Kornimate/medical-research-clean huggingface dataset:
comparison of a needle-free injection method with a needle-syringe injection method

Conditions: Growth Hormone Deficiency

Summary: the purpose of this study is to obtain psychological response and user preference information on the use of the t jet® device versus the traditional subcutaneous injection administration of tev tropin®. this study will compare subject-reported injection anxiety immediately before the administration of each dose of tev-tropin® between a needle-syringe injection method and a needle-free injection method (t-jet®)

the primary efficacy endpoint was the difference in mean subject-reported injection anxiety between the two injection methods as recorded on a 5-point fis immediately before administration. a higher score denoted greater anxiety. the injection anxiety score was to be reported by the subject from a row of five faces with values ranging from 5 (the face with the most negative affect) to 1 (the face with the most positive affect).

Eligibility criteria:
inclusion criteria: * subjects must require a routine tev-tropin® dose that does not exceed 2.5 mg in one injection (0.5 ml) using the dosing schedule individualized for each patient by their prescribing physician * male, age 7-17 years, with the capability to provide assent, as determined by the investigator and/or parent or legal guardian * clinically definite growth hormone deficiency as previously diagnosed by the investigator or other physician * subjects must be using tev-tropin® prior to enrollment for 28 days * informed consent signed by parent(s) or legal custodian of patient prior to study entry and patient assent as determined by the investigator and/or subject's parent or legal custodian exclusion criteria: * more than one subcutaneous injection per tev-tropin® dose * female gender * use of any other needle-free injection device at any time * current use of another human growth hormone product other than tev-tropin® * concurrent treatment with other routine injectable medications * history of benign intracranial hypertension * significant communication difficulties, or medical or psychiatric condition, that affects the subject's and/or caregiver's ability to perform the necessary functions to complete the study, or any condition which the investigator in their medical judgment thinks may interfere with participation in the study * use of an investigational drug within 30 days prior to randomization * contraindications related to routine use of tev-tropin® as per investigators' medical judgment (e.g., subjects with closed epiphyses, active proliferative or severe non-proliferative diabetic retinopathy, active malignancy, acute critical illness, or prader-willi syndrome who are severely obese or have severe respiratory impairment) * current participation in another pharmaceutical or device study * previous participation in this study
zimmer trabecular metal total ankle pmcf

Conditions: Degenerative Arthritis; Rheumatoid Arthritis; Post Traumatic Arthritis

Summary: the primary objective of this study is to obtain implant survivorship and clinical outcome data for commercially available zimmer trabecular metal total ankle implants used in primary or revision total ankle arthroplasty. the assessment will include implant survivorship and clinical performance measured by pain and function, quality of life data, radiographic parameters and survivorship.

the study design is a prospective, multicenter, study of the commercially available zimmer trabecular metal ankle semiconstrained implants. the study will require each site to obtain institutional review board approval prior to study enrollment. all potential study subjects will be required to participate in the informed consent process. all study subjects will undergo preoperative clinical evaluations prior to their primary or revision total ankle arthroplasty. the post-operative clinical and radiographic evaluations will be conducted at 6 weeks, 6 month, 1 year, 2, 3, 5, 7, and 10 years. follow-up surveys will occur at 4, 6, 8, and 9 years.

Eligibility criteria:
inclusion criteria: * the patient is \> 18 years of age * the patient is skeletally mature * the patient qualifies for primary or revision total ankle replacement based on physical exam and medical history including the following: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis. * the patient is willing and able to provide written informed consent * patient is willing and able to cooperate in the required post-operative therapy * the patient is willing and able to complete scheduled follow-up evaluations questionnaires as described in the informed consent * the patient has participated in the informed consent process and has signed the institutional review board/european commission approved informed consent exclusion criteria: * the patient is: a prisoner, mentally incompetent or unable to understand what participation in the study entails, a known alcohol or drug abuser, anticipated to be non-compliant. * the patient has one of the following compromising the affected limb: ankle arthrodesis with malleolar exeresis, severe neurological or vascular disease, loss of musculature or neuromuscular compromise, severe instability, maltracking or misalignment of the tibia and talus uncorrectable by surgery. * the patient has a local/systemic infection that may affect the prosthetic joint * the patient has a previous history of infection in the affected joint * the patient is known to be pregnant * the patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, charcot's disease) * the patient has a known sensitivity or allergic reaction to one or more of the implanted materials * the patient is unwilling or unable to give consent or to comply with the follow-up program

Keywords: primary ankle replacement total ankle arthroplasty total ankle replacement trabecular metal total ankle
"continuous positive airway pressure on venovenous extracorporeal membrane oxygenation for acute respiratory distress syndrome"

Conditions: Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation Complication

Summary: the calmdown trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ecmo (ultra-protective lung ventilation). the study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ards) rescued by ecmo. indeed, our hypothesis is that that early (near) apneic ventilation on venovenous ecmo for severe ards can enhance ventilator injury prevention and therefore reduce ecmo duration and mortality at day 60.


