Kornimate/medical-research-clean huggingface dataset:
evaluation of safety and efficacy of once monthly ranibizumab injections in chinese patients with wet age related macular degeneration (amd) patients

Conditions: Age Related Macular Degeneration

Summary: the purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5 mg intravitreal injections in chinese patients with subfoveal choroidal neovascularization (cnv) secondary to age-related macular degeneration (amd). the study results will support the regulatory submission in china to make ranibizumab available for clinical use.


Eligibility criteria:
inclusion criteria: * male or female chinese patients 50 years of age or greater. * patients with primary or recurrent subfoveal cnv secondary to amd. * patients who have a bcva score from 73 to 24 characters in the study eye. exclusion criteria: * active, or history of, ocular inflammation or infection in the study eye within the last 30 days. * uncontrolled glaucoma in the study eye. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: amd ranibizumab
rainbow study: ranibizumab compared with laser therapy for the treatment of infants born prematurely with retinopathy of prematurity

Conditions: Retinopathy of Prematurity

Summary: the purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (rop).

the study consisted of a screening period (screening and randomization could occur up to 3 days before the administration of the first investigational treatment), followed by a treatment and follow-up period (day 1 to day 169).

Eligibility criteria:
inclusion criteria: * preterm infants with a birth weight of less than 1500 g * bilateral rop with one of the following retinal findings in each eye: zone i, stage 1+, 2+, 3 or 3+ disease, or zone ii, stage 3+ disease, or aggressive posterior retinopathy of prematurity (ap-rop) exclusion criteria: * rop disease characteristic in either eye other than that listed above at the time of the first investigational treatment * a history of hypersensitivity (either the patient or the mother) to any of the investigational treatments or to drugs of similar chemical classes * had received any previous surgical or nonsurgical treatment for rop (e.g., ablative laser therapy or cryotherapy, vitrectomy) * had been previously exposed to any intravitreal or systemic anti-vegf agent (either the patient or the mother during this child's pregnancy) * had used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever was longer * had ocular structural abnormalities that were assessed by the investigator to have had a clinically significant impact on study assessments * had active ocular infection within 5 days before or on the day of first investigational treatment * had a history of hydrocephalus requiring treatment * had a history of any other neurological conditions that are assessed by the investigator to have a significant risk of severe impact on visual function * had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule)

Keywords: intravitreal ranibizumab laser ablation therapy retinopathy of prematurity preterm infants rainbow
phase ii study of leuprolide and testosterone for men with kennedy's disease or other motor neuron disease

Conditions: Spinal Muscular Atrophy; Amyotrophic Lateral Sclerosis; Spinobulbar Muscular Atrophy

Summary: objectives: i. evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with kennedy's disease or other motor neuron disease.

protocol outline: all patients receive androgen suppression with leuprolide acetate injections every 4 weeks for 6 months, plus hormone replacement therapy with testosterone enanthate injections every week for 24 weeks.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- men aged 18 and over with motor neuron disease, i.e.: * x-linked spinal and bulbar muscular atrophy (kennedy's disease) * confirmed by androgen receptor, exon-1 mutation genotype * amyotrophic lateral sclerosis * spinal muscular atrophy significant muscle weakness on manual muscle testing no prisoners no mental disability

Keywords: amyotrophic lateral sclerosis motor neuron disease neurologic and psychiatric disorders rare disease spinal and bulbar muscular atrophy spinal muscular atrophy kennedy's syndrome
saliva insulin responses to a standardized meal tolerance test in humans

Conditions: Diet Modification; Insulin Resistance; Hyperinsulinemia

Summary: recent evidence suggests that hyperinsulinemia (i.e., elevated insulin levels) is the primary causative factor in obesity. insulin promotes fat storage and prevents fat breakdown, suggesting that weight loss would be optimized if insulin levels are managed and kept low. understanding how different foods impact insulin levels could therefore aid in personalized weight loss (or weight maintenance) advice. it has been shown that salivary insulin can track plasma insulin following different meals and can delineate between lean and obese people. thus, it was suggested that salivary insulin could be a potential surrogate for plasma insulin. the purpose of this study is to measure fasting saliva insulin, and salivary insulin responses to a standardized meal tolerance test in individuals with different body mass index (bmi).


