Kornimate/medical-research-clean huggingface dataset:
coolcap followup study-coordination of participating centers

Conditions: Neonatal Encephalopathy

Summary: this observational study will assess long-term functional outcome of survivors from neonatal encephalopathy who were previously treated with either head cooling or with conventional care in a randomized clinical trial. children's parents will be interviewed by phone by trained staff using the weefim questionnaire to ascertain the childrens' functional performance on a set of skills basic to daily life. this instrument is able to assess a very wide range of abilities, from independently functioning to needing total assistance. the ratings will be used to examine the relationship between the outcome previously measured at 18 months age and functional outcome at school age and to triage the children into those who clearly could not be tested on standardized exams of cognitive functioning, those who potentially could, even if at a low level of cognitive ability, and those who appear to be functioning at an age-appropriate level.

previous studies have demonstrated that hypothermia for hypoxic-ischemic encephalopathy in the neonatal period is generally safe and feasible, and can improve intermediate term survival without handicap. there is, however, no information on whether cooling improves longer term (school-age) outcomes in non-handicapped survivors. the current observational trial is designed to help obtain additional followup information on children who participated in the initial randomized clinical trial of head-cooling for neonatal encephalopathy. a first step is to collect information on the current status (at 7-8 years of age) of participants in the original study using a standardized telephone questionnaire. this will allow the investigators to more appropriately target children for whom further, more detailed, in-person neurodevelopmental testing would be appropriate. given limited resources, identification of children for whom such testing would be helpful and instructive is a necessary goal.

Eligibility criteria:
inclusion criteria: * previous participation in the coolcap study * survivors to 7-8 years of age * parental consent to participation exclusion criteria: * lack of parental consent

Keywords: neonatal encephalopathy therapeutic hypothermia head cooling neonatal asphyxia
zd1839 (iressa™) in combination with docetaxel as first-line treatment in patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a multicentre, randomised (2:1), double blind, non-comparative phase ii trial of zd1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast cancer at a metastatic stage. * uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the response evaluation criteria in solid tumours (recist) criteria * world health organisation (who) performance status (ps) of 0 to 2 * life expectancy of greater than 12 weeks * normal cardiac function (left ventricular ejection fraction \[lvef\] by isotopic examination greater than or equal to 55%) exclusion criteria: * symptomatic lepto-meningeal metastasis * concomitant infectious disease * any unresolved chronic toxicity greater than ctc grade 2 from previous anticancer therapy * incomplete healing from previous oncologic or other surgery * absolute neutrophil count (anc) less than 1.5 x 109/litre (l) or platelets less than 100 x 109/l * serum creatinine greater than 1.5 times the ulrr or clearance \< 60 ml/min * alt or ast greater than 2.5 times the ulrr * alp \> 5 times the ulrr * alp \> 2.5 times the ulrr and alt or ast greater than 1.5 times the ulrr

Keywords: metastatic breast cancer
a high-resolution peripheral quantitative computed tomography study in postmenopausal women previously treated with denosumab

Conditions: Low Bone Mass; Low Bone Mineral Density; Osteoporosis; Postmenopausal Osteoporosis

Summary: to evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by high resolution-peripheral quantitative computed tomography (hr-pqct). participants randomized to either denosumab or placebo in the 20050179 (nct00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. at least 12 months should have elapsed since the patient's 20050179 end of study visit.


Eligibility criteria:
inclusion criteria: * ambulatory, postmenopausal women * randomized to either denosumab or placebo in the 20050179 (nct00293813) study and completed that study (ie, attended an end of study visit) * at least 12 months have elapsed since their end of 20050179 study visit * provide signed informed consent exclusion criteria: * subjects who failed to receive both doses of denosumab (or sq \[subcutaneous\] placebo) during the 20050179 study * subjects who were randomized to the alendronate arm during the 20050179 study * subjects diagnosed with any of the following conditions following completion of the 20050179 study: * hyperthyroidism * hyperparathyroidism * malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma) * any condition that required chronic (greater than three months cumulative and greater than 5 mg/day) glucocorticoid therapy * other diseases which affect bone metabolism * self-reported alcohol or drug abuse within the previous 12 months * any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures * received any investigational product other than denosumab in two years before the screening visit. * received \> 3 months (or equivalent) of osteoporosis treatment since having completed the 20050179 study. * current use of the following osteoporosis agents: bisphosphonates, calcitonin, fluoride, parathyroid hormone analogue, selective estrogen receptor modulators, systemic oral or transdermal estrogen (except vaginal preparations and estrogen creams which are acceptable), strontium or tibolone. * currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trial(s) (other than amgen trial 20080287), or subject is receiving other investigational agent(s).
arthroscopic rotator cuff repair utilizing mechanical bone debridement versus coblation debridement

