Kornimate/medical-research-clean huggingface dataset:
best revascularisation approach for posterior circulation strokes with isolated vertebral artery occlusions

Conditions: Ischemic Stroke; Vertebral Artery Ischemia; Arterial Occlusive Diseases; Vertebrobasilar Insufficiency

Summary: isolated vertebral artery occlusions (vao) account for approximately one third of posterior circulation occlusions, but have been given the least attention among posterior circulation strokes. if the two recent attention and baoche randomized clinical trials have proven the superiority of endovascular thrombectomy (evt) in basilar artery occlusions, data on the effectiveness and harm of acute revascularization treatment on isolated vao is scarce. we aim to investigate the impact of acute recanalisation treatments in acute ischemic stroke patients with isolated vao. in the absence of rct, observational data with appropriate statistical methods may give indications on benefits and harms of treating neglected stroke situations like acute vertebral occlusion. results may also lay the basis for prospective studies, such as randomized clinical trials.


Eligibility criteria:
inclusion criteria: * acute ischemic stroke limited to the posterior circulation * presence of uni- or bilateral vao (intracranial and/or extracranial) on at least one initial imaging study (cta, mra, dsa) * ivt, evt or bridging-treated stroke patients between 01.01.2003 and 31.12.2021 * ≥ 18 years old exclusion criteria * extension of the occlusion into the basilar artery * presence of a more distal occlusion in the pc (tandem occlusion/multilevel poster circulation occlusions) * previously known chronic occlusion of the any segment of the vertebral artery/arteries * local ethical/legal conditions in participating center not fulfilled

Keywords: prognosis revascularization treatment
a study to evaluate safety, tolerability and pharmacokinetics of da-8010 in healthy subjects

Conditions: Overactive Bladder

Summary: this study is a phase i, randomised, double-blind, placebo-controlled, dose-escalation study to evaluate safety, tolerability and pharmacokinetics after single and multiple oral administration of da-8010 in healthy subjects.

this study will be a randomised, double-blind, placebo-controlled, dose-escalation, single and multiple oral dose study conducted in 2 parts. in part a, each subject will participate in 1 treatment period only and reside at the clinical research unit (cru) from day -1 (the day before dosing) to day 3 (48 hours postdose), except for group a4, where each subject will participate in 2 treatment periods separated by a minimum of 13 days to evaluate the effect of food. in part b, each subject will participate in 1 treatment period only and reside at the cru from day -1 (1 day before dosing) until the morning of day 9 (48 hours after the final dose on day 7).

Eligibility criteria:
inclusion criteria: * bmi between 18.0 and 32.0 kg/m2 * subjects will have given their written informed consent to participate in the study and to abide by the study restrictions exclusion criteria: * subjects who do not agree to use a method of acceptable contraception * female subjects of child-bearing potential who do not agree to use a highly effective method of birth control * consume more than 28 or 21 units of alcohol per week if male or female, respective * subjects who have used nicotine-containing products (including cigarettes), within 3 months prior to the first dose administration * subjects who have used, or intend to use the product like non-prescribed systemic or topical medication, herbal remedy, vitamin/mineral supplement, within 7 days of the first dose administration * systolic blood pressure \ 140 mmhg * diastolic blood pressure \ 90 mmhg * pulse rate \ 100 bpm * positive urine drugs of abuse screen at screening or first admission * positive alcohol breath test at screening or first admission * positive cotinine test at screening or first admission * abnormality in the 12-lead ecg at screening, admission or predose on day 1 * subjects who are pregnant, breastfeeding, or lactating * subjects who are still participating in another clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of any investigational drug in the past 3 months prior to the first dose administration * subjects who have a significant history of drug allergy, as determined by the investigator * aspartate aminotransferase and/or alanine aminotransferase ≥ 1.5 × upper limit of normal (uln) or total bilirubin \> uln at screening or admission * subjects who are carriers of hbsag or hepatitis c antibody, have serum hepatitis or positive result for the test for hiv antibodies
influenza vaccination at a reduced dose using mesotherapy in hiv/aids patients at the hadassah aids center, jerusalem

Conditions: Influenza; Acquired Immune Deficiency Syndrome; HIV Infections

Summary: influenza vaccination has proved it's effectiveness over many years of usage including hiv/aids patients who are immunocompromised. in those patients, however, a noted rise in hiv viral load which follows intramuscular injection of the vaccine is of unknown significance over the long run. mesotherapy is a procedure developed and practiced in france by which a reduced and diluted amounts of antigens is being introduced by multiple intradermal injections over the torso and upper back. mesotherapy is mainly used as a vehicle for introducing pain medicine and cosmetics.

