Kornimate/medical-research-clean huggingface dataset:
ridge splitting with implant placement using autogenous tooth graft

Conditions: Dental Implant Failure Nos; Alveolar Bone Loss; Peri-Implantitis

Summary: the aim of this study is to evaluate the radiographic and the clinical outcomes of application of the alveolar ridge splitting (ars) in combination with atg, associated with immediate implant placement versus ars in combination with autogenous bone graft, associated with immediate implant placement in patients with horizontal bony insufficiency of alveolar ridges.

in cases of a narrow ridge, the alveolar ridge expansion technique by means of hand osteotomes with gradually increasing dimensions was introduced by tatum and modified by summers and it can be used regardless of the bone quality. searching for absolute biocompatible material and taking into account the features of the enamel and dentin, using the tooth as an autologous grafting material was first advocated. tooth and bone are sharing many characteristics, which supports the idea that tooth could be used as a grafting material. in fact, hydroxyapatite crystals make up the tooth inorganic composition (65%). moreover, collagen (mostly type i) and non-collagenic proteins comprised up the tooth organic component (35%). in addition, because autologous tooth graft (atg) is denser than bone, minimal resorption rates were found to be advantageous to autobone. for the purpose of employing atg as a grafting material, various methods and techniques have been suggested for developing undemineralized, demineralized or partially demineralized atg.the outcomes of utilizing undemineralized autologous tooth graft (uatg) around sdip following rsea have not yet been evaluated. therefore, the current trial aimed to assess the clinical and radiological performances of uatg for the treatment of horizontal alveolar ridge deficiencies using rsea with sdip. the aim of this study is to evaluate the radiographic and the clinical outcomes of application of the alveolar ridge splitting (ars) in combination with atg, associated with immediate implant placement versus ars in combination with autogenous bone graft, associated with immediate implant placement in patients with horizontal bony insufficiency of alveolar ridges.

Eligibility criteria:
inclusion criteria: * good general health at the time of surgery * at least 3 months of healing after tooth extraction * horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide. exclusion criteria: * a vertical bone defect in the edentulous ridge; * thick cortex in the labial/buccal with less cancellous bone inside; * obvious undercut on the labial/buccal side; * uncontrolled periodontal conditions or other oral disorders; * a history of radiotherapy in the head and neck region

Keywords: ridge splitting autogenous tooth graft simultaneous implant placement
articaine efficiency in pulpectomy of children with irreversible pulpitis under the age of four

Conditions: Dental Pulp Diseases

Summary: a two-tailed randomized controlled trial with two parallel arms is aimed to compare success proportions of the articaine and lidocaine groups in children with irreversible pulpitis under 4 years. the participants will be randomly assigned into two equal groups (82 children per group): the control group will receive lidocaine and the intervention group will receive the articaine local anesthesia. the direct observation tool flacc was considered to assess pain severity. the behavior was assessed during pulpectomy procedures using the frankl behavior rating scale (fbrs)


Eligibility criteria:
inclusion criteria: * healthy 36-47 month-children (asa class i or ii) weighing at least 15 kilograms * children should be intellectually fit, and cooperative, with no behavior or communication abnormalities * presence of a carious maxillary or mandibular second primary molars with signs and symptoms of irreversible pulpitis exclusion criteria: * molars with unrestorable crowns * molars with necrotic pulps, pathological mobility, gingival swelling or abscess, fistulous or sinus tract, or apical periodontitis
tucidinostat plus etoposide in the treatment of neuroblastoma in childhood.

Conditions: Neuroblastoma in Children

Summary: neuroblastoma is a malignant tumor that develops in infants and kids. dysregulation of histone acetylation is associated with a series of malignant tumors. neuroblastoma is caused by defective neural crest differentiation due to abnormal gene regulation.


Eligibility criteria:
inclusion criteria: 1. age 3\~18 years old; 2. patients must have a life expectancy of at least 6 weeks and a lansky (≤16 years) or karnofsky (\>16 years) score of at least 50; 3. histologically confirmed neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines; 4. patients must have a history of high-risk neuroblastoma, at least one measurable lesions according to the recist 1.1; 5. patients who have progressed, recurrent or refractory disease after first-line treatment; 6. the residual disease biopsy must be done, if patiens who have persistent disease obtain incomplete response after first line treatment; 7. patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to study registration； 8. patients have not received enzyme-induced anticonvulsant therapy; 9. patients have not received valproic acid within 30 days before admission; 10. anc ≥ 1.5×10\^9/l, plt ≥75×10\^9/l;tbil≤1.5uln, alt and ast≤3×uln（alt and ast≤5×uln if liver metastasis）;bun and cr≤1.5×uln 9）lvef ≥ 50% and qtc≤470 ms. 11. patients' guardians must be willing and able to understand and comply with the protocol for the duration of the study. exclusion criteria: 1. patients with severe cardiovascular disease; 2. patients who have previously received organ transplants; 3. inability to swallow pills; 4. female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 5. active hiv, hepatitis b or hepatitis c; 6. researchers believe that patients are unsuitable for any other situation in this study.
egg diet to improve metabolic health and function

