Kornimate/medical-research-clean huggingface dataset:
acute sleep loss and arterial stiffness

Conditions: Arterial Stiffness

Summary: the overarching goal of this study is to mimic a night shift work like schedule and characterize circadian variation in pulse wave velocity (pwv), a measure of arterial stiffness, and determine the impact of acute loss of sleep like that experienced by shift workers on pwv.

night shift work is associated with increased risk of cardiovascular disease (cvd). pulse wave velocity (pwv) is a commonly used non-invasive measure of arterial stiffness and is strongly associated with cvd. previous research links sleep loss, like that experienced by shift workers, to elevated levels or abnormal levels of pwv. in addition, there is some research that shows circadian variation in pwv, which has implications for future studies and when pwv should be assessed. the overarching goal of this study is to characterize circadian variation in pwv and determine the impact of acute loss of sleep on pwv during a schedule like that experienced by night shift workers.

Eligibility criteria:
inclusion criteria: an individual may be eligible to participate if they meet the following criteria: 1. are between the ages of 20 and 29 years; 2. have not been diagnosed or told by a healthcare clinician that they have a medical condition that may impact their blood pressure or cardiovascular health/system; 3. can abstain from smoking tobacco or chewing tobacco products; 4. can abstain from caffeine and exercise for 4 days in a row; 5. are not prescribed medications or take over the counter medications that may impact blood pressure or heart rate (a team physician will review any reported medications identified during screening); 6. do not have a physical condition that may interfere with using the upper arm, upper thigh, or access to the neck area for purposes of performing non-invasive measures linked to this protocol; and 7. feel that they can avoid working and complete the 4 day protocol without interruption. exclusion criteria: an individual will be excluded if they report: 1. a medical condition or diagnosis that may impact their blood pressure or heart rate; 2. taking any standing medications or prescriptions, other than over the counter medications or contraceptives, that may impact their blood pressure or heart rate; 3. are unable to adhere to a strict 4 day protocol that involves abstaining from caffeine, alcohol, tobacco products (nicotine), and exercise; 4. have a physical condition that may limit use of the upper arm or upper thigh or area around the neck, which is necessary for performing multiple non-invasive measures associated with this protocol. 5. being pregnant. because participants may awaken during the in-lab sleep opportunity when staff use the sphygmocor device, it is important that staff and the study team know if the participant has ever experienced the following: a\] sleep paralysis; b\] night terrors; c\] have obstructive sleep apnea which requires the use of a cpap device; d\] become angry towards others when abruptly woken up; e\] become physical towards others when abruptly woken up.
incobotulinumtoxina (xeomin) versus placebo in the treatment of blepharospasm

Conditions: Blepharospasm

Summary: patients received one injection with incobotulinumtoxina (xeomin) or placebo at baseline. thereafter, all patients who entered the open-label extension period (olex) received up to five injection sessions of incobotulinumtoxina (xeomin) during the olex period.


Eligibility criteria:
main inclusion criteria: * male or female pretreated outpatients between ages 18 and 80 years (inclusive) * a clinical diagnosis of bilateral blepharospasm (beb) characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of the orbicular oculi muscles * a need for injection of botulinum toxin (defined by a jankovic rating scale (jrs) severity subscore \>= 2) * on a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to and expected throughout the main period * source documentation of the last two consecutive injection sessions with botox® and a stable satisfactory therapeutic response directly prior to trial entry * at least 10 weeks must have been passed between the last injection with botox® for beb and baseline main exclusion criteria: * atypical variant of beb caused by inhibition of levator palpebrae muscle * myotomy or denervation surgery in the affected muscles (e.g. peripheral denervation and/or spinal cord stimulation) * the previous two injections with botox® with more than 50 units per eye * hypersensitivity to human serum albumin, sucrose, or botulinum toxin a * neuroleptic induced blepharospasm * diagnosis of myasthenia gravis, lambert-eaton syndrome, amyotrophic lateral sclerosis, or any other significant neuromuscular disease which might interfere with the trial * treatment with botulinum toxins for any indication other than beb within 4 months prior to baseline and during the trial
trial of cf101 to treat patients with psoriasis

Conditions: Plaque Psoriasis

Summary: eligible patients with psoriasis will be treated with cf101 or placebo twice daily for 16 weeks. all subjects will receive open-lable cf101 in weeks 17-32.

eligible patients will be randomly assigned to parallel dosing groups of cf101 2 mg or matching placebo tablets twice daily (bid) in a 1:1 ratio for the 16-week controlled treatment period. approximately 94 patients will be assigned to each group. medication will be taken orally bid for 16 weeks in a double-blinded fashion. at the end of 16 weeks, all patients assigned to cf101 will continue cf101, while patients originally assigned to placebo will be reassigned to cf101. assessment of peripheral blood mononuclear cell (pbmc) adenosine a3 receptor (a3ar) expression at baseline and during treatment with cf101 in selected sites.

