Kornimate/medical-research-clean huggingface dataset:
evaluation of case management for first episode psychosis using the pepsy-cm checklist

Conditions: First Episode Psychosis

Summary: psychotic disorders are often chronic conditions that lead to impaired functioning, quality of life and social integration. current research and recommendations for good practice are moving towards early detection and intervention. it is recognized that this leads to better adherence, alliance to care and knowledge of pathology for the patient, especially in young patients. for more than a decade, early intervention services (eis) are opened in france over an increasingly large territory. still too few studies assess the impact of these structures in france. these eis offer a multimodal intervention (social, professional, psychotherapeutic). the intervention of case managers (or care coordinators in french) seems to be the core of eis. the case manager has a fundamental role in the process of recovery in coordinating each individual's treatment and ensuring continuity of care. the pepsy-cm study aims to evaluate the effectiveness on the relapse rate of a 3 year program for early psychosis based on case management (pepsy-cm) compared to tau in a population of young people with a fep. a qualitative evaluation of case management practice in eis seems essential to assess the impact of case managers under real conditions. based on the australian good practice recommendations (epicc integrity tools) and the case management practice manuals, the pepsy-cm check-list questionnaire was developed to evaluate the practice of case management in the eis in france. this check-list contains different 35 items. the final score between 1(poor) to 5 (good) is established to determine the quality of the case management. qualitative data are also collected during the interview with the participants.


Eligibility criteria:
inclusion criteria: * professional working in an early intervention center treating first episodes of psychosis * professional involved in the organization/management of the center or practicing case management. exclusion criteria: * professional not working in the early intervention center * professional working in the early intervention center but not having a role in the organization or management of the center or as case manager * professional who does not take charge of people who have had a first psychotic episode

Keywords: first episode of psychosis assertive community treatment early intervention in mental health case management assertive community treatment
a pilot study to evaluate patient tolerance and nursing ease-of-use of a novel hearing protection device

Conditions: Hearing Impairment

Summary: before they are born, babies are protected from hearing very loud noises by their mother's bodies. after delivery, they are exposed to many loud noises that are potentially harmful. these noises happen in the neonatal intensive care unit (nicu). the purpose of this research project is to test the fit and the ease-of-use of a new device that may protect infant's hearing in the nicu.

despite the best efforts of neonatal intensive care unit (nicu) caregivers, vulnerable and fragile nicu patients are frequently exposed to noxious levels of noise from monitoring and respiratory equipment alarms, as well as from routine nicu care practices. particularly detrimental to sleep and auditory development are patient exposures to high frequency noises that are specifically designed to alert nicu caregivers to important changes in patient status. this pilot study will help evaluate the fit, ergonomic design and the ease-of-use of a novel hearing protection system (special ear-muffs along with a unique attachment mechanism) specifically designed top diminish the transmission of high frequency noises to patients within the nicu, while allowing some transmission of low frequency sounds, such as a mother's voice.

Eligibility criteria:
inclusion criteria: * neonate admitted to the neonatal intensive care unit * age greater than 12 hours and less than 2 weeks * informed consent from the parent(s) exclusion criteria: * significant cranial trauma noted on admission * congenital anomalies of the head and/or neck * hemodynamic instability requiring pharmacologic intervention * recommendation by the attending neonatologist not to enroll the patient
hippocampal volume and memory functions in aneurysmal subarachnoid hemorrhage

Conditions: Neurologic Disorder; Subarachnoid Hemorrhage, Aneurysmal

Summary: neuropsychological and functional long-term consequences of subarachnoid hemorrhages (sah) represent a great challenge, since sometimes considerable cognitive deficits occur without evidence of substantial brain damage. in this study, we want to examine if the frequently observed memory deficits are associated with hippocampal atrophy.

