Kornimate/medical-research-clean huggingface dataset:
anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients

Conditions: Proteinuria

Summary: proteinuria is not only a marker of chronic kidney disease (ckd) progression, but also a marker of cardiovascular disease and death. in previous studies, active vitamin d deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (gfr). and calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. calcitriol, an active form of vitamin d (1,25-dihydroxyvitamin-d3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases. therefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. they will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored.


Eligibility criteria:
inclusion criteria: * nondiabetic kidney disease patients aged 19-70 years * mdrd gfr ≥ 30 ml/min/1.73m2 * patients with residual urine protein/creatinine ratio \> 200 mg/g * adequate blood pressure control as treated systolic blood pressure \<=140 or diastolic \<=90 mmhg with ras inhibitor for more than 3 months * normotensive patients untreated with ras inhibitors * serum intact pth as 35-500 mg/dl and serum calcium less than 10.2 mg/dl * patients who have not been treated vitamin d within the 3 months prior to signing the informed consent form exclusion criteria: * patients with nephrotic-range proteinuria (24 hour urine protein \>3.5 g/24 hr) * patients with rapidly progressive glomerulonephritis * patients requiring renal replacement therapy immediately * hypercalcemia (uncorrected serum calcium level \> 10.2 mg/dl) within 3 months * malignant hypertension * heart failure (new york heart association \[nyha\] functional class ii to iv or lvef less than 40%) * severe chronic obstructive lung disease * decompensated liver disease * known allergy or hypersensitivity to vitamin d * current treatment with steroids and/or immunosuppressive agents * no other active primary malignancy requiring treatment or that limits survival to ≤ 2 years * history of noncompliance to medical regimen * inability to give an informed consent or to cooperate with researchers (e.g., psychiatric disorder)

Keywords: calcitriol off-label
glycemic objectives of women with gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus

Summary: in a previous study, the investigators established the dosage of foetal glycated hemoglobin (fgh). it represents the mean of blood sugar 4-6 before the delivery. the investigators also compared the fgh of newborn of women with and without gestational diabetes mellitus (gdm) and determined that newborn of women with gdm had significantly higher fgh that newborn of women without gdm. in this study, the investigators want to compare the fgh of newborn of gdm women randomized to a group reaching the canadian diabetes association recommended blood glucose objectives treatment (fasting: 5.3 mmol/l and 2-hour after meals: 6.7 mmol/l) to a group reaching lower blood glucose objectives (fasting: 4.8 mmol/l and 2-hour after meals: 5.9 mmol/l)


Eligibility criteria:
inclusion criteria: * gestational age between 15 and 32 weeks since last menstrual date, * received education on gestational diabetes mellitus, * able to read and understand french. exclusion criteria: * known type 1 or type 2 diabetes, * treatment interfering woth glucose metabolism, * deficit may hinder the understanding of the study.

Keywords: foetal glycated hemoglobin glycemic objectives treatment
vitamin d metabolism and the williams syndrome

Conditions: Williams Syndrome

Summary: the williams syndrome is a disease in which supravalvular aortic stenosis, an elfin facies, mental retardation and other congenital defects are sometimes associated with abnormal vitamin d and calcium metabolism. whereas some patients have been reported to show increased sensitivity to vitamin d or an exaggerated response of serum 25-hydroxyvitamin d {25(oh)d} to administration of vitamin d and to have hypercalcemia caused by increased circulating 1,25-dihydroxyvitamin d{1,25(oh)2d} in infancy and early childhood, most patients have normal calcium metabolism and normal values for circulating 25(oh)d and 1,25(oh)2d. we propose to carry out further studies of vitamin d metabolism to elucidate the mechanism(s) for abnormal vitamin d metabolism. we will determine the response of serum 1,25(oh)2d to administration of 1,25(oh)2d3. measurement of the 1,25(oh)2d in the patients compared to normal subjects will be the primary outcome.


Eligibility criteria:
age 18 years to 50 years of age, patients and normal subjects
nevirapine resistance study: nevirapine resistance among hiv-infected mothers

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether the addition of zidovudine (zdv) and lamivudine (3tc) at the onset of labor and for up to seven days postpartum to single-dose nevirapine (nvp) is associated with a lower prevalence of nvp-resistant hiv compared to single-dose nvp without zdv+3tc.

the primary purpose of the nevirapine resistance study is to compare nevirapine (nvp) resistance of hiv at two and six weeks postpartum in women who are participating in two different programs currently ongoing in lilongwe, malawi. the first program is through the hiv infection and breastfeeding: interventions for maternal and infant health, also known as the breastfeeding, antiretrovirals and nutrition (ban) study, a clinical trial where all enrolled women receive zidovudine (zdv) and lamivudine (3tc) at the onset of labor and for up to seven days postpartum in addition to single-dose nevirapine (nvp). the second program is the call to action (cta) program sponsored by the malawi ministry of health and population (mohp) and unc project. the aim of the cta program is to reduce mother to child transmission (mtct) of hiv by providing women a single dose nvp to be taken at the onset of labor. study participants are tested for nvp-resistant hiv at two and six weeks postpartum and the prevalence of nvp-resistant virus is compared among the two groups receiving different peripartum anti-retroviral regimens.

