Kornimate/medical-research-clean huggingface dataset:
spaso versus self-assisted maneuver for anterior shoulder dislocation

Conditions: Shoulder Dislocation

Summary: to compare the results and efficacy of the self-assisted boss-holzach-matter maneuver for anterior shoulder dislocation and the spaso method performed by a physician.

introduction: there are many described maneuvers in literature describing how to reduce an anterior shoulder dislocation. most of these maneuvers are performed by a trained physician, however, seldom are these taught to patients in case of recurrence or accidental dislocations that may occur far from a trained professional to treat. the boss-holzach-matter maneuver is a simple, easy to understand and easy to perform self assisted method that has not been compared to any other method. hypothesis: the boss-holzach-matter method is a less painful maneuver compared to the spaso method assuming an equal success rate. objective: to determine whether the boss-holzach-matter method is a less painful method for anterior shoulder dislocations compares to the spaso method assuming equal success rate. methodology: fifty six patients presenting acute anterior shoulder dislocation will be randomized, at the time of the admission , to either spaso reduction method performed by a physician or the self-assisted boss-holzach-matter method.

Eligibility criteria:
inclusion criteria: * patients with an acute anterior shoulder dislocation that are diagnosed in our hospital trauma area. exclusion criteria: * fracture luxation of the same shoulder. * inability to cooperate due to mental or physical condition.
the effect of intensive multifactorial therapy on endothelial function in newly diagnosed type 2 diabetes

Conditions: Endothelial Dysfunction

Summary: the endothelial dysfunction is the early event in atherosclerosis. the investigator previous study showed that impaired endothelial function exist in newly diagnosed type 2 diabetes. the investigators hypothesize that intensive multifactorial therapy including intensive blood control and intensive hypertension control as well as intensive blood lipids control of 1 year can improve vascular endothelial function. moreover, the improvement of endothelial function maintains after 5 years or 10 years of intensive multifactorial therapy, called "metabolic memorial effect of improvement of endothelial function".

* we select 1000 patients with newly diagnosed type 2 diabetes. they are divided into two groups, respectively (intensive multifactorial therapy and conventional multifactorial therapy groups). after those therapy for one year, a 10 years of follow up study will be performed. during this period, we take them together intensive education, and take conventional multifactorial therapy for both of two groups. * at the beginning (0 year),the end of intensive multifactorial therapy (1 year), 5 years and 10 years, we will measure the endothelium-dependent arterial dilation, endothelium related cytokines such as et-1, vwf,as well as blood glucose, hba1c for all of individuals. * we will compare the endothelial function,endothelium related cytokines such as et-1, vwf,as well as blood glucose, hba1c between intensive therapy group and conventional therapy group at different time points.

Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes, * age: 40 \>= age \<=70 year old, exclusion criteria: * type 1 diabetes, * mitochondrial diabetes * patients with clinical detectable angiopathy, * body mass index (bmi) \> 30 kg/m2, * age \ 70 years old, * malignant neoplasms, renal or liver diseases, * smokers * known diabetes

Keywords: newly diagnosed type 2 diabetes endothelial dysfunction intensive therapy metabolic memorial effect
the objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (adt) in patients with major depressive disorder (mdd) who have had an inadequate response to antidepressants alone

Conditions: Major Depressive Disorder

Summary: the objective of this study is to evaluate the efficacy, safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (adt) in patients with mdd who have had an inadequate response to antidepressants alone.


Eligibility criteria:
inclusion criteria: * written informed consent has been obtained. * written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, written authorization for use and release of health and research study information \[us sites\] and written data protection consent \[eu sites\]). * participant must be an outpatient at the time of visit 1 (screening). * participant meets the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria for mdd based on structured clinical interview for dsm-5 (scid-5), with a current major depressive episode of at least 8 weeks and not exceeding 24 months in duration at visit 1/screening. a diagnosis of mdd with psychotic features will be acceptable. * diagnosis of mdd confirmed through a formal adjudication process. * participant demonstrates ability to follow study instructions and likely to complete all required visits. * participant must have an inadequate response, as measured by the modified antidepressant treatment response questionnaire (atrq), to 1 to 3 antidepressants administered during the current episode at an adequate dose (as per package insert) and for at least 6 weeks duration, with at least one dose escalation during the current depressive episode. * only one antidepressant (of sufficient dose per package insert and taken for at least 6 weeks) will be allowed at randomization and participants must agree to continue taking the same adt dosing regimen through completion of visit 6/early termination (et). participants who are taking more than one antidepressant at screening, regardless of the indication, will need to discontinue all other antidepressants prior to visit 2 (baseline). * male and female participants must agree to use a medically acceptable and highly effective method of birth control during the course of the entire study. * women of childbearing potential (only) must have a negative serum β-human chorionic gonadotropin pregnancy test prior to visit 2. exclusion criteria: * diagnosis of any current psychiatric diagnosis other than mdd (including those with current intellectual development disability) with the exception of specific phobias. * participant has a history of intolerance or hypersensitivity to cariprazine or other drugs of the same class or to rescue medications.

