Kornimate/medical-research-clean huggingface dataset:
apollo device for metastatic breast cancer (mbc)

Conditions: Fatigue; Metastatic Breast Carcinoma

Summary: this is a single-arm, open label pilot intervention study with outcomes measured by electronic survey and chart review evaluating a wearable device called apollo, which is similar to a fitbit but emits vibrations. our primary objective is to assess whether or not apollo can help with symptoms of fatigue and pain in patients with metastatic breast cancer (mbc).

this study aims to provide preliminary data on the efficacy and tolerability of the apollo device in the management of fatigue and pain in patients with metastatic breast cancer (mbc). apollo is about the size of an apple watchand can be worn on the ankle, wrist, or armwith two adjustable fabric straps. apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy. in addition to the wearable, apollo is a software system that curates music for the body, rather than for the ears. the scientific principles guiding the use of apollo and mechanistic understanding of its effects on the body are consistent with the understanding of how music and therapeutic touch effect the body to convey feelings of energy, focus, or relaxation by sending safety signals to the emotional cortex (limbic system) in the brain. similar to music and touch used to facilitate a healing response in the body, there are no known side effects to this type of therapy. the promis-fatigue scale and the functional assessment of cancer therapy fatigue (fact-f) are instruments that have been previously validated in multiple diseases and will be used in this study. preliminary data on indices of pain, use of prn pain medications, health-related quality of life, sleep, anxiety and depression and tolerability/frequency of use with the apollo device in mbc will also be evaluated using: * promis pain scale * use of pain medications * health-related quality of life (hrqol) using promis-29 * promis sleep * hospital anxiety and depression scale (hads) * usage data from apollo app this study aims to identify improvement of fatigue symptoms from baseline after 4 and 8 weeks of apollo use. improvements in pain, quality of life, use of prn pain medication, anxiety and sleep.

Eligibility criteria:
inclusion criteria: * metastatic breast cancer diagnosis * fatigue score of 4 or greater at last clinic visit exclusion criteria: * not able to read and understand english * use of beta blockers, * use of medications for serious mental illness
application of nanopore adaptive sequencing

Conditions: Liver Transplant Infection

Summary: infection post liver transplantation is an important factor in the death in patients. the traditional method of diagnosing infection post liver transplantation is laboratory tests. but the sensitivity and specificity of blood tests is poor. next-generation sequencing (ngs) has greater detection rate for mycobacterium tuberculosis, anaerobes and fungi and greater sensitivity compare with blood tests. however use of ngs is limited because of the short read-length. oxford nanopore adaptive sequencing (nas) method is the third revolution in sequencing technology. for each 1 gbp of data, nas sequencing detected 45 times more microbiome sequences than nanopore standard sequencing and 2.5 times more than illumina sequencing. the purpose of this study is to compare nas with ngs and laboratory tests for the diagnostic rate of infection post liver transplantation.

based on the previous work, the investigators found that: 1. nas has a higher microbial enrichment efficiency and can detect pathogenic information more quickly compared with nanopores normal sequencing (nns); 2. nas can detect more specific pathogen fragments with short-time sequencing; 3. nas can cover more pathogenic genomes than nns in a short-time; 4. nas can detect antibiotic resistance information of pathogenic bacteria in clinical samples.

Eligibility criteria:
inclusion criteria: * accept liver transplantation * signing informed consent voluntarily * possessing ability to comprehend material information * participating this study voluntarily exclusion criteria: * participated another study * graft loss * have undergone a multi-organ transplantion or have had a previous organ transplantation * patient died

Keywords: oxford nanopore adaptive sequencing method
right ventricular diastolic dysfunction

Conditions: COPD; Emphysema; Right Heart Dysfunction

Summary: heart-lung interactions remain misunderstood whereas pulmonary and cardiac pathologies are very commonly associated. emphysema by increasing intrathoracic pressure appears to affect cardiac function. interestingly, previous studies have shown a link between the telediastolic volume of the right ventricle (measured by rmi) and the intensity of emphysema. our hypothesis is that the emphysema by increasing intrathoracic pressure leads to or accentuates right cardiac diastolic dysfunction by decreasing compliance and cardiac preload. to verify this hypothesis the investigators will perform kt loop procedures in order to acquire intracardiac pressure/volume curves before and after lung volume reduction. the pressure/volume curves allow the analysis of systolic and diastolic function, cardiac contractility and loading conditions.


