Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of iliac bifurcation stent graft system

Conditions: Aortoiliac Aneurysm; Iliac Aneurysm

Summary: a prospective, multi-centre, single-arm clinical trial to evaluate the safety and efficacy of iliac bifurcation stent graft system.

a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of endovascular treatment of the aortoiliac aneurysm or the iliac aneurysm by using iliac bifurcation stent graft system manufactured by lifetech scientific (shenzhen) co., ltd. according to the requirements of the study, 64 patients preoperatively diagnosed with the aortoiliac aneurysm or the iliac aneurysm will be recruited and be treated by iliac bifurcation stent graft system under the guidance of aortic aortography. the safety of operations, stability of releasing stent and the accuracy of positioning will be evaluated intraoperatively. the safety and efficacy of aortic endovascular treatment of iliac bifurcation stent graft system will be observed by postoperative follow up scheduled 30 days and 180 days after the operation.

Eligibility criteria:
inclusion criteria: 1. older than 18 years of age. 2. the subject or its legal representative sign the informed consent. 3. patients with the aortoiliac aneurysm or the iliac aneurysm and need to endovascular restructure the internal iliac artery. 4. the anatomical structure of the iliac artery meets the following requirements: 1. the length of the anchoring zone of the external iliac artery is ≥15mm. 2. the diameter of the anchoring zone of the external iliac artery is between 7mm and 12mm. 3. the diameter of the external iliac artery is between 6mm-10mm. 4. the length of the anchoring zone of the internal iliac artery is ≥10mm. 5. life expectancy is longer than one year. exclusion criteria: 1. the patient is under 18 years old. 2. pregnant or lactating woman. 3. the patient had a myocardial infarction or stroke within 3 months. 4. the patient had connective tissue disease, infectious aneurysm, and other active infections. 5. the patient has abdominal aortic aneurysm rupture. 6. the patient has a severe coagulation disorder. 7. allergic to the material of stent or contrast media. 8. patient's vascular morphology is not suitable for endovascular repairs, such as serious stricture, dilate, bend, sclerosis, etc. of the iliac artery. 9. patients with severe mural thrombus in the aneurysm cavity, which may affect the implantation of branch stent.

Keywords: iliac bifurcation stent graft system
prospective study of tw in the treatment of ln type v with gross proteinuria

Conditions: Lupus Nephritis; Proteinuria; CTX

Summary: the purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (tw) and ctx in ln-v patients with gross proteinuria.

compared with cyclophosphamide(ctx), to analyze the clinical effects and adverse reactions of tripterygium glycosides (tw) in ln-v patients with gross proteinuria.

Eligibility criteria:
inclusion criteria: 1. sle patients aging 18-60 years, all of whom comply to the isn/rps classification. 2. urine protein≥3.0g/24h, alb\<30g/l and scr\<1.5mg/dl. 3. all cases are type iv, confirmed by renal biopsy. 4. all patients sign the informed consent and be willing to follow-up on time exclusion criteria: 1. accepted drug therapy, such as ctx mmf csa fk506 or tw more than 2 weeks in the latest 3 months. 2. scr level above 1.5mg/dl, lasts more than 3 months. 3. heart, lung or central nervous systems involved or combined with severe infection. 4. with liver function abnormal, alt or ast being two times above the normal. 5. pregnant women or patients still in lactation.
observational study on the safety and efficacy of the medical product fructosin.

Conditions: Fructose Intolerance

Summary: fructosin® is a medical device for use in fructose intolerance. in this uncontrolled posdt market clinical follow up (pmcf) study, the safety and efficacy of oral supplementation of fructosin® in fructose intolerance will be investigated. the study participants will be informed about the nature and scope of the study during a preliminary examination (screening) and a declaration of consent will be obtained. in addition, it is determined whether fructose intolerance is present. this is determined by means of the acpq test. subsequently, the patients fill out symptom questionnaires (ibs-sss, ibs-qol, 1-week symptom questionnaire). after the eligibility check, a 14-day phase of monitoring and documentation of symptoms and complaints without taking fructosin® (observation phase) takes place. at visit 1, the patients receive the fructosin® capsules, which they take as needed, but no more than 2 x 3 times a day with fruit meals. the intake phase runs over a period of 28 days (4 weeks) during which the study participants observe and evaluate gastrointestinal symptoms with the help of the 1-weekly symptom questionnaire. in addition, the daily fructose consumption (fruit, fruit juices, smoothies) and the amount of fructosin® capsules taken are documented in a diary.