Keywords: mdd
induction chemotherapy for locally advanced head and neck squamous cell carcinoma

Conditions: Locally Advanced Malignant Neoplasm

Summary: the benefit of induction chemotherapy followed by chemoradiotherapy for locally advanced head and neck squamous cell carcinoma is unknown. the present study is investigating if this therapeutic strategy improve overall survival.


Eligibility criteria:
inclusion criteria: * confirmed histological diagnosis of squamous cell carcinoma or undifferentiated carcinoma of the oropharynx, hypopharynx or larynx; * locally advanced stage (stage iva / b - ajcc 8th edition), classified as resectable \*\* or unresectable and candidate for treatment based on radiotherapy and chemotherapy; * locally advanced stage (stage iii - ajcc 8th edition), classified as resectable or unresectable, positive p16 and candidate for treatment based on radiotherapy and chemotherapy; * it will be allowed to include a patient with cervical lymphadenectomy if the primary lesion is measurable; * presence of measurable disease according to recist 1.1 criteria; * ecog performance status of 0-1; * ≥ 18 years; * adequate marrow reserve indicated by: * absolute neutrophil count (anc) ≥ 1500 / mm³ or platelets\> 100,000 / mm³ * hemoglobin ≥ 9 g / dl - red blood cell transfusion will be allowed in the screening period if necessary * adequate renal and hepatic function: * serum bilirubin ≤ 1.5 times the upper limit of normal the tgo and tgp ≤ 3 upper limit of normal. if hepatic metastasis ≤ 5 upper limit of normal * serum creatinine ≤ 1.5 mg / dl and creatinine clearance ≥ 60 ml / min calculated by cockcroft-gault. exclusion criteria: * patient submitted to curative resection of the primary site and / or metastatic site. note: patients submitted to cervical lymphadenectomy without surgery to the primary tumor are eligible; * radiation therapy or previous chemotherapy for head / neck tumor; * patients with occult primary tumor; * t4 from any site, resectable, with invasion of cartilage or jaw; * history of bmt or stem cell therapy; * synchronous tumor or previous history of neoplasia, except for in situ carcinoma of the cervix, basal cell carcinoma or epidermoid carcinoma. patients with previous history of cancer already treated and without evidence of disease for more than 3 years may participate in the study; * prophylactic use of g-csf or gm-csf two weeks prior to the study; * clinically significant heart disease: unstable angina or myocardial infarction 6 months prior to study entry symptomatic ventricular arrhythmia the icc classified as nyha ≥ ii • uncontrolled hypercalcemia; * uncontrolled infection; * any other comorbidity that the investigator's judgment is inappropriate for the study; * peripheral neuropathy\> grade 2; * hearing loss\> grade 2; * known positive serology for hepatitis b, hepatitis c or hiv * use of antiretrovirals;
study of prevention of chemo-induced nausea and vomiting caused by moderately emetogenic chemotherapy

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

Summary: this study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. subjects will be asked to complete daily diaries while on study medication. in addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. a final assessment will be preformed on study day 20-30 at which time the subject will complete the study.

a phase ii multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study of the safety and efficacy of the oral neurokinin-1 receptor antagonist, gw679769 in combination with ondansetron hydrochloride and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer subjects receiving moderately emetogenic chemotherapy

Eligibility criteria:
inclusion criteria: * willing to provide a written informed consent prior to receiving any study-specific procedures or assessments. * diagnosed with a solid malignant tumor and has not previously received chemotherapy. * scheduled to receive chemotherapy conducive to regimens outlined in the study protocol. exclusion criteria: * not received any investigational product within 30 days of enrollment into the study. * must not be pregnant. * must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol. * must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication. * must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction). * must not have a history of peptic ulcer disease.

