Kornimate/medical-research-clean huggingface dataset:
impact of rheumatoid arthritis on body composition, bone marrow adiposity and bone mineral density: a case-control study

Conditions: Rheumatoid Arthritis

Summary: during rheumatoid arthritis (ra) (in comparison with control subjects), body composition is altered with a loss of lean body mass, bone mass and an accumulation of fat mass. determination of total body fat and particularly its abdominal distribution (visceral adiposity) is important because of the cardiovascular (excess cardiovascular risk), metabolic (insulin resistance, diabetes and dyslipidemia) and bone (increased fracture risk) risks associated with this endocrine organ. moreover, we do not have data concerning medullary adiposity in ra. this pilot case-control study will be compare body composition, bone marrow adiposity and bone mineral density in patients with ra versus healthy volunteers.


Eligibility criteria:
inclusion criteria: subjects: males and females of age (age ≥ 18 years). patients with ra according to american college of rheumatology/eular 2010 criteria, patients who have signed the informed consent controls: males and females of age (age ≥ 18 years). subjects who have signed the informed consent exclusion criteria: * patients who have received more than three anti-tnfinhibitors * patients who have previously received a janus kinase (jak) inhibitor * patients with concomitant therapies as described below : a combination with methotrexate is allowed if methotrexate is started ≥3 months before the start of the study and at a stable dosage (≤25 mg/week) for ≥4 weeks. a combination to conventional synthetic dmards (csdmards) other than methotrexate is not allowed within 4 weeks before and/or during the clinical trial * corticosteroid therapy \>10mg/d prednisolone equivalent is not allowed * intra-articular injections of corticosteroids are allowed if their number is less than or equal to 4 * intravenous corticosteroid infusions are not allowed * immunosuppressants other than methotrexate are not allowed * history or discovery of an osteoporotic fracture and/or t-score ≤-3 if ≥50 years old and/or z-score ≤-3 if \<50 years old during the screening phase, * corticosteroid therapy ≥ 10mg/d prednisolone equivalent, * pathologies or treatments affecting bone metabolism (breast cancer with antiaromatase, digestive malabsorption, stomach cancer, primary hyperparathyroidism, uncontrolled hyperthyroidism...), * history of radiotherapy on the lumbar spine or the hip studied, * patients undergoing hormone replacement therapy (hrt) or patients already under anti-osteoporotic treatment (bisphosphonates, strontium ranelate, teriparatide or denosumab) apart from calcium and/or vitamin d supplementation, chronic renal failure with creatinine clearance (ckd-epi formula) ≤ 30 ml/min,

Keywords: body composition rheumatoid arthritis visceral adiposity marrow adiposity bone mineral density
phase 3 triiodothyronine supplementation for infants after cardiopulmonary bypass

Conditions: Congenital Heart Defects

Summary: this is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. funding source - fda oopd.


Eligibility criteria:
inclusion criteria: 1. informed consent obtained 2. male and female patients \<5 months (152 days) of age 3. patients undergoing cardiopulmonary bypass exclusion criteria: 1. known thyroid disease (down syndrome is not an exclusion criterion unless patient has thyroid disease) 2. trisomy 13 and 18 3. prolonged preoperative ventilator support which would not be impacted by cardiac surgery (lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia) 4. any other condition as determined by the pi causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery 5. prior participation in the clinical trial
china alair system registry study-care study

Conditions: Asthma

Summary: the objective of this registry is to collect real-world outcome data for bronchial thermoplasty (bt) procedures in patients with severe persistent asthma who remain symptomatic despite taking standard of care maintenance medications.

data will be used to confirm the impact of bt on safety, effectiveness, quality of life, and the anticipated reduction in healthcare utilization events and cost by way of a reduction in severe asthma exacerbations.

Eligibility criteria:
inclusion criteria: 1. patient is an adult aged 18 years or older with severe persistent asthma who remains symptomatic despite taking standard of care maintenance medications. 2. patient is able to read, understand, and sign a written informed consent to participate in the registry and able to comply with the study requirements. 3. patient is able to undergo bronchoscopy in the opinion of the investigator or per hospital guidelines and as described in the alair system directions for use (dfu). exclusion criteria: 1. patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac defibrillator, or deep nerve or deep brain stimulator). 2. patient has any other medical condition that would make them inappropriate for study participation, in the investigator's opinion.
evaluation of rna from the liver tissue obtained in patients with chronic hepatitis c (0000-123)

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the quality of the rna and the reproducibility of gene expression profiling from liver tissue samples obtained by fine needle aspiration.


