Kornimate/medical-research-clean huggingface dataset:
parental presence during fracture reduction in children at the emergency department; a randomized controlled trial

Conditions: Conscious Sedation; Anxiety

Summary: though much attention has been given to the practice of parental presence during invasive procedures in children in the ed, few studies have examined the patient's perspective. the only study to have addressed this issue used a single visual analog scale, which is not a well validated tool to assess children's distress level. furthermore, no studies have assessed parental presence during fracture reduction; only a few incidental cases were reported in the literature. finally, most studies evaluating parental presence had methodological limitations because of the absence of a control group. the investigators seek to assess whether parental presence during fracture reduction under sedation, in children 8 to 18 years of age, decreases anxiety levels in both parents and children.


Eligibility criteria:
inclusion criteria for patients: * patients aged 8 to 18 years old. * patients requiring fracture reduction under conscious sedation by emergency department attending physician. * patients able to understand basic spoken english or french. inclusion criteria for parents: * parents able to understand basic spoken english or french. exclusion criteria for patients: * patients with moderate to severe mental retardation * patients with altered mental status or intoxication * patients with hemodynamic instability or several traumatic injuries (other than fractures) - these patients require several treatments and may not have time to complete our study. exclusion criteria for parents: * parents presenting unacceptable behaviors for family presence * uncooperative * physically aggressive, combative * threatening and argumentative * unstable emotionally or cannot be calmed * intoxicated or altered mental status * suspicion of child abuse * suspected perpetrator of violent crime * parents with moderate to severe mental retardation. * pregnant parent

Keywords: conscious sedation parental presence invasive procedure children anxiety
development of a lifestyle physical activity intervention to reduce risk for perinatal cannabis use

Conditions: Pregnancy; Cannabis

Summary: this study will recruit 20 women who are high risk for prenatal cannabis use for a 12-week program of using the tracker and receiving a lifestyle physical activity program. the primary outcomes will be self reported percent days of cannabis use and physical activity. secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence.

this study will recruit 20 women in an open trial who are high risk for prenatal cannabis use for a 12-week program of using a fitbit activity tracker and receiving a lifestyle physical activity program. the primary outcomes will be self reported percent days of cannabis use and physical activity. secondary outcomes include self -reported measures of depression and anxiety symptoms, adaptive coping, and self-efficacy for cannabis abstinence. the investigators will clinically monitor all participants in the study for safety and clinical deterioration, and measure a variety of symptom outcomes over the course of the intervention period during pregnancy, as well as at a postpartum follow-up.

Eligibility criteria:
inclusion criteria: * women aged 18+ * 12-25 weeks gestation with a healthy singleton pregnancy * medically cleared for moderate physical activity * self-report of cannabis use at least once/week in the 3 months prior to the pregnancy desire to not engage in prenatal cannabis use * elevated depression (epds\>=7) or anxiety (gad7\>=5) * english-speaking * owns a smartphone to enable use of the fitbit app * current physical activity does not meet health recommendations (150 min/week mod intensity activity) * expresses interest in reducing or discontinuing cannabis use exclusion criteria: * current dsm-5 diagnosis of moderate/severe substance use disorder other than cud or nicotine use disorder * use of illicit substances in the last 3 months (other than cannabis) * acute psychotic symptoms * current or recent suicidality or homicidally * current anorexia or bulimia * cognitive impairment * physical or medical problems that would not allow safe participation in moderate intensity pa (i.e., not medical cleared by ob/gyn) * has a plan to relocate away from the area during study period * recently started new mental health or substance use treatment within past 4 weeks.
retrospective review on patients with culture negative empyema

Conditions: Empyema, Pleural

Summary: empyema is associated with a wide range of complication and mortality. it is defined by either a positive pleural fluid culture or grossly pus appearance. however, little is known about the differences in aetiology and outcome between culture-positive empyema (cpe) and culture-negative empyema (cne). the aim of the current study is to look at the local prevalence of cne, and compare the clinical outcome between cpe and cne.

