Kornimate/medical-research-clean huggingface dataset:
the incidence of thoracic disc herniation in patients presenting with chronic upper back pain

Conditions: Thoracic Disc Herniation

Summary: patients who applied to the private medar hospital between february 2016 and february 2021 with chronic upper back pain and were diagnosed with thoaracic disc herniatin (tdh) (with thoracic vertebral mri) and followed up for at least 1 year will be included in the study. patients diagnosed with tdh were included in the medical treatment and/or physical therapy program. before and after these treatment programs, the pain intensity of the patients was recorded with the visual analog scale (vas). the number of patients who applied to the physical medicine and rehabilitation outpatient clinic with chronic upper back pain between february 2016 and february 2021 will be researched, and the demographic characteristics of those diagnosed with tdh will be selected and recorded in their files, their pre- and post-treatment vas scores, and the results will be analyzed statistically.


Eligibility criteria:
inclusion criteria: * 18-65 years old * admitted to the private medar hospital gölcük hospital between february 2016 and february 2021 with chronic upper back pain. * diagnosed with tdh as a result of thoracic vertebral mri exclusion criteria:patients with * vertebral fracture, * developmental spinal deformity, * spinal infection or tumor, * chronic widespread pain syndrome such as fibromyalgia, * diabetes mellitus, * polyneuropathy * rheumatological disease * under 18 years old * over 65 years old * who have had previous back and neck surgery

Keywords: chronic upper back pain thoracic disc herniation
qax576 in patients with pulmonary fibrosis secondary to systemic sclerosis

Conditions: Pulmonary Fibrosis Secondary to Systemic Sclerosis

Summary: this study will evaluate the safety, tolerability, and mechanism of action of multiple doses of qax576 in patients with pulmonary fibrosis secondary to systemic sclerosis


Eligibility criteria:
inclusion criteria: * men and women between the ages of 18 and 65 years with a confirmed diagnosis of pulmonary fibrosis secondary to systemic sclerosis * both men and women must be willing to use two forms of contraception. additional information regarding this requirement is available at screening exclusion criteria: * certain medical conditions may exclude patients from participation. * should not have participated in another clinical study within 4 weeks of study start * smokers are not eligible for participation * blood loss of donation of 400 ml or more within 2 months of study start * pregnant women or women who are breast feeding * past medical history of clinically significant ecg abnormalities * connective tissue disorders other than systemic sclerosis. * active infection or history of systemic parasitic infection * history of immunodeficiency diseases, including a positive hiv test result * history of drug or alcohol abuse within 12 months of study start * any condition that may compromise patient safety other protocol-defined inclusion/exclusion criteria may apply

Keywords: pulmonary fibrosis, systemic sclerosis
safety and immunogenicity of oral cholera vaccine in kolkata

Conditions: Cholera

Summary: the purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in eastern kolkata, west bengal, india.

cholera remains to be a serious public health problem worldwide. in the mid-1980s following technology transfer from sweden, vietnamese scientists developed and produced an oral killed monovalent cholera vaccine for vietnam's public health programs. a 2-dose regimen of this vaccine has been shown to be safe and efficacious. subsequently, a bivalent vaccine was developed containing the newly emergent o139 v. cholerae. this vaccine has several advantages over the existing swedish vaccine. it confers protection against the el tor biotype in younger children, is considerably less expensive, does not require a buffer during administration and does not require strict cold chain requirements. however, this vaccine is not licensed for use in countries other than vietnam. through ivi, an agreement between vabiotech in hanoi and shantha biotechnics pvt, ltd in india has been reached that will make the bivalent vaccine available in india. a double-blind randomized phase iii trial in a cholera-endemic area would be necessary to demonstrate the efficacy of this vaccine in other settings. this would pave the way for the introduction of the vaccine into the national immunization programme in india and the internationalization of this vaccine and licensure in other countries where it is needed. prior to the phase iii trial, a phase ii study will be performed among adults and children.

