Kornimate/medical-research-clean huggingface dataset:
phase 2/3 adaptive study of vx-147 in adult and pediatric participants with apol1- mediated proteinuric kidney disease

Conditions: Proteinuric Kidney Disease

Summary: the purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (pk) of vx-147 in adult and pediatric participants with apolipoprotein l1 (apol1)-mediated proteinuric kidney disease.


Eligibility criteria:
key inclusion criteria: * apol1 genotype of g1/g1, g2/g2, or g1/g2 * proteinuric kidney disease key exclusion criteria: * solid organ or bone marrow transplant * uncontrolled hypertension * history of diabetes mellitus * known underlying cause of kidney disease including but not limited to sickle cell disease other protocol defined inclusion/exclusion criteria apply.
intra-operative pet-ct: a novel approach to determine excision margins in lumpectomy breast cancer.

Conditions: Breast Cancer Female; Breast Neoplasms

Summary: examination of the feasibility of intra-operative pet ct to detect surgical margins in breast conservative surgery to prevent re-excision.


Eligibility criteria:
inclusion criteria: * • female and 18 years of age or older * diagnosed with an early-stage (t1 or t2, and n0 or n1; according to the tnm-classification) invasive breast cancer * eligible for breast conserving surgery exclusion criteria: * • pregnancy or lactation * diabetes * multifocal tumor disease * diagnosis of inflammatory breast cancer * appointment at the nuclear medicine department for 18f-fdg administration would result in a unacceptable delay of surgery * subject has had exposure to ionizing radiation of more than 1 msv in other research studies within the last 12 months * subject has recently (\<60 days) or is simultaneously participating in another clinical trial.
gemini study - a study of saquinavir/ritonavir in treatment-naive patients with hiv-1 infection

Conditions: HIV Infections

Summary: this 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (hiv-1) infection who have received no prior hiv treatment. patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * chronic hiv-1 infection; * treatment-naive; * hiv-1 rna viral load \>=10,000copies/ml; * women of childbearing potential must have a negative pregnancy test, and must use reliable contraception for the duration of the study and for 90 days after the last dose of study medication. exclusion criteria: * females who are pregnant or breastfeeding; * active hepatitis b infection; * previous treatment with antiretroviral medication; * patients who have received an investigational drug within the last 4 weeks.
evaluate the safety and tolerability of vandetanib in japanese patients with medullary thyroid carcinoma

Conditions: Unresectable Locally Advanced or Metastatic, Medullary Thyroid Carcinoma

Summary: open-label study to evaluate the safety and tolerability of vandetanib 300 mg/day in japanese patients with unresectable locally advanced or metastatic medullary thyroid carcinoma.

a phase i/ii, open-label study to evaluate the safety and tolerability of vandetanib 300 mg/day in japanese patients with unresectable locally advanced or metastatic medullary thyroid carcinoma

Eligibility criteria:
inclusion criteria: * written consent from female or male japanese patients aged 20 years and over. evidence of non-childbearing status for women of childbearing potential, or postmenopausal status. * previous diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic medullary thyroid carcinoma(mtc). * patients who have a good overall health status(world health organization (who) performance status 0-2). * patients who have appropriate renal conditions confirmed by test results for taking part in the study. * for patients with measurable disease(at least one lesion, not irradiated within 12 weeks of study registration, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with ct or mri). exclusion criteria: * patients with brain metastases or spinal cord compression. * patients with significant abnormal ecg (qtcb correction unmeasurable or more than 480 ms)findings and /or significant cardiac conditions or events, uncontrolled hypertension and evidence of severe lung disease. * abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance. * patients with significant abnormal laboratory findings (to include abnormal liver function tests (bilirubin more than 1.5xulrr, and alt, ast, or alp more than 2.5xulrr or 5.0xulrr if related to liver metastases). * prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before registration.

Keywords: medullary thyroid carcinoma medullary thyroid cancer vandetanib
comparison of the incidence of delirium caused by different anesthetic agents in patients undergoing liver transplantation

Conditions: Hepatocellular Carcinoma; Liver Cirrhosis

Summary: this study is a prospective observational study that analyzes the incidence of postoperative delirium in patients undergoing liver transplantation, based on the use of the inhalational anesthetic sevoflurane and the intravenous anesthetic propofol.


