Kornimate/medical-research-clean huggingface dataset:
prospective, international monosyn® quick - non interventional study

Conditions: Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery; Pediatric and Adult: Skin Closure (Dermal Sutures); Women: Episiotomy; Pediatric: Urological Interventions (Circumcision, Phimosis Etc.)

Summary: the monosyn® quick non-interventional study (nis) has been designed to implement an action within the framework of a proactive post-market surveillance system. the aim of this nis is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of monosyn® quick suture material under the daily clinical practice when used as intended.


Eligibility criteria:
inclusion criteria: * pediatric and adult patients undergoing mucosal wound or skin closure using monosyn® quick as suture material or women undergoing an episiotomy or pediatric patients undergoing an urological intervention such as a circumcision or phimosis or hypospadias etc. * written informed regarding the data collection for the post market clinical follow-up (pmcf) exclusion criteria: - none
clinical efficacy of supraclavicular block for arthroscopic shoulder surgery

Conditions: Horner's Syndrome

Summary: the aim of this study is to compare the efficacy of supraclavicular and interscalene brachial plexus blocks in the patients undergoing arthroscopic shoulder surgery.

this study aims to compare supraclavicular brachial plexus block to interscalene brachial plexus block with regard to degree of sensory and motor blockades, side effects and complications of the blocks, and frequency of intraoperative analgesics or antihypertensives use.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status i-ii * body mass index \< 35 kg/m2 exclusion criteria: * neurologic deficits on the side to be blocked * infection or inflammation at the puncture site for brachial plexus block * psychiatric disorders * patient refusal * difficulty to communicate * coagulation deficiencies

Keywords: supraclavicular brachial plexus block interscalene brachial plexus block arthroscopic shoulder surgery
silver diamine fluoride in preventing occlusal caries in primary teeth

Conditions: Dental Caries in Children

Summary: in hong kong, approximately half of the kindergarten children have dental caries (tooth decay) and the majority (\>90%) of the decayed teeth were left untreated. there is a need to generate clinical evidence for designing an effective dental caries prevention programme for preschool children in hong kong. the objective of this study is to compare the effectiveness of 38% silver diamine fluoride (sdf), 5% sodium fluoride (naf) varnish and placebo control in preventing dentine cavitated caries in primary molars in preschool children when applied semi-annually over 30 months. around 770 preschool children attending grade 1 in selected kindergartens will be invited to participate in this clinical trial. only generally healthy children with written parental consent will be included. at baseline, clinical examination will be conducted in the kindergarten to assess the tooth and oral hygiene status of the included children. after the baseline examination, the children will be randomly assigned to one of the following three study groups and the occlusal (biting) surfaces of their primary molars will receive the corresponding interventions: group a - semi-annual topical application of 38% sdf; group b - semi-annual application of 5% naf varnish; and group c - semi-annual application of placebo control with tonic water. clinical examination of the study teeth in the children will be conducted every 6 months after the baseline to assess the outcome of the intervention. the primary outcome is whether cavitated dentine caries lesion is found in the treated occlusal tooth surface. the null hypothesis tested is that there is no difference in the effectiveness of semi-annual application of 38% sdf and that of 5% naf varnish versus placebo control in preventing dentin occlusal caries in primary molars of preschool children. the results of the proposed study will provide evidence to strengthen or refute the recommendation regarding the use of sdf for preventing occlusal caries in primary molars. the study findings will be valuable for guiding decision-making among dental practitioners and health policymakers on whether sdf should be complemented in a school-based caries prevention program.


Eligibility criteria:
inclusion criteria: 1. be healthy 2. have at least one caries-free (no cavitation) primary molar exclusion criteria: 1. are uncooperative or refuse examination 2. have major systemic disease 3. present with either acute pain or infections or have gingival ulceration or stomatitis 4. have known sensitivity to fluoride, silver or other heavy-metal ions 5. are currently involved in any other research that may impact on the present study
intraperitoneal chemotherapy alone or in combination with bevacizumab for ovarian cancer with peritoneal adhesion

Conditions: Peritoneal Adhesion

Summary: background: malignant peritoneal adhesion is a common complication and prognostic factor of ovarian cancer and other primary abdominal tumors. the incidence of peritoneal adhesion in advanced primary peritoneal tumor is 32-56%, which has increased by more than 10 times in the recent decade. malignant peritoneal adhesion is closely associated with the morbidity and mortality of malignant intestinal obstruction. the peritoneal adhesion may aggravates the abdominal symptoms and reduce quality of life. further, the peritoneal adhesion may impede treatment of primary tumor, such as operation or chemotherapy, lead to a poor prognosis. objective: this study aims to treat malignant peritoneal adhesion with the combination of antiangiogenic agent and chemotherapy, evaluate the efficacy and safety of intraperitoneal antiangiogenic agent plus chemotherapy. as explosive endpoints, we will examination the expression of vegf-a in peritoneal cavity during the treatment.


