Kornimate/medical-research-clean huggingface dataset:
clinical study to assess the safety and efficacy of mechanochemical ablation with flebogrif in patients with great saphenous vein insufficiency

Conditions: Chronic Venous Insufficiency, CVI

Summary: the objective of the study is to collect clinical data of patients in whom flebogrif® will have been used for mechanochemical ablation of incompetent veins in the follow-up period, as related to the safety, clinical effectiveness, properties and advantages of flebogrif®. the proposed study is a prospective, multi-centre clinical trial assessing the safety, efficacy and quality of flebogrif® in a population of patients with the incompetent great saphenous vein, who require surgical treatment.


Eligibility criteria:
study inclusion criteria: 1. signing the informed consent form by the patient found eligible for the treatment with the mechanochemical method 2. the patient declares willingness to participate in the study and in the monitoring visits envisaged in the study protocol 3. a patient with diagnosed varicose veins and diagnosed great saphenous vein (gsv) insufficiency confirmed by ultrasound (ceap class c2-c6) 4. favourable anatomy enabling the introduction of the flebogrif® guidewire/catheter and positioning of its top part at the dedicated site (2-3 cm below sfj) 5. diameter of the treated vein of 4-10 mm 6. no data or no history indicating an allergy to the sclerosing chemicals used in the mechanochemical method (polidocanol), on the basis of the information obtained from the patient and the available medical records 7. no clinical symptoms indicating (chronic, critical) lower limb ischaemia precluding the use of compression, on the basis of a physical examination or, in unclear cases, of a doppler ultrasound examination 8. no medical information or no history of coagulation system dysfunction of the type of thrombophilia or bleeding diatheses 9. no cutaneous lesions (purulent, bullous) within the limb found eligible for treatment with the mechanochemical method 10. no clinical data indicating recent thrombosis within the deep vein system 11. no clinical data on diabetes with vascular complications 12. no clinical data indicating an active neoplastic process study exclusion criteria: 1. recent deep vein thrombosis or occlusion 2. congenital disorders with associated occlusion of deep system veins 3. pregnancy and breast-feeding 4. lower limb ischaemia 5. severe lymphatic oedema 6. bleeding diatheses 7. documented allergic reaction to sclerosing chemicals used in mechanochemical vein ablation 8. purulent dermatoses affecting the limb found eligible for treatment with mechanochemical vein ablation 9. previous procedures on insufficiency veins of the superficial system 10. acute infection 11. history of great saphenous vein thrombosis 12. end-stage kidney disease
community trial of newborn vitamin a supplementation to reduce infant mortality in rural bangladesh

Conditions: Mortality Through Six Months of Age; Vitamin A Deficiency

Summary: the purpose of this trial is determine whether a 50,000 iu oral dose of vitamin a delivered to newborn infants within the first days of life, reduces six-month infant mortality by at least 15%. the trial will also evaluate whether the survival impact of newborn vitamin a dosing is modified by concurrent weekly, routine maternal vitamin a or beta-carotene supplementation during pregnancy through three months postpartum, gestational age and birth size.

this is a randomized, double-masked, placebo-controlled, community trial of newborn vitamin a supplementation on mortality in the first six months of life. the trial is being implemented in 596 sectors (i.e. villages and/or smaller groupings), in two thanas comprising a population of \~580,000 in rural northern bangladesh (gaibandha/rangpur area) and is nested within the jivita-1 maternal supplementation study. women residing in the study area are already under 5-weekly pregnancy surveillance conducted by village-based field staff as part of the maternal supplementation trial. during their third trimester of pregnancy, women are visited by a study supervisor who explains the purpose and procedures of the study. after obtaining informed consent, women are interviewed for possible risk factors in the third trimester of pregnancy, including a 30-day history of morbidity, a 7-day dietary and alcohol intake and tobacco use questionnaire, a 7-day household chores questionnaire, and maternal anthropometry (mid upper arm circumference measurement). upon birth, household members contact the village-based field staff who immediately administers the vitamin a or placebo to the infant, according to sector assignment. after supplementation, newborns are measured for weight, length and mid-upper arm, head and chest circumference, and then followed weekly for vital status for three months, and again at six months of age. a child death initiates the process of death verification and cause of death determination.

