Kornimate/medical-research-clean huggingface dataset:
study evaluating the safety and efficacy of ncx 4251 ophthalmic suspension for the treatment of blepharitis

Conditions: Blepharitis

Summary: this is a multi-center, randomized, double-masked, placebo-controlled, phase 2b trial evaluating the safety and efficacy of ncx 4251 (fluticasone propionate nanocrystal) ophthalmic suspension 0.1% qd for the treatment of acute exacerbations of blepharitis.


Eligibility criteria:
inclusion criteria: * documented history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at screening and baseline/day 1 visits * have a qualifying best-corrected visual acuity exclusion criteria: * abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery * iop \> 21 mmhg at screening or baseline/day 1 visits * use of steroids in the past 30 days or retinoids in the past 12 months * uncontrolled systemic disease
validation of the cervicothoracic differentiation test

Conditions: Neck Pain

Summary: the goal of this clinical trial is to compare the effects of two spinal manipulations in adults between the ages of 18-65 based on the results of a non-invasive clinical test. the main question it aims to answer is: • does matched or unmatched region of manipulation based on the ctdt result in greater reduction of pain levels and improvement in range of motion in adults with neck pain compared to unmatched manipulations? participants will be asked to: * rate their pain with neck movement, complete brief questionnaires about their pain, * have their neck range of motion measured, * perform a test known as the cervico-thoracic differentiation test (ctdt), * receive either a cervical or thoracic manipulation, * repeat the range of motion measurements. * a second session will occur 7-10 days later where questionnaires and range of motion measures will be repeated. researchers will compare the effects of manipulation matched to ctdt test result to individuals in the unmatched ctdt manipulation group to see if the ctdt may indicate which region will provide a greater treatment effect for individuals with neck pain.


Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65, * must report neck pain with a visual analogue scale (vas) greater than or equal to 3/10. exclusion criteria: * history of motor vehicle accident (mva) within the past 6 months, * hypertension greater than or equal to 160/100, * non-mechanical neck pain (pain that is not reproducible with movement), * any past or present history of cancer, * upper motor neuron (cns) lesion symptoms ( a positive clonus sign, babinski sign, or hyperreflexia of dtr's), * any infection that originates from the spine * current confirmed or suspected pregnancy, or recent postpartum (6 mos), * known osteoporosis, * rheumatoid arthritis, * long-term use of corticosteroids (\>6mos), * history of neck surgery, * history of vertebral or rib fractures, * blood clotting disorders, * connective tissue disorders, * radicular/neural pain/symptoms. radicular pain and symptoms would include dermatomal changes (sensory loss or hypersensitization), myotomal changes (weaknesses of muscular along nerve distributions), decreased reflexes (hyporeflexia), pain that travels down the upper extremities, and pain that is referred into the upper extremities. * clinical signs of instability of the vertebral segments in their neck

Keywords: neck pain, manipulation
tocilizumab in fibrous dysplasia of bone

Conditions: Fibrous Dysplasia of Bone

Summary: bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. a small proportion of patients fail to respond adequately. mutated bone cells produce large amounts of interleukin-6 (il-6), with increased bone resorption as a result. inhibition of il-6 may be of interest to reduce bone resorption and therefore bone pain. tocidys is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.


Eligibility criteria:
inclusion criteria: * fibrous dysplasia of bone * previously treated with iv bisphosphonates * persistent bone pain and increased bone remodeling exclusion criteria: * chronic renal failure * serious infectious diseases * liver enzymes abnormality * pregnancy * dyslipidemia

Keywords: fibrous dysplasia of bone tocilizumab mccune-albright syndrome
improving diabetes risk factors in persons with schizophrenia or bipolar disorder by switching to ziprasidone

Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Summary: having a diagnosis of schizophrenia or bipolar disorder and being treated with certain of the newer antipsychotics are risk factors for development of diabetes. subjects with these risk factors plus obesity and/or family history of diabetes who agree to study participation will undergo an oral glucose tolerance test. if the oral glucose tolerance test demonstrates that the subject is pre-diabetic (elevated glucose levels, but below the diabetic range), he/she will have his/her insulin resistance level measured, prior to random assignment to either stay on current antipsychotic medication or switch to ziprasidone. insulin resistance will be measured again after four months. the primary hypothesis is that insulin resistance will decrease in those switched to ziprasidone relative to those continuing on their same antipsychotic medication.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder * bmi\>29.9 or family history of diabetes and/or abdominal circumference greater than 88 cm in women or 102 cm in men * pre-diabetic oral glucose tolerance test * current treatment with olanzapine, risperidone, paliperidone, or quetiapine, or combination of these * willing to switch to ziprasidone * no psychiatric hospitalizations in past three months and judged by treating clinician to be suitable for antipsychotic medication switch * able to give informed consent to study exclusion criteria: * judged to be currently suicidal, homicidal, or unable to cooperate with treatment * unstable serious medical illness * current use of drugs that interfere with glucose and fat metabolism (sulfonylureas, metformin, thiazolidinediones). the use of "statins" and fibrates will be allowed only if stable dose for past 3 months. * current diagnosis of diabetes * fasting blood glucose \>125 mg/dl

