Kornimate/medical-research-clean huggingface dataset:
evaluate efficacy and safety of pa5108 ocular implants in primary open angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: the goal of this clinical trial is to determine the dose of pa5108 ocular implant that is effective and safe for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension, compared to the standard treatment therapy.

this is a randomised, parallel, masked, active-controlled study that will evaluate the efficacy and safety of a low dose and a high dose of pa5108 ocular implant with single redosing during the study, in adults with open-angle glaucoma or ocular hypertension. the study will also collect information on the implant administration procedure and overall experience from study participants. the study plans to recruit approximately 75 participants. eligible participants will be randomly selected to receive one of the following treatments: * pa5108 ocular implant - low dose in the study eye, and latanoprost 0.005% eye drops in the other eye * pa5108 ocular implant - high dose in the study eye, and latanoprost 0.005% eye drops in the other eye * latanoprost 0.005% eye drops in both eyes (control treatment group) if allocated to receive either of the ocular implants, a second implant of the same dose will be administered at 26 weeks and participants will be followed for safety and intraocular pressure control until week 58 or until the implant is no longer visible in the study eye.

Eligibility criteria:
key inclusion criteria: * ability to provide informed consent and follow study instructions * 18 years of age or older * diagnosis of open-angle glaucoma or ocular hypertension in both eyes * qualifying iops across 2 visits following washout of iop-lowering medication, if applicable * qualifying best-corrected visual acuity bcva using early treatment diabetic retinopathy study (etdrs) chart in study eye * qualifying corneal endothelial cell density (cedc) in the study eye key exclusion criteria: * pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye. * advanced or severe glaucoma * disqualifying central corneal thickness in either eye * significant other ocular conditions that could prevent accurate assessment of iop and corneal health * uncontrolled medical conditions * have previously received, any injectable glaucoma medication into the anterior chamber of the study eye * have received intravitreal injections in the study eye within the last 3 months of the screening visit and anticipated need for an intravitreal injection during the course of the study * unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days
comparison of patient-controlled analgesia regimenfor postoperative pain in patients undergoing total knee arthroplasty

Conditions: Postoperative Pain, Acute

Summary: patients who undergoing total knee arthroplasty under spinal analgesia will be recruited and randomly assigned to the following two groups according to the regimen of pca: (a) opioid group who receive only fentanyl citrate 1200mcg for continuous infusion drug, (b) non-opioid group who receive ketorolac tromethamine 150mg with nefopam hydrochloride 100mg for continuous infusion drug. all the patients will receive additional fentanyl citrate as bolus injection drug if they need more analgesics postoperatively.


Eligibility criteria:
inclusion criteria: * asa physical status i-ii * undergoing elective total knee arthroplasty under spinal anesthesia exclusion criteria: * history of stomack ulceration * increased icp * bronchial asthma * allergy on aspirin, nsaids, nefopam * drug user of antiplatelet or anticoagulant
rehydration efficiency during ad-libitum fluid intake

Conditions: Dehydration

Summary: it is well established that rehydration with a carbohydrate-electrolyte solution is more effective in comparison to plain water. this is primarily based on the sodium-glucose co transporter, based on which the world health organization has based its oral rehydration solution recommendations. also, rehydration with a solution that includes sodium and glucose plasma osmolality should not drop as much as it happens during rehydration with water. as a result, we should have higher fluid intake due to higher thirst perception and lower urinary output due to higher levels of vasopressin. the present study aims to examine the effectiveness of a electrolyte-glucose drink on rehydration following exercise-induced dehydration.


Eligibility criteria:
inclusion criteria: * age 18-60 years * training at least 2 times per week * stable weight for the last 2 months (fluctuation less than 5 pounds) exclusion criteria: * night shifting work * thyroid medication * bariatric surgery * cardiovascular disease * renal disease * hepatic disease * participating in another study at the same time * bodyweight over 110 pounds
trial to compare mri-guided precision prone irradiation (ppi) versus ct-guided breast irradiation

Conditions: Breast Cancer

Summary: the investigators are investigating the potential role of mri-guided radiation therapy for patients receiving breast radiotherapy in the prone position with a mri-linac radiotherapy system, the precision prone irradiation (ppi) technique. hypothesis: the investigators would like to hypothesize that breast radiation therapy using mri-guided system including the mri-linac (arm 2) is comparable to the current standard of treatment using conventional ct-based system (arm 1), in terms of local control of the disease at 2 year time point.

breast conserving surgery and adjuvant whole breast radiotherapy is a standard treatment option for most patients with early-stage invasive breast cancer. recent technological advances in radiotherapy have enabled shorter treatment courses, smaller radiation fields, prone positioning, and fewer side effects associated with breast cancer treatment. to further improve target accuracy in breast radiation delivery, an emerging radiotherapy technology takes advantage of on-table mri imaging and daily adaptive planning during the radiation delivery process. the objectives of the study are to compare side effects in patients treated under either of these treatment settings and to compare recurrence (if the cancer comes back) rates at a 2-year time point. patients will have annual follow ups up to 10 years and recurrence rates will be measured at 5-year and at 10-year time points.

