Kornimate/medical-research-clean huggingface dataset:
gastrointestinal biopsychosocial research center

Conditions: Chronic Proctalgia (Also Called Levator Ani Syndrome)

Summary: this study has been completed. the following is a brief description of the aims, methods, and results of the study: previous small studies suggest that chronic proctalgia (chronic recurring pain in the anal canal or rectum), which is also called levator ani syndrome, can be treated with biofeedback to teach relaxation of pelvic floor muscles, or electrogalvanic stimulation (electrical stimulation to relax muscles), or massage of pelvic floor muscles. the aim of this study was to compare the effectiveness of these three treatments, to determine how they work physiologically, and to identify which patients are most likely to benefit. methods: subjects had to meet the diagnostic criteria for chronic proctalgia and to report pain at least once a week. they had to also be free of medical or psychiatric disorders that could explain their chronic proctalgia. patients qualified to enter the study were separated into two groups based on whether they reported tenderness when the examining physician pressed on the levator ani muscles of the pelvic floor. all 157 patients who were enrolled received 9 sessions of psychological counseling plus biofeedback or electrogalvanic stimulation or massage. the results of treatment were assessed at 1, 3, 6, and 12 months after the end of treatment.


Eligibility criteria:
inclusion criteria: recurring episodes of pain or aching in the anal canal or rectum for at least 12 weeks in the previous year. episodes last at least 20 minutes. pain must occur at least weekly during a 4-week run-in. exclusion criteria: other medical or psychiatric diagnoses that could explain recurring rectal pain. daily use of psychotropic medications. meets diagnostic criteria for irritable bowel syndrome or functional constipation. screening studies included physical examination by a gastroenterologist, colonoscopy, pelvic ultrasound, and surgical consult in all patients and referral to a gynecologist or urologist if indicated by history.

Keywords: biofeedback pelvic floor levator ani syndrome chronic proctalgia electrogalvanic stimulation massage
rhabdomyolyse in intensive care

Conditions: Rhabdomyolysis

Summary: analysis of the outcome of patients \< 18 years old, treated in an intensive care unit for severe rhabdomyolysis, regardless of etiology (renal failure rate, death rate, organ replacement rate)


Eligibility criteria:
inclusion criteria: * cpk \> 5000 ui/l * care in pediatric intensive care unit * age \< 18 years old exclusion criteria: * parental refusal

Keywords: rhabdomyolysis child intensive care
animal assisted therapy after pediatric brain injury: mediators and moderators of treatment response.

Conditions: Brain Injuries

Summary: children requiring inpatient rehabilitation treatment following acquired brain injury (abi) are at risk for poor engagement in rehabilitative therapies. a within subject crossover design will be used to determine whether involving dogs in physical and occupational therapies while receiving inpatient rehabilitation improves patient engagement, how involving dogs improves engagement, and identify who is most likely to benefit. this project addresses the critical need to establish an evidence base for animal-assisted therapies in pediatric rehabilitation, incorporates innovative methods, and has the potential to lead to improved clinical care for children and adolescents receiving intensive rehabilitation following abi.


Eligibility criteria:
inclusion criteria: * diagnosis: participants must be admitted to the inpatient rehabilitation unit for treatment of an acquired brain injury (tbi, brain tumor, infection, etc). * consent: the family must provide informed consent by parents or legal guardians. * assent: the child/adolescent must provide a signature indicating assent to participate in the study. * age at the time of screening: 4-21 years old * sex: includes both males and females * responsiveness: rancho score greater than 2 at the time of enrollment (as noted in the medical chart). exclusion criteria: * allergies: patient has a significant allergy to dogs * fear: patient has a significant fear of dogs * disease: participant is on contact precautions or has a communicable disease that may pose a risk to the dog or dog handler or has a compromised immune system where interacting with the dog and/or handler would be of significant risk to the patient. * medical history: history of developmental delay prior to abi. * behavioral history: participant or family has a history of animal abuse or cruelty. * responsiveness: rancho score of 2 or less

Keywords: pediatric brain injury animal assisted therapy inpatient rehabilitation
sc2i tissue and data repository protocol

Conditions: Critical Illness

Summary: the purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (csf, the fluid that surrounds the brain and spinal cord), wound tissue and/or wound fluids, and other body fluids and tissues from people who have been seriously injured or ill. the samples will be used to develop and assess tests and/or tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. additonal protocols to use the samples will be submitted as separate protocols.