long-term or even permanent neuropsychological impairments are frequently observed after aneurysmal subarachnoid hemorrhages (asah). among the most common impairments after asah are memory deficits. volumetric mri studies suggest an association of memory dysfunctions with temporal atrophy, especially of the hippocampus. in a previous study, 77 patients with good or moderate clinical outcome after asah were examined one year after discharge (bendel et al., 2006). temporomesial atrophy was detected without direct brain damage, e.g. by secondary ischemia. due to the effects of complex cognitive impairments on the quality of life and participation in social and professional life, this relationship will be examined in more detail in the planned study. specifically, we will investigate to what extent the frequently observed discrepancy between severe memory impairment and normal structural imaging results (no focal lesions in temporomesial areas) is due to hippocampal atrophy. in contrast to bender and colleagues, this question will be investigated in the acute phase of the disease, immediately after admission to inpatient neurological rehabilitation. over a period of 24 months, 29 neurological rehabilitation patients with asah (hunt \& hess grade i and ii) are going to be included. within the first week (day 1 to 7) after study enrollment, a native mri examination (without contrast agent) is performed, in which a high-resolution 3d-mprage sequence (t1 weighting) is measured in the sagittal plane. after checking the data quality of the 3d-mprage sequence, especially with regard to its suitability for hippocampal volume determination, a comprehensive neuropsychological examination is performed, in which specific memory and attentional functions are tested.

Eligibility criteria:
inclusion criteria: * neurological rehabilitation patients in phase b - d * at minimum eight weeks after disease onset * aneurysmal subarachnoid hemorrhage (hunt \& hess grade i or ii) * written consent from the patient's legal representative * exclusion of pregnancy exclusion criteria: * insufficient cardiorespiratory stability * previous brain damage * mental disorders (dementia, depression) * colonization with multi-resistant pathogens * mri contraindications * claustrophobia * weight \> 120 kg

Keywords: neurological rehabilitation hippocampal volume memory deficits
movement and fitness trackers in determining performance status

Conditions: Malignant Neoplasm

Summary: this trial studies the use of movement and fitness trackers in determining performance status of patients with cancer who are taking part in early phase clinical. movement and fitness trackers record movement and a number of different metrics such as steps, heart rate, and calories burned. the use of movement and fitness trackers can provide a more objective and precise estimate of patient performance status and help identify those most at risk for adverse events and hospitalization.

primary objectives: i. to determine if in-office movement trackers identify those patients who are at highest risk for serious adverse events (saes) on early and developmental therapeutics (edt) cancer trials. secondary objectives: secondary objectives are related to outpatient activity trackers. i. to determine the association between the occurrence of saes and early trial termination, with baseline measurement of activity classification using outpatient activity trackers in the 7 days after screening visit. ii. to determine the association between the occurrence of saes and early trial termination, with the change in activity level classification between the week after screening visit and the week after the start of edt. iii. to determine the association between the occurrence of saes and early trial termination, with averaged activity level classification in the first 4 weeks of the edt. outline: patients participant in movement assessment during 2 clinical trial visits. patients also wear a fitbit to track movements and complete a smartphone based patient reported outcomes (pro) diary over 5-10 minutes to measure physical function, fatigue, sleep disturbance, social isolation, appetite, and body weight for up to 180 days.

Eligibility criteria:
inclusion criteria: * a diagnosis of cancer. * undergoing screening for a university of southern california (usc)/norris therapeutic clinical trial operated by the early and developmental therapeutics program which includes both phase i and ii clinical trials. * owns a smartphone. * ability to understand and the willingness to sign a written informed consent. * willingness to wear sensors to track physical activity, global positioning system (gps) location, and provide symptom ratings each night during the screening period of their clinical trial and 180 days after starting treatments. * able to read english, spanish, or traditional chinese to complete patient reported outcomes. * able to ambulate without an assistive device. exclusion criteria: * missing lower limbs. * symptomatic brain metastases are excluded from this clinical trial. however, those with asymptomatic brain metastasis are permitted. it is permissible to have the patient on corticosteroids to eliminate symptoms of brain metastasis. * known movement disorder such as parkinson?s disease, choreoathetoid movement disorders, essential tremor if that movement disorder is of sufficient severity to require drug therapy.
a study of ft-7051 in men with mcrpc

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: this is a phase 1, open-label study that will evaluate the safety and tolerability of ft-7051 and determine the recommended phase 2 dose (rp2d) as well as pharmacokinetics (pk), preliminary anti-tumor activity, and pharmacodynamics (pd) of ft-7051 in men with metastatic castration-resistant prostate cancer who have progressed despite prior therapy and had been treated with at least one potent anti-androgen therapy. the starting dose, 25 mg once daily (qd), of ft-7051 administered discontinuously (21 days on/7 days off) in 28-day cycles.


Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosis of progressive metastatic castration-resistant prostate cancer (mcrpc) * previously failed at least one potent anti-androgen therapy * castrate levels of serum testosterone * ecog performance status 0-2 * adequate bone marrow function * adequate kidney, heart and liver function exclusion criteria: * prior solid organ transplant * prior treatment with small molecules including chemotherapy, antibody, or other experimental anticancer therapeutic within 4 weeks of first dose of study treatment * prior radiation therapy within 4 weeks prior to initiation of study treatment (including radiofrequency ablation) * prior androgen antagonist therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide) within 2 weeks * prior radium-223 therapy within 6 weeks * symptomatic, untreated or actively progressing central nervous system (cns) metastasis * unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes, active or uncontrolled infection requiring systemic therapy) or any important medical illness or abnormal laboratory finding that would, in the investigator's judgement, increase the risk to the patient associated with participation in the study * concomitant medications that cause torsades de pointes that have not reached steady state before first dose of the study drug * concomitant medications that are strong inhibitors or inducers of cyp3a4 or an inhibitor of p-gp * history of infection with human immunodeficiency virus (hiv) * active infection with hepatitis b, or hepatitis c virus

Keywords: metastatic castration-resistant prostate cancer prostate cancer urogenital disease prostatic disease hormone antagonists hormones, hormone substitutes ft-7051
efficacy and mechanisms of acupuncture for patients with advanced pancreatic cancer pain

Conditions: Pancreatic Cancer; Pain

Summary: this study compares the effect of acupuncture and placebo acupuncture on advanced pancreatic cancer pain and then investigates its potential mechanism of peripheral blood.

acupuncture may alleviate abdominal or back pain of patients with advanced pancreatic cancer. acupuncture participants would receive electroacupuncture on jiaji (ex-b2) points for 3 times in a week. placebo acupuncture participants would receive placebo acupuncture on non-point points for the same period. pain scores on numeric rating scale (nrs) and blood levels of β-endorphin and nerve growth factor are compared.

Eligibility criteria:
inclusion criteria: * advanced pancreatic cancer at ⅲ-ⅳ stage diagnosed by histological/cytological examination. * pain score of abdominal or back pain ≥3 on a numeric rating scale (nrs) graduated from 0 to 10. * stable dose of analgesics at least 72 hours before randomization. * expected survival time more than 1 month. exclusion criteria: * another cause for abdominal or back pain (such as prolapse of lumbar intervertebral disc, ulcer or other intra-abdominal disorder). * acupuncture treatment in the past. * contraindications for the use of acupuncture (such as severe allergies, bleeding tendency, infectious dermatosis and ulcer or scar at points). * unable to give informed consent.

Keywords: pancreatic cancer pain acupuncture
use of transmucosal ketamine in post stroke depression

Conditions: Post-stroke Depression

Summary: studies have shown that ketamine is very effective and has a quick onset in treatment of depression. most of these studies used intravenous ketamine in an inpatient setting and there are no large trials examining its use in post stroke depression (psd). there have been only few studies that have used other routes of administration (i.e., oral, transmucosal, intranasal, intramuscular) of ketamine which provided symptom relief for depression. the purpose of this study is to assess the effectiveness and safety of use of transmucosal ketamine in treatment of psd. we hypothesize that fast acting antidepressant effects can be achieved with tolerable side effects for translation into the general post-stroke population. to test our hypothesis, the specific aim is to: (1) demonstrate that transmucosal administration of ketamine is feasible within the post-stroke depression population and has tolerable side effects. exploratory aims will include assessment if ketamine also produces fast acting antidepressant effects.


Eligibility criteria:
inclusion criteria: * men and women (18 years of age or older) of any ethnicity diagnosed with major depressive disorder (dsm-v criteria), who have had failed to respond to prior therapy (as defined as at least one anti-depressant trial or patient was intolerant or noncompliant with anti-depressive medications). * willing to take the study drug ketamine on 2 separate occasions and comply with instructions for testing. * understands and willing to undergo risks associated with adverse effects of study medications. * willing to comply with restrictions and instructions disclosed in the consent form. exclusion criteria: * patients with blood pressure over 150 systolic or heart rate over 110 on day of medication administration * patients with a diagnosis of epilepsy * patients with a significant history of high intraocular pressure. * patients with life threatening medical problems. * participant is pregnant or breastfeeding. * infants and children * patients who lack medical decision-making capacity * patients who would require medication adjustment during time in the study. * known hypersensitivity to the study drug (ketamine). * unwilling to undergo risks associated with adverse effects of study drugs. * unwilling to comply with restrictions and instructions disclosed in the consent form
ascorbic acid levels in mds, aml, and cmml patients

