Kornimate/medical-research-clean huggingface dataset:
istent inject in oag subjects on 2 pre-op topical ocular hypotensive medications

Conditions: Primary Open Angle Glaucoma (POAG)

Summary: the purpose of this study is to evaluate the intraocular pressure (iop) lowering effect of istent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.

the purpose of this study is to evaluate the intraocular pressure (iop) lowering effect of istent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. outcomes will be evaluated at 12 and 24 months.

Eligibility criteria:
inclusion criteria: * diagnosed with primary open angle glaucoma (poag) * subject on two ocular hypotensive medications exclusion criteria: * traumatic, uveitic, neovascular, or angle closure glaucoma * fellow eye already enrolled
a dual-center study evaluating clinical acceptance of a npwt wound care system

Conditions: Diabetic Foot Ulcer; Pressure Injury; Pressure Ulcer; Surgical Wound; Acute Wound; Traumatic Wound; Dehiscence; Edema

Summary: the purpose of this study is to determine if use of the medela invia motion npwt system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.

the primary objective is to evaluate whether clinical opinion of product performance results in expected wound response and outcomes when using the medela invia motion endure npwt system during 4-week study duration. \* goal of therapy will be defined by the physician according to initial assessment: endpoints (dependent on goal of therapy): * decrease in wound volume * decrease in size of the tunneling area * decrease in size of undermining * decrease in amount of slough * increase in granulation tissue * decrease in edema/periwound swelling * the wound bed is progressing acceptably towards a transition to another treatment modality such as moist wound healing (mwh), surgical closure, or a flap or graft. \*\*study endpoint will be determined by physician at the time of enrollment, when the goal of therapy is documented\*\*

Eligibility criteria:
inclusion criteria: * adult subjects ≥18 years of age. * signed, informed consent by patient or lar * patient is determined to be in need of npwt for treatment of a diabetic foot ulcer, pressure injuries, and pressure ulcer, surgical wounds, acute/traumatic wounds and dehisced wounds, abscesses, or to prepare the wound bed for grafting or closure and/or to decrease edema * patient is comfortable (e.g. not in pain) * patient is willing and able to adhere to treatment protocol. exclusion criteria: * patient not willing to comply with follow up (f/u) clinic visits * subjects with * necrotic tissue with eschar present * untreated osteomyelitis * non-enteric and unexplored fistulas * malignancy in wound * exposed vasculature * exposed nerves * exposed anastomotic site of blood vessels or bypasses * exposed organs * subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures. * patients with concurrent conditions or co-morbidities that in the opinion of the investigator may compromise patient safety or study objectives

Keywords: negative pressure wound therapy invia motion
ability of modulated imaging and laser speckle imaging to determine burn wound severity and healing potential

Conditions: Skin Burn Multiple

Summary: according to the national burn repository 2007, the most common type of burn injury is a partial thickness burns. the current standard of care for partial thickness burns is two weeks of topical therapy and wound care. burns that do not heal within two weeks undergo surgical excision and skin grafting.

researcher can use the combination of modulated imaging and laser speckle imaging can be used as an adjuvant to standard clinical evaluation to gauge burn wound and severity of infection. researcher can image the burn wounds of and compare with current standard of care, clinical exam, and can use the outcomes information in terms of time to healing and treatment modulating imaging is a noninvasive optical modality measure the metabolic functions of the burn wound. laser speckle imaging is a noninvasive optical modality can measure blood flow of burn wound.

Eligibility criteria:
inclusion criteria: 1. male / female all age 2. subjects is an inpatient or out patient with burn wound exclusion criteria: 1. subjects cannot lied flat and still for the duration of the imaging 2. subjects pregnant.

Keywords: burn wound
a study to evaluate the safety and efficacy of pac-14028 cream in pediatric atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a phase 1 and 2 study to assess the safety and efficacy of pac-14028 cream in children with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * male and female patients aged 24 months - 12 years * who was diagnosed with atopic dermatitis according to haniffin and rajka criteria, whose affected bsa is over 5% and iga score is 2 (mild) to 3 (moderate). * who has applied stable amount of emollients daily before baseline visit * who voluntarily agreed to participate in the study and signed an informed consent form. exclusion criteria: * who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators. * who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychial disorder that can affect study results. * who has used systemic steroids, antibiotics, immunosuppressants, or received photochemical therapy within 28 days before study drug administration. * who has used topical steroids, immunosuppressants or antibiotics to treat atopic dermatitis within 14 days before study drug administration. * who has used or is expected to inevitably use prohibited concomitant medications during the study. * women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives. * who has dosed other study medications within 30 days before screening. * who is determined ineligible for study participation by investigators for any other reasons.
a study to evaluate the impact of using warm compress prior to daily injections of copaxone®

Conditions: Multiple Sclerosis

Summary: this study is designed to compare skin reactions with or without the use of warm compress prior to performing a copaxone® injection.


