Kornimate/medical-research-clean huggingface dataset:
are sleeping disorders associated with visceral hypersensitivity in irritable bowel syndrome patients ?

Conditions: Irritable Bowel Syndrome

Summary: visceral hypersensitivity is frequent in ibs population up to 60% and is correlated with severity and altered quality of life. sleeping troubles are most frequent in ibs population. insomnia is a frequent disorder with an important cost for healthcare. insomnia could decrease pain threshold. visceral hypersensitivity was never measure in patients with insomnia. the hypothesis is ibs patients with insomnia probably have lower visceral pain threshold. the objective is to assess pain threshold during a barostat procedure in in ibs patients with or without insomnia in comparison with healthy volunteers or patients with insomnia. if the hypothesis are confirmed, insomnia should be look at in ibs patients and its treatments could improve visceral hypersensitivity and ibs symptoms.


Eligibility criteria:
inclusion criteria: 1. healthy volunteers - person aged over 18 years with no ibs and no insomnia 2. patients with insomnia - patient aged over 18 years with no ibs and no insomnia 3. patients with ibs - patient aged over 18 years with ibs 4. patients with insomnia and ibs - patient aged over 18 years with ibs exclusion criteria: * active chronic organic disease * endometriosis * opioids consumption * change in chronic treatment in the last 30 days * hypersensitivity to normacol * patient with blood dyscrasia disorder known or identified, anticoagulant or antiplatelet treatments * rectal pathology * intestinal occlusion * severe renal failure * sodium retention * anal pathology (anal fissure, hemorrhoidal thrombosis) * person with administrative or judicial decision or under legal protection measure * patient participating in another trial in the last 30 days * pregnant or breastfeeding women * impossibility to keep fasting for 12 hours

Keywords: visceral hypersensitivity insomnia
trial to evaluate the safety and immunogenicity of multivalent pneumococcal vaccines in japanese adults 18 to 49 years of age

Conditions: Pneumococcal Infections

Summary: this phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy japanese adults in the united states.


Eligibility criteria:
inclusion criteria: * male or female japanese subjects 18 to 49 years of age, defined as japanese born in japan, with both parents and 4 grandparents who wer born in japan (family tree by history), and who have not lived outside of japan for more than 5 years total (confirmed by passport or interview) exclusion criteria: * participation in other studies involving investigational drug(s), investigational vaccines, or investigational medical devised within 28 days prior to study entry and/or during study participation. participation in purely observational studies is acceptable.
analysis of injectate spread during erector spinae block

Conditions: Pain; Cervical

Summary: the primary purpose of this study was to identify the espb spread level in the craniocaudal direction when performed at the t2 level. the secondary purpose was to determine the incidence of spread into epidural, paravertebral, intercostal, and intravascular injections with espb

the espb requires ultrasound guidance which enables visible local anesthetic spread underneath the erector spinae muscles. the spinalis, longissimus thoracis, and iliocostalis muscles comprise the es muscles, which run vertically along both sides of the vertebral column from the sacrum up to the skull base. the espb can be performed in the cervical, thoracic, and lumbar regions. among them, upper or mid thoracic espb has been used more widely compared to cervical and lumbar regions. previous cadaveric studies on the espb at the t5 level using computed tomography (ct) reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of methylene blue ranging from t1 to t8 vertebral segments deep to the es muscles and variable involvement of epidural, paravertebral, and intercostal spaces. the espb performed at the t2 level of the cadaver demonstrated an injected dye distribution ranging from c4 to t10. also, 36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus, paravertebral space, and even the contralateral side. the exact mechanism of action of espb remains unclear. a recent study suggested that the analgesic effect of espb could be obtained by blocking the ventral and dorsal ramus of the spinal nerves by passing through the costotransverse foramen. however, in clinical practice, we can encounter highly variable clinical outcomes or sensory block after the espb. the study of the physical spread of the injected agent can be used to predict the clinical result and elucidate the possible mechanism of action of espb.

Eligibility criteria:
inclusion criteria: * cervical facet joint arthrosis * cervical foraminal stenosis * cervical herniated intervertebral disc * myofascial pain syndrome of upper back muscle exclusion criteria: * allergy to local anesthetics or contrast medium * pregnancy * prior history of cervical spine surgery * coagulation abnormality

Keywords: pain cervical spread
electromyography during common exercises used in rehabilitation

Conditions: Motor Activity

Summary: it is generally accepted that the effectiveness of an exercise can be controlled not only by the weight or resistance applied but also by doing an exercise that would better target the desired muscle. the purpose of this study is to obtain objective information regarding selected lower extremity muscle activity during specific exercise and the influence of fatigue and speed on muscular activation.

