Kornimate/medical-research-clean huggingface dataset:
a randomized, double-blind, parallel group, placebo-controlled study to assess sts101 in the acute treatment of migraine

Conditions: Migraine; Migraine With Aura; Migraine Without Aura

Summary: study sts101-007 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of sts101 (dihydroergotamine nasal powder) in the acute treatment of migraine.

study sts101-007 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).

Eligibility criteria:
key inclusion criteria: * males or females, 18-65 years of age at the time of screening visit * subject has at least 1-year history of migraines (with or without aura), according to the international classification of headache disorder, 3rd edition (ichd3) key exclusion criteria: * pregnant or breast-feeding women * women of child-bearing potential not using or not willing to use highly effective contraception. * diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache. * history of coronary artery disease, coronary artery vasospasm (including printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery. * history of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage. * diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or bipolar disorder), dementia. other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety. * any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.

Keywords: dihydroergotamine dihydroergotamine mesylate migraine
management of spontaneous ruptured hepatocellular carcinoma

Conditions: Rupture, Spontaneous; Rupture Liver; Hepatocellular Carcinoma

Summary: to investigate the best treatment for hepatocellular carcinoma rupture

to investigate the best treatment for hepatocellular carcinoma rupture, transcatheter arterial embolization or partial hepatectomy. furthermore, to discuss the choice of emergency or staged hepatectomy.

Eligibility criteria:
inclusion criteria: * being diagnosed as hepatocellular carcinoma with tumor rupture; with complete data and without loss of follow-up exclusion criteria: * without complete data; with loss of follow-up; not hepatocellular carcinoma based on pathological diagnosis

Keywords: partial hepatectomy emergency staged peritoneal dissemination propensity score matching
the performance of da vinci sp system on extraperitoneal approach radical prostatectomy

Conditions: Prostate Cancer

Summary: the objective of this study is to evaluate the performance and safety of da vinci single port (sp) system on the surgery for extraperitoneal approach radical prostatectomy

enrolled subjects would receive extraperitoneal approach radical prostatectomy using da vinci sp system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). the preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including mri/ct and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. the hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. the postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (for sexual function, the international index of erectile function (iief-5) would be recorded before and after the surgery. for continence, the number of pads per day and 24hr total weight of pads would be recorded. no pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. international prostate symptom score (ipss) wound be recorded before and after the surgery to access voiding function).

Eligibility criteria:
inclusion criteria: 1. patients with biopsy-proved prostate cancer 2. stage clinical t1-t2n0m0 3. prostate volume ≦ 70cm (by transrectal ultrasound or other image studies) 4. bmi ≦ 35 kg/m 5. low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function) 6. age between 18 and 78 years old 7. suitable for minimally invasive surgery 8. patients willing and able to provide informed consent 9. patients willing and able to comply with study protocol requirements and follow-up exclusion criteria: 1. previous abdominal or pelvic major operation history 2. previous radiation treatment to the pelvic area 3. patients received transurethral resection of prostate in three months 4. severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions * severe heart disease (nyha functional class iii-iv) * severe lung disease (gold group c-d) 5. anatomy unsuitable for endoscopic visualization or minimally invasive surgery 6. hemodynamic or respiratory instability after anesthesia 7. working space restriction (e.g. kyphosis or severe scoliosis) 8. emergency surgery 9. untreated active infection 10. vulnerable populations

Keywords: prostate cancer radical prostatectomy da vinci sp system extraperitoneal approach
iaso-782 in autoimmune hematological diseases

Conditions: Autoimmune Thrombocytopenia; Warm Autoimmune Haemolytic Anaemia

Summary: this study is a randomized, double-blinded, and placebo-controlled phase ia clinical study in subjects with autoimmune hematological diseases. the study is designed to assess the safety and tolerability of iaso-782 for the treatment of autoimmune haematological diseases (itp and waiha).

