Kornimate/medical-research-clean huggingface dataset:
a breast support intervention for women with breast pain

Conditions: Mastodynia

Summary: the purpose of this study is to assess whether prescribing a bra to participants results in an improvement in the patient global impression of change (pgic) compared to participants who receive standard care alone.


Eligibility criteria:
inclusion criteria: * female, aged 18 years of age and above. * experiencing breast pain of any severity. * participants must be able to speak and read english fluently * participants must be a resident within the local area and not planning to move out of the area within the study timeline * participant must have attended the queen alexandra (qa) hospital for an assessment of their breast pain. * participant is willing and able to give informed consent for participation in the study. * participant is self-reported to be between a 34 and 40 under band size and a dd to g bra cup size. * able to walk on a treadmill for up to two minutes unaided and be able to walk unaided up and down a small set of steps (assessed verbally by the clinicians at qa hospital) * participants must be able to comply with the study procedures exclusion criteria: * participants are receiving any additional treatment for their breast pain that is not part of standard care (recommendation for a bra fit, topical ibuprofen, breast pain leaflet) including any cancer treatment * participants have had any surgery to the breasts within the last year * participants are currently pregnant or have been pregnant or breast fed in the past year * planning to undertake any activities or lifestyle changes which may affect their levels of breast pain e.g. trying for a baby, changing oral contraceptive, having breast surgery. * participant's data will be excluded from the analysis if they do not complete either survey at four or eight weeks (at least one follow up survey needs to be completed).

Keywords: breast pain mastalgia bras breast support
how long can labor last? person centred care during labor to increase safety for women and newborn

Conditions: Birth Outcome, Adverse; Labor Long; Labor Complication; Maternal Injury; Maternal Distress During Labor and Delivery; Neonatal and Perinatal Conditions; Labor Duration

Summary: "how long will my labor last" is a very common question for midwives who care for women during birth. to evaluate safe labor duration largely determines management and care during birth. today a standardized tool is used by midwives to evaluate normal and safe labor called the partograph. the world health organization partograph is a decision-making support tool designed to assist midwives in identifying normal labor duration and women at risk of developing complications. the tool guide the use of care interventions intended to mitigate any perceived risks. the partograph has been in use since the 1950ies and has had a profound impact on care and management during labor. normal labor progression according to the partograph is a linear progression with cervical dilation of 1 centimeter per hour (alert line) and any deviation from this should lead to an intervention.the purpose of this research project is to increase person-centred care during labor. specifically, we want to provide updated comprehensive information on labor duration and patient safety for reduction of; unnecessary medical interventions during normal labor; morbidity and mortality in the new-born; maternal complications during delivery and the puerperal period.


Eligibility criteria:
inclusion criteria: all births with labor duration exclusion criteria: elective cesarean birth
iobt versus io-rec for hypertropia with iooa (iihiooa)

Conditions: Hypertropia; Inferior Oblique Overaction

Summary: this is a multi-center, randomized double-blind controlled trial to compare the effectiveness of iobt with io-rec for the treatment of hypertropia with iooa. specific aim 1 (primary): to study the suboptimal surgical rates between iobt and io-rec for the treatment of hypertropia with iooa. specific aim 2 (secondary): to compare the surgical successful rate of iobt with io-rec for the treatment of hypertropia with iooa.

using conventional surgical procedures, such as myectomy or recession of inferior oblique muscle, higher postoperative vertical overcorrection due to contralateral concealed iooa were observed in mild primary position hypertropia with unilateral iooa. to achieve better outcome, iobt was introduced. yang et al. firstly reported that iobt might be a useful alternative surgical treatment for patients with primary position hypertropia of less than 5△ that was associated with iooa. recently, our study has reported that iobt achieved satisfactory outcomes in patients with mild primary position vertical deviation (≤10△) with unilateral iooa, without any risk of overcorrection of vertical deviation and contralateral iooa. although our results are promising, there is no enough evidence to recommend iobt for primary position hypertropia with inferior oblique overaction. a large randomized trial is needed to compare the surgical successful rate and suboptimal surgical outcomes of iobt with io-rec for primary position hypertropia with inferior oblique overaction. the proposed trial will be conducted in 9 different study sites working in the field of pediatric ophthalmology and strabismus. each site will have one certified surgeon to do all surgeries. for iobt, the whole belly of inferior oblique muscle is secured with a 6-0 absorbable suture, and then anchors to the sclera 5 mm behind the temporal insertion of the inferior rectus muscle. for io-rec, the insertion of inferior oblique muscle is excised and secured with a 6-0 absorbable suture, and then anchors to the sclera 4 mm behind and 2 mm beside the temporal insertion of the inferior rectus muscle.

