Kornimate/medical-research-clean huggingface dataset:
safety, tolerability, and immunogenicity of v419 in healthy infants when given at 2, 3, 4 and 12 months (v419-007)

Conditions: Bacterial Infections; Virus Diseases

Summary: this study will determine whether participants who receive the vaccine v419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. the study will also determine whether the immune response to v419 is similar to that of participants who receive a licensed vaccine control.


Eligibility criteria:
inclusion criteria * healthy infants able to attend all study visits * parent(s)/legal representative able to read, understand, and complete study questionnaires exclusion criteria * history of congenital or acquired immunodeficiency * received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids * history of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder * hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines * has any chronic illness that could interfere with study conduct or completion * received any immune globulin, blood, or blood-derived products since birth * received a dose of hepatitis b vaccine prior to the study * vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof * fever within 24 hours prior to enrollment * received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment * has a coagulation disorder * has developmental delay or neurological disorder * participant or his/her mother has a medical history of hepatitis b surface antigen (hbsag) seropositivity * history of measles, mumps, rubella, varicella, haemophilus influenzae type b, hepatitis b, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection

Keywords: combination vaccine diphtheria pertussis tetanus hepatitis b hep b haemophilus influenzae b hib polio poliovirus
study to evaluate the human infection of the lower respiratory tract in children at high risk

Conditions: Severe Respiratory Disease

Summary: - estimate the incidence rate of hmpv infection detected by rt-pcr from frozen nasal wash aspirates in children at high risk for severe lri disease (hospitalized at \<2 years of age).

* a prospective, epdemiological study to estimate the incidence rate of hmpv infection as determined by rt-pcr from frozen nasal wash aspirates taken from children hospitalized with lri who are at high risk for severe disease. * no study drug will be administered for this study.

Eligibility criteria:
inclusion criteria: * be premature (less than 36 weeks gestation) and less than or equal to 12 months of age, and/or * be less than or equal to 24 months of age with chd (other than uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus) that is judged to be hemodynamically significant, and/or * be less than or equal to 24 months of age with cld of prematurity (bpd) requiring medical intervention/management (i.e., supplemental oxygen, steroids, bronchodilators, or diuretics within the previous 6 months). * hospital admission diagnosis referable to an acute lower respiratory tract infection or cardio/respiratory illness with a presumed respiratory infection (e.g., bronchiolitis, bronchitis, or pneumonia or cardiac decompensation associated with respiratory infection); admission must occur between october 1 and june 30 for northern hemisphere sites, and between march 1 and november 30 for southern hemisphere sites. * study enrollment within 2 days after hospitalization. * admission from the community to the pediatric ward, neonatal intensive care unit, or the intensive care unit. * have written informed consent obtained from the parent or legal guardian prior to study entry. exclusion criteria: * known hiv infection or a mother with known hiv infection.
caries cognition and identification in adults

Conditions: Secondary Caries

Summary: this study will evaluate the effect of the international dental federation (fdi) criteria, compared to cars (caries associated with restorations or sealants) detection criteria for evaluation of caries lesions around restorations in permanent teeth, in the outcomes related to oral health of adults, in a randomized clinical trial.

the study will consist of a randomised controlled trial of two parallel groups. one group will correspond to adults who will receive the diagnosis and indication of treatment according to the standard criteria, following the fdi criteria to classify the restorations marginal conditions and the presence of secondary caries (traditional group). and the other group will receive a diagnosis and treatment decision according to a minimal intervention approach, using as reference the detection criteria "caries associated with restorations or sealants" (cars) - iccms (international caries classification and management system) - conservative group). patient evaluations will be performed yearly after 12 months. the primary outcome will be the number of surfaces restored with the need for new interventions. secondary outcomes will be the impact of oral health on quality of life and cost-effectiveness.

Eligibility criteria:
inclusion criteria: * patients seeking dental treatment at the school of dentistry; * age between 18 and 60 years; * patients who present at least one restoration of composite resin or amalgam to posterior and/or anterior teeth. exclusion criteria: * patients who refuse to participate in the research; * patients included in other surveys that involve restorations or are in systematic attendance at another clinic or service; * patients who present systemic conditions or chronic diseases that require differentiated care and follow-up - these will be referred to the specific services available at the faculty of dentistry; * patients who reside in other locations and who can not return for periodic follow-up of the interventions.

Keywords: restorations diagnosis secondary caries treatment decision
effect of a plant rich diet on in people with type 2 diabetes and obesity

Conditions: Type 2 Diabetes Mellitus in Obese

Summary: the purpose of this study is to evaluate the effect of a nutrient dense plant rich (ndpr) diet compared to a standard usda diet on glycemic control, inflammation, and cardiovascular risk in individuals with type 2 diabetes and overweight/obesity.