Eligibility criteria:
inclusion criteria: * healthy non-pregnant adults aged 18-40 years and children aged 1-17 years exclusion criteria: * diarrhea during the past week * antibiotic and anti-diarrheal medicine use during the past week * one or more episodes of diarrhea or abdominal pain lasting for 2 weeks during the past 6 months * abdominal pain, nausea, vomiting, loss of appetite or generalized ill feeling for the past 24 hours * pregnancy

Keywords: watery diarrhea cholera vaccine
hamstring stiffness after anterior cruciate ligament reconstruction

Conditions: ACL Injury; Stiffness of Knee, Not Elsewhere Classified; Sport Injury

Summary: the role of hamstring has been studied in anterior cruciate ligament (acl) injury prevention, mainly to counteract the anterior tibial translation , especially when contracting eccentrically, but also with passive stiffness. however, little is known about the passive hamstring stiffness after acl reconstruction (aclr). the primary objective of this study is to evaluate the passive stiffness of hamstring muscles after aclr by using an isokinetic device. secondary, we aimed to test the individual and surgical characteristics associated with hamstring stiffness and the impact of hamstring stiffness on rts and knee re-injury. the hypotheses are that hamstring stiffness will be lower in the aclr leg compared to the uninjured leg and to healthy individuals. also, we hypothesized that hamstring stiffness will be lower after hamstring autograft compared to patellar tendon autograft and will increase progressively after aclr to be symmetrical at the time for rts. also, we hypothesized that hamstring stiffness could be associated with better outcomes at rts (rts at same level and lower re-injury rates)


Eligibility criteria:
inclusion criteria: * patients who have had an acl reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery) * patient included in the sport medicine follow-up protocole with intermediate and final isokinetic muscular assessment at 4 months and 8 mnths after surgery respectively * patient who received the information form exclusion criteria: * patient who did not participate in all follow-up consultations and isokinetic muscular assessments * cognitive or sensory impairment making it impossible to understand the information form * neurological, traumatic or osteoarticular history responsible for muscle imbalance prior to surgery * previous severe injury on the ipsilateral or contralateral knee * recent muscle damage * acl reinjury ( graft failure) * patient with genu flexum, or constant flexed knee at 3 months after surgery * informed consent not obtained
quantitative mri for patients with sickle cell disease undergoing hematopoietic cell transplant

Conditions: Sickle Cell Disease

Summary: the primary purpose of this research is to determine if it is feasible to perform serial magnetic resonance imaging (mri) to evaluate the amount of bone marrow cells (also called cellularity) and iron stores before and after bone marrow transplantation for severe sickle cell disease.


Eligibility criteria:
inclusion criteria: * age ≥ 5 years. * diagnosis of scd (\[hemoglobin ss (hb-ss), hemoglobin sc (hb-sc) or hemoglobin s-beta thalassemia (hb-sβ) genotype\]. * patient is a candidate for an allogeneic hct. * subject or guardians have given informed consent. exclusion criteria * the need for general anesthesia for mri. * subjects with implanted magnetic devices (e.g. pacemakers) that may malfunction or move in the strong magnetic field. * a subject who is pregnant. * previous hct.

Keywords: bone marrow cellularity bone marrow transplant
how does antiretroviral therapy affect coronary atherosclerosis: a serial ct study