Eligibility criteria:
inclusion criteria: * age ≥ 4 years at the time of surgery; * vertical deviation (vd) in primary position (5△ ≤ vd ≤ 10△) * iooa for three following situations: 1. iooa +1 for the operative eye and iooa - for the follow eye; 2. iooa +2 for the operative eye and iooa ± for the follow eye; 3. iooa +2 for the operative eye and iooa +1 for the follow eye; * without amblyopia exclusion criteria: * histories of strabismus surgery or botulinum toxin injection; * histories of intraocular surgery or refractive surgery; * restrictive or paralytic strabismus; * ocular disease other than strabismus or refractive error; * craniofacial malformations affecting the orbits; * significant neurological disorders

Keywords: inferior oblique muscle belly transposition inferior oblique muscle recession inferior oblique overaction
"ultra" enhanced recovery after surgery (e.r.a.s.) in laparoscopic colectomy for cancer

Conditions: Colonic Cancer

Summary: background. enhanced recovery after surgery (e.r.a.s.) programs are now widely accepted in colonic laparoscopic resections because of faster recovery and less perioperative complications. objective. aim of this study is to assess safety and feasibility of discharging patients operated on by laparoscopic colectomy on post operative day 2 (pod 2), so long as the first flatus has passed and in the absence of complication-related symptoms. design \& settings. non-inferiority, open-label, single center, prospective, randomized study comparing "ultra" to classic e.r.a.s. with discharge on pod 2 and 4 respectively. patients. 765 patients with resectable non metastatic colonic cancer were analyzed: 384 patients were assigned to "ultra" e.r.a.s. and 381 to classic e.r.a.s. main outcome measures. demographics, clinico-pathological, asa class and morbi-mortality, along with surgical complications, re-operation and readmission rate were recorded and compared. primary end-point was mortality; secondary end-points were morbidity, re-admission and re-operation rate. limitations. it is a single center experience; it is not double-blind, with the intrinsic risk of intentional or unconscious bias; exclusion criteria because of "non compliance" may be considered arbitrary.

from january 2008 to september 2015, 765 patients were prospectively randomized for early discharge after laparoscopic colectomy according to e.r.a.s. programs: after obtained informed consent, 384 patients were randomly assigned to the "ultra" e.r.a.s. group and 381 to classic e.r.a.s. group.

Eligibility criteria:
inclusion criteria: * resectable colonic cancer exclusion criteria: * metastatic patients * t4b tumors * urgent operations (because of obstruction, perforation or bleeding refractory to conservative treatment) * huge neoplasms (\>7cm) * positive cytology in peritoneal lavage or frank carcinosis * inability to tolerate pneumoperitoneum * asa class 4 * severe portal hypertension with hepato-caval gradient \>10mmhg

Keywords: colonic cancer e.r.a.s. programs safety
use of curcumin in the lower gastrointestinal tract in familial adenomatous polyposis patients

Conditions: Familial Adenomatous Polyposis

Summary: the purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.


Eligibility criteria:
inclusion criteria: * familial adenomatous polyposis * 18 years of age or older * 5 or more adenomas of colorectum or ileum exclusion criteria: * female patient of child bearing age not on effective birth control pills * pregnant women * white blood cell (wbc) count less than 4000 * platelets (plts) less than 100,000 * blood urea nitrogen (bun) greater than 25 * creatine greater than 1.5 * patients unable to stop non-steroidal anti-inflammatory drugs (nsaids) during duration of trial * malignancy * patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease * patient on warfarin or anti-platelet drugs

Keywords: familial adenomatous polyposis patient with 5 or more adenomatous polyps in the colon or ileoanal pouch
mini-invasive preventive fixation of the contralateral femoral neck in patients operated on for a femoral neck fracture

Conditions: Femoral Neck Fractures

Summary: in france, the annual incidence of hip fracture is about 80 000 with more than 75% of these fractures occurring in patients aged 80 years old or more. about 10% percent of patients presenting with a hip fracture will sustain a contralateral hip fracture, most within 3 years. the consequences of a hip fracture are dramatic: 20% of patients die in the first year and less than half those who survive regain their previous level of function. hip fractures are invariably associated with chronic pain, reduced mobility, disability, and an increasing degree of dependence. the efficacy of pharmacological treatments to prevent a contralateral hip fracture is marginal and postponed and compliance is known to be poor. osteoporosis is associated with cortical thinning and trabecular bone loss. therefore, the mini-invasive preventive fixation (mipf) of the contralateral femoral neck is appealing. the effect is immediate and compliance is certain. morbidity is minimal because it is performed during the same operation as the fixation of the femoral neck fracture. the main objective of this study is to determine whether the mini-invasive preventive fixation (mipf) of the contralateral femoral neck in patients having a femoral neck fracture is superior to no fixation regarding the occurrence of a contralateral hip fracture within 3 years.


