat cesarean section (the rationale for choosing these women is to select only women that have no other risk factors or complications during pregnancy that might affect the outcome) * age between 18 and 40 years old * pre-pregnancy bmi between 20 and 25 kg/m2 (lean) and \>30 kg/m2 (obese) * singleton pregnancies * allowing their neonates to participate in the trial pregnant women exclusion criteria: * taking any medication except pre-natal vitamins and medication to treat normal symptoms of pregnancy like: constipation, nausea, vomiting, gastric reflux, insomnia and pain. * type 1 diabetes, type 2 diabetes or gestational diabetes; chronic or gestational hypertension * pre-eclampsia, eclampsia during this pregnancy * liver, kidney, thyroid disease, cancer * smoking or using illegal drugs or alcohol during this pregnancy * fetal umbilical blood and/or placenta are collected for another reason, i.e. parents decide on cord blood storage neonate inclusion criteria: - live neonates born to the study participating mothers neonate exclusion criteria: - neonate distress as to require admission to the neonatal intensive care unit.

Keywords: adipose tissue placenta pregnancy umbilical cord
effect of suanzaoren decoction and huanglian wendan decoction on biorhythm of insomnia patients

Conditions: Chronic Insomnia; Melatonin; Circadian Rhythm; Suanzaoren Decoction and Huanglian Wendan

Summary: the purpose of this study was to examine the impact of chinese medicine on melatonin levels in patients with insomnia

this was a single-centre, non-randomised, interventional study with a planned enrolment of 20 subjects, including 10 chinese insomnia patients and 10 healthy subjects. all subjects giving written informed consent. healthy subjects were admitted to the study ward at baseline (d-3), completed the pittsburgh sleep quality index (psqi), morning and evening questionnaire (meq), and began saliva collection at 16:00, stayed overnight in the study ward that night and were discharged the following day (d-2). insomnia patients were admitted to the study ward at baseline (d-3), completed the psqi and meq questionnaires and started saliva collection at 16:00, stayed overnight in the study ward and left the following day (d-2) after completing the relevant examinations. after 4 weeks of treatment with suanzaoren decoction and huanglian wendan decoction, the subject was re-admitted to the study ward on d30, completed the psqi and meq questionnaires and started saliva collection at 16:00, stayed overnight in the study ward and left on the following day (d31) after completing the relevant examinations. the intervention for patients with insomnia in this study was the administration of suanzaoren decoction and huanglian wendan decoction twice a day for 4 weeks. add or subtract chinese herbal medicine according to the different clinical manifestations of each patient.

Eligibility criteria:
inclusion criteria: * age 18-55, male or female； * insomnia patients: patients who met the diagnostic criteria for insomnia in the chinese guidelines for the diagnosis and treatment of insomnia in adults (2017 edition) and who were judged to have moderate-to-severe insomnia according to the insomnia severity index scale; healthy subjects: those who had normal sleep, and who met the scores of 0 to 7 on the insomnia severity index scale; * informed consent, voluntary participation in the study； exclusion criteria: * people with mental illness; * chronic insomnia with yang deficiency and yin deficiency, clinical manifestations: coldness of the whole body and hands and feet, like warmth and pressing, yellowish colour, unshaped stools, lumbago, weakness of the legs, nocturia, pale tongue with thin white moss; * pregnant, lactating women; * have a serious primary heart, liver, lung, kidney, haematological or serious disease affecting their survival, e.g. tumour or aids, scr \> 1.5n (n is the upper limit of normal), alt \> 2n (n is the upper limit of normal), blood leucocytes \< 3.0 x 109/l; * participants in any other clinical trial within 3 months prior to dosing; * those who are vulnerable to missing visits based on other circumstances that the researcher judges to be unsuitable for enrolment, such as changes in the work environment.
stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer

Conditions: Prostate Adenocarcinoma; Stage I Prostate Cancer

Summary: this clinical trial studies stereotactic body radiation therapy in treating patients with low- and intermediate-risk prostate cancer. stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

primary objectives: i. to evaluate, in terms of late toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule. secondary objectives: i. to evaluate, in terms of acute toxicity, the safety of stereotactic radiation therapy using the proposed fractionation schedule. ii. to determine stereotactic treatment efficacy through biochemical failure (phoenix criteria). iii. to determine the protocol completion rate. iv. to describe patient-reported outcomes using international index of erectile function (iief) and epic urinary and bowel assessment questionnaires. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients undergo standard daily fractions of stereotactic body radiation therapy (sbrt) over 7-8.5 weeks.