Eligibility criteria:
inclusion criteria: * at least 40 years * a smoking history * smoking cessation ≥ 6 months * fev1/fvc ≤ 0,7 * severe emphysema (destruction ≥ 50%) * peak tricuspid regurgitation velocity \< 2,8 m/s or presence of other echocardiographic "ph signs" * 15% ≤ fev1post ≤ 50% * residual volume ≥ 175% predicted * tlc ≥ 100% predicted * optimal medical management * 150m ≤ 6mwd ≤ 500m * mmrc ≥ 2 * physical activity ≥ 2/week (≥ 30minutes) exclusion criteria: * ≥2 hospitalizations/year for eacopd * recent eacopd (≤ 3months) * ≥ 50ml mucus/day * papm ≥35mmhg * paco2 ≥ 55mmhg * bubble ≥ 1/3 hemithorax * lung fibrosis, bronchiectasis, lung cancer, homolateral surgery * left ventricular ejection fraction ≤ 45%, unstable heart disease * life expectancy ≤ 1 year * contraindication to anesthesia * allergy to nitinol or silicone * corticotherapy ≥ 10mg/day * patient under legal protection
project cadence (cancer detected early can be cured)

Conditions: Thoracic Cancer; Ovarian Cancer; Liver Cancer; Prostate Cancer; Gastric Cancer; Colorectal Cancer; Breast Cancer; Esophageal Cancer; Pancreatic Cancer

Summary: with existing evidence showing the difference in mirna expression levels between non-cancer and cancer groups, the investigators assume that levels of dna methylation, rna expression as well as protein concentration will also be dysregulated during disease progression. combining the power of multi-omic cancer biomarkers, the investigators hypothesize that the sensitivity and specificity of mirxes mcst can be significantly improved compared to existing multi-cancer diagnostic tests. in this study, the investigators propose to develop and validate blood-based, multi-cancer screening tests through a multi-omics approach.

this study consists of four (4) objectives: * characterize intra-cellular multi-omic profiles of cancer and adjacent normal tissues to aid the selection of circulating cancer biomarkers. * select and verify circulating multi-omic cancer biomarkers by characterizing the circulating multi-omic profiles of the peripheral blood of cancer patients, high-risk, increased-risk, and healthy controls, guided by tissue-based cancer omics profiles. * develop multi-cancer screening in vitro diagnostic assay(s) based on the selected blood-borne circulating multi-omic cancer biomarker panel(s) and build algorithm(s) to distinguish cancer cases from control groups. * clinically validate the performance (auc, sensitivity, specificity) of the multi-cancer screening assay(s) and algorithm(s)

Eligibility criteria:
inclusion criteria: healthy average-risk cohort individuals representing the general population who self-declare to have no cancer history and have no indications suggestive of underlying cancer development. subjects will be recruited from a state-of-the-art population study. increased-risk (genetic/familial) cohort individuals carrying certain germline mutations that predispose the subjects to an increased risk of having cancer than the general population. subjects will be recruited from cancer genetics service (cgs). high-risk cohort individuals diagnosed with diseases that have a high risk of progressing to cancer. malignant cohort individuals diagnosed with cancer. wherever possible, samples for the 'malignant group' should have a representation of each cancer stage. exclusion criteria: pregnant or lactating (self-declaration), unwilling or unable to provide signed informed consent and has or had received chemotherapy or radiotherapy for cancer treatment and/or any other cancer-related treatment.

Keywords: mced diagnostic tests mirna cfdna ctdna
relapse rate in hepatitis c patients treated with peginterferon alfa-2b plus ribavirin in common clinical practice in france (p05484)(completed)

Conditions: Hepatitis C; Hepatitis C, Chronic

Summary: the objective of this study is to determine the relapse rate in the french patient population with chronic hepatitis c (chc) previously treated with peginterferon alfa-2b (peg-ifn alfa-2b) plus ribavirin according to standard clinical practice. treatment was to be completed prior to the enrollment in the current study. the study will also aim to identify factors that are predictive of relapse. relapse rate is defined as the percentage of patients with negative viral load at end of treatment who again have positive viral load at 6 months after the end of treatment.

non-probability sampling: the study population consists of adult patients over the age of 18 affected by chc who were previously treated for the first time with peg-ifn alfa-2b plus ribavirin and achieved end-of-treatment response. five hundred ninety patients must be recruited in order to evaluate the objectives of the study. the patients must meet all inclusion criteria and not meet any of the exclusion criteria in order to be included in the study.