pneumonia is a common disease and it ranked second as the leading cause of death in hong kong in 2016. among patients suffering from acute pneumonia, up to 57% of them would develop parapneumonic effusion. without proper treatment, parapneumonic effusion would progress into empyema, which is a clinical emergency. empyema leads to a longer length of hospital stay, a higher rate of complication and mortality than uncomplicated parapneumonic effusion. the mainstay of treatment for empyema is antibiotics and drainage. therefore, identification of causative microorganism is important in guiding the choice of antibiotics. the common bacterial culprits, for community acquired and hospital acquired, were identified by various local and international studies. however, the aetiological agents were still unknown in up to 40% of cases. in addition, the clinical outcomes between culture negative empyema (cne) and culture positive empyema (cpe) are largely unknown. data from one taiwanese study suggested that patients with cpe had a higher in-hospital mortality than those with cne. however, the primary objective of this study was not putting on the importance of cne. therefore, data on outcome of cne patients remain largely uncertain, either worldwide and local population. the aim of the current study is to look at the local prevalence of cne, and compare the clinical outcome between cpe and cne. through more understanding of cne, the clinical management of this patient group may be altered and a better patient outcome is anticipated.

Eligibility criteria:
inclusion criteria: i. all patients hospitalized for empyema, defined by the presence of purulent pleural fluid or positive culture result from pleural fluid ii. age greater than 18 years old exclusion criteria: i. inappropriate diagnosis of empyema after evaluation ii. tuberculous pleuritis, defined by presence of mycobacterium tuberculosis culture from pleural fluid or granulomatous inflammation on pleural biopsy histology

Keywords: culture positive empyema culture negative empyema parapneumonic effusion pleural fluid pneumonia
coronary artery disease and coronary microvascular disease in cardiomyopathies registry

Conditions: Hypertrophic; Ischemic; Restrictive Cardiomyopathy; Dilated Cardiomyopathies

Summary: long-term prognostic value of macrovascular and microvascular coronary artery stenoses in each type of cardiomyopathy.

coronary artery imaging techniques have taken a central role in the assessment of cardiovascular (cv) diagnosis over the past two decades. many patients with a cardiomyopathy are also found to have a bystander coronary artery disease, not responsible for their cardiomyopathy. however, the prognostic value of those bystander coronary artery diseases is not known. also, new imaging techniques have been developed to assess coronary microvascular disease, but the prognostic value of these findings is not known. in this study, the investigators evaluate the incidence and the prognosis of bystander coronary artery disease and microvascular disease in patients with ischemic, hypertrophic, dilated and restrictive cardiomyopathies in 5 french centers. coronary angiography, cardiac magnetic resonance (cmr), tomographic coronary artery angiography, single-photon emission computed tomography (spect), rest and stress trans-thoracic echocardiography (tte) results will be recorded. macrovascular coronary artery disease is defined by : * a stenosis \> 50 % in coronary angiography confirmed with myocardial ischemia (spect, stress echocardiography), * a stenosis \> 70 % (50% if it is the left main coronary artery) * or a stenosis 30-70 % with a fractional flow reserve (ffr) \ 23 or myocardial perfusion heterogeneity imaging (mphi) \> 4 using spect or cmr. major adverse cardiovascular events (mace) will be assessed 1 year, 2 years and 5 years after enrollment.

Eligibility criteria:
inclusion criteria: * ischemic * dilated * hypertrophic * restrictive cardiomyopathy. exclusion criteria: * pregnant women * breastfeeding women * patients under legal protection

Keywords: cardiomyopathy multimodal imaging coronary artery disease coronary microvascular disease prognosis atherosclerosis myocardial ischemia
growth hormone replacement therapy for retried professional football players

Conditions: TBI (Traumatic Brain Injury); Concussion, Brain; Sport Injury; Anterior Pituitary Hyposecretion Syndrome; Hypopituitarism; Growth Hormone Deficiency

Summary: this is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (gh) on cognitive functions of retired professional football players with growth hormone deficiency (ghd).

