Kornimate/medical-research-clean huggingface dataset:
effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain

Conditions: Low Back Pain

Summary: recently a clinical prediction rule (cpr) has been developed and validated that accurately identifies patients with low back pain that are likely to benefit from a lumbo-pelvic manipulation. the studies that developed and validated the rule used the identical manipulation procedure. however, recent evidence suggests that different manual therapy techniques may result in the same outcome.purpose: the purpose of this study is to investigate the effectiveness of three different manual therapy techniques in a subgroup of patient with low back pain that satisfy the cpr.


Eligibility criteria:
inclusion criteria: 1. chief complaint of pain and/or numbness in the lumbar spine, buttock, and/or lower extremity 2. oswestry disability score of at least 25% 3. age greater than 18 years and less than 60 years 4. at least four out of five of the following criteria: 1. duration of current episode \< 16 days (judged from the patient's self-report) 2. no symptoms extending distal to the knee (judged from the pain diagram) 3. fabq-w score \<19 4. at least one hip with \>350 internal rotation range of motion (measured in prone) 5. stiffness in the lumbar spine (judged from segmental mobility testing) exclusion criteria: 1. red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, ra, osteoporosis, prolonged history of steroid use, etc.) 2. signs consistent with nerve root compression, this includes any one of the following: 1. reproduction of low back or leg pain with straight leg raise at less than 450 2. muscle weakness involving a major muscle group of the lower extremity 3. diminished lower extremity muscle stretch reflex (quadriceps or achilles tendon) 4. diminished or absent sensation to pinprick in any lower extremity dermatome 3. prior surgery to the lumbar spine or buttock 4. current pregnancy 5. past medical history of osteoporosis or spinal compression fracture 6. inability to comply with treatment schedule (weekly sessions for four weeks)
evaluation of the efficacy of permanent course combined therapy with cytoflavin® intravenous solution and cytoflavin tablets, at 2-3 stages of rehabilitation of patients with post intensive care syndrome

Conditions: Ischemic Stroke

Summary: post intensive care syndrome (pic syndrome) is an important problem in modern intensive care strategy. understanding the mechanisms of pic syndrome helps prevent it in patients with respiratory, neuromuscular transmission, and cognitive impairments that require prolonged support of vital functions. significant role in the formation and severity of pic syndrome is played by the severity of the systemic inflammatory response, which is an individual reaction of the body, and this determines the degree of neurological and psychological deficits. chronic diseases such as diabetes mellitus, especially in the context of metabolic syndrome, worsen the course of pic syndrome and delays recovery. early initiation of rehabilitation measures in the intensive care unit and subsequent expansion of the individual rehabilitation program contributes to the rapid and successful recovery of not only vital functions, but also cognitive, motor and emotional disorders. this shortens the hospital stay of patient and improves their quality of life after discharge.


Eligibility criteria:
inclusion criteria: * men and women over 18 years of age and older; * stay in the itu and (or) intensive care unit for at least 3 days; * diagnosed "post intensive care" syndrome (pic syndrome) with moderate-to-severe severity \>3\<6 points * diagnosed modalities "critical illness polyneuropathy, respiratory neuropathy, dysphagia" of the domain "neuromuscular complications" of pic syndrome at 2-3 stages of the rehabilitation route at any value of pics severity index * diagnosed modalities "decreased gravitational gradient, decreased exercise tolerance" in the domain "vegetative-metabolic complications" at 2-3 stages of the rehabilitation route at any value of pics severity index exclusion criteria: * premorbid level of vital activity when assessed on the rehabilitation routing scale 4-5 points; * hematocrit ≤30%; * hemoglobin level ≤80 g/l; * acute cardiac failure; * acute respiratory failure; * acute renal failure; * acute liver cell failure; * use of drugs from "metabolic agents" pharmacotherapeutic group at the time of inclusion in the study * life expectancy of 6 months or less or presence of incurable diseases in decompensation stage

Keywords: post intensive care unit syndrome ischemic stroke
protective efficacy of flublok® quadrivalent versus licensed inactivated influenza vaccine in adults ≥50 years of age

Conditions: Influenza

Summary: the goal of this study is to establish that flublok quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (iiv4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population.

