Kornimate/medical-research-clean huggingface dataset:
value of target-controlled intravenous anaesthesia (tciva) in spinal cord stimulation

Conditions: Failed Back Surgery Syndrome

Summary: study design 60 patients monocenter prospective study randomized in 2 groups 36 months objectives demonstrate the superiority of target controlled intravenous anesthesia versus total anesthesia with the low back paresthesia mapping in at least 95% of patients implanted with a multicolumn lead.


Eligibility criteria:
inclusion criteria: * age \> 18 years and ≤ 80 years * fbss * radicular leg et lumbar pain * for more than 3 months after one or many spine surgeries * mixt pain (radicular leg et lumbar) with neuropathic status * failure of conservative treatment * severe uni or bilateral radicular pain \> 5 / 10 exclusion criteria: * age \ 80 years. * bmi \> 30 kg/m2. * back pain that can be treated by surgery (discogenic, vertebral instability, ...) * contraindication to tciva anesthesia under propofol remifentanil * psychiatric status * cancer * no signature of informed consent. * women of childbearing without contraception
exploratory trial of sat-003 in cancer cachexia patients with discontinued chemotherapy

Conditions: Cancer Cachexia

Summary: this clinical trial aims to evaluate the feasibility of 'sat-003' as well as its exploratory safety and efficacy in patients with cancer cachexia who have been diagnosed with solid tumors and have discontinued anticancer treatment.

cancer cachexia, characterized by weight loss, anorexia, and muscle wasting, is a metabolic imbalance resulting from impaired endocrine function. unlike simple hunger or loss of appetite, cancer cachexia leads to a reduction in weight and skeletal muscle metabolism despite normal food intake, progressively weakening the body's overall function. many cancer patients experience this condition, which can increase resistance to cancer treatment, worsen overall health, and diminish quality of life, often leading to the discontinuation of therapy. cancer cachexia is a common complication in cancer patients and is associated with high mortality rates. despite ongoing research, no effective treatment for cancer cachexia has been identified, and current therapies targeting appetite improvement or nutritional support often fail to effectively address the full spectrum of symptoms. sat-003 has been developed to alleviate the symptoms of cancer cachexia and facilitate the resumption of cancer treatment. this single-center, single-arm, prospective feasibility clinical trial aims to evaluate the feasibility, safety, and effectiveness of sat-003 in patients with cancer cachexia who have been diagnosed with solid tumors and discontinued chemotherapy.

Eligibility criteria:
inclusion criteria: 1. male or female aged 19 years and older 2. cancer cachexia patients diagnosed with solid tumors and whose anticancer treatments (surgery, radiation therapy, anticancer drugs, or chemotherapy) have been discontinued. (diagnosis criteria for cancer cachexia include: experiencing a weight loss of 5% or more over the past 6 months, having a bmi below 20 with a weight loss exceeding 2%, or having a skeletal muscle index indicative of sarcopenia (for males \< 7.26 kg/m\^2; for females \< 5.45 kg/m\^2) with a weight loss exceeding 2% 3. between 20 and 70 points of kps score 4. capable of holding and raising a smartphone with the treatment application installed 5. capable of either listening or viewing, and able to move parts of their body 6. capable of using a smartphone and application by themselves or with assistance from caregiver or guardian (in the latter case, the availability of assistance from a caregiver or guardian shoud be confirmed.) exclusion criteria: 1. have pledged discontinue further anticancer treatment 2. those whose chemotherapy or radiation therapy has already been confirmed prior to enroll 3. lack the cognitive ability to understand and adhere the instructions
leg length discrepancy and adolescent idiopathic scoliosis: clinical and radiological characteristics

Conditions: Leg Length Inequality; Scoliosis; Pelvic Obliquity

Summary: the aim of this retrospective study is to present clinical and radiological features and their relationships for differentiating functional scoliosis due to lld and lld concurrent with ais.

this study was conducted as a single-center retrospective comparative study on 47 consecutive scoliosis patients detected lld, aged 10-18 years, between 2018 and 2020. the scoliosis patients with a diagnosis of structural lld were divided into two groups according to whether there was a concurrent ais diagnosis or not. demographic data were recorded. limb length was clinically measured by direct, indirect evaluation method and new lld-scoliometer test. cobb degree, axial rotation, internal/external pelvic obliquity and lld were obtained from posteroanterior spine radiographs measured by two blinded orthopaedic spine surgeons.

