Kornimate/medical-research-clean huggingface dataset:
effects of acute, rapid lowering of ldl cholesterol with alirocumab in patients with stemi undergoing primary pci

Conditions: ST Elevation Myocardial Infarction; Acute Coronary Syndrome; Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Physiological Effects of Drugs

Summary: a randomized, double-blind, placebo controlled parallel group clinical trial evaluating the effects of acute treatment with a pcsk9 inhibitor (alirocumab) versus placebo on low-density lipoprotein (ldl) in 100 high-risk patients presenting with stemi and referred for primary pci. the objective is to determine the effect of acute, rapid lowering of ldl cholesterol with alirocumab added to high dose statin therapy in patients with stemi undergoing primary pci. the hypothesis is that, in patients with stemi undergoing primary pci, rapid lowering of ldl cholesterol with a pcsk9 inhibitor (alirocumab) initiated in the acute setting pre-pci, will favourably affect ldl cholesterol concentrations compared with placebo.


Eligibility criteria:
inclusion criteria: * patients presenting with stemi defined as both of the following: a) symptoms of myocardial ischemia lasting for ≥ 30 minutes, and b) definite ecg changes indicating stemi: st elevation of greater than 0.1 mv in two contiguous limb leads or 0.2 mv in two contiguous precordial leads. * referred for primary pci for presenting symptoms. * randomized within 12 hours of symptom onset and prior to diagnostic angiography. exclusion criteria: * age ≤18 years. * pregnancy or breastfeeding. * current or planned treatment with a pcsk9 inhibitor. * allergy or contra-indication to a pcsk9 inhibitor. * killip class ≥2. * known creatinine clearance \<30ml/min. * suspected takotsubo / stress-induced cardiomyopathy or acute pericarditis. * any other medical, geographic, or social factor making study participation impractical or precluding follow-up.
an interventional pilot study to investigate the feasibility and acceptance of a structured psychological support program for patients, caregivers, and presymptomatic carriers in hereditary transthyretin amyloidosis with cardiomyopathy

Conditions: Hereditary Transthyretin Amyloidosis

Summary: hereditary transthyretin amyloidosis (attrv) is a genetic, progressive and disabling disease that affects multiple organs and severely compromises the quality of life of patients and their families. a holistic approach is essential, which, in addition to early diagnosis and clinical management, includes psychological support to address the emotional and psychosocial impact of the disease. although specific interventions for mental well-being are recommended, studies evaluating support tools for patients with attrv cardiomyopathy and their caregivers are lacking.

the overall objective of the study is to evaluate the feasibility, acceptance and preliminary efficacy data of a structured psychological support program for patients, caregivers and presymptomatic carriers in hereditary transthyretin amyloidosis (attrv) with cardiomyopathy. the primary objective is to evaluate the feasibility of a psychological support program for patients, caregivers and presymptomatic carriers. the co-primary objective is to evaluate the acceptance by patients of the proposed psychological support program.key secondary objective: evaluate the effects of the psychological support program on the levels of anxiety and depression in patients and presymptomatic carriers of attrv during the psychological support pathway (at 6 months) and at the end (at 12 months);

Eligibility criteria:
inclusion criteria: * minimum age of 18 years; * fluent in italian; * patient, presymptomatic carrier or attrv caregiver, in charge of uoc general medicine 2 - amyloidosis center of the fondazione irccs policlinico san matteo in pavia; * signing of the specific informed consent exclusion criteria: * subjects who, although belonging to uoc general medicine 2 - amyloidosis center of the fondazione irccs policlinico san matteo in pavia - present a diagnosis of another type of amyloidosis.
hiv screening in the emergency department setting

Conditions: HIV Infections

Summary: late diagnosis of hiv infection is believed to be responsible for high rates of hiv transmission. the purpose of this study is to determine whether targeted screening versus routine screening will identify a greater number of hiv infected participants. this study will also compare the costs of the resources used for targeted screening versus routine screening.

novel strategies are needed to reduce hiv transmission, particularly among individuals who are unaware of their hiv status. emergency departments (eds) routinely receive individuals in a medical setting where an opportunity exists to screen them for hiv. the purposes of this study are to determine whether the proportion of tested participants identified as hiv infected by targeted screening exceeds routine screening and to determine whether the program resources used per infected patient identified are lower for targeted screening than for routine screening. participants will be recruited from the university of cincinnati emergency medicine clinical trials center. the existing ed-based clinical hiv counseling and testing program in a lower hiv prevalence area will randomly alternate between two strategies for offering testing to ed participants: 1) targeted screening based on self-reported hiv risk and 2) routine screening. participants will be randomly assigned to the targeted or routine screening group based on their presence in the ed during randomized days and times. at study entry an interview, blood collection, and counseling will occur. participants will be telephoned following their ed visit to be given their negative results. participants with positive results will be asked to return to the ed for notification, counseling, and connections to subsequent care. participants who are hiv infected will be transferred to the university of cincinnati infectious disease center for care.

