Kornimate/medical-research-clean huggingface dataset:
evaluation of a test mouthwash and dentifrice regimen in an in-situ model of dental erosion

Conditions: Tooth Erosion

Summary: an in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.


Eligibility criteria:
inclusion criteria: * an intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth * no current active caries or periodontal disease that may compromise the study or the health of the subjects * a gum base stimulated whole saliva flow rate greater than or equal to 0.8 ml/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 ml/minute exclusion criteria: * known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

Keywords: enamel erosion tooth remineralization tooth erosion
a study comparing sirukumab (cnto 136) monotherapy with adalimumab (humira®) monotherapy in the treatment of active rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the primary objective is to investigate the efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active rheumatoid arthritis who are intolerant to methotrexate, who are considered inappropriate for treatment with methotrexate or who are inadequate responders to methotrexate.

this is a randomized, double-blind, parallel-group, global, multicenter study of subcutaneous (sc) sirukumab monotherapy compared with adalimumab monotherapy in subjects with active rheumatoid arthritis. approximately 510 subjects will be randomly assigned in a 1:1:1 ratio to receive treatment with adalimumab 40 mg sc every 2 weeks, sirukumab 100 mg sc every 2 weeks, or 50 mg sc every 4 weeks, with approximately 170 subjects per treatment group. at week 16, subjects in all treatment groups who have \< 20% improvement from baseline in both swollen and tender joint counts will qualify for early escape. the expected duration of the study is 68 weeks. this includes 52 weeks of treatment with study agent and 16 weeks of safety follow-up after the last study agent administration. the study will end when the last subject completes the last scheduled visit (week 68 visit or completes the 16 week safety follow-up, whichever is later). subject safety will be monitored through the end of the study.

Eligibility criteria:
inclusion criteria: * have a diagnosis of rheumatoid arthritis (ra) for at least 6 months before screening * have moderately to severely active ra with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline * have previous or current treatment with methotrexate (mtx) and are considered intolerant to mtx, and/or are considered inappropriate for treatment with mtx, (including mtx-naïve subjects for whom it is inappropriate to administer mtx) and/or an inadequate responder to methotrexate * must not have received mtx or any other non-biologic dmard including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent * c-reactive protein \>= 10.00 mg/l or erythrocyte sedimentation rate \>=28 mm/hr at screening exclusion criteria: * has functional class iv as defined by the acr classification of functional status in rheumatoid arthritis * has ever received biologic therapy for ra, including but not limited to the following: tnf-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept * has ever used tofacitinib therapy or any other jak inhibitor * has received intra-articular, intramuscular, or iv corticosteroids for ra, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration * has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the m1 metabolite is measured and is undetectable

Keywords: rheumatoid arthritis cnto 136 sirukumab adalimumab humira®
relationship between body weight and glycohemoglobin

Conditions: Type 2 Diabetes Mellitus

Summary: control of body weight (bw) is important to prevent and manage type 2 diabetes. regardless of the close association, little is understood about the precise relationship between bw and glycemic control, which might be of benefit for patients with type 2 diabetes. the researchers investigated the correlation between changes in bw and glycemic control in patients with type 2 diabetes treated with a diet therapy or pioglitazone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes under reasonable glycemic control (hba1c; less than around 7%) * type 2 diabetic patients treated with the diet therapy exclusion criteria: * type 2 diabetic patients with edema, severe liver dysfunction, renal dysfunction, moderate to severe anemia or congestive heart failure * type 2 diabetic patients treated with insulin therapy

Keywords: body weight glycohemoglobin
acupuncture for prevention of itch in caesarean section

Conditions: Pruritus

Summary: this study aims to determine the effectiveness of using a commercially available acupuncture stud at the li11 acupuncture point at reducing the severity of itch caused by intrathecal diamorphine in elective caesarean section.

