Kornimate/medical-research-clean huggingface dataset:
ion us post-approval study

Conditions: Atherosclerosis; Coronary Artery Disease

Summary: the purpose of this study is to compile real-world clinical outcomes data for the ion™ paclitaxel-eluting platinum chromium coronary stent system in routine clinical practice.

the ion™ stent is the third-generation boston scientific (bsc) paclitaxel-eluting coronary stent. it is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the taxus express and taxus liberté stents. following pma approval from the fda for the ion™ paclitaxel-eluting platinum chromium coronary stent system the ion us post-approval study will compile real-world clinical outcomes data for the ion™ paclitaxel-eluting platinum chromium coronary stent system in routine clinical practice. post-approval studies of drug-eluting stents (des) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.

Eligibility criteria:
inclusion criteria: consented subjects receiving one or more ion(tm)coronary stents exclusion criteria: subjects not clinically indicated to receive an ion (tm)coronary stent

Keywords: atherosclerosis coronary artery disease
tracking depression symptoms with a health chatbot

Conditions: Depression, Postpartum; Depression, Unipolar

Summary: the goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. the investigators have developed a chatbot which will assist in performing measurement-based care (mbc) via facebook messenger. participants will be randomized to either usual care or usual care with additional chatbot care.

the goal of this research is to bridge a significant "effectiveness" gap in the treatment of depression. the investigators will be looking specifically at depressed women soon after they give birth, otherwise known as known as perinatal depression. measurement-based care (mbc) which involves the use of quantitative assessments for depression screening, diagnosis, and symptom monitoring is recognized as one of the keys to depression management. mbc can be difficult to implement within the clinical setting due to the administrative overhead and close follow-up required. it is reasonable to hypothesize that low rates of mbc adoption are responsible for low rates of adequate depression care. the investigators have developed an automated conversational agent or "chatbot" (cb) for delivering mbc via facebook messenger. the investigators hypothesize that the use of cb-mbc, which combines a conversational interface with state-of-the-art quantitative assessments, will improve depression symptom severity for patients with perinatal depression. if successful, this project will provide primary care physicians with a new and inexpensive method for delivering better and safer care to their patients with depression. this study works to determine the impact of the chatbot in improving depression outcomes for patients under treatment for perinatal depression.

Eligibility criteria:
inclusion criteria: * provider subject cohort: residents and attendings from university of chicago medical center obgyn and northshore hospital obgyn clinics. * patient subject cohort: 1. age ≥ 18 years and able to and demonstrate english reading literacy of at least 8th-grade level (realm-r ≥ 6) 2. postnatal women newly diagnosed or receiving treatment for non-psychotic unipolar depression with a severity-based entry criterion of moderate to severe (epds ≥ 12) 3. willing to participate and able to give written informed consent 4. must own a smart phone with a data plan 5. must have a facebook account and facebook messaging app on phone (or willing to create account/download app today) 6. sufficient cognitive ability to provide self-report data on a computer touchscreen/ standard computer with minimal assistance exclusion criteria: * provider subject cohort: none * patient subject cohort: 1. subjects with documented dysthymia or axis ii diagnoses 2. subjects with self-reported or documented history of: anorexia or bulimia, obsessive compulsive disorder or prior hospitalization for suicidal ideation 3. active suicidality as determined by clinician 4. non-english speakers
de novo lipogenesis in severity of nafld

Conditions: Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Bariatric Surgery Candidate; Obesity, Morbid

Summary: nafld is the most prevalent liver disease in the u.s., and there is a serious need to understand its progression to the advanced state, nonalcoholic steatohepatitis (nash). previous studies has shown that elevated de novo lipogenesis (dnl) is the unique, early event distinguishing patients with nafld from equally-obese subjects with low ihtg. the purpose of this study is to directly by measure dnl in human liver tissue and comparing it to liver histological scores from patient biopsies.

