Kornimate/medical-research-clean huggingface dataset:
post-marketing surveillance study of adalimumab (humira®) for non-infectious intermediate, posterior, or panuveitis patients

Conditions: Non-infectious Intermediate, Posterior and Panuveitis

Summary: the objective of this study is to evaluate the safety and effectiveness of humira® (adalimumab) for the treatment of non-infectious intermediate, posterior, or panuveitis patients under a routine treatment practice.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with non-infectious intermediate, posterior and pan-uveitis * patients voluntarily signed a patient authorization \& informed consent form. * decision on the treatment with humira® was made prior to any decision to approach the patient to participate in this study. * humira® treatment is indicated as per local summary of product characteristics (smpc) and professional and/or reimbursement guidelines. exclusion criteria: * a patient who are contraindications to originator adalimumab (humira®) as listed on the approved korean label. * a patient who is participating on other interventional clinical trials * prior treatment with humira®, including current course of humira® started prior to baseline visit assessments.

Keywords: non-infectious intermediate, posterior and panuveitis post-marketing surveillance humira®
therapeutic confirmatory clinical trial to evaluate the safety and efficacy of "ag npp709 syrup"

Conditions: Acute Upper Respiratory Tract Infections; Bronchitis

Summary: the purpose of this study is to assess therapeutic confirmation of ag npp709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis.


Eligibility criteria:
inclusion criteria: 1. parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent 2. patient ages between 24months and 75years 3. patient with a clinical diagnosis of acute upper respiratory tract infection or chronic inflammatory bronchitis should has any combination of at least two of following symptoms including sputum: cough, sputum, dyspnea and chest pain when breathing 4. females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection exclusion criteria: 1. patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis 2. patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders 3. patient whose fructose intolerance 4. patient who has hypersensitivity anamnesis of prospan syrup 5. patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal ekg test value that is clinically significant 6. patient whose liver or kidney function is serious abnormal: including the cases of alt, ast, bilirubin and blood creatinine value exceeding three times of their upper limit, severe liver disorders, chronic kidney disease 7. patient who has uncontrolled diabetes or uncontrolled hypertensions 8. patient who has experience to have participated in other clinical trial within two months before starting the trial 9. pregnant women, lactating women

Keywords: acute upper respiratory tract infection, chronic inflamatory bronchitis
registry study of traditional morphology grading combined with eeva in ivf treatment

Conditions: Infertility

Summary: the purpose of this study is to record and evaluate the use of traditional morphology grading combined with eeva in the treatment of in vitro fertilization.

this is a prospective, observational, single-arm, nonrandomized, multicenter study. data will be collected to establish eligibility, at baseline, during the stimulation and in vitro fertilization process, during embryo culture, at embryo transfer, at 12-18 days post egg retrieval to verify biochemical pregnancy, and then typically at 5-6 weeks gestational weeks to verify clinical pregnancy.

Eligibility criteria:
inclusion criteria: * women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs. exclusion criteria: * history of cancer. * gestational carrier.

Keywords: in vitro fertilization assisted reproductive therapy time-lapse image recording image analysis software
validation of french version of lcadl and dyspnea-12

Conditions: Copd

Summary: the main objective of this study is to develop and to validate a french version of the london chest activity of daily living (lcadl) and the dyspnea 12 and to determine the reliability of this version for the evaluation of the dyspnea in the activity of daily living in copd patients (stages severe and very severe).


Eligibility criteria:
inclusion criteria: * copd with fev1\< 50% of predictive value exclusion criteria: * fev1\> 50% of predictive value * patients with an exacerbation of copd in the previous 30 days the inclusion

Keywords: dyspnea
standard pulsed radiofrequency versus supervoltage pulsed radiofrequency glossopharyngeal nerve in oropharyngeal cancer pain

Conditions: Pulsed Radiofrequency; Super Voltage Pulsed Radiofrequency; Glossopharyngeal Nerve; Oropharyngeal Cancer; Pain

Summary: the aim of this study is to evaluate the safety and efficacy of supervoltage pulsed radiofrequency glossopharyngeal nerve therapy versus standard pulsed radiofrequency in reduction of oropharyngeal cancer pain, through visual analog scale score reduction.

