Kornimate/medical-research-clean huggingface dataset:
mps (radico cohort) (radico-mps)

Conditions: Mucopolysaccharidosis I; Mucopolysaccharidosis II; Mucopolysaccharidosis III; Mucopolysaccharidosis IV; Mucopolysaccharidosis VI; Mucopolysaccharidosis VII; Mucopolysaccharidosis IX; Multiple Sulfatase Deficiency Disease

Summary: the goal of this observational study is to characterize the epidemiology and natural history of mps diseases by building a retrospective and prospective collection of extensive phenotypic data from french mps patients.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of mps based on clinically relevant enzyme deficiency, with abnormally elevated gag urinary excretion and/or identification of pathogenic mutations. * signed informed consent or parents/guardian non-opposition for deceased patients (minor or protected major) there are no non-inclusion criteria.
characteristics and clinical significance of gut microbiota in patients with monoclonal gammopathy

Conditions: Monoclonal Gammopathy of Undetermined Significance (MGUS); Intestinal Flora; Multiple Myeloma; M-Protein

Summary: this is an observational case-control study, aiming to systematically analyze the gut microbiome characteristics of patients with monoclonal gammopathy of undetermined significance (mgus). the study will collect blood and stool samples from mgus patients, non-mgus patients (with similar diseases), and healthy controls, and perform multi-omics detection including microbiomics, peptidomics, and biochemical immunology. it will comprehensively analyze the abnormal features of the gut microbiome in mgus patients, which may help provide new biomarkers and potential mechanisms for the diagnosis, prognosis evaluation, and treatment strategies of mgus.

this is a case-control, observational single-center study aiming to investigate the impact of common comorbidities on gut microbiome structure and disease progression in patients with monoclonal gammopathy. we plan to collect samples from 11 disease categories, with each category including two groups (monoclonal gammopathy and non-monoclonal gammopathy), as well as 700 age- and gender-matched healthy controls, for a total of 2,990 samples. at enrollment, we will collect whole blood, plasma, serum, and fecal samples from the study participants, and obtain relevant information such as demographic characteristics, lifestyle, family medical history, and medication use.we will perform metagenomic, proteomic, and serum biochemical and immunological analyses on the samples to directly obtain association data between gut microbiome characteristics (as exposure factors) and clinical outcomes (as endpoints). this study will systematically analyze the dysbiosis characteristics of the gut microbiome in monoclonal gammopathy patients, identify key microbial biomarkers, and compare the microbiome structure and clinical laboratory indices between mgus patients and different comorbidity subgroups, to explore their impact on the disease diagnostic model.

Eligibility criteria:
(i) inclusion criteria: 1. age 45 years or older; 2. negative screening for monoclonal protein by maldi-tof ms; 3. no significant diseases found upon medical examination, and confirmed not to have any diseases related to this study; 4. sufficient whole blood, plasma, serum, and stool samples available, and relevant case data can be provided. (ii) exclusion criteria: 1. history of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease, or diagnosed during hospitalization; 2. antibiotic treatment received in the past month; presence of severe systemic diseases, including malignant tumors; 3. insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice, or other unqualified sample conditions.
effects of expiratory muscle strength training in adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis (AIS); Scoliosis; Adolescence

Summary: adolescent idiopathic scoliosis result in deterioration of core muscles and respiratory system. core muscles provide trunk stabilization as well as responsible for respiratory system. especially tr. abdominis, rectus abdominis, external oblic and internal oblic muscle, which are core muscles, highly active during forced expiration while diaphragm muscle also active during inspiration. thus, expiratory muscle strength training has effect not only respiratory muscle strength but also trunk stabilization. while, effects of expiratory muscle strength training in adolesecent idiopathic scoliosis is a topic that needs to be investigated, this topic has not been investigated until today. hence, this current study aimed to investigate the effects of expiratory muscle strength training on cobb angle, respiratory muscle strength, core stabilization, functional exercise capacity and quality of life.

