Kornimate/medical-research-clean huggingface dataset:
a dose-optimization study of aldurazyme® (laronidase) in patients with mucopolysaccharidosis i (mps i) disease

Conditions: Mucopolysaccharidosis I; Hurler's Syndrome; Hurler-Scheie Syndrome; Scheie Syndrome

Summary: the main purpose of this study is to evaluate differences in the pharmacodynamic response of 4 aldurazyme® (laronidase) dose regimens in patients with mucopolysaccharidosis i (mps i).


Eligibility criteria:
inclusion criteria: * have a documented diagnosis of mps i, confirmed by measurable clinical signs and symptoms of mps i, and a documented fibroblast or leukocyte α-l-iduronidase enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory. * weigh at least 12.5 kg. * have serum creatinine and blood urea nitrogen (bun) values within age appropriate normal ranges. * provide signed, written informed consent prior to any protocol-related procedures being performed. consent of a legally authorized guardian(s) is (are) required for patients under 18 years. if the patient is under 18 years old and can understand the consent, written informed consent will be required from both the patient and the authorized guardian(s). exclusion criteria: * have previously received aldurazyme® (laronidase). * have a suspected hypersensitivity to aldurazyme® (laronidase) or known hypersensitivity to components of the infusion solution. * have previously undergone hematopoietic stem cell transplantation (hsct; i.e., from bone marrow \[bmt\], peripheral blood, or umbilical cord blood) or other major organ transplantation. * have a medical condition, serious inter-current illness, or other extenuating circumstance that may interfere with study compliance including all prescribed evaluations and follow-up activities, except the 6mwt. (note: all patients may not be capable of performing the 6mwt due to age and/or maturity level. exemption from performing the 6mwt must be obtained in writing by the investigator from the sponsor's medical monitor prior to enrollment). * have an acute illness that requires surgical intervention, and/or anticipates surgery during study participation, and/or has had surgery within 30 days prior to study enrollment. * have received an investigational drug within 30 days prior to study enrollment. * is pregnant or lactating. female patients of childbearing potential must have a negative pregnancy test \[urine β-human chronic gonadotropin (hcg)\] at entry (prior to the first infusion). note: all female patients of childbearing potential and sexually mature males must be advised to use a medically accepted method of contraception throughout the study.
effect of probiotics and prebiotics in renal function in septic acute kidney injury patients

Conditions: Acute Kidney Injury; Probiotics; Sepsis

Summary: septic acute kidney injury is a condition associated with highly related to inflammatory molecules. prebiotics and probiotics have shown to improve inflammatory cascade in animal model; in this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.

acute kidney injury is most commonly caused by sepsis, where endotoxemia and an expanding inflammatory reaction play a key role in its pathogenesis, when this condition is present it is highly related to poor clinical outcomes and higher mortality rates. there is no current specific treatment, and the therapeutic approach is more orientated to complication management. in this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.

Eligibility criteria:
inclusion criteria: * sepsis by sofa * acute kidney injury by kdigo exclusion criteria: * no presence of sepsis * no presence of aki * age below 18 years * inability or contraindication for oral capsules or probiotics by nasogastric tube

Keywords: acute kidney injury probiotics sepsis shock
dexmedetomidine as an adjuvant to bupivacaine in bilateral pecs for pain control after cardiac surgeries

Conditions: Post Operative Pain

Summary: the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral pecs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision.

background: good postoperative analgesia in cardiac surgical patients helps in early recovery and ambulation. an alternative to parenteral, paravertebral, and thoracic epidural analgesia can be pectoralis nerve (pecs) block, which is a novel, less invasive regional analgesic technique. the study aims to test the quality of analgesia provided by dexmedetomidine as an adjuvant to bupivacaine bilateral pecs block in patients scheduled for cardiothoracic surgeries with median sternotomy incision. sixty adult patients between the age groups of 25 and 65 years undergoing coronary artery bypass grafting or valve surgeries through midline sternotomy under general anesthesia were enrolled in the study. patients were randomly allocated into two groups with 30 ineach group. group 1 patients will receive bilateral pecs block, whereas group 2 patients will receive bilateral pecs block with dexameditomedine postoperatively. patients will be extubated once they fulfilled extubation criteria. ventilator duration will be recorded. patients will be interrogated for pain by visual analog scale (vas) scoring at rest and cough. inspiratory flow rate will be assessed using incentive spirometry.

