Kornimate/medical-research-clean huggingface dataset:
restrictive vs liberal transfusion strategy on cardiac injury in patients undergoing surgery for fractured neck of femur

Conditions: Anemia; Cardiac Event; Kidney Injury; Fractured Hip

Summary: the investigator wishes to see if it is possible to undertake a study comparing blood transfusion at two different levels of anaemia to see which is best for patients. all patients that present to hospital with a broken hip will be able to take part in the study. if they become anaemic during their treatment they will be allocated to either be transfused when their blood count is less that 9 or less than 7. in all patients, we will measure heart damage with a blood test that is very sensitive. the investigator will also collect data on the incidence of heart attacks and other complications.

many frail and elderly patients undergo surgery for hip fractures every year. many of these patients have other health problems including heart disease and anaemia (low haemoglobin or "low blood count") either from chronic illness, from bleeding at the time of their injury or during subsequent surgery. the vast majority (more than 95%) of these patients will go on to have surgery. this surgery is often high risk. patients with this type of injury may already be frail, may be in hospital for a long time and will need rehabilitation. many of them will develop complications, including heart attacks and some will die. doctors looking after these patients commonly prescribe a blood transfusion around the time of surgery. these patient often have anaemia before surgery an lose more blood during their operations. a benefit of blood transfusion is that it may increase the amount of oxygen the blood can carry. one of the main reasons that doctors prescribe blood around the time of surgery is to prevent heart attacks, which can occur if the heart doesn't receive enough oxygen. another possible benefit of blood transfusion is that it may help patients get out of bed more quickly after surgery. this is another important aspect of their recovery. however, blood transfusions can have side effects such as causing heart failure or increasing infections after surgery. these can delay patient recovery too. although some research has been done in this area, anaesthetists and surgeons are still unsure of when to prescribe blood transfusions to these patients. in particular, uncertainty about how low the blood count should be before a blood transfusion is ordered. some doctors prescribe blood when the haemoglobin count is less than 9 and some at a lower level of 7. current guidelines suggest that prescribing at a lower haemoglobin count is better, but there is research which suggests that this level is too low if the patient has a history of heart disease.

Eligibility criteria:
inclusion criteria:adults aged over 50 years within 48 hours of admission to hospital with fractured neck of femur. exclusion criteria: age \<50 * refusal of consent of patient (or consultee) patient for palliative care.
myasthenia gravis inebilizumab trial

Conditions: Myasthenia Gravis

Summary: randomized, double-blind, placebo-controlled, phase 3, parallel-group study with optional open-label extension.

this study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites. approximately 230 participants (188 acetylcholine receptor antibody positive \[achr-ab+\] and 42 muscle-specific tyrosine kinase antibody positive \[musk-ab+\]) will be enrolled. participants with myasthenia gravis (mg) who are positive for anti-achr or anti-musk antibodies will be enrolled and analyzed. patients who do not have anti-achr or anti-musk antibodies will not be enrolled. patients with myasthenia gravis foundation of america (mgfa) classification ii, iii, or iv disease, myasthenia gravis activities of daily living (mg-adl) score at screening and randomization between 6 and 10 with \> 50% of this score attributed to non-ocular items, or an mg-adl score \>=11, quantitative myasthenia gravis (qmg) score \>= 11 at the time of screening and randomization, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study. all subjects who complete the randomized controlled period (rcp) will have the option to enroll in a 3-year (156 weeks) open-label period. study acquired from horizon in 2023.

Eligibility criteria:
inclusion criteria: 1. diagnosis of mg with anti-achr or anti-musk antibody. 2. mgfa clinical classification class ii, iii, or iv. 3. mg-adl score of 6 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items. 4. qmg score of 11 or greater. 5. participants must be on: 1. corticosteroids only, with no dose increase within 4 weeks prior to randomization, or 2. one allowed non-steroidal immunosuppressive therapy (ist), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or 3. combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal ist with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization. allowed ists, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid. exclusion criteria: 1. receipt of the following medications within the 4 weeks prior to day 1: 1. cyclosporine (except eye drops) 2. tacrolimus (except topical) 3. methotrexate 2. current use of: 1. corticosteroids (prednisone \> 40 milligram (mg)/day or \> 80 mg over a 2-day period (or equivalent dose of other corticosteroids). 2. acetylcholinesterase inhibitors (pyridostigmine) \> 480 mg/day) or unstable dose in the 2 weeks prior to day 1. 3. azathioprine \> 3 mg/kilogram (kg)/day 4. mycophenolate mofetil \> 3 grams/day or mycophenolic acid \> 1440 mg/day 5. any ist, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.