ghd is the most common anterior pituitary abnormality after traumatic brain injury (tbi). it can occur as a result of either direct pituitary or indirect hypothalamic injury. sports-related repetitive head trauma might induce pituitary dysfunction, and in particular, isolated ghd. growth hormone replacement therapy (ghrt) has long been known to have a beneficial effect on body composition and exercise capacity. however, it has recently been shown that ghrt also benefits the brain. the primary objective of the current study is to assess the effect of gh on memory, executive function and attention domains of cognitive function in ghd- professional football players with tbi. the study will also utilize the adult growth hormone deficiency assessment (aghda) questionnaire, quantitative electroencephalogram (qeeg) and magnetic resonance imaging (mri) techniques, respectively, to measure the quality of life (qol), electrical activity and structural changes in the brain that may correspond to cognitive deficits.

Eligibility criteria:
inclusion criteria: * the subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study. * former nfl player * at least one year since retirement from football * less than 76 years of age * diagnosis of ghd on clinical grounds by a neurologist and an endocrinologist ghd exclusion criteria: * history of pre-existing brain disease other than concussion or tbi * history of a premorbid disabling condition that interferes with outcome assessments * contraindication to gh therapy * type i and ii diabetes mellitus * active malignant disease * acute critical illness, heart failure, or acute respiratory failure * subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.

Keywords: tbi ghd growth hormone norditropin flexpro cognition disorders
peri-urethral bulk agent injection of bulkamid®

Conditions: Peri-urethral Bulk Agent Injection of Bulkamid® for Urinary Incontinence

Summary: there are currently different treatment options in the management of stress urinary incontinence according to the latest recommendations \[1\]. suburethral slings are currently considered the first surgical option due to an excellent cure rate of around 90%. nevertheless, due to a risk of prosthetic complications and numerous current controversies over the placement of synthetic tissue, other therapeutic alternatives must be offered to patients \[2\]. peri-urethral bulk agent injections have been used since 2006 in urinary incontinence and should be integrated into the therapeutic arsenal. this is a minimally invasive technique performed under local anesthesia on an outpatient basis. the mechanism of action is explained by better coaptation of the urethra and increased resistance to urine flow during the bladder filling phase. it also increases the strength of the striated sphincter thanks to a better arrangement of muscle fibers \[3\]. according to the european association of urology (eau), the use of bulk agents is recommended for the management of urinary incontinence in elderly and/or frail patients whose comorbidities contraindicate surgical management. these peri-urethral injections can also be offered to patients with incontinence due to sphincter deficiency but also to young women with stress urinary incontinence who are ready to accept a partial improvement in their incontinence \[1\]. the personal choice of the patient is currently a decisive factor for the implementation of a treatment for functional disorders and in particular for urinary incontinence.


Eligibility criteria:
* inclusion criteria : * women over 18 * patients who received a first peri-urethral injection of bulkamid® in the context of urinary incontinence * intervention between september 2020 and november 2022 * person having expressed his non-opposition * exclusion criteria : * inability to understand the information given * person deprived of liberty * person under guardianship

Keywords: bulkamid® bulk agent peri-urethral injection urinary incontinence
clinical observation of coronary arterial microcirculation dysfunction in diabetic patients with non- obstructive coronary artery disease

Conditions: Complications of Diabetes Mellitus; Coronary Artery Disease

Summary: the purpose of this study is to investigate the prevalence and degree of coronary arterial microcirculaiton dysfunction of non- obstructive coronary artery disease in patients with type 2 diabetes. furthermore, the risk factors of coronary arterial microcirulation would be screened and identified.


Eligibility criteria:
inclusion criteria: * diagnosis non- obstructive coronary artery disease; * positive treadmill exercise test; * positive cardiac ect test; * positive holter test exclusion criteria: * diagnosis of myocardial infarction; * diagnosis heart failure; * diagnosis of chronic kidney disease; * diagnosis of heart valvular disease; * diagnosis of malignant tumor; * positive heart transplant history; * pregnant and lactating women
a 52 week study to assess the use of bococizumab (pf-04950615; rn316) in subjects with heterozygous familial hypercholesterolemia

Conditions: Heterozygous Familial Hypercholesterolemia

Summary: this is a multicenter, randomized study in subjects with heterozygous familial hypercholesterolemia receiving highly effective statins to assess the safety, efficacy and tolerability of bococizumab (pf-04950615; rn316) to lower ldl-c.


