Kornimate/medical-research-clean huggingface dataset:
combined focused ultrasound and calcium hydroxylapatitie filler for skin laxity and volume restoration

Conditions: Skin Laxity

Summary: non-invasive treatment options such as focused ultrasound has been used with success for the treatment of skin laxity in various parts of the body including the face, neck, décolletage, arms, buttocks, thighs, and legs. with the increasing demand for greater results, researchers have started combining modalities together such as focused ultrasound and intradermal filler, with promising effects for skin laxity and volume restoration. this study aims to elucidate the efficacy and added benefits of a combination therapy using focused ultrasound (ulthera) and calcium hydroxylapatite (radiesse) for the treatment of skin laxity and volume restoration of the lower thighs, specifically the lower anterior third of the thigh.


Eligibility criteria:
inclusion criteria: 1. exhibit skin aging and laxity that will benefit from treatment as determined by the investigator/physician. 2. subjects between the ages of 18-85 years old, at the time of consent. 3. subjects may be male or female. 4. subjects can be of any fitzpatrick skin type (i-vi). 5. subjects must be able and willing to give written informed consent and to comply with the requirements of this protocol. the consent form has been standardized in english. for those patients who do not read and understand english, a consent form will be standardized and provided in a language that they read and understand. exclusion criteria: 1. children and adolescents (less than 18 years old). 2. subjects who are not willing or able to provide written consent. 3. individuals with any significant medical history including skin disorders and eating disorders as determined by the investigator/physician. 4. subjects on any substances affecting blood coagulation (including but not limited to aspirin and other non-steroid anti-inflammatory drugs, warfarin, vitamin e, fish oil, heparin, low-molecular weight heparin, novel anti-coagulants). 5. subjects with known blood coagulopathies. 6. subjects with a compromise of local blood supply (including but not limited to recent surgery, severe scarring, autoimmune diseases involving the lower thigh such as lupus, morphea, sarcoid or mixed connective tissue disease). 7. subjects who have received any treatment for skin laxity or liposuction in the last 12 weeks. 8. subjects who have experienced an increase or decrease in body weight of more than 10% in the past 24 weeks. 9. subjects who have a known hypersensitivity reaction to calcium hydroxylapatite or the components of the filler product. 10. subjects with open wounds in the area of ultrasound treatment. 11. subjects with pacemakers and/or electronic device implants in the area of ultrasound treatment. 12. female patients who are planning a pregnancy, currently pregnant or nursing.
cs-03 pressure-volume loop sub-study with rv lead positioning

Conditions: Hypertension

Summary: the position of the rv lead may have an important role in the effectiveness of the programmable hypertension control (phc) therapy by the moderato pacemaker eliciting a lag from which rv signals (qrs) are identified. the study attempts to measure rv pressure and rv volume with phc in two rv lead locations.

subjects found eligible for participation in the cs-03 study, who are indicated for a de novo pulse generator implant at the center participating in this sub-study and who are not 100% dependent on rv pacing are eligible for participation in this sub-study. patients receiving a pacemaker pulse generator exchange or who are 100% pacemaker dependent may not participate. eligible patients will be provided with an informed consent specific to this sub-study and if patients choose to participate, patients will be asked to sign the informed consent and will then undergo the procedures described below. patients will be prepared and draped for the moderato implant procedure as detailed in the main cs-03 study protocol. subjects will be instrumented prior to the moderato pacemaker implant procedure. the position of the rv lead will be tested at two sites known to elicit shortest qrs duration (the rv apical septum and the his region). a series of three test periods with the moderato system programmed to deliver predetermined phc settings will follow. following the completion of these measurements, the conductance catheter will be withdrawn and the moderato system implant will resume as described in the cs-03 protocol.

Eligibility criteria:
inclusion criteria: * subject was included in the cs-03 study * subject indicated for a de novo pulse generator implant exclusion criteria: * subject was excluded from the cs-03 study * subject is not 100% dependent on rv pacing * subject receiving a pacemaker pulse generator exchange * subject is unwilling or cannot provide informed consent for this sub study
postoperative patient-controlled perineural analgesia after orthopedic surgery by "remote control" versus "bedside care"

Conditions: Injury of Foot, Shoulder or Knee; Perineural Analgesia; Pain, Postoperative

