Kornimate/medical-research-clean huggingface dataset:
a multi-center, open label, extension study assessing the efficacy and safety of additional intravitreal injections of rbm-007 in subjects with wet age-related macular degeneration

Conditions: Exudative Age-related Macular Degeneration

Summary: this is a multi-center, open label, extension study of nct04200248 assessing the efficacy and safety of additional intravitreal injections of rbm-007 in subjects with wet age-related macular degeneration.


Eligibility criteria:
inclusion criteria: 1. provide signed written informed consent on the institutional review board (irb)/ethics committee (ec) approved informed consent form (icf) and provide authorization as appropriate for local privacy regulations. 2. male or female 55 years of age or older on the date of signing the icf and able and willing to comply with all treatment and study procedures. 3. subjects must have completed all scheduled visits of previous study. subjects can only enter this study after exiting previous study 4. subjects for which previous previous masked treatment arms with intravitreal anti-vascular endothelial growth factor (anti-vegf) agents eylea® and/or rbm-007 has not demonstrated improvement in vision; subjects with less than 15 letter best corrected visual acuity (bcva) improvement in tofu study at exit visit over its baseline. 5. diagnosis of exudative age-related macular degeneration (amd) in the study eye, as assessed by spectral domain optical coherence tomography (sd-oct). 6. absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing va improvement in the study eye. 7. bcva of 24 etdrs letters (20/320) or better in the fellow eye. 8. reasonably clear media and some fixation in the study eye to allow for good quality sd-oct and fundus photography. exclusion criteria: * 1. subjects whose vision have improved \>15 bcva letters at exit visit of previous study over its baseline 2. subjects who experienced any drug related serious adverse event during previous study
improving osteoporosis care in a home health setting

Conditions: Osteoporosis

Summary: study aims to improve osteoporosis care through patient tailored education materials in a group-randomized trial of patients referred to home health care with a history of fracture and/or an osteoporosis diagnosis. project investigators will conduct telephone surveys and examine electronic medical record data to assess fracture related morbidity and mortality, osteoporosis treatment and adherence, and use of calcium and vitamin d supplements. we hypothesize that patients that receive the intervention materials will be more likely to initiate or maintain osteoporosis treatment.


Eligibility criteria:
inclusion criteria: * prior fracture * osteoporosis diagnosis * received home health care exclusion criteria: * hospice * active cancer treatment
the effect of prefrontal cortex stimulation on antisocial and aggressive behavior

Conditions: Antisocial Behavior; Aggression

Summary: this study investigates the effect of upregulating prefrontal cortex activity on antisocial and aggressive behavior and risk factors for such behavior. in the double-blind, randomized controlled trial, participants will undergo anodal transcranial direct current stimulation bilaterally to the dorsolateral prefrontal cortex or a sham stimulation. during and after stimulation, they will complete survey and laboratory measures assessing antisocial and aggressive behavior and risk factors for antisocial and aggressive behavior. heart rate and skin conductance will also be measured.


Eligibility criteria:
inclusion criteria: * above 18 years of age * able to understand the nature of the study and give informed consent exclusion criteria: * history of or active neurologic, cardiovascular, or psychiatric disease * currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications * currently consuming anti-depressants * history of seizures * metallic implants on the scalp * participation in other transcranial magnetic stimulation (tms) or tdcs experiments on the same day * history of adverse reactions to tdcs

Keywords: antisocial behavior aggression transcranial direct current stimulation dorsolateral prefrontal cortex associated risk factors
feasibility study of the xoft® axxent® electronic brachytherapy system for the treatment of cervical cancer

Conditions: Cervical Cancer

Summary: the purpose of this study is to evaluate the safety, performance and usability of the xoft axxent electronic brachytherapy system and cervical applicator as incorporated into the physician's current standard treatment practice and in replacement of high-dose-rate after-loaders using iridium-192 or low-dose-rate cesium treatments. data will be collected on treatment delivery, safety, and acute toxicity. our hypothesis is that the treatment is safe as incorporated into the physician's current standard of practice.


Eligibility criteria:
inclusion criteria: * brachytherapy is indicated after ebrt for all cases of locally advanced disease (stages ib2 - iva) * inoperable stage ia1 and stage ia2 may be treated with tandem-based brachytherapy alone * inoperable stage ib1 should be treated radically with brachytherapy in conjunction with ebrt. concurrent chemotherapy may be considered at the physician's discretion and based on the presence of high risk features. * subjects can be treated with brachytherapy regardless of lymph node status, grade, and presence of lymphovascular invasion, tumor size, age, or histology. * medically fit for general or spinal anesthesia, or conscious sedation, for the insertion process * subjects of childbearing potential must have a negative serum pregnancy test at screening inclusion criteria: exclusion criteria: * medical contraindications to brachytherapy (scleroderma, collagen vascular disease, active lupus ) * prior pelvic radiotherapy with brachytherapy * hemoglobin level at screening \< 8 * life expectancy \< 6 months

