Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of bcx7353 as an oral treatment for the prevention of attacks in hae

Conditions: Hereditary Angioedema; HAE

Summary: this is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of oral bcx7353 in preventing acute angioedema attacks in patients with type i and type ii hae.


Eligibility criteria:
key inclusion criteria: * a clinical diagnosis of hereditary angioedema type 1 or type 2, defined as having a c1-inh functional level and a c4 level below the lower limit of the normal (lln) reference range, as assessed during the screening period. * subject weight of ≥ 40 kg * access to and ability to use one or more acute medications approved by the relevant competent authority for the treatment of acute attacks of hae * subjects must be medically appropriate for on-demand treatment as the sole medicinal management for their hae during the study. * subjects must have a specified number of investigator-confirmed attacks during the run-in period of a maximum of 56 days from the screening visit. * acceptable effective contraception * written informed consent key exclusion criteria: * pregnancy or breast-feeding * any clinically significant medical condition or medical history that, in the opinion of the investigator or sponsor, would interfere with the subject's safety or ability to participate in the study * any laboratory parameter abnormality that, in the opinion of the investigator, is clinically significant and relevant for this study * severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology * use of c1-inh within 14 days or use of androgens or tranexamic acid within 28 days prior to the screening visit for prophylaxis of hae attacks, or initiation of these drugs during the study * current participation in any other investigational drug study or received another investigational drug within 30 days of the screening visit * prior enrollment in a bcx7353 study

Keywords: bcx7353 berotralstat
autofluorescence vs clinical assessment of parathyroid glands during thyroid surgery

Conditions: Hypoparathyroidism Postprocedural

Summary: the purpose of the investigation is to study if the use of fluobeam®-lx to identify parathyroid glands through autofluorescence during thyroid surgery, may reduce the risk of postoperative hypoparathyroidism, defined as low pth in patients undergoing total thyroidectomy

temporary and permanent hypoparathyroidism is probably the most important complication of total thyroidectomy. the rate of permanent hypoparathyroidism in quality registries are in the range of is 5-7 percent of patients undergoing surgery. patients operated on benign disease with total thyroidectomy, and who suffer from permanent hypoparathyroidism (defined as medication with active vitamin d analogue therapy for more than 6 months, are at increased risk of renal insufficiency. they also have, for unclear reasons, an increased risk of suffering from malignancy, compared to patients without this complication. patients with known ischemic heart disease before surgery also have an increased risk of suffering a new episode of cardiovascular disease. finally, patients with permanent hypoparathyroidism have an increased risk of mortality compared to patients without this complication. if, by using a technique for autofluorescence (fluobeam® -lx), one can more accurately identify and avoid damage to the parathyroid glands during the surgical procedure, this would be of great importance for patients undergoing total thyroidectomy for thyroid disease. patients undergoing total thyroidectomy are randomized to the use of fluobeam® -lx to detect the parathyroid glands through autofluorescence during thyroid surgery, or clinical evaluation only (control). outcome is evaluated by parathyroid hormon (pth) levels the first postoperative day and the need for medication with calcium and vitamin d up to 6 months postoperatively.

Eligibility criteria:
inclusion criteria: patients with thyroid disease planned for total thyroidectomy regardless of diagnosis exclusion criteria: * previous thyroid surgery * previous parathyroid surgery * concurrent parathyroid surgery * renal insufficiency * pregnancy * breast feeding * allergy (contrast agent, iodine) * inability to understand study information * patient unable to participate in planned follow-up program

Keywords: hypoparathyroidism pth hypocalcemia
registry of patients treated with systemic mold-active triazoles

Conditions: Invasive Fungal Infection

Summary: the purpose of this study is to describe representative real-world patterns of care for the management of invasive fungal infections (ifis), including invasive mold infection (imi). specifically, the study goals are to examine real world patient characteristics and treatment patterns, associated healthcare resource utilization, and outcomes associated with use of mold-active triazoles (mats) to treat invasive fungal infections (ifis).


Eligibility criteria:
inclusion criteria: * patients taking one of the following target drugs at the time of enrollment: isavuconazonium sulfate (isav), voriconazole (vori), posaconazole (posa). exclusion criteria: * currently enrolled in any clinical trial with an investigational antifungal agent. individuals who subsequently enroll in an investigational antifungal study will be discontinued and data collected up to the time of investigational product will be evaluable. * patients who died before entering the study. * patients who previously participated in this registry.