Eligibility criteria:
inclusion criteria: infants born to women enrolled in a maternal supplementation trial, alive and less than 30 days of age during a newborn dosing visit exclusion criteria: infants who died before the dose could be administered or infants older than 30 days at the time of dosing

Keywords: vitamin a newborn health infant mortality supplementation micronutrients bangladesh
pharmacotherapy assessed using neuroprobing with transosseal magnetic stimulation

Conditions: Epilepsy

Summary: the goal of this observational study is to investigate how prescribed anti-seizure medications (asms) affect cortical excitability in adults with epilepsy. the main questions it aims to answer are: 1. does the magnitude of transcranial magnetic stimulation (tms)-evoked potentials (teps) measured with electroencephalography (eeg) change between off and on medication states? 2. do these changes in tep amplitude persist over time? researchers will compare each participant's measurements in the off state with those in the on state to see if teps change following asm (re)start. participants will undergo one tms-eeg session scheduled around their prescribed asm (re)start and one 1-6 months later.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons * written informed consent exclusion criteria: * presence of any electrical implants (e.g. neurostimulator or drug delivery system) or any metallic implants anywhere in the head (excluding teeth) * increased intracranial pressure * uncontrolled psychiatric disorder * use of any kind of drug or alcohol, nicotine allowed * for female participants: if pregnancy cannot be ruled out with sufficient certainty, a pregnancy test (urine) will be carried out before using tms * inability to give consent

Keywords: brain excitability anti-seizure medication transcranial magnetic stimulation
study of small bowel tumor with dual-phase enhanced computed tomography (cte) and magnetic resonance enterography (mre)

Conditions: Intestinal Neoplasms

Summary: purpose: to compare the accuracies of computed tomographic (ct) enterography and magnetic resonance (mr) enterography for the detection and radiomics characterization of small-bowel tumors (including gastrointestinal stromal tumors, adenomas and lymphomas, etc); hypothesis: mr enterography was noninferior to ct enterography for the diagnosis and evaluation of small bowel tumors in generally well-distended small bowel.

the investigators will conduct a 36-month clinical trial, the specific process is as follows: 1. incorporate patients with the above criteria, communicate with the participants to make informed consent and sign informed consent; 2. it is recommended that the attending physician issue the corresponding mre checklist and the cte checklist and make an appointment to check the same day to remind the patient to perform the corresponding bowel preparation work in advance, and perform renal function tests within 3 days before the examination; 3. the enrolled patients were measured for height and weight, and the bmi was calculated. cte and mre were performed according to the results of balanced randomization. the mre was performed on a 3.0t mri scanner; the cte examination was performed on a 320-row ct scanner, and the iodine-containing contrast agent was administered according to the patient's height and weight and gfr; 4. both examinations require an empty stomach preparation (more than 4 hours), and oral (1500ml) 2.5% mannitol aqueous solution before the examination to ensure intestinal filling, subcutaneous indwelling needle preparation, in order to save patient examination time, so the two examinations are completed within 6 hours, before the second inspection, you need to add 150-300ml of 2.5% mannitol aqueous solution; 5. the images obtained were evaluated by two imaging physicians for lesions, numbers, size changes, density/signal values, and peripheral tissue lesions obtained by the two methods; 6. after the patient has obtained a definitive diagnosis according to the routine medical procedure, the above imaging diagnosis results are compared with the confirmed diagnosis results.

Eligibility criteria:
inclusion criteria: * patients with clinical suspicion of small intestinal neoplasms and prescribed cte and/or mre examinations; * age/sex: unlimited; * patients with no severe heart, liver, kidney insufficiency; * patients who voluntarily participate in clinical trials and sign written informed consent. exclusion criteria: * patients with heart and liver insufficiency; * patients with pacemakers installed and which materials are unknown, and patients with metal implants in the body, and nerve stimulators; * patients who are allergic to iodine and intestinal contrast agents; * pregnant women, patients with acute or chronic renal failure and hemodynamic instability; * patients unable to tolerate adequate breath holding for complete ct or mr examination; * patients who can not maintain compliance and cannot strictly implement the plan.
hsk16149 for perioperative analgesia in orthopedic surgery

Conditions: Post-operative Pain

Summary: this study will compare the effect and safety of hsk16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of hsk16149 capsules for orthopedic analgesia during perioperative period.

this study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h. subjects were given 40mg or 60mg of hsk16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period. subjects will receive intravenous patient-controlled analgesia (pca) morphine for pain in the immediate postoperative period. if pca is insufficient, rescue analgesia of morphine may be given i.v. as determined by the investigator. after the treatment period, the subjects will be followed up.

