Kornimate/medical-research-clean huggingface dataset:
microwave vs. radiofrequency ablation for benign thyroid nodules: a multicenter randomized controlled trial study

Conditions: Benign Thyroid Nodules; Ablation

Summary: compared with traditional treatment methods, ultrasound-guided thermal ablation is more targeted, less invasive and more reliable. the study compared microwave ablation and radiofrequency ablation to evaluate the efficacy and safety in the treatment of benign thyroid nodules with a multicenter data, which will provide a basis for clinical treatment.

ultrasound-guided minimally invasive treatment has accurate positioning, higher targeting, no need for general anesthesia, less trauma for patients, and more reliable efficacy.currently, it mainly includes percutaneous anhydrous ethanol injection, radiofrequency ablation and microwave ablation for the treatment of thyroid nodules.currently, radiofrequency ablation and microwave ablation are mainly used to treat thyroid nodules. this study was a randomized, parallel, positive control, and non-inferiority multicenter clinical study.radiofrequency ablation was used as the positive control.follow-up was conducted at 1, 3, 6 and 12 months after ablation. the primary endpoint was the rate of nodule volume reduction at 12 months after surgery.

Eligibility criteria:
inclusion criteria: * age\>18 years and ≤75 years * the pathological diagnosis was benign thyroid nodules within 6 months * diameter ≥2cm, solid \> 80%, the number of multiple nodules≤ 3 * participate voluntarily and sign the informed consent exclusion criteria: * coagulation mechanism disorder or bleeding tendency * patients with severe cardiopulmonary insufficiency * blood pressure cannot be effectively controlled * abnormal liver function * blood glucose cannot be effectively controlled * abnormal thyroid function * allergic history of ultrasound contrast agent * suspicious lymph node metastasis in the cervical region * abnormal contralateral vocal cord function * pregnant and lactating women * have participated in clinical trials of any drug and/or medical device within 3 months prior to enrollment * the researchers believe that there are any other factors that are not suitable for inclusion or that affect participants' participation in the study. * patients with inner pacemaker, hearing aid, metal stent, titanium clip, internal (external) steel plate and other metal objects.

Keywords: microwave thyroid
insulin bolus required for high fat foods in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals. subjects will have several admissions during which the investigators will apply an iterative dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin ratio for fat to minimize postprandial hyperglycemia following higher fat meals. the investigators hypothesize that the incremental insulin dose required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (u/kg).

subjects for this study will be adults with type 1 diabetes who use an insulin pump for diabetes self-management. subjects will be admitted to the clinical research center in the morning in the fasting state. subjects will have several admissions. during the initial two admissions, subjects will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated from their usual insulin-to-carbohydrate ratio. study subjects in whom the bolus did not provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5 admissions during which they will receive the pizza-high fat meal with progressively increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target range 80-180 mg/dl.

Eligibility criteria:
inclusion criteria: * adult patients (aged 18-75 years) with type 1 diabetes \> 3 years, on insulin pump therapy. exclusion criteria: * history or symptoms suggestive of gastroparesis or gastric dysmotility; history of celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion; eating disorder; diet allergies; special diet restrictions, such as vegan; medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan); high-titre insulin autoantibodies with delayed insulin kinetics; women who are breast feeding, pregnant, or wanting to become pregnant.
regenerative surgical treatment of peri-implantitis

Conditions: Failure of Dental Implant Due to Infection; Infection; Inflammation; Peri-implantitis; Bacterial Infections; Bleeding of Subgingival Space; Molecular Sequence Variation; Periodontal Diseases; Mouth Diseases

Summary: the purpose of the study is to evaluate if surgical treatment of peri-implantitis with enamel matrix derivative (emdogain®, emd) will have an additional effect on the healing outcome, changes in the peri-implant microflora and on the inflammatory response in the periimplant pocket at 12 months.

