Kornimate/medical-research-clean huggingface dataset:
evaluating the effective and safe use of stream™ platform

Conditions: User-Centered Design; Anastomotic Leak; Colorectal Surgery; Artificial Intelligence

Summary: the study aims to demonstrate the potential for at-home monitoring using stream™ platform, through simulated-use testing. lay users, defined as subjects or nonprofessional caregivers, will be asked to operate stream™ platform. safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use. additionally, clinical testing will be conducted to identify correlations between measurements from stream™ platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (soc) that may be skipped if the subject is discharged early.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years - male or female. * subject/sdm understands and has voluntarily signed and dated informed consent form (icf). * subject underwent colorectal surgery with anastomosis. * subjects must be willing to comply with trial requirements. * subject has a prophylactic abdominal/pelvic drain after colorectal surgery. exclusion criteria: * subjects/caregiver is unwilling or unable to comply with the requirements of the protocol. * 24 hours or more have passed since the end of the subject's surgery and consent was not attained. * the subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication. * plans that the subject will be discharged in less than 3 days post-surgery. * subject has reported that they are pregnant. * subject has a permanent end stoma. * subject is delirious. * subject has severe dementia. * subject was involved in the planning and conduct of the clinical investigation. * origin™ is not compatible with the drain used on the subject. * subject and/or caregiver is/are not capable of conducting the calibrations for stream™ platform (this can be self-reported or determined by the crc/hcp/other research staff). * the subject and/or caregiver is/are unable to understand the instructions provided for the management and calibration of stream™ platform (this can be self-reported or determined by the crc/investigator/other research staff).

Keywords: anastomotic leak artificial intelligence colorectal surgery eras stream platform
treating central neuropathic pain with low dose naltrexone for people with spinal cord injury

Conditions: Central Neuropathic Pain; Spinal Cord Injury

Summary: the goal of this pilot clinical trial is to find out how well low dose naltrexone works for people with pain due to spinal cord injury. the main questions it aims to answer are: will low dose naltrexone reduce pain, and increase the quality of life for people with central neuropathic pain due to spinal cord injury. hypothesis 1: ldn will decrease the severity of cnp in adult patients with sci as measured by the neuropathic pain scale (nps) hypothesis 2: ldn will improve quality of life of patients with sci as measured by various validated clinical tools there is no comparison group. this study is being completed to give investigators more information for how to best run a larger clinical trial. participants will be asked to take an oral dose of 4.5mg of naltrexone, daily, for 12 weeks.

this study is being completed to provide the first evidence that low dose naltrexone may be able to lower pain and improve quality of life for people with pain due to spinal cord injury. data from this study will be used to plan a larger, randomized control trial. if eligible, participants will take a daily low dose naltrexone pill (4.5mg) by mouth for 12 weeks. study participants will keep a daily medicine log and a daily sleep log. the study team will check in regularly (virtual visits) with the participants and give questionnaires verbally.

Eligibility criteria:
inclusion criteria: 1. presence of a traumatic cervical or thoracic spinal cord injury 2. age ≥18 3. \>6 months from time of injury 4. central neuropathic pain related to sci, based on evaluation of a physical medicine \& rehabilitation physician 5. dn4 questionnaire ≥ 4 6. english speaking exclusion criteria: 1. adjustment in pain medications within the previous month 2. chronic opioid treatment 3. current treatment with naltrexone or other opioid antagonist 4. allergy to naltrexone 5. central neuropathic pain attributed to other etiology 6. neuropathic pain attributed to the peripheral nervous system 7. phq9 ≥15 indicating moderately severe or severe depressive symptoms 8. documented traumatic brain injury that would affect study participation, in the opinion of the investigator 9. scheduled elective surgery during the duration of the study 10. pregnant or breastfeeding 11. illicit substance use per wisconsin law

Keywords: central neuropathic pain cnp spinal cord injury sci naltrexone low dose naltrexone ldn
yangxinshi tablet intervention for exercise capacity in patients with chronic coronary syndrome

Conditions: Chronic Coronary Syndrome

Summary: this study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of yangxinshi tablets in the treatment of patients with chronic coronary syndrome (ccs).

this study plans to enrol 1200 ccs patients. a central randomized control group will be set up. the experimental and control groups will be populated at a 3:1 ratio. in addition to basic medication, the experimental group will be given yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. the treatment period is 24 weeks. the primary efficacy indicator is the 6-minute walking distance (6mwd).

