Kornimate/medical-research-clean huggingface dataset:
miracle study: a study of once-monthly intravenous mircera in hemodialysis participants with chronic renal anemia

Conditions: Anemia

Summary: this single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of mircera in hemodialysis participants with chronic renal anemia. those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent \[esa\] dose administered on week -1). subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter \[g/dl\] for switzerland and 10 to 12 g/dl for austria).


Eligibility criteria:
inclusion criteria: * adults greater than or equal to (≥) 18 years of age * chronic renal anemia * hemoglobin concentration in country-specific target range (switzerland: 11 to 13 g/dl; austria: 10 to 12 g/dl) * regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months * continuous intravenous or subcutaneous maintenance esa treatment during previous 2 months exclusion criteria: * transfusion of red blood cells during previous 2 months * significant acute or chronic bleeding, such as overt gastrointestinal bleeding * active malignant disease (except non-melanoma skin cancer)
internet cognitive behavioural therapy to patients with heart failure and depression

Conditions: Heart Failure; Depressive Symptoms

Summary: the purpose of this study is to evaluate the short (9 weeks) and long (6 and 12 months) term effects of an 9 weeks intervention of internet-based cognitive behavioural therapy on depressive symptoms, worrying/anxiety, sleep, self-care knowledge and quality of life in patients with chronic heart failure and depression.


Eligibility criteria:
inclusion criteria: * \> 18 years * have time to participate in the study, * treatment for hf according to the european society of cardiology guidelines2 * stable hf (nyha class i-iii) and not being hospitalized for hf the latest month * signs of suffering of depressive symptoms (patient health questionnaire-9 \>9 points exclusion criteria: * severe hf (nyha iv) or another severe chronic life threatening disease. * severe depression assessed to need hospital care
evaluation of the tantalus system in type 2 diabetic subjects

Conditions: Type 2 Diabetes; Obesity

Summary: metacure mc pt tan2005-013 feasibility study is a prospective, multi-center, study to evaluate the safety and functionality of the tantalus system, in the treatment of obese t2dm patients, and to assess the effect of gct ( glycemic control treatment )on weight loss and glycemic control.


Eligibility criteria:
inclusion criteria: * t2dm subjects inadequately controlled on a maximum of three oral agents * subjects with hba1c between 7 and 9% * subjects with fbg between 120 and 200 mg/dl * subjects who are 21-60 years old * women with childbearing potential (i.e. not post-menopausal or surgically sterilized) must agree to use adequate birth control methods and must agree not to conceive for at least 20 weeks * subjects with body mass index (bmi) between 30-38 (inclusive) * subjects with waist circumference \>94 cm (males) and \>80 cm (females) * subjects on stable medication program for at least three months with any oral medication program * subjects who are compliant, willing and able to participate in the follow-up visits for the study duration of approximately 26 weeks * alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial. * able to provide voluntary informed consent. exclusion criteria: * subjects at high risk of general anesthesia or surgery * subjects with prior pancreatitis * subjects with chronic hepatitis * subjects with elevated serum creatinine * subjects with proliferative diabetic retinopathy * subjects with gastroparesis or intestinal pseudo-obstruction * subjects with motility disorders of the gi tract * subjects who are receiving medications known to affect gastric motility * subjects with a past or present psychiatric condition that may impair his or her ability to comply with the study procedures * subjects who are pregnant (proven by positive hcg), or lactating * subjects who have had prior bariatric surgery * subjects with a history of peptic ulcer disease * subjects who have used another investigational device or agent in the 30 days prior to implant or are participating in any other clinical study * subjects with any new medical problem diagnosed or the worsening of an existing medical problem during the baseline evaluation period * subjects with a life-threatening co-morbidity or life expectancy of less than one year * subjects with myocardial infarction or one or more episodes of unstable angina within 6 months prior to enrollment * subjects with a history of malignant disease * subjects who are currently on chemotherapy treatment
family caregiver role in decreasing delirium in older patients with fractured femur using help principles.

Conditions: Delirium; Femoral Fracture

Summary: the hospital elder life program (help) has been shown to reduce delirium in hospitalized patients. in this study a family caregiver will apply the principles of the help program in a structured manner following training by a nurse clinical specialist in geriatrics. the effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.

approximately 30% of those aged 65 years and over will fall at least once a year. as many as 38% of all older people hospitalized following a fall are admitted with hip fractures and 93% of these will undergo surgical repair of the fracture (ministry of health, 2015). fractured femur is associated with many complications. delirium (acute confusional state) following surgery is one of the most common of these complications, it often results in adverse outcomes for both patients and caregivers (tieges et al., 2021), and places great financial burden on the health system. it must be emphasized that delirium can be prevented, and when it occurs should be recognized and treated appropriately. the help (hospital elder life program) is an accepted evidence-based model that has been proven to be effective in reducing delirium at the time of acute hospitalization (inouye et al., 1999). help (which has been implemented at the rambam healthcare campus) is a volunteer-based program using non-pharmacological interventions that include engaging patients in conversation, particularly emphasizing orientation to time and place, encouraging eating and drinking, and assisting with early mobility (inouye, 2000). the help program has been shown to reduce delirium by one-fifth in previous studies (wang et al., 2020). in this study a family caregiver will apply the principles of the help program in a structured manner following training by a nurse clinical specialist in geriatrics. the effect of this intervention in decreasing delirium in older patients treated in an acute orthopedic unit for fractured femur following a fall will be evaluated.

