Kornimate/medical-research-clean huggingface dataset:
orthodontic archwire comparison trial

Conditions: Malocclusion

Summary: the purpose of this randomized clinical trial (rct) is to compare traditional cuniti archwires and a recently marketed multiforce version of the same material for the initial alignment and leveling of dental arches, as well as the expression of earr in adult orthodontic patients.

this is a randomized clinical trial utilizing multiforce and cuniti orthodontic archwires to align and level dental arches and compare their results. a three group double blind parallel single site study at iusd will be used. patients that meet the inclusion and exclusion criteria will be recruited from the iusd orthodontic clinic. the subjects will be randomly assigned to one of the three groups by the study statistician. subjects, examiners providing subject treatment, and examiners measuring study outcomes will be blinded to treatment assignment. study population indicates a sample size of 105 subjects, each group containing 35 clinical subjects. patients will be treated with ormco titanium orthos fixed appliances and defined archwire sequence according to a clinical protocol. during the six-month study period, subjects will be seen approximately every 4 (four) weeks for regular standard of care appointments that will include archwire monitoring, photography and questionnaire completions. final study records will be taken at the end of the study period.

Eligibility criteria:
inclusion criteria: * adult \>14yrs of age * amenable to treatment with metal brackets * crowding of 3-8mm in one or both arches (non-extraction treatment) * overbite \>3mm * read and speak english without a translator * individuals in good general health at the discretion of the investigator(s) exclusion criteria: * medical/dental history (hx): * documented metabolic disorder(s) * nickel allergy * bisphosphonate treatment * amelogenesis, dentinogenesis or osteogenesis imperfect * active caries or periodontal disease * root resorption (moderate to severe) * patients who are pregnant or breast feeding or plan to be pregnant during the study

Keywords: orthodontic wires root resorption
study of axillary skin temperature as a marker of ovulation

Conditions: Infertility

Summary: infertility is the most common reason women (aged 20-45yrs)see their gp, affecting 1 in 7 couples. measuring basal body temperature is a technique that has been used since the 1930's to attempt to predict ovulation. current nice guidelines don't recommend the use of bbt charts to predict ovulation, as it has not been established to reliably confirm ovulation. the duofertility sensor a ce marked class la device provides a continuous accurate measure of axilla temperature whilst worn under the arm. the investigators plan to compare the temperature measurements of the duofertility sensor with the gold standard transvaginal ultrasound scan obtained during 10 infertile women's menstrual cycles, up to 10 cycles per women. the investigators aim to investigate if continuous axillary skin temperature measurement obtained from the duofertility sensor, provides comparable results for identifying the occurrence of ovulation as the gold standard transvaginal ultrasound scan.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation * females aged 18 to 44 years. * referred with infertility to the reproductive medicine clinic, rosie hospital * have a body mass index (bmi) above 19 and below 29 * regular menstrual cycles, i.e. no greater than 7 days difference between the shortest and longest cycle in the last 6 months * minimum menstrual cycle 21 days * maximum menstrual cycle 35 days * willing to wear a duofertility sensor continuously for 8 to 10 menstrual cycles; * willing to attend rosie hospital up to 5 times per cycle for tvs and blood tests * willing to perform twice daily lh urine tests at home from day 8 of cycle till positive * normal pelvic ultrasound and blood results obtained during screening tests exclusion criteria: * aged younger than 18 years, or older than 44 years * have a bmi less than 18 or greater than 29 * any diagnosed systemic illnesses, including but not restricted to thyroid disease, diabetes or inflammatory diseases * polycystic ovary disease * endometriosis or other pelvic pathology (including proven tubal disease) * taking steroids, including oral contraceptives or anti inflammatory drugs
study of next-generation recombinant factor ix variant in adult subjects with hemophilia b

Conditions: Hemophilia B

Summary: phase 2b, single-center, open-label study designed to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneous (sc) prophylaxis treatment regimens with cb2679d in 6 adult, male subjects with severe congenital hemophilia b.

