Kornimate/medical-research-clean huggingface dataset:
promise international

Conditions: Critical Limb Ischemia

Summary: the objective of this post-market study is to evaluate the safety and effectiveness of the limflow system in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

this study will investigate the safety and effectiveness of the limflow system for creating an arterio-venous fistula in the below-the-knee vascular system using an endovascular, minimally invasive approach for the treatment of critical limb ischemia in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Eligibility criteria:
inclusion criteria: * subject must be \> 21 and \< 95 years of age * clinical diagnosis of symptomatic critical limb ischemia, defined as rutherford category 5 or 6 * assessment that no conventional surgical or endovascular treatment is possible * proximally, the target in-flow artery at the cross-over point must be treatable with a 3.5 - 4.0 mm stent after pre-treatment (by visual estimate), and be \<50% stenosed * subject is willing and has adequate support to comply with protocol requirements, including medication regimen and follow-up visits exclusion criteria: * concomitant hepatic insufficiency, deep venous thrombus in target limb, uncorrected coagulation disorders, or current immunodeficiency disorder * prior vein stripping surgery and/or vessel harvesting for cabg in the limb intended for study * life expectancy less than 12 months * patient currently taking coumarin/warfarin which, in the opinion of the attending physician, interferes with the patient's treatment * any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal treatment * patient currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment * patient unable to give consent * pregnant or breastfeeding women * documented myocardial infarction or stroke within previous 90 days * patients suffering from renal insufficiency (gfr value less than 30 ml/min/1.73 m²) who are not on hemodialysis * patients with vasculitis and/or untreated popliteal aneurysms * patients with acute limb ischemia * prior peripheral arterial bypass procedure above or below the knee which could inhibit proximal inflow to the stent graft * lower extremity venous disease with significant edema in the target limb that may inhibit the procedure and/or jeopardize wound healing, in the investigator's opinion * known or suspected systemic or severe infection (e.g., wifi foot infection grade of 3) * known or suspected allergies or contraindications to stainless steel, nickel, or contrast agent that cannot be adequately pre-treated, or patients who cannot receive anticoagulation or antiplatelet aggregation therapy * severe heart failure, which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure (e.g., known ejection fraction of \< 40%, nyha classification iii-iv)

Keywords: desert foot no-option patients venous arterialization
assessing the impact of lipoprotein (a) lowering with pelacarsen (tqj230) on major cardiovascular events in patients with cvd

Conditions: Cardiovascular Disease and Lipoprotein(a)

Summary: this is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established cvd and elevated lp(a)


Eligibility criteria:
key inclusion criteria * lp(a) ≥ 70 mg/dl at the screening visit, measured at the central laboratory * myocardial infarction: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit * ischemic stroke: ≥ 3 months from screening and randomization to ≤ 10 years prior to the screening visit * clinically significant symptomatic peripheral artery disease key exclusion criteria * uncontrolled hypertension * heart failure new york heart association (nyha) class iv * history of malignancy of any organ system * history of hemorrhagic stroke or other major bleeding * platelet count ≤lln * active liver disease or hepatic dysfunction * significant kidney disease * pregnant or nursing women other protocol-defined inclusion/exclusion criteria may apply at the end.

Keywords: lipoprotein(a), lp(a), cvd, myocardial infarction, pad, stroke, pelacarsen
risk prediction model of mace in patients with ami based on multi-modal machine learning

Conditions: Acute Myocardial Infarction

Summary: a prospective, multicenter, observational study is adopted, with jiangsu provincial people's hospital as the leading unit, and the other 13 hospitals as cooperative units.

the deployment of an integrated cardiac rehabilitation management platform from the hospital to the outside of the hospital is uniformly arranged, and based on this platform, a study on the construction of a mace prediction model and disease risk stratification for patients with acute myocardial infarction after pci is carried out. it is planned to include 655 inpatients after pci for acute myocardial infarction. among them, the leading unit completes the enrollment and follow-up of 44 patients, and each cooperative unit completes the enrollment and follow-up of 47 patients, and competitive enrollment is allowed.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria of ami; * ages 18 - 75 years old; * meeting the indications for emergency pci surgery, with informed consent and voluntarily undergoing pci treatment; ④ accurate and complete clinical relevant data; ⑤ first diagnosis and treatment; ⑥ all patients were given unified antiplatelet therapy after the operation; ⑦ all patients were followed up for 12 months after the operation. exclusion criteria: * with malignant tumors, infections and other diseases; * blood diseases, immune system diseases, severe liver and kidney function disorders; ③ with other heart diseases such as heart failure; ④ patients undergoing surgical treatment.
circulating endothelium progenitor cells and endogenous oestrogen in healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to determine whether the number of circulating epc is different between healthy women and men.

