Kornimate/medical-research-clean huggingface dataset:
study to evaluate the effects of the cooling bolero in women with menopause symptoms

Conditions: Menopause Symptoms

Summary: the cooling bolero is a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbed heat. the vest is manufactured by nanohealth. it intended to provide moderate cooling (\~15c/59f) through indirect contact with the skin. the material in the device is safe, non-toxic, and eco-friendly. recent anecdotal studies of women with common peri-menopausal and menopausal symptoms (hot flashes, night sweats, flushing/sweating of face and neck, and intermittent sleep disturbances) have shown a reduction in both the frequency and intensity of those symptoms after using the cooling bolero. specific (moderate) temperature cooling of the neck and upper torso appears to target and mitigate these common menopausal symptoms. this pilot study attempts to collect additional data on the effects of the cooling bolero.

participants who have consented for this study will first be asked to complete a baseline assessment of their menopausal symptoms, including documentation of their baseline weight. if the assessment indicates that the participant has at least 'moderate' menopausal symptoms, then she will then enter the run-in period. during the two-week run-in period, participants will use a symptom diary for to document the frequency and severity of their menopausal symptoms. at the start of week 3, participants will return their completed run-in period symptom diary and receive their cooling bolero with instructions on how to use the product during the treatment period. during the treatment period, participants should use the cooling bolero at least two times per day (morning and evening) for one hour. as feasible, the participant should start to wear the product 30 minutes prior to meal time for these two applications. the participant may also wear the product at additional times, as desired. all applications of the cooling bolero during the four-week treatment period are to be documented in the product/symptom diary. during the treatment period, the participant will also continue to document the frequency and severity of their menopausal symptoms in the product/symptom diary. at the end of week 6, the participant will stop using the cooling bolero. she will be asked to complete a product assessment and have her weight documented. participants will be contacted at week 10 to ask about the status of menopausal symptoms after four weeks of not using the cooling bolero

Eligibility criteria:
inclusion criteria: * female who is at least 18 years old * self-reports having at least two (2) daily hot flashes associated with menopause exclusion criteria: * taking hormonal therapy (currently or within the last 3 months). * has another existing medical condition that would prevent study compliance.
impact of early mobilization on sah patients physiological parameters

Conditions: Subarachnoid Hemorrhage

Summary: the aim of the study is to evaluate the physiological response to out-of-bed mobilization in patients admitted to the intensive care unit for subarachnoid hemorrhage. more specifically, the aim is to measure the impact on cerebral perfusion, lung aeration, cardiovascular and respiratory parameters.

in patients with subarachnoid hemorrhage, the mobilization strategy has been little studied. several studies have already evaluated the consequences of mobilization in bed. because of the deleterious consequences of prolonged bed rest, and in line with recommendations, practices have evolved towards early out-of-bed mobilization, which has shown benefits. however, the physiological consequences of out-of-bed mobilization have not yet been assessed. the aim of this study is to measure the impact of early out-of-bed mobilization of patients admitted for sah on neuro-cardio-pulmonary physiological parameters.

Eligibility criteria:
inclusion criteria: age ≥ 18 years * aneurysmal sah * severity score world federation neurological surgeons i to iv * secured aneurysm * eligible for their first early mobilization exclusion criteria: * sedated patient * disturbed alertness, coma * unsecured aneurysm * patients under legal protection (guardianship, curatorship, safeguard of justice)

Keywords: early mobilization brain perfusion transcranial doppler near-infrared spectroscopy lung ultrasound
bronchoscopic emphysema treatment in the netherlands

Conditions: COPD

Summary: rationale: new bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the netherlands. it is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies. overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. this is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.

rationale: new bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the netherlands. it is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies. overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. this is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations. study design: this study is a nationwide, multicenter, observational post-marketing study with long-term follow up (5 years). study population: the study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves. main study parameters/endpoints: the main study parameter is the assessment of target lung volume reduction (tlvr) and correct placement of the valves at ct-scan at 30 days post treatment. this is the most accurate and directly treatment related endpoint which will also be used for quality control.

Eligibility criteria:
inclusion criteria: * patient is scheduled for a bronchoscopic lung volume treatment using one-way valves. exclusion criteria: * there are no exclusion criteria for this study.