this study is a single-dose escalation study in subjects with autoimmune hematological diseases. the study is designed to enroll subjects with autoimmune thrombocytopenia and warm antibody type immune haemolytic anaemia (itp and waiha). referred to the clinical pharmacological study and development experience of similar drugs, one or more dose regimens will be determined for the use in phase 1b clinical trials. this study will evaluate the safety and preliminary dose range of iaso-782 in subjects with autoimmune hematologic diseases (itp and waiha) at the following dose levels:6mg/kg and 10mg/kg.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years 2. clinically confirmed diagnosis of autoimmune thrombocytopenia (itp) or warm autoimmune haemolytic anaemia (waiha) 3. failure or relapse after at least 1 treatment for the study disease 4. stable dose of immunosuppressants for 4 weeks before screening 5. organ function or laboratory test is basically normal 6. subjects of childbearing potential and their partners must use effective contraception for at least 2 weeks before administration of investigational product, throughout the trial period, and for 28 days after the end of the trial (or early termination of the trial) 7. females of potential childbearing capacity must have a negative pregnancy test at screening 8. voluntarily participate in this study and sign the informed consent exclusion criteria: 1. history of other primary malignant neoplasm within 5 years of screening 2. secondary to other disease-induced hematopoietic destruction 3. cardiac disorder within the last 3 months 4. patients with high blood pressure that cannot be controlled by drug 5. subjects with a history of allergy to any component of the investigational drug 6. active infection requiring intravenous treatment within 30 days prior to the enrollment 7. pregnant or breastfeeding women 8. participation was being given other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of the investigational drug 9. previous treatment drugs have not been adequately washed out 10. itp patients have had any previous arterial or venous thrombosis 11. patients with itp had previous biopsy bone marrow results indicating bone marrow fibrosis (myelofibrosis mf) ≥ 2 12. uncontrolled infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c (hcv) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol 13. subjects with a history of drug abuse or mental disorder 14. other medical history or conditions that would make the subject unsuitable for the study by investigators' judge.
a study to investigate the safety and tolerability of mk-0517 in healthy subjects (mk-0517-012)

Conditions: Chemotherapy-Induced Nausea and Vomiting; Postoperative Nausea and Vomiting

Summary: this 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of mk-0517 (with and without polysorbate 80) and aprepitant in healthy adults. parts i to iv of this study will examine different doses of mk-0517 as well as two different formulations of mk-0517 (with and without polysorbate 80). part v of the study will compare single doses of intravenous non-ps80 mk-0517 to oral 125-mg capsule of aprepitant. the primary hypothesis for part v of the study is that a single intravenous dose of 100-mg or 115-mg mk-0517 is area under the plasma-time curve (auc) equivalent to that of the 125-mg oral aprepitant capsule in young healthy participants.


Eligibility criteria:
inclusion criteria: * subject is neither grossly overweight nor underweight for his/her height and body build * subject is in good health -subject is a nonsmoker * subject is willing to avoid excessive alcohol consumption for the duration of the study * subject is willing to avoid strenuous physical activity (i.e. unaccustomed weight lifting, running, bicycling) for the duration of the study * subject agrees to refrain from consumption of grapefruit (and grapefruit products) before and during the study exclusion criteria: * subject has a history of multiple and/or severe allergies to drugs or food * subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks * subject has an infection, including human immunodeficiency virus (hiv) infection * subject is a regular user of any illicit drug * subject consumes excessive amounts of alcohol * subject drinks excessive amounts of coffee, tea, cola or other caffeinated beverages * subject currently uses on a regular basis, any prescription or non prescription medications
effectiveness and tolerability of labiastick#01 in subjects with symptomatic non-hypertrophic chronic vulvar dermatoses

Conditions: Chronic Disease of Skin

Summary: the current study aims to investigate the effectiveness in clinical symptomatic control and tolerability of labiastick#01 in women with symptomatic non-hypertrophic chronic vulvar dermatoses.

vulvar dermatoses are skin disorders that affect the vulva, causing pruritus, irritation and pain. although the prevalence of these disorders is unknown, it is well accepted that the vulvar symptoms are a common problem for women. labiastick#01 has emollient agents whose main function is to increase the skin hydration, provide physical protection and decrease the symptoms and possibility of recurrence of vulvar dermatoses. the medical device should be applied once daily, in the evening, after intimal hygiene care. the primary objective of this study is to evaluate the effectiveness of labiastick#01 on the relief of pruritus caused by symptomatic non-hypertrophic chronic vulvar dermatoses.

