Kornimate/medical-research-clean huggingface dataset:
the effects of adding tcm-700c on the standard combination treatment for patients with genotype 1 hepatitis c infection

Conditions: Chronic Hepatitis C

Summary: the primary objective of this study is to evaluate the effectiveness of tcm-700c as an add-on treatment to the combination drug therapy (peginterferon α-2b plus ribavirin) for patients with genotype 1 chronic hepatitis c infections. this will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable hcv rna 24 weeks after the termination of combinational drug treatment, compared with the placebo add-on.

this was a randomized, double-blind, placebo controlled, parallel-group, phase 2 study to evaluate the effects of adding a chinese formulation (tcm-700c) on the standard combination treatment for patients with genotype 1 hepatitis c infection. patients were screened within 4 weeks before receive the first study drug dose. eligible patients at baseline were stratified according to baseline hcv rna (≤800,000 iu/ml vs \>800,000 iu/ml) and randomized with an equal chance to receive either tcm-700c or placebo as an add-on to the combination drug therapy. the combination drug therapy was peginterferon α-2b (peg-intron®, schering-plough) 1.5 micrograms/kg once weekly injection for 48 weeks plus oral ribavirin (rebetol®, shering-plough) 1000mg-1200mg daily for 48 weeks. the add-on treatment of tcm-700c or placebo was given 2 tablets thrice daily for 48 weeks. during the 48 week treatment period and 24 week untreated follow-up, patients were assessed at regular intervals for safety and efficacy at weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. patients who prematurely discontinued test drug therapy had laboratory examination re-taken on the week patient was discontinued from study.

Eligibility criteria:
inclusion criteria: * hcv strain confirmed as genotype i; * elevated alt (≥1.5 x upper limit of normal)during last 6 months * females of childbearing potential with a negative serum pregnancy test * subject must be willing to sign a written informed consent * subject must be willing and able to adhere to dose and visit schedule. exclusion criteria: * serum afp levels \> 400 ng/ml * liver biopsy within 12 months prior to study entry showed liver cirrhosis with metavir system fibrosis score of 3-4, or hepatocellular carcinoma (hcc); * co-infection with hepatitis b virus (hbv); * anti-hiv positive;

Keywords: add-on treatment botanical drug hcv genotype 1 tcm-700c genotype i
modulation of cerebral blood flow using iron chelators

Conditions: Stroke; Problem of Aging

Summary: the purpose of this study is determine if the iron chelator, desferrioxamine can increase blood levels of hypoxia-inducible transcription factor 1 (hif-1 protein) and to see if there is a corresponding increase in blood flow to the brain.


Eligibility criteria:
inclusion criteria: * healthy adults between the ages of 18-80 years. exclusion criteria: * subjects taking vasoactive medications, * hypertension, * pregnant women, smokers, * copd, * asthma, * diabetes mellitus, * intracranial or carotid stenosis, * hepatic disease, * renal disease, * bone marrow suppression, * cardiac disease, * heart failure, * iron deficiency, * history of cancer, * history of head trauma, * subarachnoid hemorrhage, * central nervous system vasculitis, * multiple sclerosis, * migraines, * seizures, * sickle cell disease or trait, * cardiac arrhythmia, * unable to give informed consent, or * poor transcranial doppler insonation windows.

Keywords: brain blood flow stroke cerebrovascular aging cerebrovascular hemodynamics
radiomics combined with frozen section prediction model for spread through air space in lung adenocarcinoma

Conditions: Lung Adenocarcinoma

Summary: a multifactorial model combining radiomics with frozen section analysis is a potential biomarker for assessing spread through air space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

spread through air space (stas) is a novel invasive pattern of lung adenocarcinoma and is also a risk factor for recurrence and worse prognosis of lung adenocarcinoma. its preoperative assessment could thus be useful to customize surgical treatment. radiomics and frozen section haave been recently proposed to predict stas in patients with lung adenocarcinoma. radiomics-based prediction model is highly sensitive but not specific for stas detection. while, frozen section is highly specific but not sensitive for stas detection in early lung adenocarcinomas. therefore, the proposed project aims to develop and validate a multifactorial model combining radiomics with frozen section analysis to assesse spread through air space during surgery, which can provide decision-making support to therapeutic planning for early-stage lung adenocarcinomas.

