Kornimate/medical-research-clean huggingface dataset:
effect of serum vitamin d on marpe treatment response

Conditions: Maxillary Transverse Deficiency Class I Malocclusion Vitamin D Deficiency Orthodontic Tooth Movement Adolescent Health

Summary: a total of 30 patients are planned to be included in the study during the first half of 2025, who will apply to the clinic. in our clinical routine, approximately 30% of rme patients are treated using the marpe method. the patients will be randomly assigned to two different groups. the first group will be referred to the pediatric endocrinology outpatient clinic at neu faculty of medicine for vitamin d level measurements at the beginning of the treatment. the second group will proceed with treatment as usual, without vitamin d measurement. at the end of the treatment, vitamin d levels of all patients in both groups will be measured.

this randomized clinical trial aims to evaluate the potential impact of serum vitamin d levels on the outcomes of miniscrew-assisted rapid palatal expansion (marpe) treatment in young adults aged 15-18 years. a total of 30 patients presenting with maxillary transverse deficiency will be recruited during the first half of 2025. patients will be randomly allocated to two groups. the intervention group will undergo vitamin d level assessment at the beginning of treatment and receive supplementation if found deficient, while the control group will proceed without initial vitamin d evaluation. serum 25-hydroxyvitamin d \[25(oh)d\] levels will be measured at t1 and t2 timepoints. intraoral scans will be performed using an itero device to assess changes in intercanine and intermolar widths, and the data will be analyzed using the orthocad software. pain levels will be recorded by the patients using a visual analog scale (vas) on specified days during the expansion phase. this study intends to determine whether baseline vitamin d status and subsequent supplementation can improve the biological response and clinical efficiency of marpe treatment.

Eligibility criteria:
inclusion criteria: * patients diagnosed with class i malocclusion * presence of maxillary transverse deficiency * adolescents aged between 15 and 18 years * no systemic diseases, cleft lip/palate, or speech disorders * no history of prior orthodontic treatment * willingness to undergo serum vitamin d testing * voluntary participation in the study with signed informed consent * good oral hygiene status exclusion criteria: * patients with systemic diseases * patients who smoke * patients with poor oral hygiene * patients with cooperation or compliance issues * patients with intellectual disabilities * patients with unmonitored or insufficient pre-treatment vitamin d levels, including: * those who had insufficient vitamin d levels before treatment, were started on supplementation by the endocrinology department, but still had insufficient levels at the t2 measurement * those who were not tested before treatment but were found to have sufficient vitamin d levels only at t2

Keywords: marpe
efficacy and safety of bile salt stimulated lipase (bssl) as replacement therapy in pasteurized breast milk for preterm infants

Conditions: Replacement Therapy in Preterm Infants

Summary: the purpose of this study is to evaluate the efficacy in preterm infants following treatment with bssl when administered in pasteurized breast milk.

in this double-blind crossover study, patients will be randomized to receive pasteurized breast milk including bssl or pasteurized breast milk without bssl for the first 7 days. after a wash-out period of 2 days the patients will "crossover" to the other treatment regimen and receive an additional 7 days treatment. the primary efficacy measurements will be made by collecting stool during the last three days of each treatment period.

Eligibility criteria:
inclusion criteria: * preterm infants * less than or equal to 32 weeks of gestational age * appropriate for gestational age * enterally fed with pasteurized breast milk

Keywords: replacement therapy pasteurized breast milk preterm infants bssl
scapular mobilization with arm movement in patients with adhesive capsulitis.

Conditions: Shoulder Adhesive Capsulitis

Summary: 50 patients with shoulder adhesive capsulitis were admitted. the patients will receive scapular mobilization (downward or upward mobilization) associated with arm movements. the percentage of improvement in shoulder rom of flexion, abduction, and external rotation; and decrease in shoulder pain and disability index (spadi).


Eligibility criteria:
inclusion criteria: * the existence of unilateral adhesive capsulitis (stage ii) with incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula exclusion criteria: * the presence of any shoulder problem contraindicated for performing exercises to the shoulder joint, such as active inflammatory disease, cancer, active infection, recent subluxations or dislocations, fractures, and surgeries near the shoulder region.

Keywords: scapular mobilization; arm movement; pain; range of motion; disability; older adults; adhesive capsulitis
a study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: the purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (as).


