Kornimate/medical-research-clean huggingface dataset:
a study to assess the effect and safety of azd6765 in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to assess the effect and safety of azd6765 in patients with major depressive disorder who exhibit inadequate response to antidepressants. azd6765 is a channel blocker of the n-methyl-d-aspartate (nmda) class of glutamate receptors.

a multicenter, randomized, double-blind, parallel group, placebo-controlled, phase iib efficacy and safety study of adjunctive azd6765 in patients with major depressive disorder (mdd) and a history of inadequate response to antidepressants

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent before initiation of any study-related procedures. * male or female patients aged 18 to 70 years, inclusive. * the patient must have a clinical diagnosis of major depressive disorder with a lifetime history of inadequate response to at least 3 antidepressants. * women of child-bearing potential must have a negative serum pregnancy test and confirmed use of a highly effective form of birth control before enrollment for a minimum of 3 months before study start. * outpatient status at screening and randomization visits. exclusion criteria: * patients with a history of diagnosed bipolar disorder or schizophrenia or schizoaffective disorder or currently exhibiting psychotic features associated with their depression; dementia or suspicion thereof. * patients who have had a suicide attempt within the last 6 months. * electroconvulsive therapy (ect), vagal nerve stimulation (vns) or transcranial magnetic stimulation (tms) or previous treatment with ketamine infusion within the 6 months prior to screening, or any history of deep brain stimulation. * patients with any history of seizure disorder (except for febrile seizures in childhood). * pregnancy or lactation.

Keywords: major depressive disorder mdd inadequate response to antidepressant therapy channel blocker of the nmda class of glutamate receptors
the benefit of structured triage of patients in the primary health care seeking care for low back pain

Conditions: Low Back Pain

Summary: this study aims to investigate if a low back pain screening tool is helpful for the caregivers to direct the rehabilitation in a more efficient way, at an earlier stage. primary health care centers in the municipality of halmstad, sweden will be enrolled to participate in the study as either "control" or "intervention". the primary health care centers who are enrolled taking part in the intervention, will use the provided screening tool when taking care of patients seeking care for low back pain. scorings from the screening tool will "label" the patients as one of three pre-defined risk levels. the caregiver will then use the provided risk level when deciding how to proceed the rehabilitation. based on the risk level identified, the patient is directed to one of three levels of treatments - including simple advice; physiotherapy; or multimodal rehabilitation. the screening tool is used as a complement to the examination, allowing the physiotherapist /gp to decide how to proceed with rehabilitation using the back screening tool, together with clinical examinations. the control group consists of patients recruited when seeking care for back pain at a primary health care service who has been randomly selected as "control". the care givers at the control primary health care will conduct as usual, not using the back pain screening tool in their clinical examinations.


Eligibility criteria:
inclusion criteria: * seeking care for low back pain at any of the included primary health care. exclusion criteria: * red flags
ai-powered ecg detecting culprit vessel blood flow abnormality in acs

Conditions: Acute Coronary Syndrome; STEMI; Coronary Occlusion; Coronary Syndrome; NSTEMI; NSTEMI - Non-ST Segment Elevation MI

Summary: ai ecg timi is an investigator-initiated, international, and multicenter registry of acute coronary syndrome patients aimed to identify electrocardiographic findings detected by an ai model predicting coronary blood flow alteration. the aim of the study is to identify electrocardiographic findings detected by an automated artificial intelligence (ai) model that can predict coronary blood flow alteration as assessed by the timi grade flow at the very moment of the invasive coronary angiography in patients with acute coronary syndromes.


Eligibility criteria:
inclusion criteria: * patients with acute coronary syndromes undergoing invasive coronary angiography as clinically indicated. * availability of a standard 12-lead ecg performed at invasive coronary angiogram before percutaneous coronary intervention (maximum within 15 min before vascular access). * age ≥18 years. exclusion criteria: * individuals presenting for a non-emergent (elective) cardiac catheterization. * individuals presenting with chronic coronary syndrome (ccs) or stable angina symptoms. * individuals without symptoms suspicious for acute coronary syndromes. * individuals with contraindications for cardiac catheterization.