itch is a very common complication of diamorphine used in spinal anaesthesia for caesarean section with a local incidence of 78%. it ranges from irritating to distressing and difficult to treat and can adversely affect maternal satisfaction, wellbeing and bonding with their baby. this trial aims to determine whether acupuncture using a commercially-available acupuncture stud at the li11 point reduces the incidence and severity of post-operative itching in patients undergoing elective caesarean section under spinal anaesthesia with intrathecal diamorphine. 80 women having a planned caesarean section under spinal anaesthesia will be recruited by informed consent and randomised to the intervention group or the control group. the intervention group will receive an acupuncture stud at the li11 point on either arm and the control group will receive acupuncture with a similar stud containing a smaller needle at a non-acupuncture point on either arm. the stud can be left in-situ until the followup visit the following morning or removed earlier at the participants discretion. all other care will be the usual clinical care including access to anti-itching drugs as required. participants will be visited by a member of the research team at 3-5 hours following the start of their spinal anaesthetic and asked to mark their itch on an 11 point visual analogue scale (vas). they will also be visited by a member of the research team the following morning, asked to rate their worst itch on the same scale and asked how troublesome they have found their itch (none, mild, moderate, severe). the administration of any anti-itch drugs will be recorded and if the acupuncture stud has not been removed it will be removed at this time. if effective, acupuncture with an acupuncture stud would provide an acceptable, convenient, safe and cost-effective treatment.

Eligibility criteria:
inclusion criteria: * asa1-3 patients with uncomplicated pregnancies undergoing elective caesarean section with a plan for spinal anaesthesia with intrathecal diamorphine. exclusion criteria: * age under 18. * pre-existing itch or conditions associated with itch (eg cholestasis of pregnancy). * pre-existing use of h1 receptor antagonists, non-selective antihistamines or ursodeoxycholic acid. * severe perioperative complication or fetal death. * conversion to general anaesthesia. * unable to understand written and spoken english.

Keywords: caesarean section
early high-volume continuous veno-venous hemofiltration for patients with severe acute pancreatitis

Conditions: Acute Pancreatitis

Summary: the purpose of this study is to determine the effect and safety of early high-volume continuous veno-venous hemofiltration for patients with severe acute pancreatitis.

the investigators anticipated that early high-volume continuous veno-venous hemofiltration (ehvcvvh) would result in a decrease of the composite of persistent organ failure or death by eliminating inflammatory mediators in blood. this study is designed to evaluate the impact of ehvcvvh on patients with severe acute pancreatitis.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of severe acute pancreatitis * written informed consent * time from onset of abdominal pain to admission ≤ 72 hours * sirs score ≥ 2 exclusion criteria: * confirmed infection * pregnancy * patients needing emergency operation for abdominal compartment syndrome * chronic renal diseases needing blood purification * previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy * acute flare-up of chronic pancreatitis * malignancy

Keywords: severe acute pancreatitis organ failure multiple organ dysfunction syndrome systemic complications continuous veno-venous hemofiltration blood purification continuous renal replacement therapy
laparoscopic ventrosuspension for women with retroverted uterus and pelvic pain syndromes: a new approach

Conditions: Chronic Pelvic Pain

Summary: in women with retroverted retroverted uterus complaining of pelvic pain, laparoscopy was done. under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. the needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. the same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision.

in women with retroverted retroverted uterus complaining of pelvic pain, laparoscopy was done. under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. the needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. the same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision using vicryl 2/0 suture.

Eligibility criteria:
inclusion criteria: * women with chronic pelvic pain for more than 6 months duration * women with retroverted retroflexed uterus * no response to analgesics * fit for laparoscopic surgery exclusion criteria: * women with other causes of pelvic pain as ovarian cysts * women with neurological disorders * psychologically disturbed, * women with systemic or pelvic infections,
human breast tissue bioavailability of topically applied limonene

Conditions: Breast Cancer

Summary: the overall objective of this project is to determine the safety and breast tissue bioavailability of limonene following massage application of limonene containing massage oil to the breast.