we will test the effectiveness of mesotherapy as a vehicle for influenza vaccination.we will use 1:10th of the amount of seasonal trivalent influenza vaccine in approx.50 hiv/aids patients.a control group of approx.50 matched patients for age ,treatment schedule and immune status will receive the regular injection of trivalent vaccine. we will follow patients clinically for symptoms compatible with seasonal influenza and for direct side effects of the vaccine.in addition we will measure anti influenza antibody in the two groups .follow up will be for 6 months following vaccination.anti influenza antibody will be measured at 1,3,6months using hemagglutination inhibition (hai) test.

Eligibility criteria:
inclusion criteria: * virologic diagnosis of hiv/aids. * any immune derangement is acceptable exclusion criteria: * allergy to eggs

Keywords: influenza in humans acquired immune deficiency syndrome immunization, active
multi-center clinical observation and mechanism study of yunnan baiyao in different stages of diabetic foot ulcer

Conditions: Diabetic Foot Ulcer Treatment

Summary: yunnan baiyao has been treating all kinds of wounds for 120 years, but the evidence of evidence-based medicine that is truly convincing is insufficient, making its best application method unclear. this study explored the possible indications and use methods of yunnan baiyao in different stages of diabetic foot, and obtained evidence-based medicine evidence of clinical efficacy. obtain the discarded tissues of diabetic foot patients in the treatment and control groups of yunnan baiyao after wound debridement, conduct transcriptome (bulkrna seq) analysis and detection on the wound tissues, and analyze the related signal pathways and functional genes with significant differences, to help clarify the possible treatment targets of yunnan baiyao.


Eligibility criteria:
inclusion criteria: 1. the age of the subjects is 18-80 years old; 2. diagnose diabetes according to who standards; 3. diagnosis of diabetic foot; 4. confirmed as one of the stages of infection progression and granulation growth; 5. voluntarily participate in this study and sign an informed consent form. exclusion criteria: 1. severe diseases such as acute myocardial infarction, heart failure, hepatitis, shock, and respiratory failure have not been corrected yet; 2. blood glucose is out of control, glucose test#fasting blood sugar\&gt;15mmol /l, glycated hemoglobin\&gt;12%; 3. there is active bleeding inside the wound, and routine basic treatment plans cannot be implemented; 4. serum albumin\&lt;20g/l; hemoglobin\&lt;60g/l; platelets\&lt;50 × 109/l; 5. late stage subjects with malignant tumors; 6. active period of autoimmune diseases; 7. have a history of allergy to yunnan baiyao; 8. the subject is unable to cooperate or has mental disorders; 9. according to the judgment of the researcher, the subject has a clear reason that cannot be removed and affects wound healing, which is not suitable for this study or cannot comply with the requirements of this study.
cicatrix cream in cutaneous groves

Conditions: Cutaneous Groves

Summary: the purpose of the study is to assess the effect of cicatrix (asian gotu kola or pennywort) usage in the treatment of cutaneous grooves. the duration of this phase 2 clinical trial will be 4 months.


Eligibility criteria:
inclusion criteria: * signed informed consent exclusion criteria: * patient that refer manifestations of high sensibility to the medication or to some of the components of the product. * patient that don't want to participate in the study. * patient not very cooperative. * responsible family not very cooperative.

Keywords: cutaneous groves
evaluation of bilateral internal iliac artery balloon occlusion in placenta accreta spectrum management

Conditions: Internal Iliac Artery; Balloon Occlusion; Placenta Accreta Spectrum

Summary: this study aims to evaluate the efficacy and safety of bilateral internal iliac artery balloon occlusion in the management of the placenta accreta spectrum.

placenta accreta spectrum (pas) is abnormal placental adhesion beyond superficial myometrium, which includes placenta accreta, placenta increta, and placenta percreta. however, there is a desire to preserve the uterus and fertility, so alternatives to hysterectomy are needed. presently, attempts to avoid hysterectomy include reducing intraoperative hemorrhage such as uterine compression sutures, intrauterine balloon tamponade, pelvic artery ligation, and spiral suturing of the lower uterine segment. intrauterine balloon tamponade may increase cs scar dehiscence, uterine rupture, and infection. combined with compression sutures, it may induce uterine necrosis. placement of balloons in the bilateral internal iliac arteries before caesarean section can reduce uterine artery pressure and intraoperative blood loss during balloon inflation, thus temporarily blocking the main blood supply of the uterus, helping to expose the visual field, shortening the operation time during surgery, and leading to opportunities for timely adjustments to the operative plan during surgery.

