Kornimate/medical-research-clean huggingface dataset:
long-term safety of spd422 in japanese adults with essential thrombocythaemia

Conditions: Essential Thrombocythemia (ET)

Summary: the purpose of this study is to provide spd422 to subjects who completed study spd422 308 and, in the opinion of the investigator, will continue to benefit from treatment.


Eligibility criteria:
inclusion criteria: * subjects must have completed study spd422 308
influence of pantoprazole on human myocardial contractility at patients with congestive heart failure

Conditions: Congestive Heart Failure

Summary: recently literature revealed facts, that show h+/k+ atpase expression is not limited tot he stomach. h+/k+ atpase was also found in smooth muscle cells and in other tissues (mccabe, r.d. et al., am j physiol. 1992). for myocard a localisation is only proven for rats yet (beisvag, v. et al., acta physiol scand. 2003). moreover biochemical hints lead us to a highly probability of a myocardial h+/k+ atpase (nagashima, r. et al., jpn heart j. 1999).

recently literature revealed facts, that show h+/k+ atpase expression is not limited tot he stomach. h+/k+ atpase was also found in smooth muscle cells and in other tissues (mccabe, r.d. et al., am j physiol. 1992). for myocard a localisation is only proven for rats yet (beisvag, v. et al., acta physiol scand. 2003). moreover biochemical hints lead us to a highly probability of a myocardial h+/k+ atpase (nagashima, r. et al., jpn heart j. 1999). aim of our clinical study is to examine, whether proton pump inhibitors have an influence on myocardial contraction of human myocard and we want to ascertain the amount of influence of a h+/k+ atpase on myocardial contraction. therefore the mechanism of a putative inhibition by proton pump inhibitors is at our focus. these findings will be of major credit regarding treatment of patients with congestive heart failure with common proton pump inhibitors. we want to find out, whether this intake may have a negative inotropic effect on the heart failure myocard.

Eligibility criteria:
inclusion criteria: 1. only patients older than 18 years. range 18 to 80 years 2. only cooperative patients 3. only patients with a need for a coronary angiography, independently from our study 4. only patients with a left ventricular ejection fraction as demanded in the study protocol 5. only patients with clinical symptoms of congestive heart failure, corresponding to new york heart association stage nyha ii or iii 6. only patients without oral or i.v. application of a proton pump inhibitor up to 48 hours prior to the study catheterization exclusion criteria: 1. manifest or severe accompanying diseases, despite of diabetes mellitus 2. intravascular or oral application of proton pump inhibitors within the last 48 hours 3. intake of metformin within the last 24 hours 4. status post heart transplant 5. pregnancy 6. known intolerance of pantoprazole 7. severe side effects of the tested substance pantoprazole, as well as pharmacokinetic interactions through cyp isoenzymes 8. existance of side effects as given in the pantoprazole drug information, among others disturbances of blood- and lymphatic system, leukopenia, thrombopenia, affections of gastrointestinal tract, nerve system affections, psychiatric affections, renal or bladder affections 9. participation in a other clinical trial

Keywords: pantoprazole congestive heart failure
gw679769 in fibromyalgia

Conditions: Depressive Disorder; Depression; Fibromyalgia

Summary: the purpose of the study is to investigate safety, tolerability and efficacy of oral gw679769 up to 120 mg dose compared to placebo in patients with acr(american college of rheumatology)-defined fibromyalgia, co-morbid with depression.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia (acr criteria). * non-severe depression (ham-d score \>14 \<24). * women must commit to consistent use of an acceptable method of birth control. exclusion criteria: * severe depression (ham-d score \> 24). * unable to discontinue medications for pain or depression. * laboratory and ecg value at screening outside sponsor defined ranges. * positive to stool occult blood test.

