Kornimate/medical-research-clean huggingface dataset:
a pivotal study to evaluate enlite™ sensor performance with ipro™2 in china

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to demonstrate the performance and safety of the enlite sensor over 144 hours (6 days) when inserted in the abdomen and used with the ipro2 in subjects age 14 - 75 years.

this study is a multi-center, randomized, prospective single-sample correlational design without controls. up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. three investigational centers in china will be used during this study. each subject will wear the following devices: • two enlite sensors each connected to an ipro2 for approximately 6 days sensor location: • the 2 enlite sensors will be worn in the abdomen area. investigational center staff will insert sensors and connect to the ipro2s. during the study, each subject will be randomized and undergo one yellow springs instrument (ysi™) frequent sample testing (fst) (day 1, 3-4, or 6). during the study, subjects will continue with their current diabetes regimen independent of the study devices. subjects will be instructed by the investigational center that they are not to use the study devices (except for the study meter) for the management of their diabetes. the study meter may be used for treatment decisions and calibration of enlite sensor.

Eligibility criteria:
inclusion criteria: 1. subject is 14 - 75 years of age at time of screening 2. subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis 3. subject has adequate venous access as assessed by investigator or appropriate staff 4. subject is willing to follow the study procedures and willing to come to study visits. 5. subject is willing to perform at least 4 self-monitoring of blood glucose (smbg) per day for 6 days exclusion criteria: 1. subject will not tolerate tape adhesive in the area of enlite sensor placement as assessed by qualified individual. 2. subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, staphylococcus infection) 3. subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks 4. subject is female and has a positive pregnancy screening test 5. females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator 6. subject is female and plans to become pregnant during the course of the study 7. subject has a hematocrit (hct) lower than the normal reference range 8. subject may not be on the research staff of those performing this study

Keywords: diabetes type i type ii
evaluation of efficacy and safety of vx-548 for acute pain after a bunionectomy

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of vx-548 for acute pain after a bunionectomy.


Eligibility criteria:
key inclusion criteria: * before surgery * participants scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., austin procedure) and internal fixation under regional anesthesia (mayo and popliteal sciatic block) * after surgery * participant is lucid and able to follow commands * all analgesic guidelines were followed during and after the bunionectomy key exclusion criteria: * before surgery * prior history of bunionectomy or or other foot surgery on the index foot; or bunionectomy on the opposite foot * history of cardiac dysrhythmias within the last 2 years requiring anti-arrhythmia treatment(s) * any prior surgery within 1 month before the first study drug dose * after surgery * participant had a type 3 deformity requiring a base wedge osteotomy, concomitant surgery such as hammertoe repair; or experienced medical complications during the bunionectomy * participant had a medical complication during the bunionectomy that, in the opinion of the investigator, should preclude randomization other protocol defined inclusion/exclusion criteria may apply.
drug use investigation for imuran (azathioprine) tablet (hepatic transplantation)

Conditions: Liver Diseases

Summary: this post-marketing surveillance (pms) study is designed to investigate the efficacy and safety of azathioprine tablets in japanese subjects whom liver transplantation is performed.


Eligibility criteria:
inclusion criteria: * subjects who undergo liver transplantation and azathioprine tablet was administered exclusion criteria: as this is pms study, there are no exclusion criteria but contraindications are as follows. * subjects with hypersensitivity to the ingredients of azathioprine tablet * subjects who is pregnant or might be pregnant * subjects whose white count is lower than 3000/cubic millimeter

Keywords: antirejection
accuracy of poct to elisa by detecting human il-6 in teeth with apical periodontitis

Conditions: Apical Periodontitis

Summary: to compare the diagnostic agreement of human il-6 chairside poct to elisa in apical periodontitis undergoing endodontic therapy which could be clinically helpful to monitor the healing of periapical tissues enabling the clinician to complete the endodontic procedure, leading to a better patient care. this study will be conducted at the conservative and endodontics department in polyclinic b, faculty of dentistry, manipal university college malaysia (mucm). it involves 30 selected patients who have single rooted tooth with apical periodontitis that undergo rct. the collection of the exudate from the canal will be on pre and post-instrumentation. the exudated will collect twice in each instrumentation for poct and elisa.