Conditions: Rotator Cuff Tears

Summary: randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.

prospective, double blind, randomized controlled trial. male and female subjects, over the age of 18 years. full thickness rotator cuff tear, requiring surgical repair. patient undergoes pre- and intra-operative assessment, and once eligibility is confirmed intra-operatively, patient is randomly assigned to receive either a) coblation debridment, or b) mechanical debridement. standard post-operative rehab program for all patients. follow-up occurs at 3, 6, 12, and 24 months post operatively and includes physical exam and patient based outcomes (questionnaires).

Eligibility criteria:
inclusion criteria: 1. the subject has signed the reb approved informed consent form (icf) specific to this study prior to enrollment 2. the subject has a repairable full thickness rotator cuff tear with an estimated full thickness size \<5cm confirmed with diagnostic mri in ap or ml dimension and /or ultrasound 3. the subject is independent, ambulatory, and can comply with all post-operative evaluations and visits 4. the subject has persistent pain and functional disability and has failed conservative treatment (e.g. pt, steroid injection, anti-inflammatory) for \> 3 months 5. the subject is at least eighteen (18) years of age and considered to be skeletally mature exclusion criteria: 1. the subject has undergone previous rotator cuff repair surgery to the affected shoulder 2. the subject has a partial thickness rotator cuff tear 3. the subject requires a concomitant labral repair 4. the subject has an irreparable rotator cuff tear 5. the subject is unable or unwilling to undergo mri scan. 6. the investigator judges the subject unlikely to remain compliant to follow-up. 7. the subject has received an investigational therapy or approved therapy for investigational use within 30 days prior to the surgery 8. the subject is a prisoner, or is known or suspected to be transient 9. the subject's condition represents a worker's compensation case 10. the subject is currently involved in a health-related litigation procedure 11. the subject currently has an acute infection in the area surrounding the surgical site 12. the subject has a major medical illness (life expectancy less than 2 years or unacceptably high operative risk 13. fatty atrophy \>50% (goutallier grade 4-5) intra-operative exclusions: 1. massive or irreparable rotator cuff tear which cannot be mobilized to the midpoint of the footprint of the rotator cuff on the greater tuberosity 2. co-existing labral pathology requiring repair with sutures
parental perception of oral health-related quality of life in sudanese refugee vs. egyptian children

Conditions: Dental Caries; Gingivitis; Oral Health; Refugee Health

Summary: this cross-sectional analytical study aims to assess and compare parental perceptions of oral health-related quality of life (ohrqol) among sudanese refugee children and egyptian children aged 6-12 years living in egypt. the study will include 192 child-parent pairs (96 sudanese refugees and 96 egyptians). data will be collected via a validated arabic questionnaire adapted from the child oral health impact profile (cohip) and clinical oral health examinations using dmft/dmft indices, gingival index, and plaque index. the study seeks to identify disparities in oral health, parental awareness, and access to dental care services, thereby informing future community-based interventions and public health policies targeting vulnerable populations such as refugee children.


Eligibility criteria:
inclusion criteria: children aged 6-12 years either sudanese refugee or egyptian national resident in cairo for at least 1 year informed consent obtained from parent or legal guardian exclusion criteria: systemic health conditions affecting oral health ongoing orthodontic treatment children with special health care needs or developmental disabilities

Keywords: dental caries gingivitis oral health refugee health
study of laser treatment of melasma

Conditions: Refractory Mixed Type Melasma

Summary: the purpose of this study is to evaluate the revlite laser in the treatment of refractory mixed type melasma.


Eligibility criteria:
inclusion criteria: * fitzpatrick skin type iii-vi * mixed (epidermal and dermal) melasma diagnosed by wood's lamp exam * age 18 or older * melasma persisting for greater than 6 months that has failed to respond to conventional treatment with hydroquinone or other topical lightening agents * written and verbal informed consent * willing and able to comply with study instructions and return to the clinic for required visits exclusion criteria: * pregnancy, breastfeeding, taking birth control pills or plans to become pregnant during the study * history of cutaneous photosensitization, porphyria, and hypersensitivity to porphyrins or photodermatosis * any skin pathology or condition that could interfere with the evaluation or requires the use of interfering topical or systemic therapy * uncorrected coagulation defect or is currently using anti-coagulation medication (including but not limited to heavy aspirin therapy) * any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study * currently enrolled in an investigational drug or device trial, or has received an investigational drug or has been treated with an investigational device within 30 days prior to entering this study * inability to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function * unreliability for the study (this includes subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits) * use of photosensitizing drugs within a timeframe where photosensitization from these drugs may still be present * need to be exposed to artificial tanning devices or excessive sunlight during the trial * diabetes type i or ii * sensitivity to hydroquinone or retin-a * evidence of a compromised immune system or hepatitis * use of bleaching creams or retinoids within the last 30 days
target heart rate and aerobic interval training