Eligibility criteria:
patients ≥ 50 yrs with histologically confirmed unilateral dcis or stage i invasive breast cancer; received breast conserving surgery (pn0 or pnx) with tumor pathology ≤ 2 cm and excision margin ≥ 1 mm inclusion criteria: * women status post segmental mastectomy * if unilateral, pt1 breast cancer excised with negative margins and/or ptis excised with negative margins. * if bilateral, pt1 breast cancer excised with negative margins and/or ptis excised with negative margins. * clinically n0 or pn0 or sentinel node negative * ductal carcinoma in situ dcis with negative margins (no dcis on inked margins). exclusion criteria: * previous radiation therapy to the ipsilateral breast. * \> 90 days from last surgery, unless s/p adjuvant chemotherapy * \> 60 days from last chemotherapy * patients unable to tolerate mri or are otherwise unsuitable for mri-based rt treatment * metastatic disease
renal tubular acidosis is highly prevalent in critically ill patients

Conditions: Acidosis, Renal Tubular

Summary: the aim of this study was to investigate the prevalence, type, and possible risk factors of rta in critically ill patients using a physical-chemical approach.

hyperchloremic acidosis is frequent in critically ill patients. renal tubular acidosis (rta) may contribute to acidemia in the state of hyperchloremic acidosis, but the prevalence of rta has never been studied in critically ill patients. therefore, we aimed to investigate the prevalence, type, and possible risk factors of rta in critically ill patients using a physical-chemical approach. this prospective, observational trial was conducted in a medical icu of a university hospital. 100 consecutive critically ill patients at the age ≥18, expected to stay in the icu for ≥24h, with the clinical necessity for a urinary catheter and the absence of anuria were included. base excess subset calculation based on a physical-chemical approach on the first seven days after icu admission was used to compare the effects of free water, chloride, albumin, and unmeasured anions on the standard base excess. calculation of the urine osmolal gap (uog) - as an approximate measure of the unmeasured urine cation ammonium - served as determinate between renal and extra-renal bicarbonate loss in the state of hyperchloremic acidosis.

Eligibility criteria:
inclusion criteria: * admitted to the medical icu of the div. of gastroenterology \& hepatology of the medical university of vienna * age ≥18 * expectancy to stay in the icu ≥24hours * clinical necessity for a urinary catheter exclusion criteria: * anuria
effects of prevention in school (ps): a swedish school-wide positive behavior support program at the primary prevention level

Conditions: Problem Behaviors Among Students; Classroom Learning Environment

Summary: prevention in school (ps) is a modified school-wide positive behavior support program at the universal prevention level, developed by swedish researchers for the school years 4 -9. by defining and teaching school rules to all teachers and students, and by consistently acknowledging students when meeting behavioural expectations, the program aims to reduce problem behaviours in school areas and to improve the classroom learning climate. against this background, the purpose of this study is to examine whether ps is more effective than schools' ordinary practices in meeting these goals.


Eligibility criteria:
inclusion criteria: * schools situated in stockholm county and in bordering counties within travelling distance from stockholm. * comprising the grades 4-9 (10-15 years). * a minimum of 2 classes/50 students in each of the grades 5-7. * a majority (min.80%)of the staff is positive towards program participation. * school management willing to take active part in change/developmental work. * a willingness to submit to study conditions (randomization etc) exclusion criteria: * participation in other ongoing research projects.
performance of the dexcom g6 continuous glucose monitoring (cgm) system in pregnant women with diabetes mellitus

Conditions: Diabetes

Summary: the purpose of this prospective observational study is to establish the performance and safety of the dexcom g6 cgm system utilized for up to a 10-day wear period in pregnant women with diabetes mellitus.

