Kornimate/medical-research-clean huggingface dataset:
effect of xen implantation on the aqueous humor proteome

Conditions: Primary Open Angle Glaucoma

Summary: the purpose of this study is to determine how the aqueous humor proteome changes after implantation of a xen microstent for treatment of glaucoma.

the purpose of this study is to determine how the aqueous humor proteome changes after implantation of a xen microstent for treatment of glaucoma using liquid chromatography mass spectrometry.

Eligibility criteria:
inclusion criteria: * male or female of any racial or ethnic origin, 18 years or older * able to provide written informed consent. * scheduled to undergo xen implantation for open angle glaucoma or already has an aqueous shunt exclusion criteria: * history of conjunctivitis or any ocular infection within the past 3 weeks. * any active inflammation of the cornea or the anterior chamber (uveitis)
a study comparing norspan patch and oral tramadol

Conditions: Osteoarthritis

Summary: this trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (tridol® sr (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.

the primary objective of this non-inferiority study with active, parallel control group is to compare and assess efficacy and safety of buprenorphine transdermal patch (norspan® patch 5 mg, 10 mg and 20 mg) and tramadol (tridol® sr (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. during the period of treatment for 8weeks, titration and maintenance is kept up after 1:1 ratio randomization.

Eligibility criteria:
inclusion criteria: * males and females aged more than 18 years. * clinical diagnosis of osteoarthritis (oa) of the hip and/or knee including fulfilling the american college of rheumatology criteria (acr criteria l13) and documentation of osteoarthritis in the relevant joint. * patients with moderate to severe osteoarthritis pain in the relevant joint, confirmed by bs-11 (box scale-11) more than 4 for their pain on average during the last week, in their primary oa joint, at both the screening and base line visits despite treatment with non-opioid analgesics. exclusion criteria: * patients being treated with high potency opioid analgesics (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (including norspan®)) for their osteoarthritis pain. * patients who have been taking any opioid analgesics within the last 4 weeks prior to the screening visit. * patients who have been using any (non-steroidal anti-infammatory) nsaid transdermal preparation less than 2 weeks prior to the screening visit.

Keywords: norspan patch buprenorphine transdermal patch (btds) efficacy buprenorphine
genetics of type 1 diabetes in chinese adolescents and youth

Conditions: Diabetes Mellitus

Summary: primary outcome: to explore the genetic susceptibility of diabetes in chinese adolescent and youth. secondary outcomes: 1. to classify diabetes by gene detection in chinese adolescent and youth. 2. to make the relationship between genotype and clinic phenotype in type 1 diabetes. 3. to evaluate the effect of environmental factors (intestinal ecosystem)in the pathogenesis of diabetes.

phase 1: baseline investigation aims: to explore genetic susceptibility of diabetes in chinese adolescent and youth. subjects and methods: 500 patients under diabetic conditions and sex,age-matched ngr healthy control(2:1) will be enrolled ,all aged from 14-30 years old. a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis will be performed in each study participant. diabetes should be diagnosed according to the who 1999 criteria,type 1 or type 2 diabetes diagnosed by clinical features recommended by international society of pediatric and adolescent diabetes ( ispad ). phase 2: cohort follow-up aims : to explore the association of genetic backgrounds and clinical characteristics in different types of diabetes in chinese adolescent and youth. subjects and methods: to recruit and follow up 200 newly diagnosed and genotyped patients for 3 years. questionnaire, anthropometric measurements, biochemical analysis performed respectively at baseline,3,6,12,24,36 months after enrollment.

Eligibility criteria:
inclusion criteria: 1. age: 14- 30 years old 2. gender: males and females 3. race: han 4. diabetes diagnosed by who cafeteria (who1999) 5. living in east china area to minimize population stratification exclusion criteria: 1. secondary diabetes caused by other diseases or drugs 2. moderate to severe liver, kidney dysfunction, i.e. alt/ast \> 2.5 times the upper limit of normal range or ccr \< 25ml/min; 3. any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.
evaluation of letters promoting colorectal cancer testing

Conditions: Cancer Colorectal

Summary: in this evaluation, 4 different versions of letters are being sent with mailers promoting colorectal cancer screening with an at-home test. the researchers hypothesize that the use of behavioral nudges in the message should lead to increased colorectal cancer screening (either with the at-home test or a colonoscopy).

colorectal cancer (crc) is the third most common cancer diagnosed in the us. mailing fecal immunochemical (fit) kits to at-risk patients is an effective way of increasing crc testing uptake, as this test can be done at home and is less intrusive compared to colonoscopies. as part of an existing program, the health system mails fit kits to eligible patients each year. although this test needs to be conducted annually, not everyone who receives the test kit returns the kits for processing. in this study, the researchers aim to test different letters with the goal of encouraging the use of fit kits or scheduling a colonoscopy. as part of this study, the kits are mailed with everything the patient will need to conduct the test at home and mail a sample back to the hospital. it also includes an introductory letter informing the patient about the program and inviting them to use the kit. the researchers are comparing a standard version of the introductory letter against 3 versions that include different combinations of behavioral nudges, specifically framing effects (loss, default, decoy) and fear appeals.

