Kornimate/medical-research-clean huggingface dataset:
investigating the pharmacokinetics of an inhaled dose of a new corticosteroid in patients with impaired liver function

Conditions: Asthma

Summary: the proposed study is designed to investigate the pharmacokinetics, pharmacodynamics (as measured by serum cortisol) and safety of gw685698x in subjects with moderate hepatic impairment and in healthy subjects following a single oral inhaled dose of gw685698x. from the study results it should be possible to assess if there is an altered risk: benefit in patients with moderate hepatic impairment


Eligibility criteria:
inclusion: * are aged between 18-70 years, inclusive. * if female, you must be incapable of becoming pregnant. * show fev1 of more than 70% of the predicted normal at screening. * are able to correctly use a diskus at the screening visit. * have body mass index within the range of 19-33 kg/m2 inclusive. * do not show a positive pre-study urine drug screen. * do not show a positive pre-study blood alcohol test. * demonstrate a clinically normal 12-lead ecg at screening. * do not show a positive blood test for hiv. if you are a healthy volunteer you must also: * have no significant abnormality on clinical examination. * have liver function tests within the reference range at screening. if you are a patient volunteer you must: * have moderate hepatic impairment * have no significant abnormality on clinical examination apart from hepatic impairment. exclusion: * suffered an upper respiratory infection in the 4 weeks before the screening visit. * suffered a lower respiratory infection in the 6 weeks before the screening visit. * taken oral corticosteroids in the 8 weeks before the screening visit. * taken inhaled, intranasal or topical steroids in the 4 weeks before the screening visit. * a prolonged heartbeat (qtc interval \>470msec). * high blood pressure (systolic \>160mmhg or diastolic \>90mmhg) or as defined by the investigator. * known sensitivity to corticosteroids. * a history of lactose intolerance. * a history of severe milk protein allergy. * donated blood in the last 3 months, or more than 1500ml (1000ml if female) in the last 12 months (including the amount taken for this study). * participated in a clinical trial within the last 3 months where you are/were exposed to a drug or device.

Keywords: hepatic impairment pharmacokinetics
clinical observation of ciprofol for anesthesia induction

Conditions: Anesthesia; Pain; Hemodynamic Instability

Summary: to evaluate the effect of ciprofol anesthesia induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.

90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 \~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. systolic blood pressure (sbp), diastolic blood pressure (dbp), heart rate (hr) and bis values at various time points during anesthesia induction were collected. at the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. the primary outcomes were the fluctuations in hemodynamic parameters during induction. the secondary outcome were adverse reactions, bis values and changes of hepatic and renal functions during induction.

Eligibility criteria:
inclusion criteria: 1. asa physical status ⅰ-ⅲ 2. age over 65 years; 3. body mass index (bmi) 20 \~ 30 kg/m2 ; 4. elective noncardiac surgery; exclusion criteria: 1. the patient or his/her family refused to participate in the clinical trial; 2. severe heart, lung, liver or kidney dysfunction; 3. expected difficult airway, requiring awake tracheal intubation; 4. those who are allergic to the drugs used in this study; 5. unsuccessful tracheal intubation twice; 6. patients with mental illness or impaired consciousness;

Keywords: anesthesia induction ciprofol propofol injection pain
a telerehabilitation program for sci

Conditions: Incomplete Spinal Cord Injury

Summary: this study evaluates a remotely supervised, home-based therapeutic program to improve upper-limb voluntary movement in adults with tetraplegia caused by incomplete spinal cord injury (isci).

spinal cord injury (sci) has been associated with serious reduction in functional independence. despite compelling evidence that treatment intensity has a profound effect on motor recovery only a small fraction of sci population are able to receive intensive in-clinic treatment. difficulty traveling to the clinic, poor adherence to assignments and high cost are limiting factors. currently, telerehabilitation programs are emerging as an alternative effective method of delivery for rehabilitation services. the literature and our preliminary findings support the model that augmentation of activity in spared corticospinal tract (cst) axons is a critical mechanism of motor improvement, and furthermore that cst activity can be increased by repetitive motor training and by electrical stimulation of the primary motor cortex (m1). however, there is still lack of knowledge on safety, feasibility and efficacy of remotely- supervised home-based therapy programs that incorporates non-invasive brain stimulation and high intensity repetitive arm exercises. to address these questions, 36 adults (above 18 years) with cervical sci will be randomly assigned to two groups in a 2:1 ratio (active stimulation group, n=24 vs control group, n=12) and receive daily treatment, 10 sessions, over 2-weeks. the anodal tdcs will be applied over primary motor cortex (m1) at an intensity of 2ma for 20 minutes and proceed with 60 minutes of repetitive arm and hand training. primary outcome measure is change in graded and redefined assessment of strength, sensibility, and prehension (grassp) from baseline to immediately after treatment and 4-weeks follow-up. the session will be supervised in real-time via videoconferencing.