Eligibility criteria:
inclusion criteria: * all adult patients between the age groups of 25 and 65 years undergoing either coronary artery bypass grafting (cabg) or valve surgeries through midline sternotomy under general anesthesia exclusion criteria: * skin erosions, hematomas or infection at the injection site. * coagulopathy, act more than 150 seconds * history of hypersensitivity to bupivacaine or dexametomedine. * the patients who are unable to use the pain score. * patients who will need prolonged post-operative ventilation or inotropic support.

Keywords: pecs dexameditomedine
pediatric asthma-educator

Conditions: Asthma

Summary: this project seeks to develop and pilot test the pediatric asthma-educator mobile application.

this project seeks to develop and pilot test the pediatric asthma-educator mobile application. the study is being conducted at montefiore medical center among pediatric (7-17 years old) patients with persistent asthma. we are collecting process and clinical outcomes in a longitudinal study design.

Eligibility criteria:
inclusion criteria: english-speaking individuals between 7-17 years with: * persistent asthma (diagnosis made by a healthcare provider) on a daily controller medication * able to give informed consent * smartphone (ios or android) access exclusion criteria * use of oral corticosteroids in the 2 weeks prior to the baseline visit * pregnancy * severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol * patients that previously received the asthma-educator application

Keywords: asthma
long term safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in south africa. the aim of this trial is to investigate long term safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in trial biasp-1240.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any trial-related activities according to local requirements. (trial-related activities are any procedure that would not have been performed during normal management of the subject) * the subject must have completed the trial biasp-1240
long-term survival outcomes according to the pathologic response after neoadjuvant treatment in pdac and the fate of the patients with good cap grade

Conditions: Pancreatic Cancer; Neoadjuvant Therapy; Pathological Complete Response

Summary: 1. neoadjuvant treatment (nat) is increasingly used in managing pancreatic ductal adenocarcinoma (pdac), necessitating dependable methods to evaluate tumor response. 2. among various pathological tumor regression grading systems, the college of american pathologists (cap) system is commonly used to predict chemo-responsiveness and survival. 3. this study aimed to analyze long-term survival outcomes based on pathologic response using the cap grade after nat in pdac and to identify clinicopathologic factors that influence a favorable pathologic response.


Eligibility criteria:
inclusion criteria: * adult patients (aged \&gt;18 years) who underwent pancreatic resection after nat at a single center between january 2009 and december 2023. * patients were initiated on nat after confirming pdac diagnosis based on pathological examination. exclusion criteria: * patients without a reported cap grade * patients who underwent palliative surgery * patients who received nat outside the specified protocol due to incomplete information.

Keywords: cap grade tumor response grading system
study to compare the oestradiol suppression, clinical efficacy and safety of two formulations of triptorelin (triptorelin pamoate pr 3-month and triptorelin acetate pr 1-month) in chinese subjects with endometriosis

Conditions: Endometriosis

Summary: to assess the efficacy of triptorelin pamoate prolonged release (pr) 3-month formulation in chinese female subjects with endometriosis by demonstrating the non-inferiority of triptorelin pamoate pr 3-month formulation injected once as compared to triptorelin acetate pr 1-month formulation injected 3 times consecutively.


Eligibility criteria:
inclusion criteria: * female subjects aged from 18 to 45 years inclusive at the date of informed consent. * a history of active and regular menstrual cycles of 21 to 35 days (inclusive) in the 6 months prior to the screening visit. * a diagnosis of endometriosis, confirmed by laparoscopy or laparotomy within10 years prior to the screening visit. * requires treatment with a gonadotrophin releasing hormone (gnrh) agonist for a period of 6 months in the judgement of the investigator. exclusion criteria: * a current history of undiagnosed abnormal genital bleeding. * received treatment with a gnrh agonist within 6 months prior to the screening visit. * received any other hormonal treatment within 3 months prior to the screening visit (oestrogens, progestogens, danazol, gestrinone and cyproterone acetate etc). * chronic pelvic pain that is not caused by endometriosis, that would interfere with the assessment of endometriosis-associated pelvic pain.
effects of non-invasive ventilation on rehabilitation outcome in copd-patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of copd in stages gold iii/ iv * receiving optimized medical treatment and long term oxygen therapy if needed * patients consent to participate in this trial * no treatment with niv in the last 4 weeks * treatment with niv in the last 4 weeks due to an acute exacerbation exclusion criteria: * treatment with niv in the last 4 weeks (except due to an acute exacerbation) * intolerance to perform niv * acute exacerbation at baseline or during pr * hypercapnia \> pco2 55mmhg * inability to perform a 6 minute walking test

Keywords: chronic obstructive pulmonary rehabilitation copd non invasive ventilation niv exercise capacity pulmonary rehabilitation
pilot study: geniculate artery embolization in knee osteoarthrosis.