Eligibility criteria:
inclusion criteria: * women who are 18-65 years of age * ecog performance status 0-1 * normal organ and marrow function * women of child-bearing potential must agree to use adequate contraception * willing to avoid consumption and use of citrus or citrus containing products throughout the study * have both breasts intact exclusion criteria: * have had cancer(s) within the past 5 years * participated in another clinical interventional trial within the past 3 months * uncontrolled intercurrent illness * pregnant or breast feeding * unable to produce nipple aspirate fluid * have known allergic or sensitive reactions to skin care products, citrus or coconut oil * have ongoing skin disorders such as eczema and psoriasis

Keywords: breast cancer prevention
the diaphragmatic initiated ventilatory assist (diva) trial

Conditions: Extubation Failure; Bronchopulmonary Dysplasia; Death

Summary: diva is a pragmatic randomized clinical trial (rct) to determine: among (p) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (i) non-invasive neurally adjusted ventilatory assist (niv-nava) (c) compared with non-synchronized nasal intermittent positive pressure ventilation (ns-nippv), will reduce the incidence of (o) extubation failure within (t) 5 days (120 hours) of extubation.

bronchopulmonary dysplasia (bpd) is the most common complication of prematurity and is the leading respiratory cause of childhood morbidity. ventilator induced lung injury (vili) an accepted and important contributor to bpd. exposure to oxygen and positive pressure ventilation leads to developmental arrest and parenchymal injury in the immature preterm lung. because even brief exposure to intubated positive pressure ventilation is injurious, avoiding invasive mechanical ventilation is the most widely acknowledged strategy to prevent vili and the long-term sequela of bpd. therefore, time on ventilators and rates of successful extubation are important endpoints of therapy. non-invasive neurally adjusted ventilatory assist (niv-nava) is an fda approved technology that consistently synchronizes non-invasive respiratory support with infant respiratory drive. the diaphragmatic initiated ventilatory assist (diva) trial is an unblinded, pragmatic, multicenter phase iii randomized clinical trial in extremely preterm infants 23 0/7- 28 6/7 weeks gestational age to determine if niv-nava, compared with non-synchronized nasal intermittent positive pressure ventilation (ns-nippv), prevents extubation failure within 5 days (120 hours) of extubation from mechanical ventilation

Eligibility criteria:
inclusion criteria: * gestational age of 23 0/7- 28 6/7 weeks at birth * intubated in the first 7 days of life * undergoing extubation following at least 12 hours of invasive mechanical ventilation * post-natal age \<32 weeks post menstrual age at time of extubation exclusion criteria: * major congenital anomalies, including pulmonary hypoplasia * neurologic disorders affecting respiratory drive (other than apnea of prematurity) * esophageal bleeding or other contraindication to ng/og catheter placement * current weight \<500 grams (based on edi catheter approval) * study ventilator not available at time eligibility criteria are met * planned surgery or invasive procedure within 5 days of extubation * informed consent not provided
assessment of cmv-specific elispot assay for predicting cmv colitis in patient with ulcerative colitis

Conditions: Ulcerative Colitis; Cytomegalovirus Infections; Disease Exacerbation

Summary: consequences of latent cytomegalovirus (cmv) infection reactivation on ulcerative colitis flare, as a flare-worsening factor or simple bystander, are debated. theoretically, cmv-specific cell-mediate immune response will further categorize the patients into high or low risk of cmv colitis. the investigators thus evaluate the usefulness of cmv-specific elispot assay in patient with ulcerative colitis flare to assess the the impact of cmv colitis on ulcerative colitis flare.

moderate to severe ulcerative colitis patients admitted in inflammatory bowel disease (ibd) center will be enrolled in this study. eligible patients had active uc with a mayo score of 6-12 points (moderate or severe disease activity). the investigators will evaluate whether cmv-specific cell-mediated immune response at admission will predict the risk of active cytomegalovirus infection (true pathogen versus bystander).

Eligibility criteria:
inclusion criteria: * moderate to severe uc require hospitalization * age 16 or more * agree with written informed consent exclusion criteria: * pregnancy * foreign * immunosuppressed patients
the impact on recurrence risk of adjuvant lenvatinib for patients with hepatocellular carcinoma and microvascular invasion (mvi) after hepatectomy : a random, controlled, stage iii clinical trial.

Conditions: Hepatocellular Carcinoma

Summary: to compare the impact on recurrence risk of adjuvant lenvatinib for patients with hepatocellular carcinoma and microvascular invasion (mvi) after hepatectomy.