Keywords: acute coronary syndrome ecg artificial intelligence occlusion myocardial infarction myocardial infarction (mi)
cognitive behavioral therapy-based group counseling

Conditions: Depression Moderate; Depression Mild

Summary: the university environment presents a valuable opportunity to reach the young population of society, which has a high risk of depression, and to provide protective mental-health services. this study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms.

this study aimed to evaluate the effectiveness of cognitive behavioral therapy-based group counseling focused on the depressive symptoms, anxiety levels, automatic thoughts, and coping ways among undergraduate nursing students with mild to moderate depressive symptoms. the study was completed with a total of 63 participants (n=31 for the intervention group and n=32 for the control group) in the 2017-2018 academic year. the effect of the intervention was evaluated with the beck depression inventory, beck anxiety inventory, automatic thoughts questionnaire, and ways of coping questionnaire. the measurements were taken 3 times: pre-test, post-test, and 2-months post-test.

Eligibility criteria:
inclusion criteria: * having mild depressive symptoms according to the bdi * having moderate depressive symptoms according to the bdi * being native speakers of turkish * agreeing to participate in the entire intervention process exclusion criteria: * having substance abuse * having another psychiatric diagnosis * using psychotropic drugs * receiving other counseling or therapy

Keywords: depression cognitive behavioral therapy group counseling nursing students
change in muscle volume in patients with unilateral femoro-acetabular impingement syndrome after hip arthroscopy

Conditions: Femoro-acetabular Impingement (FAI)

Summary: the purpose of this study was to investigate the change in muscle volume around the hip in patients with unilateral femoro-acetabular impingement (fai) after arthroscopy.

we performed a retrospective review of magnetic resonance imaging (mri) data of fai patients who underwent hip arthroscopy between january 1, 2016, and july 1, 2018. "image j" with an embedded region-of-interest (roi) tool was used to calculate the cross-sectional area (csa) of muscles on mri. wilcoxon signed-rank test was used to determine the differences between preoperative and postperative hip muscle csa. the correlations of change in muscle csa with age, gender, bmi, pain level, preoperative symptom duration, and multiple validated patient-reported outcomes were also analyzed with a spearman rank correlation test.

Eligibility criteria:
inclusion criteria: * (1) age 18-50 years; (2) symptoms, physical examination, imaging evidence in accordance with fai; (3) symptoms that were not alleviated by nonsurgical treatment; (4) the operation is performed by the same senior operator. exclusion criteria: * (1) bilateral symptoms; (2) revision surgery; (3) advanced osteoarthritis; (4) acetabular dysplasia; (5) history of hip and knee joint disease and operation; (6) osteonecrosis of hip; (7) sacroiliac joint disease

Keywords: femoro-acetabular impingement hip muscle volume cross-sectional area arthroscopy mri images
method of early diagnosis of laryngopharyngeal reflux

Conditions: Laryngopharyngeal Reflux; Laryngopharyngitis Chronic; Gastro Esophageal Reflux; Laryngitis

Summary: the investigator will issue a patient information consent for the participant in the study. 1.patients will be asked to complete the reflux symptom index questionnaire. clinical survey, medical history. 2. objective methods for assessing the patient's condition: - examination of ent organs. 3. laboratory and instrumental research methods: endoscopic laryngoscopy and video laryngoscopy, ph-metry, acoustic voice analysis. 4.sociological method. 5. subjective methods for assessing the condition of the larynx. 6. аnalysis of the received data

the investigator will issue a patient information consent for the participant in the study. 1.patients will be asked to complete the reflux symptom index questionnaire. clinical survey, medical history 2. objective methods for assessing the patient's condition: - examination of ent organs: rhinoscopy, otoscopy, pharyngoscopy and laryngoscopy 3. laboratory and instrumental research methods - endoscopic laryngoscopy and video laryngoscopy. ph-metry: the collection of mucus from the laryngopharynx for the determination of acid-base values. acoustic voice analysis: objective assessment of the voice condition 4.sociological method: determination of lifestyle, nutrition, the presence or absence of bad habits. 5. subjective methods for assessing the condition of the larynx - questionnaires. 6. аnalysis of the received data

Eligibility criteria:
inclusion criteria: * patient's informed consent * age: 18-75 years old * no serious somatic diseases. * patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching. * diagnosis: chronic pharyngitis * chronic laryngitis exclusion criteria: * disagreement to participate in scientific research * age: under 18 and over 76 * severe somatic diseases, organic lesions of the gastrointestinal tract and ent organs * patients with pulmonary pathologies * patients with allergic manifestations (seasonal hay fever, asthma, etc.) * with diagnoses: acute respiratory diseases * patients with general neuralgic disorders

