Kornimate/medical-research-clean huggingface dataset:
percutaneous minimal invasive pedicular screw and rod insertion in circumferential lumbar fusion

Conditions: Degenerative Disc Disease

Summary: convalescence after lumbar surgery is dependent on the extensiveness of the surgical procedure. minimal invasive techniques in lumbar spine surgery are reported to achieve excellent clinical results with less pain, morbidity and disability.

to achieve lumbar fusion when there is no need for decompression of the neural structures a posterior midline approach and a left anterior retroperitoneal approach is used. the retroperitoneal anterior approach to the lumbar spine offers some benefits compared with the posterior approach. dural injury and epidural scarring can be avoided, and an interbody fusion graft can be placed with minimal risk to the nerve roots. however, the extensive posterior midline approach with extensive muscle dissection is necessary to place the pedicular screws. a report of a follow-up period of 2 years of a randomized trial of minimal invasive insertion of pedicular screws and rods in lumbar fusion.

Eligibility criteria:
inclusion criteria: * degenerative disc disease in one of the three lower lumbar levels. exclusion criteria: * previous fusion, metabolic bone disease, co-morbidity or psychological instability.

Keywords: lumbar fusion pedicular screws minimal invasive technique randomized controlled trial
screening for chronic hepatitis c virus in hospitalized patients

Conditions: Hepatitis C

Summary: chronic viral hepatitis c is a public health problem and several management recommendations are available. according to the has, hepatitis c screening consists of a targeted screening of people at risk of infection by the virus, in particular to drug users, to people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who have been or have been imprisoned. our study proposes to evaluate hepatitis c screening in consenting patients hospitalized in saint joseph. these previously identified patients with comorbidities will be cared for according to current national practices that reduce hcv morbidity and mortality.

hepatitis c screening is based on a blood test, in particular the elisa test, which looks for anti-hcv antibodies. in the case of positive c viral serology, the search for the c virus from a blood test makes it possible to detect the genome (rna) of the virus, which is thus directly detected by a so-called "pcr" technique. although screening activity is important in france, it remains insufficient. in december 2016, has concluded that risk-based targeted screening has limitations and contributes to the persistence of a hidden epidemic of viral c infection. it is estimated that 75,000 people are unaware of being carriers of the hepatitis c virus. however, there is safe, effective and well-tolerated treatment. with duration of 8 to 12 weeks it allows a healing of hcv in more than 95% of subjects. afef recommendations aim to achieve viral elimination c (as early as 2025). this elimination is defined as a 90% decrease in new infections associated with a 65% reduction in hcv mortality. oms has planned this target for 2030. to achieve this goal, a number of measures are gradually being implemented focusing on universal treatment and universal screening. the hospital may be a place where systematic screening is interesting. in 2017, the prevalence of anti-hcv positive antibodies in the facility, apart from the hepato-gastroenterology service, was 1.7%, more than twice the estimated prevalence in our general population. these data give a rationale for the realization of this study.

Eligibility criteria:
inclusion criteria: * all in-patient patients and consenting to participate at the study. exclusion criteria: * refusal to participate in the study * contraindication to a blood sample (impossibility of a peripheral venous approach and any clinical condition that may indicate a venous sample) * minor patient * patient unable to express consent
correct use of sequential formoterol and budesonide inhaler capsule treatment via aerolizer and patient satisfaction in asthmatics

Conditions: Asthma

Summary: this study will evaluate the correct use of sequential formoterol and budesonide inhaler capsule treatment via aerolizer and patient satisfaction in adult asthmatics.


