Kornimate/medical-research-clean huggingface dataset:
does progesterone prevent very preterm delivery in twin pregnancies?

Conditions: Preterm Delivery

Summary: the purpose of the study is to determine whether a daily dose of 200 mg progesterone administered vaginally from 20-23 to 34 weeks' gestation will reduce the rate of preterm delivery amongst twin pregnancies.

multiple gestations account for 2% of all pregnancies, but cause more than 10% of the cases of preterm delivery. due to increasing maternal age and use of assisted reproduction the number of multiple gestations is larger than ever. if markers of preterm delivery can be identified and means of preventing preterm delivery are found, it will be possible to reduce the number of children admitted to hospital because of prematurity. recently, two larger randomised studies investigated the effect of progesterone in singleton pregnancies of women who had previously delivered preterm. they both found a significant reduction in the preterm delivery rate in the progesterone group compared to a placebo group. the study will be performed as a randomized, double-blind placebo controlled study of twin pregnancies in denmark and austria. the women will be randomised in a 1:1 ratio to two groups (progesterone versus placebo). randomisation will be stratified per centre and according to chorionicity, as the risk of preterm delivery is doubled in monochorionic twins compared to dichorionic twins.

Eligibility criteria:
inclusion criteria: * twin pregnancy * informed consent * 18-23 weeks' gestation * participants must be fluent in the language spoken in the respective centres exclusion criteria: * age \< 18 years * known allergy to progesterone or peanuts * active thromboembolic disorders or a history of hormone-associated thromboembolic disorders * rupture of membranes at the time of inclusion * monoamniotic twins * pregnancies treated for or with signs of twin-to-twin transfusion syndrome at inclusion * multiple pregnancies reduced to twin pregnancies * known significant structural or chromosomal fetal abnormality * chorionicity not assessed before 15 weeks * known or suspected malignancy in genitals or breasts * known liver disease

Keywords: preterm delivery prevention twins progesterone
xarelto for vte prophylaxis after hip or knee arthroplasty

Conditions: Venous Thromboembolism

Summary: the main goal is to provide additional information to the risk-benefit assessment of the drug.


Eligibility criteria:
inclusion criteria: * female and male patients who will undergo elective hip or knee arthroplasty. exclusion criteria: * exclusion criteria must be read in conjunction with the local product information.

Keywords: prophylaxis of venous thromboembolism
beyond covid-19: supporting resilience with a trauma-informed music composition program

Conditions: Problems Related to Life-Management Difficulty

Summary: this study explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the covid-19 pandemic.

this study explores the feasibility and acceptability of a music composition intervention to support resilience in survivors of serious illness hospitalized during the covid-19 pandemic. the pandemic introduced widespread trauma for patients facing hospitalization. therapeutic music interventions have demonstrated positive psychological effects, but none have explored the specific trauma-informed aspects of a composition-mentor program, as well as the specific impact of music composition on resilience-related traits. researchers implemented an adapted version of the new york philharmonic very young composers program (vyc): trained composer-mentors guide participants through four web-based sessions to elicit and develop participants' unique musical ideas into finished compositions. participants are then invited to view a string quartet performance of their compositions. the brief resilience scale \[brs\] and new general self-efficacy scale \[ngse\] are administered pre-intervention, post-intervention, and post-performance.

Eligibility criteria:
inclusion criteria: * 18 to 60 years of age * massachusetts residents * exhibiting english fluency * in care with an mgb provider * admitted as an inpatient for at least 3 days to an mgb hospital between march 15, 2020 and july 21, 2022 * not hospitalized within the month before starting the study. exclusion criteria: * neuropsychiatric illness impeding participation in the study including suicidality, psychosis, active substance use, and dementia
assessment of reconstruction and inverse reconstruction in right atrium by multimodal echocardiographic techniques

Conditions: Paroxysmal Atrial Fibrillation

Summary: the purpose of the study is to assess the reconstruction and inverse reconstruction in right atrium by speckle tracking echocardiography combined with real-time three dimensional echocardiography for atrial fibrillation patients before and after radiofrequency ablation (rfca)

the prevalence of atrial fibrillation (af) has increased in recent years. the construction and function of right atrium haven't shown clearly before and after radiofrequency ablation (rfca).the purpose of the study is to investigate whether rfca can lead to inverse reconstruction of right atrium for atrial fibrillation patients, which diagnosing by speckle tracking echocardiography combined with real-time three dimensional echocardiography. all patients will be followed up for 12 months.

