Kornimate/medical-research-clean huggingface dataset:
a pilot study of the effects of botulinum toxin in the treatment of provoked vestibulodynia

Conditions: Vestibulodynia

Summary: the main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.


Eligibility criteria:
inclusion criteria: * subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy) * negative screening test results * notified associated factors * menopause, surgically sterilized women or women using effective contraceptive method * good understanding and predictable adherence to the protocol * beneficiary/affiliated to french social security/social healthcare * signed informed consent form exclusion criteria: * predictable poor adherence * pregnant or breastfeeding women * myasthenia * treatment with aminoglycosides * major mental disorders * underlying etiology * vulnerable subjects (particularly adults under guardianship) * any reason deemed relevant by the investigator * current or former (in the last 3 months) participation to another clinical trial

Keywords: botulinum toxin pain improvement
boiled peanut oral immunotherapy for the treatment of peanut allergy: a pilot study

Conditions: IgE Mediated Peanut Allergy

Summary: peanut allergy is increasingly common, especially in countries such as uk and australia. there is currently no accepted routine clinical therapy to cure peanut allergy. recently studies have looked at desensitising people with peanut allergy by giving them small daily doses of roasted peanut. although this therapy works for some people, its effects are not generally long lasting and it is associated with many side effects during protocol, resulting in a significant rate of drop-outs. pilot data suggests that boiled peanut is less immunogenic than roasted peanut, and may therefore provide a safer way of inducing desensitisation in patients who are allergic to roasted peanut, by first inducing tolerance to boiled peanut. study hypothesis: increasing doses of boiled peanut can induce desensitisation to roasted peanut, in peanut-allergic individuals.


Eligibility criteria:
inclusion criteria: * ige-mediated peanut allergy, confirmed at double-blind placebo-controlled food challenge * tolerant to at least 1/4 boiled peanut (boiled for 4 hours) at open food challenge. * informed consent of parent/legal guardian and patient assent exclusion criteria: * allergic to 1/4 boiled peanut at pcfc * tolerates ≥1.4 g roasted peanut protein at entry pcfc * unstable asthma * unwilling or unable to fulfil study requirements * undergoing other forms of immunotherapy (e.g. scit or slit to aeroallergens) * previous admission to icu for management of allergic reaction to peanut * clinically significant chronic illness (other than asthma, rhinitis or eczema). * undergoing subcutaneous or sublingual immunotherapy and within the first year of therapy, for respiratory allergy. * subjects receiving anti-ige therapy, oral immunosupressants, beta-blocker or ace inhibitor therapy.

Keywords: peanut allergy desensitisation safety
direct his/lbb pacing as an alternative to biventricular pacing in patients with hfref and a typical lbbb.

Conditions: Heart Failure; Left Bundle-Branch Block

Summary: the study will investigate the feasibility of using direct his pacing or left bundle branch pacing (lbb pacing) as an alternative to biventricular pacing in patients with symptomatic heart failure and an ecg with a typical left bundle branch block pattern.

biventricular pacing has for more than a decade been standard of care for patients with hfref, lvef \< 35%, nyha ii-iv despite optimal medical treatment and an ecg with left bundle branch block (lbbb). however, it is not always ideal because of several drawbacks such as phrenic nerve capture, inability to reach late activated areas and many more. direct his pacing can in many cases capture the left bundle and provide normal electrical activation of the left ventricle but sometimes with high pacing thresholds. recently direct left bundle branch pacing has shown promise with synchronous activation of the left ventricle at low pacing thresholds. in the present study we randomize 150 patients in two centres to either conventional crt (50 patients) or his/lbb pacing (100 patients). in the his/lbb arm, direct his-pacing is attempted first but if its not possible or the pacing threshold for capturing the left bundle branch is \> 2.5 v at 1 ms we switch to placing a lbb-lead. power calculation for non-inferiority: with the 50 patients in the first his alternative study (25 biv-crt og 25 his-crt) we observed a fall in systolic volumes of 34% and 46% with a standard deviation of 13-16%. using these numbers it would take at least 108 patients to be 90% sure that the lower limit of a one-sided 97.5% confidence interval (equal to a 95% two-sided confidence interval) would be over the non-inferiority limit of -10%.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age, ischemic or non-ischemic cardiomyopathy with lvef ≤ 35% assessed by echocardiography, nyha class ii-iv heart failure symptoms despite optimal medical treatment and * either planned new implantation of a biventricular pacing system (crt-p or crt-d), where the ecg is with sinus rhythm and a typical left bundle branch block (see definition below) * or planned upgrade of an existing pacemaker or icd to a biventricular pacing system (crt-p or crt-d), where the ecg is with sinus rhythm and a typical left bundle branch block or there has been\> 90% right ventricular pacing from an existing pacemaker for at least 2 months prior to enrollment * signed informed consent typical left bundle branch block: qrs width \> 130 msec for women and \> 140 msec for men qs or rs pattern in leads v1 and v2, and mid-qrs plateau phase with or without extras in at least 2 of leads v1, v2, v5, v6, i, and avl exclusion criteria: * existing biventricular pacing system * permanent atrial fibrillation * severe renal failure with egfr \< 30 ml/min * ami or cabg within the last three months * the patient does not want to participate

