Kornimate/medical-research-clean huggingface dataset:
comparison of hbv reactivation between patients with high hbv-dna and low hbv-dna loads undergoing ici and concurrent antiviral prophylaxis: a prospective observational study

Conditions: Hepatocellular Carcinoma

Summary: immune checkpoint inhibitor (ici), including programmed cell death protein-1 (pd-1) inhibitor or programmed cell death-ligand 1 (pd-l1) inhibitor , is recommended to treat advanced hepatocellular carcinoma (hcc). however, the safety of ici in patients with a high hbv-dna load is unknown because of the potential risk of hepatitis b virus (hbv) reactivation. this study was to compare the hbv reactivation between patients with low hbv-dna loads and high hbv-dna loads undergoing antiviral prophylaxis and ici.


Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * seropositive for hepatitis b surface antigen (hbsag) * received concurrent antiviral prophylaxis and at least one cycle of ici treatment. prior use of antiviral therapy was allowed * adherence to antiviral therapy * a life expectancy of 3 months or more * an eastern cooperative oncology group performance status (ecog ps) of 0-2 exclusion criteria: * other positive viral markers, including igm antibodies to hepatitis a virus, the hepatitis c virus viral load, igg antibodies to hepatitis d virus, igm antibodies to hepatitis e virus * antibodies to human immunodeficiency virus, * a lack of hbv dna and liver function testing before the first immunotherapy and during the follow-up period.
monosialotetrahexosylganglioside for treatment of oxaliplatin induced neurotoxicity in gastrointestinal cancer

Conditions: Neurotoxicity

Summary: the purpose of this study is to determine whether monosialotetrahexosylganglioside sodium injection can relieve the neurotoxicity caused by oxaliplatin in gi cancer.

oxaliplatin is widely used in gi cancer. neutropenia and neurotoxicity are the most common adverse effects of oxaliplatin which even result in discontinue of chemotherapy, especially for patients suffered from heavily acute neurotoxicity.the continuous sense and/or motor abnormal reduce the quality of life. to date, there is no a drug to treat oxaliplatin induced neurotoxicity. monosialotetrahexosylganglioside(gm) is a component of membrane of nerve cells. previous phase ii clinical trial showed, it can reduce oxaliplatin-induced neurotoxicity (oin). but it did not investigated for curing oin in randomized control trial. a phase iii trial is needed to investigate the effect and safety of monosialotetrahexosylganglioside sodium injection for treatment oin at gi cancer. investigators design this randomized phase iii placebo-controlled trail to identify the effect of monosialotetrahexosylganglioside sodium injection as a treatment agent for oin. investigators found 2.5% patients of grade 2 or more serious oin would relieve with 3 months(data not published). investigators assume monosialotetrahexosylganglioside can reduce neurotoxicity by 30%. at the level of power 0.8, the sample size is 160 with 10% dropout. if there is no dropout, the trial will be terminated at 144 events occur.the board of tianjin cancer hospital has permitted the trial and will monitor the whole process of this study. all data will be submitted to the department of clinic trials at tianjin cancer hospital.the statistics specialist is participating this design and will afford help for data analysis.

Eligibility criteria:
inclusion criteria: 1. patients shall have normal organic function such as liver function, cardiac function and renal function; 2. male or female age \>18 years old; 3. diagnosis gi cancer with histology; 4. chronic neurotoxicity grade is 2 or more 5. karnofsky performance scores should be 80 or more 6. patients are in oxaliplatin-based chemotherapy courses or no more than 21 days after last oxaliplatin usage for patients who will discontinue oxaliplatin usage. 7. without uncured tumor except gi cancer, 8. patients should be expected to live no shorter than 3 months exclusion criteria: 1. patients who is receiving anti-neurotoxicity treatment; 2. wbc\ 1.5limitation;bun）\>1.5limitation；cr）\>1.5limitation；alt or ast\>2.5limitation（without liver metastasis）；alt or ast）\>5limitation（with liver metastasis）; 3. heart dysfunction; 4. brain metastasis with symptoms; 5. peripheral nervous system or central nervous system abnormal including diabetes mellitus patients with neuropathy; 6. in situation of oxaliplatin-based chemotherapy progressed, the next chemotherapy regime should not contain agents which will cause neurotoxicity (such as paclitaxel and cisplatin)

Keywords: gastrointestinal cancer oxaliplatin neurotoxicity
comparing cold biopsy forceps versus cold snare biopsy for colon polyps

Conditions: Colon Polyps

Summary: comparing the efficacy of cold biopsy forceps versus cold snare biopsy for removing colon polyps.

polyps were randomized to be treated with either csp or cfp. after the initial polypectomy, additional emr was performed at the polypectomy site to assess the presence of residual polyp tissue.

