Kornimate/medical-research-clean huggingface dataset:
split-face comparison study to assess elapr compared to juvéderm® for the treatment of nasolabial folds

Conditions: Aging

Summary: patients presenting to the clinic for treatment of moderate to severe nasolabial folds will be recruited to receive either elapr002b or elapr002d for the treatment of one nasolabial fold and juvéderm® ultra plus for the treatment of the second, opposite nasolabial fold.

the treatment will be repeated on day 29 (if required) and day 57 (if required) to achieve optimum cosmetic results (ocr). each treatment will consist of up to 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each nasolabial fold using a 27g needle. each patient will receive the same preparation implanted as a bolus of 0.1ml at day 1 into the mid-deep dermis of the skin of the medial aspect of the upper arm using a 27g needle, and two 2mm biopsies will be taken at the same visit on day 57, day 85 or day 169 depending on randomisation for histopathology assessment.

Eligibility criteria:
inclusion criteria: * aged 25 - 65 years * male or female * moderate to severe nlfs scored equally as a 3 or 4 out of 5 on both sides of the face using the was scale * good general health status * able to give informed consent exclusion criteria: * clinically significant abnormalities of haematology or biochemistry testing * bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged bleeding time * chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents * allergy to local anaesthetics * active infection at the treatment site * treatment of either nlf other than with a hyaluronic acid (ha) dermal filler and treatment with a ha dermal filler within 18 months of enrolment * any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication * pregnancy/lactation * history of keloid formation * systemic corticosteroids within last 12 weeks * diabetes or metabolic disorders * a history of anaphylaxis or allergic reactions including any known hypersensitivity to hyaluronic acid or lidocaine * sensitivity to juvéderm® ultra plus or juvéderm® products. * participation in any other clinical trial one month prior to treatment and for the duration of the study.

Keywords: aging
percutaneous endoscopic decompression for lumbar canal stenosis

Conditions: Lumbar Spinal Stenosis; Surgery

Summary: lumbar spinal stenosis (lss) is the most common spinal degenerative disease. for conservative treatment failure, open lumbar decompression and fusion surgery is the main surgical treatment. after decades of development, open lumbar decompression and fusion surgery has been the standard treatment. however, there are still people and conditions that cannot be covered, such as elderly people who intolerable surgery, severe osteoporosis, and re-stenosis at adjacent segments after fusion. percutaneous spinal endoscopic lumbar spinal decompression technique could be performed under local anesthesia, soft tissue damage is minimized, and effective spinal decompression can be achieved. there are still some controversial points of lss decompression under percutaneous endoscope surgery, such as the range of decompression, choice of approach, postoperative spinal stability, learning curve, surgical safety, long-term effects of endoscopic treatment of restenosis at adjacent segments after fusion surgery. the purpose of this study was to solve these controversial points. a multi-center, prospective registration study based on the real world is planned. the total sample size is about 600 cases (300 cases in endoscopic surgery group, 300 cases in open decompression and fusion group). the mid- to long-term clinical efficacy and safety were evaluated.


Eligibility criteria:
inclusion criteria: * patients with symptomatic lumbar canal stenosis(including central canal, lateral recess, foraminal and extraforaminal) despite more than 6 weeks of conservative treatment; pathology was confirmed by both computed tomography and magnetic resonance imaging the operative level≤2 exclusion criteria: * segmental instability simple disc herniation coexisting pathological conditions, such as tumor and infection
one step nucleic acid amplification in endobronchial ultrasound-guided needle aspiration samples

Conditions: Lung Neoplasms

Summary: the aim of our study is to investigate if ck19 mrna-detection via osna can accurately detect lymph node metastases in lung cancer patients using ebus-tbna samples.

regional lymph nodes are assessed before tumor resection and before initiation of chemo- or radiotherapy. endobronchial ultrasound-guided needle aspiration (ebus-tbna) is a well-established method for mediastinal and hilar lymph node staging \[2, 3\]. samples obtained via this route are much smaller than surgical lymph node biopsies, yet they are able to provide complete and thorough evaluation, this includes current molecular testing. one step nucleic acid amplification (osna), a molecular test that utilizes ck 19 mrna-concentration as a target marker is becoming a rapidly dynamic method in quick detection of sentinel lymph node (sln) metastases in breast cancer, colon cancer and other cancers. in lung cancer, the role of sln is not well established. however, recent publications suggest an accurate and rapid detection of lymph node metastases in nsclc. however this requires complete lymph node dissection either with mediastinoscopy or by other surgical means such as thoracotomy. the aim of our study is to investigate if ck19 mrna-detection via osna can accurately detect lymph node metastases in lung cancer patients using ebus-tbna samples.

