Kornimate/medical-research-clean huggingface dataset:
longitudinal endodontic study of apical preparation size

Conditions: Chronic Apical Periodontitis of Pulpal Origin

Summary: this protocol is for a clinical trial evaluating the clinical success of root canal therapy performed on teeth with chronic apical periodontitis of pulpal origin with either large or small apical root canal preparation techniques.

this randomized clinical trial will compare the clinical success of two commonly used techniques for performing non-surgical endodontic procedures on teeth with chronic apical periodontitis of pulpal origin. the first method, termed the "gt method" uses a commercially available rotary file system to instrument the root canal systems from the crown to the apical portion of the root. after completion of this technique, the apical portion of the root is prepared to the same standardized iso size #20 in all roots (i.e., 0.2 mm cross-sectional diameter). the second method, termed the "lightspeed method" uses a different commercially available rotary file system to shape the root canal systems from the apical to the crown portion of the root. after completion of this technique, the apical preparation is often larger in cross-sectional diameter than that observed after the gt method; however, an equally important distinction is that the lightspeed method customizes the final cross-sectional diameter for each root canal system, and thus each root has a similar enlargement of apical preparation size due to proportionate removal of infected dentin at the end of the root. although the lightspeed method may result in reduced bacteria in the apical portion of root canal systems, there is no evidence to date that this effect improves clinical success rates. this study will test the hypothesis that the larger apical preparation size produced by the lightspeed instrumentation system will produce a higher percentage of clinically successful treatments of teeth with apical periodontitis (ap) as compared to the gt method

Eligibility criteria:
inclusion criteria: 1. patient must be at least 18 years of age. 2. clinical indication for non-surgical root canal therapy (nsrct). 3. 1st or 2nd maxillary or mandibular molar. 4. diagnosis must be chronic apical periodontitis (cap) with or without symptoms. 5. intact, mature apices. 6. asa i or ii. exclusion criteria: 1. failure to meet any of the above 2. previous nsrct 3. previous pulpotomy or pulpectomy

Keywords: apical periodontitis, root canal therapy, apical preparation
efficacy of the nurtured heart approach to reduce adhd behaviors in children

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study evaluates the efficacy of the nurtured heart approach (nha) to reduce inattention and hyperactivity and impulsivity in children ages 6 - 8 years. participants are parents or guardians of children diagnosed with, or suspected of, attention deficit hyperactivity disorder (adhd). participants are randomized into the immediate (nha) or delayed (control) group.

the american academy of pediatrics recommends evidence-based parent and/or teacher behavioral therapy and/or medication to treat adhd. a systematic review by coates and colleagues found behavioral interventions decreased adhd behaviors in children. the nha is an intervention designed to teach parents a set of skills and attitudes to decrease adhd in children. it has been applied in a number of settings from homes, schools, and foster care agencies both in several states in the u.s. and in over 16 countries. while widely accepted, the approach has not been evaluated using scientifically rigorous methods.

Eligibility criteria:
inclusion criteria: * parent or guardian of a child diagnosed with adhd or suspected of adhd * child must be 6 - 8 years of age * access to a computer with internet exclusion criteria: * child with adhd, or suspected of adhd, cannot have a diagnosis of autism
developmental screening and nutritional intervention of severe acute malnourished children in southern punjab, pakistan

Conditions: Malnutrition in Children

Summary: i. to examine the impact of malnutrition on development quotient of children ii. to determine the effectiveness of ready to use therapeutic food (rutf) in improving the development quotient of severe acute malnourished children under five year of age. iii. to investigate the outcome of vitamin d therapeutic doses intervention with rutf rehabilitation on growth and development of malnourished children.

1. research instrument: for development quotient denver 2 screening form and tools will be used. follow up of patients for three months and for recording of their weight community management of acute malnutrition forms will be used. denver screening tool will be used for child development quotient covering all areas of development, fine motor, gross motor, language and personal social contact. 2. research settings: the study will be conducted in dera ghazi khan division at, basic health units (bhu). 3. study design: randomized controlled trial. 4. data collection: lady health visitors (lhws) will screen the children aged 6 months to 59 months in their community and will refer the severely malnourished children to outpatient therapeutic programs (otps).two groups of malnourished children will be made one study and one control group; one group will be treated with rutf and extra virgin olive oil as placebo. other will with rutf and two mega doses of vitamin d randomly, first after 15 days of enrollment and second after 15 days of first dose.

