Kornimate/medical-research-clean huggingface dataset:
role of office hysteroscope in premenopausal uterine bleeding

Conditions: Uterine Bleeding

Summary: the aim of this study is to photographically characterize the endometrium in patients presenting with abnormal uterine bleeding at age group from 20 to 45 years old. and compare dilatation and curettage with hysteroscopy in obtaining an accurate diagnosis of the etiology of abnormal uterine bleeding.

menstrual dysfunction is the cause of discomfort and disturbed healthy lifestyle. abnormal uterine bleeding (aub) is considered as a common problem in premenopausal women. aub is defined as bleeding from the uterine that is abnormal in volume, regularity, and/or timing. there are various diagnostic modalities available in the market, ranging from traditional dilation and curettage (d\&c), transvaginal sonography, hysteroscopy and saline infusion sonography. dilation and curettage is the most widely used simple day care procedure for histological evaluation of the endometrial. it was once considered as the gold standard of investigating women with aub. office hysteroscopy is a very useful technique for diagnosis and treatment of uterine pathology in an office-based environment. it is directly related to the technological explosion, which during the last years has further evolved and given us the opportunity to perform hysteroscopy without providing general anesthesia or sedation to the patients, due to the narrow width of the latest generation hysteroscopes. hysteroscopic inspection of uterine cavity is a simple and well accepted method. the direct real time visualization, real-color, hydrated, well-illuminated, and augmented vision of the uterine cavity make this diagnostic tool very accurate to detect minute focal endometrial pathology and small lesions and helping us to take well guided direct biopsies.

Eligibility criteria:
inclusion criteria: * perimenopausal women complaining of abnormal uterine bleeding. exclusion criteria: * active pelvic infections * medical disorders * bleeding tendency * hormonal treatment * pregnancy * contraceptive treatment
effect of educational intervention in patients with low-risk chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to determine if educational intervention is effective in reducing exacerbations of chronic obstructive pulmonary disease in patients with low-risk disease.

there is growing evidence about the effectiveness of case management in preventing adverse events in patients with high-risk chronic obstructive pulmonary disease(copd). but the majority of copd patients belong to the low-risk category. we propose that a less intense educational intervention will have a similar beneficial effect in reducing hospital admissions and emergency department (ed) visits in this larger group of low-risk copd patients.

Eligibility criteria:
inclusion criteria: spirometrically confirmed copd in visn23 registry. fev1/fvc \<70%. exclusion criteria:hospital admissions or ed visits in the visn23 disease registry for copd within last one year -

Keywords: copd
prevention of gastrointestinal bleeding in patients with severe ischemic heart disease

Conditions: Acute Coronary Syndrome; Acute Myocardial Infarction

Summary: aspirin and clopidogrel +/- heparin or thrombolytic co-therapy is well established and effective treatment for unstable cardiac patients. however, the major complication was gastrointestinal bleeding (gib) due to peptic ulcer. in the prevention of gib, anti-ulcer drug either h2-receptor antagonist (h2ra) and proton pump inhibitor (ppi) were commonly prescribed. there has been no prospective controlled study to compare the efficacy of these two classes of anti-ulcer drugs.


Eligibility criteria:
inclusion criteria: * patients admitted for acute coronary syndrome or acute myocardial infarction requiring active treatment with aspirin clopidogrel and (enoxaparin or thrombolytics.) exclusion criteria: * known active peptic ulcer disease or gastrointestinal within 8 wk * known iron deficiency anemia with hb \< 10 gm/dl * mechanical ventilation * active cancer, liver cirrhosis, end-stage renal failure * life expectancy \< 1 yr * known allergic to aspirin, clopidogrel, enoxaparin famotidine or esomeprazole * pregnancy, lactation, child-bearing potential in the absence of contraception, * co-prescription of nsaid, corticosteroid, or warfarin * non-oral feeding or impaired gi absorption e.g. vomiting * already on proton pump inhibitor for \> 1 day or another clinical trial drug for ulcer disease

