Kornimate/medical-research-clean huggingface dataset:
a pilot study of collaborative assessment and management of suicidality with suicidal children ("cams-4kids")

Conditions: Suicidal Ideation; Suicide, Attempted

Summary: the purpose of the study is to assess the feasibility and acceptability of cams-4kids for children with suicidal ideation and/or behavior. during this open pilot trial, we will enhance treatment procedures, refine adherence measures, and develop a treatment manual. our study sample will include 10 children, ages 5 - 11 years old, seeking outpatient services for suicidal ideation and/or behavior.

the collaborative assessment and management of suicidality (cams-jobes, 2006; 2016) is an evidence-based, therapeutic framework for addressing suicide risk in the adult population. cams-4kids, the research intervention used in this study, is a 10-session developmentally-sensitive adaptation of cams for children ages 5 - 11 years old. within the cams framework, clinicians treat patient-identified issues that contribute to their suicidal thoughts and/or behavior called "suicidal drivers." a "clinical road map" is provided through the suicide status form (ssf) that guides treatment as an assessment, treatment planning, tracking and clinical outcome tool. clinicians and children engage in the assessment and treatment planning sections of the ssf - initial form at the outset of treatment. a cams stabilization plan is also collaboratively developed which focuses on reducing access to lethal means, coping strategies, decreasing interpersonal isolation, and ways to address potential barriers to care. subsequent cams-4kids sessions include ongoing assessment and treatment plan reviews using the ssf - interim sessions form. the cams stabilization plan is also reviewed and updated as clinically indicated. treatment involves clinical interventions most appropriate to treat the patient's "suicidal drivers." clinical interventions may include coping cards, "hope journal," behavioral activation, virtual hope box, increasing social support, guided imagery, dbt relaxation skills, positive self-talk, and other cognitive-behavioral techniques. the conclusion of cams-4kids occurs after 3 consecutive sessions of effectively managing suicidal ideation and behavior. the ssf outcome/dispositional final session form is completed at the end of treatment.

Eligibility criteria:
inclusion criteria: * children between the ages of 5 - 11 years old, inclusive, at the time of consent; * current suicidal ideation and/or behavior; * resides with primary caregiver who has legal authority to consent to research participation * client of outpatient behavioral health services * outpatient or mood and anxiety program visit scheduled at least 4 weeks from the diagnostic assessment and/or discharge from the crisis stabilization unit. exclusion criteria: * the inability to understand study procedures (e.g. developmental disabilities, severe cognitive impairments, actively psychotic) * inability of the child and/or parent to speak or read english * current participation in weekly therapy sessions with outpatient behavioral health crisis team

Keywords: suicide child cams
cool-bp study: continuous versus occasional blood pressure study

Conditions: Hypertension

Summary: the cool-bp study is part of the remote hypertension program and will investigate the data provided by aktiia bracelet (a cuffless blood pressure monitor at the wrist) when integrated into the remote hypertension program. the cool bp study aims to compare weekly and monthly blood pressure averages measured manually by traditional home blood pressure monitoring to those measured automatically by the aktiia bracelet.

this is a prospective open-label single arm study. the investigational device of this study is the aktiia bracelet device. aktiia bracelet is a non-invasive blood pressure (bp) monitor intended to track systolic and diastolic blood pressure trends. the aktiia bracelet can also measure heart rate. participants who consent to participate in cool-bp will be shipped an aktiia device to participants' residence. for 6 months, patient will continue the procedures of the remote hypertension program in parallel to wearing the aktiia bracelet. the remote hypertension program is run remotely according to a clinical algorithm, where study navigators contact patients at regular intervals and monitor symptoms by regular phone calls; laboratory tests are obtained to ensure safety of the protocol's prescribed medications. any symptoms will be evaluated by the program nurse practitioner or physician and managed per standard of care. during the study, the patient completes several surveys to give opinion on aktiia product versus home blood pressure monitoring. following six months of using the aktiia.product, the participant's participation in this study will end. participants continued participation in the remote hypertension program will depend on whether participants have met the blood pressure goals outlined in that program.

