Kornimate/medical-research-clean huggingface dataset:
compound herbal formula (tpe-1) for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy

Conditions: Breast Cancer; Radiotherapy; Chinese Herbal Medicine

Summary: many breast cancer patients will taking chinese herbal medicine during receiving radiotherapy. the investigators conducted the pilot study showing compound herbal formula (tpe-1) have the effect of improving the fatigue and leukopenia during radiotherapy. so the investigators designed this double blind and controlled trial to evaluate whether tpe-1 have the effects for leukopenia and cancer-related fatigue in breast cancer patients with radiotherapy. from our initial observation for 2 years, tpe-1 is safety. the study is also designed to evaluate the safety when patients taking this formula.

tpe-1 is designed according to tcm concept. it is not anti-cancer directly, it is enhancing the qi flow and immunity of breast cancer when they are just finishing chemotherapy and on going radiotherapy. many chinese population will seeking chinese herbal medicine under the same condition.

Eligibility criteria:
inclusion criteria: * breast cancer * age between 18 to 70 yrs * finished chemotherapy (adriamycin ), will receiving radiotherapy * chinese population * kp$ between 40-100 * ecog \< 2 * wbc \>4x10(9)／l and hb \> 10g/dl * assigned informed concent. exclusion criteria: * receiving operation during 14 days * blood transfusion during one month. * alt \>100mg/dl * creatinine \>2.0mg/dl * total bilirubin \>2.0mg/dl * infection * prolation * taking anti-seizure , psychological drugs or any drugs not suitable patients * aids or any disease diagnosed by physician and not suitable patients.

Keywords: breast cancer radiotherapy chinese herbal medicine tpe-1 leukopenia
department of defense ptsd adaptive platform trial - intervention b - vilazodone

Conditions: Post Traumatic Stress Disorder

Summary: this is a phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for ptsd utilizing an adaptive platform trial design. intervention b - vilazodone will assess the safety and efficacy of vilzodone in participants with ptsd. please see nct05422612 for information on the s-21-02 master protocol.

the general structure of this adaptive platform trial (apt) consists of a 30-day screening period, a 12-week platform treatment period, and a 4-week safety follow-up. the s-21-02 platform trial will evaluate the safety and efficacy of multiple investigational products for the treatment of ptsd (see nct05422612 for master protocol information). participants are randomized among the multiple cohorts in the study and the resulting randomization enables sharing/pooling of control subjects, where all interventions may be compared to a common control (placebo). this record only includes information relevant to the vilazodone cohort. once a participant meets all eligibility criteria for the master protocol, eligibility for each currently enrolling intervention cohort is assessed. eligible participants will be randomized with equal probability into a cohort. participants randomized to the vilazodone cohort are then randomly assigned to receive either vilazodone or placebo (in a ratio of 5:3; intervention:placebo), for the duration of the 12-week treatment period. parties interested in having their intervention considered for testing within the m-pact should complete a request for information form using this webpage https://citeline.qualtrics.com/jfe/form/sv_8etqkw6tnug4z42.

Eligibility criteria:
inclusion criteria: no additional inclusion criteria beyond the inclusion criteria specified in the master protocol (nct05422612). exclusion criteria: the following exclusion criteria are in addition to the exclusion criteria specified in the master protocol (nct05422612). 1. history of treatment for ptsd with vilazodone at doses of 20 to 40 mg daily, for at least 4 weeks.
efficacy of exparel (tm) on post-operative pain after laparoscopic gastric bypass using circular eea stapler

Conditions: Post-operative Pain Management

Summary: this will be a comparative study between two cohorts of patients undergoing roux-en-y gastric bypass. one cohort (75 patients) will receive fda approved exparel® (liposome bupivacaine injection solution) injections intra-operatively at time of incision site closure. the control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of incision site closure. the medication for the control group is our current standard of care. the primary end point is post-operative pain at 24 and 48 hours measured by the visual analog scale (vas). comparison will be made between cohorts. all subjects enrolled in the study will be evaluated per nursing protocol with the verbal numerical analog scale. at 24 and 48 hours a member of the research team will administer a 2-part questionnaire containing the vas and the revised american pain society post-operative questionnaire (aps-poq-r). the latter is validated for assessment of the patient's experience of pain and it hindrance to daily activity in the post operative period.

the study will include up to 150 patients, and will consist of two cohort. the study cohort will include 75 patients who receive intraoperative exparel® injections at the incision locations in addition to our standard multimodality post-operative analgesia. the control arm will include 75 patients who meet inclusion criteria but receive standard 0.25% bupivacaine and our standard multimodality post-operative analgesia. patients will be randomized by redcap™ database system in collaboration with cleveland clinic pharmacy to receive either exparel® or the control medication (0.25% bupivacaine). consent from patients will be obtained and documented by a dedicated research personnel prior to any enrollment.

