Kornimate/medical-research-clean huggingface dataset:
a study to evaluate long-term safety, tolerability, & efficacy of bmn 111 in children with achondroplasia (ach)

Conditions: Achondroplasia

Summary: this is a phase 2, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of bmn 111 in children with achondroplasia. the primary objective is to evaluate the long-term safety and tolerability of daily sc injections of bmn 111 in children with ach who have completed two years of treatment in the 111-202 study.


Eligibility criteria:
inclusion criteria: * have completed 24 months of bmn 111 treatment in study 111-202. * parent(s) or guardian(s) are willing and able to provide written, signed informed consent. subjects under the age of majority are willing and able to provide written assent (if required). subjects who reach the age of majority in their country will be asked to provide their own written consent upon reaching the legal age of majority. * if sexually active, willing to use a highly effective method of contraception while participating in the study. * females \>= 10 years old or who have started menses must have a negative pregnancy test at baseline and be willing to have additional pregnancy tests during the study * willing and able to perform all study procedures as physically possible * parents/caregivers willing to administer daily injections to the subjects and complete the required training. exclusion criteria: * requires any investigational agent prior to completion of study period. * have a condition or circumstance that, in the view of the investigator, places the subject at high risk for poor treatment compliance or for not completing the study. * concurrent disease or condition that, in the view of the investigator, would interfere with study participation or safety evaluations for any reason. * permanently discontinued bmn 111 during the 111-202 study. * subject is pregnant at baseline visit or planning to become pregnant (self or partner) at any time during the study. * current chronic therapy with restricted medications.

Keywords: achondroplasia dwarfism bone diseases, developmental bone diseases
retrospective register for uveal melanoma

Conditions: Uveal Melanoma

Summary: background: uveal melanoma (um) is a common primary ocular malignancy associated with limited overall survival in the advanced stage of the disease. fundamental breakthrough regarding the management of the disease and the overall-survival have not yet been achieved. studies with large cohorts are difficult to perform due to limited patient numbers, therefore retrospective analyses are of great potential to gain further knowledge in a disease with high clinical needs. aim: the proposed project is a register for patients with um treated at the department of ophthalmology and optometry at the medical university of vienna between 01.01.1997 and 31.12.2021. patients and methods: patients treated for um at the department of ophthalmology and optometry at the medical university of vienna between 01.01.1997 and 31.12.2021 will be included in the register. information on the baseline characteristics, survival times and course of the disease will be gathered via retrospective chart review and saved in a password-secured database.


Eligibility criteria:
inclusion criteria * patients 18 - 99 years * diagnosis of uveal melanoma exclusion criteria * patients younger than 18 years of age * inadequate or missing information on the clinical course in patient charts
the effect of exercise training on gait and quality of life in parkinson's disease

Conditions: Parkinson's Disease

Summary: the project aims to evaluate the effects of 24 weeks of treadmill training (tt), with and without a strengthening component, on functional mobility, gait and quality of life in patients with parkinson's disease (pd). the rationale for a study of this type stems from the hypothesis that treadmill training may act as an external "pacemaker" and enhance some properties of gait. there is a need for larger scale randomized controlled trials comparing the effects of treadmill training to control groups that receive similar amounts of attention. to date, no study has combined tt and muscle strengthening, likely the optimal form of therapy. a kinesiologist supervises the training, 3 times per week, for a total of 72 one-hour exercise sessions. it is hypothesized that at the end of 6 months, treadmill training will considerably improve walking parameters and the well being of people with pd.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease * stage of ii or less on hoehn and yahr scale exclusion criteria: * having musculoskeletal impairments or having excessive pain in any joint that could limit participation in exercise program * dementia (mmse\<24) * having balance problems * live beyond 45 minutes from laval university

Keywords: physical activity, treadmill training, rehabilitation
trendy follow-up: study on endothelial function in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: basal nitric oxide (no) activity plays a pivotal role in the regulation of glomerular hemodynamics, and in animal experiments its alteration has been associated with morphological changes characteristic of diabetic nephropathy. the investigators aimed to assess in a prospective study: 1. basal no activity of renal vasculature and 2. renal hemodynamics to examine whether impairment of basal no activity of the renal vasculature is related to development and progression of diabetic nephropathy and other cardiovascular endpoints.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus exclusion criteria: * macroalbuminuria * symptomatic cardiovascular disease