Keywords: acute coronary syndrome acute myocardial infarction aspirin clopidogrel heparin thrombolytic famotidine esomeprazole
to investigate the efficacy and safety of ub-421 monotherapy in hiv-1 infected adults

Conditions: HIV-1 Infection

Summary: the purpose of this phase iii study is to evaluate the efficacy, safety and tolerability of ub-421 monotherapy in suppressing viral rebound in hiv-1 infected adults undergoing antiretroviral treatment interruption.

this is an open-label, phase iii study to evaluate the efficacy, safety and tolerability of ub-421 monotherapy in suppressing viral rebound while replace haart in virally suppressed hiv-1 infected adults. in this study, approximately 375 subjects on stable haart treatment will be randomized to receive either continuing haart treatment alone (cohort 1) or ub-421 as the monotherapy (cohort 2) in 1:2 ratio. for cohort 1, subjects will receive current standard haart treatment as the active control group. for cohort 2, ub-421 will be administered to enrolled subjects without haart treatment in the cohort 2 during the 26-week treatment period. after treatment period, both cohort 1 and cohort 2 enter 22-week follow-up period.

Eligibility criteria:
inclusion criteria: * hiv-1 sero-positive * aged 20 years or older * were not breastfeeding for women * subjects with a negative serum pregnancy test result at screening visit for women of childbearing potential * subjects agree on using birth control barrier (female or male condom) during the entire study period * subjects sign the informed consent before undergoing any study procedures exclusion criteria: * any active infection except for hiv, and required immediate therapy * any active aids-defining illness per category b and category c conditions according to the u.s. centers for disease control and prevention (cdc) classification system for hiv infection * any significant diseases (other than hiv-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined from screening, medical history, and/or physical examination that, in the investigator's opinion, would preclude the subject from participating in this study * life expectancy less than 12 months * any alcohol or illicit drug used, according to the investigator's opinion, will interfere with the subject's ability to comply with the dosing, visit schedules and protocol evaluations
a clinical study on the efficacy of cognitive distraction focus relaxation therapy based on mr

Conditions: Pain

Summary: a prospective, single blind, randomized, parallel controlled trial was conducted to evaluate the analgesic effect and safety of mr based "cognitive distraction focus relaxation therapy" in patients clinically diagnosed with chronic moderate to severe pain

multi-center, prospective, single-blind, randomized and parallel controlled trials are used to evaluate the role and impact of "digital chronic pain treatment system equipment" based on mr mixed reality technology in the clinical basic treatment of patients clinically diagnosed with chronic pain.

Eligibility criteria:
inclusion criteria: 1. 18-85 years old male and female; 2. patients clinically diagnosed with chronic pain; 3. chronic pain lasts for more than 3 months; 4. the average intensity of pain in the past month is 40mm and above (vas); 5. willing to abide by the relevant regulations of the experiment; exclusion criteria: 1. serious cognitive impairment; 2. current or previous diagnosis of epilepsy, dementia, migraine or other neurological diseases may hinder the use of mixed reality or have adverse effects; 3. symptoms of nausea or dizziness; 4. sensitive to luminous screens; 5. no stereo vision or severe hearing impairment; 6. eye, face or neck injuries, which hinder the comfortable use of glasses; 7. the evaluated patient gad-7 questionnaire 10 points and above, phq-9 questionnaire 10 points or above; 8. have used vr or mr and other related devices to treat pain; 9. other clinical studies have been completed now or recently (the past 2 months); 10. currently pregnant or planning to get pregnant during the study; 11. at present, or some immediate family members work in a digital health company or pharmaceutical company that provides acute and chronic pain treatment.
impact trial: efficacy and safety of pemvidutide in subjects with nonalcoholic steatohepatitis (nash)

Conditions: Non-Alcoholic Steatohepatitis (NASH)

Summary: purpose of this study is to assess the effects of pemvidutide on nash resolution and nash fibrosis.

a phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in nash.