Keywords: schizophrenia antipsychotics diabetes bipolar disorder
early ascitis parencentesis in sbp

Conditions: Cirrhosis; Spontaneous Bacterial Peritonitis

Summary: paracentesis at 48 hours, as recommended in international guidelines, could delay the time to effective antibiotic therapy in cases of sbp with germs resistant to empirical antibiotic therapy. earlier paracentesis at 24 hours could save time in initiating the right antibiotic therapy and improve prognosis.

international recommendations call for exploratory paracentesis to be performed on admission in all cirrhotic patients presenting with clinical ascites. based on data from a study published in 1990, the diagnosis of spontaneous bacterial infection (sbp) is defined by the presence of neutrophils (pnn) ≥ 250/mm3 in ascites fluid, irrespective of the bacteriological culture result . although culture of ascites fluid is negative in 40-60% of confirmed cases of isla, and it takes 2-5 days to obtain a result, it remains essential to best adapt antibiotic therapy. empirical antibiotic therapy is started as soon as sbp is diagnosed. response to antibiotic therapy is defined as a reduction of more than 25% in the number of pnn in ascites sampled 48 hours after initiation of treatment. however, the landmark study by akriviadis et al showed that the mean number of pnn fell significantly as early as 24 hours after the start of treatment, with a drop in pnn as early as the 6th hour. in the absence of a response to treatment, antibiotic therapy should be modified on the basis of culture results if positive, or empirically in the absence of bacteriological documentation. a recent study showed that a reduction in the number of pnn in ascites fluid after effective empirical antibiotic therapy was significantly associated with improved survival. thus, waiting 48 hours to perform a follow-up paracentesis could delay the adjustment of effective antibiotic therapy in the event of initial non-response, and thus worsen the prognosis of sbp.

Eligibility criteria:
inclusion criteria: * men and women aged 18 or over * affiliation with a french social security * signature of the informed consent form * cirrhosis * ascites fluid infection with pnn \> 250/mm3 exclusion criteria: * pregnant women * persons deprived of their liberty by judicial or administrative decision; persons under psychiatric care. * adults under legal protection * subjects within the exclusion period of another study * other cause of abdominal infection than sbp * intra-abdominal surgery \< 4 weeks

Keywords: resistant bacteria spontaneous bacterial peritonitis antibiotic early paracentesis
study of ddavp combined with txa on the blood loss and transfusion need during and after scoliosis correction surgery

Conditions: Idiopathic Scoliosis

Summary: intraoperative administration of tranexamic acid (txa,t) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. txa acts mainly by inhibit the plasminogen activator. desmopressin (ddavp ,d) can inhibit the fibrinolytic activity by inducing the release of von willebrand factor from the endothelial cells. but at the same time, it releases tissue-type plasminogen activator (t-pa), which may cripple its hemostatic effect. the investigators supposed that if the investigators combine txa with ddavp in scoliosis correction surgery, the blood loss and the transfusion need would be reduced significantly.

intraoperative administration of tranexamic acid (txa,t) reduces significantly blood loss and blood transfusion requirements during spinal posterior fusion in adolescents with scoliosis. txa acts mainly by inhibit the plasminogen activator. desmopressin (ddavp ,d) can inhibit the fibrinolytic activity by inducing the release of von willebrand factor from the endothelial cells. but at the same time, it releases tissue-type plasminogen activator (t-pa), which may cripple its hemostatic effect. the investigators designed a a randomized double-blind clinical combining txa with ddavp in scoliosis correction surgery to observe if the blood loss and the transfusion need would be reduced or not.

