Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain

Conditions: Constipation

Summary: this study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.


Eligibility criteria:
inclusion criteria: 1. male and female outpatients 18 years of age or older. 2. patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. the equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. in general, patients should be using opioids on a daily basis. 3. chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief. 4. constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. opioid-induced constipation (oic) is defined as follows: * less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions: 1. hard or very hard stools 2. sensation of incomplete evacuation 3. straining while having a bowel movement exclusion criteria: 1. patients who are receiving opioids for abdominal pain or connective tissue disorders. 2. planned discontinuation or an increase or decrease by more than 30% of the current opioid dose 3. patients who underwent major surgery within 3 months prior to screening. 4. patients with a history of prior chronic constipation (cc) that was present for more than three months and that was not related to opioid use. 5. patients with a current diagnosis of irritable bowel syndrome (ibs) constipation predominant or alternators. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: opioid, constipation, tegaserod opioid-induced constipation
effects of kinesio taping in patients with somatosensory tinnitus

Conditions: Tinnitus, Subjective

Summary: there is no specific treatment that can cure somatosensory tinnitus and usually conservative physical therapy modalities are used in the literature. the aim of the study is to investigate the effect of kinesio taping applied to sternocleidomastoid, upper trapezium and levator scapulae muscles on the somatosensory tinnitus associated with neck complaints.

the study was designed as a prospective, randomized controlled and double blind trial. patients complaining of tinnitus were firstly subjected to otologic and audiologic evaluation by an otolaryngologist. tinnitus characteristics, such as severity (tinnitus handicap index, tinnitus visual analog scale- tinnitus vas) , type (pulsatile/non-pulsatile), localization (unilateral/ bilateral) and the frequency (number of days with symptoms) were recorded. patients were excluded if they had objective tinnitus, subjective tinnitus with hearing loss or meniere's disease, vertigo, middle ear pathologies, intracranial pathologies, whiplash injury, previous cervical spinal surgery, pregnancy, infection, malignancy and if they received cervical physical rehabilitation program in the past 3 months. patients who diagnosed with somatosensory tinnitus and concomitant neck complaints (cervical-vas score \>2) at least 6 weeks were referred to physical medicine and rehabilitation outpatient clinic. before the treatment, participants' demographics data including age, gender, body-mass index (bmi) and cervical pain vas score were recorded and physical examinations (cervical joint range of motion (cervical-rom), cervical manual muscle testing (cervical-mmt) and myofascial trigger points for sternocleidomastoid, upper trapezium and levator scapulae muscles) were performed by one investigator. banding application performed for both groups once a week for four weeks. tinnitus handicap index score, tinnitus vas, rom of the cervical joint, cervical mmt, cervical pain vas, neck disability index score and myofascial trigger points of sternocleidomastoid, upper trapezium, levator scapula was evaluated in all subjects by the same investigator.

Eligibility criteria:
inclusion criteria: * subject has somatosensory tinnitus * subject has concomitant neck complaints (cervical-vas score \>2) at least 6 weeks * subject were referred to physical medicine and rehabilitation outpatient clinic exclusion criteria: * history of objective tinnitus * history of subjective tinnitus with hearing loss * history of meniere's disease * history of vertigo * hiistory of middle ear pathologies * history of intracranial pathologies * history of whiplash injury * history of previous cervical spinal surgery * history of infection or malignancy * pregnancy * history of having received cervical physical rehabilitation program in the past 3 months

Keywords: somatosensory tinnitus neck pain kinesio taping
conscious sedation efficacy of the mko melt (midazolam, ketamine, ondansetron)

Conditions: Cataract

Summary: the investigators hypothesized that the combination of valium, tramadol and zofran is superior to the substantially more expensive mko melt in patient satisfaction after cataract surgery.

the mko melt is being marketed as an anesthetic medication for cataract surgery that has the advantage that it eliminates the need for an iv in 85% of patients although that number was established anecdotally. this alternative, however, is very cost limiting.the investigators wanted to see if the current regimen (valium only) or a combination similar to the mko melt (valium + tramadol + zofran) are as good if not better than the mko melt for anesthesia and how many patients could have indeed gone with an intravenous line (didn't need any extra medications).

Eligibility criteria:
inclusion criteria: * all patients scheduled to undergo cataract surgery with drs. mayo and wade at kirby glen surgery center exclusion criteria: * age \<18 years * patient is not suitable for the medications for reasons such as unsteady gait, cane, wheelchair, severe dementia (unable to consent), terminal illness * allergy to a medication in protocol
effects of regular brisk walking in chronic stroke patients

Conditions: Stroke

Summary: chronic stroke patients (\>6 months) fulfilling including criteria were trained during 3 months. the physical training program was based on walking.

participants had been evaluated 4 times during a long follow-up period of 7 months. activity limitations were assessed at baseline (enrollment time point), 1 month, 4 months and 7 months later.

