Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the risk of developing a heart condition called valvular regurgitation in patients with acromegaly treated with either lanreotide or octreotide

Conditions: Acromegaly

Summary: the aim of the study is to compare the risk of acromegaly patients developing valvular regurgitation when receiving lanreotide or octreotide


Eligibility criteria:
inclusion criteria: * patient has a diagnosis of acromegaly * patient is being treated with lanreotide or octreotide in any dose form at the selection visit or is a de novo patient who is due to commence treatment within 2 weeks of baseline * patient started treatment with either lanreotide or octreotide when both products were available on the market in their country * patient must not change treatment form lanreotide to octreotide or vice versa for the duration of the study exclusion criteria: * patients with known significant valve abnormalities prior to treatment with either lanreotide or octreotide * patients who have received treatment with a somatostatin analogue other than lanreotide or octreotide for more than 3 months * patients who have received treatment with a gh antagonist for more than 3 months * patients who have had heart valve replacement therapy
zenith(r) connection endovascular covered stent clinical study

Conditions: Aorto-iliac Aneurysms; Iliac Aneurysms

Summary: the zenith(r) connection endovascular covered stent clinical study is a clinical investigation to study the safety and performance of the zenith(r) connection endovascular covered stent in conjunction with the zenith(r) branch endovascular graft-iliac bifurcation in the treatment of aorto-iliac and iliac aneurysms.


Eligibility criteria:
inclusion criteria: * an aortoiliac or iliac aneurysm of appropriate size * unsuitable distal sealing site for a traditional zenith® iliac leg graft within the common iliac artery exclusion criteria: * less than 18 years of age * inability or refusal to give informed consent * disease considerations that would compromise patient safety or study outcomes * unsuitable arterial anatomy

Keywords: iliac aneurysm endovascular repair
egg study with peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: the current research study has the potential to generate data that would provide solid clinical endpoints as to the impact of including eggs in a regular diet in individuals with peripheral arterial disease. any one of three potential outcomes may be observed as a result of this study, and they are predicted as follows: 1) egg consumption does not lead to a deterioration of indices of cardiovascular health; 2) egg consumption improves indices of cardiovascular health; 3) egg consumption worsens the indices of cardiovascular health.

given the hypotheses proposed, if either of the first two predictions prove to be positive, they will help encourage directive efforts to be made toward effective nutrition messages for egg consumption in the peripheral arterial disease and the healthy population. if the last prediction is positive, while least favourable, it will still establish important information to assist the industry in their efforts toward establishing population-specific nutrition messaging.

Eligibility criteria:
inclusion criteria: 1. presence of peripheral arterial disease including those with claudication as defined by an ankle brachial index of ≤ 0.90 or asymptomatic carotid stenosis of \> 50%; or who have had a previous intervention for peripheral arterial disease; 2. male or female, \> 40 years of age; 3. willing to comply with the protocol requirements; 4. willing to provide informed consent; 5. stable medication profile with no changes anticipated for the duration of the proposed study schedule (8 weeks); 6. participants having completed the flax study are eligible to participate if their completion has been more than 3 months. exclusion criteria: 1. renal failure requiring dialysis; 2. diabetes, requiring diabetic medication; participants with diabetes who do not require diabetic medication and have good glycemic control will be eligible for participation in the study. participant with elevated fasting blood glucose levels and glycated hemoglobin above 'standard of care' at baseline will not proceed with the study; 3. hyperlipidemia as defined by a cholesterol of \>4.1 mmol/l (as per the national cholesterol education program adult treatment panel iii, (ncep atp iii) guidelines; 4. hormone replacement therapy; 5. inability to adhere to a regular diet; 6. habitual egg intake of 5 or more eggs per week; 7. history of gastrointestinal reactions or allergies to eggs; 8. daily consumption of omega-3 supplements.
establishment and clinical transformation of adc drug efficacy evaluation system for breast cancer based on molecular imaging