Eligibility criteria:
inclusion criteria: 1. men and women ages 18-75 2. type 2 diabetes mellitus diagnosed \> 6 months prior to screening visit according to american diabetes association criteria 3. hba1c \>7.5% but \< 10% 4. bmi \>25 kg/m2 ; \>23 kg/m2 for asian subjects but \< 45 kg/m2 5. stable weight (variation \< 5 kg within 6 months of screening visit) 6. ability to give informed consent 7. ability to follow verbal and written instructions in english exclusion criteria: 1. active cardiac issues: history of myocardial infarction within 3 months of screening visit, unstable angina pectoris, or class iii or class iv congestive heart failure 2. persistent uncontrolled hypertension (bp \> 160/100 mmhg on or off antihypertensive medication) 3. active marijuana or intravenous drug use 4. recent weight loss (\> 5 kg within 6 months of the screening visit) 5. inflammatory or irritable bowel disease (crohn's disease, ulcerative colitis, or ibs) 6. celiac disease 7. malignancy treated with chemotherapy within the past 1 year 8. depression or psychosis requiring hospitalization within 1 year, or use of major antipsychotic or tranquilizer drugs (i.e. benzodiazepines) 9. renal insufficiency (creatinine clearance \< 30 ml/min) 10. transaminases \> 2x above the normal range 11. pregnancy within 6 months of the screening visit 12. lactation 13. history of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling 14. history of alcohol abuse within the past 5 years 15. vegetarian/vegan diet 16. dairy allergy/intolerance 17. anemia, including iron deficient and megaloblastic 18. vitamin b12 deficiency 19. leber's disease
the effect of preoperative anxiety level on the induction dose of propofol and minimum alveolar concentration (mac) hour of sevoflurane during thyroidectomy

Conditions: Thyroidectomy

Summary: this study is to evaluate the level of anxiety, and to check the correlation of induction dose and the amount of sevoflurane to keep anesthetic depth in in female patients undergoing thyroidectomy.


Eligibility criteria:
inclusion criteria: * female patients (asa physical status i and ii) aged between 20-65 years and scheduled elective thyroidectomy exclusion criteria: * cardiovascular, renal, liver disease, or psychiatric disorder
single dose study of shr4640 in healthy subjects

Conditions: Gout; Hyperuricemia

Summary: the objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of shr4640 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * body weight≥50, bmi:19-24kg/m2; * screening serum urate level ≤ 4.5 mg/dl for male and ≤ 3.5 mg/dl for female; * medically stable based on physical examination, medical history, laboratory results, vital sign measurements, and 12-lead electrocardiogram (ecg) at screening; exclusion criteria: * history of hyperuricemia or gout. * pregnancy or breastfeeding; * history or suspicion of kidney stones; * serum creatinine\>1.5mg/dl for male, \>1.2mg/dl for female; * alanine aminotransferase and/or aspartate aminotransferase\>2 upper limit of normal, or total bilirubin\>2.5 upper limit of normal.

Keywords: urate transporter 1 shr4640 single ascending dose pharmacokinetics pharmacodynamics
effectiveness of nucleos(t)ide analogs (nuc) therapy among naive chb patients in china

Conditions: Chronic Hepatitis B

Summary: to compare the effectiveness, in a real world practice setting in tier 2 cities of china, of entecavir (etv) monotherapy and lamivudine (lam) based therapies (including lam monotherapy, de novo lam + adefovir \[adv\] combination, and early add-on of adv) among chronic hepatitis b (chb) patients who are naive to nuc at enrollment to this study

sampling method: consecutive patient sampling biospecimen retention: blood samples for hbv viral load testing along the treatment period of this study

Eligibility criteria:
inclusion criteria: * chb patients, or chb patients with compensated cirrhosis, as defined by the current chinese guidelines * male or female * ≥ 18 years of age * either hepatitis b e antigen (hbeag) positive or negative * naïve to nuc (defined as no previous exposure to nuc treatment as based on patient self-report) * has compensated liver disease * patients with compensated cirrhosis * patients who consent to participate in this study * local residents with medical reimbursement coverage preferred exclusion criteria: * co-infected with hepatitis c virus (hcv) * chb patients with decompensated cirrhosis, liver failure, hepatocellular carcinoma, or any other types of malignancy at the screening phase * chb patients who are being treated by interferon therapy within 6 months immediately prior to the screening phase of this study * chb patients with a confirmed pregnancy
penta15: pharmacokinetic study of once versus twice daily abacavir in hiv-1 infected children aged 3 to <36 months