Keywords: type 2 diabetes mellitus endothelial function renal hemodynamics
radiotherapy 3 vs 6 gy in gonarthrosis and coxarthrosis

Conditions: Gonarthrosis; Coxarthrosis

Summary: this is a non-inferiority study in which the investigators compare two low-dose radiotherapy schemes, which are recommended from degro clinical practice guidelines (3 gy vs 6 gy) for the treatment of osteoarthritis and other osteodegenerative disorders. a first randomization will be carried out among the patients included in the study: * patients in arm a will be treated at 3 gy (0.5 gy/fraction, 3 fractions/week), and patients in arm b will be treated at 6 gy (1 gy/fraction, 3 fractions/week). * patients should not know the arm to which they have been randomized. * once the treatment is finished, patients will be assessed at 8 weeks. if pain does not improve, a re-irradiation will be performed. if the patients were treated with 3 gy a new randomization will be performed (3 vs 6 gy again). if the patiens were treated with 6 gy they will be re-irradiated with 6 gy again. the investigators will analyze the results obtained depending on the dose received and depending on the location of the treatment.

painfull skeletal disorders are susceptible to be treated with low-dose radiotherapy. degro guidelines recommend a dose between 3 and 6 gy at 0'5 gy/fraction or 1 gy/fraction respectively. the investigators want to verify that both treatments (3 and 6 gy) are similar to improve the pain and function in patiens with gonarthrosis and coxarthrosis, and there are no differences between both treatments, therefore, 3 gy is not less than 6 gy. in this context, a prospective multicenter study is proposed. the study will include 338 patients to assess the efficacy of low dose irradiation (3 vs 6 gy) in gonarthrosis and coxarthrosis.

Eligibility criteria:
inclusion criteria: * age \>50 years * gonarthrosis or/and coxarthrosis diagnose * at least 1 year of evolution * non response to drug or surgery treatments * risk of colateral side effects due to the comorbidity of the patient with conventional treatments. exclusion criteria: * previous high dose radiotherapy in the same location * conective tissue disease (lupus, reumathoid artritis, esclerodermia, sd. raynaud, sd. sjögren, polymiositis) * inherited hipersesitivity sindromes (ataxia-telangiectasia, fanconi's anaemya, sd. nijmegen, sd. gorlyn, sd. cockayne, sd. down, sd. gardner, sd. usher) * no follow up possibility * other study inclusion

Keywords: low dose radiotherapy anti-inflammatory effects pain release quality of life
differential gene expression in patients with heart failure and iron deficiency - effects of ferric carboxymaltose

Conditions: Heart Failure

Summary: the primary efficacy objective of this study is to evaluate the effect of ferric carboxymaltose on mitochondrial gene activation pattern after 12 weeks of treatment.


Eligibility criteria:
inclusion criteria: * patients with chronic heart failure of new york heart association class ii or iii, a left ventricular ejection fraction of ≤ 40% for patients in nyha class ii or ≤ 45% for patients in nyha class iii, a hemoglobin level at the screening visit between 9.5-13.5 g/dl, and iron deficiency, which is defined as serum ferritin level \< 100µg/l or between 100 and 299 µg/l, when transferring saturation is \< 20%. * age ≥18 years * obtained informed consent * stable pharmacological therapy during the last 4 weeks (with the exception of diuretics) exclusion criteria: * hemochromatosis, iron overload, defined as tsat \> 45% * known hypersensitivity to ferinject®. * known active infection, crp\>20 mg/l, clinically significant bleeding, active malignancy. * chronic liver disease and/or screening alanine transaminase (alt) or aspartate transaminase (ast) above three times the upper limit of the normal range. * immunosuppressive therapy or renal dialysis (current or planned within the next 6 months). * history of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months. * unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias. * acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months. * coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months. * participation in a chf training program. * known hiv/aids. * inability to fully comprehend and/or perform study procedures in the investigator's opinion. * vitamin b12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy). * pregnancy or lactation. * participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study. * anticoagulation