Eligibility criteria:
inclusion criteria: * the patient must demonstrate his/her continued willingness to participate in the study. * the patient must be at least 18 years of age, of either gender. * patients with chronic hepatitis c (any genotype) who received peg-ifn alfa-2b + ribavirin as first treatment for hepatitis c. * negative hcv-rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. only institutions using an assay with a limit of detection of 50 iu/ml or less will be eligible. exclusion criteria: * patients who completed treatment with peginterferon alfa-2b plus ribavirin more than 4 weeks before study entry. * patients with positive hcv-rna at the end of treatment (24 or 48 weeks according to the product labeling as appropriate). * patients treated for a period shorter than the enrollment period. * patients co-infected with human immunodeficiency virus (hiv). * patients co-infected with hepatitis b virus (hbv). * patients who do not use appropriate effective method of birth control after the end of treatment (according to legal recommendations).
early ablation therapy for the treatment of ischemic ventricular tachycardia in patients with implantable cardioverter defibrillators

Conditions: Ventricular Tachycardia; Ischemic

Summary: the purpose of this study is to determine if early ablation (i.e., ablation of ventricular tachycardia in patients with infrequent vt episodes) is more effective than medical therapy alone for the treatment of ischemic ventricular tachycardia in patients with implantable cardioverter defibrillators (icds) who continue to have episodes of ventricular tachycardia despite drug therapy.


Eligibility criteria:
inclusion criteria: 1. subject must be drug refractory on class i-iv aads (i.e., having vt episodes despite drug therapy) a. subject must be on at least one aad at time of enrollment 2. qualifying episode must be sustained, monomorphic ventricular tachycardia post myocardial infarction 3. icd implanted 4. 1 to 3 sustained monomorphic vt episodes requiring appropriate therapy within the previous six (6) months as determined by the investigator 5. history of myocardial infarction documented by the development of pathological q waves with or without symptoms, imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract in the absence of a nonischemic cause, or pathological findings of a healed or healing myocardial infarction 6. 18 years or older 7. able and willing to comply with all pre- and follow-up testing and requirements 8. signed informed consent form exclusion criteria: 1. age \< 18 years 2. documented intra-atrial or ventricular thrombus or other abnormality on preablation echocardiogram 3. patients with incessant ventricular tachycardia (continuous sustained vts that recur promptly despite repeated intervention for termination over several (≥ 3) hours) 4. contraindication to anticoagulation 5. nyha class iv 6. left ventricular assist devices (lvads) or other circulatory assist devices 7. stroke as confirmed by plasma d-dimer levels or acute myocardial infarction as documented by electrocardiogram or cardiac imaging within the past three (3) months. (note that a small cardiac enzyme release resulting from being in vt/shocks/etc. is not considered a myocardial infarction.) 8. patients with active ischemia who are eligible for revascularization 9. patients with idiopathic ventricular tachycardia or ventricular tachycardia of non-ischemic cause (such as nonischemic cardiomyopathy) 10. other disease process likely to limit survival to less than 12 months 11. serum creatinine of ≥ 2.5mg/dl 12. thrombocytopenia or coagulopathy 13. prior ablation for ventricular tachycardia 14. women who are pregnant (as evidenced by pregnancy test if pre-menopausal) 15. enrollment in an study evaluating an investigational device or drug 16. unable or unwilling to comply with protocol requirements 17. exclusively polymorphic ventricular tachycardia

Keywords: ischemic ventricular tachycardia implantable cardioverter defibrillators antiarrhythmic drug therapy ablation electrophysiology
effects of angeliq and prempro on blood pressure and sodium sensitivity in postmenopausal women with prehypertension

Conditions: Postmenopause; Hypertension; Pre-Hypertension

Summary: the main purpose of this study is to compare the effects of treatment of two different formulations of angeliq® and prempro on blood pressure in post-menopausal women with prehypertension.

this study has previously been posted by berlex, inc. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc.bayer healthcare pharmaceuticals, inc. is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: - postmenopausal women 45 - 65 years old with prehypertension exclusion criteria: - hormone therapy (estrogen/progestin)

Keywords: pre-hypertension in postmenopausal women
early evaluation of chemosensitivity for low/intermediated-risk mid-low stage ii/iii rectal cancer

Conditions: Rectal Cancer

Summary: chemosensitivity of rectal cancer is not discussed clearly. with previous study, the investigators design this phase ii trial to explore the effect of 2 cycles xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. with inclusion of early,intermediate,and bad stage ii/iii rectal cancer patients, four cycle of xelox chemotherapy was given. after the second cycle, mri,trus,de,endoscopy,and blood dna test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.

chemosensitivity of rectal cancer is not discussed clearly. with previous study, the investigators design this phase ii trial to explore the effect of 2 cycles xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. with inclusion of early,intermediate,and bad stage ii/iii rectal cancer patients, four cycle of xelox chemotherapy was given. after the second cycle, mri,trus,de,endoscopy,and blood dna test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.in future, a phase iii trial that explore the effect of radiation or surgery in these chemoresistant patients.