Eligibility criteria:
inclusion criteria: * hiv infected * cd4 count \> 200 cells/μl * alt \< 2.5 x upper limit of normal (uln) * hemoglobin (hb) \> 7 g/dl * age \> 18 years, or \<18 years and married (considered emancipated minors in malawi) * ability to give informed consent * evidence of hiv infection, as documented by 2 positive enzyme-linked immunosorbent assays (elisa's); or 1 positive elisa, and 1 western blot (wb); or 2 separate concurrent rapid tests. these are the world health organization (who) acceptable criteria for diagnosing hiv-1 infection in adults. * currently pregnant (with a single or multiple fetuses) * gestation \< 34 weeks * no serious current complications of pregnancy * intention to breastfeed * intention to deliver at the institution in which the study is based * other than hiv, no active serious infection, such as tuberculosis or other potentially serious illnesses * no previous use of antiretrovirals including the hivnet 012 regimen

Keywords: hiv drug resistance nevirapine anti-retroviral drugs mother-to-child transmission treatment naive pregnancy
effect of cemented implantation in shoulder replacement on blood pressure

Conditions: Blood Pressure

Summary: to clarify the downward trend of blood pressure affected by bone cement implantation during shoulder replacement operations.

a total of 350 cases of proximal humeral fracture are planned to be recruited and receive semi-shoulder replacement in department of orthopedics and trauma，peking university people's hospital．the blood pressure data are collected from patients' anesthesia records. both the systolic and diastolic blood pressure are recorded at four time spots during operation: the time before using of bone cement (time period a), 0-5 min after using cement (time period b), 5-10 min after using cement (time period c) and 10-15min after using cement (time period d). the data of blood pressure are collected according to anesthesia records．

Eligibility criteria:
inclusion criteria: •patients with three or four part of proximal humeral fracture receiving cemented shoulder replacement exclusion criteria: * pathologic fracture * severe hypertension or hypotension

Keywords: blood pressure shoulder replacement proximal humeral fracture
velocimetric study of temporal arteries in patients with horton disease using scan-doppler

Conditions: Horton Disease

Summary: the use of ultrasonography in detecting giant cell arteritis ( gca) is emerging. currently, temporal biopsy is the gold standard to diagnose gca but studies have shown the interest to use b mode ultrasonography. however, until now, the study of velocities in gca have not been yet performed.


Eligibility criteria:
inclusion criteria: * patients with suspicious giant arteritis exclusion criteria: * patients who have already been treated or diagnosed for giant arteritis
treatment of patients with skin burns using keratinocytes and skin fibroblasts

Conditions: Burns

Summary: treatment of patients with burns of the skin of the 2nd degree using: autologous keratinocytes and skin fibroblasts mixed with collagen gel 7% (tissue equivalent of the skin)

treatment of patients with burns of the skin of the 2nd degree by applying a wound covering with layer-by-layer cultured autologous keratinocytes and fibroblasts in collagen gel

Eligibility criteria:
inclusion criteria: * skin burns of the 2nd degree exclusion criteria: * acute and chronic infectious diseases: hiv, viral hepatitis, tuberculosis * mental disorders * pregnancy

Keywords: burns fibroblasts keratinocytes
a pilot study to explore the role of gut flora in gout

Conditions: Gout

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to gout

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. may be signed by parent or legal guardian in the case of minor or adult unable to provide consent 2. male or female of all ages. (interest is given to children who present with autism or crohn's and whose parents wish to analyze their children's gut flora. also of interest analysis of development of the child's microbiome. in the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) 3. diagnosis of gout by a physician exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition
consistency of pd-l1 detecting method between e1l3n and 22c3 monoclonal antibodies in nsclc patients

Conditions: Non Small Cell Lung Cancer

Summary: evaluated the correlation between the qualitative test results of xiamen aide pd-l1 antibody reagent (immunohistochemistry) and the efficacy of keytruda single-agent therapy, and the research data is used to support the registration and marketing of the assessment reagent


