Kornimate/medical-research-clean huggingface dataset:
sar231893-lps15497- "dupilumab effect on sleep in ad patients"

Conditions: Atopic Dermatitis

Summary: primary objective: to evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (ad). secondary objectives: to evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, ad related outcomes, and daytime consequences of sleep deprivation. to continue to assess the safety and tolerability throughout the study.

duration per participant was up to 28 weeks.

Eligibility criteria:
inclusion criteria: participants, male or female 18 years or older, * with diagnosed chronic ad, demonstrated 1) inadequate response to topical medications, 2) expected severity of ad and 3) sleep disturbance. * had applied skin emollients (moisturizers) at least 7 days before screening. * had applied medium potency topical corticosteroids (tcs) on all active ad lesions at least 7 days before screening. * willed and able to comply with all clinic visits and study-related procedures. * provided signed informed consent. exclusion criteria: participants excluded from the study: * with known hypersensitivity to dupixent, clinical depression, drug abuse history, sleep problems not related to ad, irregular sleep pattern, active/acute infections, severe medical conditions, laboratory abnormalities, any condition that might present unreasonable risk to participants or interfered with study assessment, or any severe concomitant illness(es) that would adversely affect the participant's participation in the study, and contraindications of topical corticosteroids. * at baseline, presence of any conditions listed as criteria for study drug discontinuation. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
fine and gross motor function and relationship with muscle tone in older adults with and without dementia

Conditions: Dementia; Gait; Balance; Muscle Tone; Fine Motor Function; Paratonia

Summary: the purpose of this study was (1) to investigate changes in gait, balance, fine motor function, and muscle tone, and (2) to find out if there is a correlation between muscle tone/presence of paratonia and motor function (gross and fine) in mild and moderate dementia.three groups of participants were included in the study: healthy elderly (n=60), participants with mild dementia (n=31) and participants with moderate dementia (n=31). measurements of fine motor function, balance, gait, presence of paratonia and muscle tone measurements were performed.


Eligibility criteria:
inclusion criteria: * age \>= 65 years * walk independently for at least 11 meters * hc: no cognitive deterioration, mid: dementia, global deterioration scale\<5, mod: dementia, global deterioration scale 5 or 6 exclusion criteria: * recent (≤ 6 months) orthopedic surgery
infracyanine green vs brilliant blue g in macular hole inverted flap surgery: a swept source oct analysis.

Conditions: Macular Holes

Summary: this study will compare by swept-source optical coherence tomography (ss-oct) the retinal morphology after inverted internal limiting membrane (i-ilm) flap vitreoretinal surgery for medium-to-large macular holes using infracyanine green (ifcg) vs brilliant blue g (bbg) dyeing. it is a single-center prospective, randomized study. one group of patients will undergo i-ilm vitrectomy with ifcg staining, the other vitrectomy with bbg staining. postoperative twelve-month corrected distance visual acuity, macular hole closure rate, and ss-oct parameters will be compared and statistically analyzed. the aim of the study is to verify if these parameters can be negatively affected by toxicity related to the use of one of the two dyes.

the purpose of this study is to compare by swept-source optical coherence tomography (ss-oct) the retinal morphology after inverted internal limiting membrane flap (i-ilm) surgery for medium-to-large macular holes (ftmhs) using infracyanine green (ifcg) vs brilliant blue g (bbg). this prospective randomized study include 40 eyes with ≥ 400 µ idiopathic ftmh undergoing ifcg or bbg-stained i-ilm technique. just before surgery, randomization is performed using the sealed-envelope technique, based on the patients' surgical chart number. the random allocation sequence is generated by the trial statistician pulling 41 standard-sized pieces of paper out of a hat. twenty pieces of paper are marked with the letter i, for ifcg, and 21 with the letter b, for bbg. the trial statistician then sequentially puts each piece of paper into 41 sealed opaque envelopes. these envelopes are numbered 1 to 41 and given to the surgeons. patients are numbered randomly from 1 to 41 based on a surgical chart number related to the baseline testing session and intervention period. clinical data collection and measurement of outcome variables are performed by personnel masked to the randomization process and not been directly involved in the patients' surgery.

Eligibility criteria:
inclusion criteria: * phakic or pseudophakic patients affected with medium to large idiopathic full thickness macular hole (ftmh), with a minimum preoperative diameter of 400 µ exclusion criteria: * patients with chorioretinal diseases except ftmh, myopia \> 5 d, history of glaucoma, previous trauma or ocular surgery other than cataract extraction, or conditions affecting visual acuity except cataract.