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. male or female 18-75 years 3. histologic diagnosis of nash and/or histologic confirmation of nash based on central pathology evaluation of a liver biopsy during screening 1. a histologic nafld activity score (nas) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocyte ballooning \[0-2\]) 2. nash fibrosis stages 2 through 3 according to the nash crn fibrosis staging system based on central pathology evaluation 4. subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment 5. bmi ≥ 27.0 kg/m2 6. subjects with type 2 diabetes mellitus (t2d) should be on a stable treatment regimen for their t2d for at least 90 days prior to screening 7. subject meets at least 3 of the 5 criteria of metabolic syndrome (american heart association 2005) 8. liver fat content by mri-pdff ≥ 8% exclusion criteria: 1. weight gain or loss \> 5% in the 3 months prior to randomization or \> 10% in the 6 months prior to screening 2. history or clinical evidence of type 1 diabetes mellitus 3. hemoglobin a1c (hba1c) \> 9.5% or clinically significant persistent hyperglycemia 4. liver conditions: 1. history of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites 2. documented causes of chronic liver disease other than nash 3. alt or ast laboratory values \> 5 × uln
duloxetine tibial plateau

Conditions: Tibial Plateau Fracture; Pain, Postoperative

Summary: the purpose of this study is to determine if duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery. participants from two institutions will be randomized to one of two treatment groups: control (group a) and treatment (group b). group a control group will receive placebo of sugar pill and bmc standard of care - namely postoperative, iv administration of opioids via a patient controlled analgesia (pca) system which utilizes a hydromorphone pump (bmc standard of care). group b, the intervention group, will receive three doses of 60 mg of oral duloxetine (right before operation, postop day 1, postop day 2). this study is important as tibial plateau surgery's postoperative pain management primarily involved providing opioids, and if duloxetine can result in reduced narcotic intake and lower pain scores, it can potentially improve patient care, rehabilitation, early movement, and shorter length of hospital stay.


Eligibility criteria:
inclusion criteria: * tibial plateau fracture that requires operative fixation * ambulatory patient prior to fracture exclusion criteria: * previous tibial plateau fracture on ipsilateral knee * history of complex regional pain syndrome in ipsilateral extremity * history of any demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance/sensation * acute or chronic knee infection in ipsilateral extremity * previous total knee arthroplasty or knee hemiarthroplasty in ipsilateral knee * allergy to morphine (used in the soc pca pump) * pregnant or breastfeeding as determined by standard of care pre-operative urine pregnancy test * polytrauma * open fracture * iv drug user * rheumatoid arthritis * revision cases * non-ambulatory * anatomical deformities of the knee * hepatic dysfunction or cirrhosis * taking selective serotonin reuptake inhibitor (ssri), serotonin-norepinephrine reuptake inhibitor (snri), monoamine oxidase inhibitors (maois), tri- or tetra- cyclic anti-depressant * renal impairment (mention in patient chart and/or creatinine clearance \<30) * moderate to severe depression * taking cyp1a2 inhibitors and cyp1a6 inhibitors

Keywords: duloxetine vas pain scores patient controlled analgesia (pca)
impact of ncpap treatment on liver function in patients with sleep apnea syndrome and nonalcoholic steatohepatitis

Conditions: Sleep Apnea Syndrome; Nonalcoholic Steatohepatitis

Summary: this study aims to evaluate the impact of nasal continuous positive airway pressure (ncpap) treatment on liver enzymes in patients with sleep apnea syndrome and nonalcoholic steatohepatitis. using a cross over design, the evolution of liver enzymes will be evaluated in 40 patients during a consecutive period of 6 weeks, with and without ncpap treatment.


Eligibility criteria:
inclusion criteria: * 18 to 70 years old * nonalcoholic steatohepatitis proven by liver biopsy * sleep apnea syndrome proven by polysomnography with an apnea-hypopnea index \> 10 events/hour * informed consent exclusion criteria: * psychiatric disorder * other cause of liver disease * professional driver
study of the effect of cardioversion on cardiac volume in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the main objectives in this study were to examine the cardiac structural and functional changes in patients with persistent and permanent af, with the aim of improving our understanding of the underlying pathophysiological mechanisms. in addition we aimed to identify variables predictive of recurrent af.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * severe pulmonary or renal disease * contraindications to magnetic resonance imaging * valvular disease * previous cardiac surgery

Keywords: atrial volume ventricular volume atrial function ventricular function magnetic resonance imaging cardioversion natriuretic peptides
metastatic colorectal cancer. real-world data analysis.