the goal of this study is to establish that flublok quadrivalent is non-inferior to fully licensed (traditional approval status) quadrivalent inactivated influenza vaccine (iiv4) in protecting against laboratory-confirmed clinical influenza disease in the ≥50 year age population. real-time polymerase chain reaction (rtpcr) will be used to confirm influenza infection and to type the strains involved, as molecular methodologies have been demonstrated to be more sensitive than other more traditional methodologies, e.g. culture. for rtpcr-positive clinical samples, reserved aliquots will be processed for culture, so that antigenic similarity to the ha present in study vaccines can be tested. in various clinical studies the investigators demonstrated that the immune response against the influenza a viruses is improved as a result of the higher hemagglutinin content. furthermore, influenza virus disease and hospitalization associated with influenza-related illness in older adults (\> 50 years) was considerably reduced (90%) following vaccination with tiv, even though the circulating influenza a strain was antigenically dissimilar to that in the vaccine. however, more recently skowronski et al. reported that the low influenza vaccine effectiveness in 2012-2013 was not associated with antigenic drift but was instead related to mutations in the egg-adapted h3n2 vaccine strain. flublok manufactured using recombinant technology does not contain the mutations responsible for the reported lower effectiveness and may thus offer improved protection when mutations such as those described are induced in the process of adapting the influenza virus to growth in eggs.

Eligibility criteria:
inclusion criteria: 1. ambulatory adults aged 50 and older. 2. medically stable, as determined by medical history and targeted physical examination. "medically stable" is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to study. 3. absence of underlying conditions that make participation in the study contrary to the subject's best interest. 4. able to understand and comply with planned study procedures. 5. provides written informed consent prior to initiation of any study procedure. exclusion criteria: 1. known contraindication to either study vaccine (see product package inserts) 2. receipt of any other influenza vaccine within 180 days prior to enrollment in this study. 3. underlying disease or ongoing therapy that might cause immunocompromise, e.g. cytotoxic agents or supraphysiologic doses of corticosteroids, such that response to vaccination might be sub-optimal.

Keywords: influenza
genetic and environmental risk factors related to esophageal cancer

Conditions: Esophageal Cancer

Summary: rationale: gathering information about genes, cigarette smoking, and diet may help doctors learn more about risk factors that may cause esophageal cancer. purpose: this clinical trial is studying genetic and environmental risk factors related to esophageal cancer.

objectives: * examine the role of several genetically-determined factors in combination with cigarette smoking and diet in the etiology and prevention of esophageal cancer. * identify polymorphisms in metabolizing enzymes (e.g., phase i or ii metabolism \[gstm1, gstt1,cyp1a1, cyp3a5, meh, nqo1, gstp1\], dna repair \[xrcc1, ercc2\], free-radical formation \[mpo, mnsod\], inflammatory genes \[ il1-beta\], metastatic potential \[mmp1\], and cell cycle or tumor suppression \[p21, p53\]) and related path genes of susceptibility for esophageal cancer. outline: blood and tumor tissue samples are collected. dna purified from these samples is analyzed using dna-based assays to determine polymorphisms in various related gene pathways. patients complete questionnaires concerning environmental, smoking and diet habits. projected accrual: a total of 1,000 tissue samples from patients and healthy participants (750 patients and 250 healthy participants) will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * diagnosis of esophageal cancer (patient) * newly diagnosed disease * receiving care at massachusetts general hospital, thoracic oncology center * friend or spouse of patient (healthy participants) patient characteristics: * no concurrent psychiatric incapacity or dementia prior concurrent therapy: * not specified

Keywords: stage 0 esophageal cancer stage i esophageal cancer stage ii esophageal cancer stage iii esophageal cancer stage iv esophageal cancer
study of the modification of the retinal nerve fiber layer in patients treated with intravitreous injection of anti-vegf

Conditions: Retinal Neovascularization

Summary: the intra-vitreous injection (ivt) of anti-vegf (vascular endothelial growth factor) is currently the standard treatment for retinal neovascularization. the vegf stimulates endothelial cells' proliferation and migration. it also increases microvascular permeability. if the vegfs have proven their efficiency in the decrease of choroidal neovascular proliferation, their impact of the head of the optic nerve's microvasculature is yet unknown. knowing that this microvasculature provides the retinal nerve fibers with oxygen, located in the area of the head of the optic nerve, a vasoconstriction induced by the anti-vegf may have an incidence on the loss of retinal nerve fibers.