Eligibility criteria:
inclusion criteria: * adults aged 19 years and older * patients undergoing liver transplantation who are scheduled to receive anesthesia with the inhaled anesthetic sevoflurane or the intravenous anesthetic propofol. exclusion criteria: * individuals with hearing loss, cognitive impairment or obvious dementia, hepatic encephalopathy, or difficulty in communication. * diagnosed with neurological disorders (e.g., brain hemorrhage, stroke, dementia, parkinson's disease, cognitive impairment, etc.).
evaluation of teleconsulting on rehabilitation after hip and knee surgical procedures

Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee

Summary: the objective of this study is to assess the medical and economic relevance of teleconsulting for rehabilitation after hip and knee surgical procedures.


Eligibility criteria:
inclusion criteria: * post hip or knee surgery * fulfilment of criteria for home rehabilitation (no need for hospital treatment post surgery) exclusion criteria: * social isolation * life threatening condition * no gsm network * no dsl network

Keywords: surgical procedures, operative
trial of ad113 and atomoxetine in osa patients with hypertension

Conditions: Obstructive Sleep Apnea; Hypertension

Summary: this is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe osa and controlled hypertension, comparing atomoxetine with ad113

the study is designed to examine the efficacy and safety of ad113 to treat obstructive sleep apnea with hypertension. the study is a two-period multi-dose randomized crossover design in which patients will undergo overnight polysomnographic (psg) testing with dosing of one of the following 2 treatments: ad113 for 10 days or atomoxetine for 10 days. participants will return 1 week after their final crossover psg for an end of study (eos) visit.

Eligibility criteria:
inclusion criteria: * between 25 to 65 years of age, inclusive, at the screening visit. * ahi 10 to 50 (hypopneas defined by 4% oxygen desaturation) * history of hypertension or blood pressure at visit 1 ≥130/80 mmhg exclusion criteria: * history of narcolepsy. * clinically significant craniofacial malformation. * clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. a medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication * cpap should not be used for at least 2 weeks prior to first study psg * history of using oral or nasal devices for the treatment of osa may enroll as long as the devices are not used during participation in the study.
innovative device for pain management by millimeter band radiation : electronic-pain killer.

Conditions: Osteoarthritis; Peripheral; Pain

Summary: in this study, in addition of conventional treatment, the efficacy of the medical device, remedee one, in medical care of patients with peripheral osteoarthritis pain is evaluated.

osteoarthritis affects 10 millions people in france (17% of the population). it's the second cause of disability and consultation after the cardiovascular diseases in france. for the moment, there is no curative treatment for osteoarthritis the main clinical sign of this disease is pain and care is based on the treatment of pain and on the improvement of functionnal disability. the proposed treatments are mainly based on the use of oral analgesics treatments . at present, patients report to be insufficiently relieved. new strategies need to be developed. the hypothesis is that the use of an innovative medical device, remedee one, can reduce the pain felt by patients, improve their quality of life and reduce the analgesics consumption. the choice is oriented on the peripheral osteoarthritis and excludes spinal osteoarthritis because it's an osteoarthritis always asymptomatic and painless.

Eligibility criteria:
inclusion criteria: * adult ≥ 50 years * patient followed in rhumatology consultation or at the center of the pain of the university hospital of grenoble or in liberal for peripheral osteoarthritis (ankle, knee, hip, shoulder, elbow, digital) clinically and radiologically confirmed according to the recommendations of the american college of rheumatology. * patient with a pain score on a visual analog scale (vas) ≥ 4 on a numerical scale of 0 to 10 (average vas intensity over the week prior to the inclusion visit), * patient with a stable analgesic treatment without introduction of a new therapeutic class within the last 3 months, * patient with a wrist size compatible with the size of the medical device * patient affiliated to social security or beneficiary of such a scheme. * having signed a consent to participate. exclusion criteria: * patient with chronic inflammatory joint disease (chronic inflammatory rheumatism, rheumatoid arthritis, psoriatic rheumatism, spondyloarthritis, lupus), * patient who received an intra-articular corticosteroid injection within 3 months prior to inclusion, * patient with surgery scheduled within the next eight months, * patient presenting at both wrists a dermatological pathology such as oozing dermatosis, hyper sweating or an unhealed lesion, * patient having a piercing or implanted metallic material on both wrists, * patient with a tattoo on both wrists, * patient deprived of liberty by judicial or administrative decision * patient subject to legal protection or unable to express his consent (guardianship or curatorship) * patient in exclusion period of another interventional study

Keywords: osteoarthritis pain medical device radiation in millimeter band life quality peripheral treatment
vitrectomy with internal limiting membrane peeling for myopic traction maculopathy

Conditions: Myopic Traction Maculopathy; Pars Plana Vitrectomy; Internal Limiting Membrane Peeling

Summary: investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy

performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. a variety of findings are seen by optical coherence tomography. epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. visual acuity change, as well as improvement of the retinal structure by oct will be examined.

