Kornimate/medical-research-clean huggingface dataset:
balance chiropractic therapy for cervical spondylotic radiculopathy

Conditions: Cervical Radiculopathy

Summary: the purpose of this study is to evaluate the therapeutic effect and safety of the balance chiropractic therapy(bct) on cervical spondylotic radiculopathy and to investigate the mechanism of which this efficacy is achieved.

the investigators propose a multi center randomized, parallel-controlled trial to evaluate the efficacy and safety of the balance chiropractic therapy for csr. participants aged 18 to 65, who are in conformity with the diagnostic criteria of csr and the pain score regarding visual analog scales is more than 4 points and less than 8 points, will be included and randomly allocated into two groups: test group and control group. participants in the test group will be treated with the balance chiropractic therapy, while the control group will receive the traction therapy. the primary outcome is pain severity (measured with a visual analogue scale (vas)). secondary outcomes will include cervical curvature (measured by borden index), a composite of functional status(measured by neck disability index ,ndi), individual patients health status(evaluated by sf-36 health survey ), and adverse events as reported in the trial.

Eligibility criteria:
inclusion criteria: * subjects who are in conformity with the diagnostic criteria of csr; * aged between18 and 65 years old; * the pain score regarding visual analog scales is more than 4 points and less than 8 points; * sign the informed consent. exclusion criteria: * subjects will be excluded if they have disorders such as vague diagnosis of acute spinal cord injury or acute spinal cord inflammation,or cervical vertigo symptom and checking for abnormal changes on transcranial doppler(tcd). * subjects will also be excluded if they have combined liver, kidney, hematopoietic system, endocrine system, cardiovascular system, nervous system and other severe primary disease,or fractures,osteoarticular tuberculosis, osteomyelitis, bone tumor, severe osteoporosis,or mental disabilities, * a weak body can not withstand the stimulation of the balance chiropractic therapy . * individuals who have acute infectious disease, stomach or duodenal ulcer with acute perforation,or treated areas with severe skin damage or skin diseases. * subjects that have received surgical treatment or neck injury, or radiofrequency of cervical intervertebral disc, or minimally invasive, or ozone, or acupuncture and moxibustion, or other manipulations or block therapy within two weeks * lactating or pregnant patients. * subjects who are participating in other clinical trials related to cervical spondylosis.

Keywords: cervical radiculopathy balance chiropractic therapy
cardiac biomarkers after marathon running and coronary atherosclerosis

Conditions: Coronary Artery Disease

Summary: this study evaluates cardiac biomarkers and their association to coronary artery disease in marathon runners.

the maracat study is an observational prospective study evaluating the association between cardiac biomarkers and coronary artery disease in 43 runners participating in the 2018 paavo nurmi marathon. the study participants were recruited according to two age criteria - under 35 years and over 44 years of age. comprehensive laboratory samples were collected immediately after the run, while the control workup was done in a separate visit with no significant physical excercise in the preceding two weeks. in the under 35 years -group, the control workup included an echocardiography, ecg and blood samples. in the over 44 years group, the control studies included coronary ct, echocardiography, ecg and laboratory tests.

Eligibility criteria:
inclusion criteria: * age under 35 years or over 44 years * participant of paavo nurmi marathon 2018 * informed consent signed exclusion criteria: * no informed consent * existing coronary artery disease
study of sar447537 (inbrx-101) compared to plasma-derived a1pi therapy in adults with aatd emphysema

Conditions: Alpha 1-Antitrypsin Deficiency; Emphysema

Summary: phase 2 study to compare sar447537 (inbrx-101) to plasma derived a1pi therapy in adults with aatd emphysema

this is a phase 2, double-blind, randomized, active-control, parallel group study to assess the pharmacokinetics, pharmacodynamics, immunogenicity, and safety of sar447537 (inbrx-101) compared to plasma-derived alpha1-proteinase inhibitor (a1pi) augmentation therapy in adults with alpha-1 antitrypsin deficiency (aatd) emphysema.

