Kornimate/medical-research-clean huggingface dataset:
validation of a novel oxygen consumption measurement technique in neonates

Conditions: Neonatal Respiratory Failure; Congenital Heart Defect

Summary: the measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming. currently, there is no device which measures either oxygen consumption, or another variable that depends on oxygen consumption - resting energy expenditure - in neonates or infants. our group has developed a new device which can attach to any ventilator and measures these two variables with accuracy in the preclinical setting, including in rodents as small as severely preterm infants. the purpose of this study is to compare measurements of oxygen consumption and energy expenditure in neonates using this device and comparing it with a gold standard which is rarely used, a douglas bag method in which expired gas is collected and later analyzed.


Eligibility criteria:
inclusion criteria. 1. mechanically ventilated neonates and infants (\<1 year of age). 2. inpatients in the cardiac or neonatal intensive care unit at boston children's hospital. 3. assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes. 4. written parental informed consent. exclusion criteria. 1. hemodynamic or respiratory instability. 2. patients on extracorporeal membrane oxygenation support. 3. clinically significant tracheo-esophageal fistula 4. measured endotracheal tube leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)
perifollicular doppler in natural cycle in vitro fertilization

Conditions: Infertility

Summary: perifollicular doppler could reflect the quality of the follicle's vascularization and, consequently, the one of the oocyte that ensues from it. perifollicuar doppler is the analysis, in ultrasound, of the blood flow in vessels surrounding the follicle. the goal of this study is to evaluate if there is a link, in natural cycle in vitro fertilization, between the quality of the vascularization and the one of the oocyte, the embryo and the pregnancy.


Eligibility criteria:
inclusion criteria: * patient with a natural in vitro fertilization cycle. * patient under 38 years old * body mass indice under 35 * ovulatory cycles between 20-35 days exclusion criteria: * patient with a stimulation in vitro fertilization cycle * patient with a naturalin vitro fertilization cycle with egg donor * patient with a natural in vitro fertilization cycle with freezing embryo * smoking patient * diabetic patient * patient with treatment of antihypertensive drug, anticoagulant, antiplatelet, vasodilator * body mass indice over 35 * patient over 38 years old * patient without ovulation or cycle over 35 days * percutaneous epididymal sperm aspiration (pesa), testicular sperm extraction (tese) or micro tese
sickle cell disease: targeting alloantibody formation reduction; risk factors, and genetics

Conditions: Alloimmunization; Sickle Cell Disease

Summary: the focus of the study is the pathophysiological mechanism of allo-antibody formation after red blood cell transfusion in sickle cell disease patients.

the main objectives of this study are to study the role of the innate and adaptive immune response in allo-antibody formation and furthermore to identify the genetic and time dependent clinical risk factors on alloimmunization in scd patients. subjects without allo-antibodies, receiving a red blood cell transfusion, will be included in this study. at 5 time points blood will be drawn from these subjects. (t0: before transfusion, t1: 1 day after transfusion, t2: 1 week after transfusion, t3: 4 weeks after transfusion, t4: 6 months after transfusion). at each time point specific markers of the immune system will be measured.

Eligibility criteria:
inclusion criteria: * sickle cell disease * receiving a red blood cell transfusion exclusion criteria: * previous positive screen for allo-antibodies * \>25 red blood cell units in the past
microscopy imaging of whole-mount stained human tissues

Conditions: Tumor, Brain; Tumor, Breast; Tumor Skin

Summary: the goal of this clinical trial is to develop an imaging platform for intraoperative tumor margin delineation in 250 cases of tumor-suffered patients. the main questions it aims to answer are: • to develop the protocol of rapid assessment of surgical specimens without need for fixation, embedding, and cryosectioning required for conventional histopathology. participants will provide a small piece of their surgical specimens from tumor removal surgery . if there is a comparison group: researchers will compare normal specimens to see if we can observe the difference.


Eligibility criteria:
inclusion criteria: 1. patients who are more than 20 years old. 2. diagnosed as patients suffered by skin tumor, brain tumor and breast tumor. exclusion criteria: 1. patients who can't speak and communicate with others. 2. patients who can't make eventual and exact pathological assessment for his/her diseases. 3. patients who only can fit for slicing tumor. 4. removed tissues which obviously vary after severe ray radiation under microscopy observation. 5. diameter of tumors are under 1 centimeter. 6. breast carcinoma in situ.

