Kornimate/medical-research-clean huggingface dataset:
dar-901 tb booster vaccine to prevent tb in adolescents

Conditions: Tuberculosis

Summary: dar-901 booster vaccine or placebo will be administered to adolescents in tanzania primed with bcg to determine if immunization reduces the risk of tb infection

dar-901 whole cell booster vaccine to prevent tb infection in adolescents ("dar-pia") this is a phase ii, 3-injection, randomized, controlled trial of dar-901 to be conducted in 13-15 year old adolescents in tanzania previously immunized with bcg. dar-901 is a whole cell inactivated non-tuberculous mycobacterial vaccine manufactured from the master cell bank of srl-172 that was used in the successful phase iii dardar trial in tanzania. the goals are to establish the safety and efficacy of dar-901 in preventing infection with tb. the 1 mg dose was selected during the current phase i dose-escalation trial of dar-901 in the us being conducted by dartmouth and aeras. the 1 mg dose corresponds to the dose of srl 172 used in the dardar trial. all subjects will be screened by the t-spot® igra (oxford immunotec, oxford, england) for evidence of tb infection. all screened subjects will have a structured interview to identify risk factors for tb infection (=positive igra). igra-positive subjects will be referred for further evaluation and will not be entered in the immunization phase of the trial. it is estimated that 1000 adolescents will need to be screened to identify a total of 650 igra-negative adolescents in the immunization phase of the trial. subjects will be and randomized 1:1 to dar-901 or saline control at 0, 2 and 4 months. doses will be administered by intradermal (id) injection in the deltoid area. igra testing will be repeated before dose 2, at 14 months, and again at 24 months. this three year study began in the first quarter of 2016 in dar es salaam, is funded by ghit-japan and will be directed by geisel school of medicine at dartmouth (pi, f. von reyn) with collaborators at muhimbili university of health and allied sciences (muhas) in tanzania and tokyo medical and dental university in japan.

Eligibility criteria:
inclusion criteria: negative igra at baseline - exclusion criteria: pregnancy, serious underlying disease -

Keywords: vaccine
cervical range of motion and stretching

Conditions: Cervical Shortening

Summary: cervical range of motion (rom) is necessary to perform normal activities of daily living and deficits are associate with various pathologies. currently, its unclear if specific myofascial stretches will improve cervical range of motion and decrease myofascial sensitivity. after a single session of the manual stretching procedure, participants immediately demonstrated increased cervical rom and pressure pain thresholds.

methods: sixty participants with no history of neck pain or trauma were randomized into one of two groups: stretching group (n = 30), or control group (n = 30). the stretching group received a standardized manual stretching protocol. the control group did not received intervention. pre and post-test measurements were recorded for both groups. within group differences and group by time interactions were evaluated for cervical range of motion rom and myofascial sensitivity. the immediate improvement in active rom of the cervical spine may prompt clinicians to consider the sequencing of treatment. stretching prior to active exercises may allow for active exercise through a larger rom. future research is needed to evaluate the immediate effects of stretching in the symptomatic population.

Eligibility criteria:
inclusion criteria: * ages of 18-60 * active cervical flexion, right lateral flexion or left cervical lateral flexion \<45˚ exclusion criteria: * minors * prisoners * individuals with cognitive impairments * recent neck surgeries * pre-existing neck injuries

Keywords: range of motion muscle sensitivity muscle stretching
a registry for the food allergy community

Conditions: Food Hypersensitivity; Anaphylaxis; Eosinophilic Esophagitis; Food Sensitivity; Food Intolerance; Food Allergy in Infants

Summary: the fare patient registry will serve as a prospective, observational food allergy reporting system that stores detailed health and other basic information about patients' real-world experiences with food allergies, to encourage open sharing of de-identified data and participation in clinical trials. the fare patient registry intends to make and support scientific discoveries by enabling the food allergy community to participate directly in research.