Eligibility criteria:
inclusion criteria: * patient has chronic hepatitis c (genotype 1) * patient has the ability to avoid use of anticoagulants, nonsteroidal anti-inflammatory drugs and aspirin for at least 5 days before the liver biopsy exclusion criteria: * patient has received any approved or investigational drugs for the treatment of hepatitis c in the six months before the liver biopsy * patient has hiv or hepatitis b virus * patient has been diagnosed with liver cancer * patient has evidence of cirrhosis on any previous liver biopsy * patient has confirmed alcohol abuse in the last 12 months * patient has participated in any investigational drug study within 90 days before the current study

Keywords: patients with chronic hepatitis c
prosthetic management of all on four versus all on six to rehabilitate completely edentulous maxillary ridge opposed by natural teeth

Conditions: Prosthesis Survival

Summary: the aim of the study to compare the anterior maxillary bone index changes for patient rehabilitated with implant supported fixed prosthesis opposed by natural teeth


Eligibility criteria:
inclusion criteria: * 1. all patient wearing a maxillary implant supported overdenture or implant supported fixed restoration and mandibular natural teeth or fixed restoration within natural dentition. 2. all patients were unsatisfied by the maxillary restoration and presented clear preference for a better prosthesis. 3. they were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. this was achieved through medical history and clinical examination by physician. 4. at least one year passed after the last restoration. 5. at least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class i according to ahuja and cagna).195 this was detected by a tentative jaw relation. exclusion criteria: * 1. patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients. 2. patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders which might affect implant lifespan. 3. long term immunosuppress and corticosteroid drug therapy. 4. patient with abnormal habits as clenching and bruxism. 5. smoking patient. 6. uncooperative patients. 7. neuromuscular diseases. 8. patient with problems in tmj.
study of the impact of exposure to outdoor and indoor pollutants in patients with asthma

Conditions: Asthma

Summary: the project is to measure exposure to outdoor and indoor air pollutants in asthma patients in order to show a possible association between variation in pollutant exposure and the occurrence of exacerbations in these patients

asthma is a chronic airway disease affecting between 6% and 7% of the french adult population. asthma is responsible for nearly 1000 deaths each year in france. air pollution (indoor and outdoor) is responsible for 7 million deaths each year according to the world health organization (who) assessment published in 2018, including 65,000 in france. studies monitoring exposure to indoor air pollutants are few in number in asthmatic patients. very little research has been devoted to continuous monitoring of indoor air quality in homes. our hypothesis is that variation in exposure to indoor air pollutants, in relation to outdoor air, would have an impact on the occurrence of exacerbations in asthmatic patients.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age, * patient with a confirmed diagnosis of asthma for at least 12 months as defined by the investigator, * patient with at least 4 asthma exacerbations in the last year * patient sleeping at least 6 nights per week in the same home exclusion criteria: * patient who is an active smoker or living with an active smoker, * patient with a diagnosis of copd, abpa or associated pulmonary fibrosis, * patient with an asthma exacerbation within 15 days prior to the inclusion visit, * patient with known occupational exposure, * patient living in a dwelling that does not allow the installation of sensors (inability to connect the sensor to the power supply, no location for the outdoor sensor...) * patient who plans to move in the next 6 months, * patient with a life expectancy of less than 6 months, * patient who has someone living in their household also included in exap, * patient who lives in an apartment and does not have a balcony or space for the outdoor sensor, * pregnant or breastfeeding women,

Keywords: asthma exacerbations outdoor and indoor air pollutants
endoscopic peroral myotomy for treatment of achalasia

Conditions: Achalasia

Summary: this study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in europe.