Eligibility criteria:
inclusion criteria: 1. age 18-75 years; 2. ccs patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis ≥ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (acs), or \>3 months after coronary revascularization; 3. moderately to severely limited exercise tolerance: the maximum 6mwd is \< 450 m, or the metabolic equivalent (met) as measured by treadmill cardiopulmonary exercise testing is \< 5 mets; 4. voluntary participation and signing of informed consent. exclusion criteria: 1. absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6mwt); 2. serious primary diseases, mental diseases, or malignant tumours that affect lifespan; 3. pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months; 4. subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.

Keywords: yangxinshi chronic coronary syndrome
an rct of trauma focused-cognitive behavioral therapy with sexually exploited, war-affected girls in the drc

Conditions: Post-traumatic Stress Symptoms; Psychosocial Distress

Summary: to date, no rct has examined the efficacy of trauma-focused cognitive behavioral therapy with sexually exploited, war affected adolescent girls in the democratic republic of congo. this study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.


Eligibility criteria:
inclusion criteria: -suicidal ideation (irrespective of score on any other measure) exclusion criteria: * psychosis * mental retardation * inability to understand swahili * one standard deviation below the mean on every measure

Keywords: trauma-focused cognitive behavior therapy sexually exploited girls post-traumatic stress symptoms psychosocial distress
natural history of oro-pharyngeal cancer precursors

Conditions: Precancerous Conditions; Leukoplakia; Erythroplasia; Oral Papillomas

Summary: oro-pharyngeal cancers can develop from squamous dysplastic precursor lesions, which occur in a subset of common white (leukoplakia), red (erythroplasia), or mixed oro-pharyngeal plaques. known risk factors for oro-pharyngeal cancer include tobacco smoke, alcohol consumption, diet and, in a subset of tumors, human papillomavirus (hpv). along the oro-pharyngeal disease continuum, there may be variations in gene expression precursor lesions as a result of exposure to smoking, alcohol and hpv. however, the components of gene expression that are most likely associated with tumorigenesis in these tissues are poorly understood. this study will focus upon early gene expression profiles in the oral cavity and oropharynx in subjects who have precursor lesions and have been exposed to the common risk factors for carcinoma development including smoking and hpv infection. this application is to conduct pilot testing and establish appropriate procedures for an international prospective cohort study of the natural history of oro-pharyngeal cancer precursors among men and women at high risk of oro-pharyngeal cancer at montefiore medical center, bronx-ny. brush biopsy specimens will be used to collect a transepithelial sample of cells from oro-pharyngeal plaques, as well as normal tissue from defined regions of the oral and pharyngeal mucosa. measurement of gene expression will employ novel high-throughput cdna microarray analysis and pcr-based hpv dna testing. oro-pharyngeal dysplasia will be diagnosed using cytopathology. under this application, we will assess our planned instruments and procedures on an initial sample of 40 subjects. this planning period will allow for precise identification of methodologies, standardization of instruments and assays to be utilized by additional participating centers in a subsequent application.


Eligibility criteria:
inclusion criteria: * established residence in the greater metropolitan area of new york city, including westchester, long island, southern connecticut and northern new jersey exclusion criteria: * no history of therapy for oral cancer in the previous 6 months
using 18f-fpeb pet to identify mglur5 availability in affective disorders

Conditions: Major Depressive Disorder; Bipolar Disorder

Summary: evidence suggests that mglur5 availability may play a key role in the biology of mood disorders. this study aimed to investigate the changes in metabotropic glutamate receptor 5 (mglur5) availability and clinical symptoms in patients with mdd and bipolar disorder(bd) after two months of vortioxetine treatment. the investigators hypothesized that patients with mdd and bp have abnormal mglur5 availability in certain brain regions, and baseline mglur5 availability can predict prognosis the prognosis of mdd and bd. fmri and noddi are also used to evaluate the function or neurite condition at baseline and 8 week


Eligibility criteria:
inclusion criteria: * meet dsm-v criteria for a current depressive episode. * being first-episode patients who were medication-naïve; * score \>17 on 17-item hamilton depression rating scale (hdrs), score \>22 on montgomery-asberg depression rating scale (madrs), and score \<6 on young mania rating scale (ymrs). * age 18 to 35. * able to give written informed consent. exclusion criteria: * have a current or past significant medical, neurological or metabolic disorder or head injury * have active, significant suicidal ideation or past suicide attempts * have implanted metallic devices or any mr contraindications * are women who are pregnant or breastfeeding * met dsm-5 criteria for substance use disorder * met dsm-5 criteria for any current axis i diagnosis (except generalized anxiety disorder) * are mdd patients present with delusions and/or hallucinations
developing and validating fertilit-e

