Kornimate/medical-research-clean huggingface dataset:
dose-finding of pb-119 administered subcutaneously once-weekly versus placebo in drug-naïve t2dm subjects

Conditions: Type 2 Diabetes Mellitus

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of pb-119 in drug-naïve subjects with t2dm.

subjects will be assessed for eligibility over a 2-week screening period prior to a 2-week run-in period and a 12-week double-blind treatment period,4-week follow up period. the eligible patients will be randomized to 1 of 3 dose cohorts (a, b, or c). each patient will subsequently be randomized within the designated cohort to active drug or placebo at a 3:1 active drug:placebo ratio.

Eligibility criteria:
inclusion criteria: 1. males and/or females between the ages of ≥18 and ≤70 years at screening 2. patients in whom t2dm has been diagnosed according to 1999 whot2dm diagnostic criteria 3. hba1c ≥7.5% and ≤11% at screening and at week -1 4. body mass index (bmi) ≥18.5 and ≤35.0 kg/m2 at screening exclusion criteria: 1. female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial 2. treatment with any glucose lowing agent(s) within 3 months prior to screening.an exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness 3. calcitonin ≥50 ng/l at screening 4. patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2 5. fasting triglyceride ≥500 mg/dl at screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening 6. any acute or chronic condition that, in the opinion of the investigator, would limit the patient's ability to complete and/or participate in this trial 7. blood amylase or lipase \>3x uln, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at screening 8. serum creatinine ≥1.5 mg/dl (male patients) or ≥1.4 mg/dl (female patients), or estimated glomerular filtration rate (egfr) \<45 ml/min/1.73 m2 at screening 9. alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>2x upper limit of normal (uln) at screening and pre-randomization 10. severe cardiovascular diseases occurring within 6 months prior to screening
modified thoracoabdominal nerve plane block in living liver donors

Conditions: Liver Failure; Acute Postoperative Pain

Summary: ultrasound-guided modified thoracoabdominal nerve plane block (m-tapa) is performed deep into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. it provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. as there are studies showing m-tapa block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. we hypothesize that m-tapa block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.

open hepatic resection for living liver transplantation donor surgery can cause severe postoperative pain and if not treated properly, may increase the risk of chronic pain development, which has a significant impact on the patient's daily life quality. the use of interfascial plane blocks for pain control has increased in recent years, as ultrasonography (usg) has become a part of daily routine. interfascial plane blocks provide effective postoperative analgesia. additionally, reducing postoperative opioid consumption may be a useful strategy to provide hemodynamic stability and promote early mobilization. case reports state interfascial plane blocks to be effective and safe for providing effective analgesia compared to systemic analgesia in living liver donor surgeries. as studies are showing m-tapa block to be effective for postoperative analgesia for other abdominal surgeries, its effect on patients undergoing living liver donor surgery has not been studied yet. we hypothesize that the m-tapa block performed in living liver donors would reduce opioid consumption in the first 48 hours after surgery.

Eligibility criteria:
inclusion criteria: patients american society of anesthesiologists (asa) classification i- ii scheduled for living liver donation surgery for liver transplantation under general anesthesia exclusion criteria: patients * with history of bleeding diathesis, * receiving anticoagulant treatment, * with allergies or sensitivity to drugs used, * with an infection on the puncture site * who do not accept the procedure or participate in the study

Keywords: modified thoracoabdominal nerve plane block liver transplantation acute postoperative pain
comparative study between three different methods for stuttering therapy in children

Conditions: Stuttering, Childhood

Summary: the aim of work is comparing between three different methods for treatment of stuttering in children in order to reach to the best method for treatment


Eligibility criteria:
inclusion criteria: * children from 5 to 15 years old with iq above 80 exclusion criteria: * 1 - mental disability. 2- psychiatric problem as autism or attention deficit hyperactive disease. 3. secondary stuttering. 4. children with sever anxiety. 5. children with history suggested epileptic fits.
enhancing school-based violence prevention

Conditions: Aggressive Childhood Behavior

Summary: the purpose of this study is to compare two versions of mental health enhanced positive behavioral interventions and supports in reducing aggression in middle school students.


