Kornimate/medical-research-clean huggingface dataset:
a study of insulin efsitora alfa (ly3209590) compared to glargine in adult participants with type 2 diabetes who are starting basal insulin for the first time (qwint-1)

Conditions: Type 2 Diabetes; T2D

Summary: the main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (ly3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (t2d) who are starting basal insulin therapy for the first time.


Eligibility criteria:
inclusion criteria: * have a diagnosis of t2d according to the world health organization criteria. * have an hba1c of 7.0% to 10.0%, inclusive, at screening. * are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study. * are insulin naive exceptions: * short-term insulin treatment for a maximum of 14 days, prior to screening, and * prior insulin treatment for gestational diabetes. exclusion criteria: * have a diagnosis of type 1 diabetes (t1d), latent autoimmune diabetes, or specific type of diabetes other than t2d, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes. * have a history of \>1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening. * have had severe hypoglycemia episodes within 6 months prior to screening. * have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of hba1c. * have had new york heart association class iv heart failure or any of these cardiovascular conditions within 3 months prior to screening * acute myocardial infarction * cerebrovascular accident (stroke), or * coronary bypass surgery. * have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example lap-band, or sleeve gastrectomy within 1 year prior to screening * have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.
thoracotomy effects on pulmonary function test and chest expansion

Conditions: Adolescent Idiopathic Scoliosis

Summary: the purpose of the present study was to investigate the effect that corrective surgery for scoliosis would have on pulmonary function as well as the circumference of the chest. as a result, the current investigation was carried out on thirty individuals who had idiopathic scoliosis and had been admitted to the hospital. before the surgery, after it had been completed (on the fifth day), and again three months later, the pulmonary function was tested.

the purpose of this study was to see how corrective scoliosis surgery affected pulmonary function and chest circumference. as a result, the current investigation was carried out on 30 individuals brought to the hospital with idiopathic scoliosis. the pulmonary function was assessed before surgery, on the fifth day following surgery, and three months thereafter.

Eligibility criteria:
inclusion criteria: • adolescent idiopathic scoliosis exclusion criteria: * smoking. * associated comorbidity that affects pft. * any contraindication interfering with performing spirometry.

Keywords: lung functions and thoracotomy
evaluation of toujeo insulin in type 2 diabetes patients inadequately control with their basal insulin treatment

Conditions: Diabetes Mellitus, Type 2

Summary: primary objective: the primary objective is to describe the effect of insulin glargine (u300) in type 2 diabetes mellitus (t2dm) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the physician decision, on glycated hemoglobin (hba1c) improvement. secondary objectives: * evolution of fasting plasma glucose * evolution of insulin dose and body weight * hypoglycemia incidence * safety * patients satisfaction when they change their insulin for hoe901-u300

the total study duration per patient is approximately 28 weeks.

Eligibility criteria:
inclusion criteria : * type 2 diabetic adult patients treated with basal insulin, with or without oral anti-diabetic agents, with or without glucagon-like peptide-1 (glp-1) receptor agonist * hba1c \> 7.5% exclusion criteria: * patients with high dose of insulin (\>1.2 u/kg) * use of prandial insulin * change of dose of antidiabetic drugs within the last 8 weeks * use of systemic glucocorticoids during at least 2 weeks in the last 12 weeks the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
virgin coconut oil as adjunctive therapy for hospitalized covid-19 patients

Conditions: Covid19

Summary: this is a research that will investigate the safety and efficacy of virgin coconut oil (vco) as an adjunctive therapy for coronavirus disease 2019 (covid-19)

this study will be a randomized controlled trial among hospitalized covid-19 patients, aged 18 years old and above, admitted at the philippine general hospital. patients will be grouped into the following: 1. group receiving standard of care 2. group receiving standard of care plus virgin coconut oil (15ml, 3x/day for 2 weeks) as adjunctive therapy. patients will be observed as regards to primary outcomes such as recovery/resolution of symptoms and duration of hospital stay

Eligibility criteria:
inclusion criteria: * symptomatic and asymptomatic covid-19 hospitalized patients * has laboratory-confirmed illness during the time of recruitment * able to take food and medicines enterally exclusion criteria: * uncontrolled or newly diagnosed diabetes mellitus * with chronic heart disease * having elevated lipid profile at baseline (admission)

Keywords: virgin coconut oil covid19
postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of head and neck

