Kornimate/medical-research-clean huggingface dataset:
trial to evaluate the effectiveness of a digital therapeutics in adults diagnosed with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study compares the effectiveness of 2 digital therapeutics in adult participants diagnosed with major depressive disorder (mdd) who are on antidepressant therapy (adt) monotherapy for the treatment of depression.

this is a pivotal, 13-week, multi-center, randomized, controlled trial to evaluate the effectiveness and safety of two digital therapeutics in adult participants diagnosed with mdd who are on antidepressant therapy (adt) monotherapy for the treatment of depression. the trial consists of a 3-week screening period, a 6-week treatment period, and a 4-week extension. trial visits will be conducted remotely either by video visit or telephone. the screening visit may be performed in person at the discretion of the investigator. eligible participants will be randomized to 1 of 2 digital therapeutics within a mobile application that will reside on the participant's personal iphone or smartphone. the trial population will include male and female participants between 22 and 64 years of age with a primary diagnosis of major depressive disorder (mdd) who are on an adt for the treatment of depression. this trial will analyze data gathered from approximately 360 participants in the united states. an interim analysis will be conducted when a targeted sample of the first 180 participants has completed week 6 or discontinued the trial prior to week 6.

Eligibility criteria:
key inclusion criteria: * participants with a current primary diagnosis of mdd. * participants with a hamilton rating scale for depression, 17-item (ham-d17) score ≥ 18 * participants who are receiving treatment with an adequate dose and duration of an adt and who are willing to maintain that same treatment regimen for the duration of this trial. * participants who are the only users of an iphone or an android smartphone, and agree to download and use the digital mobile application as required by the protocol. key exclusion criteria: * participants with an inadequate response to \> 1 adequate trial of adt for the current episode. * participants who are receiving or have received psychotherapy within 90 days prior to screening. * participants who are currently using a computer, web, or smartphone software-based application for mental health or depression. * participants with a history of schizophrenia, schizoaffective disorder, other psychotic disorder, or bipolar i/ii disorder, or current posttraumatic stress disorder, panic disorder, obsessive-compulsive disorder, or personality disorder * general anxiety disorder/social anxiety can be present as long as they are not the main disorder requiring treatment.
groin complications in open vs. percutaneous peripheral cannulation in minimally invasive cardiac surgery

Conditions: Cardiovascular Diseases

Summary: the aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery

the femoral artery (fa) and vein (fv) are considered the preferred site for peripheral cannulation during cardiac surgery. normally, a small incision is made to access the fa and fv, which is also called open surgical cannulation. afterwards, the incision site is traditionally closed with sutures (1, 2). however, groin complications such as hematoma, access-site infection and fistulas are complications that can eventually lead to a longer hospital stay (3). recently, suture-mediated closure systems (smcs) have been developed to achieve hemostasis (4). this allows for percutaneous cannulation. still, little is known about the effects on groin complications after percutaneous cannulation in cardiac surgery. therefore, a prospective randomized study is now being conducted to investigate the groin complications in open vs. percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery.

Eligibility criteria:
inclusion criteria: * \>18 years * patients undergoing elective endoscopic cardiac surgery exclusion criteria: * patients that do no understand dutch, french, or english * heavily calcified cannula introduction site * central cannulation

Keywords: peripheral cannulation open cannulation percutaneous cannulation minimally invasive cardiac surgery
us-guided sapb for rib fractures in the ed

Conditions: Rib Fractures; Rib Fracture Multiple

Summary: the purpose of this randomized controlled study is to determine whether the serratus anterior plane block reduces pain more than the usual treatment for rib fractures in the same amount of time.

patients with unilateral rib fractures in the highland hospital emergency department who agree to participate will be randomized 1:1 to either the control group or the experimental group. those in the control group will receive the usual oral and/or iv pain medication as needed. the experimental group will receive an ultrasound-guided serratus anterior plane block. numerical pain rating scale scores at rest and when taking a deep breath will be recorded pre-intervention and at times 0, 20, 40, and 60. at time 60, patients who received the sapb will receive sensory testing. patients will be offered additional pain medication as needed at times 20, 40, and 60.