it is generally accepted that the effectiveness of an exercise can be controlled not only by the weight or resistance applied but also by doing an exercise that would better target the desired muscle. information regarding selected lower extremity muscle activity during specific exercise and the influence of fatigue and speed on muscular activation may enhance exercise prescription for all parties involved. specifically, selection of specific training or rehabilitation exercises may be guided by increased awareness of specific muscle activation patterns during common exercises. methods and measures: healthy subjects between 18 - 35 years old will be recruited from the community by a sample of convenience and word of mouth. potential participants will report to the institute for human performance. the potential participants will be asked to complete all documentation including informed consent, and health screening questionnaire. the qualified participants will be familiarized with the set up and specific exercises. if eligible, surface emg recordings will be collected from the back extensors, gluteal muscles (buttocks), hamstrings (posterior thigh), quadriceps (anterior thigh), and gastrocnemius (calf) during squat and lunges exercises. for data analysis, a within subject measures analysis will be conducted using general linear models. specifically, we will use paired t-tests and an analysis of variance (anova). when applicable, post-hoc tests will be used to uncover differences among the groups of subjects on descriptor variables such as age, height, weight, rate of perceived exertion, and maximal and sub-maximal voluntary muscle performance variables (i.e. emg amplitude, frequency). the statistical significance level will be set at alpha = 0.05 for all analyses performed.

Eligibility criteria:
inclusion criteria: * healthy adults age 18-35 exclusion criteria: * subjects who report any significant respiratory-cardiovascular disease, which is not yet under control. * known orthopedic risks to strength training exercise

Keywords: motor activity, lower extremity, physical exercise
oral colecalciferol treatment in spinal cord lesion

Conditions: Spinal Cord Injury

Summary: low vitamin d is frequently seen in patients with spinal cord injury (sci) in acute and chronic periods. among its causes are insufficient sun exposure, limited oral intake, obesity, the effect of the drugs used on the absorption of vitamin d, kidney and liver diseases. if we consider patients with spinal cord injuries in turkey, it is difficult to get involved in the society, low exposure to the sun, lack of necessary health controls and immobility brings extra risk factors for the low vitamin d compared to the general population. despite turkey endocrinology and metabolism endocrine society and the international endocrine association clinical practice guidelines do not provide specific recommendations about vitamin d, for individuals with spinal cord injuries. individuals with sci are at high risk for low vitamin d. vitamin d levels need to be checked and replaced. vitamin d doses, application methods and dose intervals used in physical therapy and rehabilitation clinics are different. the aim of our study is to perform the necessary vitamin d replacement for individuals with sci who have vitamin d deficiency in different dose intervals and to compare the effects of muscle strength, muscle thickness and functional independence with the control group.

paraplegic patients who admitt to our physical therapy and rehabilitation clinic, will be included in the rehabilitation program. sixty spinal cord injured patients with serum 25 (oh) d3 levels less than 20 ng / ml will be included in the study. one of the treatment groups will receive 6,000 iu of vitamin d daily, and the other group 50,000 iu of vitamin d per week for eight weeks. patients with high calcium (ca) values in blood tests, patients with kidney stones and urinary stones in urinary ultrasonography (usg) to be performed routinely, as well as patients who refuse to use vitamin d supplements will include in the control group. spinal cord independence measure (scim version 3) will be filled in at the beginning and at the end of 8 weeks to all participants. jamar dynamometer will be measured for upper extremity muscle strength, and biceps brachii and triceps muscle thicknesses will be measured by ultrasonography.

Eligibility criteria:
inclusion criteria: 1. 18-60 years old 2. thoracic level chronic spinal cord injury 3. a, b, c, d complete / incomplete patients according to asia classification 4. 25 (oh) d3 level in serum is \<20 ng / ml 5. complete muscle strength in upper extremity exclusion criteria: 1. individuals with chronic liver, kidney, respiratory and parathyroid disease 2. chronic constipation 3. patients who have recently used vitamin d 4. use of drugs that will affect vitamin d and ca level (thiazide group diuretics, statins) 5. acute inflammation (may show false low in vitamin d levels)

Keywords: 25(oh)d hand grip strength spinal cord injuries muscle thickness
comparison of midline with lateral skin incision in simultaneous bilateral tka

Conditions: Skin Numbness and Kneeling Ability

Summary: this is a rct which compare skin numbness, kneeling ability and functional outcome between midline incision and lateral incision in patients undergoing simultaneous bilateral tka


Eligibility criteria:
inclusion criteria: * the patient undergoing simultaneous bilateral tka * normal skin sensation on both knees * informed consent * good cognitive function exclusion criteria: * previous surgical wound around the knee * peripheral vascular disease

Keywords: skin incision numbness kneeling total knee arthroplasty
incidence of urinary tract infection after urodynamic investigation

Conditions: Neurogenic Bladder

Summary: the purpose of this study is to evaluate the incidence of urinary tract infection after urodynamic investigation and to identify the involved germs.

patients with neurogenic bladder dysfunction after spinal cord injury need lifelong urologic control examinations with cmg (urodynamic examination). the manipulation may cause urinary tract infections which have to be treated. patients often noticed an infection after a cmg examination. aim of this study is the determination of the infection rate and germs. also should be noticed the pre-interventional infections and differences between the causing germs. simultaneously the investigators test the reliability of the quicktest for urinary infection. additionally the investigators will examine the quality of life in patients with neurogenic bladder dysfunction.

