Kornimate/medical-research-clean huggingface dataset:
a phase 2 study of intravenous amb-05x in tenosynovial giant cell tumor patients

Conditions: Tenosynovial Giant Cell Tumor; Pigmented Villonodular Synovitis; TGCT; PVNS - Pigmented Villonodular Synovitis

Summary: the purpose of this phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous amb-05x in the treatment of subjects with tgct.

amb-05x drug substance is a human monoclonal antibody against the colony-stimulating factor 1 receptor (csf1r).

Eligibility criteria:
inclusion criteria: 1. subject ≥ 18 years 2. a confirmed diagnosis of tgct 3. measurable disease based on recist v1.1 4. symptomatic disease 5. stable prescription of analgesic regimen 6. agrees to follow contraception guidelines 7. adequate hematologic, hepatic, and renal function, at screening 8. willing and able to complete self-assessment instruments throughout the study exclusion criteria: 1. prior investigational drug use within 4 weeks or 5 half-lives of baseline 2. current or prior radiotherapy within 3 months before baseline 3. current or prior active cancer within 3 years before baseline that requires/required therapy (eg, surgery, chemotherapy, or radiation therapy) 4. known metastatic tgct or malignant transformation of diffuse-type tgct 5. hepatitis c virus (hcv) or hepatitis b virus (hbv) or known active or chronic infection with human immuno deficiency virus (hiv) 6. known active tuberculosis (tb) 7. significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history 8. women who are pregnant or breastfeeding 9. screening fridericia-corrected qt interval(qtcf) ≥450ms (men) or ≥470ms (women) 10. mri contraindications (eg, pacemaker, loose metallic implants) 11. history of hypersensitivity to any ingredient in the study drug 12. history of drug or alcohol abuse within 3 months before baseline 13. has any other severe acute or chronic medical or psychiatric condition or clinically significant laboratory abnormality that may increase the risk associated with study participation/treatment, interfere with interpretation of study results, or, in the investigator's opinion, make the subject inappropriate for this study 14. a person who is held in detention as the result of a judicial or official decision or who is in a subordinate relationship to the sponsor or investigator 15. a subject who, in the opinion of the investigator, should not participate in the study for any reason, including if there is a question about the subject's ability to comply with study requirements

Keywords: tenosynovial giant cell tumor, tgct, pvns
a study to test the effect of cyclosporine on the immune system of patients with early hiv disease

Conditions: HIV Infections

Summary: the purpose of this study is to determine the safety and effectiveness of low doses of cyclosporine (csa) in patients with early hiv infection and to evaluate its effect on the immune system. activation of t cells (cells of the immune system) leads to hiv replication. inhibition of immune activation is therefore a potentially important area of therapy for patients with early hiv infection. csa is capable of decreasing t cell activation, which in turn may decrease hiv replication.

there is increasing data on the potential for inhibition of immune activation as primary therapy for hiv infection. the rationale of csa therapy is to decrease t cell activation in patients with early hiv infection. activation of t cells leads to translation and transcription of provirus, release of viral progeny, and ultimately cell death. t cell activation also leads to increased cell death via apoptosis. csa is capable of inhibiting both these events and thus may lead to decreased cd4 cell turnover. this study has 2 arms of 15 patients each. patients in arm i receive placebo. patients in arm ii receive csa. each arm is further divided into 2 strata. stratum 1 patients are not allowed to receive antiretroviral therapy. stratum 2 patients must receive 1 of the following 4 stable nucleoside analogue combinations: 1. zidovudine (zdv) plus lamivudine (3tc) 2. zdv plus didanosine (ddi) 3. stavudine (d4t) plus 3tc 4. d4t plus ddi.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * have a cd4 count greater than or equal to 500/mm3. * have a plasma hiv rna level greater than 600 copies/ml. * are over 18 years of age. * agree to practice abstinence or use barrier methods of birth control during the study. exclusion criteria you will not be eligible for this study if you: * have a history of an aids-defining illness, autoimmune disease, or hypertension. * have renal disease. * have any active infection other than hiv. * have used certain antiretroviral medications. * are pregnant.