Eligibility criteria:
inclusion criteria: * positive result of the acpq test after 25 g fructose ingestion. * age: 18 - 80 years; 18 years of age must be completed and the legal capacity must be given. exclusion criteria: * pregnancy and breastfeeding * congenital (hereditary) fructose intolerance * participation in a clinical trial in the past 4 weeks * at the investigator's discretion: physical findings or previous illness for which a recommendation to take fructosin is not indicated or for which an assessment of the questionnaire by the patient is not possible.
microenvironment of adipose tissue in endocannabinoid system

Conditions: Obesity

Summary: the purpose of this study is examine the relationship between adipose tissue inflammation and activation of the endocannabinoid system before and after roux-en-y gastric bypass surgery. the investigators hypothesize that the metabolic improvements and weight loss are due to mechanisms that antagonize the endocannabinoid system.


Eligibility criteria:
inclusion criteria: * bmi\>35 kg/m2 * age 20-60 yrs * approved and scheduled for gastric bypass surgery * stable body weight for past 3 months exclusion criteria: * positive pregnancy test * previous gastric surgeries * intercurrent infections * history of ketoacidosis or current metabolic acidosis * serum creatinine or liver function tests \> 2 times upper limits of normal * taking drugs that are known to affect carbohydrate or lipid metabolism other than anti-diabetes mediations.

Keywords: obesity gastric bypass surgery
spd489 low dose and high dose ranges when added to stable doses of antipsychotic medications in clinically stable adults with negative symptoms of schizophrenia

Conditions: Schizophrenia

Summary: the primary purpose of this study is to determine whether spd489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of negative symptoms.


Eligibility criteria:
inclusion criteria: * - 18 to 65 years of age * has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \>4 hours/week with the subject) * fixed home/place of residence and can be reached by telephone * on a stable dose of antipsychotic medications * able to swallow capsules exclusion criteria: * taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products * treated with clozapine in past 30 days * lifetime history of stimulant, cocaine, or amphetamine abuse or dependence * history of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of tourette's disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, parkinson's disease, or intracranial lesions * uncontrolled hypertension * history of thyroid disorder that has not been stabilized on thyroid medication * glaucoma * pregnant or nursing * subject has received an investigational product or participated in a clinical study within 30 days
effect of opioids on central control of ventilation in children with obstructive sleep apnea

Conditions: OSA; Opioid; Adenotonsillectomy

Summary: children osa exhibit varying responses to opioids. it is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity

ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). it is thought that patients with obstructive sleep apnea (osa) have increased sensitivity to opioids, and especially in opioid naïve patients. recent evidence in children suggests that patients with moderate to severe osa may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have osa. however, what is not known is wether the degree of hypoxemia experienced by patients effects the opioid sensitivity. the aim of this study is to identify if children with known osa experience a difference in opioid induced respiratory depression based on the degree of hypoxemia.

Eligibility criteria:
inclusion criteria: * patients undergoing tonsillectomy or adenotonsillectomy * ages 2 to up to 8 years * preoperative sleep study demonstrating obstructive sleep apnea * intubation without medication (e.g. no propofol prior to intubation) * requirement for airway instrumentation: lma or ett * inhalation induction of anesthesia exclusion criteria: * no obstructive sleep apnea * central sleep apnea events \>5/hour * iv induction of anesthesia * syndromic patients * known or suspected difficult airway * allergy to fentanyl * known cardiovascular medications * pulmonary hypertension * total intravenous anesthesia required * parental refusal
a study of mrna-1020 and mrna-1030 seasonal influenza vaccines in healthy adults

Conditions: Seasonal Influenza

Summary: the primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mrna-1020, mrna-1030, and mrna-1010 vaccines against vaccine-matched influenza a and b strains.