Conditions: Coronary Artery Disease

Summary: aerobic interval training is shown to be superior in increasing oxygen uptake in both healthy and patients with coronary artery disease (cad), compared to moderate continuous training. however, in cardiac rehabilitation exercise groups, exercise intensity is usually controlled with perceived exertion (borg scale). the investigators will investigate degree of agreement between target heart rate and perceived exertion during interval training in cardiac rehabilitation.


Eligibility criteria:
inclusion criteria: * referred to cardiac rehabilitation * able to perform exercise treadmill test exclusion criteria: * unstable angina * severe arrhythmias * heart failure

Keywords: exercise intensity aerobic interval training cardiac rehabilitation group exercise
acupuncture for chronic lymphedema

Conditions: Breast Cancer With Chronic Lymphedema

Summary: this study is being done because women have arm swelling for more than 6 months despite wrapping and other treatments. this swelling is called lymphedema. it is the back up of lymph system fluid that causes swelling in the arm. the swelling can just happen, but more commonly it is caused when lymph nodes are removed during cancer surgery. it can develop right after breast cancer treatment or weeks, months or even years later. in our preliminary research, the investigators found that more than 1/3 of the 33 patients showed at least a 30% reduction in lymphedema following acupuncture treatment and there were no serious adverse events during the treatment or 6 month followup. this study will include a larger group of patients. patients will be assigned to one of two groups, and results of the groups will be compared to see if acupuncture can reduce lymphedema and whether the effect lasts after acupuncture treatment is completed.


Eligibility criteria:
inclusion criteria: * women age 18 or older * lymphedema in an arm as a result of surgery, chemotherapy, and/or radiation therapy for breast cancer per breast surgeon or medical oncologist * patients must have received a clinical diagnosis of lymphedema for at least 6 months and no more than 5 years. this timeframe allows ample time for any surgically related non lymphedema swelling to subside by 6 months post-surgery, while a cap of 5 years will capture the broadest range of cases, and has been used as a timeframe in several studies including our pilot study. * the affected arm must be \>2cm larger than the unaffected arm. differences of 2 cm or more between the affected and unaffected arm are considered by experts to be clinically significant. each affected arm will be measured in two areas: upper arm and forearm. the larger of the two measures-upper arm or forearm- will be used for analysis. * classified as international society of lymphology (isl) stage ii or higher as determined by an mskcc certified lymphedema therapist (clt). exclusion criteria: * bilateral lymphedema * previous acupuncture treatment for lymphedema * concurrent diuretic use * history of primary (congenital) lymphedema * pregnant or planning to become pregnant during the course of the study * has an implanted electronically charged medical device

Keywords: acupuncture
a clinical trial to evaluate the long-term safety and tolerability of sep-363856 in patients with schizophrenia in japan

Conditions: Schizophrenia

Summary: a clinical study to investigate the long-term safety and torelability of sep-363856 in clinically stable adult patients with schizophrenia in japan.

a phase 3, 52-week, open-label study to evaluate the long-term safety and tolerability of sep-363856 in patients with schizophrenia in japan. participants will take flexible dose of sep-363856 (50 mg/day and 75 mg/day) every night at bedtime for 52 weeks in an open-label manner.

Eligibility criteria:
inclusion criteria: 1. must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities. 2. male or female between 18 to 65 years of age (inclusive) at the time of consent. 3. must meet dsm 5 criteria for schizophrenia as established by clinical interview at screening 4. must have a panss total score \>=60 at screening and baseline. 5. must have a cgi-s score \>=3 at screening and baseline 6. judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the investigator for at least 8 weeks prior to baseline and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to screening 7. in the opinion of the investigator, subjects must be generally healthy based on screening medical history, physical examination, vital signs, ecg, and clinical laboratory values (hematology, chemistry, and urinalysis). exclusion criteria: 1. have a dsm-5 diagnosis or presence of symptoms consistent with a dsm-5 diagnosis other than schizophrenia. exclusionary disorders include but are not limited to alcohol use disorder or substance (other than nicotine or caffeine) use disorder within past 12 months or for a total of \>= 10 years during the subject's lifetime, major depressive disorder, bipolar i or ii disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment 2. at significant risk of harming self, others, or objects based on investigator's judgment. 3. have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the investigator, would limit the subject's ability to complete and/or participate in the study. 4. female subjects who are pregnant or lactating. 5. have any clinically significant abnormal laboratory value(s) at screening (hematology, chemistry, and urinalysis) as determined by the investigator.
baduanjin exercise for patients with chronic heart failure on phase ii cardiac rehabilitation