Keywords: t-lymphocytes lymphocyte transformation hiv-1 drug therapy, combination immunosuppressive agents apoptosis cyclosporine anti-hiv agents
ultrasound-guided serratus and transversus thoracic muscle plane block vs. erector spinae plane block for acute poststernotomy pain

Conditions: Pain, Acute; Pain, Chest

Summary: poststernotomy pain represents a complication that can arise following cardiac surgery. inadequately managed pain has been linked to various adverse outcomes, including myocardial ischemia, cardiac arrhythmias, heightened coagulation tendencies, pulmonary complications, and elevated incidences of delirium and wound infections. the erector spinae plane (esp) block, serratus anterior plane (sap) block, and transverse thoracic muscle plane (ttmp) block are demonstrated as effective regional anesthesia techniques for sternotomy pain. while these blocks differ in ease of application and efficacy, the optimal analgesic approach for cardiac surgery remains unclear. the aim of this study is to compare the analgesic efficacy of ultrasound-guided sap and ttmp blocks combination versus esp block administered alone in patients undergoing open heart surgery.


Eligibility criteria:
inclusion criteria: * cardiac surgery with median sternotomy (valvular and coronary surgeries) exclusion criteria: * minimal invasive cardiac surgeries * revision surgeries (during postoperative 48 hours) * redo cardiac surgeries * any contraindications for regional anesthesia technique (any allergies for local anesthetics) * preoperative chronic opioid usage
tai chi for enhancing motor and cognitive function in parkinson's disease

Conditions: Parkinson Disease

Summary: the purpose of this feasibility study is to preliminarily evaluate the effects of tai chi - a mind-body exercise - on motor and cognitive function as well as quality of life in individuals recently diagnosed with parkinson's disease (pd).

specific aim 1: to assess the feasibility of recruiting and retaining individuals with pd into a 6-month randomized controlled trial of tai chi exercise. specific aim 2: to collect preliminary data on the efficacy of tai chi on improving gait and balance dynamics, physical and cognitive function, exercise activity, self-efficacy, mood, and quality of life in individuals with pd.

Eligibility criteria:
inclusion criteria: * individuals recently diagnosed with idiopathic pd (≤ 10 years) * limited disease progression * if taking pd-related medication, willingness to undergo baseline and follow-up testing while off medication * willingness to commit to the study protocols and complete tai chi program * willingness to be videotaped and audio-recorded during testing exclusion criteria: * diagnosis of any form of atypical parkinsonism * history of: stroke, head trauma, brain tumor, brain injury, seizures or other central nervous system condition, orthopedic impairment or other disease that could likely contribute to a gait disturbance or parkinsonism * any severe, chronic condition or acute medical event for which participation in exercise programs is contraindicated (e.g. debilitating rheumatoid arthritis, history of frequent falls, unhealed fracture)\*\* \*\* unless the participant is able to obtain formal written approval from his/her treating physician granting permission to participate in our tai chi exercise program * participation in brain stimulation within the past 3 months * family history of seizures or unexplained loss of consciousness * current history of dementia or severe psychiatric illness. patients with mild (non-suicidal) depression and/or anxiety may be included * acute illness requiring hospitalization within past 3 months * history of deep brain stimulation or other brain surgery * participation in brain stimulation within the past 3 months * regular use of walking aid * significant tai chi experience (\> 6 months training in past 2 years)
umbilical cord-derived mesenchymal stem cell exosomes on hair growth in patients with androgenetic alopecia

Conditions: Androgenic Alopecia

Summary: a total of 50 patients with androgenetic alopecia were selected for the study. patients who met the inclusion/exclusion criteria were randomly assigned to groups a and b in a 1:1 ratio to receive treatment, with the enrollment date designated as day 1. group a visited the clinic once each in the first, second, and third months for treatment with exosomes, while group b visited the clinic twice each in the first, second, and third months for treatment with exosomes. at the time points of 1, 2, 3, and 6 months after the start of the treatment period, dermatoscopic examinations were conducted on patients in both groups. the differences in hair growth density, hair shaft thickness, and follicle counts within a 1 cm diameter area were compared between the two groups. additionally, the data differences for each subject at baseline and at the end of the experiment were also assessed.


Eligibility criteria:
inclusion criteria:clinical diagnosis of androgenic alopecia · aga classification include：the no grade for male hair loss was ii-v, and the ludwig grade for female hair loss was i-iii exclusion criteria: (1) using medications or supplements, including finasteride, dutasteride, minoxidil or any other hormonal products, that can affect hair growth; · (2) patients with severe diseases, immune diseases, endocrine diseases and nervous system diseases; (3) patients with infection, allergic disease and malignant tumor
enhancing influenza vaccination in seniors with tlr (toll like receptor) agonists

Conditions: Influenza Vaccination in Seniors

Summary: the application of the tlr7/8 (toll like receptor) agonist gel (immune response helper) resiquimod will enhance the immune response to the intradermal influenza vaccine in seniors 65-75 years of age.