Eligibility criteria:
inclusion criteria: * moderate persistent asthmatic patients. * no previous aerolizer experience. exclusion criteria: * life-threatening asthma: a subject must not have life-threatening asthma as a history of significant asthma episode(s)requiring intubation associated with hypercapnia, respiratory arrest or hypoxic seizures, or asthma-related syncopal episode(s). * worsening of asthma: a subject must not have experienced a worsening of asthma which involved a hospitalization within 6 months of screening, or an emergency room visit three or more times in the past 6 months, or use of oral corticosteroids for worsening asthma within 3 months of screening. * unstable asthma: during screening period, a patient requires the use of \>8 puffs/day of salbutamol 100 mcg per actuation pmdi on two consecutive days. * a subject must not have had an upper respiratory tract infection within 4 weeks of screening. * fev1\< 60% at screening. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: aerolizer formoterol budesonide asthma
strengthening of the first dorsal interosseous for thumb carpometacarpal osteoarthritis

Conditions: Thumb Osteoarthritis; First Dorsal Interosseous Strengthening

Summary: to determine the effect of first dorsal interosseus (fdi) strengthening in patients with thumb carpometacarpal (cmc) osteoarthritis.

thumb cmc osteoarthritis is a normal part of aging. most patients are able to adapt to symptoms of pain and disability, other patients might benefit from non-operative interventions; e.g. splinting, corticosteroid injections, pain medication, and multiple hand exercises. the dorsal ligament complex is one of the components for stability of the thumb cmc joint. these ligaments specifically create stability for pinch and grip during the final phase of opposition. both, the opponens pollicis (op) and the first dorsal interosseous (fdi) play a key role in centralizing the metacarpal on the trapezium. a retrospective study showed that a dynamic stability modeled approach, including targeting the fdi, reduced pain and improved function in patients with thumb cmc osteoarthritis. recently, another study demonstrated that reduction of radial subluxation - the thumb metacarpal versus the trapezium cmc joint - was achieved by contraction of the dynamic stabilizers of the healthy hand, specifically with the focus on the fdi. more clinical research is needed to determine if there are efficacious (effective and low-cost) evidence-based exercise programs for pain reduction and functional improvement in patients with thumb cmc osteoarthritis. the investigators are interested in the effect of fdi strengthening in patients with thumb cmc osteoarthritis. therefore, the investigators hypothesized that there is no difference in the change of lateral pinch strength at 12 weeks between patients treated with a splint versus patients treated with a splint and fdi strengthening for thumb cmc osteoarthritis. we also tested the same hypothesis for 3-point chuck strength, vas for pain, and promis upper extremity cat.

Eligibility criteria:
inclusion criteria: * at least 18 years old * english-speaking * splint treatment for thumb carpometacarpal (cmc) osteoarthritis exclusion criteria: * less than 18 years old * rheumatoid arthritis or post-traumatic carpometacarpal (cmc) osteoarthritis * patients that received a corticosteroid injection during the appointment for treatment of thumb carpometacarpal (cmc) osteoarthritis
volatile organic compounds (vocs) as a biomarker in immune-mediated pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension; Systemic Sclerosis; Systemic Lupus

Summary: aim: to investigate the role of inflammation and auto-immunity in pulmonary arterial hypertension by using the profile of volatile organic compounds. hypothesis: first, the investigators hypothesize that at time of diagnosis the voc profiles will discriminate patients with pah-ctd and idiopathic pah (ipah) from patients with systemic sclerosis or systemic lupus erythematosus (ctd) without pah, supporting the contention that there is a overlapping inflammatory and auto-immune pathway in pah. during follow-up, the investigators will measure the voc profiles of patients in all three groups who will be treated according standard clinical care. the hypothesis is that voc profiles are affected by therapy.