Eligibility criteria:
inclusion criteria: * for student participants: in 6th and 7th grades in a study school at study entry * for teacher participants: teacher at a study school exclusion criteria: * .for student participants: intellectual disabilities, very limited reading abilities, or in foster care
influence of glucose on metabolism and clinical symptoms of patients with parkinson's disease

Conditions: Parkinson Disease; Nutritional and Metabolic Diseases; Sugar Intake

Summary: many patients with parkinson's disease (pd) report an increased consumption of fast-acting sugars. this tendency to consume sweet, high-sugar foods occurs in some patients even before the onset of cardinal motor symptoms. some recent studies have demonstrated that pd patients have an increased consumption of fast-acting carbohydrates compared to healthy controls. however, the reason for this change in eating behavior has not yet been adequately explained. it is discussed that the increased sugar intake leads to an increased dopamine release in the brain via an increase in insulin and thus to an improvement in clinical symptoms. this study investigates the influence of fast-acting carbohydrates on insulin and glucose blood levels as well as motor and non-motor symptoms in patients with pd using an oral glucose tolerance test and a placebo oral glucose tolerance test in a crossover design.


Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease, stage hoehn \& yahr 1.5-3 * ability to pause antiparkinsonian medication in the morning without relevant impairment * capacity to give consent (determined in doubt by two independent neurologists, moca ≥18) and written informed consent. * patients are between 50 and 80 years of age, with exceptions for a maximum of 5 additional patients enrolled per group * for stratification into patients with and without sweet craving, a 3-day dietary protocol should be completed once by the patients * group i: increased hunger for sweets. * group ii: no increased hunger for sweets. for the stratification into patients with and without increased hunger for sweets, participants are asked to answer the following questions: 1. do you have sudden attacks of cravings for sweets? 2. would you say that your consumption of sweet food has increased in recent years? 3. would you describe your consumption of sugary food as increased or excessive? if one of the questions is answered with yes, participants will be assigned to group i, if all questions are answered with no, participants will be assigned to group ii. exclusion criteria: * other significant neurological diseases primarily affecting the central nervous system (e.g., multiple sclerosis) * diagnosis of diabetes mellitus or prediabetes * use of medications that affect glucose metabolism, such as antidiabetics, glucocorticoids, ciclosporin, tacrolimus, sirolimus, beta-blockers, thiazide diuretics, beta-2 adrenoreceptor agonists, theophylline, clozapine, olanzapine, paliperidone, quetiapine, risperidone, tricyclic antidepressants, mirtazapine, mianserin, carbamazepine, gabapentin, pregabalin, valproic acid, lithium, antiretroviral drugs, statins * cardiac or brain pacemakers
whole grain job's tear, muscle health, blood glucose and lipid level

Conditions: Sarcopenia; Frailty; Hyperglycemia; Hyperlipidemia

Summary: background: this investigation aims to explore efficacy of taiwanese whole grain job's tear on muscle health and blood glucose and lipid levels in community-dwelling older adults. methods: an open-label, 16-week, randomized controlled, cross-over trial involving participants with subject complaint of slower gait or weakness or fall in last year were recruited. the intervention group consumed taiwanese whole grain job's tear (red job's tear) or white job's tear. assessments included laboratory tests, functional assessments, and body composition.


Eligibility criteria:
inclusion criteria: people who aged 60-95 years patients with following characteristics: feeling loss in activity detecting decline in self's walking speed. feeling tired of doing everything. having fall event in last year. people willing to follow the program and cooperate with us for following tracking. people who are neither vegan nor vegetarian people agree and be able to sign the informed consent. exclusion criteria: people with any disease affecting their limbs, including: having fracture on limbs in the past 6 months having severe arthritis in the past 6 months any other whom pi recognized as weak control of their nervous system( e.g.: parkinson's disease and stroke). people with intermittent limp caused by peripheral artery diseases people with weak control of mental disorder people with weak control of cardiopulmonary disease people with weak control of malignant tumor people with weak control of kidney diseases (egfr \<60ml/min/1.73) people with visual impairment and hearing disorder which cannot help to complete the program. people who have underwent hormone treatment and planned to undergo hormone treatment during program session. any other condition that pi recognized as not suitable
parkinstep: automated pd gait and balance assessment for optimizing dbs