Conditions: Breast Cancer

Summary: the objective of the study is to construct a noninvasive approach 68ga-ttp pet/ct to detect the trop2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of adc drug therapy.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years old, male or female, ecog score 0 or 1 points (see the table in annex 2 for the score table); 2. blood routine and liver and kidney function meet the following criteria: blood routine: wbc ≥ 4.0×109 l or neutrophil ≥1.5×109 /l, plt ≥ 100×109/l, hb≥ 90 g/l; pt or aptt ≤ 1.5 uln; liver and kidney function: t-bil ≤ 1.5×ult(upper limit of normal), alt and ast≤ 2.5 uln or ≤ 5×ult(subjects with liver metastasis), alp ≤ 2.5 uln(alp ≤ 4.5 uln if there is bone metastasis or liver metastasis); bun ≤ 1.5×ult, scr ≤ 1.5×ult; 3. patients with confirmed or suspected breast cancer; 4. expected survival ≥12 weeks; 5. good follow-up compliance; 6. women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination; 7. subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent. exclusion criteria: 1. severe abnormal liver and kidney function; 2. pregnant, pregnant and lactating women; 3. can not lie flat for half an hour; 4. unable to obtain informed consent; 5. suffering from claustrophobia or other mental illness; 6. people who are known to be allergic to the investigational drug or its excipients in the investigational therapy; 7. other conditions deemed unsuitable for participation in the trial by the investigator.
influenza and text messaging in pregnancy

Conditions: Pregnancy

Summary: a randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

history and the 2009 h1n1 influenza pandemic suggest that both seasonal and pandemic influenza infections impart disproportionate morbidity and mortality among gravidas. the influenza vaccine represents a viable, preventive health intervention to mitigate disease burden for gravidas and their neonates. despite the safety and efficacy of influenza vaccines, suboptimal maternal vaccination rates (13-24%) persist nationwide. barriers to influenza vaccination during pregnancy include patient concerns about vaccine safety and unappreciated risk of influenza infection. cellular phone text messaging has emerged as an innovative technology with advantages of ubiquity, rapid, confidential information transmission, and low cost. text messaging may represent an effective way to educate pregnant women about their particular vulnerability to influenza infection and enhance influenza vaccine uptake. we propose a randomized, controlled clinical trial to assess whether text messaging to an outpatient obstetric population can improve maternal influenza vaccine uptake.

Eligibility criteria:
inclusion criteria: 1. pregnant women less than 28 weeks estimated gestation age 2. between 14-50 years of age 3. willing to provide informed consent and undergo necessary study procedures exclusion criteria: 1. unwillingness or inability to receive text messages 2. receipt of the current season's influenza vaccine or plan to receive the influenza vaccine on the day of the enrollment visit 3. reported history of adverse reaction precluding receipt of the vaccine 4. unwillingness or inability to provide informed consent and comply with study criteria.

Keywords: pregnancy influenza vaccination
app-based motivational interviewing and artificial intelligence in diabetes management

Conditions: Diabetes Mellitus Type 2

Summary: there is an urgent need for better control and prevention of complications in type 2 diabetes mellitus (t2dm). behavioural change is critical, and while literature suggests that motivational interviewing (mi) may be effective in improving glycemic control, none has explored app-based mi designed specifically for t2dm. the overall objective of this project is to determine the effectiveness of primary care model combining app-based mi and ai-powered personalised nudges delivered through a mobile application (app) for diabetes management (empower-plus). the project aims to evaluate the effectiveness and implementation of mi and nudges through empowerplus to deliver diabetes management through a randomised controlled trial (rct). this will be a 3-arm rct with primary outcome measure being the difference in hba1c level at week 36 between the intervention and control arms. secondary outcome measures include cost-effectiveness, quality of life, medication adherence, diet, and physical activity. eligible poorly controlled t2dm patients with t2dm in polyclinics will be randomized to intervention arm who will receive empower-plus and smartwatch wearable on top of their usual clinical care. the first control group will have access to nudges delivered through app and smartwatch wearable in addition to usual clinical care but will not receive mi. the second control group will receive usual care (no access to mi, nudges and smartwatch wearable). this study is important to improve t2dm outcomes and reduce healthcare utilization by providing scientifically evaluated and transformative primary care model. leveraging on digital technology and artificial intelligence to drive personalised care, behavioural change and empowerment has huge potential for scale up.


Eligibility criteria:
inclusion criteria: * aged 21 years and above * have been diagnosed with diabetes (t2dm) * had hba1c result of ≥ 7.5% within past 3 months * physically able to exercise * able to read and converse in english * able to download the empower+ app, use the smartphone wearable tracker, and conform to the minimum smartwatch and app monitoring schedule exclusion criteria: * on bolus insulin treatment * require assistance with basic activities of daily living (badl) * have planned major operation or surgical procedure within 9 months from the time of recruitment * cognitively impaired (scored \&lt; 6 on the abbreviated mental test) * currently pregnant or lactating * current participants of ongoing clinical trials involving the usage of a smartphone wearable tracker or mobile health app to assist diabetes management * past empower study participants who refused to participate in future empower studies
comparison of dry needling and iastm on hamstring tightness in posterior pelvic tilt