Eligibility criteria:
inclusion criteria: * adult participants presenting for care in the ed exclusion criteria: * participants cognitively unable or unwilling to consent for voluntary hiv counseling and testing

Keywords: hiv prevention public health screening
a randomized controlled trial (rct) of carbon dioxide versus air insufflation during endoscopic retrograde cholangiopancreatography (ercp)

Conditions: Cholestasis

Summary: the purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (co2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ercp).


Eligibility criteria:
inclusion criteria: * age \>= 18 years * referred for ercp for any indication at unc hospitals exclusion criteria: * age \< 18 years * copd requiring oxygen or with known co2 retention * any medical condition with known co2 retention * medical instability making the procedure unsafe * absolute requirement for same-day second endoscopy * ercp performed in the or or under ga * inability to read or understand english * use of chronic opiates for pain * pregnant women

Keywords: endoscopic retrograde cholangiopancreatography carbon dioxide randomized controlled clinical trial
reversing the epidemic in africa with choices in hiv prevention (reach)

Conditions: HIV-1-infection

Summary: participants will be randomized (1:1) to one of two sequences of a vaginal ring (vr) containing 25mg of dapivirine to be inserted monthly for 24 weeks and 200 mg ftc/300 mg tdf oral tablets taken daily for 24 weeks. after completing the randomized sequence of two study product use periods, participants will then select between the two study products to use in the final 24 weeks of the trial. participants will be able to choose either or neither study product every 4 weeks during the third product use period.

the mtn-034/ipm 045 trial is a multi-site, randomized, two-sequence, three-period, open-label, crossover phase 2a trial. young adult (18-21 years old) and adolescent (16-17 years old) female participants will be enrolled in a 2:1 ratio. all the enrolled participants will use both treatment regimens in sequence. all participants will be randomly assigned to one of two treatment regimen sequences to use for the first two study product use periods, and will be able to choose between treatment regimens during the third study product use period. the total length of follow-up is approximately one and a half years which includes up to 72 weeks of product use (two 24-week periods on randomized treatment regimen and one 24-week period on freely chosen treatment regimen) plus an additional week beyond the period 3 end visit to collect data on any new or worsening aes.

Eligibility criteria:
exclusion criteria: 1. become pregnant and/or use oral prep outside the context of study. 2. at screening or enrollment, has a positive hiv test. inclusion criteria: 1. age 16 through 21 years at enrollment, verified per site standard operation procedures. 2. able and willing to provide adequate locator information and comply with all study procedural requirements.
dose-escalation study of cx-3543 in patients with advanced solid tumors or lymphomas

Conditions: Advanced Solid Tumors; Lymphoma

Summary: this phase 1 study of cx-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.

cx-4945 is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. this drug was rationally designed to target a g-quadruplex (qplx) dna structure and disrupt protein-dna interactions essential to cancer cells. the qplx targeted by quarfloxin forms within ribosomal dna (rdna) and the qplx is bound by the nucleolin protein.this phase 1 study of cx-3543 is designed to test the safety, tolerability and highest safe dose level of this drug in patients with advanced solid tumor cancers.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed solid tumors or lymphomas. * tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy. * one or more tumors measurable on radiograph or ct scan, or evaluable disease. (e.g., malignant ascites) * karnofsky performance status of greater than or equal to 70. * life expectancy of at least 3 months. * age at least 18 years. * patients must have central iv access, or agree to the insertion of a central iv line. * a negative urine pregnancy test (if female.) * acceptable liver function as evaluated by laboratory results * acceptable hematologic status as evaluated by laboratory results * no clinically significant urinalysis abnormalities * acceptable coagulation status as evaluated by laboratory results * fertile men and women must use effective contraceptive methods during the study. exclusion criteria: * seizure disorders not controlled by anticonvulsant therapy. * known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months.) * severe chronic obstructive pulmonary disease with hypoxemia or a pulmonary compromise not correctable with therapy. * major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug. * active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. * pregnant or nursing women. * treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin c.) * unwillingness or inability to comply with procedures required in this protocol. * known infection with hiv, hepatitis b, or hepatitis c. * clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis. * patients who are currently receiving any other investigational therapy. * patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones), biological agent, or formulation.