Keywords: cervical cancer brachytherapy electronic device applicator toxicity gynecologic high-dose-rate (hdr) x-ray safety external beam radiation therapy (ebrt)
study to investigate comparative efficacy, safety and immunogenicity between avt16 and entyvio

Conditions: Ulcerative Colitis

Summary: the study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of avt16 and entyvio in male and female subjects with moderate to severe active ulcerative colitis.

the study will consist of a screening period, a treatment and assessment period and an end of study visit. eligibility for the study will be determined during a screening period. subjects who meet the eligibility criteria will be randomised to either avt16 or entyvio.

Eligibility criteria:
inclusion criteria: * capable of giving signed informed consent * male and female subjects from 18 to 80 years of age * diagnosis of ulcerative colitis exclusion criteria: * diagnosis of crohn's colitis * extensive colonic resection * active or latent tuberculosis
preoperative localisation of the sentinel lymph node in breast cancer

Conditions: Breast Cancer

Summary: when a person has breast cancer it is necessary to find out whether the cancer has spread to the lymph nodes in the armpit because if it has, further treatment is likely to be needed. there are many of these nodes but when the breast cancer spreads, it does so in a step-by-step fashion, starting with the so-called sentinel lymph node (sln). at present, the only way to be sure whether there is cancer in the lymph nodes or not is to perform an operation to remove at least the sln. if the pathologist finds cancer in the sln, a second operation is usually required to remove further nodes in case they contain cancer too. surgical removal of the lymph nodes in the armpit can cause difficulties for the patient afterwards, such as pain and swelling in the arm. if there is no cancer in the sln, no further operations on the armpit are needed. the investigators wish to find out whether in some patients, operations on the armpit can be avoided completely. the first step in doing this is to test whether the investigators can find out which is the sln before the operation, using a combination of an injection and ultrasound scanning. the injection - into the skin of the breast - would be a radioactive substance, which is the usual way the surgeon finds the sln. the radioactive substance collects in the sln and the investigators would use a "gamma probe" over the surface of the armpit to detect the radiation. in this initial study, the investigators would aim to find the sln before the operation and place a marker wire in it so that the surgeon could check whether the investigators had found the correct node.


Eligibility criteria:
inclusion criteria: * diagnosed with invasive breast cancer suitable for primary surgical treatment * booked for surgical sentinel lymph node biopsy exclusion criteria: * unable to give informed consent * known bleeding disorder * previous axillary surgery * previously treated for the current tumour with chemotherapy or hormone therapy

Keywords: breast cancer sentinel lymph node
teenage functional hallux limitus and ankle dorsiflexion study

Conditions: Hallux Limitus; Ankle Joint

Summary: this study aims to identify a possible correlation between reduced mobility of the first toe under load and reduced mobility of the ankle rom in healthy adolescent basketball players. to reach this goal, two non-invasive tests will be performed to measure the amount of movement of the ankle joint and the first toe.

functional hallux limitus (fhl) is a common condition of the first metatarsophalangeal joint (mtf) characterized by reduced dorsiflexion (df) under load and has a negative effect on load transfer during toe off. this condition is especially common among athletes, even at a youth age, due to repeated loads that can lead to tissue and/or joint damage. the compensations that occur in athletes with an fhl can negatively affect sports performance and start injuries. limited ankle dorsiflexion under load is another element that can affect sports performance as well as predisposing to injury. several studies have investigated its regional interdependence but only a few have hypothesized a correlation between this limitation and fhl. the aim of this study is to understand a possible correlation between reduced ankle df and reduced mtf dorsiflexion during loading, so that preventive action can be taken to reduce the risk of injury. participants will fill in a cross-check survey to establish if there are any predisposing factors for fhl or ankle df reduction. the dorsiflexion lunge test (dlt) will be used to measure ankle dorsiflexion. the jack test will be used to measure first toe dorsiflexion under load and the dorsiflexion lunge test will be used to measure ankle df.

Eligibility criteria:
inclusion criteria: * male teenages basketball players enrolled in a competitive sports club * teenagers whose parents have signed the privacy and consent forms exclusion criteria: * athletes who have suffered in the last 3 months of lower limb musculoskeletal disorders such as pain for more than 7 days (ankle distortion outcomes, leg/foot fractures, plantar fasciopathy, metatarsalgias, etc); * athletes who have undergone surgery on their lower limb.

Keywords: functional hallux limitus ankle dorsiflexion
combination of standard lucentis therapy with micropulse diode laser for the treatment of diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: the primary objective of this study is to evaluate if a combination therapy with micropulse diode laser treatment shows non inferiority on visual acuity within 12 months in comparison to standard therapy (intravitreal injection of ranibizumab only).