Keywords: large macular hole inverted flap surgery infracyanine green brilliant blue g swept source oct
ambispective study to assess the effect of pretreatment with a levonorgestrel-releasing intrauterine system versus oral progestin

Conditions: Adenomyosis; IVF

Summary: the study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. the study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (mri). the study will involve two study arms

the study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. the study materials that will be used will include blood tests, transvaginal ultrasound and magnetic resonance imaging (mri). the study will involve two study arms: arm 1: women with adenomyosis pretreated with levonorgestrel-releasing intrauterine device (lng-ius) and proceeding with the icsi arm 2: women with adenomyosis pretreated with oral progestin "dienogest" and proceeding with the icsi primary and secondary key measurements will be used in the study. the primary measures will include: * presence of intrauterine gestational sac at 12 weeks * presence of fetal heart pulsation at 12 weeks the secondary key measures will include: * occurance of abortion in the 1st trimester * appearance of ectopic pregnancy diagnosis by: ultrasound serum β-hcg level symptoms of pain and bleeding * two serum β-hcg levels in 48hrs interval to emphasis biochemical pregnancy * recording the the baseline characteristics of the study participants

Eligibility criteria:
inclusion criteria: 1. patients diagnosed using both the transvaginal ultrasound study (tvs) and mri criteria * main criteria for sonographic and mri diagnosis of adenomyosis are: the appearance of asymmetrical thickening of the myometrium irregular cystic areas within the myometrium linear striations radiating out from the myometrium 2. patients ≤42 years old at the time of starting icsi cycle 3. cryopreserved embryo transfer cycles 4. the presence of at least one good cryopreserved day 3 embryo. exclusion criteria: 1. transfer of a poor-quality embryo (grades 3 or 4) 2. history of myomectomy 3. pelvic ultrasound that showed the presence of uterine fibroids, a hydrosalpinx or endometrial polyps (all known causes of implantation failure).
clinical outcome of implant removal versus retention after posterior fixation of thoracolumbar fractures

Conditions: Thoracolumbar

Summary: comparing clinical outcome between patients who underwent metal removal and those who retained the metal


Eligibility criteria:
inclusion criteria: * age 18-60 years * posterior fixation * six to nine months after fixation * neurologically free patient * fracture consolidation detected by ct * types a3\&a4 fractures exclusion criteria: * unstable fractures b\&c * pathological fractures * multilevel fractures * poly trauma patients

Keywords: metal removal
a biomechanical exercise program for knee oa

Conditions: Osteoarthritis, Knee

Summary: prescribing exercise for people with painful knee osteoarthritis (oa) is essential for pain management, improved function, and chronic disease prevention. exercise that decreases joint exposure to damaging loading while eliciting adequate muscular activation for strength improvements is ideal. the purpose of this 3-arm rct is to compare mobility, strength, pain, and mri outcomes between the low-loading biomechanical exercise program (be), a traditional exercise program for knee oa (te), and a control group completing meditation classes (m).

osteoarthritis (oa) is a common joint disease affecting 1 in 10 canadians. osteoarthritis commonly presents in the knee joint and is associated with mobility limitations, pain, and an increased risk of other chronic health conditions such as heart disease. it is critical to implement exercise for people with knee oa as it can be an effective method for improving pain, mobility, and cardiovascular health. a biomechanical exercise program using static yoga postures has been established in the investigators lab based on minimizing damaging knee joint loads, while effectively exercising the musculature around the knee joint. the investigators pilot project (reb#13-510) showed that a 12-week yoga program using these biomechanical exercises improved pain and mobility while keeping the medial joint loading well below that experienced during normal level walking. the next step with this exercise program is to compare clinical and tissue outcomes with that of a regularly prescribed aerobic and strengthening program, as well as a control group completing meditation classes. the investigators aim to identify differences in clinical mobility performance outcomes, muscle and fat volumes using magnetic resonance imaging (mri), and cartilage integrity using mri between the three groups using a randomized controlled trial (rct) design.