Eligibility criteria:
inclusion criteria: 1. ≥18，advanced non-small cell lung cancer confirmed by histopathology, and have received k-drug mono-therapy in the past, the return visit information is complete, with traceable information such as tumor imaging examinations before and after treatment, and the curative effect can be judged; 2. able to provide ffpe samples with a storage life of 4 years: 6 slices of continuous slices with a thickness of 3-5μm exclusion criteria: 1. pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \<100); 2. k-drug mono-therapy is neoadjuvant therapy or adjuvant therapy; 3. other situations that the investigator thinks are not suitable for participating in this clinical study
transversalis fascia plane block for iliac bone graft in children

Conditions: Postoperative Pain, Acute

Summary: the purpose of this study is to determine which method is more effective in postoperative pain control in children undergoing iliac bone grafting for alveoloplasty under general anesthesia: ultrasound-guided transverse abdominal blockade or transversalis fascia plane block


Eligibility criteria:
inclusion criteria: * children aged 7 years and older but under 18 undergoing iliac bone grafting for alveoloplasty exclusion criteria: * patients with diseases that affect pain sensitivity differently from the general population (e.g., congenital insensitivity to pain with anhidrosis, complex regional pain syndrome, etc.) * cases where there is difficulty in expressing pain (due to cognitive or functional deficits, or limited ability to communicate) * unstable vital signs (heart rate, blood pressure) * common contraindications for ropivacaine: 1) patients with a history of hypersensitivity to this drug or other amide local anesthetics, 2) patients in a state of major bleeding or shock, 3) patients with inflammation at or around the site of administration, 4) patients with sepsis, 5) intravenous regional anesthesia (bier block) * history of allergy to opioid medications * severe renal impairment (creatinine \>3.0mg/dl) * severe liver function abnormalities (aspartate transaminase \> 120 unit/l, alanine aminotransferase \> 120 unit/l) * peripheral nervous system disorders * other cases deemed unsuitable by the researcher
a safety study to assess the effects of therapeutic and supratherapeutic exenatide concentrations on qt interval in healthy subjects

Conditions: Healthy Subjects

Summary: compare the effect of exenatide (therapeutic and supratherapeutic concentrations), moxifloxacin and placebo on the qt interval.


Eligibility criteria:
inclusion criteria: * is overtly healthy, as determined by medical history and physical examination * has body mass index (bmi) between 25 and 35 kg/m2 * has fasting serum glucose \<110 mg/dl * has no clinically significant blood pressure or heart rate readings as judged by the investigator at study start * has electrocardiogram (ecg) results judged as not clinically significant by the investigator at study start exclusion criteria: * has a clinically significant medical condition that could potentially affect study participation and/or personal well-being * has an abnormality in the 12-lead ecg that, in the opinion of the investigator, increases the risk of participating in the study, such as a bazett's corrected qt (qtcb) interval \>450 ms. * family history of sudden death * personal history of unexplained syncope within last year, or family history of long qt syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months

Keywords: diabetes exenatide amylin lilly qt interval
effectiveness of buprenorphine/naloxone in reducing intravenous buprenorphine misuse in france ("rime")

Conditions: Opioid Dependency

Summary: patients who admit to using buprenorphine by the intravenous route will be randomized to either subutex or suboxone and be followed up for 3 months to determine if there is less injection with suboxone than with subutex based primarily on patient diaries. patients randomized to suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals. patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.


Eligibility criteria:
inclusion criteria: 1. male or female opioid-dependent outpatient aged 18 years or older, 2. women of childbearing potential must have a negative urine pregnancy test result at the inclusion visit (test under supervision of the investigator or designee), 3. women of childbearing potential must use an effective birth control method. women of non-childbearing potential must be postmenopausal or must be surgically sterile (hysterectomy and/or bilateral oophorectomy), 4. on buprenorphine (subutex® or generic buprenorphine) maintenance therapy at a minimum daily dose of 2 mg for at least 3 months prior to inclusion, 5. declaring buprenorphine intravenous misuse at least four times/week and showing needle marks, 6. willing to stop or reduce buprenorphine intravenous misuse, 7. having received oral and written information about the trial, and provided written informed consent prior to admission to this trial. exclusion criteria: 1. pregnancy or breast-feeding, 2. contraindication or history of hypersensitivity to buprenorphine, naloxone or to any excipient of suboxone® or subutex®, 3. any medical or psychiatric condition which in the opinion of the investigator would make participation difficult or unsafe, 4. participating in another trial, 5. patients in the exclusion period of the "fichier national des personnes qui se prêtent à des recherches biomédicales" (national index of persons participating in biomedical researches, or national index of volunteers).