Keywords: vomiting cinv emesis nausea chemotherapy-induced nausea and vomiting
the role of natural killer, complement and t-lymphocytes in covid-19 disease, a prospective monocentric study

Conditions: Complement Abnormality; Peripheral Blood Mononuclear Cells; Covid19

Summary: the current study is an open, non-randomized, monocentric, and interventional study. covid-19 patients will be recruited at uz brussel after informed consent is obtained. whole blood and serum samples will be collected during acute disease (inclusion and 7 days after inclusion) and during patient follow-up at 2 months after infection. sample storage and subsequent use in fundamental research will be performed at vub neuro-aging and viro-immunotherapy. additionally, medical records of uz brussel will be searched and epidemiological, clinical, radiological, and biological data of the selected patients will be obtained at the diagnosis time point and during follow-up. healthy volunteers will be recruited as well in the current study, as a comparison arm, after informed consent is obtained.


Eligibility criteria:
covid-19 patients inclusion criteria: * positive nasopharyngeal reverse transcriptase-polymerase chain reaction for sars-coronavirus-02 * signed inform consent healthy volunteers inclusion criteria: * signed inform consent
afatinib as second-line therapy for lung cancer with epidermal growth factor receptor (egfr) mutation

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (nsclc) harbouring a common egfr mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed diagnosis of stage iiib (with cytologically proven pleural effusion or pericardial effusion) or stage iv adenocarcinoma of the lung. patients with mixed histology are eligible if adenocarcinoma is the predominant histology. 2. documented egfr mutation (l858r and/or deletion 19) with no other known egfr mutation. 3. measureable disease according to recist 1.1. 4. radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen. 5. eastern cooperative oncology group (ecog) performance score of 0 or 1. 6. adequate organ function. exclusion criteria: 1. more than one line of prior therapy for disease. 2. previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment. 3. previous treatment with any egfr targeting tyrosine kinase inhibitor (tki) or antibody. 4. known pre-existing interstitial lung disease.
iron deficiency and hereditary haemorrhagic telangiectasia

Conditions: Hereditary Haemorrhagic Telangiectasia

Summary: managing iron deficiency is important for more than 1 billion individuals worldwide, to avoid blood transfusions, or excessive strain on vital organs that depend on iron-containing haemoglobin to deliver oxygen to the tissues. iron deficiency is a particular problem for people with the inherited condition hereditary haemorrhagic telangiectasia (hht). their iron deficiency and anaemia results from blood losses, especially from the nose (nosebleeds, and they often need additional iron to replace that lost through bleeding. our goal is to stratify hht patients into high/low absorbers of iron; to define what extra iron they need to adjust for their current and likely future blood losses; and to work out how to achieve this most safely for each individual to improve their later health. we will test the hypothesis that informed assessment of iron intake and post absorption cellular profiles changes the recommendations for iron intake for hht patients.

relevant patients due to come to clinic or the programmed investigation unit will be offered the opportunity to participate in the study. up to 100 consenting individuals will * have an additional 15 mls of supplementary research bloods taken * receive a single tablet of ferrous sulphate 200mg * fill in questionnaires that formally evaluate their nosebleed losses and dietary iron intake in the preceding 12 months * have a second blood sample later that day (20 mls of blood) the primary outcome measure is the change in serum iron levels post iron tablet. other outcome measures will include: * haematinic indices indicating whether their iron requirements have been met previously. * additional predicted iron intake requirements to adjust for haemorrhagic iron losses

Eligibility criteria:
inclusion criteria: * hereditary haemorrhagic telangiectasia (hht). definite diagnosis of hht by international criteria. * no iron tablets or treatment taken on day of assessment * ability to provide informed consent. exclusion criteria: * inability to provide informed consent * intercurrent infection or illness predicted to modify iron absorption. * needle phobia.

Keywords: iron deficiency nosebleeds
the juice study: sensitivity of skin carotenoid status to detect change in intake

Conditions: Overweight

Summary: this study is designed to see if drinking a tomato-based vegetable juice will increase skin carotenoids.

the us dietary guidelines for americans recommends that individuals consume approximately 2-4 c of vegetables each day to reduce risk of chronic disease, but current methods for assessing intake are either inaccurate (self-report) or invasive (blood carotenoid levels). recent research indicates that skin carotenoid status may be a useful biomarker of vegetable intake, but the sensitivity to dose in unknown. in this study, we propose to test the dose-response of skin carotenoids to consumption of 3 different levels of vegetable juice (with a control group receiving water). we will test skin carotenoids in two ways: using resonance raman spectroscopy (rrs), which we have previously validated, and with a new technique, pressure mediated reflection spectroscopy (rs; the "veggie meter"). we will compare the two techniques during an 8-week provided tomato-based juice intervention. skin carotenoid readings will be compared to blood carotenoid concentrations and single nucleotide polymorphisms (snps) of genes related to the uptake, transport, and metabolism of carotenoids will be examined in blood and saliva.