Conditions: Parkinson's Disease With Deep Brain Stimulation

Summary: changes in deep brain stimulation (dbs) settings can have a delayed effect on gait function, which makes it impractical to optimize dbs for gait parameters in the clinic. wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. this study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. this study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with dbs tuning for the lower extremities and gait in the future.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic parkinson's disease * age \> 21 * underwent dbs surgery targeting the subthalamic nucleus (stn) * bilateral or midline involvement when "off" dbs/medication state * clinical history of gait impairment or freezing of gait exclusion criteria: * "parkinson's plus" syndrome, secondary, or atypical parkinson's disease * underwent dbs surgery targeting the ventral intermediate (vim) * unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study) * dementia (determined by a neuropsychological assessment).
feasibility of the uricap-f for urine collection in hospitalized women

Conditions: Urinary Incontinence

Summary: the study will evaluate safety and effectiveness of the uricap-f, a non-invasive urine collection device for women, in hospitalized patients who would otherwise be treated with an indwelling catheter, pads or diapers.

following various disease conditions such as trauma, orthopaedic surgery, and infections etc., patients may be bedridden and unable to void in a bedpan or to make their way to the toilet. for lack of a better solution for urinary management, indwelling catheter and diaper use is common in hospitalized patients. there is no externally applied urine collection device on the market today for women. in such situations an indwelling catheter is often placed to relieve patients while they are incapacitated, despite lack of urinary retention. indwelling catheters, although effective, are associated with discomfort, pain, and urinary tract infections. in other cases diapers or absorbent pads may be used. these may be associated with skin irritation and infection. the study will evaluate the uricap-f, non-invasive urine collection devices for women, in hospitalized patients who are able to void or who are incontinent of urine

Eligibility criteria:
inclusion criteria: * female ≥ 18 years old * empties the bladder completely on voiding * a clinical indication for an indwelling catheter, use of pads or diapers * patient has signed an informed consent form, is cooperative and willing to complete all study procedures * absence of localized disease at the site of device application - vaginal discharge, itching, inflammation or skin condition * agrees to genital hair removal. exclusion criteria: * pregnant or breastfeeding * menstruation at time of enrolment * known allergy to silicon * dysuria * urinary retention - post-void residual urine more than 300cc * hematuria or pyuria (turbidity) on visual inspection, according to investigator judgement. * diagnosed with acute renal failure according, to investigator judgement. * serious or unstable psychological condition (e.g., eating disorders, clinical depression, anxiety, emotionally labile) which, in the opinion of the investigator, would compromise the patient's well-being or successful participation in the study * participating in another clinical study. * financial interest in the sponsor company or a competitor company by patient or a family member
adaptation of the pcip for children aged 6 to 11

Conditions: Post-Traumatic Stress Disorder in Children; Post-traumatic Stress Disorder

Summary: this study will implement a brief post-traumatic stress disorder (ptsd) intervention for children, the primary care intervention for ptsd (pcip) delivered through telehealth (computer or smartphone delivery), to 10 youth age 6-11 and their caregivers. mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. following re-aim guidelines, the investigators will assess: 1. reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) 2. adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. to understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. this treatment ranges from 1-4 sessions which last 50 minutes per session. the first session will cover psychoeducation about ptsd symptoms in children that can be delivered to the parent or both the parent and child. the first session will also teach the parent and child a breathing technique to combat the physiological impact of ptsd in children. the subsequent sessions will be tailored to meet the needs of the child's most distressing ptsd symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. each session contains coping skills that the parent and child can learn together. there is also material for parents to address behavior problems in youth. this treatment will be delivered via telehealth.


Eligibility criteria:
inclusion criteria: 1. patient referred to the shark program 2. patients must be at least 6 years old 3. the patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study; 4. patient is able to complete study activities in english. exclusion criteria: 1. suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days; 2. inability to provide informed consent or assent, and/or complete procedures in english. 3. patient is over the age of 11

Keywords: children primary care ptsd post traumatic stress disorder randomized pilot feasibility trial
pet/mri to enhance precision guidance in head and neck radiation treatment planning

Conditions: Head and Neck Neoplasms

Summary: the purpose of this study is to evaluate this new technology available at the university of wisconsin carbone cancer center in the setting of head and neck cancer radiation treatment planning. this study will also provide preliminary data critical to the development of multi-parametric, multi-modality quantitative imaging biomarkers and data analysis models for prediction of outcome in both tumors and normal tissue, which are essential for patient-specific adaptive therapy. all participants will undergo a diagnostic pet/ct and a radiation treatment planning ct per soc procedures. in addition, all participants will undergo an additional imaging set consisting of a pet/mri. it is anticipated that most patients will undergo the pet/mri on the same day as their pet/ct negating the need for a second injection of the fdg radioisotope used for soc pet imaging. all patients will receive gadolinium contrast per soc dosing guidelines for the mri portion of the pet/mri. both soc mmri pulse sequences and investigational sequences will be utilized in this study.


