Kornimate/medical-research-clean huggingface dataset:
determination of the minimum local analgesic dose of spinal chloroprocaine in labour

Conditions: Pain Relief During Labour

Summary: combined spinal-epidural (cse) analgesia has become a widely accepted approach to provide analgesia for labour pain. despite the increasingly widespread use of this technique, an optimal intrathecal drug regimen has not been established yet. several investigations using local anesthetics such as bupivacaine, levobupivacaine and ropivacaine in cse during labour have been published. but despite the reintroduction of chloroprocaine recently there haven't been any investigations about spinal chloroprocaine. chloroprocaine is already a long-know drug with a beneficial pharmacodynamic/kinetic profile. it is known for a very quick onset of action (2 - 3 minutes), high efficacy, rapid metabolism by plasma cholinesterases and short half-life both in mother and fetus. because of this beneficial profile, chloroprocaine is widely used intrathecally for surgical anesthesia. several investigations demonstrate that for surgical anesthesia doses chloroprocaine ranging from 30 - 60 mg are used and that they have an effective surgical duration of 40 - 90 minutes. despite these "standards" for surgical anesthesia, little is known about spinal chloroprocaine dose regimens. therefore the primary goal of this study is to determine the minimum adequate dose of chloroprocaine that is to be given spinally to a woman in labour using a cse procedure. we will use the up-down sequential allocation to identify the median effective dose (ed50) or concentration (ec50). the effective dose in 95% of the population (ed95) can be estimated also from an up-down sequential allocation and will become an important valuable approximation of the clinical dose.


Eligibility criteria:
inclusion criteria : * pregnant women in labour with a gestational period of 36 to 41 weeks * asa i or ii * primi- and multiparae * spontaneous or induced labor exclusion criteria : pregnant women in labour who received opiates or analgetics during the 6 hour period prior to cse
testosterone replacement for male opioid agonist maintained patients

Conditions: Chronic Pain; Opioid Addiction; Symptomatic Hypogonadism

Summary: this study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction

this study aims to assess the initial efficacy of testosterone replacement in male opioid agonist patients with symptomatic hypogonadism and chronic pain. the study has two specific aims: 1. to estimate, in male opioid agonist maintained patients, the prevalence of (a)symptomatic hypogonadism and (b) co-occurring symptomatic hypogonadism and chronic pain. 2. to conduct a pilot randomized clinical trial to obtain data regarding the feasibility, acceptability, and efficacy (compared to waitlist control) of testosterone replacement for male patients with chronic pain and opioid dependence, and symptomatic hypogonadism treated with opioid agonist maintenance treatment (n=40).

Eligibility criteria:
inclusion criteria: * between 18 and 50 years of age * male buprenorphine- or methadone-maintained patients at the apt foundation * moderate to severe chronic pain * meet criteria for symptomatic hypogonadism * understand english * interested in receiving testosterone replacement exclusion criteria: * current suicide or homicide risk * life-threatening or unstable medical condition * known or suspected prostate or chest cancer or history of polycythemia

Keywords: chronic pain opioid addiction symptomatic hypogonadism testosterone replacement opioid agonist maintenance methadone buprenorphine
treatment of urinary stress incontinence during or following correction of pelvic organ prolapse

Conditions: Pelvic Organ Prolapse

Summary: the incidence of pelvic organ prolapse (pop) in parous women is estimated over 50%. a variety of urinary, bowel and sexual symptoms may be associated with pop. moreover, a proportion of women who underwent a surgical correction of pop may occur post-surgical urinary incontinence and, thus, if this last presents as genuine stress-type or mixed-type, a second surgical intervention may be required. at this proposal, with the aim to reduce the incidence of postoperative urinary incontinence, the addition of a preventive continence procedure to a pop repair intervention has been widely proposed, but the potential benefits needs to be balanced against potential disadvantages. based on these considerations, the aim of this trial will be to compare two different surgical strategies for women with pop without urinary stress incontinence. specifically, the efficacy to associate and to follow a preventive continence procedure to the correction of pop will be compared.

women with pop not associated to urinary stress incontinence will be enrolled and randomized in two arms(groups a and b). patients of group a will be treated with unique surgery (correction of pop plus preventive continence procedure), whereas in patients of group b pop will be surgically corrected and, in case of stress or mixed postoperative incontinence, a further intervention for urinary stress incontinence will be tailored. all patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, ultrasonographic and urodynamic evaluations. during the study, the clinical outcomes, and the adverse experience will be evaluated in each patient. data will be analyzed using the intention-to-treat principle and a p value of 0.05 or less will be considered significant.

