Kornimate/medical-research-clean huggingface dataset:
supplemental oxygen in pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: to enhance understanding of supplemental oxygen-its utility in and adoption by patients with pulmonary fibrosis-by examining how patients perceive it and by determining how perceptions and patient-centered outcome measures change from before to after supplemental oxygen is prescribed.

the investigators aim to recruit patients with pf to participate in interviews and/or a one-year study of supplemental oxygen (o2). in the one-year study, the investigators will collect data before and for one year after pf patients are prescribed daily-use supplemental oxygen and compare outcomes, including shortness of breath, quality of life, fatigue, cough, and day-to-day functioning before and after o2.

Eligibility criteria:
inclusion criteria: patient-participants (using daily 02 therapy at time of enrollment) * diagnosis of pf * able to read and speak english * has been on daily-use supplemental oxygen for more than one year (not using daily 02 therapy at time of enrollment) * diagnosis of pf * able to read, speak and write in english * has not been prescribed daily-use supplemental oxygen * forced vital capacity \<75% and diffusing capacity \<65% of predicted values * subject's physician allows the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection primary supporters * self-report status of providing care or support to a person living with pulmonary fibrosis who has used supplemental oxygen for more than one year * able to speak english o2 prescribers * self-report status of being a prescriber of daily-use supplemental oxygen to pf patients * able to speak english exclusion criteria: patient-participants (using daily 02 therapy at time of enrollment) * no diagnosis of pf * unable to read and speak english * has been on daily-use supplemental oxygen for less than one year (not using daily 02 therapy at time of enrollment) * no diagnosis of pf * unable to read, speak and write in english * using supplemental oxygen during the day * subject's physician does not allow the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection primary supporters • not meeting inclusion criteria o2 prescribers • not meeting inclusion criteria

Keywords: pulmonary fibrosis interstitial lung disease connective tissue disease chronic hypersensitivity pneumonitis idiopathic pulmonary fibrosis pulmonary fibrosis of any cause primary supporters/caregivers
adductor strength in athletes suffering a groin injury

Conditions: Groin Injury

Summary: assess the difference in adductor peak strength evaluated with different instruments. hand held dynamometer vs force frame

this study aims to compare the difference in adductor strength output performed by athletes suffering a groin injury between two different assessment methods. previous studies have observed that add strength differs depending on the evaluation method. isometric strength can be measured with hand held dynamometer or with force plates (forceframe). wether one method is better in order to differenciate adductor strength between healthy and injured limb is not known to date.

Eligibility criteria:
inclusion criteria: * suffer a groin injury during the assessment period * accept participating in the study exclusion criteria: -

Keywords: multidirectional sport groin pain adductor strength
safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis

Conditions: Birch Pollen Allergy

Summary: safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis


Eligibility criteria:
inclusion criteria: * positive skin prick test reaction to birch pollen * positive rast result to birch pollen * positive provocation test result to birch pollen exclusion criteria: * serious chronic diseases * other perennial allergies

Keywords: allergy birch pollen recombinant
longitudinal monitoring of inflammation in cirrhosis

Conditions: Cirrhosis, Liver

Summary: longitudinal monitoring of inflammation using skin devices may help predict outcomes compared to traditional blood draws


Eligibility criteria:
healthy volunteers inclusion criteria: 1. age \>18 years 2. able to give consent exclusion criteria: 1. unable/unwilling to consent 2. chronic diseases 3. unable to come in daily or be available daily for 3 days. outpatients with cirrhosis: inclusion criteria: 1. age \>18 years 2. able to give consent 3. cirrhosis defined by any one of the following 1. cirrhosis on liver biopsy or transient wave elastography 2. nodular liver on imaging 3. endoscopic or radiological evidence of varices in a patient with chronic liver disease 4. platelet count \ 1 in a patient with chronic liver disease 5. patients with frank decompensation (ascites, he, variceal bleeding, hepato-pulmonary syndrome) exclusion criteria: 1. unable/unwilling to consent 2. unclear diagnosis of cirrhosis 3. unable to come in daily or be available daily for 3 days. 4. inflammatory bowel disease or other diseases that require immunosuppressive therapy use inpatients with cirrhosis: inclusion criteria: 1. age \>18 years 2. able to give consent 3. cirrhosis defined by any one of the following 1. cirrhosis on liver biopsy or transient wave elastography 2. nodular liver on imaging 3. endoscopic or radiological evidence of varices in a patient with chronic liver disease 4. platelet count \ 1 in a patient with chronic liver disease 5. patients with frank decompensation (ascites, he, variceal bleeding, hepato-pulmonary syndrome) exclusion criteria: 1. unable/unwilling to consent 2. unclear diagnosis of cirrhosis 3. unable to be seen daily or able to come in daily for 3 days (if discharged in between) 4. inflammatory bowel disease or other diseases that require immunosuppressive therapy use
autologous cd19 car-t cell therapy (syncar-001) + orthogonal il-2 (stk-009) in subjects with cd19+ hematologic malignancies