Conditions: Coronary Artery Disease; Hiv

Summary: combined antiretroviral therapy (cart) is thought to promote coronary artery disease via a number of mechanisms: abnormal lipid profiles, endothelial dysfunction, hypertension, insulin resistance and renal impairment are the main pathological mechanisms driving atherosclerosis as a consequence of cart. an association between protease inhibitors and increased cardiovascular disease risk has been shown in many large cohort trials. ct coronary angiography (ctca) is now widely used to assess for the presence of atherosclerosis, typically in patients presenting with chest pain. this imaging technique allows visualisation of the coronary arteries and quantification of any atherosclerotic disease that may be present. this technique is being increasingly used as a surrogate for cardiovascular disease risk. hart ct is an open label, prospective, randomised-control pilot study to investigate the feasibility of performing a future appropriately powered multi-centred randomised control trial using ct based outcome data as a surrogate for cardiovascular disease risk. participants will be randomised to either continue their usual cart or switch to biktarvy (a fixed dose combination of bictegravir, emtricitabine and tenofovir alafenamide). a baseline ct scan will be performed. if there is any evidence of atherosclerosis a further ct scan will be performed at the end of the study (approximately 48 weeks). this will allow quantification of any change in coronary artery plaque burden or characteristic. participants will be also followed up for any changes in metabolic health.


Eligibility criteria:
* hiv positive * undetectable viral load on cart which contain protease inhibitors (duration \>6 months at eligibility visit) * age\>40 years * stable cart * no previous documented cardiovascular disease * no contraindication to study drug * ability to give informed consent * willingness to comply with all study requirements * no symptoms of overt cardiovascular disease a definition of stable cart is no change to the medication regime in the preceding 6 months. well controlled hypertension is considered acceptable for recruitment. exclusion criteria: * active liver disease (previously diagnosed) * renal disease egfr \<30 * any ongoing infection * significant ionising radiation in preceding 12 months * known or suspected cardiovascular disease * high dose statin therapy (atorvastatin 20mg or more, rosuvastatin 20mg or more) * pregnancy or planned pregnancy * breast feeding * allergy to iodine based contrast agent * known drug resistance to nrti or integrase * any contraindication to bic/ftc/taf * current enrolment onto another ctimp. significant ionising radiation should not exceed \>25msv from medical sources. a definition of cardiovascular disease includes documented angina, previous myocardial infarction or previous coronary revascularization.

Keywords: hiv coronary artery disease atherosclerosis antiretroviral therapy computed tomography
an observational study on the natural course of chronic pancreatitis

Conditions: Chronic Pancreatitis; Genetic Mutation; Smoking, Tobacco; Drinking, Alcohol

Summary: to explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.

the present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of cp) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of cp. the observation items included the pain patterns, incidence of complications of cp, pancreatic cancer and death.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of chronic pancreatitis * agree to join the study and provide informed consent exclusion criteria: * autoimmune pancreatitis * pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis * the follow-up time less than 2 years * patients presenting with diabetes and/or steatorrhea at onset of cp.
automated robotic tcd in traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: this study's objective is to determine the safety, feasibility and efficacy of prolonged automated robotic tcd monitoring in critically ill patients with severe tbi across multiple clinical sites with varying levels of tcd availability and experience

upon informed consent, patients will undergo daily automated robotic tcd monitoring sessions for up to 4 hours a day for a total duration of at least 3 days and up to 5 days whenever clinically feasible. tcd monitoring of bilateral middle cerebral artery cerebral blood flow velocity (mca cbfv) will be performed using a robotic tcd system equipped with bilateral 2-mhz doppler probes. this system allows for continuous bilateral extended duration recording of mca cbfv, using robotically controlled tcd probes that allow automated angle correction to maintain optimal mca insonation. safety measures: patient discomfort, device dislodgement or skin lesion at the site of insonation feasibility: feasibility of using bilateral automated robotic tcd monitoring device on severe tbi patients for \>= 4 hrs per day that can provide clinically useful/meaningful data for over 50% of the total monitoring period additionally, a 5-question provider survey will be administered at each participating site to obtain bedside nurse and clinician feedback on the perceived safety and feasibility of protocol implementation.

