Kornimate/medical-research-clean huggingface dataset:
a phase 2b diabetic kidney disease study

Conditions: Diabetic Kidney Disease

Summary: a phase 2b randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of medi3506 in subjects with diabetic kidney disease

this is a phase 2b, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, pk, and immunogenicity of medi3506 on top of standard of care, including angiotensin-converting enzyme (ace) inhibitors or angiotensin receptor blockers (arbs) and dapagliflozin in adult subjects with diabetic kidney disease, defined as subjects with type 2 diabetes mellitus (t2dm) and an estimated glomerular filtration rate (egfr) of 25-75 ml/min/1.73 m2 with a uacr in the range of 100-3000 mg/g, who meet all eligibility criteria. approximately 565 subjects, among multiple countries will be randomized to medi3506 dose 1, 2, 3 or dose 4, or placebo during a treatment period of 24 weeks. all subjects will receive dapagliflozin daily, as administered orally from day 85 to day 168. the primary objective is to evaluate the effect of medi3506 on albuminuria in subjects with dkd. secondary objectives include evaluating safety, pk and the incidence of ada during the treatment period.

Eligibility criteria:
key inclusion criteria 1. adult men or women ≥ 18 years of age. 2. diabetic kidney disease dkd defined as: 1. diagnosis of t2dm 2. egfr 25-75 ml/min/1.73 m2 3. uacr 100-3000 mg albumin/g creatinine 3. bp ≤ 150/100 mmhg 4. stable dose of acei or arb key exclusion criteria 1. serum potassium \> 5.5 mmol/l 2. significant hepatic disease 3. hemoglobin a1c \> 10.5 % 4. b-type natriuretic peptide level \> 200 pg/ml 5. history of clinically significant heart disease 6. anticipated dialysis or renal transplantation within 1 year 7. history of underlying condition that predisposes the subject to infections 8. significant infection (viral, bacterial, or fungal) 9. amputation due to peripheral artery disease 10. subjects with a positive diagnostic nucleic acid test for sars-cov-2 11. pregnancy, breastfeeding or intention to become pregnant during the course of the study, 12. any other medical condition or clinically relevant abnormal findings in physical examination, laboratory results, or electrocardiogram (ecg) during screening that, in the opinion of the investigator, may compromise the safety of the subject in the study, reduce the subject's ability to participate in the study, or interfere with evaluation of the investigational product
clinical trial to compare and evaluate the safety and pharmacokinetic of ckd-501, d745, and d150 for healthy subjects in fed state.

Conditions: Type 2 Diabetes Mellitus

Summary: this is a randomized, open-label, single oral dosing, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the administration of ckd-383 and the co-administration of ckd-501, d745, and d150 for healthy subjects in fed state

participants were randomly assigned in a 1:1 ratio. the patients are prescribed oral administration of the appropriate ip(2 or 4 tablets in single dose: actual medication)

Eligibility criteria:
inclusion criteria: * healthy adults aged 19 to 65 years * based on screening, no congenital or chronic disease, who have no athological symptoms or findings(if necessary, eeg, ecg, chest and gastroscopy or gastrointestinal radiation, examination) * within 5 years prior to the start of the trial(period 1 administration) of any clinically significant mental medical history * other inclusion criteria, as defined in the protocol exclusion criteria: * who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (period 1 administration) * other exclusive criteria, as defined in the protocol
sulfamethoxazole for the treatment of primary prepl deficiency

Conditions: Hypotonia Cystinuria Syndrome; Isolated PREPL Deficiency

Summary: the investigators will evaluate whether sulfamethoxazole, a sulfamide antibiotic, improves the symptoms of primary prepl deficiency (hypotonia-cystinuria syndrome and isolated prepl deficiency).


Eligibility criteria:
inclusion criteria: * patients with molecular confirmation of primary prepl deficiency * who are able to follow the study protocol (for the primary endpoint) * who have given written informed consent exclusion criteria: * age\<2m * women of child-bearing age unless using a reliable method for contraception and not pregnant at study entrance * additional diagnosis with influence on muscle force * not able to follow the study protocol (for the primary endpoint) * history of sulfonamide hypersensitivity * diminished renal function based on serum creatinine * transaminases higher than 3 times the upper limit of normal * for the pupillometry: eye pathology with the exception of refractive errors, drugs with influence on the pupillary light reflex
dose ranging study of an ocular sirolimus (rapamycin) formulation in patients with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.


