Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of imrecoxib in subjects with hepatic insufficiency

Conditions: Knee Osteoarthritis

Summary: this clinical research study will assess pharmacokinetics and the safety of imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.


Eligibility criteria:
inclusion criteria: all subjects: * between the ages of 18 to 70 years, with bmi 18\~ 29kg/m2. * in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values(except for values related to hepatic insufficiency). hepatic impaired subjects: * hepatocirrhosis subjects verified by b-mode ultrasonography,ct ,mri or biopsy. * a child-pugh classification score clinically determined as class b. exclusion criteria: all subjects: * history of hypersensitivity to imrecoxib or its components. subjects diagnosed with tumor. * history of or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, or psychiatric diseases. * have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome p450 enzymes including cytochrome p450 3a4, cytochrome p450 2c8 and cytochrome p450 2c9 within 28 days prior to the first dose and throughout the study. * have taken other investigational drugs or participated in any clinical trial within 90 days prior to first dose of study drug in this study. hepatic impaired subjects: * subjects with hepatic failure,or severe complications caused by hepatocirrhosis.
bronchoscopic lung ablation of small thoracic tumors: the blastt registry

Conditions: Thoracic Tumors

Summary: to aggregate, integrate, and analyze data facilitating the study of md anderson patients with a known diagnosis of lung cancer or metastases to the lungs who undergo robotic assisted bronchoscopic ablation of peripheral tumors.

a. to aggregate, integrate, and analyze data facilitating the study of md anderson participants with a known diagnosis of lung cancer or metastases to the lungs who undergo robotic assisted bronchoscopic ablation of peripheral tumors. b. to assess the intra-operative, peri-operative, and long-term safety outcomes of robotic assisted bronchoscopic ablation of peripheral lung tumors. c. to evaluate different oncologic outcomes including local tumor progression (ltp) by recist criteria, local tumor progression free survival (ltpfs), progression free-survival (pfs), disease (cancer) specific survival (dss), and overall survival (os). d. to provide a deeper understanding of the evolution of radiographic findings of bronchoscopically ablated lung tumors over time. e. to evaluate tumor and participant-related risk factors that may be associated with safety (bleeding, pneumothorax, and local infection) and oncologic outcomes (ltpfs, pfs, dss, and os).

Eligibility criteria:
inclusion criteria: * md anderson participants (defined as those with an md anderson medical record number) with peripheral lung tumors (primary or metastatic) that have been or will be ablated via robotic bronchoscopy. exclusion criteria: * patient with planned bronchoscopic ablations of peripheral lung tumors that were aborted for technical reasons (ablation was not completed).
the efficacy and safety of bortezomib combined with fludarabine and cytarabine treatment for mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: mantle cell lymphoma (mcl) is a type of non-hodgkin's lymphoma (nhl) and shows poor survival. this study to evaluate the efficacy and safety of bortezomib combined with fludarabine and cytarabine treatment in the naive and relapsed mcl who are not eligible for high dose therapy and transplantation.

the eligibility criteria were pathologically confirmed, previously untreated mcl or relapsed mcl as defined by the world health organization classification; age≥18 years; eastern cooperative oncology group (ecog) performance status of 0-2; adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l), hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); normal coagulation function and electrocardiogram results. stage was defined according to the ann arbor system. the fujian medical university union hospital approved this study before subjects were enrolled. treatment dosages were as follows: days 1,4,8,and 11 subcutaneous infusion of 1.3mg/m2 bortezomib. days 1-3 intravenous infusion 25mg/m2 fludarabine. days 1-3 intravenous infusion of 500mg/m2 cytarabine. the regimen was repeated every 28 days for a maximum of six cycles.

Eligibility criteria:
inclusion criteria: inclusion criteria: 1. pathologically confirmed, previously untreated mcl or relapsed mcl as defined by the world health organization classification; 2. age≥18 years; 3. eastern cooperative oncology group (ecog) performance status of 0-2; 4. adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l), 5. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal), 6. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min); 7. normal coagulation function and electrocardiogram results. 8. willingness to provide written informed consent. exclusion criteria: 1. mcl patients who do not response or are refractory to preview treatment. 2. who do not sign the consent form. 3. whose life expectation is less than 6 months.

Keywords: mantle cell lymphoma bortezomib fludarabine cytarabine
glucose/insulin responses:subjects with type 2 diabetes consuming diabetes-specific vs standard nutritional formulas

Conditions: Diabetes Mellitus Type 2

Summary: to measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.