the glossopharyngeal nerve is the 9th cranial nerve. it has motor, sensory and parasympathetic function like trigeminal and facial nerves. it has its origin in the medulla oblongata and exits the skull via the jugular foramen, close to vagus and accessory nerves, together with the internal carotid artery and sympathetic nerves and terminates in the pharynx between the superior and middle pharyngeal constrictors, splitting into its terminal branches - lingual, pharyngeal, and tonsillar. glossopharyngeal neuralgia is an extremely uncommon occurrence and accounts for only 0.2%-1.3% of the cases with facial pain. it usually affects the male individuals above 50-year age, and the reported incidence of glossopharyngeal neuralgia is roughly 0.8 per 100,000 persons per year. as per ichd-3 (international classification of headache disease- 3) classification, glossopharyngeal neuralgia is a disease characterized by an episodic unilateral pain, with sharp and stabbing in character, with sudden onset and cessation, in the glossopharyngeal nerve distribution (jaw angle, ear, tonsillar fossa and the base of the tongue). it also affect the pharyngeal and auricular branches of the vagus nerve. pain is commonly aggravated by coughing, talking, and swallowing. pain in glossopharyngeal neuralgia has a relapsing and remitting pattern. vaso glossopharyngeal neuralgia may be associated with life-threatening cardiovascular features- syncope, hypotension, cardiac arrhythmias, in contrast to trigeminal neuralgia

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 70 years. * both sexes * american society of anesthesiologists (asa) class ii and iii. * patients under pain management for oropharyngeal cancer (failed medical treatment or intolerance to the side effects of the drug). * visual analog scale (vas) equal to or more than 6 cm in spite medical treatment. exclusion criteria: * patient refusal. * patients with local or systemic sepsis. * uncorrectable coagulopathy. * unstable cardiovascular disease. * history of psychiatric and cognitive disorders. * patients allergic to medication used.7 * unable to lie supine. * local anatomical distortion (either congenital, post-surgical or post-radiotherapy) making intervention difficult and hazardous. * elongated styloid process \> 25 mm. * age less than 18 year and more than 70 year.
goal-directed intraoperative fluid therapy in high-risk surgery

Conditions: Postoperative Complications; Fluid Overload

Summary: this study is aim to assess the effect of goal-directed intraoperative fluid therapy on patient's postoperative incidence rates of complications, length of hospitalization and hospitalization cost. this is an observational study followed cohort study design, due to the two therapies were not randomized assigned to the two cohorts. the details are described as follow.

the study will be conducted in patients undergoing either elective laparotomy of gynecological malignancies or elective major orthopaedic surgery under prone position in peking union medical college hospital. the study included two stages. in the first stage, one cohort of 300 participants with conventional fluid therapy will be involved, in which 150 patients will be selected with laparotomy of gynecological malignancies and150 patients will be selected with orthopedic surgery. all the participants in this stage will follow conventional fluid therapy to direct the amount of intraoperative fluid. specifically, the fluid will be administered based on the principle crystalloid solution (colloid solution =2-3:1). the total volume of fluid will be adjusted in accordance with blood pressure, heart rate and urine output of each patient. it is a standard procedure in peking union medical college hospital. then, the incidence of postoperative complications of each group will be recorded. in addition, sample size will be estimated based on above study's results (estimated 100 participants). in the second stage, goal-directed therapy will be applied to another cohort of 300 participants, in which 150 patients undergoing laparotomy of gynecological malignancies and 150 patients undergoing orthopedic surgery. specifically, the fluid will be administered based upon real-time monitoring stroke volume variation and cardiac output achieved by the flo-trac monitoring system. the incidence of postoperative complications of each group will be recorded.

Eligibility criteria:
inclusion criteria: 1. receiving elective laparotomy of gynecological malignancies (lgm): including cytoreductive surgery of ovarian cancer, radical hysterectomy and staging surgery of endometrial cancer ; 2. major elective orthopedic surgery (os): including spinal surgery, revision surgery of hip joints ; 3. age ≥18 years, american society of anesthesiologists physical status i ～iv; 4. no arrhythmia; 5. receiving general anesthesia; 6. requiring monitoring of direct blood pressure due to the comorbidities of patients and the nature of surgical procedures. exclusion criteria: 1. emergent surgery; 2. patients with aortic regurgitation; 3. patients with aortic stenosis, peripheral arterial diseases or other diseases contradicting to arterial canalizations; 4. patients with mental disorders or low intelligence quotient; patients who cannot cooperate or refuse to sign the consent.

Keywords: goal-directed fluid therapy intraoperative hemodynamics postoperative complications
tolvaptan extension study in participants with adpkd

Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Summary: to demonstrate whether tolvaptan modifies adpkd progression as measured by changes from baseline (from study 156-04-251) in total kidney volume (tkv) and renal function.


