Kornimate/medical-research-clean huggingface dataset:
iddsi nutritional drink for dysphagia study

Conditions: Dysphagia; Malnutrition

Summary: this study will evaluate the gastrointestinal (gi) tolerance, compliance , acceptability and safety of a ready-to-use oral nutritional supplement drink for patients with dysphagia.

dysphagia is a complex condition common in a number of diagnoses including stroke, parkinson's disease, head and neck cancer, dementia, learning disabilities and gastric/oesophageal motility disorders. a modified textured diet and/or fluid is considered as an effective intervention in management of dysphagia. the international dysphagia diet standardisation initiative (iddsi) have developed a new framework around the terms and descriptors used in the management of individuals with dysphagia. malnutrition is very common in patients with dysphagia and the use of pre-thickened oral nutritional supplements (ons) has been found as an effective way to manage this. however, due to impairment in the swallow process, dysphagic patients require pre-thickened oral nutritional supplement to ensure safe consumption of these nutritional supplements. 40 participants, requiring a new pre-thickened oral nutritional supplement in line with the new iddsi framework recruited from hospitals, outpatients clinics, care homes, community hospitals, community dietetic/speech and language therapy services or stroke rehabilitation units will receive the ready-to-use oral nutritional supplement for a 4 week intervention period. this study aims to primarily evaluate gastro-intestinal tolerance, with secondary outcomes including compliance, acceptability, nutrient intake, anthropometry and safety.

Eligibility criteria:
inclusion criteria: * male or female * age ≥ 18 years * patients with a requirement for ≥ 250kcal/day from a milkshake style ons for ≥ 4 weeks or current users of ons * patients identified to require mildly thick (iddsi level 2) fluids. * patients competent to provide written informed consent and able to answer questions * patients able to take study ons orally exclusion criteria: * patients that lack capacity to provide informed consent * patients that are unable to take study ons orally * participants with chronic renal disease requiring dialysis * participants with liver failure * participants that are pregnant or lactating * participation in other studies that may interfere with this study * participants receiving 100% total nutritional requirements from tube feeding or parenteral nutrition * patients with galactosaemia or lactose intolerance * patients receiving palliative or end of life care
a study of shr3680 in treating patients with hormone sensitive prostate cancer

Conditions: Prostate Cancer; Hormone-Dependent Prostate Cancer

Summary: the aim of this study is to compare the safety and efficacy of shr3680 with bicalutamide in the treatment of patients with hormone sensitive prostate cancer.

this is an open, multicenter, randomized phase iii trial. this clinical study compares the efficacy and safety of shr3680 with bicalutamide in the patients with hormone sensitive prostate cancer. approximately 572 patients who meet the entry criteria will be randomly assigned in a 1:1 ratio to shr3680 or bicalutamide treatment. primary endpoints of the study are radiological progress-free survival (rpfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * age≧18 year, male; * ecog performance scale 0 to 1; * histologically or cytological confirmed prostate adenocarcinoma without neuroendocrine differentiation or small cell features ; * adequate hepatic, renal, heart, and hematological functions; * patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. exclusion criteria: * subject has received any prior radiation therapy or surgery for prostate cancer, except 1 course of palliative surgical therapy if it was used at least 4 weeks prior to day 1; * previous use or are using a second-generation androgen receptor antagonist (enzalutamide, arn-509, odm-201), abiraterone, ketoconazole for prostate cancer, or other agents that will inhibit the production of androgens; * have participated in an interventional clinical trial or been treated with the following drugs in the past 4 weeks prior to day 1: 5-alpha reductase inhibitors, estrogen, progestin, and herbal products known to decrease psa levels ; * evidence of brain metastasis or primary tumors; * planned to initiate any other anti-tumor therapies during the study; * unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; clinically significant cardiovascular diseases; * history of seizure or certain conditions that may predispose to seizure; * severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Keywords: hormone sensitive prostate cancer shr3680 anti-androgen receptor
clinical study of nkg2d car-nk combined with pd-1 monoclonal antibody in the treatment of atc

Conditions: Anaplastic Throid Carcinoma

Summary: the patients with anaplastic thyroid cancer were treated with car-nk immune cells combined with pd-1 monoclonal antibody, and the safety and tolerability of the patients were observed and evaluated.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years (including boundary values), male or female. 2. be diagnosed with anaplastic thyroid cancer histopathologically with a measurable lesion≥1cm. 3. liver and kidney function is good, and can tolerate treatment. 4. be able to cooperate with the completion of treatment and follow-up work. 5. no other systemic diseases, including other malignancies. exclusion criteria: 1. need to breastfeed the baby or have fertility needs； 2. immune system diseases; 3. diseases of the blood system; 4. mental system diseases; 5. interstitial pneumonia, lung disease, etc.; 6. failure to follow rules of this study.
impact post-operative treatment on intraocular pressure post-slt on patients with primary open-angle glaucoma