Conditions: CLL/SLL; NHL; Mantle Cell Lymphoma; Follicular Lymphoma; Large B-cell Lymphoma; Indolent B-Cell Non-Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma

Summary: this is a first-in-human phase 1 study of syncar-001 + stk-009 in patients with cd19+ hematologic malignancies.

syncar-001 + stk-009 is a 2-component human orthogonal (ho) il-2 receptor-ligand cell therapy consisting of (1) syncar-001, a cd19-directed chimeric antigen receptor t cell (car-t) co-expressing an engineered il-2 beta receptor (horb); and (2) stk-009, an engineered pegylated il-2 cytokine (hoil-2) selective for horb. the study will follow a 3+3 design during dose escalation. cohort a will enroll subjects to syncar-001 + stk-009 with lymphodepletion. at dose level 3, a separate dose escalation cohort will be introduced to enroll subjects to syncar-001 + stk-009 without lymphodepletion (cohort b). subsequent dose expansions will enroll subjects at the rp2d for each cohort.

Eligibility criteria:
selected inclusion criteria: 1. histologically confirmed relapsed/refractory hematologic malignancies, including chronic lymphocytic lymphoma (cll/sll) and selected non-hodgkin's lymphoma (nhl) 2. prior or current documentation of cd19 expression or high likelihood of cd19 expression based on disease histology 3. no signs of symptoms of central nervous system (cns) disease or detectable evidence of cns or meningeal disease on magnetic resonance imaging (mri) at the time of screening selected exclusion criteria: 1. prior cd19 directed therapy including cd19 carts 2. prior allogeneic hematopoietic stem cell transplant within 6 months of enrollment 3. prior autologous hematopoietic stem cell transplant within 6 weeks of enrollment. 4. presence of gvhd

Keywords: cart cd19-cart chimeric antigen receptor il-2
effect of head elevation on lma insertion

Conditions: Laryngeal Masks; Urinary Bladder Neoplasms

Summary: the purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion according to the degree of head elevation.

the purpose of this study is to compare the first attempt success rate of laryngeal mask airway insertion between 7 cm head elevation and 14 cm head elevation in patients who undergoing transurethral bladder tumor resection.

Eligibility criteria:
inclusion criteria: * patients who are scheduled transurethral bladder tumor resection under general anesthesia * 20-79 years of age * american society of anesthesiologists physical status ≤3 * patients who are voluntarily agreed to this clinical study exclusion criteria: * history of difficult airway * expected difficult airway by physical examination * unstable teeth or teeth loss * obesity (body mass index ≥ 30) * recent history of upper respiratory infection * patients who are not fasted or who are at risk of aspiration
a comparison of combivent udv (ipratropium 500mcg and salbutamol 2.5mg) and salbutamol udv alone (2.5mg)

Conditions: Asthma

Summary: to compare the bronchodilator efficacy of ipratropium plus salbutamol (combivent) with salbutamol alone given every 20 minutes for three doses in asthmatic children with severe acute exacerbation

a comparison of ipratropium 500mcg and salbutamol 2.5mg (combivent udv) and salbutamol udv alone (2.5mg) in a double-blind, efficacy and safety study in asthmatic children with severe acute exacerbation study hypothesis: several studies, including a study conducted in an emergency room setting, demonstrated that the addition of ipratropium bromide, an anticholinergic drug, to standard salbutamol therapy significantly improves pulmonary function as compared to salbutamol alone. comparison(s): ipratropium bromide 500 mcg plus salbutamol 2.5mg (combivent) vs salbutamol (2.5mg) alone given every 20 minutes for 3 doses

Eligibility criteria:
inclusion criteria 1. all patients must have a known history of asthma and present to the hospital/clinic with severe acute exacerbation. 2. male or female patients 2 to 10 years of age. 3. parents or legal guardians of patients must sign an informed consent form prior to participation in the trial. exclusion criteria 1. patients with known or suspected hypersensitivity to study drugs 2. patients with medical condition that would contraindicate the use of beta2-adrenergic or anticholinergic medications 3. patients with first wheezing episode only 4. prior intubation for asthma for more than 24 hours 5. patients who used ipratropium within six hours prior to consultation 6. patients with concurrent stridor or possible presence of intra-thoracic foreign body 7. patients with disease known to have chronic effect on respiratory function ( e.g., cystic fibrosis or cardiac disease) 8. patients requiring immediate resuscitation or airway intervention 9. with psychiatric disease or psychosocial problems 10. patients on other investigational drugs or have used any other investigational drugs within the past month
study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery (escape-2)