Eligibility criteria:
inclusion criteria: * male or female, 18 to 80 years of age, inclusive * diagnosis of moderate-to-severe chronic plaque-type psoriasis with body surface area involvement ≥10% * duration of psoriasis of at least 6 months * physician global assessment (pga) ≥3 * candidate for systemic treatment or phototherapy for psoriasis * electrocardiogram (ecg) is normal * females of child-bearing potential must have a negative serum pregnancy test * females of child-bearing potential must be willing to use 2 methods of contraception * ability to complete the study in compliance with the protocol * ability to understand and provide written informed consent. exclusion criteria: * erythrodermic, guttate, palmar, plantar, or generalized pustular psoriasis * treatment with systemic retinoids, corticosteroids, or immunosuppressive agents within 4 weeks of the baseline visit * treatment with high potency topical corticosteroids, keratolytics, or coal tar within 2 weeks of the baseline visit * ultraviolet or dead sea therapy within 4 weeks of the baseline visit * treatment with a biological agent within a period of time equal to 5 times its circulating half-life * treatment with lithium, hydroxychloroquine or chloroquine within 2 weeks of the baseline visit * serum creatinine level greater than 1.5 times the laboratory's upper limit of normal * liver aminotransferase levels greater than the laboratory's upper limit of normal * significant acute or chronic medical or psychiatric illness * participation in another investigational drug or vaccine trial concurrently or within 30 days prior to screening visit.

Keywords: psoriasis plaque psoriasis
bci-based control for ankle exoskeleton t-flex: comparison of visual and haptic feedback with stroke survivors

Conditions: Stroke

Summary: this protocol will developed an assessment of the t-flex device controlled by brain-computer interface in patients with stroke.

brain-computer interface (bci) remains an emerging tool that seeks to improve the patient interaction with the therapeutic mechanisms and to generate neuroplasticity progressively through neuromotor abilities. motor imagery (mi) analysis is the most used paradigm based on the motor cortex's electrical activity to detect movement intention. it has been shown that motor imagery mental practice with movement-associated feedback may offer an effective strategy to facilitate motor recovery in brain injury patients. this protocol will study a bci system associated with visual and haptic feedback to facilitate mi generation and, to control a t-flex ankle exoskeleton. in this study, a group of five post-stroke patients will test four different strategies using t-flex: passive movement, active movement, motor imagination with visual stimulation and motor imagination with visual-haptic stimuli. the quantitative characterization of bci performance will be made by using statistical analysis of electroencephalographic data. finally, the patient's satisfaction will be evaluated by a questionnaire.

Eligibility criteria:
inclusion criteria: * unilateral lower extremity paresis * hemorrhagic or ischemic stroke * a minimum of six months after the acute infarction/onset of the disease * full passive range of motion in lower extremity or at least at neutral position * be able to stand freely * be able to walk with or without aid for at least 20 meters in less than 2 minutes exclusion criteria: * peripheral nervous system pathology * epilepsy * weight over 100 kg * no cognitive ability to follow the study instructions * pregnancy * use of implanted devices * instable lower extremity joints or fixed contracture

Keywords: stroke brain-computer interface exoskeleton
a study comparing safety of abacavir and lamivudine administered once-daily as a single tablet versus the same drugs administered twice-daily as separate tablets (aloha study)

Conditions: HIV Infection

Summary: this study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.

a phase iiib randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive hiv-1 infected subjects.

Eligibility criteria:
inclusion criteria: * have hiv-1 infection. * had not received any prior hiv treatment for more than 14 days. * at least 1000 copies of hiv-1 rna. * willing to provide signed informed consent. exclusion criteria: * enrolled in other investigational drug studies. * female subjects who are pregnant or breastfeeding. * history of allergy or hypersensitivity to abacavir or lamivudine. * certain medical conditions that would make subjects ineligible.

Keywords: 1592u89 gr109714 abacavir lamivudine fixed-dose combination once-daily twice-daily hiv infection naive
transcranial static magnetic field stimulation (tsms) in amyotrophic lateral sclerosis (als).