Eligibility criteria:
inclusion criteria: 1. pah-ctd patients, inclusion criteria: * classification as definite systemic sclerosis or systemic lupus erythematosus according to respectively the acr-eular criteria (16) and slicc criteria (17) * minimal age of 18 year * diagnosis of pulmonary arterial hypertension: mean pulmonary artery pressure (mpap) of ≥25 mmhg, pulmonary capillary wedge pressure (pcwp) ≤15 mmhg, and a pulmonary vascular resistance (pvr) ≥240 dynes.s.cm-5 measured by right heart catherization. 2. ipah patients, inclusion criteria: * diagnosis of pulmonary arterial hypertension: mean pulmonary artery pressure (mpap) of ≥25 mmhg, pulmonary capillary wedge pressure (pcwp) ≤15 mmhg, and a pulmonary vascular resistance (pvr) ≥240 dynes.s.cm-5 measured by right heart catherization. * no family history of pah * triggering factor is excluded: connective tissue disease, drugs or toxins, human immunodeficiency virus, congenital heart disease, portal hypertension, schistosomiasis (2) * minimal age of 18 year 3. ssc and sle (ctd) patients without pah, inclusion criteria: * classification as definite systemic sclerosis or systemic lupus erythematosus according to respectively the acr-eular criteria (16) and slicc criteria (17) * minimal age of 18 year * no signs of pah at screening visit exclusion criteria: * active or treated malignancy * tuberculosis or hepatitis b/c infection in case of start immunosuppressive therapy * need to start immediately with therapy * already use of immune suppression
pqr309 and eribulin in metastatic her2 negative and triple-negative breast cancer (piqhasso)

Conditions: Metastatic Breast Cancer

Summary: this study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics of pqr309 in combination with standard dose of eribulin in patients with locally advanced or metastatic her2-negative (escalation part) and triple negative breast cancer (expansion part).

* the primary objective of the escalation part is to assess the maximum tolerated dose (mtd) of pqr309 combined with the standard eribulin dose in patients with her2 negative breast cancer following a "modified" 3 by 3 design. * for the expansion part the objective is to evaluate efficacy of pqr309 in combination with eribulin in patients with triple negative breast cancer * once the mtd of continuous daily pqr309 dosing has been established, intermittent schedules of pqr309 ("2 days on/ 5 days off" or "monday / thursday") will be evaluated.

Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed diagnosis of breast cancer. radiological evidence of inoperable locally advanced or metastatic breast cancer. * her2 negative breast cancer (based on the most recent analyzed biopsy) defined as a negative in situ hybridization test or an immunohistochemistry status of 0, 1+ or 2+. * received at least 2 and no more than 5 prio chemotherapeutic regimens in locally advanced and/or metastatic setting. * prior therapy has to include an anthracycline and a taxane in any combination or order. * for expansion part: triple-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (ihc) status of 0,1+ or 2+er abnd pr status \<10% by local laboratory testing. exclusion criteria: * previous systemic treatment with pi3k,mtor or akt inhibitors (allowed in the escalation part). * previous treatment with eribulin (allowed in the escalation part). known hypersensitivity to any of the excipients of pqr309 or eribulin.concurrent treatment with other approved or investigational antineoplastic agent. * symptomatic central nervous system metastases. the patient must have completed any prior local treatment for cns metastases \> 28 days prior to first dose of the study drug (including radiotherapy and/or surgery). * clinically manifested diabetes mellitus(treated and/or clinical signs with fasting glucose \>125mg/dl or hba1c\>7%), or documented steroid induced diabetes mellitus.

Keywords: tnbc
safety and tolerability of artificial tears in dry eye subjects

Conditions: Dry Eye Syndrome

Summary: the safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. each subject will receive all three products in a randomly assigned order. the subject will use one product at a time for a duration of one week before switching to the next assigned product.


Eligibility criteria:
inclusion criteria: * mild, moderate or severe symptoms of dry eye exclusion criteria: * uncontrolled systemic disease * contact lens wear * participation in another clinical study
return to work and functional results of french soldiers after anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Rupture

Summary: the return to work in the military population after surgical reconstruction of the anterior cruciate ligament (acl) has been poorly investigated within the french armed forces. only american studies are available and show that this surgery has a significant impact on the operational capacity of soldiers. acl rupture is extremely frequent in active populations. this pathology has already been extensively explored in at-risk populations, particularly in sports. most studies show that the resumption of sport is greatly affected by this pathology. furthermore, an over-risk (10 times greater incidence of acl rupture) in the military has been demonstrated.


