Kornimate/medical-research-clean huggingface dataset:
a study of tarceva (erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell cancer who present epidermal growth factor receptor mutations

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this open-label study will assess the efficacy and safety of tarceva (erlotinib) in patients with locally advanced, metastatic or recurrent non-small cell lung cancer who have not received previous chemotherapy for their disease and who present epidermal growth factor receptor mutations. patients will receive tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * locally advanced (stage iiib), metastatic (stage iv) or recurrent non-small cell lung cancer with mutations in the tyrosine kinase domain of the epidermal growth factor receptor (egfr) * at least one measurable lesion according to recist criteria * european cooperative oncology group (ecog) performance status 0-2 * adequate hematological, liver and renal function * patients with stable cerebral metastases who have received surgical or radiotherapy will be eligible exclusion criteria: * previous chemotherapy or therapy against egfr for metastatic disease (neoadjuvant or adjuvant therapy after radical surgery is allowed if finalized \>/= 6 months before entering the study) * history of another neoplasm except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, radically treated prostate carcinoma with good prognosis (gleason \</= 6), or another curatively treated neoplasm without evidence of disease in the last 5 years * symptomatic cerebral metastases * any significant ophthalmologic abnormality * use of coumarins * pregnant or breast-feeding women * pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis and carcinomatosis (if this is the only presence of the disease)
postmarketing safety study of hemoporfin in patients with port wine stain

Conditions: Port-Wine Stain

Summary: this study is to provide safety information of hemoporfin during the post-marketing period as required by china food and drug administration (cfda) regulations in order to identify any potential drug related treatment factors in the chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.


Eligibility criteria:
inclusion criteria: * age range: 14 to 65 years-old； * clinically diagnosed of port-wine stain; * patients receiving hemoporfin based upon the clinical judgment of the investigator; * written informed consent signed and agreed to receive periodic follow-up exclusion criteria: * allergy to porphyrins and analogues; photosensitivity; porphyria; allergic constitution; * scar diathesis; * pregnancy or unwilling to adopt reliable contraceptive measures during the month after drug application; * be judged not suitable to participate the study by the investigators
study of eq001 (itolizumab) in systemic lupus erythematosus with or without active proliferative nephritis

Conditions: Lupus Erythematosus; Lupus Nephritis

Summary: this is a multi-center study to evaluate the safety, tolerability, pk, pd, and clinical activity of itolizumab (eq001) in subjects with systemic lupus erythematosus with or without active proliferative lupus nephritis

the study will enroll approximately 55 subjects, with up to 5 dose escalating cohorts of 6 open-label subjects enrolled for type a-sle and a single dose cohort of approximately 20 open-label subjects enrolled for type b-lupus nephritis. subjects will receive itolizumab administered subcutaneously every two weeks for a total of either 2 (type a) or 13 (type b) doses with 4 or 12 weeks of follow-up after the last dose of investigational product.

Eligibility criteria:
type a cohort key inclusion criteria: 1. is male or female, age ≥ 18 and ≤ 75 years 2. has previously been documented to have met or currently meets systemic lupus international collaborating clinics (slicc) and/or american college of rheumatology (acr) criteria for sle 3. received at least 1 immunosuppressive or immunomodulatory treatment for sle at any time in the past or currently 4. has documented elevation of antinuclear antibodies (ana) in the past or during screening 5. restricted sle treatments are stable and/or washed out 6. during screening, has adequate hematologic function type b cohort key inclusion criteria: 1. is male or female, age ≥ 18 and ≤ 75 years 2. has a diagnosis of sle 3. kidney biopsy with a histologic diagnosis of ln classes iii or iv (+/- v) 4. has a urine protein to creatinine ratio of \> 1000 mg/g 5. requires induction treatment due to newly diagnosed ln or relapsing/flaring disease or has an incomplete response to current treatment 6. has adequate hematologic function 7. restricted sle treatments are stable and/or washed out 8. most recent egfr ≥ 40 ml/min/1.73m2 9. has evidence of serologic activity key exclusion criteria: 1. acute or chronic infections requiring systemic antibacterial, antifungal, or antiviral therapy 2. positive for hepatitis b virus (hbv), hepatitis c virus (hcv), or hiv 3. active tb or a positive tb test