Keywords: left bundle branch block his-pacing lbb-pacing left bundle branch pacing
follow up of high risk hodgkin lymphoma in first complete remission

Conditions: Hodgkin Lymphoma; High Risk; Relapse

Summary: cohort study enrolled high-risk hodgkin lymphoma patients in first relapse after induction therapy followed after remission either with a systemic imaging-based surveillance (imaging cohort) or with standard clinical-based surveillance (standard cohort).


Eligibility criteria:
inclusion criteria: * high risk hodgkin lymphoma * achievement of complete response to first line therapy exclusion criteria: * comorbidities that could impair participation in follow-up procedures
efficacy of surface landmark palpation for identification of the cricoid cartilage in obstetric patients

Conditions: Aspiration Pneumonia

Summary: rapid sequence induction (rsi), with cricoid pressure is advocated for all obstetric patients undergoing general anesthesia. applying cricoid pressure correctly is crucial to prevent aspiration. using ultrasound guidance we will be assessing the ability of different disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients by anatomical landmark palpation.

obstetric patients coming for elective cesarean delivery will be recruited for the study. informed consent will be obtained from the patient. the participant (anesthesiologist, resident, nurse, or rt) will mark the center of the cricoid cartilage with the patient in the sniffing position, using fluorescent "invisible" ink. another anesthesiologist who is expert in using ultrasound will find the proximal and distal margins of the cricoid cartilage an will draw a line at the middle of the 2 margins. evaluation of the participant's assessment will be considered accurate if it falls within 5 mm from the ultrasound's measured line .the assessor will also be asked to score the ease of cricoid cartilage palpation between 1 to 10 using a visual analog scoring (vas) scale. total time taken for palpation will also be measured.

Eligibility criteria:
inclusion criteria: * patient 18 years and older * asa 1-2•having singleton pregnancy. * gestational age \>37. * elective cesarean section exclusion criteria: * patient refusal. * renal failure. * severe preeclampsia. * non- scheduled caesarean delivery (urgent). * twin pregnancy.

Keywords: cricoid cartilage, cricoid pressure, obstetric
a study of huperzine a injection in reducing postoperative delirium in elderly patients undergoing non-cardiac surgery

Conditions: Injection; Non-cardiac Surgery; Delirium in Old Age; Post Operative Delirium

Summary: to observe and study the clinical effect of huperzine a injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery


Eligibility criteria:
inclusion criteria: * ≥ 75 years old. * comply with the indication of non-cardiac surgery under general anesthesia. * anesthesia grade of american society of anesthesiologist (asa) as iii\~iv grade. * the estimated operation time ≥ 2 hours. * voluntarily sign the informed consent form. exclusion criteria: * patients with impaired renal function (cr is 1.5 times higher than the upper limit of the normal value of the central laboratory) or abnormal liver function (alanine aminotransferase(alt) and aspartate aminotransferase(ast) are 2 times higher than the upper limit of the normal value of the central laboratory). * patients who are positive for infectious diseases. * patients accompanied with central nervous system injury. * patients with previous history of delirium and epilepsy, long-term use of psychoactive drugs or preoperative assessment of delirium. * patients who involved diseases with drug taboos, bronchial asthma, mechanical intestinal obstruction and urinary tract obstruction, or serious systemic diseases, especially circulatory diseases: such as myocardial infarction, heart failure, angina pectoris, history of sinus bradycardia. * patients who are known to be allergic to narcotic drugs or huperzine a injection, or must use drugs that are not compatible with huperzine an injection. * patients who participated in other clinical trials within 3 months before this study, for any reason, who could not tolerate the test or cooperate with the examination, or who has any aphasia, audio-visual dysfunction, etc. * the investigators think that the patients is not suitable to participate in this study.