Eligibility criteria:
inclusion criteria: * non-smoker * have a body mass index greater than 18.5 kg/m2 * have not been diagnosed with type 2 diabetes or other medical conditions affecting glucose or insulin levels exclusion criteria: * you have been. diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) or any other diagnosed chronic condition that may impact your glucose or insulin levels or the outcomes of this study. * you take any medication which may affect your glucose and insulin level * unable to travel to make your testing appointments. * unable to consume the meal tolerance test drink/shake and/or provide finger stick glucose or saliva samples for the study.

Keywords: salivary insulin
effect of w-3 polyunsaturated fatty acids on serum albumin concentration in patients with acute heart failure, hypoalbuminemia, and high inflammatory activity

Conditions: Heart Failure

Summary: assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin

assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin assess the effect of high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity on: * inflammatory activity (c-reactive protein) * the development of biomarkers (ntprobnp). * the prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or olders hospitalized for acute heart failure, chronic decompensated or new onset of any etiology, presenting hypoalbuminemia (serum albumin ?3,4 g / dl) and high inflammatory activity (crp ?2,5 mg / dl). exclusion criteria: * impending doom * participating in other clinical trials * treatment with ?-3 acids in the last month prior to admission * percutaneous or surgical treatment of the cause of heart failure during hospitalization. * pregnant women. * renal failure on dialysis. * chronic liver disease child-pugh b or c. * acute infectious process. * active malignant neoplasia.
ph i oral topotecan and temozolomide for patients with malignant gliomas

Conditions: Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma

Summary: objectives: * to determine the maximum tolerated dose of oral topotecan when administered with temodar to patients with malignant glioma * to characterize any toxicity associated with the combination oral topotecan and temodar. * to observe patients for clinical antitumor response when treated with oral topotecan and temodar.

subjects are patients with glioblastoma (gbm), anaplastic astrocytoma (aa) or grade 3 or greater who astrocytic, oligodendroglial or mixed glial tumors, which were initially diagnosed by histologic examination of biopsy/resection. modified classical "3+3" phase i design used to determine maximum tolerated dose of topotecan in combination with temodar.

Eligibility criteria:
inclusion criteria: * histology: gbm, aa or grade 3 or greater who astrocytic, oligodendroglial or mixed glial tumors which were initially diagnosed by histologic exam of biopsy/resection * age: \> or equal to 18 years * performance status: karnofsky performance status \> or equal to 60% at study entry. * renal function: serum creatinine \ 60 ml/dl. * hematologic status: the following baseline studies will be required before entry: total granulocyte count \> or equal to 1000/microliter; platelet count \> 100,000/microliter * hepatic function: serum sgot \& total bilirubin \< or equal to 2.5 times uln. * note: all lab parameters must have been obtained within 1 week of registration * consent: signed informed consent, approved by irb, will be obtained prior to initiating treatment * corticosteroids: for patients currently on corticosteroids, patients should be on stable dose for 1 week prior to study entry, if clinically possible. * prior therapy: interval of at least 2 weeks between prior surgical resection or prior radiotherapy (xrt) or 1 week from completion of chemotherapy and all toxicities are \< or equal to grade 1 \& enrollment on this protocol unless there is unequivocal evidence of progressive disease. * patients with reproductive potential: patients must agree to practice effective birth control measures while on study and for 2 months after completing therapy exclusion criteria: * pregnant or breast feeding women or women or men with reproductive potential not practicing adequate contraception. this therapy may be associated with potential toxicity to the fetus or child that exceeds minimum risks necessary to meet health needs of mother * active infection requiring intravenous antibiotics * prior failure with either topotecan or temozolomide

Keywords: temodar temozolomide topotecan hycamtin malignant gliomas brain tumor anaplastic astrocytoma aa gbm glioblastoma multiform gliosarcoma
hypomethylating agent and venetoclax after allo-hsct in patients with high-risk myeloid malignancies.

Conditions: Hypomethylating Agent; Venetoclax; Myeloid Malignancy

Summary: the main objective of the study is to evaluate the efficacy and safety of maintenance therapy with hypomethylating agent and venetoclax to improve leukemia free survival for high-risk myeloid malignancies after allogeneic hematopoietic stem cell transplantation .

this is a prospective single-arm study. patients with high-risk aml or mds aged between 18-70 years old will enroll in the study. they will be given hypomethylating agents (azacytidine 32mg/m2 or decitabine 5mg/m2) for 5 days and venetoclax 400mg/d for 7 days after allogeneic hematopoietic stem cell transplantation. the maintenance therapy will start from 60th days posttransplant, repeated every 28 days until up to 1-year posttransplant. the 1-year leukemia-free survival rate，1-year cumulative recurrence rate, and 1-year overall survival will be analyzed.