Conditions: Hypertension

Summary: the purpose of this study is to establish the efficacy of of clevidipine versus placebo in treating postoperative hypertension. approximately 100 patients with postoperative hypertension undergoing coronary artery bypass grafting (cabg), off-pump coronary artery bypass (opcab) or minimally invasive direct coronary artery bypass (midcab) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or placebo.

the primary objective was to determine the efficacy of clevidipine versus placebo in treating postoperative hypertension by comparing the incidence of bailout in the clevidipine and placebo treatment groups during the 30-minute time period from initiation of study drug. secondary objectives included assessments of efficacy through measuring time to target blood pressure (bp) lowering effect defined as 15% reduction in sbp, change in mean arterial pressure (map) and the incidence of bailout by causality. assessments for safety included change in heart rate (hr) from baseline.

Eligibility criteria:
pre-randomization inclusion criteria: * provide written informed consent before initiation of any study-related procedures. * be at least 18 years of age * be scheduled for cardiac surgery (including coronary artery bypass grafting \[cabg\], off pump coronary artery bypass \[opcab\], minimally invasive direct coronary artery bypass \[midcab\] surgery, and/or valve replacement/repair procedures) pre-randomization exclusion criteria: * women of child-bearing potential (unless they have a negative pregnancy test) * recent cerebrovascular accident (within 3 months before randomization) * known intolerance to calcium channel blockers * allergy to soybean oil or egg lecithin (components of the lipid vehicle) * pre-existing left bundle branch block or permanent ventricular pacing * any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial. * participation in another therapeutic drug or therapeutic device trial within 30 days of starting study post-randomization inclusion criteria: * expected to survive beyond 24 hours post-surgical procedure * no surgical complications or conditions, present or anticipated, that preclude them from inclusion in a double blind, placebo-controlled study * determined to be hypertensive (sbp \> 140 mm hg) within 4 hours of arrival in a postoperative setting * it is the investigator's intent to lower the patient's sbp by a minimum of 15% from its baseline value

Keywords: postoperative hypertension
feasibility of virtual reality delivery of pain neuroscience education

Conditions: Low Back Pain

Summary: randomized clinical trail (rct) for patients already planned to attend physical therapy for chronic low back pain. patients will be randomized to receive physical therapy (pt) as usual or pt plus pain education delivered via virtual-reality headset.

there is an increasing emphasis in physical therapy and healthcare in general on enhancing patients' ability to self-manage spinal pain as a strategy to reduce disability for impacted individuals and escalating healthcare costs. this change in emphasis requires a paradigm shift on the part of practitioners and patients alike in how they conceptualize and respond to pain. pne is a promising education strategy that has been shown to influence patient-reported outcomes in those with chronic pain and has been shown to influence the provider's beliefs about pain. however, the delivery of this education has proven difficult for providers in terms of comfortability and time-efficiency. a standardized delivery a pne by experts in the field could prove efficient and effective. study design the investigators' overall goal is to determine the feasibility of vr-delivered pain neuroscience education (pne). secondarily, the investigators would like to see if these interventions are best targeted to specific individuals. to accomplish these goals, the investigators will conduct a randomized clinical trial, randomly assigning participants to receive virtual reality (vr) education in addition to usual care or usual care with no additional education.

Eligibility criteria:
inclusion criteria: * i. age 18-75 at time of first physical therapy session ii. primary reason for physical therapy is low back pain iii. history of low back pain \>/= 12 weeks exclusion criteria: * i. age \>75y/o or \<18 y/o ii. red flag condition that prohibits participation in physical therapy: * systemic metabolic disorder * neurological or muscular degenerative disorder (including epilepsy) * systemic infection * cardiopulmonary or pulmonary disorder with contraindication to physical exercise iii. recent spinal surgery (\<12 months) iv. specific spinal pathologies, such as severe stenosis or spondylolisthesis or fracture v. acute radiculopathy or compromised nerve root vi. currently known to be pregnant
reconnecting to ourselves and others in virtual meetings (room)

Conditions: Mood Disorders; Anxiety Disorders; Psychotic Disorders

Summary: this study aimed to determine the feasibility and acceptability of delivering resilience training in multi-user virtual reality.