Eligibility criteria:
inclusion criteria: * bariatric surgery patients * laparoscopic roux-en-y gastric bypass * use of eea stapler anastomosis exclusion criteria: * age \<18 years * previous history of roux-en-y gastric bypass * patients undergoing other bariatric procedures * pre-operative opioid analgesics
infusion of depleted t cells following unrelated donor stem cell transplant (icat)

Conditions: Haematological Malignancies

Summary: the purpose of this study is to evaluate whether the administration of allodepleted donor t cells to patients with haematological malignancies after stem cell transplant can improve the recovery of the patients immune system.


Eligibility criteria:
inclusion criteria: * age ≥16 years * underlying haematological malignancy * planned allogeneic peripheral blood stem cell transplantation from a 10/10 or 9/10 hla matched unrelated donor, using an alemtuzumab-based conditioning protocol * written informed consent exclusion criteria: * life expectancy \< 6 weeks * female patients who are pregnant and lactating * patients who are serologically positive for hepatitis b, c or hiv pre-sct

Keywords: transplant cd25/71 allodepleted donor t cells infection acute myeloid leukaemia acute lymphoblastic leukaemia adult diffuse large b-cell lymphoma mantle cell lymphoma
hyrax vs. invisalign palatal expander clinical study

Conditions: Malocclusions; Narrow Maxilla; Narrow Maxillary Arch; Crowding

Summary: the purpose of this study is to compare expansion result and the overall experience between the invisalign palatal expander and the hyrax expander.


Eligibility criteria:
inclusion criteria: * subject ages 6-11 years old * subject must need maxillary expansion * subjects must have erupted dentition in the area of the primary molars or permanent premolars and the first permanent molar exclusion criteria: * subjects with palatal exostosis/surface aberration/ cleft palate * subject's dentition not compatible with device or allergy to device materials * subject with active caries, periodontal disease, tmd
fluoxetine to reduce cocaine use in cocaine and opioid addicts

Conditions: Cocaine-Related Disorders; Opioid-Related Disorders

Summary: cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. fluoxetine, a medication that is currently used to treat depression and anxiety disorders, may also be effective at diminishing cocaine use in individuals with severe cocaine addiction. this study will evaluate the effectiveness of fluoxetine at reducing cocaine use in individuals addicted to cocaine and opioids who are concurrently receiving methadone treatment.

individuals addicted to cocaine often experience feelings of restlessness, irritability, anxiety, and paranoia. reducing cocaine use can lead to depression. in an attempt to alleviate the depressive symptoms, individuals may resume drug use. fluoxetine, a medication that is currently used to treat depression and panic attacks, may assist at reducing cocaine use in individuals addicted to cocaine. by increasing serotonin, a chemical in the brain that helps maintain mental balance, fluoxetine may lessen depressive symptoms and decrease the reinforcing effects of cocaine. voucher incentive programs, in which items or services are offered as a reward for remaining drug-free, are also a useful component of substance abuse treatment. preliminary research has shown that fluoxetine, when combined with an incentive program, is an effective treatment for reducing cocaine use. further research is needed to confirm the benefits of fluoxetine for cocaine and opioid addicts. the purpose of this study is to evaluate the effectiveness of fluoxetine, in combination with a voucher incentive program, at reducing cocaine use in methadone-maintained cocaine and opioid addicts. this 33-week study will enroll individuals addicted to both cocaine and opioids who are concurrently enrolled in a methadone treatment program. participants will be randomly assigned to receive either 60 mg of fluoxetine or placebo on a daily basis for 12 weeks from weeks 8 through 19. study visits will occur once a week. questionnaires and self-reports will be completed to assess medication side effects and cocaine use. cocaine levels will be monitored three times a week with urine tests. during the 12 weeks of treatment, participants will also be randomly assigned to either take part in a voucher incentives program or not take part in the program. participants in the voucher program will receive a voucher that may be exchanged for various items and services for each urine test with a negative cocaine result.

Eligibility criteria:
inclusion criteria: * currently dependent on opioids * currently dependent on cocaine * eligible to receive methadone maintenance treatment exclusion criteria: * current significant medical or psychiatric illness * current use of a specific serotonin reuptake inhibitor (ssri) * history of allergy to ssri medications

Keywords: cocaine addiction cocaine dependence opiate addiction opiate dependence
the prognostic significance of premature ventricular complexes in patients without structural heart disease

Conditions: Premature Ventricular Complexes Multiple; Premature Ventricular Contraction

Summary: with this project the investigators aim to investigate whether premature ventricular complexes (pvc) have a prognostic significance in persons without structural heart disease. further the investigators look at the possible connection between pvc-morphology and clinical outcome and investigate whether advanced cardiac imaging-methods may identify subtle signs of heart disease in pvc-patients with normal findings at echocardiography.