Conditions: HIV Infection

Summary: to compare the plasma pharmacokinetic (pk) parameters of q24h versus q12h dosing of abacavir in hiv-1-infected infants and children aged 3 months to 36 months the secondary objectives of penta15 were: to compare the plasma pk parameters of q24h versus q12h dosing of lamivudine in hiv-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine in combination with abacavir to compare age-related differences in the pk parameters of q24h versus q12h dosing of abacavir and lamivudine infants and children in 3 age groups (≥3 to \<12 months, ≥12 to \<24 months and ≥24 to \<36 months) to describe child and family acceptability of and adherence to q24h compared to q12h dosage regimens of abacavir and lamivudine


Eligibility criteria:
inclusion criteria: * infants and children with confirmed presence of hiv-1 infection * infants and children aged 3 to \<36 months * parents/guardians able and willing to give written, informed consent * currently on combination art including abacavir (abc) oral solution with or without lamivudine (3tc) oral solution, for at least 12 weeks and expected to stay on this regimen for at least a further 12 weeks. * hiv-1 rna viral load either; * suppressed hiv-1 rna viral load (i.e. \<400 copies/ml) * non-suppressed, but low, hiv-1 rna viral load (i.e. 400-20 000 copies/ml). the non-suppressed children should have had a stable or decreasing hiv-1 rna viral load prior to study entry and should be considered to be still gaining benefit from the current regimen * stable or rising cd4+ cell percent prior to study entry and should not be expected to fall within the next 12 weeks. exclusion criteria: * intercurrent illness * receiving concomitant therapy except prophylactic antibiotics * abnormal renal or liver function (grade 3 or above)

Keywords: hiv abacavir lamivudine pharmacokinetics
safety and efficacy study of umbilical cord/placenta-derived mesenchymal stem cells to treat myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: the purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (mscs) derived from human umbilical cord/placenta at a dose of 1.0e+6 msc/kg on the subjects for refractory anemia (ra) and refractory anemia with ring sideroblast (rars) of myelodysplastic syndromes (mds).

myelodysplastic syndromes are bone marrow stem cell disorders resulting in disorderly and ineffective hematopoiesis. mds is characterized by variable degrees of cytopenias (anemia, neutropenia, and thrombocytopenia ) and risk of transformation to leukemia. to date treatment of mds is unsatisfactory: chemotherapy has a limited role in the management of leukemic progression; autologous stem cell transplantation does not prolong relapse-free survival and stem cell transplantation is poorly tolerated in older individuals. some mds patients have been shown to respond to a wide variety of immunosuppressive agents ranging from corticosteroids to csa and antithymocyte globulin (atg). however, the overall response rate is less than 30%. in fact, few treatments appear to change the natural history of mds. the management of mds patients therefore remains to be improved. human mscs isolated from wharton's jelly of the umbilical cord/placenta have been shown to have immunosuppressive, stimulating hematopoiesis and tissue repairing properties. this study will evaluate the safety and effectiveness of msc transplant in the mds patients. this study will last about 3 years. participants will be randomly assigned to receive either msc transplant (group 1) or csa therapy alone (group 2). patients will undergo msc transplant at the start of the study (defined as day 0). after 3 months, patients will receive the second msc transplantation when one responds well to the treatment. after 3, 6 and 12 months from the first transplantation, patients will be evaluated.

Eligibility criteria:
inclusion criteria: 1. patient age 18\~80 years old with plan to infuse mscs. 2. histologically documented or cytologically confirmed diagnosis of mds with who classification of mds-ra and mds-rars. 3. patients must have an ecog 0\~2. 4. no moderate or sever organ dysfunction: ejection fraction\>45%; creatinine \<176 mmol/l. 5. no active severe viral or fungus infection. 6. each patient must sign written informed consent. exclusion criteria: 1. psychiatric condition that would limit informed consent. 2. hiv positive 3. positive pregnancy test 4. patient has enrolled another clinical trial study within last 4 weeks.