Keywords: solid tumors lymphoma g-quadruplex
osteopathic manipulative treatment in oncology patients' management

Conditions: Geriatric Oncology; Osteopathy in Other Diseases Classified Elsewhere

Summary: the aim of present study was to study the osteopathic manipulative effects on pain relief and quality of life improvement on hospitalized oncology geriatric patients. a non-randomized comparison trial was performed in unit of oncology rehabilitation, palazzolo institute, don carlo gnocchi foundation onlus, milan, italy, from september 2015 to march 2016. 23 older oncology patients were unrolled and allocated in two experimental groups: study group (omt group, n=12) underwent to osteopathic manipulative treatment associated to physiotherapy and control group (pt group, n = 11) underwent only physiotherapy. at enrollment (t0), 23 recruited oncology patients completed the socio-demographic forms and were evaluated, from external examiner, pain intensity and quality of life. all patients were revaluated at the end of treatment (t4) for quality of life and every week (t1, t2, t3 and t4) for pain intensity. standard level of significance was p\<0.05.


Eligibility criteria:
inclusion criteria: * oncology patients * male and female * age≥65 years * with a clinical prognosis of 6-24 months * diagnosis of multifactorial hyperkinetic syndrome (i.e. metastatic surgery) * pain intensity score higher than 3, measured with numeric rating scale (nrs) exclusion criteria: * patients were receiving chemotherapy or radiotherapy treatment at the time of the study * with mental disorders (mmse\<10) * the presence of infection * anticoagulation therapy * cardiopulmonary disease * clinical instability post-surgery.

Keywords: geriatric oncology pain osteopathic manipulative treatment quality of life
study of ipilimumab and dasatinib combination therapy in patients with chronic or accelerated chronic myeloid leukemia

Conditions: Leukemia, Myeloid, Chronic

Summary: the purpose of the study is to assess the safety of ipilimumab and dasatinib combination therapy in patients with cml


Eligibility criteria:
inclusion criteria: * ph+ cml on dasatinib therapy * loss of cytogenetic or molecular response while on dasatinib therapy * on stable dose of dasatinib for a minimum of 12 weeks and with \< 14 day interruption of treatment exclusion criteria: * blast crisis cml * autoimmune disease * uncontrolled or significant cardiovascular disease
salvage ovarian fang™ vaccine + carboplatinum

Conditions: Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Summary: this is a phase ii study of vigil™ autologous tumor cell vaccine integrated with carboplatinum. all patients will have vigil™ prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking. patients meeting eligibility criteria will receive either carboplatinum alone (auc 6/30 minute infusion) or carboplatinum (auc 5/30 minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to vigil™ 1.0 x 10e7 cells/intradermal injection, once every 3 weeks.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed papillary serous or endometrioid ovarian cancer. 2. previous randomization to gradalis, inc. protocol cl-ptl 105; observation arm (group b) or or patients with vaccine prepared for cl-ptl 105 but did not otherwise qualify. 3. recurrent cisplatinum-sensitive disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic ca-125 levels greater than 100 u/ml at two consecutive measurements after a 6 month period after platinum treatment. 4. successful manufacturing of 4 vials of vigil™ vaccine. 5. recovered from all clinically relevant toxicities related to prior therapies. 6. ecog ps 0-2 prior to vigil™ vaccine administration. 7. normal organ and marrow function as defined below: 1. absolute granulocyte count ≥ 1,500/mm3 2. absolute lymphocyte count ≥ 200/mm3 3. platelets ≥ 100,000/mm3 4. total bilirubin ≤ 1.5 x uln 5. ast(sgot)/alt(sgpt)/alkaline phosphatase ≤ 2.5 x uln 6. creatinine \< 1.5 mg/dl 8. patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy. 9. ability to understand and the willingness to sign a written informed protocol specific consent. exclusion criteria: 1. surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. chemotherapy within 3 weeks prior to vaccination. steroid therapy within 1 week prior to vaccination. 2. patient must not have received any other investigational agents within 4 weeks prior to study entry. 3. patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation. 4. patients with history of brain metastases. 5. patients with compromised pulmonary disease. 6. short term (\<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded. 7. prior splenectomy. 8. prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years. 9. kaposi's sarcoma. 10. patients with peripheral neuropathy ≥2 (paclitaxel). 11. uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements. 12. patients with known hiv. 13. patients with chronic hepatitis b and c infection. 14. patients with uncontrolled autoimmune diseases.

Keywords: ovarian cancer
effects of different doses of pinitol on carbohydrate metabolism parameters in healthy subjects

Conditions: Healthy; Insulin Sensitivity

Summary: the purpose of this study was to assess the acute effects of increasing doses of pinitol on glucose tolerance and insulin sensitivity and to evaluate the absorption of pinitol after consumption of an oral nutritive pinitol-enriched beverage in healthy subjects.