Eligibility criteria:
inclusion criteria: * highly myopic patients, having a refractive errors (spherical equivalent) of more than - 8 diopter, or an axial length more than 26.5 mm. * best corrected visual acuity less than 0.1 * spectral domain optical coherence tomography showed; staphylomatous changes, with either: macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane at least 6 months follow-up exclusion criteria: * eyes with diffuse chorioretinal macular atrophy * concomitant presence of a choroidal neovascular membrane * young patients less than 21 years old. * history of trauma * dense media opacity (corneal/ lenticular)
effect of mirror therapy on lower extremity motor control and gait in patients with stroke

Conditions: Stroke

Summary: mirror therapy may be an effective intervention in increasing motor control and gait performance in patients with stroke.

using a mirrored image of the uninvolved extremity superimposed upon the involved extremity during exercise may facilitate improved motor control in patients after stroke.

Eligibility criteria:
inclusion criteria: * lower extremity brunnstrom stage 2, * lower extremity modified ashworth \< 3, * has the ability to follow 3-step command in english, * has only unilateral involvement. exclusion criteria: * lower extremity brunnstrom stage 1, * lower extremity modified ashworth 3 or higher, * history of prior stroke, * passive range of motion limitation of hip and or knee flexion \< 90, * has visual deficits which prevent participation.
vitamin d, hba1c and vitamin b12 levels in patients

Conditions: Serum HbA1c and Vitamin D, Vitamin B12 Values in Periodontal Diseases

Summary: abstract aim: to compare the serum vitamin d, hba1c and vitamin b12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 periodontal disease classification. materials and methods: a total of 606 (378 female, 228 male) patients were included in the study. the periodontal status of the patients was diagnosed with gingivitis, stage 1,2,3 and 4 periodontitis groups were formed. hba1c, vitamin d and vitamin b12 values of the patients were compared and analyzed. result: conclusion:

bstract aim: to compare the serum vitamin d, hba1c and vitamin b12 levels in patients with gingivitis and four different periodontitis stages diagnosed according to the 2017 periodontal disease classification as determined by the american academy of periodontology and the european federation of periodontology (aap-efp) materials and methods: a total of 606 (378 female, 228 male) patients were included in the study. the periodontal status of the patients was diagnosed with gingivitis, stage 1,2,3 and 4 periodontitis groups were formed. hba1c, vitamin d and vitamin b12 values of the patients were compared and analyzed.

Eligibility criteria:
inclusion criteria: * patients diagnosed with gingivitis or periodontitis with complete periodontal diagnostic data (gingival index(löe, 1967), plaque index(löe, 1967), periodontal pocket depths(pd), clinical attachment loss (cal), radiological data- interdental bone loss (ibl) data * non-smoker * vit d, hba1c and b12 vit in blood on the date of application to the clinic and/or in the last 3 months. patients with data on values were included in the study. exclusion criteria: * patients with missing data and not allowing data use * smoker * the data of pregnant and lactating patients were not included in the study.

Keywords: diabetes mellitus periodontitis risk factors vitamin
new strategy to predict early sepsis

Conditions: Sepsis

Summary: this is an observational prospective multicentre study on patients attending the emergency department and suspected to have sepsis. blood markers characteristic of a cellular reprogramming (cr) signature and predicting severe sepsis and organ failure will be measured and validated.

sepsis is a life-threatening medical condition caused by an infection and the complex and dysfunctional way by which the human body attempts to deal with it. it can affect people of all ages, causing 18-30 million cases and 5-8 million deaths annually worldwide. however, early diagnosis of sepsis is challenging due to the diversity and overlap of symptoms with other disorders and the lack of an early and accurate diagnostic method. hancock and colleagues defined a gene expression signature characteristic of biological changes occurring during sepsis, known as cellular reprogramming (cr) and reflecting a type of immune amnesia (inability to respond to bacterial signals). this signature was shown to predict the development of sepsis and organ failure at first clinical presentation in the emergency room, by examining patient blood samples taken during an initial pilot single-center study. this project will validate and refine the cr signature and demonstrate reproducibility, specificity, and sensitivity in a larger multi-center study to enable a new strategy to predict sepsis.