Eligibility criteria:
inclusion criteria: * males and females 18 years and older, capable of providing informed consent indicating awareness of the investigational nature of the study, in keeping with institutional policy. * written informed consent must be obtained from each patient prior to entering the study. * patients with moderate to severe pain (nrs 4 to 10) as a result of one or more rib fractures occurring at levels t2-t8, measured on a self-reported nrs. exclusion criteria: * patient refusal * patients with significant pain from other injuries (as determined at the discretion of the treating physician) * patients deemed critically ill by provider * patients with decompensated psychiatric disorders * pregnant patients (positive urine or serum b-hcg) * history of heart block or bradycardia * history of uncontrolled seizures * patients allergic to lidocaine, bupivacaine, ropivacaine, or morphine * patients with bilateral rib fractures

Keywords: nerve block serratus anterior plane block ultrasound emergency department
newer therapeutic targets in head and neck cancers

Conditions: Head Neck Cancer; Oral Cancer

Summary: based on the recently identified mutations in hnsccs, the major pathologic pathways implicated in the tumorigenesis of hnscc include dysregulation of four processes: 1. cellular survival and proliferation (e.g., tp53, egfr, met, and pik3ca); 2. cell-cycle control (e.g., cdkn2a and ccnd1); 3. cellular differentiation (e.g., notch1); and 4. adhesion and invasion signaling (e.g., fat1).7 tp53, egfr, pik3ca, cdkn2a, ccnd1, and met participate in several common signaling pathways. alterations of these genes are most frequently seen in alcohol and tobacco-related hnscc. however their role in prognostication and selection of therapeutics is not known

sample size: patients with squamous cell carcinoma of oral cavity fulfilling the inclusion and exclusion criteria and willing to participate will be included in this study. method: comprehensive history and physical examination of the patients will be carried out and all the details will be recorded in the preset proforma. all routine investigations as indicated including a biopsy to establish a diagnosis and ct of the head and neck to measure the tumor dimensions and stage the disease before initiation of treatment will be recorded. the paraffin embedded tissue will be studied for expression of various genetic mutations using ngs platform. brush cytology will be collected in liquid medium for hpv typing using pcr. the ion ampliseq™ cancer hotspot panel v3 will be used to detect hotspot regions of 161 oncogenes and tumor suppressor genes this research panel, with improved primer design, contains 4,648 total 4 pools (dna pool 1: 1,891 amplicons. dna pool 2: 1,890 amplicons. rna pool 1: 447 amplicons. rna pool 2: 420 amplicons.), enabling researchers to sequence challenging samples of formalin-fixed, paraffin-embedded (ffpe) tissue. copy number variants (cnvs), gene fusions, insertions-deletions (indels), single nucleotide polymorphisms (snps), somatic variants are identified. hpv dna pcr methodology dna will be isolated by using qiaamp dna mini kit (qiagen, hilden, germany). the presence of hpv will be detected by using the digene® hc2 hpv dna test- the digene hc2 hpv dna test uses hybrid capture 2 technology to detect high-risk and low-risk hpv genotypes. it uses in vitro microplate assay based on signal-amplified nucleic acid hybridization that uses chemiluminescence for the qualitative detection of 18 types of human papillomavirus (hpv) (13 high risk and 5 low risk) dna in cervical specimens. the test uses an rna probe cocktail that detects 13 high-risk hpv types (16/18/31/33/35/39/45/51/52/56/58/59/68) and 5 low-risk types (6/11/42/43/44).

Eligibility criteria:
inclusion criteria: * histologically proven cases of primary head and neck cancers. exclusion criteria: * patients under 18 years of age * pregnant and lactating women * multiple cancers or patients with cancer of other sites.