Conditions: Metastatic Colorectal Cancer

Summary: the treatment choices, duration and outcomes in patients with ras wild type (ras wt) metastatic colorectal cancer (mcrc). retrospective, multi-center, real-world data analysis

in this study, with the given rationale is to reveal treatment approaches, survival data, side effect profile and their management in our country in ras wt mcrc patients by means of the real-world data collection.

Eligibility criteria:
inclusion criteria: 1. patients who have been histologically diagnosed with mcrc 2. patients over the age of 18 3. patients receiving at least a cycle systemic treatment for metastatic disease 4. ras wild type patients 5. patients who has demographic, histopathological and clinical information exclusion criteria: 1. patients diagnosed as mcrc but only referred to bsc 2. patients with ras mutation 3. patients who were included in any clinical trial except standard treatments during their treatment
dexmedetomidine in tap block for inguinal hernia repair

Conditions: Inguinal Hernia; Analgesia; Pain, Acute; Pain, Chronic; Pain, Neuropathic

Summary: this prospective double-blind randomized study will aim at evaluating the short- and long-term postoperative analgesic efficacy of the ultrasound-guided transversus abdominis plane (tap) block with a combination of local anesthetic and dexmedetomidine in inguinal hernia repair under general anesthesia

inguinal hernia repair is one of the most commonly performed surgical procedures worldwide, especially in the day-case setting. it can be accompanied by moderate to severe postoperative pain, which can delay return to normal daily activities or lead to the development of chronic pain. chronic pain after hernia repair has a reported prevalence ranging between 0% and 43% with both nociceptive and neuropathic features. the transversus abdominis plane (tap) block is an effective regional anesthetic technique to reduce postoperative pain intensity, time to first rescue anesthetic administration and opioid demand after upper and lower abdominal surgery. dexmedetomidine is a selective α2-adrenergic agonist with analgesic properties that has been shown to prolong local anesthetic action when used as an adjunct to local anesthetic solutions in neuraxial anesthesia. the aim of this prospective, double-blind placebo controlled randomized study will be to evaluate the analgesic efficacy of ultrasound-guided tap block where local anesthetic is supplemented by dexmedetomidine in patients undergoing unilateral elective inguinal hernia repair with the lichtenstein technique under general anesthesia.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) patients i-iii undergoing inguinal hernia repair with a mesh * open hernia repair * elective surgery exclusion criteria: * inability to consent to the study due to language barriers or cognitive dysfunction - * bilateral inguinal hernia repair, * body mass index over 40 kg m-2, * skin infection at the puncture site * contraindication to paracetamol or non-steroidal anti-inflammatory drug (nsaids) administration * known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers * coagulation abnormalities * history of gastroesophageal reflux and preoperative use of opioids or nsaids for chronic pain conditions * reoperation of recurrent inguinal hernia after previous mesh repair

Keywords: transversus abdominis plane block dexmedetomidine
bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (cteph)

Conditions: Pulmonary Hypertension

Summary: the present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable cteph.


Eligibility criteria:
inclusion criteria: * patients having completed the 16-week treatment period of protocol ac-052-366 (nct00313222) * signed informed consent exclusion criteria: * any major violation of protocol ac-052-366 (nct00313222) * pregnancy or breast-feeding

Keywords: pulmonary hypertension bosentan benefit cteph inoperable chronic thromboembolic pulmonary hypertension (cteph)
dota-toc in metastasized neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: the investigators aim to explore the efficacy of \[90y-dota\]-toc and \[177ludota\]-toc therapy in advanced neuroendocrine cancer. therefore, the investigators assess response, survival and long-term safety profile of systemic \[90y-dota\]-toc and \[177ludota\]-toc treatment in metastasized neuroendocrine cancer patients. adverse events are assessed according to the criteria of the national cancer institute. survival analyses are performed using multiple regression models.