Eligibility criteria:
inclusion criteria: * treated with a statin. * fasting ldl-c \> 70 mg/dl and triglyceride \<=400 mg/dl. * high or very high risk of incurring a cardiovascular event. * heterozygous familial hypercholesterolemia. exclusion criteria: * pregnant or breastfeeding females. * cardiovascular or cerebrovascular event of procedures during the past 30 days. * congestive heart failure nyha class iv. * poorly controlled hypertension.

Keywords: high risk of cardiovascular events heterozygous familial hypercholesterolemia
in our study we compare results of two oncoplastic breast surgery (short scar reduction mammoplasty and wise pattern reduction mammoplasty) as surgical treatment of breast cancer

Conditions: Evaluation of Short Scar Periareolar Inferior Pedicle Reduction Mammoplasty in Oncoplastic Breast Surgery

Summary: in our study we compare results of two oncoplastic breast surgery (short scar reduction mammoplasty and wise pattern reduction mammoplasty) as surgical treatment of breast cancer


Eligibility criteria:
inclusion criteria: 1. female patients with ages ranging from 25 to 75 years. 2. patients with operable breast cancer (stage i, ii and iiia). 3. patients with moderate to large /ptotic breasts. exclusion criteria: 1. patients with a contraindication to breast conservative surgery: 1. multi-centric disease that can't be incorporated by local excision through a single incision that achieves adequate safety margin and satisfactory cosmetic results. 2. inflammatory carcinoma. 3. contraindications to postoperative radiation e.g. pregnancy, pre-existing lung disease with reduced diffusing capacity and pulmonary tb. 4. diffuse suspicious malignant micro-calcification on mammography. 5. inability to attain negative surgical margins. 6. cardiomyopathy 7. connective tissue disorders with significant vasculitis. 2. previous chest wall or breast radiation. 3. patients' refusal participation.
mycophenolate vs azathioprin in autoimmune hepatitis

Conditions: Autoimmune Hepatitis

Summary: a study with 20 de novo patients with autoimmune hepatitis, 10 receiving azathioprin and 10 receiving mycophenolat mofetil.


Eligibility criteria:
inclusion criteria: * de novo autoimmune hepatitis * consent exclusion criteria: * age below 18 * pregnancy

Keywords: prednisolone dosage
maxillary versus bi-maxillary posterior segments intrusion adult subjects with skeletal open bite

Conditions: Dental Malocclusion

Summary: compare between bi-maxillary (maxillary and mandibular) posterior dento-alveolar intrusion and maxillary posterior dento-alveolar intrusion as regards open bite closure.

now, maxillary posterior dento-alveolar intrusion has been validated as a conservative treatment modality for treatment of skeletal open bite in adult patients. however, it was proved that mandibular posterior teeth extrusion take place during the treatment which results in reduction in the amount of open. bite closure. therefore, the aim of our study is to compare in a randomized clinical trial methodology between maxillary posterior dento-alveolar intrusion and combined maxillary and mandibular posterior dento-alveolar intrusion in terms of anterior open bite closure.

Eligibility criteria:
inclusion criteria: * skeletal open bite with a dental open bite ranging from 3-8 mm. * adequate incisal show at rest and on smiling * full set of posterior teeth from first premolar to second molar (with the exception of one tooth in one quadrant). exclusion criteria: * dental open bites without skeletal components * previous orthodontic treatment * medically compromised patients

Keywords: molar intrusion open bite mini-screws
dora: a doravirine-based first-line antiretroviral therapy for women of reproductive potential living with hiv

Conditions: HIV-1-infection

Summary: this is a pilot study investigating the safety of doravirine (dor) in combination with lamivudine (3tc) and tenofovir disoproxil fumarate (tdf) administered over 48 weeks in women of reproductive potential living with hiv-1 switched from efavirenz or dolutegravir-based antiretroviral therapy on metabolic and neuropsychiatric outcomes.