Eligibility criteria:
inclusion criteria: 1. male or female, 18 years or older, with a diagnosis of rrms 2. willing and able to complete all procedures and evaluations related to the study. 3. willing to provide informed consent exclusion criteria: 1. taking any other immunomodulatory therapy in conjunction with copaxone®. 2. has a significant medical illness other than ms which may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study. 3. any situation which the investigator or nurse feels may interfere with participation in the study. 4. pregnant, or trying to become pregnant, or breast feeding during the study. 5. previously participated in this study.
efficacy of sitagliptin and glibenclamide on the glucose variability in japanese participants with type 2 diabetes mellitus (mk-0431-355)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a study of the efficacy of sitagliptin and glibenclamide in a short-term treatment on the glucose variability using continuous glucose monitoring (cgm) in japanese participants with type 2 diabetes mellitus (t2dm). the primary hypothesis is that treatment with sitagliptin will be superior to treatment with glibenclamide in the change from baseline in mean amplitude of glycemic excursions (mage) through continuous glucose monitoring (cgm) after 13 days of treatment.


Eligibility criteria:
inclusion criteria: * japanese participants with a diagnosis of type 2 diabetes mellitus exclusion criteria: * history of type 1 diabetes mellitus or ketoacidosis * history of insulin or thiazolidinedione (including fixed-dose drug combinations containing one of these drugs) in the 12 weeks before study participation
the efficacy and safety of leflunomide or azathioprine therapy in myasthenia gravis patients after expand thymectomy

Conditions: Myasthenia Gravis

Summary: this is a randomized controlled clinical study. the investigators screen of eligible patients, randomized divide into the following two groups: corticosteroids + azathioprine group, corticosteroids + leflunomide group. the investigators treat the enrolled patients, estimate efficacy and observed the side effects according to the requirements of program. the investigators establish a clinical database for recording patients date and statistical analysis. evaluation of short-term and long-term efficacy of thymectomized myasthenia gravis patients in the different group prove that what kind of treatment can improve the cure rate. the investigators will evaluate the acute toxicity (gastrointestinal side effects, liver and kidney dysfunction) and long-term toxicity (immune dysfunction, gonadal suppression) when the investigators apply these therapy in the treatment of different clinical types of myasthenia gravis.


Eligibility criteria:
inclusion criteria: 1. 12 to 65 years； 2. myasthenia gravis: 1. patients who are diagnosed as generalized or ocular myasthenia gravis 2. have experienced extended thymectomy (including thymic hyperplasia and thymoma)， no significant complications in 6 months after operation , and does not received any immunosuppressants or glucocorticoids treatments. 3. do not applied in plasmapheresis or immunoglobulins treatment during 3 months . 4. women of child-bearing period do not have a plan of pregnant for at least 3 year. 5. written consent of the patient, after informing exclusion criteria: 1. the liver , kidney or glycometabolic function is abnormal 2. seriously complications, such as infection or symptom in central nervous system, 3. the patients who suffering from malignancy or a history of malignancy, a variety of sexually transmitted diseases and hiv infection, tuberculosis infection, and other condition which need to prohibit the use of immunosuppressive patients. 4. be allergic to leflunomide, azathioprine 5. pregnant or suckling period woman 6. accompanied with mental disorders and have difficult to communication 7. experienced myasthenia crisis in 3 months. 8. suffering from clear cardiopulmonary functional and brain abnormalities 9. have a history of refractory hypertension or peptic ulcer . 10. one of the white blood cells, hemoglobin, and platelet count obvious abnormalities

Keywords: myasthenia gravis leflunomide
carotid imt (intima media thickening) study (0524a-041)(terminated)

Conditions: Hypercholesterolemia, Familial

Summary: this is a 105-week clinical study in patients with heterozygous familial hypercholesterolemia on intensive low density lipoprotein-cholesterol (ldl-c) lowering therapy intended to assess the affects of mk0524a on carotid intima media thickening using ultrasound compared to patients taking placebo. there will be 12 scheduled clinic visits involving review of medical history, physical exam, vital signs, laboratory testing, ultrasound imaging, and electrocardiograms.


