Kornimate/medical-research-clean huggingface dataset:
bespoke vs standard instrumentation in tkr

Conditions: Knee Osteoarthritis

Summary: total knee replacements are operations that are offered to patients who have severe arthritis pain that is affecting daily activities that is no longer controlled with painkillers. the operation will replace the worn joints with metal implants and a plastic spacer. total knee replacements are successful operations in the vast majority of patients. however, a small minority of patients are not entirely satisfied with the outcome of their knee replacement. researchers are studying whether the precise positioning of the implant has an effect on the outcome. this study will look at whether patient-specific instrumentation improves implant position and if it leads to improved patient function so that we know what to recommend in the future.


Eligibility criteria:
inclusion criteria: * patients with osteoarthritis of the knee which is sufficiently symptomatic to require knee arthroplasty as assessed by their consultant orthopaedic surgeon exclusion criteria: * patients with inflammatory arthropathy, patients requiring bone augmentation, patients with ligament incompetence or valgus deformity \>5 degrees.

Keywords: total knee arthroplasty stability osteoarthritis knee functional outcome gait patient specific instrumentation
the safety, tolerability, and immunogenicity profiles of a single dose of v114, pneumovax® 23, or prevnar 13® in adults 50 years of age or older (v114-002)

Conditions: Pneumococcal Infections

Summary: the purpose of the study is to see if an investigational vaccine for streptococcus pneumonia disease (v114) has comparable safety, tolerability, and antibody response to pneumococcal polysaccharide vaccine (pneumovax® 23) and 13-valent pneumococcal conjugate vaccine (prevnar 13®) when administered to healthy adults 50 years of age or older. the primary hypothesis is the serotype-specific immunoglobulin g (igg) geometric mean concentrations (gmcs) as measured by the pneumococcal electrochemiluminescence (pn ecl) assay at one month postvaccination in subjects who receive v114 will be noninferior to those measured in subjects who receive pneumovax® 23.


Eligibility criteria:
inclusion criteria: -without fever for 72 hours prior to vaccination exclusion criteria: * prior receipt of any pneumococcal polysaccharide vaccine or any pneumococcal conjugate vaccine * known or suspected to be immunocompromised * functional or anatomic asplenia * history of autoimmune disease * evidence of dementia or cognitive impairment * use of any immunosuppressive therapy * received a licensed non-live vaccine administered within the 14 days prior to receipt of study vaccine or scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine * received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days of receipt of study vaccine * received any vaccine containing diphtheria toxoid within 6 months prior to receipt of study vaccine * received a blood transfusion or blood products within the 6 months before receipt of study vaccine or scheduled to receive a blood transfusion or blood product within 30 days of receipt of study vaccine * history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease * received antibiotic therapy for any acute illness within 72 hours before receipt of study vaccine

Keywords: pneumococcal vaccines
uab alzheimer's disease center core cohort - tau imaging substudy

Conditions: Alzheimer Disease

Summary: the primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the pet tracer av-1451 in participants in the uab-adc cohort. the amount and distribution of av-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing uab-adc study. assessment of interactions between race and vascular risk factors, brain tau levels measured with av-1451-pet, and cognitive status will be the primary outcome of this imaging study. individuals participating in this av-1451-pet/mri study will also be enrolled in an ongoing \[c-11\]pib-pet/mri study (irb-300001005, ind-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.


Eligibility criteria:
inclusion criteria: 1. enrollment in the uab-adc study under a separate irb-approved research protocol. 2. enrollment in the uab-adc amyloid-pet substudy under a separate irb-approved research protocol. the amyloid-pet study does not have to have been completed prior to enrollment and participation in this tau-pet study. 3. negative urine or serum hcg test within 2 days of \[f-18\]av-1451 administration in women of child bearing potential. women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing. exclusion criteria: 1. meets any exclusion criteria for the uab-adc study. 2. inability or contraindication for undergoing mri and/or pet imaging 3. inability to participate in the imaging studies due to severity of dementia
immune effects of vitamin d in hemodialysis patients

Conditions: End Stage Renal Disease; Hemodialysis; Inflammatory Response; Cardiovascular Disease

Summary: the purpose of this study to examine whether vitamin d can reduce the activation of the immune system during dialysis. when activated, the immune cells release certain substances, called cytokines, which can be measured from small blood samples. we want to study to what degree the immune system is activated during a regular dialysis treatment and whether the time point of vitamin d administration, either right before the start or right at the end of a dialysis treatment, has an impact on the activation of the immune system.