Conditions: Glaucoma; Inflammatory Response

Summary: the present study's main objective is to assess if there is a significant difference between either of the treatments frequently used in post-op, namely a topic cortisone-based treatment, an non-steroidal anti-inflammatory drug (nsaid) or simply a placebo, in order to gain the best long term (6 months) efficacy of the slt.

the selective laser trabeculoplasty (slt) is the laser treatment of choice for treating glaucoma. a there is however a controversy regarding the use of drops post-treatment. indeed, some would prefer not to pharmacologically modulate the post-op inflammatory response which can be an integral part of the treatment by favouring the mobilisation of the macrophages which participate to the trabeculae "cleaning". others will prefer to calm the inflammatory reaction and choose an anti-inflammatory drug (either steroidal or non-steroidal).

Eligibility criteria:
inclusion criteria: * patients suffering from with primary open-angle glaucoma. * patients with iop \> 21 mmhg, uncontrolled with medical treatment or due to non-compliance, or to whom this is the first glaucoma treatment. * patients \> 18 years old, able to consent. * patients consenting to the trial. exclusion criteria: * patients suffering from chronic glaucoma other than primary open-angle glaucoma * patients who had changes done to their anti-glaucoma treatments over the last 6 weeks or following the slt * patients under oral corticosteroid treatment at the time of the operation or those who have stopped during the preceding month. * patients suffering from an important corneal disease which interferes with the capacity to visualize the entire trabeculae. * monophthalmic patients. * patients who already underwent a glaucoma treatment to the eye requiring treatment. * patients who already underwent a glaucoma treatment using slt or alt (argon laser trabeculoplasty) * patients who underwent cataract surgery in the past 3 months. * pregnant patients.

Keywords: glaucoma ocular hypertension intraocular pressure trabeculectomy
long-term effect of steroid on metabolic diseases in asthmatics

Conditions: Asthma; Osteoporosis, Osteopenia; Osteoporosis Risk; Osteoporotic Fractures

Summary: the goal of this retrospective/observational study is to compare the clinical outcomes between the high-cumulative-dose group and the low- cumulative-dose group of oral/inhaled corticosteroid in the long-term management of asthma patients. the main hypothesis are: i. high cumulative dose of corticosteroid is related to the prevalence of osteoporosis/osteoporosis in the long-term management of adult asthma. ii. high cumulative dose of corticosteroid can affect populations that have a high-risk of osteoporosis (females over 50 years of age). iii. high cumulative dose of corticosteroid is related to the prevalence of diabetes mellitus, hypertension, and hyperlipidemia in the long-term management of adult asthma. iv. high cumulative dose of corticosteroid affects bone metabolism-related diagnostic tests and laboratory values and the prescription rate of bone metabolism-related medications.


Eligibility criteria:
a. inclusion criteria i. adult asthmatics (over 18 years) who have maintained inhaled corticosteroid with or without systemic corticosteroid for more than 12 months before the index date in our medical center. ii. at least 1 asthma diagnosis within 1 year before the first corticosteroid exposure date by asthma specialists at ajou university medical center (aumc, suwon, south korea) with informed consent. iii. a high cumulative dose is defined as the dose of corticosteroids above the mean cumulative dose of corticosteroids prescribed during 1 year. iv. the equivalent dose will use for calculating the mean cumulative dose of each inhaled corticosteroid inhaler or systemic corticosteroid prescribed. v. prescriptions within 365 days from the first prescription will be assumed to be continuous, and the cohort end date will be defined as the end of the continuous drug exposure. b. exclusion criteria i. patients younger than 18 years ii. patients younger than 50 years and males in high-risk population cohorts iii. patients with osteoporosis or osteoporosis-related major fracture outcomes (pathological fracture due to osteoporosis, closed fracture of the femur, pelvis, and vertebral column) before the index date iv. patients with corticosteroid-related outcomes (diabetes mellitus, hypertension, hyperlipidemia) before the index date (for secondary endpoint).