Eligibility criteria:
inclusion criteria: * male or female patients at least 18 years of age * subject has ankylosing spondylitis (as) as per the modified new york (mny) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years * subjects has moderate-to-severe active disease defined by bath ankylosing spondylitis disease activity index (basdai) \>=4 and spinal pain \>=4 on a 0 to 10 numeric rating scale * subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (nsaids) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to nsaid therapy * patients who have taken a tumor necrosis factor alpha (tnfα) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks * patients currently taking nsaids, cyclooxygenase 2 (cox-2) inhibitors, analgesics, corticosteroids, methotrexate (mtx), leflunomide (lef), sulfasalazine (ssz), hydroxychloroquine (hcq) and/or apremilast can be allowed if they fulfill specific requirements prior to study entry exclusion criteria: * total ankylosis of the spine * treatment with more than 1 tnfα inhibitor and/or more than 2 additional non-tnfα biological response modifiers, or any interleukin (il)-17 biological response modifier at any time are excluded * active infection or history of recent serious infections * viral hepatitis b or c or human immunodeficiency virus (hiv) infection * any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or tb (bacillus calmette-guerin) vaccination within 1 year prior entering the study * known tuberculosis (tb) infection, at high risk of acquiring tb infection, or current or history of nontuberculous mycobacterium (ntmb) infection * subject has any active malignancy or history of malignancy within 5 years prior to the screening visit except treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer * diagnosis of inflammatory conditions other than axspa, eg, rheumatoid arthritis. patients with a diagnosis of crohn's disease, ulcerative colitis, or other inflammatory bowel disease (ibd) are allowed as long as they have no active symptomatic disease when entering the study. * presence of active suicidal ideation, or moderately severe major depression or severe major depression * female patients who are breastfeeding, pregnant, or planning to become pregnant during the study * subject has a history of chronic alcohol or drug abuse within 6 months prior to screening

Keywords: ankylosing spondylitis as bimekizumab axial spondyloarthritis
acquisition and long-term observation of patients with severe allergic reactions

Conditions: Anaphylaxis

Summary: the anaphylaxis registry aims to assess data in a standardized form about symptoms, triggers, cofactors and therapy management from patients who experienced an anaphylactic reaction. this should improve diagnosis and long-term management of these life-threatening allergic reactions.

a better understanding of the triggers and pathology of anaphylactic reactions could lead to a better diagnosis and prophylaxis to avoid the occurence of these life-threatening allergic reactions. this can be an advantage for affected persons regarding the their treatment and long-term management. the anaphylaxis registry is an opportunity to gather these standardized data. the blood sampling is optional for the patient, however, it will contribute to the better understanding of the sensitization profile and possible mechanisms. recent publications showed a correlation between an anaphylactic reaction and certain biomarkers. those data will be validated in a larger number of population with identification of further biomarkers. it is presumed that certain genetic and epigenetic polymorphisms are abundant for patients who experienced an anaphylaxis. to summarize, this study aims to contribute to a better understanding of the anaphylaxis in general, the diagnosis, and the prognosis with different severities. with the identification of a certain trigger, the obtained understanding may help to decrease the risk of or prevent future repeating reactions.

Eligibility criteria:
inclusion criteria: * anaphylactic reaction within the past 12 months exclusion criteria: -
a study of tirzepatide (ly3298176) in participants with obesity or overweight for the maintenance of weight loss

Conditions: Obesity; Overweight

Summary: this was a study of tirzepatide in participants with obesity or overweight. the main purpose was to learn more about how tirzepatide maintained body weight loss. the study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. the study lasted about 2 years (25 visits).


Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease * history of at least one unsuccessful dietary effort to lose body weight exclusion criteria: * diabetes mellitus * change in body weight greater than 5 kg within 3 months prior to starting study * obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity * history of pancreatitis * family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men-2) * history of significant active or unstable major depressive disorder (mdd) or other severe psychiatric disorder within the last 2 years * any lifetime history of a suicide attempt

Keywords: metabolism and nutrition disorder prediabetes
safety and efficacy study of idelalisib (gs-1101, cal-101) in patients with previously treated low-grade lymphoma

Conditions: Indolent Non-Hodgkin's Lymphoma; Follicular Lymphoma; Small Lymphocytic Lymphoma; Marginal Zone Lymphoma

Summary: the primary objectives of this study is to evaluate the safety and efficacy of idelalisib (gs-1101, cal-101) in participants with previously treated indolent non-hodgkin lymphoma (inhl). eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.