Conditions: Obesity

Summary: the purpose of this study is to determine the effects of change in diet quality (carbohydrate restriction versus fat restriction) on body composition, fat distribution, cardiometabolic risk factors, physical function, and quality of life in aging adults with obesity.

the purpose of this study is to determine the effects of change in diet quality (carbohydrate restriction versus fat restriction) on body composition, fat distribution, cardiometabolic risk factors, physical function, and quality of life in aging adults with obesity. data from previous studies support the hypothesis that consumption of lower-cho, higher-fat food sources rich in high-quality proteins and essential fatty acids, such as whole eggs, has beneficial effects on metabolic health. the study will test the hypothesis that a reduced cho higher- fat, egg-rich diet induces selective depletion of total and abdominal adiposity, preserves lean mass, and reduces inflammation and oxidative stress. in turn, these favorable changes in body composition, fat distribution, and metabolic health will confer improvements in physical function in obese, aging adults. results from this study will form an empirical basis for developing an easily implemented, non-pharmacologic treatment (i.e. change diet quality by incorporating more low carbohydrate, whole foods such as eggs) to prevent or reverse sarcopenia and other age-related diseases of metabolic origins.

Eligibility criteria:
inclusion criteria: 1. between 60-75 years of age, 2. have a bmi ranging from 30-40 kg/m2, 3. sedentary (\<2h/wk of intentional exercise, and agree to maintain their level of activity throughout the study). exclusion criteria: 1. those with uncontrolled diabetes, 2. unwilling to eat the prescribed diets, 3. recent weight change (+/- 10 lbs. in previous year), 4. history of eating disorder, 5. difficulty chewing and swallowing solid food, 6. digestive diseases, 7. cognitive impairment, 8. uncontrolled blood pressure (systolic blood pressure \> 159 or diastolic blood pressure \>95 mm hg), 9. history of non-skin cancer in the last 5 years, 10. cardiovascular disease event; severe pulmonary disease; renal failure; major liver dysfunction, 11. current/recent smoker, 12. use of estrogen or testosterone replacement therapy, 13. current use of oral corticosteroids (\>5 d/mth), 14. using medications for treatment of psychosis or manic-depressive illness, and 15. dependence on others for food procurement or preparation.

Keywords: obesity low carbohydrate diet metabolism body composition visceral fat older adults insulin sensitivity
study of subcutaneous immunoglobulin in patients with pid requiring igg replacement therapy

Conditions: Primary Immune Deficiency

Summary: the objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of igpro20 in patients with primary humoral immunodeficiency (pid).

the entire study consists of a 12-week wash-in/wash-out period followed by a 12-month treatment period. pharmacokinetic (pk) parameters were assessed in a sub-group of subjects.

Eligibility criteria:
inclusion criteria: * male or female aged 2 to 75 years * subjects with primary humoral immunodeficiency, namely with a diagnosis of: cvid (common variable immunodeficiency) as defined by pagid (pan-american group for immunodeficiency) and esid (european society for immunodeficiencies) or xla (x-linked agammaglobulinemia) * written informed consent exclusion criteria: * newly diagnosed pid * evidence of an active serious infection at the time of screening (i.e., but not limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis) * malignancies of lymphoid cells such as lymphocytic leukemia, non-hodgkin's lymphoma and immunodeficiency with thymoma * known hyperprolinemia * hypoalbuminemia, protein-losing enteropathies, and any proteinuria * allergic reactions to immunoglobulins or other blood products * known antibodies to immunoglobulin a (iga) * the subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone equivalent/kg/day) or other systemic immunosuppressants * female who is pregnant, breast feeding or planning a pregnancy during the course of the study * participation in a study with an investigational product other than (ivig) within 1 month prior to enrollment * a positive result at screening on any of the following viral markers: human immunodeficiency virus (hiv), hepatitis c virus (hcv) and hepatitis b virus (hbv) * aspartate aminotransferase (asat) or alanine aminotransferase (alat) concentration \> 2.5 times the upper normal limit (unl) * creatinine concentration \> 1.5 times the unl * any condition that is likely to interfere with evaluation of the study drug or satisfactory conduct of the trial

Keywords: immune globulin subcutaneous scig primary immunodeficiency pid
quality of life in chronic obstructive pulmonary disease (copd) patients after switching to tiotropium plus olodaterol fixed dose combination in greece

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this non-interventional study (nis) is to evaluate changes within 3 months in quality of life according to health status evaluated with the copd assessment test (cat) in copd patients who have recently switched (within one week) from tiotropium monotherapy (spiriva® handihaler®) to dual therapy with tiotropium bromide plus olodaterol (spiolto® respimat®), in the greek private and public sector pulmonary offices and clinics.


