Kornimate/medical-research-clean huggingface dataset:
cholesterol and pharmacogenetic study

Conditions: Hyperlipidemia; Hypercholesterolemia; Coronary Heart Disease; Cardiovascular Disease

Summary: the overall objective of the cap study was to determine genetic influences on efficacy of simvastatin treatment with regard to ldl cholesterol reduction and changes in other markers of cardiovascular disease risk.

despite widespread use of statin therapy for reducing risk of cardiovascular disease risk, there is considerable inter-individual variation in statin efficacy, and it would be desirable to identify markers that would be predictive of the magnitude of beneficial response. the effect of statin most strongly associated with improved clinical outcomes is reduction in ldl cholesterol. the cap study was a six week non-randomized, open label study of simvastatin 40 mg/day in a group of 335 african-american and 609 caucasian volunteer subjects. measurements of plasma lipids and lipoproteins, as well as other markers of cardiovascular disease risk, were obtained at the screening and entry visits, and after four and six weeks of simvastatin treatment. both baseline measurements and changes in response to simvastatin therapy are being used to test for associations with genetic polymorphisms. significant findings are being replicated in other study cohorts.

Eligibility criteria:
inclusion criteria: * at least 30 years of age * total cholesterol between 160 to 400 mg/dl * \> 3 grandparents of african-american descent or \> 3 grandparents of caucasian descent * serum triglycerides \< 400 mg/dl * fasting glucose \< 126 mg/dl exclusion criteria: * use of lipid-lowering medication * use of over-the-counter products containing sterol or stanol esters or fish oil * recent or planned change in dietary intake or weight change of more than 4.5 kg * use of corticosteroids, immunosuppressive drugs or drugs affecting the cyp3a4 system * known liver disease or elevated transaminase levels * elevated creatine phosphokinase levels \> 10 times upper limits of normal * uncontrolled blood pressure, or diabetes mellitus * abnormal renal or thyroid function * current alcohol or drug abuse * major illness in the preceding three months * pregnancy * know intolerance to statins * racial ancestry other than african-american or caucasian

Keywords: statins cholesterol pharmacogenetics
identification of liver tumours using bip - biopsy system

Conditions: Liver Biopsy

Summary: this clinical device investigation is conducted by performing liver biopsies using the bip - biopsy tool. the aim is to assess the feasibility of bioimpedance spectroscopy based biopsy tool guidance method and test how well bip biopsy system is able to distinguish liver tumours from surrounding tissue. in addition, user feedback is obtained to improve the usability of the investigational device. the study does not affect the traditional treatment procedure and only the patients in clinical need for diagnosis by liver biopsy are included on voluntary basis. the invasive products used in actual biopsy operation are designed so that their performance is essentially equal to the currently used biopsy devices, the only difference is the measurement capability of biopsy needle and connection to measurement device.


Eligibility criteria:
inclusion criteria: * consenting adults undergoing ultrasound-guided core liver biopsy to diagnose liver tumour or other abnormalities * identifiable non-tumorous liver tissue along the planned needle injection path. exclusion criteria: * inability to give informed consent * being under aged * being pregnant * being high risk patient * lack of identifiable non-tumorous liver tissue along the injection path to the tumour location * known contraindications to liver biopsy.

Keywords: bioimpedance biopsy liver tumour biopsy needle guidance
applying pet/mr in neuroendocrine tumors - imaging dynamic processes in both modalities

Conditions: Neuroendocrine Tumors

Summary: neuroendocrine tumors (net's) are characterized, among other features, by presence of high concentration of somatostatin receptors. in recent years, for purposes of positron emission tomography (pet) imaging, somatostatin receptor ligands have been labelled with the positron emitting radioisotope 68ga to form molecules that bind to these somatostatin receptors that are present in high concentration in net's and in low concentrations, if at all, in normal tissues. in the last 10-15 years, radioactively labelled versions of these molecules have been used for both diagnostic and therapeutic purposes in the management of patients with net's. the main goal of this study is to assess the feasibility of performing dynamic 68ga-dotatate pet in the pet/mri system and analyzing the effect of diffusion and perfusion over ki values.

working hypotheses 1. the pet/mr system will provide dynamic pet images of at least comparable quality compared to pet/ct. dynamic pet/mr will be feasible, with the 45 minute dynamic pet acquisition occurring during the mr sequences, eliminating the need for the patient to undergo two separate lengthy studies. 2. diffusion and perfusion parameters extracted from mri sequences will provide information that improves the process of ki evaluation. 3. the use of advanced statistics methodologies, such as those used in radiomics, to correlate ki data with diffusion and perfusion data will provide a quantification tool that will improve staging, prediction and monitoring after treatment. 4. parametric patlak ki images calculated from the dynamic series of pet images will show better contrast between tumors and normal tissue, as compared to contrast in the conventional static images obtained from the last time frame of the dynamic image series. tumors identified on the static pet image will be visualized at least as well on patlak ki images, and possibly additional tumor foci may be identified. mri should assist in confirming and interpreting such findings. research plan population: 50 patients with nets that have evidence of at least one abdominal lesion with diameter greater than 2cm. all patients will be aged 18 years or older of both sexes. inclusion criteria: patients with confirmed net. exclusion criteria: patients younger than 18 years; pregnancy; other known active malignancy; contraindication to mri tests or intravenous contrast agents.

