Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of brinzolamide/brimonidine fixed combination

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to compare the safety and intraocular pressure (iop)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (brinz/brim) to: * its individual components (brinz and brim), and * the concomitant administration of brinz and brim (brinz+brim).

this study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at week 2 and week 6 (or early exit). a washout period based on previous ocular medication preceded eligibility visit 1. subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 4 study drug groups for 6 weeks. study drug instillation began the morning after the second eligibility visit. the study was terminated by the sponsor out of caution due to microgel formation in the brinz/brim formulation. 13 remaining active subjects were discontinued. further analysis revealed that neither the drop size nor the concentration of the active ingredients was affected.

Eligibility criteria:
inclusion criteria: * sign informed consent document. * diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s. * other protocol-specified inclusion criteria may apply. exclusion criteria: * females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. * any form of glaucoma other than open-angle glaucoma. * severe central vision loss in either eye. * chronic, recurrent, or severe inflammatory eye disease. * ocular trauma within the preceding 6 months. * ocular infection or ocular inflammation within the preceding 3 months. * clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. * best-corrected visual acuity score worse than 55 letters using the early treatment diabetic retinopathy study chart. * other ocular pathology (including severe dry eye) that may, in the opinion of the investigator, preclude the administration of study product. * ocular surgery within the preceding 6 months. * ocular laser surgery within the preceding 3 months. * any abnormality preventing reliable applanation tonometry. * any other conditions, including severe illness, which could make the patient, in the opinion of the investigator, unsuitable for the study. * other protocol-specified exclusion criteria may apply.

Keywords: open-angle glaucoma ocular hypertension brinzolamide brimonidine intraocular pressure
out patient talc slurry via indwelling pleural catheter for malignant pleural effusion vs usual inpatient management

Conditions: Pleural Effusion, Malignant

Summary: this is a multicentre randomised controlled trial evaluating global health related quality of life outcomes in patients with malignant pleural effusions. patients will be randomised to receive either chest drain and talc pleurodesis or indwelling pleural catheter and talc pleurodesis. patients will be followed up for 3 months post intervention


Eligibility criteria:
inclusion criteria: 1. diagnosis of malignant pleural effusion 2. who performance status 2 or less unless performance status is impaired by presence of effusion and likely to significantly improve with drainage 3. expected survival greater than 3 months exclusion criteria: 1. age less than 18 years old 2. pregnant or lactating 3. known allergy to talc or lignocaine 4. lack of symptomatic relief from effusion drainage 5. at least twice weekly drainage cannot be undertaken 6. lymphoma or small cell carcinoma except\*: 1. failure of chemotherapy 2. deemed for palliative management 7. non malignant effusions 8. loculated pleural effusion 9. unable to provide written informed consent to trial participation
regulatory pms study for lucentis® in patients with retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: this study is an open-labeled, multicenter, single arm, observational post-marketing surveillance study under routine clinical practice with no mandated treatments, visits or assessments.

the investigators will collect safety information and evaluate effectiveness in patients who are prescribed with lucentis® (ranibizumab) injection in retinopathy of prematurity indication after receiving informed consent over a period of 4 weeks. subjects who received multiple doses, i.e., 2 or more doses, of lucentis® injection will be defined as subjects with long-term use, and the safety and effectiveness information of up to 12 weeks will be collected and analyzed separately.

Eligibility criteria:
inclusion criteria: 1. premature infants with retinopathy of prematurity (rop) 2. patients (infants) prescribed with lucentis® injection according to the product approval information in the republic of korea 3. in the case that the legal guardian of the patient (infant) provided a written consent to participate in this study exclusion criteria: 1. in the case that the legal guardian of the patient (infant) does not want participation in this study 2. in the case that it falls under any of the contraindications listed in local prescribing information of lucentis® injection * patients with hypersensitivity to the active substance or to any of the excipients * patients with an active or suspected ocular or periocular infection. * patients with active intraocular inflammation

Keywords: retinopathy of prematurity nis post-marketing surveillance lucentis ranibizumab korea
efficacy of newborn vitamin a supplementation versus placebo in improving child survival (neovita trial)

Conditions: Neonatal Vitamin A Supplementation

Summary: the study is a large randomized controlled trial to assess the efficacy and safety of neonatal vitamin a supplementation administered to neonates once orally either on the day of birth or in the next 2 days in improving infant survival in the first 6 months of life.

