Kornimate/medical-research-clean huggingface dataset:
efficacy and tolerability of ecopipam in adults with childhood onset fluency disorder (stuttering).

Conditions: Stuttering, Adult; Childhood-onset Fluency Disorder; Speech Disorders; Language Disorders; Communication Disorder

Summary: the primary objective of this study is to evaluate the efficacy and tolerability of ecopipam in reducing stuttering symptoms. it is hypothesized that ecopipam effectively reduces stuttering symptoms as measured on the ssi-iv total score, the cgi, sss and oases.


Eligibility criteria:
inclusion criteria: subjects can be enrolled in the study only if they meet all of the following criteria: 1. subjects must satisfy dsm-iv criteria for childhood onset fluency disorder (stuttering). 2. the nature of stuttering must be developmental in origin with the onset prior to ten years of age. 3. subjects must have a score of moderate or higher on the ssi-iv. 4. women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device). 5. subjects will be male or female from the ages of 18-60. 6. subject must have a madrs total score of ≤ 13 (normal mood) 7. subjects will be of only english speaking. exclusion criteria: subjects will be excluded from the study for any of the following reasons: 1. adult individuals who lack capacity to consent for themselves. 2. stuttering related to a known neurologic cause (e.g. head trauma, stroke). 3. unstable medical or psychiatric illness. 4. active substance abuse within three months prior to study inclusion. 5. any illness that would require the concomitant use of a cns active medication during the course of the study. 6. subjects with parkinson's dementia or other degenerative neurologic illness. 7. suffer from irregular heart rate or seizures 8. subjects who are pregnant or nursing an infant. 9. subject with a madrs ≥ 14 10. breastfeeding a child during the course of the study or for one month following completion 11. it is the investigator's opinion that the subject poses a significant suicide risk by the following criteria: 1. it is the investigator's opinion that the subject may be at risk of suicide. 2. the subject responds "yes" to question #4 (active suicidal ideation with specific plan and intent) on the baseline visit of the columbia suicide severity rating scale (c-ssrs), if the most recent episode occurred within the past 12 months.

Keywords: stuttering childhood onset fluency disorder ecopipam
physiotherapy in stress urinary incontinence

Conditions: Urinary Incontinence,Stress

Summary: the goal of this randomized controlled trial is to evaluate and compare the effects of functional magnetic stimulation and pelvic floor muscle training on pelvic floor muscle function, urinary incontinence symptoms and quality of life in women with stress urinary incontinence. the main questions it aims to answer are: * what is the effect of functional magnetic stimulation on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? * what is the effect of pelvic floor muscle training program on pelvic floor muscle function, symptoms of urinary incontinence and quality of life in women with stress urinary incontinence? * which intervention is more effective - functional magnetic stimulation or pelvic floor muscle training program? participants will be evaluated before and after the intervention with the following methods: * international consultation on incontinence questionnaire-short form (iciq-sf); * incontinence impact questionnaire-short form (iiq-7); * pelvic floor muscle strength and endurance will be assessed with a "pelvexiser" perineometer.

the study was performed in the period of 07/21/2021-30/10/2021. the study included 48 women 29-49 years old who have complained of stress urinary incontinence for at least 4 weeks, who gave birth and signed the consent form. women complaining of vaginismus, suffering from urinary tract infection, cancer, epilepsy or skin conditions with implanted pacemakers, metal implants and pregnant women were excluded from the study. study participants were randomly divided into two groups: the i group (n=24), in which participants underwent functional magnetic stimulation (fms) and the ii group (n=24) in which subjects received pelvic floor muscle training (pfmt) program. participants were evaluated before the intervention and repeated after 6 weeks. subjects responded to a general questionnaire before the intervention, before and after the intervention, the international consultation on incontinence questionnaire-short form (iciq-sf) and incontinence impact questionnaire-short form (iiq-7) were used to assess the symptoms of urinary incontinence and their impact on quality of life. pelvic floor muscle strength and endurance were assessed with a "pelvexiser" perineometer. statistical analysis was performed by ibm spss statistics 26.0 and microsoft excel software 365.