this pilot study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a single center setting in europe. 16 patients are enrolled to evaluate feasibility, safety and efficacy of peroral endoscopic myotomy. main outcome measurement is the eckhardt symptom score 3 month after therapy. primary outcome: -eckhardt symptom score 3 month after therapy. secondary outcomes: * lower esophageal sphincter pressure at 3 month after therapy. * reflux symptoms at 3 month after therapy. for this prospective study, inclusion criteria are achalasia, as diagnosed by established methods (contrast fluoroscopy, manometry, esophagal-gastro-duodenoscopy) and age greater than 18 years. previous therapy, such as esophageal surgery or previous myotomy are exclusion criterion. a forward-viewing upper endoscope is used with a transparent distal cap attachment. carbon dioxide gas is necessary for insufflation during the procedures. an endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. an electric generator is used with spray coagulation mode. a coagulating forceps is used for hemostasis as needed. closure of the mucosal entry site is performed using standard endoscopic clips.

Eligibility criteria:
inclusion criteria: * patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagal-gastro-duodenoscopy which are consistent with the diagnosis * persons of age \> 18 years with medical indication for surgical myotomy or endoscopic balloon dilatation * signed written informed consent. exclusion criteria: * patients with previous surgery of the stomach or esophagus * patients with known coagulopathy * previous achalasia-treatment with surgery * patients with liver cirrhosis and/or esophageal varices * active esophagitis * eosinophilic esophagitis * barrett's esophagus * pregnancy * stricture of the esophagus * malignant or premalignant esophageal lesion * candida esophagitis * hiatal hernia \> 2cm

Keywords: achalasia heller myotomy dysphagia peroral endoscopic myotomy
infection rate of vertical expandable prosthetic titanium rib implants (veptr)

Conditions: Infection

Summary: the study is conducted to analyse the infection rate in children treated with veptr-implants for severe spine or thoracic deformities.

spinal and thoracic deformities in children can be treated with vertical expandable prosthetic titanium ribs (veptr©, synthes gmbh®) to stimulate thoracic and spinal growth. with these implants children's symptoms and conditions can be slowed, halted or even reversed. because of the dynamic character of the deformity and the growth of the children, the implants have to be lengthened about every half a year. with each operation there is a small risk of infection, which might increase with number of previous surgeries. implant associated infections are often not clinical apparent and only found in microbiological analysis. to objectify the infection rate, identify potential precursors of infections and the relevance of asymptomatic infections in children with these implants a prospective study is conducted.

Eligibility criteria:
inclusion criteria: * all patients admitted at the university children's hospital basel in whom a veptr©-implant or parts of it will be removed. exclusion criteria: * obvious contamination of an explanted component occurred in the operating room.

Keywords: infection rate of veptr-implants veptr. vertical expandable prosthetic titanium rib
cultivated limbal epithelial transplantation (clet) for limbal stem cell deficiency (lscd)

Conditions: Limbal Stem-cell Deficiency

Summary: clet is a published treatment for the management of corneal failure due to extensive lscd. due to our previous studies on this novel treatment, the regulatory agency of spain "agencia española de medicamentos y productos sanitarios (aemps)" authorized our institution (ioba-university of valladolid) to perform this kind of therapy (clet) in a case-by-case base following the special situation medicines policy procedure in spain. upon approval of the permanent authorization patients will be included as specified by aemps.the objective of this study is to perform a protocolized treatment and follow up so that results can be reported to the scientific community.


Eligibility criteria:
total and/or severe lscd of any etiology in one or both eyes.

Keywords: limbal stem cell deficiency corneal failure limbal epithelial stem cells ocular surface corneal blindness
hirrem developmental study

Conditions: Sleep Initiation and Maintenance Disorders; Anxiety; Post-Traumatic Stress Disorder; Hot Flashes; Headache; Traumatic Brain Injury; Post Concussion Symptoms

Summary: the purpose of this study is to explore the functional and physiological effects associated with the use of high-resolution, relational, resonance-based, electroencephalic mirroring (hirrem), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. this is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of hirrem on an objective, physiological common denominator (heart rate variability, hrv), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.