Keywords: myasthenia gravis
efficacy and adverse effects of prapchompoothaweep remedy and loratadine for treatment in ar patients

Conditions: Allergic Rhinitis; Adverse Drug Event; Quality of Life

Summary: 1. to compare the effectiveness of prapchompoothaweep crude drug at 3,000 mg per day and loratadine 10 mg per day for treatment in allergic rhinitis patients. (clinical trial phase ii) 2. to evaluate the safety and adverse effect of prapchompoothaweep crude drug at 3,000 mg and loratadine 10 mg for allergic rhinitis patients.

this study is a double blind randomized controlled trial study. the volunteers will be divided into 2 groups. one is received prapchompoothaweep crude drug capsule at 1,000 mg 3 times a day before meals and the other is received loratadine 10 mg per day before meals. it takes 6 weeks to complete the project for each volunteers. before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out period). all volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy and adverse effect after received drugs. the researcher will record characteristic data such as gender, age, bmi, vital signs and symptoms . the adverse effect will be monitored by hematology test e.g. liver function test, renal function test, lipid profile and blood sugar test.

Eligibility criteria:
inclusion criteria: * aged between 18-70 years old. * patients with history of allergic rhinitis based on aria guidelines. (itching and nasal obstruction, watery nasal discharge, sneezing ,congestion) * patients with moderate allergic rhinitis was diagnosed by physicians. * have no nasal septum perforation, nasal polyp or sinus surgery. * have no serious medical conditions: heart disease, liver disease, renal disease, hypertension, peptic ulcer and gastroesophageal reflux disease (gerd), severe asthma, tuberculosis. * have normal range of hematology test for liver and renal function. * no pregnant or lactation. * do not taking a medicine constantly. * volunteers are willing to participate this study. exclusion criteria: * allergic reactions to prapchompoothaweep remedy and loratadine. * allergic reaction to dairy products. * have severe urticaria and anaphylaxis. * have a serious condition of immunodeficiency disease: hiv in the previous month before being recruited in the study. * participate in another study.

Keywords: loratadine prapchompoothaweep allergic rhinitis
cryospray ablation of surgical resection specimens to determine safety and histological effect in the lung

Conditions: Lung Cancer

Summary: the purpose of this study is to evaluate the feasibility and general safety in the human airway as well as assess the safety and depth and area of treatment using liquid nitrogen sprayed through a catheter via flexible fiber optic bronchoscopy (ffb) using surgical resection specimens from patients undergoing lobectomy.

the primary endpoints for this study are patient safety and the histological effects of cryospray therapy in lobectomy patients. the proposed study is a single center study to evaluate the safety and treatment effect of sprayed liquid nitrogen through a catheter via ffb using surgical resection specimens from patients undergoing lobectomy.

Eligibility criteria:
inclusion criteria: * age 18 years of age * lobectomy planned based on clinical situation not related to this study. * deemed operable based on institutional criteria. exclusion criteria: * pregnant or nursing * planning to sire a child while enrolled in the study * known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines. * refusal or inability to give consent. * concurrent chemotherapy. * prior radiation therapy which involved the lungs * medical contraindication or potential problem that would preclude study participation * concurrent participation in other experimental studies * uncontrolled coagulopathy or bleeding diathesis * serious medical illness, including: * uncontrolled congestive heart failure * uncontrolled angina * myocardial infarction * cerebrovascular accident within 6 months prior to study entry

Keywords: lung cancer cryopsray ablation csa therapy csa treatment lobectomy lung resection
utilizing telemedicine for hypertension treatment lifestyle modification in central harlem

Conditions: Hypertension

Summary: the purpose of this study is to test the feasibility of creating a health education telemedicine curriculum that can be delivered by weill cornell medicine faculty and medical students and ny-presbyterian hospital resident physicians to community dwelling adults in an under-resourced local community.


Eligibility criteria:
inclusion criteria: * male or female greater than or equal to 18 years of age. * self-report of a hypertension diagnosis. exclusion criteria: * pregnant or breastfeeding. * end-stage renal disease on hemodialysis.
phase i vorinostat concurrent with stereotactic radiosurgery (srs) in brain metastases from non-small cell lung cancer

Conditions: Brain Cancer; Neoplasm Metastasis; Lung Cancer; Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd) of vorinostat given concurrently with stereotactic radiosurgery (srs) to treat non-small cell lung cancer (nsclca) brain metastases in patient with 1-4 lesions.