Eligibility criteria:
inclusion criteria: * complains of stress incontinence for at least 4 weeks; * women who have given birth. exclusion criteria: * pregnancy; * vaginism; * urinal infection; * oncological disorders; * epilepsy; * skin problems; * if they had an implanted heart pacemaker, metal implants.

Keywords: stress incontinence pelvic floor functional magnetic stimulation muscle training
imagery rescripting and imaginal exposure for anxiety symptoms

Conditions: Social Anxiety; Generalized Anxiety; Obsessive-Compulsive Symptom; Panic

Summary: this study will recruit 460 participants who self-report high symptoms of anxiety. participants will be randomly assigned to one of 4 groups: one analog intervention of imagery rescripting (ir) for memories, an analog intervention of ir for future events, and analog intervention of imaginal exposure (ie) for memories and an analog intervention of ie for future events. we will examine the efficacy and mechanisms behind each intervention.

after being informed about the study potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. they will be randomly assigned to one of four conditions (imagery rescripting past; imagery rescripting future; imaginal exposure past; imaginal exposure future) at a 1:1:1:1 ratio (n = 115 per group). participant will be assigned using a variance minimization method that controls for between group variance in continuous and categorical variables- spin, asi-3, oci-r, gad-7 and gender with a completely random assignment p random = .2 (for algorithm see sella et al., 2018). participants will attend three \~1.5 hour online zoom sessions (baseline-assessment and measurement, intervention, post assessment and measurement and follow-up measurement). in this multiple baseline study, participant will enter the intervention phase either 7 or 14 days after the baseline stage. assessors will be blind to the treatment condition.

Eligibility criteria:
inclusion criteria: we will recruit participants based on attainment of spin score \>= 24 and/or asi-3 scores \>=23 and/or oci-r subscale scores (not including hoarding subscale) \>=6 and/or gad-7 scores \>= 9 . exclusion criteria: diagnosis of psychosis, active suicidality, post-traumatic stress disorder, acute stress disorder. can't report a negative imagery related to a future social scenario. attending active psychotherapy sessions. started/stopped taking psychotherapeutic medications in the last 3 months.
ppi to promote the psychological well-being of children living in poverty

Conditions: Adolescent Development

Summary: positive psychology interventions use positive psychology techniques to identify meaning and value in life events to raise positive feelings and emotions. application of ppis has steadily increased in clinical and non-clinical samples. however, that meta-analysis did not include any study in a chinese population, and it remains unclear whether ppis are applicable in the hong kong chinese context.

a randomized controlled trial will be conducted. a convenience sample of 120 patients age 13 to 17 years with no cognitive and/or behavioral problem(s) will be recruited in secondary school around kwai chung estate participants will be randomized into experimental and control group. the experimental group, who will receive a 1.5-hour workshop covering positive psychology techniques delivered by a qualified research assistant, in groups of less than 5 people, and a booster intervention at 1 week. the control group will received no intervention. data collection will be conducted at baseline, 1 week, 1month, 3months and 6 months for both groups.

Eligibility criteria:
inclusion criteria: * age from 13-17 * can read chinese and speak cantonese exclusion criteria: * with identified cognitive and/or behavioral problem(s) * with identified mental problem(s) * participating in any mental health service/programme and/or receiving any psychiatric medication.