Eligibility criteria:
inclusion criteria: * ct-scan suspicious for lung cancer, * enlarged mediastinal lymph nodes (\>10 mm), * ebus-tbna to be performed, * age: 18-99 years exclusion criteria: * age: \<18 years

Keywords: nsclc, sclc, lung cancer, ebus-tbna
a phase i multicenter clinical trial to evaluate the safety and immunogenicity of vaccinia derived hiv-1 recombinant envelope glycoprotein (gp160) of human immunodeficiency virus: evaluation of accelerated schedules

Conditions: HIV Infections

Summary: to evaluate the safety and immune response to vaccinia-derived hiv-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation. although recent advances have been made in antiviral therapy against aids, there is currently no cure for aids. it is likely that ultimate control of the disease depends on the development of safe and effective vaccines against hiv.

although recent advances have been made in antiviral therapy against aids, there is currently no cure for aids. it is likely that ultimate control of the disease depends on the development of safe and effective vaccines against hiv. thirty healthy adult volunteers without identifiable high-risk behavior for hiv-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. subjects are followed for 1 year after the last injection. per 05/13/94 amendment, 10 subjects at the st. louis university site receive an additional boost 18-24 months after the last injection.

Eligibility criteria:
inclusion criteria patients must be: * normal, healthy, hiv-negative adults who fully comprehend the purpose and details of the study. * available for 1 year of follow-up. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * they or their sexual partners have identifiable high-risk behavior for hiv infection. * positive syphilis serology (e.g., vdrl). * positive for circulating hepatitis b antigen. patients with the following prior conditions are excluded: * history of positive ppd (tuberculin test). * history of immunodeficiency or chronic illness. * evidence of depression or under treatment for psychiatric problems during the past year. prior medication: excluded: * immunosuppressive medications. prior treatment: excluded: * blood transfusions or cryoprecipitates within the past 6 months. risk behavior: excluded: * high-risk behavior for hiv infection. * history of intravenous drug use. * more than one sexual partner in the last 6 months. * syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Keywords: vaccines, synthetic vaccinia virus viral vaccines hiv-1 drug evaluation hiv envelope protein gp160 drug administration schedule aids vaccines hiv seronegativity hiv preventive vaccine
comparison of vibration and dry needle in trigger point therapy

Conditions: Myofascial Pain Syndrome; Trigger Point Pain, Myofascial

Summary: the aim of this study is to compare the effects of localized vibration and dry needling applied to the trigger point in the individuals with acute myofascial pain syndrome.pressure pain threshold (ppt) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (sf-36) were used for secondary outcome measures.

the patients were divided into two groups as dry needling and localized vibration using the permuted block randomization method. the study was completed with 20 (17 women, 3 men) in the dry needling group and 20 in localized vibration (15 women, 5 men). in both applications, a total of 3 sessions were made to the patients at 1-day intervals.patients' age, gender, duration of pain, localization, presence of additional disease, drug use were questioned and recorded. pressure pain threshold (ppt) was used for the primary outcome measure of the study, and pain intensity, pain tolerance and short form (sf-36) were used for secondary outcome measures. all evaluation criteria except sf-36 were made before, immediately after and 1 day after each session, 1 week after the last session. sf-36 was evaluated before the 1st session treatment, after the 3rd session treatment and 1 week after the 3rd session treatment.

Eligibility criteria:
inclusion criteria: * at least one active myofascial trigger point in the upper trapezius muscle * symptoms lasting 1 day to 2 weeks * cases who did not receive any physical therapy or medication to relieve pain exclusion criteria: * sensory defect in the area to be treated with vibration * active inflammatory, rheumatological or infectious disease * peripheral nerve lesions such as polyneuropathy, radiculopathy * having a cardiac disorder (rhythm / conduction disorder, cardiac pacemaker, ischemic heart disease) * diagnosis of fibromyalgia or other common musculoskeletal pain syndromes with an intact skin surface in the area to be vibrated * patients with a history of panic attacks

Keywords: myofascial pain syndrome trigger point dry needling vibration
focussed echocardiography to detect preoperative hypovolemia and left ventricular dysfunction as a predictor of post-induction hypotension