Eligibility criteria:
inclusion criteria: * pelvic organ prolapse stage 2-3 * absence of subjective urinary stress incontinence exclusion criteria: * pregnancy * \<12 months postpartum * systemic disease known to affect bladder function * current chemotherapy or radiation therapy * urethral diverticulum, augmentation cytoplasty, or artificial sphincter * recent pelvic surgery * patient age under 18 and over 80 * any previous pelvic surgery, diabetes mellitus and collagen disease

Keywords: pelvic organ prolapse urinary incontinence mesh
serial therapeutic and antifungal monitoring protocol

Conditions: Candidemia

Summary: the objective of this study is to investigate t2candida performance as a monitoring tool for post-therapy clearance of candida compared to blood culture. this study will collect a t2clinical specimen and companion blood culture from patients who have exhibited a positive blood culture by gram stain for yeast, and who are receiving treatment with antifungal therapy.

one blood culture and one set of t2clinical specimens will be collected at specified intervals to monitor the clearance of candida infection from the bloodstream. each t2 result will be compared to the companion blood culture result. the comparison will determine if the presence of antifungal therapy inhibits blood culture and leads to an incidence of blood culture false negative test results. the t2 result, which is not impacted by the presence of antifungal therapy, can show that the pathogen is still present for some additional period of time.

Eligibility criteria:
inclusion criteria: * subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them. * subject is between 18-95 years of age * subject has a blood culture result that is positive for yeast within 36 hours of enrollment exclusion criteria: * subject has other co-morbid condition(s) that, in the opinion of the investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study * all t2 bio individual clinical research specimens contain \< 3 ml of blood * use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of t2 bio blood specimens.

Keywords: candida blood culture antifungal therapy sepsis
compassion - congenital multicenter trial of pulmonic valve regurgitation studying the sapien interventional thv

Conditions: Pulmonary Valve Insufficiency; Pulmonary Regurgitation; Dysfunctional RVOT Conduit; Pulmonary Obstruction; Pulmonary Stenosis

Summary: to assess the safety and effectiveness of pulmonic thv implantation in subjects with dysfunctional rvot conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or rvot conduit obstruction (mean gradient of \>=35mmhg) by tte.

the study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (us) with no site representing more than 30% of the implanted subjects. the subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional rvot conduit requiring treatment for moderate or severe pulmonary regurgitation and/or rvot conduit obstruction.

Eligibility criteria:
inclusion criteria 1. weight must be equal to or exceed 35 kilograms. 2. in situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter. 3. subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by tte or rvot conduit obstruction with a mean gradient of \>= 35 mmhg by tte. 4. subject is symptomatic as evidenced by cardiopulmonary exercise testing. 5. the subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board (irb) of the respective clinical site. 6. the subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits. 7. catheterization is determined to be feasible by the treating physician. exclusion criteria 1. active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics) 2. previously enrolled in this study. 3. subject with pre-existing prosthetic heart valves in any position\*. 4. severe chest wall deformity. 5. leukopenia (wbc\<3000 mm3). 6. acute or chronic anemia (hb \<9 g/dl).

Keywords: pulmonic regurgitation pulmonary valve conduit stenosis congenital heart defect
evaluation of sb-751689 administered at supratherapeutic dose levels in healthy adult subjects.

Conditions: Osteoporosis

Summary: this study will evaluate the safety, tolerability and exposure of sb-751689 when administered alone at supratherapeutic doses and when sb-751689 is co administered with ketoconazole, a pgp/cyp3a4 inhibitor that increases exposure of sb-751689. data from this study will enable the planning and conduct of a qtc study for sb-751689.