Keywords: intraoperative assessment whole-mount h&e staining surgical border assessment
the cantata-d2 trial (canagliflozin treatment and trial analysis - dpp-4 inhibitor second comparator trial)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.

canagliflozin is a drug that is being tested to see if it may be useful in treating patients diagnosed with type 2 diabetes mellitus (t2dm). this is a randomized (study drug assigned by chance), double-blind (neither the patient or the study doctor will know the name of the assigned treatment), multicenter study to determine the efficacy, safety, and tolerability of canagliflozin 300 mg compared to sitagliptin 100 mg (an antihyperglycemic drug) in patients with t2dm who are not achieving an adequate response from current antihyperglycemic therapy with metformin and sulphonylurea to control their diabetes. approximately 720 patients with t2dm who are receiving combination therapy with metformin and sulphonylurea will receive the addition of once-daily treatment with canagliflozin 300 mg or sitagliptin 100 mg capsules for 52 weeks. patients will participate in the study for approximately 59 to 72 weeks. during treatment, patients will be monitored for safety by review of adverse events, results from laboratory tests, 12-lead electrocardiograms (ecgs), vital signs measurements, body weight, physical examinations, and self monitored blood glucose (smbg) measurements. the primary outcome measure in the study is the effect of canagliflozin compared to sitagliptin on hemoglobin a1c (hba1c) after 52 weeks of treatment. study drug will be taken orally (by mouth) once daily before the first meal each day unless otherwise specified. patients will take single-blind placebo for 2 weeks before randomization. after randomization, patients in the study will take double-blind canagliflozin 300 mg or matching sitagliptin 100 mg for 52 weeks.

Eligibility criteria:
inclusion criteria: * all patients must have a diagnosis of t2dm and be currently treated with metformin and sulphonylurea * patients in the study must have a hba1c between \>=7 and \<=10.5% and a fasting plasma glucose (fpg) \<300 mg/dl (16.7 mmol/l) exclusion criteria: * history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * or a severe hypoglycemic episode within 6 months before screening

Keywords: canagliflozin sitagliptin (januvia) metformin sulphonylurea hemoglobin a1c type 2 diabetes mellitus
computer guided esthetic crown lengthening

Conditions: Altered Passive Eruption of Teeth; Guided Surgery; Gummy Smile

Summary: the objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3d printed surgical stents in management of excessive gingival display due to altered passive eruption.

the objective of the present study was to evaluate the effectiveness of surgical esthetic crown lengthening using digitally assisted 3d printed surgical stents in management of excessive gingival display due to altered passive eruption. primary objectives: wound healing score: the clinical features of periodontal wound healing were measured according to hagenaars et al using the following parameters: swelling of the soft tissue , color of the gingiva, probing pocket depth, bleeding index, plaque index, clinical attachment level. these signs were assessed at 1 week, 3 months and 6 months post-operative. operating time: the time needed to complete each procedure was calculated in minutes by using a stopwatch from the time of the first incision till the completion of bone removal. secondary objectives: patient satisfaction: was assessed using visual analogue scale at 24 hours, 7 days and 14 days post operatively. (zero is for minimum pain and ten is for maximum pain). gingival margin stability: the position of gingival margin in relation to a reference point was evaluated immediately after surgery, 3 months and 6 months healing period .

Eligibility criteria:
inclusion criteria: 1. males and females within age range of 20-40 years. 2. systemic (medically) free individuals. 3. excessive gingival display in the esthetic zone (more than 3mm of gingival display at full smiling) 4. patients with good oral hygiene. exclusion criteria: 1. smokers (15) 2. teeth with compromised periodontium. 3. pregnant and lactating females. 4. the vulnerable group: patients with mental or physical disabilities. 5. patients with parafunctional habits. 6. medications that affect periodontal wound healing. 7. periodontal surgery in the esthetic zone in the past 6 months.
the foot exercises in patellofemoral pain

Conditions: Patellofemoral Pain Syndrome; Anterior Knee Pain Syndrome; Pronation Deformity of the Foot; Exercise; Pain; Biomechanics; Functionality

Summary: the purpose of this study is to investigate the additional effects of short foot exercises on pain, biomechanical characteristics and functionality of lower extremity in patients with patellofemoral pain.


Eligibility criteria:
inclusion criteria: * aged between 25-60 * diagnosed as patellofemoral pain syndrome exclusion criteria: * pregnancy * having walking disability * having a trauma, knee surgery or other arthritis

Keywords: patellofemoral pain foot deformity foot pronation short foot exercise
exploring mechanisms for neuropsychiatric symptoms of parkinson disease using transcranial direct current stimulation

Conditions: Idiopathic Parkinson's Disease; Parkinson Disease; Depression

Summary: this study evaluates the effect of transcranial direct current stimulation (tdcs) on non-motor symptoms of parkinson's disease, including depression and cognitive symptoms. participants are randomized to receive active or sham tdcs for 30 minutes over 10 treatment sessions.