Keywords: asthma osteoporosis corticosteroid inhaled corticosteroid fractures
effect of methylphenidate on balance in children with attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: attention deficit hyperactivity disorder is a neurodevelopmental disorder that may have poor motor coordination and balance control. the effect of methylphenidate treatment on balance and fall risk is still unclear. this study aimed to evaluate the effect of methylphenidate (mph) treatment on balance, fall risk, and sensorimotor integration in children with attention deficit hyperactivity disorder (adhd).

children who were diagnosed with adhd for the first time were classified in the adhd group (n=33), children with adhd who were treated with mph for a minimum of 3 months were classified in the treatment group (n=32), and typically developing children were classified in the third-the control group (n=20) in this observational cross-sectional study. fall risk, static postural balance and sensorimotor integration were assessed using the biodex balance system.postural stability tests, including overall stability index (osi), anterior-posterior stability index (apsi), and medial-lateral stability index (mlsi), were used to evaluate postural control. the modified clinical test of sensory interaction in balance (m-ctsib) testing protocol was used to evaluate sensory integration capabilities and balance. fall risk was evaluated by biodex balance system.

Eligibility criteria:
inclusion criteria: * children who were diagnosed with adhd for the first time according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v, american psychiatric association, 2013) exclusion criteria: * neurological disorders * psychiatric disorders * musculoskeletal disorders * cardiopulmonary diseases * visual impairments * developmental coordination disorders that could affect balance

Keywords: attention deficit hyperactivity disorder methylphenidate postural balance
study comparing the safety and efficacy of intravenous cxa-201 and intravenous meropenem in complicated intraabdominal infections

Conditions: Complicated Intra-abdominal Infection

Summary: this is a phase 3, multicenter, prospective, randomized, double-blind, double dummy study of cxa-201 intravenous (iv) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with complicated intraabdominal infections (ciai).

approximately, 500 subjects will be enrolled into this study, randomized 1:1 to receive cxa-201 and metronidazole or comparator (meropenem). subject participation will require a minimum commitment of 38 days and a maximum of 45 days. an end of treatment (eot) visit will occur within 24 hours following the last dose of study drug administration/drug discontinuation. a test of cure (toc)/safety visit will be conducted 26 to 30 days following the first dose of study drug administration. a last follow-up (lfu) visit will be conducted 38 to 45 days after the first dose of study drug.

Eligibility criteria:
inclusion criteria: * diagnoses of ciai. * subject requires surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug. exclusion criteria: * simple appendicitis; acute suppurative cholangitis; infected necrotizing pancreatitis; pancreatic abscess; or pelvic infections. * complicated intraabdominal infection managed by staged abdominal repair (star), open abdomen technique including temporary closure of the abdomen, or any situation where infection source control is not likely to be achieved. * use of systemic antibiotic therapy for iai for more than 24 hours prior to the first dose of study drug, unless there is a documented treatment failure with such therapy. * have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to iv study drug therapy. (drugs with only gram-positive activity \[e.g., daptomycin, vancomycin, linezolid\] are allowed). * severe impairment of renal function (estimated crcl \< 30 ml/min), or requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (\< 20 ml/h urine output over 24 hours). * the presence of hepatic disease at baseline. * considered unlikely to survive the 4 to 5 week study period. * any rapidly-progressing disease or immediately life-threatening illness (including respiratory failure and septic shock). * have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibacterial (a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment), including cephalosporins, carbapenems, penicillins, or ß-lactamase inhibitors, or metronidazole, or nitroimidazole derivatives. * women who are pregnant or nursing.

Keywords: ciai
effect of deep oscillation treatment as a method for recovery in soccer

Conditions: Sports Physical Therapy

Summary: the purpose of this study is to evaluate the effects of deep oscillation (do) self-treatment on recovery after fatiguing soccer training. we investigate deep oscillation (do) self treatment as a measure to promote regeneration, hypothesizing that do leads to an accelerated recovery within the first 48h after fatiguing training with positive effect on the maximum strength, rated perceived exertion, creatinkinase (ck) values and doms compared to no treatment after an .

recovery time between in association football (soccer) often is not long enough to completely restore. insufficient recovery can result in a reduced performance and suboptimal development in the training process and a higher risk for injuries. the purpose of this study is to evaluate the effects of deep oscillation (do) self-treatment on recovery after fatiguing soccer training. deep oscillation is a unique method which is characterized by an alternating electrostatic which results in a deep resonance vibration of patients tissue. methods: in a randomized crossover study design including 10 soccer players of the 5th german devision the following parameters will be evaluated directly before and 48h after an fatiguing soccer specific exercise: maximum isokinetic strength of the leg and hip extensors and flexors (con-trex® leg press, physiomed, germany), rating of perceived exertion (rpe) during isokinetic testing (borg scale 6-20) and creatine kinase (ck) serum levels. delayed onset muscle soreness (doms; visual analogue scale 1-10) will be recorded 24 and 48h post-exercise. at random half of the group will perform a do self-treatment twice daily (4 applications) for 15 minutes each, whereas the other half gets no intervention. 4 weeks later in a cross-over design the same procedure will be conducted again.