Eligibility criteria:
inclusion criteria: 1. female and male patients ≥40 years of age 2. patients diagnosed with copd who have been using tiotropium administered with spiriva® handihaler® for at least 3 months before a recent switch (within last week) to a combination therapy with tiotropium bromide plus olodaterol administered with spiolto® respimat® has been made 3. written informed consent prior to participation 4. patient should be able to read, comprehend and complete study questionnaires exclusion criteria: 1. patients with contraindications according to spiolto® respimat® smpc 2. patients who have been treated with inhaled corticosteroids (ics) as maintenance therapy\* or with a long-acting beta2 adrenoceptor agonist (laba)/long-acting muscarinic antagonist (lama) combination (free or fixed dose) in the previous 6 weeks \*note: patients with temporary corticosteroids (cs) use during acute exacerbations in the previous 6 weeks can enter the study 3. patients who have been treated with spiriva® respimat®, with other lama different than spiriva®, or with a combination of spiriva®+laba/ics in the previous 6 weeks 4. patients diagnosed with asthma or with asthma copd overlap syndrome (aco) 5. patients for whom availability at the enrolling site during the planned study period of approximately 3 months is not possible 6. pregnancy and lactation 7. patients currently listed for lung transplantation 8. current participation in any clinical trial or any other non-interventional study of a drug or device. further exclusion criteria apply.
self-help and recovery guide in eating disorders

Conditions: Anorexia Nervosa

Summary: the aim of this study is to test a novel guided self-help intervention for patients with anorexia nervosa. the 6-week intervention includes the use of self-help materials (i.e. a workbook and short video-clips) and weekly guidance from a peer mentor (i.e. a person recovered from anorexia nervosa). self-reports will be completed at baseline, end of 6 weeks, and 6- and 12 months follow-up. participants interested in taking part will be randomly allocated to one of two groups.

this trial investigates whether a guided self-care intervention (recovery mantra) is a useful addition to treatment as usual (tau) for individuals with anorexia nervosa (an). recovery mantra, a 6-week self-care intervention supplemented by peer mentorship, is a module extension of the maudsley model of treatment for adults with an and targets the maintenance factors identified by the cognitive-interpersonal model of the illness. patients accessing outpatient services for an are randomised to either tau or tau plus recovery mantra. outcomes variables include changes in body weight at the end of the intervention (primary) and changes in body weight and eating disorder symptoms at immediate and extended follow-ups (6-months and 12-months; secondary). change is also assessed for the domains identified by the theoretical model, including, motivation, hope, confidence to change, positive mood, cognitive flexibility, therapeutic alliance and social adjustment. feedback from peer mentors is gathered to understand the impact of providing guidance on their own well-being. results from this exploratory investigation will determine whether a larger clinical trial is justifiable and feasible for this affordable intervention which has potential for high reach and scalability.

Eligibility criteria:
inclusion criteria: - referral to one of the participating specialist adult outpatient eating disorder clinics with a primary dsm-5 diagnosis of anorexia nervosa or osfed (other specified feeding or eating disorder) with a body mass index (bmi; kg/m2) of 18.5 or below. osfed will be defined as having features of anorexia but missing at least two of the four diagnostic criteria. exclusion criteria: * insufficient knowledge of english * severe mental or physical illness needing treatment in its own right (e.g. psychosis or diabetes mellitus).

Keywords: guided self-help peer mentoring anorexia nervosa eating disorders
the effect of periodontal treatment on the level of free radicals in the saliva

Conditions: Periodontitis

Summary: this study will examine the relationship between free radicals in the saliva and periodontitis. 30 adults, 15 with periodontitis and 15 as a control group will give a sample of saliva before treatment and after treatment. the investigators will examine the free radicals in both groups.

periodontal disease is a chronic adult condition. bacteria implicated in the etiology of this disease causes destruction of connective tissue and bone. as a result of stimulation by bacterial antigen pmn produces free radicals via respiratory burst as a part of host response to infection. free radicals can be defined as molecules or molecular fragments with an unpaired electron which imparts certain characteristics to the free radicals such as reactivity . reactive free radicals are able to produce chemical modifications and to damage proteins, lipids, carbohydrates and nucleotides in the tissues.

