Kornimate/medical-research-clean huggingface dataset:
toradol (ketorolac) in breast surgery to reduce pain & opioid use

Conditions: Breast Reduction; Breast Reconstruction

Summary: the purpose of this study is to investigate whether perioperative single-dose administration of ketorolac (toradol) can reduce post-operative pain after breast surgery, thereby decreasing post-operative opioid use.

the investigators will perform a double blinded, prospective randomized trial of perioperative ketorolac (toradol) on breast reduction and breast reconstruction procedures. patients will be randomized into three groups: group 1 will receive a perioperative dose of ketorolac (toradol, 15mg), group 2 will receive ketorolac (toradol, 30mg), and group 3 will be the control and receive a placebo of saline. patients will be asked to complete a diary or log of their average pain and pain medication use to be turned in at a 2 week follow up visit. the patients, surgeons, anesthesiologist will not know whether the patient received ketorolac (toradol) intraoperatively. patients' pain will be assessed using pain scores in the immediate post-operative period, on post-operative day 1, and at their two-week follow up appointment. if patients leave the same day then they will only have two pain score assessments; on day of surgery and at their two-week follow up. additionally, patients will be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being extreme pain) in morning and evenings using a patient diary for the two week post-op period. the patient's opioid use will be measured by their opioid use during their hospital stay, as well as how many prescription narcotic pills the patient used to manage their pain at home, as documented using the patient diary.

Eligibility criteria:
inclusion criteria: * patient consents to study * adult females needing breast reconstruction or breast reduction (day surgeries) exclusion criteria: * patients with known kidney disease * patient does not consent * patients with history of bleeding disorder, peptic ulcer disease, renal disease, blood thinners use, bariatric surgery and any other contraindications of toradol use * patients currently taking aspirin * pregnant women (not standard to operate on this population anyway)
clomiphene stair-step protocol for ovulation induction in women with polycystic ovarian syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol to induce ovulation in women with polycystic ovarian syndrome (pcos) compared to traditional protocol. methods:this was a randomized controlled clinical trial at the fertility clinic of al sadder teaching hospital at al- najaf city, iraq . it included 140 women who met all of the inclusion criteria, they were divided into two groups; 65 patients for the stair step protocol and 75 patients for the traditional protocol.

overall study design this was a randomized clinical trial using toss a coin as randomization technique carried out on subfertile women attending the fertility clinic of al sadder teaching hospital at al- najaf city, iraq from may 2010 till may 2011. 170 infertile women were selected at that time for study participation after their written consent. participant, recruitment and randomization: the diagnostic criteria adopted for pcos was according to rotterdam eshre/asrm sponsored pcos consensus workshop group, 2004 based on the presence of two of the following three criteria: i.e. oligo- and/or anovulation, hyperandrogenism clinical and/or biochemical, polycystic ovaries, an ovary with 12 or more follicles measuring 2-9 mm indiameter and increased ovarian volume (\>10 cm3) on transvaginal ultrasound(1) .

Eligibility criteria:
inclusion criteria:female in the reproductive age who is subfertile with the diagnosis of polycystic ovarian syndrome, serum fsh≤10 miu/ml with spontaneous menses or positive bleeding response to progestagen withdrawal. - exclusion criteria:male factor (moderate to severe) infertility, bilateral tubal blockage diagnosed by hystrosalpingographgy or laparoscopy and patients on metformin or other medication. -

Keywords: polycystic ovarian syndrome stair step traditional protocol
bay 77-1931 long-term extension from phase ii study

Conditions: Hyperphosphatemia

Summary: a long-term study of bay77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis


Eligibility criteria:
inclusion criteria: * undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least exclusion criteria: * pre-dialysis serum phosphate levels of 10.0mg/dl during the washout period
healthy hearts: leveraging the diabetes prevention program to decrease health disparities in women of reproductive age

Conditions: Prediabetic State; Gestational Weight Gain; Hypertension; Overweight or Obesity

Summary: nearly half of women have obesity and/or hypertension (htn). specific to women, pregnancy creates a vulnerable window for excess gestational weight gain (gwg), exacerbating intergenerational risks for obesity, htn, type 2 diabetes (t2d), and cardiovascular disease (cvd) across the lifespan. healthy lifestyles are the first-line recommendations for prevention and treatment of overweight/obesity, htn, t2d, and cvd. the diabetes prevention program (dpp) is a well-established, centers for disease control and prevention (cdc)-led public health program focusing on healthy lifestyle changes and is effective at reducing 5-7% of body weight, lowering risks for t2d. interestingly, research investigating the dpp as a lifestyle intervention for other chronic conditions (i.e., overweight/obesity and htn) is lacking, demonstrating a missed opportunity. the aim of this study is to determine the initial effects of the first 6-months and after receiving the full 12-months of the virtual dpp compared to the dpp expanded with a cdc-approved htn prevention component (dpp+) on physical activity, diet, weight, and cvd risk factors in 30 prediabetic women (18-45 years old) with a history of excess gwg, overweight/obesity, and htn. participants will be recruited through university of texas medical branch (utmb) community-based clinics using epic. the participants will be randomized into 2 groups (dpp and dpp+) and guided through the 12-month virtual dpp or dpp+ program using utmb dpp personnel.


