Kornimate/medical-research-clean huggingface dataset:
stability of the knee joint after anterior cruciate ligament and anterolateral ligament reconstruction

Conditions: Cruciate Ligament Rupture

Summary: the objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle acl reconstruction (sb) with addition of the all reconstruction and to compare it with the double-bundle acl reconstruction technique (db) and to analyse when the all is necessary to reconstruct.

background rotational instability after the anterior cruciate ligament (acl) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (all). there are more techniques to improve the rotational stability of the knee. the objective of this randomised cohort study was: (1) to evaluate the knee rotational stability after the single-bundle acl reconstruction (sb) with addition of the all reconstruction and to compare it with the double-bundle acl reconstruction technique (db). (2) to analyse when the all is necessary to reconstruct. methods 60 patients underwent the acl reconstruction with the average age of 29.5 years. in thirty patient's knees the acl was replaced with quadriceps muscle graft using the sb technique in combination with the all reconstruction by the gracilis graft (all group). with another thirty patients the acl was reconstructed performing db technique with the use of hamstring tendons (db group). the rotational stability was studied before and after the reconstruction of the acl in time "zero" using the computer navigation system. in the all group, the rotational stability was also analysed after the all reconstruction.

Eligibility criteria:
inclusion criteria: * the isolated acl lesion * the absence of the previous surgery on the knee joint * the body mass index (bmi) less than 30. exclusion criteria: * associated injuries of the tissue around the knee joint
diabetes mellitus and pregnancy : knowledge assessment

Conditions: Diabetes Mellitus

Summary: diabetes, a chronic and frequent disease, is a risk factor of pregnancy complications such as preeclampsia, congenital malformations and macrosomia. preconception care is all methods to assess the best prognostic for a diabetic pregnancy. among these methods, contraception is very important to plan the pregnancy on a chosen moment. the content of the preconception care is well established. however, information of diabetic women concerning contraception and giabetic pregnancy has been little studied.

the aim of the study is to describe the knowledge of the patients with diabetes concerning contraception and pregnancy planning.

Eligibility criteria:
inclusion criteria : * patients aged between 18 and 40 years old * with type 1 or type 2 diabetes mellitus * consulting in the department of diabetology in reims and charleville mezieres hospitals * accepting to participate in the study exclusion criteria : * patients with secondary diabetes (endocrine, pancreatic or genetical origin) * with postmenopausal status * without capacity to have a pregnancy (uterine aplasia, hysterectomy)

Keywords: diabetes mellitus pregnancy contraception
evaluation of blood brain barrier integrity and structural abnormalities in mps iiib patients using multimodal magnetic resonance imaging

Conditions: MPS IIIB (Sanfilippo B Syndrome)

Summary: the purpose of the study is to characterize structural abnormalities in the brain and the integrity of the blood brain barrier in patients with mucopolysaccharidosis type iiib (mps iiib).


Eligibility criteria:
inclusion criteria: * subject and/or subject's parent or legal guardian provides informed consent * subject is ≥5 years of age. * subject has a definitive diagnosis of mps iiib, as determined by either a documented deficiency in alpha-n-acetylglucosaminidase (naglu) enzyme activity or documented functionally-relevant mutations in both alleles of the naglu gene. exclusion criteria: * the subject has any internal or non-removable external metal items that may present a safety risk (for mri), or any other medical condition or circumstance in which an mri is contraindicated. * the subject has a known or suspected hypersensitivity to anaesthesia, a bleeding disorder, or any other medical condition or circumstance in which a lumbar puncture (for collection of csf) is contraindicated. * previous allergic reaction to gadolinium-based mri contrast media.

Keywords: mps iiib mucopolysaccharidosis mucopolysaccharidosis type iiib sanfilippo syndrome metabolism, inborn errors metabolic diseases genetic diseases, inborn
a study to determine the effects of npsp795 on the calcium-sensing receptor in subjects with autosomal dominant hypocalcemia as measured by pth levels and blood calcium concentrations

Conditions: Autosomal Dominant Hypocalcemia (ADH)

Summary: this is an open-label study looking at the effects of npsp795 (a selective calcium receptor antagonist) on activating mutations of the calcium-sensing receptor in patients with autosomal dominant hypocalcemia. patients with adh have low blood calcium levels and an inappropriately increased renal calcium excretion, decreased renal phosphate excretion, and hyperphosphatemia. pth and blood calcium levels will be tested during and after the iv infusion of npsp795. concentrations of npsp795 and length of time of iv infusion will vary depending on measured levels of ionized calcium.