Eligibility criteria:
inclusion criteria: 1.patients with confirmed net. exclusion criteria: 1. patients younger than 18 years. 2. patients pregnancy. 3. patients with other known active malignancy. 4. patients contraindication to mri tests or intravenous contrast agents.
efficacy and safety study of cb-5945 for the treatment of opioid-induced constipation

Conditions: Opioid-Induced Constipation

Summary: the purpose of this study is to evaluate the safety and efficacy of cb-5945 for the treatment of opioid-induced constipation (oic)in adults taking opioid therapy for chronic non-cancer pain.

this is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with oic taking opioid therapy for chronic non-cancer pain. approximately 600 participants (300 participants per treatment group) with oic will be randomized at approximately 75 study centers to receive either oral 0.25 mg cb-5945 bid or oral matching placebo bid for the 12-week double-blind treatment period, followed by a 4-week follow-up period. all randomized participants will be evaluated for clinical response for duration of their study participation. all participants will be followed for safety for 4 weeks after last dose of the study medication, regardless of when they discontinue study medication. the clinical study report for this study includes pooled results for studies 5945-oic-12-02 (nct01901302) 5945-oic-12-03 (nct01901328), and 5945-oic-12-04 (nct01901341).

Eligibility criteria:
key inclusion criteria: * is taking a stable daily dose of opioids of ≥30 mg morphine equivalent total daily dose (metdd) for chronic non-cancer pain * has constipation that is caused by the chronic use of opioids * is willing to use only the study provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (e.g., lubiprostone) from screening until the last study assessment key exclusion criteria: * has gastrointestinal (gi) or pelvic disorders known to affect bowel transit (for example \[e.g.\], obstruction) or contribute to bowel dysfunction * has evidence of intestinal obstruction * has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening * has an active malignancy of any type (participants with a history of successfully treated malignancy \>5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled) * is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone) * is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)

Keywords: opioid constipation chronic pain
a phase i/ii safety and immunogenicity trial of ubi microparticulate monovalent (hiv-1 mn) branched peptide vaccine in hiv-1 seronegative human subjects

Conditions: HIV Infections

Summary: to evaluate the safety and immunogenicity of a combination of microparticulate monovalent hiv-1 mn synthetic branched peptide candidate vaccine for oral administration and monovalent hiv-1 mn synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk hiv-negative volunteers.

volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28, and 168. specifically, group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent vaccine given on day 168. group 2 receives the intramuscular vaccine first, on day 0, followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. volunteers are followed for 1 year.

Eligibility criteria:
inclusion criteria volunteers must have: * normal history and physical exam. * hiv negativity. * cd4 count \>= 400 cells/mm3. * intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry. * normal urine dipstick with esterase and nitrite. exclusion criteria co-existing condition: volunteers with the following symptoms or conditions are excluded: * active tuberculosis. * occupational or other responsibilities that would prevent completion of study. volunteers with the following prior conditions are excluded: * history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. * psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study. * history of anaphylaxis or other serious adverse reactions to vaccines. * history of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy. * acute gastroenteritis or gastrointestinal surgery within the past 12 months. prior medication: excluded: * live or attenuated vaccine within the past 60 days. * illicit or experimental agents within the past 30 days. intermediate or high risk sexual behavior. injection drug use within the past 12 months.

Keywords: vaccines, synthetic hiv-1 hiv envelope protein gp120 aids vaccines hiv seronegativity
ultrasonographic evaluation of diaphragm and quadriceps in chronic obstructive pulmonary disease (copd) patients

Conditions: COPD; COPD Exacerbation

Summary: the purpose of this study is to evaluate the prognostic role of echographic diaphragmatic assessment and vastus lateralis muscle ultrasound (us) in two independent populations of patients hospitalized for exacerbated chronic obstructive pulmonary disease (copd) or undergoing pulmonary rehabilitation. specific aims of this protocol are: 1) to analyze the correlation between qualitative and quantitative us parameters and severity of illness indicators and respiratory function data; 2) to detect the postrehabilitation outcomes in terms of diaphragmatic and vastus lateralis muscle function, assessed by us, and the correlation between these outcomes and indicators of pulmonary rehabilitation treatment effectiveness; 3) to evaluate the ability of qualitative and quantitative us parameters to predict in-hospital mortality and length of stay; 4) to evaluate the ability of qualitative and quantitative us parameters to predict exacerbation rate, hospitalization rate and mortality rate six months after the discharge.