Eligibility criteria:
inclusion criteria: * idiopathic scoliosis patients undergoing posterior scoliosis correction surgery * american society of anesthesiologists(asa) classification:ⅰ-ⅱ * patients who agreed to participate in this study and has signed the informed consent exclusion criteria: * blood disease，such as anaemia, idiopathic thrombocytopenic purpura(itp) * history of bleeding or ecchymosis * disorders of laboratory examination on platelets(plt),prothrombin time(pt),activated partial thromboplastin time(aptt),fibrinogen,d-dimers * hypertension * cardiac disease,such as unstable angina, myocardial infarction in recent sis months, cardiac disfunction, congenital heart disease, pulmonary heart disease * cerebral ischemia * administering with anticoagulants or nonsteroidal anti-inflammatory drug(nsaid) * hepatic or renal disease or disfunction * blood transfusion in recent one month

Keywords: desmopressin tranexamic acid blood loss transfusion need posterior scoliosis orthopedics
study to evaluate the safety and efficacy of spr001 in subjects with classic congenital adrenal hyperplasia

Conditions: Congenital Adrenal Hyperplasia; CAH - Congenital Adrenal Hyperplasia; CAH - 21-Hydroxylase Deficiency

Summary: this is a phase 2 study of spr001 for the treatment of classic cah that will provide 12 weeks of open-label treatment to eligible subjects.

this is a phase 2 study of spr001 for the treatment of classic cah that will provide 12 weeks of open-label treatment to eligible subjects. to be eligible for this study, an individual must either have completed study spr001-201 or meet eligibility criteria for spr001-naïve subjects. the expected duration of study participation for each subject is up to approximately 5 months. this includes a screening period of ≤30 days, a treatment period of 12 weeks, and a safety follow-up period of 30 days.

Eligibility criteria:
inclusion criteria: * is approved by the sponsor's medical monitor * is on a stable regimen of glucocorticoid replacement for ≥30 days before baseline that is expected to remain stable throughout the study * if screening for this study occurs \>3 months after the subject's final follow-up visit in study spr001-201, the subject will have serum 17-ohp measured at screening. * agrees to follow contraception guidelines * is able to understand all study procedures and risks involved and provides written informed consent indicating willingness to comply with all aspects of the protocol exclusion criteria: * experienced a clinically significant ae considered at least possibly related to spr001 in study spr001-201 * if screening for this study occurs \>3 months after the subject's final follow-up visit in study spr001-201, the subject will be screened for any clinically significant unstable medical condition, medically significant illness, or chronic disease occurring within 30 days of screening * is at increased risk of suicide * clinically significant depression or anxiety at screening or baseline * clinically significant abnormal clinical or laboratory assessments must be discussed with the medical monitor to determine eligibility for this study. * subjects who routinely work overnight shifts require medical monitor approval for enrollment * females who are pregnant or lactating * use of any other investigational drug within 30 days or 5 half-lives before screening * use of prohibited concomitant medications (including rosiglitazone, testosterone, and strong inhibitors and/or inducers of cyp3a4) within 30 days or 5 half-lives of baseline. medications metabolized by cyp3a4, 2c8, 2c9, or 2c19, especially those that are sensitive substrates or substrates with narrow therapeutic ranges should be discussed on a case-by-case basis with the medical monitor.
a novel non-invasive acoustic diagnostic for the diagnosis of coronary artery disease the cad-det validation study

Conditions: Coronary Artery Disease; Cardiovascular Diseases; Atherosclerosis; Coronary Occlusion

Summary: the purpose of the study is to collect acoustic, ecg, and clinical data from consenting participants, so that ausculsciences can perform analysis on the sounds produced by the heart and determine the accuracy of the cad-det system for detecting cad.

this is a prospective multi-center clinical trial. using the cad-det, acoustic and electrical cardiac data will be collected from participants with intermediate pretest probability of cad who are referred to invasive coronary angiography (ica). the cad-det recording will be administered prior to the scheduled ica procedure. the data collected by cad-det will be processed using ausculsciences' data analysis application (daa) to produce a patient's indication for cad.

Eligibility criteria:
inclusion criteria: 1. stable 2. \>/= 19 years old 3. suspected obstructive cad 4. referred to ica exclusion criteria: 1. documented cad or coronary revascularization 2. age \< 19 years old 3. acute coronary syndromes 4. congenital heart disease or heart transplantation 5. dextrocardia 6. uncontrolled irregular heart rhythm (atrial arrhythmia (fibrillation, flutter) or frequent pacs or pvcs (\>10/minute)) 7. resting heart rate \> 110 bpm 8. known hemodynamically-significant valvular heart disease, audible diastolic murmurs, or hypertrophic or non-ischemic cardiomyopathy 9. chest wall deformity or wounds in adhesive application areas 10. pregnancy 11. unwillingness or inability to provide informed consent or to comply with the study protocol
a study of intravenous m1-c6v1 for locally advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: a phase i study of the safety and tolerability of m1-c6v1 administered via intravenously for treatment of patients with locally advanced or metastatic solid tumors

this study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple iv injections of m1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of m1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of m1-c6v1, and preliminarily exploring the anti-tumor effects of m1-c6v1.

