Kornimate/medical-research-clean huggingface dataset:
an intervention study on transcranial photobiomodulation in children with attention deficit hyperactivity disorder

Conditions: ADHD - Attention Deficit Disorder with Hyperactivity

Summary: this study aims to intervene in children and adolescents with adhd using transcranial photobiomodulation, comparing its effects on executive function at the levels of electroencephalography (eeg), eye tracking, and cognitive behavior. the goal is to identify the most effective clinical treatment strategy for adhd patients.

this study is conducted as a randomized double-blind trial to investigate the effects of photobiomodulation therapy on adhd. initially, standardized assessment tools (physician ratings and parent self-reports) are employed to evaluate baseline clinical symptoms in adhd patients who meet the inclusion and exclusion criteria. the experiment utilizes a within-subject design (within-subject factors: real versus sham stimulation), with each participant randomly assigned to receive two interventions-one real and one sham stimulation-administered in a counterbalanced order, with at least a one-week interval between the two sessions. immediately following the intervention, standardized assessment tools are used to evaluate multidimensional clinical symptoms, and data related to executive function, including cognitive behavioral data, electroencephalographic data, and eye-tracking data, are collected. the intervention is carried out by trained technicians in accordance with the randomization results, while maintaining blinding for both clinical evaluators and participants.

Eligibility criteria:
inclusion criteria: 1. age between 6 and 18 years; 2. clinically diagnosed with adhd by a psychiatrist; 3. confirmed by the researcher (child psychiatrist) to meet the diagnostic criteria for attention-deficit/hyperactivity disorder as outlined in the fifth edition of the diagnostic and statistical manual of mental disorders (dsm-5); 4. m.i.n.i. kid interview shows only adhd, with no other comorbidities; 5. able to cooperate with transcranial photobiomodulation. 6. the participant and their guardian fully understand the study procedures and content and agree to participate in the study, signing the informed consent form. exclusion criteria: 1. diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder; 2. presence of severe physical diseases or conditions, such as significant intracranial lesions, thyroid disorders, epilepsy, congenital heart disease, severe hematologic disorders, systemic lupus erythematosus, auditory or visual impairments, etc.; 3. presence of significant structural brain abnormalities on imaging studies; 4. presence of severe neurological diseases with a clear family history or potential risk; 5. presence of metal implants or a pacemaker, or holes or fractures in the skull; 6. currently undergoing other adhd treatments (e.g., methylphenidate or other pharmacological treatments, behavioral therapy, etc.) or has discontinued such treatments for less than 2 weeks; 7. raven's progressive matrices iq score \< 85.

Keywords: tpbm adhd
assessment of the new provox life system for pulmonary health and quality of life after total laryngectomy

Conditions: Laryngectomy

Summary: background: the benefits of using heat and moisture exchangers (hmes) for pulmonary rehabilitation after total laryngectomy are widely known. however, current available hmes do not reach the level of humidification capacity of the nose, and patients adherence to using an hme 24/7 is not always possible. provox life hmes and attachments are a new range of hmes and attachments, with improved humidification/breathability performance, and designed to suit different situations. purpose and aim: in this clinical trial, the new provox life system was assessed for pulmonary rehabilitation and qol after total laryngectomy, and compared with currently available hmes and attachments. methods: forty laryngectomized patients, who were previous users of hmes, were randomized to usual care or provox life for 6 weeks, after which a cross-over occurred. data was collected at baseline, and after the end of each study period. additionally, patients filled in a diary and tally sheet to record their forced expectorations and coughing.