Eligibility criteria:
inclusion criteria: * between december 2018-2020 * scoliotic patients, who detected lld * ages 10 to 18 years * patients who have two or more clinical records at least 6 months apart * who accepted to participate in the study. exclusion criteria: * neurological disease * a history of spinal surgery/tumors * the diagnosis of ais without lld or trauma

Keywords: leg length discrepancy adolescent idiopathic scoliosis leg length discrepancy scoliometer test
antibiotic treatment of recurrent episodes of asthma in children

Conditions: Childhood Asthma With Acute Exacerbation

Summary: copsac has discovered that asthmatic exacerbations are as closely linked to bacterial as to viral infection. the current study will examine whether treatment of asthmatic exacerbations with macrolide antibiotics - in the abscence of clear clinical bacterial infection which would in any case precipitate antibiotic treatment - has an effect on either the particular episode, or subsequently. macrolide antibiotics are chosen for ease of administration ensuring high compliance, antibiotic appropriacy, and anti-inflammatory properties.


Eligibility criteria:
inclusion criteria: * participation in the copsac2010 cohort * recurrent wheeze * and others exclusion criteria: * macrolide allergy * heart, liver or kidney disease. * and others

Keywords: wheeze infections
clinical trial to assess the efficacy and safety of yyc405 in type 2 diabetes patients

Conditions: Type 2 Diabetes

Summary: phase 3 study to assess the efficacy and safety of yyc405 in type 2 diabetes patients

phase 3 study to assess the efficacy and safety of yyc405-t when added to metformin and dapagliflozin combination therapy in patients with type 2 diabetes mellitus who have inadequate glycemic control

Eligibility criteria:
inclusion criteria: * patient who contsent to participate in this tiral by written informed consent form * a man or woman over 20 years old * type 2 diabetes patients exclusion criteria: * patients with severe renal impairment, end-stage renal disease or on dialysis * type 1 diabetes patients * patients with a history of acute or chronic target acidosis, including lactic acidosis and diabetic ketoacidosis
study to evaluate the safety and efficacy tpi asm8 in subjects with asthma

Conditions: Allergic Asthma

Summary: the researchers propose to study the airways of asthmatics given tpi asm8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.

early and late asthmatic responses were attenuated by asm8 and by placebo solution.methacholine challenge was not affected by study medication. other parameters were unchanged.

Eligibility criteria:
inclusion criteria: * men and women 18 to 65 years of age * intermittent mild to moderate allergic asthma as defined by ats/ers criteria * history of episodic wheeze and shortness of breath exclusion criteria: * significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness, asthma exacerbation or respiratory infection in the preceding 6 weeks * use of oral/injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs or anticoagulants

Keywords: steroid-naive, non-smokers mild to moderate allergic asthmatic adults
non-interventional observation of practical implementation, efficacy and safety of continuous infusion with kogenate bayer in surgery

Conditions: Hemophilia A

Summary: the objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with kogenate bayer in surgery.


Eligibility criteria:
inclusion criteria: * in-patients with diagnosis of severe haemophilia a (fviii \ 150 exposure days), without any history of inhibitors, a negative inhibitor test should be available, decision taken by the investigator to administer kogenate bayer via continuous infusion during and after surgery.

Keywords: continuous infusion surgery severe haemophilia a
evaluation in 15 participants of blood flow, comfort and efficiency, using 1 vs 36 hz stimulation via textile electrodes

Conditions: Hemodynamic Instability; Pain

Summary: muscle contractions induced by calf low-intensity neuromuscular electrical stimulation (c-li-nmes) can increase venous return and may reduce venous thromboembolism. this study aimed to compare the effect of different c-li-nmes frequencies and plateau times on hemodynamics, discomfort and energy efficiency, when applied via sock-integrated transverse textile electrodes.

fifteen healthy participants were stimulated via two 3x3cm transverse textile electrodes integrated in a sock, with ten different combinations of frequency (1hz or 36hz) and plateau times (0.5/1.5/3/5/7s), with gradually increasing nmes-intensity until plantar flexion-induction. at this point, popliteal peak venous velocity (pvv), time-averaged mean velocity (tamv) and ejection volume (ev) were assessed by doppler-ultrasound, discomfort by a numerical rating scale (nrs, 0-10) and values for current amplitude and energy were calculated based on the nmes-device´s intensity level. values expressed with median (interquartile range), significance set to p\<0.05.