Conditions: Myelodysplastic Syndromes; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; MDS; AML; CMML

Summary: this study is a non-interventional, specimen collection translational study to evaluate vitamin c levels in the peripheral blood of acute myeloid leukemia (aml), myelodysplastic syndrome (mds), or chronic myelomonocytic leukemia (cmml) patients.

it has previously been established that hematological cancer patients with myelodysplastic syndrome (mds) or acute myeloid leukemia (aml) often exhibit severe vitamin c deficiency from a cohort of patients in copenhagen. in this study, the investigators aim to determine if those results are conserved in another population/geographical location.

Eligibility criteria:
inclusion criteria: * patients actively receiving treatment for acute myeloid leukemia (aml), myelodysplastic syndrome (mds), or chronic myelomonocytic leukemia (cmml). * patients diagnosed with aml, mds, or cmml and are treatment naïve. * patients who are 18 years old or older. exclusion criteria: * patients deemed as too ill to participate as determined by the clinical investigator. * non-english speaking patients * patients unable to provide informed consent.

Keywords: vitamin c ascorbic acid epigenetics 5-hydroxymethylcytosine 5-methylcytosine
motor rehabilitation and physical, mental and cognitive health in patients with stroke

Conditions: ACV

Summary: this study analyzes the effectiveness of a motor rehabilitation program in the functional recovery of stroke patients and its impact physiotherapy, occupational therapy, and neuropsychology are used to measure improvements in balance, mobility, independence in daily activities, and cognitive functions. the intervention involves the use of the lokomat, a technologically advanced robot-assisted gait training device. patients are supported in a harness on a treadmill while the robotic system guides their legs through a natural gait cycle. the results will help clarify the relationship between motor recovery and overall well-being, providing evidence to optimize therapeutic strategies for stroke patients.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of ischemic or hemorrhagic stroke. * age equal to or greater than 18 years. * patients in the subacute or chronic phase of stroke (≥ 3 months since the event). * ability to participate in a motor rehabilitation program. * absence of advanced neurodegenerative diseases that may interfere with the evaluation of results. * ability to understand and follow basic instructions of the rehabilitation program. * informed consent signed by the patient or his/her legal representative. exclusion criteria: * people under 60 years of age. * presence of serious comorbidities that prevent physical activity or rehabilitation (e.g. severe heart failure, advanced chronic obstructive pulmonary disease). * patients with severe cognitive impairments that make it difficult to follow the program (e.g. advanced dementia). * use of drugs that significantly affect motor and cognitive function, interfering with the evaluation of rehabilitation. * presence of active infections or unstable medical conditions requiring hospitalization. * history of another neurological disorder that may affect functional recovery (e.g. parkinson's disease, multiple sclerosis). * participation in another rehabilitation program at the same time, which may interfere with the results of the study.
a prospective trial of behavioral therapy for chronic cough

Conditions: Cough

Summary: this study seeks to explore whether heart rate variability (hrv) biofeedback can be effective in the treatment of chronic cough. chronic cough has many causes, including asthma, postnasal drip, and gastroesophageal reflux disease (gerd), each with a specific treatment. however, among a subset of cough patients, no clear cause is found despite extensive workup, and traditional treatment methods do not provide relief. several studies revealed less common causes of chronic cough and disordered breathing such as vagal neuropathy, paradoxical vocal fold motion, and stress. additional research identified links between the neurological networks that produce the cough reflex and those that maintain normal breathing. hrv biofeedback is a self-regulation technique that uses computer equipment to monitor heart rate and breathing, two key functions of the autonomic nervous system. by using this non-invasive behavioral technique, cough patients can regulate their breathing and autonomic function, potentially leading to improved autonomic balance and a reduction in cough symptoms.


Eligibility criteria:
inclusion criteria: * 8+ weeks of cough, fluent english speaker, have access to an electronic mobile device exclusion criteria: * on neuromodulator therapy, cardiac arrhythmia, dysphagia, prior hrvb or mindfulness, head and neck surgery of the oropharynx, neck or larynx, lung surgery, pulmonary pathology other than asthma, tourette syndrome, ace inhibitor use, current or recent smoker. added exclusion criteria as of march 2020 - history of covid+.