Eligibility criteria:
inclusion criteria: 1. pathologically and radiologically confirmed stage iv or postoperative recurrence ovarian cancer. 2. age of 18-70, karnofsky score higher than 80. 3. no severe functional damage of major organ, normal liver and kidney function. 4. peritoneal adhesion. (1) peritoneal adhesions diagnosed by microlaparoscopy or abdominal operations, and classification according to nair criteria is performed. (1) must be met. (2) peritoneal adhesion symptoms, intermittent abdominal pain, abdominal distension, nausea and vomiting, hard to pass stools or gas; (3) peritoneal adhesion signs，abdominal distension, abdominal tenderness, reduced or absent bowel sounds; (4) b ultrasound or ct or mri show peritoneal adhesion or adhesion-related complications. exclusion criteria: 1. complete intestinal obstruction and suitable for surgery. 2. patients known to be allergic to bevacizumab or any of the components of the drug. 3. other ongoing anti-tumor treatment. 4. heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure 5. active wound infection and a history of uncontrolled psychiatric illness. -

Keywords: bevacizumab intraperitoneal administration ovarian cancer peritoneal adhesion
efficacy of physical activity for the management of stereotyped behavior and anxiety in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder (ASD); Stereotyped Behavior; Anxiety

Summary: the primary purpose of the study is to investigate whether physical activity can significantly manage stereotyped behavior and anxiety in children diagnosed with autism spectrum disorder (asd). the study aims to contribute to the existing literature by providing robust evidence on the efficacy of physical activity intervention for asd, which could inform clinical practices and improve treatment outcomes.

the current quantitative study will be carried out in two phases. a cross-sectional survey will assess the autism category (mild, moderate and severe), stereotyped behavior and anxiety in autistic children during the first phase. a randomized controlled trial (rct) will be done during the second phase where children with autism spectrum disorder who are identified with moderate category of autism, stereotyped behavior and anxiety will be categorized into two groups i.e. waitlist control group and intervention group through the process of randomization. then physical activity intervention would be applied to participants in the intervention group. the control group is the waitlist control group so initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed. the physical activity intervention would be implemented on participants using individual and in-person modes. the pre-and post-assessment will be done at times 1 and 2 within and between control and interventional groups. after doing post assessment the difference between pre and post-assessment will be compared to explore the efficacy of physical activity intervention in children with autism spectrum disorder.

Eligibility criteria:
inclusion criteria: autistic children who are students of special education school. only autistic children age 8 to 12 are part of the study. the participants who completed the informed consent will be part of the study. participants who were showing symptoms of mild to moderate level of autistic symptoms as assessed by childhood autism rating scale. participants should not have any physical or other mental health condition that would prevent them from engaging in physical activity sessions safely were part of this study. exclusion criteria: adults students are not part of the study. autistic children who are not part of special education school. the participants who are severe autism category not part of the study. the participants who are under serious clinical condition will not be part of study.
effects of shoe longitudinal bending stiffness

Conditions: Runners

Summary: carbon plates inserted in competitive running shoes have been increasingly used in the past 2-3 years and several investigations have shown that these plates increase the longitudinal bending stiffness (lbs) of the shoe. it leads to a redistribution of muscle work and to a modification of the force generation conditions, which may reduce the energy cost of running (cr) and improve performance.

only one study has investigated the effects of lbs in running bouts longer than 8 minutes but on the biomechanics part, and their effects on neuromuscular fatigue and prolonged running performance. the aim of this study is to compare shoes with and without carbon plates during a prolonged (21 km) running exercise on cr, plantar flexor neuromuscular fatigue and running kinetics and kinematics to estimate the changes high-lbs may induce on fatigue and subsequent performance.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 and ≤ 50 years. * men * experienced, well-trained endurance runners with the capacity to run 21km in less than 1h 40 and who train more than 5h a week. * free from muscular, bone or joint injuries * free from neurologic disease * approval received from a physician exclusion criteria: * currently participating in a structured exercise program * injury in the 3 months prior to the protocol * chronic joint pathologies (e.g.: repetitive sprains, patellar or ligament problems) * the intake of corticosteroids within 3 months (inhalation, infiltration or history of prolonged corticosteroid therapy).

