Kornimate/medical-research-clean huggingface dataset:
effect of vitamin d supplementation on fasting glucose and interleukin-10 (il-10) in arab women with impaired fasting glucose

Conditions: Obesity

Summary: obesity, and its metabolic consequences - impaired fasting glucose (ifg) and diabetes, is highly prevalent among arab women in israel and the middle east. since life style modification is difficult to achieve in this population it is important to assess whether other modifiable risk factors can be detected. there is evidence that the homeostasis of vitamin d has a significant role in the eventual development of diabetes. previous cross sectional studies have shown that low 25 (oh) vitamin d levels are related to glucose intolerance, diabetes, insulin resistance and metabolic syndrome. the study hypothesis is that 25(oh) vitamin d deficiency is highly prevalent among arab women with ifg and that vitamin d supplementation may improve ifg and by that reduce the risk for future overt diabetes. additionally, obesity is associated with a low-grade inflammation of white adipose tissue (wat) resulting from chronic activation of the innate immune system. in obesity, there is an increased production and secretion of a wide range of inflammatory molecules including interleukin-10 (il-10), which may have systemic effects on wat and other organs. to that end the investigators will assess the influence of vitamin d supplementation on il-10 and hs-crp.

eligible women will be invited by their primary care physician to participate in the study. after signing an informed consent women will be randomized to receive oral vitamin d 100,000 iu or similar placebo once a month for three consecutive months. pertinent clinical and demographic date will be documented and relevant laboratory test will be performed by the primary care team. one month after the third dose the same data and tests will be retrieved on each woman. compliance with the study protocol will be enhanced and confirmed by a research assistant. objectives: to assess the relationship between ifg and 25(oh) vitamin d levels in overweight arab women. to assess whether vitamin d supplementation significantly improves ifg. to assess whether vitamin d supplementation significantly modifies il-10 and hs-crp.

Eligibility criteria:
inclusion criteria: * arab women, age 40-65 * no significant handicap or disabilities in adl * bmi \> 25 kg/m2 * ifg of 100-125 mg/dl exclusion criteria: * diabetes mellitus * other medical conditions that may have an effect on ifg (cancer, chronic renal failure, inflammatory diseases etc) * history of vascular disease * regular use of medications that may affect ifg (steroids, hrt, diuretics etc) * hypercalcemia (albumin corrected ca \>10.3 mg/dl) * inability to sign an informed consent due to mental or psychiatric ailment

Keywords: fasting glucose obesity arab women interleukin diabetes impaired fasting glucose (ifg)
a study to evaluate the safety and efficacy of additional doses of azx100 drug product following excision of keloid scars

Conditions: Scar Prevention; Scar Reduction

Summary: the purpose of this study was to determine the safety of azx100 drug product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.


Eligibility criteria:
inclusion criteria: * keloid scar located below the neck between 1 and 3 cm long and less than 1 cm at its widest point * willing to undergo keloid scar excision surgery * healthy adult male or non-pregnant female * non-diabetic * body mass index in the range of 18-35 * no clinically significant abnormal values on a full blood safety screen * non-smoker and non-nicotine user for the previous six months exclusion criteria: * history or clinical evidence of acute or chronic disease * history of cancer within the last 5 years, except for surgically removed cancers of the skin that are not near the keloid area * history of anaphylactic shock or anaphylactoid (hypersensitivity) reaction * allergy to local anesthesia, including lidocaine and epinephrine * dermatologic disorders, except for folliculitis and acne * on therapy with steroids * on therapy with a drug that would affect collagen synthesis * positive urine test for nicotine or drugs of abuse * positive blood test for hiv 1 or 2, hepatitis b or hepatitis c * positive blood test for anti-azx100 antibodies * participation in another study within 60 days prior to enrollment * blood donation within 7 days before dosing with study drug * plasma donation within 3 days before dosing with study drug * tattoo within approximately 3 cm of the keloid scar that will be removed * apply any lotion or cream on or near the keloid scar that will be removed within 14 days before dosing with study drug * use of a tanning bed or tanning light within the 3 months before enrollment * intend to use any scar improving product during of the study (1 year) * history of drug addiction or excessive use of alcohol * previous drug treatment of the keloid scar within the last 3 years, or have had any laser, irradiation, or surgical treatment of the keloid scar that will be removed

Keywords: azx100 patient and observer scar assessment scale posas visual analog scale vas keloid scarring scar reduction scar prevention
single and multiple ascending dose study of aer-01

Conditions: COPD

Summary: this is a first-in-human, randomized, double-blind, placebo-controlled, phase 1 study of aer-01 (solution for inhalation, delivered via nebulizer) to assess the safety, tolerability and pk of aer-01. the study will be conducted in 2 parts: a single ascending dose (sad) part in hvs (part a) and a 7-day multiple ascending dose (mad) part in hvs(part b).