Eligibility criteria:
inclusion criteria: * subjects with a heterozygous activating mutation of the casr gene (adh); if not previously confirmed, genetic testing will be performed at the screening visit * at least 18 years of age * body mass index (bmi) ≥ 18.5 to \< 39 kg/m2 exclusion criteria: * diseases or conditions that might compromise any major body system or interfere with the pharmacokinetics of npsp795 * history of treatment with pth 1-84 or 1-34 within the previous 6 months * history of hypocalcemia requiring frequent iv calcium infusions * history of hypocalcemic seizure within the past 3 months * blood 25-hydroxy vitamin d level \ 25 ng/ml, the subject will be eligible to continue on to the treatment phase of the study * estimated glomerular filtration rate (gfr) \< 25 ml/minute, and/or abnormal hepatic, hematologic, and/or clotting function * 12 lead resting electrocardiogram (ecg) with clinically significant abnormalities * concomitant medications with the potential to interfere with npsp795 metabolism * history of thyroid or parathyroid surgery

Keywords: autosomal dominant hypocalcemia hypocalcemia adh hypoparathyroidism
a study of siliphos in adults with non-alcoholic steatohepatitis (nash)

Conditions: Fatty Liver

Summary: the purpose of this study is to evaluate the dietary supplement siliphos, which comes from milk thistle, to determine whether it is safe and well-tolerated in adults who have non-alcoholic steatohepatitis (nash). an additional aim of this study is to determine whether siliphos may be beneficial in treatment of nash as indicated by improvement in liver enzymes (alt and ast). the study hypothesis is that siliphos will be safe and well-tolerated in people with nash and will result in a decrease in the liver enzymes alt and ast.

non-alcoholic fatty liver disease (nafld) encompasses a spectrum of liver conditions characterized by fat accumulation in the liver. non-alcoholic steatohepatitis (nash) is one form of nafld that may progress to cirrhosis in some people. currently, there are no medications that are approved for the treatment of nash. milk thistle is sold over-the-counter as a dietary supplement. milk thistle has been used for hundreds of years as a supplement to support liver function, and is commonly taken by people with a variety of liver conditions. milk thistle may help to reduce inflammation and fibrosis (scar tissue) in the liver, so it may be beneficial in the treatment of nash. as nafld is very common in the population, there are probably many people with nafld taking milk thistle supplements. however, there are no published studies of milk thistle in nafld. therefore, this study is designed to provide preliminary evidence of the safety, tolerability, and efficacy of milk thistle in people with nash. comparison: the milk thistle supplement (called siliphos) will be compared to a placebo (sugar pill) in this study.

Eligibility criteria:
inclusion criteria: * liver biopsy within 12 months demonstrating nash * abnormal alt exclusion criteria: * uncontrolled diabetes * hepatitis b, hepatitis c, or other chronic liver conditions * abnormal kidney function * excess alcohol consumption

Keywords: clinical trials pilot projects milk thistle liver function tests
a phase 2 study to determine the safety and efficacy of bind-014 (docetaxel nanoparticles for injectable suspension) as second-line therapy to patients with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of bind-014 in patients with advanced non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * males or females at least 18 years of age * diagnosis of nsclc with locally advanced or metastatic disease * previously treated with one platinum-based chemotherapy * disease status must be that of measurable and/or evaluable disease * performance status of 0 to 1 on the ecog scale * prior chemotherapy completed at least 3 weeks prior to study enrollment * prior radiation therapy allowed to \< 25% of the bone marrow * patient compliance and geographic proximity that allow adequate follow-up * adequate organ function * patients with reproductive potential must use contraceptive methods * signed informed consent from patient exclusion criteria: * active infection * pregnancy or planning to become pregnant * breast feeding * serious concomitant systemic disorders * second primary malignancy * patients who are symptomatic from brain metastasis * presence of detectable (by physical exam) third-space fluid collections * more than 1 prior cytotoxic chemotherapy regimen for advanced disease * prior treatment with docetaxel * history of severe hypersensitivity reaction to polysorbate 80 * peripheral neuropathy at study entry * patients known to be hiv positive * patients known to be seropositive for hepatitis c hepatitis b * congenital long qt syndrome, congestive heart failure, or bradyarrhythmia

Keywords: nsclc lung cancer
validation of the pnq for cipn patients.