primary study objective: to determine the accuracy of dexcom g6 cgm system glucose readings in reference to arterialized venous sample ysi glucose measurements in pregnant women with diabetes mellitus. secondary study objective: to assess the safety of the dexcom g6 cgm system, through characterization of device-related adverse events (aes), in pregnant women with diabetes mellitus.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. currently in the 2nd or 3rd trimester of pregnancy; 3. diagnosis of gdm, t1dm, or t2dm; 4. willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site; 5. able to follow study procedures; 6. able to speak, read, and write in english or spanish. exclusion criteria: 1. extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites; 2. known allergy to medical-grade adhesives; 3. hematocrit of \< 30%; 4. prescribed tocolytic drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications, including, but not limited to, pre-eclampsia or hellp syndrome (hemolysis, elevated liver enzymes, and a low platelet count) during current pregnancy; 5. currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period; 6. require a magnetic resonance imaging (mri) scan, computed tomography (ct) scan, or diathermy during the sensor wear period; 7. current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study.); 8. working for a competitive medical device company or having an immediate family member or person living within the same household who works for such a company (e.g., medtronic, glysens inc., abbott laboratories, roche, senseonics, waveform, and ascencia/poctech); 9. any condition that, in the opinion of the investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose excessive risk to study staff handling venous blood samples (e.g., known history of hiv or hepatitis b or c).
novel nutrition solutions for sarcopenia

Conditions: Sarcopenia

Summary: this study will examine the effect of leucine-enriched protein supplementation, alone and in combination with long chain n-3 polyunsaturated fatty acids (lc n-3 pufa), on muscle mass and function in older adults at risk of sarcopenia. the investigators hypothesize that lc n-3 pufa supplementation will further enhance the efficacy of the leucine-enriched protein.

the progressive loss of skeletal muscle mass and function with advancing age, termed sarcopenia, contributes substantially to disability, physical dependence, and mortality among older adults. aging is associated with an attenuated muscle protein synthetic response to the ingestion of small to moderate protein doses compared to younger persons. several studies have reported that the acute, postprandial muscle protein synthesis (mps) response to a suboptimal protein dose is enhanced when the leucine content of the protein bolus is increased. this indicates that supplementing the lower-protein daily meals (i.e., breakfast and lunch) with leucine may represent a practical strategy to augment the mps response to these meals and, subsequently, attenuate sarcopenic muscle mass loss over time. in addition, lc n-3 pufa supplementation has been shown to enhance the mps response to amino acid infusion older adults suggesting that combined leucine and lc n-3 pufa supplementation be particularly effective for improving daily mps, muscle mass and function in older adults.

Eligibility criteria:
inclusion criteria: * age: ≥65 y * sex: males and females * low muscle mass (assessed via bioelectrical impedance analysis using cut-offs from janssen, 2004) and/or low handgrip strength (\< 30 kg men, \<20kg women) exclusion criteria: * bmi \>35 kg/m2 * cancer - malignancy in the past 5 years * multiple sclerosis, parkinsons disease * chronic kidney disease * liver failure * diabetes * conditions that will affect ability to consume, digest and/or absorb the study drink (i.e. cows milk protein allergy, inflammatory bowel disease) * smokers * cognitive function \< 21 on mini-mental state examination * excess alcohol intake * regular resistance training * total walking incapacity * musculoskeletal or neuromuscular impairments that could interfere with strength testing * medications interfering with muscle metabolism * adherence to a high energy or high protein diet three months before starting and during the study. use of protein containing or amino acid containing nutritional supplements three months before starting and during the study. * high consumers of oily fish. * weight change \> 3 kg past 3 months
heavy metal exposure in predicting peripheral neuropathy in patients with stage i-iii breast cancer undergoing chemotherapy

Conditions: Male Breast Cancer; Neurotoxicity; Peripheral Neuropathy; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Summary: this research trial studies heavy metal exposure in predicting peripheral neuropathy in patients with stage i-iii breast cancer undergoing chemotherapy. studying samples of blood and urine in the laboratory for heavy metal exposure from patients receiving chemotherapy may help doctors find out whether side effects from chemotherapy are related to heavy metal exposure.

primary objectives: i. to describe the correlation, if any, of specific heavy metals with high grade symptoms of peripheral neuropathy, defined as grade \>= 3 peripheral neuropathy, (utilizing the common terminology criterial for adverse events \[ctcae\] version \[v.\] 4.0) in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy. secondary objectives: i. to characterize the range of specific heavy metals in a cohort of breast cancer patients undergoing (neo)adjuvant chemotherapy treatment. ii. to evaluate the reproducibility of sera and urine testing of heavy metal levels by inductively coupled plasma mass spectrometry (icp-ms) testing in a cohort of breast cancer patients undergoing (neo)adjuvant taxane chemotherapy. outline: patients undergo serum and urine sample collection for heavy metal analysis by icp-ms at baseline and at the completion of treatment. patients also complete neurotoxicity assessment questionnaire at baseline and at the completion of treatment.

Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed invasive mammary carcinoma; any histologic sub-type allowed * patients must be diagnosed with stage i, ii or iii breast cancer * patients must be undergoing treatment with an adjuvant or neoadjuvant cytotoxic chemotherapy that includes a taxane, specifically paclitaxel, nab-paclitaxel (abraxane), or docetaxel * patients may have received prior endocrine and/or radiation therapy * patients must have the ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients who have been previously treated with cytotoxic chemotherapy * patients with pre-existing peripheral neuropathy
nebulized pl for post-covid-19 syndrome

Conditions: Covid19

Summary: to evaluate and compare nebulized platelet lysate to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-covid-19 ards syndrome.

this is a double-blind, randomized, placebo controlled single-center study using nebulized platelet lysate compared to placebo control of saline administered via handheld nebulizer 1x daily for eight weeks to determine effect on lung function in patients with post-covid-19 ards syndrome. 20 patients randomized to treatment group: inhaled nebulized platelet lysate (pl) 1x daily for eight weeks 20 patients randomized to control group: inhaled nebulized saline, 1x daily for eight weeks. outcomes will be measured at 4-weeks, 8-weeks, 3-months, 6- months goals for this study are as follows: 1. investigate and compare the efficacy of autologous pl inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 4-weeks compared to saline control (phase 1), early treatment timepoint. 2. investigate and compare the efficacy of autologous pl inhaled via handheld ultrasonic nebulizer, 2-ml once per day for 8-weeks compared to saline control (phase 1), final treatment timepoint. 3. investigate, compare, and monitor long term function and quality of life through 6-months for treatment arm compared to control.

Eligibility criteria:
inclusion criteria: 1. voluntary signature of the irb approved informed consent 2. at least 4-weeks post ventilator or oxygen dependent ards treated for at least 48 hours in the icu 3. patient is stable enough to have been discharged home 4. male or female ages 18-85 5. two weeks to 1-year post hospital discharge 6. ongoing activity intolerance due to dyspnea related to ards 7. is independent, ambulatory, and can comply with all post-operative evaluations and visits 8. 6-minute walk test distance of \< 450 m 9. sf-36 physical component score \< 60 10. ards caused by viral pneumonia including covid-19 confirmed through an rna anti-body test 11. normal to mild post-ards reactive airway disease exclusion criteria: 1. oxygen dependent on nasal canula greater than 2-l per minute 2. dependent on inhaled corticosteroid at the discretion of the physician 3. unable to complete any of the outcomes measured (spirometry, 6mwd, sf-36, etc.) 4. active known secondary bacterial or viral infection 5. active moderate or severe post-ards reactive airway disease at the discretion of the physician 6. pre-morbid copd 7. medication list will be reviewed on a case by case basis to allow for flexibility as post-covid-19 patients' medication list may vary 8. other medical comorbidities/conditions that may preclude participation in the study
study of tumor tissue samples from patients with stage i, stage ii, or stage iii malignant melanoma

Conditions: Melanoma (Skin)

Summary: rationale: studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. purpose: this research study is looking at tumor tissue samples from patients with stage i, stage ii, or stage iii malignant melanoma.

objectives: * determine the genetic profile of primary melanomas with and without synchronous regional nodal involvement by examining for 1) activating mutations b-raf and n-ras associated with melanoma development, and 2) allelic imbalances across the genome. * compare the genetic profile of primary melanomas from patients with and without lymph node involvement. * determine the combinations of genetic lesions that correlate with nodal metastasis by adopting a statistical machine learning approach to build a lesion-based classifier for nodal metastasis. outline: laser capture microdissection is performed on the archived tissue samples to isolate melanoma cells. dna is then purified from the samples and amplified using pcr. matrix-assisted laser desorption/ionization (maldi)-time of flight mass spectrometry technology is used to detect mutations of b-raf and n-ras. single nucleotide polymorphism arrays are also performed. information about the patient's demographics (e.g., tnm staging, sex, age, and tissue collection dates) will be gathered by chart review or from the multidisciplinary melanoma conference at university hospitals tumor conference report in order to match cases.

Eligibility criteria:
inclusion criteria: * node positive group (experimental group) * primary melanoma \> 2 mm in depth * metastasis must be \> 0.1 mm and detectable by ihc or hematoxylin and eosin (h\&e) to be considered node positive * slides and block for primary and node must be archived in uh dermatopathology * node negative group (control group) * primary melanoma \> 2 mm in depth * a negative sentinel lymph node must be negative by ihc and h\&e * no stage iv disease * no acral and mucosal histology * no history of prior invasive melanoma * underwent primary excision and sentinel lymph node biopsy within 3 months of each other * archived tissue available * slides and block for primary tumor and node biopsy must be archived in university hospitals case medical center (uh) dermatopathology exclusion criteria: * acral and mucosal histology * previous diagnosis of invasive melanoma * previous chemotherapy or immunotherapy * patients who are found to have stage iv disease during workup

Keywords: stage i melanoma stage ii melanoma stage iii melanoma