Eligibility criteria:
inclusion criteria: 1. diagnosis of a chronic incomplete cervical lesion as defined by the american spinal injury association impairment scale classification and at least for 6 months post-injury; 2. upper-extremity weakness associated with tetraplegia with minimal residual thumb and index; finger movement sufficient to grip small objects such as marble; 3. no brain injury; 4. no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study; 5. no contradiction to tdcs; 6. access to internet at home. exclusion criteria: 1. prior history of seizure; 2. chronic use of neuroactive medication (e.g., neurostimulants, anticonvulsants, or antidepressants); 3. any joint contracture or severe spasticity in the affected upper extremity, as measured by a modified ashworth score ≥ than 3 out of 4.

Keywords: cervical spinal cord injury upper limb tdcs telerehabilitation
conservative treatment for hip osteoarthritis

Conditions: Osteoarthritis, Hip

Summary: the purpose of the study is to evaluate the effect of manual treatment and a patient education programme for patients without indication for hip surgery.

hip osteoarthritis (hip oa) is the second most common arthritis of the larger joints and may result in pain and disability and lead to reduced quality of life (qol). the prevalence of hip oa, in the adult population, \> 35 years, is estimated to 4-11% in the western society. in specific countries hip oa affects up to 25% in adults \> 60 years. with a growing elder population, these prevalence rates will increase and the demand for cost-effective and safe interventions will increase as well. international guidelines, 2008, on the management of hip and knee oa recommend a combination of non-pharmacological and pharmacological treatment. for years the majority of interventional research for hip and knee oa has focused on surgery and drugs. surgery is an option, when pain and disability have reached severe levels, and an increasing group of patients are today looking for other treatment options than drug treatment (pharmacological). in the last 4-6 years, new randomized controlled trials (rct) have shown promising results with non-pharmacological treatment, such as exercise, patient education, manual therapy and acupuncture. the purpose of this rct is to investigate the effect of combining manual treatment and a patient education programme and compare it to a minimal intervention in form of a home stretching programme. it will further investigate the specific effect of manual treatment.

Eligibility criteria:
inclusion criteria: * patients referred from general practitioner, chiropractor or orthopaedic surgeon * unilateral hip pain of minimum 3 months' duration * radiology criteria for hip oa: joint space width (jsw) \ 10% * adequate mastering of the danish language to complete instructions and questionnaires exclusion criteria: * inflammatory joint disease * previous hip or knee alloplastic * secondary arthritis due to hip fracture or infection * bilateral hip pain * hip dysplasia with a ce angle \> 25 degrees and an aa angle \> 10 degrees * low back pain which dominates over the hip pain * malignant disease * patients with paresis or paralysis after neuromuscular, cerebrovascular or polyneuropathic disease * hip pain resulting from labral tear, bursitis and/or snapping hip syndrome * polyarthritis * received manual treatment for the hip within the last year

Keywords: osteoarthritis manual therapy manipulation hip school chiropractic patient education
micromegaly and discrepancy between growth hormone and igf1 at the diagnosis and follow-up of acromegalic patients

Conditions: Acromegaly

Summary: the diagnosis and the follow-up of acromegalic patients are based on the mesurement of growth hormone (gh) and igf1 rates. however, the literature described some cases of patient for whom the investigators observed a discrepancy between gh and igf1 rates. since the acromegaly is a rare disease and this phenomenon concerns about 30% of these patients, there is a lack of investigations about consequences that this discordance may induces. in this study, the investigators aimed at assessing if patients with discordance between gh and igf1 rates present a different risk of recurrence and complications related to acromegaly, from patients with concordant results.


Eligibility criteria:
inclusion criteria: * acromegaly followed up in one of the center (montpellier, nimes or béziers hospital, independent endocrinologist) between 2010 and 2021 * age over 18 years old * measurement of gh and igf1 rates at the last visit control available exclusion criteria: * lost to follow-up * status about complications related to acromegaly unknown

Keywords: endocrinology acromegaly discrepancy complications
impact of videos on patient anxiety and satisfaction

Conditions: Mohs Surgery

Summary: the purpose of this research is to look at how educational videos might affect patient satisfaction and anxiety before mohs surgery day. patients will be randomized to either: 1) a group that receives educational videos before the visit in addition to standard-of-care written and verbal instructions or 2) a group that receives only standard-of-care written and verbal instructions.

the primary objective of this study is to determine if pre-operative videos describing the patient's forthcoming day in the mohs clinic decrease pre-operative patient anxiety and increase postoperative patient satisfaction, when added to standard of care written and verbal instruction. design/study type this study will be a randomized control trial in which patients will be randomized to either the intervention (pre-operative mohs surgery video viewing) or control (standard of care) group in order to understand the impact of the video on patient anxiety and satisfaction. patients will be randomized using an accelerated biased coin design in the statistical program r.