Eligibility criteria:
inclusion criteria: * older than 18 * no medical problems exclusion criteria: * medical problems

Keywords: saliva free-radicals periodontitis
study to evaluate the efficacy of tacrolimus in rheumatoid arthritis patients shown unsuccessful response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: this study is to evaluate efficacy of 6 months treatment of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response against methotrexate.


Eligibility criteria:
inclusion criteria: * patients with more than 6 months history of rheumatoid arthritis according to acr criteria * patients who have been treated unsuccessfully to more than single dmards including methotrexate at the discretion of investigator * esr ≥ 30 mm/h or crp ≥ 1.0 mg/dl (esr: erythrocyte sedimentation rate, crp: c-reactive protein) * patients are required to have at least 3 of 66 joints assessed as swollen * patients are required to have at least 6 of 68 joints assessed as painful with pressure exclusion criteria: * pregnant or breast-feeding patients. patients who plan to bear children or breast-feed during the study and within 6 month after completion of study * previous experience of tacrolimus (ointment excluded) * renal impairment or serum creatinine \> 1.4 mg/dl * liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, sgot/sgpt \> 2x upper limit normal * patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:blood glucose level \>110mg/dl before the meal and \>200mg/dl after the meal hba1c \> 6.4% * cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications * other investigational drug within last 30 days * patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study

Keywords: tacrolimus prograf calcinurin inhibitor rheumatoid arthritis (ra)
an observational study of kadcyla safety in breast cancer

Conditions: Breast Cancer

Summary: this is a phase iv, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive kadcyla (trastuzumab emtansine). patients administered kadcyla infusion at physician's discretion will be registered for this surveillance in korea. patients will be asked to provide informed consent; data will be collected by electronic case report forms for approximately 8 years.


Eligibility criteria:
inclusion criteria: * patients who are administered with kadcyla at physician's discretion will be registered for this study. the use of kadcyla in the patients must fall into the approved indication in korea. exclusion criteria: * patients not receiving treatment for breast cancer with kadcyla according to standard of care and in line with the current summary of product characteristics (spc)/local labeling. * a pediatric patient (age ≤18 years) * hypersensitivity for kadcyla or any ingredient in this product
adjuvant durvalumab plus regorafenib vs untreated control in stage iv colorectal cancer patients with no evidence of disease (ned): viva trial

Conditions: Colorectal Cancer Stage IV; No Evidence of Disease State

Summary: the purpose of this study is to evaluate the efficacy of durvalumab plus regorafenib versus observation for patients with stage iv colorectal cancer achieving the no evidence of disease state. the ned state can be achieved in any line of treatment and it is defined as: 1. r0 resection for surgery, 2. the complete ablation defect covering the lesion on ct scan for radiofrequency, 3. the erogation of ≥ 60 gy for stereotactic radiotherapy, 4. complete response to antineoplastic treatments on ct scan. in all these cases cea and ca 19.9 must be within normal limits at the time of randomization. participants in this study will receive: experimental arm: regorafenib 90 mg d1-21 every 28 days plus durvalumab 1500 mg every 28 days for 1 year control arm: observation (crossover to experimental arm is allowed in case of relapse) tumor assessment will be performed every 12 weeks.

the safety run-in phase is planned for the first 4 patients randomized to the experimental arm using a starting dose of 60 mg/die of regorafenib (and fixed 1500 mg of durvalumab), to be escalated after 2 months to 90 mg/die if \< 2 patients report serious adverse events.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years; ecog ps 0-1; 2. body weight \>30 kg; 3. histologically confirmed diagnosis of colorectal adenocarcinoma; 4. patients must be in ned after completion of any treatments for stage iv crc, including resections, rfa; rt with or without neoadjuvant/adjuvant therapies or cr after chemotherapy; 5. patients must be randomized within 10 weeks since the achievement of the ned state. those who have also received adjuvant therapy following the locoregional treatment are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle; 6. ned state ascertained by means of ct scan and/or pet scan and/or mri scan; 7. life expectancy of at least 12 weeks; 8. cea within normal limits; 9. no residual toxicity from previous chemotherapy; 10. adequate organ function; exclusion criteria: 1. msi/dmmr patients; 2. any unresolved toxicity nci ctcae grade ≥2 from previous anticancer therapy with the exception of alopecia and vitiligo; 3. active or prior documented autoimmune or inflammatory disorders; 4. relevant concomitant comorbidities;

Keywords: ned state adjuvant tyrosine kinase inhibitors immunotherapy