Eligibility criteria:
inclusion criteria: * patient having single root tooth with ap that is negative to the pulp sensitivity test * presence of periapical lesion exclusion criteria: * pregnancy
study to compare the bioavailability of extended release metformin hcl tablet versus glucophage xr® tablets in healthy human volunteers under fasting condition

Conditions: Type 2 Diabetes

Summary: objective: to compare the bioavailability of extended release metformin hcl tablet(test formulation, torrent pharmaceuticals ltd.,india) versus glucophage xr® tablets ( reference formulation, bristol-myers squibb company, usa) in healthy human volunteers under fasting condition. study design: an open-label, randomised, 2-period, 2-treatment,crossover study under fasting condition.


Eligibility criteria:
inclusion criteria: * subjects must meet all of the following criteria in order to be included in the study: 1. sex: male. 2. age: 18 - 45 years. 3. subject with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. 4. healthy and willing to participate in the study. 5. subject willing to adhere to the protocol requirements and to provide written informed consent. 6. non-smokers or smoker who smokes less than 10 cigarettes a day. exclusion criteria: * the subjects will be excluded from the study based on the following criteria: 1. clinically relevant abnormalities in the results of the laboratory screening evaluation. 2. clinically significant abnormal ecg or chest x-ray. 3. systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. 4. pulse rate less than 50/minute or more than 100/minute. 5. oral temperature less than 95°f or more than 98.6°f. 6. respiratory rate less than 12/minute or more than 20/minute 7. addiction to alcohol or history of any drug abuse within the past 2 years. 8. recent history of kidney or liver dysfunction. 9. history of allergy to the test drug or any drug chemically similar to the drug under investigation. 10. administration/ intake of prescription or otc medication for two weeks before the study. 11. patients suffering from any chronic illness such as arthritis, asthma etc. 12. hiv, hcv, hbsag positive subjects. 13. opioids, tetra hydrocannabinoids, amphetamine, barbiturates, benzodiazepine, cocaine positive subjects based on urine test. 14. subjects suffering from any psychiatric (acute or chronic) illness requiring medications. 15. administration of any investigational products in the period 0 to 3 months before entry to the study. 16. intake of barbiturates or any enzyme-inducing drug in last three months. 17. history of significant blood loss due to any reason, including blood donation in the past 12 weeks. the total blood loss in last 3 months including for this study will not exceed 350ml. 18. history of any bleeding disorder. 19. existence of any surgical or medical condition, which, in the judgement of the chief investigator and/or clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of subjects. 20. inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
peripherally inserted versus centrally inserted central venous catheters in the neurosurgical intensive care unit

Conditions: Thromboses, Venous; Infection; Economic Problems

Summary: this study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.


Eligibility criteria:
inclusion criteria: * adult patients admitted to the neurosurgical intensive care unit , who require central access for the treatment of their illness. exclusion criteria: * insertion of the central catheter in emergency situations; * anatomical abnormalities of upper extremity affecting picc placement; * current or recent (within 1 month) diagnosis of bacteremia * current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis; * presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;
monopolar radiofrequency versus pulsed dye laser for treatment of acne scars

Conditions: Acne Atrophica

Summary: background: the acne scar is a common disorder characterized by skin eruption or abnormalities on face, chest, and/or back in the adolescence which affect the cosmetic appearance. purpose: the main aim of this study was to investigate whether monopolar radiofrequency (mrf) or pulsed dye laser (pdl) is more effective in the cases suffering from acne scars in the form of reducing acne scars and improving the cosmetic appearance.

thirty patients suffering from moderate or severe acne scars were randomly assigned into two equal groups. group a (mrf group): received 2 sessions per week with mrf for 8 weeks. group b (pdl group): received 1 session per week with pdl for 8 weeks. the severity of acne scars was assessed before and after treatment by using the clinical evaluation scale for acne scarring (ecca) scale and the self-assessment of clinical acne-related scars (scars) scale. quality of life and the emotional impact of acne scars were evaluated by the facial acne scar quality of life (fasqol) scale.