Keywords: mold-active triazoles
lp(a) lowering study of pelacarsen (tqj230) with background inclisiran in participants with elevated lp(a) and established ascvd

Conditions: Atherosclerotic Cardiovascular Disease (ASCVD)

Summary: the purpose of the study ctqj230a12304, is to evaluate the efficacy, safety, and tolerability of pelacarsen (tqj230) compared to placebo in participants with ascvd who have elevated lipoprotein(a) (lp(a)), and who are on background inclisiran treatment for elevated low-density lipoprotein cholesterol (ldl-c).

this is a randomized, double-blind, placebo-controlled, multicenter, parallel group study followed by an open-label treatment period.

Eligibility criteria:
key inclusion criteria: * male and female participants 18 to ≤80 years of age at screening visit * established ascvd, defined as documented coronary heart disease (chd), cerebrovascular disease (cvd), or peripheral arterial disease (pad) at screening visit * on stable dose of local guideline recommended lipid lowering therapy for at least 30 days prior to screening visit * participants must successfully complete the run-in period of background inclisiran treatment in order to be randomized * on standard of care (soc) treatment for other cvd risk factors including hypertension and diabetes for at least 30 days prior to randomization/baseline visit * central laboratory reported lp(a) ≥175 nmol/l at screening visit * central laboratory reported ldl-c \>70 mg/dl (or \>1.8 mmol/l) at screening visit key exclusion criteria: * prior treatment with inclisiran * any other pcsk9 inhibitor (e.g., evolocumab, alirocumab) use within 4 months prior to screening visit * uncontrolled hypertension at randomization/baseline visit * heart failure new york heart association (nyha) class iv at screening visit or at randomization/baseline visit (day 1) * triglycerides ≥400 mg/dl at screening visit * history of malignancy of any organ system within the past 5 years * myocardial infarction, stroke or other major bleeding, coronary or lower limb re vascularization, major cardiac or non-cardiac surgery between screening visit and randomization/baseline visit (day 1) * central laboratory reported platelet count \<140,000 per mm3 * active liver disease or hepatic dysfunction at screening visit * significant kidney disease at screening visit * pregnant or nursing women at screening visit * any uncontrolled chronic or serious medical condition which may pose an immediate risk to clinical stability of the study participant at screening visit * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: lipoprotein(a) cardiovascular disease ascvd pelacarsen (tqj230)
weight-bearing of surgically treated acetabular fractures.

Conditions: Acetabular Fracture

Summary: the purpose of this study is to determine whether patients with operatively treated acetabular fractures benefit from early weight-bearing as tolerated. the study compares two groups ( n = 25 each), which are randomised into either weight-bearing as tolerated or touch-down weight-bearing for 6-8 weeks postoperatively. both study groups are stratified according to * type of fracture (anterior approach vs anterior + additional posterior approach) * dislocated dome vs non-dislocated/ non existing separate dome fragment patients, who are eligible to participate in the trial but choose not to participate in randomisation are asked to enrol in a prospective cohort follow-up cohort. this is to examine a potential participation bias in the rct groups. these patients will not be counted into the target amount of 50 rct patients.

for the past 20 years, the established treatment of dislocated acetabular fractures has been surgical reduction and stable osteosynthesis. good long-term results have been reported in these patients. at present, the mobilisation of these patients after surgery is generally restricted for several weeks ranging from 6-12 weeks touch-down- or non-weight-bearing with no uniform protocol. however there is no scientific evidence for limiting post operative weight-bearing. accordingly the need of studies on weight-bearing surrounding periarticular fractures has been advocated. acetabular fractures in the elderly population are becoming more common and pose significant challenges for treatment including postoperative rehabilitation. our aim is to investigate if patients benefit of a more liberal weight-bearing regime postoperatively. the primary outcome is measured at 1 year, secondary outcomes are followed up to 10 years postoperatively

Eligibility criteria:
inclusion criteria: * unilateral dislocated acetabulum fracture (displacement of over 2mm in preoperative ct scan) * the osteosynthesis is performed during 21 days after initial trauma * the patient is willing to participate in the follow-up exclusion criteria: * unwillingness to participate in randomisation * bilateral fracture * letournel \& judet type both column or posterior column and wall fractures * any other injury that prevents the patient from partial weight bearing * open fracture of the acetabulum * pathologic fracture (fragility fractures are not an exclusion criteria) * prior functional disability in the pelvis or lower extremity * non-compliance due to dementia or other mental disability * prior daily pain medication due to hip-pain * unwillingness to accept one of the two mobilisation protocols * prior hip replacement on injured side * bmi \> 40

Keywords: acetabulum periarticular fracture weight-bearing
the effect of intervention with probiotic k56 on body fat reduction in obese subjects

Conditions: Obesity

Summary: the aim of the present study was to investigate the effect of intervention with lactobacillus paracasei k56 on body fat, metabolic risk markers,inflammatory markers and gut microbiota composition in obesity.

recent data suggest that gut microbiota can function as an environmental factor that modulates the amount of body fat and obese individuals have an altered gut microbiota.the results of previous animal studies have suggest that a probiotic strain lactobacillus paracasei k56 have reduced high-fat diet induced obesity. in this randomised,double blind ,placebo controlled study, the participants were randomly assigned to probiotic k56 group or placebo group to evaluate the fat-reducing effect of the lactobacillus paracasei k56 by continuously supplementing probiotic or placebo capsules.