Eligibility criteria:
inclusion criteria: * fluent in written and spoken english * already enrolled in the remote hypertension program * average of last 3 office blood pressures \>140/90 mm hg in last 18 months or last office blood pressure \>140/90 mm hg in last 6 months or referred by md and last 1 blood pressure \>130/80 mm hg * own an iphone exclusion criteria: * tachycardia (heart rate at rest \> 120bpm) * atrial fibrillation, persistent * severe heart failure (lvef\<35%) * pheochromocytoma * raynaud's disease * trembling and shivering * known pregnancy * breastfeeding * arteriovenous fistula * arm amputation * exfoliative skin disease * lymphoedema * known allergy to silicone * not massachusetts resident * last mgb office visit \>3 years * no-mgb provider * terminal medical condition * ckd 4-5 (egfr ≤ 30 ml/mn)

Keywords: hypertension
effects of laser therapy and led therapy on elderly individuals with temporomandibular disorder

Conditions: Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder

Summary: temporomandibular disorder (tmd) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and neck. tmd can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. the disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction and headache. the etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase in emotional stress. studies have demonstrated that phototherapy is an efficient option for the treatment of tmd, leading to improvements in pain and orofacial function. the aim of the proposed study is to analyze the effects of low-level laser therapy and light-emitting diode (led) therapy on pain and function in patients with tmd. methods: a randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70 years of age allocated to either a laser group or led group submitted to twelve sessions of phototherapy. the research diagnostic criteria for tmds will be used to evaluate all participants. pain will be measured using the visual analog scale. orofacial function will be measured based on maximum vertical mandibular movement and muscle tension (determined through palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscles). electromyographic analysis of the masseter and anterior temporal muscles will also be performed.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of tmd based on the rdc/tmd; * age between 40 and 70 years. exclusion criteria: * dentofacial anomalies; * currently in orthodontic or orthopedic treatment for the jaw; * currently undergoing physical therapy; * currently undergoing psychological treatment; * use of muscle relaxant or anti-inflammatory agent.
fever after tick bite study

Conditions: Tick-Bite; Fever; Tick Fever; Tick-Borne Diseases; Encephalitis, Tick-Borne; Tick Bites

Summary: the proposed study is a collaboration between microbiology, su/sahlgrenska and the infectious diseases clinic at su/östra as well as several infectious diseases clinics throughout sweden aiming at improving microbiological diagnostic assays regarding the early identification of tick-borne microorganisms (including as of yet unidentified pathogens) capable of causing human disease using modern diagnostic tools. at the initial study visit (day 0) plasma, serum, urine, saliva, and pbmcs (and tick, if available) will be collected from patients developing fever within two weeks after a tick bite. additional follow-up samples will be obtained after 9 and 30 days as well as after 6 months. the initial samples will be analyzed using (a) directed multiplex pcr analysis for tick-borne encephalitis (tbe), borrelia, anaplasma, neoerlichia, rickettsia, coxiella, tularemia, and babesiosis in plasma, whole blood and urine, (b) conventional igm and igg serology for tbe, (c) "next generation sequencing" (ngs) for the detection of bacterial 16s rrna as well as unknown viruses, (d) potential biomarkers, and (e) host genetic factors. among patients where initial sampling indicates the presence of a potential pathogen or in patients developing neurological symptoms, a lumbar puncture will be performed and csf will be further analyzed. samples will also be evaluated regarding potential microbiological factors predisposing for severity of infection. the primary objective of the study is to improve diagnostic tools in the initial early phase of infections caused by tick-borne pathogens, especially tbe prior to the affliction of the central nervous system, and to attempt to identify which factors impact the course of infection as it is believed that approximately 75% of infected individuals resolve their infection in this first phase whereas others develop meningoencephalitis with significant subsequent neurological sequelae. secondary objectives of the study include investigating for the presence of and treating other tick-borne pathogens, setting the stage for coming clinical trials evaluating novel anti-viral therapies for tbe.


Eligibility criteria:
inclusion criteria: * written informed consent * male and female patients ≥18 years of age * medical history of tick bite within past 2 weeks * documented or medical history of fever (≥38°c) within past 2 weeks exclusion criteria: * inability or unwillingness to provide informed consent or abide by the requirements of the study * presence of urinary tract symptoms * presence of non-tick related, infectious agent causing fever, e.g. a respiratory virus * presence of other medical, non-infectious cause of fever
a study to learn about the effectiveness of cancer medicines in patients with metastatic non-small cell lung cancer in norway.