Eligibility criteria:
inclusion criteria: * enrollment in medicare health maintenance organization (hmo) and preferred provider organization (ppo; age 65 and older) or commercial hmo in one large employer's group * has a flag indicating that the person is due for a colon cancer screening exclusion criteria: - members who are on the do not contact list at geisinger health plan

Keywords: mass screening communication occult blood colonoscopy risk reduction behavior economics, behavioral psychology loss framing fear appeals default effect decoy effect
doxorubicin in treating women with advanced breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. giving drugs in different forms may kill more tumor cells. purpose: phase ii trial to study the effectiveness of doxorubicin in treating women with advanced metastatic breast cancer.

objectives: i. determine the antitumor activity of doxorubicin-hpma conjugate (pk1) in women with advanced breast cancer. outline: this is an open label, multicenter study. patients receive doxorubicin-hpma conjugate (pk1) by intravenous infusion once every 3 weeks. patients may receive a total of 6 courses of treatment in the absence of toxicity and progressive disease. projected accrual: 14-25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically proven advanced metastatic carcinoma of the breast bidimensionally measurable disease no brain or leptomeningeal disease patient characteristics: age: over 18 performance status: who 0-2 life expectancy: at least 3 months hematopoietic: hemoglobin at least 10 g/dl neutrophil count at least 2,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 11.7 mg/dl ast/alt no greater than 2 times upper limit of normal (5 times upper limit of normal in presence of liver metastases) renal: creatinine no greater than 1.7 mg/dl cardiovascular: no concurrent treatment for congestive cardiac failure cardiac function within normal limits by muga or echo scan, if prior anthracycline therapy other: not pregnant or nursing fertile patients must use effective contraception no concurrent nonmalignant systemic disease no active uncontrolled infection no prior history of malignant disease except: squamous cell carcinoma of the skin curatively treated carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: no concurrent immunological therapy chemotherapy: at least 1 prior chemotherapy regimen for advanced disease (including adjuvant therapy), but not more than 2 prior regimens at least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered cumulative dose of prior epirubicin no greater than 450 mg/m2 cumulative dose of prior doxorubicin no greater than 240 mg/m2 no concurrent chemotherapy endocrine therapy: no concurrent hormonal therapy low dose steroid therapy allowed if dose established at least 4 weeks prior to study radiotherapy: at least 4 weeks since prior radiotherapy and recovered surgery: not specified other: no concurrent experimental therapy

Keywords: stage iv breast cancer recurrent breast cancer
kinesio taping and calf muscle fatigue

Conditions: Fatigue

Summary: muscle fatigue results in decreased ability in muscles to generate force. kinesio tape may reverse the adverse effects of fatigue. thus this study will examine the acute effects of kinesio tape on muscle fatigue.

the participants will be divided into three groups; 1. experimental group: kinesio tape with 50% tension will be applied; 2. sham group: kinesio tape without any tension will be applied; 3. placebo group: rigid tape without any tension will be applied.

Eligibility criteria:
inclusion criteria: * healthy cooperative individuals. * female athletes who were engaged in training at least 3 times a week. * the subject should perform a minimum of 23 hell raises. exclusion criteria: * musculoskeletal injuries, cardio-pulmonary vestibular and neurological complication and systemic disorder. * consumption of any pre-workout supplement in the last 6 months. * involvement in any other training program.

Keywords: calf muscle kinesio tape muscle fatigue heel raises
carfilzomib, daratumumab, lenalidomide and dexamethasone as first line treatment in multiple myeloma

Conditions: Multiple Myeloma

Summary: carfilzomib in combination with lenalidomide, daratumumab and dexamethasone (krdd) can induce profound clinical responses. the investigators want to observe the effectiveness of the quadruple therapy of carfilzomib, lenalidomide, daratumumab and dexamethasone on patients receiving 8 cycles of krdd with autologous stem cell transplantation versus patients with 8 cycles of krdd without autologous stem cell transplantation.


Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed and previously untreated multiple myeloma by the international myeloma working group criteria that requires treatment based on: presence of elevated calcium, renal failure, anemia and/or bone lesions (crab) clonal bone marrow plasma cells ³ 60% involved/uninvolved serum free light chain ratio ³ 100 \>1 focal lesions on mri studies (³5 mm in size) 2. age \> 18 years 3. functional stage of 0 - 1 measured by the eastern cooperative oncology group (ecog) scale. 4. capacity and willingness to provide a written informed consent. exclusion criteria: 1. poems syndrome 2. systemic amyloidosis 3. plasma cells leukemia 4. radiotherapy on multiple sites on the period of 4 weeks before the initiation of treatment (1 week if it is one region) 5. improper liver function: total bilirubin \> 1.5 x upper limit of normal (uln) or \> 3 x uln in patients with gilbert syndrome, alanine aminotransferase (alt) and aspartate aminotransferase (ast) \> 3.0 x uln. 6. non-controlled systematic active infection (viral, bacterial and/or fungic). 7. patients with known infection by human immunodeficiency virus (hiv). 8. active infection by hepatitis b. 9. active infection by hepatitis c. 10. significant cardiovascular diseases as uncontrolled or symptomatic arrhythmias, congestive heart failure or acute myocardial infarction within 2 months prior to screening, or any new york heart association (nyha) class 3 or 4 heart disease. 11. diagnosis of previous malignancies for 2 years, with exception of patients with basal or squamous cell carcinoma or "in situ" carcinoma of cervix or breast. 12. history of allergic reaction or severe anaphylaxis to humanized or murine monoclonal antibodies. 13. pregnant or lactating women.

Keywords: newly diagnosed
retain: retaining opioid users entering medication assisted treatment and encouraging hcv/hiv testing

Conditions: Opioid-Related Disorders; Opioid-use Disorder; Drug Addiction; Substance Use Disorders

Summary: the purpose of this research study is to: 1. assess how well individuals entering medication assisted treatment like the retain e-health application as measured by their feedback on the intervention. 2. test the impact of retain on knowledge about medication-assisted treatment(mat). 3. assess treatment retention rates in patients completing the retain intervention. 4. test the impact of retain on knowledge about hcv/hiv 5. test the impact of retain on interest in being tested for hcv/hiv

the pre-post study of retain will: 1) assess the acceptability of retain as measured by participant feedback about the intervention; 2) test the impact of retain on knowledge about mat, as measured by the mat knowledge assessment; 3) assess mat retention rates in patients completing the retain intervention; 4) test the impact of retain on knowledge about hcv/ hiv; 5) test the impact of retain on interest in being tested for hcv/hiv. the acceptability of retain will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. the average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. pre-/post-changes in the percent of correct knowledge assessment items (i.e., about mat and hcv/hiv) and interest in hcv/hiv testing will be analyzed using a wilcoxon signed-rank test. the 3- and 6-month retention rates for retain participants will be compared, using fisher's exact tests, to the overall treatment retention rates at 3- and 6- months for the uc health mat clinics as determined by the retrospective chart review.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. starting mat with methadone or suboxone or in mat for less than 2 weeks; exclusion criteria: 3. does not sign the "short form" consent form
outcomes and perceptions of the implementation of the jada device in a stage ii postpartum hemorrhage management protocol in referral hospitals of the colombian pacific region

Conditions: Post Partum Haemorrhage

Summary: this study focuses on postpartum hemorrhage (pph), a condition that stands out as the leading cause of global maternal mortality. annually, about 14 million women experience pph, resulting in approximately 70,000 deaths. this condition presents a higher risk in low- and middle-income countries (lmics), particularly where access to quality care is limited. recognizing the urgency of addressing this public health problem, the colombian ministry of health and social protection has implemented the maternal mortality reduction acceleration plan (pare) to improve maternal mortality indicators and meet the sustainable development goals (sdgs). the project will evaluate the results and perception of a new device in the management of stage ii pph in referral hospitals in the department of valle del cauca, integrated in the hospital padrino strategy. this initiative seeks not only to improve the understanding and treatment of pph, but also to strengthen institutional capacities through education, creation of telecare networks and care services adapted to local needs.