Eligibility criteria:
inclusion criteria: * patients older than 40 years old and * patients who are receiving colonoscopies and * patients who have colon polyps exclusion criteria: * patients who have not agreed to the study * patients with bleeding tendencies

Keywords: cold biopsy forceps cold snare biopsy
immunogenicity and safety study of gsk biologicals' meningococcal conjugate vaccine when co-administered with routine vaccines in healthy infants and toddlers

Conditions: Meningococcal Infection

Summary: this study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine gsk 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

this protocol has been updated following protocol amendment 1 date 26 july 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.

Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that parent(s)/legally acceptable representative(s) \[lar(s)\] can and will comply with the requirements of the protocol. * a male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. * written informed consent obtained from the parent(s)/lar(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. * born after a gestation period of at least 36 weeks. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * extended administration of immunosuppressants or other immune-modifying drugs since birth. * planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine and seasonal or pandemic influenza vaccine. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * previous vaccination against diphtheria , tetanus, pertussis, polio (with the exception of a birth dose of opv), haemophilus influenzae type b, streptococcus pneumonia. * history of receipt of meningococcal vaccine. * subjects who received a birth dose hepatitis b vaccines within the 30 days before the administration of the first study vaccine. * history of or intercurrent diphtheria, tetanus, pertussis, polio, haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * family history of congenital or hereditary immunodeficiency. * history of any reaction or hypersensitivity likely to be exacerbated by any component of th

Keywords: meningococcal conjugate vaccine serogroups a,c, w-135 or y meningococcal diseases immunogenicity neisseria meningitidis co-administration routine vaccines
effects of pulse consumption on bone health of postmenopausal women

Conditions: Menopause

Summary: this study will investigate the effects of the addition of 100 grams/day of cooked pulses (i.e. lentil, pinto beans, peas, chickpeas, kidney beans) to the diet of postmenopausal women for 12 weeks on gut health, metabolic outcomes and bone biomarkers.

with approximately 1.3 million women reaching menopause each year in the us and about one-third of a woman's life is spent in this state, it is imperative to identify effective, safe, and economical approaches that can minimize disease risk that is associated with this phase of life. pulses are excellent source of fiber, protein, essential amino acids, vitamins, minerals and phytochemicals, that can act as prebiotics and prevent gut dysbiosis and promote a healthy gut. a few studies in overweight or obese adults have shown the health benefits of pulses, including gut modulating potential. however, studies examining the use of pulse crops are limited, especially in alleviating health risks associated with menopause. the objective of this study is to evaluate the prebiotic potential of pulse-based diet and consequent effects on metabolic and bone biomarkers in postmenopausal women. we hypothesize that daily intake of pulses, due to its nutrient content and many other bioactive compounds including fiber content, will beneficially affect gut health and subsequently improve metabolic outcomes and bone markers in postmenopausal women. to accomplish our objectives, 40 postmenopausal women (50- 65 y old and ≥ 1 y menopause) will be recruited and will be asked to consume 100 g/d of pulse (alternate between lentils, pinto beans, peas, chickpeas, and kidney beans) for 3 months. pulse intake, anthropometric measures, markers of gut and bone health, and metabolic outcomes will be assessed at baseline and at the end of pulse consumption. once the study was underway and we got more funding, women were given the option to continue pulse supplementation for another six months to examine changes on bone density.