Eligibility criteria:
inclusion criteria: * abel to provide written informed consent is obtained in the english language * age 18 to 95 years old * movement disorder society clinical diagnostic criteria for probable idiopathic parkinson disease * report disabling depressive or neuropsychiatric symptoms prior to study entry * capacity to understand the nature of the study; exclusion criteria: * known structural brain disease such as a neoplasm, abscess etc. * pre-existing skull / scalp defects that would impede standardized electrode placement * current electronic or metal implants * diagnosis of bipolar disorder, post-traumatic stress disorder, a psychotic disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening; * concurrent treatment with medication which may affect tdcs (benzodiazepines, anticonvulsants, dextromethorphan and pseudoephedrine) * endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening; * history of substance abuse or dependence in the 2 months prior to screening; * considered to be at significant risk of committing homicide; * unstable medical condition; * score less than 22 on the montreal cognitive assessment (moca) * women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study; * there has been a change in their depression or psychotherapy treatment regimen in the 2 weeks preceding screening;
transcranial direct current stimulation (tdcs) augments the effects of gamified, mobile attention bias modification

Conditions: Anxiety; Stress

Summary: the present study tested whether transcranial direct current stimulation (tdcs) across the prefrontal cortex (pfc), versus sham stimulation, effectively augments the beneficial effects of a gamified attention bias modification training (abmt) mobile app.

anxiety-related attentional bias (ab) is the preferential processing of threat observed in clinical and sub-clinical anxiety. attention bias modification training (abmt) is a computerized cognitive training technique designed to systematically direct attention away from threat and ameliorate ab, but mixed and null findings have highlighted gaps in our understanding of mechanisms underlying abmt and how to design the most effective delivery systems. one neuromodulation technique, transcranial direct current stimulation (tdcs) across the prefrontal cortex (pfc) may augment the effects of abmt by strengthening top-down cognitive control processes, but the evidence base is limited and has not been generalized to current approaches in digital therapeutics, such as mobile applications. the present study tested whether tdcs across the pfc, versus sham stimulation, effectively augments the beneficial effects of a gamified abmt mobile app. thirty-eight adults (mage = 23.92, sd = 4.75; 18 females) evidencing low-to-moderate anxiety symptoms were randomly assigned to active or sham tdcs for 30-minutes while receiving abmt via a mobile app. participants reported on potential moderators of abmt, including life stress and trait anxiety. ecg was recorded during a subsequent stressor to generate respiratory sinus arrhythmia (rsa) suppression as a metric of stress resilience.

Eligibility criteria:
inclusion criteria: * mild - moderate anxiety exclusion criteria: * psychotic disorder * substance use disorder

Keywords: anxiety, stress
quantitative versus qualitative fecal immunochemical tests (fit) to prioritize urgency of colonoscopy referral

Conditions: Colorectal Cancer

Summary: the main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative fecal immunochemical tests (fit) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative fit and appointment-based referral).

it is hypothesized that quantitative fit will enable faster detection of advanced neoplasms compared to qualitative fit.

Eligibility criteria:
inclusion criteria: * adults aged 50 years and above exclusion criteria: * lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding * personal history of colorectal tumour or cancer * family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer

Keywords: colorectal cancer screening fecal occult blood fecal immunochemical test qualitative quantitative
a phase 3 study of alxn2060 in japanese participants with symptomatic attr-cm

Conditions: Symptomatic Transthyretin Amyloid Cardiomyopathy

Summary: this prospective study is designed to evaluate the efficacy, safety, and tolerability of alxn2060 (also known as ag10), as well as to establish its pharmacokinetic and pharmacodynamic profile in japanese participants with symptomatic attr-cm administered on a background of stable heart failure therapy.

participants will receive alxn2060 for 12 months (part a). following the last visit (month 12) of part a, participants will continue the study in part b, which will last for an additional 18 months (30 months from day 1), during which all participants will continue to receive oral treatment with alxn2060. following completion of month 30 assessments in part b, participants will be offered the opportunity to continue to receive alxn2060 in the extension period, which will last until alxn2060 is approved in japan or for up to 24 additional months, whichever occurs first.