Eligibility criteria:
inclusion criteria: * patients who are at the university hospitals cleveland medical center mohs clinic to undergo a linear closure on the face. * fluent english speakers exclusion criteria: * non-fluent english speakers

Keywords: anxiety patient satisfaction video education skin cancer linear closure on the face
phase 2 study to evaluate aln-ttrsc (revusiran) in patients with transthyretin (ttr) cardiac amyloidosis

Conditions: TTR-mediated Amyloidosis

Summary: the purpose of this study is to determine the pharmacokinetics, pharmacodynamics and exploratory clinical activity of aln-ttrsc (revusiran) in patients with transthyretin (ttr) cardiac amyloidosis.


Eligibility criteria:
inclusion criteria: * ttr cardiac amyloidosis; * women of child-bearing potential (wocbp) must have a negative pregnancy test, cannot be breast feeding, and must be willing to use 2 highly effective methods of contraception; * male subjects agree to use appropriate contraception; * adequate blood counts, liver, renal and heart function; * adequate karnofsky performance status; * adequate new york heart association (nyha) classification score; * clinically stable on heart medications; * adequate 6-minute walk test; * willing to give written informed consent and are willing to comply with the study requirements. exclusion criteria: * known human immunodeficiency virus (hiv) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection; * subjects with a history of multiple drug allergies or intolerance to sc injection; * received an investigational agent other than tafamidis, diflunisal, doxycycline or tauroursodeoxycholic acid, or an investigational device within 30 days prior to first dose of study; * uncontrolled hypertension, ischemic heart disease or cardiac arrhythmia; * untreated hypo- or hyperthyroidism; * prior major organ transplant; * considered unfit for the study by the principal investigator.

Keywords: rnai therapeutic
use of probiotic bacteria in prevention of allergic disease in children 1999-2008

Conditions: Atopic Dermatitis; Food Hypersensitivity; Allergic Rhinitis, Seasonal; Allergic Conjunctivitis; Asthma

Summary: the aim of the study is to find out if allergic diseases can be prevented buy giving probiotic bacteria to pregnant mothers and their newborn infants


Eligibility criteria:
inclusion criteria: * mother or father fo child with doctor diagnoses allergic disease exclusion criteria: * prematurity, major malformations
the effect of supraglottic airway insertion on the accuracy of cricothyroid membrane identification in females

Conditions: Airway Obstruction

Summary: prospective, observational, study that will examine if a sited supraglottic airway (the igel) will increase the accuracy of identifying the cricothyroid membrane in female patients. consented patients that meet inclusion criteria are assessed by clinicians under general anaesthesia with and without a supraglottic airway in situ. the accuracy of ctm identification by palpation will be evaluated using ultrasound.

palpation of the airway structures results in misidentification of the cricothyroid membrane (ctm) in a high proportion of women. female front of neck anatomy is less distinct compared to males with reduced angulation of the laryngeal cartilages making it harder to distinguish the relevant landmarks. in obese patients, overlying subcutaneous tissue compounds this problem and several studies have demonstrated poor success identifying the ctm by palpation in this population. supraglottic airway device (sad) insertion precedes emergency front of neck access attempts in the stepwise progression from failed intubation to cricothyroidotomy. the nature and clinical implication of sad insertion on cricothyroidotomy remain unstudied. sixty four patients will undergo front of neck airway assessment by volunteer clinicians with and without a sad in situ (control and sad assessments, within-subjects design). the patients are fasting women presenting for routine gynaecological surgery. eight anaesthetists, at different levels of training, will perform eight individual ctm assessments with and without the sad in situ. ultrasound images will be captured in the sagittal plane immediately before and after supraglottic airway insertion. images are then downloaded, anonymised and randomised for blinded digital analysis.