Eligibility criteria:
inclusion criteria (group a): * copd diagnosis * previous or actual cigarette smoking history * copd exacerbation requiring hospitalization * obtained written informed consent exclusion criteria: * pleural effusion extended for more than two intercostal spaces * interstitial lung diseases * major surgery in the previous 30 days * right pleurodesis or fibrothorax * right stroke outcomes * technical impossibility to perform ultrasound evaluations * conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons * absence of written informed consent inclusion criteria (group b): * copd diagnosis * previous or actual cigarette smoking history * copd exacerbation requiring hospitalization in the previous 30 days * indication to undergo a pulmonary rehabilitation protocol * obtained written informed consent exclusion criteria: * pleural effusion extended for more than two intercostal spaces * interstitial lung diseases * major surgery in the previous 30 days * right pleurodesis or fibrothorax * right stroke outcomes * technical impossibility to perform ultrasound evaluations * conditions, clinical or otherwise, that in the investigator's judgment may interfere with the study, or not recommending participation for security reasons * absence of written informed consent

Keywords: multidimensional evaluation copd pulmonary rehabilitation diaphragmatic ultrasound vastus lateralis muscle ultrasound
acth gel therapy in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this research study is to evaluate if the study drug, acth gel helps decrease the disease symptoms in people with rheumatoid arthritis (ra) who are already taking medications prescribed by their physician and are still experiencing disease symptoms. acth gel has been a food and drug administration-approved treatment for rheumatoid arthritis since 1952, and in 2010 the fda retained ra as a disease approved for acth gel use. despite its fda approval there is very limited data on its how well acth gel works in improving the symptoms of people with ra.

this study is for people who are currently taking a biologic therapy for rheumatoid arthritis and who are still experiencing symptoms. subjects are given the acth gel to take twice each week for 12 weeks as a supplement to current therapies. subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks. we will obtain a blood sample for research purposes.

Eligibility criteria:
inclusion criteria: * 18 year of age and older * ra diagnosis by american college of rheumatology criteria * active disease (cdai \> 10) * have received at least are biologic agent for at least 6 months * may or may not be receiving oral daily steroids (less than or equal to 20 mg/day) of prednisone equivalent * no current active infections requiring antibiotics * patients must be on stable doses of ra therapies (e.g., methotrexate or other ra therapies for at least 4 weeks prior to baseline visit) exclusion criteria: * less than 18 years of age * unable or unwilling to give informed consent * have an active infection requiring the use of antibiotics * women who are pregnant * uncontrolled hypertension * abnormal renal function * abnormal liver function as defined by and increased alanine transaminase (alt,) and aspartate aminotransferase (ast) that is greater than 5 times normal.

Keywords: rheumatoid arthritis acth gel
performance of the dexcom continuous glucose monitoring (cgm) system in pregnant women with diabetes mellitus

Conditions: Diabetes Mellitus

Summary: performance of the dexcom continuous glucose monitoring (cgm) system in pregnant women with diabetes mellitus


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * confirmed pregnancy * diagnosis of gestational diabetes (gdm), type 1 diabetes mellitus (t1dm), or type 2 diabetes mellitus (t2dm) * willing to wear up to the required number of systems for the total duration of study wear * able to follow study procedures; * able to speak, read, and write in english or spanish. exclusion criteria: * extensive skin changes/diseases that preclude wearing the required number of systems at the proposed wear sites * known allergy to medical-grade adhesives * hematocrit outside specification * prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy * currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period * currently using hydroxyurea for treatment * require a magnetic resonance imaging (mri) scan, computed tomography (ct) scan, or diathermy during the sensor wear period
connect® mm- the multiple myeloma disease registry

Conditions: Multiple Myeloma

Summary: the purpose of the connect® mm registry is to explore the natural history and real world management of patients with newly diagnosed symptomatic multiple myeloma (mm) and provide unique insights into the management of mm and the impact of this hematologic disorder on patients.


Eligibility criteria:
inclusion criteria: cohort 1 and 2 * newly diagnosed with symptomatic mm within 2 months of enrollment in connect® mm registry * age ≥18 years * willing and able to provide signed informed consent * agrees to complete patient assessment questionnaires either alone or with minimal assistance from caregivers and/or trained site personnel cohort 3 * received 1l therapy for symptomatic active mm and subsequently has evidence of disease progression. prior 1l mm treatment received, including anti-myeloma therapy, transplant, chemotherapy, radiation, and surgery, must be known. * initiated or intends to initiate 2l systemic therapy for mm after the first documented relapsed/refractory date (i.e. 1l pd). * enrollment date must be within 90 days of start date (or intended start date) of 2l systemic therapy. exclusion criteria: cohort 1 and 2 - none cohort 3 * patient's 1l mm treatment was for smoldering mm or mgus, and not for symptomatic mm * currently active in any mm registry, including but not limited to, the connect® mm registry or another celgene/bms-sponsored registry. * patients who have discontinued from connect® mm or another celgene/bms-sponsored registry could be considered for enrollment in cohort 3, if inclusion and exclusion criteria are met. * currently enrolled or intending to enroll within 90 days in any interventional clinical trial in which any treatment is an investigational product that cannot be identified