the study is an individually randomized trial conducted in two districts in the state of haryana. community informants report births to the enrolment team. at enrolment, the team explains the study to the family and in those willing, written consent is obtained from the parents of the infant. the infant is given the dose of vitamin a/placebo and a form containing baseline socioeconomic characteristics and information on feeding practices of the infant and mother is filled. after enrollment, each infant is visited by the enrollment team at hospital or home 1 day and 3 days after supplementation to document any illnesses in the baby. newborns with illnesses are referred/escorted to the nearest health facility for management. enrolled infants are visited when aged 29 days, 3, 6 and 12 months to document vital status and hospitalizations since the last visit. information on feeding practices, immunization, maternal intake of vitamin a rich foods and supplements, and intake of any supplement containing vitamin a by the infant is recorded at these visits. subgroup analyses includes the effect of vitamin a supplementation in lbw and non lbw infants, male and female infants, immunized and unimmunized infants, infants of families in the poorest and richest quintiles and by vitamin a intake of mothers. for all deaths, verbal autopsy interviews are conducted. blood specimens are obtained in a subsample of infants at 2 weeks and 3 months of age and in a subsample of mothers at 3 months of age. quality control activities include independent and supervised checks and are conducted for a subsample by a separate team. a dsmb has been constituted for the study. all deaths occurring within 72 hours of supplementation will be reported to the sas erc and to the who coordinating unit. at the recent dsmb meeting in february 2012, the dsmb recommended an increase in sample size to 45,000 instead of the earlier estimate of 40,200 because of somewhat lower than expected mortality rates. this increase in sample size is expected to preserve the specified power of 0.85 and the corresponding level of precision anticipated at the design stage. similar trials are being funded by the world health organization (geneva) in ghana and tanzania.

Eligibility criteria:
inclusion criteria: * consent to participate * all births in the study area that are contacted by enrolment team within the eligible age window exclusion criteria: * unable to feed on offering feeds, as reported by the mother * mother does not intend to stay in the study area for at least 6 months

Keywords: vitamin a neonatal mortality infant mortality
mitoq treatment of claudication: myofiber and micro-vessel pathology

Conditions: Peripheral Arterial Disease

Summary: in our research, we are delving into whether taking mitoq for six months can improve the symptoms and function of people diagnosed with peripheral artery disease, especially those who suffer from leg pain while walking, known as intermittent claudication. we will be checking if mitoq helps people with claudication walk better, be more active every day, feel better about their lives, and if it enhances the health of their leg muscles.

this study will investigate whether taking mitoq for six months can improve the walking ability, daily activity levels, and quality of life of people with claudication (leg pain) caused by peripheral artery disease (pad). we'll also look at how mitoq affects their calf muscles. here's what we'll be checking: muscle health: we'll examine muscle tissue samples under a microscope to see if mitoq improves muscle health and function. body chemistry: we'll check blood tests to see if mitoq affects overall health markers. mitochondrial health: we'll see if mitoq reduces damage to mitochondria (the cell's powerhouses) and helps the body get rid of damaged ones. we'll also see if it improves how well mitochondria function. blood flow: we'll measure blood flow in the legs and see if mitoq improves the function of tiny blood vessels in the calf muscles. in short, we want to see if mitoq can improve various aspects of health in people with claudication and pad, and if these improvements are linked to better functioning mitochondria in their muscles.

Eligibility criteria:
inclusion criteria: 1. a positive history of chronic claudication 2. exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon 3. documented lower extremity arterial occlusive disease based on ankle/brachial index measurements and/or arterial imaging 4. stable blood pressure, lipid and diabetes regimens and risk factor control for 6 weeks. exclusion criteria: 1. rest pain or tissue loss due to pad (fontaine stage iii and iv) 2. acute lower extremity ischemic event 3. walking capacity significantly and primarily limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology.
non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation - effects on ptsd

Conditions: Stress Disorders, Post-Traumatic; Depression; Anxiety

Summary: through many years, the standard care has been to use continuous sedation of critically ill patients during mechanical ventilation. however, preliminary randomised clinical trials indicate that it is beneficial to reduce the sedation level in these patients. the nonseda trial is an investigator-initiated, randomised, clinical, parallel-group, multinational, superiority trial designed to include 700 patients from at least six icus in denmark, norway and sweden, comparing no sedation with sedation and a daily wake-up trial during mechanical ventilation. this is a substudy of the nonseda trial, concerning 250 patients included at trialsite kolding, denmark. the aim of the substudy is to assess the effects of no sedation on posttraumatic stress disorder after discharge from icu. our hypothesis is that critically ill patients who are not sedated during mechanical ventilation will have less posttraumatic stress disorder after discharge.