Eligibility criteria:
inclusion criteria: * 1 year without menstrual cycle exclusion criteria: * any medication use (for the past 6 m) that affects glucose, lipids, bone and inflammation markers, dietary supplements, and non-steroidal anti-inflammatory medications * allergy to pulse crops * tobacco use * excessive alcohol intake * antibiotic use * major surgery within 6 m of study enrollment

Keywords: bone health pulses microbiome
psychotherapy enhancement for therapeutic community (tc) retention - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to evaluate the efficacy of dual focus schema therapy in comparison to individual drug counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of therapeutic community (tc) residents.

therapeutic community (tc) treatment can be effective psychosocial modality for addiction, but premature dropout remains a major problem. personality disorders are very common in residential programs, and tcs regard personality disturbance as core to all people with addiction. severe personality dysfunction is associated with higher dropout rates from tcs, and adding cognitive-behavioral treatments may improve retention and outcome. we hypothesize that severe personality disturbance causes significant problems with an individual?s initial adjustment and effective utilization of tc processes and techniques. we predict that a behavioral therapy that targets personality pathology will result in better early retention and engagement than will a more standard addiction counseling approach. to begin to improve retention, tc research must begin to systematically evaluate the impact of adding interventions targeted at decreasing premature dropouts through controlled clinical trials. we have developed the first empirically tested treatment manual for the full range of personality disorders in substance abusers and propose to conduct a randomized clinical trial to evaluate the efficacy of dual focus schema therapy in comparison to individual drug counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of 100 tc residents. in addition to evaluating retention differences, we will analyze the rate and degree of change for these two conditions monthly and at 6, 12, 18, and 24-month follow-up for psychological indicators related to personality disorder and therapeutic processes related to the tc.

Eligibility criteria:
admission for residential tc treatment at apt residential services division inclusion criteria: adolescent or adult substance abuser; provide 2 or more contacts; ability to read and speak english exclusion criteria: acute suicidality, homicidality, psychosis, mania
rw treatment patterns and outcomes in postmenopausal hr+/her2- mbc patients treated with palbociclib plus letrozole as initial endocrine therapy at community oncology practices in the u.s.

Conditions: Breast Cancer

Summary: this is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with hr+/her2- mbc who received palbociclib plus letrozole as initial endocrine-based therapy in us community oncology network settings.


Eligibility criteria:
inclusion criteria: * patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. diagnosed with locoregional recurrent or metastatic female breast cancer. 2. pathologically confirmed hr-positive/her2-negative diagnosis. 3. received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer: 1. initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its fda approval. 2. at least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib. 4. postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib. 5. ≥18 year old at initiation of palbociclib. exclusion criteria: * no exclusion criteria will be imposed for the selection of patients.
mobile app for risk reduction of type 2 diabetes

Conditions: Prediabetic State

Summary: the aim of this feasibility study is to investigate whether a full scale rct on the efficacy of a mobile app for risk reduction on type 2 diabetes can be conducted in the way it is planned or whether it needs to be modified. this will be investigated through a feasibility study (small scale rct) on the efficacy of mobile technology on risk reduction of type 2 diabetes.

a small scale rct will be carried out a the collaborating healthy life centres (hlc). trained health personnel will deliver the lifestyle programs at these centres, and the content of their programs should be in line with the national guidelines for physical activity and nutrition. the study sample 60 participants with high risk of developing diabetes type 2. the participants will be randomized into three study arms, 20 participants in each. one group, the intervention group, will receive the mobile app, the second group will receive group-based lifestyle intervention at the hlcs and the third group will receive group based lifestyle intervention at the hlcs and a mobile application. the middle arm will serve as the control arm for both the non-inferiority trial ( mobile application group and hlc lifestyle intervention only) and for the superiority trial (hlc lifestyle intervention plus mobile app and hlc intervention only).

Eligibility criteria:
inclusion criteria: * smart phone * prediabetes exclusion criteria: * not interested in lifestyle change

Keywords: prevention
the effects of hydrogen-rich formulation for treatment of sport-related soft tissue injuries