Eligibility criteria:
inclusion criteria: * individuals with diagnosed food allergy exclusion criteria: * individuals without food allergy

Keywords: food allergy
transoesophageal echocardiography in liver transplantation

Conditions: End Stage Liver Disease

Summary: severe hypotension during reperfusion in liver transplantation is a frequent adverse event. rare data exist so far about pathophysiology of this phenomenon. the exact role of left ventricular function, which might be impaired causing hypotension, has not been elucidated during the period of reperfusion. goal of this study is to: * perform transesophageal echocardiography in order to assess systolic and diastolic left ventricular function during reperfusion * determine inflammatory mediators in the plasma which could cause left ventricular dysfunction


Eligibility criteria:
inclusion criteria: * patients on waiting list for liver transplantation. * age: 18-75 years. exclusion criteria: * strictures, tumours and diverticula of the oesophagus. * history of oesophageal varices with recent bleeding. * oesophageal varices and prothrombin time less than 20% or platetlets les than 30000/ml. * instable cervical spine. * involvement in other studies.
immun response in children with mis-c

Conditions: MIS-C Multisystem Inflammatory Syndrome in Children

Summary: multi-system inflammatory syndrome in children (mis-c) is a post-viral inflammatory vasculopathy of children and adolescents following covid-19 infection. it affects one of 1000-5000 children. latency between mild or asymptomatic covid-19 infection and mis-c is 4-6 weeks. the immune response in mis-c seems to be dysregulated and different from that during acute sars-cov-2 infection. the investigators are planning to investigate the immune response in children with mis-c. rna and protein expression of cytokines and immune cell-related markers will be determined via multiplex elisa, facs, quantitative pcr, rnaseq, and western blot. the use of highly sensitive multiplex methods will allow for the analysis of a large number of parameters in the smallest possible amount of sample. sample preparation and analysis will be performed in close collaboration with the centre for molecular medicine cologne (cmmc) and the institute of virology. with this project the investigators hope to identify risk factors for developing mis-c and extend the knowledge on therapeutic options for the treatment of this condition.


Eligibility criteria:
inclusion criteria: * diagnosed with mis-c (who criteria) * \<18 years * hospitalized in the children´s university hospital of cologne exclusion criteria: * no informed consent
tolerability, safety and efficacy of rki983 eye drops in subjects with primary open angle glaucoma and ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this study will evaluate the tolerability and safety of rki983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.


Eligibility criteria:
inclusion criteria: * males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension * females must be post-menopausal or surgically sterile exclusion criteria: * other types of glaucoma * eye pressure lowering surgeries * a history of or current eye conditions or medical problems that would prohibit the use of an investigational drug other protocol-defined inclusion/exclusion criteria may apply.

Keywords: glaucoma ocular hypertension rki983 primary open angle glaucoma and ocular hypertension
exercise training in sarcoidosis (extras study)

Conditions: Sarcoidosis

Summary: exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness. the present researchers reason that skeletal muscle weakness is, at least in part, related to physical inactivity and therefore partially reversible following a structured exercise training program. nevertheless, the effects of exercise training have never been studied in patients with sarcoidosis. therefore, the present study is undertaken to explore the effects of exercise training in patients with sarcoidosis. a priori, the following hypotheses are formulated: * a 12-week exercise training program improves health status, quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention. * a 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention. * a 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.

the extras study is a prospective, randomized, controlled, 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa. consenting participants will be assessed at baseline (before randomization, week 0) and at weeks 12 and 24.