Eligibility criteria:
inclusion criteria: * endotracheally intubated * expected time on ventilator \> 24 hours * age ≥ 18 years * informed consent exclusion criteria: * severe head trauma where therapeutic coma is indicated * therapeutic hypothermia where therapeutic coma is indicated * status epilepticus where therapeutic coma is indicated * patient has participated in the study before * patient is transferred from another icu with length of stay \> 48 hours * patient is comatose at admission * pao2/fio2 ≤ 9, if sedation is necessary for oxygenation * patient does not speak danish, swedish or norwegian at a reasonable level

Keywords: critical care respiration, artificial
study of bhv-1300 in graves' disease

Conditions: Graves Disease

Summary: the purpose of this study is to determine if bhv-1300 is a safe and effective treatment in participants with graves' disease.


Eligibility criteria:
key inclusion criteria: 1. participants must have serologically confirmed graves' disease. 2. participants must have active hyperthyroidism due to graves' disease. key exclusion criteria: 1. history of hyperthyroidism not caused by graves' disease (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within six weeks of the baseline visit. 2. history of treatment with radioactive iodine or thyroid surgery.

Keywords: autoimmune thyroid disease hyperthyroidism anti thyroid drug thyroid disease autoimmune diseases endocrine system diseases
user satisfaction of customised 3d printed ankle-foot orthosis in comparison to thermoformed ankle-foot orthosis for patients with neurological conditions: a preliminary study

Conditions: Stroke; Spinal Cord Injuries; Nerve Palsy

Summary: study design and subject recruitment: this was a cross-sectional study in a single centre outpatient setting at the foot care and limb design centre, tan tock seng hospital. as this was a proof-of-concept clinical trial for the introduction of 3d printed afos as a patient service, only 5 subjects were recruited based on consecutive sampling. interventions: thermoformed afos moulded over the subject's lower limb plaster model served as the control intervention. the plaster models were rectified by an orthotist with over 20 years of experience and the afo design was determined according to the subject's clinical presentation and needs. the afos were manufactured from 4 - 5mm thick homopolymer polypropylene. 3d printed afos served as the treatment intervention. it was fabricated through 3d scanning with an artec eva 3d scanner (artec 3d, luxembourg, luxembourg) and an adjustable perspex glass foot plate, cad modelling with the ortenshape software (proteor, saint-apollinaire, france), and printed using fused deposition modelling with the fortus 450mc (stratasys, minnesota, united states). the 3d printed afo is printed of polyamide nylon-12 material in the same thickness as the thermoformed afo. there were no blinding procedures as both interventions were distinctly different and it is not possible to blind subjects with daily use of the afos. trial schedule: a thermoformed and a 3d printed afo were fitted to each subject in a single session. the quest survey was administered post-fitting. subjects brought home both afos and were instructed to wear them during ambulation, alternating between the afos daily. subjects returned for follow-up at 3 weeks and 6 weeks post-fitting for necessary adjustments and the administration of the quest surveys was repeated for each afo.


Eligibility criteria:
inclusion criteria: * existing patients of the centre, * clinical need for an afo due to neurological disorders. exclusion criteria: * cognitive impairment * lower limb volume fluctuations * severe foot/ ankle varus or valgus deformities * lower limb contractures of over 10° * non-community ambulators

Keywords: 3d print digitisation ankle-foot orthosis user satisfaction
a phase iii study assessing the efficacy and safety of de-117 ophthalmic solution compared with timolol maleate ophthalmic solution 0.5% in subjects with glaucoma or ocular hypertension - spectrum 3 study

Conditions: Glaucoma and Ocular Hypertension

Summary: this is a phase iii, randomized, double-masked, active-controlled, parallel-group, multi-center study. subjects diagnosed with glaucoma or oht who meet eligibility criteria at visit 1 (screening) will washout of their current topical iop-lowering medication(s), if any. after completing the required washout period, subjects will return for visit 2 (baseline, day 1). subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months. adult subjects will receive open-label de-117 ophthalmic solution for an additional 9 months. approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or oht who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either: * de-117 ophthalmic solution once daily and vehicle once daily, or * timolol maleate ophthalmic solution 0.5% twice daily. the study will evaluate the efficacy and safety of de-117 ophthalmic solution compared with timolol maleate ophthalmic solution 0.5% in subjects with glaucoma or oht through month 3 and will provide additional safety data through month 12 for subjects receiving de-117.


Eligibility criteria:
inclusion criteria: • glaucoma or ocular hypertension exclusion criteria: * females who are pregnant, nursing, or planning a pregnancy * any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
psoas compartment block versus periarticular local anesthetic for total hip arthroplasty

Conditions: Osteoarthritis; Arthroplasty

Summary: the primary objective of this study is to examine whether there is a difference in the level of resting pain following total hip arthroplasty with an anterior approach with use of a psoas compartment block versus a local periarticular anesthetic infiltration

a single-center, prospective, randomized clinical trial with a total of 100 patients. one orthopaedic adult reconstruction surgeon at beaumont hospital royal oak (jjv) will perform all surgeries. after the patient has consented they will be randomized to one of the following two groups: 1. psoas compartment block (n=50) 2. periarticular local anesthetic infiltration (n=50), the patient will be blinded to the study group.