the pulse project consists of four different studies: * in study one the investigators include patients who are evaluated because of pvcs and have no signs of structural heart disease at echocardiography and exercise test. the investigators follow them (average follow-up time 3,5 years) to investigate if they have a higher mortality och cardiovascular morbidity than standard population * in study two the investigators carry out a sub-group analysis of the population in study one to assess whether pvc:s different sites of origin (morphology) are related to the clinical outcome * in study three the investigators include persons with a high pvc-burden (at least 10 000 pvc:s/day) and normal echocardiography. the included subjects undergo magnetic resonance (mr) to investigate whether it can identify signs of heart disease where standard echocardiography cannot

Eligibility criteria:
inclusion criteria: - diagnosed with premature ventricular complexes at three major hospitals in stockholm, sweden exclusion criteria: * history of myocardial infarction * undergone coronary arterty bypass grafting (cabg) * finding of heart failure at echocardiography * direct or indirect findings of coronary ischaemia at exercise test, coronary angiography or other equivalent examination

Keywords: premature ventricular complexes beats prognosis
secukinumab efficacy and safety study in patients with rheumatoid arthritis and inadequate response to anti-tnfα agents.

Conditions: Rheumatoid Arthritis

Summary: this study will provide efficacy and safety data of the secukinumab pre-filled syringe (pfs) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-tnf-α agents.


Eligibility criteria:
inclusion criteria: • presence of rheumatoid arthritis classified by acr 2010 revised criteria for at least 3 months •disease activity defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66 at baseline and with: either anti-ccp antibodies positive or rheumatoid factor positive and with either hscrp ≥ 10 mg/l or esr ≥28 mm/1st hr •intake of at least one anti-tnf-α agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration exclusion criteria: * current ra functional status class iv according to the acr 1991 revised criteria •previous use of secukinumab or other biologic drug directly targeting il-17 or il-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes. other protocol-defined inclusion/exclusion criteria may apply

Keywords: rheumatoid arthritis, ra, il-17 blocker, subcutaneous, self-injection, ain457, ain457f, secukinumab, anti-tnfα, pre-filled syringe
a phase i study of ak159 in healthy postmenopausal women

Conditions: Osteoporosis

Summary: the objective of this study is to investigate the pharmacokinetics, safety, and tolerability of ak159 administered to healthy postmenopausal women.

this study consists of two parts: part 1 and part 2. the part 1 is a single-center, randomized, 2-way crossover study that investigates the pharmacokinetics, safety, and tolerability of teriparatide after a single dose of ak159 (5 levels) and estimates the relative bioavailability of ak159 with subcutaneous teriparatide acetate in healthy post-menopausal women. the part 2 is a multiple-center, randomized, double-blind, positive- and placebo-controlled, parallel study that compares the pharmacokinetics, bone makers, safety, and tolerability of teriparatide after a weekly doses of ak159 (4 levels) for 6 weeks with placebo and a weekly doses of subcutaneous teriparatide acetate in healthy post-menopausal women.

Eligibility criteria:
inclusion criteria: * healthy postmenopausal ethnic japanese women * at least 45 years of age at the time consent is obtained * give voluntary consent in writing with a sufficient understanding of the study. exclusion criteria: * clinical abnormality identified in the laboratory tests * weight \< 40.0 kg * body mass index \ =30.5 * history of disease of the kidneys, liver, heart, brain, or other organ that makes them ineligible as subjects * previously received radiation treatment potentially affecting bone * clinical abnormality identified in the 12-lead ecgs performed at the study center during the screening period * systolic blood pressure \< 90 mmhg * serum calcium level exceeding 10.4 mg/dl * history of contact dermatitis or skin disease potentially compromising study evaluation * used drugs which impact bone metabolism in the 8-week period preceding investigational product administration * used a bisphosphonate * used a teriparatide product

Keywords: ak159, teriparatide acetate
evaluation of influenza-specific immune responses in children and adults during the 2010-2011 influenza season in the u.s.

Conditions: Influenza

Summary: this is a specimen collection protocol designed with the purpose of understanding the immune responses to influenza in children and adult subjects through collection of blood specimens and influenza medical history data. this protocol will allow the investigators to evaluate influenza-specific immune responses to a variety of influenza strains in a broad age range of the u.s. population early and late in the 2010-2011 influenza season. immune responses will be evaluated using blood samples. the underlying hypothesis for this protocol is that the detailed characterization of immune responses to influenza in subjects from different age groups will further the understanding of immune responses cross-reactivity and advance development of influenza vaccines that are cross-reactive against old, new and re-emerging influenza strains.