Eligibility criteria:
inclusion criteria: 1. with a history of paroxysmal af (paf) and paf record within 6 months prior to ablation, confirming at least one of the following findings: af lasting for ≥30 s recorded in holter or 12-lead ecg. 2. no response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment. 3. can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures. 4. aged 18-80 years. exclusion criteria: 1. with acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction; 2. in the list of heart transplantation; 3. expected survival less than 1 year; 4. with other hemorrhagic diseases and anticoagulant therapy is not allowed; 5. thrombosis in left atrium; 6. heart failure, new york heart association(nyha) iii/iv or eject fraction(ef)\<40%; 7. patients with uncontrolled cancer; 8. significant hepatic or renal impairment (and/or alanine transaminase(alt) or aspartate transaminase(ast) \>2 times upper limit of normal, creatinine clearance rate(ccr)\<50%); 9. previous catheter radiofrequency ablation for af or cardiac surgery; 10. pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.

Keywords: right atrium echocardiography remodeling
mr imaging of knee osteoarthritis and acute knee injuries

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to use better magnetic resonance imaging (mri) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries.

the study will examine the pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes; and evaluate t1p relaxation methods and its' relating to cartilage loss. the protocol is geared towards sequences utilizing 3 tesla magnetic resonance imaging (mri) that will enable the measures of cartilage volume and t2. measures cartilage volume and t2 are more established mr methods for studying osteoarthritis (oa). all oa and anterior cruciate ligament (acl) subjects will undergo mr imaging of the knee joint at 3 tesla at baseline,, and three annual follow up time points. regions of interest will include the total tibial and femoral cartilage, and sub-division such as the medial and lateral compartments of the tibial and femoral cartilage to account for localized disease activity and progression. bone marrow edema size, mr spectroscopy based marrow fat/water content, and trabecular bone microarchitecture underlying the edema will be measured in the oa and acl groups to determine whether there is any distinction between these measures in oa and in traumatic acl injury, cross-sectionally and longitudinally, and their relation to cartilage loss and oa progression.

Eligibility criteria:
inclusion criteria: * healthy volunteers will have had no previous knee symptoms or surgery * patients with mild arthritic symptoms and kellgren lawrence score of 2 * patients with severe arthritic symptoms and kellgren lawrence score of 3, or 4 * patients with acute acl injury with associated bone contusion and bone edema * patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures * patient is willing to participate in the proposed study as evidenced by providing written informed consent. exclusion criteria: * current use of an investigational drug * conditions other than oa which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy or a stroke.) * patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to mri

Keywords: osteoarthritis, knee anterior cruciate ligament magnetic resonance imaging
therapeutic use of tadekinig alfa in nlrc4 mutation and xiap deficiency as open label extension

Conditions: XIAP Deficiency; NLRC4-MAS

Summary: this is an open-label extension study for patients previously enrolled in the ab2 bio ltd. ongoing phase iii clinical trial nlrc4/xiap.2016.001 (ind n° 127953). this ole study will evaluate the long-term safety and tolerability of tadekinig alfa in patients suffering from pediatric monogenic autoinflammatory diseases harboring deleterious mutations of nlrc4 and xiap.

pediatric auto-inflammatory conditions related to spontaneous activating mutations of the nlrc4 and with recurrent mas-like flares with constitutive il-18 hypersecretion, may require long-term blockade of the il-18 pathway. patients with x-linked inhibitor of apoptosis (xiap) deficiency and suffering from hemophagocytic-lymphohistiocytosis (hlh), a mas-like syndrome, also show high levels of serum il-18 and may benefit from il-18 blockade treatment until a curative hematopoietic stem cell transplantation can be performed the safety of il-18 blockade during long-term periods is of major interest for the treatment of these patients

Eligibility criteria:
inclusion criteria: (both criteria must be met) 1. patients have participated in ab2 bio ltd. phase iii clinical trial nlrc4/xiap.2016.001 (ind n° 127953) by one of the following mechanisms : a) patients that have completed the first 18-week rct phase of the preceding clinical trial but were not eligible for the rw phase due to flare symptoms. or b) patients that completed the first 18-week rct phase and completed the rw phase of the preceding clinical trial. or c) patients who have exited either the rct or rw phase of the preceding clinical trial due to treatment failure requiring rescue immunosuppression. such patients must wait a minimum of 4 weeks after treatment discontinuation from the preceding clinical trial before enrolling in this ole. if patients do not consent to enroll in the ole after their early termination in the main study, they will be asked to continue with the planned visits of the main study 2. women of childbearing potential with negative urine pregnancy test (upt) at all visits exclusion criteria: 1. patients may not enter the ole if they voluntarily withdrew from rct or rw study or if the time period between participation exceeds 3 months 2. evidence or history of malignancy 3. evidence of invasive or life-threatening infection 4. history of tuberculosis 5. life-threatening bleeding within 2 weeks of screening 6. vaccination with a live vaccine within the previous 3 months 7. evidence of severe organ compromise including but not limited to: (see details in the protocol) 8. pregnant or breastfeeding females 9. inability to follow highly effective birth control recommendations during the study and until 1 month after the end of the treatment. 10. inability to provide informed consent, and also assent if applicable 11. life expectancy less than 4 weeks 12. concomitant use of other immunosuppression except nsaids, glucocorticoids, cyclosporine, tacrolimus, il-1 inhibitors (anakinra, canakinumab, or rilonacept)
computer-based cognitive training for individuals with parkinson's disease