study design: open pilot study in health volunteers in the hospital saint-antoine's clinical investigation centre (cic). recruitment and course of the study: the subjects will be recruited among the cic's pool of healthy volunteers. volunteer people will then have biological and clinical baseline examinations. if they match the inclusion criteria, an appointment will be taken for the blood sample intend for the characterization of the epc and hormonal plasma levels evaluation. the participation will not exceed 2 months. young women will have to come between the 9th and the 11th day after the beginning of menses). a total of 150 ml of peripheral blood will be collected. the study will last 18 months.

Eligibility criteria:
inclusion criteria: * bmi between 19 and 25 kg/m² * non menopausal women : * age 18 to 40 years, * regular menstrual cycles * no hormone therapy as contraceptives * postmenopausal women : * age above 55 years old * amenorrhoea since 5 years at least * no hormone therapy since at least 3 month exclusion criteria: * no medical insurance * inclusion in another study * smoking, statins treatment, uncontrolled diabetes or hypertension and personal history of cardiovascular disease.

Keywords: endothelial progenitor cells estrogen menopause cardiovascular risk
combined microneedling and topical pentoxifylline vesrus intalesional pentoxifylline in treatment of alopecia areata: intra-indiviual comparative study

Conditions: Alopecia Areata

Summary: alopecia areata (aa) is a common autoimmune disease that targets hair follicles with a prevalence of approximately 0.1% and a lifetime incidence of approximately 1.7%. aa is the third most prevalent nonscarring hair loss disease. pentoxifylline (ptx) is a non-selective inhibitor of phosphodiesterases, which moderates the intracellular levels of cyclic adenosine monophosphate and cyclic guanosine monophosphate by decreasing their hydrolysis and augmenting cyclic nucleotide-dependent signal transduction which leads to a wide spectrum of effects on the inflammation. ptx has anti inflammatory effects by inhibiting the pro-inflammatory cytokines (eg, il-1, il-6, and il-8).intralesional therapy has a number of advantages over topical therapy, including a faster and longer duration of action, penetration that is deeper than topical therapy, removal of the need for long-term topical medication, and improved patient compliance.the effect of microneedling for treatment of aa is supposed to stimulate the dermal papilla and stem cells by mechanical trauma and increasing the blood supply to the hair follicles.


Eligibility criteria:
inclusion criteria: * all patients over the age of 18 years of both sex, with a clinical diagnosis of localised aa of two or more aa scalp patches in the same patient. exclusion criteria: * patients who received systemic or topical treatment for a.a in the previous three months prior to the start of the study. * patients who are pregnant or lactating. * patients who have bleeding or coagulation disorders. * patients with autoimmune diseases, liver, or renal diseases were excluded from the study.
the dtg-switch study: longitudinal analysis of virologic failure and drug resistance at and after switching to dolutegravir-based first-line art

Conditions: Hiv; Drug Resistancy; Virologic Failure

Summary: this is a prospective observational cohort study of 2820 patients on first-line art switching to a dtg-based first-line regimen, according to the standard of care. the study is conducted in malawi and zambia, in art programs that participate in the iedea collaboration. sequencing will be done on blood samples of patients with a viral load above 400 copies/ml to identify mutations.

dolutegravir (dtg), a second-generation integrase strand transfer inhibitor (insti), is widely used in high-income countries and is recommended by the world health organization (who) as an alternative first-line art regimen. in countries where viral load monitoring is not routinely available many patients on first-line art will be switched to a dtg-based regimen despite the detectable viral load, which could increase the risk of selection of resistance to dtg as the majority of patients with virologic failure on first-line efv-based art have nrti mutations. the investigators hypothesize that the proportion of patients experiencing virologic failure 48 and 96 weeks after switching to a dtg-based regimen will be higher in patients who switched with virologic failure (vl\>400 copies/ml) compared to patients who switched with suppressed viral replication (vl\<400 copies/ml). this is a prospective observational cohort study of 2820 patients on first-line art switching to a dtg-based first-line regimen, according to the standard of care. the study is conducted in malawi and zambia, in art programs that participate in the iedea collaboration. at the time of switching to dtg, a baseline study assessment will be done, and a blood sample will be taken. sequencing will be done on blood samples of patients with a viral load above 400 copies/ml to identify mutations.