Eligibility criteria:
inclusion criteria: * patient stable on chronic hemodialysis for more than 3 months. * pth level between 150 - 800 pg/ml. * ability to give informed consent. * serum calcium levels (corrected for albumin level of 4.0 g/dl) less than 10.5 mg/dl for the last three consecutive measurements. * serum phosphorus levels between 2.5 and 7.0 mg/dl for the last three consecutive measurements. * ca x p-product of less than 75 mg2/dl2 in the last three consecutive measurements. exclusion criteria: * known active malignancy. * liver disease defined as serum aspartate aminotransferase, alanine aminotransferase, or gamma-glutamyltransferase levels more than 2 times the upper limits of normal. * pth levels between 150 pg/ml and 800 pg/ml. * hypercalcemia or hypercalcemic episodes within the last 4 weeks. * ca x p-product more than 75 mg2/dl2 within the last 4 weeks. * any clinical significant infections which are or have been treated with antibiotics within 6 weeks prior to start of the study. * chronic viral infection (hiv, hepatitis b or c). * currently on immunosuppressive medication (steroids, cyclosporine, etc...). * hematocrit less than 30 %. * history of blood disorders other than renal anemia. * age of less than 18 years or more than 75 years. * hypersensitivity to paricalcitol or any ingredient of the product. * parathyroidectomy. * participation in another study at the same time.
hsk7653 treatment in patients with type 2 diabetes who are not controlled with diet and exercise

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the efficacy of hsk7653 (as monotherapy) compared with placebo after 24 weeks, and the safety (up to 52 weeks) of hsk7653 in chinese patients with type 2 diabetes who are insufficient glycaemic control with diet and exercise.

the treatment period is composed of a 24-week double-blind period (week 1-24) and a 28-week open-label period (week 25-52). during the double-blind period, participants will receive 10 mg or 25 mg dose of hsk7653 and matching placebo, or placebo only. during the open-label period, all participants will receive 25 mg dose of hsk7653.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 75 years, male and female patients; * type 2 diabetes mellitus; * control the blood glucose level only with diet and exercise in last 8 weeks; * did not receive regular long-term medication of oral hypoglycemic drugs or insulin within 1 year prior to informed consent; * hba1c in the range of ≥7.5 to ≤11.0% at screening; * fpg \< 15 mmol/l at screening; * bmi (body mass index) in the range of ≥ 18.0 kg/m² to ≤ 35.0 kg/m² at screening. exclusion criteria: * diabetic ketoacidosis, hyperglycemia hypertonic state, serious complications of diabetes, myocardial infarction, stroke within 6 months prior to informed consent; * history of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent; * current hemoglobinopathy, uncontrolled hypertension, serious nephropathy or hepatopathy prior to informed consent; * serious gastrointestinal disease within 2 weeks prior to informed consent; * serious infection, trauma and surgery within 3 months prior to informed consent; * history of treatment with dipeptidyl-peptidase 4 (dpp-4) inhibitor, glucose-dependent insulinotropic polypeptide (gip) or glucagon-like peptide-1 (glp-1) receptor agonist; * treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent; * hemoglobin (hgb) \< 10.0 g/dl(100 g/l); * alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent; * active infectious diseases; * participation in another trial with an investigational drug or instrument within 3 months prior to informed consent; * women who are nursing or pregnant, or subjects with birth plans; * contraindication for metformin; * other protocol-defined inclusion/exclusion criteria.

Keywords: t2dm
observational study: safety and effectiveness of obinutuzumab in chronic lymphocytic leukemia in argentina

Conditions: Chronic Lymphocytic Leukemia

Summary: this observational study aims to study the effectiveness and safety of obinutuzumab in common clinical practice settings in argentina. the study population comprises all patients with chronic lymphocytic leukemia (cll) that have received the indication for treatment with obinutuzumab as per routine clinical practice.


Eligibility criteria:
inclusion criteria: * have received at least one dose of obinutuzumab as per local label and clinical practice. exclusion criteria: * included in clinical trial

Keywords: cll, obinutuzumab, treatment
advanced bolus calculator for type 1 diabetes (abc4d)

Conditions: Type 1 Diabetes

Summary: this study aims to assess the safety and efficacy of a novel advanced bolus calculator in subjects with type 1 diabetes. insulin bolus calculators have been developed to aid insulin dose adjustment and existing standard insulin bolus calculator consist of a simple algorithm that requires five subject-specific parameters as input to generate a recommended bolus insulin dose: * current blood glucose (mmol/l) * target blood glucose (mmol/l) * insulin-to-carbohydrate ratio (grams of carbohydrate per 1 unit of insulin) * total grams of carbohydrate in meals * insulin sensitivity factor (reduction in glucose per 1 unit of insulin)