Eligibility criteria:
inclusion criteria include but are not limited to: * diagnosed with diabetes mellitus * macular edema secondary to diabetic retinopathy * visual acuity of 20/40 to 20/200 in study eye exclusion criteria include but are not limited to: * any other ocular disease that could compromise vision in the study eye * any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery * capsulotomy of the study eye within 30 days prior to study start
rheumatology informatics system for effectiveness

Conditions: Rheumatoid Arthritis; Osteoarthritis; Gout

Summary: the rise registry is an enhanced version of the acr's rheumatology clinical registry (rcr) and allows for a simplified entry process, while establishing a best-in-class resource to manage your patient population and improve patient care. rise provides participants with an infrastructure for robust quality improvement activities leading to improved patient outcomes, patient population management and quality reporting related to rheumatic diseases and drug safety. rise gives physicians and researchers the information they need to optimize patient outcomes, meet reporting requirements, and make discoveries that advance rheumatology.

rise helps providers benchmark performances on key rheumatology clinical quality measures and align with best practice standards. the rise benchmarking tool allows providers to view the details of their patient population against established rheumatology quality metrics. rise allows access to aggregate data from other participating sites so providers can view their patient population in comparison to other rise participants. rise is integrated into an electronic health records (ehr) system, bringing a single point of entry into one solution for filing for quality-based incentive payments, avoiding penalties, complying with reporting requirements and tracking caseloads for quality monitoring and improvement initiatives. rise collects the data needed to meet current federal reporting requirements. participating in rise helps push the field of rheumatology practice forward. rise provides a source of information on patient outcomes and quality care for rheumatology leading to new discoveries, better understanding and a source of comparative effectiveness research.

Eligibility criteria:
inclusion criteria: * patients 18 years of age and older with one of the following diagnoses: rheumatoid arthritis, osteoarthritis, gout exclusion criteria: -

Keywords: rheumatoid arthritis osteoarthritis gout
expanded access of adagrasib (mrtx849) in patients with advanced solid tumors who have a kras g12c mutation

Conditions: Advanced Cancer; Metastatic Cancer; Malignant Neoplasm

Summary: the objective of this eap is to provide expanded access of adagrasib (mrtx849) to patients with previously treated advanced solid tumors harboring a kras g12c mutation.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of an advanced/metastatic solid tumor * confirmed presence of a krasg12c mutation * ineligible for an ongoing clinical trial of mrtx849 * no available or not eligible for standard of care treatment * adequate organ function * cns metastases (within set parameters) are allowed * ecog performance status of ≤ 2 exclusion criteria: * history of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of mrtx849 treatment or result in inability to swallow * prior therapy targeting a kras g12c mutation * other active cancer

Keywords: adagrasib expanded access
long term sidus pmcf

Conditions: Osteoarthritis; Post-traumatic; Arthrosis

Summary: the objectives of this study are to assess the safety and performance of the sidus stem-free shoulder arthroplasty system in unilateral primary total shoulder arthroplasty.

the data collected from this study will serve the purpose of assessing safety and performance of the sidus shoulder. safety: will be assessed by monitoring the frequency and incidence of adverse events (ae), serious adverse events (sae), and unanticipated adverse device effects (uade). performance: will be determined by analyzing the implant survival, overall pain and functional performances (based on the ases patient questionnaire and range of motion) and radiographic parameters of subjects who received the sidus shoulder. implant survival will be based on removal or intended removal and determined using the observed component years (ocy) model as it is not anticipated that there will be adequate data at the 10 years follow-up to support kaplan-meier survivorship analysis. in the instance that there is sufficient data to perform kaplan-meier analysis, the analysis will be performed.

Eligibility criteria:
inclusion criteria: * patient must have previously participated in the sidus ide clinical trial. * patient must not have undergone revision of the sidus shoulder. * patient must be able and willing to complete the protocol required follow-up. * patient must be able and willing to sign the irb/ec approved informed consent. exclusion criteria: * patient is a prisoner. * patient is a current alcohol or drug abuser. * uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * patient did not previously participate in the sidus ide clinical trial. * patient no longer has sidus shoulder implanted.
a study of a4i antagonist in patients with relapsing multiple sclerosis.