Keywords: huperzine a injection postoperative delirium non-cardiac surgery elderly patients
optimizing growth in infants receiving modified fat breast milk for the treatment of chylothorax

Conditions: Chylothorax

Summary: breast milk is the reference normative standard for infant feeding. when an infant is diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to the presence of long chain triglycerides (lct) that contribute to persistent chylous drainage. in its place, the infant is prescribed a therapeutic formula high in medium chain triglycerides (mct) as treatment for chylothorax. families and health care providers are interested in using breast milk, in a modified fat form, as treatment for chylothorax instead. this study will assess growth in infants receiving one of two nutrient enriched modified fat breast milk (mfbm) treatments for chylothorax. if either of the proposed nutrient enrichment methods support growth, mfbm will become a standard chylothorax treatment option for infants at sickkids.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of chylothorax following cardiothoracic surgery * previously receiving a minimum of 50% of feeds from breast milk 3 days prior to surgical procedure * parents/caregivers would like to continue to provide breast milk during chylothorax treatment exclusion criteria: * diagnoses of chylothorax classified as either congenital, obstructive, or traumatic not following cardiothoracic surgery * patient has a chromosomal anomaly that affects growth (i.e. trisomy 21, trisomy 18 etc.) * patient receiving less than 50% of feeds from breast milk (or mother does not have intention to provide breast milk) * neither parent/caregiver/family member able to communicate effectively in english

Keywords: breast milk chylothorax infants cardiac surgery modified fat breast milk
bioequivalency study of mycophenolate mofetil 250 mg capsules under fed conditions

Conditions: Prophylaxis of Organ Rejection

Summary: the objective of this study was to prove the bioequivalence of mycophenolate mofetil 250 mg capsules under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. treatment with known enzyme altering drugs. history of allergic or adverse response to mycophenolate mofetil or any comparable or similar product.
mentored clinical career award in adolescent substance abuse

Conditions: Substance-Related Disorders

Summary: the goal of this project is to determine the barriers to, and risks and benefits of random laboratory drug testing for adolescents with identified drug or alcohol problems.

use of drugs and alcohol is associated with a variety of health care problems, making settings where adolescents receive routine medical care ideal for implementation of routine screening and early intervention. however, little research has been conducted on the efficacy of interventions for adolescent primary care patients who are using drugs or alcohol. urine drug testing can be used for a variety of indications, including school or work based population surveillance, verification of history, or monitoring of individuals who are in treatment for a drug-use disorder. this study will focus exclusively on the therapeutic use of urine drug testing. drug testing can be a useful therapeutic adjuvant for patients with drug-use disorders in a variety of settings. this study will investigate the use of random laboratory drug testing as a therapeutic intervention for teens with drug problem use, abuse or dependence. we have 5 objectives: 1. to develop a standardized protocol for random urine drug testing, produce a manual and training protocol, and refine the protocol in preparation for a future efficacy trial. 2. to estimate the cost of a random drug-testing program. 3. to determine the factors that are associated with willingness to be tested, and barriers to enrolling adolescents in laboratory drug testing programs. 4. to perform an initial, small-scale experimental trial of the random drug testing protocol. the purpose of this trial is to estimate the effect size of the intervention and will be used in calculating the sample size for a future stage 1b trial. 5. to determine the potential risks to adolescents who participate in a random drug testing program, including possible breach of confidentiality, greater conflict between the parent and child, more difficulty with communication between clinician and patient, increased use of drugs not detected by routine urine screens (i.e. inhalants), and increased use of strategies and products known to defeat drug tests.

Eligibility criteria:
inclusion criteria: * adolescents ages 12-21 * participants must have use of alcohol, cannabis, or another substance on at least 2 occasions in the 30 days preceding their initial assessment or 6 or more times in the past 90 days * participants must have health insurance or be willing to pay for the laboratory costs associated with drug testing. * participants must provide informed assent and, for those under 18, parental consent. exclusion criteria: * participants who require immediate hospitalization or immediate referral to residential substance abuse treatment * participants who cannot understand or read english at a 6th grade reading level * participants who are enrolled in the asap buprenorphine program * participants who report previous use of inhalants or any other substance that is not easily detected with urine drug testing

Keywords: alcohol abuse drug abuse
dexmedetomidine vs propofol on the recordings of deep brain activity measured through implanted stimulators

Conditions: Parkinson's Disease

Summary: this clinical trial has been designed to study and compare changes in deep brain activity (field potentials) in parkinson's disease (pd) patients while awake, and during sedation with dexmedetomidine or propofol. the recording is made through a deep brain stimulation (dbs) electrode implanted for pd management. the investigators hypothesize that dexmedetomidine produces fewer changes as compared to propofol, and that those changes are consistent and recognizable when compared to activity in patients not exposed to any sedation. typification of those changes would in the future allow for patients to undergo this surgery comfortably while not compromising the quality of the recording and of the final clinical outcome. the principal variable analyzed is the signal's power in each of the frequency bands, absolute and relative. the analysis will include usual clinical methods such as rapid fourier transform (fft) and window fast fourier transform (wfft), wavelet analysis, gabor, and coherence.

comparative clinical trial, non blinded, controlled and sequential, evaluating the effects of propofol and dexmedetomidine in the basal ganglia of pd patients through a dbs electrode. it is a phase iv clinical trial evaluating the effects of a drug outside the approved. the study takes part in three phases: 1. dbs placement under sedation with dexmedetomidine at 0.2 μg/kg/h. this will be called "dexmedetomidine record". 2. four days later and with no sedation, a recording will be registered in one of the specialized electrically isolated rooms at the neurophysiology department. this will be dubbed "basal recording". the equipment used is also the standard one used for routine postoperative recordings. 3. 5 days after the initial surgery, and following the protocol in place for these procedures, the tunnelization and battery placement will take place. this is done under general anaesthesia. during anaesthetic induction, the patient is exposed to incremental doses of propofol. different plasmatic concentrations will be targeted using the mathematical model in the target controlled infusion (tci) pump. these recordings will be called "propofol at a 0.5, 1, 1.5, 2, 2.5 μg/ml".