a convenience of children with adolescent idiopathic scoliosis, 10-19 years, is going to recruited from gazi university, faculty of health sciences, department of physiotherapy and rehabilitation. patients will randomly allocate to either a treatment group or control group. the treatments group will receive expiratory muscle strength training at 50% maximal expiratory presssure while, the control group will receive sham expiratory muscle strength training without physiological load. groups are going to train for a total of 25 breathe/day, 5 days/week, for 6 weeks. before and after treatment, all of patients progression of scoliosis will be evaluated by calculating cobb angle, respiratory muscle strength using with electronic mouth pressure device, core stability using with mc-gill endurance test and the stabilizer biofeedback unit, functional exercise capacity using with six minute walk test (6mwt) and six minute pegboard and ring test (6mpbrt), quality of life using with scoliosis research society -22 questionnare (srs-22) and daily living activity of upper extremity using with quick-dash questionnare.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with idiopathic scoliosis, * aged between 10 and 19 years, * with a cobb angle ranging from 10 to 45 degrees. exclusion criteria: * individuals who have undergone spinal surgery, * who have received conservative or surgical treatment for scoliosis, * individuals with neurological, neuromuscular, systemic, rheumatological, or musculoskeletal disorders, or conditions affecting balance and walking, * individuals with a history of cardiac or pulmonary diseases that could affect respiratory function and exercise capacity.

Keywords: adolescent idiopathic scoliosis expiratory muscle strength training cobb angle core stability functional exercise capacity respiratory muscle stregth
clinical study of sorafenib and zoledronic acid to treat advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: sorafenib ,an oral multikinase inhibitor targeting several tyrosine-kinase receptors with antiangiogenesis and antiproliferation of hcc, is the first approved target therapy for hcc. zoledronic acid is used for treatment of bone metastasis of diverse malignant cancer. emerging data suggest that zoledronic acid may also exhibit anticancer properties. the objectives of the study is to evaluate the safety of sorafenib combined with zoledronic acid and to evaluate overall survival and time to progression.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features * patient with unresectable primary hepatocellular carcinoma * child-pugh class a or b, score ≤ 7 * ecog score 0-2 * expected survival time not less than 12 weeks * at least one tumor nodule with one uni-dimension of ≥ 1 cm * peripheral platelet of or more than 50×10(9)/l * peripheral hemoglobin of or more than 85g/l * peripheral albumen of or more than 28g/l * total bilirubin ≤3.0mg/dl * alt and ast ≤ 5.0 x the upper limit of normal * serum amylase ≤ 1.5x the upper limit of normal * serum creatinine ≤ 1.5x upper limit of normal * pt-inr\<2.3 or pt prolong no more than 4s of normal exclusion criteria: * congestive heart failure \> nyha class 2 * history of active coronary disease( except myocardial infarction more than 6 months ago) * receive anti-arrhythmia treatment(except β-receptor blocker,calcium channel blocker and digoxin) * uncontrollable hypertension * active clinically serious infections (\> 2 nci-ctc version 3.0) * history of hiv infection * inclined to hemorrhage or active hemorrhage with 1 month * substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study * pregnant or breast-feeding.women of childbearing potential must have a negative pregnancy test performed within 7 days prior to enrolling in this portion of the study * known or suspected allergy to any agent given in association with this trial * concomitant anti-cancer therapy (except immunotherapy and chinese traditional treatment) * surgical operation within 4 weeks prior to enrolling in this portion of the study

Keywords: hepatocellular carcinoma sorafenib zoledronic acid toxic reaction
efficacy and safety of canagliflozin (ta-7284) in patients with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the purpose of this study is to evaluate the efficacy and safety of canagliflozin (ta-7284) in japanese patients with diabetic nephropathy, compared with placebo


Eligibility criteria:
inclusion criteria: additional criteria check may apply for qualification: * glycated hemoglobin(hba1c) of ≥6.5% and ≤12.0% * egfr of ≥30 ml/min/1.73m2 and \<90 ml/min/1.73m2 * the median uacr of the first morning void urine samples is ≥300 mg/g cr and ≤5000 mg/g cr * patients who are taking on angiotensin-converting enzyme inhibitor (ace-i) or angiotensin receptor blocker (arb) * patients who are under dietary management and taking therapeutic exercise for diabetes exclusion criteria: additional criteria check may apply for qualification: * type i diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes * a diagnosis of non-diabetic renal disease * hereditary glucose-galactose malabsorption or primary renal glucosuria * class iv heart failure symptoms according to new york heart association (nyha) functional classification * severe hepatic disorder or severe renal disorder * blood potassium level \>5.5 mmol/l * stable blood pressure (diastolic blood pressure (dbp) ≥100mmhg or systolic blood pressure (sbp) ≥180mmhg)

Keywords: diabetic nephropathy canagliflozin canaglu diabetes mellitus, type 2
kids safe and smokefree (kiss)