Eligibility criteria:
inclusion criteria: * age ≥18 years old * patients treated with anti-vegf according to the french summary of product characteristics (spc) * patients who have been informed of the trial and who are not opposed to participate in the study exclusion criteria: * patients presenting a retinal condition, including the optic nerve * patients treated with anti-vegf in both eyes * pregnant women * lack of affiliation to social security or universal health coverage

Keywords: retinal neovascularization anti-vegf retinal nerve fiber layer (rnfl)
panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters

Conditions: Neovascular

Summary: is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters?


Eligibility criteria:
inclusion criteria: * untreated proliferative diabetic retinopathy exclusion criteria: * previous photocoagulation

Keywords: diabetic retinopathy diabetic macular edema panretinal photocoagulation
effect of a soluble fibre blend and medium chain triglycerides on body composition and cardiometabolic risk factors

Conditions: People Who Are Overweight or Obesity

Summary: the purpose of this study is to investigate whether the addition of capsules containing soluble fibre complex emulsified with medium chain triglycerides and taken before with meals will lead to a significant amount of weight loss, reduced glycemic volatility and diminished cardio metabolic risk factors in overweight and obese individuals when compared to a placebo control. we believe that those participants taking 3-6 capsules per day of the treatment capsules over a 14 week period will loose a significant amount of weight compared to the placebo group.


Eligibility criteria:
inclusion criteria: * bmi 27 - 35 kg/m2 exclusion criteria: -
prevention of linear growth failure in infants and young children with lipid-based nutrient supplements (ilins-dose)

Conditions: Malnutrition

Summary: the use of lipid-based nutrients (lns), such as nutributter or fortified spread (fs), have been associated with improved growth and development outcomes among infants in ghana and malawi. modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. such modified products have proven acceptable to infants and their guardians in malawi and ghana. in the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified lns. additionally, the investigators will test a hypothesis that lns that does not contain milk promotes growth as well as milk-containing lns when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural malawi.

six-month old healthy infants are identified through community surveys in the study area. 1920 infants meeting set criteria are randomised into receiving the following intervention between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements, with delayed intervention between 18-30 months of age (st-di), 2) 10 g / day milk-containing lns (lns-10gm), 3) 20 g / day milk-containing lns (lns-20gm), 4) 20 g / day milk-free lns (lns-20gnom), 5) 40 g / day milk-containing lns, (lns-40gm) 6) 40 g / day milk-free lns (lns-40gnom). the families receive the food supplements at 2-weekly intervals and the participants undergo a morbidity evaluation weekly, a limited development assessment at 4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses at enrollment and at 18 months. growth outcome analyses are done at 18 and at 42 months of age.

Eligibility criteria:
inclusion criteria: * signed informed consent from at least one guardian * age 5.50 months to 6.49 months * availability during the period of the study. * permanent resident of mangochi district hospital or namwera health centre catchment area exclusion criteria: * weight for length z score (wlz) \< -2.0 * presence of oedema * severe anaemia (hb\<50 g / l) * severe illness warranting hospital referral * history of allergy towards peanut * history of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care * concurrent participation in any other clinical trial

Keywords: stunting growth failure malnutrition lipid based nutrient supplement lns prevention malawi sub-saharan africa dietary supplementation efficacy
three types of nucleotide/nucleoside analogues therapy in patients with hepatitis b virus related compensated cirrhosis

Conditions: Hepatitis B; Compensated Cirrhosis

Summary: this study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

hepatitis b virus infection remains a serious public health problem in china. nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. entecavir, tenofovir disoproxil fumarate and tenofovir alafenamide are first line drug in china. but there still lacks of data of tenofovir alafenamide in treatment of hepatitis b virus related compensated cirrhosis. this study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.

Eligibility criteria:
inclusion criteria: 1. positive hepatitis b surface antigen or hepatitis b virus dna \> 0.5 year; 2. age from 18 to 65 years old; 3. hepatitis b virus dna positive; 4. cirrhosis or portal hypertension is found through ultrasonography, computed tomography or magnetic resonance imaging; 5. do not receive nucleotide/nucleoside analogues treatment in the past half year. exclusion criteria: 1. complications of decompensated cirrhosis: ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc; 2. other active liver diseases; 3. hepatocellular carcinoma or other malignancy; 4. pregnancy or lactation; 5. human immunodeficiency virus infection or congenital immune deficiency diseases; 6. severe diabetes, autoimmune diseases; 7. other important organ dysfunctions; 8. using glucocorticoid; 9. patients can not follow-up; 10. investigator considering inappropriate.