Eligibility criteria:
inclusion criteria: * women with prediabetes and eligible for the dpp, overweight/obesity, htn (diagnosed or 3 successive high blood pressure readings), and history of excess gestational weight gain during most recent pregnancy exclusion criteria: * pregnant and lactating women, participants planning to move out of galveston county within the next year

Keywords: prediabetic state gestational weight gain hypertension overweight or obesity women's health cardiovascular disease
to evaluate the efficacy and safety of sunpharma1505 compared with reference1505 in subjects with active rheumatoid arthritis

Conditions: Active Rheumatoid Arthritis

Summary: this study is designated to evaluate the safety and efficacy of sunpharma1505 in subjects with active rheumatoid arthritis who are experiencing a flare/exacerbation.


Eligibility criteria:
inclusion criteria: 1. subjects able and willing to give written informed consent and is available for entire study. 2. male or female ≥ 18 years old 3. willing and able to comply with the study protocol visits, assessments and accessible for follow up 4. known diagnosed rheumatoid arthritis 5. subjects of child bearing potential should be non-lactating and must be practicing an acceptable method of birth control as judged by the investigator exclusion criteria: 1. subjects who are pregnant or intend to become pregnant during the study 2. subject with positive hepatitis panel and / or anti-hepatitis b core antibodies, and / or hepatitis c virus antibody \[anti-hcv\]), and / or a positive human immunodeficiency virus (hiv) antibody. 3. known sensitivity to any component of the study drug or previous hypersensitivity reaction or other clinically significant reaction to iv medications, biologic therapy or iv radiocontrast agents. 4. active infection requiring systemic treatment 5. planned surgery during the study period or had undergone major surgery within the 60 days prior to the screening visit.
add-on study of msi-195 (s-adenosyl-l-methionine, same) for patients with major depressive disorder (mdd)

Conditions: Major Depressive Disorder (MDD)

Summary: the purpose of this study is to determine the efficacy and safety of 800 mg msi-195 in reducing symptoms of depression in major depressive disorder (mdd)patients with inadequate response to current antidepressant therapy.


Eligibility criteria:
inclusion criteria: * meets the diagnostic and statistical manual of mental disorder, 4th edition, text revision (dsm-iv-tr) criteria for major depressive disorder (mdd) * a total score of 16 or higher on the hamilton rating scale for depression- 17 item version (ham-d17) at the screening and baseline visits, with a score of ≥2 on mood item 1. * have experienced 1-4 prior major depressive episodes. patients with more than 5 lifetime episodes (including current episode) will require discussion with the medical monitor prior to inclusion. * failed 1-3 treatment regimens in the current depressive episode * received an adequate dose and duration of antidepressant therapy (adt) (on adt for at least 6 weeks with a stable dose for at least 3 weeks) exclusion criteria: * failed 4 or more adequate treatment regimens in current episode of depression * patient may have a significant risk for suicidal behavior during the course of their participation in the study * intolerance to same; prior use of msi-195 * history of any of the following psychiatric disorders: eating disorder within 6 months; obsessive compulsive disorder, psychotic disorder, bipolar disorder, mental retardation, dementia or other forms of cognitive impairment at any time or alcohol or substance abuse * \>3x upper limit of normal (uln) alkaline phosphatase, aspartate aminotransferase (ast), alanine aminotransferase (alt); \>1.5x uln total bilirubin * pregnant or lactating women * any history of seizures, excluding febrile seizures * known positivity for human immunodeficiency virus

Keywords: depressive disorder
sustaining recovery for people on opioid agonist treatment with conversational agents

Conditions: Opioid Use Disorder

Summary: this study aims to improve retention in buprenorphine treatment, a medication used for opioid use disorder, through the use of a smartphone-delivered recovery support intervention. the intervention involves an embodied conversational agent (eca), a virtual, animated computer agent designed to simulate natural face-to-face conversations. ecas have been shown to help individuals manage their healthcare in other settings, and this study seeks to evaluate their potential in supporting patients on medication for opioid use disorder (moud).

one hundred participants will be enrolled in the study from the office-based addiction treatment (obat) clinic at boston medical center (bmc). the participants will be randomly assigned to one of two groups: 75 will receive the eca intervention in addition to usual care, while 25 will receive treatment as usual. the eca group will be further divided into three subgroups based on different engagement strategies: 1) technical support only, 2) technical support with additional messages from the eca on behalf of obat clinic staff, and 3) the same as group 2, but with incentives if they log into the app for 15 days that month. the primary outcome is retention in buprenorphine treatment over 12 months.