Keywords: neuromuscular fatigue energetic cost of running longitudinal bending stiffness
registry observing endobarrier® treatment outcomes in subjects with type 2 diabetes and/or obesity

Conditions: Type 2 Diabetes; Obesity

Summary: the purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the endobarrier in the post market setting where the product had conformité européene (ce mark) regulatory approval and in accordance to the approved indication for use.

this was a worldwide observational registry of the use of the endobarrier for inclusion of subjects treated with the endobarrier in centers in australia, chile, and the netherlands. the registry was open to all subjects at participating centers that received the endobarrier.

Eligibility criteria:
inclusion criteria: * as per ifu, the endobarrier gi liner system is used for the treatment of obese type 2 diabetes with bmi greater than or equal to 30 kg/m2, or obese patients with bmi greater than or equal to 30 kg/m2 with less than or equal to 1 co-morbidities, or obese patients with bmi greater than 35 kg/m2. the gi liner is indicated for a maximum implant duration of 12 months. exclusion criteria: as per instructions for use (ifu) * women who are pregnant * requirement for prescription anticoagulation therapy * history of inflammatory bowel disease or condition of the gastrointestinal tract, such as peptic ulcer disease (pud), ulcers, or crohn's disease * pancreatitis, uncontrolled gastroesophageal reflux disease (gerd), known infection at the time of implant * symptomatic coronary artery disease or pulmonary dysfunction * history of coagulopathy * bleeding diathesis, upper gi bleeding conditions such as esophageal or gastric varices, or congenital or acquired intestinal telangiectasia * congenital or acquired anomalies of the gi tract such as atresias or stenosis * previous gi surgery that could affect the ability to place the endobarrier gastrointestinal liner or its function * iron deficiency and/or iron deficiency anemia * active symptoms of kidney stones or known presence of gallstones * inability to discontinue use of non-steroidal anti-inflammatory drugs during the implant period * family or patient history of known diagnosis or pre-existing condition of systemic lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder * h. pylori positive status (patients may receive the endobarrier gastrointestinal liner if they had a prior history and were successfully treated)
studying the effect of changing immunosuppression in case of polyoma bk virus infection of the renal transplant

Conditions: Disorder Related to Renal Transplantation; Immunosuppression Related Infectious Disease; Virus Diseases

Summary: polyomavirus bk nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. the investigators hypothesis is that switching to an mtor-based scheme is superior to a general decrease of a calcineurin inhibitor (cni)-based scheme. the study will be performed as a prospective, randomized, parallel group comparison.

the study group (n=62) will be switched from cni to everolimus while the control group (n=62) will get a general reduction of the cni-based immunosuppression. follow-up and duration of intervention per patient will be 24 months, duration of the trial 72 months including 4 years of recruitment.

Eligibility criteria:
inclusion criteria: * preceding renal transplantation * functioning graft with a permanent creatinine clearance of more than 25ml/min * biopsy-confirmed polyoma bk virus nephropathy * age over 18 years old exclusion criteria: * allergy or non-tolerance of the study medication everolimus * pregnancy

Keywords: renal transplantation polyoma bk virus infection everolimus calcineurin inhibitor mtor inhibitor
therapeutic effect of quercetin and the current treatment of erosive and atrophic oral lichen planus

Conditions: Atrophic Oral Lichen Planus; Erosive Oral Lichen Planus

Summary: lichen planus (lp) is a common chronic inflammatory mucocutaneous disease with an immunologic etiology ,which has number of different clinical forms. alternative natural or herbal origine drugs with antioxidant and anti-inflammatory properties have been used individually or in combination with systemic corticosteroids in order to decrease adverse drug reactions. this study was conducted to evaluate the effect of quercetin on treatment of erosive -atrophic lesions of oral lichen planus (olp).


Eligibility criteria:
inclusion criteria: * confirmation of clinical diagnosis of atrophic and erosive lichen planus by histological examination * two weeks wash out periods after the last treatment * having the experience of atrophic and erosive lesion greater than 1 cm having the experience of pain and burning greater than 3.5 in vas score exclusion criteria: * confirmation of dysplasia and malignancy in histologic examination * confirmation of lichenoid reaction in histologic examination * pregnancy and breast feeding * using fluorokinolon and cyclosporin which interact with quercetin

Keywords: lichen planus quercetin
rhinitis in the elderly: the role of vitamin d

Conditions: Rhinitis

Summary: a study of the role of vitamin d in elderly subjects with perennial and/or nonallergic rhinitis. the hypothesis is that vitamin d supplementation will improve rhinitis symptoms and rhinitis related quality of life.

rhinitis in the elderly is poorly understood as this group of patients has been ignored in almost all rhinitis studies. vitamin d deficiency and insufficiency are very common, especially in the elderly. vitamin d may play an important role in respiratory disease as shown by studies in asthma. this is a randomized, double-blind, placebo controlled, cross-over study. the investigators will look for the effect of vitamin d 4,000 i.u/day vs. placebo for six weeks on symptom scores and rhinitis related quality of life. this study will be performed in the period nov. 1, 2013 and march 31, 2014, to try to avoid seasonal fluctuations of serum vitamin d due to sun exposure. the investigators will also look for possible associations between serum vitamin d at baseline and study subjects demographics, treatment, and symptom scores.