Eligibility criteria:
inclusion criteria: 1. male or female between the ages of 18 and 75 years (included); 2. elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours; 3. 18kg/m\^2≤bmi≤30 kg/m\^2; 4. american society of anesthesiologists (asa) grade i and ii; exclusion criteria: 1. any of the following medical histories or conditions prior to screening: * long history of chronic pain; * history of severe cardiovascular or respiratory disease; * history of neurological or psychiatric disorders; * history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system; * major surgery within 3 months; * patients with high bleeding risk; * history of renal disease treated with dialysis within 28 days before surgery; * have active infection within the past 2 weeks; 2. use of any of the following medications or treatments: * opioid analgesics for more than 10 consecutive days within 3 months prior to screening; * other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label); 3. abnormal laboratory tests during screening: 4. hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmhg and/or diastolic blood pressure ≥100 mmhg), or systolic blood pressure ≤90 mmhg during screening; 5. a history of drug abuse, and/or alcohol abuse in the 3 months prior to screening; 6. participated in another clinical trial and received imp within 30 days prior to screening; 7. pregnant or lactating women; 8. unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of imp;
clinical trial of nebulized hypertonic saline to attenuate post-traumatic acute lung injury

Conditions: Acute Lung Injury; Adult Respiratory Distress Syndrome

Summary: this study evaluates the use of nebulized hypertonic saline (aerosolized salt water) as a preventive treatment for post-traumatic acute lung injury (ali). both animal and human research indicate that aerosolized salt water might help reduce harmful inflammation with minimal risks.

despite over 40 years of investigation, acute lung injury (ali) remains a leading cause of morbidity in critically ill patients, and a disease for which there is no effective pharmacologic therapy. our group and others have focused on the anti-inflammatory effects of intravenous hypertonic saline (hts) acting on the injured endothelium with promising results experimentally, but failed to confirm the benefit clinically. recent work, however, has shown that inhaled or nebulized hts targeted at the epithelium is safe and effective in treating cystic fibrosis, copd, and neonatal bronchiolitis. recognizing the central role of the pulmonary epithelium in ali, nebulization has the advantage of achieving high concentrations of the therapy without producing systemic side effects. thus, we hypothesize that nebulized hypertonic saline will attenuate acute lung injury following trauma.

Eligibility criteria:
inclusion criteria: * adult 18 ≤ age ≤ 65 * trauma with a 9 ≤ niss ≤ 36 * ≤10 units of rbc in the first 6 hours (as this is a major risk factor for ards and mof in this population) exclusion criteria: * direct or indirect lung injury * elevated intracranial pressure requiring treatment, including but not limited to mannitol, intravenous hypertonic saline, and ventricular drainage * history of severe chronic respiratory disease * child-pugh class c liver failure * prisoners * pregnant women

Keywords: trauma acute lung injury adult respiratory distress syndrome
treatment of parkinson disease and multiple system atrophy using intranasal insulin.

Conditions: Parkinson Disease; Multiple System Atrophy

Summary: parkinson disease (pd) and multiple system atrophy (msa) are progressive neurodegenerative disorders characterized by abnormal accumulation of α-synuclein. there is no effective treatment that can slow down the disease progression and both disorders are associated with severe cognitive decline. it was shown that intranasal insulin (ini) improves learning and memory in healthy and cognitively impaired non-diabetic adults. the proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( nct01206322) has shown that a single 40 international units dose of intranasal insulin improves visuospatial memory in diabetes and control subjects. this proposal includes randomized, double blinded, placebo-controlled trial of intranasal insulin (40 international units daily) in treatment of pd and msa. the study will evaluate 22 patients with pd and 22 patients with msa. total duration of the study will be 2 years. the primary goal is to assess the efficacy of ini in treatment of cognitive abnormalities in both pd and msa. the primary efficacy end point will be change of the cognitive scale ratings.