Eligibility criteria:
inclusion criteria: * adults ≥18 * blunt tbi with glasgow coma score (gcs) ≤8 * injury within 72 hours * adequate tcd windows * ability to obtain informed consent from a legally authorized representative (lar) exclusion criteria: * catastrophic brain injury with grim prognosis (e.g.: gcs 3 with bilateral mid-position pupil) * c- spine fracture with evidence of spinal cord injury * severe skull or scalp injury precluding device placement * planned decompressive hemicraniectomy * continuous fever for \>6 hours at the time of enrollment (despite treatment) * lack of tcd window
effect of tailored preventive program on caires incidence using international caries classification and management system (iccms) a randomized clinical trial

Conditions: Dental Caries

Summary: this study will be conducted to evaluate the effect of tailored preventive program on caries incidence using international caries classification and management system (iccms) at a follow up periods of 3 ,6 and 12 months.

a total number of 144 high caries risk dental students were selected based on the applied caries risk assessment method (cambra). in the study group they were given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm f) following the instructions in addition to fluoride mouth rinse. for the clinical approach motivational engagement was done by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. this in addition to pits and fissures sealant, f- varnish 2 times /year. recalls up were done at 3, 6 and 12 months by recording the caries prevalence , application of fluoride varnish every 6 months and dietary intake interventions. in the control group participants assigned to the control condition will be advised to maintain their existing lifestyles. for ethical reasons, if the program shows its effectiveness, it will be made available to all groups at the end of the study.

Eligibility criteria:
inclusion criteria: * dental student. * no malocclusion. * medically free exclusion criteria: * compromised medical history. * severe or active periodontal disease. * heavy bruxism or a traumatic occlusion
study in hfpef patients to compare the effect of azd9977 and spironolactone on serum potassium

Conditions: Heart Failure

Summary: this is a phase i, multicentre study to compare the effect of azd9977 and spironolactone on serum potassium \[sk+\] during 28 days in patients with hfmref or hfpef and egfr in the range of ≥40 and ≤70 ml/min/1.73m2.


Eligibility criteria:
inclusion criteria: * symptoms and signs consistent with a diagnosis of heart failure (hf) * left ventricular ejection fraction (lvef) ≥40% by transthoracic echocardiography within the past 12 months * plasma nt-probnp level ≥125 pg/ml (≥ 600pg/ml if patient has persistent or permanent atrial fibrillation, atrial flutter, or atrial tachycardia) * estimated glomerular filtration rate (egfr) ≥40 and ≤70ml/min/1.73m2 (by ckd-epi formula). * baseline serum potassium (sk+) level ≥3.5 and ≤4.8mmol/l. * stable doses of the following medications at baseline for at least 4 weeks prior to randomisation: angiotensin receptor blocker (arb) or angiotensin converting enzyme inhibitor (acei) loop diuretic (up to a 120mg furosemide dose or equivalent exclusion criteria: * patients with documented lvef \<40% at any time (i.e. patients with previously impaired lvef that has now improved are not permitted). * patients experiencing acute decompensation of heart failure requiring hospital admission or escalation in therapy. * primary cardiomyopathy (e.g. constrictive, restrictive, infiltrative, toxic, hypertrophic, congenital or any primary cardiomyopathy in judgment of investigator). * hyponatraemia, defined as serum na+ \<135 mmol/l at the time of enrollment. * persistent resting sinus tachycardia \>110 bpm or sinus bradycardia \<45bpm. * systolic blood pressure (bp) \ 180mmhg. * diastolic bp \ 100 mmhg. * patients previously intolerant to mra (e.g. spironolactone or eplerenone) for any reason. * medical conditions associated with development of hyperkalaemia (e.g. addison's disease). * alanine aminotransferase (alt) or aspartate aminotransferase (ast) level ≥2.0 times the upper limit of normal (uln). * patients who have been taking an mr antagonist within 1 month prior to randomization.