Eligibility criteria:
inclusion criteria: * obesity : bmi\>=30kg/m2,or percent body fat(pbf) \>=25% for male, \>=30% for female. （note: if pbf was eligible, it was recommended that 26 ≤ bmi ≤ 40） * age: 40 - 65 years old adults * who has the conditions to preserve the test samples at low temperature throughout the whole process exclusion criteria: * patients with severe chronic diseases（heart, liver, kidney, hematopoietic system, tumor and other serious diseases, mental illness and organ surgery history, etc.) and complications; * patients with severe allergy and immunodeficiency; * patients with a clear history of gastrointestinal diseases (ulcer, irritable bowel syndrome, etc.); * history of intervention with fat-reducing drugs or health products in the past 2 months * take weight control measures (diet, exercise, etc.) within the past month * participation in other clinical trials within the past 3 months * who have used antibiotics in the past 2weeks ; * those who cannot guarantee to maintain their current lifestyle during the trial period * those who fail to consume the tested samples as required, or fail to follow up on time, resulting in failure to determine the efficacy

Keywords: obesity lactobacillus paracasei body fat visceral fat area gut microbiota
investigating the relation between environmental factors and activity-participation in children with cerebral palsy

Conditions: Cerebral Palsy; Activity; Participation

Summary: cerebral palsy (cp) is a chronic condition that causes the most childhood disabilities on worldwide. impairment in movement and posture development seen in children with cp it causes difficulties in performing activities and affect in emotional, social, and cognitive abilities cause limited participation in everyday life. the icf-cy child is divided into five categories: body structure and functions, activities, participation, environmental and personal factors, it is treated holistically. initially, children with cp have adopted the view that environmental factors can also affect functionality, while focusing on the treatment of motor disorders to reduce activity and participation limitations in physiotherapy and rehabilitation applications. environmental factors; the environment in which the child lives, his family, the devices he uses, health and care services, and government policies. these factors vary according to each country's own cultural and economic opportunities. the investigator planned to do this study because we found that there is a need for a comprehensive study of children with sp in turkey, which does not reveal the relationship between environmental factors and activity and level of participation.

the study consist of two phases: 1. european child environment questionnaire (eceq) will translate in to turkish in the first phase. * forvard translation (translate to turkish from english) * expert opinion (turkish version will control by expert) * back translation (turkish version will translate to english) * cultural adaptation validity and reliability study will done 2. the relationship between environmental factors and activity and participation will be investigated in the second phase. eligibility criteria * 2-18 years old * cerebral palsy diagnosed * children or family who understand and speek turkish language * children or family who know writing and reading * volunteer to join the study outcome measures 1. clinical classifications: gross motor function classification system (gmfcs) for classifying gross motor function levels manuel ability classification system (macs) for classifying fine motor function levels communication function classification system (cfcs) for classifying communication function levels eating drinking abilities classsification system (edacs) for classifying eating and drinking functions levels will be used 2. activity evaluation: gross motor function measurement (gmfm) pediatric evaluation of disabilty inventory (pedi) will be used 3. participation: life habits questionnaire (life-h) will be used 4. environmental factors: european child environment questionnaire (eceq) impact on family scale (ipfam) will be used

Eligibility criteria:
inclusion criteria: * diagnosed cerebral palsy * volunteer to join the study * know writing and reading * speeking turkish exclusion criteria: * seconder neurologic impairment * not complete the evaluation

Keywords: cerebral palsy, activity, participation, environmental factors, icf-cy
cerebral hypoperfusion at transcranial color-coded doppler.

