Kornimate/medical-research-clean huggingface dataset:
mind body therapy for the treatment of chronic pain

Conditions: Chronic Pain; Chronic Pain Syndrome

Summary: chronic pain syndromes without identified organic etiology remain a challenge for physicians. many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. the goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. the study is a randomized, partially blinded trial examining the effectiveness of mind body syndrome therapy (mbst) in reducing disability from back pain and alleviating back pain. the investigators will secondarily investigate whether mbst can improve participant quality of life and reduce the need for pain-related hospitalization. the design of the this study consists of 3 arms with one being the intervention (mbst), one being usual care, and one being a second mind-body intervention (active control). this education program consists of a series of personal interviews and group and/or individualized lectures/sessions. participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the mbst program.


Eligibility criteria:
inclusion criteria: * adult patient 18 \> years old * chronic back pain * pain persistent for ≥3 days/week for the past 3 months prior to enrollment * willingness to consider mind-body intervention exclusion criteria: * patients \< 18 years of age * diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome. pain related to disc disease is not an exclusion unless there are neurological impairments. * patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia and bipolar disorder.
covid breath test - ancon

Conditions: Covid19

Summary: this study is designed to look at the effectiveness of a new technology call nanotechnology biomarker tagging (nbt) in detecting covid-19 infection using breath samples of patients. participation in this study is expected to take less than one month and will consist of a breath sample being taken by the research team, a cheek swab being taken by the research team, a questionnaire that will be completed by the participant with the help of the research teams, and a review of your medical record.


Eligibility criteria:
inclusion criteria: * age 18 years and older * patients that present for covid-19 testing, have tested covid negative, or covid positive patients. exclusion criteria: * unable to consent * patients on a ventilator * pregnant women
are the stone density and location useful parameters for small kidney stones?

Conditions: Kidney Calculi; Kidney Stone

Summary: the investigators aimed to evaluate whether these parameters could be guides for us in the selection of rirs or mini-pnl procedures in kidney stones that are smaller than 2 cm. the patients that have kidney stones smaller than two cm and be planned to undergo surgery were randomized into 2 groups prospectively. rirs was performed in the rirs group using a 7.5-f fiberoptic flexible ureterorenoscope while mini-pcnl group was dilated up to 16.5f and mini-pcnl was performed with 12f nephroscopy. preoperative characteristics, operative and postoperative results were compared in two groups. thereafter, intra and intergroup comparisons were made to determine the effects of hu value, indicating the stone density, higher or less than 677 and the stone location on stone-free rates.


Eligibility criteria:
inclusion criteria: * patients were evaluated with non-contrast abdominopelvic ct after a detailed anamnesis and physical examination. * patients, who had a kidney stone with a maximum diameter of less than 2 cm and who did not prefer to undergo eswl, were taken into the study. exclusion criteria: * patients with anomalous kidneys, skeletal deformities, severe obesity (bmi\> 35) and those underwent eswl treatment previously for the same stone were excluded from the study.
teletherapy for upper extremity fracture rehabilitation (tele-rehab study)

Conditions: Upper Limb Surgery; Occupational Therapy

Summary: following upper limb surgeries, patients could receive occupational therapy either in-person or remotely (teletherapy). the investigators currently do not know which occupational therapy delivery is better in terms of clinical outcomes and patient recovery. the proposed study is a pilot randomized controlled trial (rct) testing the feasibility of comparing in-person occupational therapy to teletherapy following operative fixation of upper extremity fracture. it is a single site, parallel-arm, randomized controlled trial to compare teletherapy versus in-person occupational therapy. patients who are eligible will be randomized similar to a flip of a coin (1:1) to occupational therapy in-person or through a telemedicine platform. patients would also complete surveys at each follow-up visit to measure clinical outcomes.


Eligibility criteria:
inclusion criteria: * participants must have had operative fixation of upper extremity fracture located between the humeral shaft and distal radius (inclusive) who are indicated for outpatient occupational therapy. * participants at least 18 years (≥ 18 years of age). * english-speaking participants exclusion criteria: * participants unable to consent * vulnerable populations including prisoners and marginally housed patients * additional traumatic conditions that may affect the ultimate-use pattern of the injured limb including traumatic brain injury, spinal cord injury, peripheral nerve injury, or associated soft tissue injury requiring specific postoperative activity modifications. * contralateral upper extremity injury that prevents participating in the standardized exercises. * initiation of occupational therapy (ot) during an inpatient hospital stay * pre-existing comorbidities that may interfere with communication or that may limit the use of standard telecommunications tools (sight/hearing impaired, speech impaired) * patients without a smart-phone or internet access.