Eligibility criteria:
inclusion criteria: - participants who had successfully completed a phase 1, 2, or 3 tolvaptan adpkd or renal impairment study, with a confirmed diagnosis of adpkd from prior studies \[either 156-04-251 (nct00428948) or 156-04-250 (nct00413777), 156-06-260, 156-09-284 (nct01336972), 156-09-285 (nct01210560), and 156-09-290 (nct01451827)\]. exclusion criteria: * participants unable to provide written informed consent. * participants (men or women) would not adhere to the reproductive precautions as outlined in the informed consent form. * participants (women only) with a positive urine pregnancy test. * participants who were pregnant or breast-feeding. * participants unable to take oral medications. * participants who had allergic reactions to tolvaptan or chemically related structures such as benzazepines (benzazepril, conivaptan, fenoldopam mesylate, or mirtazapine). * participants with disorders in thirst recognition or an inability to access fluids. * participants with critical electrolyte imbalances, as determined by the investigator * participants with or at risk of significant hypovolemia, as determined by investigator. * participants with significant anemia, as determined by investigator. * participants with a history of substance abuse (within the last 3 years). * participants who were taking other experimental (that is, non-marketed) therapies or were participating in another clinical drug or device study; participating in the off-drug follow-up period of another adpkd trial with tolvaptan was permitted. * participants unable to complete magnetic resonance imaging (mri) assessments (for example, participants with ferro-magnetic prostheses, aneurysm clips, severe claustrophobia). * participants who had taken a vasopressin antagonist (outside of previous participation in a tolvaptan study). * participants unable to comply with anti-hypertensive or other important medical therapy. * participants with advanced diabetes. * participants who were taking medications or had an illness that could confound endpoint assessments (including taking approved therapies for the purpose of affecting polycystic kidney disease \[pkd\] cysts).

Keywords: kidney disease adpkd autosomal dominant polycystic kidney disease adult polycystic kidney disease
mindfulness training and parent-coaching interventions for autism spectrum disorder

Conditions: Autism Spectrum Disorder; Parents; Stress

Summary: caregivers of children with autism spectrum disorder (asd) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. the proposed work tests a novel treatment paradigm that blends mindfulness based stress reduction (mbsr) with an empirically supported and manualized parent training program (parent-implemented early start denver model \[p-esdm\]). we hypothesize that directly treating parental distress, while simultaneously providing evidence-based parent training, may greatly enhance child-focused intervention and provide benefits that resonate across the family.


Eligibility criteria:
inclusion criteria: * child has diagnosis of autism spectrum disorder * child at least 12 months of age but less than 36 months at time of consent * parent speaks and reads fluent english exclusion criteria: * severe child sensorimotor impairment that would impact participation in treatment
pemetrexed as the first treatment in advanced or metastatic breast cancer

Conditions: Breast Cancer; Breast Neoplasms, Male; Carcinoma, Ductal

Summary: the purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect dna for future research regarding metastatic breast cancer. the collection of dna is optional to the patient.


Eligibility criteria:
inclusion criteria: * must have been diagnosed with either advanced or metastatic breast cancer. * chemotherapy has not been given for advanced or metastatic breast cancer. * the diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery. * able to carry out work of a light nature (for example, light housework, office work). * must be at least 18 years old. exclusion criteria: * have received prior bone marrow or peripheral stem cell transplantation. * have received prior chemotherapy for metastatic breast cancer. * are currently pregnant or breast-feeding. * have an active infection that your doctor decides will affect your safety. * are unable to take folic acid or vitamin b12.
post transplant study

Conditions: Kidney Tansplant; Secondary Hyperparathyroidism; Hyperparathyroidism

Summary: retrospective chart review to gather information on sensipar patterns of use and effects on biochemical parameters in renal transplant recipients


Eligibility criteria:
inclusion criteria: * adults \>= 18 years old * subjects who have received sensipar for a duration of at least 3 months, beginning at least 3 months after a kidney transplant. subjects must have begun sensipar teatment no later than februry 28, 2005 at treating physician's discretion. exclusion criteria: * subjects who received sensipar before undergoing a kidney transplant * subjects receiving dialysis post-transplant

Keywords: sensipar cinacalcet mimpara
junior emergency physician learning curve to perform transcranial doppler on brain-damage patients

Conditions: Brain Damage

Summary: transcranial doppler is a noninvasive tool. using velocity measurements and pulsatility index it allows the evaluation of cerebral haemodynamics. in patients presenting brain injury cerebral perfusion may be impaired. indirect cerebral blood flow can be monitored and risk of neurological worsening can be detected using transcranial doppler. education and performance of emergency physicians must be evaluated on brain-injured patients because this tool is operator dependent. the main objective of this study is to estimate the average number of exams required to learn transcranial doppler within junior emergency physicians with the achievement of their learning curve. we will perform a prospective, monocentric, observational study within the neurosurgical resuscitation department of grenoble alpes university hospital.

the transcranial dopplers will be carry out on 75 brain-damaged patients by 13 emergency residents physicians after a theoretical and practical training. they will be evaluated by 8 experts. the primary endpoint will be the mean number of transcranial dopplers required to have an excellent concordance between resident and expert. the concordance between the doppler findings of the resident and the expert would exceed 0.8 before 30 examinations. the learning curve assessed on the duration necessary to acquire good quality data should decrease rapidly with the repetition of the examinations. validating the transcranial doppler learning curve for junior emergency physician would allow them to perform this exam safely and efficiently. transcranial doppler may be easy and fast to learn but the persistence of its competency over time should be evaluated.