Keywords: bronchoscopy emphysema
a study to assess efficacy and safety of pertuzumab given in combination with trastuzumab and vinorelbine in participants with metastatic or locally advanced human epidermal growth factor receptor (her) 2-positive breast cancer

Conditions: Breast Cancer

Summary: this two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (herceptin) and vinorelbine in first line participants with metastatic or locally advanced her2-positive breast cancer. participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (iv) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection * her2-positive as assessed by local laboratory on primary or metastatic tumor * at least one measurable lesion and/or non-measurable disease evaluable according to recist v1.1 criteria * eastern cooperative oncology group (ecog) performance status 0 or 1 * left ventricular ejection fraction (lvef) of at least 55% * life expectancy of at least 12 weeks exclusion criteria: * previous systemic non-hormonal anti-cancer therapy in the metastatic or locally advanced breast cancer setting * previous approved or investigative anti-her2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months * history of persistent grade 2 or higher (national cancer institute common terminology criteria \[nci-ctc\], version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy * radiographic evidence of central nervous system metastases that are not well controlled with local therapy (irradiation or surgery) * current peripheral neuropathy of nci-ctc, version 4.0 grade 3 or greater * history of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage 1 uterine cancer, or cancers with a similar curative outcome as those mentioned above * serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the participants at high risk for treatment-related complications * inadequate hematologic, liver, or renal function * uncontrolled hypertension or clinically significant cardiovascular disease * hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) infection * current chronic daily treatment with corticosteroids (\>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids
acetaminophen and post circumcision pain control

Conditions: Pain; Circumcision

Summary: infants do not routinely receive acetaminophen for pain control after circumcision. this study will determine if acetaminophen is effective at controlling infant pain after circumcision using nerve block and oral dextrose. infants will undergo the routine circumcision procedure, and half will be randomly selected to receive half acetaminophen immediately at the end of the procedure. afterwards, infant's vitals signs (heart rate, respiratory rate, oxygen saturation), the neonatal infant pain scale (nips), and salivary cortisol levels will be checked in regular intervals up to 4 hours. the nips is a validated pain scoring system based on the appearance of the infant. a reduction in nips for those infants who receive acetaminophen versus nothing will be the primary outcome to determine if the study is significant.

male circumcision is a common surgical procedure performed in the newborn period. the american academy of pediatrics task force on circumcision recently published an update on circumcision policy stating the benefits of male circumcision outweigh the risks. given this update, the investigators anticipate a percentage of families who were previously undecided about circumcision will choose to have their newborn circumcised. a common concern for both parents and physicians is effective pain control. for intra-operative pain control, dorsal penile nerve block (dpnb) has been found to be the most effective when compared to emla (lidocaine-prilocaine) or placebo. acetaminophen is a relatively safe, easy to administer analgesic. prior studies have suggested that acetaminophen could be helpful in postoperative comfort. however, studies examining the effectiveness of acetaminophen for postoperative pain control in infants who received dpnb are lacking. in addition, prior studies have been incomplete in the assessment of neonatal pain.

Eligibility criteria:
inclusion criteria: healthy newborns between 36-42 weeks gestational age admitted to the well baby nursery who's parents are requesting circumcision. eligibility includes 1. apgar score at 5 minutes \>7 2. birthweight greater than 2.4 kg 3. age of at least 10 hours 4. at least one void. exclusion criteria: 1. newborns of substance abusing mothers. 2. newborns with any contraindications to routine circumcision, anatomical or hematologic.

Keywords: infant pain acetaminophen circumcision
study of omega-3 fatty acids regarding ergogenic, anti-inflammatory and obesity inhibitory effects in 8 year old children

Conditions: Lifestyle-related Condition; Overweight and Obesity; Essential Fatty Acid Deficiency

Summary: this study hypothesizes that supplementation of omega-3 fatty acids (om3) can increase physical activity, inhibit rapid gain in body weight and bmi in both sedentary and normally active 8 year old children. the purpose is secondarily to explore patterns of associations between om3 supplementation, baseline and follow-up levels in all studied parameters. the study also aims to study if basal levels of om3 are correlated with physical activity and to study if there is an association between basal levels of om3 and the effect of om3 supplementation on physical activity. to study if there is an effect of om3 supplementation on triglyceride and ldl cholesterol levels and to study if there are more pronounced effects on children with higher levels. to study if om3 supplementation, compared with placebo reduce weight increase among children at risk to become overweight. to study if there is an association between effects of om3 on physical activity, weight and risk markers in blood. to study if there are any gender differences.