Eligibility criteria:
inclusion criteria: * women attending for routine surgery exclusion criteria: * unable to give informed consent * abnormal neck anatomy * history of gastroesophageal reflux * history of neck surgery or radiotherapy * contraindication to supraglottic airway device insertion
clinical and radiological results of total hip arthroplasty using a ceramic friction pair

Conditions: Hip Replacement; Primary, Secondary or Post-traumatic Osteoarthrosis; Femur Head Necrosis; Congenital Dislocations

Summary: the aim of this study is to assess safety and general performance of total hip arthroplasty, composed of a meije duo® femoral stem associated with a dynacup® cup, and using the friction pair biolox® delta ceramic.


Eligibility criteria:
inclusion criteria: * male or female patient implanted with a primary total hip replacement using a ceramic friction pair including meije duo® stem associated with a dynacup® cup. * aged of more than 18 years at the time of the surgery. * patient with a follow-up of at least 2 years after surgery based on a consecutive and exhaustive series of patients operated within the inclusion period. * able to understand information to participate to the study. exclusion criteria: * patient having a tumoral pathology. * patient having expressed opposition to the study participation.

Keywords: arthroplasty hip replacement ceramic acetabular cup femoral stem
effects of emotional stimuli in patients with disorders of consciousness

Conditions: Disorder of Consciousness

Summary: disentangling the vegetative state from the minimally conscious state is often difficult when relying only on behavioral observation. in this study, the investigators explored a new event-related potential paradigm as an alternative method for the detection of voluntary brain activity and cognitive abilities in the patients with disorders of consciousness.

auditory emotional stimuli have potential beneficial effects on cognitive functions and consciousness in patients with disorders of consciousness (doc); however, precise and accurate quantitative indices to estimate cerebral activation to different auditory stimuli remain scarce. in this study, investigators assessed the response of different brain regions to emotional stimuli using erp(event-related potential),and further investigated the brain activation network.

Eligibility criteria:
patients: inclusion criteria: 1. disorders of consciousness (traumatic brain injury, stroke or anoxic encephalopathy) 2. coma diagnosis (plum and posner, 1966), vegetative state (task force, 1994) or minimally conscious state (giacino, ashwal et al. 2002) 3. lack of autonomic crisis since one week minimum 4. medical condition considered stable 5. patients who do not present hearing loss. peaks i and ii of brainstem auditory evoked potentials (baep) will be normal. exclusion criteria: 1. hearing problem 2. uncontrolled epilepsy 3. autonomic crises 4. medical unstable state 5. pregnant or likely to be (interrogation data) or breastfeeding woman healthy controls: inclusion criteria: 1. subjects with normal hearing 2. absence of neurological disorder 3. subjects able to understand the experimental instructions exclusion criteria: 1. hearing problems and / or hearing loss higher than 30 decibels hearing level (db hl) at a frequency band from 250 to 8000 hz 2. neurological disorders 3. pregnant or likely to be (interrogation data) or breastfeeding woman

Keywords: erp;doc;auditory
hrs9531 controls weight regain in obese subjects

Conditions: Obesity

Summary: this is a single-center, double-blinded, randomized, placebo-controlled phase ii study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of hrs9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients


Eligibility criteria:
inclusion criteria: 1. 30-60 years old, female and male. 2. bmi:30-40kg/m2. 3. non diabetes or type 2 diabetes with hba1c between 7-10%. exclusion criteria: 1. weight change ≤5 kg within 3 months. 2. hb\<110g/l. 3. serum triglycerides 5.7 mmol/l. 4. impaired liver function ：alt or ast≥3×uln，tb≥2×uln. 5. impaired renal function：egft \< 45 ml/min. 6. hemodiastase or serum lipase≥3×uln. 7. tsh\>6.0 miu/l or\<0.4 miu/l. 8. systolic blood pressure ≥160 mmhg or diastolic blood pressure ≥100 mmhg. 9. lth questionnaire-9 (phq-9) score ≥15. 10. type 1 diabetes. 11. proliferative diabetic retinopathy, ketoacidosis or hyperglycemia hypertonic state within 3 months. 12. in the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
effect of a lateral nerve of the thigh block on postoperative pain after total hip replacement surgery

Conditions: Pain, Postoperative; Anesthesia, Conduction; Arthroplasty, Replacement, Hip

Summary: the purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (ncfl) blockade on postoperative pain after total hip replacement surgery. the ncfl-block is a pure sensory block. we hypothesized that the ncfl-block would reduced the postoperative pain without delaying mobilization.


Eligibility criteria:
inclusion criteria: * primary total hip replacement exclusion criteria: * general anaesthesia * allergy to local anesthetics of the amide type * revision surgery * bilateral surgery * chronic pain patient * women in the fertile age

Keywords: postoperative pain regional anaesthesia total hip replacement nervus cutaneous femoral lateralis