Kornimate/medical-research-clean huggingface dataset:
the glow study - the yang system

Conditions: Diabetes Mellitus; Glucose

Summary: this is an open label, interventional, monocentric, prospective early feasibility study, designed to evaluate the safety of implant and short-term integration into the tissue of the yang sensor. in addition, the set up will enable data collection which will be used to develop the software algorithm to allow real-time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in adults with diabetes mellitus, in a future version of the device.


Eligibility criteria:
inclusion criteria: t1dm patients * subjects willing to sign an informed consent form (icf), * adult subjects, age ≥ 18, ≤ 50 years old * body mass index (bmi) 20≥, ≤ 27.5 \[kg/m2\] * subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc) * patients with type 1 diabetes mellitus (t1dm) according to who criteria, diagnosed for at least 12 months prior to screening * subjects being on insulin pump for at least 12 months healthy volunteers * subjects willing to sign an informed consent form (icf), * adult subjects, age ≥ 18, ≤ 50 years old * bmi 20≥, ≤ 27.5 * subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc) * healthy subjects, as self-declared and confirmed by screening assessments and principal investigator's judgment exclusion criteria: * subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, hypothyroidism, known allergic reaction to ibuprofen/paracetamol/acetylsalicylic acid) * for people with diabetes: history of severe hypoglycaemia in the previous 6 months. severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure * for people with diabetes: history of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months * any blood disorder identified by haematocrit \ 55% * history of hepatitis b, hepatitis c, or hiv * a condition requiring or likely to require magnetic resonance imaging (mri) during the study duration * female subjects who are pregnant, planning on becoming pregnant or nursing * any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol. * coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication * any long-term drug treatments other than insulin, such as statins, low-dose aspirin, fibrates etc. * the presence of any other active implanted device except for insulin pumps (as defined further in protocol) * the presence of any other cgm sensor or transmitter located in abdomen (other location is acceptable) * impaired fasting glucose or impaired glucose tolerance (for healthy volunteers) * any contraindication to the use of the yang system as listed in the device ifu (i.e. any known allergy to pdms)
visual feedback in chronic neck pain

Conditions: Neck Pain

Summary: the objective of this study is to evaluate the impact of visual feedback of the posterior region of the cervical spine on pain intensity and range of motion.

60 patients with chronic idiopathic neck pain will be randomly assigned into one of two groups: a group receiving visual feedback when performing 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) and a group performing the same task without visual feedback. participants will be assessed for pain intensity, pain location, disability, range of motion, kinesiophobia, catastrophizing and anxiety both at baseline and after visual the intervention (i.e., neck movements with and without visual feedback).

Eligibility criteria:
inclusion criteria: * to have idiopathic neck pain defined as neck pain unrelated to any known pathology or lesion felt at least once a week in the last 3 months, located between the nuchal line and a horizontal line passing through t1 and pain intensity of at least 3 in the visual analogue scale. exclusion criteria: * history of cervical or facial trauma, radiculopathy, history of surgery in the vertebral segment in question, congenital anomalies involving the spine (cervical, thoracic and lumbar spine) or any neurological or rheumatic pathology, and, finally, evidence of significant visual changes, or of deficits not corrected by lenses or glasses.
a rct on the preventive effect of hfnc on postoperative pulmonary complications in patients with gynecologic neoplasms

Conditions: Gynecologic Surgery; High-flow Nasal Cannula; Post-operative Pulmonary Complications

Summary: patients at high risk of post-operative pulmonary complications (ppc) will be screened out from gynecological tumor patients undergoing surgical treatment, and randomly assigned into the hfnc group and control group, which uses conventional nasal cannula oxygen therapy. the primary outcome is the incidence of ppc, including postoperative hypoxemia, atelectasis, pneumonia, etc. secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

this randomized con aims to enroll patients at high risk of developing post-operative pulmonary complications after gynecological surgery, the eligible patients will be randomly assigned to receive oxygen therapy via high-flow nasal cannula or conventional nasal cannula. the study primary outcome is the incidence of post-operative pulmonary complications, including postoperative hypoxemia, atelectasis, pneumonia, etc. secondary outcomes are the improvement of postoperative oxygenation, antibiotic use, length of hospital stay, adverse events related to oxygen therapy, etc.