Eligibility criteria:
inclusion criteria: * participants with tumors of the head and neck region (nasal cavity, oral cavity, pharynx, larynx, sinuses, salivary glands, and head and neck skin) who are candidates for radiation treatment. exclusion criteria: * contraindications for mri: all patients will be screened with standard uwhc mri screening procedures: * any person with the following will be excluded: cardiac pacemaker, metal fragments in or around the eye, venous umbrella, permanent eyeliner or permanent artificial eyebrows. patents with the following potentially non-mri compatible devices will undergo screening using the standard uwhc mri screening protocol by trained uwhc personnel: cardiac pacemaker, heart valve replacement, intracranial aneurysm clips, middle ear, eye, joint, or penile implants, joint replacements, implantable hearing aids, neurostimulator devices, insulin pumps, shunts/stents, metal mesh/coil implants; metal plate/pin/screws/wires, or any other metallic implants. also patients with anatomical constraints limiting the feasibility of mri will be excluded. - issue of pregnancy: we will exclude all known pregnant females from the study to avoid the potential risk of fetal injury upon exposure to the pet scan. determination of pregnancy will be based upon the standard screening procedures in place for radiation therapy. * persons who are not fluent in english * anyone who can not provide written informed consent
swift outpatient alternatives for rapid stabilization

Conditions: Suicidal Ideation; Suicide Attempt

Summary: the goal of this clinical trial is to improve the effective outpatient management of acute youth suicide risk by optimizing intervention components to build an efficient, evidence-based intervention that is responsive to the needs of, and coordinated with, providers in primary care settings. the main questions are: 1. what is the strongest combination of soars components associated with reduction in youth suicidal thoughts and behavior (stb)? 2. do age and stb history moderate the impact of the effects of the soars intervention components? 3. do therapeutic alliance, youth and caregiver self-efficacy account for changes in youth stbs? 4. what helps medical outpatient providers refer to soars and continue care after soars?

the investigators are comparing different treatment sequences for suicidal thoughts and behaviors. the treatment package families are assigned will be determined by randomization. all participants will receive 1 session of collaborative assessment and management of suicidality (cams) and care management. cams treatment primarily focuses on working with a therapist to understand the reasons why the participants are thinking about suicide additional components which the participant may be randomly assigned to receive include coping skills training for youth, skills training for parents, and additional safety strategies. each treatment type is designed to help adolescents and young adults with suicide risk. participants will be randomly assigned to an intervention sequence for a minimum of 1 session (120 minutes) and maximum of 8 sessions (440 minutes, divided across separate youth and caregiver components). caregivers will receive at least 1 session and a maximum of 4 sessions. depending on the randomization, caregivers may be assigned to receive skills related to caregiving and safe storage of items that could be used for harm. to see how the treatment is going participants will receive study assessments at the beginning of the study, 1-month, and 2-months. study assessments will ask about demographics, suicide attempts, suicidal ideation, non-suicidal self-injury, experiences with treatment, substance use, and social experiences. the research team will also collect information from medical records.

Eligibility criteria:
inclusion criteria: * acute suicidal thoughts or past month suicide attempt as reported on positive responses to the ask suicide screening questionnaire (asq), exclusion criteria: * urgent medical care secondary to self-injurious behavior, psychosis, eating disorder that requires full or partial inpatient care, or * intellectual disability warranting a different treatment pathway; * limited english, spanish, vietnamese, or chinese proficiency that would interfere with ability to complete study assessments; * unwillingness to participate in psychotherapy, * caregiver unwilling or ineligible to participate; * and previous enrollment in soars program or other p50 project as to not confuse longitudinal follow-up.