Eligibility criteria:
inclusion criteria: * written informed consent provided by the subject, who can be male or female * subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations and able to converse with study personnel including by personal telephone * male or female age 65-75 years at visit 1 * in generally good health (stable chronic conditions acceptable), living independently or with minimal assistance (clinical frailty score 1-5) and able to attend clinic appointments * receipt of influenza vaccination for the 2012-2013 influenza season exclusion criteria: * receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of visit 1 or planned administration of any non-study vaccines between visits 1 and 2 * systemic hypersensitivity to influenza vaccine, hen's eggs or other vaccine constituent e.g. neomycin sulphate, kanamycin, formalin * severe reaction to any previous influenza vaccine or vaccine component * bleeding disorder, including anticoagulant therapy or thrombocytopenia, that contraindicates im (intramuscular) injection or blood collection (does not include daily low dose asa (acetylsalicylic acid), plavix, and certain other mild anticoagulants with minimal bleeding risk) * incapacity to provide fully informed consent or be attentive to follow-up observations, resulting from cognitive impairment, abuse of alcohol, or drug addiction * lack of telephone access, inadequate fluency in english, uncertain availability during the 4 week study participation * immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months of visit 1 * receipt of blood or blood products within 3 months of visit 1 * unstable medical conditions, as indicated by a requirement for hospitalization or a substantial medication change to stabilize said condition within 3 months. * personal frailty, determined by clinical frailty score of 6-7 (moderately frail or severely frail)or failure on the tug test (timed up and go time greater than 10 seconds) or inability to walk 1/4 mile, based on self report * history of guillain-barre syndrome * psoriasis * recent or current febrile illness with oral temperature greater or equal to 38.0 degrees centigrade or other moderate to severe illness within the previous 48 hours (may vaccinate once condition has resolved)

Keywords: influenza, human influenza vaccines older adults immune response
use of intra-operative shear wave ultrasound vibrometry for characterization of esophageal malignant tumors

Conditions: Esophageal Cancer

Summary: using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.

use of ultrasound-based vibrometry in this setting would allow for a relatively simple study and translation of clinical practice, as the same devices are already used in this setting, and operators have familiarity with the equipment. incorporating another additional method to generate contrast for determining malignant tissue from normal based on biomechanical properties with the same probe would have benefit as an additional diagnostic modality.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * scheduled to undergo esophageal reconstruction for presumed or known esophageal cancer * subject is able to understand the study procedures and provide informed consent. exclusion criteria: * subject is pregnant or breast feeding.
spine registration using 3d scanning

Conditions: Spinal Fusion; Spinal Stenosis; Scoliosis; Spondylolisthesis

Summary: the primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.


Eligibility criteria:
inclusion criteria: 1. patients that require exposure of bony posterior spine anatomy for localization as standard of care. 2. clinically planned for spine surgery. 3. able to provide written informed consent from subject or subject's legal representative, using irb approved consent form, and ability for subject to comply with the protocol requirements of the study. exclusion criteria: 1. language problems that would prevent from properly understanding instructions. 2. requirement of an interpreter. 3. patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study. 4. special populations: pregnant women, prisoners. 5. minimally invasive spine surgery that does not expose the necessary bone/s. 6. spine surgery without posterior exposure.
pharmacist case finding and intervention for vascular prevention trial

Conditions: Cardiovascular Risk Factors; Blood Pressure; Cardiovascular Disease; Diabetes; Dyslipidemia

Summary: heart disease is a common and serious medical condition which causes nearly one in every three deaths worldwide every year. the factors which increase people's risk for heart disease are well-known, but there needs to be more support given to people to reduce their risk of heart disease. pharmacists are front line primary healthcare providers who see patients more frequently than any other healthcare provider and can help people reduce their risk of heart disease. this research project aims to see whether a pharmacist-led intervention can help people reduce their risk of heart disease. the potential impact of this project is to empower people to understand how to reduce their risk of heart disease and reduce the burden of heart disease on the community.