Eligibility criteria:
inclusion criteria: * body mass index of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the screening visit. * for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding. exclusion criteria: * participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection or covid-19 as defined by the centers for disease control and prevention (cdc) or has had a positive sars-cov-2 test in the past 10 days prior to the screening visit. * participant is acutely ill or febrile (temperature ≥38.0 degrees celsius \[°c\]/100.4 degrees fahrenheit \[°f\]) 72 hours prior to or at the screening visit or day 1. * any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. * participant has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 180 days prior to screening (for corticosteroids ≥10 milligrams \[mg\]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. * participant has received or plans to receive any licensed or authorized vaccine, including covid-19 vaccines, ≤28 days prior to the study injection (day 1) or plans to receive a licensed or authorized vaccine within 28 days after the study injection. * participant has received a northern hemisphere (nh) 2021-2022 seasonal influenza vaccine or any other influenza vaccine within 180 days prior to day 1. * participant tested positive for influenza by cdc-recommended testing methods within 180 days prior to day 1. * participant has donated ≥450 milliliters (ml) of blood products within 28 days prior to the screening visit or plans to donate blood products during the study. note: other inclusion/exclusion criteria may apply.

Keywords: influenza vaccine mrna-1020 mrna-1030 moderna
a study to evaluate sigma-1 and dopamine-2 receptor occupancy by pridopidine in the human brain of healthy volunteers and in patients with huntington's disease

Conditions: Health Volunteers, Huntington Disease

Summary: the purpose of this study is to demonstrate engagement of pridopidine with s1r and d2r (optional) in the living human brain. no formal statistical analysis will be conducted


Eligibility criteria:
inclusion criteria: * in general, good physical health as determined by medical history and psychiatric history, suicidality assessment \& physical examination * men who are potentially fertile (not surgically \[eg, vasectomy\] or congenitally sterile * patients with huntington's disease (hd): diagnosis of hd and with an onset of hd after 18 years of age * additional criteria apply, please contact the investigator for more information exclusion criteria: * the subject has been previously exposed to ionizing radiation or radioactive substances as a result of clinical research or medical treatment in the past 10 years. * the subject has a counterindication to having an mri * history of alcohol, narcotic, or any other substance dependence in the past 2 years * additional exclusion criteria to patients with huntington's disease: * the patient has a severe motor impairment that might cause artifacts. * patients with a known history of long qt syndrome or a first degree relative with this condition. * treatment with any investigational product within 6 weeks of screening or patients planning to participate in another clinical study assessing any investigational product during the study. * additional criteria apply, please contact the investigator for more information
observation study to evaluate the efficacy and safety of ifosfamide/mesna in patients with metastatic castration-resistant prostate cancer

Conditions: Prostatic Neoplasm

Summary: prostate cancer is the 2nd most common cancer in men worldwide. based on the results of several recent clinical trials, systemic treatments including hormone inhibitors, docetaxel, cabazitaxel, and parp inhibitors are being used as standard treatment for patients with metastatic castration-resistant prostate cancer. however, there is insufficient research on salvage therapy for patients with metastatic castration-resistant prostate cancer who have failed standard treatment. in this study, the investigators will evaluate the effectiveness and safety of ifosfamide in castration-resistant prostate cancer by analyzing the treatment outcomes of patients who received ifosfamide/mesna treatment as salvage therapy.

1. retrospective analysis of the treatment outcomes of patients with metastatic castration-resistant prostate cancer who who received ifosfamide/mesna will be conducted. 2. information regarding demographics (age, gender, and etc.), disease status (stage, metastatic lesion, and etc.), treatment details (administered anticancer drugs, treatment response to drug, and disease progression with progression date), and survival (death with date of death) will be recorded. 3. statistical method was applied to analyze the correlation between clinical indicators and survival rate.

Eligibility criteria:
inclusion criteria: 1. 19 years and older adult male 2. patients with histologically confirmed prostate cancer 3. castration-resistant prostate cancer 4. ecog 2 or less 5. patients with previous docetaxel exposure 6. patients with available psa level 7. patients with evaluable disease based on recist 1.1 exclusion criteria: 1. patients with other primary cancers diagnosed within 3 years other than prostate cancer 2. patients with a history of organ transplantation 3. hormone sensitive prostate cancer 4. ecog 3 or higher 5. patients without previous docetaxel exposure 6. patients previously exposed to ifosfamide 7. patients without available psa level 8. patients without evaluable disease based on recist 1.1

Keywords: castration-resistant prostate cancer ifosfamide/mesna efficacy safety
assessment of giant cell arteritis medical practices in france

Conditions: Giant Cell Arteritis

Summary: the purpose of this study is to describe medical practices in patients with gca in terms of patient journey, diagnostic methods and specific gca treatments since diagnosis.