Keywords: systemic lupus erythematosus active proliferative lupus nephritis
short-term dual antiplatelet therapy after deployment of bioabsorbable polymer everolimus-eluting stent

Conditions: Coronary Artery Disease

Summary: to compare the clinical outcomes of p2y12 antagonist monotherapy with aspirin plus p2y12 antagonist following 3-month of dapt in patients undergoing pci with bioabsorbable polymer everolimus-eluting stents (synergy®)


Eligibility criteria:
inclusion criteria: 1. age 19+ 2. patients treated with a new generation of evelorimus-eluting stents (synergy®) 3. patients who understand the content of the subject description and voluntarily sign the subject exclusion criteria: 1. age 86+ 2. hemodynamically unstable patient 3. severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent 4. patients at high risk of bleeding, anemia, thrombocytopenia 5. patients requiring oral anticoagulants 6. pregnant women or women of childbearing age 7. life expectancy is less than one year 8. patients receiving a potent cyp3a4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir) 9. patients with a history of intracranial hemorrhage 10. patients with moderate to severe hepatic impairment 11. patients underwent coronary intervention with stenting within 1 year 12. patients with left-main lesions requiring coronary intervention 13. patients with chronic stricture lesions requiring treatment 14. patients with in-stent restenosis in a lesion requiring treatment 15. patients with bifurcation lesions requiring stenting in lateral branches 16. patients with lesions requiring more than 3 stents
evaluation of the safety and efficacy of hemophilia b gene therapy drug

Conditions: Hemophilia B

Summary: this is a multi-center, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of bbm-h901 injection in hemophilia b subjects with ≤2 international unit per deciliter (iu/dl) residual factor ix (fix) levels. bbm-h901 is an adeno-associated virus (aav) vector derived from recombinant dna techniques to contain an expression cassette of the human factor ix (hfix) transgene and raises circulating levels of endogenous fix.


Eligibility criteria:
inclusion criteria: 1. males ≥ 18 years of age; 2. have hemophilia b with ≤2 iu/dl (≤2 %) endogenous fix activity levels; 3. have had ≥100 prior exposure days (eds) to any recombinant and/or plasma-derived fix protein products based on historical data from the subjects' records/histories; 4. have had bleeding events and/or injected with fix protein products (including recombination and plasma source) during the last 12 weeks documented in the subjects' medical records; 5. have no prior history of hypersensitivity or anaphylaxis associated with any fix or iv immunoglobulin administration; 6. agree to use a reliable barrier contraception method from the beginning of signing the informed consent to 52 weeks after administration. exclusion criteria: 1. being positive for hepatitis b surface antigen (hbsag) or hepatitis b virus-dna (hbv-dna). being positive for hepatitis c virus antibody (hcv-ab) or hepatitis c virus rna (hcv-rna). subjects with medical history of hepatitis b or c can be regarded as negative only when 2 required samplings are conducted at least 3 months apart and both test results of indicators aforementioned are negative, i.e. subjects with natural clearance and anti-viral therapy clearance for hepatitis b or c are eligible; 2. have potential liver diseases, such as previous diagnosis of portal hypertension, splenomegaly, hepatic encephalopathy or liver fibrosis (fibrosis stage ≥ 3); nodules or cysts were found by b ultrasound, or elevated alpha-fetoprotein was detected by laboratory tests. subjects who are not eligible for the study if the abnormalities are clinically significant regarding to the medical judgement of the investigator; 3. hiv positive patients; 4. have participated in a previous gene therapy research trial before screening, or in a clinical study with an investigational drug within 5 half-life of the investigational product, whichever is longer; 5. have alcohol or drug dependence, or cannot stop drinking throughout the study; 6. any concurrent clinically significant major disease or condition that the investigator deems unsuitable for participation in the study.