Eligibility criteria:
inclusion criteria: * males and females aged 65 years and older * acute hospitalization in the orthopedic unit for fractured femur post-fall * expected or actual surgical intervention for treatment of fracture * at least one family caregiver involved in supporting the patient during hospitalization exclusion criteria: * documented conditions that have been clinically active during the previous 6 months: including psychiatric illness; cerebrovascular disease; brain malignancy; alcohol abuse; drug abuse * terminal disease * delirium * inability to assess for delirium due to advanced dementia or sensory deprivation (marked impairment of vision or hearing) or any other condition that limits communication with the patient

Keywords: elderly acute hospitalization family caregiver hospital elder life program
feasibility of early swallowing and speech intervention for head and neck cancer patients treated surgically

Conditions: Dysphagia; Head and Neck Cancer

Summary: oral cavity cancer (occ) is one of the most common cancers worldwide, with tongue cancer being one of the most common subtypes. patients with oral cancers can experience painful swallowing, swallowing difficulty (dysphagia), and associated weight loss long after surgery. not only is dysphagia an independent predictor of quality of life (qol) in cancer survivorship, it can also have a devastating impact on the health of patients resulting from complications such as pneumonia, malnutrition and feeding tube dependence. emerging evidence suggests that patients undergoing surgery benefit from engaging with speech-language pathologists (slps) before problems arise, to learn swallow strategies that may become useful in their rehabilitation. this in turn has the potential to reduce complications and minimize the length of feeding tube dependency. this study will assess the feasibility of conducting a prospective clinical trial that would evaluate the effects on patient health, function and overall benefit of early and systematic slp speech and swallowing intervention for head and neck cancer patients planned for curative surgical treatment. we will also assess long-term changes in select clinical and patient-reported outcomes comparing their status before, and one month after, treatment.


Eligibility criteria:
inclusion criteria: * newly diagnosed patients with at least t2 stage tongue scc who are planned for partial glossectomy and free flap reconstruction and are anticipated to achieve a post-operative independent oral intake. * proficient in spoken and written english exclusion criteria: * patients who are planned for total glossectomy

Keywords: dysphagia head and neck cancer speech language pathology surgery speech early intervention medical outcomes
sunitinib and capecitabine for first line colon cancer

Conditions: Metastatic Colorectal Cancer

Summary: this study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. the purpose of this study is to find out if capecitabine and sunitinib can be used together to improve progression-free survival in colorectal cancer. all patients will take two medicines (sunitinib and capecitabine) by mouth every day until their cancer gets worse.

this is a single-center, open-label, one-arm study. patients will be stratified by prior adjuvant therapy and ecog performance status at study entry. in this study, we propose to obtain pet scans at baseline, 2 weeks, 8 weeks and 24 weeks from the initiation of treatment. response at 2 weeks, 8 weeks and 24 weeks will be correlated to progression-free survival, overall survival and response according to recist criteria. we will collect plasma and urine samples from enrolled patients before and four weeks after sunitinib treatment. the samples will be analyzed and results correlated with patient clinical outcomes in order to explore the underlying mechanism of sunitinib induced hypertension.

Eligibility criteria:
inclusion criteria: * histologically confirmed, newly diagnosed metastatic colorectal cancer * measurable or evaluable disease in which surgical resection with curative intent is not possible * no adjuvant chemotherapy within 6 months of enrollment * no prior sunitinib or other receptor tyrosine kinase inhibitors * 18 years of age or greater * anticipated survival of at least 6 months * ambulatory with an ecog performance status of 0 or 1 and able to maintain weight * normal organ and marrow function * must agree to avoid pregnancy or fathering a child through out study participation * ability to understand and willingness to sign a written informed consent document exclusion criteria: * chemotherapy or radiotherapy within 6 months of enrollment * receiving any other investigational agents * known untreated brain metastases, uncontrolled seizure disorders, encephalitis, or multiple sclerosis * not able to ingest oral medications with normal absorption from the gi tract * uncontrolled hypertension * history of severe/unstable angina, heart attack, congestive heart failure, transient ischemic attack, or stroke within 6 months of enrollment * cardiac dysrhythmias * history of clinically significant bleeding within the past 6 months, including gross hemoptysis or hematuria, or underlying coagulopathy * history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months of study enrollment * current treatment with therapeutic doses of coumadin * concurrent malignancy other than colorectal cancer * known dihydropyrimidine dehydrogenase deficiency * uncontrolled intercurrent illness including ongoing or active infection or psychiatric illness that would limit compliance with study requirements. * pregnant and nursing women