Eligibility criteria:
inclusion criteria: * patients undergoing unilateral primary total hip arthroplasty by dr. james verner at beaumont hospital royal oak * have a diagnosis of primary osteoarthritis (i.e. degenerative joint disease) * surgical approach is anterior exclusion criteria: * minors (age less than 18 years) * pregnant (surgically sterile, post-menopausal, or negative blood test) * previous ipsilateral hip surgery * lumbar instrumentation * acute trauma * rheumatoid arthritis * avascular necrosis * hip dysplasia * known sensitivity, allergy, or contraindication to anesthetics being used in the study * narcotic sensitivity * history of over 6 months of opioid dependency prior to surgery (excluding tramadol) * peripheral neuropathy * mental/cognitive impairment that would interfere with the patient's self-assessments of function, pain, or quality of life
long-term study in patients with chronic kidney disease and hyperphosphatemia on hemodialysis

Conditions: Chronic Kidney Disease; Renal Dialysis; Renal Insufficiency; Hyperphosphatemia

Summary: this is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of asp1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.


Eligibility criteria:
inclusion criteria: * chronic kidney disease patients on hemodialysis * hyperphosphatemia * written informed consent exclusion criteria: * patients with gastrointestinal surgery or enterectomy * severe cardiac disease patients * patients with severe constipation or diarrhea * patients with a complication of malignant tumors * patients with uncontrolled hypertension * patients treated with parathyroid intervention

Keywords: hyperphosphatemia hemodialysis ckd asp1585
mhealth family self-management

Conditions: Transplantation; Pediatric ALL

Summary: this innovative research will address a gap in the literature involving the evaluation of the impact of an individualized family-centered mhealth application to enhance daily post-discharge communication following pediatric transplant. this proposal lays the foundation for future research with myfami (self-management intervention) at multiple pediatric transplant centers and builds the science from which to consider post discharge monitoring and decrease cost of care in other pediatric chronic illness populations.


Eligibility criteria:
inclusion criteria: pediatric patients: 1. has undergone a heart, kidney, or liver transplant being discharged home from the hospital 2. has two eligible family members available to answer questions about the patient family members will be eligible for participation upon meeting the following inclusion criteria: 1. is english speaking (to date the instruments being used have been validated for english speaking participants only) 2. is 18 years of age or older 3. has a pediatric family member (\< 18 years old) who has undergone a heart, kidney, or liver transplant being discharged home from the hospital. exclusion criteria for the family members are: 1. presence of significant communication or cognitive impairment that would preclude completion of questionnaires based on self-report; or 2. the pediatric family member has experienced a previous transplant based on self report. participants unable to speak and read english will be excluded due to the lack of resources to develop the app and communicate via facetime in different languages. we will recruit family members from three types of transplant populations to allow for sufficient sample in a limited time frame for this complex pediatric surgery and high-risk population. -
linagliptin as add on therapy to empagliflozin 10 mg or 25 mg with background metformin in patient with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the study is to investigate the efficacy, safety and tolerability of linagliptin 5 mg qd compared to placebo given for 24 weeks in inadequately controlled t2dm patients on empagliflozin 10 mg or 25 mg and maximum tolerated dose of metformin. the primary objective of efficacy evaluation is planned after 24 weeks of treatment. the study is designed to show superiority of the combination of empagliflozin and linagliptin over empagliflozin alone.


Eligibility criteria:
inclusion criteria: 1. signed and dated icf (informed consent form) 2. male or female on diet and exercise regime and on stable background metformin \> or equal to 1500 mg or maximun dose according to local label 3. hba1c (glicoslated hemoglobin) \> or equal to 8% and \< or equal to 10.5 % at visit 1 4. hba1c \> or equal to 7 and \< or equal to 10.5 at visit 4 5. age \> or equal to 18 years 6. bmi (body mass index) \< or equal to 45 exclusion criteria: 1. uncontrolled hyperglycemia during open label period and placebo add on "run-in" period 2. use of any other antidiabetic 3. renal function below 60 ml/min/1.73 m2 4. antiobesity drugs or aggresive diets 5. gastorintestinal surgeries 6. current systemic steroids or uncontrolled endocrine disorders other than diabetes type 2 7. acute coronary syndrome and stroke within 3 months of informed consent 8. known allergies to dpp-iv (dypeptidil peptidase iv) or sglt-2 (sodium glucose transporter 2) inhibitors