Eligibility criteria:
inclusion criteria * all the selected children of severe uncomplicated acute malnutrition of concerned age group whose parents or guardians have give written consent for the study * mid upper arm circumference (muac) less than 11.5 cm or weight for height (wfh) less then minus 3 standard deviation. exclusion criteria * children above the concerned age group * refusal of parents for taking part in the study. * child having severe acute malnutrition (sam) with complications have loss of appetite, lower respiratory tract infection indicated by chest in drawing, severe vomiting. * temperature greater then 39°c or hypothermia less then 35°c, very pale, oedema, unconsciousness.
a study of the bruton's tyrosine kinase (btk) inhibitor ibrutinib in participants with steroid dependent/refractory chronic graft versus host disease (cgvhd)

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to evaluate efficacy of ibrutinib in japanese participants with steroid dependent/refractory chronic graft versus host disease (cgvhd) by measuring overall cgvhd response (complete response \[cr\] and partial response \[pr\] defined by national institutes of health \[nih\] consensus development project criteria \[2014\]).


Eligibility criteria:
inclusion criteria: * steroid dependent/refractory chronic graft versus host disease (cgvhd) defined as modified national institutes of health (nih) criteria (2014) below at any time post-hematopoietic cell transplant (post-hct): a) dependent disease, defined as, when glucocorticoid (prednisolone doses greater than or equal to \[\>=\] 0.25 milligram per kilogram per day (mg/kg/day)or \>=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks. in case of inability to taper the dose to less than or equal to (\ =1 mg/kg/day for at least 1 week) or persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks * participants must be receiving baseline systemic glucocorticoid therapy for cgvhd at study entry. the dose of steroids must be stable for 14 days prior to starting ibrutinib * at the time of trial enrollment, participants may be receiving other immunosuppressive therapies in addition to glucocorticoids. immunosuppressant doses must be stable for 14 days prior to starting ibrutinib * clinically stable or worsening cgvhd for a minimum of 14 days between screening and day 1 cgvhd response assessment * karnofsky or lansky (participants less than \[\ =60 exclusion criteria: * active acute graft versus host disease (gvhd) * more than 3 previous systemic treatments for cgvhd. treatment with glucocorticoids is considered a treatment for cgvhd and should be included in determining the number of previous treatments * history of treatment with a tyrosine kinase inhibitor (example \[e.g.\] imatinib), purine analogs, or other cancer chemotherapy in the 4 weeks prior to starting ibrutinib. participants may have received ibrutinib pre-transplant for other reasons besides cgvhd such as for the treatment of leukemia or lymphoma * history of treatment with monoclonal t and b cell antibodies in the 8 weeks prior to starting ibrutinib * vaccinated with live, attenuated vaccines within 4 weeks of first dose of ibrutinib
treatment, parallel assignment, double blind (subject, outcomes assessor), efficacy study

Conditions: Overactive Bladder

Summary: the purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder.

patient registry: participants experiencing overactive bladder will be recruited from hospital outpatients and clinic-community. the diagnosis was made by the urologists. the random number table was generated by the computer. sample size: according to the preliminary experiment combined the literature. sample size is based on the primary outcome. the first step: one-tailed test: the electroacupuncture group vs solifenacin group is 79.5% vs 54.8%( α=0.05, β=0.20, n=51). the second step: two-tailed test :the electroacupuncture group vs placebo group is 54.5% vs 20.9%,(α=0.05, β=0.20, n=37). to combine the first and second step, 51 cases in each group are needed. allowing for a 10% dropout, 57 cases in each group are needed. so we set the sample size is 60. quality control 1. strict training on staff participating in the trial. 2. rigorous control of the process of randomization. 3. specific inclusion and exclusion criteria. 4. strict outcome assessors and statisticians. 5. the standard of the drugs, acupuncture apparatus, inspection equipment are consistant. 6. outcome assessment, completion of case report forms and data management will be under strict supervision.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of overactive bladder. 2. frequent micturition.（average urinary frequency of ≥8 voids per day） 3. no relevant drug use within 2 weeks and no acupuncture treatment within 1 month before the study; not in other clinical trials. 4. self-reported bladder symptoms ≥3 months 5. capable of giving informed consent . 6. capable and willing to follow all study-related procedures exclusion criteria: * frequent micturition and urinary urgency are secondary to other diseases. * clinical diagnosis of simple stress urinary incontinence. * patients with urinary track infection and vagenal infection. * patients with implantable pelvic stimulator. * current use of electric therapy on pelvic area/back/legs. * current use of clostridium botulinum therapy on vesical or pelvic muscles. * participation in any clinical inverstigation involving or impacting gynecological/urinary/renal function. * suffering from severe cardiac/hepatic/renal injury or cognitive disorder/aphasia/ dysphrenia/malnutrition, or in poor perform status and unable to cooperate. * patients in gestation and in lactation period. * patients in coagulation disorders or taking anticoagulation drugs. * people with cardiac pacemaker or metal allergy. * patients having got eletroacupunture therapy or solifenacin in 4 weeks before the study. * patients are afraid of needles.
characterization of local and systemic bone markers in diabetes patients with charcot osteoarthropathy