Eligibility criteria:
inclusion criteria: * patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at sc2i sites (grady memorial hospital, emory univeristy hospital, and duke university health systems) * healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury. * ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent. exclusion criteria: * any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.
risk factors for treatment failure of scabies in autochthonous populations of french guiana (guyagale)

Conditions: Scabies

Summary: scabies is a neglected tropical disease, particularly important in autochthonous populations. treatment failures could explain the high prevalence of this disease in amerindian and maroon populations of french guiana. our main objective is to look for specific sociodemographic risk factors for treatment failure of scabies in the remote areas of french guiana. a secondary objective is to evaluate the prevalence of scabies and its complications.

scabies is known to be a health issue of particular importance in marginal and autochthonous populations throughout the world. french guiana is a french territory harbouring several autochthonous populations living in remote rainforest areas. the prevalence of scabies remains high in these areas despite primary care offered by the local health centres. a prevalence of 2.5% was found in two amerindian villages in a retrospective study in 2019. therapeutic failures are known to be one of the main causes of a long-lasting high prevalence. in low-resources populations, socio-economic factors and promiscuity are particularly incriminated. the role played by these factors should be studied in french guiana. secondary complications such as impetigo and post-streptococcal glomerulonephritis should be evaluated, as they represent an important part of the global burden of scabies. this study will be conducted from april to august 2021 in remote settlements of french guiana. patients will be seen during a first inclusion consultation, realized by the same investigator (rb). all patients with diagnosis of " confirmed " or " clinical " scabies according to the international alliance for the control of scabies will be included in case of agreement. patients will be treated according to the current protocol in the health centres for remote areas of french guiana (according to the european guidelines for the treatment of scabies: two doses of ivermectin 0.2mg/kg on day 1 and day 7 ; benzyl benzoate 10% or permethrin 5% for children under 15kg or pregnant women). the follow-up consultation will take place six weeks later. the same investigator (rb) will assess treatment failure or success. research of etiologic factors associated with treatment failure; multicentric regional sample category 3 non-interventional human person research (riph 3)

Eligibility criteria:
* inclusion criteria : * confirmed or clinical scabies according to the criteria of the international alliance for the control of scabies * agreement to answer to the follow-up questionnaire * agreement to come back for a six-weeks follow-up consultation. * exclusion criteria: * patient with possible diagnosis of scabies, not fulfilling the criteria for " confirmed " or " clinical " scabies * refusal of the questionnaire or the follow-up consultation

Keywords: scabies risk factors prevalence indigenous population
physical rehabilitation of older persons following a community-acquired infection hospitalization: a feasibility study

Conditions: Community-acquired Pneumonia; Urinary Tract Infections

Summary: community-acquired infections such as community-acquired pneumonia (cap) and urinary tract infection (uti) remain leading causes of hospitalization and death due to infections in older persons in europe. hospitalization often results in further disabilities and frailty for older and frail individuals, from which some may never recover. physical activity is well-established as a cornerstone in the primary prevention and treatment of several noncommunicable diseases. however, there is currently no established rehabilitation model following a pneumonia or other infection, nor is there any evidence to support the impact of rehabilitation on the mental and physical health of older and frail individuals following a pneumonia hospitalization or other infection. the aim of the feasibility study is to evaluate a patient-centered and individualized exercise intervention that is kick-started during hospitalization and continued for 3 months after discharge with video-supervised home-based exercise training to patients hospitalized with cap or uti compared to standard care with regard to safety, clinical outcomes, patients' perception, functional ability, organizational aspects, and economic aspects.


Eligibility criteria:
inclusion criteria: * patients aged ≥65 years or ≤65 years if the presence of at least one chronic disease (e.g., diabetes, copd, heart failure, etc.) * suspicious of a lower respiratory tract infection and * presence of one or more symptoms of a lower respiratory tract infection such as fever ≥38.3°c, hypothermia \<35.0°c, new onset of cough, pleuritic chest pain, dyspnea, or altered breath sounds on auscultation. * positive urine nitrate test and/or leukocyturia as depicted by positive esterase test or microscopy and * presence of one or more symptoms of urinary tract infection such as dysuria, urgent or frequent urination, perineal or suprapubic pain, costo-vertebral tenderness or flank pain, fever (ear or rectal temperature of ≥38.2°c or axillary temperature of ≥38.0°c), or history of feeling feverish with shivering or rigors in the past 24 hours. * functionally independent before hospitalization and expected to be discharged to their own homes. * signed informed consent. exclusion criteria: * hospitalization within the past 14 days. * inability to participate in the study due to dementia, paralysis, or other disorders. * severe aortic valve stenosis or terminal illness. * unstable cardiac arrhythmic disease. * high risk for non-adherence as determined by screening evaluation. * already participating in regular exercise training. * unable to understand danish. * unwilling or unable to give informed consent.