Eligibility criteria:
inclusion criteria: * main diagnosis: previously diagnosed sarcoidosis according to the latest ats/ers/wasog statement on sarcoidosis (ajrccm 1999) exclusion criteria: * a history of neurosarcoidosis * undergoing structured exercise training at the time of enrollment or in the preceding 6 months * current participation in a pharmacological study * cardiovascular abnormalities on the ecg during baseline peak exercise test * a 'normal' baseline peak oxygen uptake (≥90% of the predicted values) in combination with a 'normal' quadriceps peak torque or distance walked in 6 minutes

Keywords: exercise training resistance training endurance training boeck's sarcoid besnier-boeck disease
a prospective observational registry of patients treated with lupkynis® (voclosporin) in the us

Conditions: Lupus Nephritis

Summary: this registry is an observational study designed to assess the utilization and effectiveness of lupkynis in adult patients with lupus nephritis (ln) in the united states (us).

this registry is an observational study designed to assess the utilization and effectiveness of lupkynis in patients with lupus nephritis (ln) in the united states (us). this registry is intended to benefit and support interests of patients, clinicians, regulatory bodies, payers, and industry by obtaining longitudinal data on lupkynis.

Eligibility criteria:
inclusion criteria: * lupus nephritis (ln) confirmed by biopsy * initiating or have initiated treatment with commercial lupkynis as per us approved prescribing information (pi) * written informed consent exclusion criteria: - off-label use (use of lupkynis outside of the fda-approved us prescribing information)
prevalence of neuropathic pain after non-instrumented lumbar spinal surgery

Conditions: Lumbar Disc Herniation; Lumbar Spinal Stenosis

Summary: chronic neuropathic pain following lumbar spine surgery is often under-diagnosed and difficult to relieve. it can persist long after the operation, sometimes for months or even years, and has a major impact on the quality of life of patients who suffer from it. however, the scientific literature on the subject remains relatively poor, as evidenced by the absence of scientific studies on the prevalence of neuropathic pain after lumbar spinal surgery, whether instrumented or not. the main aim of this study is to determine whether lumbar spine surgery has an impact on the prevalence of neuropathic pain. participants will be followed up and complete a quality-of-life questionnaire for one year after surgery.


Eligibility criteria:
nclusion criteria: * patients admitted for scheduled primary lumbar spine surgery without pedicle osteosynthesis or interbody cage. * pathology concerned by programmed surgery: herniated disc or lumbar spinal stenosis, uncomplicated by motor or sphincter deficits. * delay between 1st painful symptoms and surgery \> 48h. non-inclusion criteria: * surgery scheduled within 48 hours of onset of symptoms. * presence of cauda equina syndrome * presence of motor-radicular deficit * patients with neurological pathology prior to surgery * major cognitive or sensory disorders preventing completion of the self-questionnaire * patients under guardianship * patients not covered by french social security. * patients who develop an identified neurological pathology after surgery, regardless of the initial surgery (e.g. multiple sclerosis, spinal cord injury, etc.).

Keywords: neuropathic pain lumbar spinal surgery
pre-clinical white matter changes and associated connectivity effects in fabry disease

Conditions: Fabry Disease

Summary: the purpose of this research project is: * to use an advanced quantitative mri technique (fbfi) to detect and quantify brain lesion in patients with fd * to use fmri to identify altered brain function * to use fbfi and fmri together to map altered connectivity in response to brain lesions

fabry disease (fd) is a lysosomal storage disease caused by a deficiency in an enzyme that degrades components of the outer cell wall. a deficiency of this enzyme in humans has been associated with stroke. in males with fd, 6.9% have a stroke by 39 years of age. in females with fd, 4.3% have a stroke by 46 years of age. magnetic resonance imaging (mri) is the main tool for studying stroke in fd. importantly, mri has identified other types of lesions in the brain beyond that caused by stroke. these additional lesions may herald stroke or be a different manifestation of fd in the brain. these lesions are seen in \>50% of men and women with fd. diffusion-based imaging mri has been the leading approach for studying these lesions in fd. however, these lesions that appear to be specific to fd are difficult to quantify, analyze, and interpret using this and other current mri methods. the investigators would like to use a form of mri called fast bound-pool fraction imaging (fbfi), which is a technique better suited to capture and quantify these lesions, to study these lesions in patients with fd. in parallel, the investigators would like to use functional mri (fmri) to study how these lesions alter brain function and connectivity in fd. the combination of these techniques (fbfi + fmri) will also provide us the opportunity to study brain plasticity in response to injury as fabry disease is slowly progressive over decades allowing the brain to remodel connections to maintain function.