Eligibility criteria:
inclusion criteria: * patients with mild to severe acne scar * patients with acne scar in the face exclusion criteria: * smokers and alcohol drinker * patients who had a history of diabetes, circulatory or sensory disorders * patients who had a history of frequent sunburns * patients with nodulocystic acne

Keywords: acne scars monopolar radiofrequency pulsed dye laser
a comparison of one versus two doses of influenza vaccine in children 5-8 years of age

Conditions: Influenza

Summary: the purpose of the study was to find out if children 5 through 8 years of age who are getting influenza vaccine for the first time should get one or two doses.

currently, two doses of influenza vaccine are recommended for children younger than 9 years receiving influenza vaccine for the first time. while the scientific support for 2 doses of vaccine in infants and toddlers is sound, the need for 2 doses of vaccine for adequate immunogenicity in older children is less certain. if the immunogenicity of a one-dose vaccine regimen is comparable to a two-dose regimen, then one dose would be preferable for reasons of safety, practicality and economics, and would reduce a major barrier to vaccination in this injection-adverse age group. this study compared the immunogenicity and reactogenicity of one versus two doses of influenza vaccine in children aged 5 to 8 years old receiving influenza vaccine for the first time. all children enrolled in the study received two doses of vaccine, and the immune response after one dose of vaccine was compared to the immune response after two doses of vaccine.

Eligibility criteria:
inclusion criteria: * immunocompetent children who are at least 5 and no more than 8 years of age on the date of the first vaccination. * parents able to give informed consent and child available for all study visits. * family able to understand and comply with planned study procedures. * family must have telephone accessibility. exclusion criteria: * previous receipt of influenza vaccine of any kind (shot or nasal spray). * active cancer or blood system abnormalities such as leukemia. * immunocompromising illnesses or current receipt of immunosuppressive agents * allergy to eggs or egg protein, or to gentamicin (an antibiotic that is present in trace amounts in the vaccine). * any acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses. temporary exclusion criteria: acute disease, defined as the presence of moderate or severe illness with or without fever, at the time of enrollment. influenza vaccine may be administered to children with minor illnesses, such as diarrhea, mild upper respiratory infection and low-grade febrile illness with an oral temperature \<100.4 f.

Keywords: influenza vaccination immunization flu immunogenicity
assessment of healing and function after reconstruction surgery for bone sarcomas

Conditions: Bone Sarcoma; Osteosarcoma; Chondrosarcoma; Ewing's Sarcoma; Osseous Sarcoma; Bone Neoplasm

Summary: the purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery. the study will look at the level of function for a period of 3 years after the surgery. another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery


Eligibility criteria:
inclusion criteria: * all patients undergoing reconstructive surgery for neoplasms involving bone on the orthopaedic surgery service at msk * current or prior history of primary neoplasms involving osseous structures, including all subtypes * confirmation of diagnosis that has been performed by the msk's department of pathology via direct review of tissue/slides * patients must read and understand english * age \>/=4 * patients must read and understand english exclusion criteria: * patients that weight \<17 kilograms

Keywords: 18-014 memorial sloan kettering cancer center
clinical study on prevention and treatment of pyrotinib associated diarrhea with traditional chinese medicine

Conditions: Diarrhea Caused by Antitumor Drugs

Summary: pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. at present, there is no particularly effective drug for diarrhea induced by pyrotinib. trying to intervene with traditional chinese medicine may bring better results to patients.

pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. at present, there is no particularly effective drug for diarrhea induced by pyrotinib. trying to intervene with traditional chinese medicine may bring better results to patients.

Eligibility criteria:
inclusion criteria: * 1. meet the following two conditions: 1. planned administration of pyrotinib ≥ 21 days; 2. grade 1-3 diarrhea after taking pyrotinib, and it is planned to continue taking pyrotinib; 2. age ≥ 18 years old; 3. ecog ps 0-2； 4. life expectancy ≥ 6 months; 5. voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up exclusion criteria: 1. those who may be allergic to pyrotinib or excipients; 2. it has many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc; 3. patients with biliary obstruction; 4. participate in other diarrhea related clinical trials; 5. female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptives during the whole test period; 6. according to the researchers' judgment, there are serious diseases that endanger the safety of patients, or affect the patients to complete the study (including, but not limited to, severe hypertension and severe diabetes, which can not be controlled by drugs). 7. any other circumstances in which the investigator believes that the patient is not suitable to participate in this study.