Eligibility criteria:
inclusion criteria: * capacity to understand, consent and commit for the three phases of the study. * older than 18 years old. * the patient is scheduled for dbs electrode placement for pd treatment by his neurologist. exclusion criteria: * allergy or hypersensibility to dexmedetomidine or propofol * cardiac blockade (types 2 and 3) without an implanted pacemaker * low blood pressure (mean \< 60 mmhg) or symptoms of low cardiac output. * severe cerebrovascular disease. * pregnancy or nursing mothers.

Keywords: deep brain stimulation dexmedetomidine propofol
a safety study of lactobacillus reuteri bgp-014 in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of lactobacillus reuteri bgp-014 in mild to moderate active ulcerative colitis (uc) patients as an oral administered local treatment in addition to standard of care (soc) treatment.


Eligibility criteria:
inclusion criteria: * the subject has given written consent to participate in the study. * diagnosed previously with uc (\> 6 months earlier) determined by clinical and endoscopic histopathology (pathology showing chronic inflammatory changes). ≥1 documented previous flare-up and with last resolved flare \>3 months away. * active uc determined by sigmoidoscopy before randomisation of study (baseline) and defined as a total mayo index score of 4 to 10 points (endoscopic subscore ≥1, rectal bleeding ≥1). * permitted concomitant soc medications include: oral aminosalicylates (5-asa), with a stable dose (1.6-4.8g/ day) for at least 12 days prior to screening, visit 1. steroids (dose ≤15mg at screening, visit 1) with further tapering of dose in accordance with soc until steroid tx termination. immunomodulator, as: 6-mercaptopurine, azathioprine, methotrexate (stable dose for \> 12 weeks prior to screening, visit 1). * females of childbearing potential must use effective contraceptives exclusion criteria: 1. involvement in any investigational drug or device study within 30 days prior to this study 2. known intolerance of 5-asa or sulphasalazine medications 3. biologics or fmt treatment less than 12 weeks before screening 4. no 5-asa or steroid topical treatment is allowed 5. antibiotic treatment \< 1 month prior the study 6. unable to maintain stable dose of nsaids and ppis 7. evidence of on-going extensive colitis 8. fever, defined as a temperature of \>38.5 °c, at visit 1 9. anaemia, hb value below 100 10. evidence of on-going toxic megacolon 11. presence of obstructive diseases of the gastrointestinal system 12. any clinically significant concomitant disease that might interfere with patient safety 13. unwilling to withdraw probiotic supplements. yoghurts without supplemented bacteria are permitted 14. pregnant 15. planned abdominal surgery 16. judged unable by the physician to comprehend information regarding the study
genetic counseling and lifestyle change for diabetes prevention

Conditions: Pre-diabetes; Overweight; Metabolic Syndrome

Summary: this study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. controls will not be tested. all subjects will be enrolled in a 12-week diabetes prevention program.

this study will examine the impact diabetes genetic counseling on patient motivation and disease prevention behaviors among subjects with pre-diabetes. we will randomize subjects with pre-diabetes to genetic testing vs. no genetic testing in order to obtain an unconfounded test of the hypothesis that genetic testing will change patient behavior. intervention subjects will be provided with their individual diabetes genotype risk score derived from aggregating the combined results of 37 diabetes risk-associated genetic loci. because patients can receive either "higher risk" or "lower risk" genetic test results, we will separately examine the impact of "higher risk" and "lower risk" test results compared to untested controls. all subjects will be enrolled in a 12-week diabetes prevention program.

Eligibility criteria:
inclusion criteria: * overweight (body mass index ≥ 29.1 kg/m2 in men, ≥ 27.2 kg/m2 in women) with at least 2 other formal criteria for metabolic syndrome (see table -ncep atp-iii criteria) * adult (\> 21 years of age) * no diagnosis or treatment for diabetes (type 1 or type 2) or cardiovascular disease (e.g. myocardial infraction, coronary bypass surgery, congestive heart failure, peripheral vascular disease) * physically able and willing to participate in a 12-week group session curriculum for weight loss and dietary change * able to understand and communicate effectively in english

Keywords: type 2 diabetes genetics genetic counseling diabetes prevention