the diabetes technology team at imperial college have developed a novel advanced bolus calculator. the complete integrated system consists of a commercially available smartphone that holds the novel advanced algorithm. the system requires regular updates of cases derived from retrospective blinded continuous glucose monitoring data and for this a commercially available glucose sensor will be used. each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (blood glucose following a meal). the novel decision support algorithm is based on case-based reasoning (cbr). cbr is an artificial intelligence technique that tries to solve newly encountered problems by applying the solutions learned from solved problems encountered in the past. the end-product is therefore a subject specific insulin bolus calculator that continues to improve with time. the project utilises commercially available glucose sensors and smartphones (iphone), integrated with a novel algorithm for insulin bolus calculation. the aim of the abc4d is to minimise high and low glucose excursions which are associated with the complications of diabetes including blindness, kidney failure, nerve damage and cardiovascular disease. an interim analysis was conducted in phase 4 after 25 participants completed the study (in line with the protocol) and it was agreed to stop the study at this stage. a further protocol amendment was approved by rec/mhra to commence abc4d phase 5 (different ct.gov number: nct03963219).

Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * diagnosis of t1dm for \> 1 year * on mdi using a basal-bolus insulin regime * structured education in previous 3 years * hba1c ≤ 86mmol/mol * no severe hypoglycaemia (defined as needing 3rd party assistance) in previous year exclusion criteria: * recurrent severe hypoglycaemia * pregnant or planning pregnancy * breastfeeding * enrolled in other clinical trials * have active malignancy or under investigation for malignancy * addison's disease * gastroparesis * autonomic neuropathy * concomitant use of glp-1 analogues and gliptins * visual impairment * reduced manual dexterity

Keywords: type 1 diabetes advanced bolus calculator
radiation therapy in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer

Conditions: Breast Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to kill tumor cells. specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. it is not yet known which radiation therapy schedule is more effective in treating breast cancer. purpose: this randomized phase iii trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.

objectives: * to test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence. outline: this is a multicenter study. patients are stratified according to center. patients are randomized to 1 of 3 treatment arms. * arm i (control): patients undergo sequential boost dose intensity-modulated radiotherapy (imrt) 5 days a week for 4.6 weeks (23 fractions; 56 gy). * arm ii: patients undergo concurrent boost dose imrt 5 days a week for 3 weeks (15 fractions; 48 gy). * arm iii: patients undergo concurrent boost dose imrt 5 days a week for 3 weeks (15 fractions; 53 gy). quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. photograph assessments of the breasts are taken at baseline and at 3 and 5 years. blood samples are collected at baseline and periodically thereafter. tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor. after completion of study treatment, patients are followed annually for 10 years.

Eligibility criteria:
disease characteristics: * histologically confirmed invasive breast cancer * resectable, unilateral disease * t1-3, n0-1, m0 disease * has undergone prior breast conservation surgery with complete microscopic resection and received appropriate systemic therapy for early breast cancer * requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following: * age 18-49 years * tumor size \> 2.0 cm after primary surgery (maximum microscopic diameter of invasive component) * tumor of any size treated by primary medical therapy * grade iii disease * minimum microscopic margin of noncancerous tissue \< 5 mm (excluding deep margin if at deep fascia) * lymphovascular invasion * axillary node positive * hormone receptor status not specified patient characteristics: * menopausal status not specified * no prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix prior concurrent therapy: * see disease characteristics * no prior mastectomy * no concurrent chemotherapy except primary or sequential chemotherapy

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer
nas treatment - opiate versus non-opiate

Conditions: Neonatal Abstinence Syndrome

Summary: the purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. the treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. morphine is a narcotic medicine, with is included in most pain killers. clonidine is another drug, but is different from morphine. it is also used for babies, and even adults for withdrawal symptoms. both drugs are effective, but the purpose of this study is to see if one may be better than the other.

withdrawal from drugs, called neonatal abstinence syndrome (nas), is a group of symptoms that occurs to babies whose mother took or used drugs (prescription, addicting, illegal, pain pills, or drugs for addiction treatment) during pregnancy. medicines the mother takes while pregnant, the baby also takes. babies may experience withdrawal after delivery, and may need treatment. there are different ways to treat babies with withdrawal - about 50% of doctors use morphine, an opiate, to treat these babies, the rest uses other drugs, like clonidine and phenobarbitol.