Keywords: colorectal cancer sunitinib capecitabine
enteral glutamine in neurologically-injured patients

Conditions: Neurologic Injury; Traumatic Brain Injury

Summary: nutrition is an important part of the recovery process after having a head injury so that subjects can gain strength and fight off infection. liquid nutrition formulas are often given to patients through a tube that has been placed into the intestines for feeding when they are unable to eat on their own. some reports suggest that nutrition with extra amounts of the amino acid called glutamine may decrease infections and hospital stay in severely injured patients.the purpose of this study is to evaluate if giving extra amounts of an amino acid called glutamine with liquid nutrition formulas will decrease the risk of infection and length of stay in the intensive care unit after having a head injury.


Eligibility criteria:
inclusion criteria: * males * nonpregnant females * aged 18-75 years old * glasgow coma scores of 3-12 * injury severity scores greater than or equal to 20 * requiring enteral nutrition for a minimum of 5 days exclusion criteria: * documented hepatic dysfunction * acute renal failure (creatinine clearance \< 15 ml/min) * gastrointestinal malabsorptive disorder * infection at time of admission
the effect of sitting and standing posture on trunk rotation in patients with idiopathic scoliosis

Conditions: Scoliosis Idiopathic

Summary: the aim of this study is to investigate the acute effect of activities of daily living on trunk rotation in patients with adolescent idiopathic scoliosis.

patients with ais who applied to bandırma onyedi eylül university physiotherapy and rehabilitation department will be included in this study. individuals diagnosed with ais, whose cobb angle is between 20º -50º, who do not have any chronic diseases that require neurological or psychiatric medication, and who volunteer to participate in the study will be included. individuals with any contraindications for exercise, previous spine surgery, thoracic apex curvature of 6 or more, mental problems, non-idiopathic scoliosis but with different causes will be excluded from the study. to determine the demographic characteristics of the participants, age, gender, weight, height, presence of chronic disease, age at first diagnosis, exercise habits, treatments, and brace use will be questioned. the atr will be used to measure degrees of trunk rotation to monitor the effects of treatment without radiographic evaluation. on the first day, the demographic characteristics of the participants will be questioned, cobb angles, risser findings, and atr degrees will be recorded. after the first day, all postural activities and measurements will be taken on different days (at least three days apart) not to affect the degrees of trunk rotation in patients with ais.

Eligibility criteria:
inclusion criteria: * being diagnosed with ais between the ages of 10-35 * cobb angle between 20º -50º, * to be able to continue the program to be applied, * not having a chronic disease that requires the use of any neurological or psychiatric medication, * the willingness of parents and/or patients to participate in the study. exclusion criteria: * the patient has any contraindications for exercise, * having had previous spine surgery, * having a curvature of 6 or more thoracic apex, * having any mental problems, * the fact that scoliosis is not idiopathic but has arisen for different reasons (neurological, congenital, etc.)
a phase i-ii study of hm781-36b combined with paclitaxel and trastuzumab in her-2 positive advanced gastric cancer

Conditions: HER-2 Positive Advanced Gastric Cancer

Summary: \[phase i\] the main objective of this study is to evaluate the safety, tolerability and determine the recommended dose (rd) of hm781-36b(poziotinib)combined with paclitaxel and trastuzumab \[phase ii\] the main objective of this study is to evaluate anticancer activity through determination of response rate of hm781-36b(poziotinib)combined with paclitaxel and trastuzumab in patients with her-2 positive advanced gastric cancer

besides the main objectives, there are other objectives as follows: \[phase i\] 1. to assess the pharmacokinetic profile of hm781-36b(poziotinib) combined with paclitaxel and trastuzumab 2. to evaluate anticancer activity of hm781-36b(poziotinib) combined with paclitaxel and trastuzumab in patients with her-2 positive advanced gastric cancer 3. to evaluate pfs(progression-free survival), ttp (time to tumor progression), and dor (duration of overall response) \[phase ii\] 1. to assess the safety, tolerability of hm781-36b(poziotinib) combined with paclitaxel and trastuzumab 2. to evaluate tumor response through determination of disease control rate , pfs(progression-free survival), ttp (time to tumor progression), and dor (duration of overall response)