Conditions: Malignant Neoplasm

Summary: the main purpose of this project is to adapt and validate an ehealth fertility preservation decision-making support tool (fertilit-e) for young adults with cancer.

the overarching goal is to utilize innovations in ehealth technology to address fertility preservation knowledge deficits and decision-making options for young adults with cancer ages 18-39 years of age. every year, approximately 70,000 young adults (ages 18-39) are diagnosed with cancer, which can significantly affect their health-related quality of life in multiple areas, including the potential for infertility or other reproductive challenges. despite this, very few young adults diagnosed with cancer are actually provided fertility preservation information let alone effective strategies or tools for how to best navigate their fertility preservation options. it is critical to provide decision-making information and support about infertility risk and existing interventions to maintain reproductive potential in a delivery mode that is most congruent with this population's health communication style, such as ehealth applications. the goal is to adapt and optimize fertility preservation content in a tailored mhealth tool for fertility preservation decision-making. more specifically, the team will adapt fertility-preservation content for tailored, rapid, and clear dissemination of information in an engaging, cross-platform, patient-friendly mhealth format. the study team will alpha-test this tool with an ethnically diverse sample of cross-cultural end users to collect qualitative data and evaluate usability and comprehensibility to refine content and design. no formal hypothesis testing will be done.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of cancer during ages 15 to 39. * will be receiving or have received treatment associated with a risk of infertility (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic surgery with potential impact on reproductive function). * considered or wish they had considered fertility preservation treatments. * able to speak, read, and understand english. * able to provide informed consent. * have internet access. * have a laptop or desktop computer that can connect to webex. exclusion criteria: * infertility diagnosis prior to cancer diagnosis. * history of fertility preservation or fertility treatments prior to their cancer diagnosis. * are more than five years post-cancer-related treatments (i.e., systemic chemotherapy, pelvic radiotherapy, and/or pelvic surgery).

Keywords: cancer fertility preservation
optimizing hand rehabilitation post-stroke using interactive virtual environments

Conditions: Cerebrovascular Accident; Hemiparesis; Hemiplegia

Summary: the complexity of sensorimotor control required for hand function as well as the wide range of recovery of manipulative abilities makes rehabilitation of the hand most challenging. the investigators past work has shown that training in a virtual environment (ve) using repetitive, adaptive algorithms has the potential to be an effective rehabilitation medium to facilitate motor recovery of hand function. these findings are in accordance with current neuroscience literature in animals and motor control literature in humans. the investigators are now in a position to refine and optimize elements of the training paradigms to enhance neuroplasticity. the investigators first aim tests if and how competition among body parts for neural representations stifles functional gains from different types of training regimens. the second aim tests the functional benefits of unilateral versus bilateral training regimens.the third aim tests whether functional improvements gained from training in a virtual environment transfer to other (untrained) skills in the real world.

the complexity of sensorimotor control required for hand function as well as the wide range of recovery of manipulative abilities makes rehabilitation of the hand most challenging. the investigators past work has shown that training in a virtual environment (ve) using repetitive, adaptive algorithms has the potential to be an effective rehabilitation medium to facilitate motor recovery of hand function. these findings are in accordance with current neuroscience literature in animals and motor control literature in humans. the investigators are now in a position to refine and optimize elements of the training paradigms to enhance neuroplasticity. the investigators first aim tests if and how competition among body parts for neural representations stifles functional gains from different types of training regimens. the second aim tests the functional benefits of unilateral versus bilateral training regimens.the third aim tests whether functional improvements gained from training in a virtual environment transfer to other (untrained) skills in the real world.

Eligibility criteria:
inclusion criteria: * six months post cerebrovascular accident * residual upper extremity impairment that affects participation * at least ten degrees of active finger extension * tolerate passive shoulder flexion to chest level exclusion criteria: * severe neglect * severe aphasia

Keywords: cerebrovascular accident robotics virtual reality rehabilitation neuroplasticity
the santa cruz diabetic retinopathy utilizing artificial intelligence study

Conditions: Diabetic Retinopathy

Summary: in this clinical trial, we plan to evaluate the usefulness of artificial intelligence (ai) software paired with a handheld retinal camera to compare diabetic retinopathy status in bolivian patients as read by retina specialists versus the ai software.