Keywords: next generation sequencing predictive biomarker
a trial investigating lu ag09222 with ubrogepant in participants with migraine

Conditions: Migraine

Summary: the main goal of this trial is to learn more about the safety and tolerability of lu ag09222 when taken together with ubrogepant. this includes looking for any new or worsening medical issues the participants have with the treatment. during the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either lu ag09222 or a placebo.


Eligibility criteria:
inclusion criteria: * the participant has a diagnosis of migraine as defined by ichd-3 guidelines confirmed at the screening visit. * the participant has a history of migraine onset ≥12 months prior to the screening visit. * the participant has ≥2 migraine days and headache occurring on \<15 days per month for each month within the past 3 months prior to the screening visit. * the participant has a body mass index (bmi) ≥18.5 and ≤ 35 kilograms per meter squared (kg/m\^2) at the screening visit. exclusion criteria: * the participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (pacap) treatment. * the participant has participated in a clinical trial \<30 days prior to the screening visit. * the participant has taken any investigational medicinal product (imp) \<3 months or \<5 half-lives of that product, whichever is longer, prior to visit 1. * the participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods. * the participant has known or suspected hypersensitivity or intolerance to the imp, auxiliary medicinal product (axmp), or their excipients. note: other inclusion and exclusion criteria may apply.
understanding the genetic basis of atherosclerosis and peripheral arterial disease

Conditions: Peripheral Vascular Diseases

Summary: atherosclerosis, a condition in which fatty deposits build up along the inner walls of arteries, can occur throughout the body. the purpose of this study is to examine the possible genetic differences that may influence where atherosclerosis occurs.

plaque build-up caused by atherosclerosis increases the risk of blood clots, heart attack, and stroke. blockages of plaque can occur in different areas of the body. pad, a circulatory disorder in which blockages occur in the peripheral arteries, is one manifestation of atherosclerosis. individuals with pad experience reduced blood flow to the legs, which may cause leg pain while walking. coronary artery disease (cad), in which plaque builds up in arteries leading to the heart, is another atherosclerosis-related condition. individuals with pad and cad have similar atherosclerosis risk factors, but it remains unknown why some individuals develop one disease and not the other. genetic differences may influence where atherosclerosis develops. the goal of the study is to identify genetic variations that may cause inherited differences in plaque distribution. this study will enroll individuals with pad who have been referred by their doctor for a coronary angiogram to confirm the presence of cad. a control group composed of individuals who do not have pad, but have similar risk factors for atherosclerosis, will also be enrolled. all participants will attend one study visit. they will undergo a coronary angiogram, a procedure in which a special dye is inserted intravenously into an artery of the heart. x-rays will be taken to document how blood flows through the artery. questionnaires assessing quality of life, exercise habits, tobacco exposure, and family medical history will be completed. participants will also undergo blood pressure measurements and blood collection for genetic analysis. yearly follow-up phone calls will occur for 5 years to document any hospitalizations.

Eligibility criteria:
inclusion criteria: * hemodynamically significant pad, as documented by an ankle-brachial index less than 0.9; control group participants will not have pad * received a referral for an elective coronary angiogram * suspected cad exclusion criteria: * history of radiation treatment * history of organ transplant * history of viral diseases (i.e. hiv, hepatitis)

Keywords: peripheral arterial disease atherosclerosis
evaluation of survival in patients with metastatic breast cancer receiving high-dose chemotherapy with autologous haematopoietic stem cell transplantation

Conditions: Breast Neoplasms

Summary: the objective of this study was to evaluate the outcome of patients affected with different subtypes of metastatic breast cancer following treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation.