Eligibility criteria:
fabry cohort inclusion criteria: * have fabry disease * must be 18yrs or older exclusion criteria: * subjects who are claustrophobic * have metal implants * cannot pass the mri safety screening questionnaire. unaffected controls inclusion criteria: * must be 18yrs or older * unaffected with fabry disease * considered healthy with no previous history of stroke, multiple sclerosis, diabetes mellitus, or other neurologic disease. exclusion criteria: * subjects who are claustrophobic * have metal implants * cannot pass the mri safety screening questionnaire.

Keywords: fabry mri (magnetic resonance imaging) fabry brain lesions
premedication for less invasive surfactant administration study (prelisa)

Conditions: Respiratory Distress Syndrome, Newborn

Summary: the purpose of this study is to conduct a double blinded randomized control trial to determine the safety and efficacy of using iv fentanyl and atropine prior to less invasive surfactant administration (lisa) procedure in preterm infants with respiratory distress syndrome compared to the local standard of care to perform this procedure without any premedication. hypothesis: in infants greater than or equal to 29 weeks gestational age requiring the less invasive surfactant administration procedure, premedication with a combination of iv atropine and iv fentanyl will be associated with fewer combined bradycardia events, defined as heartrate less than 100 beats per minute for longer than 10 seconds, and hypoxemia events, defined as saturations less than or equal to 80% for longer than 30 seconds, during the procedure compared with placebo. specific aims: * to determine if infants receiving iv fentanyl and atropine prior to lisa will have a decrease in hypoxemia and bradycardia events during the procedure compared to infants receiving placebo * to determine if infants receiving premedication prior to less invasive surfactant administration will have higher procedure first attempt success rate compared with infants receiving placebo * to determine the effect of premedication on cerebral oxygenation compared to placebo during and for 12 hours after less invasive surfactant administration using cerebral near infrared spectroscopy * to determine the effect of premedication prior to less invasive surfactant administration on the need for mechanical ventilation for 24 hours after the procedure


Eligibility criteria:
inclusion criteria: * infants ≥29 weeks gestational age between 0-72 hours of life on cpap for respiratory support who qualify for the lisa procedure as determined by the primary team using parkland optisurf guidelines exclusion criteria: * infants requiring intubation prior to surfactant therapy * infants with known severe congenital anomalies (including complex congenital heart disease, airway, and central nervous system anomalies) * infants born to mothers with known opioid addiction or in a methadone treatment program

Keywords: premedication for less invasive surfactant administration fentanyl and atropine for less invasive surfactant administration cerebral near infrared spectroscopy monitoring in neonates premedication for lisa fentanyl and atropine for lisa cerebral nirs monitoring in neonates
evaluation of phlebotomy as a treatment for non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the purpose of this study is to evaluate the use of phlebotomy (blood taking)as a treatment for patients with non-alcoholic fatty liver disease.

in this study phlebotomy will be evaluated as a therapy for non-alcoholic fatty liver disease (nafld), a common and important cause of liver disease. phlebotomy has been used for many years in the treatment of disorders of iron overload such as hemochromatosis, where it is well tolerated and improves symptoms and survival. there is some evidence that it is also effective in treating nafld. however, previous studies have not evaluated whether phlebotomy improves liver biopsy findings. we will measure the severity disease in nafld patients prior to phlebotomy therapy and again at the end of treatment. this will allow us to accurately determine the benefit of this therapy in these patients.