Conditions: Parkinson's Disease; Mild Cognitive Impairment

Summary: computer-based cognitive training for individuals with parkinson's disease" is a 3-arm randomized controlled trial (rct) comparing brain fitness, insight, and an active control (ac) training program to evaluate the feasibility of empirically supported computer-based cognitive training programs (cctps) for patients diagnosed with parkinson's disease (pd) with mild cognitive impairment (mci). this pilot study aims to address the need for increased interventions to target non-motor symptoms associated with pd.

patients meeting criteria for mci will be initially randomized to one of the 3 conditions. participants will complete cognitive training exercises on their home or clinic-provided computers for 60 minutes per day, 5 days per week. compliance and performance will be monitored on a weekly basis and at completion of the study. outcome measures will be collected one week before initiation of the intervention and within one week completion of the intervention. neuropsychological functioning, including tests of processing speed, attention, and executive functioning, will serve as primary outcome measures. patient reported outcomes, including measures of overall qol and disease-specific qol, and support-person reported outcomes (if applicable), including measures of overall qol and caregiver burden, will be secondary outcome measures. this pilot study promises to evaluate computer-based cognitive training in a novel population and expand access to cognitive rehabilitation services, and is designed to improve cognitive functioning and qol among a wide range of individuals with pd.

Eligibility criteria:
inclusion criteria: * participants eligible for this study must speak english and have a confirmed medical diagnosis of parkinson's disease and meet established criteria for mci in pd (litvan et al., 2012), defined as individuals with performances of approximately -1 to -2 standard deviations below the mean on at least two tests within five cognitive domains assessed in their clinical neuropsychological evaluations. exclusion criteria: * exclusion criteria include diagnosis of pd dementia based on movement disorder society task force criteria (emre et al., 2007) and other pd-associated comorbid conditions (e.g., severe anxiety, depression, excessive daytime sleepiness, or psychosis) that significantly influence cognitive testing (litvan et al., 2012).

Keywords: parkinson's disease mild cognitive impairment
evaluating the patient-ventilator synchrony during mechanical ventilation in patients with acute lung injury

Conditions: Mechanically Ventilated ICU Patients

Summary: the overall purpose to the study is to prospectively study how often patients with and without acute lung injury (ali) have patient-ventilator asynchrony demonstrated as stacked breaths. the investigators seek to describe the quantity of stacked breaths by continuously recording flow, volume, and pressure waveforms routinely displayed on the vent. the investigators also seek to describe how primary icu teams manage asynchrony documenting interventions of sedation or vent manipulation and what modality is most successful.


Eligibility criteria:
inclusion criteria: age \> 18 years intubated and mechanically ventilated diagnosed with acute lung injury (ali) or requiring mechanical ventilation for reasons other than ali exclusion criteria: neurological deficits (acute or chronic) that prevent effective diaphragm activity. * neuromuscular disease affecting the diaphragm * neuromuscular blockade
device-based qrs evaluation

Conditions: Heart Failure

Summary: the purpose of this study is to collect simultaneous surface electrocardiogram (ecg) recordings and cardiac resynchronization therapy (crt) intracardiac electrogram (iegm) recordings of variations in electrical synchrony.


Eligibility criteria:
inclusion criteria: * already implanted with sjm quadripolar crt pacing system * ability to provide informed consent for study participation * willing to comply with the study evaluation requirements * at least 18 years of age exclusion criteria: * resting ventricular rate \>100 bpm * intrinsic pr interval \> 300 ms * paroxysmal or persistent atrial tachycardia or atrial fibrillation documented * pregnant or plans to become pregnant during the study
the ideal deep venous thrombosis (dvt) study

Conditions: Postthrombotic Syndrome

Summary: in the netherlands, 25.000 patients each year are diagnosed with deep venous thrombosis (dvt). elastic compression stocking (ecs) therapy reduces the incidence of post thrombotic syndrome (pts) following dvt from 50% without ecs to 20-30% after ecs therapy for two years. it is however unclear whether all patients benefit to the same extent from this therapy or what the optimal duration of ecs therapy for individual patients should be. ecs therapy is not only costly, inconvenient and demanding but sometimes also even debilitating. substantial costs could be saved by tailoring therapy to individual needs and as a result the quality of life for individual patients can be expected to improve. this study aims to assess the costs and effects of tailoring the duration of ecs therapy after dvt to individual patients needs. ecs therapy with a standard duration of 24 months will be compared with tailored ecs therapy, following an initial therapeutic period of 6 months, in patients with acute proximal dvt. the primary outcome is the percentage of patients with pts at two year follow-up. this is a multi-center, randomized, allocation concealed, single-blinded clinical trial.