Keywords: bone marrow disease mds-ra mds-rars umbilical cord/placenta-derived msc transplant
billroth-ii modified versus roux-en-y after distal gastrectomy for gastric cancer

Conditions: Gastric Cancer; Distal Gastrectomy

Summary: there are billroth-i, billroth-ii, billroth-ii with braun, and roux-en-y reconstruction after distal gastrectomy. hypothesis: billroth-ii modified method is non-inferior to roux-en-y method in terms of reducing reflux esophagitis after distal gastrectomy for gastric cancer patients.

since the first gastrectomy by theodore billroth in 1881, this procedure remained a curative treatment for gastric cancer. reconstruction method after gastrectomy may affect complication rates, post-operative nutritional status, and quality of life (qol). there are several reconstruction methods for distal gastrectomy, including billroth i (b-i), billroth ii (b-ii), roux-en-y (r-y). b-i and b-ii were considered better than r-y in terms of shorten operation time and lessen blood loss due to technical simplicity. in contrast, r-y was better in terms of preventing bile reflux and remnant gastritis, which can increase remnant stomach cancer and worsen qol. however, long term qol was similar between b-i and r-y in some randomized controlled trials. although bile reflux was higher in b-i and b-ii groups, remnant gastric cancer was similar between 3 groups in this study. in brief, which one is the ideal reconstruction after distal gastrectomy is still controversial. at our center, reconstruction after distal and sub-total gastrectomy including b-i, b-ii, b-ii with braun anastomosis, and r-y, depended mostly on surgeons' preferences. from 2018, to decrease bile reflux rate while not increasing operation time, we applied modified b-ii technique with 3-5 sutures between the afferent loop to the gastric remnant. this study was conducted to evaluate the efficacy of this method by comparing it with the r-y method.

Eligibility criteria:
inclusion criteria: * patients confirmed with gastric cancer * indicated for radical distal gastrectomy (ct1 to ct4a, any n, m0; according to ajcc/uicc 8th tnm staging for gastric cancer) * age from 18- to 80-year-old * agreed to participate in study with written inform consent exclusion criteria: * pregnant patients * an american society of anesthesiology (asa) score of higher than 4 * concurrent cancer or history of previous other cancers * previous gastrectomy * complications including bleeding, perforation required emergency gastrectomy

Keywords: gastric cancer distal gastrectomy reconstruction gastric adenocarcinoma roux-en-y
anchor versus parachute suturing technique in arteriovenous fistula creation for hemodialysis

Conditions: Arterio-venous Fistula

Summary: randomized controlled study to compare the results of two surgical techniques for avf creation, including the anchor technique (group a) and parachute technique (group b). the study population will be patients referred to the vascular surgery department for the creation of hemodialysis access. patients will be advised to undergo elective surgery for avf once their renal glomerular filtration rate estimated (egfr) is less than 15 ml/min. primary outcome: functional maturation of arterio-venous fistula \[ time frame: six months\] ready fistula for cannulation, vein length at least 10 cm, diameter more than 6 mm, depth not more than 6 mm, and ability of the access to deliver a flow rate of 600ml/min and maintain dialysis for 4 hours.

introduction aim of the work to compare the results of two surgical techniques for avf creation, including the anchor technique (group a) and parachute technique (group b). patients and the method study location: we will submit the study protocol for approval by kafr elsheikh medical research ethics committee, faculty of medicine, kafr elsheikh university. study design: randomized controlled study will be conducted in the department of vascular surgery in kafr el sheikh. time of study: we started in march 2022. study population: the study population will be patients referred to the vascular surgery department for the creation of hemodialysis access. patients will be advised to undergo elective surgery for avf once their renal glomerular filtration rate estimated (egfr) is less than 15 ml/min. the number of patients: this study will be done on 150 cases, 75 cases in group a (anchor technique) and another 75 in group b (parachute technique).

Eligibility criteria:
inclusion criteria: * eighteen years of age or older. * need for avf creation for vascular access for planned hemodialysis (within one year), including distal - radio-cephalic, proximal brachio-cephalic configurations. * vein mapping studies completed 2.5-3 mm minimum vein diameter on mapping. exclusion criteria: * ipsilateral proximal venous and arterial occlusion or stenosis * systemic or local infection at the site planned for avf creation. * anticipated inability to keep 30-day post-operative follow-up appointment. * revision avf, synthetic graft avf, or lower limb avf. * patients with absent distal pulses and chronic ischemia of the upper limb. * recent cannulation of puncture of the vein within two weeks before its use in avf creation. * vasculitis (collagen diseases)
evaluation of dental implants placed in preserved and non-preserved post-extraction ridges

Conditions: Dental Implant Failed; Platelet-rich Fibrin; Alveolar Rege Preservation; Alveolar Bone Loss

Summary: a prospective study to evaluate and compare implants placed in preserved versus non-preserved extraction sockets using l-prf (leucocyte- and platelet-rich fibrin) after 1, 3 and 5 years.


Eligibility criteria:
inclusion criteria: * health patients, american society of anesthesiologists (asa) i or ii * patients who need to submit tooth extraction (pre-molar, canine and incisor teeth which present ideal conditions to receive dental implants after 3 months. exclusion criteria: * systemic diseases related with healing disorders * poor oral hygiene * pregnant or lactating patient * use of flap elevation for dental extraction