Eligibility criteria:
inclusion criteria: * total laryngectomy, irrespective of pharynx reconstruction method * 18 years or older * provox xtrahme user * provox adhesive user * longer than 3 months after total laryngectomy * longer than 6 weeks after postoperative radiotherapy exclusion criteria: * medical problems prohibiting the use of hme or adhesive * active recurrent or metastatic disease (medical deterioration) * recent pulmonary infections/unstable pulmonary condition * reduced mobility of arms and/or hands, unable to remove an hme * unable to understand the patient information and/or unable to give informed consent * insufficient cognitive ability to handle the hme or adhesive * larybutton users

Keywords: pulmonary rehabilitation quality of life heat and moisture exchangers
comparison of virtual reality to tablet-based distraction in children

Conditions: Anxiety, Separation

Summary: the proposed study is a prospective randomized trial to be performed in pediatric patient's ages 4 to 10 years undergoing surgical procedures requiring general anesthesia. the purpose is to compare the effectiveness of interactive tablet devices vs. virtual reality headsets. the primary outcome measure being patient anxiety at the time of separation. other comparison measures will include preoperative parent/caregiver anxiety, anesthesia mask acceptance characteristics at the time of induction, and time to fully recover in the post-operative period.

after receiving irb approval from our institution and consent from parents or guardians, asa i or ii status children ages 4 - 10 presenting for surgery requiring general anesthesia were recruited for this study. they were assigned to either tablet- or vr-based groups. at our institution, tablet-based distraction is widely used and represents standard practice. children in this control group were given tablets in the preoperative holding area before transport to the operating room. content consisted of entertainment apps providing access to music videos, movies and games targeting various age groups. the study group was given a virtual reality smartphone headset in the preoperative holding area prior to transport to the operating room. this headset was chosen because of its low cost and wide compatibility for a variety of smartphones. the content consisted of several vr environments that the child/parent could choose from. in both groups, the distraction with tablet or vr was continued throughout separation from caregivers, transport to the operating room, placement of monitors and mask induction of general anesthesia. anxiety at time of separation was measured by the modified yale preoperative anxiety scale (mypas). caregiver anxiety was measured using the state-trait anxiety inventory for adults (stai). mask acceptance at induction of anesthesia was determined by using the mask acceptance scale.

Eligibility criteria:
inclusion criteria: * children 4-10 years of age * undergoing procedure that requires general anesthesia exclusion criteria: * emergent procedure * asa iii-iv * patients with facial skin lesions * patients with significant history of motion sickness * visually impaired patients * patients unable to wear a virtual reality headset * patients receiving pharmacological intervention to decrease preoperative anxiety
the status of autonomic tone before tourniquet deflation during total knee replacement

Conditions: Hypotension; Blood Pressure, Low

Summary: this study evaluates the influences of the status of sympathovagal balance before tourniquet deflation on a decrease in arterial blood pressure following the deflation during total knee replacement arthroplasty

patients present with different hemodynamic profiles after intraoperative tourniquet deflation during total knee replacement arthroplasty. sympathovagal balance can be measured before tourniquet deflation and might determine the hemodynamic response to tourniquet deflation.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists physical status i - ii 2. body mass index \< 35 kg/m2 exclusion criteria: 1. coagulation deficiencies 2. known allergies to local anesthetics 3. neurologic deficit on the side being operated on 4. inflammation at the lumbar puncture site 5. cardiac conduction disorders or arrhythmias 6. congestive heart failure 7. serum electrolyte abnormalities 8. psychiatric disorders 9. patient's refusal 10. difficulty communicating with medical personnel 11. severe hypovolemia 12. increased intracranial pressure 13. severe aortic stenosis 14. severe mitral stenosis
incidence and clinical impact of serum hyperamylasemia (poh) after pancreatectomy on postoperative outcome and patient safety

Conditions: Pancreatectomy; Hyperamylasemia; Pancreatitis, Acute

Summary: recent evidence suggests that postoperative hyperamylasemia (poh) is a predictor of morbidity after pancreatectomy. this is based on the assumption that pancreatitis after pancreatectomy (ppap) is a major trigger for the development of complications and is indicated by hyperamylasemia. standardized prospective analysis and correlation with other laboratory parameters, hasn't been performed to date. therefore the overall study aims are: * to prospectively evaluate the incidence and assess the clinical value of biochemical changes for the postoperative course. * to confirm and improve the definition and classification of postpancreatectomy acute pancreatitis (ppap) of the international study group of pancreatic surgery (isgps) and to provide knowledge for effective early management of complications.