Eligibility criteria:
inclusion criteria: * diagnosis of opioid use disorder (oud) * within 14 days of intake at recruitment site (bmc obat) and 30 days of current buprenorphine treatment episode * possession of a smartphone that has minimum requirements * english-speaking * willing to release electronic health record (ehr) data * able to provide at least two alternate contacts who usually know how to get in touch with them * able to provide informed consent and participate in this study exclusion criteria: * treatment with sublingual buprenorphine in the 30 days prior to current treatment episode (56 days for long acting injectable buprenorphine), excluding bridge prescriptions of less than three days * incarceration anticipated within 12 months of enrollment * inability to comprehend the study protocol, defined as failing three times to answer correctly a set of questions during the consent process * inability to use the eca app (i.e., due to markedly limited visual or auditory acuity or motor function required to interact with the eca)

Keywords: embodied conversational agent (eca) buprenorphine treatment medication for opioid use disorder (moud) office based addiction treatment supportive application for recovery assistance (sara) smartphone delivered intervention
study evaluating gemtuzumab ozogamicin in acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.


Eligibility criteria:
inclusion criteria: * morphologic diagnosis of aml from bone marrow aspirate and biopsy * flow cytometry, performed at the study site, must demonstrate that the patient has aml that is cd33+, based on local laboratory criteria * age 18 years or older for relapsed or refractory patients for phase i of this study exclusion criteria: * patients with de novo aml of the m3 subtype * aml following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of \> 2 months duration * aml secondary to exposure to chemotherapy or radiation
computer assisted implant surgery and immediate loading

Conditions: Edentulous Jaws

Summary: purpose: the aim of this study was to analyze the clinical and radiographic outcomes of 23 edentulous jaws treated with 3d software planning, guided surgery, immediate loading and restored with cad-cam zirconia and titanium full arch frameworks. material \& methods: this study was designed as a prospective clinical trial. twenty patients have been consecutively rehabilitated with an immediately loaded implant supported fixed full prosthesis. a total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were placed , 22 of which in fresh post extraction sockets. all the implants were inserted with an insertion torque of 35/45 ncm. 117 out of 120 implants were immediately loaded the other 3 were delayed loaded. outcome measures were implants survival, radiographic marginal bone-levels and bone remodeling, soft tissue parameters and complications.


Eligibility criteria:
inclusion criteria were: -edentulous patients or patients with hopeless teeth in need to be restored with full arches prosthesis exclusion criteria were: * presence of systemic diseases (i.e. haematologic disease, uncontrolled diabetes, serious coagulopathies and diseases of the immune system) * irradiation to the head or neck region within 12 months before surgery * presence severe bruxism or clenching habits * pregnancy * poor oral hygiene * poor motivation to return for scheduled follow-up visit

Keywords: computer assisted implant surgery, immediate loading, cad/cam
covid-19 outbreak and solid organ transplantation (sot) : an international web-based survey

Conditions: COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION

Summary: background covid-19 has brought into questioning the equitable distribution of resources. solid organ transplants (sot) are life-saving procedures. rapid changes in the management of patients are occurring, with potential for inequity. drawing on professionals across transplant specialities, we investigated resource distribution specifically for sot to guide healthcare policies. a multidisciplinary team developed a survey. the survey included demographic questions to contextualise respondents, questions on resource allocation for sot. multiple strategies were used to distribute the survey internationally. descriptive, uni-multivariate ordinal regressions analysis were performed. open comments were analysed using qualitative methods.


Eligibility criteria:
inclusion criteria: * transplant surgeons, referring doctors, transplant physicians, transplant coordinators, transplant icu doctors, covid-19 icu, infectious disease doctors, pulmonologists, internist, and ethicists exclusion criteria: * not applicable

Keywords: covid-19 solid organ transplantation
a study of kynteles injection (vedolizumab) in adults with moderate to severe ulcerative colitis or crohn's disease or chronic pouchitis

Conditions: Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Summary: in this study, participants with ulcerative colitis or crohn's disease or pouchitis will be treated with kynteles injection (vedolizumab) according to their clinic's standard practice. the main aim of the study is to check for side effects from treatment with kynteles injection (vedolizumab). another aim is to learn how many participants have improved symptoms after treatment with kynteles injection (vedolizumab).

this is a non-interventional, prospective, post-marketing study of participants with inflammatory bowel disease (ibd) (ulcerative colitis (uc) or crohn's disease (cd)), who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or an tnf-alpha antagonist or participants with pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis (ipaa) for uc, and have had an inadequate response with, or lost response to antibiotic therapy. this study will evaluate the safety and effectiveness of kynteles injection (vedolizumab) in a routine clinical practice setting under real world conditions. this study will enroll approximately 600 participants. the data will be prospectively collected, at the centers from routinely scheduled follow-up visits and recorded into electronic case report forms (e-crfs). this multi-center trial will be conducted in south korea. the overall time for data collection in the study will be approximately 6 years.