Keywords: nk1-antagonist depression fibromyalgia gw679769 outpatient
evaluating the impact of 18f-fdg-pet-ct on risk stratification and treatment adaptation for patients with muscle invasive bladder cancer

Conditions: Muscle-Invasive Bladder Carcinoma

Summary: evaluate the impact of 18f-fdg-pet-ct on the staging of patients with muscle invasive bladder cancer. based on the results of 2 18f-fdg-pet-ct's patients are stratified in non-metastatic, oligometastatic and polymetastatic bladder cancer patients and the treatment is adapted accordingly to improve overall survival.


Eligibility criteria:
inclusion criteria: * histopathology-proven mibc on turb or ≥ t3 on conventional imaging treated with mibc radical treatment * t1-4 n0-3 m0 mibc on conventional imaging (thoracic ct and abdominopelvic ct/ mri) * age \> 18 years * who 0-2 * willingness to undergo 18f-fdg-pet-ct * willingness to undergo mdt or immunotherapy, in case of diagnosis of oligometastatic or polymetastatic disease on 18f-fdg-pet-ct, respectively * willingness and ability to provide a signed informed consent according to ich/gcp and national/local regulations exclusion criteria: * presence of distant metastasis on conventional imaging (thoracic ct and abdominopelvic ct/ mri) * refusal of or having contraindications to 18f-fdg-pet-ct * refusal of mdt or immunotherapy * prior radiotherapy unabling mdt * contraindications to radiotherapy (including active inflammatory bowel disease) * contraindications to immunotherapy * other primary tumor diagnosed \< 5 years ago and for which treatment is still required, except for diagnosis of non-metastatic prostate cancer at time of diagnosis of mibc or non-melanoma skin cancer.

Keywords: 18f-fdg-pet-ct staging distand metastasis oligometastatic disease metastasis directed therapy immunotherapy
the role of pelvic peritonization in laparoscopic or robotic low anterior resection

Conditions: Rectum Cancer

Summary: a randomized controlled clinical trial to compare the short and long outcomes of low anterior resection for middle-low rectal cancer with or without pelvic peritonization.


Eligibility criteria:
inclusion criteria: * matching the diagnostic criteria of rectal adenocarcinoma * laparoscopic or robotic radical surgery for rectal cancer * preoperative tnm staging t1-3n0-2m0 * no history of malignant tumors by preoperative examination * middle and low rectal cancer * tumor size of 4 cm or less * asa 1-3 scores * written informed consent by the patient * the patient is willing to randomize to any group exclusion criteria: * previous abdominal surgery * past malignant tumor history * preoperative examination suggests distant metastasis * be participating or have participated in other clinical studies related to rectal cancer surgery within 6 months * emergency operation elimination criteria * the tumor is confirmed to be t4b during the operation or other tumors are found to be combined with other tumors during the operation * the anastomosis is located above the peritoneum reflex * intraoperative conversion to laparotomy * change the surgical method to perform miles or hartmann surgery * postoperative pathologically confirmed non-adenocarcinoma * the patient asked to withdraw

Keywords: anastomotic leakage complication reoperation pelvic peritonization
vaginal hygiene wash as adjunct treatment in bacterial vaginosis

Conditions: Bacterial Vaginoses

Summary: this study compares the effect of vaginal hygiene wash versus placebo as adjunct treatment with oral metronidazole in treatment of women with bacterial vaginosis

this is a randomized controlled trial comparing the trial hygiene wash against placebo wash as adjunct treatment with oral metronidazole in women with bacterial vaginosis, with microbial analysis of vaginal flora compared to healthy control women

Eligibility criteria:
inclusion criteria: * 1. premenopausal women who are sexually active 2.willing to use hygiene wash together with prescribed oral antibiotics 3. able to undergo pelvic examination for sampling of vaginal discharge exclusion criteria: * 1. unable to comply with pelvic examination or hygiene wash 2. concurrent use of hormonal treatment or antibiotic therapy 3. intrauterine device either copper or levonorgestrel-releasing system 4. women with known diabetes mellitus 5. pregnant women

Keywords: vaginal hygiene wash bacterial vaginosis microbial analysis
evaluate the effectiveness of self-care multifaceted strategy in heart failure patients

