Kornimate/medical-research-clean huggingface dataset:
clinical pharmacology trial to investigate the dose of opc-61815 injection equivalent to tolvaptan 15-mg tablet in patients with congestive heart failure

Conditions: Congestive Heart Failure

Summary: the dose for intravenous administration of opc-61815 achieving tolvaptan exposure equivalent to that for oral administration of tolvaptan 15-mg tablet will be investigated by administering opc-61815 injection 2 to 16mg or tolvaptan 15-mg oral tablet to subjects with congestive heart failure.


Eligibility criteria:
inclusion criteria: 1. subjects who are currently on treatment with any of the following diuretics * loop diuretics equivalent to furosemide tablet or fine granules at a dose of 40 mg/day or higher * concomitant use of a loop diuretic and a thiazide diuretic (including thiazide analogs) at any dose * concomitant use of a loop diuretic and an aldosterone antagonist or potassium-sparing diuretic agent at any dose 2. subjects with congestive heart failure in whom lower limb edema, pulmonary congestion, and/or jugular venous distension due to volume overload is present 3. subjects who are currently hospitalized or who are able to be hospitalized during the trial exclusion criteria: 1. subjects with acute heart failure 2. subjects with a history of hypersensitivity to any of ingredients of opc-61815 or tolvaptan 3. subjects who are unable to sense thirst or who have difficulty with fluid intake
communication issues in patient and provider discussions of immunotherapy

Conditions: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Summary: this trials studies communication issues in patient and provider discussions about immunotherapy. the goal of this study is to describe where patients have heard about immunotherapy, what the participants understand about it, how physicians and other healthcare workers describe immunotherapy, and how educational videos may support patient knowledge about immunotherapy.

primary objectives: i. to identify misestimations about the risks and benefits of immunotherapy resulting from media hype or other sources and assess if these misestimations persist post-provider conversation about immunotherapy. ii. to qualitatively describe patient reported misunderstandings and to assess patient understanding of technical terms and metaphors used in the immunotherapy conversation. iii. to identify provider and patient preferences for information to be communicated about immunotherapy. iv. develop videos that describe immunotherapy and test their efficacy in improving understanding using pre and post methodology. outline: patients and their providers undergo observation during a conversation about immunotherapy. then participate in an interview over 20 minutes. understanding of educational videos is then tested.

Eligibility criteria:
inclusion criteria: * aims 1-3: all patients and providers who may have a discussion about immunotherapy at the winship cancer institute * aim 4: any cancer patient
effect of alogliptin/pioglitazone on the preservation of long-term beta-cell function

Conditions: Diabetes

Summary: all subjects will be randomized as alo/pio combo group (intervention) or glim/met combo group (control) after intensive coad treatment based on identical protocol. * all subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks. * any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients * patient who had been diagnosed within the previous 12 months with hba1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy exclusion criteria: * the use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months * previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks * the use of insulin within the 3 months prior to screening * others
myocardial protection with perhexiline in left ventricular hypertrophy

Conditions: Myocardial Reperfusion Injury; Cardiac Output, Low; Hypertrophy, Left Ventricular

Summary: open-heart surgery causes injury of the heart muscle. although this is usually mild, temporary and reversible, if it is severe it can endanger life and require additional high cost care. during surgery, techniques are used to protect the heart from injury, but these remain imperfect. patients with a thickened wall of the heart (left ventricular hypertrophy) may be at greater risk. this study assesses the effect of facilitating sugar metabolism (a more efficient fuel) by the heart muscle using the drug perhexiline given before the operation. this treatment has a sound experimental basis for improving outcome. if this improvement is confirmed surgical results could be improved. the investigators will be studying heart function, heart muscle energy stores and chemicals which quantify the amount of heart muscle injury. the investigators' hypothesis is that perhexiline will improve the protection of the heart by decreasing damage that may occur during heart surgery.


Eligibility criteria:
inclusion criteria: * adult * first-time * aortic valve surgery for aortic stenosis +/- coronary artery bypass exclusion criteria: * diabetes mellitus * renal impairment with creatinine greater than or equal to 200micromol/l * atrial fibrillation * amiodarone therapy, recent (in last month) or current * hepatic impairment, significant preoperative * peripheral neuropathy * pregnancy or breast-feeding * emergency surgery or required on clinical grounds within 5 days of referral

Keywords: perhexiline aortic valve stenosis hypertrophy, left ventricular myocardial reperfusion injury cardiac output, low troponin
parent management training, oregon

Conditions: Child Behavior Problems

Summary: the purpose of the study is to examine the effects of parent management training oregon (pmto) compared to treatment as usual (tau) for parents with children aged 3 and 12 showing behavioral problems.

this project estimates the causal effect of parent management training, oregon (pmto) in a danish context. the study design is an rct where pmto is compared to treatment as usual (tau). the target population is parents with children aged 3 and 12 showing behavioral problems. the primary outcome estimates changes in child behavior, and is measured three times: baseline, seven months follow-up, and 19 month follow-up.