this is a randomised controlled clinical trial. recruiting 31 patient with periimplantitis at one or more implants in need for surgical treatment. randomisation to test group (emd) with surgical treatment and additional application of enamel matrix derivative (emdogain®) or surgical treatment alone in the control group (non-emd). treatment of existing periodontitis performed before recruitment. baseline examination including samples of microbiota and peri-implant fluid followed by surgical treatment. access surgery to remove chronic inflammatory tissue and clean the implant surface from biofilm and implant stone with hand instrument and ultrasonic device with special tips for implants, followed by polishing the implant surface with a gauze, super floss and rinsing with saline. allocation with a performed block randomisation at the stage of surgery, after cleaning of implant surface. application of enamel matrix derivative (emdogain®) or not, just before closure of flap. after surgery rinsing with chlorhexidine 0.2% twice a day in 6 weeks. no systemic antibiotic used in this study. supportive care program, including hygiene instructions and professional cleaning supragingival at implants and teeth at 2 weeks, 3, 6, 9 and 12 months after treatment. examination with measurements of pocket depth and bone levels at radiographs at baseline just before surgery and 12 months and prevalence of bleeding on probing, pus or recession as well as full mouth plaque score and full mouth bleeding score at 3, 6, 9 and 12 months. microbial sampling performed with endodontic paper points at baseline and 2 weeks after surgery as well 3, 6 and 12 months from implant site with at baseline the deepest pocket. sampling of the peri-implant fluid from the peri-implant pocket at baseline, 3, 6, and 12 months from implant site with at baseline the deepest pocket. removal of bridges performed to give accessibility at baseline examination/surgery and at 12 months.

Eligibility criteria:
inclusion criteria: * peri-implant angular bone loss ≥3 mm, measured at radiographs * deep pocket ≥5 mm combined with bleeding and/or pus exclusion criteria: * individuals with uncontrolled diabetes (hba1c \> 7,0%) * individuals where prophylaxis of antibiotic is indicated * medication with prednisolon or other anti-inflammatory drug * medication with gingival hyperplasia known as a side effect * systemic antibiotic intake the last 3 months

Keywords: peri-implantitis regenerative therapy surgical therapy enamel matrix derivative peri-implant microflora peri-implant fluid
comparison of gw433908 and nelfinavir in hiv patients who have not had antiretroviral therapy

Conditions: HIV Infections

Summary: the purpose of this study is to compare gw433908 and nelfinavir when each is given with abacavir and lamivudine to hiv patients who have not taken antiretroviral drugs.

patients are randomized in a 2:1 scheme to 1 of 2 treatment groups. group 1 receives gw433908 plus abacavir (abc) plus lamivudine (3tc); group 2 receives nelfinavir (nfv) plus abc plus 3tc. patients undergo safety and efficacy assessments at the screening visit, day 1 (entry), and weeks 1, 2, 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter. a follow-up visit is performed 4 weeks after the permanent discontinuation of study drug. detailed assessments for the development of lipodystrophy/fat redistribution occur at day 1, week 24, week 48, and every 16 weeks thereafter. patients have examinations and laboratory tests performed at visits.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 13 years old (consent of parent or guardian required if under 18). * agree to use a proven barrier method of birth control (e.g., spermicide plus condom) during the study period (hormonal birth control will not be accepted), if able to have children. * have received less than 4 weeks treatment with any nucleoside reverse transcriptase inhibitor (nrti) and have never received any nonnucleoside reverse transcriptase inhibitor (nnrt) or protease inhibitor (pi). * have a viral load (amount of hiv in the blood) of 5,000 copies/ml or more, or have a positive result at the screening visit. exclusion criteria patients will not be eligible for this study if they: * abuse drugs or alcohol in a way that would interfere with the study, in the opinion of the doctor. patients stable on methadone will be considered for participation. * have an active/acute cdc category c event. * are unable to absorb or take medicines by mouth. * are pregnant or breast-feeding. * have a serious medical condition (such as diabetes, heart problem, hepatitis) that might affect the safety of the patient. * have had pancreatitis or hepatitis within the last 6 months. * have been treated with radiation or chemotherapy within 28 days before the study drug will be taken, or will have the need for these during the study. * have taken drugs that affect the immune system (such as corticosteroids, interleukins, interferons) or that have anti-hiv activity (such as hydroxyurea or foscarnet) within 28 days before the study drug will be taken. * have received hiv vaccine within 3 months before the study drug will be taken. * have received certain other drugs within 28 days before the study drug will be taken, or think that they will be needed during the study. * have received experimental treatments. * have allergies which might interfere with the study, in the opinion of the doctor.

Keywords: hiv-1 drug therapy, combination hiv protease inhibitors lamivudine nelfinavir reverse transcriptase inhibitors anti-hiv agents abacavir
positron emission tomography (pet) imaging of brain amyloid compared to post-mortem levels

Conditions: Brain Fibrillarab Levels

Summary: to determine the level of association between quantitative regional estimates of brain uptake of \[18f\]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.


Eligibility criteria:
inclusion criteria: * the subject has a short life expectancy (approximately 1 year or less) as estimated by the investigator. * the subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia. * the subject's general health is adequate to undergo the study procedures. exclusion criteria: * the subject has a contraindication for pet. * the subject has a known or suspected hypersensitivity/allergy to \[18f\]flutemetamol or to any of the excipients. * the subject is unable to tolerate or cooperate with study procedures.