Conditions: Heart Failure

Summary: study design: a randomized, multicenter, national, phase ii clinical trial aimed at evaluating the effectiveness of self-care promotion using a multifaceted strategy based on sending text messages(sms)to patients with heart failure. methodological quality: * central randomization with allocation concealment; * decision committee for blind outcome assessment; * intention-to-treat analysis

study design -a randomized, multicenter, national, phase ii clinical trial aimed at evaluating the effectiveness of self-care promotion using a multifaceted strategy based on sending text messages(sms) to patients with heart failure. methodological quality -central randomization with allocation concealment; decision committee for blind outcome assessment; intention-to-treat analysis primary objective -to develop and evaluate the feasibility of a monitoring, education and self-care strategy to optimize the management of patients with heart failure (hf) after hospital discharge. secondary objectives -to evaluate, in patients with heart failure, the effect of a self-care promotion program using a multifaceted strategy in comparison to the usual care about acceptability to the application of sms, patient and / or family satisfaction with care, quality of life scales health scales, self-care scales and knowledge on hf, visual analog scale of dyspnea, and clinical outcomes at 30 and 180 days. experimental group: -self-care promotion using a multifaceted strategy based on the use of a tele-monitoring device, based on short message system (sms) messages and self-care teaching tools. patients will receive daily messages to optimize self-care in heart failure with the following functions: * customized reminders about medication schedules * weight and symptoms of decompensation monitoring assessing a decision tree with diuretics adjustment if needed and alerts that define the need to contact a health professional for early intervention before deterioration of the clinical state, identifying situations that require clinical intervention. * educational content on heart failure for the patient (symptoms of the disease, healthy habits for hf, warning signs for severity) * diary for registration of visits to health services and clinical setting. control group: -usual outpatient care follow-up * follow up will be at least 180 days from the inclusion in the study. * sample size estimation 350 patients per group (700 patients)

Eligibility criteria:
inclusion criteria: * adults (\> 18 years) * heart failure of any etiology * vulnerable period after episode of acute decompensation * cellular telephony acess; * left ventricular ejection fraction (lvef \<40%), exclusion criteria: * cardiac transplant wait list; * surgical or percutaneous (coronary or valvular) treatment at last 3 months * hf terminal ; * life expectancy \<1 year; * another drug or device study at last 30 days * prior randomization in the study
evaluating artisential laparoscopic instruments in gynecologic surgery

Conditions: Pelvic Organ Prolapse; Abnormal Uterine Bleeding; Mesh Augmentation; Laparoscopic Surgery; Robotic Surgical Suturing; Laparoscopic Hysterectomy; Minimally Invasive Surgery

Summary: this study evaluates the efficacy and safety of artisential laparoscopic instruments in minimally invasive gynecologic surgery.

the artisential laparoscopic instrument is a novel device that allows multi-directional articulation during laparoscopic surgery. there are currently no studies evaluating the efficacy or safety of this device in minimally invasive gynecologic surgery. the investigators aim to compare the efficacy and safety of the artisential instrument with conventional laparoscopic or robotic instruments. patients who are scheduled for a laparoscopic or robotic hysterectomy and/or laparoscopic or robotic sacrocolpopexy will be invited to participate in this study. during the suturing portion of the surgery (either vaginal cuff closure during a hysterectomy, or mesh attachment during a sacrocolpopexy), operating times and safety outcomes will be measured. the approach for vaginal cuff closure will be randomly selected. the approach for mesh attachment suturing will be based on the primary surgical approach (conventional laparoscopy or robotic) and compared to suturing with the artisential and an internally controlled environment. therefore, half of the knots placed during a case will be with the artisential laparoscopic device, and the other half will be placed either with robotic instruments or conventional laparoscopic instruments.