Conditions: Multiple Sclerosis

Summary: this study will compare the effect of a4i antagonist and placebo on mri lesions,on clinical endpoints, and safety in patients with relapsing multiple sclerosis (ms). eligible patients will be randomized to receive placebo or a4i antagonist, 20mg, 80mg or 300mg, po bid. patients will undergo mri brain scans and ms clinical evaluations at intervals throughout the study. 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, 18-59 years of age; * relapsing multiple sclerosis patients with types 1-4 (established through mcdonald criteria); * \>=1 ms attack or a gd-enhancing mri lesion between 1 month and 1 year before enrollment; * edss score of \<=6.5; * inadequate response to approved treatment(canada only). exclusion criteria: * ms attack within 1 month before enrollment; * systemic corticosteroids within 1 month before enrollment; * ms treatments (non-symptomatic) within specified periods before enrollment; * an infection requiring systemic anti-infective treatment or vaccination with a live vaccine within 1 month before enrollment.
the influence of compression stockings on skin's barrier function at patients with chronic venous disease

Conditions: Venous Insufficiency

Summary: the purpose of this study is to investigate if wearing of compression stockings influences the skin moisture. conservative stockings are compared with urea containing compression stockings to find out if using urea prevents dehydration of the skin while wearing the urea compression stockings. secondary aim was to find out if urea containing stockings increase the compliance to wear the compression stockings regulary by patients with diagnosed chronic venous insufficiency.


Eligibility criteria:
inclusion criteria: * clincial diagnosis of chronic venous insufficiency * age: 18-80 years * patient's information and willingness to participate exclusion criteria: * age under 18 years * lower limp edema not caused by venous insufficiency * acute deep venous thrombosis * arterial occlusive disease * diabetes mellitus with neuropathy or peripheral arterial disturbance of perfusion * immobile patients * pregnancy
evaluation of the safety and the efficacy of carfilzomib combined with cyclophosphamide and dexamethasone (ccyd) or lenalidomide and dex (crd) followed by asct or 12 cycles of carf combined with dex and len for patients eligible for asct with newly diagnosed multiple myeloma.

Conditions: MULTIPLE MYELOMA (MM)

Summary: this study will evaluate the safety and the efficacy of carfilzomib combined with cyclophosphamide and dexamethasone (ccyd) or lenalidomide and dexamethasone (crd) followed by autologous transplantation asct or 12 cycles of carfilzomib combined with dexamethasone and lenalidomide for patients eligible for asct with newly diagnosed multiple myeloma. as a secondary endpoint this study will evaluate the best maintenance treatment between lenalidomide and lenalidomide combined with carfilzomib. four hundred seventy-seven patients, males and females aged \> 18 years, enrolled in several sites, will take part in this study. the duration of the study is approximately 5 years.


Eligibility criteria:
inclusion criteria: age ≥ 18 years newly diagnosed mm based on standard crab criteria (see appendix b). patient \< 65 years eligible for asct. patient has measurable disease according to imwg (international myeloma working group) criteria. patient has given voluntary written informed consent. patient agrees to use acceptable methods for contraception. patient has a karnofsky performance status ≥ 60% pretreatment clinical laboratory values within 30 days of enrolment: platelet count ≥50 x 109/l (≥30 x 109 /l if myeloma involvement in the bone marrow is \> 50%) absolute neutrophil count (anc) ≥ 1 x 109/l without the use of growth factors corrected serum calcium ≤14 mg/dl (3.5 mmol/l) alanine transaminase (alt): ≤ 3 x the upper limit normal (uln) total bilirubin: ≤ 2 x the uln calculated or measured creatinine clearance: ≥ 30 ml/minute. lvef≥40%. 2-d transthoracic echocardiogram (echo) is the preferred method of evaluation. multigated acquisition scan (muga) is acceptable if echo is not available life expectancy ≥ 3 months exclusion criteria: previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid \ 2 cm patients ineligible for autologous transplantation pregnant or lactating females presence of: clinical active infectious hepatitis type a, b, c or hiv acute active infection requiring antibiotics or infiltrative pulmonary disease myocardial infarction or unstable angina ≤ 4 months or other clinically significant heart disease peripheral neuropathy or neuropathic pain grade 2 or higher, as defined by national cancer institute common toxicity criteria (nci ctc) 4.0 known history of allergy to captisol ® (a cyclodextrin derivative used to solubilize carfilzomib) contraindication to any of the required drugs or supportive treatments invasive malignancy within the past 3 years serious medical condition, laboratory abnormality or psychiatric illness that prevented the subject from the enrolment or place the subject at unacceptable risk.
pediatric prospective personalized immune and target identification trial

Conditions: Central Nervous System Neoplasms; Pediatric Cancer; GEN1 Gene Mutation; Tumor, Brain

Summary: pprosperitit is a prospective clinical study assessing the use of comprehensive molecular profiling to define the best matching targeted and immune treatment for relapsed, refractory or very high risk pediatric cns tumors.

pprosperitit will identify specific molecular changes by using genomic sequencing technologies in refractory/recurrent or very high-risk pediatric cns tumors. the study will employ an analytically validated comparison of a selection of targeted agents/immune therapies on the basis of commercially available comprehensive genomic profiling foundationoneheme panel (f1heme, comprising dna and rna analysis) vs selection of agents based on more complex dna/rna/protein based analyses. this will be coupled to a computer algorithm that uses preexisting definitions and prioritization of target-agent pairs to assign patients by actionable mutation results to a targeted treatment. the selection of targeted agents will be performed by a multidisciplinary molecular tumor board, but the recommended treatment will not be a part of the pprospertit study.