Eligibility criteria:
inclusion criteria: 1. established diagnosis of attr-cm with either wild-type ttr or a variant ttr genotype. 2. history of heart failure evidenced by at least 1 prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated pressures or heart failure symptoms that required or requires ongoing treatment with a diuretic. 3. new york heart association class i-iii symptoms due to attr-cm. 4. on stable doses of cardiovascular medical therapy. 5. completed ≥ 150 meters on the 6mwt on 2 tests prior to day 1. 6. left ventricular (lv) wall (interventricular septum or lv posterior wall) thickness ≥ 12 millimeters. 7. biomarkers of myocardial wall stress: n-terminal pro-brain-type natriuretic pep (nt-probnp) level ≥ 300 picograms/milliliter (pg/ml). exclusion criteria: 1. acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening. 2. hemodynamic instability at screening. 3. likely to undergo heart transplantation within a year of screening. 4. current treatment with marketed drug products and other investigational agents for the treatment of attr-cm. 5. current treatment with calcium channel blockers with conduction system effects (for example, verapamil, diltiazem). the use of dihydropyridine calcium channel blockers is allowed. 6. confirmed diagnosis of light-chain (al) amyloidosis. 7. biomarkers of myocardial wall stress: nt-probnp ≥ 8,500 pg/ml. 8. measure of kidney function, estimated glomerular filtration rate by modification of diet in renal disease formula \< 30 ml/minute/1.73 meters squared.
pv reconnection after pvai at different power settings and adenosine provocation

Conditions: Paroxysmal Atrial Fibrillation

Summary: in this prospective randomized study, we aim to compare the rate of pv reconnection following pvai performed at different energy settings (30 watts vs 40 watts) where dormant pv conduction will be unmasked by adenosine-provocation.

background: the efficiency of catheter ablation in drug-refractory atrial fibrillation (af) is compromised by high incidence of post-ablation af recurrences requiring multiple ablation procedures (1). post-pvai (pulmonary vein antrum isolation) af recurrence is mostly due to reconnection of the previously isolated pvs (2). earlier studies have revealed that elimination of dormant pv conduction revealed by adenosine-provocation ensures better outcome as reconnection mostly happens due to presence of incompletely ablated tissue and identification and complete ablation decrease chance of recurrence (1). adenosine is specifically chosen for induction of triggers because it is known to transiently or permanently re-establish left atrium-pulmonary vein (la-pv) conduction after apparently successful pv isolation (3). datino et al have demonstrated in the canines that adenosine selectively hyperpolarizes the pvs by increasing inward rectifier potassium (k+) current and restores excitability (4). as incompletely ablated tissue can potentially cause af recurrence, the depth and extension of the lesion are crucial factors in determining the success-rate of ablation; these in turn are directly influenced by catheter type and the radio-frequency (rf) energy settings (5). in a previous study, matiello et al have reported cooled-tip catheter at 40w setting to be more effective in preventing recurrence than that with 30w setting (5). however, none of the earlier studies have examined the rate of pv reconnection when af ablation is done at different power settings using open-irrigated catheters after the dormant sites are revealed by adenosine-challenge. hypothesis: use of higher wattage during ablation before and after adenosine-challenge is associated with lower rate of pv reconnection.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patients presenting with drug-refractory paf undergoing first ablation 3. ability to understand and provide signed informed consent exclusion criteria: 1. previous catheter ablation or maze procedure in left atrium 2. reversible causes of atrial arrhythmia such as hyperthyroidism, sarcoidosis, pulmonary embolism etc

Keywords: paf
optimum menstrual cycle time for endometrioma excision

Conditions: Endometriosis; Endometrioma

Summary: this study evaluates the optimum day of menstrual period for the excision of endometriomas to minimize the damage of surgery to normal ovarian tissue. patients will be grouped as follicular, ovulatory and luteal according to menstrual days. ovarian damage will be evaluated with both pathologic examination and anti-mullerian hormone levels before and after the surgery.

endometriosis is a common gynecologic disease seen in about 10% of women in reproductive age. the most common site of endometriosis is overt. cystic formation of ovarian endometriosis is called endometrioma (chocolate cyst). definitive treatment of endometriomas is excision by laparoscopy. the disadvantage of this surgery is the removal of some of the normal ovarian follicles within cystectomy material. this procedure can damage the ovarian reserves with the treatment of endometriomas, which are already the cause of infertility, and lead to the conditions such as infertility or early menopause. it has been understood that the ovarian reserves of the patients who underwent endometrioma cystectomy with the decrease of the anti-mullerian hormone values, which is an over reserve parameter.

Eligibility criteria:
inclusion criteria: * 4 to 10 cm unilateral ovarian endometrioma * having clinically indication of laparoscopic ovarian endometrioma excision exclusion criteria: * prior gynecologic surgery * prior abdominal surgery * additional operation in the same session * having the diagnosis of premature ovarian failure or ovarian insufficiency * having any diagnosis of malignancy * having diagnosis of a non-gynecologic chronicle disease

Keywords: ovarian reserve endometriosis endometrioma