Conditions: Osteoarthritis, Knee

Summary: geniculate artery embolization (gae) has recently been described and studied as a palliative treatment for osteoarthrosis-related knee pain in patients un-eligible for surgical intervention. this treatment is based on the hypothesis that hypervascularization and associated increased nerve proliferation are possible sources of chronic pain following the morphological changes of osteoarthrosis. a large animal model has shown digital subtraction arteriography to be well correlated to both the histological findings of synovial inflammation and synovial contrast enhancement on magnetic resonance imaging. this embolization technique has also been applied to other regions of the musculoskeletal system including the elbow and the shoulder.

primary objective confirm the efficacy and the effectiveness of geniculate artery embolization for pain control in knee osteoarthrosis. secondary objective evaluate the effectiveness of geniculate artery embolization for pain control in specific population: young patients between 18 and 50 years old with advanced osteoarthritis (kl grade 3 or 4) for whom an orthopedic surgeon has deemed a total knee arthroplasty is not an appropriate therapy, and whom have failed conservative management for at least 6 months. investigators propose a prospective pilot study on 40 patients with osteoarthrosis.

Eligibility criteria:
inclusion criteria: * 18 years and older * moderate to severe knee pain (visual analog scale (vas) \> 70 mm) * pain refractory to at least 6 months of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections) * localized pain on physical examination * kellgren-lawrence (kl) score on knee x-ray * patients 50 years old and over : grade 1, 2, 3 or 4 * 18-50 years old: kl grade 3 or 4 exclusion criteria: * current local infection * life expectancy less than 6 months * known advanced atherosclerosis * rheumatoid or infectious arthritis * prior knee surgery * uncorrectable coagulopathy including international normalized ratio (inr) \> 1.5 or platelets \< 50,000 * iodine allergy * renal dysfunction as defined by gfr \< 60ml/min obtained within the past 30 days. * diabetic patient * previous embolization of the geniculate arteries during the last year

Keywords: embolization, osteoarthritis, knee, geniculate artery
tissue-specific effects of insufficient sleep

Conditions: Healthy

Summary: this study plans to learn more about how sleep loss impacts the way the body responds to sugar. this work will have important implications for development of treatments and countermeasures for people who are not able to get enough sleep for various reasons.

participants will stay in the hospital for 6 days and will not be able to leave. sleep habits will be measured for 7 days before the study. a research diet that is designed to maintain weight will be provided for 3 days before the study and during the study. multiple tests will be performed, including metabolic testing and muscle and fat biopsies, both when participants first arrive and have had normal sleep and again after 4 nights of only 5 hours time in bed. the visit takes place at the clinical translational research center (ctrc) at the university of colorado denver, anschutz medical campus. it will take approximately 2 weeks to complete this study.

Eligibility criteria:
inclusion criteria: 1. healthy, lean participants. 2. no regular physical activity (\<20 minutes/day). no exercise will be allowed for 3 days prior to study start. 3. habitual sleep duration between 7-9.25h. subjects must also be willing and able to keep a 9h time-in-bed schedule for 1 week prior to study admission. 4. potential subjects must have lived at denver altitude or higher for at least 3 months to inpatient study. exclusion criteria: 1. current or history of any clinically significant medical, psychiatric, or sleep disorder. 2. use or history of any drugs, medications, supplements, caffeine, and alcohol. 3. current or history of shiftwork in six months prior to laboratory study. 4. travel more than one time zone in three weeks prior to laboratory study. 5. blood donation in the 30 days prior to inpatient study.