Keywords: multiple myeloma mm disease registry connect®
a comparison study of persistence of upadacitinib vs. tnf-inhibitors in a german real-world setting

Conditions: Moderate to Severe Rheumatoid Arthritis

Summary: this study will compare the retention rates for upa vs. tnfi treatment in adult participants with moderate to severe active ra per local label and according to local standard of care this is a mono-country, prospective, multi-center observational study in patients with moderate to severe active ra receiving upa or tnfi therapy. around 678 participants will be enrolled in approximately 80 sites in germany. study recruitment will last approximately 24 months, and the study participation time will be up to 24 months, for a total study duration of approximately 48 months.


Eligibility criteria:
inclusion criteria: * current or past participants with a confirmed diagnosis of moderate to severe active ra upon judgement of the treating physician. * physician decision on participant treatment with upadacitinib (upa) or tumor necrosis factor inhibitor (tnfi) must have been reached prior to and independently of recruitment in the study * upa or tnfi prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies exclusion criteria: * participation in a clinical trial with an investigational drug (within a minimum of 30 days or 5 half-lives of the investigational drug \[whichever is longer\] prior to baseline) * prior treatment with upadacitinib * prior treatment with the same tumor necrosis factor inhibitor as the one prescribed for this study

Keywords: moderate to severe rheumatoid arthritis rheumatoid arthritis upadacitinib tumor necrosis factor inhibitor treatment
preliminary study of ca-008 (vocacapsaicin) in patients undergoing ventral hernia repair

Conditions: Postsurgical Pain

Summary: a three-part, phase 1/2, randomized, double-blind, placebo-controlled, adaptive safety, pharmacokinetics, and preliminary efficacy study of ca-008 (vocacapsaicin) in patients undergoing ventral hernia repair


Eligibility criteria:
inclusion criteria: * scheduled elective, primary, open laparotomy with vhr, with retromuscular, preperitoneal mesh placement, with midline fascial reconstruction * asa physical class 1, 2, or 3 * bmi \</= 40 kg/m2 * aged 18-80 years old exclusion criteria: * concurrent condition requiring analgesic treatment during study period * opioid tolerant * known allergy to capsaicin or other study medication * use of prohibited medications
genomics and efficacy of post-prostatectomy salvage radiotherapy with 'extreme' hypofractionation

Conditions: Prostatic Neoplasms

Summary: the study aims to validate the decipher® genomic test, in which patients with biochemical recurrence after radical prostatectomy are treated with salvage radiotherapy with extreme hypofractionation (5+ gy/fraction). validating the decipher® genomic classifier based on the expression of 22 rna genes in the prospective study "essbrt"

the essbrt study ("early salvage stereotactic radiotherapy (essbrt) for biochemical recurrence after radical prostatectomy: a phase ii study", rs1705/22 - opinion of the central ethics committee irccs lazio, section ifo - fondazione bietti of 4 august 2022; nct05667636) is a prospective phase ii study developed and currently active at the institute's radiotherapy unit, in which patients with biochemical recurrence of the disease after rp are treated on the prostatic lodge, and possibly on the pelvic lymph node stations, with hypofractionated radiotherapy in 5 sessions (5 gy/fx). the aim is to be able to have a genomic classifier, such as decipher®, for the patients enrolled in this protocol in order to complete the predictive evaluation. furthermore, the project plans to profile pca samples using a 'comprehensive' panel of about 500 genes that allows to identify a specific molecular profile in the respective risk classes (low, intermediate and high) stratified with decipher®. this evaluation would allow to identify the mutational structure of prostate cancer in an early stage of the disease, in particular by identifying the molecular alterations of the genes involved in homologous recombination repair (hrr) such as brca1, brca2, atm, cdk12, chek2, palb2. the hypothesis is that the decipher® risk classes (low, intermediate and high) correspond to a different risk of biochemical disease progression (defined as an increase in total psa of 0.2 ng/ml above the nadir) independently or in addition to conventional clinicopathological criteria.

Eligibility criteria:
inclusion criteria: * patients enrolled at ire under the "essbrt" protocol (meeting the criteria of the same); * patients who express written informed consent personally or through their legal representative/witness/curator/guardian/support administrator (participation in the ancillary study and data processing) exclusion criteria: * all exclusion criteria adopted for the "essbrt" study.