Conditions: Head-and-neck Cancer; Squamous Cell Carcinoma

Summary: this is a non-randomized, phase ii, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(hnscc).the primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in hnscc patients.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed squamous cell carcinoma of the head and neck.site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses) 2. gross total resection, with pathology demonstrating one or more of the following risk factors: 1. histologic extracapsular nodal extension 2. histologic involvement of ≥ 2 regional lymph nodes 3. invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual 3. no evidence of distant metastases 4. no synchronous or concurrent head and neck primary tumors 5. karnofsky score over 60 6. adequate organ function including the following: 1. absolute neutrophil count (anc) \>= 1.5 \* 10\^9/l 2. platelets count \>= 100 \* 10\^9/l 3. hemoglobin \>= 10 g/dl 4. ast and alt \<= 2.5 times institutional upper limit of normal (uln) 5. total bilirubin \<= 1.5 times institutional uln 6. creatinine clearance \>= 50 ml/min 7. serum creatine \<= 1 times uln 7. signed written informed consent exclusion criteria: 1. evidence of distant metastasis 2. prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Keywords: docetaxel concurrent chemoradiotherapy high-risk squamous cell carcinoma head-and-neck cancer
phase ii study of the multichannel auditory brain stem implant for deafness following surgery for neurofibromatosis 2

Conditions: Neurofibromatosis 2

Summary: objectives: i. define the tonotopocity of multichannel brain stem stimulation and use this information to better program the auditory brain stem implant for an individual. ii. optimize device fitting by combining monopolar and bipolar stimulation, and individual psychoacoustic channels for each patient, to increase the number of usable information channels for each patient and reduce or eliminate undesirable side effects. iii. evaluate performance and learning effects using optimized fitting procedures.

protocol outline: patients undergo surgery to remove the first side or second side tumor, during which the multichannel auditory brain stem implant is implanted. initial stimulation is conducted 4-6 weeks after surgery. patients are followed every 3 months for the first year, then annually thereafter.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- confirmed diagnosis of neurofibromatosis type 2 scheduled to undergo first side or second side tumor removal first side implantation performed only on patients with onset of symptoms prior to age 40 --prior/concurrent therapy-- if a nonfunctional auditory brain stem implant (abi) is present (implanted during the removal of a first side tumor), a multichannel abi may be implanted during the removal of a second side tumor --patient characteristics-- english is the primary language

Keywords: acoustic neuroma genetic diseases and dysmorphic syndromes hearing loss neurofibromatosis neurologic and psychiatric disorders rare disease
a phase i, study to evaluate the safety and tolerability of intravenous ezn-2208 in patients with advanced solid tumors or lymphoma (ezn-2208-01)

Conditions: Advanced Solid Tumors; Lymphoma

Summary: the goal of this clinical research study is to find the highest tolerable dose of ezn-2208 that can be given to patients with advanced cancer or lymphoma. the safety of the study drug and its effect on the disease will also be studied. enzon will also perform pharmacokinetic (pk) testing of ezn-2208. pk testing measures the amount of a drug in the body at different time points.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy * measurable or evaluable disease * score of 0 to 2 on the ecog performance scale exclusion criteria: * concurrent serious medical illness * known, clinically suspected, or history of central nervous system (cns) tumor involvement * active diarrhea * known history of coagulation disorder * patients requiring cytochrome p450 3a4 (cyp3a4) enzyme inducing medications * requirement for ketoconazole or other strong inhibitor of cyp3a4 enzymes * prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin c or nitrosoureas) prior to the scheduled administration of ezn-2208
a pilot study of the effect of the combination of inhaled nitric oxide and prone position under eit monitoring on efficacy in patients with ards

Conditions: ARDS

Summary: investigating the impact of combined inhaled nitric oxide and prone positioning on the efficacy in ards patients


Eligibility criteria:
inclusion criteria: 1. age 18-80 years; 2. patients with moderate to severe ards on mechanical ventilation exclusion criteria: 1. patients with severe asthma or acute exacerbation of chronic obstructive pulmonary disease (copd), lung tumors, post-lung resection, and post-lung transplantation. 2. patients with hemodynamic instability requiring vasopressor support: dopamine or dobutamine \>15 µg/kg/min, norepinephrine \>0.3 µg/kg/min. 3. cardiogenic pulmonary edema. 4. patients with severe facial deformities, facial trauma, or severe thoracoabdominal trauma that precludes prone positioning ventilation. 5. mid to late pregnancy. 6. patients with a history of malignancy or other irreversible diseases/conditions, including those in the terminal stage. 7. patients expected to be discharged soon or requiring invasive mechanical ventilation for less than 24 hours. 8. patients currently participating in other studies.
investigation of inter-rater and test-retest reliability of y balance test in individuals with pes planus