Keywords: upper limb surgery upper extremity injury occupational therapy
community-engaged bidirectional pandemic crisis and emergency risk communication with covid-19 vaccine messages to minority populations

Conditions: Vaccine Preventable Disease

Summary: a cluster randomized trial will be conducted prior to widespread vaccine availability to the general public. community-informed covid-19 vaccine messages will be disseminated to participants. at baseline, 2 weeks and 4 weeks, the study team will survey participants to assess knowledge and attitudes about covid-19 vaccines, including intention to be vaccinated.

a cluster randomized trial with 80 participants from the social networks of 8 cls will be conducted prior to widespread vaccine availability to the general public. four cls and social networks (cluster of 10 per network) will be randomly assigned to receive the intervention immediately or after a delay of 2 weeks. intervention participants will be invited to a closed social media group on the platform of their choice. cls, selected for trustworthiness within vulnerable populations, will disseminate community-informed covid-19 vaccine messages to members of their social networks and engage in bidirectional communication with cenr partners to refine messages. at baseline, 2 weeks and 4 weeks, participants will be surveyed to assess knowledge and attitudes about covid-19 vaccines, including intention to be vaccinated.

Eligibility criteria:
inclusion criteria: * self-identification within a cls social network * age 18 or greater * functional internet access. exclusion criteria: * does not self-identify within a cls social network * is under the age of 18 * does not have functional internet access.

Keywords: hesitancy
a study of rhgaa in patients with late-onset pompe disease

Conditions: Pompe Disease (Late-onset); Glycogen Storage Disease Type II (GSD-II); Acid Maltase Deficiency Disease; Glycogenosis 2

Summary: pompe disease (also known as glycogen storage disease type ii) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (gaa). normally, gaa is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. in patients with pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function. the overall objective is to evaluate the safety, pharmacokinetics (pk) and efficacy of myozyme treatment.


Eligibility criteria:
inclusion criteria: * patient's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related procedures; patient's signature required if patient understands informed consent * patient must have a diagnosis of pompe disease based on deficient endogenous gaa activity or gaa gene mutations * patient must have demonstrable muscle weakness * patient must be greater than or equal to five years of age and younger than eighteen years of age * patient must be able to provide 3 reproducible fvc tests in sitting position during screening * patient must perform muscle function testing * patient must ambulate 10 meters (assistive devices permitted) * patient and legal guardian must comply with the clinical protocol exclusion criteria: * patient requires the use of invasive ventilatory support * patient requires the use of noninvasive ventilatory support while awake and in an upright position * patient has received enzyme replacement therapy with gaa from any source * patient has used an investigational product within 30 days prior to study enrollment, or is currently enrolled in another clinical or observational study * patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that, may significantly interfere with study compliance, including all prescribed evaluations and follow-up activities * female patients pregnant, lactating or unwilling to practice birth control methods during study * male patients unwilling to use barrier contraceptives during study

Keywords: glycogen storage disease type ii gsd-ii pompe disease
the comparison of cognition, depression and anxiety, and quality of life after hip fracture surgery under general or regional anesthesia

Conditions: Postoperative Cognitive Dysfunction; Hip Fractures; Depression, Anxiety; Quality of Life

Summary: postoperative cognitive dysfunction is a relatively common in elderly patients after hip surgery, but exact mechanism of its onset is still unclear as well as contributing factors. there is also increased incidence of depression and anxiety. both affect the recovery after surgery, slow it down and reduce the quality of life. patients will be divided into two groups, operated under regional anaesthesia and operated under general anaesthesia, and monitored after surgery. patients will be tested before and after surgery to evaluate postoperative cognitive deficits, depression and anxiety scale and health-related quality of life questionnaire.