Conditions: Non-Small Cell Lung Cancer

Summary: the main purpose of the study is to learn about the effectiveness and treatment sequence of lung cancer medicines. this study is performed outside of clinical trials in norway in patients with metastatic non-small cell lung cancer. non-small cell lung cancer is a group of lung cancers named for the kinds of cells found in the cancer and how the cells look under a microscope. metastasis is when the cancer cells spread to other parts of the body. this study includes patient's data from the database who: * are 18 years of age or older. * are confirmed to have metastatic non-small cell lung cancer between 01 january 2009 and 31 december 2022. the study is based on data collection from 3 national health registries: * the cancer registry of norway (crn), * the norwegian patient registry (npr), * the norwegian drug registry (ndr). data from these registries will be linked at an individual patient level to create a single, unified dataset. the information collected includes: diagnosis, cancer stage at diagnosis, date of diagnosis, birth year, type of medicinal treatment, date of treatment start and end, treating hospital, age, gender, etc.


Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years old with histologically confirmed stage iiib, iiic, iva, or ivb nsclc at the time of diagnosis 2. received their first nsclc diagnosis (stage iiib, iiic, iva, or ivb) between 01 january 2009, and latest available year exclusion criteria: 1. patients ≥ 18 years old with histologically confirmed stage iiib, iiic, iva, or ivb nsclc at the time of diagnosis who received radiation therapy with curative intent, defined as a radiation dose larger than 50gy 2. if the data include patients diagnosed after 2021, iiib patients will be excluded due to changes in the guideline. the updated guidelines for 2022 recommends that patients diagnosed with stage iiib who have surgery with the intent to cure should not have ''curative'' radiation (i.e.: it is not possible to exclude these from the population from 2022).
single port versus four ports laparoscopic cholecystectomy and early postoperative pain

Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting; Postoperative Complications

Summary: this is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.

this study is a randomized, two-arm, double-blinded three-center trial to compare single-port transumbilical laparoscopic cholecystectomy with conventional 4-port laparoscopic cholecystectomy. 120 patients are included with a 1:1 randomization. three centers participate in the trial. inclusion criteria: female patients, asa i-iii, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis. exclusion criteria: expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery. pain and nausea is measured on vas before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation. cosmesis is evaluated after 28 days. patients are telephone-interviewed after 12 months and asked about port hernia formation. if hernia is suspected patients are called in for an abdominal ultrasonography.

Eligibility criteria:
inclusion criteria: * asa i-iii * planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis exclusion criteria: * expected poor compliance * history of cholecystitis or severe pancreatitis * earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery

Keywords: single site surgery laparoscopic surgery pain nausea
a follow-up study to evaluate the safety of allo-asc-dfu in allo-asc-dfu-101 clinical trial

Conditions: Diabetic Foot Ulcer

Summary: this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-dfu treatment in phase 1 clinical trial (allo-asc-dfu-101) for 23 months.

this is an open-label follow up study to evaluate the safety for the subjects with allo-asc-dfu treatment in phase 1 clinical trial (allo-asc-dfu-101) for 23 months. allo-asc-dfu is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (vegf) and hepatocyte growth factor (hgf), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a diabetic foot ulcer.

Eligibility criteria:
inclusion criteria: 1. subjects who are treated with allo-asc-dfu sheet in phase 1 clinical trial of allo-asc-dfu-101. 2. subjects who are able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. subjects who are considered not suitable for the study by the principal investigator (for example, subjects requiring surgical procedure on target site).
water- and salt-homeostasis in healthy humans, and in patients with heart- or lung disease

Conditions: Healthy Volunteers; Heart Failure; Aortic Stenosis; Ischemic Heart Disease; Pulmonary Hypertension

Summary: the purpose of the study is to determine whether the excretion of renal water- and salt-channels in the urine reflects the handling of water and salt in the kidneys, and whether the excretion can be used to monitor and/or predict the effects of treatment of certain heart or lung diseases.

the purpose of the study is to determine whether the excretion of renal water- and salt-channels (aquaporin-2 and epithelial sodium channels) in the urine accurately reflects the handling of water and salt in the distal tubules af the kidneys, and whether quantification of these channels in the urine is useful to monitor and/or predict the effects of pharmacologic or surgical treatment of heart failure and heart failure-related diseases (aortic stenosis, acute and chronic ischemic heart disease or pulmonary hypertension)