this is a cross-sectional, non-interventional, national (france), multicentre study, conducted on a population of 300 patients with gca, to describe gca management and patient characteristics. the study will be conducted in accordance with the professional code of ethics and the good epidemiological practice guidelines developed by the association of french-speaking epidemiologists. the information will be collected during a single visit to the internist or rheumatologist as part of the usual management of the patient with gca. the physician will not perform any additional examinations specific to the study. the physician will inform the patient about the study before inclusion and seek her/his non-opposition. a patient information form will be given to each patient by the physician. patients who are eligible to participate in the study and who verbally accept automatic processing of their personal data, will be included in the study. data will be collected from the medical file and from patient questionnaires on health status (sf-36 \[36-item short form survey instrument\], eq5d \[euroqol-5 dimensions\]) and fatigue (facit-fatigue). in addition, gca activity will be evaluated using a global arteritis activity visual analog scale (vas) to be completed by the patient and the physician.

Eligibility criteria:
inclusion criteria: * at least 50 years old. * suffering from gca as per investigator judgement, newly diagnosed or not. * starting or under treatment for gca. * informed verbally and in writing about this study and not objecting to their data being electronically processed or subjected to data quality control. non-inclusion criteria: * unable to consent * participation to a randomised controlled clinical trial
a clinical study of gadoteric acid in non-coronary magnetic resonance (mr) angiography

Conditions: Arterial Occlusive Disease

Summary: this is a clinical study of gadoteric acid in non-coronary mr angiography.


Eligibility criteria:
inclusion criteria: * male or female, at least the age of legal maturity * strongly suspected of having non-coronary arterial disease, detected clinically * scheduled to undergo x-ray angiography examination * female patients must be using effective contraception or be surgically sterilized or post-menopausal. * females of childbearing potential must have a documented negative urine pregnancy test. exclusion criteria: * contraindication to magnetic resonance imaging (mri) * any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations * congenital morphologic vascular abnormalities * known allergy to gadolinium chelates * pregnant, breast feeding, or planning to become pregnant during the trial * received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (mra) examination.
transdermal lidocaine for pain control during hysterosalpingography

Conditions: Infertility, Female

Summary: the study aims to investigate the effectiveness of transdermal lidocaine patch for pain control during hysterosalpingography

hysterosalpingography can cause pain and discomfort in several ways: use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye

Eligibility criteria:
inclusion criteria: * any patient came for hysterosalpingography exclusion criteria: * any patient has contraindication to hysterosalpingography
eating behaviors among weight-discordant siblings

Conditions: Obesity

Summary: the purpose of this study was to compare weight-discordant siblings in eating in the absence of hunger, caloric compensation, and the quality of their habitual diet. the investigator hypothesized that, within families and controlling for age differences, overweight and obese siblings would show greater eating in the absence of hunger, poorer caloric compensation, and poorer diet quality (e.g., increased percent of energy from fat and caloric beverages) compared to normal-weight siblings.

the study used a discordant sibling design to compare putative obesity-promoting eating traits among siblings, 5-12 years, who were raised in the same household, but were discordant for weight status (normal-weight: bmi-for-age between 5 and less than the 85th percentile; overweight/obese: bmi-for-age greater or equal to the 85th percentile). forty-seven pairs of same-sex siblings (boys and girls) were recruited from the greater philadelphia area to participate in a 4-week study during which their eating behaviors and body composition were assessed. the study tested the hypotheses that overweight/obese, compared to normal-weight, siblings exhibit 1) a weaker ability to compensate for calories, 2) a greater susceptibility towards eating in the absence of hunger, and 3) habitual dietary intakes that favor increased dietary energy density (kcal/g) and increased %energy derived from fat and caloric beverages. the use of a behavioral genetics design to study eating phenotypes among siblings is a unique approach to elucidate shared and non-shared environmental influences that can contribute to variations in weight status during childhood.

Eligibility criteria:
inclusion criteria: * same-sex; * weight discordant (normal-weight vs. overweight/obese); * meet age criteria; * like most foods that were served in the study. exclusion criteria: * serious medical conditions or medication use known to affect appetite, food intake and body weight; * developmental or psychiatric conditions; * food allergies or nutrient intolerances (including lactose intolerance).