Eligibility criteria:
inclusion criteria: * patients intended for surgical treatment of hip fractures ≥ 60 years * patients who are category asa i to asa iii will be included in research * sufficient cognitive ability * only those patients who have agreed to be participants in the research and have signed the consent for participation and informed consent. exclusion criteria: * patients who refused to participate in the survey and who did not sign informed consent * patients with asa iv or more * patients under 60 years * severe psychiatric disorders involving the use of psychopharmaceuticals back three months * all patients who have other fractures in addition to hip fractures * polytrauma * all patients scheduled for more than one surgical intervention during the procedure, or within the next 8 weeks * patients who have been diagnosed with dementia, and / or are receiving anti-dementia drugs

Keywords: hip fracture surgery regional anaesthesia general anaesthesia postoperative cognitive dysfunction depression anxiety quality of life
safety of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for tourette syndrome

Conditions: Tourette Syndrome

Summary: this trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of tourette syndrome

this patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of tourette syndrome. patients will receive a single intravenous infusion of uc-mscs. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of tourette syndrome * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: tourette syndrome stem cell treatment
pharmacokinetic and safety study of travoprost 0.004% in pediatric glaucoma patients

Conditions: Glaucoma; Ocular Hypertension

Summary: the purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (pk) profiles of travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension patients.


Eligibility criteria:
inclusion criteria: * diagnosis of glaucoma or ocular hypertension in at least 1 eye. * parent/legal guardian must provide informed consent, and children must agree to sign an approved assent form when applicable. * must agree to comply with the requirements of the study and must be accompanied by a parent/guardian. * other protocol-defined inclusion criteria may apply. exclusion criteria: * females of childbearing potential that are currently pregnant, have a positive result on a pregnancy test at the screening visit, intend to become pregnant during the study period, are breast feeding, or are not using birth control measures. * one sighted eye or monocular, including patients who cannot be dosed in both eyes for any reason. * history of chronic, recurrent or severe inflammatory eye disease. * ocular trauma requiring medical attention within the past 3 months prior to the screening visit. * ocular infection or ocular inflammation within the past 30 days prior to the screening visit. * clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment. * other severe ocular pathology (including severe dry eye), that in the opinion of the investigator, would preclude the administration of a topical prostaglandin analogue. * intraocular surgery within the past 30 days prior to the screening visit. * any abnormality preventing reliable tonometry. * any other conditions including severe illness which would make the patient, in the opinion of the investigator, unsuitable for the study. * hypersensitivity to prostaglandin analogues or to any component of the study medications in the opinion of the investigator. * therapy with another investigational agent or device within 30 days prior to the screening visit. * body weight \< 5kg. * other protocol-defined exclusion criteria may apply.

Keywords: pediatric glaucoma pediatric ocular hypertension travoprost
comparative study between alzheimer's and multi-infarct dementia

Conditions: Dementia

Summary: dementia is a neurological disease that causes cognitive and behavioral impairments that could ultimately interfere with the ability to function at work or to do the usual daily activities. it is recognized as a healthcare and social burden and remains challenging in terms of proper diagnosis and treatment.

biomarkers are needed to identify at-risk individuals, stage their disease, and track disease progression. such biomarkers should be noninvasive, inexpensive, and simple to acquire. neurodegeneration biomarkers in csf include neurofilament light (nfl), chitinase 3-like protein 1 (chi3l1). nfl for example increases in several neurologic conditions, including ad. in addition, nfl can be detected in serum using standard immunoassay formats. higher csf levels of chi3l1 are seen in patients with neurological disorders such as ms patients experiencing relapses of ms. in addition, c-x-c motif chemokine 13 (cxcl13) is a crucial homeostatic chemokine expressed in lymphoid organs, and it is essential for the recruitment and compartmentalization of lymphocytes. in ms, cxcl13 regulates homing of b cells and subsets of t cells to inflammatory foci in cns by interacting with the cxcr5 receptor. the levels of cxcl13 are elevated in the csf of patients with ms compared to healthy controls, as well as in other neuroinflammatory diseases. cxcl13 may be considered a csf biomarker of intrathecal b cell response, as its levels correlate with the count of b cells, the igg index, and the presence and ocbs in the csf. transcranial magnetic stimulation (tms) assesses several cortical properties such as excitability, plasticity, and connectivity in humans. tms has been applied to patients with dementia, enabling the identification of potential markers of the pathophysiology and predictors of cognitive decline; moreover, applied repetitively, tms holds promise as a potential therapeutic intervention.