Eligibility criteria:
inclusion criteria: * children in second grade of swedish primary school willing to participate

Keywords: omega-3 physical activity children obesity sedentary accelerometry bmi fatty acids inflammatory markers intervention randomized double blind
predictors of scar dehiscence in patients with previous caesarean section

Conditions: Cesarean Section; Dehiscence

Summary: in recent decades, the percentage of cesarean section deliveries has dramatically increased in most countries. concomitantly, the rates of vaginal birth after cesarean have decreased steadily. the pregnant women with previous cesarean section face a difficult choice for their next delivery between a trial of labor after cesarean or repeat caesarean section delivery. the performance of multiple cesarean section exposes women to greater risks of complications; furthermore, the risk of complications increases with each subsequent cesarean section. in fact, women with previous cesarean section are more likely to experience short and long-term maternal complications in future pregnancies, or a trial of labor after cesarean, with the risk of \[uterine dehiscence, uterine rupture, genitourinary tract damage, hemorrhage and hysterectomy, abnormal placentation (placenta previa and placenta accreta) and difficulties during surgery


Eligibility criteria:
inclusion criteria: 1. pregnant full-term 37-42 weeks. 2. previous one caesarean section exclusion criteria: 1. absolute indication of cesarean section in previous and in current pregnancy 2. pregnant women with hemoglobin \<9 3. pregnant women with bleeding tendency 4. pregnant women with collagen disease 5. pregnant women with pre-eclampsia and eclampsia 6. pregnant women with gestational diabetes 7. multiple pregnancy
a study looking into the effect of nnc 55-0414 in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. a seven day dose escalation study in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * diet treatment only for at least two weeks * body mass index (bmi) between 22-34 kg/m2 inclusive * hba1c between 6.5-12.0% inclusive * fasting blood glucose (fbg) between 7.0-18.0 mmol/l inclusive * patients should be negative (lesser than 70 ku/l) for antibodies against glutamic acid decarboxylase (gad) exclusion criteria: * pharmacological treatment with medication or pancreatitis that the investigator expected to interfere with blood glucose levels * history of cancer or any clinically significant cardiovascular respiratory, hepatic, haematological, gastrointestinal, dermatological, venereal, neurological or psychiatric disorder as judged by the investigator * impaired renal function, serum creatinine greater than 150µmol/l * patients, who were known to have serum hepatitis or who were carriers of the hepatitis b surface antigen (hbsag) or hepatitis c antibodies, or had a positive result to the test for hiv 1/2 antibodies * patients, who had received an investigational drug in the four months new chemical entity or licensed product preceding the start of dosing * patients, who had donated plasma or blood in the past month, or in excess of 500 ml in the past 12 weeks * patients who had a significant history of alcoholism or drug/chemical abuse
safety and performance of the neuroform atlas™ stent system

Conditions: Intracranial Aneurysm

Summary: the objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in france.

this proposed atlas fr study will be a retrospective review conducted to expand our knowledge of the clinical outcomes in subjects treated in france between 01 february 2017 and 01 march 2018. this will provide a comprehensive data set that is specifically representative of the atlas stent use in france.

Eligibility criteria:
inclusion criteria: * patient who had undergone a stent assisted intracranial aneurysm coiling with neuroform atlas for the treatment of intracranial aneurysm(s) between 1st feb 2017 and 1st march 2 018. * patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data
bone augmentation techniques in extraction sockets

Conditions: Tooth Loss

Summary: the study will compare the density and strength of regenerated bone in extraction sockets after being grafted with two different materials: bone allograft and bone allograft with amnion. the investigators hypothesize that sockets grafted with the amnion graft will exhibit enhanced healing patterns and will accelerate the formation of regenerated bone in the grafted areas.