Keywords: amyloid pet-positron emission tomography suvr-standard uptake value ratios
a novel mhealth application guided by an optimization algorithm for t1d sensor-augmented insulin injection users

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1

Summary: the artificial pancreas lab at mcgill university has developed an optimization algorithm for adults with type 1 diabetes (t1d) on multiple daily injection (mdi) therapy with the adjunctive use of glucose sensor technology, collectively known as sensor-augmented mdi therapy. the algorithm is designed to estimate optimal basal-bolus parameters based on the patient's glucose, insulin and meal data over several days. the investigators hope that this algorithm will be better able to improve long-term glycemic targets by reducing hba1c levels compared to sensor-augmented mdi therapy alone.

the changes in eligibility criteria indicated below are from a previously approved amendment but were inadvertently omitted in the previous prs update made in november of 2020. therefore, this note serves to clarify the order of updates. inclusion: hba1c ≥ 7.5% in the last 2 months (modification) exclusion: * more than 1 slow-acting injection and unwilling to switch to once a day for the study (addition) * severe hypoglycemic episode within one month of admission (addition) in the subsequent amendment, we modified the timeframe for the hba1c inclusion criterion to obtain a more accurate representation of their current glucose control at the time of enrollment.

Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years of age 2. clinical diagnosis of type 1 diabetes for at least 12 months. the diagnosis of type 1 diabetes is based on the investigator's judgment; c peptide level and antibody determinations are not needed. 3. undergoing multiple daily injection therapy. 4. baseline hba1c value ≥ 7.5% (up to 7 days before or after screening). exclusion criteria: 1. serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 2. failure to comply with the study protocol or with the team's recommendations. 3. injection of isophane insulin (nph) or any intermediate-acting insulin 4. more than 1 slow-acting injection and unwilling to switch to once a day for the study 5. current or ≤ 1-month use of other antihyperglycemic agents (sodium-glucose cotransporter 2 inhibitor (sglt2), glucagon-like peptide-1 (glp-1), metformin, acarbose, etc....). 6. pregnancy 7. severe hypoglycemic episode within one month of admission. 8. severe diabetic ketoacidosis episode within one month of admission 9. clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator 10. recent (\<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery 11. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

Keywords: multiple daily injections, type 1 diabetes optimization algorithm
to assess the safety and tolerance of infant formula with locust bean gum in infants with regurgitation

Conditions: Regurgitation, Gastric; Diarrhea

Summary: a randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (solar)


Eligibility criteria:
inclusion criteria: 1. singleton infants with regurgitation who are otherwise healthy 2. diagnosed with regurgitation according to the (adapted) rome iv diagnostic criteria. 3. term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days 4. aged \> 3 weeks (21 days) and \< 9 weeks (63 days) at screening 5. exclusively formula fed for ≥ 7 days before screening 6. written informed consent from the parent(s) and/or legally acceptable representative(s) exclusion criteria: 1. low birth weight for gestational age and gender 2. infants diagnosed with or suspected to have gastroesophageal reflux disease (gerd). i 3. infants who received any of the following medication within 4 weeks prior to screening: systemic antibiotics, prokinetics and/or proton pump inhibitors and/or (other) medication to treat regurgitation 4. infants who already consumed a thickened anti-regurgitation (ar) formula or used thickening supplements 5. infants who already started complementary feeding 6. infants with a gastrointestinal infection within 4 weeks prior to screening 7. infants with a congenital condition, previous or current illness, and/or medication use that could interfere with the main study outcomes according to the investigator 8. infants known or suspected to have: allergy for fish, soy protein, soy oil or corn; lactose intolerance; galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients and/or requiring a fibre-free diet 9. infants known or suspected to have allergy to cow's milk protein 10. presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement 11. participation in any other studies involving investigational or marketed products concomitantly or prior to screening 12. incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements
melatonin and vaccine response, immunity, and chronobiology study

Conditions: Vaccine Response; Sleep; Circadian Rhythm Disorders

Summary: this study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.

vaccination is critical to public health and disease prevention. however, despite the many scientific advancements and vaccines on the market, they are not always fully effective. adjuvants are often used to boost immunity, but they are associated with more side effects, possible allergic reactions and public mistrust that supports vaccine hesitancy. many factors affect vaccine efficacy and host immunity. sleep, circadian health and melatonin have been studied in the past to affect immune response to vaccines and infection. patient education about better sleep habits and/or melatonin use are potentially safe, cost effective, and accessible interventions that may improve host immunity and vaccine effectiveness. however, neither have been studied rigorously and at this time, are not actively implemented in the clinical arena. hence, we propose a study comparing vaccine immunogenicity based on sleep quality, chronotype, and exogenous melatonin.