Eligibility criteria:
inclusion criteria: 1. .endoscopy and biopsy verified rectal cancer within 12cm from anal verge; 2. .primary mri, trus, abdomino-chest ct diagnosed early or intermediate or bad stage ii/iii rectal cancer; 3. .age from 20-75; 4. .with informed consent; exclusion criteria: 1. .refuse the further treatment after recruiting; 2. .diagnosis of peritoneal metastasis in the surgery;

Keywords: rectal cancer； neoadjuvant chemotherapy
evaluation of high throughput sequencing for screening of pathogens in immunocompromised patients with suspected infectious disease.

Conditions: Immunodeficiency and Suspected Infection

Summary: the study patients are patients suffering from primary or secondary immunodeficiencies investigated in the hospital necker for a suspected infectious disease. the study purpose is to assess the performance of a high throughput sequencing method, the pathoquest method (from sample preparation to bio informatic analysis), versus the classic diagnostic approach. the study will evaluate the capacity of the pathoquest method to detect pathogens responsible for an infectious disease episode and will also evaluate the delay of obtention of results compared to the classic diagnostic approach.


Eligibility criteria:
summary of inclusion criteria: 1. primary or secondary immunodeficiencies defined by * solid organ transplantation and immunosuppressive drug * recent chemotherapy * hematopoïetic stem cells transplantation * primary immune deficiency * auto-immune disease * hiv infection 2. infection suspicion 3. microbiological investigation 4. adult or child above 1 year 5. hospitalization at necker-enfants malades hospital 6. registration to healthcare organism 7. icf signature summary of exclusion criteria: 1. obvious diagnosis following clinical examination 2. participation in a clinical trial for a new drug 3. people under legal guardianship 4. people unable to fulfil the required medical follow-up
moxifloxacin vs. polytrim for conjunctivitis

Conditions: Conjunctivitis

Summary: the purpose of the study is to compare the effect of polytrim ophthalmic solution and moxifloxacin ophthalmic solution in treating your child's pink eye. both these medications are approved by the food and drug administration, for treatment of conjunctivitis. this study will investigate if both of the medications are equally good.


Eligibility criteria:
inclusion criteria: * 1 - 18 years of age with presumed bacterial conjunctivitis. exclusion criteria: * previous antibiotics or to receive systemic antibiotic.
evaluation of the postoperative agitation prevention and analgesic efficacy of perioperative dexmedetomidine infusion in a pediatric patient group to undergo tonsillectomy and adenoidectomy

Conditions: Anxiety; Postoperative Pain; Bleeding

Summary: dexmedetomidine is a drug known for its pain-relieving and restlessness-reducing effects. the purpose of this run is to use the association between this use during surgery and the attrition of post-operative pain and discomfort. in the research, laboratory and monitoring results will be obtained before, during and after the operation. postoperative patient complaints will be evaluated at the postoperative service visit. this study is decided on a completely voluntary basis.


Eligibility criteria:
inclusion criteria: patients with asa 1-2, aged 2-10 years, scheduled for elective tonsillectomy and/or adenoidectomy operation will be included. exclusion criteria: developmental delay anxiety disorder known history of allergy to alpha-2 agonistic agents use of antipsychotic medication beta blocker use of anticonvulsant drugs chronic pain syndrome with cardiac and craniofacial anomalies

Keywords: dexmedetomidine tonsillectomy adenoidectomy postoperative anxiety
a study to assess the pharmacokinetics of dapivirine (tmc120) vaginal microbicide gel

Conditions: HIV Infections

Summary: approximately 18 women will be enrolled in this single-center, double-blind, randomized phase i study to assess vaginal tissue and fluid levels, plasma levels and pharmacokinetics of dapivirine (tmc120) gel, which will be applied for 10 consecutive days in 18 healthy hiv-negative women ages 18 to 50. volunteers will be randomized in a 1:1:1 ratio to receive 2.5ml dapivirine vaginal microbicide gel at one of three concentrations.


Eligibility criteria:
inclusion criteria: * hiv-negative * willing to participate and sign and informed consent form. * willing to be tested for hiv and to use an experimental vaginal gel. * willing to use a reliable form of contraception during the study. * willing to undergo pelvic examinations with colposcopy according to the protocol throughout the study. * normal cervical assessment. * willing to abstain from using any vaginal product (other than the study product). * willing to be sexually abstinent from day 1 until completion of study product use on day 10. exclusion criteria: * currently pregnant or breast-feeding. * currently has any clinically detectable abnormality on the vulva, vaginal walls or cervix. * currently has laboratory confirmed gonorrhea, chlamydia, trichomonas or syphilis, has genital ulcer disease (gud) or vaginal candidiasis symptoms; or has an hsv-2 lesion as indicated by clinical diagnosis or laboratory test. * symptomatic bacterial vaginosis (bv) and unwilling to undergo treatment. * current use of injection drugs.

Keywords: hiv-1 hiv seronegativity