Conditions: Hypotension

Summary: this is an observational study to evaluate the role of a bed side focus assessed transthoracic echocardiography (fate) in identifying the patients at a potential risk of developing hypotension secondary to general anesthesia induction using the fate parameters like velocity time integral ( vti ), inferior venacava diameter , caval index and left ventricular end end diastolic area.

various haemodynamic parameters like central venous pressure , pulmonary capillary wedge pressure , systolic pulse pressure variations , stroke volume variation , pleth variability index etc are being used as markers of volume status and which in turn have been used as indicators of post general anesthesia induction hypotension in the past . in the current study the investigators aim to validate the role of a bed side 2-d transthoracic echocardiography (tte) as a guide to identify the volume status of the patient before induction and clinically observe for the haemodynamic changes in the form of mean arterial pressure variations in the immediate post induction period. the investigators aim to perform preoperative bed side transthoracic echocardiography in 150 american society of anesthesiologists grade-i/ii patients posted for routine general anaesthesia procedures and assess their volume status . then the investigators would collect 10 mean arterial pressure recordings at one minute interval in the immediate postinduction period and assess the accuracy of tte in identifying potential patients at risk of developing post induction hypotension.

Eligibility criteria:
inclusion criteria: * any asa - i/ii patient posted for a routine general anaesthesia procedure and who do not fit with the exclusion criteria. exclusion criteria: * a) extremes of age \ 60 years b) bmi\ 40 c) patients with pre-existing hemodynamic instability, ventricular dysfunction and sepsis. d) patients on beta blocking agents. e) preinduction mean arterial pressure of \<70 mm hg.

Keywords: post general anaesthesia induced
motor learning and multi-session tdcs in parkinson's disease

Conditions: Parkinson Disease

Summary: the present study seeks to examine the efficacy of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with parkinson's disease on sequential motor learning performance.

parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. beyond the visibly recognisable motor symptoms of parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. in healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions. the present study seeks to examine the effect of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with parkinson's disease on sequential motor learning performance. participants will be required to attend eight laboratory sessions, comprising five intervention and three assessment sessions and will be tested on their ability to learn a 16-digit finger tapping sequence with their right hand. sessions one to five will form the intervention and will be performed at the same time on consecutive days (i.e. mon-fri). in addition, session one will double as a baseline assessment and intervention session. assessments sessions will be performed once before the intervention (session one), and three times following the intervention on day three, one week, and four weeks post intervention.

Eligibility criteria:
inclusion criteria: * right-handed (edinburgh handedness inventory; ≥50) * cognitively capable (montreal cognitive assessment (moca); ≥23) * mild to moderate parkinson's disease severity (hoehn and yar disease stage 2-3) * on stable dopaminergic medication exclusion criteria: * history of stroke * comorbidity * cephalic implants

Keywords: parkinson's disease transcranial direct current stimulation motor sequence learning
feasibility of constraint-induced therapy combined with visual-spatial cueing strategy in patients with acute stroke

Conditions: Acute Stroke

Summary: the aim of this study is to test the feasibility of a constraint intervention combined with visual-spatial cueing strategy in patients with acute stroke to improve their daily life activities.

as part of treatment in acute stroke (from d0 to d14), the investigators were able to observe that despite motor recovery during physiotherapy sessions, it remained difficult for some patients to use their affected arm (aa) during activities of daily life (adl). this mechanism of "learned non-use" would be due to a cognitive process decreasing the use of the aa and could partly explain that 75% of patients maintain an upper limb deficit at 3-6 month post-stroke. in order to combat this phenomenon, a bottom up method (sensorimotor action on the deficit) of constraint-induced movement therapy (cimt) has been developed and consists in immobilizing the unaffected arm to force the use of the aa. this technique has proved its effectiveness in the chronic phase and has also recently been proven to improve motor performance in the acute phase. transposing progress on adl, however, remains difficult because cimt does not contain adequate behavioral strategies. to help the patient mobilize these strategies, coupling of cimt with a top-down method (conscious action on motor skills) has been successfully tested as an intervention of an occupational therapist with the patient at least 1h / day. this intervention remains not compatible with the investigators care organization because the caregiver can not spend that amount of time with each patient. investigators therefore propose to associate cimt with another top down technique: visual-spatial cueing (use of panels and/or visual messages to encourage the conscious use of the aa) and investigators want to evaluate the effectiveness of this treatment on learning transfer to adl. the objective of our study will be to test the feasibility of setting up such an intervention.