Eligibility criteria:
inclusion criteria: * age\>18 years * metastatic breast cancer * treatment with high-dose chemotherapy and autologous haematopoietic progenitor cell transplantation between 2003 and 2012 exclusion criteria: * lack of follow-up data

Keywords: metastatic breast cancer high-dose chemotherapy autologous haematopoietic progenitor cell transplantation
hereditary spherocytosis and vascular function

Conditions: Hereditary Spherocytosis

Summary: background : patients with hereditary spherocytosis (hs) are characterized by increased red blood cell (rbc) fragility and a loss of rbc deformability. while the clinical variability of the disease may be heterogenous from one patient to another, some studies reported the occurrence of vascular complications, notably in patients who have been splenectomized. purpose : the aim of the study is to test the associations between the degree of vascular dysfunction and the extent of hemolysis, the amount of circulating microparticles, the level of erythrosis and the degree of rbc biophysical alterations. abstract : recent studies reported the occurrence of vascular complications in patients with hs, notably in patients who have previously been splenectomized. however, the exact reasons of these complications are unknown and no study investigated the vascular function in hs patients. main objective highlight the presence of altered vascular function in hs patients and test the relationships with the level of hemolysis and circulating microparticles. secondary objectives to evaluate the associations between clinical severity and 1) the level of vascular dysfunction and 2) several biomarkers (hemolysis, hematological parameters, circulating microparticles, erythrosis, rbc biophysical properties).


Eligibility criteria:
inclusion criteria: healthy controls: * age ≥ 6 years old * written, informed and signed consent by the healthy volunteer, or by both parents or legal guardian if the healthy volunteer is a minor * healthy volunteer affiliated to a social security scheme or assimilated * healthy volunteer not subject to any legal protection measure patients with hereditary spherocytosis: * age ≥ 6 years old * patient with hereditary or non-splenectomized spherocytosis * written, informed and signed consent by the patient, or by at least one of the two parents or legal guardian if the patient is a minor * patient affiliated to a social security scheme or assimilated * patient not subject to any legal protection measure exclusion criteria: healthy controls: * pregnant or lactating woman * subjects with hereditary spherocytosis or other characterized condition by chronic hemolysis * subjects with known pathology affecting the vascular system * blood donation (less than a month old) * not affiliated to a social security scheme * patient participating in another interventional research protocol that may interfere with this protocol (according to the investigator's judgment). patients with hereditary spherocytosis: * patient who received a blood transfusion in the 3 months preceding * pregnant or lactating woman * any disease or condition other than hereditary spherocytosis, chronic or not, likely to induce chronic or acute intravascular hemolysis * patient participating in another interventional research protocol that may interfere with this protocol (according to the investigator's judgment).

Keywords: hereditary spherocytosis hemolysis microparticles vascular function red blood cell
efficacy and tolerability study of device, rd047-26 for the treatment of mild to moderate atopic dermatitis in adults

Conditions: Atopic Dermatitis; Pruritus

Summary: the purpose of this study is to find out if investigational device, rd047-26, is safe and useful for the treatment of mild to moderate atopic dermatitis.

rd047-26, a device, may be tolerable and effective for the treatment of mild to moderate atopic dermatitis with associated pruritus in adults. the treatment effect will be evaluated by the subject and investigator.

Eligibility criteria:
inclusion criteria: * written informed consent * female or male, 18 to 65 years of age and in good general health * clinical diagnosis of stable mild to moderate atopic dermatitis * willing and able to follow study instructions and likely to complete all study requirements exclusion criteria: * severe or uncontrolled asthma * pregnant, nursing, or planning a pregnancy during the study; or is a wocbp but is not willing to use an effective method of birth control * current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to baseline (day 0)

Keywords: atopic dermatitis pruritus
zephyr valve japan post-marketing surveillance

Conditions: Emphysema; COPD; Severe Emphysema

Summary: this is a multicenter, prospective, observational surveillance enrolling 140 consecutive patients with severe emphysema who are candidates for bronchoscopic lung volume reduction using zephyr endobronchial valve at up to 20 centers across japan and followed for 12 months.