Eligibility criteria:
inclusion criteria: * age 18-64 * eligible to receive flu vaccination (at military hospital, deers eligible) exclusion criteria: * allergy or contraindication to getting flu vaccine * pregnancy or likelihood of getting pregnant in next few weeks * medical history of doctor diagnosed immune-compromising condition (hiv/aids, cancer, diabetes, significant cardiovascular disease) or doctor diagnosed sleep disorder (insomnia, narcolepsy).\*sleep apnea is an exclusion unless stable on treatment with cpap or oral device for more than3 months. * currently taking any immune suppressants or immunomodulating treatments (systemic corticosteroids, chemotherapy, etc, within the past 3 months) or sleep medication or supplement (including over the counter medications and melatonin, within the past 1 month).

Keywords: sleep circadian health vaccine immunogenicity melatonin
self-monitoring and reminder texts to increase physical activity after cancer: a pilot randomized controlled trial

Conditions: Colon Cancer; Rectum Cancer

Summary: epidemiologic data consistently indicate that colorectal cancer survivors can improve their quality-of-life and prognosis by engaging in physical activity. this study aims to build on this epidemiologic work and translate the findings to inform and change patient behavior. the specific aims are to: (1) develop a mobile technology physical activity intervention among colorectal cancer patients who have completed therapy. (2) conduct a 3-month pilot randomized controlled trial utilizing mobile technology to increase physical activity among 40 men and women who have completed standard cytotoxic chemotherapy for primary stage i-iii colorectal cancer at the ucsf helen diller family comprehensive cancer center. participants in the intervention arm will receive a fitbit® for self-monitoring, interactive text messages, and educational print materials; participants in the control arm will receive educational print materials at baseline and will be given a fitbit® after completion of the 3-mo. follow-up assessment.


Eligibility criteria:
inclusion criteria: * stage i-iii colon or rectal adenocarcinoma * completed standard cytotoxic chemotherapy if medically indicated * be considered disease-free at baseline * be able to speak and read english * have no contra-indication to moderate to vigorous aerobic exercise * be able to walk unassisted * be inactive at baseline (\<150 min/week of moderate physical activity) * have access to a mobile phone * be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
implementing a combination of clinical parameters, biomarkers and socs for the etiology diagnoses of pneumonia in pediatric patients

Conditions: Pneumonia

Summary: participants who meet the inclusion and exclusion criteria will be enrolled and then having a daily follow up for maximum of 13 days' hospitalization. next follow up will be taken time at day 14th after hospitalization date, either on ward or policlinic. the participations will be ended by day 30th after hospitalization date when the called follow up is done by investigator.

this study will collect demographic data, medical history, clinical data, treatment, and risk factors of pneumonia. the study also record the supporting examination results include but not limited to complete blood count (cbc) results, blood gas analyses result, crp, pct, culture result, rapid test for influenza, respiratory syncytial virus (rsv), legionella, and chest x-ray. in order to produce a robust data, this study will conduct the serological and molecular tests at the reference laboratory. whole blood, serum, urine, nasal pharyngeal swab (nps), sputum/induced sputum, and other respiratory specimens (if available) will be collected for storage and testing at enrollment. plasma from 48-72 hours after hospitalization and left-over respiratory specimens on day 2 and 3 of hospitalization will also be collected to be stored. for additional, at day 14th after hospitalization serum will be processed from 4 ml of blood for archiving and testing at the reference laboratory. this study will be conducted at following ina-respond sites: * rsu kabupaten tangerang, tangerang * rsup dr. kariadi, semarang * rsup dr. sardjito, yogyakarta rsu kabupaten tangerang located in banten province is type b or district referral hospital. while rsup dr kariadi in semarang and rsup dr sardjito in yogyakarta are type a hospital which is a level of province referral. maximum duration for participants' accrual will be 2 years since the first participant enrolled. however, the study laboratory testing may take up to 6 months to be completed.

Eligibility criteria:
inclusion criteria: * pediatric inpatients whose ages range from 2 months to 5 years * meet the case definition for pneumonia which is cough or fever with at least one other following symptoms: * shortness of breath * tachypnea * grunting * crackles/rhonchi * decreased vesicular breath sound * bronchial breath sound * chest x-ray consistent with pneumonia * comply with all study procedures including to store required specimens for diagnostic testing and archiving. exclusion criteria: * being hospitalized for more than 24 hours at enrollment * having a cancer or history of cancer * having a history of long term exposed of steroid (at the minimum of 2 months) * having any condition that might interfere with study procedure and compliance (based on clinicians' judgement)