Conditions: Rehabilitation With CHF; NYHA Class I or II

Summary: chronic heart failure (chf) is the end stage of various kinds of cardiovascular diseases with high mortality. after a long period of medical treatment or surgical treatment, patients suffered great pain physically and mentally. how to improve the quality of life and prognosis in patients with chf, which is a hot topic in the field of cardiac rehabilitation now. baduanjin, as one of the traditional chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for chf patients. to investigate the efficacy and safety of baduanjin exercise for patients with coronary heart disease complicated with chronic heart failure (chf). a randomized, controlled and prospective clinical trial was designed.


Eligibility criteria:
inclusion criteria: * aged from 40 to 75 years; * diagnosed with chronic heart failure caused by coronary heart disease; * nyha class i or ii; * patients with an ejection fraction (lvef) more than 40%; * participants in accordance with the guidelines define as stage ii cardiac rehabilitation; * participants signed the informed consent freely and voluntarily. exclusion criteria: * the condition was serious or movement restrained by other diseases; * in the acute stage of chronic heart failure; * participants with poorly control of blood pressure (sbp≥180mmhg or dbp≥100mmhg); * resting heart rate is beating over 120 beats a minute, or merged with malignant arrhythmia; * participants who have contraindications to cardiopulmonary test or exercise training; * patients who have other serious acute， chronic organic disease or mental disorders; * participants practiced in any kinds of traditional chinese medicine exercises in last three months.

Keywords: baduanjin; chf; 6mwt; cpet
image-enhanced endoscopy (iee) for diagnosis of non-erosive reflux disease

Conditions: GERD

Summary: when treating persistent heartburn from gastroesophageal reflux disease (gerd) that does not respond to conventional treatment (a class of medications called proton pump inhibitors), it is important to be able to distinguish between erosive gerd and non-erosive gerd (called nerd). currently the best method the investigators have to make this distinction is esophageal 24-hour ph and impedance testing. the test involves inserting a catheter into the esophagus through the nose and having the catheter maintained in this position for 24 hours this test is invasive, can be uncomfortable, and it is expensive and time consuming. the investigators are hoping that image enhanced technology will identify characteristics that are found more commonly in patients with non-erosive gerd compared to controls and therefore provide evidence that may allow us to replace ph and impedance testing with the image enhanced endoscopy as the best way to diagnose nerd. participants will be either patients undergoing an upper endoscopy as part of their standard clinical evaluation for heartburn that does not respond to ppis or patients undergoing standard clinical evaluation endoscopy for other reasons.

evaluation of the utility of image-enhanced endoscopy (iee) in the diagnosis of non-erosive reflux disease (nerd), defined as heartburn documented to be associated with reflux on impedance-ph testing in the absence of erosions on standard white-light endoscopy (wle) during initial endoscopy. the investigators will examine the following characteristics for iee sensitivity, specificity, positive predictive values, and negative predictive value: squamo-columnar junction (scj) vascularity, micro-erosions, scj pit pattern, and combinations of these characteristics. the investigators will also look at abnormal morphology of intra-papillary capillary loops (ipcls) using the newer generation narrow band light (nbi-190 endoscopes and assess the identification of their presence using i-scan. additionally, the investigators will examine real-time diagnostic yield of reflux diseases by iee (in vivo diagnosis of reflux disease) and analyze obtained images and results to calculate inter-observer agreement. iee utilized will be commonly available i-scan (pentax) and narrow band imaging (olympus). consecutive patients who meet eligibility criteria and are scheduled for upper endoscopy at locations specified in this record will be invited to participate.

Eligibility criteria:
inclusion criteria: * patients scheduled for an upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices without heartburn or other gerd symptoms and patients scheduled for upper endoscopy for heartburn not resolving with ppis exclusion criteria: * patients who have evidence of erosive esophagitis under white-light endoscopy * patients with barrett's esophagus or esophageal malignancy on prior or current endoscopy * patients unable or unwilling to sign informed consent

Keywords: heartburn gerd nerd non-erosive reflux disease