Kornimate/medical-research-clean huggingface dataset:
high vs. standard dose rifampicin for effusive tuberculous pericarditis

Conditions: Tuberculous Pericarditis; HIV Status

Summary: the investigators hypothesise that high dose rif (rif35) will increase pericardial fluid rif exposure and so enhance mycobacterial clearance, compared to standard of care dosing (rif10). this phase 2b randomized, placebo-controlled, double-blinded trial will evaluate the efficacy and safety of rif 35mg/kg compared 10mg/kg, added to standard first-line att, for the treatment of pctb.

impi-3 - a randomized controlled trial of high vs. standard dose rifampicin for effusive tuberculous pericarditis phase 2b randomized, placebo-controlled, double-blinded clinical trial the trial will enroll 100 adult participants with pericardial tb from two research sites in south africa, with no exclusions being made on the basis of sex/gender, racial or ethnic group. consenting participants will be stratified by hiv status and pcf gx-ultra status, then randomized 1:1 to receive either standard of care anti-tuberculosis treatment (att) or standard of care plus high dose rifampicin (rif), both administered orally for 2 months, followed by a continuation phase of 4 months' rh at standard doses.

Eligibility criteria:
inclusion criteria: 1. aged \>18 years 2. suspected pctb with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole) 3. consent to study participation including testing for hiv-1 (if hiv status is unknown) 4. microbiologically detected mtb in pcf or diagnosis of probable pctb. probable pctb (in the absence of a positive pericardial fluid culture) will be defined as per mayosi et al.4: 1. evidence of pericarditis with microbiologic confirmation of mtb- infection elsewhere in the body and/or 2. exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 u/l) 5. participant will undergo pericardiocentesis (as per clinical indication) 6. within 5 days of att initiation exclusion criteria: 1. glomerular filtration rate \<30ml/min or renal failure requiring dialysis 2. rifampin-resistant tb 3. severe concurrent opportunistic infection 4. contraindication to placement of intra-pericardial catheter 5. failed pericardiocentesis procedure and/or failure of placement of intra-pericardial catheter 6. any disease or condition in which the use of the standard anti-tb drugs (or any of their components) are contraindicated. this includes, but is not limited to, allergy to any tb drug or their components. 7. in females: a positive urine pregnancy test result 8. confirmed autoimmune disorders (e.g. systemic lupus erythematosus) additional exclusions for gadolinium contrasted cmr 1. any implanted devices that are not mr compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.) 2. claustrophobia 3. gadolinium allergy 4. inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure) 5. breastfeeding
delayed clamping and milking the umbilical cord in preterm infants

Conditions: Premature Birth

Summary: this is a randomized controlled trial that will compare the effects of delayed umbilical cord clamping to umbilical cord milking in preterm infants (less than 34 weeks gestation). the infants' hemoglobin and hematocrit levels in the neonatal intensive care unit (nicu) will be evaluated, as well as the rates of necrotizing enterocolitis, intraventricular hemorrhage, and blood transfusions. the hypothesis is that milking the umbilical cord prior to clamping is superior to simply delayed cord clamping, presumably providing an increased blood volume to the preterm neonate improving its outcomes.

the optimal timing for clamping the umbilical cord after birth in preterm infants has been a subject of controversy and debate for many years. it has been until recently the standard practice in ob/gyn to clamp the umbilical cord immediately post delivery to allow for immediate transition resuscitation of the neonate, especially in preterm infants. due to the fact that optimal timing for cord clamping has yet to be definitively established in the preterm population, more information is needed. immediate cord clamping, however, could preclude the infant from an extra boost in blood volume that may prove beneficial later in the newborn life. directly comparing the recently recommended practice of delayed umbilical cord clamping to milking the umbilical cord prior to clamping has the potential to prove beneficial for the neonates in question, as well as change daily obstetrical practices. in this study all infants below 34 weeks will be randomized into one of two groups: delayed cord clamping and milking the umbilical cord prior to clamping. the decision was made not to include immediate cord clamping due to a recent american congress of obstetricians and gynecologists (acog) recommendation that all preterm infants have their cord clamping be delayed. their outcomes will be measured by serial hemoglobin and hematocrit levels while in the nicu, the incidence of necrotizing enterocolitis, incidence of intraventricular hemorrhage, and the need for neonatal blood transfusions.