Eligibility criteria:
inclusion criteria: patients * on first-line art for 6 months or longer * switching to any dtg-based treatment exclusion criteria: * no informed consent

Keywords: hiv drug resistancy virologic failure dtg-based regimen drug resistance mutations
phase ii pilot controlled study of short vs longer term pimozide (orap) therapy in tourette syndrome

Conditions: Tourette Syndrome

Summary: objectives: i. determine whether the time period between randomization and endpoint is longer in the short term pimozide therapy or longer term therapy in patients with tourette syndrome. ii. determine whether tic severity, medication side effects, academic performance and psychosocial functioning are better in the short term pimozide therapy or longer term pimozide therapy.

protocol outline: this is a combined open label and double blind randomized study. patients receive pimozide (open label) orally until a stable level of tic control is achieved and remains unchanged for at least 1 month. then, patients are randomized to one of two possible double blind treatments. in the short term pimozide group, patients receive pimozide over 2 weeks. then, pimozide is gradually replaced by an inactive placebo within the following 10 weeks. patients in the long term pimozide group receive pimozide. patients continue treatment for 12 months or until a worsening of tics or behavioral symptoms are present for which an increased dosage is required. patients who do not experience an exacerbation of tics requiring an increase in dosage are followed for 1 year from the date of entry.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- dsm-iii-r criteria for tourette syndrome chronic motor tic disorder with tics sufficiently severe to require neuroleptic therapy --prior/concurrent therapy-- no clonidine for at least 2 weeks or any neuroleptic (e.g., haloperidol, pimozide) within 3 months prior to study stable dosage of other medications (e.g., antiobsessional, stimulant) for at least 3 months prior to and during study required

Keywords: tourette syndrome neurologic and psychiatric disorders rare disease
study of k201 injection on restoration of sinus rhythm in subjects who are in atrial fibrillation

Conditions: Atrial Fibrillation

Summary: to evaluate the effects of k201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.


Eligibility criteria:
inclusion criteria: * symptomatic atrial fibrillation * atrial fibrillation documented by ecg * adherence to local clinical standards or the acc/aha/esc practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment. exclusion criteria: * systolic blood pressure \<100 mmhg * heart rate \<50 bpm * temperature \>38°c * qt or qtcb \>440 ms * qrs \>140 ms * paced atrial or ventricular rhythm on ecg * serum potassium \<3.5 meq/l * history of receiving another intravenous class i or class iii antiarrhythmic drug within 3 days of randomization * history of amiodarone in last 6 months. * clinical evidence of acute coronary syndrome * acute pulmonary edema or embolism * hyperthyroidism * acute pericarditis * history of failed electrical cardioversion at any time * history of torsades des pointes * history of familial long qt interval syndrome * history of ventricular tachycardia requiring drug or device therapy * history of nyha heart failure class 3 or 4.
frequency of vitamin d deficiency in premature newborn born before 32 weeks and/or with a birth weight under 1500g

Conditions: Vitamin D Deficiency

Summary: vitamin d plays an important role in phosphocalcic metabolism and bone homeostasis in newborns. premature newborns are at risk of vitamin d deficiency and may require supplementation. in this context, the french society of pediatrics (société française de pédiatrie) recommends systematic vitamin d testing at 1 month. the aim of this study was to determine the frequency of vitamin d deficiency in premature newborns.


Eligibility criteria:
inclusion criteria: * premature newborns born at a gestational age less than 32 weeks and/or birth weight less than 1500g * having received at least one dosage of 25 oh vitamin d.- exclusion criteria: * - newborn whose parents or legal guardian refuse the use of their data for this research
seroquel in bipolar depression versus ssri

Conditions: Bipolar Disorder; Bipolar Depression; Depression

Summary: the purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.


Eligibility criteria:
inclusion criteria: * male and female out-patients aged 18 to 65 years inclusive * diagnosis of bipolar disorder (bipolar i or bipolar ii), most recent episode depressed exclusion criteria: * current period of depression lasting less than 4 weeks or more than 12 months * use of prohibited medication * substance or alcohol dependence or abuse * current suicide risk or suicide attempt within 6 months * breast feeding or pregnancy * clinically relevant disease or clinical finding

Keywords: bipolar disorder bipolar depression depression
phase ii trial of hm61713 for the treatment of ≥2nd line t790m mutation positive adenocarcinoma of the lung

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of hm61713 in patients with t790m-positive non-small cell lung cancer (nsclc) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (egfr-tki).

this is a single-arm, open-label, phase 2 study to assess the anti-tumor efficacy of oral single agent hm61713 administered to patients with t790m-positive nsclc after treatment with an egfr-tki as measured by objective response rate (orr).