the development of nonalcoholic fatty liver disease (nafld) progresses from a state of elevated intrahepatic triglycerides (ihtg) to liver inflammation, and ultimately, hepatic apoptosis and fibrosis. nafld is the most prevalent liver disease in the u.s., and there is a serious need to understand its progression to the advanced state, nonalcoholic steatohepatitis (nash). elevated de novo lipogenesis (dnl) is the unique, early event distinguishing patients with nafld from equally-obese participants with low ihtg. dnl is the process of liver synthesis of fatty acids (fas) from carbohydrate. in humans, studies have shown that dnl significantly predicts the magnitude of ihtg, however, it is unknown whether the pathway plays a role in disease progression. evidence supporting this concept includes the fact that the primary product of dnl is the saturated fa, palmitate, which in cell culture has been shown to significantly contribute to oxidative stress and inflammation. recent rodent data show that upregulation of dnl through dietary supplementation of sucrose exacerbated the hepatotoxic effects of excess dietary fas. a preliminary abstract presented by others at the 2017 liver meeting suggested that dnl may not be different between patients with low and high liver fibrosis, although these data were collected using an indirect measure of liver disease. here, in the present study, the hypothesis will be tested directly by measuring dnl in human liver tissue and comparing it to liver histological scores (nafld activity score, nas) from patient samples.

Eligibility criteria:
inclusion and exclusion criteria are similar to the criteria set by a larger project (nct03151798). inclusion criteria: * men and women (pre and post-menopausal) * overweight/obese with bmi ≥ 25.9 or ≤ 50.0 kg/m2 * characteristics of the metabolic syndrome, pre-diabetes (fasting glucose 100-125 mg/dl or 2h glucose 140-200 mg/dl) or diabetes type ii * 22-65 years of age * use of tobacco products or no use of these products * sedentary, ≤ 60 minutes per week of structured physical activity exclusion criteria: • the following conditions exclude subjects for this project because bariatric surgery would not be performed in these populations. individuals with acute disease or advanced cardiac, liver, or renal disease, excessive alcohol use, anticoagulation therapy, or any severe co-morbid condition limiting life expectancy \< 1 year. women pregnant or trying to become pregnant.
triscend japan study

Conditions: Tricuspid Valve Regurgitation; Heart Valve Diseases; Cardiovascular Diseases

Summary: a prospective, open, non-randomized, multicenter, clinical trial to evaluate the safety and effectiveness of the edwards ewj-202 transcatheter tricuspid valve replacement system in the treatment of patients with at least severe tricuspid regurgitation despite medical therapy. subjects will be followed at discharge, 30 days, 6 months and annually through 5 years.


Eligibility criteria:
inclusion criteria: * symptomatic tricuspid regurgitation (tr) despite medical therapy * tr graded as severe or greater * appropriate for transcatheter tricuspid valve replacement per the local heart team exclusion criteria: * tricuspid valve anatomic contraindications * need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months * hemodynamic instability * refractory heart failure requiring advanced intervention * currently participating in another investigational study

Keywords: transcatheter tricuspid disease valve replacement tricuspid valve
multicomponent intervention to reduce sexual risk and substance use

Conditions: HIV; Sexually Transmitted Infections; Substance Use

Summary: the objective is to expand and refine an intervention for transgender women (tw) into a 7-session individual- and group-based intervention that is scalable for community settings to reduce sexual risk and substance use and to increase stigma-coping and risk-buffering behaviors among tw in nyc. the investigators will pilot test the intervention with 20 tw and subsequently, conduct a randomized controlled trial with 240 tw to compare the intervention to a wait list control condition.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * identify as a transgender woman (assigned male at birth and currently identify as female) * report 3 or more acts of unprotected anal or vaginal sex in the past 90 days and at least 1 in the past 30 days * report 5 or more days of illicit drug use in the past 90 days and at least 2 in the past 30 * provide contact information * reside in the nyc metropolitan area * able to complete a survey in english (spanish-language assistance can be provided by bilingual staff) * provide informed consent exclusion criteria: * unstable, serious psychiatric symptoms * current suicidal/homicidal ideation * evidence of gross cognitive impairment * currently enrolled in a drug abuse treatment or enrolled in an hiv risk or drug use intervention study