Eligibility criteria:
inclusion criteria: 1. subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy. 2. subject voluntarily agrees to participate in this study and signs an institutional review board -approved informed consent prior to performing any of the screening visit procedures. 3. males and females at least 18 years of age, inclusive, at the screening visit. 4. have at least one measurable lesion. 5. an eastern cooperative oncology group (ecog) score of 0-1, 1 week before the first administration of imp. 6. an estimated survival time of ≥ 12 weeks. exclusion criteria: 1. subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (aids) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy. 2. subject has received any anti-tumor treatment 4 weeks before using the imp, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy. 3. subject has received systemic glucocorticoids (prednisone \>10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of imp. 4. subject has received immunomodulatory drugs, including but not limited to thymosin, il-2, ifn, etc. within 14 days prior to first administration of imp.

Keywords: m1-c6v1 solid tumor oncolytic virus vrt106
accuracy of pulse oximeters with profound hypoxia during motion

Conditions: Hypoxia

Summary: the aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. study will be used with patients during controlled motion.

this study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by nihon kohden corporation sufficiently to support performance claims for an fda 510k submission or iso technical file. specifically, spo2 and pulse rate accuracy will be assessed for a nihon kohden olv-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients during controlled motion.

Eligibility criteria:
inclusion criteria: * both male and female subjects who can give written informed consent * healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile * meeting the demographic requirements exclusion criteria: * age below 18 or over 50 * pregnant women * significant arrhythmia * blood pressure above 150 systolic or 90 diastolic * subjects whom the investigator consider ineligible for the study
clinical and microbiological evaluation of the efficacy of herbal mouthwashes in gingivitis

Conditions: Periodontal Diseases

Summary: plaque-induced gingivitis is a clinical condition that appears to cause persistent inflammation in gingiva. it is a preliminary cause to periodontitis but it can be inverted to address the risk of periodontitis development. this randomize controlled clinical trial (rct) aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non-surgical periodontal therapy (nspt) in patients with gingivitis. a total of 52 patients diagnosed with gingivitis were incorporated into the rct and categorized into four groups as follows: tea tree oil (tebodont®), thyme hydrosol (arifoglu®), essential oil (listerine®), and placebo. the patients were advised to wash with15 ml of prescribed mouthwash twice a day for a period of 3rd months after nspt. clinical periodontal measurements; including plaque index (pi), gingival index (gi) and probing pocket depth (ppd) and microbiological sampling, were performed before enrollment and in 3rd months. plaque samples were examined by quantitative polymerase chain reaction(qpcr).

this randomize controlled clinical trial aims to clinically and microbiologically evaluate the effectiveness of different herbal mouthwashes as an adjunct treatment to non- surgical periodontal therapy in patients with gingivitis.

Eligibility criteria:
inclusion criteria: * according to efp in 2017, gingivitis patients with a ppd ≤3 mm, bop in the whole mouth ≥ % 10 and no radiological bone loss * having ≥ 20 teeth * male or female ≥ 18 years old * systemically healthy patients exclusion criteria: * using of any antioxidant or antimicrobial agent in the last 6 months •. smoking * pregnancy * alcoholism

Keywords: gingivitis essential oil tea tree oil thyme qpcr
vitamin d serum levels in monosymptomatic enuretic and non enuretic children

Conditions: Nocturnal Enuresis

Summary: we are group of researchers interested in causes and management of nocturnal enuresis, we embarked on this research on 2020 and we reached promising results regarding the role of vitamin d serum level in etiology and management of monosymptomatic enuresis.

this research was conducted as a comparative study regarding serum vitamin d levels in monosymptomatic enuretic and non enuretic children, also we compared urine osmolality and nocturnal polyuria in both groups and we found that low vitamin d levels are correlated with low nocturnal urine osmolality and increased incidence of nocturnal polyuria

Eligibility criteria:
inclusion criteria: * patients with pmne. * which was defined as bedwetting frequency of 3 or more nights per week for at least 2 weeks of observation. * didn't receive any previous treatment for enuresis. exclusion criteria: * patients with non-monosymptomatic enuresis (associated with storage and/or voiding symptoms). -patients with anatomical abnormalities (meatal stenosis, hypospadias, epispadias, etc.). * patients with neurological diseases. * patients with renal impairment. * patient with previous pelvic, urological or brain and spinal cord surgery. * patients with chronic constipation and irritable bowel habits. * patients with active urinary tract infection. * patients who are on vitamin d supplements.

Keywords: nocturnal enuresis vitamin d