Eligibility criteria:
inclusion criteria health volunteers: * healthy volunteers: male or female aged ≥18 to ≤65 years. * current non-smoker or casual smoker participants * females must not be pregnant or lactating exclusion criteria: * history of unstable medical conditions or major surgical procedures over the 12 months prior to screening. * history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic (excluding history of recurrent urinary tract infection), neurologic (excluding history of migraine), dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition that in the opinion of the pi or designee might obfuscate the study data. * history of malignancy of any type, other than in situ cervical cancer or surgically excised non melanomatous skin cancers, within 5 years before screening. part b participants with copd and moderate airflow limitation * has evidence of significant lung restriction on pulmonary function testing or a history of interstitial lung disease (including sarcoidosis and idiopathic pulmonary fibrosis), severe bronchiectasis, cystic fibrosis (asthma is not an exclusion.
topical ibuprofen for delayed onset mulscle soreness

Conditions: Pain

Summary: the objective of this study is to compare the efficacy and safety of ibuprofen 5% topical gel versus placebo administered two or three times daily for the treatment of pain associated with delayed onset muscle soreness following intense eccentric exercise of the elbow flexor muscles.


Eligibility criteria:
inclusion criteria: males or females, 18 to 65 years of age, who have not engaged in upper extremity fitness activities for a minimum of 3 months prior to entry in the study; subjects must be willing to refrain from use of pharmacologic or non pharmacologic treatments (ie, heat, ice, massage) and other forms of soreness relief during the study exclusion criteria: use of corticosteroids or short- or long-acting non-steroidal anti-inflammatory drugs

Keywords: delayed onset muscle soreness ibuprofen topical
allogeneic umbilical cord mesenchymal stem cell transplantation for type 1 diabetes with diabetic ketoacidosis

Conditions: Ketoacidosis, Diabetic

Summary: this is a phase ii trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. the purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.

to assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. all the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. clinical and laboratory manifestations are compared before and after transplantation.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * duration of disease less than 12 months from diagnosis * with the history of diabetic ketoacidosis exclusion criteria: * pregnancy * severe psychiatric disorder * severe organic impairment(renal,hepatic,cardiac,pulmonary) * active infectious disease * previous or present neoplastic disease

Keywords: umbilical cord stem cell diabetic ketoacidosis
optimizing catheter insertion technique for ultrasound-guided continuous peripheral nerve blocks

Conditions: Pain, Postoperative

Summary: continuous peripheral nerve blocks (cpnb; also known as "perineural" catheters) provide target-specific pain control for a variety of surgeries. there has been increasing interest in the use of ultrasound guidance for regional anesthesia, and many techniques using ultrasound alone for perineural catheter insertion have been described. catheters may be placed at various points along the brachial plexus (for upper extremity procedures) or in proximity to the femoral and/or sciatic nerve (for lower extremity procedures). to date, the optimal ultrasound scanning technique, catheter insertion endpoint, catheter placement location per indication, for the majority of ultrasound-guided continuous peripheral nerve blocks remain unknown. this study will help provide important information related to optimal ultrasound scanning techniques and will help identify ways to improve the success rates, onset times, and analgesic effectiveness of these techniques for real patients undergoing surgical procedures.

primary aim: to determine if there is an optimal scanning technique for ultrasound-guided perineural catheter insertion that will result in the most accurate tip placement in proximity to the target nerve or plexus. secondary aim: to determine if there is an optimal location for ultrasound-guided perineural catheter insertion along a target nerve or plexus that will result in maximum local anesthetic infusion benefits.

Eligibility criteria:
inclusion criteria: * at least 18 years of age; * undergoing unilateral, upper (at or distal to the elbow) or lower (hip or distal) extremity orthopedic surgery, with moderate-to-severe postoperative pain expected; and * desiring a continuous perineural catheter for postoperative analgesia. exclusion criteria: * patients who will have difficulty understanding the study protocol or caring for the infusion pump/catheter system; or * patients with any known contraindication to study medications, insulin-dependent diabetes mellitus, neuropathy of any etiology in the affected extremity; * patients with a contraindication to regional blockade (eg, clotting deficiency); * patients with any known acute or chronic hepatic or renal insufficiency or failure; * patients with any additional surgical site outside of the catheter-affected area (eg, iliac crest bone graft in addition to hand surgery); * patients with chronic opioid use (defined as daily use for more than 4 weeks prior to surgery) or active illicit substance abuse; * patient weighing \< 40 kg; * pregnancy; * incarceration; or * inability to communicate with the investigators and hospital staff.