Eligibility criteria:
inclusion criteria: 1. severe acute respiratory distress syndrome refractory to conventional therapy placed on vv-ecmo support in the 48 hours (maximum tolerance : +2h) preceding inclusion. 2. obtain informed consent from a close relative or surrogate. according to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patient is unable to give his/her consent and when the close relative/surrogate/family member are absent. close relative/surrogate/family member consent will be asked as soon as possible after randomization. the patient will be asked as soon as possible to give his/her consent for the continuation of the trial when his/her condition will allow. 3. social security registration (except ame) exclusion criteria: 1. age \< 18 2. pregnancy or breastfeeding 3. initiation of vv-ecmo \> 48 h (maximum tolerance : +2h) 4. cardiac arrest with cumulated no flow time \&gt;10 minutes before ecmo (within 48 hours prior to inclusion) 5. irreversible neurological pathology 6. end-stage chronic lung disease 7. contraindications for high peep level: untreated pneumothorax, barotrauma 8. irreversible ards with no hope for lung function recovery 9. patient moribund on the day of randomization, saps ii \&gt;90 10. liver cirrhosis (child b or c) 11. lung transplantation 12. burns on more than 20 % of the body surface 13. participation in another interventional study or being in the exclusion period at the end of a previous study, expect dressing-ecmo trial, which evaluates the use of sterile adhesive transparent dressings impregnated with chlorhexidine gluconate on the cumulative incidence of ecmo cannula-related infection episodes. 14. individuals under guardianship, or permanently legally incompetent adults

Keywords: ecmo ards cpap
the impact of laparotomy and analgesia methods on diaphragm

Conditions: Colorectal Neoplasms; Gastrectomy

Summary: major abdominal surgeries are traditionally performed via laparotomy. analgesia is routinely administered during the postoperative period. the goal is to investigate the effects of laparotomy and analgesia methods on diaphragm function.

laparotomy is typically performed through a midline incision during major abdominal surgeries. patients have difficulty breathing deeply after surgery, particularly because of pain. intravenous drug administration, epidural catheter placement, and abdominal plane blocks are common methods of analgesia. in this study, the investigators will measure the diaphragm muscle thickness at the xiphoid level at the anterior axillary line in the supine position in participants who underwent laparotomy before and one hour after the operation, using ultrasonography m mode during inspiration, expiration, and forced inspiration. the investigators will test the effects of analgesia methods on diaphragm contraction in participants undergoing laparotomy.

Eligibility criteria:
inclusion criteria: * over 18 years, * major abdominal surgery cases exclusion criteria: * body mass index (bmi) \>35 kg/m2 * illiteracy, * communication issues, * neuromuscular disorders, * advanced chronic respiratory disease, * previous abdominal or thoracic surgery
knee osteoarthritis, kinesiophobia and physical activity

Conditions: Fear of Pain; Knee Osteoarthritis; Physical Activity

Summary: although the importance of regular physical activity in patients with knee osteoarthritis is known, and fear of movement is considered as one of the causes of physical inactivity and is widely researched in terms of its role in the pathogenesis of pain, there remains to be limited number of studies on kinesiophobia in these patients. in this study, we aimed to evaluate the levels of kinesiophobia and physical activity in patients with knee osteoarthritis and to investigate whether they were associated with demographic characteristics, body mass index, pain intensity, depression, disability, radiological grade, and quality of life.

a total of 96 female and male patients aged 50 to 75 years with knee osteoarthritis (oa) and knee pain lasting for more than three months (knee pain intensity over 20 mm on visual analog scale-vas) were included in the study. the severity of pain at night, pain at rest and activity-related pain was evaluated by visual analog scale (vas), kinesiophobia by tampa scale of kinesiophobia (tsk) and brief fear of movement scale (bfom), depression by the beck depression inventory (bdi), disability by the western ontario and mcmaster universities arthritis index (womac), physical activity level by the international physical activity questionnaire (ipaq) short form and quality of life by the short form 12 health survey questionnaire (sf-12). age, gender, marital status, educational status, additional disease, drug history, and sociodemographic data such as bmi were obtained from the patients and recorded in the evaluation form.