Eligibility criteria:
inclusion criteria: 1. males or females 18-80 years of age, inclusive, at the time of screening 2. diagnosis of aatd 3. evidence of emphysema secondary to aatd 4. fev1 of ≥ 30% and ≤ 80% predicted at screening 5. current non-smoking status. exclusion criteria: 1. receipt of a1pi augmentation therapy within 5 weeks prior to the first dose of study drug 2. known or suspected allergy to components of sar447537 (inbrx-101), a1pi or human igg 3. known selective or severe immunoglobulin a (iga) deficiency 4. known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes 5. received iv immunoglobulins, monoclonal antibodies and/or other biologic therapies within 30 days 6. on waiting list for lung or liver transplant 7. acute respiratory tract infection or copd exacerbation within 4 weeks prior to or during screening 8. evidence of decompensated cirrhosis 9. active cancers or has a history of malignancy within 5 years prior to screening 10. history of unstable cor pulmonale 11. clinically significant congestive heart failure

Keywords: aatd alpha 1-antitrypsin deficiency emphysema sar447537 inbrx-101 a1pi aat
different dietary interventions and glycemia in t1dm

Conditions: Diabetes Mellitus, Type 1

Summary: the aim of the present study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (t1d).

the aim of the present crossover study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (t1d). three different isocaloric diets, namely, a mediterranean style diet, a low-carbohydrate diet and a reference diet were provided to patients with t1d for three separate weeks, in a random order, and with 7-day washout periods in-between. glycemia was assessed during each 7-day period using a continuous glucose monitoring system. participants were recruited from the outpatient diabetes clinic of a university hospital in athens, greece. the primary outcome was time spent in euglycaemic range (tir: 70-140mg/dl) during the diet period. secondary outcomes were: (a) time spent below euglycaemic range (tbr: \ 140mg/dl); (c) glycaemic variability and (d) insulin needs.

Eligibility criteria:
inclusion criteria: * adults with t1d receiving mdi therapy * sufficient education and knowledge on carbohydrate counting * motivation to follow a specific dietary schedule * frequent (7 times a-day) self-monitoring of blood glucose (smbg) * willingness to wear a cgm system exclusion criteria: * hba1c \>8% * lack of severe diabetic complications, such as cardiovascular disease, proliferative retinopathy, nephropathy with estimated glomerular filtration rate (egfr) ≤ 60 or gastroparesis

Keywords: diabetes mellitus, type 1 glycemia continuous glucose monitoring diet
safety, efficacy and pk of bivv001 in pediatric patients with hemophilia a

Conditions: Hemophilia A

Summary: primary objective: - to evaluate the safety of bivv001 in previously treated pediatric participants with hemophilia a. secondary objectives: * to evaluate the efficacy of bivv001 as a prophylaxis treatment. * to evaluate the efficacy of bivv001 in the treatment of bleeding episodes. * to evaluate bivv001 consumption for prevention and treatment of bleeding episodes. * to evaluate the effect of bivv001 prophylaxis on joint health outcomes. * to evaluate the effect of bivv001 prophylaxis on quality of life (qol) outcomes. * to evaluate the efficacy of bivv001 for perioperative management. * to evaluate the safety and tolerability of bivv001 treatment. * to assess the pharmacokinetics (pk) of bivv001.

study duration per participants was approximately 60 weeks (maximum 8 weeks for screening and 52 weeks of treatment). all participants completing or remaining at the end of study were offered participation in the planned extension trial.