Eligibility criteria:
inclusion criteria: * age 18-99 years of age * voluntary participation exclusion criteria: * pregnancy * pacemaker * ongoing thromboprophylaxis * skin wounds * vascular abnormalities * previous vascular system surgery in the lower limbs

Keywords: neuromuscular electrical stimulation hemodynamics physical inactivity
3 month outcome of ziv-aflibercept for dme

Conditions: Diabetic Macular Edema

Summary: the purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.

multi-studies have shown that intravitreal aflibercept (eylea) is effective and safe in diabetic macular edema (dme) treatment and has gained fda approval but it is expansive where ziv aflibercept (zaltrap) has the same molecule but with high osmilar buffer solution which is fda approved for colon rectus cancer treatment and it is cost effective. studies have shown that intravitreal ziv aflibercept is safe and nontoxic despite the high osmolarity and even has short term effect in wet age related macular degeneration.

Eligibility criteria:
inclusion criteria: * patients with central diabetic macular edema * best corrected visual acuity is 20/25 or less * central macular thickness more than 250 microns * patients who are able to come for all follow-up exclusion criteria: * significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. * myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization * for women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years. * macular edema is present that is considered to be related to ocular surgery such as cataract extraction * substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more * history of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. * exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis

Keywords: dme anti vegf vegf trap diabetes diabetic retinopathy zaltrap ziv aflibercept
double blind placebo controlled dose ranging study of the efficacy and safety of ssr149744c 100 or 300 mg for the prevention of ventricular arrhythmia-triggered icd interventions

Conditions: Arrhythmia; Tachycardia, Ventricular; Ventricular Fibrillation

Summary: primary objective: * to assess the efficacy of ssr149744c for the prevention of ventricular arrhythmia-triggered icd interventions. secondary objectives: * to assess versus placebo the tolerability of the different dose regimens of ssr149744c in the selected population. * to document ssr149744c plasma level during the study.


Eligibility criteria:
inclusion criteria: * patient with an icd implanted during the previous year for documented spontaneous life-threatening ventricular arrhythmia or implanted with an icd and with at least one appropriate icd therapy (shock or anti-tachycardia pacing) for ventricular tachycardia or ventricular fibrillation in the previous year. * left ventricular ejection fraction measured by 2d-echocardiography must have been documented to be less than 40% in the last 6 months. exclusion criteria: main criteria (non-exhaustive list): * women of childbearing potential without adequate birthcontrol, pregnant women, breastfeeding women, conditions which increase the risk of severe antiarrhythmic drug side effects, severe associated conditions.

Keywords: tachycardia, ventricular ventricular fibrillation defibrillators implantable arrhythmia anti-arrhythmia agents
effects of omega-3 fatty acid supplementation on inflammatory response in multisystem trauma patients

Conditions: Multiple Trauma

Summary: this study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. the main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo

this prospective, randomized study will evaluate the effects of omega-3 fatty acid supplementation on inflammatory response in multi-injured trauma patients. its primary objective is to compare the intensity of inflammation between an active omega-3 group and a placebo group.

Eligibility criteria:
inclusion criteria: * multi-system blunt trauma patients * ages 18 through 65 years, inclusive * admission to icu * nasogastric or nasoenteric feeding tube in place * intention of primary medical team to feed the patient enterally exclusion criteria: * expected mortality within 48 hours * intracranial hemorrhage * pregnant or breast feeding * patient, surrogate, or physician not committed to full support * refractory shock * unable to obtain enteral access * presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction * current total parenteral nutrition (tpn) use, or intent to use tpn within 7 days * current gastrointestinal bleeding * requirement for vasopressors

Keywords: trauma
rct of ballon technique vs selective ophthalmic artery infusion for the retinoblastoma patients

Conditions: Retinoblastoma; IAC; Selective Ophthalmic Artery Infusion; Ballon Technique

Summary: retinoblastoma is the most common intraocular tumor in children..iac--targeted treatment for intraocular retinoblastoma,is minimally invasive procedure that infuse chemotherapy select into the ophthalmic artery, its can increasing the drug concentration reaching the tumor and reducing systemic toxicity compared with traditional intravenous treatment.: one is ballon technique , another is selective ophthalmic artery infusion.this study evaluates the difference of ballon technique and selective ophthalmic artery infusion effect in the treatment of retinoblastoma. half of participants will receive, ballon technique while the other half will receive selective ophthalmic artery infusion

delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. two alternative means can be used,the purpose of this study is to show that ballon technique and soai delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment.