Eligibility criteria:
inclusion criteria: 1. male or female subjects who are at least 18 years old who have full legal capacity to volunteer on the date the informed consent is signed; 2. subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination dates; 3. subjects who have been diagnosed with type i or type ii diabetes mellitus. exclusion criteria: 1. subjects unable to tolerate ophthalmic imaging; 2. subjects who have been scheduled for but have not yet undergone the following surgeries: cataract surgery (including any related follow-up procedures) or vitrectomy. 3. subject blind in one eye due to any cause 4. subjects who have a condition or a situation, which in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
evaluating a low-cost therapeutic device in managing head and neck cancer patients with radiation-related trismus

Conditions: Trismus; Head and Neck Cancer

Summary: this trial evaluates how well a new therapeutic device works in managing trismus in patients who received radiation treatment for head and neck cancer. radiation therapy is a common form of treatment in patients with head and neck cancers. however, changes to surrounding tissue following radiation therapy may lead to trismus, an inability to open the mouth fully. this can create significant functional impairment leading to malnutrition due to impaired chewing, risk of dental infections due to impaired oral hygiene, difficulty with speech, and decreased health-related quality of life. exercise therapy is the mainstay of treatment for post-radiation trismus to help improve mobility and flexibility and increase range of mouth opening. this new device is non-invasive and is similar to other jaw stretching devices where a mouthpiece is placed between the teeth and a hand-lever is used to spread open the upper and lower jaw. however, it will also have additional sensors to measure pressure exerted by the hands and jaw as well as the distance to open the mouth which could help guide therapy. this study may help doctors customize a device to patient-specific needs, provide real-time feedback, and encourage compliance for trismus exercise therapy.

primary objective: i. to assess the clinical efficacy of the trismus device, as measured by the change in maximum interincisal opening over the six-week treatment period. secondary objective: i. to assess participants compliance rates and jaw opening pressures when using this device. outline: participants are assigned to 1 of 2 parts. part i: participants test the trismus device and complete questionnaires on study. part ii: participants undergo exercise therapy with the trismus device under supervision of a speech language pathologist on study. participants will be on study for up to 6 weeks with a follow-up visit 7 days after completion.

Eligibility criteria:
inclusion criteria: * male or female \>= 18 years of age at visit 1. * documentation of a radiation-induced trismus diagnosis as evidenced by one or more clinical features consistent with the trismus phenotype (maximum interincisal opening (mio) \< 35 mm) and a history of head and neck radiation * written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. exclusion criteria: * presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. * minors (age \< 18 years) or patients with inability to provide informed consent.

Keywords: radiation-related
research on three-level prevention and intervention for elderly depression in urban community

Conditions: Depression in Old Age

Summary: the goal of this clinical trial is to compare the effect of three level interventions(universal prevention, selective prevention and targeted prevention) in elderly depression and find out the most efficient intervention path. the main questions it aims to answer are: * whether the pre-disease three-level prevention model (universal prevention, selective prevention and targeted prevention) is applicable for elderly depression in urban communities; * which level of intervention has the best effect on elderly depression. participants will be given the following treatments: * level 1 intervention(universal prevention): health education related to depression to strengthen the participants' self-care skills to reduce sub-health risk factors. * level 2 intervention(selective prevention): psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) aimed at risk factors to prevent more severe depressive symptoms. * level 3 intervention(targeted prevention): therapeutic psychosocial interventions (including but not limited to cognitive behavioral therapy, acceptance commitment therapy, mindfulness training) to reduce patients' depressive symptoms. researchers will compare control group to see if the three levels of intervention have a significant effect.


Eligibility criteria:
inclusion criteria: 1. aged 60 and above; 2. permanent residents of urban communities in china; 3. geriatric depression scale (gds-15) \< 9 points; 4. there are susceptibility factors such as living alone, poverty, and suffering from serious diseases. exclusion criteria: 1. there is suicidal behavior or risk; 2. a history of any other mental illness, including drug or alcohol dependence; 3. those who have speech and hearing disorder and cannot communicate normally; 4. geriatric depression scale (gds-15) ≥10 points; 5. do not agree to participate in the research.