Keywords: diarrhea pyrotinib traditional chinese medicine
incidence of the out- and in hospital cardiac arrest at a tertiary hospital in germany

Conditions: Resuscitation

Summary: incidence of the background information, incidence and special characteristics of out- and in-hospital cardiac arrest at a tertiary hospital in germany.

to evaluate background information for planning a ecpr program at a tertiary hospital, the investigators planned a prospective study of every out- and in-hospital cardiac arrest.

Eligibility criteria:
inclusion criteria: * all patients with a cardiac arrest exclusion criteria: * not complete fill out evaluation forms
incisional hernia repair by abdominal wall component release with contemporary onlay mesh fixation

Conditions: Incisional Hernia; Onlay Mesh; Abdominal Wall Component Release

Summary: there is a great expansion in the presentation of complex incisional hernia defects. primary closure for most cases is impossible with a high rate of recurrence. component separation provides an autologous repair of the defect but still has considerable recurrence rate. reinforcement of component separation provides a more strength full repair and may be less recurrence.

the surgical correction was done under general anesthesia. after scrubbing and draping, an elliptical incision was performed . open the hernia sac then reduce the contents with adhesolysis as required. subcutaneous flaps on both sides were created in a manner that permit to spread an 8 cm mesh after the closure of the abdominal wall. approximate the facia after trimming of its edges with clamps with a manner that allow 1to 2 cm overlap in the midline without tension. in case of tension do selective myofascial advancement (sequential components release). our steps would be first a unilateral posterior rectus sheath release (1-2 cm longuitodinal incision lateral to linea alba) and reassess, if tension still present, bilateral posterior sheath release should be performed.if tension still present, do a unilateral then bilateral external oblique release as required (1-2 cm lateral to the linea semilunaris along the length of the abdominal wall). close the defect with prolene 1 then cover with onlay wide pore mesh fixation with 2/0 prolene. close the skin after placement of 2 subcutaneous suction drains.

Eligibility criteria:
inclusion criteria: * age of 16 years and older. * both sexes. * patients with clean incisional hernia of stage i, ii and iii according to the ventral hernia staging system were included. exclusion criteria: * - obese patients with bmi ≥35 kg/m2, patients with contaminated hernia stage ii and iii, patients with collagen disease, patients with history of aortobifemoral bypass, patients refusing mesh hernioplasty, females in childbearing age who looks for further children, patients unfit for surgery according to asa criteria, patients with a parastomal hernia, patient with a stoma and patients with uncontrolled diabetics, active smokers, and patients with copd were excluded
study of efficacy and safety of tinospora crispa-extract product compared with the acetaminophen

Conditions: Patients With Body Temperature Between 37.8-38.5; No Sign of Infection; No Liver and Kidney Problem

Summary: hypothesis: tinospora crispa-extract product can reduce pyretic similar to acetaminophen. this study aims to investigate the efficacy and safety of tinospora crispa-extract product compared with the acetaminophen. total of 96 patients with body temperature between 37.8-38.5 without any signs of infections will be enrolled in this study. patients will be randomly divided into 3 groups: first group will receive acetaminophen 1000 mg every 6 hr, second group will receive tinospora crispa-extract product 2000 mg twice daily and the third group will receive placebo twice daily.

patients in each group will be monitored for body temperature at baseline (at the time of enrollment) and at 1, 2, 4, 6, 8, 24 h after receiving the tested material.

Eligibility criteria:
inclusion criteria: * age over 18 years old * body temperature between 37.8-38.5 * body weight not less than 40 kg but not over 100 kg * liver enzymes do not exceed 2 times of normal value * can comply with study protocol exclusion criteria: * have allergic history of any tested compounds * fever from other causes, not by uri * take any herbal medicines during 2 weeks before enrollment * physicians decide to withdraw the subjects with any reasons

Keywords: fever body temperature