Eligibility criteria:
inclusion criteria: 1. males or females older than 17 years. 2. clinical diagnosis of parkinson disease or multiple system atrophy. 3. provide written informed consent to participate in the study. 4. understand that they may withdraw their consent at any time. exclusion criteria: 1. women who are pregnant or lactating. 2. in the investigator's opinion, have significant systemic, hepatic, cardiovascular, renal or other illness that can interfere based on investigator judgment with the trial. 3. history of dementia. 4. unable to walk without help for at least 1 minute. 5. history of allergic reaction to insulin. 6. the presence of inflammation of nasal cavity that may prevents absorption of insulin.

Keywords: parkinson disease multiple system atrophy intranasal insulin
patient satisfaction and adaptation of dentures printed at 0 versus 45 degrees

Conditions: Edentulous Jaw

Summary: this pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees.

this pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of zero degrees versus forty five degrees. since there is no sufficient evidence surrounding the topic at hand, a randomized clinical trial must be conducted in an attempt to gap the clinical knowledge regarding printing orientation and its effect on denture base adaptation and patient satisfaction. the main question and the one that needs further investigations as stated by goodacre would these differences in these build up angles have a true clinical effect on denture adaptation and denture retention

Eligibility criteria:
inclusion criteria: 1. patients above the age of 40 2. patients with opposing full natural dentition or completely or partially edentulous arches 3. opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants 4. cooperative patients that are willing to attend all follow-up periods. 5. patients with healthy attached mucosa of appropriate thickness free from any inflammation. 6- patients free from any systemic disease that might affect the health of the bone or of the mucosa eg diabetes exclusion criteria: 1. patients with any temporomandibular joint disorder or parafunctional habits 2. patients with flabby or flat ridges 3. patients with extreme anatomical limitations such as a large torus that requires surgical excision. 4. patients with a history of allergy to dentures made of resins. 5. patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections. 6. patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
oran park mask external clinical study (3) marketing claims study

Conditions: Obstructive Sleep Apnea

Summary: the goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype oran park mask system (referred to as mask a in this study protocol) in the home environment. comparisons will be made against fisher \& paykel's evora full mask system (referred to as mask b in this study protocol, an fda cleared benchmark mask) and the participant's own mask. patients diagnosed with obstructive sleep apnea and are current cpap users on a tube down full-face mask system will be recruited to the study to evaluate the oran park mask system and the evora full mask system for up to 7 nights each, in the home environment, whilst using their own cpap device. the overall purpose is to evaluate the performance of the prototype oran park mask system compared to an fda cleared benchmark mask (evora full) in relation to seal, comfort, usability, ease of use, preference, ahi, and objective therapy data.


Eligibility criteria:
inclusion criteria: * participants willing to give written informed consent * participants who can read and comprehend english * participants who ≥ 18 years of age * participants being treated for osa for ≥ 12 months * participants who have met cms compliance for cpap therapy over the last 3 months * participants who have been using a resmed cloud connected airsense10 or airsense 11 device compatible with airview, for more than 12 months * participants currently using a suitable mask system\* * participants who can trial the masks for up to 7 nights each * note\*: suitable mask system includes any tube down full face mask (e.g. airfit f30, airfit f20, airtouch f20, airfit f10, quattro air, quattro fx, mirage quattro, simplus, amara, amara gel, comfort gel full face mask, evora full) exclusion criteria: * participants using bi-level flow generators * participants who are or may be pregnant * participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: copd, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury. * participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (non-ferrous implants may be acceptable) * participants who use a rental unit for airsense 10 or airsense 11 device * participants believed to be unsuitable for inclusion by the researcher
data collection for motor function and gait pattern analysis of patients with chronic stroke

Conditions: Chronic Stroke

Summary: in chronic stroke patients, the data for motor function and gait pattern analysis was obtained.


Eligibility criteria:
inclusion criteria: * stroke patients with hemiplegia over 19 years old * ischemic or hemorrhagic stroke patients over 6 months of onset * functional ambulation category scale with 3 or more scales and a person who can walk independently regardless of using of walking aids * a person who understands and voluntarily participates in this study and signs a research agreement exclusion criteria: * patients of artificial heartbeat * patients with claustrophobia * patients with intracranial metal implants * patients who are contraindicated for other common mri scans * patients difficult to walk due to problems such as visual field defect, fracture, severe muscle paralysis, cognitive impairment * those who have a score of fma score of 80 or more and have very slight motor impairment

Keywords: motor function gait pattern