Eligibility criteria:
inclusion criteria: * families with children that are eligible for pmto and at least one other type of family training program exclusion criteria: * the family does not want to participate

Keywords: parent training child behavior randomized controlled trials
use of the combination of olmesartan and hydrochlorothiazide in essential hypertension

Conditions: Essential Hypertension

Summary: the study will evaluate the blood pressure lowering effects of two different dosages of the combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high blood pressure.


Eligibility criteria:
inclusion criteria: * male or female europeans aged 18 years or older with moderate to severe hypertension (htn) exclusion criteria: * female patients of childbearing potential pregnant, lactating or planning to become pregnant during the trial period. * patients with serious disorders which may limit the ability to evaluate the efficacy or safety of the study medication, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or oncological, neurological and psychiatric diseases. * patients having a history of the following within the last six months: * myocardial infarction, * unstable angina pectoris, * percutaneous coronary intervention, * severe heart failure, * hypertensive encephalopathy, * cerebrovascular accident (stroke) or * transient ischaemic attack. * patients with clinically significant abnormal laboratory values at screening. * patients with secondary htn.

Keywords: moderate-to-severe hypertension essential hypertension combination therapy fixed-combination dose
evaluation of safety and activity of celaderm in healing venous leg ulcers

Conditions: Leg Ulcer; Varicose Ulcer

Summary: this pilot study was designed to test the safety of celaderm(tm) in treating venous leg ulcers and to give preliminary information about the efficacy of two different celaderm(tm) dosing regimens.

celaderm(tm) weekly for four weeks or biweekly for four treatments combined with profore(r) compression vs. profore(r) compression alone.

Eligibility criteria:
inclusion criteria: * venous ulcer \> 1 month and \< 12 months in duration; 2 to 20 sq cm in surface area; not infected * confirmatory venous ultrasound showing prior dvt and concurrent venous reflux * ankle-brachial index 0.80 or greater exclusion criteria: * cutaneous malignancy * recent treatment with corticosteroids or chemotherapeutic agents * wound exposed bone, tendon or neurovascular structure * wound infected and requiring antibiotics

Keywords: wound leg venous chronic wound healing
virtual reality (vr) paediatric tracheostomy training

Conditions: Educational Study

Summary: this study aims to evaluate the use of an unsupervised virtual reality training tool. this tool is used to teach nurses, doctors and other healthcare workers and their students how to manage tracheostomy emergencies in children.


Eligibility criteria:
inclusion criteria: * healthcare student * clinical experience needed * healthcare staff * based at manchester university foundation trust, or the university of manchester exclusion criteria: * not a healthcare student * not a healthcare student - have no clinical experience * not healthcare staff but working in the national health service * not based at manchester university foundation trust, or the university of manchester

Keywords: virtual reality tracheostomy training paediatric
special drug use-results survey of prograf capsule in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.

the purpose of this study is to confirm the safety of 24 weeks-treatment with the combination of tacrolimus + biological agents, and to assess the efficacy using sdai, cdai, das28-crp, mmp-3, mhaq in patients with rheumatoid arthritis who have not achieved sdai remission despite of using biological agents for over 8 weeks.

Eligibility criteria:
inclusion criteria: * patients with rheumatoid arthritis who have been treated with biological agents over 8 weeks but have not achieved sdai remission (sdai \< 3.3)
cavilon breast trial: comparison of cavilon durable barrier cream to glycerine ("sorbolene") cream

Conditions: Breast Cancer

Summary: this study has patients using two different moisturising creams during radiation therapy after mastectomy. these are cavilon and sorbolene. it is hypothesised that skin reactions may be reduced by the cavilon cream compared to sorbolene.

skin reactions are a common and undesirable result of radiation treatment. preventative measures are often used although there are few controlled trials. commonly employed agents for established reactions have included sorbolene (10% glycerine), silver sulphadiazine, hydrocolloid dressings, topical steroids, salt water or bicarbonate of soda water solution bathing and hydrogen peroxide. one trial found that cavilon no-sting barrier film reduced grade 3 skin reaction compared to sorbolene, although this film did not contain any moisturising agents. general hypothesis: that in a paired double blind randomised study peak and overall skin reactions experienced by post mastectomy breast cancer patients receiving radiotherapy may be reduced by cavilon durable barrier cream (cdbc) compared to sorbolene. alternative hypothesis of primary outcome: the frequency of grade 3 or more skin reaction will be reduced from 35% to 25% for skin care using sorbolene or cdbc respectively. alternative hypothesis of secondary outcome: the mean area under the curve (auc) of total skin reaction will be reduced from 9 to 8 for skin care using sorbolene or cdbc respectively.