Keywords: heart failure
a study to investigate the effect of steady-state tmc278 on the pharmacokinetics of a single dose of digoxin

Conditions: Healthy

Summary: the purpose of this study is to investigate the effect of steady-state (constant concentration of medication in the blood) tmc278 on the single dose pharmacokinetics (what the body does to the medication) of digoxin.

this is an open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), crossover (method used to switch patients from one treatment arm to another in a clinical study) study to investigate the effect of steady-state tmc278 on the single dose pharmacokinetics of digoxin. the study consists of 3 phases, including screening phase, treatment phase, and follow-up phase. after the screening phase, participants will be randomized to one of 2 treatment sequences consisting of treatments a and b, ie, sequence ab (11 participants), and sequence ba (11 participants). treatment phase includes, treatment a: digoxin 0.5 mg (single oral dose), and treatment b: tmc278 25 mg once daily with digoxin 0.5 mg (single oral dose). the 2 consecutive sequences will be separated by a washout period (period when receiving no treatment) of at least 14 days. safety evaluations for adverse events, clinical laboratory tests, electrocardiograms, cardiac telemetry, vital signs, physical examination, alcohol breath test, and specific toxicities will be monitored throughout the study.the study duration for treatment phase will be at least 26 days.

Eligibility criteria:
inclusion criteria: * women must be postmenopausal for at least 2 years, or be surgically sterile * men must agree to use a highly effective method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study medication exclusion criteria: * a positive hiv-1 or hiv-2 test at screening * hepatitis a, b or c infection at screening * history of clinically relevant heart rhythm disturbances * history of idiopathic hypertrophic subaortic stenosis, atrioventricular block, ventricular tachycardia/ventricular fibrillation or family history of sudden cardiac death

Keywords: healthy tmc278 tmc278ifd1001 human immunodeficiency virus - type 1 pharmacokinetics digoxin
does preoperative vaginal preparation with povidone-iodine before cesarean delivery reduce the risk of endometritis?

Conditions: Postpartum Endometritis

Summary: cesarean delivery rates are increasing in turkey and a major component of this increase is cesarean on demand. although data on the rate of cesarean delivery in turkey is limited, a national study reported a rate of 23.8%. infectious morbidity, consisting primarily of endomyometritis and wound infection, remains a leading cause of postoperative complications. estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and obstetric variables. infection following cesarean delivery results in not only increased hospital stay but also increases the cost of care. strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and altering the uterine position during repair of the uterine incision. despite these interventions, endometritis is still major problem after cesarean delivery. endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing an important role. the microbes endogenous to the vagina change throughout the course of pregnancy and parturition. larsen and galask noted that anaerobic species located in the vagina increase dramatically by the third postpartum day. in many cases, the surgeon's hand, reaching below the infant's head or presenting part, is in direct contact with the vagina. vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95% confidence interval \[ci\] 58%, 100%) of cesareans that follow labor. in these cases, vaginal flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision. vaginal preparation has been shown to decrease the quantitative load of vaginal microorganisms as well as to remove certain species of bacteria.


Eligibility criteria:
inclusion criteria: * women older than 38 weeks estimated gestational age and required cesarean section. exclusion criteria: * highly emergent cesarean * allergy to povidone iodine * chorioamnionitis on admission * fever on admission
narrow-band imaging versus standard white light for the detection of serrated lesions in the proximal colon

Conditions: Colon Cancer

Summary: this is a study to determine if using narrow-band imaging of the colon, rather than the usual white light on the colon, will improve the detection of a type of polyp called serrated. the polyps are called serrated because of their appearance under the microscope after they have been removed. they tend to be located up high in the colon, far away from the rectum. they have been definitely shown to be a type of precancerous polyp and it is possible that using narrow-band imaging will make it easier to see them, as they can be quite difficult to see with standard white light.

this is a randomized controlled trial comparing the use of narrow-band imaging (illumination of the colon in blue light)versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. the reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. these lesions share molecular features with a group of cancers that occur primarily in the proximal colon. these molecular features include cpg island methylator phenotype (cimp) and microsatellite instability. these lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. narrow-band imaging has anecdotally been used to highlight the appearance of these lesions. this study will test whether narrow-band imaging increases the detection of serrated lesions in a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * age 50-85 * intact colon and rectum * american society of anesthesiology risk class 1, 2 or 3 exclusion criteria: * no prior surgical resection of colon or rectum

Keywords: proximal colon cancer serrated colon lesions narrow band imaging
primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (hipec)

Conditions: Ovarian Cancer

Summary: stage iii epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

the objective of this study is to prove that treatment with primary cytoreductive surgery in combination with hipec (treatment arm) improves outcome compared to primary cytoreductive surgery without hipec (standard arm) with acceptable morbidity, in patients with figo stage iii epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.

