Kornimate/medical-research-clean huggingface dataset:
oral nifedipine versus iv labetalol in severe pre eclampsia

Conditions: Severe Pre-Eclampsia, Antepartum

Summary: objective: to determine the efficacy of nifedipine and labetalol in terms of control of bp in pre eclamptic pregnant patients design: randomised control trial setting: department obstetrics \& gynaecology, services hospital, services institute of medical sciences. lahore population: pregnant patients with bp 160/110 or symptoms of severe preeclampsia methods: patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmhg is achieved. crossover treatment is given if the initial treatment regimen is unsuccessful

gestational hypertension is associated with increased risk of maternal morbidity and mortality. parenteral therapy needs more resources, more monitoring and supervision. oral therapy is cheap, easily available, easy to administer especially in resource constrained settings objective: to determine the efficacy of nifedipine and labetalol in terms of control of bp in pre eclamptic pregnant patients design: randomised control trial setting: department obstetrics \& gynaecology, services hospital, services institute of medical sciences.lahore population: pregnant patients with bp 160/110 mm hg or symptoms of severe preeclampsia methods: patients are randomised to receive nifedipine (10 mg tablet, orally, up to five doses) and intravenous placebo saline injection or intravenous labetalol injection (in an escalating dose regimen of 20, 40, 80, 80 and 80 mg) and a placebo tablet every 15 minutes until the target blood pressure of ≤140/90mmhg is achieved. crossover treatment is given if the initial treatment regimen is unsuccessful

Eligibility criteria:
inclusion criteria: * gestational age 24 to 41 weeks * bp \> 160/110 mm hg with proteinuria * patients with s/s of imminent eclampsia as headache, visual disturbance. exclusion criteria: * gestational age \< 24 wks * non proteinuric chronic hypertension * eclampsia * cardiac patients, asthma, severe renal disease, allergy to nifedipine or labetalol

Keywords: severe pre eclampsia nifidepine labetalol
efficacy/safety of lansoprazole in patients with frequent heartburn

Conditions: Heartburn

Summary: heartburn, a burning sensation in the chest or throat, occurs in many patients when acidic stomach contents move into the esophagus from the stomach. this study will investigate the safety and efficacy of lansoprazole 15 mg once a day in treating frequent heartburn.


Eligibility criteria:
inclusion criteria: 1. experiencing heartburn at least 2 days per week over the past month. 2. having heartburn that responds to heartburn medication. 3. be willing to discontinue the use of heartburn treatment for 7 days prior to inclusion in the study. exclusion criteria: 1. having history of erosive esophagitis or gastroesophageal reflux disease diagnosed by a physician and confirmed by testing (endoscopy). 2. be unwilling to take only the study medication, and antacid provided as a rescue medication for relief of acute heartburn during the study. other protocol-defined inclusion or exclusion criteria may apply

Keywords: heartburn, frequent heartburn, proton pump inhibitor, lansoprazole
a safety study of sgn-cd123a in patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the study will examine the safety profile of sgn-cd123a. the study will test increasing doses of sgn-cd123a given every 3 weeks to patients.

this study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of sgn-cd123a. the study will be conducted in 2 parts: 1. part a is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (mtd) of sgn-cd123a 2. part b is the dose-expansion portion of the trial, designed to evaluate sgn-cd123a in patients with differing cd123 expression levels dose-escalation in part a will be conducted using a 3+3 study design. patients with cd123-detectable aml will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of sgn-cd123a treatment at an assigned dose level in 3-week cycles. after completion of dose-escalation, patients will be enrolled in part b of the study. patients enrolled in part b will receive up to 2 induction cycles of sgn-cd123a treatment at a dose level and frequency determined by results in part a. for both part a and part b, a third induction cycle may be permitted with the approval of the study medical monitor. if a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of sgn-cd123a may be administered.