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed advanced gastric cancer including gastroesophageal junction adenocarcinoma 2. at least one measurable lesion defined by recist(v1.1) 3. fish+ or ihc3+ (regardless of fish results) 4. age≥19 5. ecog ≤ 2 6. life expectancy ≥ 12 weeks 7. adequate bone marrow and no abnormal heart and lung function 8. no radiotherapy, other anticancer drugs or immunotherapy is allowed during this study 9. subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures exclusion criteria: 1. patients with a history of hypersensitivity to trastuzumab and who have been treated with medicine including cremophor el 2. patients who have a current active malignancy other than gastric adenocarcinoma (with exception of non-melanoma skin cancer or cervical cancer in situ) 3. patients who have previously received taxane-based chemotherapy 4. the presence of central nervous system metastases 5. patients who have a blood tumor such as leukemia, or who had previously received, or are planning to receive, the bone marrow transplant 6. patients with uncontrolled infection 7. patients who have gi malabsorption or difficulty taking oral medication 8. patients with following diseases are excluded: 9. patients with psychiatric or congenital disorder which can affect adherence or make hard to follow the requirements of the protocol 10. pregnant or breastfeeding women or women of childbearing who do not use an appropriate method of contraception (male patient should also use an appropriate method of contraception)

Keywords: hm781-36b, paclitaxel, trastuzumab
study of risk factors for therapeutic failure in chronic non-infectious uveitis after first-line immunosuppressive therapy

Conditions: Uveitis

Summary: uveitis is an inflammatory disease of the uvea, constituting the 4th leading cause of legal blindness worldwide and the 3rd leading cause of avoidable blindness . it is not a rare condition, with an incidence of 17 to 52 per 100,000 population and a prevalence of 38 to 204 per 100,000 population. in the case of cortico-dependence, it is generally accepted to propose sparing with a conventional immunosuppressant, whose efficacy is estimated at around 70%, compared with biotherapies, which are considered more effective (over 90%) but only available as 2nd-line treatment. however, there are few studies on the failure factors of this first-line treatment, such as macular thickness , gender, or vitamin d deficiency. risk factors for flare-ups are nevertheless known, notably ethnicity, and smoking. the aim of this study is to identify risk factors for treatment failure after three months of first-line immunosuppressive therapy in patients with chronic non-infectious uveitis at amiens-picardie university hospital.


Eligibility criteria:
inclusion criteria: * age : \> 18 years old * uveitis requiring immunosuppressive therapy. * including at least one posterior involvement according to the sun terminology: posterior, or intermediate and posterior, or anterior and posterior, or panuveitis. exclusion criteria: * uveitis associated with multiple sclerosis or systemic lupus erythematosus. * ocular involvement in behcet's disease requiring biologic therapy as first-line immunosuppressive treatment. * uveitis without posterior segment involvement. * infectious uveitis. * patients objecting to the use of their personal data for research purposes.

Keywords: uveitis
adaptive radiotherapy in head and neck tumor patients

Conditions: Head and Neck Neoplasms; Head and Neck Cancer; Adaptive Radiotherapy; Optimization

Summary: most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. if the field-set up margins are broad, the consequence may be that quality of life is impaired. the study group of nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard imrt (nutting c, finneran l, roe j, petkar i, rooney k, hall e; dars triallist group. dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - authors' reply. lancet oncol. 2023 oct;24(10):e398. doi: 10.1016/s1470-2045(23)00457-6. pmid: 37797636.) the study group concluded that the results suggest that dysphagia-optimized imrt improves patient-reported swallowing function compared to standard imrt. do-imrt should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and art could further improve outcomes.

most newly diagnosed oropharyngeal and hypopharyngeal cancers are treated with radiochemotherapy with curative intent. if the field-set up margins are broad, the consequence may be that quality of life is impaired. the study group of nutting et al. (2023) investigated this year whether dysphagia-optimized intensity-modulated radiotherapy can reduce the radiation dose to structures associated with dysphagia and aspiration and improve swallowing function compared to standard imrt (nutting c, finneran l, roe j, petkar i, rooney k, hall e; dars triallist group. dysphagia-optimized intensity-modulated radiotherapy versus standard radiotherapy in patients with pharyngeal cancer - authors' reply. lancet oncol. 2023 oct;24(10):e398. doi: 10.1016/s1470-2045(23)00457-6. pmid: 37797636.) the study group concluded that the results suggest that dysphagia-optimized imrt improves patient-reported swallowing function compared to standard imrt. do-imrt should be considered the new standard of care for patients receiving radiotherapy for pharyngeal cancer, and art could further improve outcomes. thus, in this trial we analyze art in head and neck cancer in a prospective randomized trial.

Eligibility criteria:
inclusion criteria: ecog 0/1 no prior cancer treatment exclusion criteria: ecog 2-4 prior cancer treatment

Keywords: head and neck neoplasms head and neck cancer adaptive radiotherapy optimization