Eligibility criteria:
inclusion criteria: * symptomatic heart failure * severe valvular aortic stenosis * acute coronary syndrome * medically refractory chronic angina pectoris or pulmonary hypertension with preserved left ventricular function exclusion criteria: * pregnancy * drug abuse * malignant disease * significant disease of other organs including endocrine diseases

Keywords: aquaporin epithelial sodium channels heart failure valvular heart disease ischemic heart disease
a study of the efficacy and safety of orvepitant in subjects with pruritus associated with atopic dermatitis

Conditions: Pruritus; Atopic Dermatitis

Summary: the purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of pruritus associated with atopic dermatitis.

a multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with pruritus associated with atopic dermatitis. doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups. each group will compromise of approximately 100 subjects, randomized 1:1:1:1 (approximately 400 subjects in total). all subjects will enter a two-week screening period to determine eligibility. eligible subjects will be randomized at the baseline/day 1 visit and enter a 12-week double-blind dosing period. during this period there will be four visits at weeks 2, 4, 8 and 12. there will be a final safety follow-up visit four weeks after the end of the treatment period.

Eligibility criteria:
key inclusion criteria: * documented diagnosis of atopic dermatitis for ≥ 6 months confirmed by either the uk working party definition or the hanifin definition * subjects must have chronic (\> 6 months) pruritus which is unresponsive or inadequately responsive to current therapies such as topical steroids or antihistamines * subjects must have atopic dermatitis with a severity \> 3 on the iga and easi ≥12 at screening visit/visit 1 key exclusion criteria: * presence of, or history of, any other inflammatory dermatosis or skin conditions which may cause pruritus * any other possible cause for pruritus eg systemic, neurological, idiopathic, or metabolic * acute super-infection of ad lesions requiring treatment with antibiotics within 4 weeks of visit 2 * inability to comply with the use of prohibited and allowed medications as described in the protocol.
a study to investigate safety and efficacy of cp-690,550 for induction therapy in subjects with moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: this study investigates safety and efficacy of cp-690,550 in adult patients with moderate to severe crohn's disease. the study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).


Eligibility criteria:
inclusion criteria: * male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in india and 65 years in the netherlands). * subjects with clinical diagnosis of crohn's disease for at least 6 months prior to screening. * subjects with active moderate to severe ileal, ileocolic, or colonic cd defined by a baseline score of crohn's disease activity index (cdai) of 220 to 450 at baseline. exclusion criteria: * diagnosis of indeterminate colitis, ulcerative colitis (uc), or clinical findings suggestive of uc. * subjects diagnosed with crohn's disease but without previous exposure to treatment (i.e., treatment-naïve). * subjects receiving the following treatment for crohn's disease: * azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline. * anti-tnfα therapy within 8 weeks prior to baseline. * interferon therapy within 8 weeks prior to baseline. * cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline. * intravenous corticosteroids within 2 weeks prior to baseline.
relationship between initial probing depth and changes in clinical parameters following non-surgical periodontal treatment in chronic periodontitis patients

Conditions: Chronic Periodontitis

Summary: aim: the aim of this study was to evaluate the relationship between initial probing depth (ipd) and changes in clinical parameters following non-surgical periodontal treatment (npt) in chronic periodontitis patients. material and methods: a total of 1672 periodontal pockets having 3 mm≤ipd≤9 mm in 15 chronic periodontitis patients were included. npt consisting of oral hygiene instructions, scaling and root planing was applied in two sessions. probing depth (pd), clinical attachment level, gingival recession (gr) were measured before and eight weeks after treatment. pocket sites were grouped according to their ipd and root number of teeth as single- or multi-rooted.


Eligibility criteria:
inclusion criteria: * systemically healthy, * non-smoker, * chronic periodontitis diagnosed according to armitage 1, * aged between 35 and 65, * not received any periodontal treatment within the last 3 months, • have horizontal bone loss radiographically, * presence at least 20 natural teeth except third molars * consent to participate in the study. exclusion criteria: * any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, hiv infection), * smoking, * antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study, * any physical limitations or restrictions that might preclude normal oral hygiene procedures.

Keywords: chronic periodontitis, dental scaling, periodontal pockets