Eligibility criteria:
inclusion criteria: 1. intraoperative frozen section diagnosis and final pathology diagnosis are available 2. preoperative standard non-enhanced ct is available 3. pathologically confirmed exclusion criteria: 1. with a previous history of radiation therapy, chemotherapy or biopsy 2. the time interval between the ct examination and surgery was more than two weeks

Keywords: spread through air space radiomics frozen section prediction model
decisionmaking for abnormal uterine bleeding (aub)

Conditions: Abnormal Uterine Bleeding

Summary: the purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (aub) is useful and if it will improve patient satisfaction with clinical care and decision making. this study is a two-part study. the first pilot tests the computerized tool to ensure it is understood by patients, then the second part is a randomized study (computerized tool versus usual care) to see if improvements are made in satisfaction and if there are reductions in decision regret.

the purpose of this study is to determine if using a computer survey about preferences for treatment of abnormal uterine bleeding (aub) is useful and if it will improve patient satisfaction with clinical care and decision making. this study was designed to develop and test the use of aca as part of routine clinical care for women diagnosed with aub. after pilot testing, the aca survey is administered in this study where patients are assigned to receive the aca or to usual care.

Eligibility criteria:
inclusion criteria: * have received a diagnosis of dysfunctional or abnormal uterine bleeding (aub) that is recommended for treatment * have not yet selected or initiated treatment for current aub diagnosis * be at least 18 years of age. * be possible candidates for either medical or surgical therapy * able to provide informed consent for treatment options for oneself exclusion criteria: * are currently being treated for cancer * any cancer diagnosis within the past 2 years (other than non-melanoma skin cancer) * aub due to serious pelvic pathology, medications, pregnancy or systemic disease that limits their range of treatment options * are not recommended for surgical intervention * are not recommended for medical intervention * are under 18 years of age * have not received a diagnosis of aub * are currently being treated for aub

Keywords: decision making abnormal uterine bleeding adaptive conjoint analysis satisfaction regret
a study of the effectiveness of moderna covid-19 vaccine

Conditions: SARS-CoV-2; COVID-19

Summary: this is an observational cohort study to evaluate real-world vaccine effectiveness and durability of moderna covid-19 vaccine among a diverse population at kaiser permanente southern california (kpsc). the primary objective of this study is to evaluate the vaccine effectiveness (ve) of receipt of moderna covid-19 vaccine in preventing sars-cov-2 infection and severe covid-19 disease. sars-cov-2 infection will be defined as a positive antigen test result as well as a positive molecular diagnostic test among symptomatic or asymptomatic participants or a covid-19 diagnosis code. severe covid-19 disease will be defined as covid-19 hospitalization or mortality.

this study utilized electronic healthcare data collected within the kaiser permanente southern california (kpsc) integrated healthcare system which provides care to over 4.6 million individuals. participants in this study received vaccination and were assessed for study outcomes as part of routine care. vaccination information and study outcome status was assessed using procedure, diagnostic, and laboratory code information. medical chart review was conducted to assess the association of severe outcomes (hospitalization and death) with covid-19 illness. analyses assessing absolute vaccine effectiveness will identify participants who receive moderna covid vaccine from the kpsc electronic healthcare database and match them to unvaccinated participants based on age, sex, race/ethnicity, and data of vaccination (index date). vaccinated and unvaccinated participants will then be followed-up in the database for the occurrence of study outcomes. cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status. analyses of relative vaccine effectiveness will identify participants who receive specific dose number and formulation of moderna covid vaccine (group n) from the kpsc electronic healthcare database and match them to a group of vaccinated participants with a different dose/formulation type (i.e. group n-1). similar matching criteria will be applied. both groups will be followed for study outcomes and cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.

Eligibility criteria:
inclusion criteria: * aged ≥18 years at index date (participants aged 6 months through 17 years will also be included after food and drug administration \[fda\] authorization to vaccinate younger age groups) * kpsc member for ≥12 months prior to index date through 14 days after the index date (allowing a 31-day gap) exclusion criteria: * receipt of a covid-19 vaccine other than moderna covid-19 vaccine prior to or on the index date * receipt of 2 doses of moderna covid-19 vaccine \<24 days apart for 2-dose exposed cohort * receipt of any covid-19 vaccine \<14 days after the index date * no health care utilization and no vaccination from the 2 years prior to the index date through the index date * occurrence of a covid-19 outcome \<14 days after the index date
the effect of pasteurized; pasteurized and homogenized and uht treated homogenized cow's milk on gastrointestinal symptoms in sensitive adults

Conditions: Unidentified Gastrointestinal Discomfort Following Dairy Consumption

Summary: this study aims to investigate differences in digestion rates and gastrointestinal problems caused by pasteurized; pasturized and homogenized as well as uht-treated homogenized cow's milks in healthy adults by diary of symptoms, blood glucose and triacylglycerol levels and plasma cytokine levels.