Eligibility criteria:
inclusion criteria: * adults (18 years or older) * clinical diagnosis of at least one of the following conditions: * diabetes, * chronic kidney disease, * chronic inflammatory condition (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, systemic lupus erythematosus or psoriasis), * atherosclerotic vascular disease, * hypertension, * obesity (defined as body mass index greater than 30), * current tobacco or vape use exclusion criteria: * unwilling to participate/sign consent form; * unwilling or unable to participate in regular follow-up visits; or * pregnant

Keywords: cardiovascular blood pressure diabetes dyslipidemia
regorafenib in subjects with metastatic colorectal cancer (crc) who have progressed after standard therapy

Conditions: Colorectal Neoplasms

Summary: this is a phase iii b, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access. regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. a kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. by specifically targeting these proteins, regorafenib may stop cancer growth. the growth of the tumor may be decreased by preventing these specific proteins from functioning. the primary endpoint of this study will be safety.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 years of age * life expectancy of at least 3 months * histological or cytological documentation of adenocarcinoma of the colon or rectum. all other histological types are excluded. * subjects with metastatic colorectal cancer (stage iv) * progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab (if kras wt) (wt: wild type) * ecog performance status of ≤ 1 (ecog: eastern cooperative oncology group) * adequate bone marrow, liver and renal function * women of childbearing potential and men must agree to use adequate contraception exclusion criteria: * prior treatment with regorafenib * congestive heart failure \>/= new york heart association (nyha) class 2 * uncontrolled hypertension (systolic blood pressure \> 140 mmhg or diastolic pressure \> 90 mmhg despite optimal medical management) * any hemorrhage or bleeding event \>/= ctcae grade 3 within 4 weeks prior to the start of study medication. * persistent proteinuria of ctcae grade 3 (\>3.5g/24 hours) * unresolved toxicity higher than ctcae (v. 4.0) grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity \</= grade 2 * systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin c) before starting to receive study medication
comparison of efficacy, safety, and tolerability of itca 650 to empagliflozin and glimepiride as add-on metformin

Conditions: Diabetes Mellitus, Type 2

Summary: a phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of itca 650 compared to empagliflozin and to glimepiride, as add-on therapy to metformin in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * diagnosis of t2d 3 months prior to the screening visit. * body mass index (bmi) between ≥25 to ≤45 kg/m2 at the screening visit. * glycosylated hemoglobin a1c (hba1c) ≥7.5 and ≤10.5%. 5. 6. on a stable (3 months prior to the screening visit) treatment regimen of metformin monotherapy of ≥1500 mg/day). exclusion criteria: * history of type 1 diabetes. * prior participation in a clinical study involving itca 650. * treatment with any glp-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to screening. * history or evidence, within the last 6 months prior to the screening visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke. * history or evidence of acute or chronic pancreatitis. * history of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2. * treatment of medications that affect gi motility. * history of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients. * women that are pregnant, lactating, or planning to become pregnant. * chronic (\>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.
the tailgate study: a pilot study measuring the impact of acute alcohol intake on intrahepatic lipid

Conditions: Obesity

Summary: college drinking associated with sporting events is characterized by excess alcohol, along with food intake, over the duration of hours has the potential to cause a build up of fat in the liver. fatty liver can increase blood glucose concentrations leading to a prediabetes like state. the present study will determine how overweight men respond to the over-consumption of alcohol/food to identify which characteristics might protect some men from fatty liver, while others might be more susceptible to this condition. the goal of this work is to determine the direct impact of alcohol/food intake to cause acute fatty liver through the stimulation of de novo lipogenesis in 20 overweight, healthy men. understanding individual susceptibility to alcohol-induced fatty liver will aid in the development of strategies designed to help people mitigate these risks. hypothesis is that 5h excess consumption of alcohol and food will increase liver triglycerides by 4% or more, in comparison to fasting state.

subjects will participate in a single screening visit and a 24 hours in-patient stay at the clinical research center for treatment and tests. no drugs will be used in this study, however, amounts of alcohol will be consumed to achieve, and maintain a breath alcohol at the legal limit (0.10). the goals are to quantitate the increase in lipogenesis due to acute alcohol/food intake and to determine the effects of acute alcohol/food intake on liver-triglycerides.

Eligibility criteria:
inclusion criteria: * men * age 21-40 * bmi 25.1-35.0 kg/m2 * waste girth \< 55 inches * nonsmoking * moderate consumer of alcohol * fasting blood glucose \< 125 mg/dl, alanine transaminase activity \< 40 milliunits/l, plasma triglycerides \< 200 mg/dl * sedentary * free of metabolic disorders exclusion criteria: * bmi \ 35.0 kg/m2 * waste girth of greater 55 inches * use of any tabacco product * fasting plasma glucose ≥125 mg/dl, alanine transaminase activity ≥ 40 milliunits/l, plasma triglycerides ≥125 mg/dl * physically active * diabetes or other diseases that impact blood glucose or lipids * fatty liver disease

Keywords: obesity