Eligibility criteria:
inclusion criteria: * all patients undergoing pancreatic resection for malignant and benign disease with or without pancreatic anastomosis * patients aged 18-85 years * willingness to participate as demonstrated by giving a written informed consent. exclusion criteria: * necrosectomy (endoscopic or open) for primary acute pancreatitis or within laparotomy * age less than 18 years * surgical drainage procedures without pancreatic resection (cystojejunostomy for pancreatic pseudocysts) * one-stage total pancreatectomy * missing written consent
structured non-operative treatment of knee osteoarthritis

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (nsaids) and pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis. the h1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment at the primary endpoint, which is follow-up 12months after the start of the treatment. see statistical analysis plan available under "links" for further description of the study.

knee osteoarthritis (oa) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. in addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults. it is recommended both nationally and internationally that the treatment of knee osteoarthritis should include multiple treatment modalities. clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement. however if the patient is not a candidate for total knee replacement, the patient most often receives only information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. this postponement of treatment can lead to a worsening of pain and function and a worse outcome after treatment. therefore, the current treatment strategy for the patient group is problematic. the current practice may be due to the lack of studies with high level of evidence that have examined the optimal non-operative treatment approach and compared it with the current standard treatment for this group of patients.

Eligibility criteria:
inclusion criteria: * knee-oa detected by x-ray (kellgren \& lawrence grade 1 or greater) * koos4 of ≤ 75 * considered not to be a candidate for total knee replacement (tkr) by the orthopedic surgeon. * the participant is \> 18 years of age. * the participant can provide relevant and adequate, informed consent. exclusion criteria: * prior tka ipsilateral * rheumatoid arthritis * mean vas \> 60mm the last week on a 0-100mm scale * possible pregnancy or planning pregnancy; * inability to comply with the protocol; * inadequacy in written and spoken danish.

Keywords: osteoarthritis, knee treatment outcome time factors rehabilitation combined modality therapy middle aged aged aged, 80 and over male female humans analysis of variance
pharmacokinetics and relative bioavailability of bococizumab (pf-04950615; rn316) when administered to the abdomen, thigh or upper arm

Conditions: Hypercholesterolemia

Summary: this study aims to characterize the single dose pharmacokinetics of pf-04950616 following subcutaneous injection to the abdomen, upper arm or the thigh.


Eligibility criteria:
inclusion criteria: * male and female subjects 18 to 65 years of age. * body mass index (bmi) ≤ 33 kg/m2, and total body weight of 60 kg to 90 kg (132 lbs to 198 lbs). * fasting ldl-c must be \> 130 mg/dl (borderline high per ncep atp iii criteria) at two qualifying visits: initial screening (days -28 to -14) and day -7. exclusion criteria: * poorly controlled type 1 or type 2 diabetes mellitus (hba1c \> 9.0%). * history of a cardiovascular or cerebrovascular event (eg, mi, stroke, tia) or related procedure (eg, angioplasty) during the past year. * subjects who meet the new york heart association (nyha) criteria for congestive heart failure (chf) classes iii or iv.

Keywords: pharmacokinetics bioavailability pf-04950615
a study of rituximab (mabthera) in participants with chronic lymphocytic leukemia (cll)

Conditions: Lymphocytic Leukemia, Chronic

Summary: this study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with b-cell cll.


Eligibility criteria:
inclusion criteria: * adult participants greater than or equal to (≥) 18 years of age * b-cell cll * no previous treatment for leukemia exclusion criteria: * history of other malignancies within 2 years before study entry, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, prostate cancer, or breast cancer * comorbid condition requiring long-term (greater than \[\>\] 1 month) systemic corticosteroids during study treatment * known infection with hepatitis b or c virus or with human immunodeficiency virus (hiv)
fondaparinux eu-rmp (adherence)

Conditions: Acute Coronary Syndrome

Summary: fondaparinux, a synthetic and specific factor xa inhibitor, was granted an acs indication by health canada in march 2007 and by the emea in september 2007. among acs patients, fondaparinux is indicated for the treatment of ua/nstemi in patients for whom urgent pci (within 2 hours) is not indicated, and for the treatment of stemi in patients who are managed with thrombolytics or who are initially to receive no other form of reperfusion therapy. the approved prescribing information for fondaparinux in acs provides recommendations for use in patients undergoing pci. the purpose of this study is to evaluate physician adherence to this prescribing information in acs patients treated with fondaparinux and who undergo pci. the primary endpoint is the proportion of patients with acs treated with fondaparinux, for whom the prescribing information during pci was followed (i.e., adjunctive anticoagulant therapy administered at the time of pci). measurement of the effectiveness or safety of fondaparinux use in acs patients is not within the scope of this study. arixtra® is a trademark of the glaxosmithkline group of companies.


