Kornimate/medical-research-clean huggingface dataset:
secretin in refeeding

Conditions: Anorexia in Adolescence

Summary: patients with restrictive-type anorexia nervosa who are admitted to the hospital for feeding often urinate excessive amounts. others have changes in the way that they handle acid and base. these issues prolong hospitalizations. current data suggest that one hormone--named secretin--may control both urine output and how the body handles acid and base. this study will evaluate whether secretin levels are different in anorexic patients who urinate an excessive amount compared to those who urinate normal amounts. for this study, patients will have one extra blood draw before and after one meal during their hospitalization. the blood draw before the meal coincides with a standard of care blood draw. also after the meal, subjects will be asked to provide one extra urine sample. information from subject's medical records will also be used.


Eligibility criteria:
inclusion criteria: * group 1: * male and female patients * age 13-24 years * diagnosis of restrictive-type anorexia nervosa * hospitalization for nutritional support * \>4 cc/kg/day of urine output (a.k.a. "fluid dumpers"; n=5) * group 2: * male and female patients * age 13-24 years * diagnosis of restrictive-type anorexia nervosa * hospitalization for nutritional support * \<2 cc/kg/d of urine output (a.k.a. "non-dumpers"; n=5) exclusion criteria: * 5150 hold * anti-depressant, anti-psychotic, or anticonvulsant medications * previous hospitalization within the past 6 months * underlying metabolic disorder not related to anorexia nervosa (including chronic kidney disease, renal tubular disorders, and underlying endocrine disorders) * pregnancy * ng or g-tube feeds after day 2 of hospitalization * \> 10% of nutritional needs from supplemental feeds
peer facilitated waitlist controlled transportation study

Conditions: Serious Mental Illness

Summary: the goal of this clinical trial is to test the effectiveness of a peer-facilitated travel intervention in adults with serious mental illnesses. this project aims to address the following hypotheses: 1. individuals with smi receiving either of the two peer-mediated travel training transportation interventions will experience an increase in transportation self-efficacy and transportation skills. 2. participants in the intervention arms will increase their transport utilization, participate in significantly more activities in the community, and make significantly more trips in the community. 3. individuals with smi receiving peer-mediated travel training interventions will retain post-test levels of community participation and self-efficacy 2 months after intervention. participants will be assigned to an 8-week travel-training intervention either using a bike-share program or public transportation. all participants will complete three data-collection research interviews.

this project proposes using a two-armed, waitlist controlled trial to test the effectiveness of peer-facilitated travel interventions and their ability to enhance community mobility and increase feelings of self-efficacy in individuals with serious mental illness (smi). the first intervention arm is an 8-week bikeshare intervention, which consists of individual trainings on using a bike sharing program; the second intervention arm is an 8-week public transportation intervention, which consists of individual trainings for using public transportation in the philadelphia area. the investigators seek to enroll a total of 180 individuals from community mental health agencies in the philadelphia area and expect recruitment to take 3 years. eligible participants will be individuals who meet criteria indicating that they have an smi, are between the ages of 18-65, and are both willing and able to learn to use public transportation and ride a bicycle. data will be collected via face-to-face or web-based video call interviews at 3 time points: baseline, 2-months post-baseline, and 4-months post-baseline. participants will also complete short surveys about their travel behaviors over the phone in the seven days after each interview. there will also be a subsample of participants who will provide additional gps data.

Eligibility criteria:
inclusion criteria: * are between the ages of 18 and 65 * are diagnosed with a smi (confirmed via the mini) * score at least an 8 on a travel skills assessment * indicates that they can ride a bicycle * have expressed interest in using a bikeshare and public transportation * are able to provide informed consent exclusion criteria: * score less than 8 on a travel skills assessment * express no interest in independent transportation * are non-english speaking individuals * are unable to provide consent * are living in a setting where mobility and participation is restricted * have a limiting physical condition that would prevent their ability to ride a bicycle independently
cyclasol for the treatment of moderate to severe dry-eye disease (ded)

Conditions: Dry Eye Syndromes

Summary: the objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of cyclasol ophthalmic solutions to placebo (vehicle) and restasis for the treatment of the signs and symptoms of dry eye disease (ded).

this phase 2 study explored the safety, efficacy and tolerability of two cyclasol concentrations as one drop twice daily versus vehicle (placebo). in addition to the masked vehicle control arm, an open-label comparator arm consisting of restasis was included. the study explored a range of signs and symptoms of ded to gain an understanding of the possible treatment effects in comparison to vehicle and estimation of effect sizes. in line with current treatment guidelines, the proposed phase 2 population consisted of patients suffering from moderate to severe ded. the primary treatment comparisons in this study were between the two cyclasol concentrations versus vehicle for the sign variable total corneal fluorescein staining and the symptom variable dryness severity visual analogue scale at day 113. all other comparisons between treatments groups were considered secondary analyses.