Keywords: peripheral nerve block perineural catheter orthopedic surgery ultrasound
calling for care: cell phones for mood telemetry in teens

Conditions: Bipolar Disorder; Cyclothymia; Borderline Personality Disorder

Summary: we will modify our existing vmq/vadis mood telemetry software to run on a motorola platform, and enhance it to collect information on both mood symptoms (currently covered by the vmq/vadis) as well as daily life stressors (currently outside the vmq/vadis' scope). by doing so, we will be able us to examine the role of daily stressors in the lives of teens with and without mood swings, to identify how changes in mood triggered by stressful events are similar to or different from mood changes linked to the bipolar disorder, borderline personality disorder, or other forms of affective instability.


Eligibility criteria:
inclusion criteria: * age 14-20yrs, * either (i) self-reported healthy with no past / present history of substance use problems or (ii) self-reported severe mood swings interfering with daily life. * fluent in english. exclusion criteria: * inability to be trained successfully on the mht software or to complete questionnaires without assistance. * unwillingness to sign / maintain a contract with a cell phone service provider. * lack of parental assent / willingness to act as guarantor for cell phone provider contract

Keywords: mental health telemetry mood telemetry mood bipolar disorder affective instability cyclothymia electronic diaries mood diaries mood swings
effects of "alliance180 program" on well-being

Conditions: Trauma and Stressor Related Disorders

Summary: the goal of this clinical trial is to evaluate the effects of the alliance180 program on physical and psychological well-being on adults who are/were us veterans, first responders and/or front line healthcare workers. the study aims are: * aim #1: to evaluate the effect of the alliance180 program on physical and psychological well-being in adults who are/were us veterans, first responders and/or front line healthcare workers; * aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention. participants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the alliance180 program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the alliance180 program. demographic information will be documented during the baseline research session.

all data collection will occur remotely using redcap (via university of north carolina, chapel hill). as this is a single-arm, feasibility/pilot study, all participants will follow the same protocol. 1. baseline research session: self-report completion of demographic information, perception of safety (neuroception of psychological safety, npss) and trauma experience (posttraumatic stress disorder checklist dsm-5, pcl-5), autonomic reactivity (body perception questionnaire, bpq), anxiety/depression (hospital anxiety and depression scale, hads), and perception of events and goals related to purpose in life (purpose in life scale). 2. participate in the 3-day alliance180 program (intervention), which includes the transformative equine experience. 3. post-intervention research sessions: 1 week, 1 month, 3 months and 6 months after completing the alliance180 program, self-report completion of perception of safety and trauma experience (npss, pcl-5), autonomic reactivity (bpq), anxiety/depression (hads) and purpose of events and goals related to purpose in life (purpose in life scale).

Eligibility criteria:
inclusion criteria: * 18 years or older * enrollment in an upcoming "alliance180 program". (enrollment is limited to adults who currently or formerly serve as us veterans, first responders and/or front line healthcare workers and are currently experiencing symptoms related to trauma exposure) exclusion criteria: - individuals who have previously completed the "alliance180 program"

Keywords: anxiety depression autonomic reactivity polyvagal theory
a prospective registry for patients at high-risk for pancreatic cancer

Conditions: Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; PDAC; PDAC - Pancreatic Ductal Adenocarcinoma

Summary: this study aims to facilitate discovery and validation of tests for early detection in subjects at high risk for pancreatic ductal adenocarcinoma (pdac) and to facilitate the use of state-of-the-art machine learning-based algorithms that utilize databases and images with the purpose of identifying early stages of pancreatic cancer, as well as people at high-risk.the study also aims to provide a platform for development of an interventional protocol for early detection of pdac.


