Kornimate/medical-research-clean huggingface dataset:
multi center case control study on multiple risk factors of aplastic anemia

Conditions: Aplastic Anemia

Summary: to ascertain the risk factors of aa in zhejiang province of china at the moment, especially the comprehensive multiple factors risks. the author conducted a case-control research included 338 aa cases and 1464 controls. subjects were surveyed using same standard questionnaire including personal data, past histories of diseases, family history and histories of occupational and daily exposure to harmful substances. single and multiple logistic regression analyses were made using spss17.0 on the dates to study potential factors in the development of aa.


Eligibility criteria:
inclusion criteria: * all the patients of aa group met a aa diagnostic criteria；the control group were chosen from other departments who were under acute infection (such as pneumonia), acute abdominal emergency (such as appendicitis), cataract surgery; * 1-65 years old, male or female; * sign the informed consent. exclusion criteria: * with myelodysplastic syndrome, leukaemia, multiple myeloma,megaloblastic anaemia, paroxysmal sleep hemoglobinuria disease blood disease, etc. * history of tumor, radiation or chemotherapy, once accept the immunological therapy, autoimmune diseases or allergic disease patients; * patients with neurological diseases.

Keywords: case-control study multiple risk factors
effects of berries and berry fractions on metabolic diseases

Conditions: Type 2 Diabetes; Atherosclerosis

Summary: the study hypothesis is that the bioactive compounds of sea buckthorn berries (hippophaë rhamnoides), their fractions, and bilberries (vaccinium myrtillus). have positive effects on lipid and carbohydrate metabolism and will thus reduce the risk of developing metabolic diseases.

the aim of the project was to investigate whether it is possible to reduce the risk of metabolic diseases with supplementing the diet with sea buckthorn berries (hippophaë rhamnoides), their bioactive fractions, and bilberries (vaccinium myrtillus). the study design was a randomized cross-over clinical trial. the participants were slightly and moderately overweight female subjects. in total, 110 female volunteers were recruited, and they followed four different berry diets (bilberry, sea buckthorn, sea buckthorn phenolic extract and sea buckthorn oil) in a randomized order for 33-35 days. each intervention was followed by a wash-out period of 30-39 days. blood samples were drawn and physical measurements were performed after each period. eighty volunteers completed the study. different markers of lipid and carbohydrate metabolism and inflammation were measured form the blood samples.

Eligibility criteria:
inclusion criteria: * bmi 26-34 * total cholesterol 4.5-8 mmol/l * ldl chol \>2.5 mmol/l * triglycerides \<4 mmol/l * glucose \<6 mmol/l * insulin \<25 mu/l * blood pressure \<160/99 mm hg * hemoglobin \>120 g/l * thyroid-stimulating hormone 0.3-4.2 mu/l * alat \<60 u/l * creatinine \<115 umol/l exclusion criteria: * pregnancy * menopause, * regular smoking * previously diagnosed diabetes (other than gestational) * thyroid, renal, hematological, or hepatic dysfunction * previous myocardial infarction * cardiovascular medication * treatment with regular medication other than allergy medication or joint lubricates * on-going inflammatory disease
study of the efficacy and safety of letrozole combined with trastuzumab in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: phase iv trial to investigate the effect of the combination of letrozole with trastuzumab in metastatic breast cancer patients


Eligibility criteria:
inclusion criteria: * postmenopausal * her-2 overexpression and er and/or pgr positive * metastatic breast cancer exclusion criteria: * previous treatment with trastuzumab * significant liver or renal impairment * erbb2 negative and/or er and pgr negative other protocol-defined inclusion / exclusion criteria may apply.