the amniotic allograft is a cryopreserved allograft tissue matrix derived from human placental tissues recovered from live healthy donors. amniotic tissue is an abundant source of collagen which provides an extracellular matrix to act as a natural scaffold for cellular attachment in the body; collagen provides a structural tissue matrix that facilitates cellular migration and proliferation in-vivo. the product is developed using proprietory techniques by biodlogics, llc. the amniotic allograft growth factors are thought to enhance formation of a supportive scaffold for regeneration, to facilitate interactions between cell types, and to influence anti-inflammatory, anti-microbial and immuno-privilege activities. atraumatic extractions and socket grafts will be performed. dental implants will be inserted into the grafted areas 8 weeks post-graft. the implants will be restored and followed for 24 months post-insertion.

Eligibility criteria:
inclusion criteria: 1. be a registered university of alabama at birmingham (uab) dental school patient 2. existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction 3. healthy enough to undergo the proposed therapy 4. demonstrated willingness to comply with study directions and time-line 5. able to consent for themselves 6. able to read and understand the informed consent form - exclusion criteria: 1. pregnant or lactating at the time of enrollment 2. previous malignant neoplasm 3. known hypersensitivity to bone grafting materials 4. know hypersensitivity to titanium 5. any medical of medication that in the opinion of the investigators may adversely affect bone healing 6. any indication of an inability to make autonomous decisions -

Keywords: allograft amnion allograft
effect of laser acupuncture alone or combined with pranayama exercise on inflammation in allergic rhinitis

Conditions: Allergic Rhinitis

Summary: allergic rhinitis (ar) represents one of the most common global health problems with seriously increasing incidence over the last decades.the goal of the treatment of rhinitis is to prevent or reduce the symptoms through reduction of the inflammation of affected tissues. acupuncture and pranayama yoga exercises had reported a significant improvement in daily symptoms and an increase of symptom-free days in many studies enrolling patients.

sixty egyptian children with allergic rhinitis, after randomization, will be divided to 2 groups; the first 30-children group will receive 2-session per-week laser stimulation for 6 weeks to some selected acupoints and daily pranyama exercises (nearly every session will be one hour, for six weeks), the second group will receive 2-session per-week laser stimulation for six weeks to some bilateral selected acupoints. the stimulated points will be (li 19, li 20, st2, and st4. st6, st7, st17, st36, si18, bl2, gb14, gv24 and exhn5). every acupoint will be stimulated with laser power of 100 mw that will be used on a spot area of 1 cm2 for 1 minute.

Eligibility criteria:
inclusion criteria: * allergic rhinitis children * physician-based diagnosis of allergic rhinitis exclusion criteria: * children with intellectual disabilities * chest disease or heart disease or local congenital nose deformities * participants received within-previous-six-months self-prescribed or by-therapist prescribed complementary therapies
outcome after coronary artery bypass grafting

Conditions: Coronary Artery Disease; Myocardial Infarction; Angina Pectoris

Summary: the e-cabg registry is a multicenter, european registry collecting data on the preoperative characteristics, treatment strategies and outcome of patients undergoing isolated coronary artery bypass grafting (cabg).

improvements in the surgical treatment of coronary artery disease are possible only when implementation of current methods and development of new methods are based on the solid ground of large and reliable clinical data. furthermore, clinical findings assume even more significance when detected in study populations from different institutions with heterogeneous referral pathways, baseline clinical characteristics and perioperative treatment strategies. the rationale of this european multicenter study is therefore to prospectively collect data on baseline characteristics, operative and anesthesiological methods and postoperative outcome of patients undergoing cabg in eleven cardiac surgery centers from five european countries. this multicenter prospective registrywill provide data to evaluate the prognostic impact of a number of patients' risk factors as well as the efficacy and safety of operative methods and drugs used during the pre-, peri- and postoperative period.

Eligibility criteria:
inclusion criteria: * patients of aged \> 18 years undergoing isolated cabg for stable coronary artery disease or acute coronary syndrome. patients undergoing maze procedure will be included in this registry. exclusion criteria: * patients undergoing any other major cardiac surgery procedure will be excluded from this registry.

Keywords: cabg coronary artery bypass surgery coronary artery bypass grafting coronary surgery myocardial infarction coronary artery disease off-pump euroscore