Eligibility criteria:
inclusion criteria: * signed and dated informed consent * 18-75 years of age * history of type 2 diabetes * males and non-pregnant, non-lactating females exclusion criteria: * subject uses insulin for glucose control * significant cardiovascular event \<12 weeks prior to study entry * active malignancies * history of end stage renal disease * history of organ transplant * current hepatic disease * intervention for hib * takes niacin * history of gastroparesis * active disease that may interfere with nutrient intake * allergy or intolerance to ingredients in the study products
treadmill training with lower extremity amputees

Conditions: Traumatic Amputation of Lower Extremity

Summary: many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. the purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.


Eligibility criteria:
inclusion criteria: * leg amputation that is either below the knee, through the knee, or above the knee * ability to walk with prosthetic * comfortably fitted with a prosthesis for at least 6 months * not currently receiving physical therapy for gait training * able to tolerate a moderate intensity exercise program exclusion criteria: * people with severe cardiac or pulmonary disease that limits ability to exercise. * people with too much discomfort and/or pain that restricts their ability to walk. * people with active wounds on their residual limb or contralateral foot. * people who weigh more than 360lbs or are taller than 6'11" as the unweighing system can not support any greater load or height.

Keywords: amputees
testimonials and navigation in rheumatology

Conditions: Rheumatologic Disease; Autoimmune Diseases

Summary: the overall goal of this study is to determine whether a novel, multi-modal, patient-directed behavioral intervention initiated in rheumatology clinics is an effective approach to improve uptake of updated covid-19 vaccine.

black and latinx persons are at higher risk for certain autoimmune and inflammatory rheumatic diseases (aird) and have experienced worse covid-19 outcomes compared to their white counterparts. given the risks of severe covid-19 outcomes such as hospitalization and death in people with aird, covid-19 vaccine is recommended in this population. historically, overall vaccine uptake among people with airds has been low, and this vaccine reluctance has extended to covid-19 vaccination. while additional covid-19 vaccine doses have offered considerable added protection against severe outcomes, only 20% of all vaccinated persons in alabama (al) and 45% in massachusetts have obtained an additional dose of covid-19 vaccine as of october 2022. racial and ethnic minority groups have faced disparities in obtaining subsequent covid-19 vaccines, particularly in under-resourced communities, including those in alabama and massachusetts. together, these obstacles exacerbate existing health inequities among people of color and perpetuate worse covid-19 outcomes. we will conduct a randomized controlled study to test an intervention that seeks to address gaps in covid-19 vaccine information and access inequities common in black and latinx populations.

Eligibility criteria:
inclusion criteria: * adults (18+ years) with known aird * black race and/or latinx ethnicity * individuals who have not obtained the updated covid-19 vaccine series (self-report) exclusion criteria: -lack of access to phone

Keywords: covid-19 vaccination rheumatic diseases
osteoporosis in children and adults following liver transplantation

Conditions: Osteoporosis; Liver Transplantation

Summary: this pilot project aims to 1) estimate the prevalence of osteoporosis in adults having undergone liver transplantation in childhood, and 2) identify risk factors for osteoporosis in this group. we aim to study 40 individuals.

background: osteoporosis is defined as an absolute decrease in the amount of bone (volume and/or density). chronic liver disease is associated with osteoporosis in both adults and children. bone density is also decreased in the months immediately after liver transplantation, but improves to pretransplant values after 1 to 2 years. immunosuppressive agents, most notably steroids, are a cause of osteoporosis. however, studies on adults have shown that bone densities afer transplantation continue to improve within the normal range for healthy adults. in the case of children, bone accretion is necessary for growth. chronic liver disease and transplantation in childhood will have an adverse effect on bone metabolism and the outcome in terms of bone density after the growth period cannot be predicted on individuals transplanted as adults or other transplant groups.

Eligibility criteria:
* liver transplantation in childhood or young adulthood
pharmacological properties of salmeterol

Conditions: Pharmacokinetics in Healthy Young Men

Summary: the objective of the study is to help establish a urinary threshold for salmeterol on the world anti-doping agency prohibited list, to avoid supratherapeutic of this substance in competitive sports. hence, there is no hypothesis as such.