Keywords: heart failure. oral selective mineralocorticoid receptor modulator. heart failure with preserved ejection fraction (hfpef).
blood biomarker study to diagnose adolescent sport concussion

Conditions: Brain Concussion

Summary: concussions are one of the most complex conditions to manage in sport medicine due to the individualized clinical presentation, caused by a complex neurometabolic cascade, and the lack of a diagnostic standard. there is currently no objective measurement for concussion and the reliance on subjective reporting and clinical judgement is imperfect. in previous clinical studies the investigators determined cutoff values of plasma phosphatidylcholines that provided strong indication that a concussion had occurred. based on this data, the investigators have developed a custom assay, which will work together with a capillary blood collection device. the current clinical trial will be conducted in two parts. part a will allow the investigators to determine precise auc cut-off values for the propriety, novel custom assay, and in part b the investigators will assess the safety and efficacy of this device for concussion diagnosis in adolescent athletes aged 13-17.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent/assent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female athletes, aged 13-17 inclusive exclusion criteria: 1. individuals who have suffered a known concussion within the 6 months prior to enrollment 2. individuals who suffer from an acute neurological disorder 3. known pregnancy
optic nerve sheath diameter in preeclampsia

Conditions: Pre-Eclampsia

Summary: severe preeclampsia is associated with an elevation in intracranial pressure (icp). optic nerve sheath diameter is a non-invasive surrogate of invasive icp measurement. this study targets to evaluate the icp in patients with or without preeclampsia.

mri studies have shown that brain edema due to an elevation in icp develops in up to 70% of women with preeclampsia. optic nerve sheath diameter is used to estimate the icp and has been shown to correlate well with invasive icp measurement. the present study aims to compare icp using optic nerve sheath diameter in women with or without preeclampsia.

Eligibility criteria:
inclusion criteria: * must be diagnosed as preeclampsia * age must be \> 18 years exclusion criteria: * history of previous intracranial pathology or surgery * glaucoma
evaluation of adrenal androgens in normal and obese girls after suppression and stimulation

Conditions: Hyperandrogenemia; Polycystic Ovary Syndrome; Obesity

Summary: women with polycystic ovary syndrome (pcos) often have irregular menstrual periods, too much facial and body hair, and weight gain. women with pcos also have a hard time becoming pregnant. girls with high levels of the male hormone testosterone often develop pcos as adults. some girls with high levels of male hormone will develop normal hormone levels as they grow up, but most girls continue to have high levels of male hormone as adults. the purpose of this study is to understand where the male and female hormones come from in girls as they get older. the investigators think the adrenal gland, makes most of the hormones in young girls and that the ovary and the adrenal gland make these hormones in older girls. the investigators would like to find out whether an overactive adrenal gland makes these hormones higher in girls who are overweight, compared to those who are not overweight.

we propose that the adrenal gland is the predominant source of the early morning rise in progesterone and testosterone which is more marked in early puberty. specifically, we hypothesize that dexamethasone administration at 22:00 will be associated with a dampened progesterone and testosterone rise the subsequent morning in normal girls. we also propose that the adrenal gland is the source of the excess androgen production in young obese girls, and that dexamethasone will decrease their early morning testosterone and progesterone levels. we will explore the hypothesis that functional adrenal hyperandrogenism, or acth hyperresponsiveness, is one mechanism underlying this excess adrenal androgen production seen in obesity.

Eligibility criteria:
inclusion criteria: * normal and obese (\>95th bmi%) females * weight of 24 kg or more * early to late puberty (expected age range 7-18) * screening labs within age-appropriate normal range, with the exception of a mildly low hematocrit (see below) and the hormonal abnormalities inherent in obesity which could include mildly elevated lh, lipids, testosterone, prolactin, dheas, e2, glucose, and insulin; and decreased follicle-stimulating hormone (fsh) and/or sex hormone-binding globulin (shbg) exclusion criteria: * screening labs outside of age-appropriate normal range * hemoglobin \<12 mg/dl and hematocrit\<36% (subjects will be offered the opportunity to take iron supplementation for 60 days if their hematocrit is slightly low (33-36%) (suggestive of iron deficiency anemia) and will then return for retesting of their hemoglobin/hematocrit. if still \<36%, they will be excluded.) * morning cortisol \<5 g/dl * 17-hydroxyprogesterone \>295 ng/dl * weight\<24 kg * history of cushing's syndrome or adrenal insufficiency * pregnant (self reported)