Conditions: Chemotherapy-induced Peripheral Neuropathy

Summary: the patient neurotoxicity questionnaire (pnq) represents a diagnostic tool concerning patients with chemotherapy induced peripheral neuropathy (cipn). application of such a tool in the greek clinical praxis requires validation. validation consists of three stages: translation, reverse translation, and patient application. 100 oncologic patients were assessed by comparing the pnq to the nci-ctcae at the chemotherapy onset and 2nd, 4th, and 6th sessions. specific requirements of the diagnostic tool (compliance, validity, concordance, sensitivity, specificity, reliability) were statistically evaluated. differences between translated texts and between the reverse translation and the original were considered negligible. at the 2nd, 4th and 6th session compliance was 98%, 95% and 93% while cronbach's α was 0,57 0,69 and 0,81 respectively. cohen's weighted κ was 0,67 and 0,58, spearman's ρ was 0,7 and 0,98 while auc of the roc was 1 and 0,9 for the sensory and the motor part respectively. the variance's linear regression analysis confirmed cipn worsening over time (p-value\<0,0001). the greek version remains close to the original. compliance rates reflect easy pnq application. cohen's κ values highlight the physicians' tension to underestimate the patients' condition. spearman's ρ, cronbach's α and auc values reflect good validity, reliability and specificity of the pnq respectively. finally, the linear analysis confirmed the pnq sensitivity over time. the pnq validation in greek adds a crucial tool in the physicians' armory. it can now draw the necessary information to modify the chemotherapy and analgesic treatment schemes at both preventive and acute levels.


Eligibility criteria:
inclusion criteria: * patients older than 18 and under 80 years of age * patients that undergo chemotherapy for the first time * patients regardless of cancer type * patients regardless of social and education underground * patients able to communicate with personnel exclusion criteria: * pediatric patients * preexisting neurological condition * patients already under chemotherapy treatment * patients unable to communicate with personnel

Keywords: chemotherapy peripheral neuropathy questionnaire
cml pediatric itk response according to molecular identification at diagnosis

Conditions: Chronic Myeloid Leukemia

Summary: treatment of chronic myeloid leukemia (cml) has been revolutionized by tyrosine kinase inhibitor (tki). nevertheless, case of failure and suboptimal response are still observed even in children. pediatric cml is a rare disease and differs from adult in terms of disease presentation and treatment response underlying a likely different cml biology. molecular mechanisms that induce resistance to tki are still poorly characterized except mutations in the tyrosine kinase domain of bcr::abl1. we propose to search for a molecular signature to predict the response to tki in the pediatric population.

commonly mutated genes associated with myeloid malignancies have been described in acceleration phase and blastic phase but also at diagnostic in adult chronic phase-cml (cp-cml). the impact of these mutations on treatment response is still debated but several studies observed a worse outcome in adult patients with some mutations. in children only one study explored the molecular status of 30 genes in 21 children and young adults. they found a higher proportion of asxl1 mutations in children than in adult they did not observed any significant difference in overall survival of asxl1 mutated versus non-mutated patients but probably due the small size of the cohort. we propose here, to investigate retrospectively on dna at diagnosis of 88 cp-cml children the mutation status of 64 genes by next generation sequencing and to see if there is an association with the response to tki treatment. we will complete the molecular signature by analyzing the differentially genetic expression profile by rna-seq on peripheral blood rna of 8 patients with ccr at 12 months (and/or a bcr ::abl1 is ≤1%is) and 8 patients with no ccr at 12 months.

Eligibility criteria:
inclusion criteria: * age at diagnosis less than or equal to 18 years * presence of a philadelphia chromosome detected by cytogenetic analysis (conventional karyotype or fluorescence in situ hybridization (fish)) and a bcr ::abl1 transcript e13a2 ou e14a2 * diagnosis in chronic phase according to the european leukemia net (eln) criteria * first-line treatment with tkis * possible pre-treatment with hydroxyurea * dna available at diagnosis * rna available for a sub-group patients (8 responders vs 8 no responders) exclusion criteria: * age at diagnosis more than 18 years * diagnosis in accelerated phase or blastic phase * first line treatment other than tki

Keywords: chronic myeloid leukemia children molecular landscape tki response expression profile
development and assessment of feasibility of non-invasive multiple sensor hypo-sense as a tool for detection of hypoglycemia

Conditions: Type 1 Diabetes; Nocturnal Hypoglycemia

Summary: hypo sense is a non- invasive method for detection of hypoglycemia. the hypo sense combines an array of non-invasive sensors which monitors the patient's physiological parameters (heart \& respiration rate, perspiration, skin temperature and arm motion) designed as a wrist watch device. the hypo sense is intended for monitoring symptoms of hypoglycemia in diabetic patients in hospital environment among type 1 and type 2 diabetes adults as an adjunctive device to reference methods the proposed study will be consisting of two main segments: the primary aim of segment 1 of the study is data collection and calibration of the hypo sense sensor prototype compared to standard invasive reference glucometer. the primary aim of segment 2 of the study is to validate the hypo sense prototype performance in detecting hypoglycemic events. during the first segment of the study we intend to collect in parallel measurements of blood glucose using reference method (capillary glucometer) and continuous data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced. the reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. this model will translate the set of the physiological recorded parameters into detection of hypoglycemic events. during the second segment of the study we intend to evaluate the validity of the hypo sense sensor ability to detect hypoglycemic events compared to standard invasive reference method (capillary glucometer).