Eligibility criteria:
inclusion criteria: * ages 18 or more years * post total mastectomy * planned dose at least 45 gy in 25 fractions * ecog 0-2 * able to attend weekly during treatment for review and photo and for up to 6 weeks after radiotherapy * patients capable of childbearing using adequate contraception * written informed consent exclusion criteria: * previous radiotherapy to the chest wall to be treated * macroscopic cutaneous involvement by malignancy at time of radiotherapy * known allergy to product contents * patients who are pregnant or lactating.

Keywords: skin care radiotherapy
a multi-center outcomes clinical study of the pyrotitan™ hra shoulder implant in humeral head resurfacing

Conditions: Arthritis

Summary: this study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the pyrotitan™ hra shoulder prosthesis humeral replacement.

this study is designed as a multi-center, nonrandomized, uncontrolled, unblinded, prospective clinical outcomes investigation to evaluate the short, mid and long term performance of the pyrotitan™ hra shoulder prosthesis humeral replacement. the pyrotitan™ hra shoulder prosthesis device configuration will include humeral resurfacing cap without cement. patients will be selected for recruitment into the study based upon the normally accepted criteria for primary shoulder resurfacing arthroplasty. the investigation will be conducted by up to 10 international surgeons experienced in hra. 387 subjects with pyrotitan™ hra shoulder prosthesis arthroplasties will be implanted and followed for 10 years.

Eligibility criteria:
inclusion criteria: 1. patients selected for inclusion will present for primary shoulder surface replacement or arthroplasty with any of the following diagnoses: * osteoarthritis * rheumatoid / inflammatory arthritis * post-traumatic arthritis. * focal and large (hill-sachs) osteochondral defects. 2. subject is able to or capable of providing consent to participate in the clinical investigation. 3. subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires. 4. subject is at least 21 years of age and skeletally mature at the time of surgery. exclusion criteria: 1. have destruction of the proximal humerus to preclude rigid fixation of the humeral component. 2. insufficient bone quality as determined by intra-operative evaluation. 3. have arthritis with defective rotator cuff. 4. have had a failed rotator cuff surgery. 5. have loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. 6. have evidence of active infection. 7. present with a condition of neuromuscular compromise of the shoulder (e.g., neuropathic joints or brachioplexis injury with a flail shoulder joint). 8. are unwilling or unable to comply with a rehabilitation program or would fail to return for the postoperative follow-up visits prescribed by the protocol. 9. are skeletally immature. 10. have a known allergic reaction to pyrocarbon. 11. have other conditions such as central nervous system disturbances, alcohol or drug addiction, etc. that may make effective evaluation of the joint replacement difficult or impossible. 12. are currently participating in another clinical study. 13. have known, active metastatic or neoplastic disease. 14. are taking \> 10mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery. 15. are under 21 years of age or over 75. . 16. require glenoid replacement (glenoid classification).
combined training on body composition of postmenopausal women undergoing treatment for breast cancer

Conditions: Breast Cancer; Aromatase Inhibitors; Postmenopausal

Summary: breast cancer is a multifactorial disease affecting women, and one of the treatments for its healing and survival is hormone therapy. aromatase inhibitors are third-generation drugs that promote lower chance of metastasis, but their side effects include the loss of bone mineral density and increased fat percentage. in this way, the combined training (combined resistance and endurance training) may be an interesting strategy to minimize the side effects of aromatase inhibitors, providing better quality of life, survival and changes in body composition.


Eligibility criteria:
inclusion criteria: * postmenopausal, defined by the absence of periods for the past 12 months; * breast cancer diagnosis stages 1 to 3; * the adjuvant treatment for breast cancer and / or neoadjuvant aromatase inhibitors * no abnormalities on screening physical or any health problems that contraindicate study participation; * no contraindications for treadmill testing or entry into a training program, including any of the following: * myocardial infarction within the past 6 months * pulmonary edema * myocarditis pericarditis * unstable angina * pulmonary embolism or deep vein thrombosis * uncontrolled hypertension (i.e., blood pressure \> 200/100 mm hg) * uncontrolled arrhythmia * no significant mental illness * have medical certificate to perform exercise testing and participate in combined training * able to answer questionnaires * no concurrent participation in any other organized exercise program; * live in presidente prudente * sign the consent form and formal clarification for participation in the study. exclusion criteria: * accumulating 3 unexcused absences or 4 consecutive unexcused absences during the month.