Eligibility criteria:
inclusion criteria: * healthy adults aged 18-60yrs, with bmi of 19-31kg/m2. * females must be of non-childbearing potential. * subjects must be able to give consent and comply with restrictions of study. exclusion criteria: * clinically relevant abnormality from history, physical, 12-lead ecg, holter monitoring, or clinical laboratory examination. * positive urine drug screen. * positive urine test for alcohol. * contine levels indicative of smoking. * positive hiv or hep b and/or c assay. * history or smoking in last year or \>10 pack/year history of smoking overall. * history of regular alcohol consumption (7 units/week for women and 14 units/week for men) within 6 months of study. * history of drug abuse within 6 months of study. * participation in another drug trial within 30 days of first dose. * exposure to more than 4 new chemical entities within 12 months of first dose. * use of prescription and non-prescription drugs including dietary supplements, herbals and st. john's wort within 14 days of first dose. * consumption of red wine, grapefruit, grapefruit juice and grapefruit products within 14 days of first dose. * donation of blood in excess of 500 ml within 56 days of dosing. * evidence of renal, hepatic or biliary impairment. * history of serious gastrointestinal disease or history of gastrointestinal surgical procedure that might affect absorption of study drug. * history of sensitivity to any of the study medications. * history of clinically significant cardiovascular disease. * history of pernicious anemia, pancreatitis, osteosarcoma or kidney stones. medical conditions which might alter bone metabolism. * liver function tests above uln at screening and pth, glucose, and cpk outside the reference range at screening. * males unwilling to refrain from fathering a child during the study and for 14 days following the last dose of study medication.

Keywords: sb-751689, calcium-sensing receptor antagonist (car), osteoporosis, parathyroid hormone (pth), oral dose
the combined effect of dairy and exercise on bone and inflammation

Conditions: Healthy; Females; Bone; Inflammation

Summary: this study analyzes whether dairy supplementation positively impacts loading exercise-induced bone cell activity and inflammation in healthy young females.

introduction: two million individuals at a cost of around 2.3 billion dollars a year in canada suffer from osteoporosis. research that emphasizes the treatment of this disease is important, but so is research that focuses on prevention; reducing bone loss and/or increasing bone mass when young. in addition, inflammation is an issue as it strongly relates to chronic disease. countermeasures to improve bone health and inflammation, such as nutrition and exercise, should be explored and implemented. the proposed research combines both nutrition and exercise along with the assessment of bone turnover markers and inflammation in healthy young females, and aims to determine whether dairy versus a carbohydrate-based beverage positively impacts acute bone turnover and the inflammatory response following a bout of resistance and plyometric exercise. design: randomized controlled crossover trial. participants: 13 healthy university aged females. methods: participants were asked to complete 2 different acute exercise and nutritional supplement trials. each trial will be assigned in random order. the two trials were: 1) exercise+carbohydrate (cho), and 2) exercise+milk (milk). the whole study, per participant, took a maximum of 8-12 weeks to complete as each supplement trial was separated by \~4 weeks. each treatment is outlined below. \*\*\*\*\*\*due to covid-19, we removed the treatment trial which involved milk+creatine supplementation. despite randomization, and before the trial was closed, only 11 participants completed this trial\*\*\*\*\*\*\*\* anticipated results: the investigators anticipate that dairy and exercise will have a greater positive impact on acute bone cell activity and inflammation in healthy young females compared to exercise and cho.

Eligibility criteria:
inclusion criteria: * female between the ages of 18 and 30 years * normal bmi (18.5-24.9) kg/m2 * low to moderately physically active (0-2 times/week) * no allergy to dairy protein or lactose intolerance * on no medication related to a chronic condition * on birth control (or not but with regular mensural cycle)

Keywords: bone health females dairy exercise inflammation
effect of paracetamol, dexketoprofen trometamol, lidocaine spray, pethidine and diclofenac sodium application for pain relief during fractional curettage

Conditions: Pain and Curettage

Summary: patients frequently experience pain from moderate to severe during gynecologic procedures. this study is a prospective, randomized, placebo-controlled trial and aimed to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage procedure.

a total of 144 mutiparous subjects randomly allocated one of six groups. the first group (control group) consisted of 22 participants and they did not receive any treatment. the second group consisted of 26 participants receiving oral 25 mg dexketoprofen trometamol. the third group consisted of 23 participants receiving 2 puff lidocaine sprays on cervical mucosa. the forth group consisted of 25 participants receiving 100 mg pethidine. the fifth group consisted of 23 participants receiving 1000 mg intravenous paracetamol and the sixth group consisted of 25 participants receiving diclofenac sodium.