Keywords: hemophilia b;gene therapy;adeno-associated virus
routine iron prophylaxis during pregnancy

Conditions: Pregnancy

Summary: comparison of two policies of iron administration during pregnancy in regard to health and program feasibility in an area with endemic malaria and high prevalence of hiv infection. the policies are: 1) routine iron prophylaxis, 2) screening and therapy with iron.

aim of the study: comparison of two policies of iron administration during pregnancy in regard to health of the mother and infant and program feasibility. the two groups compared are: 1. routine iron prophylaxis 2. screening of anaemia and therapy with iron hypothesis: group 2 will have better health outcomes. study groups: routine group: 60 mg per day of ferrous sulphate (combination with folic acid) daily. screening and therapy: hb measurement on each visit, hb \>9g/dl þ only folic acid, hb \<9g/dl þ 60/120 mg of ferrous sulphate daily(+ folic acid) methods: a pragmatic randomised controlled trial with non-blind design. total intended sample size was 4000 women. study site: mozambique, maputo city. women are randomised individually and allocated into the two groups; 1) routine iron prophylaxis, 2) screening and therapy for anemia. the recruitment of pregnant women was done in two health centres, one in maputo city and one in maputo province. the women are followed in prenatal visits and until delivery.

Eligibility criteria:
inclusion criteria: * pregnant women at their first prenatal visit exclusion criteria: * women under 18 years, high obstetric risk pregnancies

Keywords: iron prophylaxis pregnancy birth weight prematurity perinatal mortality
comparison of transfers of fresh and thawed embryos in high responder patients

Conditions: Infertility

Summary: this study tests the hypothesis that controlled ovarian stimulation impairs endometrial receptivity in high responders.

the purpose of this study is to determine if blastocyst transfers in cycles of post-thaw extended culture (ptec) have different efficacy than transfers of fresh blastocysts in patients with expected high response to ovarian stimulation. multiple studies have found altered endometrial histology and gene expression following controlled ovarian stimulation. ptec cycles require cryopreservation of the entire 2pn oocyte cohort in the prior cycle. once thawed, the embryos are cultured to the blastocyst stage before transfer. in typical cycles using frozen-thawed embryos, many thawed embryos that appear to survive do not actually resume and continue development. ptec ensures the transfer of embryos that resumed development and continued developing at least to the blastocyst stage (4-5 days post-thaw). the viability of a blastocyst in a ptec cycle has been shown to be on par with that of a fresh blastocyst. therefore, comparing outcomes of blastocyst transfers in ptec cycles with that in fresh autologous cycles allows the potential endometrial impact of controlled ovarian stimulation to be assessed.

Eligibility criteria:
inclusion criteria: 1. female patient 18 to 40 years of age seeking their first ivf treatment. 2. cycle day 3 fsh less than 10.0 iu/l. 3. more than 15 antral follicles observed on ultrasound. exclusion criteria: 1. failure to follow the protocol. 2. embryo biopsy. 3. any prior ivf cycle(s).

Keywords: ivf in vitro fertilization blastocyst transfer endometrial receptivity embryo cryopreservation
safety and immunogenicity study of candidate hiv-1 vaccine given to healthy infants born to hiv-1/2-uninfected mothers

Conditions: HIV-1; HIV Infections

Summary: objectives: safety and immunogenicity of mva.hiva vaccine in 20-week-old healthy gambian infants born to hiv-1/2-uninfected mothers. gross impact of mva.hiva on the immunogenicity of epi vaccines (dtwphib, hepb, pcv-7 and opv) when administered at 20 weeks (4 weeks after the last epi vaccines), who have had bcg vaccine within the first 4 weeks of life.