Eligibility criteria:
inclusion criteria: * hospitalized patient in neurovascular unit for stroke * time since stroke between 2 and 4 days * movement capacity of the upper arm (against gravity) : * ability to extend actively the metacarpophalangeal and interphalangeal joints at least 10°, and the wrist 20° * ability to bend actively the elbow at least 45° * ability to bend and abduct actively the shoulder at least ≥ 45° * age ≥ 18 years old * patient agreement to join the study * patient covered by french social security exclusion criteria: * excessive spasticity : score \> 2 on the modified ashworth scale * excessive pain in the affected arm : score ≥ 4 on the visual analogue scale * joint limitation on the affected arm * patient under guardianship or curatorship * pregnant or breastfeeding woman
the safety and immunogenicity research of live attenuated varicella vaccine after the 2 doses vaccination

Conditions: Varicella

Summary: through evaluating the immunogenicity and safety for varicella vaccine two doses immune procedure we could supply scientific and practical evidence for this two doses immune procedure promotion and management.

healthy participants aged 1 to 12 years old who had never received varicella vaccine are divided into three age groups, 1 to 3 years old group, 4 to 6 years old group and 7-12 years old group. in each age group, participants are randomly divided into experiment group and control groups.

Eligibility criteria:
inclusion criteria: -participants from shanxi province are between 1-12 years old are in good healthy determined through medical inquiry, physical examination, clinical judgment of the investor. exclusion criteria: 1. having a fever (axillary temperature\>37.0℃) before enrollment; 2. having a disease history of seizures, brain disease and the vaccination history of allergies and convulsions; 3. antibiotics allergy; 4. having a problem of intramuscular injection because thrombocytopenia or other blood coagulation disorder; 5. having immunodeficiency or under immunosuppression therapy, radiation therapy; 6. having respiratory diseases, acute infection, chronic disease and hiv infection; 7. having systemic skin rash, skin tinea, herpes; 8. chronic liver and kidney disease; 9. heart disease, and severe hypertension; 10. have received whole blood, plasma or immunoglobulin therapy 3 months before enrollment; 11. have received other live attenuated vaccine vaccination in 30 days before enrollment; 12. had been infected with varicella virus and displayed symptom; 13. have received one or two dose of varicella vaccine before enrollment; 14. congenital malformations, growth disorders such as down's syndrome, diabetes, sickle cell anemia and nervous disorders 15. guillain-barre syndrome 16. thyroid resection history or thyroid disease treatment in the past 12 months; 17. asthma 18. have participated in other clinical research; 19. have serious adverse reactions after vaccination, such as allergies, hives, breathing difficulties, angioneurotic edema.
randomized, placebo-controlled study: effects of lavender aromatherapy on preoperative anxiety in breast patients

Conditions: Anxiety; Generalized; Breast Diseases; Surgery

Summary: the study is designed to see if lavender aroma therapy reduces pre-operative anxiety in breast surgery patients.

many patients undergoing surgery experience anxiety in the preoperative setting. pharmacologic anxiolytics require monitoring and cause excess sedation which often interferes with the ability to assess and obtain consent from a patient in the preoperative holding area. lavender aromatherapy is an alternative treatment for anxiety which is safe, inexpensive, easy to administer, and not overly sedating. in addition to its benefits in the preoperative setting, anxiolysis and reduction in sympathetic drive can lead to reduction in the intraoperative anesthetic and postoperative analgesic requirements. this in turn can lead to faster recovery and expedited discharge from the post anesthesia care unit. in the proposed study, we would evaluate the efficacy of aromatherapy with lavender oil in reducing anxiety prior to breast surgery. the study group would receive lavender oil preoperatively and the placebo group would receive unscented oil preoperatively. before and after treatment, anxiety level would be measured using the spielberger state-trait anxiety inventory. additionally, vital signs and bispectral index (bis) will be measured before and after treatment, as further indicators of anxiety level. we hypothesize that lavender aromatherapy will decrease anxiety and subsequently will reduce blood pressure, heart rate, and bis.

Eligibility criteria:
inclusion criteria: female; age 18+; american society of anesthesiologists (asa) i-iii; undergoing elective breast surgery exclusion criteria: male; history of asthma/bronchitis/chronic obstructive pulmonary disease (copd)/contact dermatitis to cosmetic fragrances/pregnancy; significant laboratory abnormalities.

Keywords: re-operative anxiety breast surgery lavender oil aromatherapy