Eligibility criteria:
inclusion criteria: * patients with neurogenic lower urinary tract dysfunction with scheduled urodynamic investigation * no antibiotic treatment * written informed consent exclusion criteria: * pregnancy and breastfeeding * current antibiotic therapy

Keywords: urinary tract infection urodynamics spinal cord injury
patient outcomes in simulation education (poise) intravenous (iv) and lumbar puncture (lp) multi-institution protocol

Conditions: Infant Lumbar Puncture

Summary: this study aims to compare the clinical efficacy of multimedia audiovisual training to hands on "practice till perfect" training for pediatric and emergency medicine residents' procedural skills. this initial study will explore the success rates on infant lumbar puncture and child intravenous access skills in post-graduate year one pediatric residents.


Eligibility criteria:
inclusion criteria: pediatric interns at poise network hospitals

Keywords: intravenous line simulation education
perioperative neuroprotection of stellate ganglion block

Conditions: Intracranial Aneurysm

Summary: to investigate whether stellate ganglion block is helpful to brain protection during cranial aneurysm surgery

the vasospasm after cranial aneurysm surgery have a higher incidence, but not have an ideal treatment method. at present, the medical treatment is very limited effect to prevent the perioperative cerebral ischemia.stellate ganglion block （sgb）is an effective and well-tolerated approach to the treatment of cvs in various clinical settings.resent study indicated that sgb has a protective effect on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage.therefore,we hypothesized that the preoperative sgb would be a effective treatment for improvement of vasospasm after cranial aneurysm surgery.

Eligibility criteria:
inclusion criteria: * aneurysm subarachnoid hemorrhage patients scheduled for cranial aneurysm surgery， * asa grade：ⅱ-ⅲ， * hunt～hess grade :ⅰ-ⅲ, * have a informed consent. exclusion criteria: * history of mental illness， * local infection who can't do stellate ganglion block， * pregnant or lactating， * nausea cancer or diabetes， * participated the study or other related research in the last 30 days， * unruptured aneurysms patients

Keywords: stellate ganglion block aneurysm surgery cognitive recovery cerebral vasospasm
the savella pregnancy registry

Conditions: Fibromyalgia

Summary: the savella pregnancy registry is a us based registry designed to monitor pregnancies exposed to savella (milnacipran hci). this is an observational, exposure-registration and follow-up registry designed primarily to estimate the prevalence of major congenital anomalies, and secondarily to estimate the prevalence of recognized spontaneous abortions, stillbirths, induced abortions, minor congenital anomalies, and any serious adverse pregnancy outcomes among pregnancies exposed to savella as well as adverse outcomes observed during the first year of life in off-springs born from these exposed pregnancies. live offspring are followed from birth until age one. the savella pregnancy registry is sponsored by abbvie (formerly actavis plc, forest laboratories inc., and allergan) and managed by syneos health.

registry enrollment is voluntary and initiated by pregnant patients or their healthcare providers (hcp). patient-initiated reports must be verified by the hcp. enrollment should occur as early in pregnancy as possible, preferably before any prenatal testing has occurred; however, enrollment at any time during pregnancy is allowed. near the estimated date of delivery, the registry prompts the hcp to provide pregnancy outcome data. if a live birth is reported, the registry conducts follow-up with the infant's hcp at outcome, 4 months, and 12 months of age. if a birth defect is indicated, the registry requests additional targeted follow-up information from the hcp. data are collected on exposure to savella, potential confounding factors, pregnancy outcome, and pediatric outcome for all live born babies. cases are reviewed and classified according to type of birth defects. adverse event cases are forwarded to allergan.

Eligibility criteria:
inclusion criteria: * females exposed to savella during pregnancy * willing to provide verbal consent * 18 y/o, us citizen exclusion criteria: * male * under 18 y/o * females not pregnant, not exposed to savella

Keywords: savella pregnant savella pregnancy fibromyalgia pregnant fibromyalgia pregnancy pregnancy registry savella
pranayama breathing and uncontrolled hypertension

Conditions: Uncontrolled Hypertension

Summary: this study will compare participants who have uncontrolled hypertension and perform a set of five breathing exercises (pranayama breathing) to a control group. the purpose of the study is to determine the effect of the breathing exercises on reduction of blood pressure.

