Kornimate/medical-research-clean huggingface dataset:
high-intensity training for men with prostate cancer on active surveillance: a feasibility study

Conditions: Prostate Cancer

Summary: this is a randomized study aiming to assess the feasibility of a phase ii randomized controlled trial of different high-intensity training interventions and usual care (uc) in men with prostate cancer (pca) undergoing active surveillance (as).

primary objectives: the primary objective of this study is to assess the feasibility of conducting a three-armed randomized controlled trial comparing high-intensity interval training (hiit), high-intensity resistance training (hirt), and usual care (uc) in men with pca on as. the secondary exploratory objective of this study is to assess changes in cardiorespiratory fitness, musculoskeletal strength, body composition, circulating blood markers, and participant-self-reported outcomes (e.g., quality of life, anxiety, fear of disease progression) after 8 weeks of hiit, hirt, or uc. methods: participants will be randomized in a 1:1:1 ratio to hiit, hirt or uc group. participants in the hiit and hirt group will undergo training 3 times per week (two supervised and one home-based/unsupervised training session) for 8 weeks. the uc group will be directed towards publicly available literature on physical activity (e.g., cancer care ontario's physical activity guidelines for cancer survivors) and will receive an individualized exercise program upon completion of their final fitness assessment.

Eligibility criteria:
inclusion criteria: * 18 years or older; * initiating or currently on as for pca; * not currently engaging in high-intensity aerobic and/or resistance training at 85%hrmax or ≥9 rpe in the borg 0-10 rpe scale; * willing and able to travel to the study-designated facilities; * proficient in english; * able to provide written informed consent; * pass the screening cpet by achieving volitional exhaustion (rate of perceived exertion (rpe) ≥ 9 using the borg 0-10 rpe scale) in the absence of any cardiorespiratory abnormalities. exclusion criteria: * uncontrolled hypertension (≥2/3 of readings of \> 160/90), regardless of whether on a regimen of anti-hypertensive therapy or not; * been diagnosed with congestive heart failure (new york heart association class ii, iii or iv); * a history of serious cardiovascular events (within 12 months) including, but not limited to, transient ischemic attack (tia), cerebrovascular accident (cva), or myocardial infarction (mi); * a medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the study physician, would make this protocol unreasonably hazardous for the patient; * a history of a psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol; * serious or non-healing wound, ulcer, or bone fracture; * experience shortness of breath, chest discomfort, or palpitations when performing activities of daily living; * ongoing restriction of physical activity; * developed chest pain in the past month

Keywords: active surveillance prostate cancer high-intensity interval training resistance training
probiotics for prophylaxis of postoperative hirschsprungs associated enterocolitis

Conditions: Hirschsprung Disease

Summary: hirschsprungs associated enterocolitis (haec) with incidence up to 30% postoperatively. the objective of the trial is to prevent postoperative haec by using probiotics.

randomised controlled study with two arms. all cases following up for post operative hirschsprungs surgery are included in this study. first arm will receive a probiotics in the form of sachet for 6 months. second arm will receive a multivitamin as placebo. comparative analysis between the two groups for baseline and followup prevalence of hirschsprungs associated enterocolitis.

Eligibility criteria:
inclusion criteria: * hirschsprungs disease confirmed preoperative and postoperative specimen pathology exclusion criteria: * other cases of enterocolitis and constipation
the prevalence of rheumatic heart disease in school children in fiji

Conditions: Rheumatic Heart Disease

Summary: this study is an epidemiological observational cross-sectional study designed to estimate the prevalence of echocardiographically confirmed rhd in school children from 5-14 years of age in fiji. the study will be conducted in the central division of fiji within a selection of up to16 primary schools located in the korovou/tailevu and rewa/nausori sub-divisions. school children will be enrolled after informed consent has been obtained. a standard cardiac examination (auscultation) will be performed as part of the routine annual health check by both school nurses, who have attended a training workshop, and by a paediatrician. all children with or without murmur will have a screening echocardiogram performed at a subsequent visit. children found to have possible, probable or definite rhd or other cardiac pathology on the screening echocardiogram, will have a full echocardiogram performed by the echocardiography technician at the time of the second study visit. they will all also be referred to a paediatric cardiologist for further investigation and management and monitoring . cases of rhd will be referred to and followed up by the national fiji rhd register based at cwmh in suva.