Eligibility criteria:
inclusion criteria: * homogenized and pasteurized milk causes gastrointestinal problems (self-reported) unhomogenized and unpasteurized milk does not cause gastrointestinal problems (self-reported) * age 18-65 * bmi 18,5 - 30 * hemoglobin under normal range * fasting plasma alanine aminotransferase alat \< 60 u/l (normal liver function) * fasting plasma thyroid-stimulating hormone (tsh) 0.4 - 4.5 mu/l (normal thyroid function) * fasting plasma creatinine \< 118 umol/l (normal kidney function) exclusion criteria: * pace maker * crohn's disease or other disease of the intestinal tract * intestinal operation within the last 3 months * difficult dysphagia * smoking * constipation * lactose intolerance * coeliac disease
prospective observational study comparing calcium and sodium levofolinate in combination with 5-fluorouracil (5fu) /or in folfiri regimen

Conditions: Gastrointestinal Cancer; CALCIUM LEVOFOLINATO (Ca-lev); SODIUM LEVOFOLINATO (Na-lev)

Summary: prospective observational study comparing calcium and sodium levofolinate in combination with 5fu/or in folfiri regimen on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed folfiri in standard clinical practice.

this is an observational, perspective trial on patients affected by gastrointestinal cancer (any site of disease along with gastrointestinal tract) who have been prescribed folfiri in standard clinical practice. all patients will be treated and monitored according to the local clinical practice. no additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

Eligibility criteria:
inclusion criteria: 1. patients affected by gastrointestinal cancer including: * advanced colon-rectal cancer, * biliary tract cancer, * pancreatic carcinoma, * advanced gastric or gastro-esophageal junction adenocarcinoma requiring treatment according to folfiri schedule 2. participant is willing and able to give informed consent for participation in the study. 3. male or female aged \>18 years. 4. life expectancy \> 3 months 5. performance status (ps) 0-1 exclusion criteria: 1. patients with known hypersensitivity to 5-fu or folinic acid , or to any of the excipients

Keywords: levofolinic acid gastrointestinal cancer folfiri
effect of muscle energy technique versus myofascial release on cervical and lumbar pain

Conditions: Lumbar Pain Syndrome; Cervical Pain

Summary: the aim of the study is to determine the effect of muscle energy technique versus myofascial release on cervical and lumbar pain in premenopausal women with fibromyalgia

fibromyalgia is an idiopathic, non articular pain syndrome with generalized tender points. it is multisystem disease characterized by sleep disturbance and fatigue. it affect 5% of the world population. the incidence is higher in women than in men. and the age is between 30 and 35 years old.

Eligibility criteria:
inclusion criteria: * premenopausal women with fibromyalgia * ages ranges between 30 - 45 years old * body mass index \< 35 kg/m2 * all are medically stable exclusion criteria: * specific cervical and lumbar pain * smokers * pregnant women * medically unstable * postmenopausal women

Keywords: cervical pain,lumbar pain,fibromyalgia
the effect of intensive controlled exercise in the early stages of amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: amyotrophic lateral sclerosis (als) is a progressive neurological disorder characterized by amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. the disease is usually fatal within 2-3 years and until now there is no cure. als patients are usually supported by a multidisciplinary team. one of the members of this team is the physical therapist. the aim of physical therapy might be to enhance or to preserve cardiovascular fitness and muscle strength. some authors suggest, however, that a moderate to high intensive exercise programme might lead to overuse weakness (an undesired fast progression of muscle weakness). the primary objective of this study is therefore to investigate whether regular moderate to high intensity exercise program in als can maintain or optimize cardiorespiratory fitness and muscle strength. a secondary objective is to investigate whether such a programme leads to overuse weakness and if there is a positive influence on patient's disability, fatigue and quality of life.


Eligibility criteria:
inclusion criteria: * older dan 18 years written informed consent don't use walking adds such as a cane patients must met el escorial criteria for probable or definite als exclusion criteria: * patients who are depending on intermittent or continuous mechanical ventilation patients who are not able to understand and conform to the instructions patients who already perform an exercise programme that can compare with our study patients who have severe cardiopulmonary problems, dm or other problems concerning connective tissue.

Keywords: amyotrophic lateral sclerosis exercise fatigue quality-of-life
navigant study- treatment patterns in mcrpc (metastatic castrate resistant prostate cancer )

Conditions: Prostatic Neoplasms, Castration-Resistant

Summary: categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including radium-223 for patients with mcrpc.

this is a chart review of 200 xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.