Keywords: breast cancer metastatic trastuzumab letrozole
docetaxel plus capecitabine in newly diagnosed localized or locally advanced prostate cancer

Conditions: Prostate Cancer

Summary: purpose: the purpose of this clinical trial is to look at the chemotherapy combination of docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate cancer, and to determine if this treatment is an acceptable, effective and a safe treatment option. in addition, this clinical trial will evaluate how this treatment affects chemicals (enzymes), and other cancer related genetic changes in the tumor. optional: this clinical trial will conduct extra imaging studies for research purposes including combined endorectal prostate magnetic resonance imaging (mri), magnetic resonance spectroscopy (mrsi) and diffusion weighted imaging (dwi) to evaluate prostate cancer and response to study treatment.


Eligibility criteria:
patients must have newly diagnosed prostate cancer with at least one of the following criteria: * clinical stage \> t2 * psa \> 15 ng/ml * biopsy gleason's sum \> 8 * all patients must have a minimum psa value of \> 5 ng/ml. * patients may not have evidence of distant systemic metastasis. * patients may not undergo concurrent hormonal, biologic, or chemotherapy. * patients may not have prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil. * patients with a history of severe reaction to docetaxel or other drugs formulated with polysorbate 80 will not be eligible. * patients may not have an underlying cardiac disease.
study of pyridoxine for hand-foot syndrome

Conditions: Hand-foot Syndrome

Summary: although pyridoxine has been used empirically for the prevention of capecitabine associated hand-foot syndrome (hfs), its efficacy needs to be demonstrated in prospective controlled trials. the investigators therefore performed a prospective randomized double-blind study to determine whether pyridoxine 200 mg/day can prevent the development of hfs when given concurrently with capecitabine. the investigators also tested the ability of pyridoxine to treat primary occurrence of grade 2-3 hfs.

although pyridoxine has been used empirically for the prevention of capecitabine associated hfs, its efficacy needs to be demonstrated in prospective controlled trials. we estimated that the hfs rate with placebo and pyridoxine would be 0.35 and 0.18, respectively, and we therefore calculated that a sample size of 345 patients would be necessary to detect these hazard rates with an 80% power (β=0.2) and two-sided significance level of α=0.05. we assumed a follow up loss rate of 10%, thus requiring 380 patients to be randomized. chemotherapy-naive patients with gastrointestinal tract cancers who were scheduled for capecitabine-containing chemotherapy were assigned to receive oral pyridoxine or placebo in randomized double-blind placebo controlled study. pyridoxine 100 mg b.i.d was prescribed to the patients in the pyridoxine group, identical placebo 100 mg b.i.d was prescribed in the placebo group by the closed envelop randomization. patients were stratified by chemotherapy regimen: capecitabine alone (x), capecitabine and cisplatin (xp), or docetaxel, capecitabine, and cisplatin (dxp). patients were observed until nci ctc grade 2 or 3 hfs developed or capecitabine-containing chemotherapy ended. patients in the placebo group who developed grade 2 or 3 hfs were randomized to receive pyridoxine or placebo for the next chemotherapy cycle to determine whether pyridoxine could improve hfs, and the same treatment was continued for 2 chemotherapy cycles.

Eligibility criteria:
inclusion criteria: * gastrointestinal tract cancer patients treated with capecitabine-containing chemotherapy as a first-line treatment were randomly allocated to concurrent treatment with pyridoxine or placebo. * all patients were 18 to 70 years old * had eastern cooperative oncology group (ecog) performance status of 2 or lower * an estimated life expectancy \> 3 months * adequate bone marrow function, including white blood cell (wbc) count of \>3500 cells/㎕ and platelet count of \>100000/㎕ * adequate renal function (serum creatinine concentration \<1.5 mg/㎗) * adequate liver function with (serum bilirubin concentration \ 2.5 mg/㎗). exclusion criteria: * previous treatment for hfs * hypersensitivity to pyridoxine * a combination of other malignancies * serious illnesses or medical conditions * immune suppression or positive human immunodeficiency virus (hiv) serology * pregnant or lactating women.