Eligibility criteria:
inclusion criteria: * military personnel who underwent first-line acl reconstruction surgery between january 2014 and may 2019 exclusion criteria: * people who have had acl reconstruction surgery after initial failure * people with a multiligamentous knee condition
a phase ii study in patients with moderate to severe active ulcerative colitis.

Conditions: Ulcerative Colitis

Summary: the proposed study is a randomized, double-blind,placebo-controlled, multicenter phase ii study to investigate the safety and efficacy of shr0302 in patients with moderate to severe active ulcerative colitis. the study aims to evaluate the optimal dose of shr0302 and time needed to induce clinical response in active ulcerative colitis patients. this is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. early withdrawn subjects during the first treatment phase can not enter the extension phase. the total duration of the study participation, including extension and follow-up, will be approximately 18 weeks. shr0302 is a janus kinase 1(jak1) inhibitor, capable of blocking janus kinase-signal transducer and activator of transcription (jak-stats) pathway and controlling inflammation. therefore it has the potential to be a treatment for ulcerative colitis.


Eligibility criteria:
inclusion criteria: * male and female subject age ≥ 18 and ≤75 years of age at randomization. * active ulcerative colitis with a 9-point modified mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (the duration of the time between endoscopy and baseline should not exceed 10 days and allow central over read turn over before randomization). * subject should have at least three-month history of ulcerative colitis diagnosis at randomization. exclusion criteria: * diagnosis of indeterminate colitis, or clinical findings suggestive of crohn's disease. * subjects with ulcerative colitis, which is confined to a proctitis (distal 15 cm or less). * treatment naïve subjects diagnosed with ulcerative colitis (without previous exposure to treatment).
the severity assessment model for aecopd with combination of disease and syndrome

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Summary: the establishment of the aecopd severity assessment model can quickly and accurately evaluate the condition, which is of great significance for standardizing diagnosis and treatment, improving efficacy, and improving prognosis. at the same time, it can provide ideas and methods for the research of disease assessment models in related fields.

accurate assessment of the condition is the prerequisite and basis for standardized clinical treatment. traditional chinese medicine has shown good efficacy and advantages in treating aecopd, but currently there is no ideal standard for judging the severity, nor is there an accurate, practical, and tcm specific disease assessment tool. therefore, this project integrates multidimensional variables of traditional chinese and western medicine, and intends to conduct research on the construction of a disease syndrome combined aecopd disease assessment model through literature review, expert consultation, clinical investigation, and machine learning algorithms, and establish preliminary grading standards for the severity of aecopd disease. ultimately, it provides ideas and methods for the rapid and accurate assessment of aecopd, standardized diagnosis and treatment, improved efficacy, improved prognosis, and research on disease assessment models in related fields.

Eligibility criteria:
inclusion criteria: * meets aecopd diagnostic criteria. * voluntarily participate in the research and sign the consent form exclusion criteria: * individuals with severe mental disorders and cognitive impairments who are unable to communicate normally

Keywords: acute exacerbation of chronic obstructive pulmonary disease severity assessment model combination of disease and syndrome classification and regression trees artificial neural network
chronic cold acclimation stimulates the browning of subcutaneous white adipose in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes; Cold Acclimation

Summary: adipose tissues, which include white adipose tissue (wat) and brown adipose tissue (bat), play an essential role in regulating whole-body energy homeostasis. recent studies also reveal the presence of a subset of cells in wat that could be induced by environmental or hormonal factors to become "brown-like" cells, and this "beigeing" process has been suggested to have strong antiobesity an antidiabetic benefits. more recently, one study showed that short-term cold acclimation (10 days) improved insulin sensitivity, but did not activate the browning of subcutaneous white adipose in patients with type 2 diabetes mellitus. here, investigators hypothesize that a chronic cold acclimation can activate the the browning of subcutaneous white adipose in patients with type 2 diabetes mellitus.