Eligibility criteria:
inclusion criteria: * healthy infants, 19 weeks of age, with weight for age z-scores within 2 standard deviations of normal. * have received all standard epi immunizations according to national immunization programme. * written informed consent by parent. * mother hiv-1/2-uninfected. exclusion criteria: * acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). all vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e. axillary temperature of \<37.5 °c ). * axillary temperature of ≥ 37.5 °c at the time of vaccination. * any clinically significant abnormal finding on screening from biochemistry or haematology at 19 weeks. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products. * presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine. * invasive bacterial infections (pneumonia, meningitis). * any other on-going chronic illness requiring hospital specialist supervision. * administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate. * any history of anaphylaxis in reaction to vaccination. * research physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome. * likelihood of travel away from the study area. * untreated malaria infection. * any other clinical evidence of infection.

Keywords: hiv preventive vaccine
paroxetine-referenced study evaluating three doses of dvs sr in outpatients with mdd

Conditions: Depressive Disorder, Major

Summary: this study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (dvs sr) in subjects with major depressive disorder.

the primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (dvs sr) in chinese, taiwanese, south korean, and indian subjects with major depressive disorder (mdd) receiving daily doses of 50 mg, 100 mg, or 200 mg. the secondary objective is to obtain additional information regarding the efficacy of dvs sr in subjects with mdd receiving daily doses of 50 mg, 100 mg, or 200 mg. additional objectives include obtaining general and functional quality of life outcome data.

Eligibility criteria:
primary inclusion criteria: 1. outpatient men and women at least 18 years of age. 2. have a primary diagnosis of mdd based on the criteria in the diagnostic and statistical manual of mental disorders, 4th edition (dsm iv), single or recurrent episode, without psychotic features. 3. have a ham d17 total score ≥20 at the screening and baseline (study day 1) visit. primary exclusion criteria: 1. treatment with dvs sr at any time in the past. 2. significant risk of suicide based on clinical judgment, including common suicidal thoughts and suicide having been considered as a possible solution even without specific plans or intent. 3. any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or any other medical condition that might confound the study or put the subject at greater risk during study participation.

Keywords: major depressive disorder mdd depression
a study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics (pk) of oral tak-994 in an acute sleep phase delay paradigm in healthy male participants

Conditions: Healthy Volunteers

Summary: the purpose of this study is to assess the safety and tolerability of tak-994 and to determine the effect of tak-994 (compared to placebo) on sleepiness, as measured by mean sleep latency on the maintenance of wakefulness test (mwt), in an acute sleep phase delay paradigm in healthy participants.

the drug being tested in this study is called tak-994. the study will evaluate the safety/tolerability, pd, and pk of tak-994 in an acute sleep phase delay paradigm in healthy participants. the study will enroll up to approximately 18 healthy participants. participants will be randomly assigned to 1 of the 3 treatment sequences which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * tak-994 dose a + placebo + tak-994 dose b * tak-994 dose b + tak-994 dose a + placebo * placebo + tak-994 dose b + tak-994 dose a this single center trial will be conducted in the united states. the overall time to participate in this study is approximately 10 weeks. participants will be followed up remotely on day 7 after the last dose of study drug for a follow-up assessment.