Conditions: Arthropathy, Neurogenic; Diabetes Complications; Diabetes Mellitus

Summary: the study is designed to investigate biomarkers related to bone turnover in diabetics with charcot foot. this is done by measuring local blood samples in the feet, and systemically in a vene and an artery. measurements are done before and after cooling the feet in icewater to lower the bloodflow. patients will be compared with healthy diabetic controls.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 1 or 2 * charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist exclusion criteria: * osteoporosis * anti-osteoporotic treatment * lower extremity amputation * lower extremity infection
prevention of intrauterine adhesion after adhesiolysis with novel tri-block degradable polymer film.

Conditions: Asherman Syndrome; Intrauterine Adhesion

Summary: preg2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named womed leaf

preg2 is a prospective, multi-center, randomized, controlled, two arm clinical study. the objective is to evaluate the efficacy of womed leaf in preventing intrauterine adhesion recurrence after adhesiolysis compared to adhesiolysis alone. the study will be performed on women with moderate or severe adhesions (afs score \>=5) scheduled for adhesiolysis. indeed, the risk of intrauterine adhesion is very high (up to 60%) in this population of patients. a follow-up diagnostic hysteroscopy will be performed 6-8 weeks after the adhesiolysis procedure to determine the presence and severity of iuas according to the american fertility society and european society of gynecologic endoscopy classification systems of adhesions. fertility-related outcome will include live pregnancy at 1 year, 2 years and 3 years and will be reported as secondary endpoints. 154 women are planned to be included in the preg2 study.

Eligibility criteria:
inclusion criteria: * women with moderate or severe intrauterine adhesions according to the afs classification, i.e afs score \>=5, confirmed by hysteroscopy right before adhesiolysis * scheduled for hysteroscopic adhesiolysis * age above or equal to 18 * subjects who are willing to provide a written informed consent. * subjects who can comply with the study follow-up (second look hysteroscopy) and other study requirements * subjects who agree to refrain from intercourse or use a reliable form of barrier contraception to prevent unintended pregnancy until the follow-up hysteroscopy. * subjects who agree to avoid all intrauterine devices (iuds) until the follow-up hysteroscopy. exclusion criteria: pre-operative criteria * post menopause * pregnant (confirmed by a positive pregnancy test) or lactating * abnormal uterine cavity according to eshre classification i to v such as unicornis, bicornis, septate, duplex * known or suspected endometrial hyperplasia * history of cervical or endometrial cancer * active pelvic infection or history of pelvic peritonitis * history of endometrial ablation * known contraindication or hypersensitivity to womed leaf component * current participation in another clinical investigation that has not yet received the primary endpoint. * any other condition that makes participation in the study contrary to the patient's best interests. intra-operative criteria, post adhesiolysis: * perforation during adhesiolysis * uterine depth \ 10cm

Keywords: asherman syndrome intrauterine adhesion hysteroscopy adhesiolysis adhesion prevention infertility
comparison of short versus 12 months prasugrel plus aspirin in patients with acute coronary syndromes treated with percutaneous coronary intervention and everolimus-eluting stents

Conditions: Acute Coronary Syndrome

Summary: the sort out xii dual antiplatelet treatment (dapt) duration trial, is a clinical randomized controlled superiority and non-inferiority trial to compare whether prasugrel alone versus prasugrel plus aspirin from month 1 to month 12 after percutaneous coronary intervention with and everolimus-eluting stent in patients with acute coronary syndromes (1) is superior regarding clinically relevant bleeding and (2) non-inferior regarding safety (cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization)


Eligibility criteria:
inclusion criteria: * all patients aged ≥18 years with acute coronary syndromes who are treated with an everolimus-eluting drug-eluting stent can undergo randomization if they can be treated with prasugrel for 12 months. * postmenopausal women or use of contraceptive drugs (absence of menstruation in at least 12 consecutive months or continuously usage of contraceptive drugs (a contraceptive implant, an intrauterine device, birth-control pills, transdermal patches, vaginal ring, or depot injection). exclusion criteria: * age \< 18 years * not able to consent to study participating (eg. intubated patients) * do not speak danish * life expectancy \<1 year * allergic to study related treatment * non-vitamin k antagonist oral anticoagulants (noac) or warfarin treatment * contraindication for 12 months prasugrel treatment

Keywords: drug-eluting stent dual antiplatelet treatment
mre evaluation for spinal cord tumor surgery: stiffness and adhesion assessment