Keywords: laryngopharyngeal reflux laryngopharyngitis chronic gastro esophageal reflux laryngitis ph monitoring ph metric acoustic voice analysis
developing breast (cancer) organoids

Conditions: Breast Cancer

Summary: currently, only a few validated biomarkers and models exist guiding or predicting treatment response for specific patient groups. therefore, a patient-tailored clinical model needs to be developed to address tumour heterogeneity and thereby guide treatment selection on an individualized level. organoids are patient-derived aggregates that grow in 3d and maintain self- renewal pluripotency and lineage-specific differentiation. therefore, in contrast with conventional cell lines, they are thought to sustain patient heterogeneity and characteristics and are consequently already in use for drug response screening. this now offers the opportunity to investigate if the primary patient breast cancer organoid platform reflects disease progression, treatment response and relapse in patients with different clinical breast cancer subtypes. goal: to develop a living biobank from prospective patient-derived breast cancer tissue. the questions we will address are: 1. do patient-derived breast cancer organoids retain the clinical behaviour and characteristics of the primary patient tumour? 2. can bc organoids be used to derive prognostic and predictive biomarkers to inform treatment decisions? 3. can the investigators utilize bc organoids to discover novel actionable targets and combination treatments for therapeutic intervention for breast cancer patients? 4. can bc organoids be used to discover mechanisms of treatment resistance and relapse?

the investigators will select patients with a diagnosis of breast cancer who undergo breast surgery. patients will be asked informed consent for the use of a small (0,2-1 cm3) sample of the excised breast tumour and the collection of a blood sample (6ml)for whole-exome sequencing (wes) to compare the genetic profile of the patients with the organoids and the patient biopsy. the patients will not undergo any additional treatment or procedure in addition to the planned routine procedure for the surgical resection of their primary breast tumour. patient will undergo standard diagnostic procedures and treatment according to the dutch breast cancer surgery guidelines. after surgery, the pathologist will provide -after pathological diagnosis- rest (tumour) tissue from the resection to the lab. this material will then be used to develop breast cancer organoids. as part of the routine surgical procedure, 6 ml of blood will be collected. participation in this study does not lead to additional actions other than reading the patient information and signing the informed consent. therefore, participation does not change the patient's treatment or outcome.

Eligibility criteria:
inclusion criteria: * female, * \>18 years, * family anamneses * breast cancer (proven by histopathology), included subtypes; (er-,pr- her2-); (er+, pr+, her2-); (er+, pr+ her2+). * primary surgery (lumpectomy or mastectomy) exclusion criteria: - physically or mentally incapable or incompetent to sign informed consent
the self match study: a study of informed choice in the treatment of addiction

Conditions: Alcohol Dependence

Summary: the purpose of this study is to determine whether patient self-matching (as compared with treatment as usual by expert matching) improves quality of life, retention, and outcome for patients being treated for alcohol problems. there are at least two good reasons for offering patients a choice when the goal is a change in their behavior. the first is that patients are likely to know what treatment works best for them. secondly, being allowed to choose between options may increase compliance in treatment. as a randomized controlled trial, this study will compare the efficacy of patient self-matching versus treatment-as-usual expert matching. the self-match study is expected to increase knowledge on the importance of involving the alcohol dependent patient in choosing what treatment method is best for him/her instead of having experts to do that. the investigators expect to discover patient involvement as a way to improve compliance in treatment, hence preventing that patients drop out of treatment to early. if this hypothesis proves to be right, clinicians will have a viable strategy for matching treatment methods to patients, since the strategy does not demand further resources in the treatment system.


Eligibility criteria:
inclusion criteria: 1. fulfilling dsm-iv criteria for alcohol abuse or dependence. 2. native danish speaking. 3. having no severe psychosis or cognitive impairment. 4. accepting to participate in the study. exclusion criteria: -

Keywords: informed choice alcohol use disorder addiction treatment
rabies immunization concomitant with jev in children

Conditions: Rabies

Summary: background. the world health organization recommends pre-exposure vaccination (prep) to protect children living in canine rabies endemic countries. including prep in national childhood immunization programs (epi) is a viable option. methods. in an open-label phase ii clinical trial, 200 healthy toddlers were randomized to receive purified chick embryo cell vaccine (pcecv) in a 3-dose full-im (1ml), half-im (0.5ml), 3-id (0.1ml), or a 2-dose 2-id (0.1ml) regimen, all in combination with two doses of japanese encephalitis (jev), or jev alone. one booster dose of pcecv (im or id) and jev, or jev alone was administered concomitantly one year after primary vaccination. safety was evaluated after each injection. blood was drawn on days 0 and 49, one year later prior to booster and on days 7 and 28 post-booster, and at two and three years post primary vaccination. all sera were analyzed for rabies and je virus neutralizing antibodies (rvna, jevna).