Eligibility criteria:
inclusion criteria: * all patients age 18 years and older with histologically proven non-small cell lung cancer and 1-4 brain metastases, each measuring less than 2 cm will be eligible. prior surgery or radiation is allowed as long as the target metastatic lesion(s) has not been treated with previous radiation. * adequate organ function (section 3.1.10). * ecog performance status 0-2. * life expectancy of \>=12 weeks. * systemic chemotherapy washout period \>=7 days. exclusion criteria: patients who have previously been treated with whole brain irradiation, pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent.
interdisciplinary study group of lupus erythematosus (isgle)

Conditions: Cutaneous Lupus Erythematosus

Summary: cutaneous lupus erythematosus (cle) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. the aim of this study is to create a standardized evaluation of the different subtypes of this disease in order to receive an overview of the spectrum of clinical and laboratory features as well as the therapeutic strategies for patients with cle.

methods: a core set questionnaire has been developed in the course of the "european society of cutaneous lupus erythematosus (euscle)", and a total of 40 patients (32 females, 8 males) in two centres, germany and sweden, were included in this study. results: cle was diagnosed in 39 individuals (5 with acute cle, 10 with subacute cle, 13 with chronic cle, and 18 with intermittent cle) and one individual presented with a systemic manifestation of the disease. furthermore, disease onset and duration as well as activity and damage of skin lesions using a modified clasi were examined. interestingly, 75% of the patients with cle showed a positive history of photosensitivity, but only 62.5% exhibited characteristic lesions after standardized phototesting. laboratory analysis revealed positive antinuclear antibodies in 50% of the patients, positive anti-ro/ssa in 12 and positive anti-la/ssb antibodies in 8 cases. the predominantly used treatments included sunscreens (38 patients), topical steroids (31 patients), topical calcineurin inhibitors (12 patients), chloroquine (19 patients), hydroxychloroquine (11 patients), and systemic steroids (12 patients). conclusions: the new core set questionnaire enables the clinician to characterize the different skin manifestations involved in cle and to evaluate disease activity and reasonable treatment modalities. furthermore, epidemiological data and laboratory features can be assessed for the various subtypes. in the future, this standardized evaluation might lead to the development of diagnostic guidelines and evidence based therapeutic strategies thus improving quality of care for patients with cle.

Eligibility criteria:
inclusion criteria: * cutaneous lupus erythematosus confirmed by histological analysis * photoprovocation-test performed in advance * written informed consent available prior to any procedures exclusion criteria: * patients with conditions that are contrary to the above mentioned criteria

Keywords: cutaneous lupus erythematosus standardized evaluation core set questionnaire epidemiological data laboratory features
effects of a school-based intervention to increase the water consumption in elementary school children

Conditions: Water Consumption; Drinking Behavior

Summary: the purpose of this controlled intervention study is to evaluate the effectiveness of a school-based intervention aiming at increasing the water consumption in elementary school children. the intervention schools received refillable water bottles and drying racks for all school children as well as educational material. the focus of the intervention is the promotion of drinking tap water.

this pilot project, called "h2noe-wasserschulen" (water schools in lower austria), aims to increase the water consumption of school children in elementary schools, to raise awareness of water drinking in children, parents and school teachers and to promote water drinking in lower austria in general. by increasing the consumption of water, the consumption of sugar-sweetened beverages may decrease and in the long run may have a positive impact on children's body weight and tooth status. all intervention schools receive refillable water bottles for each school child and drying racks for each classroom. furthermore, in each school an information session for all school teachers is held and the teachers receive prepared educational material. the control schools do not receive the water bottles nor the educational material. for the study, the investigators recruited 22 intervention schools and 32 control schools. outcomes will be measured by paper and pencil questionnaires of school children at third grade of participating elementary schools in lower austria and with online questionnaires of teachers at baseline, at the end of the intervention (after one school year/june 2019) and at the one-year follow-up (after two school years/june 2020). for process evaluation outcomes, the investigators will carry out focus group discussions with a subsample of school children and teachers and include questions in the respective questionnaires for school children, teachers and school headmasters. parents will have the possibility to give feedback online.

Eligibility criteria:
for the intervention schools: inclusion criteria: * elementary school in niederösterreich (upper austria, a province of austria) * no juice provided with the school milk programme for the school children taking part in the survey: inclusion criteria: * school children in third class of elementary school (at baseline) * written declaration of consent by a parent/guardian

Keywords: child health promotion longitudinal studies surveys and questionnaires beverages water/administration & dosage austria program evaluation students/statistics & numerical data food preferences follow-up studies school setting behavioural change
a study of imc-a12 in combination with sorafenib in participants with advanced cancer of the liver

Conditions: Hepatocellular Carcinoma

Summary: to determine if imc-a12 given in combination with sorafenib is safe and effective for participants with advanced liver cancer.

the purpose of this study is to determine progression-free survival (pfs) in participants with unresectable hepatocellular carcinoma who have received no prior systemic therapy when treated with imc-a12 administered every three weeks in combination with oral sorafenib administered twice daily.