Eligibility criteria:
inclusion criteria: * stroke onset \> or = 6 months * able to walk without human assistance (may use walking aid) * sign informed consent form * approval from physician for participation in study * live in belgium or in benin exclusion criteria: * cardiac history of active unstable angina, recent (less than 3 months) myocardial infarction, or congestive heart failure * orthopedic, circulatory, or chronic pain conditions restricting exercise; * dementia; * severe receptive or global aphasia with inability to follow 2-step commands; * co-morbid non-stroke neurological disorder that impairs mobility (e.g. ms or parkinson's);

Keywords: activity limitations restriction of participation chronic stroke survival physical activity walking
zmax compared to augmentin in sinusitis

Conditions: Sinusitis

Summary: this study will enroll patients with bacterial sinusitis who will be treated with either zmax (azithromycin extended release) or augmentin (amoxicillin/clavulanate). the purpose of the study is to compare early resolution of symptoms between the two treatments. patients will report resolution of their sinusitis symptoms through a daily questionnaire. there will be two follow-up telephone interviews on days 12 and 28 to evaluate quality of life, satisfaction with therapy, and use of healthcare services.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of acute uncomplicated bacterial maxillary sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days, and no longer than 30 days: * facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and * presence of one or more of the following signs: * discolored (yellow-green) nasal discharge * discolored (yellow-green) drainage in the posterior pharynx * discolored (yellow-green) discharge from the maxillary sinus orifice * two or more of the following symptoms are present: * fever, as defined by: * oral temperature: \>38c or \>100.4f, or * tympanic temperature: \>38.5c or \>101.2f * frequent coughing * nasal congestion, * post-nasal drainage. exclusion criteria: * treatment with any systemic antibiotic within 30 days prior to enrollment * symptoms of sinusitis lasting for longer than 30 days; * four or more episodes of acute sinusitis within the preceding 12 months;
usg cmbb dsa study

Conditions: Cervicalgia

Summary: injections that freeze neck joints can be done using x-rays or ultrasound imaging, which as a newer way of guiding the needle to the right spot. this study will look at how often freezing liquid goes into a blood vessel during neck injections that freeze neck joints when ultrasound guidance is used to place the needle. when this happens, it can go undetected because it does not make the patient feel any different, however it could cause a test block to be falsely negative, leading to the wrong diagnosis. based on previous studies, we think that this happens rarely, and the purpose of this study is to prove that conclusively

cervical medial branch blocks (cmbb) are commonly employed for the diagnosis and management of facet-related pain. the latter constitutes the most important cause of axial neck pain and has been implicated in 40% of all cases. in addition, the upper cervical joints can also cause cervicogenic headaches, an often-debilitating condition representing up to 20% of chronic headaches3. well-defined pain referral patterns for each joint can help operators select the appropriate injection level. while fluoroscopy has long been the imaging standard for spinal procedures, ultrasound guidance (usg) is being increasingly adopted as an alternative and presents several advantages such as the ability to identify and avoid soft tissue structures such as blood vessels during needle insertion. from a clinical perspective, avoiding blood vessels and reducing the incidence of vascular breach can lessen the occurrence of intravascular injections that are associated with false negative diagnostic blocks. indeed, a recent study examining the safety of usg cmbb reported a lower incidence of vascular breach than previous studies that had used fluoroscopic guidance. while these findings suggested a potential benefit associated with usg, further confirmatory studies employing digital subtraction angiography (dsa), the current imaging standard to detect intravascular spread, are required. we hypothesize that usg will be associated will a lower incidence of intravascular spread during primary needle placement than has been reported with fluoroscopic guidance.

Eligibility criteria:
inclusion criteria: consenting patients over 19 years of age undergoing an ultrasound-guided cervical medial branch blocks as part of their usual care. exclusion criteria: subjects with one or more of the following characteristics will be excluded from the study: known bleeding disorder or coagulopathy patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, at iii agents) inability to visualize targeted structures on ultrasound known allergy to contrast agents

Keywords: ultrasound cervical medial branch block safety digital subtraction angiography
growth factors and hepatic progenitor cells in acute liver failure

Conditions: the Focus of the Study is to Correlate the Growth Factors in Serum With the Progenitor Cells in Liver

Summary: to study the correlation of serological growth factors and the hepatic progenitor cells involved in liver regeneration of liver failure.


Eligibility criteria:
inclusion criteria: acute liver failure received iver transplantation exclusion criteria: pregnancy sepsis heart failure
reframe rpd post-market clinical study

Conditions: Missing Teeth; Dental Wear

Summary: to evaluate the change in patient oral health-related quality of life (ohrqol) from wearing a cobalt chrome (cocr) removable partial denture (rpd) to wearing the solvay dental 360tm polymer removable partial denture (rpd) for 8 weeks.

cohort study conducted in the united states \& united kingdom to assess oral health related quality of life (ohrqol) in patients receiving the study polymer removable partial denture (rpd) as compared to their baseline cobalt chrome (cocr) removable partial denture (rpd) oral health quality of life (ohrqol).