Eligibility criteria:
inclusion criteria: * the inclusion criteria for all subjects were age range of 18-65 years, body mass index of 20-30 kg/m2 and clinically normal kidney function, liver function, heart function, protein status and haematological profile. exclusion criteria: * exclusion criteria were pregnancy or lactation, alteration of carbohydrate metabolism, fasting glycaemia ≥5.55 mmol/l on at least two previous occasions, diabetes, or medication known to interfere with glucose metabolism.

Keywords: glucose insulin 3-o-methyl-d-chiro-inositol
measuring parkinson's disease with tear fluid

Conditions: Idiopathic Parkinson Disease

Summary: the purpose of this study is to assess whether tear secretion in patients with parkinson's disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that will be reflected in changes in the protein composition of tear fluid, which can be measured relatively easily, cost-effectively, and non-invasively. tear fluid samples will be collected from parkinson's patients, and through biochemical assays, the profile of proteins in tears will be characterized and compared to that from control subjects. the profiles will be analyzed with respect to any differences between parkinson's patients and control subjects. if differences appear, the levels of these potential biomarkers in parkinson's patients will be compared to the severity of their disease.


Eligibility criteria:
inclusion criteria: * established parkinson's disease for at least 6 months * healthy controls without neurological illness exclusion criteria: * currently taking anti-cholinergic medication * dementia * have an exposure to neuroleptic medications other than quetiapine or clozapine in the 6 months prior to screening * have an active eye infection or have had eye surgery within 3 months prior to screening * control subjects will be excluded if they have a history of neurological disease * pd subjects will be excluded if they have an atypical parkinsonian syndrome
immunophenotyping of plasma cells and immune effector cells in peripheral whole blood and bone marrow samples from multiple myeloma (mm) patients

Conditions: Multiple Myeloma

Summary: the objective of this study is to evaluate the immune profile of plasma cells and immune effector cells in paired peripheral whole blood and bone marrow samples from mm patients by standardized flow cytometry. the quantitative and/or qualitative variation of these immune effectors according to the different status of myeloma pathology (diagnosis, relapse or refractory). it is interesting to assess the extent to which a particular immune profile is associated with a better therapeutic response for a given treatment. in addition, the study will validate the stability of the samples between t0 (\< 4 hours after sampling) and t0 + 72 hours.

study the biomarkers recorded on plasma cells and normal leukocytes including t lymphocytes (naïve, effectors and memories), b lymphocytes, treg, nk, monocytes as well as their activation markers (cd25, pd-1) in paired bone marrow and blood samples. validate the pre-analytical stability of the samples between t0 (\< 4 hours after sampling) and t0 + 72 hours. secondary objectives: validate the strategy of quantification of receptors on plasma cells by direct labeling in flow cytometry. validate a new method for measuring receptor occupancy by a drug. validate the pre-analytical stability of the absolute quantitative expression of the receptors and the specific marker cd138 on samples between t0 (\< 4 hours after sampling) and t0 + 72 hours. the study will be enrolling 20 patients.

Eligibility criteria:
inclusion criteria: * multiple myeloma without treatment exclusion criteria: -

Keywords: immune response plasma cells multiple myeloma drugs targeting plasma cells
the ipeer2peer program for adolescents with juvenile idiopathic arthritis

Conditions: Juvenile Idiopathic Arthritis

Summary: the ipeer2peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. this study will compare two groups of teens: those who are in the ipeer2peer program and those in the control group (no mentor).

arthritis is a common childhood illness that makes everyday activities hard for young people. it is a long-lasting illness that can make you feel pain, tired and emotionally upset. this can make it hard for children and teens to see friends and do the activities that they like. the goal of this project is to find out if the newly developed peer mentoring program called ipeer2peer helps teens with arthritis take better care of their illness and feel more connected to other people with arthritis. the ipeer2peer program matches teens with arthritis to an older mentor who has learned to manage their arthritis well and can support them emotionally and socially. this study will compare two groups of teens: those who are in the ipeer2peer program and those in the control group (no mentor).

Eligibility criteria:
inclusion criteria: * males and females 12-18 years old * rheumatologist-diagnosed jia according to ilar criteria * able to speak and read english * access to a computer, smartphone or tablet capable of using free skype software (note: participants who do not have adequate internet access will be provided with portable internet sticks) * willing and able to complete online measures. exclusion criteria: * significant cognitive impairments * major co-morbid illnesses (medical or psychiatric conditions) likely to influence hrql assessment * participating in other peer support or self-management interventions.