Eligibility criteria:
inclusion criteria: * patients 18y or older * diagnosis of non-alcoholic fatty liver disease exclusion criteria: * unable or unwilling to provide informed consent * alcohol consumption of \>10g/day for women and \>20g/day for men

Keywords: non-alcoholic fatty liver disease liver fibrosis metabolic syndrome iron overload phlebotomy
mind-body online therapy in gynecological oncology

Conditions: Gynecologic Cancer

Summary: in this randomized-controlled two-arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for gynecological cancer patients with primary diagnoses is examined. different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind-body focus are available for the patients. the goal of the intervention is to improve or maintain the quality of life.


Eligibility criteria:
inclusion criteria: * at least 18 years old * oncologic disease: first diagnosed; within the first 12 weeks of diagnosis, first-line treatment (either systemic treatment - including chemotherapy, hormonal therapy or targeted therapy - or radiotherapy), notes: (1) patients treated for first recurrence of a tumor previously treated with curative intent are also eligible. (2) psychological distress is taken into account by stratification according to the stress thermometer. in research, this procedure corresponds to the current state-of-the-art. individual subgroups (e.g. cancer stages) can then be studied post-hoc. * sufficient computer skills and internet access * availability of an emergency address * written informed consent by signing the informed consent form exclusion criteria: * patient unable to provide written informed consent by signing informed consent form * insufficient knowledge of german * moderate to severe depressive symptomatology (bdi \> 18; ham-d17 ≥ 17) during t1 survey * suicidality (bdi suicidality item \> 1; ham-d17 suicidality item ≥ 2) in the context of the t1 survey * diagnosis of psychotic, bipolar, or other serious mental or somatic disorder requiring immediate treatment * male breast cancer patients

Keywords: mind body mbm mind body medicin online therapy online-therapie internettherapie internet therapy selbsthilfeintervention onkologie oncology krebs cancer gynäkologie gynecology frauenklinik frauenheilkunde psychosomatik psychosomatics psychotherapie psychotherapy
france pci registry : national observatory of interventional cardiology

Conditions: Interventional; Cardiology; Angioplasty; Coronary; STEMI; Database

Summary: rigorous clinical practice assessment is a key factor to improve patient's care and prognosis in interventional cardiology (ic). a multicentric ic observational study (crac), fully integrated to usual coronary activity report software, started in centre val de loire (cvl) region in 2014. crac observatory was conduced on five ic cathlab of cvl region. quality of collected data is regularly evaluated and allowed building an exhaustive, and reliable database. this solution could easily be developed in other french regions.


Eligibility criteria:
inclusion criteria: * age =\>18 years at enrollment * patient who have had a coronary angiogram or angioplasty exclusion criteria: * patient who didn't want to participated
ultrasound-guided erector spinae plan block in patients undergoing eswl

Conditions: Urinary System Stones; Pain

Summary: extracorporeal shock wave lithotripsy (eswl) is widely used in the treatment of urinary tract stones and is generally applied to outpatients. to achieve fragmentation in eswl, shock waves must be applied with sufficient power and time. providing effective analgesia during this procedure is crucial to the success of the procedure. erector spinae plan block (espb) was first described in 2016 and, it is frequently used for postoperative analgesia in urinary system surgery. this study aimed to investigate the efficacy of espb in patients undergoing eswl.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-ii patients undergoing extracorporeal shockwave lithotripsy exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications * emergency cases

Keywords: extracorporeal shockwave lithotripsy erector spinae plane block
randomized phase 2 with cpg-odn in malignant glioblastoma

Conditions: Glioblastoma

Summary: the purpose of this study is to determine whether the immunostimulating agent cpg-odn is effective in the treatment of glioblastoma


Eligibility criteria:
inclusion criteria: * glioblastoma * karnofsky performance status ≥ 60% exclusion criteria: * severe or uncontrolled systemic disease * active auto-immune disease * uncontrolled epilepsia * platelets \< 100 000/mm3 ; or neutrophils \<500 /mm3 ; or lymphocytes \<300/ mm3

Keywords: glioblastoma immunotherapy