Summary: perineural injection of local anesthesic is currently the reference method for the treatment of post operative pain in a patient undergoing major orthopedic surgery. postoperative pain is a dynamic phenomena in every patient. it is classified as intense during the first postoperative hours after surgery, and decreases in a non-linear manner over the days following the procedure. pca (patient control analgesia) infusion of local anesthesic allows an adaptation of the local analgesia doses to the evaluated pain scores, as well as permit a decrease in adverse events related to the continuous infusion technique (motor or sensory blockade, paresthesia, etc.). the physician can also modify the pump settings according to the postoperative rehabilitation plan.the use of new communication techniques such as "telemedecine" may be of interest in reducing treatment onset time and optimizing pain management. the remote control consists to change the settings of the pump after if the anesthesiologist was informed in real time (via a smartphone or a tablet) on patient pain level, sensory and motor blockades. the physician goes to a dedicated website (micrel caretm). and makes the necessary changes by remote control via a gprs (general packet radio service) connexion. the aim of this prospective, comparative, multicentric trial is to compare the effectiveness of patient management through two communication modalities: remote control versus bedside care.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective orthopedic surgery * patients older than 18 years old * patient with a surgical indication (foot, shoulder or knee) which can require placement of a perineural catheter * patients classified asa class i to iii * informed consent exclusion criteria: * contraindication to regional anesthesia or local anesthetics * contraindication to paracetamol, ketoprofen or morphine (depending on the selected rescue analgesia) * hospital discharge less than 48 hours after surgery * psychomotor disease (teletransmission contraindication) * patient undergoing surgery with a duration greater than 4 hours * patient with a duration of perineural catheter less than 48 hours * protected patient * patient enrolled in another study * patient who can't understand local language

Keywords: patient-controlled perineural analgesia postoperative orthopedic surgery "remote control" versus "at bedside care" comparative medico-economic evaluation
efficacy & safety of orally administered valsartan/amlodipine combo therapy vs amlodipine monotherapy in patients with stage ii hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the blood pressure lowering effects of a valsartan/amlodipine combination treatment and amlodipine monotherapy for the treatment of stage ii hypertensive patients (mssbp ≥ 160 mmhg).


Eligibility criteria:
inclusion criteria: * 18 years of age or older. * moderate to severe high blood pressure. this is defined as a systolic pressure (the top number) greater than or equal to 160 mmhg and less than 200 mmhg. exclusion criteria: * history of allergy or hypersensitivity to arbs, ccbs, thiazide diuretics * inability to stop all prior blood pressure medications safely * systolic bp ≥ 200 mmhg and/or diastolic bp ≥ 120 mmhg * controlled blood pressure (systolic bp \< 140 mmhg) taking more than 3 antihypertensive medications at screening * systolic bp ≥ 140 mmhg and \< 180 mmhg taking more than two antihypertensive medications at screening * systolic bp ≥ 180 mmhg taking more than one antihypertensive medication at screening * history of stroke, angioplasty, coronary artery bypass graft surgery, heart attack or unstable angina * type 1 diabetes * poorly controlled type 2 diabetes * history of heart failure * arrhythmia * significant valvular heart disease * active gout * history of autoimmune diseases * history of multiple drug allergies * liver disease * pancreatic injury within 1 year of screening * evidence of kidney impairment or history of dialysis * any surgical or medical condition which might alter the absorption, distribution, metabolism, or excretion of any drug. this could include currently active gastritis, ulcers, or gastrointestinal/rectal bleeding, or urinary tract obstruction. * women of child-bearing potential (wocbp), defined as all women physiologically capable of becoming pregnant, would be excluded unless they are post-menopausal, surgically sterile or are using acceptable methods of contraception. the use of hormonal contraceptives is not allowed * pregnant or nursing (lactating) women * history of malignancy of any organ system within the past five years * any severe, life-threatening disease within the past five years * history of drug or alcohol abuse within the last 2 years. other protocol-defined inclusion/exclusion criteria may apply

Keywords: blood pressure venous pressure systolic pressure diastolic pressure pulse pressure
a comparative study to assess the prevention of surgical site infection (ssi's) in revision total joint arthroplasty patients treated with single-use negative pressure wound therapy (pico™) or standard care dressings (aquacel® ag surgical dressing)

Conditions: Surgical Wound Infection

Summary: the aim of this study is to assess the prevention of incision healing complications in patients undergoing revision tka and tha treated with either single-use npwt (pico) compared to standard of care dressings (aquacel ag surgical dressing). all patients undergoing a revision tka and tha who consent to taking part in the study, and meet the eligibility criteria will be included onto the study. patients will be followed up for a period of up to 3 months to determine if there are any latent incision healing complications