Eligibility criteria:
inclusion criteria: * admitted to neonatal intensive care unit (nicu)- gestational age (ga) \>or= 35 wks * known prenatal opiate exposure (maternal history, positive opiate screen, positive neonatal urine or meconium screen) * symptomatic with finnegan neonatal abstinence scores meeting nicu protocol for treatment exclusion criteria: * seizures * major congenital malformations * unlikely to survive * parents not able to understand english

Keywords: prenatal opiate exposure neonatal withdrawal pharmacologic treatment
use of the stethoscope to confirm breathing tube placement

Conditions: Intubation, Endotracheal

Summary: this study is intended to validate the use of neck auscultation with an electronic stethoscope during intubation to confirm tracheal tube placement. it is hypothesized that the ability to confirm correct tube placement with this technique will be similar to that of the end-tidal co2 monitor, the current gold-standard device for confirming tracheal intubation.

unrecognized esophageal intubation results in disastrous consequences. fortunately, a variety of techniques have been cited to confirm placement of the endotracheal tube. however, even end-tidal co2 monitoring, considered to be the gold standard, has been associated with false positive and false negative results. in addition, use of this monitor requires ventilation through the tube, resulting in gastric distention if the esophagus has been intubated. when the lateral neck is auscultated during insertion of an endotracheal tube, there is a distinct difference between the sounds generated by a tube placed in the esophagus compared to a tube inserted into the trachea. stethoscopes are readily available in any or setting, and ventilation and release of cricoid pressure need not occur prior to confirmation of tube placement. however, this technique has yet to be validated. a series of sounds heard at the lateral neck during both tracheal and esophageal intubation will be recorded using an electronic stethoscope. these sound files will be played to a group including both experienced and inexperienced intubators, who will be asked to identify which sounds represent tracheal and esophageal intubation. overall accuracy will be determined for the group of listeners.

Eligibility criteria:
inclusion criteria: * elective surgery requiring general anesthesia with endotracheal intubation exclusion criteria: * anticipated difficult intubation * contraindication to esophageal intubation

Keywords: intubation, endotracheal anesthesia, general
iron deficiency in pulmonary hypertension

Conditions: Idiopathic Pulmonary Arterial Hypertension

Summary: patients with idiopathic pulmonary arterial hypertension (ipah) and iron deficiency were previously shown to have a decreased six-minute walking distance. therefore the investigators hypothesized that intravenous iron administration would improve exercise capacity in iron deficient ipah patients. 30 patients will be recruited for iron infusions. at baseline and after 12 weeks (endpoint)exercise test will be performed.

background: patients with pulmonary arterial hypertension (pah) develop progressive right heart failure which eventually will lead to death. during progression of the disease the physical performance of the patients deteriorates. maintaining their exercise capacity is a major goal in pah treatment. iron treatment is known to have a positive effect on physical performance in patients with left heart failure and iron deficiency. whether this is also effective in patients with right heart failure (pah) and iron deficiency is until now unknown. objective: to evaluate the effects of intravenous iron supplementation on exercise capacity in iron deficient ipah patients. study design: intervention study study population: patients with idiopathic pulmonary arterial hypertension (ipah) and iron deficiency patients receive an iron bolus infusion of 1000 mg iron after baseline measurements. main study parameters/endpoints: primary endpoint: six minute walking distance (6wmd) secondary endpoints: cardiopulmonary exercise test, myoglobin concentration in quadriceps muscle, quadriceps muscle fiber strength, serum iron parameters, serum inflammatory parameters, quality of life (qol), and nyha functional class. the patients will be hospitalised two days at the beginning and two days at the end of the study to perform the exercise and strength tests, six minute walking distance and for biopsy of the quadriceps muscle. also nyha functional class will be determined and a qol questionnaire has to be filled in. after the baseline measurements an iron infusion will be given (ferinject 1000mg). the investigators hypothesize that iron deficient ipah patients will benefit from iron treatment with improved exercise capacity reflected in an increased 6mwd.

Eligibility criteria:
inclusion criteria: * stable idiopathic pulmonary arterial hypertension (stable disease for at least 3 months) * iron deficiency (serum iron below 10 μmol/l, decreased transferrin saturation (\< 15% in females and \< 20% in males) and serum ferritin \< 100 μg/l) irrespective of the coexistence of anaemia exclusion criteria: * current iron therapy (oral or iv) * current other study medication for pah * history of anaemia or current treatment for anaemia * liver function impairment * chronic disease other than pah (rheumatism, asthma, chronic infection) * acute infection

Keywords: pulmonary arterial hypertension iron deficiency exercise
effect of gluten free diet in patients with burning mouth syndrome

Conditions: Burning Mouth Syndrome

Summary: gluten free diet (gfd) is now being tested in patients affected by schizophrenia, autism and multiple sclerosis, making gfd a possible therapeutic weapon not only for celiac disease or gluten sensitivity. in this protocol we investigate the effect of gfd in patients affected by burning mouth syndrome (bms), a disease of unknown origin characterized by oral and especially tongue burning sensation, deeply decreasing the quality of life of patients


Eligibility criteria:
inclusion criteria: -primary bms exclusion criteria: * celiac disease * psychiatric disorders * intestinal autoimmune diseases * ongoing cancer

Keywords: burning mouth syndrome gluten gluten free diet