Eligibility criteria:
inclusion criteria: 1. be a current nonsmoker who has not used tobacco- or nicotine-containing products (example, nicotine patch) for at least 6 months prior to the first dose of study drug. 2. have regular sleep-wake habits (example, routinely spending 6.5 to 8 hour sleeping nightly, not oversleeping by more than 3 hour on weekends \[that is, total sleep not more than 11 hour\]) as determined by investigator interviews and confirmed in 5-day actigraphy records and regularly fall asleep between 9:30 pm and 12:00 am. exclusion criteria: 1. have a positive alcohol or drug screen or a history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to: beer \[354 ml/12 ounces\], wine \[118 ml/4 ounces\], or distilled spirits \[29.5 ml/1 ounce\] per day). 2. have excessive sleepiness, defined by a self-reported epworth sleepiness scale (ess) score at screening greater than (\>) 10; irregular work hours; or routine night-shift work within 1 month before randomization. 3. have a prior history of or currently is experiencing any known/suspected sleep disorder (including obstructive sleep apnea and restless leg syndrome), any disorder associated with excessive daytime sleepiness (eds), or any diagnosis interfering with assessment of sleepiness. 4. at the time of screening, be receiving treatment with nasal/oronasal positive airway pressure for any reason. 5. have abnormal findings on the initial polysomnography conducted on day -1 (check-in) of the first treatment period. 6. have traveled across 2 or more time zones within the 2 weeks before screening. 7. have caffeine consumption of more than 400 milligram (mg)/day for 2 weeks before screening (1 serving of coffee is approximately equivalent to 120 mg of caffeine).

Keywords: drug therapy
effects of imt on dyspnea, pf and quality of life in patients with cabg

Conditions: Exercise

Summary: patient in the intervention group will be treated with routine pysical therapy, inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs). patients in the intervention group will receive treatment until discharge from hospital.

a randomized control trial in which two groups one is intervention and the other is controlled group .patient in the intervention group will be treated with routine pysical therapy, inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs). patients in the intervention group will receive treatment until discharge from hospital. on the day of discharge they will be assessed using 6 minute walk test, borg rate of perceive exertion and health related quality of life scale. data will be analyzed using spss 25.

Eligibility criteria:
inclusion criteria: * both gender patients * patients who agreed to participate * age: 35 to 55 exclusion criteria: * patients with history of angioplasty or cabg * chronic renal failure * cardiac arrhythmias * history of stroke * unstable angina

Keywords: functional capacity lung capacity rehabilitation
preopioid versus nonopioid in total knee arthroplasty (tka)

Conditions: Postoperative Pain

Summary: observational study evaluating pain response after total knee arthroplasty (tka) in patients taking strong, weak or no opioids preoperatively.


Eligibility criteria:
inclusion criteria: patients operated with elective, primary, unilateral total knee arthroplasty (tka) (taking strong or weak opioid daily for minimum 4 weeks or opioid naive patients) exclusion criteria: * bilateral / revision arthroplasty * disease affection central or peripheral nerve function * alcohol and medical abuse * daily use of glucocorticoids * malignancy * bmi \> 40 * dementia or other cognitive dysfunction * treatment of anxiety or depression

Keywords: postoperative pain postoperative opioid requirements
efficacy and safety study of second-line treatment for hypertension with autosomal dominant polycystic kidney disease(adpkd)

Conditions: Kidney, Polycystic, Autosomal Dominant

Summary: this phase ii study examines the safety and efficacy of combination therapy for hypertension in patients with autosomal dominant polycystic kidney disease (adpkd). this study examines the safety and efficacy of combination therapy by imidapril (acei) or cilnidipine (ccb) in adpkd patients whose blood pressure is not controlled under 120/80 mmhg by candesartan (arb) alone.

maximum dosage of candesartan is 8 mg/day. dosage of imidapril is in the range of 2.5-10 mg/day. dosage of cilnidipine is in the range of 5-20mg/day.

Eligibility criteria:
inclusion criteria: * adpkd patients * blood pressure measured at out-patient setting is above 120/80 mmhg * age between 20 and 60 years old * egfr more than 30 ml/min/1.73m2 * patients give informed consent exclusion criteria: * patients with severe cardiovascular and hepatic disorders * patients with complications of central nervous vascular disorders * women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods * patients currently engaging in other experimental protocol * patients with intracranial aneurysma * patients who must use diuretics * allergic patients to candesartan or cilnidipine * patients whose hypertension is not controlled by medication of this protocol

Keywords: autosomal dominant polycystic kidney disease hypertension angiotensin-ii receptor blocker calcium channel blocker angiotensin converting enzyme inhibitor kidney volume egfr