Keywords: transgender women sexual risk substance use hiv prevention behavioral intervention
sp-420 in subjects with transfusion-dependent beta-thalassemia or other rare anemias

Conditions: Iron Overload; Beta-Thalassemia

Summary: the purpose of this study is to test the safety and tolerability of sp-420 and it's efficacy in terms of lowering iron in subjects with beta-thalassemia or other rare anemias who need regular blood transfusions.


Eligibility criteria:
inclusion criteria: * at least 18 years old * iron-overload secondary to β-thalassemia (homozygote or compound heterozygote) or other rare anemias (e.g., aplastic anemia, pure red-cell dysplasia ) requiring chronic rbc transfusions and iron chelation therapy * on a stable dose of iron chelation for at least 4 weeks prior to screening visit * weight ≥35 kg at screening * willing to discontinue current iron chelation therapy 7 days (± 3 days) prior to the first dose of sp-420 and for the duration of the current study * lic ≥5 and ≤25 mg/g dry weight on the r2-mri obtained within 2 weeks prior to the baseline visit * cardiac t2\* score \> 12 msec obtained on the mri obtained within 2 weeks prior to the baseline visit exclusion criteria: * pregnant or breast-feeding * current malignancy with the exceptions of localized basal cell or squamous cell skin cancer or localized prostate cancer or is receiving immunotherapy, chemotherapy or radiation therapy for a malignancy * current myelodysplastic syndrome * alanine aminotransferase (alt) \>4 times the upper limit of normal, decompensated cirrhosis, or ascites at screening * past history of clinically significant kidney disease (per the principal investigator) * serum creatinine greater than the upper limit of normal during screening * urine protein to creatinine ratio \> 0.5 mg/mg during screening * ongoing symptoms of cardiac dysfunction or failure * ongoing symptoms of neuropathy, including peripheral sensory neuropathy, peripheral motor neuropathy, or paresthesia at screening * received another investigational drug within 30 days or investigational antibody within 90 days of day 1 of the study * other condition that, in the opinion of the pi, would interfere with the conduct of the study

Keywords: chelator
alopecia areata registry

Conditions: Alopecia Areata; Alopecia Totalis; Alopecia Universalis; Autoimmune Hair Loss; Alopecia Partialis

Summary: alopecia areata is the loss of hair in patches that can proceed to loss of all hair (alopecia totalis or universalis). the purpose of the registry is to collect patient information and blood samples from people with alopecia areata.

alopecia areata is a condition in which hair is lost either from part of the scalp, all of the scalp, or the entire body, and it affects 1% to 2% of the population. it is thought to be an autoimmune disease and in some cases the disease is hereditary. the alopecia areata registry will collect information and blood samples from clinically well-characterized patients with these three forms of alopecia areata: alopecia partialis (patchy loss of the scalp hair), alopecia totalis (total loss of all scalp hair), and alopecia universalis (complete loss of all hair everywhere on the body). this will be a collection of patients in multi-generational families, twins, single patients with patchy, persistent transient alopecia areata or long-standing alopecia totalis/universalis and with controls (persons unaffected and not related to alopecia patients). information from these patients will be used to search the human genome for disease-associated loci and/or genes. researchers interested in doing pathophysiology or treatment studies of this disease will also be able to contact patients having the appropriate form of the disease for the studies in question. patients who have been diagnosed with alopecia areata by a dermatologist will be eligible for the registry. patients will fill out an information form online (alopeciaareataregistry.org). patients who have a family history or specific types of alopecia will be invited to participate in a more detailed questionnaire and physical exam and have blood samples drawn.

Eligibility criteria:
inclusion criteria * diagnosed with alopecia areata by a dermatologist * united states resident accepts health volunteers: non blood-related individuals who are unaffected with alopecia areata and do not live in the same household with alopecia areata patient.