Eligibility criteria:
inclusion criteria: * candidate for primary crs * histological or cytological proven figo stage iii primary epithelial ovarian, fallopian tube, or extra-ovarian cancer exclusion criteria: * history of previous malignancies within 5 years prior to inclusion * figo stage iv disease * complete primary cytoreduction is impossible * prior treatment for the current malignancy

Keywords: ovarian cancer hipec ovhipec primary debulking
respiratory and hemodynamic changes induced in mechanically ventilated patients for covid-19

Conditions: COVID-19; ARDS; Sars-CoV2

Summary: in the present context, it seems necessary to try to describe as precisely as possible the physiological alterations due to covid-19. from these observations, therapeutic proposals adapted to this new disease may then be developed, particularly in the symptomatic management of the critically ill patient. it therefore seems essential to rigorously study these modifications, as they have been studied in the past for ards. the aim of this non-interventional study is to describe precisely the respiratory and hemodynamic changes induced by covid-19 in mechanically ventilated patients .


Eligibility criteria:
inclusion criteria: * hospitalized in intensive care for a sars-cov2 infection * requiring invasive ventilation, * intubated for less than 72 hours with pao2/fio2 ratio \< 200 mmhg exclusion criteria: * patient mechanically ventilated for 72 hours or more * patient with documented respiratory co-infection * patient with a contraindication to pulmonary artery catheter insertion: high risk of bleeding, pre-existing high degree of atrioventricular heart block , pace maker * patient with spontaneous ventilation * patient with severe ards with static compliance of the respiratory system \< 20 ml/cmh2o * patient with severe ards with indication of prone positioning at inclusion. * patient with a cardiac condition that renders the measurement of pulmonary artery occlusion pressure uninterpretable as a surrogate for left ventricle end diastolic pressure (severe mitral insufficiency, severe mitral stricture, severe aortic insufficiency). * patient with intracardiac shunt * patient with ecmo * minors and pregnant women. * person not affiliated to or not benefiting from a social security scheme.
the effect of z-338 in subjects with functional dyspepsia

Conditions: Functioanl Dyspepsia

Summary: z-338; phaseiib, single-centre, randomized, double-blind, placebo-controlled, parallel group study in subjects with functional dyspepsia, evaluate the motility of gastro-duodenum by ultrasound


Eligibility criteria:
inclusion criteria: * postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at visit 1. * upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at visit 1. exclusion criteria: * subjects that heartburn should be the most bothersome symptom * subjects presenting with primary complaints relieved by stool movements (ibs) * subjects with diabetes by treatment * subjects that heartburn should be more than moderate
pregabalin for treatment of patients with postherpetic neuralgia (phn)

Conditions: Postherpetic Neuralgia ( PHN )

Summary: to prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (phn).


Eligibility criteria:
inclusion criteria: * male or female chinese subjects, ages ≥18 at screening * subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (phn). subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash * at screening (v1), subjects must have a score ≥40mm on the 100-mm visual analog scale (vas) of the short form-mcgill pain questionnaire (sf-mpq, see appendix 3) * at randomization (v2), subjects must have a score ≥40mm on the 100-mm visual analog scale (vas) of the short form-mcgill pain questionnaire (sf-mpq, see appendix 3) * at randomization (v2), subjects must have completed at least 5 daily pain diaries (dprs, see appendix 2) and have an average daily pain score ≥4 over the past 7 days exclusion criteria: * subjects who demonstrate a high response to placebo, with 30% decrease on the pain visual analog scale (vas) at randomization as compared to screening * subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ﹥3

Keywords: pregabalin postherpetic neuralgia ( phn )