Eligibility criteria:
inclusion criteria: * informed consent will be obtained for all participants * all children between the ages of 5-14 years are eligible for the study. exclusion criteria: * none

Keywords: rheumatic heart disease streptococcus fiji
a study of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis who have an inadequate response to dmards or anti-tnf

Conditions: Rheumatoid Arthritis

Summary: this open-label, single arm study will evaluate the safety and efficacy of roactemra/actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (dmards) or anti-tnf. patients will receive roactemra/actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. non-biologic dmard therapy may be continued throughout the study. anticipated time on study treatment is 24 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * active moderate to severe rheumatoid arthritis of \>/= 6 months duration * \>/=1 non-biologic dmard and/or anti-tnf therapy at stable dose for \>/=8 weeks at any time prior to study treatment * inadequate clinical response to non-biologic dmard or anti-tnf therapy * oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug exclusion criteria: * pregnant or lactating women * major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment * rheumatic autoimmune disease other than ra * functional class iv (acr classification) * prior history of or current joint disease other than ra * intraarticular or parenteral corticosteroids within 6 weeks prior to baseline * previous treatment with roactemra/actemra * known active current or history of recurrent infection * history of or currently active primary or secondary immunodeficiency * active tuberculosis requiring treatment within the previous 3 years * positive for hiv
measuring patient expectations for thyroid surgery

Conditions: Thyroid Cancer

Summary: the purpose of this study is to learn more about what patients undergoing surgery for thyroid cancer expect from their surgery. your input may help us to better prepare and inform patients about their disease and its treatment.


Eligibility criteria:
inclusion criteria: * age ≥18 years * english speaking * patients with confirmed thyroid malignancy confirmed by preoperative fine needle biopsy (any stage) planned for surgical excision exclusion criteria: * inability to speak or understand english * inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability * prior thyroid surgery * prior radioactive iodine treatment, external beam radiation or chemotherapy

Keywords: surgery interview 11-087
lower limb surveillance during va-ecls

Conditions: Cardiogenic Shock; Cardiac Arrest; Lower Limb Ischemia

Summary: temporary cardiac support by va-ecls can lead to lower limb ischemia. the aim of this study is to evaluate a multi-modal strategy (physical examination, nirs monitoring and angiography through the reperfusion canula) of lower limb surveillance.

va ecls is used as a temporary circulatory support during cardiogenic shock and refractory cardiac arrest. complications of va ecls include hemorrhagic, infectious and ischemic events. va ecls requires arterial and venous canules which are frequently positioned in the femoral artery and vein, which carries the risk of lower limb ischemia due to retrograde flow and obstruction of the femoral artery lumen. va ischemia during va ecls is frequent (11-52%) and requires the use of reperfusion canula in the femoral common artery on va ecls implantation in a primary prevention strategy, before lower limb ischemia occurs. even with this strategy, lower limb ischemia can occur due to arterial thrombosis, arterial spasm or insufficient blood flow through the reperfusion canula. lower limb complications are prevented by monitoring of regional oxygen saturation, control of the reperfusion canula position (ultrasound, angiography) and rapid management when lower limb ischemia is suspected. there are no clear recommendations regarding prevention of lower limb complications during va ecls and arterial angiography has been described to diagnose ischemic events and evaluate the effectiveness of an intervention such as injection of vasodilators. this study is a prospective evaluation of a strategy to prevent lower limb complications during va ecls with a systematic arterial angiography on va ecls implantation and when lower limb ischemia is suspected (regional oxygen tissue saturation \ 15% between both lower limbs) in addition to continuous nirs monitoring of lower limbs during va ecls.

Eligibility criteria:
inclusion criteria: * temporary circulatory support with va ecls * age \> 18 years exclusion criteria: * pregnancy * history of iodinated contrast allergy * history of lower limb amputation above the ankle * lower limb ischemia before starting of va-ecls * femoro-axillary va-ecls * absence of the lower limb reperfusion canula

Keywords: va-ecmo va-ecls near-infrared spectroscopy (nirs)
efficacy of a low fiber diet for pediatric colonoscopy prep

Conditions: Colitis; Gastrointestinal Diseases; Pediatric Disorder; Pediatric Crohns Disease; Procedural Sequelae

Summary: this study is designed to evaluate if pediatric patients who are undergoing a bowel preparation in anticipation of a colonoscopy may be able to take in a low fiber diet instead of a standard, clear liquid diet, while still accomplishing an adequate bowel prep.