Eligibility criteria:
inclusion criteria: * relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens * patients may be eligible after only 1 previous regimen if in a high risk category * adequate baseline renal and hepatic function * eastern cooperative oncology group status of 0 or 1 * cd123-detectable leukemia exclusion criteria: * cerebral/meningeal disease related to underlying malignancy * promyelocytic leukemia * history of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide \<50% predicted * prior hematopoietic stem cell transplant * antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine) * cardio or cerebral vascular event within 6 months

Keywords: acute myeloid leukemia antibody-drug conjugate cd123 antigen drug therapy aml leukemia, myeloid, acute
effect of ctdcs during balance training on cerebellar ataxia

Conditions: Cerebellar Ataxia; Cerebellum; Injury; Balance

Summary: cerebellar ataxia is a neurologic symptom caused by damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. there is a high rate (93%) of fallings for this population that could limit daily life activities. pharmacological interventions are not able to modify the balance, therefore, new approaches to rehabilitate must be studied. ctdcs is a non-invasive brain stimulation that seems to be a new and innovator technique to restore ataxia symptoms. the purpose of this study is to evaluate the effects of ctdcs associated with balance training on cerebellar ataxia patients. a counterbalanced crossover, sham-controlled, triple blind trial will be performed. all subjects will receive the real and sham ctdcs associated to balance training. the anodal ctdcs (2 ma, 20 minutes) or sham (2ma, 30 seconds) will be applied during balance training at biodex balance system (bbs). the balance will be the primary outcome and will be evaluated through posture control at biodex balance system. ataxia' severity and functional mobility will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (sara) and 10 meters walking test, respectively.


Eligibility criteria:
inclusion criteria: * cerebellar ataxia * score \> 1 ≤ 4 on posture of scale for assessment and rating of ataxia exclusion criteria: * individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests; * pacemaker; * history of seizures; * metallic implants in the head or neck; * medication change (3 months) during the period of study

Keywords: biodex balance system posture control ataxia' severity ctdcs
a study of hrs-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumors.

Conditions: Biliary Tract Cancer

Summary: the study was designed to evaluate the efficacy and safety of hrs-4642 monotherapy or in combination with adebrelimab in the treatment of advanced biliary tract tumor patients.


Eligibility criteria:
inclusion criteria: 1. 18-75 years old, male or female. 2. histologically or cytologically confirmed diagnosis of advanced biliary tract cancer. 3. unresectable or metastatic advanced patients with progression or intolerance for ≥ one line of systemic therapy, including patients who metastasize during or within 6 months after neoadjuvant or adjuvant therapy (adjuvant therapy or neoadjuvant therapy must include gemcitabine-based chemotherapy). 4. have at least one measurable lesion according to the response evaluation criteria in solid tumors (recist v1.1). 5. ecog performance status of 0-1. 6. with a life expectancy of ≥3 months. 7. have adequate laboratory parameters and organ functions during the screening period. exclusion criteria: 1. known history of hypersensitivity to any components of hrs-4642 or adebrelimab. 2. prior anti-tumor chemotherapy within 4 weeks before the study drug administration. small molecular targeted drugs (including oral targeted drugs for other clinical trials) with a half-life of less than 5 or 7 days from the first medication. 3. patients with untreated or active central nervous system tumor metastasis. 4. other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

Keywords: kras g12d biliary tract cancer
topical alprostadil for female sexual arousal disorder

Conditions: Sexual Dysfunction, Physiological

Summary: approximately 300 patients with female sexual arousal disorder who meet eligibility criteria will be enrolled and randomized to receive either active drug or matching placebo. after a two-month, non-treatment period, patients will receive study drug for 6 months and will record information about sexual encounters in a daily diary. study drug will be applied directly to the genital area 30-60 minutes before initiation of sexual activity. the endpoint of the study is based on the use of a standard measure of sexual function (fsep).

this is a multicenter, double-blind, randomized, placebo-controlled, parallel-design study involving about 300 women who are 21-60 years of age inclusive, who have undergone a hysterectomy (with or without oophorectomy), and who have a primary diagnosis of fsad. the diagnosis of fsad will be made based on a medical and sexual history and confirmed using a structured interview by trained personnel. study subjects will undergo a 2-month non-treatment run-in period followed by a 6-month period of blinded study therapy. study drug is applied topically to the genitalia 30-60 minutes prior to initiation of sexual activity. study subjects will complete several questionnaires at various times during the study and will complete a daily diary. the study endpoint is based on the fsep and other standard questionnaires, as well as safety and tolerability of study drug.