Eligibility criteria:
inclusion criteria: 1. no age limit, no gender limit, monocular or binocular affected; 2. new diagnosed cases, without any previous treatment; 3. clinical diagnosed as retinoblastoma, and in group c, d or e according to iirc standard; binocular affected with one eye enucleated; 4. normal bone marrow function 5. normal liver function 6. normal kidney function 7. normal coagulation function 8. to be willing to take part in the clinical trial and sign the informed consent form; 9. to be willing to have these tumor sites surgically removed and do the follow up accordingly. exclusion criteria: 1. diagnosis is not clear; 2. with other sever ocular diseases (for example: neovascular glaucoma, iris neovascularization); 3. with sever systemic diseases, include abnormal liver or kidney function, abnormal routine blood test or coagulation function, congenital heart diseases and dysaudia; 4. took part in other clinical study within 3 months; 5. refuse to take part in this clinical study; 6. is not willing to do the follow up accordingly or follow up less than 2 times.
iron status and myelination in premature infants

Conditions: Neurodevelopmental Outcome

Summary: premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.


Eligibility criteria:
inclusion criteria: * babies less than or equal to 33 weeks gestational age exclusion criteria: * infants with cranio-facial malformations * torch infections * infants with hearing disorders * infants receiving erythropoietin * infants with subnormal vitamin e levels * infants with severe anemia * infants who are not on full feeds * infant with in-utero exposure to cocaine

Keywords: premature infants iron neurodevelopment
immunogenicity and safety of combined vaccine to prevent measles, mumps, rubella and chickenpox diseases

Conditions: Mumps; Rubella; Measles; Varicella

Summary: this is a study to assess the immunogenicity and safety of glaxosmithkline (gsk) biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.


Eligibility criteria:
inclusion criteria: * a male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination. exclusion criteria: * history of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial * planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Keywords: prophylaxis measles, mumps, rubella and chickenpox
safety, tolerability, and pharmacokinetics of ab-836 in healthy subjects and subjects with chronic hbv infection

Conditions: Chronic Hepatitis

Summary: this three-part, phase 1 protocol will be the first clinical study of ab-836. parts 1 and 2a/b will be a phase 1a sad/mad of ab-836 in healthy adult subjects. part 3 will be a phase 1b dose-ranging assessment of ab-836 in non-cirrhotic chronic hepatitis b (chb) subjects.


Eligibility criteria:
inclusion criteria: * healthy subjects 1. male and female (not of childbearing potential in part 1 and 2a) subjects between 18 and 45 years old 2. free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, and clinical laboratory test results. 3. bmi of 18-32 kg/m2. * chb subjects: 1. male or female between 18 and 65 years old. 2. chronic hbv infection documented as a positive hbsag, hbv dna, or hbeag test at least 6 months prior to the screening visit, or a historical liver biopsy consistent with chronic hbv infection 3. for cohort f, g, h: 1. hbv dna ≥2,000 iu/ml at screening (subjects may be either treatment-naïve or treatment-experienced but currently off-treatment). 2. alt ≤ 5x uln 4. for cohort i: 1. hbv dna \<lloq at screening 2. subjects must have been receiving either taf, tdf, or etv consistently for ≥6 months prior to day 1 and are willing to continue with the same na treatment through the final study visit. 3. alt ≤ 2.5 x uln 5. hbsag ≥250 iu/ml at screening exclusion criteria: * chb subjects 1. advanced fibrosis, cirrhosis or other signs of advanced liver disease as assessed by clinical history, ultrasound or fibroscan, or history of cirrhosis or any clinically significant medical condition associated with chronic liver disease. 2. co-infection with hiv or other non-b hepatitis viruses. 3. any clinically significant or unstable medical condition or illness that could confound study findings. 4. subjects who are unwilling to comply with protocol contraception requirements, and female subjects who are pregnant or breastfeeding. 5. previous treatment with a capsid inhibitor, core inhibitor, or core protein assembly modifier \[cpam or cam\]) within 6 months of the day 1 visit, or prior treatment with an hbv-targeted sirna or antisense oligonucleotide compound at any time.
registry of dupuytren's contracture treatment outcomes

Conditions: Dupuytren's Disease

Summary: experience with microbial collagenase (trade name xiapex) in europe currently is limited to randomised controlled studies.while such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical "real-life" setting under clinical practice conditions.thus, the present study aims to collect data on the * drug utilization of microbial collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice * context of microbial collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy) * effectiveness (with focus on functionality) * tolerability * patient-related outcomes: patient satisfaction, health-related quality of life * physician satisfaction with therapy * resource utilization (hospital stays, drug consumption, concomitant medication etc.) * long-term outcomes


Eligibility criteria:
inclusion criteria: * palpable cord due to dupuytren's disease (pretreated or untreated) * satisfactory knowledge of german to be able to fill out questionnaires * written informed consent exclusion criteria: * contraindication to microbial collagenase (according to prescription information)