Eligibility criteria:
inclusion criteria: * male and female 12-18 months old toddlers will be included in the study if they; * are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator; * are available for all the visits scheduled in the study; * have been granted a written informed consent signed by their parents exclusion criteria: * a history of rabies immunization; * a history of japanese encephalitis immunization or disease; * a significant acute or chronic infectious disease at the time of enrollment; * fever \> 38.0 degree c (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment; * being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment; * administration of any vaccine within the past 14 days before enrollment; * known immunodeficiency or an autoimmune disease; * known hypersensitivity to neomycin, tetracycline, amphotericin-b; * planned surgery during the study period; * being enrolled in any other investigational trial contemporaneously; * the family plans to leave the area of the study site before the end of study period; * history of febrile convulsions; * history of wheezing

Keywords: rabies vaccination pre-exposure prophylaxis rabies virus neutralizing antibody antibody response immunologic memory of rabies vaccination safety of rabies vaccination administered in pre-exposure regimens both intramuscular and intradermal routes
preload and autonomic responses with cardiac neuromodulation therapy (cnt) (cs-06)

Conditions: Bradycardia; Hypertension, Systolic

Summary: this investigation will evaluate the effect of rv pacing lead position on cardiac function and the modulation of the autonomic nervous system with cardiac neuromodulation therapy (cnt) pacing signals. the study will be performed acutely prior to a pacemaker implant.

subjects indicated for a dual chamber pacemaker implant or replacement who are not 100% dependent on right ventricular pacing may be eligible to participate in the study. this investigation will evaluate the effect of rv pacing lead position on cardiac function and the modulation of the autonomic nervous system using cardiac neuromodulation therapy (cnt) pacing signals at different positions of the rv pacing lead. a standard conductance catheter will be introduced through the femoral artery and advanced into the left ventricle to measure cardiac volumes and pressure. arterial blood pressure will be measured from the other femoral artery with an additional sheath. the moderato® ipg will be used to generate cardiac neuromodulation therapy (cnt) signals and deliver them to the patient through the cable and leads. a range of cnt signal parameters will be used to assess the effect on sympathetic activity at different positions of the rv pacing lead. ventricular pressure and volume readings from the conductance catheter and arterial pressure readings will be recorded and analyzed to assess the effect of cnt signals on cardiac function, sympathetic activity and blood pressure. the effects of cnt signal over a range of parameter settings will be studied for the different rv lead positions.

Eligibility criteria:
inclusion criteria: 1. subject is ≥ 18 years of age 2. subject requires implantation or replacement of a dual chamber pacemaker or requires an upgrade from a single chamber to a dual chamber pacemaker 3. subject has known hypertension 4. subject is willing and able to comply with the study and procedures. exclusion criteria: 1. subject has symptoms of heart failure, nyha class ii or greater 2. subject has significant (\>2+) mitral regurgitation, aortic regurgitation or aortic stenosis. 3. subject has permanent atrial fibrillation 4. subject has atrial fibrillation on the day of the study. 5. subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm 6. subject is on dialysis 7. subject has a history of prior neurological events (stroke or tia) within the past year or a neurological event (stroke or tia) at any prior time that has resulted in residual neurologic deficit. 8. subject has a history of autonomic dysfunction 9. women who are pregnant or breast-feeding 10. subject cannot or is unwilling to provide informed consent.
cervical intraepithelial neoplasm (cin)-warts efficacy trial in women (gardasil)(v501-013)(completed)

Conditions: Cervical Cancer; Genital Warts

Summary: the primary purpose of the study is to determine if gardasil (v501) with four components is able to prevent cervical cancer, cervical dysplasia, including cervical intraepithelial neoplasia (cin)(any grade) and adenocarcinoma in situ (ais), and genital warts.


Eligibility criteria:
inclusion criteria: * female with an intact uterus with lifetime history of 0-4 sexual partners exclusion criteria: * prior human papillomavirus (hpv) vaccination * prior abnormal paps * history of genital warts