Eligibility criteria:
inclusion criteria: * women and men * 80 years or older * operated on for a femoral neck fracture * presenting one, or more, added clinical risk factor of hip fracture\* * a fragility fracture in the past five years * a history of fall in the past 12 months (not considering the fall that led to the present fracture) * a very high risk of falling: use of psychoactive medication or impaired vision or impaired neuromuscular function * bmi lower than 20kg/m2 * giving her/his consent. * affiliated to the social security exclusion criteria: * history of a contralateral proximal femoral fracture * history of a surgical operation of the contralateral proximal femur * ongoing infection (bone or soft-tissue) on the contralateral hip * contraindication of mipf of the contralateral hip * non ambulatory patients * patients already included in the study * patients with contraindication to the medical devices under evaluation * patients not suitable for a surgical procedure (including not suitable for an anaesthetic) * patients with a benign or malignant bone lesion of the contralateral femur * patients included in another clinical research which could directly have an effect on the femoral neck bone strength * patients presenting with a grade 4 kellgren-lawrence osteoarthritis of the contralateral hip and reporting significant clinical symptoms * patients with an life expectancy of less than 3 months * patients with a legal representative (tutorship or guardianship) and insane patients will be excluded
evaluation of efficacy on exercise tolerance of symbicort (budesonide/formoterol) compared to placebo and oxis in patients with severe copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with symbicort, oxis or placebo in patients with severe chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * \>=40 years of age * diagnosed copd with symptoms \>= 2 years * pre-bronchodilatory fev1 \<=50% of pn exclusion criteria: * current respiratory tract disorder other than copd * history of asthma or rhinitis * significant or unstable cardiovascular disorder

Keywords: copd
a study of renal autologous cell therapy (react) in participants with type 2 diabetes and chronic kidney disease

Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Diseases

Summary: the purpose of this study is to assess the safety and efficacy (including durability) of up to 2 react injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with t2dm and ckd.

randomized multi-center, blinded intervention, two cohort , study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. cohort 1 participants will undergo sham procedures and be followed for 5 years post last simulated injection.. cohort 2 participants will receive 2 react injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.

Eligibility criteria:
inclusion criteria: 1. the participant is male or female, 30 to 80 years of age on the date of informed consent. 2. the participant has a clinical diagnosis of t2dm in their health record. 3. the participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record. 4. the participant has a serum glycosylated hemoglobin (hba1c) less than 10% at the screening visit. 5. the participant has a documented clinical diagnosis of an egfr greater than or equal to 20 and less than or equal to 44 ml/min/1.73m², not requiring renal dialysis. 6. the participant has an urinary albumin-to-creatinine ratio (uacr) of greater than or equal to 300 and less than or equal to 5,000 mg/g. exclusion criteria: 1. the participant has a history of type 1 diabetes mellitus. 2. the participant has a history of renal transplantation. 3. the participant has a mean systolic blood pressure greater than or equal to 140 mmhg and/or mean diastolic blood pressure greater than or equal to 90 mmhg at screening, across 3 measurements while seated. 4. the participant has hemoglobin level less than 10 g/dl and is not responsive to the standard medical intervention for ckd-related anemia prior to randomization.

Keywords: react type 2 diabetes mellitus
posttraumatic stress symptoms among rescuers at risk

Conditions: Trauma; PTSD; Self Efficacy; Coping Skills; Suicidal Ideation

Summary: this cross-sectional, anonymous online survey aims to examine how salient variables influence ptss, well-being, and suicidal ideation across the following professions of rescue workers: firefighters, ambulance personnel, police officers, and emergency and psychiatric nurses. ptss, coping strategies, well-being, suicidal ideation, previously experienced and work-related trauma, and self-efficacy were measured and analyzed using multiple regression and structural equation modeling.

employees of rescue and emergency services are at a risk of posttraumatic stress symptoms (ptss) due to exposure to trauma and work-related stressors. salient predictors for the development of ptss among rescue workers have been identified; however, little is known about how predictors (e.g. coping strategies) differ among professions requiring repeated engagement in emergencies. the present survey examines how these variables influence ptss, well-being, and suicidal ideation across different professions of rescue workers using multiple regression and structural equation modeling.