Eligibility criteria:
inclusion criteria: * patients who are 18 to 70 years of age with heterozygous familial hypercholesterolemia and a ldl-c greater than or equal to 100mg/dl and triglycerides less than or equal to 400mg/dl at visit 1 while on a stable dose of intensive ldl-c lowering therapy exclusion criteria: * a condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study * patients with less than 80% drug study compliance * patients with chronic medical conditions known to influence serum lipids or lipoproteins or significantly affect the ultrasound acoustic window * patients with unstable dose of medications * pregnant or lactating women, or women intending to become pregnant are excluded * patient with diabetes mellitus that is poorly controlled, or is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of +/- 10 units of insulin) * patients with the following conditions: high grade stenosis (greater than 75%) of the carotid artery, chronic heart failure, uncontrolled/unstable cardiac arrhythmias, unstable hypertension, active or chronic hepatobiliary or hepatic disease, hiv positive, episode of gout (within 1 year)
evaluate the use of a new probiotic strain in couples with fertility problems and dysbiosis.

Conditions: Infertility; Vaginal Flora Imbalance; Genital Disorder

Summary: pilot study to evaluate the effect of the strain lactobacillus ps11610 on the microbiota of the female and male genital tract in couples with fertility problems. couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. the estimated duration of the study will be 7 and a half months.

pilot study to evaluate the effect of the strain lactobacillus ps11610 on the microbiota of the female and male genital tract in couples with fertility problems. couples who have started treatment for artificial insemination or who are on the waiting list for an invitro fertilization treatment will be invited to participate. the estimated duration of the study will be 7 and a half months. four visits are included in the study period.

Eligibility criteria:
inclusion criteria: * couples with ages between 20 and 40 * couples under an assisted reproduction treatment: artificial insemination or in vitro fertilization. * signature of informed consent exclusion criteria: * anovulation * hyperprolactinemia * hypogonadotropic hypergonadism * hypergonadotropic hypergonadism * hyperandrogenisms * polycystic ovary syndrome * endometriosis * pelvic adhesions * myomas, polyps and / or uterine synechia * diagnosis of tubal factor (hydrosalpinx, tubal obstructions) * low ovarian reserve * azoospermia * sperm motility (a + b) \<25% * sperm morphology ≤2% * with chronic diseases that cause intestinal malabsorption * with known congenital or acquired immunodeficiency. * obesity (imc ≥ 30) * current history or diagnosis of alcohol, tobacco and drug abuse * uncertainty about the willingness or ability of the participants to comply with the requirements of the protocol.
application of 68ga-dota-tate and 68ga-dota-jr11 pet/ct in the diagnosis and evaluation of tio

Conditions: Tumor-Induced Osteomalacia

Summary: this is an open-label whole-body pet/ct study for investigating the value of 68ga-dota-tate and 68ga-dota-jr11 pet/ct in patients with tumor-induced osteomalacia.

tumor-induced osteomalacia (tio), also known as oncogenic osteomalacia, is a rare paraneoplastic syndrome. the key to the cure of tio is surgical resection of the culprit tumor. over the last decade, 68ga-labeled sstr-based imaging has made a significant impact in detecting the culprit tumor of tio 68ga-dota-tate is the most used sstr pet tracer for the detection of tio and it was recommended as first-line imaging method for localization of the causative tumor. however, false positive, including fracture and/or inflammation, in 68ga-dota-tate pet/ct is a challenge in image interpretation, which may make the causative tumor indistinguishable in multiple suspicious lesions. there is no effective way to identify multiple suspicious lesions with intensive increased uptake on 68ga-dota-tate pet/ct. 68ga-dota-jr11 is a sstr2 specific antagonist used for pet tracer. however, the sstr2 affinity of 68ga-dota-jr11 is lower than 68ga-dota-tate, which means that the uptake of 68ga-dota-jr11 by suspected lesions may be lower than that of 68ga-dota-tate. the purpose of this prospective study is to compare the sensitivity of 68ga-dota-jr11 and 68ga-dota-tate pet/ct for detecting the responsible tumor of tio and investigate if 68ga-dota-jr11 pet/ct can identify the culprit tumor of tio in multiple suspicious lesions.

