Kornimate/medical-research-clean huggingface dataset:
association between patients' perceptions of success in post-op pain management and overall experience with care

Conditions: Postoperative Pain

Summary: assessing the association between patients' perceptions of success with post-operative pain management and overall experience with care.

a study to assess the association between patients' perceptions of success with post-operative pain management following total hip replacement or hysterectomy surgery and their later perception of pain management while in the hospital and the hospital overall.

Eligibility criteria:
inclusion criteria: * subject must be 18 years of age or older * subject (or their legally acceptable representative) must have signed an informed consent form (icf) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study * subject is receiving a unilateral total hip replacement or a hysterectomy (total abdominal hysterectomy, total abdominal hysterectomy/bilateral salpingo-oophorectomy, total vaginal hysterectomy, or total vaginal hysterectomy/salpingo-oophorectomy) * subject is expected to remain hospitalized for at least 24 hours post-operatively * subject is expected to experience pain requiring iv pca or non-pca (non-patient controlled opioids via iv, im, sc, or po routes of administration) opioids for at least 24 hours after surgery * subject is classified as american society of anesthesiology (asa) category i, ii, or iii * subject is willing to complete the required post-operative survey measures to be completed in the hospital * subject is willing to complete a post-discharge survey (including hcahps survey instrument) via telephone approximately two-weeks (14 days) post-discharge exclusion criteria: * subject is having an operation other than the surgical procedures selected for inclusion (e.g., bilateral or partial hip replacement, or hip revision) * subject cannot read, write, and communicate in english * subject has a history of tolerance to opioids including those prescribed opioids in the 3 month period leading up to the perioperative period (i.e., a subject is considered to have a potential tolerance to opioids if for 4 consecutive days prior to surgery they have been taking a short acting/short acting combination opioid analgesic greater than 120 mg codein daily, 40 mg hydrocodone daily, 200 mg tramadol daily, or 40 mg oxycodone daily or if they were on any dose of strong opioid analgesic such as morphine, hydromorphone, or fentanyl) * subject has a history of allergy to opioids reported pre-operatively or documented in medical history * subject is scheduled to receive additional surgical procedures beyond those listed within 72 hours of the initial surgery
a phase 2 study of iw-3300 for the treatment of bladder pain in subjects with interstitial cystitis/bladder pain syndrome

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Summary: the aim of this study is to assess whether iw-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (ic/bps). the main question the study aims to answer is whether iw-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). subjects will be assigned to receive either the study drug or placebo by chance.

this is a phase 2, randomized, placebo-controlled, parallel-assignment, 12-week, adaptive design study to evaluate the efficacy, safety, and tolerability of iw-3300 in subjects with ic/bps. subjects will be randomized 1:1:1 to iw-3300 100 µg, iw-3300 300 µg, or matching placebo administered as a rectal foam. the study has 4 periods, which are the screening (up to 30 days), pretreatment (up to 21 days), study treatment (12 weeks), and follow-up periods (2 weeks) which consists of 7 onsite study visits and 1 follow-up phone call. subjects will administer the study drug at home for 12 weeks.

Eligibility criteria:
inclusion criteria: * diagnosed with ic/bps by a urologist or other clinician specializing in ic/bps * chronic bladder pain associated with filling the bladder over the past 6 months * compliant with ediary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period * has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency \>8×day, urgency * body mass index (bmi) ≤40 kg/m2 * willing to use a rectally administered product once daily for 12 weeks exclusion criteria: * male subject has history of bacterial prostatitis or benign prostatic hyperplasia with active symptoms that are difficult to distinguish from ic/bps * has a condition that can be a contraindication to using a rectal foam * has cancer under active treatment or a history of uterine, cervical, pelvic, colorectal, ovarian, or vaginal cancer * has a history of benign or malignant bladder tumors * has an active urinary tract infection or had ≥2 utis within the past 90 days * has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years * has a malabsorption syndrome * had surgery in the pelvic or abdominal region within the past 90 days or is planning pelvic or abdominal region surgical procedures before the end of the study * has received a cystoscopy with or without hydrodistension for diagnostic purposes (ie, not for pain relief) within the past 30 days or a cystoscopy with therapeutic hydrodistension (ie, for pain relief) within the past 90 days or is planning a cystoscopy for any reason before the end of the study * has history of pelvic irradiation or radiation cystitis, or drug-induced cystitis. * has a recent history of drug or alcohol abuse
comparing continuation or de-escalation of bone modifying agents (bma) in patients treated for over 2 years for bone metastases from either breast or castration-resistant prostate cancer