Eligibility criteria:
inclusion criteria: * age ≥ 18 year * able to provide written informed consent * meets criteria as a high-risk individual as defined by protocol exclusion criteria: * individual who has a personal history of pancreatic ductal adenocarcinoma (pdac) * history of total pancreatectomy
use of high flow nasal cannula oxygen and covid-19 acute hypoxemic respiratory failure

Conditions: Respiratory Syndrome, Acute, Severe; Hypoxic Respiratory Failure; Viral Pneumonia

Summary: nasal high flow oxygen therapy (nhf) is commonly used as first line ventilatory support in patients with acute hypoxemic respiratory failure (ahrf). it's use has been initially limited in covid-19 patients presenting with ahrf. the aim of the study is to describe the use of nhf in covid-19-related ahrf and report the changes in the respiratory-oxygenation index (termed rox index) over time in these patients.

nasal high flow oxygen therapy (nhf) is one of the newer methods of oxygenation commonly used in critical care during acute hypoxemic respiratory failure (ahrf). for various reasons (fear of a putative risk of viral dispersion; initial recommendations for rapid intubation due to the rapid deterioration of patients), nhf seems to have been seldomly used during the current covid-19 epidemic in france. however, the world health organization, and other scientific societies list nhf among the possible options for ventilatory support. one of the risks however, identified with nhf is to delay an intubation that would have become necessary. this delay seems to be associated with a poorer prognosis for patients. the respiratory-oxygenation index (termed rox index) (defined as the ratio of pulse oximetry (spo2) over inspired fraction in oxygen (fio2) over respiratory rate (rr); spo2/fio2/rr) is used - along with other criteria - to assist the clinician in deciding whether or not to intubate patients on nhf for ahrf. in investigators'icu, nhf is used in patients admitted for ahrfrelated to covid-19 and the rox index is measured and monitoring in investigators' patients. investigators' initial experience - consistent with feedback from other icus - suggests that the respiratory rate of patients with covid-19-related ahrf is sometimes lower than would be expected given the depth of the hypoxemia. in this case, the rox index thresholds previously identified for predicting the success or failure of nhf could be different in the case of covid-19-associated ahrf. the purpose of this work is to describe the use of nhf in covid-19 patients with ahrf and the evolution of the rox score over time in patients initially treated with nhf.

Eligibility criteria:
inclusion criteria: * covid-19 pneumonia * acute hypoxemic respiratory failure * need for nasal high flow therapy as first line therapy * admission to intensive care exclusion criteria: * intubation prior to nhf therapy
analyze previously collected biopsy samples from participants who completed the "splash: split-body randomized clinical trial of poly-l-lactic acid for adipogenesis and volumization of the hip dell" study

Conditions: Lateral Gluteal Depression

Summary: primary objective: use immunofluorescence (if) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-l-lactic acid (plla) or saline.

sixteen female adults that participated in splash study will be enrolled in this retrospective study. it aims to analyze previously collected biopsy samples from participants who completed the "splash: split-body randomized clinical trial of poly-l-lactic acid for adipogenesis and volumization of the hip dell" study. the study will use immunohistology to assess changes in adipose tissue associated with treatment with plla (poly-l-lactic acid). we hypothesize that specimens treated with plla will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens.

Eligibility criteria:
inclusion criteria: * subjects who completed all biopsies in the previous splash trial "a single center, double- blinded, split-body, randomized clinical trial of injectable poly-l-lactic acid for volumization and adipogenesis of the hip dell - protocol number sculptra-hip-dell-2021-12" . exclusion criteria: * subjects who had biopsies of poor quality, insufficient tissue, or were otherwise unsuitable for immunofluorescence analysis.
early detection of malnutrition in oncology patients and elderly patients

Conditions: Malnutrition

Summary: the project is a national, prospective, multicenter, non-interventional pilot project of malnutrition screening in the czech republic. the main goal of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure for the early detection of malnutrition in oncology patients and hospitalised patients patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment.

the main goal of the project is the early detection of malnutrition in oncology patients and hospitalised patients 65 years of age and older, as this has a significant effect on the quality of life and the effectiveness of the services provided oncological treatment. another goal of the project will be the creation of a unified diagnostic proposal process and methodological material for determining malnutrition. this process will then be designed as the standard of nursing practice for patients with an oncological diagnosis and for persons older than 65 years such that, so that an adequate nutritional intervention is started in time, which will lead to a higher tolerance of demanding treatment and thus to increase the quality of life. the project will include testing the procedure on a sample of approx. 1,500 oncological and 500 geriatric patients. the project is supported by the european social fund (operational program employment plus) and the state budget of the czech republic and is registered by the ministry of labour and social affairs of the czech republic under id: cz.03.02.02/00/22_005/0000282.

Eligibility criteria:
inclusion criteria: cohort oncological patients: * 18+ * an oncological diagnosis * a survival prognosis of at least 3 months cohort patients older than 65 years: * 65+ * hospitalization at least 14 days or longer exclusion criteria (both cohorts): * not agreeing to participate in the project

Keywords: malnutrition oncology gerontology