Eligibility criteria:
inclusion criteria: * male * 18-45 years * healthy exclusion criteria: * chronic disease * smoking * habitual use of medicine * allergy towards salmeterol * unable to exercise on a bike ergometer

Keywords: salmeterol pharmacokinetics doping beta2-agonists long-acting beta2-agonists
the optimal timing of primaquine to prevent malaria transmission after artemisinin-combination therapy

Conditions: Malaria Transmission

Summary: the investigators' hypothesis is that "the correct timing of gametocytocidal drug in combination with an effective artemisinin combination therapy can limit the infectiousness of malaria-infected individuals to less than one week after initiation of treatment"

global malaria elimination is back on the agenda, gametocytocidal drugs such as primaquine are currently advocated for use in the interventions that aim to interrupt malaria transmission and hence elimination. mature gametocytes are responsible for malaria transmission. artemisinin based combination therapies (acts) has limited effect on the young gametocytes. primaquine is able to clear mature gametocytes that remain after treatment with acts. complete clearance of mature gametocytes will depend on the ideal time primaquine is given after act. it is important therefore that is administered at optimal time in order to have significant impact on clearing gametocytes to interrupt malaria transmission. an additional consideration is operational administration of primaquine and compliance both of which are likely to be enhanced if the drug is administered on the day of diagnosis. in this study, the investigators aim to determine optimal timing of primaquine administration in addition to act by comparing administration on day 0 with administration on day 2. the investigators' primary end points are gametocyte prevalence and density by microscopy and quantitative nucleic acid based amplification (qt-nasba) on day 14, which will be compared between the two primaquine treatment arms.

Eligibility criteria:
inclusion criteria: * age 3 years - 17 years * residents of research area * willingness to come for complete scheduled follow-up. * uncomplicated malaria with p. falciparum mono-infection * axillary temperature \> 37.5°c and \< 39.5°c, or history of fever in previous 48 hours. * no history of adverse reactions to study medication * understanding of the procedures of the study by parent or guardian and willing to participate by signing written informed consent forms exclusion criteria: * haemoglobin below 9g/dl * inability to take drugs orally * known hypersensitivity to any of the drugs given * reported treatment with antimalarial chemotherapy in the past 2 weeks * evidence of chronic disease or acute infection other than malaria * domicile outside the study area * signs of severe malaria( such as respiratory distress, altered consciousness deep breathing, anaemia) * participating in other malaria studies conducted in the region * mixed malaria parasite species infection * positive pregnant test by urine (upt) if participant is female aged above 12 years * g6pd deficient using the fluorescence spot test
assessment of nutritional knowledge, habits, and eating behavior in athletic women to evaluate the possible impact on their menstrual function

Conditions: Hypothalamic Amenorrhea, Functional

Summary: the present study aims to investigate the degree of knowledge about nutrition and dietary habits in athletic women through validated questionnaires and to evaluate a possible impact on their menstrual function, including women with a diagnosis of functional hypothalamic amenorrhea (fha) and women who present with a different menstrual dysfunction (oligomenorrhea or polymenorrhea in absence of organic causes).


Eligibility criteria:
inclusion criteria: * female sex * age 16-30 years * physical activity \> 2 days per week * informed consent from the patient and/or an authorized legal representative exclusion criteria: * menstrual disorders of organic cause (ovarian cysts, uterine fibroids, polyps, etc.) * concomitant non-reproductive organic diseases (hypertension, diabetes, etc.) * use of psychopharmacological therapies * language barrier

Keywords: functional hypothalamic amenorrhea eating disorders
pep005 gel - evaluation of the safety and efficacy of ingenol mebutate gel on a superficial basal cell carcinoma on the trunk or extremities

Conditions: Superficial Basal Cell Carcinoma

Summary: this study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with pep005 (ingenol mebutate) gel, 0.05% will be safe and tolerable in patients with superficial basal cell carcinoma (sbcc) lesions on the trunk and extremities.


Eligibility criteria:
inclusion criteria: * must be male or female and at least 18 years of age * female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception * ability to provide informed consent * primary diagnosed and histologically confirmed sbcc located on the trunk or extremities which is suitable for excision exclusion criteria: * location of the sbcc lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area. * undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit. * use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit * use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area. * have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or uvb in the last 4 weeks * have undergone treatment with 5-fu, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit. * use of systemic retinoids. * those who are currently participating in any other clinical trial * those known or suspected of not being able to comply with the requirements of the protocol * females who are pregnant or are breastfeeding

Keywords: pep005 peplin sbcc
study of mln4924, a novel inhibitor of nedd8 activating enzyme, in adult patients with lymphoma or multiple myeloma

Conditions: Hematologic Malignancies; Multiple Myeloma; Lymphoma; Hodgkin Lymphoma