Keywords: poverty positive psychology depressive symptoms self-esteem quality of life
68ga-htk03149 for use as a diagnostic radiopharmaceutical

Conditions: Prostate Cancer; Prostatic Neoplasm; Prostatic Disease; Urogenital Neoplasms; Disease Attributes; Neoplasms

Summary: this is a preliminary evaluation of a radiotracer's biodistribution in human subjects. it is a prospective, single-centre, open-label, single group assignment interventional study. prostate cancer is very common, and psma imaging is currently the most accurate means of localizing these tumours. the goal is to evaluate the biodistribution and safety of \[68ga\]htk03149 pet/ct for prostate cancer imaging.

each subject will have a pet/ct scan using \[68ga\]htk03149 . the \[68ga\]htk03149 radioactive tracer is manufactured for this study under a clinical trial application filed with health canada. after providing informed written consent subjects will complete a medical history questionnaire. monitoring of adverse events there will be short-term evaluation of adverse events by comparison of vital signs before and after administration of \[68ga\]htk03149 . eighteen to seventy-two hours after \[68ga\]htk03149 administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. the study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire. follow-up assessments the following information will be collected up to 12 months following the pet/ct scans: initiation of a new treatment, laboratory results and pathology reports, results of imaging studies, final clinical diagnosis by physician and relevant clinical notes. the study is expected to take up to 1 year for accrual.

Eligibility criteria:
inclusion criteria: * participants with newly diagnosed or documented prostate cancers (pca), with at least one measurable lesion based on ct, mr or at least one visualised lesion on pet/ct imaging (either from an 18f-dcfpyl or 68ga-psma-11 pet). * ecog performance status of 2 or less. exclusion criteria: * medically unstable (eg. acute illness, unstable vital signs) * unable to lie supine for the duration of imaging * unable to provide written consent * exceeds safe weight limit of the pet/ct bed (204.5 kg) or unable to fit through the pet/ct bore (diameter 70 cm) * patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes. * patients with baseline alt or ast higher than 5× uln or 250 u/l. * patients with elevated baseline levels of total bilirubin (higher than 1.2× uln, or 1.3 mg/dl, (with exception of gilbert's syndrome), with inr \>1.2, or platelet count below the lower limit of normal (typically \<150 000/μl. * patients with elevated alkaline phosphatase (alp), equal to or higher than 2× uln or 250 u/l, unless the alp elevation is not from a hepatic origin.
upper gi serial tumour biopsies

Conditions: Oesophageal Cancer; Gastric Cancer

Summary: this is a prospective translational research study in which tumour samples, blood samples and other biospecimens will be requested from patients with locally advanced or metastatic malignant oesophageal and gastric carcinoma. there are two parts to the study: * part a - evaluation of serial tumour biopsies * part b - evaluation of circulating biomarkers and other biospecimens

this is a prospective, non-randomised, non-interventional, translational research study in which patients with locally advanced or metastatic oesophageal and gastric carcinoma will be asked to donate tissue, blood and other available biospecimens for translational and biomarker research. this is an exploratory biomarker study to generate preliminary data for future research projects incorporating identified aberrations. the overall aims of the study are to employ serial tumour biopsies, blood borne biomarkers and other biospecimens to investigate mechanisms of resistance to systemic therapy and develop predictive biomarkers of this resistance in patients with locally advanced and metastatic malignant oesophageal and gastric carcinoma. blood biomarkers will include enumeration and characterisation of circulating blood cell subtypes, as well as the evaluation of circulating cell-free proteins and nucleic acids. other biospecimens include urine, stool and hair follicle samples that the patient is willing to donate for research purposes, and ascitic, pleural, pericardial or cerebral spinal fluid, available to collect as part of clinically indicated procedures (standard care) and surplus to routine clinical requirements. these other biospecimens would be stored at the biobank.

Eligibility criteria:
inclusion criteria: 1. age of 18 years or more. 2. patients must have given written informed consent. 3. evidence of locally advanced or metastatic oesophageal and gastric carcinoma, i.e. stage iii or iv disease. 4. accessible tumour that can be safely biopsied using radiological or surgical techniques (if consenting to part a). 5. full blood count and coagulation tests within acceptable parameters (if consenting to part a). exclusion criteria: 1. inability to provide informed consent. 2. history of significant bleeding disorder (patients on anticoagulation are eligible if the anticoagulation can be safely managed to allow fresh tumour biopsies and blood sampling). 3. history of hiv, hepatitis b/c or other transmissible human disease. 4. any conditions where research biopsies or blood sampling may increase risk of complications for the patient and/or investigator, including high risk groups such as intravenous drug users.
kintsugi voice device pivotal study