Eligibility criteria:
inclusion criteria: * able and willing to give written informed consent. * woman, with 18 or more years. * diagnosed with symptomatic non-hypertrophic chronic vulvar dermatoses. * a pruritus score of at least 20 on a 100-mm vas-pr. * willing and able to comply with the study requirements. * participant of childbearing potential agrees to remain abstinent or to use an acceptable contraceptive measure for the entire duration of the study. * participant not of childbearing potential (e.g., is not sexually active, whose current partner is not of reproductive potential). exclusion criteria: * received systemic immunosuppressant therapy (e.g. systemic corticosteroids) within 4 weeks prior to admission. * treated with daily topical therapy (e.g. topical corticosteroids, pimecrolimus, and tacrolimus) at the target vulvar area within 2 weeks prior to admission, which in the opinion of the investigator might compromise study results. * immunocompromised (e.g., lymphoma, aids, wiskott-aldrich syndrome) or have an uncontrolled malignant disease. * suffers from systemic or generalized infections (bacterial, viral or fungal). * diagnosis of psoriasis, candidiasis, vulvar intraepithelial neoplasia or carcinoma of the vulva. * pregnancy or breastfeeding. * documented and consistent history of hypersensitivity reactions to similar topical products. * any condition that in the opinion of the investigator might prevent the subject from completing the study or interfere with the interpretation of the study results.
amyloidosis typing using mass spectrometry-based proteomics: a new accurate tool for difficult typing

Conditions: Amyloidosis

Summary: the main objective is to establish that a new technique of amyloidosis typing by proteomics (based on nanolc-ms/ms mass spectrometry) allows typing in \> 90% of observations in patients whose amyloidosis is reported to have failed typing (impossible typing, uncertain or inconsistent) with the traditional anatomopathological approach, and this in a cohort of 40 patients identified consecutively in the department of pathological anatomy and cytology of the university hospital of toulouse and included prospectively.


Eligibility criteria:
inclusion criteria: * diagnosis of amyloidosis by red congo staining and birefringence in polarized light on tissue sampling * immunolabeling amyloidosis typing 1. impossible (no frozen sample available) 2. or inconclusive (doubtful) 3. or inconsistent with clinical, biological, genetic and iconographic data * signature of the informed consent form exclusion criteria: * insufficient tissue material to perform the new technique * person placed under judicial protection * pregnant and breastfeeding women

Keywords: mass spectrometry based proteomic analysis nanolc-ms/ms amyloidosis typing
a randomized, double-masked, placebo-controlled two cross over study comparing the effects of moxaverine and placebo on ocular blood flow

Conditions: Ischemia

Summary: it is known that several common eye diseases are associated with ocular perfusion abnormalities. moxaverine is used in the therapy of perfusion abnormalities in the brain, the heart and the extremities because of its direct vasodilatory effects. the present study seeked to investigate whether moxaverine alters ocular blood flow in healthy volunteers after intravenous administration.


Eligibility criteria:
inclusion criteria: * 6 healthy volunteers of either sex * age 18-35 yrs. * body mass index between 15th and 85th percentile, nonsmokers exclusion criteria: * regular use of medication * abuse of alcoholic beverages or drugs * participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug * symptoms of a clinically relevant illness in the 3 weeks before the first study day * history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs * blood donation during the previous 3 weeks * ametropy less 3 dpt * acute gastric bleeding, massive cerebral hemorrhage related to stroke * women: pregnancy or lactation.
exercise training in patients with non-cystic fibrosis (cf) bronchiectasis