Eligibility criteria:
inclusion criteria: * the participant has histologically or cytologically confirmed, unresectable hcc * the participant has at least one target lesion measurable according to response evaluation criteria in solid tumors (recist) guidelines. target lesion(s) must not lay within a previously irradiated, ablated, or chemoembolized area. if a lesion does lie in such an area, there must be evidence of growth on successive imaging studies, including tumor hypervascularity, in order for such a lesion to be considered a target lesion * the participant has not received prior systemic therapy for hcc. participants may have received prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation, or cryosurgery * the participant has fasting serum glucose \<160 milligrams/deciliter (mg/dl) or below the upper limit of normal (uln) and/or hemoglobin a1c \<7%. if baseline nonfasting glucose \<160 mg/dl, fasting glucose measurement is not required * the participant has the ability to understand and the willingness to sign a written informed consent document exclusion criteria: * the participant has brain metastases * the participant has acute hepatitis * the participant has poorly controlled diabetes mellitus. participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range and that they are on a stable dietary or therapeutic regimen for this condition * the participant has congestive heart failure \> class ii new york heart association (nyha), unstable angina pectoris, new onset of angina pectoris, myocardial infarction within the past 6 months, or cardiac ventricular arrhythmias requiring antiarrhythmic therapy * the participant has experienced a hemorrhage or bleeding event ≥ national cancer institute-common terminology criteria for adverse events (nci-ctcae) grade 3 within 4 weeks prior first dose of study therapy

Keywords: hepatocellular carcinoma liver neoplasms antibodies, monoclonal
study of absorption characteristics of two multivitamin mineral formulations (gel vs. tablet/capsule)

Conditions: Vitamin Deficiency

Summary: this clinical study is designed to evaluate difference in the auc of the absorption of multivitamin and minerals defined in the protocol

this clinical study is designed to evaluate difference in the auc of the absorption of multivitamin and minerals: 1. tablet/capsule administration - up to 20 healthy volunteers will be recruited to the study. the tablet/capsule will be administered as a single dose after 12 hours of fasting. the participants will be monitored during 6 hours for the level of minerals and multivitamin minerals in the blood, adverse events and vital signs. 2. gel administration - the gel will be administrated to the same group of patients in the single dose after 12 hours of fasting. the participants will be monitored during 6 hours for the level of minerals and multivitamin minerals in the blood, adverse events and vital signs.

Eligibility criteria:
inclusion criteria: * healthy male or female and aged 18-65 years * bmi - 19-24 * subject is not pregnant and is not nursing * signed informed consent form exclusion criteria: * current use of multivitamin or mineral complexes (washout of 4 days before visit 2 is permitted) * participants with known vitamins or mineral deficiencies * diabetes type ii * smoking * subjects who have undergone surgery within the last 3 months. * subjects with a clinically significant (during last 3 months) infectious, immune-mediated or active malignant disease. * subjects who are receiving an elemental diet or parenteral nutrition. * subjects who are treated with insulin. * women with childbearing potential unless surgically sterile or using adequate contraception (either iud, oral or depo-provera contraceptive, or barrier plus spermicide); pregnant or breastfeeding mothers. * subjects who will be unavailable for the duration of the trial, who are unlikely to be compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason. * known sensitivity to any ingredients in the study product * history of addiction or drug abuse * alcoholic regular use
comparison of two universal composites in posterior teeth

Conditions: Dental Caries

Summary: the aim of this randomized, prospective clinical study was to compare the clinical performance of a universal light-curing, ultra-fine particle hybrid composite with a new version of this product produced by the same manufacturer in class 1 and class 2 lesions.

a total of 80 (13 class 1 and 67 class 2) lesions in 40 patients (21 females, 19 males) with ages ranging between 18-38 years (23.15±5.15) were either restored with charisma or charisma classic (heraeus kulzer) in combination with an etch and rinse adhesive system (gluma 2 bond) under rubber dam isolation by two experienced operators according to the manufacturer's instructions. two independent examiners, who were blinded to the composites used evaluated the restorations according to the fdi (world dental federation) criteria. bite-wing radiographs and intraoral digital photographs were taken before and after treatment and at 6 months. the statistical analyses were carried out with mcnemar, pearson chi-square and cochran q tests (p\<0.05).

Eligibility criteria:
inclusion criteria: * a need for at least two but not more than four posterior tooth-colored restorations * the presence of teeth to be restored in occlusion * teeth that were symptomless and vital * a normal periodontal status * a good likelihood of recall availability. exclusion criteria: * partly erupted teeth * absence of adjacent and antagonist teeth * poor periodontal status * adverse medical history * potential behavioral problems.

Keywords: composite resin clinical trial fdi (world dental federation) criteria