Keywords: cap uti
comparison of the immediate effects of manual therapy techniques in non-specific neck pain

Conditions: Manual Therapies; Neck Pain

Summary: the aim of this study is to investigate the effects of manual therapy techniques on joint range of motion, pain tolerance, grip strength, and functionality in individuals with non-specific neck pain. the study is experimental in design. individuals aged between 18 and 55 who were diagnosed with non-specific neck pain and met the inclusion criteria participated in the study.

participants who agreed to take part and signed the informed consent form were asked to complete the "patient assessment form" during the initial interview. in addition, the following assessment tools were used: the cervical range of motion (crom) device to evaluate joint range of motion, a hand dynamometer to assess grip strength, an algometer to measure pain tolerance, and the "neck disability index" to evaluate functionality. participants were then randomly assigned to one of three groups: group 1: atlanto-occipital manipulation group 2: cervical mobilization group 3: trigger point therapy participants in the first group received atlanto-occipital manipulation, those in the second group underwent grade ii-iii mobilization techniques, and those in the third group received trigger point therapy, which consisted of ischemic compression followed by myofascial stretching on the upper trapezius muscle. immediately after the treatments, joint range of motion, pain tolerance, and functionality were reassessed. the manual therapy interventions for all three groups were performed by different specialized physiotherapists trained in these techniques. the evaluations, however, were conducted by another physiotherapist who was blinded to the treatments (double-blind study). the data were statistically analyzed using the statistical package for the social sciences program, and a p-value of less than 0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * be between the ages of 18 and 55 * have been diagnosed with non-specific neck pain by a specialized physician * have been experiencing neck pain for less than 3 months * have a neck pain level of at least 3 on the visual analog scale * have bilateral active trigger points in the upper trapezius muscle * have restricted active cervical range of motion exclusion criteria: * presence of neurological deficit or radicular pain * history of pathology or surgery in the cranio-cervical region * positive response in the extension-rotation test * use of anticoagulants or corticosteroids * presence of one or more red flags defined for non-specific neck pain

Keywords: manual therapy techniques non-specific neck pain immediate effects
effect of spinal ketorolac after acute opioid exposure

Conditions: Healthy

Summary: this research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. the medication in this study may have a role in better treatment of pain. the goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. the sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. this study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. the investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous \[iv\] narcotic painkiller): 1. how much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream? 2. what pain relieving effects does spinal ketorolac have when given with iv remifentanil?

intravenous (iv) remifentanil stimulates spinal cox activity, leading to increased cerebrospinal fluid csf) prostaglandin e2 (pge2) concentrations and areas of capsaicin-induced mechanical hypersensitivity after remifentanil infusion, and these effects will be blocked by intrathecal ketorolac. areas of mechanical hyperalgesia and allodynia will be established by topical capsaicin + intermittent heat in healthy volunteers, who will be randomized to receive intrathecal saline or ketorolac during remifentanil infusion, with primary outcome measure area of hyperalgesia and secondary outcome measure cerebrospinal fluid (csf) prostaglandin e2 (pge2) concentration after stopping remifentanil.

Eligibility criteria:
inclusion criteria: * healthy * american society of anesthesiologist (asa) i or ii classification * between the ages of 18-55 * weigh less than 250 pounds * without chronic pain exclusion criteria: * taking analgesics in the last 2 weeks * positive urine drug screen * pregnancy * currently taking any prescription antidepressants or other medications that are mood altering * liver or kidney disease * stomach ulcers * allergies to ketorolac, lidocaine, or capsaicin cream * lung disease (copd)

Keywords: healthy volunteers analgesia pain healthy subjects
a clinical study to investigate the efficacy and safety of lacosamide as an add on therapy in children with epilepsy with partial-onset seizures

Conditions: Epilepsy

Summary: the purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (lcm) in pediatric subjects.