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study aims to evaluate safety and efficacy of tsms in als patients and to obtain preliminary data about the effects of tsms on cortical excitability. to this purpose, 40 als patients will be recruited and randomized to real or sham tsms. after at least 3 months follow-up, they will undergo tsms, daily for 120 min, at home, for 6 consecutive months. clinical status will be tested before, during and after the stimulation period. moreover, cortical excitability will be tested by transcranial magnetic stimulation (tms) before and after the stimulation period.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * diagnosis of als according to revised el escorial criteria and awaji-shima criteria * disease duration \< 24 months * alsfrs-r \> 30 at the recruitment * alsfrs-r decline \> 1 in the at least 3-months period before the intervention * normal respiratory functionality (fvc \> 80% and alsfrs-r items 10,11,12 \> 4) at the recruitment * treatment with riluzole 50 mg x 2/die exclusion criteria: * inclusion in other clinical trials * presence of tracheotomy or/and peg (percutaneous endoscopic gastrostomy) * contraindications to magnetic fields exposure * pregnancy or breast-feeding * history of epilepsy or seizures * assumption of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines. * cognitive impairment * lack of informed consent

Keywords: amyotrophic lateral sclerosis als transcranial magnetic stimulation static magnetic field tsms
prebiotics in the prevention of necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis

Summary: necrotizing enterocolitis (nec) is the most common gastrointestinal catastrophe affecting 10-15% of premature neonates of \<1500 gm. nec is a disease of the immature intestine, characterized by impaired mucosal barrier function leading to increased gut permeability. we have previously demonstrated a protective effect of probiotic administration against the development of nec. others have shown that prebiotics can stimulate natural production of bifidobacteria and lactobacillus in the preterm gut. we have therefore hypothesized that prophylactic administration of prebiotics would also provide protection against necrotizing enterocolitis in the premature neonate, without the potential for sepsis which has been reported on rare occasions with probiotics administration.

specifically, we hope to demonstrate that fewer of the babies who are treated with galacto-oligosaccharides (gos) will develop nec as compared with controls. preterm neonates, \<1750 gm birth weight will potentially be candidates for study. they will be randomly assigned to receive one of two milk additives from the time enteral feeds are begun until 35 weeks post-conceptual age: prebiotics (gos) or placebo (water). all infants will be followed prospectively for signs of feeding intolerance and/or development of nec. these will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * preterm neonates * \< 1750 gm birth weight exclusion criteria: * infants who are deemed unlikely to survive * infants with significant congenital malformations * infants with other gastrointestinal problems

Keywords: galacto-oligosaccharides prebiotics nec
comparison of sport injury anxiety of athletes doing sports on different surfaces

Conditions: Athletic Injuries

Summary: due to its nature, sports are an activity in which injuries are common. sports injuries have athletic and environmental reasons. in sports injuries, although the medical team is generally interested in the physiological aspect of the injury, in recent years, the psychological aspect of the injury has also started to be taken care of. one of these psychological aspects is anxiety. athletes who develop sports injury anxiety are more prone to injury. one of the environmental reasons is the ground for sports. we could not find a study in the literature comparing the anxiety levels of those who do sports on different grounds in different sports branches. our study will provide support to the literature in this direction.

the study will be carried out on volunteers after the approval of the ethics committee. before the research, individuals and / or their relatives will be informed about the purpose and content of the study. volunteer athletes between the ages of 18-35 without any known health problems will be included in the study after obtaining their informed consent. 150 athletes competing on turf, artificial turf and wooden parquet will be included in our study. the data of our study will be collected by google survey. after obtaining the demographic information of the athletes participating in our study, the data on injury anxiety will be collected with the sports injury anxiety scale.

Eligibility criteria:
inclusion criteria: * to be a healthy, previous injury athlete exclusion criteria: * have an ongoing injury

Keywords: sports injuries anxiety surface
chimeric switch receptor modified t cells for patients with pd-l1+ recurrent or metastatic malignant tumors

Conditions: Recurrent PD-L1+ Malignant Tumors; Metastatic PD-L1+ Malignant Tumors

Summary: a chimeric switch receptor, which was constructed by fusing the pd1 extracellular ligand binding domain to the cd28 intracellular costimulatory domain, was designed to target pd-l 1 positive tumors . in this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous chimeric switch receptor modified t cells (csr t) in adult patients with pd-l1 positive, recurrent or metastatic malignant tumors.