Eligibility criteria:
inclusion criteria: * admitted to labor \& delivery at good samaritan trihealth hospital in cincinnati, ohio with expected/possible preterm delivery between 23-34 weeks gestation * care provided by good samaritan trihealth hospital's faculty medical center or tri-state maternal fetal medicine exclusion criteria: * declined to participate * known congenital anomalies * precipitous delivery preventing completion of the protocol * placental abruption around the time of or as indication for delivery * mother has uterine rupture * non reassuring fetal heart tracing (fht) immediately prior/leading to delivery * multiple gestation * parvo b19 * infants known to be at risk of anemia due to isoimmunization (mother has red blood cell antibodies

Keywords: premature birth umbilical cord clamping
safety and immunogenicity study of adenovirus-vectored, intranasal pandemic influenza vaccine.

Conditions: Influenza A Subtype H5N1 Infection

Summary: the purpose of this study is to test the recombinant vaccine for safety and immunogenicity in healthy adults volunteers. single dose, intranasally administered vaccine using an adenovirus-recombinant vector has provided a safe route for inducing protection in animals against pandemic influenza in preclinical studies. the vaccine is non-replicating, tissue culture based and designed for intranasal delivery.

objectives: the primary objective is to evaluate the safety of the adhvn1203/04.h5 vaccine when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age. the secondary objective is to evaluated the immunogenicity of the adhvn1203/04.h5 vaccine at three different doses (10e8, 10e9 and 10e10 viral particles) when administered intranasally in two doses with an interval of 28 days in healthy adults 19-49 years of age.

Eligibility criteria:
inclusion criteria: * healthy males and females in good general health, 19-49 years of age * subjects must provide written consent * willing to participate through study completion * willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogenicity analysis * female of child-bearing age must have a negative urine pregnancy test and be stable on a reliable means of contraception. * meet screening criteria for hematology, chemistry and urinalysis exclusion criteria: * pregnant (or possibly pregnant) and lactating women * any flu/cold symptoms and/or fever greater than 101 degrees in 3 days prior to study enrollment * any intranasal steroid medication administered in the 10 days prior to study enrollment * history of chronic rhinitis or presence of pre-existing nasal septal defects, nasal polyps or other gross abnormalities * any previous nasal cautery or significant surgery for nasal septal defects * any regular past or current use of intranasal illicit drugs or history of intravenous illicit drug use * asthma that is greater than mild in severity * diagnosed active hepatitis b or c * hiv positive at screening * known or suspected malignancy, leukemia, or lymphoma * immunosuppressed, altered or compromised immune status as a consequence of disease or treatment with systemic corticosteroids * receipt of an influenza vaccine within the past 6 months * receipt of any vaccine in the past 30 days * receipt of any investigational drug in the past 30 days * known diabetes mellitus * history of anaphylaxis or angioedema * hypertension that is not well controlled * any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator would serve to interfere or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participants's ability to give informed consent

Keywords: influenza vaccine pandemic avian influenza adenovirus strain 5 vectored vaccine intranasal tissue-culture derived non-replicating
testosterone therapy in heart failure

Conditions: Heart Failure; Hypogonadism

Summary: the purpose of this study is to evaluate whether benefits of topical testosterone on symptoms and function of male hf patients, and its effects on rehospitalization rates and quality of life.

recent evidence has started to emerge regarding the benefits of testosterone in the heart failure (hf) population. firstly, testosterone directly augments vascular resistance by causing vasodilation of peripheral vessels which can decrease afterload and improve cardiac output. in addition, testosterone causes coronary artery vasodilation and improves cardiac ischemic threshold based on subjective and objective measures. clinically, several studies have pointed out the potential benefits patients with hf can derive from testosterone therapy. measures of cardiopulmonary function tests, six minute walk test, incremental shuttle walk test and baroreflex sensitivity, all of which have prognostic implications for patients with hf, show improvement with the addition of testosterone therapy to traditional-medical management. in addition to these objective measurements, mood, nyha functional class and muscle strength are all improved by treatment with testosterone supplementation. while past studies have used functional and prognostic measures as outcomes, other issues common in patients with hf, such as sexual dysfunction and repeat hospitalizations, have the potential for improvement with testosterone therapy the majority of studies performed in the past have utilized intramuscular or transdermal patch delivery systems of testosterone as a means for supplementation. these methods have inherent issues as a means of treatment as patients often times do not have the means to receive intramuscular injections and patches have a high level of skin reactions making compliance difficult. topical administration of testosterone gel may prove to be a more efficacious method for testosterone supplementation with a lower side effect profile and adequate absorption. it has been used with success by the general public for treatment of hypogonadal symptoms, but has not been studied in the hf population. with the emergence of studies showing promising benefits of testosterone supplementation in the hf population, the ease of topical administration for this population would provide benefits to millions suffering from hf. the investigators study aims to find the benefits of topical testosterone on symptoms and function of hf patients, and its effects on rehospitalization rates and quality of life.