Keywords: baldness autoimmunity hair alopecia areata alopecia partialis alopecia totalis alopecia universalis autoimmune hair loss
myoglobin removal with cytosorb in rhabdomyolysis

Conditions: Acute Kidney Injury; Rhabdomyolysis; Endothelial Dysfunction

Summary: the aim of this observational study is to assess whether myoglobin removal with cytosorb® ameliorates endothelial damage in severe rhabdomyolysis patients who are admitted to the intensive care unit. the primary objective of the study is: - does myoglobin removal with cytosorb® reduces glycocalyx degradation markers? patients with severe rhabdomyolysis will receive the intervention and blood samples will be obtained in regular intervals.

rhabdomyolysis is characterized by destruction of muscle by various causes and is diagnosed by increased creatine kinase concentrations in the blood. myoglobin released into the blood may cause acute kidney injury in up to half of these patients. the mortality caused by severe rhabdomyolysis is also high (32%). extracorporeal modalities, such as cytosorb (cs) can effectively eliminate the myoglobin from the bloodstream. in addition to ischemic and inflammatory damage, myoglobin also causes direct endothelial cell injury. degradation of the endothelial glycocalyx layer can be assessed by several biomarkers such as syndecan-1, heparan sulfate, cadherin however, it is not fully known whether myoglobin elimination improves the outcomes or it is irrelevant of the outcome. the investigator hypothesized that myoglobin elimination with cs alleviates the damage inflicted upon the endothelium and may have a role in improving patient outcomes in severe rhabdomyolysis.

Eligibility criteria:
inclusion criteria: * patients with creatine kinase \> 5000 iu/l. * myoglobin results can be obtained only after 5 working days after sampling in our center, therefore it cannot be used as an inclusion criteria. * gfr below 40 ml/min. exclusion criteria: * high dose vasopressor requirement * not expected to survive \> 24 h * lack of consent to participate

Keywords: myoglobin rhabdomyolysis acute kidney injury
second line colorectal cancer therapy in combination with combination of fol- folinic acid(leucovorin), f - fluorouracil and ox - oxaliplatin (folfox)

Conditions: Colorectal Cancer

Summary: the primary purpose of this study is to compare the efficacy of azd2171 in combination with folfox to the efficacy of bevacizumab in combination with folfox, in the second-line treatment of patients with metastatic colorectal cancer


Eligibility criteria:
inclusion criteria: * clinical diagnosis of colon or rectal cancer, * received prior systemic therapy for cancer, * cancer must have progressed during or after first treatment exclusion criteria: * prior treatment with a vegf inhibitor, * poorly controlled hypertension

Keywords: colorectal cancer phase ii metastatic colorectal cancer azd2171 recentin
efficacy, tolerability and safety of rki983 (0.05% & 0.10%) vs xalatan in patients with poag or ocular hypertension

Conditions: Glaucoma; Ocular Hypertension

Summary: this purpose of this study is to access the efficacy, tolerability and safety of rki983 (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients with poag or ocular hypertension.