Eligibility criteria:
inclusion criteria: - all outpatients undergoing colonoscopy at our institution exclusion criteria: * unstable medical condition * metabolic disease * inpatient status * requiring an emergency colonoscopy
an up to twelve week safety and efficacy study with a topical gel to treat common warts in pediatric subjects

Conditions: Warts

Summary: the primary purpose of this study is to evaluate the effectiveness in pediatric subjects of three different strengths of resiquimod gel applied to common wart(s) three times a week for up to twelve weeks. a second purpose is to evaluate the safety of the drug.


Eligibility criteria:
inclusion criteria: * diagnosis of common wart(s) * ages between 3 to 11 exclusion criteria: * other types of wart(s), ie. plantar * currently participating in another clinical study * chronic viral hepatitis b or c

Keywords: wart(s) common wart(s) children pediatric 3m pharmaceuticals resiquimod
aggressive behavior induced by selective serotonin reuptake inhibitors (ssris) during the first month of treatment

Conditions: Adverse Effects; Aggression

Summary: ssris are the first line of therapy for anxiety and depressive disorders and for many other clinical diagnoses. one of the most disturbing side effects that is observed is a tendency towards aggressiveness among patients receiving medications from this group, mainly during the first month of therapy. aggressive behavior tends to occur in some individuals but not in others. in some sub-groups of people, personality and character traits might make a person more prone to aggressive behavior. in this study the investigators try to estimate the tendency towards aggressive behavior in patients prescribed to a medication from the ssri group. by using a comparative computer simulation they hope to be able to detect delicate changes and to maybe get some clues of the personalities prone to aggressive behavior in the future.

selective serotonin reuptake inhibitors (ssris) became the first line therapy for anxiety and depressive disorders and for many other clinical diagnoses. one of the most disturbing side effects that is observed is a tendency towards aggressiveness among patients receiving medications from this group, mainly during the first (one month) period of therapy. aggressive behavior tends to occur in some individuals but not in others. until now most of the cases and reports in the literature demonstrate the extreme events of aggressive behavior. these personality or any other character traits that are more prone to develop aggressiveness have not been studied and it is not clear if this side effect manifests itself just in the extreme rare cases or if it is a more common phenomenon that occurs in a wider group of people. in this study we try to estimate the tendency towards aggressive behavior of patients prescribed to a medication of the ssri group. by using a comparative computer simulation we hope to be able to detect more delicate changes and maybe to get some clues of the personalities prone to aggressive behavior in the future.

Eligibility criteria:
inclusion criteria: * age above 18 years * instructed by his/her family physician to start taking a medicine in the ssri group exclusion criteria: * according to the family practitioner's record: under ssri, snri, or nri treatment during the previous 3 months or at the time of entry into the study. * diagnosed with schizophrenia or active psychosis or impaired judgment * anti-social personality disorder * drug use or alcohol abuse

Keywords: aggressive ssri's simulation behavioral side effects, psychological adverse effects serotonin reuptake inhibitors aggressive behavior computer simulation
periodontal disease and post-menopausal osteoporosis

Conditions: Osteoporosis; Osteopenia; Periodontal Disease

Summary: the aim of this study was to investigate the levels of rankl and osteoprotegerin, and their relationship in gingival crevicular fluid of post-menopausal women with osteoporosis/osteopenia and chronic periodontitis simultaneously and evaluate the effect that the use of bisphosphonates in periodontal disease. study hypothesis: "the osteoporosis / osteopenia in postmenopausal women patients with periodontal disease affect the ratio rankl / opg in gingival crevicular fluid samples favoring osteoclastogenesis processes "

81 active periodontal sites from 31 postmenopausal women aged 45-70 years with chronic periodontitis were studied. samples of gingival crevicular fluid were collected by paper strips and elisa test was conducted to determine the total concentration of rankl, opg, and then obtain the values of the rankl / opg ratio. we analyzed 66 samples of gingival crevicular fluid obtained from active periodontal sites of 17 patients with osteopenia / osteoporosis and 15 samples gingival crevicular fluid obtained from active periodontal sites obtained of 14 controls patients with normal osseous condition. statistical analyzes were computed and analyzed using graphpad software. to determine if the data correspond to a normal distribution the d'agostino-pearson test was used. the values of cytokines (rankl and opg) and its ratio (rankl / opg) were compared using mann-whitney test t u. analysis spearman correlation and linear regression for statistic was also performed to determine whether there was any relationship between the variables analyzed. it was considered as statistically significant p value ≤ 0.05.