this is a pilot, open label, single-arm, single centre, phase 3, switch study exploring the safety of of doravirine (dor) in combination with lamivudine (3tc) and tenofovir disoproxil fumarate (tdf) administered over 48 weeks in women of reproductive potential living with hiv-1 switched from efavirenz or dolutegravir-based antiretroviral therapy. the metabolic and neuropsychiatric outcomes among women (and their infants) in a representative african female population of reproductive potential will be investigated. approximately 100 women aged between 18 and 49 years old will be administered a once-daily, fixed-dose combination of doravirine 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg (dor/3tc/tdf). the study includes screening and baseline visits, 4 study visits from week 4 to week 36, and an end of study visit at week 48.

Eligibility criteria:
inclusion criteria: * females, aged 18-49 years and ≥ 40 kg * on a first-line efv or dtg-containing regimen for at least six months and not more than 3 years * plasma hiv-1 rna \< 50 copies/ml in last 60 days * calculated creatinine clearance (crcl) \> 50 ml/min (cockcroft-gault formula) * baseline weight measurement available at art initiation. exclusion criteria: * virological failure on any other regimen * women who are pregnant at the time of the screening or enrolment visits or have had a pregnancy gestation ≥ 28 weeks in the preceding 2 years * active tuberculosis and/or are on antituberculosis therapy at the time of the screening or enrolment visits * taking (and cannot discontinue) prohibited concomitant medications listed in protocol at least two weeks prior to the enrolment visit and for the duration of the study period (see potential drug interactions section for list).

Keywords: doravirine delstrigo dor/3tc/tdf women of reproductive potential
dendritic cells in patients with acute or chronic skin graft versus host disease

Conditions: Acute Graft-versus-host Disease; Acute GVHD; Chronic Graft-versus-host Disease; Chronic GVHD

Summary: dendritic cells (dcs) serve as sentries for the immune system. dcs recognize foreign compounds (antigens) in the body, which they internalize and process. when dcs uptake foreign antigens, they migrate to secondary lymphoid organs, where the processed antigens are presented to t cells. various dc subsets with unique cell lineages, surface protein markers, and tissue localization determinants have been identified. for example, langerhans cells (lcs) and interstitial dendritic cells (intdcs) are dcs found in stratified epithelia, such as the skin. though both are expressed in the skin, they differ with respect to their origin and surface protein content and can activate distinct types of immune responses. they may also have different specificities for the capture of antigens and presentation to circulating t cells. to date, it is unknown what role, if any, the different dc populations that reside or repopulate in the skin play in the development and progression of skin graft-versus-host disease (gvhd) following bone marrow transplant.


Eligibility criteria:
inclusion criteria: * at least 18 years of age at enrollment * willing and able to sign the informed consent * current diagnosis/suspected diagnosis of acute skin gvhd or current diagnosis/suspected diagnosis of chronic skin gvhd exclusion criteria: * known infection with hepatitis b or c, htlv, or hiv * pregnant females
a study to evaluate onm-100, an intraoperative fluorescence imaging agent for the detection of cancer

Conditions: Breast Cancer; Head and Neck Squamous Cell Carcinoma; Colorectal Cancer; Prostate Cancer; Ovarian Cancer; Urothelial Carcinoma; Non-small Cell Lung Cancer

Summary: this study is to evaluate diagnostic performance, safety and timing of post-dose imaging of onm-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.


Eligibility criteria:
inclusion criteria: * biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection * part 1: biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (hnscc) or breast cancer * part 2: biopsy-confirmed diagnosis of hnscc, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer. * part 3: stage 2 to 4 hnscc including t0 or tx unknown primary cancers exclusion criteria: * histologically diagnosed by an excisional biopsy procedure * tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible * life expectancy \<12 weeks * hepatic impairment (child-pugh score \>5) or significant liver disease including active hepatitis or cirrhosis