Eligibility criteria:
inclusion criteria: * active soccer player in of the 5th devision exclusion criteria: * health problems * medication with impact on the endpoints

Keywords: recovery deep oscillation soccer sports training electrotherapy physical therapy
timing of acute palliative care consultation in critically ill patients

Conditions: Multiple Organ Failure; End Stage Cardiac Failure; End Stage Chronic Obstructive Airways Disease; Chronic Kidney Disease Stage 5; Hepatic Encephalopathy; Sepsis; Dementia; Multiple Sclerosis; Parkinson's Disease; In-Hospital Cardiac Arrest; Solid Organ Cancer

Summary: a prospective randomized controlled trial studying the ordering of palliative care consultations in the emergency department (ig) versus later palliative care consultations in the hospital--icu or hospital ward(cg). patients will be randomly allocated to ig or cg with a 1:1 ratio.


Eligibility criteria:
inclusion criteria: * greater than or equal to 65 years old * treated in a resuscitation room for unstable vital signs or respiratory compromise * one or more of the following: * advanced or metastatic solid organ cancer * end stage organ failure of the heart, lung/copd, kidney on dialysis, hepatic encephalopathy * suspected sepsis * advanced dementia, end-state multiple sclerosis or parkinson's disease * status post cardiac arrest with coma (glascow coma score \<7) * patient is from a skilled nursing facility exclusion criteria: * lack decision capacity and have no relative available during ed stay to consent to the study (legally authorized representative-lar) * enrolled in hospice care prior to randomization * a copy of a completed advance directive which names a designated proxy provided physically to the medical team prior to randomization * wearing a dnr bracelet * have been previously enrolled in this study

Keywords: palliative care emergency department
pilot study of the safety and efficacy of carvedilol in pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the purpose of this study is to determine whether carvedilol treatment of patients with pulmonary arterial hypertension and associated right heart failure is safe and results in an improved function of the right heart.

patients with pulmonary arterial hypertension (pah) will be treated with carvedilol for 24 weeks. during this time, carvedilol will be titrated from an initial dose of 3.125mg bid to a maximal dose of 25mg bid. at the start and end of the study, we will obtain cardiac mri, 6 minute walk distance, brain natriuretic peptide (serum), echocardiogram, and functional class assessment. our primary outcome is a change in right ventricular ejection fraction with cardiac mri.

Eligibility criteria:
inclusion criteria: * idiopathic, familial or associated pah, who group 1 * nyha class ii or iii * clinically stable with optimized pah treatment for at least 3 months * no or minimal evidence of fluid overload or volume depletion, with or without diuretic treatment * age \> 18 years * mean pulmonary artery pressure (mpap) \> 25 mmhg * 6 minute walk distance (6mwd) over 100m exclusion criteria: * structural heart disease unrelated to pah * recent (\<3 months) treatment with an intravenous positive inotropic agent * current use of β-blockers * history of reactive airways disease * history of adverse reaction to β-blockers * heart block on ecg or resting heart rate \< 60 bpm * cardiac index \< 1.8 l/min/m2 * systemic hypotension (systolic pressure \< 90 mmhg) * pulmonary capillary wedge pressure \> 15 mmhg * inability to give informed consent * contraindications to ct and/or pet scanning * coagulopathy (inr\>1.5 or platelet count\<50000/mm3) * severe renal insufficiency (creatinine clearance \<30 ml/min/m2) * malignancy or any co-morbidity limiting survival or conditions predicting inability to complete the study.
r3tha rehabilitation feasibility and usability study

Conditions: Stroke

Summary: the purpose of this study is to assess how the rehabilitation technologies for hand and arm (r3tha) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of r3tha as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.


Eligibility criteria:
inclusion criteria: 1. must be between the ages of 20 and 80 2. must have enough movement in my arms and hands to actively interact with the video games as determined by study staff 3. must have internet access at home. 4. must be comfortable performing basic functions on a computer, such as browsing the internet. 5. must be able to sit without a loss of balance while performing activities with my arms and hands as determined by study staff. exclusion criteria: severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff. 2) thinking problems or have difficulty following instructions 3) unable to interact with an entire computer screen due to spatial neglect 4) difficulty understanding words spoken to me (receptive aphasia) 5) any other disabling nervous system condition (besides stroke) that has caused residual weakness, impaired range of motion, or spasticity 6) severe arthritis that limits hand and arm movements 7) not independent in functional activities/mobility prior to stroke