single-center, open-label phase 2b study will evaluate the pk, pd, efficacy and safety parameters of sc prophylaxis treatment regimens with cb2679d in adult subjects with hemophilia b. the study will enroll and dose subcutaneously, a total of 6 adult male subjects with severe congenital hemophilia b. during the treatment period, the subject will receive an iv dose of 50 iu/kg followed 35 ± 5 minutes later by a sc dose of 100 iu/kg. daily sc doses of 100 iu/kg will be administered until day 28 (28 total sc doses). on day 1, pk, pd, and safety assessments will be done at pre-iv dose and repeated 35 (± 5) minutes later prior to the sc dose. subsequent pk, pd and safety assessments will be performed pre-dose on days 2, 3, 7, 14, 21 and 28. during the washout period, pk, pd, and safety assessments will be done on days 29, 30, 31, 32 and 33. daily fix activity levels will be measured, unless fix activity level is known to be \< 5%, as measured by local laboratory. an end of study visit will occur 30 days (± 2 days) after the last dose of study drug.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of severe (\<2%) congenital hemophilia b. * male, age 18 or older. * agreement to use highly effective birth control throughout the study. * affirmation of informed consent with signature confirmation before any trial-related activities. * stated willingness to comply with all study procedures and availability for the duration of the study. exclusion criteria: * history or a family history of fix inhibitors. * positive antibody to fix detected by central laboratory at screening. * previous participation in and subsequent treatment in a clinical trial within the previous 30 days or 3-half-lives, whichever is longer, or absence of clinical effect. * have a coagulation disorder other than congenital hemophilia b. * factor ix gene mutation 128g\>a. * significant contraindication to participation.
ocular comorbidity in atopic dermatitis

Conditions: Atopic Keratoconjunctivitis

Summary: a clinical characterization of a large cohort of patients with different severities of ad and ocular symptoms/atopic keratoconjunktivitis (akc). the data will contribute to assess the frequency of complications in order to give a rationale for focused prevention and treatment strategy.

atopic dermatitis (ad), a very common inflammatory skin condition of child and adulthood, is strongly associated with ocular disease. accordingly, about 20% experience conjunctivitis at some point, and many have chronic disease. atopic keratoconjunctivitis (akc) is the most feared as it may lead to blindness. little is known about the etiology, the immune infiltrate, as well as predictive factors of akc and the clinical characteristics of ad patients who develop this entity. we expect this project to enable clinicians to better identify akc patients in the future as well as improve the understanding of the pathogenesis of akc. the ocular findings will be compared between ad severity and a control group without ocular symptoms.

Eligibility criteria:
inclusion criteria: * danish talking * diagnosed with atopic dermatitis (ad) * current or previous ocular symptoms suspected to be atopic keratoconjunctivitis exclusion criteria: * no pause in eyedrops * ocular infections within the last 3 months * use of local or systemic antibiotics within the last 3 months * significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, previous cerebral infarction or bleeding, lung diseases and autoimmune diseases other than atopic dermatitis and related comorbidities. the diseases are accepted if they are well treated or do not require treatment * current pregnant or breastfeeding * use of contact lenses, unless these are paused 2 weeks before the examination or they are due to keratoconus treatment * if the eye symptoms turn out not to be related to atopic keratoconjunctivitis * if it is assessed that the individual cannot participate sufficiently for the examination
patient understanding (cognitive debriefing) of a daily diary of gastroparesis symptoms

Conditions: Diabetes Mellitus; Gastroparesis

Summary: the primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.


Eligibility criteria:
inclusion criteria: 1. subject has type 1 or type 2 diabetes mellitus 2. subject is 18 to 70 years old 3. subject has chronic, active symptoms of gastroparesis for at least the past three months 4. subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the smartpill® wireless motility capsule 5. subject can speak and read english 6. subject is able to give his/her informed consent exclusion criteria: 1. subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit -

Keywords: cognitive debriefing
evaluation of a synbiotic formula in patient with covid-19

Conditions: Coronavirus

Summary: a series of microbiota were correlated inversely with the disease severity and virus load. gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.

coronavirus can target multiple organs due to the hyperactive immune response with cytokine storms. several studies have detected sars-cov-2 in stool samples and indicated that the virus could spread via faeces. importantly, covid-19 uses the same receptor as sars and this doorway can also be found in the intestine. the cell entry receptor, known as angiotensin converting enzyme 2 (ace2) receptor mediate entry of sars-cov-2 and is highly expressed in small bowel enterocytes. ace2 is important in controlling intestinal inflammation and its disruption may lead to diarrhoea. in our previous study, stool samples from 15 patients with covid-19 were analysed. depleted symbionts and gut dysbiosis were noted even after patients were detected negative of sars-cov-2. a series of microbiota were correlated inversely with the disease severity and virus load. gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes. in july 2020, there are more than 15 billion confirmed cases globally with 620 thousand deaths. currently, there are more than 2000 confirmed cases of covid-19 in hong kong. it is important to rebalance the gut microbiota in covid-19 patients and to improve the symptoms and the quality of life of these patients.