Eligibility criteria:
inclusion criteria: * male * nyha class ii-iv heart failure * age \> 35 \< 80 * total testosterone level of \<5 ng/ml exclusion criteria: * elevated prostate specific antigen * elevated total or free testosterone level * prostate cancer or evidence of symptomatic prostatism * untreated prolactinemia or history of breast cancer

Keywords: heart failure hypogonadism testosterone
the effect of virtual reality experience on infusion-related pain

Conditions: Virtual Reality

Summary: this clinical trial aims to analyze the effect of virtual reality experience on infusion-related pain with lumbar epidural catheterization.

patients with chronic pain are to suffer from acute pain during their chronic pain-relieving interventions. however, there is no active countermeasure against pain during these procedures. this prospective randomized clinical study seeks to find an appropriate solution to the procedure related acute pain of these patients by actively utilizing virtual reality experiences.

Eligibility criteria:
inclusion criteria: if all of the following conditions are met * a person with chronic low back pain that lasts more than 3 months due to spinal stenosis or lumbar disc disease. * adults over 20 * those who decided to participate out of his/her own free will and signed in written consent exclusion criteria: if the patient meets one or more of the following criteria, he or she cannot participate this clinical trial. * in case of contraindication to general lumbar catheterization (e.g. coatulopathy, infection, etc) * hearing and vision impairments * affective disorder * history of epilepsy or seizure * if communication is not possible due to impaired cognitive ability * those who have been deemed inappropriate by the researchers
bariatric surgery and pharmacokinetics of irbesartan

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on irbesartan are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics irbesartan
bio-predisc-tia swiss cohort study

Conditions: Cerebrovascular Disease, Ischemic Stroke

Summary: this research project aims at contributing to improve tia diagnosis and management by using predisc scores and specific biomarkers thought to have elevated levels in tia patients. a swift and accurate tia diagnosis allows starting treatment of the patient adequately and shortly after the event. the shorter the time between the event and treatment onset, the better the outcome. this approach will be an important step forward in tia diagnosis and management, similarly to acute coronary syndrome as discussed above.


Eligibility criteria:
inclusion criteria: * patients with suspected tia (defined as the acute onset of focal neurological symptoms lasting \<24 h and presumed to be caused by brain ischemia at the time of referral) within 48 h of symptoms onset. * at least 18 years old. * having given their informed consent. exclusion criteria: * · patients with ocular tia (amaurosis fugax). * patients that still have neurological deficits at the moment of inclusion. * contraindication to perform mri. * for women: pregnancy.
hyoscine butyl bromide in reducing pain during hsg

Conditions: Pain Relief With HSG

Summary: many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(nsaid) are used to relieve pain from gynecological procedure and dysmenorrhea. hyoscine-n-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. some studies reported hyoscine can't relieve pain in minor gynecological procedures. so the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in hsg procedure.


Eligibility criteria:
inclusion criteria: the infertile women who indicated for hsg. exclusion criteria: * contraindications to hyoscine or nsaid - known sensitivity to these drugs * known sensitivity to contrast media * abnormal uterine bleeding * genital tract infection * suspected pregnancy
study of a long lasting local anesthestic for hand, wrist or finger surgery

Conditions: Hand Injuries; Wrist Injuries; Finger Injuries

Summary: the purpose of this study is to compare exparel, a new, long-lasting numbing medication and a shorter-acting nerve block to a traditional single-shot nerve block in patients having hand, wrist or finger surgery.


Eligibility criteria:
inclusion criteria: * patients 18 years or older having hand, wrist, or finger surgery * ability to understand and provide informed consent * american society of anesthesiologists status i-iii * presence of a responsible adult caregiver for 48-72 hours after surgery exclusion criteria: * patient refusal or inability to provide informed consent * true allergy, not sensitivity to local anesthetics, midazolam, fentanyl, hydromorphone, propofol * pregnancy * hepatic or renal failure * evidence of infection at or near the proposed needle insertion site * any sensorimotor deficit of the upper extremity * bmi greater than or equal to 35 * uncontrolled or severe pulmonary disease * anticoagulant use (not aspirin or non-steroidal anti-inflammatories) * chronic pain patients

Keywords: hand surgery wrist surgery finger surgery anesthesia regional anesthesia postoperative pain
physical telerehabilitation in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study aims to evaluate the efficacy of the ms hat (multiple sclerosis home automated telemanagement) system as an adjunct to the current standard of medical care for patients with ms (pwms). the individual patient with ms will be the unit of analysis. for each participant, the investigators will assess the effect of home automated telemanagement (hat) on functional outcomes, levels of disablement including impairment, activity and participation, socio-behavioral parameters, and satisfaction with medical care as described below.

people with multiple sclerosis may develop severe disability over the time. physical therapy including regular exercise helps patients with severe disability to maintain muscle strength, reduce disease symptoms and improve quality of life. however physical therapy programs at clinical settings require constant travel which may limit access of patients with mobility disability to these services on continuous basis.technology can allow patients with mobility disability exercise at home under supervision of their rehabilitation team. currently it is unclear how effective this approach is. the study aims to demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, less symptoms and better quality of life. if so, other patients with significant mobility disability will be able to take advantage of this technology. this approach can be extended to people with different diseases causing mobility impairment and it can be used not only for physical but also for cognitive and occupational rehabilitation.