Eligibility criteria:
inclusion criteria: employee at the rescue or emergency services. the participation in the anonymous online study is voluntary and promoted by the department heads at the places of work corresponding to the studied professions. no ethical approval is needed as the survey was voluntary and anonymous and participants gave consent to use the data with their participation. exclusion criteria: * none

Keywords: ptsd trauma coping self efficacy
prevention of cisplatin-induced nephrotoxicity

Conditions: Acute Kidney Injury; Renal Tubulopathy

Summary: the research design is a prospective, randomized, controlled clinical trial in children to study effect of aminophylline in preserving renal function in oncologic patient received cisplatin either combined with other cmt or used alone. the participants in both groups will receive standard protocol pre-cisplatin infusion which include hydration with 5%dnss/2 with kcl and mgso4 iv infusion. in the treatment group, the participants will receive aminophylline infusion in the first 24 hours along with cisplatin, followed by oral aminophylline oral three times daily orally for 4 consecutive days post cisplatin. the aminophylline serum level will be maintained at the therapeutic range 10-20 mg. the side effect of aminophylline including nausea, vomiting and ecg will be monitored. the collected data including urine volume, gfr (estimated by cystatin c-creatinine based equation and by radiopharmaceutical-tc dtpa), and renal tubular biomarker (urine b2 macroglobulin and urine ngal) will be collected at baseline before receiving cisplatin, 24 hours and 5 days post cisplatin.


Eligibility criteria:
inclusion criteria: * age under 18 years old * oncology patients who receive cisplatin-based therapy exclusion criteria: * preexisting renal anomalies * preexisting gfr less than 60 ml/min/1.73 m2 * contraindication of aminophylline including structural heart disease, arrhythmia, hyperthyroidism, chronic liver disease, epilepsy * aminophylline use within 24 hours prior to study entry

Keywords: acute kidney injury chemotherapy induced kidney related complication
how your patients' non-rem sleep changes on sedatives in the intensive care units

Conditions: Delirium; Respiratory Failure

Summary: the purpose of this study is to study the effect of two standard of care sedative medications on sleep stages and total sleep time. the investigators hypothesize that the α2 agonist, dexmedetomidine, will improve sleep quality by increasing n2 and n3 sleep as well as total sleep time when compared to gaba agonists.

this is a single center randomized pilot study comparing the effects of an α2 agonist (dexmedetomidine) versus gaba agonists (propofol or a benzodiazepine) on total sleep time and sleep quality. for the purposes of enrollment and analysis all benzodiazepines used for sedation (mainly midazolam and lorazepam) will be considered equivalent. patients who are mechanically ventilated and sedated will be enrolled. the initial sedative will be determined by the managing medical team and the medication will be active at the time of enrollment. the patients will then be randomized to either continue their current sedative or be switched to either propofol or dexmedetomidine. psg data will be collected for up to 96 hours, beginning at enrollment for all patients. the analysis of psg will not begin until after a 8 hour "washout" period has completed to minimize carryover effect of prior sedatives.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the medical intensive care unit who require mechanical ventilation and are sedated with a gaba agonist with the expectation of being mechanically ventilated for greater than 24 hours. exclusion criteria: * subjects who are less than 18 years * subjects who are pregnant (a pregnancy test will be performed on all women of child bearing age) * inability to obtain informed consent from the patient or his/her surrogate * subjects who are physiologically benzodiazepine dependent, and at risk of withdrawal syndromes * subjects with anoxic brain injuries, strokes, or neurotrauma * medical team following patient unwilling to change sedation regimen * subjects who are moribund and not expected to survive 24 hours or actively withdrawing medical support * documented allergy to study medications * subjects with advanced heart block at time of screening * prisoners * rass target of less than or equal to -4 at the time of screening * psg equipment unavailable

Keywords: sedative gaba alpha 2 agonist propofol midazolam lorazepam dexmedetomidine sleep electroencephalogram polysomnogram icu
user surveillance in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the aim of the non-interventional study is to document the daily doses in acute and remission therapy, the frequence of doses (1, 2, 3 or 4 times daily), when rectal dosage forms are added and, when and how long steroids are given.


Eligibility criteria:
inclusion criteria: * therapeutic need according to spc * written informed consent exclusion criteria: * contraindications according to spc
effect of rhythmic upper-limb training in stroke patients

Conditions: Cerebral Stroke

Summary: the purpose of this study is to determine whether rhythmic upper-limb movement training in post-stroke patients allows to improve only this particular type of movements or if it also improves some parameters of discrete movements. based on our results we hope to be able to answer a fundamental question: are rhythmic and discrete movements two independent primitives?

patients are assessed four times during this longitudinal study. one month separates the first two assessment, next patients are trained 12 times during one month with rhythmic movement training on an end-effector robot. after this month, patients are assessed a third time and three months later a fourth time in order to study long-time benefits of the therapy.

Eligibility criteria:
inclusion criteria: * more than 6 months post-stroke patients * fugl-meyer between 7 and 55 * maintain the same intensity of rehabilitation during the study exclusion criteria: * cerebellar stroke * severe aphasia or cognitive disorder * any other neurological disorder

Keywords: rhythmic versus discrete movements rehabilitation