Eligibility criteria:
inclusion criteria: * patient scheduled for robotic or laparoscopic total hysterectomy * patient scheduled for robotic or laparoscopic sacrocolpopexy exclusion criteria: * not a candidate for the above surgical procedures

Keywords: laparoscopic surgery laparoscopic suturing laparoscopic instruments pelvic organ prolapse sacrocolpopexy minimally invasive surgery vaginal cuff closure
arimidex observational: reason for and effect of change from tamoxifen

Conditions: Breast Cancer

Summary: the purpose of this study is to analyse the effect on quality of life after 3 months of treatment after changing adjuvant therapy from tamoxifen to arimidex.


Eligibility criteria:
inclusion criteria: * postmenopausal * hormone sensitive breast cancer * patient uses tamoxifen or has stopped taking tamoxifen less than 7 days ago exclusion criteria: * visceral metastases * patients with signs of progression at the moment of changing therapy * patients who have used other endocrine treatments for breast cancer besides tamoxifen

Keywords: adjuvant
study of ono-4578 with and without ono-4538 in subjects advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: the objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ono-4578 and combinations of ono-4578 and ono-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.


Eligibility criteria:
inclusion criteria: * advanced or metastatic solid tumors (part a, b) * unresectable, advanced or recurrent gastric cancer previously treated with anti-pd-(l)1 antibodies or naive to anti-pd-(l)1 antibodies (part c) * unresectable, advanced or recurrent colorectal cancer(part d) * life expectancy of at least 3 months * patients with ecog performance status 0 or 1 exclusion criteria: * patients with severe complication * patients with multiple primary cancers
head and neck cancer rehabilitation: the care feasibility study

Conditions: Head and Neck Cancer Survivors

Summary: introduction: as both the number of cancer survivors and the length of survival time are increasing, long-term health issues related to cancer and its treatment are becoming more prevalent. research suggests that exercise can mitigate a number of negative health consequences of head and neck cancer and improve physical function and quality of life. multi-modal exercise interventions have been proposed as a cornerstone for survivorship care. however, studies evaluating exercise programmes in head and neck cancer populations are lacking. purpose: to evaluate the feasibility and acceptability of a multi-modal exercise rehabilitation programme for survivors of head and neck cancer in a real-world, standard practice setting. methods and analysis: in this single-arm prospective feasibility study, survivors of head and neck cancer (n=29) will undergo a 10-week multi-modal exercise programme. the study population will comprise of cancer survivors attending outpatient services in an irish national cancer centre. participants will be aged 18 or older and have completed treatment with curative intent. feasibility will be evaluated in terms of recruitment, adherence and compliance to the programme. secondary outcomes will examine physical function and quality of life measures. in addition, the acceptability of the programme will be assessed through patient feedback. ethics and dissemination: ethical approval is pending from the st. james's hospital and tallaght university hospital research and ethics committee. the study results will be used to optimise the intervention content, and may serve as the foundation for a larger definitive trial. results will be disseminated through peer-review journals, congresses and relevant clinical groups.


Eligibility criteria:
inclusion criteria: * informed consent * over 18 years old * in the first two years after treatment for head and neck cancer * medically fit to participate in low to moderate physical activity exclusion criteria: * individuals with moderate or severe cognitive impairment * pregnancy * receiving treatment in the palliative setting

Keywords: exercise rehabilitation survivorship
determining dysphagia awareness in caregivers