Eligibility criteria:
inclusion criteria: * children ages 6 through 17 years and adults 18 years of age or older * able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process * able and willing to complete the informed consent/assent process * willing to donate blood for storage and for research, at least at three study visits * willing to have genetic tests performed on stored blood for research purposes exclusion criteria: * known to be pregnant. * medical, psychiatric, occupational or other condition that, in the judgment of the site investigator, is a contraindication to protocol participation or impairs a subject's ability to give informed consent. * bleeding disorder diagnosis or any contraindications to blood drawing as assessed by the site investigator * immune system known to be compromised by hiv or other active infection, active cancer, or systemic immunosuppressive treatments. * seasonal influenza vaccine within the 12 weeks prior to enrollment. * another subject from the same household enrolled into the same age group.

Keywords: influenza healthy volunteer immunity antibody blood sample
mobility rehab, a therapist-assisted system for gait rehabilitation

Conditions: Parkinson Disease; Stroke; Multiple Sclerosis; Gait Disorders, Neurologic; Gait Disorder, Sensorimotor; Gait, Unsteady; Gait Ataxia; Gait, Stumbling; Gait, Shuffling

Summary: phase ii of this study includes a pragmatic clinical trial which will take place at northwest rehabilitation associates (nwra) in salem, or to verify the efficacy of the system in a physical therapy clinic.

this phase ii project is a collaboration among: 1) apdm, an innovative small business that has successfully commercialized several innovative products to quantify human movement; 2) the balance disorders laboratory in the department of neurology at oregon health \& science university (ohsu); and 3) northwest rehabilitation associates (nwra), a nationally-recognized outpatient rehabilitation center that will test the effectiveness of mobility rehab for adults with mobility disturbances. the objective of this phase ii application is to prepare the mobility rehab system for commercialization and demonstrate its efficacy for mobility training. our hypothesis is that feedback-based rehabilitation will be more effective than standard rehabilitation for gait in older adults with gait disturbances. in this phase ii, we will use a pragmatic clinical trial to evaluate the effectiveness of mobility rehab on 300 patients with various types of gait disturbances in a physical therapy clinic. in addition to visual feedback, the system will be optimized in phase ii to also provide verbal feedback commands for patients during training.

Eligibility criteria:
inclusion criteria: * 60-89 years old * gait disturbances requiring physical therapy exclusion criteria: * unable to follow instructions (up to the practitioner's judgement)

Keywords: gait balance falls mobility feedback
celecoxib inhibition of aromatase expression and inflammation in adipose tissue of obese postmenopausal women

Conditions: Obesity

Summary: the study plans to find out whether celebrex may be potentially useful to decrease inflammation in fat tissues and thereby lower the production of substances such as estrogens that may increase the risk of developing breast cancer and lead to a poor outcome of the disease.

this study seeks to examine how effective the celebrex may be in reducing inflammation, crown-like structures in fat tissue, the enzyme aromatase, pge-m in the urine and estrogen in blood and urine. volunteer subjects will be expected to stay in the hospital for about 2 weeks taking celebrex for approximately 10 days while eating a diet similar to what they consumed before coming into the hospital for the study.

Eligibility criteria:
inclusion criteria: * postmenopausal woman defined as: 24 consecutive months without a menstrual period and currently not taking any medication known to induce amenorrhea. * serum estradiol \< 20 pg/ml * body mass index of 35-50 * stable weight defined as (+/- 5 %) of body weight for at least three months * 40-70 years of age * fluent in english exclusion criteria: * known hypersensitivity to celecoxib or sulfonamides * known peptic ulcer disease * hypertension bp \> 150/90 (on 2 occasions after resting) * fasting blood glucose \> 165 mg/dl * hiv positive * screening creatinine \> 2x upper limit of normal * screening lft results \> 2x upper limit of normal * smokers (or stopped \< 3 months ago) * framingham risk score \> 15 * evidence of active coronary disease by history and/or ekg * subjects who consume 25 grams of soy protein/day or more than 45 mg of isoflavones/day, for subjects who consume this amount of soy, they may stop for 14 days prior to admission * currently taking nsaids, aspirin, (if \> once a week, stopped \<30 days ago). * consuming \> 3 servings of fish or seafood/week * currently taking fish oil, omega-3 supplements or other herbal supplements that exceed gras (generally recognized as safe) levels, (if currently taking fish oil/omega-3 supplements, there must be a 30 day washout period) * current use of anti-coagulants * currently taking any weight control medication * currently taking thioridazine * currently taking lithium * currently taking any estrogen/progesterone hormones including vaginal cream, e-string, or vaginal tablets * currently taking any medication that can alter fat stores as determined by the principal investigator * history of inflammatory bowel disease or other chronic inflammatory disorders * history of any malignancy other than non-melanoma skin cancer in the past 5 years * history of any bleeding disorder * history of cardiovascular disease * diagnosis of asthma * any medical, psychological or social condition that, in the opinion of the investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.

Keywords: obesity post-menopausal