Eligibility criteria:
inclusion criteria: * with the absence of 3 or less teeth per saddle, excluding third molars * partial denture in one arch only * with previous denture wearing experience, and cobalt chrome (cocr) removable partial denture (rpd) fitted in the previous 24 months and the patient is currently and routinely wearing the denture * with a stable oral health in terms of absence of disease activity affecting the periodontium, dental hard tissues (caries), pulp and the structural/aesthetic integrity of restored teeth * with at least 1 posterior natural tooth occlusal stop (molar or premolar) * class i, class ii and class iii (kennedy's classification) * occlusal spacing (static and dynamic) around clasp assembly including the occlusal rest exclusion criteria: * patients requiring extensive treatment prior to the provision of a removable partial denture (rpd) * patients with active primary disease; caries, periodontal disease or symptoms of pulpal or apical pathology to the remaining teeth * patients with irreversibly compromised structural/aesthetic integrity of restored teeth that cannot be restored as part of the provision of treatment. * patients with an opposing removable partial denture (rpd). removable partial denture (rpd) to only be in one arch and must oppose a full denture or a dentate arch which provides a stable occlusal relationship * canines are not to be replaced with the removable partial denture's (rpds). patients must have their natural canines present
non-inferiority trial of iontophoretic corneal collagen crosslinking (cxl) compared to standard corneal collagen crosslinking in progressive keratoconus.

Conditions: Progressive Keratoconus

Summary: the primary purpose of the protocol is to compare the current standard cxl with iontophoretic cxl to provide evidence in relation to the efficacy and safety in progressive keratoconus. corneal collagen crosslinking (cxl) is the first surgical procedure that appears to halt the progression of keratoconus. in the current standard cxl, the central corneal epithelium must be debrided to efficiently permeate the corneal stroma with riboflavin. the epithelium debridement can cause severe pain, infection and stromal haze. the study hypothesis is that iontophorese cxl is as effective as standard cxl to stabilize a progressive keratoconus.

keratoconus is a common bilateral progressive corneal ecstatic disease causing visual impairment by inducing irregular astigmatism and corneal opacities. this disorder typically begins during teenage years, progresses until the age of 30 to 40 years and, in severe forms, may need a corneal transplantation. cxl has changed the natural evolution of keratoconus. it creates links between collagen fibrils in order to rigidify the corneal stroma and slow down the progression of keratoconus. the corneal stroma is soaked with a riboflavin solution before being exposed to ultraviolet-a radiation. in the current standard cxl, the central corneal epithelium must be debrided to allow the penetration of riboflavin into the cornea with a risk of side effects, such as pain for the first two post-operative days, temporary loss of visual acuity during the first three months, and serious complications such as infection and stromal opacity due to corneal scarring. iontophoresis is a non invasive technique in which a weak electric current is used to enhance the penetration of riboflavin into the cornea. the iontophoresis technique could allow intrastromal riboflavin diffusion, while keeping the corneal epithelium on, combining the efficiency of the standard procedure without the side effects of epithelial debridement.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * corneal thickness ≥ 400 µm * progressive stage 1 to 3 keratoconus (krumeich classification) exclusion criteria: * corneal thickness \< 400µm * stage 4 keratoconus (krumeich classification) * concomitant corneal disease * history of corneal surgery

Keywords: progressive keratoconus standard cxl iontophoretic cxl keratometry
study to detect hypotensive episodes during spinal anesthesia for cesarean section using a noninvasive continuous device

Conditions: Hypotension

Summary: hypotension after spinal anesthesia for cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. these changes are poorly depicted by oscillometric measurements. the investigators hypothesized, that a continuous noninvasive device detects more hypotensive periods with lower blood pressures.


Eligibility criteria:
inclusion criteria: * asa physical status i or ii * week of pregnancy \>36 exclusion criteria: * emergency cases
clinical efficacy study comparing visionscope imaging (vsi) to magnetic resonance imaging (mri) in injuries of the knee

Conditions: Meniscus Tears; Loose Bodies; Articular Osteoarthritis; Articular or Capsular Trauma

Summary: the purpose of the study is to accumulate efficacy data on visionscope imaging (vsi) for pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries). the study will compare vsi's accuracy to mri's in diagnosing the same injuries. the hypothesis is the visionscope imaging system will be able to provide direct visualization and diagnostic images of inside the joint capsule space without fluid distention in the knee. this study will provide valuable feedback on the ability of the visionscope system to provide physicians with the information they need to make a definitive diagnosis.