Eligibility criteria:
inclusion criteria: * an institutional review board (irb)/independent ethics committee (iec) approved written informed consent form (icf) is signed and dated by the subject or legal representative. the icf or a specific assent form, where required, will be signed and dated by minors * subject has completed the transition period of sp0967 \[nct02477839\] or sp0969 \[nct01921205\] for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy * subject is expected to benefit from participation, in the opinion of the investigator * subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator * subject is male or female aged 1 month to ≤17 years * subject has a diagnosis of epilepsy with partial-onset seizures exclusion criteria: * subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (lcm) * subject meets a mandatory withdrawal criterion (ie, must withdraw criterion) for sp0967 or sp0969, or is experiencing an ongoing serious adverse event (sae) * for subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('yes') to either question 4 or question 5 of the columbia-suicide severity rating scale (c-ssrs) at visit 1 * female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception

Keywords: lacosamide vimpat ucb epilepsy partial-onset seizures pediatric
a study to observe how insulin glargine 300 u/ml is working and is tolerated in elderly patients ≥75 years of age with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: primary objective: - glycemic control after initiation or switch to insulin glargine 300 u/ml in everyday clinical practice secondary objective: - treatment satisfaction

study duration per participant is expected to be approximately 24 weeks

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (t2dm) with oral antidiabetic drug (oad) ± glucagon-like-peptide-1 receptor agonist (glp-1-ra) ± basal insulin (other than insulin glargine 300 u/ml) * age ≥75 years incl. patients from outpatient and inpatient care forms * glycohaemoglobin (hba1c) ≥8.0% and ≤11.0% * inadequate glycaemic control (hba1c), defined by the treating physician * ability and willingness to perform fasting blood glucose (bg) measurements themselves or with the support of third parties * signed consent form exclusion criteria: * type 1 diabetes mellitus * age \<75 years * contraindications to insulin glargine 300 u/ml * short-acting insulin in medication * current participation in clinical research * life expectancy \<1 year * known alcohol or drug abuse * mini mental state examination score ≤19 the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
cc-5013 plus dexamethasone versus dexamethasone alone in previously treated subjects with multiple myeloma

Conditions: Multiple Myeloma

Summary: randomized subjects will receive cc-5013 plus high-dose dexamethasone or placebo appearing identical to cc-5013 plus high-dose dexamethasone in 4-week cycles. each subject will participate in a treatment phase and a follow-up phase.

this was a phase 3, multicenter, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of cc-5013 plus oral pulse high-dose dexamethasone and oral pulse high-dose dexamethasone therapy alone in subjects with relapsed or refractory multiple myeloma. eligible subjects were randomized in a 1:1 ratio to 1 of 2 treatment groups: subjects in the cc-5013/dex treatment group took 25 mg of cc-5013 orally once daily on days 1 to 21 and a matching placebo capsule once daily on days 22 to 28 of each 28-day cycle; subjects in the placebo/dex treatment group took 1 placebo capsule on days 1 to 28 of each 28-day cycle. subjects in both treatment groups took 40 mg of dexamethasone orally once daily on days 1 to 4, 9 to 12, and 17 to 20 of each 28-day cycle for the first 4 cycles of therapy. beginning with cycle 5, the dose of dexamethasone was reduced to 40 mg orally once daily on days 1 to 4 for the remaining cycles.

Eligibility criteria:
inclusion criteria: * prior or current diagnosis durie-salmon stage ii or iii multiple myeloma. * no more than 3 previous anti-myeloma regimens * no high-dose dexamethasone (total monthly dose of dexamethasone greater than 200 mg) within 6 months of study randomization. * measurable levels of myeloma paraprotein in serum or urine (24-hour collection sample). exclusion criteria: * prior development of disease progression during high-dose dexamethasone containing therapy. * laboratory abnormalities: absolute neutrophil count less than 1,000 cells/mm cubed * laboratory abnormalities: platelet count less than 75,000/mm cubed * laboratory abnormalities: serum creatinine greater than 2.5 mg/dl * laboratory abnormalities: serum glutamic oxaloacetic transaminase (sgot, aspartate transaminase \[ast\]) or serum glutamic pyruvic transaminase (sgpt, alanine transaminase \[alt\])greater than 3.0 x upper limit of normal * laboratory abnormalities: serum total bilirubin greater than 2.0 mg/dl * prior history of malignancies other than multiple myeloma unless the subject has been free of the disease for greater than or equal to 5 years. * known hypersensitivity to thalidomide or dexamethasone. * development of a desquamating rash while taking thalidomide.

Keywords: multiple myeloma refractory and relapsed revlimid cc5013