Eligibility criteria:
inclusion criteria: * adult patients : ≥ 18 year and older * hospitalized in the neurosurgical resuscitation or intensive care unit * brain - damaged patients exclusion criteria: * any craniotemporal lesion impeding satisfactory tdc examination : no transtemporal doppler window, patient with craniectomy. * patient with meningo-encephalitis * patient with cerebral vasculitis * patient without health insurance coverage * patient subject to a legal protection measure * pregnant woman , parturient or nursing

Keywords: transcranial doppler learning curve emergency traumatic brain injury
a clinical study of a natural remedy for rheumatoid arthritis vs. commonly used conventional medications

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the efficacy and safety of a combined therapy for rheumatoid arthritis (ra). the combined therapy contained paeoniflorin (brand name: pafulin), which has anti-inflammation properties, and cervus and cucumis polypeptide injection (brand name: songmeile), which has bone healing, pain relieving, and anti-inflammation properties. the hypothesis is that this remedy, which has long been used by the world's largest ra community, is effective and safe when tested by modern clinical standards and criteria.

this is a double-blinded randomized study on the treatment of rheumatoid arthritis. in particular, patients were randomly assigned to one of the following treatment groups: paeoniflorin (pae) + cervus and cucumis polypeptide injection (ccpi), methotrexate (mtx) + leflunomide (lef), and mtx + lef + ccpi. the therapeutic effectiveness was evaluated by the 7 core set measures of american college of rheumatology (acr). adverse effects, their severity, and the evaluators' professional judgments of relationships between the adverse effects and the drugs were documented.

Eligibility criteria:
inclusion criteria: * age of 18 years or older * active ra, defined by at least 8 swollen joints and at least 10 tender joints (excluding distal interphalangeal joints) * an erythrocyte sedimentation rate (esr) of at least 28 mm per hour * the 1987 revised american college of rheumatology (acr) criteria for diagnosis of ra for at least 6 months * not use of nsaids within two weeks * agreement to participate in this study. exclusion criteria: * poor compliance * severe medical conditions * abnormalities in liver, or kidney function, or in haematological parameters, * pregnancy or breast feeding
efficacy study of aminoflavone prodrug to treat breast cancer

Conditions: Breast Neoplasm

Summary: this is a phase ii study to assess the efficacy of aminoflavone prodrug in triple negative and er+ breast cancer.


Eligibility criteria:
inclusion criteria: * er+ or tn breast cancer * progression on an aromatase inhibitor if er+ * prior treatment with taxane if tn * 18 years or older * adequate organ function * measurable lesion exclusion criteria: * symptomatic pulmonary disease * brain metastases * pregnant females

Keywords: breast cancer
effect of pericapsular nerve group (peng) block for perioperative analgesia in geriatric patients with hip fractures

Conditions: Hip Fractures

Summary: the goal of this clinical trial is to evaluate the analgesic effect of pericapsular nerve group (peng) block in elderly patients with hip fractures undergoing hip surgery . and to evaluate its effect in reducing post operative complications .

all patients meeting the inclusion criteria will be informed about the study goal , methods and procedure in clear language. a written informed consent will be taken. all patients ,once arrived to the or, monitor will be attached, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of l3-l4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle. at the end of surgery,all patients will receive peng block through ultrasound. the regional block was performed with the patient in the supine position. a curvilinear low-frequency ultrasound probe (2-5mhz) was initially placed in a transverse plane over the aiis and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. in this view, the ipe, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. a 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. following negative aspiration, the local anesthetic solution was injected in 5-ml increments while observing for adequate fluid spread in this plane for a total volume of 20 ml bupivacaine 0.25%.

Eligibility criteria:
inclusion criteria: * patients must age 60 years or more . * patients must belong to american society of anesthesiologists (asa) classification class ii or iii exclusion criteria: * age \< 60 years * asa iiii * refusal of peripheral nerve block * infection at the site of injection * coagulopathy inr \> 1.8 * platelets count \< 50,000 * known allergy to used medications.