Eligibility criteria:
inclusion criteria: * signed informed consent form and hipaa (health insurance portability and accountability act ) document * patient-reported history of dry eye in both eyes * current use of over-the-counter and/or prescription eye drops for dry eye symptoms * ability and willingness to follow instructions, including participation in all study assessments and visits exclusion criteria: * women who are pregnant, nursing or planning a pregnancy * unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control * clinically significant slit-lamp findings or abnormal lid anatomy at screening * ded secondary to scarring or ocular or periocular malignancy * history of herpetic keratitis * active ocular allergies or ocular allergies that are expected to be active during the study period * ongoing ocular or systemic infection at screening or baseline * wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study * history of no response to previous topical cyclosporine a and/or use of topical cyclosporine a within 6 months prior to screening * intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period * presence of an uncontrolled systemic disease * presence of a known allergy and/or sensitivity to the study drug or its components
targeted internal radiation therapy in advanced hcc patients.

Conditions: Internal Radiation; Advanced Hepatocellular Carcinoma

Summary: the aim of this study is to evaluate the 131i-chtnt-1/b treatment effect and safety of individual therapy using randomized controlled study, in order to acquire the evidence of evidence-based medicine and create a new program of targeted internal radiation therapy in advanced hcc patients.


Eligibility criteria:
inclusion criteria: 1. via clinical diagnosis and confirm it is advanced hepatocellular carcinoma 2. mrecist estimation: necrosis region in hcc 3. negative iodine allergy test 4. liver function ：child-pugh a/b exclusion criteria: 1. reject to attend； 2. impossible to come to our hospital for physical examination regularly. 3. blood clotting function hindrance; 4, patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.

Keywords: 131i-chtnt-1/b treatment
a phase 1/2 study of hki-272 (neratinib) in combination with trastuzumab (herceptin) in subjects with advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: the purpose of this study is to determine the safety and efficacy of hki-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.

open label phase 1/2 study of ascending multiple oral doses of hki-272 in combination with iv trastuzumab in subjects with advanced human epidermal growth factor receptor 2 positive (her2+) breast cancer. three to six subjects will be enrolled in each dose group. adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 21. when the maximum tolerated dose (mtd) of hki-272 plus trastuzumab is determined, an additional 30 subjects will be enrolled at that dose level, and followed for progression free survival for approximately 1 year.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis of breast cancer with current stage iiib, iiic or iv not curable by available therapy * progression following at least one herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting) * her2 positive breast cancer * at least one measurable target lesion * adequate performance status * adequate cardiac, kidney, and liver function * adequate blood counts * willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control exclusion criteria: * more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease * major surgery, chemotherapy, radiotherapy, investigational agents, herceptin or other cancer therapy within 2 weeks of treatment day 1 * prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2 * extensive visceral disease * active central nervous system metastases * pregnant or breast feeding women * significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom * prior exposure to hki-272 or other her2 targeted agents (except herceptin and tykerb) * significant cardiac disease or dysfunction * history of life-threatening hypersensitivity to herceptin * inability or unwillingness to swallow hki-272 capsules * any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin

Keywords: hki-272 neratinib trastuzumab breast cancer nerlynx pb-272 her2
three levels of force application for maxillary protraction

Conditions: Skeletal Class 3 Malocclusion Due to Maxillary Deficiency

Summary: the aim of this study is to evaluate dentoskeletal changes concomitant with different three levels of force application for maxillary protraction in growing patients with skeletal class 3 malocclusion.

nanda reported that numerous experimental studies on primates have shown orthopedic changes in response to extraoral forces; however, very few studies have made an attempt to analyze the different force variables and their relationship to facial sutures. in consideration of the variables, experimental and clinical studies were initiated in their laboratory in 1972. a study on protraction of midfacial bones on primates reported that the point of force application significantly influences the center of rotation of the maxilla in rhesus monkeys. our unpublished data also show that centers of rotation are influenced by the magnitude of force. the study showed that the maxilla can be successfully protracted by means of carefully controlled forces. based on the aforementioned data, we can hypothesize that the point of force application for maxillary protraction in relation to the center of resistance of maxilla could be utilized in order to correct skeletal class 3 malocclusions with different vertical dimension discrepancies.