Eligibility criteria:
inclusion criteria: * patients with gynecologic neoplasms, including benign gynecologic tumors and malignant gynecologic tumors, who are 18 to 90 years old and are scheduled for surgical treatment in our center shall receive plain chest ct scan within 1 week before surgery, and the estimated surgical time shall be ≥2 hours, and at least one of the following conditions shall be met: 1. assess respiratory risk in surgical patients in catalonia (arrspc) ≥45 points; 2. bmi≥30; 3. moderate to severe asthma; 4. moderate to severe chronic obstructive pulmonary disease (copd); 5. smoking history ≥20 packs/year exclusion criteria: 1. patients with lung metastasis of malignant tumor or primary lung malignant tumor; 2. previous lung surgery or radiotherapy; 3. the surgery involved segmental bowel resection.
bio monitoring in patients with preserved left ventricular function after diagnosed myocardial infarction

Conditions: Myocardial Infarction; Myocardial Infarction, Acute; Myocardial Infarction Old

Summary: the bio\|guard-mi study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors, decreases the risk of major adverse cardiac events.

patients randomized to the biomonitor arm will receive an implantable cardiac monitor (icm; biomonitor) with remote monitoring function (home monitoring®). if the device detects and reports an arrhythmia, patients will be appropriately examined and treated. patients randomized to the control arm will receive best proven treatment, but no implantable cardiac monitor.

Eligibility criteria:
inclusion criteria: * patient has a history of mi according to guidelines * cha2ds2-vasc-score ≥ 4 in men / ≥ 5 in women * lvef \> 35 % as estimated within 6 months before enrollment but after conclusion of ami treatment * patient accepts activation of home monitoring® * patient is able to understand the nature of the clinical study and has provided written informed consent exclusion criteria: * patients with hemorrhagic diathesis * permanent oral anticoagulation treatment for atrial fibrillation * indication for chronic renal dialysis * pacemaker or icd implanted or indication for implantation * parkinson's disease * life expectancy \< 1 year * participation in another interventional clinical investigation * age \< 18 years * woman who are pregnant or breast feeding
predicting the success of dry eye disease interventions using clinical tests

Conditions: Dry Eye

Summary: this is a single site, prospective, cross-sectional, controlled clinical study on a total of 66 subjects. the subjects are divided into two groups: hypertonic saline non-responders (33 subjects) and hypertonic saline responders (33 subjects). after completion of questionnaires, the subjects will undergo dry eye disease testing and functional nerve testing. subjects who qualify will be dispensed 4 weeks of preservative free artificial tears and instructed to instill one drop into each eye twice daily. subjects will return for a follow up visit 4 weeks later (± 4 days), during which subjects will complete the questionnaires again and the dry eye disease tests and functional nerve tests will be repeated.


Eligibility criteria:
inclusion criteria: group 1 (hypertonic saline non-responders): * at least 18 years of age * ability to consent * diagnosis of dry eye disease (ded) based on: * symptoms of ded, shown with sande score of 50mm or greater * two or more of the following objective signs in the same eye: 1. schirmer test of 10 mm or less over 5 minutes; 2. fluorescein tear break-up time (ftbut) of 7 seconds or less; 3. meibomian gland expression (mge) grade of 2 or greater for at least 3 out of 5 glands * hs response result of one of the following: * reduction of discomfort/pain rating * no change of discomfort/pain rating * increase in discomfort/pain rating score of 1 step or less group 2 (hypertonic saline non-responders): * at least 18 years of age * ability to consent * diagnosis of ded based on: * symptoms of ded, shown with sande score 50mm or greater * two or more of the following objective signs in the same eye: 1. schirmer test of 10 mm or less over 5 minutes; 2. fluorescein tear break-up time (ftbut) of 7 seconds or less; 3. meibomian gland expression (mge) grade of 2 or greater for at least 3 out of 5 glands * hs response result of an increase in discomfort/pain rating of greater than 1 step exclusion criteria: * presence of centralized pain as indicated by a proparacaine challenge test (pct) of less than 50% ocular surface discomfort reduction * unable to speak english * history of ocular surgery, corneal infection, or corneal injury within the last 3 months * active ocular allergies or other condition that could impact the study results * allergic to benzalkonium chloride "bak" (an eye-drop preservative) * changes in topical or systemic medications in the last 3 months or anticipated changes in medication during the course of treatment * use of other topical treatments * concurrent enrollment in other studies that in the opinion of the investigator will interfere with the results of this study * use of contact lenses within the last month

Keywords: dry eye artifical tear
compassionate use of omegaven in the treatment of parenteral nutrition induced hepatic injury

Conditions: Liver Disease; Impaired Liver Function; Parenteral Nutrition Associated Liver Disease

Summary: this study is being done to determine if an investigational study drug called omegaven can help to improve liver disease thought to be caused by total parenteral nutrition (tpn). tpn is intravenous feeding (iv feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.

patients with direct bilirubin \>2gm/dl and short bowel syndrome are eligible for enrollment. omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid preparations.