Eligibility criteria:
inclusion criteria: * women aged 21-60 who have undergone a hysterectomy * have a primary diagnosis of female sexual arousal disorder * be willing to comply with all study requirements and visit schedules exclusion criteria: * known allergy to alprostadil or product excipients * have a genital inflammatory or infectious condition or std * have a significant medical condition that would interfere with the study * have received an investigational drug within the prior 30 days

Keywords: female sexual arousal disorder female sexual dysfunction
oxygen insufflation via flexible scope

Conditions: Insertion of a Flexible Bronchoscope; Airway Management When Secretions Obstruct the Larynx

Summary: the investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. we provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm h2o which are relatively safe pressure-levels. the endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. the procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. the setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. the procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. additionally, subjective scores regarding the benefit of using insufflation will be obtained

the investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. we provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm h2o which are relatively safe pressure-levels. the endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. the procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. the setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. the procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. additionally, subjective scores regarding the benefit of using insufflation will be obtained

Eligibility criteria:
inclusion criteria: anesthesiologists attending the airway course "airwaymanagement for anaesthesiologists" - exclusion criteria: * non acceptance of participation

Keywords: flaxible scope guided intubation fibreoptic intubation the bleeding airway the difficult airway
131i-mibg with myeloablative chemotherapy and autologous stem cell transplantation for the treatment of high-risk neuroblastoma

Conditions: Neuroblastoma

Summary: this trial is studying how well iodine i 131 metaiodobenzylguanidine together with combination chemotherapy works in treating patients who are undergoing an autologous peripheral stem cell for high risk or relapsed neuroblastoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed neuroblastoma and/or demonstration of tumor cells in bone marrow with elevated urinary catecholamine metabolites * high risk according cog (children oncology group)or relapse or refractory * as at least one i131-mibg avid target lesion determined by diagnostic mibg scan * glomerular filtration rate or creatinine clearance \> 60 ml/min * no tumor cell in bone marrow by routine morphology aspiration and biopsy before peripheral stem cell collection * no active infection exclusion criteria: * impaired renal function * no avid i131-mibg lesion * active infection

Keywords: neuroblastoma mibg autologous peripheral stem cell transplantation
comparison of anesthesia type in patients undergoing transabdominal cervico isthmic cerclage (tcic)

Conditions: Cervical Incompetence

Summary: the investigator aimed to compare the effect of anesthesia on overall postoperative outcomes including post-operative pain score and the fetal well-being (heart rate) in patients undergoing transabdominal cervico isthmic cerclage(tcic). the investigator divided the patients into two groups. the first group was the patients who undergo general anesthesia with postoperative wound patient-controlled analgesia device(pca) and the second group was the patients who undergo combined spinal-epidural anesthesia(cse) with postoperative epidural catheter pca device for pain control.

transabdominal cervico isthmic cerclage(tcic) is performed for the pregnants with incompetent internal os of the cervix(iioc) to maintain pregnancy. it is the operation that incise the lower abdomen and ligate the cervix in pelvic cavity. in our center, the surgery was conventionally performed under general anesthesia. also, for pain control, operator has been inserting a catheter into the incision site and connected the wound pca. in this way, there were some limitations that the wound pca could only control the somatic pain and there were significant rates of post-operative nausea and vomiting as common complication of general anesthesia. thus, the investigator planned to conduct combined spinal-epidural anesthesia(cse) with postoperative pain control with epidural catheter and compare overall postoperative outcomes with conventional general anesthesia.

Eligibility criteria:
inclusion criteria: * patients who undergo tcic for iioc and agree to participate in this study. exclusion criteria: * hepatic failure * chronic kidney disease(\>stage iii) * hypersensitivity, allergic response and/or resistance to drugs used in this study(ex. pethidine, ropivacaine) * spinal anesthesia is not possible * refuse to participate in the study * cannot understand the agreement * body weight is under 50 kg or over 100 kg
endoscopic resection of early esophageal tumors in the context of cirrhosis or portal hypertension

Conditions: Esophageal Neoplasms; Cirrhosis; Portal Hypertension

Summary: cirrhotic patients may be at high risk for esophageal cancer. endoscopic resection is the standard treatment for superficial tumors. however, cirrhosis might be associated with upper gastrointestinal bleeding, particularly in case of portal hypertension or coagulopathy. this study aims to assess safety, efficacy and methods to prevent potential complications in cirrhosis or portal hypertension context for esophageal endoscopic resection. this retrospective multicentric french-belgian study includes all consecutive patients with cirrhosis or portal hypertension who underwent esophageal endoscopic resection from january 2005 to 2021.


Eligibility criteria:
inclusion criteria: * older than 18 years with cirrhosis or portal hypertension who underwent endoscopic resection of an early esophageal tumor exclusion criteria: * younger than 18
does ai-assisted colonoscopy improve adenoma detection in screening colonoscopy?

