Kornimate/medical-research-clean huggingface dataset:
ranibizumab for the treatment of choroidal neovascularisation (cnv) secondary to pathological myopia (pm): an individualized regimen

Conditions: Choroidal Neovascularisation

Summary: this study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (cnv) secondary to myopia using an individualized as-needed (prn) dosing schedule. eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria. patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. the main assessments will include visual acuity tests, eye examinations, optical coherence tomography (oct) to assess retinal thickness, fundus photography and fluorescein angiography (fa), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.


Eligibility criteria:
inclusion criteria: * male or female outpatients of any race, aged 18 years or older * diagnosis of active primary or recurrent subfoveal or juxtafoveal cnv secondary to pm * diagnosis of high myopia of at least -6 dioptres in the study eye spherical equivalent. for subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must have been at least -6 dioptres * patients who have a bcva score between 78 and 24 letters in the study eye using early treatment diabetic retinopathy study (etdrs)-like grading charts (approximately 6/9 - 6/96 snellen equivalent) * patients must give fully informed consent and be willing and able to comply with all study procedures exclusion criteria: * history of any surgical intervention in the study eye within two months preceding screening * previous macular laser photocoagulation, treatment with intravitreal steroids, verteporfin with photodynamic therapy (visudyne®) or anti-vegf agents ranibizumab, bevacizumab or pegaptanib sodium (macugen®) in the study eye * previous treatment with intravenously administered bevacizumab (avastin®) * prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes * history of allergic reaction to fluorescein * concurrent use of systemic anti-vegf agents other protocol-defined inclusion/exclusion criteria may apply

Keywords: choroidal neovascularisation pathological myopia
comparison of bone microarchitecture analysed by hrpqct and pqct in pathologies with bone loss and/or muscle loss

Conditions: Osteoporosis Risk; Bone Loss

Summary: the study aims to utilize medical devices, such as the xtreme ct and xct 3000, to assess bone and muscle microarchitecture for various pathologies. the devices provide crucial data on bone and muscle density, aiding in understanding fracture risks associated with conditions like rheumatoid arthritis and neurological disorders. current methods like dxa scanning have limitations in predicting fracture risks accurately due to their inability to assess cortical and trabecular microstructure. the study emphasizes the importance of evaluating cortical porosity and trabecular volume loss, especially in conditions like post-menopausal osteoporosis and sarcopenia. additionally, it explores the impact of neurological disorders, renal insufficiency, and endocrinopathies on bone health. furthermore, the study aims to establish a control group to differentiate pathological changes from age-related variations. expected outcomes include a comprehensive understanding of bone microarchitecture alterations across various pathologies and the potential to improve fracture risk estimation beyond conventional methods like dexa scanning. ultimately, the study anticipates facilitating better management strategies to reduce fracture risks associated with these conditions.


Eligibility criteria:
inclusion criteria: for the patients: women or men treated at the saint-etienne university hospital and presenting an osteoporotic risk with one of the following associated pathologies: * osteoporosis defined by: history of a documented brittle bone fracture * bone fragility: patient with indication for bone densitometry but no history of fracture * inflammatory joint disease: * rheumatoid arthritis * spondyloarthritis * chronic kidney disease * endocrinopathies: * primary hyperparathyroidism * constitutional thinness * anorexia nervosa * obesity (bmi \>30) * sarcopenia * neuropathies - parkinson's disease for the controls: acute episode of spinal or radiculalgia (less than one month old) with corticosteroid treatment of less than 1 month signature of written consent exclusion criteria: * no sign written consent for the controls: * medications inducing bone loss: * anti-aromasin or gnrh agonist for at least 6 months, * corticosteroids (dose ≥ 5 mg/d for 6 months) * anti-epileptic drugs: carbamazepine, phenobarbital, phenytoin, primidone, valproic acid for at least 6 months) * history of fracture due to bone fragility * taking bone-targeting medication (biphosphonate, teriparatide, strontium ranelate)

Keywords: bone microarchitecture bone fragility osteoporosis
a study of trv130 for the treatment of pain after bunionectomy

Conditions: Acute Pain

Summary: the primary objective is to evaluate the analgesic efficacy of iv trv130 compared with placebo in patients with acute postoperative pain after bunionectomy.

the primary objective is to evaluate the analgesic efficacy of iv trv130 compared with placebo in patients with acute postoperative pain after bunionectomy. the results section also includes data from the morphine arms.

Eligibility criteria:
inclusion criteria: * has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures. * experiences a pain intensity rating of ≥ 4 on an 11 point nrs * able to provide written informed consent before any study procedure. exclusion criteria: * asa physical status classification system classification of p3 or worse * has surgical or post-surgical complications. * has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs. * has previously participated in another trv130 clinical study.