Eligibility criteria:
inclusion criteria: * bmi 18.5-29.9 kg/m2 exclusion criteria: * weigh less than 110 lbs * currently dieting to lose weight * allergic to tomatoes or vegetables * pregnant, lactating, or planning to become pregnant * currently use tobacco products or vape * eat more that 2 cups of vegetables per day * have high blood sugar (≥200 mg/dl) * have high blood pressure (≥140/90 mm hg) * have a medical condition such as diabetes or high blood pressure * taking medication that lowers cholesterol or triglycerides
strategies for antithrombotic treatment following transcatheter edge-to-edge repair in patients without an indication for oral anticoagulant

Conditions: Mitral Regurgitation

Summary: mitral regurgitation (mr) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). transcatheter edge-to-edge repair (teer) is now a well-established strategy in high-risk patients with mr. globally, over 250,000 patients have benefited from the teer technique. however, no dedicated study has prospectively evaluated different antithrombotic strategies following teer in patients undergone teer procedure. current guidelines do not provide any recommendations for the antithrombotic management of teer. consequently, considerable treatment variation exists in clinical studies and practice. the investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following teer in patients without an indication for oac.


Eligibility criteria:
inclusion criteria: * patients who had undergone successful teer (defined as techinal success according to mvarc ); * ability to understand the requirements of the trial and willingness to comply with the trial protocol procedures; * provide written informed consent form； * women of childbearing potential must use an acceptable method of contraception from signing the informed consent form until the date of the last dose of antithrombotic drug; * the heart team agrees on the antithrombotic strategies. exclusion criteria: * severe renal impairment (creatinine clearance rate\<15ml/min or on dialysis); * postoperative persistent bleeding (overt bleeding either associated with a drop in the hemoglobin of 3.0 g/dl or requiring transfusion of 3 u of whole blood or packed red blood cells) or occurrence of vascular complications; * platelet count≤30×10\^9/l; * need for reoperation; * history of intracranial or intracerebral hemorrhage; * history of gastrointestinal ulcers or hemorrhage; * any hepatic disease associated with coagulopathy (child-pugh b or c); * allergy, intolerance or contraindication to oral anticoagulation or antiplatelet drug; * need for long-term oral anticoagulation; * current double antiplatelet therapy； * patients who have participated in another drug or device investigational study within the past 30 days; * life expectancy \<12 months; * pregnant or breastfeeding women.

Keywords: transcatheter edge-to-edge repair (teer) mitral regurgitation cardiovascular diseases embolism and thrombosis bleeding aspirin clopidogrel antithrombotic treatment platelet aggregation inhibitors antiplatelet drug single antiplatelet therapy（sapt） double antiplatelet therapy（dapt） stroke myocardial infarction
safety and efficacy of spd476 (mesalazine) given twice daily (2.4 g/day) vs spd476 given as a single dose (4.8 g/day) in subjects with acute mild to moderate ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the aim of this study was to investigate the safety and efficacy of spd476 2.4 g/day given twice daily (\[bid\] ie 1.2 g/day bid) and spd476 4.8g/day given qd compared to placebo in subjects with acute, mild to moderate ulcerative colitis.


Eligibility criteria:
inclusion criteria: * newly diagnosed or diagnosis of relapsing (relapsed \<= 6 weeks to baseline) mild to moderate ulcerative colitis * women not of childbearing potential or wocp who agreed to use an effective contraceptive method exclusion criteria: * severe ulcerative colitis or relapsed for \> 6 weeks prior to baseline * subjects who had relapsed on maintenance therapy with doses of mesalazine \> 2.0 g/day * subjects with crohn's disease, proctitis, bleeding disorders or active peptic ulcer disease * subjects with asthma if they were known to be mesalazine-sensitive * subjects who were at immediate or significant risk of toxic megacolon * subjects who had previous resective colonic surgery * subjects who had moderate or severe renal impairment