Eligibility criteria:
inclusion criteria: * discharge diagnosis of acs (ua/nstemi or stemi) * pci during the hospitalization * anticoagulant treatment with fondaparinux exclusion criteria: * enrollment at the time of the index hospitalization in a clinical study that could influence acs treatment practices, specifically the in-hospital use of anticoagulation

Keywords: prescribing information
18794 - human photo toxicity test

Conditions: Sunscreening Agents

Summary: to determine the phototoxic potential of a topically applied article in human subjects.


Eligibility criteria:
inclusion criteria: * be male or female between the ages of 18 and 60 inclusive; * be lightly pigmented (fitzpatrick skin type i, ii, iii); * have read and signed the written informed consent form and have completed a hipaa authorization form in conformance with 45cfr parts 160 and 164; * be in general good health as determined by the subject's medical history and in the discretion of the investigator. exclusion criteria: * have a visible sunburn; * have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses; * must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product. * have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products.
open-label safety extension study of 2.5, 5 and 10 mg of vortioxetine (lu aa21004) in long-term treatment of major depressive disorder in adults

Conditions: Major Depressive Disorder

Summary: the purpose of the study is to evaluate long-term safety and tolerability of vortioxetine over a period of 52 weeks in patients with major depressive disorder (mdd) having completed 8-week acute treatment.


Eligibility criteria:
inclusion criteria: - patients who completed 8-week short-term treatment study for major depressive episode, nct00635219 / 11984a exclusion criteria: * any current psychiatric disorder other than mdd as defined in the diagnostic and statistical manual of mental disorders, fourth ed., text revision (dsm-iv tr) * female patients of childbearing potential who are not using effective contraception * use of any psychoactive medication other protocol-defined inclusion and exclusion criteria may apply.

Keywords: major depressive disorder long-term safety open-label
a study of neoadjuvant nivolumab + palbociclib + anastrozole in post-menopausal women and men with primary breast cancer

Conditions: Breast Cancer; Cancer

Summary: a randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with er+/her2- breast cancer


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * participants must have untreated, unilateral, histologically confirmed er+, her2- invasive breast cancer with primary tumor ≥2 cm in largest diameter (ct1-3) in one dimension by clinical or radiographic exam, for whom neoadjuvant endocrine monotherapy deemed to be a suitable therapy. * participants must be deemed eligible for surgery and must agree to undergo surgery after completion of neoadjuvant therapy and agree to provide tumor tissue at baseline, on-treatment, and at surgery. * women must have documented proof that they are not of childbearing potential. * participants must have a performance status (ps) ≤ 1 on the eastern cooperative oncology group (ecog) scale exclusion criteria: * participants who may have had any treatment, including radiotherapy, chemotherapy, and/or targeted therapy administered for the currently diagnosed breast cancer prior to enrollment or for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment. * participants who have a history of or active, known or suspected autoimmune disease, or other syndrome that requires systemic steroids above physiological replacement dose or autoimmune agents for the past 2 years. * prior treatment with either et or cdk4/6 inhibitors for breast cancer (bc) within 5 years or an anti-pd-1, anti-pd-l1, anti-pd-l2, or anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways, or history of allergy, or hypersensitivity to study drug components * prior malignancy active within the previous 3 years or participants with serious or uncontrolled medical disorders. * personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), long or short qt syndrome, brugada syndrome, or known history of corrected qt prolongation, torsade de pointes, or sudden cardiac arrest. other protocol-defined inclusion/exclusion criteria apply.

Keywords: nivolumab breast cancer cancer er+ her2- neoadjuvant