Conditions: Spinal Cord Tumors

Summary: in spinal cord tumors requiring surgical intervention, the resection difficulty is determined by two significant factors: tumor stiffness and adhesion to surrounding tissue. the stiffness of the tumor dictates the complexity of removal, while strong adhesion presents additional challenges during the surgical procedure. this clinical trial aims to assess the clinical utility of magnetic resonance elastography (mre), in evaluating the stiffness and adhesion of spinal cord tumors and guiding surgical planning to selecting the most appropriate surgical approach for patients with spinal cord tumors.

spinal cord tumors are a common condition in neurosurgery, including neurofibroma, spinal meningioma, ependymoma, glioma, spinal lipoma, and so on. magnetic resonance imaging (mri) plays a crucial role in the preoperative evaluation and planning of spinal cord tumor surgery. it provides detailed information about the tumor's location, size, and relationship to adjacent structures. however, routine mri may not always provide sufficient information about the tumor's stiffness or adhesion, which can impact surgical planning and postoperative outcomes. magnetic resonance elastography and slip interface imaging can help measure the mechanical properties of tissues, including their stiffness or adhesion. by combining the above methods, surgeons can identify areas of potential tumor adherence or invasion into surrounding structures, allowing for more precise surgical resection and minimizing the risk of damage to critical neural tissue.

Eligibility criteria:
inclusion criteria: * all patients undergoing spinal cord tumor resection surgery are eligible for inclusion in the study cohort. exclusion criteria: * patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who cannot remove dentures, insulin pumps, or contraceptive rings) * pregnant women in the first trimester (within three months) * patients with severe claustrophobia or anxiety * patients with severe fever * patients who can not tolerate mre * patients with vascular malformations and aneurysms. * patients who do not sign an informed consent

Keywords: mre slip interface imaging glioma magnetic resonance elastography spinal meningioma neurofibroma ependymoma astrocytoma glioblastoma spinal lipoma
extension study to evaluate safety and efficacy of ctp-543 in adults with alopecia areata

Conditions: Alopecia Areata

Summary: the overall objectives of the study are to evaluate long-term safety of ctp-543 and to assess long-term effects of ctp-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.


Eligibility criteria:
inclusion criteria: * have completed 24 weeks of treatment in a previous qualifying ctp-543 clinical trial exclusion criteria: * active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or untreated actinic keratosis * females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study medication * donation of blood at any point throughout the study and for 30 days after last dose of study medication
a study to learn what participants think of treatment with betamethasone plus loratadine to treat their acute allergic rhinitis, also known as hay fever in mexico

Conditions: Rhinitis, Allergic

Summary: acute allergic rhinitis is a common allergic reaction to things like pollen or dust. it causes inflammation inside the nose, resulting in symptoms similar to the common cold. allergic rhinitis is also known as hay fever. in this study, the researchers want to learn what participants think of betamethasone plus loratadine as a treatment for their acute allergic rhinitis. these participants will have used betamethasone plus loratadine as a treatment for their acute allergic rhinitis within the past two months. during the study, participants will complete an online questionnaire about their experience with betamethasone plus loratadine.


Eligibility criteria:
inclusion criteria: * participants who used betamethasone plus loratadine within the previous 2 months for the treatment of acute episodes of allergic rhinitis * participants allowing to use the data for research and marketing purposes as well as talking to authorities * participants allowing us to use the pseudo-randomized individual data for further data analysis * able to read and understand the language of the online questionnaire exclusion criteria: - none
fluid balance and body weight changes in critically ill adult patients

Conditions: Critical Illness; Fluid Overload

Summary: positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.however, observational studies showed poor agreement between fluid balance and body weight changes. the objective of the study is to compare the measurements of fb and bw over time and to assess correlation with icu mortality.

positive fluid status has been consistently associated with worse prognosis in critically ill adult patients. daily and cumulative fluid balance (fb) is a routine nursing activity in intensive care unit (icu). in view of the potential for errors in the calculation of fb totals and the problem of accounting for insensible fluid losses, measurement of body weight (bw) changes is an alternative non-invasive method commonly used for estimating body fluid status. its accuracy over fb assumes a one kilogram change in bw equates to a one liter gain or loss in body fluid volume. however, observational studies showed poor agreement between those measurements, particularly among individuals staying more than a week in icu possibly due to muscle and fat loss as well as bone demineralization. the objective of the study is to compare the measurements of fb and bw over time and to assess correlation with icu mortality.

Eligibility criteria:
inclusion criteria: * individuals aged \>18 years-old admitted to icu; * expected length of icu stay superior to 24 hours. exclusion criteria: * individuals receiving oral diet; * actual body weight superior to 227kgs or 501lb.

Keywords: fluid balance body weight change critical illness