Conditions: Depression; Depression Moderate; Depression Severe; Depression Mild

Summary: a prospective, single arm, non-randomized, pivotal clinical validation study to evaluate the ability of the kintsugi voice device (the device) to aid clinical assessment for depression by comparing its output with a diagnosis made by a clinician using the structured clinical interview for dsm-5 (scid-5-rv) for up to 1000 english speaking adult patients ages 22 and older living in the united states. recruitment will occur for 1 year and participation will be for up to 2 weeks


Eligibility criteria:
inclusion criteria: age \>22 at the time of informed consent self-reported disruption to activities of daily living (e.g. missed scheduled healthcare appointments, unable to concentrate on tasks like reading, working, or completing daily activities, or difficult completing activities such as exercise, diet, or recreation) access to a laptop, smartphone, tablet, or other device with a functioning microphone and access to the internet stated willingness to be video and audio recorded as part of the study stated willingness to comply with all study procedures and availability for the duration of the study functional english capacity in the home environment availability for the duration of the study resides in the united states at the time of consent and during completion of study - exclusion criteria: * participants with at least one of the following conditions will be excluded: any impairment that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (e.g., visual impairment, motor impairment, and/or hearing impairment) any lifetime history of neurological disease that impacts their ability to speak and/or use a computer to complete online surveys and/or a virtual clinician assessment (e.g., central nervous system disorders, multiple sclerosis, amyotrophic lateral sclerosis, and/or parkinson's disease) any lifetime history of stroke, cognitive defect (e.g., dementia or alzheimer's disease), and/or traumatic brain injury presence of voice disorders that impacts their ability to speak (e.g., acute or chronic laryngitis, vocal cord paresis or paralysis, or spasmodic dysphonia) past or active heavy smokers (an average of \>20 cigarettes per day) subjects who have previously participated in any kintsugi-sponsored study
improving sleep quality after total joint arthroplasty ( tja)

Conditions: Pain After TJA

Summary: the purpose of this study is the evaluate and improve sleep quality after total joint replacement.

patients in early stage after tka tend to suffer from sleep problem. sleep disturbances frequently occur in patients after surgery, and its occurrence is harmful for postoperative recovery. many factors can affect the quality of sleep after a major surgery including anesthesia-type, narcotic use and discomfort due to pain or restricted leg movements. pain directly leads to sleep disruption or even deprivation and, in turn, poor-quality sleep aggravates pain sensation. there seems to be a vicious circle: pain - poor-quality sleep - intensified pain - even poorer-quality sleep. presumably, if a patient suffers from catastrophizing, depression and anxiety , the result of tka will be worse due to poor sleep.

Eligibility criteria:
inclusion criteria -adults 18 years and older exclusion criteria - 1. no chronic pain 2. patients underwent revision or bilateral surgery. 3. patients underwent fracture. 4. patients suffering from dementia / delirium 5. patients on narcotics greater than 10mg hydrocodom before surgery 6. not willing to participate
a study to evaluate the efficacy and safety of cj-30001 and cj-30002 in type 2 diabetes mellitus patients

Conditions: Diabetes Mellitus

Summary: the aim of this study is to evaluate the efficacy and safety fo cj-30001/cj-30002.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus * 20\~69 years old * bmi \< 30kg/m2 * hba1c between 7% and 11% * receiving no oral antihyperglycemic agent for more than seven days for at least 8 weeks * willing to adhere to protocol requirements and sign a informed consent form exclusion criteria: * subjects with type 1 diabetes mellitus * fpg \> 270mg/dl * subjects having insulin treatment * subjects with acute or chornic metaboic acidosis * subjects with cardiovascular disease * subjects with chronic gi disease * subjects with a history of substance or alchol abuse within 1 year * subjects with a history of hypersensitivity to biguanide or a-gi * subjects with hypopituitarism or hypocorticalism * subjects with cancer * subjects who take corticosteriods or plan to take corticosteroid * ast and alt \> 2.5 times the upper limit of normal * creatinine level \> 1.5mg/dl in male and 1.4mg/dl in female * sbp \> 150mmhg or dbp \> 90mmhg * subjects who work the night shift * female subjects who are pregnant, breastfeeding or not using medically acceptable birth control * subjects who have participated in other study within 3 months * subjects judged to be unsuitable for this trial by investigator
assessing efficacy of intravenous acetaminophen for perioperative pain treatment in spinal surgery