Eligibility criteria:
inclusion criteria: * age from 18 to 40 years. * women with placenta accreta spectrum based on ultrasound (us) and/or magnetic resonance imaging (mri) findings. exclusion criteria: * women with a bleeding disorder. * history of known allergy to contrast media. * women with impaired renal function. * emergency cesarean section. * women had severe attack of bleeding before the operation affecting patient's general condition. * women had previous four or more cesarean scars. * if ultrasound (us) and magnetic resonance imaging (mri) suspect the presence of placenta accrete preoperative, then intraoperative the placenta is found to have normal adhesion to the uterine wall, this case will be excluded.
effect of olanzapine on opioid craving and misuse among patients receiving opioids for cancer-related pain: a pilot double-blind, randomized control trial

Conditions: Misuse, Opioid

Summary: to learn about the effectiveness of taking the antipsychotic medication olanzapine to help lower opioid craving.

primary objective to determine the effect of olanzapine on opioid craving among patients receiving opioids for cancer pain (opioid craving scale; opioid craving visual analogue scale, change from baseline) secondary objective to determine the effect of olanzapine on opioid misuse among patients receiving opioids for cancer pain (current opioid misuse measure, change from baseline) exploratory objective * to estimate the effect of olanzapine and placebo on the amount of opioid use among patients receiving opioids for cancer pain (morphine equivalent daily dose) * to determine the effect of olanzapine and placebo on pain intensity among patients receiving opioids for cancer pain (brief pain inventory) * to determine the effect of olanzapine and placebo on overall symptom burden among patients receiving opioids for cancer pain (esas symptom distress score) * to estimate the differences between the olanzapine and placebo effects on opioid craving and misuse measures (opioid craving scale, opioid craving visual analogue scale, current opioid misuse measure) * to determine the adverse effects of olanzapine and placebo among patients receiving opioids for cancer pain (national cancer institute common terminology criteria for adverse events version 5.0)

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. diagnosis of cancer pain 3. receiving long-term opioid therapy (≥ 7 days)32 4. active use of opioids within the past 7 days 5. opioid misuse behavior (comm score ≥ 9/68) 6. seen by a supportive care clinic or pain clinic clinician 7. ecog performance status ≥ 2/4 8. ability to communicate in english 9. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. contraindications to, or allergic to, olanzapine 2. current use of any antipsychotic medication (e.g. quetiapine, haloperidol, risperidone, etc.) 3. history of oud or other substance use disorders, except marijuana 4. history of formal psychiatric diagnoses (e.g. bipolar disorder, schizophrenia, major depressive disorder, or anorexia nervosa) 5. hepatic insufficiency (defined as alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 3 times the highest normal value, or total bilirubin \>1.5 times the highest normal value) within the past month 6. history of uncontrolled diabetes mellitus or hyperglycemia (fasting ≥ 200 mg/dl) within the past month 7. history of seizure disorder or neuroleptic malignant syndrome 8. history of cardiac disease (e.g. coronary artery disease, congestive heart failure) 9. (females only) known pregnancy, as communicated to study personnel by clinicians; females of childbearing potential will receive advice to use methods of contraception per usual care.
efficacy and safety of triple-targeted drug therapy in treatment-naive patients with non-low-risk pah: a real-world, multicenter study

Conditions: Arterial Pulmonary Hypertension (PAH)

Summary: this study is a multicenter, prospective, observational study aimed at investigating the efficacy and safety of triple targeted drug therapy in patients with arterial pulmonary hypertension (pah) who are not at low risk and are receiving initial treatment. the prognosis of arterial pulmonary hypertension is explored.