Eligibility criteria:
inclusion criteria: the patients will be included in the study if they have the following: 1. an age range from 7 to 10 years. 2. patients diagnosed to have skeletal class 3 malocclusion due to retruded maxilla and/or combined maxillary retrusion with mild mandibular protrusion. (based on cephalometric analysis) 3. no serious systemic diseases and/or medical treatment that could interfere with orthodontic tooth movement such as analgesics, non-steroidal anti-inflammatory drugs, and hormone supplements or antibiotics. 4. good oral hygiene and periodontal conditions. 5. no evidence of craniofacial anomalies, such as cleft lip and palate or previous history of trauma, bruxism or parafunctions. 6. no previous orthodontic or orthognathic treatment. exclusion criteria: the patients will be excluded from the study if they have the following: 1. systemic diseases or medications that could interfere with orthodontic treatment. 2. poor oral hygiene or periodontally compromised patients. 3. craniofacial anomalies or previous history of trauma, bruxism or parafunctions. 4. previous orthodontic treatment.
vitamin e or lipoic acid on serum oxyphytosterol concentrations

Conditions: Oxidative Stress

Summary: background of the study: we now know that plant sterols can oxidize, which results in the formation of oxyphytosterols. animal studies have suggested that oxyphytosterols are atherogenic components, however this relation has not yet been studied in humans. in our previous study (metc 09-3-088) we have shown in healthy volunteers that serum oxyphytosterol concentrations are linked to oxidative stress status (i.e. we were able to identify high and low sterol oxidizers). from the literature is known that especially type ii diabetics and igt subjects are characterized by increased oxidative stress markers and reduced antioxidant capacity. for this reason we also want to evaluate the oxyphytosterol concentrations in this population. moreover, we know propose to evaluate the effect of antioxidant supplementation, i.e. vitamin e or lipoic acid, on serum oxyphytosterol concentrations in type ii diabetic patients. if possible to lower oxyphytosterol concentrations in these populations this is obviously beneficial in case oxyphytosterols turn out to be atherogenic. the major objective of the present study is to examine the effect of consuming vitamin e (804 mg) or lipoic acid (600 mg) for 4 weeks on fasting oxyphytosterol concentrations in subjects with impaired glucose tolerance or type 2 diabetes.


Eligibility criteria:
inclusion criteria: * aged between 18 and 75 years * body mass index (bmi) between 20-35 kg/m2 * mean serum total cholesterol \<8.0 mmol/l * mean serum triacylglycerol \<3.0 mmol/l * diagnosed with diabetes mellitus type 2 on a clinical basis or impaired glucose tolerance (defined as blood glucose \>7.8 mmol/l and \<11.0 mmol/l, two hours after ingesting 75 gram glucose in 150 ml water) exclusion criteria: * unstable body weight (weight gain or loss \> 3 kg in the past two months) * active cardiovascular diseases like congestive heart failure or recent (\<6 months) event (acute myocardial infarction, cerebral vascular incident) * severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis * use of medication such as corticosteroids, diuretics or lipid lowering therapy * use of insulin therapy * abuse of drugs or alcohol (\>21 units per week) * not willing to stop the consumption of vitamin supplements, containing lipoic acid and/or vitamin e, 1 month before the start of the study (wash-in period) * use of an investigational product within another biomedical study within the previous month * pregnant or breast-feeding women * current smoker