Eligibility criteria:
inclusion criteria: * patients with aml or mds and have received allogeneic hematopoietic cell transplantation; * patients with aml must have one of the following high-risk factors: cytogenetics and molecular features consistent with adverse risk group by european leukemianet classification for aml； require more than 2 courses of induction chemotherapy to reach complete remission； extramedullary myeloid malignancy；≥cr2； presence of measurable residual disease at the time of hsct. \* * patients with mds must have one of the following high-risk factors: ipss-r scores are high-risk or very high-risk； presence of tp53 mutation； presence of measurable residual disease at the time of hsct. \* * cbc: anc ≥ 1.0 × 10e9/l, hb ≥ 80g/l, and plt ≥ 50 × 10e9/l； * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. * presence of measurable residual disease at the time of hsct is defined as the following: blast percentage in bone marrow detected by flow cytometry ≥0.01%； presence of fusion gene or mutated gene by qpcr. exclusion criteria: * concurrent use of targeted drugs ; * resistant to venetoclax before transplantation; * allergic to decitabine , azacitidine or venetoclax; * active grade ii or higher acute gvhd ; * active moderate or severe chronic gvhd ; * diseases recurrence (abnormal myeloid cells detected by flow cytometry \>0.01%, presence of wt1 or other genes, or extramedullary malignancy ), percentage of donor cells in bone marrow \<90% or graft rejection: * cbc: anc \< 1.0 × 10e9/l, or plt \< 50 × 10e9/l； * severe organ dysfunction: elevated aspartate transaminase (ast) /alanine transaminase (alt), or direct bilirubin \>3 times upper limit of normal; creatinine clearance (ccr)\ 1.5 times upper limit of normal, whether hemodialysis treatment is performed; * active uncontrolled systemic fungal, bacterial, or viral infection * pregnant or lactating women; * other severe complications and not suitable judged by researchers.
a study of fluvestrant combined with oral vinorelbine in hormone receptor-positive advanced breast cancer

Conditions: Hormone Receptor Positive Advanced Breast Cancer

Summary: this is a single-center phase ii study designed to evaluated the efficacy and safety of fulvestrant in combination with oral vinorelbine in hormone receptor-positive advanced breast cancer

this is a single-group, single-center phase ii trial. patients with hormone-receptor-positive, her2-negative recurrent or metastatic breast cancer who had not previously received any systemic antitumor therapy for advanced disease were treated with fulvestrant combined with oral vinorelbine as a first-line regimen. key issues to be addressed in this study: to observe and evaluate the efficacy and safety of fulvestrant combined with oral vinorelbine in the treatment of hormone-receptor-positive and her2-negative advanced breast cancer. thirty patients are planned to be enrolled.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 year-old women; pathologically or cytologically confirmed breast cancer; hormone receptor-positive * ecog score: 0-1, expected survival time ≥ 3months; * recurrence after adjuvant therapy or metastatic breast cancer and chemotherapy naïve in the metastatic setting or had one prior regimen for metastatic breast cancer. * patients must have measurable disease according to recist criteria version 1.1. bone metastases lesions were excluded. * the patients have adequate hematologic and organ function. exclusion criteria: * patients with symptomatic brain metastases. * patients who are known or suspected to be allergic to the active ingredient or excipients of the investigational drug. * received ≥1 standard chemotherapy regimen (excluding endocrine therapy) for advanced breast cancer. * participation in other clinical trials within 4 weeks before enrollment. * severe cardiovascular disease, including history of congestive heart failure, acute myocardial infarction within 6 months before enrollment, transmural myocardial infarction measured by ecg, uncontrolled arrhythmia, angina requiring therapy, clinically significant valvular heart disease, uncontrolled hypertension. * severe or uncontrolled infection. * any factors that affect the oral administration and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); * active malignancy in the past 5 years (other than carcinoma in situ of the cervix or basal cell carcinoma of the skin). * patients who are pregnant , breastfeeding ,or refuse to use adequate contraception during the course of participation. * need to concurrent other cancer therapy(other than palliative care for non-target lesions). * other ineligible conditions according to the researcher's judgment.
the effects of ethanol on intestinal permeability and gut hormones

Conditions: Insulin Resistance; Ethanol; Incretin Effect

Summary: the aime of this study is to envsitigate if ethanol has an incretin effect. this is done by administration of ethanol orally vs. an isoethanolaemic i.v. infusion of ethanol.