Conditions: Soft Tissue Injuries

Summary: since hydrogen therapy in humans seems to be beneficial for treating inflammation, ischemia-reperfusion injury and oxidative stress, it seems plausible to evaluate the effects of exogenously administered hydrogen as an element of instant management of sport-related soft tissue injuries (e.g. muscle sprain, ligament strain, tendonitis, contusion). the main aim of the present study will be to examine the effects of two-week hydrogen-rich oral and topical administration on the inflammation, recovery and functional abilities in competitive male and female athletes after acute soft-tissue injury. during the season 2012/2013 (from february to june) subjects (36 professional athletes) will be recruited and examined by certified sports medicine specialist in the out-patient clinics of the center for health, exercise and sport sciences in the first 24 hours after the sport-related soft tissue injury was sustained. the subjects will be allocated to a double-blind design to three randomly assigned trials. during the period of 2 weeks subjects in the placebo group (pla) will receive traditional treatment protocol after the soft-tissue injury, consisting of rice protocol during the first 48 h and sub-acute protocol thereafter. subjects in the first experimental group will follow the above procedures with additional administration of oral hydrogen-rich capsules (4 capsules three times per day) throughout the study. subjects in the second experimental group will follow the procedures of first experimental group with additional administration of hydrogen-rick packs 6 times per day for 20 minutes throughout the study. participants will be evaluated at the beginning of the study (e.g. at the time of the injury report), after 7 and 14 days after baseline testing for: a) serum c-reactive protein, plasma viscosity and interleukin 6 level, b) pain intensity during rest and walking, c) degree of joint swelling, d) passive joint flexibility, and, e) subjective side-effects. the investigators expect that the administration of hydrogen will significantly improve inflammation outcomes (e.g. decrease in serum c-reactive protein) as compared to the placebo, with topical hydrogen administration will additionally improve post-injury recovery outcomes (e.g. pain intensity, degree of swelling). these results could support the hypothesis that hydrogen-rich intervention may be included as an element of immediate treatment for sport-related soft tissue injuries.


Eligibility criteria:
inclusion criteria: * recent history of acute soft-tissue sports injury * professional athletes exclusion criteria: * not ambulatory patients * clinical findings classed as more severe than grade ii

Keywords: inflammation pain intensity flexibility rice protocol swelling
lrrk2, gba and other genetic biomarkers in eastern european (ashkenazi) jews with and without parkinson's disease

Conditions: Parkinson Disease; LRRK2; GBA Gene Mutation

Summary: single site observational study focused on elucidating the genes and biochemical pathways involved in causing parkinson disease.

this single site study, is enrolling parkinson disease (pd) patients and their family members and is limited to participants of ashkenazi (eastern european) jewish descent with gba and lrrk2 mutations, or with 3 or more family members with pd. follow-up will be for three years. participants must be in the new york city area yearly and willing to come to mount sinai downtown for yearly 2 hour study visits which include obtaining personal medical and family history information, blood, urine and spinal fluid samples, neurological exam and neuropsychiatric testing. de-identified data and samples will be securely stored at a central nih-run repository for access by other researchers. spinal fluid collection is encouraged but optional.

Eligibility criteria:
inclusion criteria: * parkinson disease patients and their family members and is limited to participants of ashkenazi (eastern european) jewish descent with gba and lrrk2 mutations, or with 3 or more family members with pd * participants must be local to the new york city area and willing to come to mount sinai downtown for annual 2 hour study visits which include obtaining personal medical and family history information, blood, urine and spinal fluid samples, neurological exam and neuropsychiatric testing. spinal fluid collection is encouraged but optional. exclusion criteria: -patients who do not have parkinson disease or family members of ashkenazi (eastern european) jewish descent who either has a gba or lrrk2 mutations or who has 3 or more family members with pd.

Keywords: parkinson's disease parkinsonian disorders lrrk2 gba movement disorders neurodegenerative diseases
pharmacokinetic study on n-acetylneuraminic acid

Conditions: Nonaka Myopathy; Hereditary Inclusion Body Myopathy

Summary: the aim of this study is to investigate pharmacokinetics and safety of n-acetylneuraminic acid in patients with distal myopathy with rimmed vacuoles (dmrv) - hereditary inclusion body myopathy (hibm). dosages are 800mg single and three times a day and 800mg 3 times a day for 5 consecutive days. n-acetylneuraminic acid and n-glycolylneuraminic acid in serum and urine are measured before and after oral administration of n-acetylneuraminic acid.


Eligibility criteria:
inclusion criteria: * confirmed mutations in gne gene * no severe complications when informed consent is obtained * more than 40 kg in weight before administration exclusion criteria: * hepatic laboratory parameters (ast, alt, γ-gtp) or renal laboratory parameters (cr, bun) are greater than three times of upper limit of reference value * presence or history of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, gastrointestinal, brain, psychiatric, neurologic disease * intake of supplement contains sialic acid, st. john's wort or grapefruit within 7 days * enrollment in another investigational study within 3 months * more than 400 ml blood donation within 3 months * presence of alcohol or drug dependency * women who are pregnant , breast feeding or possible to be pregnant. * patients whom the investigator judges not to be appropriate for the subject

Keywords: n-acetylneuraminic acid, pharmacokinetics hibm