Keywords: oxyphytosterols oxidative stress vitamin e lipoic acid
a study to look at how safe nnc0268-0965 is in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study looks at the safety and tolerability of the new medicine nnc0268-0965 (referred to as insulin 965), its concentration in the blood and its effect on the blood sugar for the treatment of diabetes. the study will test how insulin 965 is tolerated by the body, how it is taken up in the blood, how long it stays there and how the blood sugar is lowered. participants will either get the new insulin 965 or the already marketed insulin glargine u100 (lantus®) - which treatment is decided by chance. participants will get six injections (one per day) of either insulin 965 or insulin glargine u100 under the skin of the left thigh. the study will last for about 5 weeks. participants will have 6 clinic visits with the study doctor. participants can only be in the study if the study doctor thinks that there are no risks for their health. women can only take part in the study if they can't have children.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. * diagnosed with type 2 diabetes mellitus 180 days or more prior to the day of screening. * male subject or female subject of non-child bearing potential. non-child bearing potential being surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (as defined as no menses for 12 months without an alternative medical cause) prior to the day of screening. * current total daily insulin treatment between 0.25 (i)u/kg/day and 1.2 (i)u/kg/day (both inclusive). * hba1c equal to or below 9.5% exclusion criteria: * male of reproductive age who, or whose partner(s), is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). adequate contraceptive measures include that the male subject uses a condom during intercourse and that the partner practices adequate contraception (risk of pregnancy must be lower than 1%). * use of glp-1 receptor agonists (e.g. exenatide, liraglutide, semaglutide) within 3 months prior to screening.
s-1 concurrent with radiotherapy versus radiotherapy for elderly patients with esophageal cancer

Conditions: Esophageal Cancer; Chemoradiation

Summary: this was a randomised, multicenter, phase 3 trial. patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to s-1 concurrent with radiotherapy or radiotherapy alone.the primary endpoint was overall survival.


Eligibility criteria:
inclusion criteria: * histological or cytologic diagnosis of esophageal carcinoma * ecog performance status 0-1 * age:70-85 years * joined the study voluntarily and signed informed consent form * patients must not have received any prior anticancer therapy * stage ⅰ-ⅳb（ajcc 2009） * target lesions can be measured according to recist criteria * no serious system dysfunction and immuno-deficiency, adequate organ function including the following: hemoglobin ≥9 g/dl, wbc≥3x109/l, neutrophils (anc )≥1.5x109/l, platelet count ≥100x 109/l, tbil\<1.5 x uln, alt and ast ≦ 2.5 x uln, creatinine ≦ 1.5 x uln exclusion criteria: * multiple carcinomas of the esophagus, * biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula, * metastatic disease (m1b), * a primary tumor that extended to within 2 cm of the gastroesophageal junction, * prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor, * history of a second malignancy other than nonmelanoma skin cancer
patient registry of roflumilast in real life

Conditions: Chronic Obstructive Pulmonary Disease

Summary: a patient registry to capture real life data and demonstrate the performance of roflumilast (daxas®) in a standard clinical practice.

the drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. roflumilast is approved for and marketed globally for maintenance treatment of severe chronic obstructive pulmonary disease (copd) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. this study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. the study will enroll approximately 1350 (eu)+600(north asia) patients. this multi-centre trial will be conducted in at least 4 eu and 2 north asian countries. the overall time to participate in this study is 12 months. no visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study. participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.

Eligibility criteria:
inclusion criteria: * signed informed consent to the data collection * roflumilast (daxas®) treatment initiated in roflumilast (daxas®) naïve patients at the time of registry exclusion criteria: there are no exclusion criteria per se. however it is expected that patients are treated according to locally approved marketing authorisation.

Keywords: drug therapy
blood loss after early txa in hip fractures.

Conditions: Hip Fractures

Summary: our present study aims to initiate txa administration immediately upon diagnosis of hip fracture in the emergency department. this will be a single blind randomized controlled trial comparing early administration of txa in the ed in addition to perioperative dosing versus the standard perioperative administration only. the study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. we will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.

consent will be obtained for study enrollment from the patient or legal decision maker. the patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation. treatment drug and saline placebo will be blinded from the patient. treatment arm patients will receive a dose of 10 mg/kg of txa iv as soon as possible in the ed. they will then receive repeat doses prior to skin incision and again after the end of surgery. control group will receive a placebo dose of normal saline in the ed and then the standard 10 mg/kg txa doses prior to surgery and again after the end of surgery. the perioperative doses will not be blinded.

Eligibility criteria:
inclusion criteria: * femoral neck, intertrochanteric, subtrochanteric femur fracture * age \>18 * undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon exclusion criteria: * age \<18 * concomitant fracture * preoperative anemia needing blood transfusion before surgery * severe comorbidity (active cancer, severe pulmonary disease, esrd) * allergy for tranexamic acid * history of acute thromboembolic event (deep vein thrombosis, pulmonary embolism, stroke, tia) in the previous 12 months * myocardial infarction in the previous 12 months * renal function impairment (creatinine clearance \<30 ml/min), or kidney transplant * history of hypercoagulability (factor v leiden, protein c/s deficiency)

Keywords: tranexamic acid txa hip fracture