Eligibility criteria:
inclusion criteria: * patients must have low or intermediate risk adenocarcinoma of the prostate as defined by: * low-risk disease - histopathology score (gleason sum): =\<6, t-stage (per current ajcc staging criteria): t1c-t2a, and psa: \<10 * intermediate-risk disease as either: * histopathology score (gleason sum) =\ 10 but =\< 20; or * histopathology score (gleason sum) 7 with =\< 50% of any cores positive, t-stage (per current ajcc staging criteria): t1c-t2a, and psa \< 10 * charlson index of comorbidity score =\< 4 * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease * patients with a history of cancer other than skin cancer within 5 years of the initiation of protocol treatment * patients with a history of pelvic irradiation for any reason * life expectancy \< 10 years - prior treatment with an anti-androgen, luteinizing hormone-releasing hormone (lhrh) agonist, or a combination of the two * prior radiation therapy, brachytherapy, or cryotherapy * prior surgical procedure involving peri-rectal and peri-prostatic area
a pilot study for pupillary assessment to predict car-t related neurotoxicity

Conditions: Neurotoxicity

Summary: to learn about the relationship between changes in pupil size and reactivity and the start of neurological side effects in patients after receiving car-t cell therapy.

primary objective: to assess the association between the status of npi drop from baseline (prior to car t-cell infusion) to the lowest npi post axi-cel (cd19 car-t cell) infusion and the status of immune effector cell-associated neurotoxicity onset within 10 days post cd19 car-t cell infusion. secondary objective: to evaluate the largest absolute difference in npi between two eyes (∆ npi) and assess its association with severity of clinical symptoms as measured by immune effector cell encephalopathy (ice) and or radiographic / eeg findings exploratory objective: to assess the feasibility and safety of a pupillometer use in patient treated with axi-cel therapy.

Eligibility criteria:
inclusion criteria: to be considered eligible for study participation, patient will satisfy all relevant inclusion criteria and none of the exclusion criteria. inclusion criteria: 1. ages eligible for study: 18 years and above (adult, older adult) 2. sexes eligible for study: all 3. patient with histologically proven dlbcl, pmbcl or tfl, or follicular lymphoma receiving axi-cel car-t cell therapy in the inpatient setting at md anderson cancer center 4. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. patients who have already been administered car-t cell therapy. 2. the patient who is unwilling or unable to comply with the requirements of the study including being able to be assessed with pupillometer 3. patient has a condition which places him at an unacceptable risk as determined by the investigator
national gilles de la tourette study group

Conditions: Tourette Syndrome

Summary: tourette syndrome is rare. in france, about 3000 patients have a severe form of the disease. the aim of this study is to collect clinical characteristics in 200 patients with tourette syndrome.


Eligibility criteria:
inclusion criteria: * tourette syndrome exclusion criteria: * severe cognitive disorders
influencing factors and trigger mechanism of relapse in expectant fathers who quit smoking

Conditions: Smoking Cessation

Summary: the purpose of this study is to describe the relapse rate and characteristics of expectant fathers who quit smoking during their wives' pregnancy, to explore the influencing factors and triggering mechanisms,and describe their experience.

participants will be invited to recall their smoking status and experience during their wife's pregnancy (all participants and required to complete the questionnaire, and some of them will be invited to participate in semi-structured interviews). in the quantitative study,participants need to finish the questionnaire,which includes the demographic information sheet, characteristics of smoking sheet, history of smoking cessation sheet, smoking hazard questionnaire, motivation to quit smoking sheet, ability to quit smoking sheet, alcohol consumption, exercise. in the qualitative study,participants need to participate in semi-structured interview.the interview begins with "have you tried smoking cessation before? why? what is the result", and explores in-depth analysis based on the participants' answers.

Eligibility criteria:
inclusion criteria: * (1) all participants should be aged 18 or above; * (2) the newborn of the participant is alive, and the number of days of birth is ≤28 days; * (3) all participants should have actively quit smoking during his wife's pregnancy, and maintained it for at least 24 hours; * (4) all participants should be smoking at least 1 cigarette per day on average for at least 1 month in the past 1 year; * (5) all participants should be able to communicate in mandarin (including reading chinese). exclusion criteria: * all participants who meet the above criteria but are currently involved in other smoking cessation programs or the pilot study and/or mentally or physically unfit for communication will be excluded.

Keywords: expectant fathers smoking relapse mix-method study paternal behavior