Eligibility criteria:
inclusion criteria: 1. patient ≥18 years old 2. male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females 3. subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty 4. subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the investigator, sub-investigator or other designated study staff member has explained the study procedures, risks, and contact information 5. subjects deemed able to understand and comply with study visit schedule and procedures exclusion criteria: 1. wounds that require daily inspection 2. active bleeding within the surgical site 3. pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception 4. subjects on warfarin therapy. resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic inr levels 5. skin integrity issues that preclude the use of negative pressure wound therapy (npwt) 6. subjects undergoing primary total joint procedures 7. subjects with a known history of poor compliance with medical treatment 8. subjects who have participated in this trial previously and who were withdrawn 9 . subjects with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
organ-preserving management in patients with complete or near-complete tumour response after preoperative radio(chemo)therapy for rectal cancer

Conditions: Rectal Neoplasms; Rectal Cancer

Summary: watch-and-wait strategy in rectal cancer is gaining momentum. there is a large variability in reporting the proportion of patients achieving clinical complete response (ccr) after routinely delivered preoperative radio(chemo)therapy, likely because of patients' selection. this proportion in population-based level is poorly defined. in addition, predictive factors for ccr are also poorly defined. it is known that ccr response is observed often in small tumours. however, ccr proportion in large cancers has not been sufficiently evaluated. for example, even though pathological complete response (pcr) does occur in large fixed cancer, it is unknown whether ccr does also occur because persistent fibrous stroma may mimic residual cancer in all of such cases. this is a prospective observational population-based cohort study on low rectal cancer to answer the question of how often clinical or near-clinical tumour response occur after routinely delivered preoperative radiotherapy in relation to the pre-treatment tumour characteristics. the additional question was how often pcr occur in relation to the pre-treatment tumour characteristics in the patients managed by total mesorectal excision because of persistent tumour after radiotherapy. the additional aim was the implementation of watch-and-wait strategy or full-thickness local excision (as an option instead of total mesorectal excision in the patients with sustained near-ccr) within a frame of a prospective study. in the patients managed by organ preservation, the secondary outcome measures were: i) local regrowth rate, ii) effectiveness of salvage surgery, iii) disease-free survival at 3 years and overall survival at 5 years, iv) anorectal function.


Eligibility criteria:
inclusion criteria: * primary rectal cancer * low tumour (accessible by digital rectal examination) * routine preoperative radio(chemo)therapy according to the institutional policy; short-course radiation and immediate surgery is not allowed. * informed consent for watch-and-wait strategy or local excision in patients with ccr and near-ccr exclusion criteria: * recurrent cancer * cancers situated in the upper rectum * distant metastases

Keywords: rectal cancer preoperative radiotherapy organ preservation watch-and-wait
a study of ly3154207 in healthy participants and participants with parkinson's disease

Conditions: Parkinson's Disease

Summary: this two-part study will evaluate how safe ly3154207 is and the effects it has on the body. part a will include healthy participants. each participant will receive daily doses of ly3154207 or placebo for 14 days. part a will last approximately 4 weeks including a 17 day stay in the clinical research unit (cru) and follow-up. part b is contingent on the results of part a. part b will include participants with parkinson's disease. each participant will receive daily doses of ly3154207 or placebo for 14 days. part b will last approximately 4 weeks including a 17 day stay in the cru and follow-up. both part a and part b will require screening within 30 days prior to the start of the study.


Eligibility criteria:
inclusion criteria: part a: * overtly healthy males or females, as determined by medical history and physical examination * female participants not of child-bearing potential part b: * have a clinical diagnosis of idiopathic parkinson's disease for at least 1 year and on stable medication for at least 4 weeks part a and b * are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures * have given written informed consent * have a body mass index (bmi) of 18.0 to 29.9 kilograms per square meter (kg/m²) exclusion criteria: * have participated, in the last 30 days, in a clinical trial involving an investigational product * have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; or constituting a risk when taking the study medication; or interfering with the interpretation of study data
the reliability and validity of perioperative cognitive test network platform for monitoring neurocognitive changes

Conditions: Perioperative Neurocognitive Disorders

Summary: this study aimed to analyze the reliability and validity of the results of the new designed perioperative cognitive test network platform, and to judge the reliability and scientific nature of the perioperative cognitive test. and then to explore whether the perioperative cognitive test network platform can be used to evaluate the changes of perioperative cognitive function of patients.

two cohorts of elderly healthy volunteers and elderly patients undergoing abdominal surgery will be included in this study. the cognitive function of the patients was tested one day before and seven days after operation. healthy volunteers had two cognitive function tests at the same interval. the normality test is used to evaluate whether the test results accord with the normal distribution. the internal consistency of the test was evaluated by calculating the cronbach coefficient, the content validity was evaluated by experts and the content validity index was calculated, and the construct validity of the test was evaluated by exploratory factor analysis and confirmatory factor analysis. the validity of the test was evaluated by calculating the effect scale.