Eligibility criteria:
inclusion criteria: * signing an inform consent form prior to any trial related procedure * type 1 diabetes diagnosed at least 12 months prior to study inclusion * age \> 18 years old exclusion criteria: * participating in other device or drug study * any significant disease or condition, including psychiatric disorders that in the opinion of the investigator is likely to affect patient's compliance or ability to complete the study * patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease * chronic skin problem in the lower inner arm * pregnant or breast feeding women

Keywords: type 1 diabetes hypoglycemia detection non-invasive sensor nocturnal hypoglycemia
comparing the effects of different types of exercise on glucose handling

Conditions: Glycemic Control; Insulin Sensitivity; Sex Differences

Summary: the purpose of the proposed study is to compare the acute effects of different types of exercise modalities on glucose handling in young, healthy males and females. the exercise modalities that will be compared include: a high intensity interval exercise (hiie) protocol, a moderate intensity continuous exercise (mice) protocol and a low-load, high-repetition (ll-hr) resistance exercise protocol.

the purpose of this study is to compare the effects of different exercise modalities (high intensity interval exercise, moderate intensity continuous exercise, and low-load-high repetition resistance exercise) on blood sugar control in young healthy, males and females. to test this theory, a sugar challenge (oral glucose tolerance test - ogtt) will be performed during the pre-testing visit to determine the baseline blood sugar response. an ogtt will also be performed 2 hours after each single exercise session to determine how each type of exercise affects the blood sugar response. investigators will take multiple blood samples throughout the trial to allow us to measure blood sugar, insulin and concentrations and oxidative stress. muscle biopsies will be taken before and after each exercise bout so that investigators can examine the underlying mechanisms that contribute to the effectiveness of the different types of exercise on blood sugar control. investigators will also use an ultrasound to measure factors related to of cardiovascular health such as artery stress and vascular conductance during the exercise bouts. direct benefits of this study include characterizing sex differences of blood sugar handling after single exercise sessions. this study could have direct benefits on deterring the effectiveness of different forms of exercise on blood sugar levels.

Eligibility criteria:
inclusion criteria: * in order to participate in this study, participants must be a healthy man or woman between the ages of 18 and 30 years. exclusion criteria: * presence of chronic health condition(s) \[i.e. metabolic (i.e. type 1 or type 2 diabetes), cardiovascular (i.e hypertension), respiratory (i.e. chronic pulmonary obstructive disorder) or digestive (i.e. ulcerative colitis) disorders. * are pregnant, or suspect that they may be pregnant, or nursing * inability to complete the single exercise sessions. * regularly participate in cardiovascular (\>3 sessions/week) or resistance training (\>2 sessions/week) exercise. * have an allergy to local anesthetic (or family history of allergy) * have undergone a barium swallow or an infusion of a contrast agent in the past 3 weeks * are taking prescription anti-coagulant or anti-platelet medications (e.g., warfarin, heparin, clopidogrel) * inability to exercise as suggested by the get active questionnaire (gaq) * bmi \> 27 kg/m2
out-of pocket payments in patients with lymphedema

Conditions: Primary Lymphedema

Summary: primary lymphedema is a chronic condition posing a high burden on patients. clinical guidelines emphasize the role of compression therapy by prescription medical devices. even in a mandatory publicly funded health insurance system, out-of-pocket payments (oopp) may exist due to the price and reimbursement setting processes. oopp may threaten the equity of care and drive patients to forgo care. the investigators aim was to analyze the distributive effects of oopp for primary lymphedema patients in france. a prospective, multicenter study will be conducted in france in 2015 on patients with primary lymphedema. household ability to pay will be specified by net income and oopp will be assessed prospectively over 6 months for outpatient care (visits, drugs, medical devices, nursing care, biological tests, imaging, physiotherapy and transportations). both mandatory and voluntary health insurance reimbursements will be considered. the investigators will combine concentration curves and concentration indices to assess the distributive effects.


Eligibility criteria:
inclusion criteria: * patient aged over six years, with primary lymphedema, regardless of the severity of the disease; * patient treated in one of the centres participating in the study; * patient (and her legal representative for minors) who gave her written consent \[or did not refuse to participate, according to local law\]; * patient with internet access and an active email address. exclusion criteria: * patients with concomitant chronic venous insufficiency; * patient not covered by any health care insurance scheme; * people protected under the law.