Conditions: Bronchiectasis

Summary: the aim of this project is to examine the short and long term effects of an 8 week, twice weekly, outpatient exercise training program for people with bronchiectasis. participants will be randomly allocated to undergo a supervised exercise training program at the alfred, austin hospital or sir charles gairdner hospital. the hypotheses of this study are: 1. patients with bronchiectasis who complete an exercise program will have a higher exercise capacity and better quality of life and these improvements will be sustained for up to 12 months after completion 2. exercise training will significantly reduce the incidence of pulmonary exacerbations, use of antibiotics and rate of hospitalisation

bronchiectasis not related to cystic fibrosis (non-cf bronchiectasis) is a chronic respiratory condition characterised by permanent dilatation of the airways arising from bronchial inflammation and infection. predominant symptoms include daily productive cough, dyspnoea and generalised fatigue. this profile is associated with diminished health-related quality of life (hrqol) and reduced exercise tolerance. available medical treatments for bronchiectasis include antibiotic and inhalation therapy. to date, there is no evidence that these treatments can reduce the exacerbation rate or modify the rate of disease progression. while international guidelines for pulmonary rehabilitation recommend the inclusion of patients with bronchiectasis, there is a deficiency in evidence supporting exercise training in this population. it is proposed that a standard exercise training program conducted according to australian guidelines for pulmonary rehabilitation will improve both exercise capacity, quality of life and reduce the number of acute infections in both the short and long term in people with bronchiectasis.

Eligibility criteria:
inclusion criteria: * diagnosis of bronchiectasis (hrct) * stable medical status for last 4 weeks * history of 2 exacerbations in the last 2 years * dysnpoea on exertion (modified medical research council score \>1) exclusion criteria: * concurrent diagnosis of copd (physician diagnosis and history of 10 pack year smoking) * concurrent diagnosis of asthma (history of atopic disease and evidence of bronchodilator reversibility of 12% or 200ml in fev1 or fvc) * concurrent diagnosis of interstitial lung disease * concurrent diagnosis of cystic fibrosis * medical condition which could place patient at risk during exercise training (angina, neurological or orthopaedic condition) * prior completion of pulmonary rehabilitation within the last 12 months
a study of the efficacy and safety of monotherapy with bcd-264 and darzalex in subjects with relapsed and refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the aim of this study is to confirm the comparability of the efficacy and safety profiles of bcd-264 and darzalex as monotherapy for relapsed and refractory multiple myeloma in subjects previously treated with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy.


Eligibility criteria:
inclusion criteria: 1. signed informed consent form. 2. age ≥ 18 years at the time of signing of the informed consent form. 3. documented diagnosis of multiple myeloma according to imwg criteria 4. measurable disease at screening: 1. m-protein in serum ≥ 1.0 g/dl (10 g/l) or in 24-hour urine ≥ 200 mg; or 2. light chain myeloma: serum "involved" flc level ≥ 10 mg/dl (100 mg/l) and abnormal κ/λ flc ratio . 5. at least a partial response according to imwg criteria to at least 1 prior line of therapy. 6. subjects with relapsed and refractory multiple myeloma who previously received therapy with proteasome inhibitors and immunomodulatory drugs, and who had disease progression on prior therapy 7. ecog score 0-2. 8. not pregnant and willing to use contraception. 9. consent to bone marrow biopsy in the study. exclusion criteria: 1. prior treatment with daratumumab or other anti-cd38 therapy. 2. prior treatment for multiple myeloma within 2 weeks or 5 half-lives before the date of randomization, except for a short course of glucocorticoids 3. autologous hematopoietic stem cell transplantation within 12 weeks prior to the date of randomization. 4. allogeneic hematopoietic stem cell transplantation, regardless of timing. 5. scheduled hematopoietic stem cell transplantation prior to progressive disease during this study. 6. plasma cell leukemia, poems syndrome or amyloidosis. 7. waldenstrom macroglobulinemia or other concomitant diseases with hyperproduction of monoclonal igm (m-protein) in the absence of clonal proliferation of plasma cells with lytic bone involvement. 8. a history of other malignancies within the last 5 years, with the exception of squamous cell and basal cell skin cancer, cervical, breast carcinoma in situ, or other non-invasive malignancies that, in the investigator's opinion are considered to have been adequately treated and have a minimal risk of recurrence for 5 years. 9. plasmapheresis within 28 days prior to randomization. 10. clinical signs of meningeal involvement of multiple myeloma. 11. pregnancy or breastfeeding, as well as planning pregnancy throughout the study and within 3 months after the last dose of daratumumab; for male subjects, planning to conceive a child throughout the study and within 3 months after the last dose of daratumumab.