Conditions: Flatfoot

Summary: pes planus is characterized by the descent of the medial longitudinal arch, eversion of the hindfoot, and dorsiflexion and abduction of the midfoot. disorders in the bones of the foot, dysfunction of the tibialis posterior muscle, shortness of the achilles tendon or weakness in the muscles may pose a risk for pes planus. in a study in which 80 female participants aged 65 and over participated voluntarily, it was shown that 90% of the deformities seen in the foot were pes planus. in another study conducted with adults aged 18-21 years, pes planus was found with a rate of 13.6%. in a study in a group of 500 people aged 18-25 years, this rate was found to be 29%. since exercise, physical activity and walking for a long time will cause foot and leg pain in people with pes planus, the level of physical activity of these people may be limited. there are studies examining the relationship between pes planus and different physical parameters. it has been determined as a result of some studies that the balance, which is one of these parameters, is negatively affected by the presence of pes planus. according to the literature, many studies have used the y test in the evaluation of dynamic balance in individuals with pes planus. however the reliability of the y balance test, which is a valid and reliable method for assessing balance in healthy individuals, has not been found in individuals with pes planus.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the study, * being between the ages of 18-40, * having pes planus. exclusion criteria: * having had lower extremity or spine surgery, * having a neurological or rheumatic disease, * having a problem with vision and hearing, * having suffered a lower extremity injury in the last 1 year, * presence of acute or chronic pain, * regular participation in sports activities, * being pregnant, * ambulation with an assistive device, * active participation in treatment, * presence of lower extremity inequality.

Keywords: postural balance reproducibility of results
effect of antenatal corticosteroids on neonatal morbidity.

Conditions: Neonatal Respiratory Distress Syndrome

Summary: it will be a randomized controlled trial. there will be two study groups. study group 1 will be given dexamethasone while study group 2 will be given betamethasone. the control group will be given placebo.

the study will be a double blind randomised controlled trial. there will be two study groups and one control group. the first study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular dexamethasone sodium phosphate. the second study group will be the pregnant women at risk of late preterm birth that will receive antenatal corticosteroids in the form of intramuscular betamethasone sodium phosphate. the control group will be pregnant women at risk of late preterm birth that will be given intramuscular water for injection.

Eligibility criteria:
inclusion criteria: * pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation and a probability of delivery in the late preterm period irrespective of diagnosis who give consent. * pregnant women at 34 weeks 0 days to 36 weeks 6 days of gestation scheduled for elective/emergency delivery in the late preterm period irrespective of indication and route of delivery who give consent. exclusion criteria: * evidence of chrioamnionitis. * evidence of foetal distress. * history of use of antenatal corticosteroids in index pregnancy. * women who do not give consent.

Keywords: antenal corticosteroids late preterm delivery neonatal morbidity
nitazoxanide in prevention of secondary spontaneous peritonitis

Conditions: Spontaneous Bacterial Peritonitis

Summary: the study is to evaluate the possible efficacy and safety of nitazoxanide as an adjuvant therapy in the secondary prevention of sbp in patient with cirrhosis.

due to high recurrence rate of spontaneous bacterial peritonitis , we will study and evaluate the possible efficacy and safety of ntz as an adjuvant therapy in the secondary prevention of sbp in patient with cirrhosis.

Eligibility criteria:
inclusion criteria: * patients aged 21 - 65 years old with cirrhosis and ascites who had at least one previous confirmed episode of spontaneous bacterial peritonitis. exclusion criteria: * exclusion criteria included active gastrointestinal bleeding hepatic encephalopathy (\>grade 2) hepatocellular carcinoma (hcc) or other malignancies allergy to used medications.
intravenous tnk for acute ischemicstroke in china

Conditions: Stroke, Ischemic

Summary: acute ischemic stroke is the most common type of stroke, accounting for about 60%-80% of all stroke, with high incidence, high mortality, high disability rate, has become the first cause of death in china. at present, only ultra-early thrombolytic therapy, endovascular therapy and antiplatelet therapy have obtained evidence-based medical evidence in ischemic stroke treatment, but only thrombolytic therapy and endovascular therapy can improve the good prognosis of patients. intravenous thrombolytic therapy within 4.5 hours after the onset of ischemic stroke symptoms has been shown to be effective, which is recommended in the guidelines. in most countries, alteplase (r-tpa) is the only drug approved for the treatment of acute ischemic stroke. recombinant human tnk tissue-type plasminogen activator (rhtnk-tpa) is a modified recombinant tissue-type plasminogen activator, with no procoagulant effect and a longer half life. in recent years, there are some studies on the comparison of therapeutic effects of tnk-tpa and rt-pa in patients with acute ischemic stroke, and tnk shows promising especially for large artery occlussion. at present, there are few reports on the application of rhtnk-tpa in chinese stroke patients. the aim of this study is to evaluate the efficacy and safety of rhtnk-tpa in chinese patients with ischemic stroke in a prospective, multicenter registration study.