Eligibility criteria:
inclusion criteria: * legal age (18 yrs) * informed consent * acute objectively documented dvt of the leg * adequate anticoagulation exclusion criteria: * previous dvt in the affected leg * recurrent dvt in the first 6 months following inclusion * preexistent venous insufficiency (skin signs c4-c6 on ceap score or requiring ecs therapy) * contraindication for elastic compression therapy (arterial insufficiency) * active thrombolysis * life expectancy \< 6 months

Keywords: elastic compression stockings deep venous thrombosis post thrombotic syndrome
impact of flash glucose monitoring in people with type 2 diabetes using non-insulin antihyperglycemic therapy

Conditions: Diabetes Mellitus, Type 2; Glucose

Summary: the objective of this study is to evaluate the effectiveness of a flash glucose monitor device in achieving optimal glycemic control among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy.

the immediate study is a multi-centre, randomized controlled, open-label, two-phase cross-over study evaluating the effectiveness of a flash glucose monitor device to increase the proportion of time spent in target glucose range (3.9 to 10.0 mmol/l) among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy compared to a control group not using a flash glucose monitor device. the study will consist of two phases; each 16 weeks long. in phase 1, study participants who meet eligibility criteria will be randomized to receive a flash glucose monitor device combined with diabetes self-management education, or diabetes self-management education alone. in phase 2, participants initially assigned to receive education alone will crossover to receive a flash glucose monitor device while participants initially using the flash glucose monitor will continue using their device. no diabetes self-management education will be provided during phase 2.

Eligibility criteria:
inclusion criteria: eligible participants must be an adult aged 18 years or older and: * a clinical diagnosis of t2d, with diagnosis known for six months or more; * an hba1c of \> 7.5%; * using one or more non-insulin antihyperglycemic therapy for a minimum of six months, with dose stability of 3 months; and * no previous history of using cgm or fgm devices. exclusion criteria: participants will be excluded from the study if they: * have a history of insulin use \> 3 months * are pregnant or breastfeeding * have diabetic retinopathy * have an estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 * have unstable cardiovascular disease * use other implanted medical devices, such as pacemakers * have had more than one episode of severe hypoglycemia during the past 6 months or evidence of hypoglycemia unawareness * anticipate or require regular magnetic resonance imaging, computed tomography scan, or high-frequency electrical heat (diathermy) treatment

Keywords: type 2 diabetes flash sensor glucose technology glucose monitoring randomized controlled trial
efficacy and safety of stent implantation in symptomatic extra- and intracranial artery stenosis

Conditions: Stroke; Transient Ischemic Attack; Atherosclerosis; Stenosis; Stents

Summary: the purpose of this study is to evaluate the efficacy and safety of stent implantation in patients with symptomatic extra- and intracranial artery stenosis and to determine its role in secondary prevention of ischemic stroke.


Eligibility criteria:
inclusion criteria: 1. aged between above 40 year-old and 75 year-old. 2. ischemic stroke related to extra- and intracranial atherosclerosis stenosis, transient ischemic attack (tia ), onset time within 90 days 3. implantation of stent should be at least 1 week after stroke onset, and patient's medical condition stable, no time limit for tia, 4. stenosed ica or mca or ba or va is the candidate arteries for stent implantation. 5. degree of stenosis of target artery ranges between 51%-99% 6. modified rankin score≤3 or nihss score ≤4 7. informed consent is obtained. exclusion criteria: patients will be excluded from entry if any of the criteria listed below are met: 1. target stenosis artery is not suitable for stent implantation after evaluation. 2. previous carotid endarterectomy or carotid artery stent ,or intracranial artery stent implantation. 3. ischemic stroke is caused by conditions other than atherosclerosis . 4. documented non-atherosclerosis angiopathy. 5. clinically unstable at the time of enrollment, 6. conditions which may lead to cardiogenic embolism : arterial fibrillation，left ventricular thrombi,myocardiac infarction within 6 weeks,etc. 7. severe hypertension (systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg) 8. severe co-morbid or unstable medical condition, ie，severe heart failure, pulmonary failure or renal failure, liver dysfunction (serum liver enzyme twice or more than normal level),malignancy with likelihood of death within the next 2 years 9. significant memory or behavioral disorder, ie, alzheimer disease, etc.daily care needed. 10. concurrent participation in another clinical trial 11. unable to return follow up 12. history of hemorrhagic disease(ie, intracranial hemorrhage, idiopathic thrombocytopenic purpura,etc ) or bleeding tendency conditions. 13. intracranial arteriovenous malformation or aneurysm.

Keywords: stroke transietn ischemic attack stents stenosis