Eligibility criteria:
inclusion criteria: 1. patient informed consent form must be appropriately obtained under the applicable local and regulatory requirements. each patient must sign a consent form prior the enrollment to document their willingness to participate. 2. the subject is male or female, aged 1 - 19 years 3. the subject must have a histologically proven recurrent/ refractory or very high-risk cns tumors 4. patients must be in good overall physical condition, which allows tumor biopsy 5. patients must have a life expectancy of at least 3 months. 6. patients must have a tumor amenable to image-guided or direct vision biopsy and be willing and able to undergo a tumor biopsy and/or blood taking for molecular profiling. 7. patients must be accessible for follow-up. exclusion criteria: 1. patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 2. pregnant and/or breastfeeding women, if applicable 3. no intention to treat the patient.

Keywords: pediatric oncology, cns tumors, personalized medicine
endoscopic repair of frontal sinus csf leak

Conditions: CSF Leakage

Summary: this retrospective study was conducted on patients with frontal sinus leaks came to ent departments of al-azhar university hospital, new damietta, egypt, for a period of five years.

all patients in this study were evaluated during the follow-up period. patients' age, sex, occupation, residence, and telephone number were recorded for each participant for demographic purposes. general and local examinations were also performed preoperatively as usual. medical history, surgical approach, leakage site, complications, reconstruction technique, and follow-up were recorded. all cases were treated by endonasal endoscopy * complete sphenoethmoidectomy. * draf type iia, iib, and iii according to defect location. * defect less than 3 mm closed by a plug of fat and facia lata or middle turbinate mucosa. * defect more than 3 mm closed by underlying facia lata, underlying cartilage, and overlay facia lata.

Eligibility criteria:
inclusion criteria: * patients who underwent endoscopic frontal sinus repair. traumatic or spontaneous patients with a csf leak at a minimum of six months not responding to conservative measures were included. exclusion criteria: * known malignancy or patients with frontal leak due to extensive tumor resection or intracranial injury
point-of-care ultrasound in greater trochanteric pain syndrome

Conditions: Greater Trochanteric Pain Syndrome

Summary: greater trochanteric pain syndrome (gtps) is a common cause of musculoskeletal pain. the primary aim of this study is to describe the soft tissue and bony structural ultrasound (us) findings identified in the lateral hip and iliotibial band (itb) in patients presenting with greater trochanteric pain syndrome (gtps) in an outpatient rheumatology clinic.

gtps, widely known as trochanteric bursitis, encompasses a spectrum of disorders (gluteal tendinopathy, tears, bursitis, and itb syndrome) that are difficult to distinguish by clinical exam alone. better understanding of us imaging characteristics in relation to clinical symptoms may be helpful in identifying those patients who would most benefit from corticosteroid injections and other non-operative treatment options. point-of-care musculoskeletal us use has been shown to reduce repeated hospital appointments, improve accuracy of diagnosis, and provide expedited treatment, thus improving quality of care in an outpatient musculoskeletal clinic. us assessment is not routinely included in the management of gtps patients and ideal imaging modalities are not established.

Eligibility criteria:
inclusion criteria: * lateral hip pain thought to be due to gtps as evidenced by tenderness to palpation of the lateral hip over the greater trochanter * have a pain score of at least 2 out of 10 on an 11-point numeric rating scale * lateral hip pain for at least 1 week * for participants with bilateral gtps, the most symptomatic hip will be considered the study hip * have a telephone exclusion criteria: * inability to give informed consent * bmi \> 40 * evidence of severe oa of the study hip by x-ray * avascular necrosis of the study hip * groin pain at rest or with log-rolling * hip internal rotation range of motion \< 15 degrees * prior fracture involving the study hip or femur * prior hip surgery or prosthesis in the painful hip * paralysis or paresis of the lower extremity * wheelchair bound * open wound or skin lesions in the lateral hip

Keywords: greater trochanteric pain syndrome trochanteric bursitis lateral hip pain