background: systemic treatment with the 90yttrium (90y) labeled, tetraazacyclododecanetetraacetic acid (dota) modified somatostatin analog tyr3-octreotide (toc) was introduced in 1998 (otte et al. lancet 1998). \[90y-dota\]-toc is administered intravenously and binds to the somatostatin receptor subtype 2, located on the surface of the tumor cell, and exerts its cytotoxic effects by β-irradiation. the treatment has moderate acute hematologic and nephrologic toxicity and has developed into a promising therapeutic tool for tumors expressing its target receptor (iten et al. clin cancer res 2007, iten et al. cancer 2009). study aim: to explore the efficacy of \[90y-dota\]-toc and \[177ludota\]-toc therapy in advanced neuroendocrine cancer. study hypothesis: response to dota-toc is correlated with prolonged survival. study type: clinical phase ii, single-center, open-label trial patients: 1500 patients

Eligibility criteria:
inclusion criteria: * histologically confirmed neuroendocrine cancer * stage ivc disease by definition of the american joint committee on cancer, i.e. occurrence of distant metastases * visible tumor uptake in the pretherapeutic somatostatin receptor subtype 2 scintigraphy (111in-octreoscan) exclusion criteria: * concurrent anti-tumor treatment * secondary malignancies * pregnancy * breast-feeding * incontinence * severe concomitant illness including severe psychiatric disorders

Keywords: dotatoc somatostatin radiopeptide yttrium lutetium neuroendocrine cancer
convergence insufficiency treatment trial (citt)

Conditions: Convergence Insufficiency; Binocular Vision Disorder

Summary: the purposes of the citt are: * to determine whether home-based pencil push-up therapy, home-based pencil push-ups with computer vision therapy/orthoptics or office-based vt/orthoptics more effective than placebo treatment, and whether there are differences between the three treatments in improving subject symptoms and signs. * to evaluate whether improvements in outcome measures are still present after one year of observation.

convergence insufficiency is a prevalent and distinct binocular vision disorder. typical symptoms include double vision, eyestrain, headaches, and blurred vision while reading. it affects approximately 5% of children in the united states, and may have a serious impact on an individual's performance in school, choice of jobs, and quality of life. there is no consensus regarding the most effective treatment for convergence insufficiency. two commonly prescribed treatments are home-based pencil push-up therapy and office-based vision therapy/orthoptics. significant differences exist between these two treatment modalities in cost and number of office visits required, with pencil push-up therapy being less expensive and less time intensive. there have been no well-designed studies that have compared the effectiveness of these two treatments. the convergence insufficiency treatment trial (citt) is a prospective, masked, placebo-controlled, multi-center clinical trial in which 208 subjects between the ages of 9 to \< 18 years will be randomly assigned to: 1) home-based pencil push-up therapy, 2) home-based pencil push-ups with computer vision therapy/orthoptics, 3) office-based vision therapy/orthoptics, or 4) placebo office-based vision therapy/orthoptics. the primary outcome measure is a measure of symptoms using a 15-item survey, the ci symptom survey. secondary outcome measures are two common clinical tests of the eyes' ability to converge when performing close work. patients will be tested at the eligibility examination, and by masked examiners after 4, 8 and 12 weeks of treatment have been completed during the 12-week treatment phase. long term follow-up will be assessed at 6 and 12 months after the completion of active treatment.

Eligibility criteria:
inclusion criteria: * children between the ages of 9 and 17 years with symptomatic convergence insufficiency * exophoria at near at least 4δ greater than at far * insufficient positive fusional convergence at near * a receded near point of convergence of ≥6 cm break * ci symptom survey score ≥16 exclusion criteria: * previous treatment with office-based vision therapy/orthoptics or pencil push-ups * systemic diseases known to affect accommodation, vergence and ocular motility * developmental disability, mental retardation, attention deficit hyperactivity disorder (adhd), or learning disability diagnosis that in the investigator's discretion would interfere with treatment

Keywords: vision therapy orthoptics pencil push-up therapy