Eligibility criteria:
inclusion criteria : * participant must be younger than 12 years of age, at the time of signing the informed consent. * severe hemophilia a defined as \<1 international units per deciliter (iu/dl) (\<1 percent \[%\]) endogenous factor viii (fviii) as documented either by central laboratory testing at screening or in historical medical records from a clinical laboratory demonstrating \<1% fviii coagulant activity (fviii:c) or a documented genotype known to produce severe hemophilia a. * previous treatment for hemophilia a (prophylaxis or on-demand) with any recombinant and/or plasma-derived fviii, or cryoprecipitate for at least 150 exposure days (eds) for participants aged 6 to \<12 years and above 50 eds for participants aged \<6 years. * weight above or equal to 10 kg. exclusion criteria: * history of hypersensitivity or anaphylaxis associated with any fviii product. * history of a positive inhibitor (to fviii) test defined as greater than or equal to (\>=) 0.6 bethesda units (bu/ml), or any value greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 bu/ml, or clinical signs or symptoms of decreased response to fviii administrations. family history of inhibitors would not exclude the participant. * positive inhibitor test result, defined as \>=0.6 bu/ml at screening. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
assessment of fetal pancreatic size and maternal serum biomarkers in gdm

Conditions: Gestational Diabetes

Summary: the investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (ga) and insulin-regulated aminopeptidase (irap) for gestational diabetes mellitus (gdm).

the investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (ga) and insulin-regulated aminopeptidase (irap) for gestational diabetes mellitus (gdm).in this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers ga and irap were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, gdm was confirmed with the 75-g oral glucose tolerance test (ogtt) and the fetal pancreas size was measured in all the participants again.

Eligibility criteria:
inclusion criteria: * maternal age between 18 and 42 years * gestational age between 20 and 28 weeks exclusion criteria: * multiple pregnancies * pregestational diabetes * fetal congenital malformations * placental and amniotic fluid abnormalities * preeclampsia * severe systemic disease * long-term systemic drug usage
the use of biorepair peribioma toothpaste and mousse for home oral care in patients undergoing periodontal therapy

Conditions: Periodontal Diseases

Summary: this is a split-mouth randomized clinical trial in which a new domiciliary oral care protocol with biorepair peribioma toothpaste and mousse is evaluated in periodontal patients.

this is a split-mouth randomized clinical trial that aims to suggest an innovative protocol for domiciliary oral care of periodontal patients. in details, home use of biorepair peribioma toothpaste and mousse is proposed as a support of professional hygiene sessions. patients that respond to the eligibility criteria and that sign the informed consent are recruited for periodontal therapy.the first professional hygiene session is performed at the baseline (t0); the following ones will be performed after 3 (t1) and 6 months (t2) from the baseline. in each session, periodontal indices of inflammation are detected; then, subgingival removal of plaque and tartar is performed, followed by glycine air-flow application in periodontal pockets. a microbiological test is perfomed in order to detect red and orange complex bacteria. at this time, patients are randomly allocated into two groups: * trial group: domiciliary oral hygiene with biorepair peribioma toothpaste and mousse twice a day until t2 session. * control group: home oral hygiene with curasept toothpaste (0,2% chlorhexidine) twice a day until t2 session. at the end of t1 and t2 professional session, a satisfaction survey about peribioma toothpaste and mousse will ben given to the patients.

Eligibility criteria:
inclusion criteria: * presence of periodontal disease according to the recent 2017 classification (2017 world workshop on the classification of periodontal and peri-implant diseases and conditions): severity grade ii-iii and complexity grade i-ii. * presence of bilateral periodontal probes, for at least one tooth per side up to 20 elements with pathologic probes). * patients' good compliance exclusion criteria: * patients with cardiac pacemaker * patients suffering from neurological disorders * patients suffering from psychological disorders * pregnant women

Keywords: dental hygiene periodontal non-surgical therapy split-mouth
efficacy of memantine in prevention of oxaliplatin-induced peripheral neurotoxicity

Conditions: Cancer

Summary: memantine is a drug for the management of alzheimer's disease (ad) due to its promising neuroprotective properties. we hypothesize that memantine possesses a beneficial role against chemotherapy-induced neuronal damages.