Keywords: moderate to severe acute pain bunionectomy
a pharmacokinetic study to assess nevirapine [viramune] levels in hiv infected patients with impaired hepatic functions

Conditions: HIV Infections; Hepatic Insufficiency

Summary: the objective of this study was to evaluate the steady-state clearance of nevirapine among hiv-1 positive patients with hepatic fibrosis, and to examine whether the degree of hepatic impairment influences clearance.


Eligibility criteria:
inclusion 1. male or female subjects \>=18 years of age with hiv-1 infection and chronic liver disease as reflected by a documented biopsy with hepatic fibrosis present. 2. a. participants must be receiving nevirapine 200 mg twice daily as part of a stable arv regimen for a minimum of 6 weeks prior to trough level sample collection. b. participants receiving nevirapine 400 mg once daily as part of a stable arv regimen for a minimum of 6 weeks, who are willing to switch to nevirapi0 mg twice daily for a minimum of 14 days prior to trough collection. 3. participants must have uoxylin and eosin (h and e) stained slide and one trichrome stained pathology slide available at the time of enrollment. there is no time restriction on liver biopsy slides that pathologically confirm the presence of cirrhosis. the presence of cirrhosis must be documented on the liver biopsy report. exclusion 1. current (within the past 4 weeks) hiv antiviral therapy with other nnrti's. 2. concurrent use (within the past 7 days) of any of the following: 1. systemic azole antifungal agents (fluconazole, itraconazole, ketoconazole, etc.) 2. clarithromycin 3. rifampin 4. st john's wort 3. inability to provide a blood sample. 4. patients who have evidence for hepatic or other encephalopathy above grade 1 5. patients with renal failure who require dialysis. 6. pregnant and/or breast feeding women..
post-marketing surveillance of bixalomer in patients with pre-dialysis chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the objective of this study is to assess the long-term safety and efficacy of bixalomer under post-marketed setting.


Eligibility criteria:
inclusion criteria: * patients with pre-dialysis chronic kidney disease complicated by hyperphosphatemia who used bixalomer for the first time

Keywords: kiklin bixalomer chronic kidney disease
t cell mediated adaptive therapy for her2-positive neoplasms of digestive system

Conditions: Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Liver Cancer; Gallbladder Cancer; Bowel Cancer

Summary: this phase i trial is to investigate the safety and the possible side effects of bi-specific antibody armed t-cell therapy when given together with low-dose il-2 in treating patients with her2-positive neoplasms of digestive system. expanded autologues t cells that have been coated with bi-specific antibodies, such as anti-cd3 and anti-human epidermal growth factor receptor 2 (her2), may stimulate the immune system in different ways and stop tumor cells from growing. interleukin-2 may stimulate white blood cells to kill tumor cells.

primary objectives: i. perform a phase i clinical trial to clearly define the toxicity profile of iv her2bi armed t cells in patients with neoplasms of digestive system. secondary objectives: i. evaluate phenotype, cytokine profiles and tumor markers, cytotoxicity directed at laboratory her2 positive cancer cell lines. ii. evaluate the clinical symptoms and signs, clinical responses, imaging examination of pretherapy and post-treatment, cytokine profiles and tumor markers in serum before and after treatment, time to progression, and overall survival. outline: this is a safety study of iv infused her2bi-armed activated t cells. patients receive her2bi armed t cells iv weekly for 4 weeks. patients also receive low-dose interleukin subcutaneously (sc) daily beginning 3 days before the first her2bi armed t cells infusion. treatment continues in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: 1. patient with her2-positive neoplasms of digestive system: ihc 3+ 2. clinical staging: phase iii or above 3. ages: \< 65 4. expected survival time: \> 1 year 5. quality of life: \> 60 6. the functions of important organs( heart, liver, lung, kidney and etc.)are normal 7. the volunteers with informed consent exclusion criteria: 1. patient with her2-negative neoplasms of digestive system 2. hepatic renal dysfunction 3. cardiopulmonary insufficiency 4. mental disorder 5. allergic condition 6. with other malignant tumor 7. lactating women 8. patients with infection or received chemotherapy in the past two weeks 9. patient with autoimmune disease using immunosuppressive drug 10. patient with organ transplantation with long term use of immunosupresive drug
acp-196 alone and in combination with pembrolizumab in subjects with advanced or metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: acp-196 alone and in combination with pembrolizumab in subjects with advanced or metastatic pancreatic cancer