Eligibility criteria:
inclusion criteria: * pregnant women who are admitted to the obstetrics service scheduled for vaginal delivery in any of the participating hospitals: fundación valle del lili, hospital universitario del valle and hospital luis ablanque de la plata. * patient admitted during the shift of one of the gynecologists trained in the use of the jada device in the context of the research project. criteria for the use of jada device: * pregnant women over or equal to 18 years of age. * gestational age of pregnancy greater than 32 weeks of gestation. * pregnant with vaginal delivery. * pregnant with postpartum hemorrhage due to uterine atony that does not respond to treatment with uterotonics and uterine massage. * postpartum hemorrhage uterine stage/stage ii. * vaginal delivery attended in a health institution in the context of the hospital padrino strategy (fundación valle del lili or hospital universitario del valle or hospital luis ablanque de la plata). exclusion criteria: * patients who, according to the attending physician's criteria, are not candidates for vaginal delivery. * abnormality of the normal uterine anatomy. * placental abnormalities. * maternal anemia with hemoglobin less than 7 mg/dl prior to delivery. * those who do not sign informed consent.

Keywords: maternal mortality shock index care bundle
study to evaluate the efficacy, safety and tolerability of an oral aripiprazole/escitalopram combination therapy in participants with major depressive disorder (mdd)

Conditions: Major Depressive Disorder (MDD)

Summary: this will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral aripiprazole/escitalopram combination therapy in participants with mdd who have demonstrated an incomplete response to a prospective trial of escitalopram, and report a treatment history for the current mdd episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than escitalopram. an inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the massachusetts general hospital antidepressant treatment response questionnaire (atrq) and evaluated by the investigator as part of the participant's medical and psychiatric history. an adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the atrq.

the study will be organized as follows: * screening phase * single-blind prospective treatment phase * single-blind continuation phase (responder)or double-blind randomization phase (non-responder) * 30 day post treatment follow-up assigned interventions: * escitalopram monotherapy * aripiprazole/escitalopram combination therapy * aripiprazole monotherapy

Eligibility criteria:
inclusion criteria: * participants with a current diagnosis of a major depressive episode. the current depressive episode must be ≥8 weeks in duration * participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period * participants with a 17-item hamilton depression rating scale (ham-d17) total score ≥18 at the baseline for the prospective treatment phase exclusion criteria: * lack of prior treatment with an antidepressant during the current depressive episode * participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode. * participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode * participants with epilepsy or significant history of seizure disorders * participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder * participants who have received electroconvulsive therapy (ect) in the last 10 years

Keywords: major depressive disorder mdd depression
a multiple ascending doses (mad) study of pmg1015 in idiopathic pulmonary fibrosis subjects

Conditions: IPF

Summary: this is a phase 1b randomized, double-blind, placebo-controlled, multiple ascending doses (mad) study of pmg1015 in idiopathic pulmonary fibrosis (ipf) subjects. this study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of pmg1015 after mad.


Eligibility criteria:
key inclusion criteria: 1. diagnosis of ipf as defined by current american thoracic society (ats)/european respiratory society (ers)/japanese respiratory society (jrs)/latin american thoracic association (alat) clinical practice guidelines for ipf (2022) (pathological examination refers to transbronchial lung cryobiopsy or surgical/pleuroscopic lung biopsy); 2. forced vital capacity percent predicted (fvcpp) ≥45% at screening; 3. diffusing capacity of the lung for carbon monoxide (dlco; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening; 4. subjects not receiving any approved ipf treatment (pirfenidone or nintedanib) within 1 month before enrollment for any reasons key exclusion criteria: 1. patients with instable condition of ipf as assessed by the investigator at screening, and those with acute exacerbation of ipf during screening or within 3 months prior to randomization; 2. patients who are likely to be lung transplant recipients within 6 months or expected to survive less than 1 year as assessed by the investigator at screening; 3. patients accompanying with an interstitial lung disease other than ipf; 4. patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator; 5. patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. bosentan) within 1 month prior to screening; 6. patients accompanying with other uncontrolled underlying diseases, for which the patient is not considered suitable for the study as assessed by the investigator; 7. patients who had active tuberculosis within 12 months prior to screening, or clinical symptoms of bacterial, viral, fungal or microbial infections requiring intervention within 4 weeks prior to randomization; 8. patients who have known allergic reaction to the investigational product or its active pharmaceutical ingredients (apis), or history of allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies or any substances contained in the excipients; 9. pregnant or lactating women; female subjects who plan to become pregnant during the study, or patients who are not willing to take contraceptive measures as required by the protocol during the study; 10. other conditions that preclude the patient from participating in the study as assessed by the investigator.