Keywords: hepatitis b virus compensated cirrhosis nucleoside nucleotide
insoles adapted in flip-flop sandals in people with heel pain

Conditions: Heel Pain Syndrome; Heel

Summary: introduction: persistent hindfoot pains are very common and prevalent complaints in the brazilian population. one of the treatments recommended for these conditions in the literature is the use of insoles. however, to use this resource it is necessary that the individual wear closed shoes and this is an obstacle to treatment in cities with hot climate. thinking about an alternative treatment, the customized slippers with the corrective elements of the insoles can be an alternative to increase adherence to this type of treatment. objective: to compare different types of hindfoot elements in insoles adapted in slippers in individuals with persistent hindfoot pain.

methodology: this is a protocol for a controlled, randomized, blinded clinical trial. eighty participants with persistent hindfoot pain will be evaluated and randomized into two intervention groups: insoles adapted to flip-flops and flip-flops with sham insole. the evaluations will be carried out at baseline (t0), after six (t6) and twelve weeks (t12) of the use of flip-flops, in addition to the follow-up that will be carried out four weeks after the end of the intervention (t16). the primary outcome will be pain, using the numerical pain scale and the secondary outcomes will be: foot function, using the foot function index questionnaire, functional capacity in walking, using the six-minute walk test and pain catastrophizing using the scale. of pain catastrophizing. statistical analysis: data will be analyzed by t-student, mann-whitney and repeated measures anova tests and will be analyzed by intention to treat. ethics and disclosure: this protocol was approved by the ethics committee of ufrn/facisa (number 4,018,821). the results of the study will be disseminated to participants and submitted to a peer-reviewed journal and scientific meetings.

Eligibility criteria:
inclusion criteria: * individuals of both sexes, aged 18 to 65 years; * persistent heel pain for at least three months based on self-reported criteria: heel pain accompanying the first steps in the morning, after a period of inactivity, and/or during prolonged weight-bearing; * pain intensity between 3 and 8 points, according to the numerical rating scale (nrs) \[22\]; * individuals who can wear flip-flop sandals for at least four hours per day for 12 weeks. exclusion criteria: * clinical diagnosis of neuropathic pain or neurodegenerative disorders, persistent heel pain due to rheumatic conditions, and previous ankle and foot surgeries; * physical therapy treatment in the last three months; * corticosteroid injection into feet in the last six months; * inability to answer study-related questionnaires; * individuals scheduled to travel in the next six months.
analysis of medication data with the apomining-database

Conditions: Delirium

Summary: the primary objective of this study is to analyse medication data from the biocog study with the apomining-database and to determine the positive and negative predictive value from the apomining-database for prediction of postoperative delirium (pod).

from 2014-2017 the biocog study (clinicaltrials.gov identifier: nct02265263) collected data from 439 perioperative elderly patients in campus virchow - klinikum, universitätsmedizin berlin. according to the study protocol, a delirium assessment was performed each day after operation until the 7th postoperative day. at this time, it is known which patients developed postoperative delirium (pod) and which did not. additionally, from each patient data on long-term medication before operation and applied medication during operation and in the recovery room were collected. in this study, the investiagtors analyse the long-term medication and the perioperative medication from biocog-study patients with the apomining-database (http://www.apothesen.de/index.php?id=878; apothesengmbh; bad münstereifel; germany). the apomining-database is a medication database, which analyse tolerability and risks of medications for the elderly. the database generates a hit once a medication reveal a risk for delirium. additionally, the database can calculate the anticholinergic burden of the medication according to the prescribing information. whereas the investigators already know, which patient developed a pod, they will determine positive and negative predictive value from the apomining-database for prediction of postoperative delirium.

Eligibility criteria:
inclusion criteria: * from biocog study (nct02265263) exclusion criteria: * from biocog study (nct02265263) additionally for this analysis: inclusion criteria: • enrollment at campus virchow - klinikum, charité - universitätsmedizin berlin exclusion criteria: * no delirium assessment * no long-term medication before operation