Eligibility criteria:
inclusion criteria: * 50 years of age or older * knee pain on most days of the week * less than 30 minutes of morning stiffness * bony enlargement * bony tenderness to palpation * signs of inflammation * able to safely climb 2 flights of stairs without aid exclusion criteria: * any other forms of arthritis * osteoporosis * history of patellofemoral symptoms * active non-arthritic knee disease * knee surgery * use of cane or walking aid * unstable heart condition * neurological conditions * skin allergy to medical tape * hip or ankle injuries in past 3 months * any injuries that would prohibit participation in yoga * ipsilateral hip or ankle conditions * currently receiving cancer treatment * currently pregnant

Keywords: exercise magnetic resonance imaging
predicting early tumor recurrence in patients with esophageal squamous cell carcinoma

Conditions: Esophageal Cancer; Recurrence; DNA Methylation

Summary: the prognosis of patients with esophageal squamous cell carcinoma (escc) who develop post-operative early tumor recurrence is often relatively poor. therefore, biomarker that can detect micro metastases before the start of treatment is required. epigenomic alterations such as dna methylation have attracted attention as promising biomarkers. the investigators aim to predict early recurrence based on whole genome dna methylation analysis of esophageal cancer.

prognosis for patients with esophageal squamous cell carcinoma (escc) remains poor. surgery is one of the standard treatments for patients with escc who are considered to have a curative resection, however, approximately 40% of patients develop tumor recurrence within two years after surgery. the main cause of poor prognosis in escc patients undergoing surgery is postoperative tumor recurrence due to the presence of latent micro-metastases at the time of surgery. even with today's advances in preoperative diagnostic techniques, predicting early tumor recurrence remains difficult due to the lack of established methods. epigenetic markers, especially dna methylation, are considered ideal markers for predicting cancer metastasis due to their cancer-specific methylation patterns, biological stability, and technical reproducibility. our study aims to evaluate methylation of surgical specimens to assess residual disease and predict early recurrence.

Eligibility criteria:
inclusion criteria: 1. patients who had histologically confirmed escc. 2. patients who had undergone only complete esophagectomy with radical lymph node dissection without chemotherapy or radiotherapy before or after surgery. 3. patients for whom tissue samples are available 4. patients who were followed-up completely, with information on observation periods of at least 2 years after surgery. 5. written informed consent following full study information is provided to the patient. exclusion criteria: 1. patients lacking clinical information within 2 years of surgery. 2. patients with multiple cancers.
stalevo in early wearing-off patients

Conditions: Idiopathic Parkinson's Disease

Summary: the purpose of this study is to demonstrate in patients with parkinson's disease that, when compared to levodopa/carbidopa, stalevo will delay the time from initiation of study drug to the time an increase in antiparkinsonian medication is required due to inadequately controlled parkinsonian symptoms.


Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease * treatment with 3 equal daily doses of levodopa/carbidopa up to 450 mg/day * unchanged antiparkinsonian medication for 6 weeks prior to baseline exclusion criteria: * secondary or atypical parkinsonism * patients with daily unpredictable off periods or painful dyskinesia
acute effects of meteorological factors and air pollution on cardiovascular health

Conditions: Cardiovascular System; Health

Summary: the goal of this observational study is to analyze the acute effects of meteorological factors and air pollution on cardiovascular system. the main question it aims to answer is: 1. how do meteorological factors and air pollution affect cardiovascular system? 2. what is the interaction between meteorological factors and air pollution on cardiovascular system? participants will: 1. provide their health data obtained in physical examination, including but not limited to blood pressure, blood routine, urine routine and b-ultrasound. 2. agree that the research team will use their personal identification number, gender, age, education level and other information for statistical analysis of the data.

the collected data include: id number (or unique identification code similar to id number), physical examination date, work unit, occupation, gender, age, systolic blood pressure, diastolic blood pressure, height, weight, blood routine, urine routine and blood biochemical examination results,color doppler (or b-ultrasound) examination results (thyroid color doppler, abdominal color doppler, urinary color doppler, cardiac color doppler, cervical vascular color doppler, etc.), electrocardiogram, cardiac cta, carbon 13 breath test, and written diagnosis results of liver fibrosis.

Eligibility criteria:
inclusion criteria: ·relevant records in the physical examination database shall be ≥3 times ·≥18 years old exclusion criteria: * relevant records in the physical examination database shall be ≥３times * serious heart and lung diseases * malignant tumors * serious mental illness in the past

Keywords: cardiovascular system air pollution exposure acute effect weather
neoadjuvant propanolol in breast cancer

Conditions: Breast Cancer

Summary: this trial is a phase ii study using the "window-of-opportunity" design in which the treatment-free window between breast cancer diagnosis and surgical tumor resection is used to study the biological effects of the beta blocker propranolol .