Keywords: combined training breast cancer body composition postmenopausal women aromatase inhibitors quality of life
study of amifostine and imrt for protecting salivary glands in head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to determine whether amifostine provides additional protection of salivary gland function over that achieved with imrt alone.


Eligibility criteria:
inclusion criteria: * pathologically confirmed squamous cell cancer of the head and neck * eligible sites: oral cavity, oropharynx, hypopharynx, larynx. * patients requiring postoperative imrt. * kps \> 70%. * patient has signed specific protocol consent prior to registration. * calcium test within normal limits. * no previous malignancy except for non-melanoma skin cancer or cancer not of head and neck and controlled for at least 5 years. * labs completed with 30 days of registration (cbc \& platelet, ca++, alk phos, sgot, bili, albumin) cxr and ct simulation. * liver ct if alk phos, sgot, or bili elevated. * bone scan if elevated alk phos exclusion criteria: * metastatic disease. * patient using salagen or concurrent chemotherapy. * previous xrt for head and neck tumors. * active untreated infection.
pentafecta outcomes after robot-assisted laparoscopic radical prostatectomy

Conditions: Prostate Cancer; Erectile Dysfunction; Complication of Surgical Procedure; Urinary Incontinence

Summary: robot-assisted laparoscopic radical prostatectomy (ralrp) is a surgical technique for the treatment of prostate cancer. the aim of this study was to report our initial experience with ralrp, by applying the concept of pentafecta. pentafecta consists of the five main outcomes in the postoperative period of ralrp: erectile dysfunction, urinary incontinence, postoperative complications, surgical margins and biochemical failure.

this study will describe a initial experience in ralrp in brazilian university hospital. the follow-up of patients was performed as an examination at the medical consultation every three months. complications were categorized according to the clavien classification system. biochemical failure was established by psa level. continence was defined as patients who remain dry and who do not require any kind of protection in their everyday activities. sexual potency was defined as the ability to get and keep an erection for long enough to have satisfying sexual relations with or without the use of type-5 phosphodiesterase inhibitors (pde-5) and a sexual health inventory for men (shim) score greater or equal to 21. positive surgical margin is defined as the presence of neoplastic glands in direct contact with the ink on the surface of the piece, with no interposed connective tissue.

Eligibility criteria:
inclusion criteria: • patients diagnosed with localized prostate adenocarcinoma submitted to surgical treatment with robot-assisted laparoscopic radical prostatectomy exclusion criteria: * patients undergoing other treatments for adenocarcinoma of the prostate * conversion to open prostatectomy * loss of follow-up

Keywords: robot-assisted prostatectomy pentafecta biochemical failure surgical margin
additional effect of cranial base release on cervical range and proprioception in patients with mechanical neck pain

Conditions: Neck Pain

Summary: mechanical neck pain is the second most commonly occurring musculoskeletal disorder worldwide, ranking 4th in overall disability. it is referred to as nonspecific generalized neck pain with mechanical characteristics with a primary location between the supranuchal line and the first thoracic spinous process, includingpatients suffering from mechanical neck pain are reported to have several impairments, including pain, reduced cervical rom, neck disability, and proprioceptive dysfunction. the treatment indicated involves the use of electrotherapy and thermal modalities. in addition, the use of different manual therapy techniques is advocated; however, the most effective management is still debatable. evidence suggests that natural apophyseal glides have a significant positive effect on mechanical neck pain patients. so the study will identify the additional effect of cranial base release with natural apophyseal glides in alleviating pain and its effects on proprioception.


Eligibility criteria:
inclusion criteria: * patients diagnosed with mechanical neck pain having reproducible non-specific neck pain with a primary location between the supranuchal line and the first thoracic spinous process * male and female * age 18-40 years * pain severity on nprs \>3 * neck disability score of 20% or above * problem not older than 2 months exclusion criteria: * patients with history of * recent significant trauma (including whiplash) * radiculopathy * cervical fracture * neck surgery * dizziness, vertigo * myelopathy, malignancy * metabolic disease * diagnosed osteoporosis, rheumatoid arthritis * long-term corticosteroid and/or painkiller drug use

Keywords: range of motion, proprioception