Conditions: Second Hand Tobacco Smoke; Nicotine Dependence

Summary: the study's primary aim is to test the hypothesis that an intervention integrating pediatric clinic-level quality improvement with home-level behavioral counseling (cqi+bc) will result in greater reductions in child cotinine (a biomarker of secondhand smoke exposure) and reported cigarettes exposed/day than a clinic-level quality improvement plus attention control intervention (cqi+a). a secondary aim is to test the hypothesis that relative to cqi+a, cqi+bc will result in higher cotinine-verified, 7-day point prevalence quit rate among parents.

child secondhand smoke exposure (shse) is a significant public health problem that has been linked to asthma, acute respiratory illnesses, otitis, and sids, and is associated with increased risk of cancers, cardiovascular disease, and behavior problems. this project will test the effectiveness of a comprehensive multilevel intervention to reduce young children's shse in minority and medically underserved communities known to have the highest shse-related morbidity and mortality risk. first, we will provide a clinic-level quality improvement (cqi) intervention to improve the care of pediatric patients with shse in four pediatric clinics in north and west philadelphia. we will then randomize eligible parents visiting the cqi clinics into either a home-level behavioral counseling intervention (cqi+bc) or a home-level attention control intervention (cqi+a). in addition to clinic-level intervention, cqi+bc provides personalized, behavioral counseling with intensive skills training and support where shse occurs (in the home), as well as systems navigation to facilitate access to and effective use of reimbursable nicotine replacement therapy and smoking cessation medication. participants will complete assessments at pre-treatment, 3-month end of treatment, and 12-month follow-up.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * english-speaking * parent or legal guardian of child under 11 years old who lives with him/her * daily smoker exclusion criteria: * non-nicotine drug dependence * psychiatric disturbance (bipolar, schizophrenia, psychosis) * pregnant * inadequate health literacy

Keywords: smoking cessation secondhand smoke passive smoking cotinine nicotine replacement products
phase 1 study of levocetirizine

Conditions: Dermatitis

Summary: this is a single center, single blind, single dose, randomized, partial cross-over study to confirm bioequivalence between levocetirizine and cetirizine.


Eligibility criteria:
inclusion criteria: 1. japanese healthy male subjects aged between 20 and 64 years of age inclusive. healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies, and other tests. 2. body weight ≥ 50 kg and bmi within the range 18.50-25.00 kg/m2 inclusive. 3. non-smokers (at least 6 months). 4. clinical laboratory tests data obtained at screening meet the following: ast(got), alt(gpt), total-bilirubin, bun, creatinine, uric acid,: below the upper normal range 5. normal 12-lead egc finding at screening; qtc interval \<450msec 6. capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. exclusion criteria: 1. the subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator. 2. the subject has an allergy for any drug or idiosyncrasy. 3. the subject has a history of allergic rhinitis. 4. the subject has a history or presence of clinically significant gastrointestinal, hepatic or renal disease or other condition known to interfere with absorption, distribution, metabolism or elimination of drugs. 5. the subject is currently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational drug or device. 6. the subject has participated in a clinical study with an investigational or a non-investigational drug or device during the previous 4 months. 7. the subject has a history or current conditions of drug abuse or alcoholism. 8. history of regular alcohol consumption exceeding on average, 14 drinks/week (1 drink = 150ml of wine or 360ml of beer or 45ml of 80 proof distilled spirits). 9. the subject is positive for urine drug screening. 10. the subject is positive for syphilis, hbs antigen, hcv antibody, hiv antibody, htlv-1 antibody. 11. the subject has donated a unit of blood "\>400ml" within the previous 4 months or "\>200ml" within the previous 1 month.
cervicitis by iontophoresis

Conditions: CERVICITIS

Summary: the purpose of the study is to: investigate effect of iontophoresis on managing uterine cervicitis.


Eligibility criteria:
inclusion criteria: 1. all patients have vaginal discharge. 2. all patients have irregular vaginal bleeding, especially after sexual intercourse. 3. all patients have dyspareunia. 4. all patients have lower abdominal pain. 5. group a: 20 women will receive oral medication (antibiotic zesrosin) and hot water with antiseptic. 6. group b: 20 women will receive medication by iontophoresis (antibiotic ceftriaxone) and hot water with antiseptic. exclusion criteria: 1. patients with a history of hypersensitivity or adverse reactions associated with the delivered drug in (ceftriaxone). 2. patients with prior medical histories of cardiac arrhythmias or hypercoagulability should not receive the procedure near cardiac pacemakers and superficial blood vessels. 3. in the vicinity of embedded wires, stapes, orthopedic implants, and areas of skin with lesions and impaired sensation. 4. it either should not be used or used with extreme caution during pregnancy.
effects of eldoa versus post facilitation stretching technique in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study aims to assess whether elongation longitudinaux avec decoaption osteo articulaire versus post assistance extending strategy have effects on knee torment. and to check its impact on actual capacity.