Eligibility criteria:
inclusion criteria: * suspected or confirmed untreated tio patients; * 68ga-dota-tate and 68ga-dota-jr11 pet/ct within two weeks; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
patient specific instrumentation in tkr

Conditions: Osteoarthritis of the Knee

Summary: this is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. patient specific instrumentation is an individualised system for total knee replacement surgery. the system has been marketed and is already in use in some centres. the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. this study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.

this is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. patient specific instrumentation is an individualised system for total knee replacement surgery. the system has been marketed and is already in use in some centres. the process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an mri scan of their knee, hip and ankle. from this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy. the jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. this study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.

Eligibility criteria:
inclusion criteria: * males and females aged 18-75 years at time of surgery. * those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the knee. * those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme. * patients who signed the study consent form prior to surgery. exclusion criteria: * pregnant women. * those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems. * those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition. * previous knee surgery including those already treated by with a total knee replacement (i.e. requiring a revision knee replacement). * muscle contracture around the knee joint * individuals with active or suspected infection or sepsis. * patients with contraindication to mri
skin irritation test of leo 80185 gel in healthy japanese subjects

Conditions: Skin and Connective Tissue Diseases

Summary: the purpose of the study is to investigate skin irritation of leo 80185 gel, gel vehicle and liquid paraffin in healthy japanese male subjects.


Eligibility criteria:
inclusion criteria: 1. signed informed consent has been obtained. 2. healthy japanese male subjects. 3. aged 20 to 40 years inclusive. 4. subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn). 5. subjects without a significant abnormality, as judged by the (sub)investigator exclusion criteria: 1. body mass index outside the range 18-25 kg/m² 2. history of alcohol or drug abuse. 3. history of allergic reaction to any medications. 4. any disease that could in any way confound assessment of the test sites. 5. known or suspected hypersensitivity to any component of leo 80185 gel. 6. known or suspected hepatic, renal or cardiac disorders. 7. known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening. 8. subjects suspected of infection based on the infection testing results from the sample taken during screening (hepatitis b surface antigen, hcv antibody, hiv antigen/antibody, serological test for syphilis). 9. use of systemic, locally injected or inhaled corticosteroids within 4 weeks of day 1. 10. use of vitamin d or calcium supplements, or systemic vitamin d analogues within 4 weeks of day 1. 11. use of any medication (systemic or topical) within 2 weeks of day 1. 12. subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives of day 1, whichever is longest. 13. current participation in any other interventional clinical trial. 14. previously enrolled in this clinical trial. 15. previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight). 16. exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of day 1. 17. subjects (or their partner) not using an adequate method of contraception during the trial (day 1-4). 18. in the opinion of the (sub)investigator, participation in the trial is inappropriate.

Keywords: leo 80185 gel calcipotriol betamethasone
hemodynamic profile of terlipressin and octreotide in patients with cirrhosis and portal hypertension. a randomised, single blinded clinical trial.

Conditions: Liver Cirrhosis Portal

Summary: clinical trial to compare the effects of terlipressin and octreotide in the reduction of portal hypertension measured as hepatic venous pressure gradient (hvpg) in patients with liver cirrhosis


Eligibility criteria:
inclusion criteria: 1. age: 18-75 years old. 2. liver cirrhosis 3. portal hypertension 4. stable disease in the absence of vasoactive agents 5. signed informed consent form exclusion criteria: * 1. patients on medications that can prolong qt interval 2. patients with hcc not fulfilling milan criteria for transplant 3. grade ii-iv hepatic encephalopathy 4. gi bleeding in the last 10 days 5. child-pugh c above 12 points 6. bacterial infection in the last 10 days 7. hvpg \ 2mg/dl 10. serum bilirubin \>5mg/dl 11. inr\>2.5 12. uncontrolled cardiovascular disease 13. hiv infection 14. extra hepatic malignancies 15. heart failure nyha grade iii/iv, copd gold\>2 16. morbid obesity 17. coronary heart disease or intestinal ischemia 18. pregnancy or breastfeeding