Eligibility criteria:
inclusion criteria: * diagnosis of non-ischemic diabetic macular edema with resulting reduction in visual functionality by determination of best corrected visual acuity (bcva), ophthalmologic investigation, sd-oct, fag and anamnesis * bcva between 0.05 and 0.6 or retinal thickness \> 300 µm determined by sd-oct * the informed consent form must be signed before any study specific tests or procedures are done * confirmation of the subject's health insurance coverage prior to the first screening visit * age at least 18 years (inclusive) at the first screening visit * ability to understand and follow study-related instructions exclusion criteria: * severe ischemic maculopathy of the study eye * active neovascularization of iris or retina in the study eye * history of intravitreal injection of vegf-inhibitor or steroids in study eye within the last 3 month * pathologies of the anterior segment of the study eye with reduced visual acuity (e.g. corneal opacification, advanced cataract) * advanced glaucoma with central defects of the visual field in study eye * retinal pathologies with reduced visus (e.g. central scars, age related macular degeneration) in study eye * retinal vascular occlusion in medical history of study eye * active or suspected ocular or periocular infections * active intraocular inflammation in study eye * intraocular surgery of study eye within the last 6 months * laser therapy of study eye within the last 6 months * systemic steroid therapy within the last 3 month * hba1c \>10% * systolic blood pressure above 170 mmhg and diastolic blood pressure above 110 mmhg (after at least 3 min in supine position) * pregnant or breast-feeding woman and woman without adequate method of contraception. * known hypersensitivity to the active substance or to any of the excipients
weight loss on the web: a pilot study comparing a commercial website to a structured behavioral intervention

Conditions: Obesity; Diet Therapy; Weight Loss

Summary: the primary purpose of this study was to compare weight loss achieved through a behavioral online intervention vs. a commercial self-help website. the investigators hypothesized that there would be no difference in weight loss between groups.

obesity has reached epidemic proportions in the united states. novel approaches are needed to address this issue on a broad scale. the internet holds promise as a way to disseminate effective weight loss strategies. the primary purpose of this study was to compare weight loss achieved through a behavioral online intervention vs. a commercial self-help website. a second aim was to evaluate the utilization of web components and their relationship to weight loss between groups and within groups in order to determine what aspects of web usage correlate to weight loss.

Eligibility criteria:
inclusion criteria: * bmi between 25 and 39.9 kg/m2 * 18 or older exclusion criteria: * planned to move within 1 year * planned a pregnancy within 1 year * take medications with weight implications * unable to exercise moderately * participating in another weight loss program * lacked minimum computer requirements

Keywords: internet weight management behavior therapy self-help commercial program obesity
nipe as an indicator of pain in sedated/ventilated patient under 3 years-old hospitalized in intensive care unit

Conditions: Ventilator Lung; Newborn

Summary: the main objective is to assess correlation between newborn infant parasympathetic index values and external evaluation by comfort behaviour scale during painful medical cares in sedated intubated children admitted in pediatric intensive care unit.

the assessment of pain in patient hospitalized in intensive care remains a challenge, especially for patients which are unable to communicate their pain intensity. self-reported scales are widely used for children's pain assessment but cannot be used in sedated or non-communicable patients. the gold standard for pain evaluation in sedated-ventilated patient in pediatric intensive care unit is the comfort behaviour scale (cbs). however, this method remains subjective, depending on training and ability to use this clinical tool by the examiner. the newborn infant parasympathetic evaluation (nipe) is a non-invasive system based on the analysis variability in high frequency (\> 0.15 hz) which reflects the parasympathetic activity related to respiratory fluctuations of heart rate. with a numerical index ranging from 0 to 100, nipe values, measured continuously, has been developed to evaluate the degree of pain intensity. in this study, the hypothese is the nipe could be used as an indicator of pain in sedated/intubated children under 3 years-old hospitalized in pediatric intensive care unit. this study did not change the procedure of care before or after and had no impact on care.

Eligibility criteria:
inclusion criteria: * all consecutive patient ≤ 3 year-old, mechanically ventilated exclusion criteria: * withdraw life-support, * unstable condition preventing planned routine procedures of care, * conditions precluding the use of nipe (cardiac transplant, absence of sinus cardiac rhythm, apnea or respiratory rate ≤ 25 /min, pacemaker and use of atropine and/or isoprenaline and conditions of days of availability for nipe)

Keywords: pediatric pain heart rate variability intensive care unit analgesia
etco2 for monitoring and predicting severity of dka in pediatric emergency, doha, qatar.