Eligibility criteria:
inclusion criteria: 1. patients must be 2 months -10 years of age 2. patients who are pn dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require pn for at least another 30 days 3. patients considered eligible for study participation must have parenteral nutrition associated liver disease (pnald) as defined by a direct bilirubin of \>2.0mg/dl. other causes of liver disease should be excluded. a liver biopsy is not necessary for treatment 4. 2 consecutive direct bilirubin test results \>2.0mg/dl 5. the patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic tpn, avoiding overfeeding, reduction/removal of copper and manganese from tpn, advancement of enteral feeding, and use of ursodiol (actigall) 6. subjects who are currently under treatment for pnald with compassionate use omegaven and have a direct bilirubin of\< 2, but who remain tpn dependent and require continued therapy with omegaven exclusion criteria: 1. other known causes of chronic liver disease (hepatitis c, cystic fibrosis, biliary atresia and alpha 1 anti-trypsin deficiency) 2. enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team) 3. the parent, guardian, or child is unwilling to provide consent or assent 4. allergy to any fish product, egg protein, and/or previous allergy to omegaven 5. active coagulopathies characterized by on-going bleeding or by a requirement for clotting factor replacement such as fresh frozen plasma or cryoprecipitate to maintain homeostasis 6. impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis 7. unstable diabetes mellitus 8. stroke/embolism 9. collapse and shock 10. undefined coma status 11. active infection at time of initiation of omegaven® up until such time as child is afebrile with stable vital signs and one negative 48 hour culture

Keywords: tpn liver function parenteral nutritional fat emulsions
maximum tolerated dose of lapatinib when given with carboplatin for recurrent ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to determine the maximum tolerated dose of lapatinib with carboplatin auc 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of lapatinib in combination with carboplatin auc 6 in this cohort of patients.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of epithelial ovarian or primary peritoneal cancer * measurable disease or evaluable disease with ca125 \>100 * one prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed * recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy * 19 years of age or older * life expectancy of greater than 12 weeks * performance status of 0, 1 or 2 (based on gog performance status) * normal bone marrow, renal and hepatic function based upon lab tests * cardiac ejection fraction within institutional normal range * ability to swallow and retain oral medication * ability to understand a written informed consent document exclusion criteria: * patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study * epithelial ovarian tumors of low malignant potential, stromal or germ cell origin * non-measurable or non-evaluable disease * archived tumor tissue not available for assay * patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines * patients with known brain metastases * history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent. * uncontrolled inter-current illness * patients who are pregnant * hiv-positive patients receiving combination anti-retroviral therapy * patients with gi tract disease resulting in an inability to take oral medication

Keywords: ovarian cancer
iol power calculation using dual schiempflug analyzer

Conditions: Cataract

Summary: this study evaluates the various ocular parameters which are necessary for ocular biometry and the calculated iol powers using both dual schiempflug analyzer and optical low-coherence refelctometry.

the measured keratometry, axial length, anterior chamber depth, lens thickness, white-to-white corneal diameter, and calculated iol powers using various formulas including hoffer q, holladay i, srk ii and srk t measured by dual schiempflug analyzer and optical low-coherence refelctometry will be compared.

Eligibility criteria:
inclusion criteria: * axial length between 21.0 and 27.0 mm * older than 20 years old exclusion criteria: * other ophthalmic diseases such as severe dry eye, glaucoma, and age-related macular degeneration * previous ophthalmic surgery including cataract surgery, and refractive surgery * very dense media which cannot be measured by the optical biometries * severe zonulysis

Keywords: dual sheimpflug analyzer intraocular lens power optical low-coherence reflectometry
a study to investigate the effects on blood pressure and pulse rate of a single 100mg dose of sildenafil in patients with benign prostatic hyperplasia who are being treated with doxazosin

Conditions: Benign Prostatic Hyperplasia

Summary: to investigate the effects of a single dose of sildenafil (100 mg) or placebo on blood pressure and pulse rate in subjects taking doxazosin for benign prostatic hyperplasia (bph). to investigate the pharmacokinetics of doxazosin when co-administered with sildenafil 100 mg, and to investigate the safety and toleration of sildenafil 100 mg when co-administered with doxazosin.