Eligibility criteria:
inclusion criteria: 1. aged 18 or above; and 2. a confirmed diagnosis of sars-cov.2 infection using the pcr according to the standard of according to centre for health protection, department of health, hk and released from isolation at recruitment. 3. written informed consent obtained exclusion criteria: 1. known allergy or intolerance to the intervention product or its components 2. any known medical condition that would prevent taking oral probiotics or increase risks associated with probiotics including but not limited to inability to swallow/aspiration risk and no other methods of delivery (e.g., no g/j tube) 3. known increased infection risk due to immunosuppression such as: * prior organ or hematopoietic stem cell transplant * neutropenia (anc \<500 cells/ul) * hiv and cd4 \<200 cells/ul 4. known increased infection risk due to endovascular due to: * rheumatic heart disease * congenital heart defect, * mechanical heart valves * endocarditis * endovascular grafts * permanent endovascular devices such as permanent (not short-term) hemodialysis catheters, pacemakers, or defibrillators 5. documented pregnancy

Keywords: microbiota
study of the diagnostic efficacy of "real time" niris 1300e optical coherence tomography (oct) imaging system in the management of pre-invasive and invasive neoplasia of the uterine cervix

Conditions: Cervical Intraepithelial Neoplasia; Cervix Cancer; Cervical Dysplasia; CIN; Human Papillomavirus

Summary: optical coherence tomography (oct) is a technology using harmless near infra-red light scatter to produce an image. prior studies with oct have demonstrated that oct of the uterine cervix can differentiate between grades of pre-invasive and invasive cervical disease and cancer. this study will evaluate the ability of the niris 1300e imaging (oct) system to detect pre-invasive cervical disease and cervical cancer.

b. specific aims 1. primary. to determine the sensitivity, specificity, positive and negative predictive values for niris 1300e oct enhanced gynecologic examination (via-oct vs.colposcopy-biopsy) for the detection of lesions equal or greater than cervical intraepithelial neoplasia ii (cin ii) and cancer in a "real time" clinical evaluation. 2. secondary. to examine the ease of use of niris 1300e oct in a real time clinical setting in order to assess its potential application during a "see and treat" or "single episode of care" clinic visit.

Eligibility criteria:
inclusion criteria: 1. female subjects \> 18 years of age 2. subject must voluntarily sign a patient informed consent form specific to the study. 3. subject must be physically and mentally willing to comply with all study requirements, especially conduct of a colposcopy exam. 4. participant must be attending the center for cervical diagnosis. exclusion criteria: 1. based on clinical history, physical exam and patient presentation, the subject is unable to provide adequate informed consent and/or comply with the study requirements. 2. subject is a prisoner. 3. subject is pregnant. 4. subject has had a hysterectomy 5. subject has received prior pelvic radiotherapy.

Keywords: human papillomavirus optical coherence tomography imaging systems cervical intraepithelial neoplasia cervical cancer cervical dysplasia
biomarkers for the surgical treatment of rotator cuff tears

Conditions: Rotator Cuff Tears

Summary: identification of biomarkers that can predict the outcome of the surgical treatment (i.e. the rate of re-rupture) of tears in the rotator cuff tendon.

rotator cuff tears (i.e. structural failure and tissue disruption in at least one of the four muscles and tendons that form the rotator cuff) are extremely common injuries and represent the most common muscle-tendon tear in patients. repair of rotator cuff tears is usually advocated for painful tears with functional impairment. however, high failure rates of 13-68% have been reported for surgical repair of rotator cuff tears, irrespective of the surgical technique employed. higher rates of re-rupture are associated with larger tears, increased patient age, and increased fatty degeneration of the cuff muscles. there is no general consensus as to the causes of re-rupture; where mechanical factors, the existing techniques of suturing, and biological factors are considered as the main factors of recurrence.

Eligibility criteria:
inclusion criteria: * full-thickness rotator cuff tear (isolated transmural supraspinatus muscle tear or combined with infraspinatus and subscapularis tears) with fat content \<50% (goutallier stage 0-2), as confirmed by magnetic resonance imaging * acute or chronic ruptures * older than 40 years of age * voluntary participation in this study * written informed consent to participate in this study exclusion criteria: * contraindication because of ethical reasons * pregnant or lactating women * intention/wish to become pregnant during the course of this study * unsafe contraception * clinical co-morbidities, such as renal insufficiency, hepatic dysfunction, cardiovascular disease * known or suspected non-adherence to the study protocol * smoker * drug or alcohol addicted * uncapable of following instructions, e.g. because of insufficient proficiency in languages, psychological problems, dementia, etc. * participation in other clinical trials during the duration of this study, as well as 30 d before inclusion in this study * claustrophobia * systemic corticoid steroid therapy