this is a multicenter, prospective, observational surveillance across 20 centers in japan enrolling 140 consecutive adult patients with hyperinflation of the lungs due to severe emphysema who are considered to be appropriate candidates for blvr using zephyr endobronchial valve (ebv, pulmonx corporation) and confirmed to have little to no collateral ventilation in the target lobe. enrolled (consented) subjects will undergo a bronchoscopy procedure with the chartis assessment to confirm that little to no collateral ventilation is present (cv- status) followed by ebv placement in the most diseased lobe. subject will be hospitalized for a minimum of 3 nights for observation and followed up for 12 months. subjects with collateral ventilation will be exited from the surveillance without treatment. the primary endpoint is incidence rate of pneumothorax at day 45 post-index procedure. the effectiveness will be evaluated from baseline to specified timepoint based on changes in lung function, exercise capacity, dyspnea and quality of life. a high-resolution computed tomography (hrct) will be performed at day 45 and month 12 to determine treated lobe volume reduction (tlvr). lung function will be assessed at month 3, 6 and 12 by measuring post-bronchodilator forced expiratory volume in 1 second (fev1), residual volume (rv) and 6 minutes walking distance. the safety will be evaluated based on incident rate of treatment emergent adverse events through month 12. subjects will be required to complete a pulmonary rehabilitation program between day 45 and month 3 per local/national guidelines.

Eligibility criteria:
inclusion criteria: 1. patient is deemed eligible for blvr using zephyr valve, as determined by their treating physician in accordance with japanese guidelines and approved instruction for use. these include: * recent respiratory rehabilitation completed within the last 6 months * not actively smoking (for at least 4 months) * tlc ≥ 100% * rv ≥ 175% * fev1 15-45% post-bronchodilator * 6mwd 100-500 m * mmrc score ≥ 2 * no coagulation disorder * no evidence of active respiratory infection 2. patient has little to no collateral ventilation (cv-) between the target and ipsilateral lobe as confirmed by chartis prior to undergoing blvr. 3. patient is willing and able to provide informed consent to allow data collection. exclusion criteria: none

Keywords: bronchoscopic lung volume reduction zephyr valves
pain assessment in the intensive care unit

Conditions: Delirium; Critical Illness

Summary: pain assessment using self-report scales (visual analogue scale, numerical rating scale), is recommended in the general population, however it is not always possible in patients with altered neurological status such as sedated patients or patients with delirium. consequently, pain assessment is highly challenging in these icu patients. this is a prospective observational study assessing 3 behavioral pain scales in the icu. the hypothesis of this proposal is that one of the three icu pain scales has a more important reliability than the others. such a scale could be recommended to be used to measure pain intensity in icu patients not able to communicate.

the aims of this observational study are to measure and compare the psychometric properties of behavioral pain scale (bps), critical care pain observation tool (cpot) and non verbal pain scale (nvps) at baseline and following repositioning procedure in the icu

Eligibility criteria:
inclusion criteria: * age \> 18 years * not comatose, defined by a richmond agitation sedation scale (rass) ≥ -3, i.e. between -3 and +4 * not able to self-report accurately their pain intensity using a visually enlarged 0-10 numeric rating scale exclusion criteria: -neurological deficits (acute or chronic) that prevent observation of the muscle tonus or movement. for example: * quadriplegia * current use of neuromuscular blocking agents * severe brain injuries
undisplaced femoral neck fractures

Conditions: Hip Fractures; Femoral Neck Fractures; Undisplaced Fracture; Internal Fixation; Complications; Arthroplasty Complications

Summary: purpose the purpose of this study is to compare the clinical outcome and the rate of reoperations in a cohort of patients with undisplaced femoral neck fractures treated with internal fixation and patients with displaced femoral neck fractures treated with hip arthroplasty. methods in a consecutive series of patients we compared the results of internal fixation for undisplaced femoral neck fractures with those of hip arthroplasty for displaced fractures (control group) of elderly patients. risk of reoperation and patient reported hip function assessed with harris hip score and womac were used as outcome measurements.


Eligibility criteria:
inclusion criteria: above 65 years old displaced femoral neck fracture treated with hip arthroplasty undisplaced femoral neck fracture treated with internal fixation exclusion criteria: * pathologic fracture