Summary: this is an open-label, multicenter, phase 1, dose escalation study of mln4924 in adult patients with lymphoma or multiple myeloma. the patient population will consist of adults with a confirmed diagnosis of lymphoma (waldenstrom's macroglobulinemia is permitted) or multiple myeloma that is relapsed and/or refractory after at least 2 prior standard chemotherapeutic regimens and for which no curative option exists. patients in the expansion cohort, schedule e, must specifically have hodgkin lymphoma, dlbcl-gcb subtype, dlbcl-non-gcb subtype, or mantle cell lymphoma (mcl). patients with multiple myeloma will no longer be evaluated as a part of this study.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status 0-2. * patients must have a confirmed diagnosis of lymphoma (waldenstrom's macroglobulinemia is permitted) or multiple myeloma that is relapsed and/or refractory after at least 2 prior standard chemotherapeutic regimens and for which no curative option exists. 1. as of protocol amendment 7, patients in the expansion cohort, schedule e, must specifically have hodgkin lymphoma, dlbcl-gcb subtype, dlbcl-non-gcb subtype, or mantle cell lymphoma (mcl). patients with multiple myeloma will no longer be evaluated as a part of this study. * tumor that is evaluable by radiography, serum or urine electrophoresis (for patients with multiple myeloma), or clinical evaluations. 1. as of protocol amendment 7, tumor that is evaluable by radiography or clinical evaluations. * suitable venous access for the conduct of blood sampling for mln4924 * adequate organ function exclusion criteria: * systemic antineoplastic therapy within 21 days preceding first dose of study treatment, or rituximab therapy within 2 months preceding first dose of study treatment (unless there was evidence of pd since their last dose of rituximab). * treatment with corticosteroids within 7 days preceding first dose of study treatment. * prior treatment with radiation therapy involving \>25% of bone marrow; any radiotherapy within 14 days before first dose of study treatment. * treatment with cyp3a inducers within 14 days before the first dose of mln4924. moderate and strong cyp3a inhibitors and cyp3a inducers are not permitted during the study. * patients requiring coumadin who cannot be switched to a low molecular weight heparin should not be considered for this study. * absolute neutrophil count less than 1,000/mm3; platelet count less than 75,000/mm3. * calculated creatinine clearance less than or equal to 50 ml/minute.
cesarean-scar thickness and closure technique

Conditions: Uterine Scar Remodeling

Summary: the aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy closure technique.

the aim of this prospective, randomized controlled trial was to longitudinally evaluate uterine-scar remodeling via transvaginal ultrasound after single- or double-layer uterine closure six weeks and at least six months after cesarean delivery. the women were included at their booking visit for an elective cd or during labor before an nonemergent cd. they were randomly assigned for three different uterotomy suture techniques: the uterus was closed with a continuous single layer locked stitch or continuous single unlocked layer or double layer. six weeks and between six and twenty-four month after their cesarean delivery the women were examined by transvaginal ultrasound with an empty maternal bladder, in a supine decubitus position using a ge e8 system equipped with a 5-9 mhz transducer (ge healthcare, milwaukee, wi). the measurement of the uterine scar thickness was performed perpendicular to the uterine wall and was defined as shortest visible distance between the decidua and the delineation of the endometrium at the level of the cesarean scar.

Eligibility criteria:
inclusion criteria: * elective cesarean section * cesarean section during labor exclusion criteria: * emergency cesarean section * declined to participate
vildagliptin and endothelium-dependent vasodilatation

Conditions: Type 2 Diabetes; Endothelial Dysfunction

Summary: rationale: cardiovascular complications in type 2 diabetes are the leading cause of morbidity and mortality associated with the disease. endothelial dysfunction is regarded as an important factor in these vascular complications. the introduction of glucagon-like peptide-1 (glp-1) analogues and dipeptidyl peptidase iv (dpp-iv) inhibitors for the treatment of type 2 diabetes is of special interest because of possible influences on endothelial function. numerous reports have shown that glp-1 improves endothelial function. objective: to determine whether a four week treatment with vildagliptin compared to acarbose improves endothelial dysfunction in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * age 35-75 years * treatment with metformin monotherapy or metformin combination therapy * hba1c \<8.0% exclusion criteria: * renal disease defined as creatinine level \> 130 umol/l * liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range * current use of acetylsalicylic acid or vitamine k antagonists * history of smoking within the past year * history of or current abuse of drugs or alcohol * history of heartfailure (nyha class iii or iv) * abnormalities on ecg that might interfere with current study protocol * pregnancy or breastfeeding * inability to understand the nature and extent of the trial and procedures required * presence of any medical condition that might interfere with the current study protocol * participation in a drug trial within 60 days prior to the first dose
a post-marketing surveillance to assess safety and efficacy of twotopsplus.

Conditions: Hypertension

Summary: post-marketing surveillance of twotopsplus.

this study will collect clinical data, mainly focused on safety, in korean population as per the requirement of mfds for market authorization.

Eligibility criteria:
inclusion criteria: * the patient diagnosed with hypertension. * the patient who is first prescribed and administered twotopsplus tab. exclusion criteria: * the patients who are overreacting to this drug or its components. * the patients with severe renal impairment.