Conditions: Screening Colonoscopy

Summary: to date, there is a lack of large-scale randomized controlled study using ai assistance in the detection of polyps/adenoma in a screening population. the correlation of fecal occult blood test (fit or fobt) and the advantage of ai-assisted colonoscopy has not been investigated. there is also a lack of information of the benefit of ai-assisted colonoscopy in experienced colonoscopist versus trainee/resident.

there are several studies showing that ai-assisted colonoscopy can help in identifying and characterizing polyps found on colonoscopy. * byrne et al demonstrated that their ai model for real-time assessment of endoscopic video images of colorectal polyp can differentiate between hyperplastic diminutive polyps vs adenomatous polyps with sensitivity of 98% and specificity of 83% (byrne et al. gut 2019) * urban et al designed and trained deep cnns to detect polyps in archived video with a roc curve of 0.991 and accuracy of 96.4%. the total number of polyps identified is significantly higher but mainly in the small (1-3mm and 4-6mm polyps) (urban et al. gastroenterol 2018) * wang et al conducted an open, non-blinded trial consecutive patients (n=1058) prospectively randomized to undergo diagnostic colonoscopy with or without ai assistance. they found that ai system increased adr from 20.3% to 29.1% and the mean number of adenomas per patients from 0.31 to 0.53. this was due to a higher number of diminutive polyps found while there was no statistic difference in larger adenoma. (wang et al. gut 2019). in this study, they excluded patients with ibd, crc and colorectal surgery. the patients presented with symptoms to hospital for investigation. to date, there is a lack of large-scale randomized controlled study using ai assistance in the detection of polyps/adenoma in a screening population. the correlation of fecal occult blood test (fit or fobt) and the advantage of ai-assisted colonoscopy has not been investigated. there is also a lack of information of the benefit of ai-assisted colonoscopy in experienced colonoscopist versus trainee/resident.

Eligibility criteria:
inclusion criteria * patients receiving colonoscopy screening * patients aged 45-75 years * both patients who have or have not done a fit test and both fit +ve and fit -ve subjects exclusion criteria * patients who have symptom(s) suggestive of colorectal diseases * patients who have a history of inflammatory bowel disease, colorectal cancer or polyposis syndrome (anaemia, bloody stool, tenesmus and obstructive symptoms) * patients who had colonoscopy or other investigation of colon and rectum in the past 10 years * patients who had surgery for colorectal diseases * patients who cannot tolerate bowel preparation or have suboptimal bowel preparations (boston bowel preparation scale) * cannot reach caecum * patients who are incompetent in giving informed consent
registry to evaluate efficacy of xience/promus versus cypher in reducing late loss after stenting

Conditions: Coronary Artery Disease

Summary: the objective of this study is to evaluate the safety and long-term effectiveness of coronary stenting with the everolimus-eluting stent (ees) and to determine clinical device and procedural success during commercial use of ees in the real world. the investigators will compare ees (xience/promus, prospective arm) with sirolimus-eluting stent (ses, cypher, retrospective arm).


Eligibility criteria:
inclusion criteria: * the patient agrees to participate in this study by signing the informed consent form. * alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. exclusion criteria: * there are no exclusion criteria for this registry.

Keywords: everolimus sirolimus drug eluting stent
the prevalence of chronic pain and continued opioid use after cardiac surgery

Conditions: Chronic Pain; Cardiac Surgery; Opioid Use

Summary: the authors propose to evaluate the prevalence of chronic post-operative pain (cpop) and continued opioid use in the population that has undergone cardiac surgery at the montreal heart institute. in addition, the authors wish to evaluate the presence of known risk factors for cpop in this population.

this study will use a 15-minute telephone survey to prospectively evaluate the prevalence and intensity of chronic pain 6 months and 1 year after cardiac surgery. data on the level of post-operative pain experienced on days 1 to 4, at the time of surgery, as well as opioid consumption, adjuvant pain treatments and other variables of interest that are currently recorded prospectively at time of surgery will be culled from patient charts. additionally, the possibility of continued opioid use by patients at 6 months post-surgery will be evaluated.

Eligibility criteria:
inclusion criteria: all patients who have surgery at the montreal heart institute between october 1 2017 and october 1 2018 will be eligible for selection. exclusion criteria: patients who have declined to be contacted after surgery as noted on the mhi form "consent for futur projects". all patients who accepted to be contacted but decline to participate when contacted after their surgery. patients who cannot be reached by phone. patients who cannot speak french

Keywords: chronic pain cardiac surgery opioids