Eligibility criteria:
inclusion criteria: * females must be post-menopausal or surgically sterile, or must use concomitantly two acceptable forms of effective contraception * clinical diagnosis of poag or oh * for study eyes not previously treated with anti-glaucoma medications * iop must be ≥ 22 mm hg at least at two assessment time-points at screening, and * iop must be ≥ 22 mm hg at least at two assessment time-points at baseline, and * iop must be ≥ 20 mm hg and ≤ 36 mm hg at all screening and baseline assessment time-points. * or for study eyes previously treated with anti-glaucoma medications * iop must be ≥ 14 mm hg and ≤ 24 mm hg at least at two assessment time-points at screening. * iop must be ≥ 22 mm hg at least at two assessment time-points at baseline (after wash-out) * iop must be ≥ 20 mm hg and ≤ 36 mm hg at all baseline assessment time-points exclusion criteria: * history of or current clinically significant ocular conditions in either eye that would contraindicate the use of an investigational drug or latanoprost (e.g. active intraocular inflammation), or that might affect interpretation of the results of the study. * history or presence of clinically significant medical problems that contraindicate the use of an investigational drug or latanoprost, including but not limited to: * uncontrolled hypertension with systolic blood pressure ≥ 160 mm hg and/or diastolic blood pressure ≥ 100 mm hg measured at more than one blood pressure reading at screening or baseline; * myocardial infarction within the 3 months period prior to randomization; * active severe viral infections such as active encephalitis, meningitis, hepatitis, herpes simplex, or herpes zoster (minor viral upper respiratory infections such as colds do not require exclusion.) * presence of moderate or severe (grade 2 or 3) conjunctival hyperemia in the study eye at baseline visit. * argon laser trabeculoplasty or any prior iop lowering surgery in the study eye. * ocular surgery in the study eye within 3 months prior to the screening visit. other protocol-defined inclusion/exclusion criteria may apply

Keywords: glaucoma, primary open-angle glaucoma (poag), ocular hypertension (oh), intraocular pressure (iop)
efficacy of an ocular bandage contact lens for the treatment of dry eye after complicated and combined cataract surgery

Conditions: Cataract; Lens Subluxation; Hypermature Cataract; Corneal Opacity; Small Pupil

Summary: to study the efficacy of an ocular bandage contact lens for the treatment of dry eye after complicated and combined cataract surgery


Eligibility criteria:
inclusion criteria: 1. cataract patients（age 40-80） 2. complex symptom（such as:corneal opacity、small pupil、zonule relaxationlens subluxation、shallow anterior chamber、hypermature cataract、hard nucleus,etc） 3. dry eye disease exclusion criteria: 1. simplex age-related cataract 2. contact lens use 3. ocular therapies such as 0.05% cyclosporine a or steroids in the last 3 months 4. any systemic diseases such as heart diseases, diabetes and psychosis

Keywords: bandage contact lens cataract surgery dry eye
statin therapy to reduce progression in women with platinum sensitive ovarian cancer

Conditions: Recurrent Ovarian Cancer; Platinum-sensitive Ovarian Cancer

Summary: this is a single arm pilot trial to evaluate the feasibility of using a simvastatin intervention, and to evaluate its effects on cancer progression, among 20 patients with platinum-sensitive ovarian cancer, treated with carboplatin and liposomal doxorubicin at cedars-sinai medical center.

this is a pilot study of statin therapy to examine the feasibility of simvastatin use to reduce disease progression in 20 patients with platinum-sensitive ovarian cancer at cedars-sinai medical center. this study will focus on patients with recurrent platinum sensitive ovarian cancer to increase the likelihood that this population will experience recurrent disease during the 6-month intervention and follow-up. in addition, this population of patients has a narrow range of standard of care carboplatin doublet combinations that are prescribed, enabling the investigators to create a more homogenous study population. given their high risk of developing recurrent disease, women with platinum sensitive ovarian cancer, have the potential to derive the maximum benefit from an intervention that could delay disease progression and enhance survival.

Eligibility criteria:
inclusion criteria: * recurrent platinum sensitive ovarian cancer, all histologies (serous, endometrioid, mucinous, clear cell). platinum sensitivity defined as ≥ 6 months since last platinum treatment. * no contraindication to carboplatin and/or liposomal doxorubicin or simvastatin. exclusion criteria: * prior or current use of any statin medication * current systemic use of medications known to interact with statins * current use of any other investigational agents * liver disease, active cirrhosis * uncontrolled intercurrent illness * history of chronic myopathy * prior cancer other than ovarian cancer or non-melanomatous skin cancers * known active infection with hiv * current excessive alcohol consumption (average alcohol consumption of more than 5 drinks per day) * prior exposure to doxorubicin or liposomal doxorubicin * hemoglobin a1c \>8.0%

Keywords: simvastatin