Eligibility criteria:
inclusion criteria: * age: at least 20 years of age * cytologically or histologically confirmed adenocarcinoma of locally advanced or metastatic nsclc which is not amenable to curative surgery or radiotherapy * radiologically confirmed disease progression after at least one line of treatment with an egfr-tki * at least one documented egfr mutation which is known to be related with susceptibility to egfr-tkis (including g719x, exon 19 deletion, l858r, and l861q) * world health organization (who) performance score of 0 to 1 with life expectancy of at least 3 months * centrally confirmed t790m mutation positive tumor status from a tumor sample taken after confirmation of disease progression on the most recent anticancer treatment regimen * at least one lesion (excluding the brain), not previously irradiated that can be accurately measured per recist version 1.1 * adequate hematological and biological function * females of child-bearing potential must agree to use adequate contraception and for 3 months after the last dose of study drug * male patients should be documented to be sterile or agree to use barrier contraception * recovery to ≤ grade 1 or baseline of any toxicities, except for stable sensory neuropathy ≤ grade 2 and alopecia exclusion criteria: * known history of hypersensitivity to active or inactive excipients of hm61713 or drugs with a similar chemical structure of hm61713 * previous treatment with anticancer therapies, egfr-tki, hm61713, or other drugs that target t790m-positive mutant egfr with sparing of wild-type, investigational agent(s) within 28 days prior to the first administration of study drug, radiotherapy * any non-study related significant surgical procedures within the past 28 days prior to the first administration of study drug * spinal cord compression, leptomeningeal carcinomatosis or active symptomatic brain metastases * history of any other malignancy * clinically significant uncontrolled condition(s) * active or chronic pancreatitis * anyone with cardiac abnormalities or history * presence or history of ild, drug-induced ild, or presence of radiation pneumonitis * pregnant or breast feeding * in the opinion of the investigator, the patient is an unsuitable candidate to receive hm61713

Keywords: nsclc egfr-tki non small cell lung cancer hm61713 t790m-positive lung cancer phase ii olmutinib
low-dose combination of three antihypertensive drugs

Conditions: Arterial Hypertension

Summary: the aim of the study is to compare the efficacy and safety of low-dose combination of three antihypertensive drugs versus fixed high-dose combination of two antihypertensive drugs in arterial hypertension

the aim of the study is to compare the efficacy and safety of commercially available low-dose combination of three antihypertensive drugs versus commercially available fixed high-dose combination of two antihypertensive drugs in arterial hypertension

Eligibility criteria:
inclusion criteria: patients with arterial hypertension resistant to monotherapy exclusion criteria: none

Keywords: arterial hypertension antihypertensive drugs
consumption of whole grains and legumes modulates the genetic effect of the apoa5 -1131c variant

Conditions: Subjects With Mild Hypertriglyceridemia in Type 2 DM

Summary: we examined whether a substitution of whole grains and legumes for refined rice in a high carbohydrate diet (about 65% of energy derived from carbohydrate) may modify the effect of this variant on changes in apolipoprotein a-v (apoa-v) and triglyceride concentrations.

we genotyped the apoa5 -1131t\>c in individuals with impaired fasting glucose (ifg) or newly diagnosed type 2 diabetes, who were randomly assigned to either a group ingesting whole grain and legume meals daily or a control group for 12 weeks.

Eligibility criteria:
inclusion criteria: * subjects who were in in impaired fasting glucose (ifg, 100≤ fasting glucose \<126 mg/dl) and newly diagnosed type 2 diabetes (fasting glucose ≥126 mg/dl) were referred to the department of family medicine or internal medicine. they were rechecked for their health and lipid profiles, and then those who satisfied the study criteria were recommended to participate in the dietary intervention program exclusion criteria: * current and/or past history of cardiovascular disease including angina * liver or kidney dysfunction * thyroid or pituitary disease * unstable weight loss/gain (≥2 kg) over the previous 6months * pregnancy or lactation. subjects who were taking medication were also excluded