Eligibility criteria:
inclusion criteria: * multiparous participants * abnormal uterine bleeding * postmenopausal bleeding * myoma uteri causing menometrorrhagia * cervical polyp * tamoxifen treatment for breast cancer * adnexial mass exclusion criteria: * abortions * pregnancy * primiparity * diabetes mellitus * tendency to bleed such as thrombocytopenia * factor deficiency * functional disorders of platelets

Keywords: curettage; analgesia; paracetamol; lidocaine; dexketoprofen trometamol; pethidine; diclofenac.
non-invasive diagnostics of pulmonary hypertension with dual energy computed tomography

Conditions: Pulmonary Arterial Hypertension

Summary: the aim of the study is to determine relevant hemodynamic parameters for the diagnostics of pulmonary arterial hypertension (pah) by dynamic contrast enhanced dual-energy ct (de-ct). in this pilot study the investigators investigate patients who underwent right heart catheterisation with de-ct to determine hemodynamic parameters and control the results by other clinical investigations. the investigators expect that using this non-invasive method, parameters relevant for the diagnosis of the patients with pah, like pulmonary blood volume, blood flow and perfusion heterogeneity, can be determined.

pulmonary arterial hypertension (pah) is a rare, life-threatening disease. it is characterized by the elevation of pulmonary arterial pressure and pulmonary vascular resistance. a remodeling of small pulmonary vessels characterized by the proliferation of the adventitia, the hypertrophy of the media and fibrosis of the intima can be observed on the microscopic level. non-invasive techniques for hemodynamic assessment and identification of early pulmonary vascular remodeling and pulmonary hypertension have a marked practical advantage as compared to invasive right heart catheterization, however, their accuracy and reliability is not well established. in the present study the investigators examine patients who underwent right heart catheterization and are scheduled for a thorax ct with an additional dynamic contrast-enhanced de-ct protocol and derive established parameters for the diagnosis of pah as well as novel parameters from the ct scans. these are compared to results from the right-heart catheterization and other investigations routinely carried out on these patients.

Eligibility criteria:
inclusion criteria: * patients with right heart catheterization data exclusion criteria: * patients with decreased renal function * patients who received ct in the previous six months * intolerance of contrast material * other standard ct contraindications

Keywords: early diagnosis of pulmonary arterial hypertension dynamic dual-energy computed tomography
a study of evacetrapib (ly2484595) in participants with severe renal impairment and in healthy participants

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment compared to participants with normal renal (kidney) function. this study will last approximately 8 weeks.


Eligibility criteria:
inclusion criteria: * female participants are not of child-bearing potential * have a body mass index of 18 to 40 kilograms per square meter (kg/m\^2) * participants with normal renal function - healthy as determined by medical history, physical examination, and other screening procedures, with normal renal function (assessed by estimated creatinine clearance \[clcr\] greater than or equal to 90 milliliters per minute \[ml/min\] at screening) * participants with severe renal impairment - estimated clcr less than 30 ml/min at screening and are not undergoing hemodialysis exclusion criteria: * have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data * participants who are unwilling to comply with the dietary requirements/restrictions during the study * hemoglobin less than 9 grams/deciliter (g/dl) or significant active hematological disease from causes other than underlying renal disease
passive tactile stimulation for stroke rehabilitation

Conditions: Stroke; Stroke, Ischemic; Stroke Hemorrhagic; Spasticity as Sequela of Stroke

Summary: stroke can lead to weakness and spasticity in the arm or hand. the purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.


Eligibility criteria:
inclusion criteria: * age 18 and older. * diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement. * willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the phase in progress. * able to provide informed consent. exclusion criteria: * patients with severe contracture that precludes modified ashworth score (mas) testing.

Keywords: spasticity tone hemiplegia hemiparesis arm hand vibration
effects of allopurinol on diastolic function in chronic heart failure patients

Conditions: Chronic Heart Failure

Summary: in patients with chronic heart failure (chf)due to dilated cardiomyopathy diastolic dysfunction occurs frequently and is related to a poor outcome. we have previously shown that parameters of diastolic function significantly correlate with uric acid levels, a marker of impaired oxidative metabolism. we aimed to determine whether inhibition of xanthine oxidase with allopurinol might affect diastolic function in patients with chf.


Eligibility criteria:
inclusion criteria: * chronic heart failure; * left ventricular systolic dysfunction (ejection fraction \<45%) * stable clinical conditions in the previous three months * optimal medical therapy for chf * normal sinus rhythm * written informed consent * age \>18 years exclusion criteria: * renal failure (s-creatinine \>2.5 mg/dl) * already on allopurinol * malignancies * chronic inflammatory diseases

Keywords: chronic heart failure diastolic dysfunction uric acid