Eligibility criteria:
inclusion criteria: * previously treated relapsed or refractory b-cell inhl * provide written informed consent exclusion criteria: * pregnant or nursing * active, serious infection requiring systemic therapy * positive test for hiv antibodies * active hepatitis b or c viral infection

Keywords: indolent non-hodgkin's lymphoma non-hodgkin lymphoma inhl nhl cal-101 pi3k phosphatidylinositol 3-kinase follicular lymphoma (fl) small lymphocytic lymphoma (sll) marginal zone lymphoma (mzl)
feasibility study of an integrated diagnostic system to manage heart failure

Conditions: Heart Failure

Summary: the purpose of this clinical trial is to evaluate the potential benefits of a new heart failure diagnostic system for heart failure patients with implanted cardiac resynchronization therapy devices. this system consists of patient tools, a new heart failure risk score and a new clinician website. this study will evaluate this new system as a whole and establish the feasibility of implementing it into clinical practice.


Eligibility criteria:
inclusion criteria: * subject is willing and able to provide written informed consent * subject is at least 18 years of age * subject is willing and able to comply with the clinical investigation plan * subject is currently enrolled in the medtronic carelink® network * subject is currently a new heart association (nyha) functional class iii or nyha functional class ii with a heart failure related hospitalization within the past 180 days * subject has a medtronic concerto®/consulta® cardiac resynchronization therapy (crt)device implanted for at least 180 days * subject has been prescribed daily oral diuretic therapy for the management of heart failure exclusion criteria: * subject is enrolled in a concurrent study with the exception of a study approved by the indicate hf clinical trial leader * subject has a life expectancy of less than 1 year * subject's crt device has an estimated battery life of less than 2 years

Keywords: heart failure home monitoring integrated diagnostics cardiac resynchronization therapy with defibrillator (crt d)
treatment outcomes in bile duct stones

Conditions: Gallstone; Bile Duct Obstruction; Bile Duct Diseases

Summary: this registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.

gallstone diseases are common, affecting 20 million patients in the united states with associated costs of over us $6 billion. common bile duct (cbd) stones in turn occur in 15-20% patients with gallstone disease and require treatment due to risk of infection and pancreatitis. endoscopic treatment via endoscopic retrograde cholangiopancreatography (ercp) is the treatment modality of choice in cbd stones. the most simple treatment techniques include biliary sphincterotomy and stone extraction via the use of standard devices such as a stone retrieval balloons or stone retrieval baskets. however, patients with difficult bile duct stones require advanced maneuvers namely mechanical lithotripsy, large balloon sphincteroplasty (lbs) of the major duodenal papilla and single operator cholangioscopy-guided lithotripsy (soc-ll). currently, there are no standardized treatment approaches in the management of cbd stones, especially in the management of difficult cbd stones. therefore, ercp in patients with difficult cbd stones can be inefficient and prolonged with use of multiple devices and techniques. in an effort to standardize the management of bile duct stones, we have devised an algorithm for the treatment of bile duct stones using current standard of care methods, taking into account the size of bile duct stones, size of bile duct and availability of endoscopic expertise. the objective of this registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic treatment of bile duct stones when utilizing an algorithmic management approach.

Eligibility criteria:
inclusion criteria: 1. all patients with confirmed or suspected bile duct stones undergoing endoscopic therapy for treatment of bile duct stones 2. patients 18 years or over exclusion criteria: 1. patients not undergoing endoscopic therapy for bile duct stones 2. patients \< 18 years of age
stress and mental ill-health in the workplace: evaluation of an intervention for the prevention of sick leave

Conditions: Common Mental Disorders and/or Stress Related Symptoms

Summary: purpose common mental disorders (cmd:s) are the leading cause of sick-leave spells in sweden, resulting in suffering for the individual and financial costs for the employer as well as for society at large. studies on interventions that address stress and mental ill-health and that focus on sick leave and return to work (rtw) show little or no effect of commonly used methods such as medication or psychological approaches. furthermore, these interventions often focus on the individual's symptoms without considering their work situation. the occupational health services (ohs) has knowledge of the employee's work environment and can offer treatment facilitating the employee's rtw and improving the employee's work ability while taking into account both the individual and the work situation. the intervention in the current study will be performed at the ohs. the study aim is two-fold: first, an intervention that addresses both individual and workplace related aspects among employees with work-related cmd:s and/or stress related symptoms will be evaluated. in particular, the treatment's cost-effectiveness and impact on sick leave and mental health will be studied. secondly, the concerned ohs staff's adherence to the intended treatment and associations with the outcome of the intervention will be assessed.