Eligibility criteria:
no criteria: inclusion criteria: older than 18 years old and younger than 75 years; ecog ps\<3; proven hepatocellular carcinoma with mvi according pathological examination; not previous treated for tumor; tumor was removed in operation; no recurrence occurence at 4 to 7 weeks after surgery; the lab test could meet: neutrophil count≥1.5×109/l; hemoglobin≥80g/l; platelet count≥60×109/l; serum albumin≥28g/l; total bilirubin\<3-times upper limit of normal; alt\<5-times upper limit of normal; ast\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; pt≤upper limit of normal plus 6 seconds; inr≤2.3; sign up consent; unrolled by other clinical trials about hepatocellular carcinoma. exclusion criteria: cannot tolerate lenvatinib; cns or bone metastasis exits; known history of other malignancy; be allergic to related drugs; underwent organ transplantation before; be treated before (interferon included); known history of hiv infection; known history of drug or alcohol abuse; have gi hemorreage or cardiac/brain vascular events within 30 days; pregnancy;
effect of ly2062430 on the progression of alzheimer's disease

Conditions: Alzheimer's Disease

Summary: alzheimer's disease (ad) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. ad is thought to be caused by an excess of a-beta amyloid, a sticky protein in the brain that forms amyloid plaques. treatments that slow the synthesis or deposition of a-beta amyloid, or that increase clearance, might be expected to slow the progression of ad. ly2062430 (solanezumab) is a humanized anti-a beta peptide immunoglobulin g-1 (igg1) monoclonal antibody being developed for the treatment of ad. the primary hypothesis being tested is that ly2062430 will slow cognitive and functional decline in ad as compared with placebo. each patient's participation will last approximately 19 months. patients taking approved ad medications may participate in this study and continue taking these medications during the study.


Eligibility criteria:
inclusion criteria: * meets criteria for mild to moderate alzheimer's disease (ad) with mini-mental state examination score of 16 through 26 at screening * modified hachinski ischemia scale score of less than or equal to 4 * geriatric depression scale score of less than or equal to 6 * a magnetic resonance imaging (mri) or computerized tomography (ct) scan in the last 2 years with no findings inconsistent with a diagnosis of ad * if receiving concurrent ad treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to randomization exclusion criteria: * has serious or unstable illness(es) * does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week) * meets national institute of neurological disorders and stroke/association internationale pour la recherche et l'enseignement en neurosciences (ninds/airen) criteria for vascular dementia * does not have good venous access, such that intravenous (iv) drug delivery would be difficult * has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain * has allergies to humanized monoclonal antibodies * chronic alcohol and/or drug abuse within the past 5 years * has any contraindications for mri studies * requires treatment with another monoclonal antibody
drug use investigation of kaletra

Conditions: Human Immunodeficiency Virus

Summary: this non-interventional, post-marketing observational study was conducted to obtain data, such as safety and effectiveness, from the use of lopinavir/ritonavir (kaletra) in clinical practice and investigate the necessity to conduct a follow-up post-marketing clinical study in japan.


Eligibility criteria:
inclusion criteria: * all patients prescribed kaletra for the treatment of hiv are eligible for this survey. exclusion criteria: * contraindications according to the package insert: * patients with a history of hypersensitivity to any ingredient of kaletra * patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol

Keywords: human immunodeficiency virus
umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis b cirrhosis

Conditions: Liver Cirrhosis

Summary: this study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis b cirrhosis.


Eligibility criteria:
inclusion criteria: * aged between 20 and 60 (male or female) * diagnosed chronic decompensated hepatitis b cirrhosis with a course of more than 5 years * not suitable for liver transplantation or there is no donor liver source * no serious bleeding tendency or active bleeding * no hepatic encephalopathy * after strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score * subjects voluntarily participate in this study and sign informed consent exclusion criteria: * be less than 20 years old or more than 60 years old * cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis c virus and autoimmune hepatitis * found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives * patients with hypersplenism who need splenectomy * history of tumors in other organs * pt prolongation is greater than 3 seconds * use of human serum albumin within 3 weeks prior to clinical registration * clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration * spontaneous peritonitis * active infection (viral or bacterial) * pregnant or lactating women * the researcher considers it inappropriate to participate in this study