Eligibility criteria:
inclusion criteria: 1. men or women of at least 50-80 years of age. 2. are reliable in individual data and willing to make themselves available for the duration of the study 3. clear written informed consent obtained from 1st degree of relative from each patient participant and control himself in the trial. exclusion criteria: 1. age below 50 years and above 80 years. 2. other neurological disorders or psychiatric disorders; previous history of stroke; metabolic disturbance; other major medical illnesses; epilepsy; inflammatory, autoimmune, or infectious disease; metallic objects in the body; craniotomy in the past. 3. presence of clinically significant medical or psychiatric condition that may increase the risk associated with the study 4. participation in any other type of medical research that may interfere with the interpretation of the study. 5. patients with severe motor disability (bed-ridden) that may interfere with the study procedure. 6. patients with history of seizures or epilepsy including history in a first degree relative
pro-2-cool device clinical study

Conditions: Mild Traumatic Brain Injury

Summary: this study is being conducted to quantify the clinical safety and efficacy of head and neck cooling when applied up to 8 days after mild traumatic brain injury (mtbi) among adolescents participating in sporting activities.

this is a single-center, prospective, randomized, non-blinded, dual-arm comparator study that will include two-phases, the 60-patient pilot study (30 patients in the treatment arm and 30 patients in the control arm) followed by a pivotal study (up to 200 patients in the treatment and control arm combined) for a total of up to 260 patients overall in both phases. the pilot study will serve as an opportunity to assess the protocol and make adjustments, if necessary. in addition, descriptive statistics including effect size will be calculated and the safety of the device will be assessed at the conclusion of the pilot study. subjects will be assigned to study arm based on a block randomization schedule generated a priori. the study sponsor believes that the device and therapeutic treatment that will be evaluated in this study is a non-significant risk (nsr) to the subjects.

Eligibility criteria:
inclusion criteria: * males and females ages 12 - 21 years * initial provider visit is within 8 days of mtbi injury * confirmed mtbi diagnosis from sporting activities * in generally good health as confirmed by medical history and as determined by site investigator * has a symptom score of at least 7 (analogous of the scat5 symptoms score) * has informed consent obtained per protocol and as required per institutional review board (irb) exclusion criteria: * cleared to return to play during initial visit * suffers a serious tbi as evidenced by worsening symptoms, specifically: * seizure * hospitalization * existing positive diagnostic testing, which include radiology scans that indicate brain bleed * slurred speech, which has not resolved within 72 hours of mtbi injury * sustains another head or neck injury at the time of mtbi injury which requires medical treatment * known or disclosed pregnancy or breast-feeding * history of a serious medical or psychiatric disorder that include: * suicide attempt in the last 6 months * unmanaged depression or anxiety * hospitalization in the last 6 months for psychiatric treatment * history of reynaud's disease or phenomenon, cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia * previously diagnosed with a cerebrovascular disorder * is unable to understand the study requirements or the informed consent * currently enrolled in another investigational research study that may confound the results of this study * non-english speaking subjects and parents/legal guardians

Keywords: concussion tbi mtbi
investigation of the effects of sedentary behaviour and moderate exercise on glucose tolerance and insulin sensitivity

Conditions: Sedentary Lifestyle; Insulin Sensitivity; Glucose Metabolism

Summary: individuals with pre-diabetes or diabetes would benefit from low impact methods that would improve their insulin sensitivity and aid in maintaining glucose homeostasis. physical activity helps the body decrease its insulin resistance and burn excess sugar. many diabetics also suffer from obesity and specific forms or durations of physical exercise may not be viable options for these individuals. determining whether short bursts of moderate exercise improve blood glucose levels in healthy humans may identify a further method for diabetics to improve their glucose homeostasis. the aim of this study is to determine the most effective moderate exercise that can be completed in 3 minutes and its effectiveness on improving glucose handling, in response to a single day of standardized high-fat and high-carbohydrate feeding in comparison to periods of prolonged sitting.


Eligibility criteria:
inclusion criteria: * healthy * bmi between 18-30 kg/m² * non-smoker exclusion criteria: * pregnant * diabetes * kidney disease * liver disease * cardiovascular disease * cancer
long-term safety and tolerability of affitope ad01

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to assess the long-term tolerability and -safety of affitope ad01 applied during affiris 001


Eligibility criteria:
inclusion criteria: * written informed consent signed and dated by the patient or the patient's legal representative and the caregiver * patients having participated in affiris 001 and received at least 1 vaccination with affitope ad01 * availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits. exclusion criteria: * patients having received no vaccination with affitope ad01 * contraindication for mri imaging * history of questionable compliance to visit schedule, patients not expected to complete the clinical trial

Keywords: alzheimer morbus alzheimer alzheimer vaccine vaccine ad a-beta immunotherapy