Keywords: rotator cuff tear rotator cuff repair biomarker predictive factors skeletal muscle tendon subacromial bursa
methyldopa for reduction of dq8 antigen presentation in at-risk subjects for type 1 diabetes

Conditions: Type1 Diabetes Mellitus

Summary: a study is to see if methyldopa can change the immune system's attack on insulin producing cells in people at early stages of type 1 diabetes.

the study is a randomized, double blinded, placebo-controlled, multi-center crossover clinical trial. eligible subjects will be randomized in a 1:1 allocation ratio to one of two treatment schedules: first methyldopa then placebo vs. first placebo then methyldopa. the study objective is to assess the safety, efficacy, and mode of action of methyldopa to reduce dq8 antigen presentation in individuals at stage 1 and 2 of type 1 diabetes (t1d).

Eligibility criteria:
inclusion criteria: * participant in trialnet pathway to prevention study (tn01) * willing to provide informed consent or, if the subject is \<18 years of age, have a parent or legal guardian provide informed consent * confirmed positive for one or more autoantibodies, one of which is insulin autoantibody (miaa) * positive for at least one gene encoding hla-dq8 (dqb\*0302) * if a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and during the study * have normal or abnormal glucose tolerance on ogtt performed within 7 weeks of randomization exclusion criteria: * inability or unwillingness of a participant to give written informed consent or comply with study protocol * history of clinically significant anemia or hemoglobin \<10 g/dl * evidence of liver dysfunction * history of renal insufficiency * history of symptomatic hypotension including positional hypotension * systolic bp \< 100 mmhg for adults or blood pressure \< 5th percentile for age/height/gender in children and adolescents * use of a treatment that is known to cause a significant, ongoing change in the course of diabetes or immunologic status, within 4 weeks prior to participation. this includes high-dose inhaled, extensive topical or systemic glucocorticoids * females who are pregnant at the time of screening, breastfeeding or unwilling to defer pregnancy during the 16-month study period. (female participant must be at least 100 days postpartum before enrollment into study) * unable to avoid concurrent antihypertensive medications, monoamine oxidase (mao) inhibitors, lithium, or medications containing ferrous sulfate or ferrous gluconate * unable to avoid medications that affect stomach ph, such as proton pump inhibitors or histamine h2 receptor blockers * past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study

Keywords: trialnet
the benefit of prophylactic anticonvulsant in post cardiac arrest syndrome with induced mild hypothermia

Conditions: Cardiac Arrest

Summary: cardiac arrest is a leading cause of sudden death, but the survival rate of cardiac arrest is only 5-35%. although, the first resuscitation of cardiac arrest patient would be success, the hypoxic brain injury after cardiac arrest is an important cause of the mortality and the morbidity. for the management of the hypoxic brain injury after cardiac arrest, american heart association and european resuscitation council recommend induced mild hypothermia therapy. and, ilcor(international liaison committee on resuscitation) announced the standard treatment of post cardiac arrest syndrome(the success state of first resuscitation of the cardiac arrest patient) included the induced mild hypothermia therapy at september, 2008. the generalized seizure and myoclonus arise in over 60% of post cardiac arrest syndrome patients and they are very difficult to control. also, the occurrence of them implies poor prognosis of the patient. although, mild hypothermia therapy could be decrease the development and propagation of generalized seizure and myoclonus theologically, the therapy could not prevent the development and propagation of them entirely. therefore, the use of prophylactic anticonvulsant should be needed. but, there is not randomized control study about the use of prophylactic anticonvulsant. we hypothesized that the use of prophylactic anticonvulsant to post cardiac arrest syndrome patients would decrease the rate of occurrence of generalized seizure and myoclonus and would improve the neurologic outcome. we planed that we used two anti-epileptic drugs - valproate, clonazepam - for the prophylactic anticonvulsant. the valproate and clonazepam are in general use for prevention and treatment of generalized seizure and myoclonus and are recommended to treat of generalized seizure and myoclonus to post cardiac arrest syndrome patients by 2008 guideline of ilcor.


Eligibility criteria:
inclusion criteria: * age : over 18, under 80 * witnessed arrest * successful first resuscitation (rosc should be last for 20 min.) * coma or semicoma state * mean arterial pressure \> 60mmhg * peripheral oxygen saturation \> 85% * expected life span before cardiac arrest \> 3 month. * performance scale before cardiac arrest \> 3 month. exclusion criteria: * cause of arrest * sepsis, progression of malignancy, trauma, hemorrhagic shock * known coagulopathy * major operation within 7 days * previous seizure history * current use of valproate or clonazepam

Keywords: cardiac arrest prophylactic anticonvulsant