Conditions: Breast Cancer; Castration-resistant Prostate Cancer

Summary: the investigators propose is to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating bma after a minimum of two years of bma treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer


Eligibility criteria:
inclusion criteria: * patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer or breast cancer who are currently receiving bma * patient has received bma for 2 or more years counting from the first bma dose for bone metastases * age 18 years or older * able to provide verbal consent exclusion criteria: * definite contraindication for bma * history of, or current evidence of osteonecrosis of the jaw * radiotherapy or surgery to the bone planned within 4 weeks after randomization * current hypercalcemia defined as corrected serum calcium of \> 3 mmol/l (from standard bloodwork completed within one month prior to treatment dose)

Keywords: bone modifying agents bma breast cancer castration-resistant prostate cancer
pain monitoring of herniated disc surgery patients with oura ring

Conditions: Pain Measurement

Summary: the objective of this research study is to show whether data given by oura ring could be used to objectively measure patients pain and well-being before and after disc surgery.

the study will consist of a total 30 disc prolapse patients. patients are given oura rings along with other treatment. patients use oura rings before and after disc surgery. patients will also fill beck depression inventory (bdi) and pain detect inquiries in the beginning and in the end of study. patients symptoms will also be followed daily by electrical symptom diary. oura rings technology is based on photoplethysmography( ppg). ppg is a noninvasive method to detect blood volume changes in the microvascular bed of tissue. ppg waveform varies by respiration, sympathetic nervous system activity and thermoregulation. oura ring gives information of patients activity level, calorie consumption, steps count, resting heart rate,heart rate variability, respiration rate, body temperature, sleep depth and quality of sleep. data collected with oura ring after disc surgery will be compared to data collected before surgery.

Eligibility criteria:
inclusion criteria: * upcoming herniated disc surgery, ability to give a written informed concent exclusion criteria: * sleep apnea, condition with irregular heart rate, lack of cooperation

Keywords: pain oura ring activity measurment herniated disc
efficacy and safety of sr58611a in patients with major depressive disorder (sirius)

Conditions: Major Depressive Disorder

Summary: to evaluate the efficacy of two fixed doses of sr58611a (175 mg q12 and 350 mg q12) compared to placebo in patients with major depressive disorder (mdd) using paroxetine (20 mg qd) as positive control. in addition, the tolerability and safety of sr58611a in patients with mdd will be evaluated.


Eligibility criteria:
inclusion criteria: * patient with major depressive disorder diagnosed according to diagnostic and statistical manual of mental disorders dsm-iv-tr * patient meets criteria for a recurrent major depressive episode (mde) * patient meets severity assessments of depression specified by the study exclusion criteria: * patient is at immediate risk for suicidal behavior * patient is with a unstable medical condition * patient with psychotic features, catatonic features, seasonal pattern or postpartum onset * patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data * patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months * patient has been treated with paroxetine (paxil) within the previous 6 months * patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study

Keywords: depression clinical trials major depressive disorder
unhealthy alcohol drinking and anesthetic requirement in women

Conditions: General Anesthesia

Summary: unhealthy alcohol drinking is negatively influencing health of people and costing a large number of annual finance via "secondhand" effects. additionally, unhealthy alcohol use covers a spectrum that is associated with varying degrees of risk to health. the investigators hypothesized that unhealthy alcohol drinking resulted in significant increase in anesthetic requirement during general anesthesia. this investigation would clarify the association between unhealthy alcohol use and the intraoperative consumption of anesthetics, and provide clinical evidence for preoperative assessment with respect to the alcohol drinking habit.


Eligibility criteria:
inclusion criteria: * asa physical status i-ii * chinese * 19-45yr * undergoing general anesthesia exclusion criteria: * a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records. * participants younger than 18yr，older than 45yr or pregnancy was eliminated. * those who were not willing to or could not finish the whole study at any time.

Keywords: anesthetics sedatives analgesics
effect of food form on satiety and gastric emptying

Conditions: Appetite

Summary: our objective is to determine whether food form (liquid vs. solid) alters gastric emptying, satiety, and food intake, when all macronutrients and fiber are controlled. the study population will include 10 healthy women, who have a normal body mass index. we have chosen to evaluate only women because this is a small pilot study and one of our endpoints is gastric emptying. gastric emptying is known to differ between men and women. gastric emptying will be evaluated using the smartpill technology, satiety will be evaluated using computerized visual analog scales/questions, and food intake will be measured by providing subjects with an ad libitum/buffet-style lunch. our hypothesis is that our subjects will be less hungry after they eat a solid breakfast compared to a liquid breakfast. we also hypothesize that our subjects will have a slower gastric emptying time after they eat the solid meal. lastly, we think subjects will want to eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for breakfast.