Eligibility criteria:
inclusion criteria: * the employee suffers from stress related symptoms or work-related common mental disorders. * the employee is either not on sick leave or is on sick leave for a maximum of 3 consecutive months (full or part time). * the employee understands both written and spoken swedish. * the employees nearest supervisor should be aware of the employees visit(s) at the ohs (to avoid differential selection into the experimental and the control condition) exclusion criteria: * bullying * pregnancy * post traumatic stress-disorder * severe mental disorders (e.g. psychosis) * any co-morbidity that may substantially affect the employee's ability to work and/or quality of life.

Keywords: sick-leave return to work occupational health common mental disorder depression anxiety disorders adjustment disorders problem solving therapy occupational health services randomized controlled trial intervention studies occupational stress
effect of roselle-based drink on blood pressure and skin

Conditions: Other Skin and Subcutaneous Infections

Summary: this randomized, placebo-controlled, double-blind, and cross-over study was designed to check whether the roselle-based drink (2 bottles every day) can alter blood pressure and skin condition in elderly healthy subjects.

the subjects were assigned into two groups (control group and test group), each group subject was requested to drink 2 bottles every day (100 ml/bottle, one in the morning and another in the evening), the rate of drinking is 75.42%. there are 39 subjects (25 females and 14 males) completely involved in the thirteen-month trial (cross-over). blood samples were collected at the initial, 3rd, 6th, 7th, 10th, 13th months of the trial. skin examinations were performed at the initial, 6th, 7th, 13th months.

Eligibility criteria:
inclusion criteria: * healthy adults * subjects should not be under any medication * subject must be able to drink exclusion criteria: * subjects with chronic renal, liver or cardiac disorders, diabetes, hyperlipidemia. * also pregnant women, chain smokers, high alcohol consumers should not be included.
development and validation of a postoperative re-fracture risk model for osteoporotic spinal fractures

Conditions: Osteoporosis Fracture; Osteoporosis Vertebral; Compression Fracture; Perform PVP / PKP Treatment

Summary: in this project, ideal-iq technology and pdff and r2\* image-based imaging methods are used to analyze the intrinsic relationship between preoperative vertebral bone marrow fat content, magnetic susceptibility properties of bone tissue and bone strength (bone volume and bone mass), to explore the mechanism of vertebral re-fracture after pvp / pkp, and to explore the imaging markers for the risk of postoperative vertebral re-fracture after pvp / pkp. to construct a precise and individualized risk assessment model of vertebral re-fracture after pvp/ pkp by combining clinical risk factors, preoperative quantitative mri parameters (pdff, r2\*) and imaging characteristics, so as to achieve the goal of objectively and accurately evaluating the risk of vertebral re-fracture at the early stage of the postoperative period (1 year).


Eligibility criteria:
inclusion criteria: * patients diagnosed with osteoporotic vertebral fractures of the thoracic and lumbar level with reference to the 2022 edition of the osteoporotic fractures guidelines (2022 edition); * the presence of bone marrow edema or hemorrhage (acute fracture) in the fractured vertebrae is clearly defined by mr examination, and the responsible vertebrae is treated with pvp / pkp; * number of fractured vertebrae: 1-3 vertebral compression fractures (including old fractures). exclusion criteria: * history of severe scoliosis, vertebroplasty, or internal spinal fixation; * presence of spinal infection and malignant neoplastic disease; * presence of mental disease, cognitive impairment, or critical illness (e.g., severe cardiac or cerebrovascular disease).

Keywords: osteoporosis spinal vertebral fractures pvp / pkp treatment
mechanisms and therapeutic effects of the relaxation response in elderly hypertensive patients

Conditions: Hypertension

Summary: the purpose of this study is to determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension.

the purpose of this study is to determine whether the relaxation response is more effective than health education training (attention control) in reducing systolic blood pressure and anti-hypertensive medication elimination in elderly adults with isolated systolic hypertension.

Eligibility criteria:
inclusion criteria: * 55 years or older * currently taking at least 2 anti-hypertensive medications * systolic blood pressure between 140-159 mmhg * diastolic blood pressure less than 90 mmhg * read and understand english * access to a telephone * ability to attend all study visits exclusion criteria: * other cardiovascular disease * major medical illness * previous experience with any rr eliciting technique * current use of:beta-agonist bronchodilators, systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than ssris), dicyclomine, bile acid binding resins, or sympathomimetic medication