untreated or uncontrolled hypertension is a leading cause of heart disease, stroke, and kidney failure. hypertension, is a modifiable risk factor that may be successfully treated using one or a combination of treatment options, including medication, diet, exercise, tobacco cessation, or complementary and alternative medicine such as breathing exercises. a well-established cascade of adverse health outcomes are associated with hypertension as well as increased mortality rates. for patient-centered care, providing patients with additional strategies for their health care also has the potential to empower the patient, augment patient-physician team approach to the patient's health care, and support the standards of care for treating hypertension. as explained by mccaffrey et al from their focus group work with patients, "participants do not want prescription medications except as a last resort and feel that conventional medicine overemphasizes prescription medicines. this may be because of a combination of factors including distrust in conventional medicine, fear of side effects from medicines, and an underlying belief that the body can heal itself given the right nutrition, rest, and time" using a randomized controlled trial study design with a 1-month and 3-month follow-up, the investigators hypothesize that practicing breathing at least 5 times per week will show a mean reduction in systolic (sbp) and diastolic (dbp) blood pressures in uncontrolled hypertensive patients compared to control patients. participants will be randomized into one of three arms of the study. for the intervention arm, participants will be either assigned to a weekly class for the pranayama breathing instruction and practice or given a dvd that contains instructions on the breathing exercises and the 15-minute practice session.

Eligibility criteria:
inclusion criteria * english-speaking adults * less than 60 years of age with bp measurements of ≥140/ ≥90 mm hg * 60 years of age or older with bp measurements of ≥150/ ≥90 mm hg * diagnosed with diabetes with bp measurements of ≥140/ ≥90 mm hg * patients with bp measurements of \<180/ \<110 mm hg without hypertensive urgency symptoms exclusion criteria: comorbidities of copd, renal disease or chronic alcoholism -
a study of cisplatin plus radiotherapy compared to cetuximab plus radiotherapy in locally advanced head and neck cancer.

Conditions: Locally Advanced Head and Neck Cancer

Summary: the primary endpoint in this study is to investigate if there is a difference in overall survival in patients with locally advanced head and neck cancer, randomized to either radiotherapy and cetuximab or radiotherapy and cisplatin. a second randomization is performed in patients with t3-t4 tumors; allocated radiotherapy either 68.0 gy or 73.1 gy.


Eligibility criteria:
inclusion criteria: * age at least 18 years * histologically or cytologically confirmed , previous untreated head and neck squamous cell cancer of the oral cavity, hypopharynx, larynx or of the oral cavity aimed for unimodal treatment with radiotherapy with curative intent * tumor stage iii and iv , but no evidence of distant metastases beyond the regional nodes in the neck * who/eastern cooperative oncology group (ecog) performance status 0-2 * the patient must be expected to withstand radiotherapy combined with cisplatin or cetuximab * the patient must be able to understand the information about the treatment and give a written informed concent to participate in the trial * adequate follow-up study must be possible; this will exclude a patient who is uncooperative * adequate renal function, creatinine clearance over 50 ml/min/1.73 estimated according to local practice at each study centre exclusion criteria: * previous malignant disease in the head and neck region, with exception for basal cell carcinoma or curatively treated squamous cell carcinoma of the skin with follow-up time of at least 3 years * concomitant or previous malignancies. exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri, or other previous malignancy with a disease-free interval of at least 5 years * two or more synchronous primary head and neck squamous cell cancer at time of diagnosis * co-existing disease prejudicing survival (expected survival less than 6 months) * absolute neutrophil count less than 1.5 x 109/l * platelet count less than 100 x 109/l * bilirubin over 1.5 times upper limit of normal * aspartate aminotransferase (asat) or alanine aminotransferase (alat) more than 3 times upper limit of normal * pregnancy or lactation * allergy to study drug or to the excipients in their formulation * neuropathy grade 2 or more according to common terminology criteria for adverse events (ctcae) v.4.0 * hearing loss/tinnitus is a relative exclusion criteria; the responsible physician decides whether the patient may be included in the study * severe cardiac illness; myocardial infarction within 6 months prior to randomization, severe congestive heart failure, severe cardiomyopathy, ventricular arrythmia, unstable angina, uncontrolled hypertension

Keywords: head and neck cancer cetuximab cisplatin radiotherapy quality of life human papilloma virus health economy biomarker investigations
personality profiles, values and empathy: differences between ovo/lacto-vegetarians and vegans

Conditions: Personality

Summary: main goal is to collect and analyze possible differences between ovo / lacto-vegetarians and vegans with respect to their personality profiles, values and empathy through validated questionnaires. main hypothesis: vegans and ovo / lacto-vegetarians differ in their personality, empathy and values


Eligibility criteria:
inclusion criteria: * age 18-80 years of age exclusion criteria: * age under 18 and above 80 years of age

Keywords: personality profiles values empathy quality of life vegetarians vegans