Eligibility criteria:
inclusion criteria: * consent and sign the informed consent form * non-low-risk pah treatment-naive patients exclusion criteria: * positive acute vascular response test for idiopathic/hereditary/drug-related arterial pulmonary hypertension * pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis (pvod/pch) with arterial pulmonary * pregnant or lactating women * suffering from mental illness or cognitive impairment * pah patients with concurrent malignant tumors * patients with moderate to severe hepatic impairment, renal impairment, and severe anemia * currently participating in other interventional clinical studies * key clinical data is incomplete, or the investigator considers that the patient has other factors that make them unsuitable for this study.
impact of time on sexual function (fsfi® score) after hysterectomy

Conditions: Time Between Hysterectomy and Resumption of Sexual Relations; Sexual Function

Summary: in france, more than 62 000 hysterectomies are performed each year. female sexual function is the result of multiple psychological, social and physiological factors. there is no information in the current literature about the optimum time between the surgery and the sexual relation resumption. the primary outcome is to assess the impact of advising time between hysterectomy and sexual relation resumption by using fsfi® score. secondaries outcomes are: to describe and compare post-operative complications in the two groups of the study, to describe the follow-up of the recommendation concerning time between surgery and sexual relation resumption and to describe why this recommendation was not followed. this study is based on 4 questionnaires: fsfi® pre-operative and post-operative, pre-operative questionnaire and post-operative questionnaire. this is a monocentric, comparative, of superiority, randomised and prospective study. patients are randomised into two groups: sexual relation resumption advised 4 weeks after surgery, or 8 weeks. the inclusion criteria are more than 18 years, francophone, in sexual activity, scheduled for a total hysterectomy for benign indication (menometrorrhagia, fibroma, adenomyosis, endometriosis, pelvic floor disorders, low-grade endometrial cancer), considering vaginal, laparoscopic and abdominal approach, and a written consent. non-inclusion criteria are illiteracy, cognitive disorders, without social security, deprived liberty by judicial or administrative decision, psychiatric care, patient with legal protection, patient incapable of giving consent. if our conclusions confirmed our hypothesis, it can improve clinical practices by providing additional informations for surgeon and patient, to undergo this surgery as serenely as possible.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old, * francophone, * sexually active, * receiving a conservative or non-conservative total hysterectomy for benign pathology\*, * having signed a consent form. all surgical approaches are considered, laparoscopic approach with laparoscopic or vaginal closure, vaginal approach and laparotomy. \*the indications for the procedure selected for this study include: * menometrorrhagia, * fibroids, * adenomyosis, * endometriosis, * pelvic statics disorder, * cervical dysplasia, * endometrial cancer not requiring lymph node dissection or additional treatment.

Keywords: benign gynaecological disease hysterectomy sexual function fsfi® score
combination of cryosurgery and nk immunotherapy for advanced esophageal cancer

Conditions: Metastatic Esophageal Cancer

Summary: the aim of this study is the safety and efficacy of cryosurgery plus nk immunotherapy to advanced esophageal cancer.

by enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (nk) cells for advanced esophageal cancer. the safety will be evaluated by statistics of adverse reactions.the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 5 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: esophageal cancer nk immunotherapy safety efficacy
efficacy and safety of xen® gel stent and post-operative management in patients with open angle glaucoma

Conditions: Open-angle Glaucoma

Summary: to evaluate the efficacy of postoperative management with 5-fluorouracil injections after xen gel stent implantation.


Eligibility criteria:
inclusion criteria: * diagnosis of primary open angle glaucoma * trabecular meshwork visible in gonioscopy * medicated iop of ≥ 15 mmhg and ≤ 35 mmhg * taking 1 to 5 iop-lowering medications * area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal) * signed inform consent exclusion criteria: * angle closure glaucoma * secondary open angle glaucoma * previous glaucoma shunt/valve in the target quadrant * presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant * active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) * active iris neovascularization or neovascularization of the iris within 6 months of the surgical date * anterior chamber intraocular lens * presence of intraocular silicone oil * vitreous present in the anterior chamber * impaired episcleral venous drainage (e.g., sturge-weber or nanophthalmos or other evidence of elevated venous pressure) * known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde) * history of dermatologic keloid formation * previous photorefractive keratectomy
study to evaluate the efficacy and safety of amg 301 in migraine prevention

Conditions: Chronic Migraine or Episodic Migraine

Summary: to evaluate the effect of amg 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

a phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of amg 301 in subjects with chronic migraine or episodic migraine.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form. * history of migraine (with or without aura) for ≥ 12 months before screening according to the international headache society (ihs) classification ichd-iii (headache classification committee of the international headache society, 2013) * migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening. * failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy exclusion criteria: * older than 50 years of age at migraine onset. * history of cluster headache, hemiplegic migraine headache. * unable to differentiate migraine from other headaches. * migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period. * history or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

Keywords: migraine headache prevention prophylaxis