Conditions: Hamstring Contractures

Summary: the purpose of the study is to compare the effects of dry needling (dn) and instrument-assisted soft tissue mobilization (iastm) on pain, range of motion, lower extremity functional status on hamstring tightness in patients with posterior pelvic tilt.

a study conducted analyzed the effects of a 3-week combined treatment using transcutaneous electrical nerve stimulation (tens) and instrument-assisted soft tissue mobilization (iastm) on chronic back pain. the findings showed that this short-term combined treatment led to reduced pain levels and improved motor function in chronic low back pain (clbp) patients. these results suggest that tens and iastm could be beneficial as a complementary approach for managing chronic low back pain. in a randomized trial which shows the results by comparing the efficacy of dry needling (dn) and graston techniques (gr) in treating upper trapezius myofascial trigger points. both interventions, were administered twice a week for 2 weeks and when combined with conventional treatment and home exercises, showed significant improvements. however, dn demonstrated superior outcomes in terms of the myofascial diagnostic scale, neck disability index, pain rating, and cervical range of motion. these findings highlight the effectiveness of dn in targeting trigger points and optimizing clinical outcomes. a notable lacuna persists in the literature concerning the effects of dry needling (dn) and instrument-assisted soft tissue mobilization (iastm) on patients diagnosed with hamstring tightness and concurrent posterior pelvic tilt. the dearth of comparative research, inadequate incorporation of comprehensive outcome measures, and the paucity of studies targeting this specific patient cohort contribute to this research gap. addressing this gap would yield valuable insights into the comparative efficacies and outcomes of dn and iastm pertaining to pain modulation, range of motion enhancement and optimization of lower extremity functional status in this distinct population subset.

Eligibility criteria:
inclusion criteria: * lack of greater or equal to 20 degrees of supine active knee extension * passive slr less or equal to 75 degrees * atraumatic back or knee pain greater or equal to 2 weeks * individuals willing to participate in the required treatment sessions and follow-up assessments * posterior pelvic tilt 8.9 standard deviation of 4.5 degree exclusion criteria: * history of herniated lumbar disc/radiculopathy * prior surgery in the hip, knee, or back * self-reported pregnancy * history of blood borne pathogens/infectious disease/active infection * metal allergy * positive instability tests indicative of ligamentous tear * positive meniscal tests

Keywords: dry needling hamstring tightness iastm posterior pelvic tilt
therapeutic drug monitoring (tdm) in generic tenofovir/lamivudine/efavirenz

Conditions: HIV

Summary: the purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in thai hiv-infected patients.

the trial drug fdc of tdf/3tc/efv is a new formulation combining fixed doses of the nucleoside reverse transcriptase inhibitors lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg with the non nucleoside reverse transcriptase inhibitor efavirenz 600 mg for once daily and one-tablet haart. co-formulated tdf/3tc/efv demonstrated bioequivalent to original individual efv 3tc and tdf in indian healthy volunteers (unpublished data). it has not been evaluated in clinical trials.

Eligibility criteria:
inclusion criteria: * signed informed consent * evidence of hiv infection * age\> 18 years * on a tdf/3tc/efv (separated pills) containing haart regimen with a vl \< 50 copies within 24 weeks or arv naïve * egfr \>70 cc/min * currently having no aids defining illness * no history of nrti/nnrti/pi failure * willing to adhere to the protocol requirements exclusion criteria: * any history of taking cyp450 inhibitors or inducers drugs within 14 days of enrollment in the study * current pregnancy or lactating or plan to be pregnant * active opportunistic infection * alt more than 2 x upper limit * creatinine more than 1.5 time the upper limit * active drug abuse

Keywords: fixed dose combinations tenofovir lamivudine efavirenz therapeutic drug levels safety and efficacy hiv to evaluation new formulations of fdc of tdf/3tc/efv
development of exercise promotion program using a mobile community

Conditions: Breast Cancer; Physical Activity

Summary: this study aims to investigate the effect of a mobile community based on a smart phone application to enhance physical activities of breast cancer survivors.