Eligibility criteria:
inclusion criteria: * male and female adults and children aged 11 years and older. * subjects who are over the age of 18 must be able to give informed consent. children must be able to sign an assent form and have a signed parental permission form. * subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached. * subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, asperger syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, ptsd, substance abuse disorder, traumatic brain injury, and others. exclusion criteria: * subjects who fail to meet inclusion criteria. * subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission. * subjects physically unable to come to the study visits. * subjects with a known seizure disorder. * subjects with severe bilateral hearing impairment (hirrem requires the use of headphones). * subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator. * subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.

Keywords: hirrem neuro-technology closed-loop acoustic stimulation allostatic heart rate variability baroreflex sensitivity traumatic brain injury sports concussion ptsd hot flashes headache insomnia
long-acting tacrolimus for the treatment of resistant lupus nephritis

Conditions: Lupus Nephritis

Summary: glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (sle). around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of t-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. the investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. twenty-five patients with biopsy-proven lupus nephritis will be recruited. they will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. proteinuria, renal function, clinical and serologic lupus activity will be monitored. this study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.


Eligibility criteria:
inclusion criteria: * age over 18 with informed consent. * fulfill the revised american college of rheumatology criteria for sle * biopsy-proven class iii, iv, or v lupus nephritis within the past 24 months. * could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil). * nb. complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine \<15% above the base-line value. * female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study. exclusion criteria: * abnormal liver function tests * hepatitis b surface antigen or hepatitis c antibody positive * diabetic * receiving nsaid or other agents known to influence urinary * protein excretion * allergic or intolerant to macrolide antibiotics or tacrolimus

Keywords: glomerulonephritis systemic lupus erythematosus
renal colic and urolithiasis in poland

Conditions: Renal Colic; Urolithiasis

Summary: the aim of this study is to analyze the prevalence, effect on quality of life, and treatment-related behaviors for renal colic and urolithiasis in a population-representative sample of poles. we will be using an internet interview format for renal colic and urolithiasis evaluation. the study will include respondents representative for age and place of residence with adequate proportions of respondents from urban and rural areas.


Eligibility criteria:
inclusion criteria: - consent to participate exclusion criteria: - lack of consent to participate
dose-dense abvd first line therapy in early stage unfavorable hodgkin's lymphoma

Conditions: Hodgkin Lymphoma

Summary: prospective, multicenter, phase ii trial designed to assess whether intensification of abvd (dd-abvd) is feasible and can improve the outcome of patients with early stage hodgkin lymphoma.

dose-density has been shown to be an important factor for complete remission rate and longterm survival in lymphomas. the aims of this study were to find out whether intensification of abvd (dd-abvd) is feasible and can improve the outcome of patients with early stage hodgkin lymphoma. in view of emerging data on the role of early pet in defining prognosis in hodgkin lymphoma patients, the percentage of fdg-pet (fluorodeoxyglucose positron emission tomography) negativity after two cycle was chosen as the parameter to evaluate dd-abvd activity.

Eligibility criteria:
inclusion criteria: * age 18-70 years * histologically confirmed hodgkin lymphoma stage i, ii unfavorable according to eortc (european organisation for research and treatment of cancer) criteria, with exclusion of stage ii b bulky. * previously untreated * ecog (eastern cooperative oncology group) performance status 0 - 2 * staging with fdg-pet (fluorodeoxyglucose positron emission tomography) * written informed consent * adequate liver and renal function (total serum bilirubin \< 2.5 x uln, ast/sgot and/or alt/sgpt ≤ 2.5 x upper limit of normal (uln) or ≤ 5.0 x uln if the transaminase elevation is due to disease involvement, serum creatinine \< 2.5 x uln) exclusion criteria: * concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease. * uncontrolled diabetes mellitus (with fasting glucose levels above 200mg/dl) * other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for ≥ 3 years * patients with a known history of hiv seropositivity * active hcv infection (pcr + ; ast\> 1.5-2x un) * woman who is pregnant or breast feeding. fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. women of childbearing potential (wocbp) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months. * negative pregnancy test at baseline is required (serum β hcg). * male patient whose sexual partner(s) are wocbp who are not willing to use a effective contraception during the study and 3 months after the end of treatment * nodular lymphocyte prevalence histological subtype

Keywords: hl hodgkin lymphoma first line therapy