Eligibility criteria:
inclusion criteria: * healthy women * age 18 - 35 * body mass index in the healthy range between 18.5 and 25 * proficient english speakers * non-smoking * not taking medications * non-dieting (weight stable over last 3 months) * able to swallow a large capsule exclusion criteria: * irregular or erratic breakfast eating patterns * food allergies to ingredients commonly found in test products or pizza * distaste for test products or pizza * bmi less than 18.5 or greater than 25 * weight change \> 5 kg in last 3 months (intentional or unintentional) * difficulty swallowing * cardiovascular disease * diabetes mellitus (fasting blood sugar \> 126 mg/dl) * cancer in prior 5 years (except basal cell carcinoma of skin) * kidney or liver disease * any gastrointestinal conditions that may affect digestion and absorption * recent bacterial infection (\< 3 months) * chronic medication use * history of drug or alcohol abuse in prior 6 months * concurrent or recent intervention study participation * vegetarians or people who ate more than approximately 15 g of fiber per day * pregnant or lactating women * women with irregular menstrual cycles

Keywords: appetite satiety gastric emptying time food intake food form
evaluation of angioplasty in the treatment of chronic cerebrospinal venous insufficiency (ccsvi) in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the study is being done to determine if venous angioplasty is an effective treatment for chronic cerebrospinal venous insufficiency (ccsvi). in this condition, areas of narrowing or blockages are present in the internal jugular or azygos veins (veins which drain blood from the central nervous system) and these blockages may be associated with symptoms classically attributed to ms. therefore, angioplasty may help to improve the symptoms associated with ccsvi and multiple sclerosis (ms). in this study, the investigators will evaluate the effectiveness of angioplasty in the treatment of ccsvi by comparing two the outcomes of two groups of patients: one group with ccsvi diagnosed on a venogram and treated with angioplasty and one group with ccsvi diagnosed on a venogram but not treated. the patients enrolled in this study, and the neurologist evaluating patients after the procedure, will not know whether or not they were treated with angioplasty.


Eligibility criteria:
inclusion criteria: * patients who are willing to comply with the protocol requirements and can be contacted by telephone * patients 18-60 years of age * patients with clinically definite multiple sclerosis by polman criteria * patients with a history of ms as defined above with an edss between 3-6. * patients with a significant stenosis of the internal jugular or azygos vein on the basis of magnetic resonance venography or doppler ultrasound. exclusion criteria: * patients with renal insufficiency based on an estimated gfr \<45 * patients with a known severe allergy to iodine or gadolinium-based contrast agents which cannot be adequately pre-medicated * patients with a known allergy to nickel * patients who pregnant * patients with a contraindication to anticoagulation or anti-platelet medication * patients with a contraindication to drugs used for conscious sedation during interventional procedures, including versed and fentanyl * patients with a history of deep venous thrombosis of the lower extremities * patients with occlusion of the right and left common femoral veins * patients who have had any changes in their disease modifying drug regimen for ms during the 6 months prior to enrollment in this trial. this would include the addition of any new medications, a change in the dosage of any medications, or the removal of any medications from a patient's drug regimen * patients with a life expectancy \<18 months * patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial

Keywords: multiple sclerosis angioplasty vein
complete occlusion of coilable aneurysms

Conditions: Intracranial Aneurysm

Summary: to compare the safety and effectiveness of pipeline embolization device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms


Eligibility criteria:
inclusion criteria: * age 21 to 75 years, inclusive * patient has a single target ia that: 1. is located in the following regions of the internal carotid artery: i. paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. cavernous iii. petrous 2. is saccular 3. has a parent vessel with diameter 2.5-5.0 mm * if target ia has a neck \>4 mm, at least 2 of 3 members of an independent expert committee (iec) have confirmed that coil embolization with optional adjunctive techniques\*\* has a very high likelihood of procedural success (i.e., coil placement and retention) * subject has provided written informed consent using the irb-approved consent form * subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements * \*\* adjunctive techniques include intravascular balloons \["balloon remodeling"\], 3d coils, dual catheter techniques. exclusion criteria: * target ia has both neck \>4 mm and size (maximum fundus diameter) \>10 mm * more than one ia requires treatment in the next 6 months * subarachnoid hemorrhage in the past 60 days * any intracranial hemorrhage in the last 42 days * major surgery in the last 42 days * coils in place in the target ia * unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days) * known irreversible bleeding disorder * platelet count \< 100 x 103 cells/mm3 or known platelet dysfunction * inability to tolerate, documented evidence of adverse reaction or contraindication to study medications * prior stent placement at target site * contraindication to ct scan and mri * known allergy to contrast used in angiography that cannot be medically controlled * known severe allergy to platinum or cobalt/chromium alloys * relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dl) * woman of child-bearing potential who cannot provide a negative pregnancy test * evidence of active infection at the time of treatment * other known conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis) * current use of cocaine or other illicit substance * any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days * extracranial stenosis greater than 50% in the carotid artery * intracranial stenosis greater than 50% in the treated vessel