Conditions: Caregiver Awareness About Dysphagia

Summary: genetic, neuromuscular, gastrointestinal, cardiorespiratory diseases and congenital abnormalities can cause dysphagia in children (1, 2). various symptoms such as coughing during or after feeding, vomiting, recurrent lung infections, inability to gaining weight, difficulty in oromotor control, nasal regurgitation, and prolonged feeding time can be seen in children whose growth and development are affected due to dysphagia (3). the primary aim of dysphagia rehabilitation is; gaining a child's age-appropriate nutritional experience by ensuring safe swallowing; supporting growth and development (1). rehabilitation consists of active or passive oral motor exercises, sensory training, thickened fluids, positioning and their combinations (4, 5). the caregiver is one of the most important partners of the rehabilitation program and should apply feding modifications and positioning for safe swallowing during each feeding. in addition, the exercise approaches recommended by the health personnel should be performed in order to improve the swallowing function at certain times of the day (5). according to a study in patients with neurologenic caregivers' failure to comply with dysphagia strategies; chest infections, aspiration pneumonia, prolongation of hospital stay, and adverse clinical outcomes resulting in death (6). therefore, the role of caregivers is very important in the perisistence and success of rehabilitation is great. the level of knowledge and awareness of the caregiver directly affects the rehabilitation effectiveness. the knowledge and awareness of the caregiver directly affects the effectiveness of rehabilitation, as it is the caregiver who is most interested and spends time with the child. the caregiver, who has knowledge about dysphagia, symptoms and management, will give the necessary importance to rehabilitation and will be more aware of the child's existing condition. thus, communication with health personnel will be strengthened, effectiveness of rehabilitation will increase. the aim of this study; to determine the level of knowledge of the caregiver about dysphagias and symptoms.


Eligibility criteria:
inclusion criteria: * persons who provided primary care for children younger than 18 years with dysphagia exclusion criteria: * doesn't accept to participate to study

Keywords: caregiver awareness dysphagia children
a study evaluating systemic exposure and pharmacodynamics in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.


Eligibility criteria:
inclusion criteria: * able to understand the requirements of the study and provide consent * medical diagnosis of copd * a current or prior history of at least 10-pack years of cigarette smoking * female of child-bearing potential to use adequate birth control exclusion criteria: * diagnosis of asthma * other significant disease than copd * has donated a unit of blood within 30 days of study, or intends to donate * qtc greater than 0.460 seconds * subjects who had radiation or chemotherapy in the previous 12 months * subjects who had lung resection * history of illegal drug abuse or alcohol abuse within the past 5 years

Keywords: chronic obstructive pulmonary disease copd pharmacodynamic pharmacokinetic
pre to postoperative smoking cessation

Conditions: Cigarette Smoking; Obesity

Summary: the study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention into a hospital setting, and assess measures of postsurgical recovery as a function of smoking cessation status.

this study will evaluate the feasibility of integrating an intensive pre- post-surgical smoking cessation intervention (i.e., varenicline + monetary incentives + brief counseling) into a hospital setting by recruiting elective bariatric surgery patients and assessing theoretically relevant baseline characteristics (e.g., factors influencing smoking decisions, such as smoking motivation, delayed discounting, and distress tolerance) that may predict smoking cessation and post-surgical recovery outcomes. participants will be required to attend a screening visit at the behavioral pharmacology research unit (bpru) located on the johns hopkins bayview medical campus, during which the participants will answer questionnaires, complete computerized tasks, and undergo sensory testing. participants will then attend approximately 6 weekly study visits leading up to their bariatric surgery, and approximately 6 more weekly study visits after the surgery, as well as a 30-day follow-up visit, all located at the bpru at johns hopkins bayview. during the 6 pre-surgery visits and 6 post-surgery visits, participants will undergo an intensive smoking cessation treatment that includes administration of a medication called varenicline that has been fda-approved for smoking cessation, as well as behavioral counseling sessions and monetary incentives for remaining smoke-free. after completing all study visits, participants will be asked to return for a 30-day follow-up visit, during which they will complete several study measures once more. throughout the study, participants will be asked to periodically complete questionnaires, computerized tasks, and sensory testing. investigators will also track outcomes associated with post-surgical recovery, including duration of hospital stay, hospital readmission, post-surgical complications, and prescription pain-killer use post-surgery.

Eligibility criteria:
inclusion criteria: * smoker who has surgery scheduled 5-10 weeks in advance exclusion criteria: * being contraindicated for varenicline use * evidence of psychiatric instability * being unwilling/unable to adhere to the study schedule * be unwilling to provide study access to medical records * being otherwise judged by the study team to be inappropriate for study participation