Eligibility criteria:
inclusion criteria: * stage 0-iii breast cancer exclusion criteria: * stage iv breast cancer * breast cancer recurrence or metastasis * severe medical illness
a study of avastin (bevacizumab) added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this study will evaluate efficacy, safety and tolerability of avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. the anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * metastatic pancreatic cancer (adenocarcinoma); * good liver, kidney, and bone marrow function. exclusion criteria: * previous systemic treatment for metastatic pancreatic cancer; * pregnant or lactating females; * fertile men, or women of childbearing potential, not using adequate contraception; * major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start; * current or recent treatment (within 30 days prior to starting study treatment) with another investigational drug, or participation in another investigational study.
lithium versus paroxetine in major depression

Conditions: Major Depressive Disorder

Summary: this study is being done to look at how well people respond to two different drug treatments for depression. clinically, people can respond differently to different treatments for reasons which are not always clear. some research shows that people with a family history of bipolar disorder or completed suicide may react differently to standard medications used to treat depression than those without a family history. the investigators need to know if these drugs are effective to use in patients with depression who have a family history of bipolar disorder or completed suicide.

lithium is a mood stabilizing drug that has been used to treat people with both bipolar disorder and depression for the last 50 years. it is available to the public by prescription in canada and has been used by millions of people world wide. paroxetine is an antidepressant drug that has been used to treat people with depression for the past 10 years. it is also available to the public by prescription in canada and has been used by millions world wide. subjects who join the study, will be given one of the study drugs, either lithium or paroxetine. subjects will be randomized "like the flip of a coin" to receive either lithium or paroxetine. the study drug will be taken once a day by mouth and the daily dose adjusted to find the right dose for the subject. the study drug will be taken for a 6-week period and subjects will be assessed by the research team on a weekly basis.

Eligibility criteria:
inclusion criteria: * men or women * age of 18 years or older * meet criteria for major depressive episode, and have a family history of bipolar disorder or completed suicide exclusion criteria: * subjects not able to give informed consent * pregnant or breast-feeding women * current panic disorder, post traumatic stress disorder or psychosis * subjects with a history of mania or hypomania * subjects with active substance abuse or dependence in the last 6 months * current depressive episode less than 4 weeks or greater than 12 months in duration * adequate trial of lithium or paroxetine (lithium level ≥ 0.6mmols/l; paroxetine 20mgs ≥ 5 weeks) for this episode of depression * concurrent use of other antidepressants or augmenting agents for the treatment of depression * clinically significant medical illness, in particular renal impairment

Keywords: depression bipolar disorder manic depressive illness
a study of intracardiac ultrasound with the nuvision nav ultrasound catheter

Conditions: Scar-related Atrial Tachycardia; Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation; Ventricular Tachycardia; Premature Ventricular Complex

Summary: the purpose of this study is to assess the performance and safety of using the investigational catheter.


Eligibility criteria:
inclusion criteria: * diagnosed with and candidate for clinically-indicated cardiac ablation procedure for the management of ventricular tachycardia, premature ventricular complex, scar-related atrial tachycardia or atrial fibrillation (participants having undergone a previous ablation procedure may be included) * signed participants informed consent form (icf) * able and willing to comply with all pre-, post-, and follow-up testing and requirements exclusion criteria: * structural heart defect which can only be repaired by cardiac surgery * pericarditis within 6 months * left ventricular ejection fraction (lvef) less than or equal to (\<=) 25 percent (%) for ventricular tachycardia (vt) participants * lvef \<= 40% for participants with atrial arrhythmia * history of chronic gastro-intestinal medical problems involving the esophagus, stomach and/or untreated acid reflux * history of abnormal bleeding and/or clotting disorder * clinically significant infection or sepsis * history of stroke or transient ischemic attack (tia) within the past 6 months of enrollment * uncontrolled heart failure or new york heart association (nyha) function class iv * implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6 weeks (42 days) * implanted with a mechanical valve * diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation * any of the following within 6 months of enrollment: major surgery except for the index procedure, myocardial infarction, unstable angina, percutaneous coronary intervention * participants with any other significant uncontrolled or unstable medical condition (such as uncontrolled bradyarrhythmia's, ventricular arrhythmias, hyperthyroidism, or significant coagulation disorder) * significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation * categorized as vulnerable population and requires special treatment with respect to safeguards of well-being * concurrent enrollment in an investigational study evaluating another device or drug
a study of mk0777 in the treatment of outpatients with generalized anxiety disorder (0777-020)

Conditions: Anxiety Disorders

Summary: the study will look at the effect of mk0777on reducing anxiety in subjects with general anxiety disorder. this is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (full information is available to trial participants).


Eligibility criteria:
inclusion criteria: * diagnosis of general anxiety order exclusion criteria: * women who are pregnant or breast-feeding * history of severe drug reaction * history of severe drug withdrawal symptoms such as seizures or delirium * disease of cardiovascular system * disease of the liver, kidneys, endocrine system, metabolic system or eyes * history of seizures or seizure disorder * history of drug or alcohol abuse