Eligibility criteria:
inclusion criteria: * male or female * presenting to the emergency department * attending physician suspects possible sepsis based on at least 2 sign of systemic inflammatory response syndrome (sirs) criteria and suspicion of infection exclusion criteria: * patient is terminal (death anticipated in 12 hours) * informed consent unobtainable if the subject survives to hospital discharge. * subjects who are unable to provide blood as a standard of care. * blood sample could not be taken within 24 hours of a physician's first contact with the patient.
trial to evaluate the safety and tolerability of repeated intravitreal injection of ibi302 in neovascular amd patients

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study is designed for multi-center, open-label, randomized, dose escalation phase i trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of ibi302 in neovascular amd patients.


Eligibility criteria:
inclusion criteria: inclusion criteria 1. male or female patient ≥ 50 yrs. of age. 2. active subfoveal or parafoveal cnv secondary to neovascular amd. 3. willing and able to sign informed consent form and comply with visit and study procedures per protocol. exclusion criteria 1. presence of uncontrolled glaucoma in the study eye (defined as iop≥30mmhg despite the standardized treatment); 2. presence of active intraocular or periocular inflammation or infection; 3. history of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine; 4. participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study; 5. diabetic patients have any of the following conditions:hba1c\>7.5% when screening;
study of the diagnostic value of stable calcium isotope profiling in bone and calcium disorders

Conditions: Bone Diseases; Osteomalacia; Osteoporosis

Summary: the purpose of this study is to determine whether mass spectrometry analysis of stable (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of bone and calcium disorders.

the aim of this pilot study is to explore the diagnostic value of mc-icp-ms (multicollector inductively coupled plasma mass spectrometry) or tims (thermal ionization mass spectrometry) measurement of endogenous stable calcium isotopes in plasma and urine samples in patients seen during routine clinical care at the outpatient clinics (incl. center for metabolic bone diseases) of the university hospitals leuven.

Eligibility criteria:
inclusion criteria: * dxa (dual energy x-ray absorptiometry) t-score known clinically to be = or \< -2.5 or presence of low-energy osteoporotic fractures (i.e. excluding those of the skull, fingers and toes) \[for osteoporosis and calcium malabsorption patients\] exclusion criteria: * inability to provide written informed consent

Keywords: bone turnover markers calcium isotopes
safety and efficacy of long-acting repeatable octreotide acetate for injectable suspension vs. surgery in treatment-naïve patients with acromegaly

Conditions: Acromegaly

Summary: currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. the objective of this study is to assess the safety and efficacy of long-acting repeatable formulation of octreotide and to compare it to the safety and efficacy of surgery in patients with acromegaly who have not had any previous treatment for acromegaly.


Eligibility criteria:
inclusion criteria: * newly diagnosed or previously untreated acromegalic patients * lack of suppression of gh nadir to \<1.0 µg/l, after oral administration of 75 g of glucose (ogtt) * igf-i levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) exclusion criteria: * requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass * no evidence of pituitary adenoma on magnetic resonance imaging (mri) * symptomatic cholelithiasis other protocol-defined exclusion criteria may apply.

Keywords: acromegaly untreated newly diagnosed octreotide lar pituitary surgery
a phase 3 study of opc-262 in patients with type 2 diabetes

Conditions: Diabetes, Type 2

Summary: the purpose of this study is to investigate the safety of opc-262 administered orally in combination with another oral antihyperglycemic agent


Eligibility criteria:
inclusion criteria: * 1) patients who are capable of giving informed consent * 2) patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner exclusion criteria: * patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
clinical trial to evaluate the efficacy and safety of dw1125 and dw1125a

Conditions: Hypercholesterolemia, Dyslipidemia

Summary: a randomized, double blind, parallel, multi-center, phase 3 clinical trial to evaluate the efficacy and safety of dw1125 and dw1125a in patient with primary hypercholesterolemia or mixed dyslipidemia


Eligibility criteria:
inclusion criteria: * both gender, the person aged 19 or older * patients who are diagnosed with primary hypercholesterolemia or mixed dyslipidemia * ldl- c ≤ 250 mg/dl and tg \< 500 mg/dl on fasting status exclusion criteria: * patients with myopathy, rhabdomyolysis, fibromyalgia, hereditary neuromuscular disorders or family history, or creatine kinase(ck) ≥ 2 x upper limit of normal(uln) on visit 1 * patients with severe renal disorders, estimated flomerular filtration rate (egfr) \< 30 ml/min/1.73m\^2 on visit 1 * patients with hepatic failure or active or chronic hepatobiliary diseases or aspartate transaminase (ast) or alanine aminotransferase (alt) ≥ 2.0 x uln on visit 1