Eligibility criteria:
inclusion criteria: * caucasian male between 20 and 50 years of age * body mass index (bmi) between 19 and 25 kg/m2 * weekly alcohol intake of less than 14 units of alcohol (of 12 g) * normal fasting plasma glucose concentration (i.e. \<6 mmol/l) and normal glycated haemoglobin a1c (hba1c) (i.e. ≤42 mmol/mol) * normal haemoglobin * informed consent exclusion criteria: * first-degree relatives with diabetes and/or liver disease * liver disease or other alcohol-related diseases, diabetes mellitus * liver disease (serum alat and/or serum asat \>2 × normal values) * nephropathy (serum creatinine above normal range and/or albuminuria)

Keywords: incretin effect ethanol
efficacy and safety of deb-bace with sequential arotinib and tirelizumab in the treatment of advanced nsclc

Conditions: Carcinoma, Non-Small Cell Lung

Summary: this is a prospective, open-labelled study to evaluate the efficacy and safety of arterial infusion chemotherapy combined with drug loaded microspheres embolization with sequential arotinib and tirelizumab in the treatment of advanced nsclc. the progression-free-survival (pfs) will be evaluated as the primary endpoints.


Eligibility criteria:
inclusion criteria: 1. has fully understood and voluntarily signed an written informed consent and agreed to follow the research plan treatment and visiting plan; 2. aged \>=18 years, \<= 85 years; 3. patients with nsclc diagnosed by imaging and histopathology; tnm stage was iii-iv; 4. initial diagnosis, failure of first-line treatment, refusal or inability to perform routine treatment (surgery, radiotherapy and chemotherapy); 5. eastern cooperative oncology group (ecog) performance status 0-1; 6. expected survival period ≥ 3 months. exclusion criteria: 1. known hypersensitivity to any of the study drugs or excipients; 2. hypertension that is not controlled by the drug; 3. international normalized ratio (inr) \> 1.5 or partially activated prothrombin time (aptt) \> 1.5 × uln; 4. wbc count \< 3000 /mm3; 5. platlet count \< 50000 /mm3; 6. poorly controlled diabetes before enrollment; 7. clinically significant electrolyte abnormalities judged by researchers; 8. patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment; 9. cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure, new york heart association (nyha) grade \> 2; ventricular arrhythmia requiring drug treatment; lvef (left ventricular ejection fraction) \< 50%; 10. active infection or serious infection that is not controlled by drug; 11. history of clinically significant hepatic disease (alt and/or ast \>5 times the upper normal limit); 12. women who are pregnant or lactating; 13. urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g; 14. have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
dexamethasone for postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: the investigators want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of postoperative nausea and vomiting (ponv) in patients undergoing laparoscopic cholecystectomy.

more than half of the patients undergoing laparoscopic cholecystectomy will have postoperative nausea and vomiting (ponv). ponv is related to surgical, anesthetic and patient factors. we want to test the efficacy of these anesthetic antiemetic measures collectively with or without ondansetron or dexamethasone, in the prevention of ponv in patients undergoing laparoscopic cholecystectomy. three groups to be studied : (group o) will receive 4 mg ondansetron, (group d) will receive 8 mg dexamethasone and (group p) will receive normal saline .

Eligibility criteria:
inclusion criteria: * (asa) grade i and ii, aged (18-70 years) who are scheduled for elective laparoscopic cholecystectomy under general anesthesia at the department of anesthesia and intensive care, university of jordan, amman, jordan between november 2007 and march 2008 exclusion criteria: * all patients who received antiemetics or cortisone within 48 hr before surgery or those who required opioids before and after surgeries * pregnant, breast feeding ladies * any patient with bmi (body mass index) \> 34 kg/m² * patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses or those with history of motion sickness were also excluded from the study protocol

Keywords: postoperative nausea and vomiting ondansetron dexamethasone
montelukast in perennial allergic rhinitis - 2001-2002 study (0476-246)

Conditions: Perennial Allergic Rhinitis

Summary: this study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. cetirizine is included in the study as an active control.


Eligibility criteria:
inclusion criteria: * patient has a documented clinical history of perennial allergic rhinitis * patient is a nonsmoker * patient is in good general health exclusion criteria: * patient is hospitalized * patient is a woman who is \<8 weeks postpartum or is breast-feeding * patient is a current or past abuser of alcohol or illicit drugs