Eligibility criteria:
inclusion criteria: knee osteoarthritis aged 50 to 75 years knee pain lasting for than three months knee pain intensity over 20 mm on visual analog scale-vas exclusion criteria: knee operation, malignant diseases systemic infectious diseases inflammatory diseases fibromyalgia syndrome physical therapy and/or a knee injection within the last three months antidepressants, pregabalin or duloxetine usage

Keywords: kinesiophobia osteoarthritis fear of movement tampa physical inactivity
treating cognitive deficits in traumatic spinal cord injury (sci)

Conditions: Spinal Cord Injuries

Summary: the purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (sci) population. the study is designed to research how well different types of techniques can help people with sci improve in areas where they might have difficulties such as memory or processing speed, (time it takes to process information provided).

the objectives of the currently proposed randomized clinical trial are to (1) apply a treatment protocol for processing speed and learning and memory impairments, well-validated in other neurological populations, to individuals with sci with objectively observable deficits in these areas and document efficacy on standard neuropsychological testing; (2) assess the effectiveness of the interventions in persons with sci utilizing global measures of everyday life; (3) evaluate the long-term benefit of treatment. prior to enrollment in the study protocol, all potential subjects will undergo a 2-part screening: (1) an initial screening examination via telephone during which basic information will be gathered and (2) a detailed, in-person screening that will be completed on if the subject passes the initial screen. individuals must meet full screening criteria to be eligible for participation.

Eligibility criteria:
inclusion criteria: * i am between the ages of 18 and 75 years old. * i have a spinal cord injury with the level of injury between c1-t12. * i am non-ambulatory (i use a wheelchair as my primary means of getting around). * i have an ais grade of a, b or c as determined by study staff examination. * my injury occurred at least 1 year ago. * my primary language is english. exclusion criteria: * i have a current illness or infection. my enrollment in this study can be delayed until my current illness or infection is successfully treated. * i have any neurological condition other than sci (alzheimer's disease, dementia, stroke, multiple sclerosis, parkinson's disease, etc.). * i have a diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder. * i have a history of hypertension or diabetes mellitus (due to its impact on brain function). * my vision is impaired- more than 20/60 in worst eye (with prescription eyewear). * i have been taking steroids, benzodiazepines, or certain neuroleptics within past month, the study doctor will review my medications with me.
risk factors for the leakage of anticancer drugs to systemic circulation by transcatheter arterial chemoembolization

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma (hcc) is the most common malignant tumor of the liver. transcatheter arterial chemoembolization (tace) is the traditional method for the palliative management of patients with hcc. few previous studies had demonstrated that the serum level of anticancer drug from patients treated by tace was similar to those treated by systemic chemotherapy. the defense ability of the patient treated by tace may thus be influenced by the leakage of anticancer drug to the systemic circulation. since more than 80% patients with hcc also have liver cirrhosis, the toxicity for those anticancer drugs with hepatic transformation will be increased caused by the cirrhotic liver. the severity of pancytopenia in cirrhosis will be exacerbated by the effect of bone marrow suppression caused by anticancer drugs. patients are at high risk for infection and hemorrhage. therefore, it is of clinical importance to prevent or decrease the leakage of anticancer drugs to systemic circulation in patients treated by tace. the procedures of tace performed by previous studies were not constant and the distributions of tumor vessels were not evaluated in detail. the possible risk factors for the leakage of anticancer drug have not been investigated. this project will collect 60 patients with hcc including 30 patients with hepatitis b and 30 patients with hepatitis c. the blood levels of anticancer drugs (epirubicin, mitomycin c and cisplatin) will be determined within one hour and at the third day after tace.


Eligibility criteria:
inclusion criteria: * patients with hepatocellular carcinoma caused by hepatitis b or c who will be treated by tace exclusion criteria: * previously treated by antiviral drugs for hepatitis b or c

Keywords: epirubicin mitomycin c cisplatin hepatocellular carcinoma
venous thromboembolism (vte) treatment study in japanese deep vein thrombosis (dvt) patients

Conditions: Deep Vein Thrombosis

Summary: the objective of this study is to evaluate the efficacy, safety, pharmacokinetics (pk) and pharmacodynamics (pd) of two different dosages of rivaroxaban in the treatment of deep vein thrombosis (dvt) and the prevention of the occurrence and the recurrence of dvt or pulmonary embolism (pe) in japanese patients with acute symptomatic dvt without symptomatic pe.

the general design of the trial is open label between the rivaroxaban and the reference arm. however, there are two groups in the rivaroxaban arm only for the initial 3 weeks. between these two groups and in this initial period, the study is blinded.