Eligibility criteria:
inclusion criteria: 1. patients with pd-l1 positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic cancer, renal cancer, colorectal cancer, lymphoma, breast cancer and lung cancer; 2. measurable tumors by recist1.1 standard; 3. patients are 18 to 70 years old; 4. life expectancy \> 3months; 5. kps ≥70; 6. satisfactory major organ functions: adequate heart function with lvef≥50%; no obvious abnormities in ecg; pulse oximetry ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤3uln; bilirubin ≤2.0 mg/dl ; 7. blood: hgb ≥ 80 g/l, anc ≥ 1×10\^9/l, plt ≥ 50×10\^9/l; 8. women of reproductive potential must have a negative pregnancy test. male and female of reproductive potential must agree to use birth control during the study and one year post study. exclusion criteria: 1. patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy 2. active infection. 3. hiv positive. 4. active hepatitis b virus infection or hepatitis c virus infection. 5. currently enrolled in other study. 6. patients, in the opinion of investigators, may not be eligible or are not able to comply with the study. 7. patients with allergic disease, or are allergic to t cell products or other biological agents used in the study. 8. patients whose tumors have metastasized to bone, or have clinical signs of bone metastasis, such as bone and joint pain. 9. patients with brain metastasis, or have clinical signs of brain metastasis, such as loss of self-consciousness.
phase ib study to evaluate prs-080 in anemic chronic kidney disease patients

Conditions: Anemia of Chronic Kidney Disease

Summary: anticalins® are engineered human proteins that are able to bind specific target molecules. the anticalin prs-080#022-dp to be investigated in this study is directed against hepcidin and is intended for the treatment of anemia of chronic disease. this phase ib study shall investigate the safety, pharmacokinetics and pharmacodynamics of a single administration of prs-080#022-dp in anemic stage 5 chronic kidney disease patients undergoing hemodialysis.

this is a multi-center, randomized, double-blind, placebo-controlled, single ascending dose phase ib study in anemic stage 5 chronic kidney disease patients requiring hemodialysis. eligible subjects will undergo screening assessments and prs-080#22-dp will be administered by intravenous infusion. the study will consist of 3 dose cohorts of 2 mg/kg, 4 mg/kg, and 8 mg/kg body weight with 8 subjects in each cohort. using a standard 6+2 design, 6 subjects in each cohort will be randomized to prs-080#022-dp and 2 subjects in each cohort will be randomized to placebo. the decision to escalate the dose will be based on an interim analysis of clinical safety and safety laboratory data. safety and tolerability, pharmacokinetics, pharmacodynamics as well as potential immunogenicity will be investigated.

Eligibility criteria:
inclusion criteria: * patients with stage 5 chronic kidney disease having been on hemodialysis for at least 90 days * patients being on stable erythropoiesis-stimulating agent (esa) dose * hemoglobin (hb) 9 - 11 g/dl * ferritin ≥ 300 ng/ml. * transferrin saturation (tsat) ≤ 30% * hepcidin 5 - 50 nmol/l exclusion criteria: * anemia due to causes other than chronic kidney disease, including hemoglobinopathies, hemolytic anemias, myelodysplasia or malignancy * blood transfusion within 2 months before administration of study medication. * iron treatment from 1 week before study medication administration until 1 week after study medication administration. * previous enrollment in this study * current or previous (within 60 days before study medication administration) treatment with another investigational drug and/or medical device or participation in another clinical study. * pregnancy or breast-feeding women of child bearing age. * known allergy to any component of the prs-080#022-dp formulation * positive for hepatitis b surface antigen, anti-hepatitis c virus antibody, or human immunodeficiency virus * planned surgery during the study period * unwilling or unable to comply with the protocol, in the judgment of the investigator * unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, apoplexy or coronary artery bypass grafting \<3 months prior screening. * congestive heart failure: new york heart association class iii or iv.

Keywords: hepcidin hemoglobin iron anemia of chronic disease
digital training interventions for low back pain

Conditions: Low Back Pain

Summary: the patients will be clinically examined, as well as evaluated with patient reported outcome measures (proms) and magnet resonance imaging (mri) at baseline and at follow-ups.

the overall aim is to evaluate two different types of digital training interventions supervised by physiotherapists compared to daily physical activity in terms of clinical, imaging-based and patient-reported outcome in patients with low back pain. furthermore, to evaluate whether new diagnostic mri methods can identify longitudinal spine tissue changes and to analyse if there is an exercise-related difference. patients seeking primary health care for lower back pain will be randomized to three groups. the patients will be clinically examined, assessed with magnet resonance imaging (mri) and patient reported outcome measures (proms) will be evaluated at baseline and at follow-ups. a detailed description of the study protocol, see attached document.

Eligibility criteria:
inclusion criteria: * low back pain\> 3 months * age 18-50 years * access to computer/tablet/mobile phone exclusion criteria: * inadequate swedish as the language is an obstacle to be able to fully understand written and oral information regarding the project and to follow training instructions * other ongoing treatment/exercise for their low back pain * patients with radiating leg pain and neurological symptoms where herniated discs are suspected * previous back/neck surgery * pregnancy * diagnosed systematic diseases engaging the spine as rheumatoid arthritis, ankylosing spondylitis * factors that prevent an mri examination, such as claustrophobia, metal implants, etc.

Keywords: mri physiotherapy supervised digital training