Conditions: Diabetes Mellitus

Summary: metabolic acidosis is one of the important and life-threatening pathophysiological changes in dka and its monitoring is essential. it is known that the level of carbon dioxide (co2) in the blood is correlating with the degree of metabolic acidosis. the co2 level can be measured via the exhaled air by nasal cannula capnography (etco2) which is currently utilized to monitor the patient ventilation in many situations. our primary objective is to study the degree of correlation between continuous etco2 monitoring and the severity of metabolic acidosis in blood gas measurement in patients with diabetic keto-acidosis (dka). secondary objectives are: ability of etco2 in ruling in or out dka; discriminating the different severity grades of dka. it is a cross-sectional, observational, prospective cohort study in convenience sample of children presenting with clinical manifestations consistent with dka. will be conducted in pediatric emergency center, hamad general hospital. will include all dka patients and excluding any condition or medication that affect the acid-base status.

the study will be conducted in pediatric emergency center, hamad general hospital, a recognized academic institution, in doha, qatar. the dka was defined as: hyperglycemia (blood glucose \>11 mmol/l or 200 mg/dl), venous ph \<7.3 and/ or bicarbonate \<15 mmol/l, and the association with, ketonemia, and ketonuria. the severity of dka is categorized as mild (venous ph \<7.3 or bicarbonate \<15 mmol/l), moderate (venous ph \<7.2 or bicarbonate \< 10 mmol/l) and severe (venous ph \< 7.1 or bicarbonate \<5 mmol/l). eligible patients are all children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not. the patients with the following criteria are excluded: older than 14 years of age, airway obstruction, chest infection, complex congenital heart disease, congestive heart failure, central or peripheral neurological disorders, hyper/hypothermia, and sever pain. physicians and nurses, and research assistance staff will be trained in the use of nasal capnography including the proper size, connection and wave forms shapes and its interpretation.

Eligibility criteria:
inclusion criteria: all children with already known or newly diagnosed diabetics, regardless weather has been enrolled in previous encounter or not. exclusion criteria: 1. older than 14 years of age 2. airway obstruction 3. chest infection 4. complex congenital heart disease 5. congestive heart failure 6. central or peripheral neurological disorders 7. hyper/hypothermia 8. severe pain

Keywords: diabetic ketoacidosis end tidal carbon dioxide capnography
psychological treatment of overweight binge eaters

Conditions: Binge Eating Disorder; Cognitive Therapy/Methods; Mental Disorders/Epidemiology; Obesity/Epidemiology; Obesity/Therapy

Summary: cognitive-behavioral therapy (cbt) has documented efficacy for the treatment of binge eating disorder (bed). interpersonal psychotherapy (ipt) has been shown to reduce binge eating but its long-term impact and time course on other bed-related symptoms remain largely unknown. this study compares the effects of group cbt and group ipt across bed-related symptoms among overweight individuals with bed.

cognitive-behavioral therapy (cbt) has documented efficacy for the treatment of binge eating disorder (bed). interpersonal psychotherapy (ipt) has been shown to reduce binge eating but its long-term impact and time course on other bed-related symptoms remain largely unknown. this study compares the effects of group cbt and group ipt across bed-related symptoms among overweight individuals with bed. methods: one hundred sixty-two overweight patients meeting dsm-iv criteria for bed were randomly assigned to 20 weekly sessions of either group cbt or group ipt. assessments of binge eating and associated eating disorder psychopathology, general psychological functioning, and weight occurred before treatment, at posttreatment, and at 4-month intervals up to 12 months following treatment. results: binge-eating recovery rates were equivalent for cbt and ipt at posttreatment (64 \[79%\] of 81 vs 59 \[73%\] of 81) and at 1-year follow-up (48 \[59%\] of 81 vs 50 \[62%\] of 81). binge eating increased slightly through follow-up but remained significantly below pretreatment levels. across treatments, patients had similar significant reductions in associated eating disorders and psychiatric symptoms and maintenance of gains through follow-up. dietary restraint decreased more quickly in cbt but ipt had equivalent levels by later follow-ups. patients' relative weight decreased significantly but only slightly, with the greatest reduction among patients sustaining recovery from binge eating from posttreatment to 1-year follow-up. conclusions: group ipt is a viable alternative to group cbt for the treatment of overweight patients with bed. although lacking a nonspecific control condition limits conclusions about treatment specificity, both treatments showed initial and long-term efficacy for the core and related symptoms of bed.

Eligibility criteria:
inclusion criteria: * dsm-iv research criteria for binge-eating disorder * average of greater than or equal to 2 days of binge eating per week for at least 6 months' duration * marked stress regarding binge eating * at least 3 to 5 associated behavioral features (e.g. eating when not physically hungry) other study criteria * 18-65 years old * body mass index, 27-48 kg/m squared exclusion criteria: * pregnant or planning to become pregnant * taking weight-affecting or psychotropic medications * psychiatric conditions warranting immediate treatment * current enrollment in psychotherapy or a weight loss program

Keywords: body mass index bulimia/therapy comorbidity interpersonal relations psychotherapy/methods