Eligibility criteria:
inclusion criteria: histologically confirmed diagnosis of stage iii colorectal cancer performance status \< 2 according to eastern cooperative oncology group (ecog) score adequate renal function (glomerular filtration rate ≥ 90) exclusion criteria: preexisting neuropathic or brain disorders, a previous use of chemotherapeutic agents including oxaliplatin use of drugs reported to have neuroprotective role
xanthohumol and metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to determine the pharmacokinetics (pk) of xanthohumol (xn). small amounts of xanthohumol occur naturally in hops, used to make beer, and xn is also found in beer itself. studies in animals have shown that xn can lower blood sugar and blood lipids such as triglycerides, which can contribute to heart disease. the purpose of this study is to see how much of the xn is absorbed into the blood and how fast it leaves the body when taken by mouth. once the pk study has been done, the investigators' long-term goal is to learn if xanthohumol can lower risk factors for heart disease and type-2 diabetes in humans.


Eligibility criteria:
* bmi 18-32 kg/m2 (to avoid confounders with extreme obesity). * smoking or non-smoking. * having normal or clinically acceptable physical examination and clinical laboratory tests. * willing to abstain from beer consumption for four days prior to and during the study because beer contains xn and related prenylated (pn) flavonoids, such as ix, 8-pn and 6-pn. * not currently taking prescription drugs. * not having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study. * if female, not pregnant (as confirmed by urine pregnancy test), breastfeeding, or planning to become pregnant before completing the study, and using effective method of contraception (hormonal methods not permitted). * if male with a partner of childbearing potential, willing to inform their partner of their participation in this clinical study and use highly effective methods of birth control during the study. * not currently following an extreme diet, such as atkin's, zone or ornish, and willing to maintain their current diet without extreme changes for the duration of the study.

Keywords: xanthohumol metabolic syndrome
phase ii dose-finding of oral sss17 for anemia in non-dialysis ckd

Conditions: Anemia in Pre-Dialysis Patients

Summary: this study primarily evaluates the efficacy and safety of oral sss17 capsules in treating anemia in patients with non-dialysis chronic kidney disease, as well as the pharmacokinetic and pharmacodynamic (pk/pd) characteristics of different doses of sss17 capsules for anemia treatment in this patient population.

this dose-finding study comprises three distinct dosing cohorts:cohort 1-3 once weekly . each cohort will enroll patients at a 4:1 ratio (sss17:placebo), allocating 32 subjects to active treatment and 8 to placebo control per group. the total planned enrollment is 120 non-dialysis chronic kidney disease (ckd) patients with anemia. the trial will initiate with cohort 1. dosing regimens for subsequent cohorts may be modified based on predefined pharmacokinetic (pk), pharmacodynamic (pd), and safety evaluations from preceding cohorts, including potential adjustments to dose levels and/or administration frequency.

Eligibility criteria:
inclusion criteria: 1. non-dialysis ckd patients aged 18-75 years. 2. screening egfr \<60 ml/min/1.73 m² . 3. mean hb ≥7.0 g/dl and \<10.0 g/dl . 4. agreement to use medically acceptable contraception from icf signing until 6 months post-trial. exclusion criteria: 1. hypoxia-inducible factor prolyl hydroxylase inhibitors within 5 weeks pre-randomization. 2. erythropoiesis-stimulating agents, androgens, iv iron , or other anemia drugs within 6 weeks pre-randomization. 3. blood donation/transfusion within 3 months 4. transferrin saturation ≤20% and ferritin ≤100 μg/l at screening. 5. uncorrected folate or vitamin b12 deficiency pre-randomization. 6. systolic bp \>170 mmhg, diastolic bp \>110 mmhg. 7. ipth \>500 pg/ml. 8. acute/chronic pancreatitis or amylase/lipase \>3×uln. 9. nyha class iii/iv heart failure or significant arrhythmias . 10. proliferative diabetic retinopathy, macular edema, or other neovascular retinal disorders requiring treatment. 11. active hbv, hcv, hiv, or clinically significant uncontrolled infections. 12. current/pplanned dialysis, prior nephrectomy, polycystic kidney disease, or hemochromatosis. 13. organ transplant recipient/candidate，participation in other drug trials within 3 months，substance abuse history. 14. pregnancy, lactation, or refusal of contraception. 15. hypersensitivity to study drug components.
a study investigating the safety and efficacy of lampalizumab intravitreal injections in participants with geographic atrophy secondary to age-related macular degeneration