Eligibility criteria:
inclusion criteria: * age \>21 * confirmed diagnosis of multiple sclerosis based on mcdonald criteria * edss range 5.0-8.0 * mini-mental state examination (mmse) \> 22 or presence of a caregiver to assist in daily exercise regimen exclusion criteria: * coronary artery disease * congestive heart failure * uncontrolled hypertension * epilepsy * pacemaker or implanted defibrillator * unstable fractures or other musculoskeletal diagnoses

Keywords: multiple sclerosis telerehabilitation physical rehabilitation
traumatic extradural hematoma in paediatric age group

Conditions: Extradural Hematoma

Summary: the aim of this study is to assess the clinical and radiological characteristics of children with traumatic extradural hematoma and factors affecting the initial neurological status and outcome.

extradural hematoma (edh) represents 2.7-4% of traumatic brain injury .edh is a potentially lethal condition which is easily cured if diagnosed early .edh is less frequent in pediatric age group than in adults. the mean age of pediatric patients harboring edh is between 6 and 10 years and it is rare among infants under the age of 12 months. edh in children differs significantly from adults in terms of mode of injury, prognostic factors, and outcome. edh in children may follow a trivial trauma and the course is more insidious and associated skull fractures is less frequent and these factors make it difficult to diagnose and often challenging to manage. the reported rate of mortality from edh in children is varying from 0% and 17%, the criteria for choosing the surgical evacuation vs. conservative management in pediatric age group still ill-defined this is what encouraged the investigators to carry this study to present our experience in the management of edh in children aged less than 18 years.

Eligibility criteria:
inclusion criteria: * all pediatric patients with traumatic extradural hematoma presenting at our institute and managed surgically. exclusion criteria: * patients aged more than 18 years old. * patients with other traumatic brain injuries like: acute subdural hematoma, intra-cerebral hematoma and subarachnoid hemorrhage.

Keywords: paediatrics
biceps tenodesis with 360 suture anchor versus self locking tenodesis in the absence of rotator cuff tears

Conditions: SLAP Lesion

Summary: this is a prospective randomized controlled trial. the aim of this study is to compare the clinical results and complications of self-locking biceps tenodesis and double-loop 360 lasso biceps tenodesis for the treatment of pathology of the long head of the biceps or superior labrum anterior-posterior (slap) during shoulder arthroscopy in patients without arthroscopic rotator cuff tears. currently, there is no consensus on the use of tenodesis versus tenotomy to treat pathology of the long head of the biceps during arthroscopic rotator cuff repair. numerous studies have examined the clinical results of long biceps tenotomy versus long biceps tenodesis, and there is no evidence to date of superiority of either technique. however, these studies were carried out on patients with rotator cuff tears, and so it has not been possible to directly compare the two procedures. at clinique générale, we use a new, innovative technique called autobloc tenodesis to treat pathologies of the long head of the biceps. there are no comparative studies between autobloc tenodesis of the biceps and biceps tenodesis in patients without rotator cuff tears. given its potential advantages, autobloc biceps tenodesis could become the new technique of choice for treating biceps longus tendon pathology, potentially reducing differences in outcomes such as popeye deformity. the information provided by this study could potentially guide future clinical practice, helping surgeons choose the most appropriate treatment for their patients with long biceps tendon pathology.


Eligibility criteria:
inclusion criteria: * tendinopathy of the long head of the biceps based on clinical symptoms or slap-type lesion * partial thickness rupture or absence of rupture of the rotator cuff of the subscapular, supraspinatus and/or infraspinatus tendons, diagnosed preoperatively on ultrasound, arthro-ct or mri. exclusion criteria: * osteoarthritis of the glenohumeral joint, defined by narrowing of the glenohumeral joint space or osteophytes, using ap radiography of the affected shoulder. * distance between acromion and humeral head measuring 6 mm or less * previous shoulder surgery. * dementia or inability to complete questionnaires and assessments. * pregnant or breast-feeding patient * protected adult patient * patient not covered by social security.

Keywords: biceps tenodesis imaging tendon repair