Eligibility criteria:
inclusion criteria: * men and women \>/= 20 years of age in patients with confirmed acute symptomatic proximal deep vein thrombosis (dvt) without symptomatic pulmonary embolism (pe) exclusion criteria: * thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of dvt * more than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of dvt to randomization * calculated creatinine clearance (clcr) \< 30 ml/min * subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk * active bleeding or high risk for bleeding contraindicating treatment with unfractioned heparin (ufh) or warfarin * systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 110 mmhg

Keywords: acute symptomatic deep vein thrombosis
pfa for paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the purpose of this study is to verify the safety and efficacy of the cardiac pulse ablation system in paroxysmal atrial fibrillation to provide the basis for product registration and clinical application. the trial will be conducted at a clinical center with appropriate clinical cases, and paroxysmal atrial fibrillation ablation procedures will be performed by an authorized investigator using the trial product. the effectiveness and safety of the cardiac pulse ablation system in the treatment of paroxysmal atrial fibrillation will be verified by collecting the treatment success rate, immediate ablation success rate, procedure time and device use evaluation within 12 months after the procedure.


Eligibility criteria:
inclusion criteria: * ≥18 and ≤75 years of age. * paroxysmal atrial fibrillation diagnosed by electrocardiogram or holter ecg (including single-lead ecg recorder, lasting≥30s) within 1 year prior to enrollment. * clinical diagnosis of paroxysmal atrial fibrillation. * symptomatic patients who are ineffective or intolerant to at least one antiarrhythmic medication; or patients who are willing to undergo ablation despite not being on medication. * fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol. exclusion criteria: * patients who have undergone left atrial surgery * left atrial thrombosis * patients of childbearing age who are unable to use effective contraception during the 12-month period after enrollment * anterior and posterior left atrial diameter ≥ 50 mm * left ventricular ejection fraction (lvef) ≤ 40% * previous atrial septal repair or atrial mucinous tumor * active implants (e.g. pacemakers, icds, etc.) in the body * nyha class iii-iv cardiac function \[appendix 1\] * clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack) * cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) * those with acute or severe systemic infections * patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial * patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders * patients who have participated or are participating in other clinical trials within 3 months prior to enrollment * patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Keywords: pulse field ablation pfa paroxysmal atrial fibrillation paf
lower urinary tract symptoms in women and adjustment disorder

Conditions: Lower Urinary Tract Symptoms; Adjustment Disorders

Summary: our hypothesis that the prevalence of ad in uro-gynecologic patients with luts who are seeking medical help for their condition is higher than that of the general population (indicated by high scores at the adnm-20; score above 48). taking into consideration that affective disorders, anxiety and depression among patients with luts present with a prevalence of 17-23% \[20\] as well as through long personal experience, we hypothesize that the prevalence of ad in this group is 20%.


Eligibility criteria:
inclusion criteria: * female patients seeking medical help for lower urinary tract symptoms * german speaking exclusion criteria: * pelvic floor prolapse symptoms or stage iii or more by medical examination * inability to understand the purpose of the study
effects of hyperthyroidism on amount and activity of brown adipose tissue

Conditions: Hyperthyroidism

Summary: the investigators wish to evaluate the effect of thyroid hormones on brown adipose tissue in humans in an observational study on patients with thyrotoxicosis. in the investigators evaluation the investigators will use fdg-pet/ct, indirect calorimetry and fat biopsies in the acute phase of the disease and in the euthyroid phase after treatment. it is the investigators hypothesis that high levels of circulating t3 might affect amount and function of brown adipose tissue.

10 patients with thyreotoxicosis (t3 \> 3 nmol/l and suppressed tsh) will be investigated at diagnosis and after 3-6 months of euthyroidism induced by antithyroid treatment. the patients will all be over the age of 50 due to the radiation given by the scans (requested by the local ethical committee). all will be scanned for active bat by the integrated fdg pet-ct before and after treatment.bat is activated by means of crushed ice placed under the feet in individualized intervals during the scan procedure. indirect calorimetry is done to determine the basal metabolic rate and subcutaneous fat biopsy to examine the effect on subcutaneous white fat and the possible "browning" effect.

Eligibility criteria:
inclusion criteria: * men and women with hyperthyroidism (t3 \> 3 nmol/l) * \> 50 years old * women must be postmenopausal exclusion criteria: * thyrotoxic crises * severe concurrent sickness that will make it unsafe to postpone treatment, this includes severe kidney disease (creatinin over 160)- and heart disease (nyha group 3 and 4). * diabetes * former and current treatment with interleukin-2 * patients who are already treated with β-blockers * severe claustrophobia * bmi \> 30 kg/m2

Keywords: brown adipose tissue