Keywords: sleep blood sugar
infuse morphine study

Conditions: Pain

Summary: double-blind study comparing the pharmacokinetics, safety and tolerability of morphine administered subcutaneously (sc) with and without human recombinant hyaluronidase (hylenex) and intravenously conducted in patients in a hospice care setting or through a palliative care medicine setting. in this within-patient controlled study, each eligible study patient receives a single injection by each of the three methods of morphine administration, sequentially on three consecutive days, according to the order specified by a randomization schedule. each of the three injections consists of 5 mg of morphine (1.0 ml of 5 mg/ml solution). the hylenex injection will be 1 ml of 150 units. although the iv administration will not be blinded, the two sc injections will be double-blinded, using the same volume of normal saline (0.9% sodium chloride) placebo (1.0 ml) as hylenex.


Eligibility criteria:
inclusion criteria: 1. males or females at least 18 years of age who are patients of san diego hospice \& palliative care or recruited through san diego hospice \& palliative care or the ucsd center for pain and palliative medicine. 2. during the treatment days of the study, on opioid therapy other than morphine that is equivalent to ≥ 60 mg oral morphine per day and without unacceptable toxicity. 3. vital signs (bp, hr, rr) within normal range. 4. adequate venous access in both upper extremities. 5. a negative pregnancy test (if female of child-bearing potential) within 7 days prior to first injection. 6. life expectancy ≥ ten days. 7. decision-making capacity. 8. signed, written irb-approved informed consent. - exclusion criteria: 1. known hypersensitivity or history of any toxicity to morphine. 2. morphine within the 4 days prior to the first study medication injection or anticipated to be receiving morphine during any of the treatment days in this study. 3. any contraindication to morphine. 4. known hypersensitivity to naloxone. 5. known allergy to hyaluronidase or any other ingredient in the formulation of hylenex. 6. known allergy to bee or vespid venom. 7. contraindication to iv heparin lock or known hypersensitivity to heparin. 8. edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh. 9. hemoglobin \< 10 g/dl. 10. presence of any other medical condition that would present an unacceptable safety risk to the patient. 11. participation in a study of any investigational drug or device within 30 days of enrollment in this study.

Keywords: hyaluronidase hylenex subcutaneous morphine absorption bioavailability pk study of morphine in patients with pain
fitostimoline vaginal pessaries in women with hysterectomy. randomized, perspective, monoscentric study.

Conditions: Vaginal Bleeding

Summary: clinical evaluation of fitostimoline vaginal pessaries in the treatment of hysterectomy. an observational, randomized, perspective study performed on 60 women where 30 women are treated with fitostimoline pessaries and 30 women are treated with the standard of care.


Eligibility criteria:
inclusion criteria: * patient aged between 35 and 80 years * patient undergoing hysterectomy * willingness to understand the procedures and aims of the study exclusion criteria: * anamnestic or clinical data of metabolic or endocrine diseases (such as uncontrolled diabetes mellitus) or any other local and / or systemic pathology potentially able to interfere with the study parameters; * concomitant treatment with antibiotics / antiseptics, nsaids, analgesics (excl. paracetamol) * non-therapeutic use of psychoactive substances; * abuse of drugs and / or alcohol / smoking; * neurological disorders or psychiatric conditions potentially capable of affecting the validity of the consent and / or compromising the patient's adherence to the study procedures; * known allergy, hypersensitivity or intolerance to the constituents of the preparations under study; * any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieving the objectives of the study, perfecting its completion; * presumption of poor reliability or collaboration; * treatment with any preparation in the last 30 days prior to the start of the study; * patients already enrolled in this study; * center staff directly involved in the study and close relatives
a double-blind, randomized conversion to monotherapy study to evaluate the efficacy and safety of brivaracetam in subjects (≥ 16 to 75 years old) with partial onset seizures

Conditions: Epilepsy

Summary: antiepileptic drugs (aeds) are the main treatment for epilepsy; however, only a limited number of aeds are approved for use as monotherapy. the objective of this study is to evaluate the efficacy of brivaracetam (brv) in the conversion of partial onset seizure patients from combination treatment to monotherapy


Eligibility criteria:
inclusion criteria: * subjects from 16 to 75 years, both inclusive * well-characterized focal epilepsy or epileptic syndrome * subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week baseline period * subjects on a stable dose of at least 1 but no more than 2 concomitant antiepileptic drugs (aeds) with the second aed ≤ 50 % of the minimum recommended maintenance dose exclusion criteria: * seizure type ia non-motor as only seizure type * history or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding visit 1 or during baseline * other serious uncontrolled disease

Keywords: epilepsy; monotherapy partial onset seizures adults and adolescents