all subjects must receive metformin therapy, patients have chronic cold acclimation intervention for 33 days. during the subsequent cold acclimation period, subjects are exposed to an environmental temperature of 14-15 °c for 33 consecutive days, with cold exposure for 2 h on the first day, 4 h on the second day and 6 h on the third through the 33th day.biopsy for subcutaneous white adipose and skeletal muscle was performed before and after the intervention program under local anesthesia. the brown fat characteristics and insulin signaling of biopsy samples will be measured. the expression levels of uncoupling protein-1 (ucp-1), peroxisome proliferator-activated receptor r coactivator 1 a (pgc1a), growth factor receptor binding protein-10 (grb10), pr domain containing 16 (prdm16) will be determined before and after the intervention programme from the biopsy samples. in addition, a combination of positron emission tomography (pet) and computed tomography (ct) - with the glucose analogue 18f-fluorodeoxyglucose (18f-fdg) as a tracer will be performed for brown adipose tissue before and after the intervention programme.insulin sensitivity will be checked before and after the intervention programme by insulin clamp assay, and endothelial function will be measured by ultrasound.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * 18-60 years old * body mass index 18.5-28 kg/m2 * hba1c \< 6.5% * well controlled diabetes exclusion criteria: * type 1 diabetes * body mass index \< 18.5 kg/m2 * body mass index \> 28 kg/m2 * female * taking any drugs other than metformin * haemoglobina1c \>=6.50%

Keywords: brown adipose tissue subcutaneous white adipose tissue white adipose tissue
parathyroid autofluorescence visualization in thyroid surgery: impact on postoperative hypocalcemia

Conditions: Hypocalcemia

Summary: this multicenter, randomized controlled trial evaluates the clinical impact of parathyroid autofluorescence visualization using near infrared light (nir) during total thyroidectomy (tt). it compares patients who undergo tt associated or not with lymph node dissection (lnd) with nir vs without nir use during surgery.

total thyroidectomy (tt) is responsible for postoperative hypocalcemia in 20-30% of patients, which is definitive in 1-4% of operated patients (1). this complication is mainly due to surgery-induced parathyroid dysfunction, which could be improved by a better intraoperative identification of the parathyroids. intraoperative parathyroid auto-fluorescence visualization (without any dye injection) using near infrared light (nir) is an emerging technique, which allows correct identification of normal parathyroids in almost all cases (2), but the clinical impact of nir is unknown. the aim of this prospective, comparative randomized study, is to compare 2 groups of patients: patients operated with nir (nir+) vs patients operated without nir (nir-). the main objective of this study is to assess the impact of intraoperative use of nir camera on postoperative hypocalcemia. secondary objectives are to assess the impact of nir on the visualization, autotransplantation and inadvertent resection rates during tt.

Eligibility criteria:
inclusion criteria: * all patients eligible for one-stage total thyroidectomy, associated or not to lymph node dissection (tt +/- lnd). exclusion criteria: * combined parathyroid and thyroid disease (including patients with enlarged parathyroids incidentally found during surgery and resected)

Keywords: postoperative hypocalcemia near infrared imaging parathyroid autofluorescence
bvs implantation in patients with variant angina and moderate coronary artery disease

Conditions: Angina Pectoris, Variant

Summary: the purpose of this study is to determine whether bvs(bioresorbable vascular scaffold) implantation with optimal medical therapy can improve the outcome of patients with variant angina and moderate coronary artery disease.


Eligibility criteria:
inclusion criteria: * age 19 and more * vasospastic angina diagnosed by provocation test including ergonovine provocation coronary angiography or ergonovine echocardiogram * no-ischemia producing moderate coronary artery disease(stenosis\>50%, ffr\>0.8) exclusion criteria: * ischemic coronary lesion * organic heart disease associated with myocardial ischemia or sudden cardiac death * history of percutaneous coronary intervention * cerebrovascular diseases or peripheral disease * nyha iii and iv * cardiac pacemaker or implantable defibrillator * pregnancy or breast feeding * life expectancy less than 2 years

Keywords: bioresorbable vascular scaffold variant angina moderate coronary artery disease vasospastic angina