Conditions: Lumbar; Injury

Summary: spinal surgeries are generally associated with intense pain in the postoperative period, especially for the initial few days. the aim of this study is to examine the effect of intraoperative intravenous acetaminophen in spine surgery on postoperative analgesic requirements, pain scores, patient satisfaction, and clinical recovery. enrolled patients are randomized to receive either intravenous acetaminophen or placebo at the time of surgical closure. it is hypothesized that patients receiving intravenous acetaminophen will have improved pain scores, require less opiate medication, and have better patient satisfaction than those receiving placebo.


Eligibility criteria:
inclusion criteria: * patients undergoing 1-2 levels primary spine surgery ≥18 years old exclusion criteria: * chronic opiate users * more than 3 levels or revision spine surgery * liver disease patients include elevated lft, hepatitis a, hepatitis b or hepatitis c, cirrhosis, fatty liver disease, and any other liver diseases caused by drugs, poisons, or alcohol(s) * allergy/hypersensitivity to acetaminophen * patients that have used acetaminophen during the 24 hours before their scheduled surgery subjects who were unable to communicate in english were further excluded because of their inability to complete the postoperative questionnaires
associated factors in perioperative hypoglycemia in patients with diabetes

Conditions: Diabetes; Hypoglycemia

Summary: the purpose of the study is to review incidences of mild, moderate, and severe hypoglycemia in preoperative care units, operating rooms, and postanesthesia care units and analyze associated conditions and treatment.

with evidence linking surgical morbidity to hyperglycemia (high blood sugar), attention to glucose control is warranted during surgery as well as in the postoperative period. consequently, measures to prevent and treat hyperglycemia - coupled with fasting status - places patients at considerable risk for perioperative hypoglycemia (low blood sugar). outpatient patient studies support that profound hypoglycemia can be deleterious and even fatal to patients. this descriptive study will utilize retrospective chart review to examine factors associated with hypoglycemia. charts from 700 subjects who experienced blood glucose values less than 70 mg/dl primarily in the preoperative and postanesthesia care units at william beaumont hospital-royal oak will be reviewed. another 1600 charts will be screened for subsequent intraoperative hypoglycemia: 800 that had low normal preoperative glucose values and 800 that had high preoperative values (with likelihood of insulin therapy). numerous factors believed to be associated with perioperative hypoglycemia will be analyzed including type and duration of diabetes, usual diabetes treatment regimen and alterations on day of surgery, self-reported usual fasting blood sugar range, duration of fasting, type of surgery and anesthesia, co-morbidities, and medications associated with hypoglycemia. determining factors associated with perioperative hypoglycemia will improve prediction of which patients are at highest risk for hypoglycemia, enabling healthcare providers to institute more conservative insulin therapy when indicated, initiate early maintenance intravenous dextrose, and/ or perform more frequent glucose testing. identifying associated factors will improve hypoglycemic predictions and interventions which should lead to safer, more effective care for patients with diabetes.

Eligibility criteria:
inclusion criteria: * patients who underwent surgery at william beaumont hospital in royal oak, michigan between january 1, 2003, and january 1, 2009. * point of care testing identified a blood sugar value less than 69 mg/dl at any time in the perioperative area; or a value between 70-89 mg/dl in the preoperative area; or a glucose value greater than 250 mg/dl in the preoperative area. exclusion criteria: * obstetric patients.

Keywords: perioperative hypoglycemia diabetes surgery surgery