Eligibility criteria:
inclusion criteria: * patients were diagnosed with bone metastatic castration-resistant prostate cancer (mcrpc) per medical chart. * patients were at least 18 years of age as of the first diagnosis for mcrpc. * patients must have received at least one intravenous injection of radium-223 (xofigo). * first injection of radium-223 must have started between periods 1-january-2014 to 30-june-2014 or 15-november-2014 to present. * patients must have a minimum of 12 months documented follow-up records following last radium-223 treatment or death within 12 months of last dose. exclusion criteria: * patients who received radium-223 as part in an interventional clinical trial * actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.
comparison of the efficacy of a protocol for the withdrawal of neurosedation from the usual strategy in cerebroses

Conditions: Withdrawal Syndrome; Cerebral Lesion

Summary: the withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the incidence is estimated at 32.1%. cerebrospatized patients are probably more prone to withdrawal because they require high doses of sedation. moreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of the therapeutic management).


Eligibility criteria:
inclusion criteria: * major patient * admitted in neuroreanimation * cerebroséé (tc-hsa-avc) * mono or multi failing * after a neurosedation ≥ 3 days by hypnotic type benzodiazepine (midazolam®) and morphinomimetic (sufentanyl®) in ivse * affiliation to social security * agreement of the person of confidence exclusion criteria: * addiction to opiates, cocaine or cannabis * neurological pathology before hospitalization * patient suffering from cardiac arrest * pregnant woman * sedation window * patient under tutelage or curatorship or deprived of public law
a study of incb018424 phosphate cream in subjects with vitiligo

Conditions: Vitiligo

Summary: the purpose of this study will be to examine the efficacy, safety, and tolerability of ruxolitinib cream in subjects with vitiligo.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of vitiligo. * vitiligo with depigmented areas including: * at least 0.5% of the total body surface area (bsa) on the face (0.5% bsa is approximately equal to the area of the participant's palm \[without digits\]) and * at least 3% of the total bsa on nonfacial areas (3% bsa is approximately equal to the area of 3 of the participant's handprints \[palm plus 5 digits\]). * participants who agree to discontinue all agents used to treat vitiligo from screening through the final follow-up visit. over-the-counter preparations deemed acceptable by the investigator and camouflage makeups are permitted. exclusion criteria: * conditions at baseline that would interfere with evaluation of vitiligo. * participants who are receiving any kind of phototherapy, including tanning beds. * participants with other dermatologic disease besides vitiligo whose presence or treatments could complicate the assessment of repigmentation. * participants who have used skin bleaching treatments for past treatment of vitiligo or other pigmented areas. * participants who have received any of the following treatments within the minimum specified timeframes. * use of any biologic, investigational, or experimental therapy or procedure for vitiligo within 12 weeks or 5 half-lives (whichever is longer) of screening. * use of laser or light-based vitiligo treatments, including tanning beds, within 8 weeks of screening. * use of immunomodulating oral or systemic medications (eg, corticosteroids, methotrexate, cyclosporine) or topical treatments that may affect vitiligo (eg, corticosteroids, tacrolimus/pimecrolimus, retinoids) within 4 weeks of screening. * use of any prior and concomitant therapy not listed above that may interfere with the objective of the study as per discretion of the investigator, including drugs that cause photosensitivity or skin pigmentation (eg, antibiotics such as tetracyclines, antifungals) within 8 weeks of screening. * participants with a clinically significant abnormal thyroid-stimulating hormone or free t4 at screening. * participants with protocol-defined cytopenias at screening * participants with severely impaired liver function. * participants with impaired renal function. * participants taking potent systemic cytochrome p450 3a4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before the baseline visit. * participants who have previously received jak inhibitor therapy, systemic or topical.

Keywords: vitiligo depigmenting disorder topical jak inhibitor
the role of psychosocial and other quality of life parameters in evaluating functional changes prior to and following laser in-situ keratomileusis (lasik)changes laser in-situ keratomileusis (lasik)

Conditions: Keratomileusis, Laser In Situ

Summary: to evaluate the changes in quality of life parameters after lasik surgery.

our purpose is to evaluate the changes in quality of life parameters after lasik surgery. we intend to create a questionnaire to delineate the changes that occur in lasik patients at the pre-operative visit and at the 1-month and 3-month post-operative visits. additional questionnaires will be administered to demonstrate the validity of the new questionnaire. the approximate time the patient will be required to spend in clinic will be approximately 45 minutes at each of the three visits.

Eligibility criteria:
inclusion criteria: all refractive surgery patients with otherwise normal eyes undergoing routine lasik as a primary refractive procedure for myopia, hyperopia or astigmatism. - exclusion criteria: patients who elect to perform alternative refractive surgery such as prk, rk, or intacts™. -

Keywords: patients who have undergone routine lasik as a primary refractive procedure for myopia, hyperopia, or astigmatism.