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age * ecog performance status of 0 or 1 * histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic * prior therapy with ≥ 1 systemic chemotherapy regimen for unresectable or metastatic pancreatic cancer or unwilling/unable to receive systemic chemotherapy exclusion criteria: * prior malignancy (other than pancreatic cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \< 2 years. * known central nervous system (cns) metastases and/or carcinomatous meningitis * significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening * malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction * breastfeeding or pregnant
a pilot trial of twice-weekly versus thrice-weekly hemodialysis in patients with incident end-stage kidney disease

Conditions: End Stage Renal Failure on Dialysis

Summary: the optimal frequency of hemodialysis treatments in patients with incident end-stage kidney disease in not known. this pilot trial will randomize patients with incident end-stage kidney disease due to chronic kidney disease progression to two different regimens of hemodialysis: i) twice-weekly hemodialysis for six weeks with adjuvant pharmacologic medications followed by thrice-weekly hemodialysis, or ii) thrice-weekly hemodialysis. the study will test feasibility of stepwise hemodialysis, and the effects of the two regimens of hemodialysis on residual kidney function.


Eligibility criteria:
inclusion criteria: * age ≥18 years * incident eskd from ckd progression (including a failing renal transplant) * are deemed to require dialysis initiation by the treating nephrologist * have elected hd for renal replacement therapy (rrt) exclusion criteria: * have urine output \<500ml per day * have eskd as a result of severe acute kidney injury (aki) (stage 3 aki defined by acute kidney injury network \[akin\]) criteria) * abrupt decline in kidney function preceding hd therapy initiation (i.e., if egfr was ≥30 ml/min/1.73 m2 3 months prior to the initiation of dialysis therapy) * are scheduled to undergo transplantation from a live donor within the next 6 months * have an active diagnosis of hepatorenal syndrome * have a significant malignancy that is likely to impact survival * have a medical condition that would jeopardize the safety of the subject.

Keywords: hemodialysis kidney disease kidney function
safety study on adcd40l gene therapy for bladder cancer

Conditions: Bladder Cancer

Summary: the study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (adcd40l) in patients with urinary bladder cancer. tolerance, toxicity and immunological parameters will be evaluated during and post treatment.


Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of transitional cell carcinoma of the bladder * ecog 0-2 * 18 years of age or older * signed informed consent * for the phase i part: patient scheduled for cystectomy exclusion criteria: * woman of childbearing potential (fertile woman) * other malignancy within 5 years of study, except for non-melanoma skin cancer * metastatic disease * previous exposure to any intravesical therapy for bladder cancer: within 3 months for chemotherapy and within 6 months for bcg therapy. * previous pelvic radiation or treatment with any cytotoxic, immunologic or chemotherapeutic agent for non-malignant conditions within 5 years of study. * clinically abnormal hepatic, renal or bone marrow function, or coagulation disorders in the opinion of the investigator. * chronic urinary tract infections. * serous infection of g.u. surgery, except for bladder cancer, within 1 month of study requiring more than 3 days of hospital care. * vesical capacity \ 150 ml after spontaneous voiding. * previous exposure to any experimental drug within 3 months from enrolment. * any significant medical or psychiatric illness that would prevent the patient from giving informed consent of from following the study procedures. * patients who presently have urothelial cell carcinoma of the upper g.u. tract * patients with systemic autoimmune disease * patients that do not consent to that tissue and blood samples are stored in a biobank * treatment with systemically administered corticosteroids and nsaid within 4 weeks prior to first study treatment
hepatic steatosis and fibrosis in rheumatoid arthritis patients

Conditions: Hepatic Steatosis and Fibrosis in Rheumatoid Arthritis Patients

Summary: studying the prevalence of hepatic steatosis and fibrosis in a large scale of patients with ra and healthy controls


Eligibility criteria:
inclusion criteria: 1. ra according to the american college of rheumatology (acr)/eular 2010 criteria (aletaha et al., 2010) 2. age≥18 years exclusion criteria: * history of hepatitis b and c virus infection. * receiving hepatotoxic drugs other than ra-specific drugs. * alcohol abuse (i30 g/day in men and ⩾20 g/day in women). * diagnosis of wilson's disease, α1-antitrypsin deficiency or hemochromatosis. * autoimmune liver disease. * cancer. * pregnancy.