* patients will be recruited from the garbar breast care center and university medical center following diagnosis of invasive breast cancer by breast biopsy. * the sympatholytic nonselective beta blocker propranolol will be administered to all participants in a non-randomized manner at an equal dose of 1.5 mg/kg/day. * following surgical resection of the tumor , the primary endpoint of this study is quantified by comparing the proliferative index of the tumor before propranolol administration (quantified using the initial tumor biopsy) and after 3 weeks of propranolol (quantified using the surgically resected tumor). * additional molecular analyses and evaluation of safety and toxicity will also be performed to better understand the effects of this treatment on breast cancers and patient adherence to the drug.

Eligibility criteria:
inclusion criteria: * ages 18- 65 * diagnosis of stage i-iii breast cancer , confirmed by a core biopsy * planning to undergo definitive surgery including mastectomy or breast conserving surgery * systolic blood pressure must be \>100 mmhg but no more than 140 mmhg and/or diastolic \> 60 mmhg and no more than 95 mmhg. * normal baseline ekg exclusion criteria: * pregnancy; potential subjects of female bearing age will have to complete a pregnancy test during screening to ensure that they are not pregnant. potential patients who are post-menopausal must have confirmed one year without menstrual cycle. * free of major medical illnesses including: * uncontrolled diabetes (hba1c of ≤ 8 if previously tested) * uncontrolled hypertension: bp \>systolic 140/ diastolic \> 95 * cardiac diseases (history of cardiac valve disease, coronary artery disease, congestive heart failure, a-v block, peripheral vascular disease, any cardiac arrhythmia/bradycardia) with the exception of the diagnosed cancer. * histories of asthma, bronchospastic disease, or obstructive pulmonary disease * previously diagnosed thyrotoxicosis * severe allergic reactions to medications which are included in the beta blocker family * previously or currently treated with a beta adrenergic receptor antagonist * patients with locally advanced or inflammatory breast cancer not amenable to surgical resection * patients taking any of the following medications will be excluded: * drugs that are categorized as digitalis glycosides, beta-blockers and calcium channel blockers, ace inhibitors and alpha blockers * amiodarone * cimetidine * ciprofloxacin * delavudin * dobutamine * ethanol * fluconazole * fluoxetine * fluvoxamine * haloperidol * imipramine * isoniazid * isoproterenol * luvoxamine * paroxetine * phenytoin * phenobarbital. * propafenone. * quinidine * reserpine * rifampin * ritonavir * rizatriptan. * tenioposide * theophylline * thyroxine * tolbutamide. * warfarin * zileuton * zolmitriptan

Keywords: b adrenergic pathway b blocker
aspirin resistance and percutaneous coronary intervention (pci)

Conditions: Stable Angina

Summary: the objective of this study is to evaluate if aggressive antiplatelet therapy would reduce ischemic events in aspirin (asa) resistant patients after percutaneous coronary intervention (pci).

this is the first us based randomized double blinded prospective study using triple antiplatelet therapy and double dose plavix maintenance dose in aspirin resistant patients undergoing elective pci through femoral access. the primary outcome of this study is an elevation of cardiac enzymes within 24 hours after the pci with a secondary outcome of a composite of major adverse cardiac events of death, mi, stent thrombosis and urgent revascularization and bleeding up to 30 days.

Eligibility criteria:
inclusion criteria: * age older than 18 years * scheduled for elective or ad-hos pci * aspirin use daily for greater or equal to one week * aspirin resistant (aru greater than or equal to 550 on verify now-asa exclusion criteria: * pre-procedural elevation of cardiac biomarkers (ck-mb greater or equal to 10.4ng/dl or tnl greater or equal to 0.4ng/dl * administration of any gp iib/iiia inhibitor, anticoagulation or lytic therapy in the previous 30 days * ongoing bleeding or bleeding diathesis, contraindications for anticoagulation or increased bleeding risk or history of bleeding in the last eight weeks * previous stroke or transient ischemic attack or any intracranial pathology in the last six months, major surgery or trauma within the previous six weeks * platelet count less than hundred thousand per cubic millimeter or hematocrit \<33% or hemoglobin \<11 g per deciliter * subjects who received full dose low molecular weight heparin within six hours prior to randomization * allergy or intolerance to any of the study drugs or the presence of any serious comorbidity with life expectancy of ≤1year * scheduled for saphenous vein graft intervention, chronic total occlusions or with impaired renal function (egfr\<60ml/min) or patients who were taking anticoagulants or antiplatelet agents other than aspirin and clopidogrel or nonsteroidal anti-inflammatory drugs within two weeks before the pci procedure

Keywords: major adverse cardiovascular event mace death mi ck mb greater 3x normal urgent revascularization stent thrombosis bleeding