Keywords: hand-foot syndrome capecitabine pyridoxine prevention
analgesic efficacy and safety of v116517 in subjects with moderate to severe chronic pain due to postherpetic neuralgia (phn)

Conditions: Postherpetic Neuralgia; Pain

Summary: the primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of v116517 versus placebo.


Eligibility criteria:
key inclusion criteria: 1. subjects with chronic pain due to phn as their primary pain condition and some degree of pain every day from this condition. 2. clinical diagnosis of phn based on history of painful dermatomal blistering rash resolving in a few weeks followed by persistent pain in the same region of ≥ 3 months duration. key exclusion criteria: 1. subjects with chronic pain conditions other than phn as their predominant pain condition, including gout, pseudo gout, psoriatic arthritis, active lyme disease, rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic pain conditions, bursitis, or acute injury or signs of active infection in the target pain area. 2. subjects who cannot or will not agree to stop all concomitant analgesic medications apart from specified protocol supplemental analgesic medications. 3. subjects with a recent history of seizure within the past 5 years. 4. subjects who use opioids more than 4 days per week. 5. subjects with clinically unstable medical conditions, including cardiac disease (unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia); respiratory disease; biliary tract disease; hypothyroidism; adrenal cortical insufficiency; or any other medical condition that in the investigator's opinion is inadequately treated and precludes entry into the study. 6. subjects with a history of suicide attempts, or subjects clinically judged by the principal investigator (pi) to be at serious risk of suicide. 7. phn-pain-condition-specific exclusions: * subjects who received pain-control interventions including neurolytic blocks or neurosurgical procedures to the affected nerve or spinal cord segment, spinal cord, stimulators, or neuraxial infusion pumps. 8. active-comparator-related exclusions: * subjects who are allergic to or cannot tolerate pregabalin or acetaminophen. other protocol specific inclusion/exclusion criteria may apply.

Keywords: pain neuralgia, postherpetic
efficacy and safety of ultra-low dose methadone as adjuvant analgesic in cancer patients with pain

Conditions: Pain, Intractable

Summary: the research hypothesis of this study is: in patients with moderate to severe cancer related pain, the addition of low dose methadone to an existing opioid significantly reduces pain severity compared to low doses morphine.


Eligibility criteria:
inclusion criteria: * patients diagnosed of cancer-related pain of more than 3 months duration * pain relief during the last week rated unsatisfactory by the patient * pain severity during the last week rated moderate (between 4 and 7/10) * analgesic therapy must have been stable for 7 days * able to understand english or french * willing and able to give written informed consent exclusion criteria: * patients who are currently receiving or have received methadone as analgesic in the last 6 months * contraindication to receive methadone (allergy, qtc segment on the ecg\>450msec, concurrent treatment with medication that could increase methadone's effects) * patients presenting with changes in their cancer status/treatment with potential effects on their pain severity, during the duration of the trial (eg: new metastasis, indication for radiotherapy) * patients whose life expectancy is shorter than 2 months * patients with cognitive impairment presenting with difficulties understanding the trial and completing the research questionnaires * pregnant or lactating women (women of childbearing potential must have negative pregnancy test)
long-term extension study of tak-438 for the prevention of recurrent gastric or duodenal ulcers during therapy of low-dose aspirin

Conditions: Gastric Ulcers; Duodenal Ulcers

Summary: the purpose of this study is to evaluate the safety of tak-438, once daily (qd), during long-term concomitant low-dose aspirin therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of low-dose aspirin.


Eligibility criteria:
inclusion criteria: 1. participants who require continuous low-dose aspirin therapy during the treatment period with the study drug 2. participants who have completed the preceding study 3. outpatient (including inpatient for examinations) exclusion criteria: 1. participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study 2. participants who are scheduled to change the type and dosage regimen of low-dose aspirin 3. participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study 4. participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology 5. participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery 6. participants with a previous or current history of zollinger-ellison syndrome, or other gastric acid hypersecretion disorders 7. participants with a previous or current history of aspirin-induced asthma

Keywords: drug therapy
evaluation of take and safety of a smallpox vaccine in healthy young adults

Conditions: Smallpox; Poxvirus Infection

Summary: primary objective: to estimate the smallpox vaccination take rate in healthy young adults not previously vaccinated with a smallpox vaccine. secondary objectives: to describe antibody response to vaccination and evaluate the take for each subject at various timepoints for each batch and pooled batches and to evaluate local signs, symptoms, and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.