Keywords: substance abuse, intravenous buprenorphine
cinjall: treatment for children with acute lymphocytic leukemia

Conditions: Acute Lymphocytic Leukemia

Summary: the purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (all). at the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.

outline of therapy: combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half years. therapy will be divided into five phases: induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia cells in the bone marrow). consolidation (11 weeks): chemotherapy given to consolidate the remission. delayed intensification (7 weeks) intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse. intensive continuation (approximately 1 year): eight week cycles of chemotherapy, given eight times. continuation (final year of therapy): eight week cycles of largely oral chemotherapy, with one clinic visit for a lumbar puncture every eight weeks. irradiation: radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis. follow-up: after the conclusion of therapy, there will be periodic office visits, initially monthly, then gradually spaced out to annual visits. the purpose of these visits is to evaluate for late side-effects of therapy.

Eligibility criteria:
inclusion: * newly diagnosed all, excluding mature b-cell all (surface ig positive) * patients with overt cns (central nervous system) or testicular disease are eligible * informed consent according to institutional and fda guidelines. * adequate organ function is required. * hiv seropositive patients will not be excluded from this study. * patients greater than 1 year of age and less than 29.99 years of age are eligible. exclusion criteria * patients with medical, psychological, or psychiatric problems that are likely to compromise their ability to tolerate intensive therapy will be ineligible. * all patients with evidence of significant organ dysfunction not thought to be attributable to all (patients with clinically significant congestive heart failure, cardiac ejection fraction \ 2, serum creatinine \>2) will be ineligible. note: echocardiogram or muga are required prior to therapy only for those patients with history or physical findings suggestive of cardiac dysfunction not directly attributable to anemia or all. note: patients with total bilirubin \>2 but direct (conjugated) bilirubin less than the upper limit of normal will still be eligible. these patients should be evaluated for deficiency of the enzyme glucuronyl transferase.

Keywords: acute lymphocytic leukemia leukemia
phase i/ii safety and immunogenicity of pandemic live attenuated influenza vaccine (plaiv) candidate strain a/17/ca/2009/38 (h1n1) in healthy thais

Conditions: Healthy

Summary: the purpose of this study is to evaluate safety and reactogenicity of pandemic live attenuated influenza vaccine (plaiv) manufactured by gpo, thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using hai test, micro neutralization assays.

part a: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 eid50 or 6.6-7.5 log10 eid50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo. part b: total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). there are 3 stratified age groups: \>12-18 years, \>18-49 years and \>49 years.

Eligibility criteria:
inclusion criteria: * healthy * age 9 - \>49 years old * having thai id card or equivalent * are seronegative to the specific h1n1 influenza virus determined by antibody titer less than 1:10 by hai test to the corresponding antigen * anti hiv - negative * all hematology \& biochemistry within normal range * able to read and write and sign written informed consent exclusion criteria: * known history of egg allergy * having had recently influenza infection confirmed as h1n1 (indeed all other types if influenza and vaccination with seasonal vaccine will not interfere) * history of bronchial asthma * history of chronic lung diseases * history of chronic rhinitis * history of immunodeficiency state * history of immunosuppression * acute infectious and noninfectious diseases (within 2 weeks) * exacerbation of chronic diseases or cancer or hiv positives * anamnestic leukocytosis, hepatitis b and c positives * the volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment * participation in other research study * pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding * any concomitant medication with aspirin

Keywords: flu h1n1 gpo plaiv
treatments for brain metastases with poor prognostic factors

Conditions: Brain Metastases

Summary: the goal of this observational study is to learn about treatments in brain metastases with poor prognostic factors. the main questions it aims to answer are: * what kind of local treatment provides a survival benefit for patients with poor prognostic factors? * what kind of systemic treatment provides a survival benefit for patients with poor prognostic factors? * will the combination of local treatment and systemic treatment provide a survival benefit for patients with poor prognostic factors? participants will be asked to provide personal information about their living status, symptoms, and disease control during the follow-up.


Eligibility criteria:
inclusion criteria: 1. evidence of pathological diagnosis of primary tumor; 2. brain metastases confirmed by enhanced magnetic resonance imaging; 3. complete clinical information exclusion criteria: 1. survival time less than 30 days; 2. if surgical treatment is accepted, the surgical treatment is not tumor resection, but ventricle puncture, biopsy and other non-tumor reducing surgery; 3. incomplete clinical data; 4. patients with 2 or more types of tumors.

Keywords: brain metastases local treatments systemic treatments poor prognosis