Eligibility criteria:
inclusion criteria: * subjects 65 years old and older with perennial and/or nonallergic rhinitis exclusion criteria: * current smokers, digoxin, liver disease, anticoagulants (except for aspirin), planning a surgical procedure during the study period.
the asthma control rate achieved by budesonide/formoterol in clinical practice in china

Conditions: Asthma

Summary: this is a multi-centre, cross-sectional study planned to be conducted in china. the study aims to observe about 1500 asthma patients who have already received budesonide/formoterol combination treatment by physicians' determination and whose medications are aligned with the package insert of budesonide/formoterol approved in china.

the asthma control rate achieved by budesonide/formoterol in clinical practice in china.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of asthma at least 6 months; 2. prescribed with budesonide/formoterol treatment at least 3 months before enrolled; 3. has used the same maintenance dose of budesonide/formoterol for at least 4 weeks before enrolled. exclusion criteria: 1. participation in any clinical study within 3 months; 2. have copd history/suspicious copd; 3. ≥ 10 pack years of smoking history 4. used any other asthma maintenance medication accompanied with budesonide/formoterol within 3 months before enrolled 5. with asthma exacerbation (defined as asthma symptom deterioration resulting oral/rectal/parenteral gcs medication or emergency room treatment or hospitalisation) within 4 weeks before enrolled

Keywords: asthma control rate budesonide/formoterol non-interventional study
comparison of the balloon-expandable edwards valve and self-expandable corevalve evolut r or evolut pro system for the treatment of small, severely dysfunctional surgical aortic bioprotheses. the 'lyten' trial

Conditions: Aortic Valve Stenosis; Regurgitation, Aortic; Prosthesis Failure

Summary: the treatment with transcatheter aortic valve implantation (tavi) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe prosthesis-patient mismatch (ppm) following the procedure.

this is a prospective, multicenter, randomized open-label trial including patients with surgical aortic bioprosthetic dysfunction in the presence of a small (≤23mm; inner diameter ≤21 mm) stented surgical valve. following the heart team's decision to proceed with a tavi-viv procedure, patients will be randomized to either receive an edwards (sapien xt or sapien 3) valve or a corevalve evolut r or evolut pro system. new iterations of these valve models may also be included.

Eligibility criteria:
inclusion criteria: * patients with surgical aortic bioprosthetic dysfunction defined as severe aortic stenosis and/or regurgitation approved for a viv procedure by the heart team * stented surgical valves. * small (≤23mm) surgical valve exclusion criteria: - stentless or sutureless surgical valves
pharmacokinetic study of venetoclax tablets crushed and dissolved into a solution

Conditions: Hematologic Malignancy; Leukemia; Lymphoma; Acute Lymphocytic Leukemia; ALL; Acute Myelogenous Leukemia; AML; Chronic Myelogenous Leukemia; CML; Myeloproliferative Neoplasm; Non Hodgkin Lymphoma; Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; Follicular Lymphoma; Burkitt Lymphoma; T-cell Lymphoma; B Cell Lymphoma; Peripheral T Cell Lymphoma; Cutaneous B-Cell Lymphoma

Summary: the use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. for patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. however, no pk data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown. primary objectives • to determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution secondary objectives * to evaluate the safety of crushed venetoclax tablets administered as an oral solution * to determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate cyp3a inhibitors * to determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. po vs ng tube vs g-tube) * to determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution

peripheral blood will be drawn at multiple time points to evaluate venetoclax pharmacokinetics in patients who are receiving venetoclax solution made from crushed tablets as part of their oncology treatment.

Eligibility criteria:
inclusion criteria: * age: patients must be \<39 years of age at time of study enrollment * diagnosis: patients may have a diagnosis of any hematologic malignancy * central access: patients must have an existing venous or arterial access line for pk blood draws * weight requirement: patients must weigh at least 5.5 kg at the time of enrollment * venetoclax: patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (po) or via nasogastric (ng), or g-tube as prescribed by their treating oncologist. * concurrent chemotherapy medications: patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents. exclusion criteria: * pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax. * males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.

Keywords: venetoclax pediatric aml pediatric relapsed/refractory aml