the primary objective of this study is to accumulate efficacy data on the visionscope imaging system (vsi) for pre-operative diagnoses when it is used to provide illumination and visualization of articular cavities. the study will analyze the visionscope system's accuracy compared to mri in diagnosing and confirming meniscus tears, chondral defects, loose bodies, minor arthritis, and/or any articular or capsular trauma. the hypothesis of the study is that the visionscope system will be able to obtain direct visualization and diagnostic images of the intercapsular space without fluid distention in the knee. this study will provide feedback on the ability of the visionscope system to potentially eliminate the need for mri scans. additionally, a cost-analysis comparison between the use of vsi vs. mri for the diagnosis of orthopaedic knee injuries will be conducted. finally, the study will help develop an algorithm of potential use for the vsi system in the management of knee pathologies.

Eligibility criteria:
inclusion criteria: * suspected meniscal injuries to the knee * suspected articular cartilage injuries to the knee exclusion criteria: * acute traumatic hemarthroses and/or concomitant ligament injury * active systemic infection * allergy to silicone or any medication used during the procedure * enrollment in another pharmacological or medical device study * institutionalized persons, prisoners and persons with decisional incapacity * investigator's own students and employees

Keywords: knee injuries meniscus injuries articular cartilage injuries orthopaedic diagnostic magnetic resonance imaging
elderly patients with acute myeloid leukemia (aml), maintenance phase after complete remission (cr)

Conditions: Acute Myeloid Leukemia

Summary: phase ii multicentric trial open label, multicenter, randomized to evaluate the efficacy of a maintenance therapy in first complete remission after induction for elderly (≥ 60) fit patients with poor prognosis acute myeloid leukemia (aml). the disease-free survival (dfs) of the patients included in this study will be compared to the ones of the two previously reported groups of patients treated with the same lia induction therapy

* the primary objective of this study will be to improve the dfs with an alternate schema combining azacitidine and lenalidomide in elderly fit patients with previously untreated aml and with high risk cytogenetics or secondary aml, who achieved either a complete remission after an lia induction therapy * the secondary objectives will be to determine the relapse incidence, overall survival, event free survival at 1 and 2 years of follow-up, toxicities of the treatment, incidence of infectious events. * to define a gene expression and promoter methylation signatures associated with cr and absence of relapse when patients received azacitidine and lenalidomide. gene promoter methylation and gene expression profiling will be performed at diagnosis, at cr, and after 2 courses of azacitidine and lenalidomide in order to give insight within the mechanisms involved by the use of these 2 drugs and to identify new epigenetic prognostic markers.

Eligibility criteria:
inclusion criteria: * cytologically or histologically confirmed acute myeloid leukemia (aml) with : * at least 60 years of age and fit for intensive chemotherapy: ps \<2 (ecog) * absence of significant co-morbidities * less than 75 years\* of age * lam with high risk features (blasts \> 20% in bone marrow) * poor risk cytogenetics * life expectancy \> 1 month * affiliated to social security regimen * no granulocytic sarcoma as sole site of disease * able and willing to provide written and signed informed consent exclusion criteria: * total bilirubin \> 2 times upper limit of normal * ast and alt and/or alkaline phosphatase \> 4 times upper limit of normal if not in relation with aml. * factor v \< 50% without dic (disseminated intravascular coagulation) * nyha class iii or iv congestive heart failure (echo \< 40%, lvef \< 50%),unstable angina pectoris, serious cardiac arrhythmia * renal failure not related to aml: serum creatinin \> 170 μmol/l or clearance of creatinin ≤ 50 ml/mn * known hiv 1- hiv 2 positivity * prior therapy with azacitidine or lenalidomide * psychiatric illness or social situations that would preclude compliance with study requirements * uncontrolled infection * urgent chemotherapy for dic, spontaneous tumoral lyse syndrome, leucostase without cytogentic results * women who are pregnant or breastfeeding * women who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy * men who are unwilling or unable to use an acceptable method of birth control

Keywords: maintenance treatment disease free survival
a study of the effects of pf-04958242 in subjects with age-related hearing loss

Conditions: Hearing Loss, Sensorineural

Summary: the objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of pf-04958242 and placebo in subjects with age-related hearing loss.

this study was previously posted by pfizer, inc. sponsorship of the trial was transferred to biogen.

Eligibility criteria:
inclusion criteria: * subjects must have a current diagnosis of age related sensorineural hearing loss in the range of 30-60 db, averaged over 2 and 4 khz in at least one ear. * subjects must have symmetric hearing loss * subjects who can read, speak and comprehend english. exclusion criteria: * subjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss * subjects who have hearing disorders other than age related sensorineural hearing loss * subjects with moderate or greater tinnitus * pregnant females; breastfeeding females; females of childbearing potential

Keywords: age related sensorineural hearing loss pf-04958242