Keywords: neurovascular embolization therapeutic embolization
the role of tc 99m mdp spect/ct in osteoarthritis

Conditions: Osteoarthritis

Summary: evaluation of the diagnostic value of spect/ct in patients with knee and/or hip oa, whether it is related to clinical findings and it could reflect clinical disease activity, and to determine the usefulness of spect/ct in early detection of oa.

osteoarthritis (oa) is a slowly developing chronic degenerative joint disease that progresses over years. after the classification and reporting of oa were established by american college of rheumatology in 1986, the diagnosis has depended on the patients' symptoms and supported by plain radiographic findings. since x-ray image has a discrepancy with clinical findings, the therapeutic modalities tend to depend on the clinical symptoms, rather than the objective imaging findings. mri is a non-invasive and a very sensitive tool in detecting the early bony change such as bone marrow oedema, but it has some limitation in that it may have false positive or false negative results in the detection of the patella-femoral (pf) lesions. bone scintigraphy is relatively sensitive because it reflects the early physiological changes of joints. but its image is planar that it cannot give enough information for the anatomic localization, and the image is overlapped. to compensate for the defects of these imaging methods, bone single photon emission computed tomography (spect) has emerged as useful imaging tools in the diagnosis of oa. based upon the fact that subchondral bony changes precede joint space narrowing in oa, bone spect seems to be a very useful tool in early oa, reflecting the early bony changes. the use of spect/ct offers the benefit of combined anatomical, mechanical (ct) and functional imaging (spect), which represents a relevant improvement in preoperative diagnosis and follow-up after procedures.

Eligibility criteria:
inclusion criteria: * adult patient above 30 years old. * clinically diagnosed osteoarthritis before treatment. * patient with refractory active osteoarthritis (not responding to treatment). * ability to sleep in fixed position for about 25 minutes * ability to provide informed consent. exclusion criteria: * patient with resolved osteoarthritis. * patient with other disease in joints: * avascular necrosis * stress fracture * neuropathic pain
randomized trial of transcranial theta-burst stimulation and transcranial direct current stimulation

Conditions: Stroke

Summary: background: stroke is a leading cause of adult disability. non-invasive brain stimulation can induce significant and sustained improvements in functional outcome. however the effect is inconsistent and difficult to predict, in particular in the subacute phase after stroke. although several different stimulation techniques are available, it is unknown which is suitable for which patient. objectives: this study has three main objectives: 1. to compare the effects of two techniques of non-invasive brain stimulation (ctbc, continuous theta-burst stimulation; tdcs, direct current transcranial stimulation) on clinical recovery in patients with subacute stroke. 2. to assess the effect of these brain stimulation techniques on brain organization with non-invasive imaging. 3. to find clinical and neural predictors of responsiveness to brain stimulation therapy. method: 45 patients with ischemic or hemorrhagic stroke will be randomly assigned to one of 3 groups: ctbs, tdcs, or sham stimulation. each group will receive the corresponding stimulation therapy 3 times per week for 3 weeks, immediately before intensive physical therapy. before and after the treatment period, standardized assessments of sensorimotor function areas are obtained together with electroencephalography and functional magnetic resonance recordings. these recordings will be used to analyze and compare the neural effects of each treatment modality. clinical implication: the results of this study might help optimize and individualize stimulation treatment for patients with subacute stroke. it may hence facilitate the transfer of brain stimulation therapy to routine clinical practice.


Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke leading to unilateral deficits in motor function with significant impact on independence and daily activities at the beginning of rehabilitation * less than 10 weeks after stroke onset. exclusion criteria: * epileptic seizures * metallic objects in the brain * presence of implants or neural stimulators * pregnancy * sleep deprivation * recent traumatic brain injury * delirium or disturbed vigilance * inability to participate in 1h treatment sessions * severe language comprehension deficits * skull breach * new stroke lesions during rehabilitation * medical complications

Keywords: stroke brain stimulation electroencephalography functional magnetic resonance imaging functional connectivity