Eligibility criteria:
inclusion criteria: * women between 45-70 years with absorptiometry dual energy x-ray (dexa). * control group: post-menopausal women with periodontal disease and normal osseous condition. * study group: post-menopausal womens with periodontal disease and osteoporosis/osteopenia with and without bisphosphonate treatment (risedronate or ibandronate 150 mg) for longer than 3 months before the study and another. exclusion criteria: * patients with history of aggressive periodontitis and had received any periodontal treatment when they entered the study * patients with any systemic illness (except osteopenia/osteoporosis) * patients who received antibiotic or non-steroidal anti-inflammatory therapy in the 6 months prior to the study.
effectiveness of a mobile-based hiv prevention intervention involving incentive policy for doctors in liangshan, china

Conditions: HIV/AIDS

Summary: this study will be carried out in liangshan yi autonomous prefecture, sichuan province, china, using a single-blinded randomized controlled trial design to measure the effects of a mobile-based hiv-related information intervention on group hiv/aids prevention. village doctors will be responsible for sending the hiv-related health education information to the participants. the aim of this study is to develop a generalizable, effective, acceptable, and convenient mobile-based information intervention model to improve hiv-related knowledge, attitudes, practices, and health outcomes in poverty-stricken areas in china and measure the impact of incentive policies on the work of village doctors in liangshan, china.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * has mobile phone with internet service * has and use wechat and tiktok account regularly * willing to provide informed consent * speak mandarin chinese or yi ethnic group's language exclusion criteria: * diagnosed with psychiatric disorders * diagnosed with severe cognitive impairment * diagnosed with severe physical disabilities * has already attended or is currently attending another intervention program * plan on moving out of liangshan in the 18-month study period
mobilization of stem cells with amd3100 (plerixafor) in multiple myeloma patients

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determine whether the combination of amd3100 (plerixafor) and granulocyte colony-stimulating factor (g-csf, generic name of filgrastim) is better than g-csf alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.

a peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. currently filgrastim (g-csf), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. this study is intended to determine whether the combination of plerixafor with filgrastim (g-csf)is better than filgrastim (g-csf) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions. this study was previously posted by anormed, inc. in november 2006, anormed, inc. was acquired by genzyme corporation. genzyme corporation is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma in first or second complete or partial remission * \>= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and velcade were not considered prior chemotherapy for the purpose of this study) * recovered from all acute toxic effects of prior chemotherapy * eastern cooperative oncology group (ecog) performance status of 0 or 1 * white blood cell count (wbc) \> 2.5\*10\^9/l * absolute polymorphonuclear leukocytes (pmn) count \> 1.5\*10\^9/l * platelet (plt) \> 100\*10\^9/l * serum creatinine \<=2.2 mg/dl * cardiac and pulmonary status sufficient to undergo apheresis and transplantation * negative for hiv exclusion criteria): * failed previous stem cell collection * previous stem cell transplantation * brain metastases or myelomatous meningitis * radiation to ≥ 50% of the pelvis * abnormal electrocardiogram (ecg) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality * received bone-seeking radionuclides (e.g. holmium) * a residual acute medical condition resulting from prior chemotherapy
a study to evaluate the interchangeability of v114 and prevnar 13™ in healthy infants (v114-027/pneu-direction)

Conditions: Pneumococcal Infections

Summary: the goal of this study is to evaluate the safety, tolerability, and immunogenicity of the pneumococcal conjugate vaccines (pcvs) v114 and prevnar 13™ in healthy infants switched from prevnar 13™ to v114 during the four-dose pcv immunization schedule.


Eligibility criteria:
inclusion criteria: * is healthy, based on clinical judgment of the investigator * has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent. exclusion criteria: * has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease * has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (pcv), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine * has any contraindication to the concomitant study vaccines being administered in the study * has a known or suspected impairment of immunological function * has a history of congenital or acquired immunodeficiency * has or his/her mother has a documented human immunodeficiency virus (hiv) infection * has or his/her mother has a documented hepatitis b surface antigen - positive test * has known or history of functional or anatomic asplenia * has failure to thrive based on the clinical judgment of the investigator * has a known coagulation disorder contraindicating intramuscular vaccination * has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders) * has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders * has received a dose of any pneumococcal vaccine prior to study entry * has received \>1 dose of monovalent hepatitis b vaccine or hepatitis b based combination vaccine prior to study entry * has received a dose of rotavirus vaccine prior to study entry * has received a blood transfusion or blood products, including immunoglobulins * has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study * has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study * has an immediate family member (e.g., parent/legal guardian or sibling) who is investigational site or sponsor staff directly involved with this study.