Eligibility criteria:
inclusion criteria: * patients who weighed between 132 and 220 lb (60 and 100 kg) with benign prostatic hyperplasia (bph) * a total psa (prostate specific antigen) measurement of less than or equal to 10 µg/l within the 12 months prior to screening, were currently on doxazosin treatment for bph, had been treated with doxazosin for a minimum of 2 months prior to first dose of study medication, and had received a minimum of 4 mg doxazosin once daily (from doxazosin supplied for this study) for 2 weeks prior to the first dose of study medication. exclusion criteria: * subjects with a recent history (i.e. within 6 months prior to screening) of stroke or myocardial infarction * subjects with severe cardiovascular disorders such as unstable angina or severe congestive heart failure * subjects with known hereditary degenerative retinal disorders, such as retinitis pigmentosa * subjects with a supine systolic/diastolic blood pressure of \>170/100 mmhg or \<100/60 mmhg either at screening or at the pre-dose measurements * subjects receiving any other antihypertensive therapy other than doxazosin in the 3 weeks prior to the first dose of study medication.
effectiveness of app-based relaxation for patients with chronic neck pain

Conditions: Chronic Neck Pain

Summary: the aim of the pragmatic randomized study is to evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone.

objective: to evaluate whether additional relaxation technique is more effective in the reduction of chronic neck pain compared to usual care alone. study design: open single-centered randomized two-armed pragmatic trial. participants: 220 patients aged 18-65 years with chronic (\>12 weeks) neck pain and a mean pain score ≥ 4 on a numeric rating scale (nrs) in the last week before randomization who will be randomly allocated to two groups (relaxation, usual care alone as waiting list) intervention: participants apply either a daily 15-minute relaxation exercise guided by a smartphone application ("app"). or apply no additional intervention. the exercise should be applied daily, (minimally, five days per week) for 6 months. the app contains audios to guide autogenic training, muscle relaxation training and guided imagery. on a daily basis, participants can select one of the three exercises which they want to apply. main outcome measure: the primary outcome is the mean pain intensity after 3 months measured by the daily pain intensity on the nrs.

Eligibility criteria:
inclusion criteria: * female or male * 18-65 years of age * chronic neck pain for at least 12 weeks * if additional back pain is reported, neck pain has to be predominant * intensity of the average neck pain ≥ 4 on the numeric rating scale (nrs) in the last week * presence of a smartphone (iphone, android phone) and willingness to do data entry through a smart phone application (app) * physical and mental ability to participate in the study * willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by a smart phone application * written and oral informed consent exclusion criteria: * neck pain caused by a known malignant disease * neck pain caused by trauma * known rheumatic disorder * history or planned surgery of the spinal column of the neck in the next 6 months * known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc * regular intake of analgesics (\>1x per week) because of additional diseases * intake of centrally acting analgesics * known severe acute or chronic disorder, that do not allow participation in the therapy * other known diseases, that do not allow participation in the therapy * known alcohol or substance abuse * no sufficient german language skills * current application for a benefit * participation in another clinical trial during six months before the study and parallel to the study * conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 6 months

Keywords: chronic neck pain relaxation technique comparative effectiveness research
using point-of-care-ultrasound (pocus) to assess gastric contents among fasting pre-operative patients taking glp-1 agonists.

Conditions: Delayed Gastric Emptying; Gastroparesis

Summary: given the increased prescription of glp-1 agonists for both diabetes and obesity management and the implications of the proposed delayed gastric emptying in the setting of an anesthetic, it is critical to determine if patients taking glp-1 agonists have an increased rate of delayed gastric emptying. the purpose of this prospective gastric ultrasound evaluation of pre-operative patients is to determine the incidence of a full stomach despite a standard pre-operative fasting period.


Eligibility criteria:
inclusion criteria: * glp-1 agonist use within previous 30 days * appropriately fasted per standard guidelines exclusion criteria: * history of gastric surgery / gastric volume reduction * critical illness * inability to provide informed consent * \<18 years of age

Keywords: glp-1 agonists retained gastric contents glucagon-like peptide receptor-1 agonists perioperative