Keywords: hepatic steatosis rheumatoid arthritis
the multicenter cardiology monitoring platform registry

Conditions: Heart Failure; Cardiomyopathies; Atrial Fibrillation; Ventricular Arrythmia; Coronary Artery Disease; Ventricular Tachycardia

Summary: the multicenter cardiology monitoring platform registry (mcmp-registry) is a prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional). it's objective is to optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes.

rationale: heart failure (hf) represents a heterogeneous range of clinical overlapping cardiomyopathy phenotypes, resulting from multifactorial environmental insults in the presence or absence of a genetic predisposition. a better understanding of (early) cardiomyopathy phenotypes, related cardiovascular diseases, their underlying pathophysiological processes, and their related disease burden is key to pave the way for novel preventive and/or intervention studies. objective: to optimize (early) diagnosis and risk-stratification of (early) cardiovascular diseases, specifically cardiomyopathy phenotypes, arrhythmias, and coronary artery disease, and to create a better understanding of underlying pathophysiological processes. study design: the multicenter cardiology monitoring platform registry (mcmp-registry) is an investigator-initiated multicentre prospective observational registry including multi-omics (diagnostic) measurements performed as part of routine clinical care, bio-banking (optional), and yearly questionnaires (optional). study population: all subjects aged ≥16 years that have been referred to the cardiology or genetics department for cardiac symptoms, cardiac screening or cardiogenetic screening are eligible for inclusion. main study parameters/endpoints: this is a prospective registry from which multiple research questions can be answered. in general, two main approaches will be used: (a) a data-driven (multi-)omics approach which aims to identify clusters of patients to predict clinical outcome, to improve (early) diagnosis, and/or to identify clusters of patients that share underlying pathophysiological processes; (b) a hypothesis-driven approach in which clinical parameters are tested for their (incremental) diagnostic and/or prognostic value.

Eligibility criteria:
inclusion criteria: * referred to the cardiology or genetic department for heart failure like symptoms (as stated in the esc 2016 guidelines(3)) or for cardiac/cardiogenetic screening; * age ≥16 years. exclusion criteria: * unwillingness to participate or unable to give written informed consent (e.g. due to language barriers or severe intellectual disability).

Keywords: heart failure registry cardiomyopathy atrial fibrillation ventricular tachycardia coronary artery disease
effect of a treatment optimization program to improve satisfaction with viagra

Conditions: Impotence

Summary: this study will demonstrate if a treatment optimization program has an impact on the satisfaction with viagra treatment in men with erectile dysfunction


Eligibility criteria:
inclusion criteria: * male subjects above age of majority for whom sildenafil is prescribed for the first time within the usual practice of medicine exclusion criteria: * male subjects who have used any ed medical treatments over the last month, with the exception of testosterone and/or herbal therapies * subjects who do not have the possibility of viewing the video either through a computer, vcr or a dvd
a global study to assess the effects of medi4736 (durvalumab), given as monotherapy or in combination with tremelimumab determined by pd-l1 expression versus standard of care in patients with locally advanced or metastatic non small cell lung cancer

Conditions: Non - Small Cell Lung Cancer NSCLC

Summary: this study is a phase iii, randomised, open label, multi-centre study assessing the efficacy and safety of medi4736 (durvalumab) versus standard of care in nsclc patients with pd-l1 positive tumours and the combination of medi4736 (durvalumab) plus tremelimumab (medi4736+treme) versus standard of care in nsclc patients with pd-l1-negative tumours in the treatment of male and female patients with locally advanced or metastatic nsclc (stage iiib-iv), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for nsclc. patients with known egfr (epidermal growth factor receptor) tyrosine kinase (tk) activating mutations and anaplastic lymphoma kinase (alk) rearrangements are not eligible for the study (prospective testing is not planned within this study). the standard of care options are: an egfr tyrosine kinase inhibitor (erlotinib \[tarceva®\]), gemcitabine or vinorelbine (navelbine®)

the study has an umbrella design with 2 sub-studies: sub-study a (randomizing patients with pd-l1 positive tumours 1:1 into medi4736 (durvalumab) vs. standard of care) and sub-study b (randomizing patients with pd-l1 negative tumours 2:3:1:2 into medi4736 (durvalumab) vs. medi4736 (durvalumab) plus tremelimumab vs. tremelimumab vs. standard of care. the two substudies may have different durations of recruitment periods due to differences in patient population (pd-l1 expression). they may not run concurrently with start and completion of recruitment potentially occurring at different time points.

Eligibility criteria:
inclusion criteria: * aged at least 18 years * documented evidence of nsclc (stage iiib/ iv disease) * disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of nsclc * world health organization (who) performance status of 0 or 1 * estimated life expectancy more than 12 weeks exclusion criteria: * prior exposure to any anti-pd-1 or anti-pd-l1 antibody or anti-ctla4 * brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) * active or prior documented autoimmune disease within the past 2 years * evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis b, c and hiv * any unresolved toxicity ctcae (common terminology criteria of adverse events) \>grade 2 from previous anti-cancer therapy * known egfr tk activating mutations or alk rearrangements * any prior grade ≥3 immune-related adverse event (irae) while receiving any previous immunotherapy agent, or any unresolved irae \>grade 1 * active or prior documented inflammatory bowel disease (eg, crohn's disease, ulcerative colitis)