Eligibility criteria:
inclusion criteria: * aged 18 to 25 years on the day of screening * informed consent form signed * able to attend all scheduled visits and to comply with all trial procedures * for a woman, inability to bear a child or negative serum pregnancy test performed at screening (visit 01) * subject entitled to national social security * subject registered in the french file of healthy volunteers in clinical trials * for a woman of child-bearing potential: use of an effective method of contraception (hormonal or barrier method) from at least 3 months prior to screening to 3 months following trial vaccination * for a woman, inability to bear a child or negative urine pregnancy test. exclusion criteria: * previous smallpox vaccination confirmed by vaccination record or typical scar * participation in another trial in the 3 months before or during the trial period * acute intercurrent or chronic illness during the trial * breast-feeding * allergy or sensitivity to any known components of vaccinia immune globulin or previous reaction to immunoglobulins or trial vaccine * congenital or acquired immunodeficiency or immunosuppressive therapy or any treatment including corticosteroids * treatment with antiviral drugs within 1 month before vaccination * history of organ or bone marrow transplant or skin disorders * personal or family history of autoimmune disease or cardiac disease, including cardiac risk factors * history or current central nervous system disease * ongoing acute infectious disease * blood or blood-derived products received in the past 6 months * any vaccination with a live-attenuated vaccine within the 60 days or other vaccines within 40 days preceding the trial vaccination * vaccination planned in the 8 weeks following the trial vaccination * planned or foreseeable close contact after vaccination with infants less than 12 months, or with immuno-suppressed persons, pregnant and/or lactating woman, or practice of contact or water sports after vaccination before the crust separates * skin wound near the vaccination site * apparent lack of personal hygiene * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * hiv, hepatitis b or hepatitis c seropositivity (screening tests) * abnormal lab values for hematological parameters or cardiac enzyme (screening tests) * feverish illness (oral temperature \>=37.5°c, rectal equivalent temperature \>=38.0°c) on the day of vaccination.

Keywords: smallpox orthopoxvirus poxvirus vaccina virus lister strain bioterrorism
the effectiveness of multimedia education for patients with type 2 diabe mellitus

Conditions: Type 2 Diabetes Mellitus; Insulin; Education

Summary: a total of 72 type 2 diabetes who began insulin therapy using a pen injector participated in this study. the experimental (n = 36) and control (n = 36) groups received multimedia and regular health education program. four structured questionnaires were used, and videotapes were applied to demonstrate injection skills.

to explore the effectiveness of two types health education on knowledge in diabetes and insulin injection, skills in insulin injection, self-efficacy in insulin injection, injection performance rate, satisfaction with health education,nursing hours, and biophysical indicators among the type 2 diabetes who began insulin therapy using a pen injector.with a repeated measures experimental study design, a total of 72 type 2 diabetes who began insulin therapy using a pen injector participated in this study. the experimental (n = 36) and control (n = 36) groups received multimedia and regular health education program. four structured questionnaires were used, and videotapes were applied to demonstrate injection skills.

Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes. 2. first received insulin injection with lantus, levemir or novomix. 3. ability to communicate in mandarin or taiwanese. 4. ability to self-inject insulin. exclusion criteria: 1. cognitive impairment or dementia, inability to manage self-care. 2. severe or unstable medical conditions.
a comparison of methotrexate alone or combined to infliximab or to pulse methylprednisolone in early rheumatoid arthritis: a magnetic resonance imaging study

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to compare the effects of methotrexate (mtx) alone or in combination with intravenous (iv) methylprednisolone (mp) or infliximab (ifx) on mri-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (ra) patients.

the effects of glucocorticoïds and infliximab have never been compared in early ra using mri as primary outcome measure. in the current study, we compare the effects of mtx alone or in combination with intravenous (iv) methylprednisolone (mp) pulse therapy or ifx on mri-detected synovitis, bone edema and erosive changes in early ra patients.

Eligibility criteria:
inclusion criteria: * patients were eligible for this study if they met the american rheumatism association classification criteria for ra (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count \[sjc\] ≥ 6 \[by the 66 joints count\] and a tender joint count \[tjc\] ≥ 8 \[by the 68 joints count\]) and had not been treated with mtx before. * patients were eligible for this study if they met the american rheumatism association classification criteria for ra (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count \[sjc\] ≥ 6 \[by the 66 joints count\] and a tender joint count \[tjc\] ≥ 8 \[by the 68 joints count\]) and had not been treated with mtx before. exclusion criteria: * exclusion criteria included past/current history of tuberculosis, congestive heart disease, past treatment with gc for more than 3 months (and not during the 4 weeks before inclusion), previous treatment with more than 2 dmards, mtx, iv mp pulse.

Keywords: early rheumatoid arthritis, glucocorticoids, pulse therapy, infliximab, tnf blockade
desensitization of highly sensitized deceased donor renal transplantation candidates

Conditions: Kidney Failure

Summary: some patients who need kidney transplants have high levels of antibodies that make them incompatible with most potential deceased donor kidney offers. these patients are considered highly-sensitized and are very difficult to transplant because the likelihood that they will receive a compatible organ is very low. there are some medications and procedures that can decrease the antibody levels and this can increase the chance of finding a compatible donor for these patients. in this study the investigators will give two medications (ivig and rituximab) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplant. after the investigators administer these medications, the investigators will continue to check for compatibility as organ offers are received. if a compatible organ offer is received, the investigators will perform the transplant using that organ. the investigators hypothesize that these medications will lower antibody levels and increase the chance that a these patients are able to receive a compatible kidney transplant.


Eligibility criteria:
inclusion criteria: * ages 18-75 * end-stage renal disease on dialysis * panel reactive antibody (pra) \> 60% * have been evaluated for and are currently listed for deceased donor renal transplantation exclusion criteria: * have contraindication to transplantation * have contraindication to receiving ivig * have allergy to ivig * have received ivig for desensitization previously without effect * pregnant women or those intending to become pregnant
evaluation of ai cost prediction model to enroll patients in complex care management program

Conditions: Chronic Disease

Summary: currently, ucla health (specifically the office of population health and accountable care, or ophac) runs a complex care management program called proactive care (goal is to reduce care utilization by providing personalized care navigation/case management). every month, an ai population risk tool runs to identify around 250 of the 480,000 or so ucla primary care patients, and rns contact these 250 patients to enroll in proactive care. starting in december 2024, ophac launched a new method of enrolling ucla's medicare advantage (ma) patients into proactive care: an ai cost prediction model. the idea is the same-- the top 250 highest predicted cost patients will be enrolled in proactive care. the investigators will evaluate this model and subsequent enrollment into the program by randomizing the waitlist of ma patients waiting to enroll in proactive care, thereby creating a control group. the top 500 highest predicted cost patients will be identified each month, and following a 1:1 randomization, 250 will be contacted for enrollment and the rest will be put on a wait-list control group for 10 months unless otherwise requested by their provider to be enrolled in the proactive care program earlier.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * enrolled in a ucla managed care plan * cost prediction model identifies patient as having high predicted costs over the next 12 months exclusion criteria: * currently enrolled in any ucla care management program * enrolled in any ucla care management program in the last 12 months * already has an active referral to a care management program

Keywords: high utilization complex care management cost prediction model