Conditions: Cerebral Injury

Summary: background. cerebral ischemia is a major secondary factor contributing to worsening outcomes in patients with acute brain injuries. transcranial color-coded doppler (tccd) is a reliable method for evaluating cerebral perfusion and is recommended for use in emergency settings to reduce secondary injuries. however, there is no established treatment protocol for managing cerebral hypoperfusion as detected by tccd. objective. the primary objective of this study is to assess the efficacy of individual steps in a standardized treatment protocol to normalize tccd parameters in patients with cerebral hypoperfusion. the secondary objective is to investigate the concordance between invasive intracranial pressure (icp) measurements and those estimated through tccd using the czosnyka formula. methods. this prospective multicenter observational study will enroll patients with acute brain injury admitted in emergency or intensive care settings. inclusion criteria include age over 18, glasgow coma scale \<9, and evidence of cerebral hypoperfusion based on tccd performed on m1 tract of at least one middle cerebral artery. the hypoperfusion is defined as the concurrent presence of at least two of the following parameters: mean velocity below 30 cm/s, diastolic velocity below 20 cm/s, pulsatility index above 1.4. patients will undergo a stepwise treatment approach involving normocapnia verification, autoregulation testing increasing mean arterial pressure by 10 mmhg, and hyperosmolar therapy. the effectiveness of each intervention will be assessed by tccd readings. endpoints. the primary endpoint is the percentage of patients who normalize cerebral perfusion parameters at each step of the protocol. the secondary endpoint is the concordance between invasive icp measurements and those estimated through tccd. sample size. the study aims to recruit 100 patients over 24 months. data analysis will include descriptive statistics, with significant results considered at p \< 0.05.


Eligibility criteria:
inclusion criteria: * age over 18 years * patients with intraparenchymal cerebral hemorrhage, subarachnoid hemorrhage, head trauma, or hydrocephalus * glasgow coma scale belowe 9 * need for invasive mechanical ventilation * arterial catheter for invasive blood pressure monitoring and blood sampling * presence of doppler parameters of cerebral hypoperfusion (concurrent presence of two or more of the following conditions: pi \> 1.4, diastolic velocity \< 20 cm/s, and mean velocity \< 30 cm/s detected in at least one middle cerebral artery) exclusion criteria: * absence of transtemporal windows bilaterally on tccd * documented severe aortic valve insufficiency * heart rate less than 40 bpm * patients with suspected vasospasm on tccd
intervention to improve hiv self-care among people who inject drugs

Conditions: Hiv; Substance Use Disorders

Summary: this study will implement a pilot randomized controlled trial (rct, n=70) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in hiv-care among substance using hiv+ pwid sub-optimally engaged in hiv care.

eligible study participants will be screened and enrolled at fenway health (boston, ma). all participants will receive substance use treatment referral information if interested. participants will be randomized to one of two treatment arms. participants in both arms will receive a mobile application-facilitated incentivized directly observed therapy (idot) intervention. participants in the control arm will receive idot alone. participants in the intervention arm will receive idot in combination with the istrive intervention. after randomization, participants in the istrive intervention group will attend 6 therapy sessions focused on behavioral strategies for improving hiv self-care, meta-cognitive awareness of emotions and thoughts, cognitive restructuring, and assertive communication skills. participants in the istrive intervention arm will also receive texts messages containing customized compassionate self-statements to enhance hiv-related self-care. all participants will be compensated for every research visit and adherence to the idot protocol.

Eligibility criteria:
inclusion criteria: * hiv positive * hiv virally unsuppressed (\>20 copies/ml) in past year or no past-year hiv viral load result * drug use behavior endorsed in past 6 months * able to provide informed consent * 18 years or older * english speaking exclusion criteria: * hiv negative * denying drug use in past 6 months
pain relieving potentials of combination of oral duloxetine and intravenous magnesium sulphate in post mastectomy pain

Conditions: Duloxetine; Magnesium Sulphate; Post-mastectomy Pain Syndrome

Summary: this study aims to evaluate the effect of combined duloxetine and iv magnesium sulphate to decrease acute and chronic post mastectomy pain. the study will be conducted in national cancer institute and all the participants will be enrolled from female patients scheduled for modified radical mastectomy under general anesthesia in national cancer institute, cairo university.

it has been reported recently that duloxetine improved the quality of recovery in patients subjected to hysterectomy. in this context, mastectomy has a negative consequence starting from cancer diagnosis to the squeal of cancer-related treatments and it has been estimated that 20%-30% of patients with breast cancer suffer from depression and anxiety. magnesium also antagonizes the release of inflammatory mediators such as histamine, serotonin, and cytokines in peripheral tissues.

Eligibility criteria:
inclusion criteria: * age from 18 to 65 years old. * american society of anesthesiologists (asa) physical i-ii * scheduled for modified radical mastectomy (mrm) under general anesthesia. exclusion criteria: * liver or kidney disease * patient with previous chronic pain on opioids * patients on antidepressants and antipsychotics. * allergies to study drugs