Conditions: Geographic Atrophy

Summary: this study is a phase iii, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (ga) secondary to age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * participants aged greater than or equal to (\>/=) 50 years * well demarcated area(s) of geographic atrophy (ga) secondary to age-related macular degeneration (amd) with no evidence of prior or active choroidal neovascularization (cnv) in both eyes exclusion criteria: ocular exclusion criteria (study eye): * history of vitrectomy surgery, submacular surgery, or other surgical intervention for amd * previous laser photocoagulation for cnv, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy * previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) ocular exclusion criteria (both eyes): * ga in either eye due to causes other than amd * previous treatment with eculizumab, lampalizumab, and/or fenretinide
characterization of pulmonary artery stenoses in alagille syndrome - a medical record review

Conditions: Alagille Syndrome

Summary: patients who have alagille syndrome (ags) also frequently have blockages (or "stenoses") of their pulmonary arteries. little is known about the degree or variability of these stenoses, or the effect of this disease on the right ventricle (the chamber of the heart which pumps blood to the lungs). this study will first quantify and describe pulmonary artery stenosis in patients with alagille syndrome. the study will also assess the effect of these stenoses on the right ventricle. the investigators hope to learn the degree and characteristics of pulmonary artery stenosis in alagille syndrome. the investigators also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with alagille syndrome. this information is critical in the management of patients with alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well.

the investigators hope to learn the degree and characteristics of pulmonary artery stenosis in alagille syndrome. we also hope to learn the effect of this pulmonary artery stenosis on the right ventricle in patients with alagille syndrome. this information is critical in the management of patients with alagille syndrome, as there is currently no data to guide clinicians on the management of pulmonary artery stenosis. furthermore, the information from this study may help physicians manage pulmonary artery stenosis in other patients as well. for the third aim, we hope to learn about the different blood vessel abnormalities in the brain, and which abnormalities are most likely to lead to stroke.

Eligibility criteria:
inclusion criteria: * diagnosis of alagille syndrome exclusion criteria: * none
a pilot study to identify biomarkers associated with chronic traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the aim of this research is to determine if the biological fluids (blood/saliva) from chronic brain-injured patients (both blast and non-penetrating tbi) contain reproducible protein markers. to accomplish this two populations of chronic tbi patients who are receiving treatment at the institute for research and rehabilitation (tirr): blast injury victims and non-penetrating tbi will be studied. using multiple proteomic approaches including mass spectrometry, multiplex elisas, and antibody microarrays, as well as rna profiling, the investigators aim to identify biomarkers in the blood/saliva of patients suffering from chronic tbi and to determine the similarities/differences between the blast and non-penetrating injury groups. identification of these biochemical changes will give insight into the long-lasting changes associated with head injury, and may identify new targets for treating the associated pathologies.


Eligibility criteria:
chronic tbi patients: inclusion criteria have a history of head trauma manifesting in one or more of the following: * loss of consciousness * post-traumatic amnesia * focal neurologic deficits, seizure * persistent symptoms of increased arousal (e.g. difficulty falling or staying asleep, anger and hypervigilance) * impairment in social, occupational, or other important areas of functioning (e.g. problems with work and relationships.) exclusion criteria inability to obtain informed consent and if they are non-communicative (i.e. in a vegetative state). healthy volunteers: inclusion criteria * no significant medical history * take no medications (other than birth control pills) * fever free * no history of head trauma or recent injury/infection * no history of neurological or psychiatric disorders or alcohol or drug dependency. exclusion criteria * inability to provide informed consent * age/gender match not available in tbi cohort

Keywords: tbi brain injury