Eligibility criteria:
inclusion criteria: 1. age ≥18 ; 2. the time from onset to treatment was less than 4.5 hours; 3. ischemic stroke confirmed by head ct or mri; 4. there are measurable neurological deficits; 5. first onset or previous onset without obvious sequelae (mrs ≤1 score) ; 6. signed informed consent. exclusion criteria: 1. severe neurologic deficits before onset (mrs ≥2) ; 2. significant head trauma or stroke in the last 3 months; 3. subarachnoid hemorrhage; 4. a history of intracranial hemorrhage or head injury or acute stroke within 3 months; 5. intracranial tumors, arteriovenous malformations or aneurysms; 6. intracranial or spinal cord surgery within 3 months; 7. non-compressible arterial puncture within 7 days; 8. gastrointestinal or urinary tract hemorrhage within last 21 days; 9. major surgery within 1 month; 10. thrombocytopenia (platelet count \<10×109/l); 11. use of heparin or oral anticoagulation therapy within 48 hours; 12. use of warfarin with an international normalised ratio \>1.7 or pt \>15 s; 13. uncontrolled hypertension (systolic \>180 mmhg or diastolic\>110 mmhg) ; 14. the blood glucose concentration \<50 mg/dl (2.7 mmol/l); 15. severe systemic disease with poor life expectancy (\<3 months); ; 16. allergic to research drug; 17. within 3 months or participating in other clinical trials; 18. other conditions due to which investigators consider study participation inappropriate.
oral imaging for porphyrin biomarkers

Conditions: Dental Plaque

Summary: the purpose of this study was to use the principle of fluorescence to identify oral diseases not readily visible to the naked eye. a imaging device with a removable and modular head consisting of arrays of light emitting diodes (leds) with differing wavelengths (405nm,450nm or white) was used to image teeth to detect fluorescent biomarkers such as porphyrins associated with poor oral health (plaque). the process utilizes illumination of the teeth and gums using a specific array of leds in the visible and near-visible spectrum and is non-invasive. successful implementation of the device would provide proof-of- concept validation for its use as a safe, rapidly deployable solution to assess oral hygiene.

to use the device, an interchangeable head with a specific led wavelength was selected (to target a specific oral disease). the optical filter can be exchanged for another if necessary (this is done prior to the subject visit as to not prolong the time of the visit). during operation, led intensity can be altered using the rotary dimmer switch. the procedure took place during a routine dental visit once consent was obtained. the device was covered in a clear disposable plastic sheath (consolidated plastics, stow, oh) or equivalent sterile disposable camera bag. after both the subject and clinician wore uv protective eyeware, a series of images and videos were taken. these included detailed frames of all 4 incisors and all 4 canines. a video of the camera aperture passing over the select teeth was also taken. additional images focusing on areas of interest to the clinician were taken, with area of capture and device mode recorded. the total time required to capture all images and video is expected to be approximately 5 minutes. as a control, an acteon soprocare a commercial device operating under the same fluorescence principle was also used. images and video of the aforementioned eight target teeth in each mode were similarly captured for comparison to the test device.

Eligibility criteria:
inclusion criteria: * adults aged 18-70. subjects with identifiable dental diseases must have otherwise healthy tissues/structures in which to control against. exclusion criteria: subjects under 18 years of age will not be invited to participate

Keywords: imaging
sbrt followed by chemoimmunotherapy of toripalimab plus docetaxel and cisplatin for larynx preservation in patients with locally regionally advanced squamous cell carcinoma of the larynx and hypopharynx

Conditions: Laryngeal Cancer; Hypopharynx Cancer

Summary: this trial aims to evaluate the safety and efficiency of sbrt followed by chemoimmunotherapy of toripalimab plus docetaxel and cisplatin for patients with locally regionally advanced squamous cell carcinoma of the larynx and hypopharynx


Eligibility criteria:
inclusion criteria: * laryngeal (t3-4n0-3m0 ) and hypopharyngeal ( t2-4n0-3m0) cancers staged by ajcc8th * age 18-70 * ps score 0-1 * normal functions to tolerate chemotherapy, immunotherapy and radiotherapy exclusion criteria: * patients with a combination of other malignant tumours * individuals with contraindications to immunotherapy

Keywords: sbrt immunotherapy larynx preservation laryngeal cancer hypopharynx cancer