Eligibility criteria:
inclusion criteria: * age over 65 * scheduled for abdominal surgery under general anesthesia (grade 3-4 surgery based on surgical grade) * informed consent has been obtained * healthy volunteer groups are listed as age-and sex-matched community groups exclusion criteria: * unable to follow instruction and finish the firtst procedure * has severe visual or auditory problems * history of drug or alcohol abuse (drinking more than 5u daily in the past 3 months, 1u equals 10ml or 8g pure alcohol, equivalent to \>50 liquor over 100ml, two two * are diagnosed neuropsychological disease that needs treatment * clear history of severe cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), parkinson's syndrome, schizophrenia, bipolar disorder, depression, dementia, alzheimer's disease, etc * severe head trauma, carbon monoxide poisoning and other loss of consciousness more than 30 minutes * mmse score ≤23 * participated this study or being participating other clinical research
long-term study of fk949e in elderly bipolar disorder patients

Conditions: Bipolar Disorder; Elderly

Summary: fk949e was administered to elderly bipolar disorder patients with major depressive episode for 52 weeks. its safety, efficacy, and plasma concentration change were evaluated in an open-label manner.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar i or ii disorder as specified in the diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr), with a major depressive episode * able to participate in the study with understanding of and compliance with subject requirements during the study in the investigator's or subinvestigator's opinion * male subjects must agree to take appropriate contraceptive measures with condoms during the study period. * female subjects must be confirmed to have no childbearing potential during the study period exclusion criteria: * concurrent or previous history of dsm-iv-tr axis i disorders, except bipolar disorder, within the last 6 months before informed consent * concurrence of dsm-iv-tr axis ii disorder that was considered to greatly affect patient's current mental status. * the young mania rating scale (ymrs) total score of 13 points or more. * nine or more mood episodes within the last 12 months before informed consent. * lack of response to at least 6-week treatment with at least 2 antidepressants for the current major depressive episode in the investigator's or subinvestigator's opinion * the current major depressive episode persisting for more than 12 months or less than 4 weeks before informed consent. * history of substance dependence (other than caffeine and nicotine) or alcohol abuse or dependence. * treatment with a depot antipsychotic within the last 49 days before primary registration. * unable to suspend antipsychotics or antidepressants after primary registration * treatment with two or more of mood stabilizers (lithium carbonate and/or sodium valproate) and lamotrigine, if these drugs, except one of either drug, cannot be suspended after primary registration. * unable to suspend antiepileptics (except lamotrigine and sodium valproate), antianxiety agents, hypnotics, sedatives, psychostimulants, antiparkinsonian agents, cerebral ameliorators, antidementia agents, or anorectics, except those specified as conditionally-allowed concomitant drugs, from 7 days before primary registration * electroconvulsive therapy within the last 83 days before primary registration. * a possible need of psychotherapy during the study period (unless the therapy has been commenced at least 83 days before primary registration). * the hamilton depression rating scale (ham-d17) suicide score of 3 points or more, history of suicide attempt within the last 6 months before informed consent, or the risk of suicide in the investigator's or subinvestigator's opinion

Keywords: patients major depressive episode fk949e
study to evaluate the efficacy and safety of sph3127 in patients with mild-moderate essential hypertension

Conditions: Essential Hypertension

Summary: the primary aim of the study is to assess the antihypertensive efficacy of sph3127 in patients with mild to moderate essential hypertension.


Eligibility criteria:
inclusion criteria: 1. male or female of age ≥18 years; 2. diagnosed with mild-moderate essential hypertension; 3. participant has understood the study-required procedures, voluntarily signed informed consent. exclusion criteria: 1. diagnosed with secondary hypertension, suspected grade 3 hypertension, acute hypertension, or at risk when current antihypertensive therapy discontinued; 2. suffered by severe heart disease within 6 months; 3. suffered by severe cerebrovascular disease within 6 months; 4. suffered by severe or malignant retinopathy; 5. out of controlled diabetes; 6. history of malignant tumor; 7. history of mental disorder; 8. subject is planning or in use of other antihypertensive drugs or other drugs may affect blood pressure during the trial; 9. alcohol or drug abuse; 10. pregnant, lactating women or subject is planning to pregnant within 6 months after the trial; 11. assessed by the investigators as unsuitable for participating in the study.