Eligibility criteria:
inclusion criteria for college student participants: 1. 18-30 years old 2. enrolled in an undergraduate program inclusion criteria for healthcare provider participants: 1. at least 18 years old 2. employed in the healthcare field with some direct patient contact exclusion criteria: 1. inability to provide informed consent 2. not proficient in english 3. acute symptoms of a psychiatric illness needing immediate care (such as acute psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by self-report that necessitates close monitoring or inpatient or partial hospitalization. 4. enrolled in current psychotherapy with frequency of more than once per month
shapes: supporting multimorbid older people

Conditions: Heart Failure; Diabetes; Diabetes Mellitus

Summary: the smart \& healthy ageing through people engaging in supportive systems (shapes) innovation action is a horizon 2020, eu-wide project looking at how technology can enable the older population to live healthier lives at home. it involves the development, piloting and deployment of a large scale, eu-standardised open platform. this platform will integrate with a wide-range of technological, organisational, clinical, educational and societal solutions seeking to facilitate long-term healthy and active aging. within this project are 7 pilot themes investigating various potential uses of the platform, in northern ireland we are leading on medicines control and optimisation. this pilot is focused on identifying, managing and improving deficiencies in adherence to medicines and treatments of older individuals living with permanent or temporary reduced functions or capabilities due to chronic, age-related illnesses and living at home. digital solutions (including blood pressure monitors, pulse oximeters, weight scales and glucometers) will be used to enable self-monitoring of the individual's physiological parameters. data will also be used to develop an algorithm to help predict decompensations in participants with heart failure and dynamic personal ranges will also be developed. in the future this may enable early opportunities to adjust medicines and treatments so as to deliver safer and more effective use of medicines in-home, however, in this pilot there will be no changes to treatment. the target population is composed of older individuals (+65 years) living at home with heart failure and/or diabetes. we aim to recruit 30 people (for 3 months) to our pilot in northern ireland. we are working closely with colleagues in spain, czech republic, cyprus and germany to run similar pilots within their healthcare systems.


Eligibility criteria:
inclusion criteria: * northern health and social care trust service user * ≥60 years * diagnosed with heart failure and/or diabetes mellitus (treatment includes regular self-monitoring of blood glucose) * lives at home or in supported living accommodation (category 1 or 2). * category 1 - self-contained accommodation for the more active elderly, which may include an element of scheme supervisor support and/or additional communal facilities * category 2 - scheme supervisor supported self-contained accommodation for the less active elderly, which includes the full range of communal facilities * has stable self-reported wi-fi connection at home * has access to an appropriate android smartphone or tablet * android device running version 8 or above; supports wi-fi; supports ble; front facing camera for facial recognition * self-reported stable disease state, the participant feels well enough to take part in the pilot * self-reported confident user of smartphone/tablet exclusion criteria: * participant report of cognitive impairment * wears an electronic medical device or implant (e.g. pacemaker, electrocardiogram)
evaluation of performance characteristics and applicability in oncology of devices customized medical devices made by 3d printing

Conditions: Sarcoma; Intracranial Neoplasm; Pelvic Bone Neoplasm

Summary: technologies 3d are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3d printing. in fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. this new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies.


Eligibility criteria:
inclusion criteria: * primary tumor of the pelvic bone primary meta-diaphysial tumor of the long bones; squamous cell carcinoma of the oral cavity in the upper and/or lower jaw. over 10 years of age * primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor aged 7-18 years * intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary aged 18-70years * signed informed consent form exclusion criteria: * inoperability; * presence of pathological fractures.
study to evaluate the leish-111f + mpl-se vaccine in healthy adults not previously exposed to leishmania parasite

Conditions: Cutaneous Leishmaniasis

Summary: this study will evaluate the safety and immunogenicity of the leish-111f + mpl-se vaccine in adult subjects who have no evidence of previous exposure to the leishmania parasite.

cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of leishmania disease. all available medical therapies require weeks of treatment and cause significant toxicity. it appears that leishmania infections can be eliminated or prevented by t helper 1 immune responses. these findings argue that a vaccine that generates a t helper 1 response against the parasite will prevent the infection and disease. this is a phase 2, randomized, double blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity in montenegro skin test (mst)-negative healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. the vaccine, identified as leish-111f + mpl-se, consists of a recombinant three-antigen leishmania polyprotein (leish-111f, 10 μg) together with the adjuvant mpl-se (25 μg). in addition, the safety and immunogenicity of the vaccine will be compared to that of the leish-111f protein (10 μg) given alone. the vaccine, leish-111f protein alone or placebo will be given to each study subject three times at 4 week intervals.

Eligibility criteria:
inclusion criteria: * must have negative montenegro skin test (0 mm) * must be in good general health with normal lab values * negative for hiv, hepatitis b and c exclusion criteria: * history of leishmaniasis or exposure to leishmania vaccine or mpl-se * nursing or pregnant female

Keywords: leishmaniasis subunit vaccine prevention t cell