a randomized controlled trial will be conducted at safi teaching hospital, faisal teaching hospital and allied hospital fsd after the synopsis has been approved. patients will be enrolled using a simple random sampling technique. patients with knee osteoarthritis will be chosen based on pre-established inclusion and exclusion requirements. patients will receive elongation longitudinaux avec decoaption osteo articulaire, and post-facilitation stretching techniques. two tools will be used to find out the comparison of both groups; numeric pain rating scale; for knee pain and lower extremity functional scale; to check the ability of the patient to perform the everyday task and for evaluation of functional impairments for patients with a disorder of lower extremities. the assessment will need to be done at baseline and follow up will be 15 days after treatment. each patient will be asked to give their informed consent. statistical package of social sciences version 20 will be used for data entry and analysis.

Eligibility criteria:
inclusion criteria: * it includes both male and female diagnose with knee osteoarthritis according to history, physical examination and radiological findings and also patient who score more than 3 on numeric pain rating scale * osteoarthritis grade of 3 and lower as determined by using kallgran and lawrence radiographic classification. exclusion criteria: * if patient is unable to walk or exercise without functional aid and have previous knee surgery. * patient with heart condition.

Keywords: comparative elongation longitudinaux avec decoaption osteo articulaire post facilitation stretching technique knee osteoarthritis randomized control trial
post market clinical follow up study with the cervical disc prothesis move®-c

Conditions: Discopathy; Herniated Cervical Disc; Stenoses, Spinal; Radiculopathy

Summary: study design: international, prospective, multicentre, non-randomised, observational study according to § 23b mpg. objectives: observational study to confirm the safety and performance of the cervical disc prosthesis move®-c.

this clinical investigation is conducted to gain post market results on the cervical disc prosthesis move®-c and to demonstrate the safety and performance. besides, it is aimed to gain knowledge concerning the development of patients' quality of life (qol) after the implantation of the cervical disc prosthesis move®-c and to collect data for the analysis of the range of motion (rom), which is an essential parameter for motion-preserving implants.

Eligibility criteria:
inclusion criteria: 1. diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal, 2. documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated, 3. no surgical treatment regarding the planned index surgery within the last six weeks prior implantation, 4. unsuccessful conservative medical care regarding the indication within the last six weeks, 5. age ≥18 years, 6. patient must agree to fully participate in the clinical trial and give informed consent in writing, 7. patient is capable to realise the nature, aims and possible consequences of the clinical trial (mpg §20.2.1), 8. patient information has been provided and all written consents of the patient are available. exclusion criteria: * known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use: 1. bone mineral density with t-score ≤ -1.5 as determined by spine dxa if male ≥ 60 years of age or female ≥ 50 years of age, 2. active systemic infection or infection at the operative site, 3. sustained osteoporotic fracture of the spine, hip or wrist, 4. spinal metastases, 5. known allergy to titanium or polycarbonate-urethane, 6. confirmed pregnancy, 7. severe cervical myelopathy, 8. patients requiring a treatment that destabilises the spine (e.g. posterior element decompression), 9. advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis), 10. advanced degenerative changes (e.g. spondylosis) at the index vertebral level, 11. patient is kept in an institution under judicial or official orders (mpg §20.3).

Keywords: herniated disc cervical spine discopathy radiculopathy
ebus guided cryo biopsy of solitary pulmonary nodules

Conditions: Yield of Cryo Biopsy in Lung Cancer; Solitary Pulmonary Nodule

Summary: to proof the feasibility and safety of ebus guided transbronchial cryo biopsies in peripheral lung lesions

solitary pulmonary nodule are a diagnostic dilemma. nowadays not only the basic tissue diagnosis is necessary, molecular signals are state of the art. therefore more tissue is necessary. with a cryoprobe the amount of tissue is increased compared to the classical forceps biopsy. until now, the use of the cryoprobe ism´t show in peripheral lung tissue.

Eligibility criteria:
inclusion criteria: * solitary pulmonary nodule \< 4 cm * no endobronchial lesion * indication for bronchoscopy exclusion criteria: * coagulopathy * pulmonary hypertension * pregnancy

Keywords: solitary pulmonary nodules transbronchial lung biopsy endobronchial ultrasound