Eligibility criteria:
inclusion criteria: 1. with moderately to severely active uc and cd, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tnf-α antagonist 2. with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ipaa for uc, and have had an inadequate response with, or lost response to antibiotic therapy. exclusion criteria: 1. with hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the kynteles injection (vedolizumab) or to any of its excipients 2. with active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as progressive multifocal leukoencephalopathy (pml) 3. treated with kynteles injection (vedolizumab) outside of the locally approved label in south korea.

Keywords: drug therapy
the relationships between gene polymorphisms of lta4h and dexamethasone treatment for tuberculous meningitis

Conditions: Tuberculous Meningitis

Summary: the study aimed to evaluate the relationships between the gene polymorphisms of leukotriene a4 hydrolase(lta4h) and dexamethasone treatment for tuberculous meningitis in chinese patients.


Eligibility criteria:
inclusion criteria: patients were eligible to enter the study if they met the diagnositic criteria for possible, probable or definite tuberculosis meningitis(tbm). exclusion criteria: patients were excluded if they were infected with hiv, diagnosed as carcinomatous meningitis, viral meningitis, purulent meningitis, cryptococcus meningitis.
circulating il-6, clusterin and irisin in obese subjects

Conditions: Obesity

Summary: evaluate the circulating levels of il-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and their sexual dimorphism also identify the association of il-6, clusterin and irisin with insulin resistance.

aim: firstly, this study aimed at assessing the circulating levels of il-6, clusterin and irisin in obese subjects of both sexes who had different classes of obesity and evaluating their sexual dimorphism and secondly evaluate the association of il-6, clusterin and irisin with insulin resistance. method: this study was conducted on 176 non-diabetic subjects of both sexes. participants were classified according to their sex into two groups; the male and female groups. the male group (88 men) was classified according to bmi into; group 1 (22 lean men), group 2 (22 class i obese men), group 3 (22 class ii obese men), and group 4 (22 class iii obese men). the female group (88 women) was also classified according to bmi exactly as the male group. fasting blood glucose, fasting insulin, lipid panel, serum il-6, clusterin and irisin levels were measured. one-way analysis of variance followed by tukey's as post hoc test was used for comparison of variables.

Eligibility criteria:
inclusion criteria: * healthy female and male * age matched adult non-diabetic non-smoker males and females' exclusion criteria: * smokers, subjects with a history of diabetes mellitus, liver, renal, thyroid, inflammatory diseases, and females on contraceptives pills. patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, anti-hyperlipidemics, non-selective beta blockers, thiazides, etc.) and subjects with organic causes of obesity were also excluded from this study.
urine-based molecular testing vs cystoscopy for surveillance of nonmuscle invasive bladder cancer (nmibc)

Conditions: Non-muscle Invasive Bladder Cancer

Summary: the purpose of this study is to evaluate patient-reported preference for urine based molecular testing (cxbladder monitor) compared to cystoscopy for patients on surveillance for nonmuscle invasive bladder cancer (nmibc). urine based molecular testing involves noninvasive testing of a urine sample for biomarkers associated with disease recurrence. cystoscopy is an examination of the bladder and urethra using a thin tube like instrument that is inserted into the urethra.


Eligibility criteria:
inclusion criteria: * male or female with a history of histologically confirmed nonmuscle invasive bladder cancer (nmibc) who have at least 6 months of disease-free survival from last recurrence. * able to provide urine for testing and comply with study protocol. * have an email address and be willing to complete surveys online. exclusion criteria: * history of non-urothelial bladder cancer (primary squamous, adenocarcinoma, and small cell carcinoma) * patients with predominant (\>50%) variant histology * patients with a history of upper tract and/or urethral cancer * women who are pregnant
noninvasive monitoring of uterine activity and fetal heart rate

Conditions: Fetal Heart Rate or Rhythm Abnormality Affecting Newborn During Labor; Uterine Contractions; Obstetric Complication

Summary: a clinical study designed to validate the safety and performance of the truelabor™ device in monitoring labor vs. current standard of care.


Eligibility criteria:
inclusion criteria: * women who are on \>=37w0d of gestation * maternal age \> 18 years old * singleton pregnancy * cephalic presentation * patient requiring internal monitoring for obstetric indications * informed consent exclusion criteria: * major fetal anomalies * patients with implanted electronic devices of any kind * patients using exterior electronic devices of any kind during the procedure * patients with irritated skin or open wound on the abdominal wall

Keywords: fetal heart rate uterine activity truelabor ob tools non invasive monitoring