cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Remimazolam in OPCAB Surgery

Remimazolam is a novel short-acting benzodiazepine drug that acts on the benzodiazepine binding site of gamma-aminobutryic acid (GABA) A receptor, is metabolized by esterase, and has a context-sensitive half-time of about 6-7 minutes. Looking at some previous studies using Remimazolam, the safety and efficacy as a general anesthetic have been sufficiently proven.

In particular, compared to intravenous anesthetic agents such as propofol, the action time of anesthetics is relatively longer, but the frequency of hypotension is low. However, most studies have been conducted on patients of American Society Anesthesiologist (ASA) class I-II, and studies on patients with high severity have not yet been sufficiently secured.

Therefore, this study aims to compare the efficacy and safety of Remimazolam as an anesthetic with Sevoflurane in terms of hemodynamics in patients with high severity undergoing OPCAB surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 19 years of age or older to receive OPCAB surgery
* Clinical diagnosis of coronary artery obstructive disease

Exclusion Criteria:

* Ejection fraction \< 35% at preoperative ECHO test
* Mitral regurgitation \> grade 2 at preoperative ECHO test
* Currently using inotropics
* Currently receiving mechanical support
Diabetes Scorecard Educational Intervention Study

The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled Type II diabetes (HbA1c ≥ 8%)

Exclusion Criteria:

* Type I Diabetes
* HbA1c \< 8%
* Inability to understand the diabetes scorecard due to condition (i.e. dementia, mental retardation, etc) or language barrier
* Pregnancy
* Planning to move within the next year
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer

The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (\< 50%).


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
2. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment.
3. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study.
4. At least 1 measurable lesion as defined per RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

1. Has mixed small cell lung cancer.
2. Participants with known actionable mutations (including but not limited to EGFR, ALK, BRAF, RET, and ROSI mutations) for which a targeted therapy is available per local standard of care.
3. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease.
4. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.

NOTE: Other protocol and sub-study protocol defined criteria may apply
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder

The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional therapy to one of the five following medications: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole. These medications are already FDA (Food and Drug Administration)-approved treatments for mania.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
* In need of psychiatric treatment
* Cooperation and willingness to complete all aspects of the study

Exclusion Criteria:

* Current diagnosis other than bipolar I disorder
* History of schizophrenia or schizoaffective disorder
* Drug dependence within 1 month prior to study start or testing positive in a urine drug test
* Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
* Any form of psychotherapy within 1 month prior to study start
Carbohydrate Restriction for Gestational Diabetes Mellitus

There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.


Eligibility Criteria:
Inclusion Criteria:

* Gestational diabetes mellitus
* Single pregnancy

Exclusion Criteria:

* Multiple pregnancy
* High risk pregnancy (any other concomitant illness, excluding hypertension and obesity)
* Low ability to understand and follow a diet
* Need to use insulin different from regular insulin
Volume Kinetics for Hyperoncotic Albumin in Burn Patients as Well as for Healthy Subjects

Treatment with colloidal solutions has during long time been a cornerstone within intensive care. Lately, doubts have been raised about synthetic colloids, and the natural albumin has been used more and more.

One of these solutions is the hyperoncotic "Albumin 20%". However there are still many aspects of the physiological effects of hyperoncotic albumin, that are not known. In this study physiological effects will be studied in burn patients and healthy subjects. The colloid osmotic pressure and the increase of the plasma volume will be measured in 15 healthy subjects and in 15 burn patients. The effect on the plasma volume will be studied using hemoglobin as a marker of dilution. Colloids osmotic pressure and albumin concentration will be measured directly and urin production will also be measured. Blood samples will be collected during 4 to 5 hours to achieve a profile over the changes.

Healthy individuals are asked to refrain from eating and drinking the night before the study. Two hours before study start, the subjects may take a sandwich and a glas to drink. Patients will also be asked to keep the same rules unless they receive parenteral nutrition. Shortly before the study, the subjects are asked to leave an urine sample.

After 15 minutes of rest the first bood samples are taken. An infusion 3 ml/kg bodyweight Albumin 20% is given during 30 minutes. The first hour after study start (start of infusion) blood samples are taken every 10 minutes. The following 4 hours another 9 blood samples are collected. Hemoglobin, albumin and colloidosmotic pressure will be measured at every occasion.

C-reactive protein, interleukin-6, Syndecan -1 as well as heparan sulfate, will be measured before, after 1 hour and 5 hours after study start.

The total volume of blood collected will be 150 ml. If the study subjects have a low urin output, acetated Ringers will be given at the end of the study. Liberal fluid intake is recommended the same day and the next.

Eligibility Criteria:
Inclusion Criteria:

* For healthy individuals: Healthy, without allergies and with the age of 18 years or above.
* For patients: Burn injury exceeding 6-8 Total Burned Surface Area %

Exclusion Criteria:

* Heart failure
* Signs of kidney injury/failure
* Severe allergies
GlideScope Spectrum Video Laryngoscope Blades and Stylet for Use in Neonate & Pre-Adolescent Populations

The overall purpose of this study is to assess the functionality \& impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models.

The overall purpose of this study is to assess the functionality \& impact of the use of the newly designed GlideScope Spectrum pediatric video laryngoscope blades and stylet for the orotracheal intubation of neonates and pediatric patients, utilizing manikin models. The hypothesis is that the Spectrum laryngoscope blades and stylet can improve the time and/or success of orotracheal intubation in a manikin.

Secondary aims of this study include assessing the impact of Spectrum pediatric video laryngoscope blades under simulated normal and difficult airway conditions on glottic view grade, mouth space, ease of blade insertion, ease of tracheal tube insertion, mechanisms of tracheal tube insertion impediment, and perceived overall clinical \& functional usefulness in airways with predictors of difficult intubation.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesia and emergency medicine providers who perform pediatric orotracheal intubations
* Able to give voluntary consent to participate in the study
* Are experienced with orotracheal intubation (\> 50 times) using direct laryngoscopy or video laryngoscopy

Exclusion Criteria:

* Volunteers who are \< 18 years of age
* Volunteers unable to read or understand English
* Unable to physically meet the demands of orotracheal intubation or those who have heart, wrist, or low back disease. Are not experienced with pediatric orotracheal intubations
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6-12wks of Age

The purpose of the present study is to demonstrate that the changes in the manufacturing process for the commercial lot of the pneumococcal conjugate vaccine GSK1024850A have no clinical impact and that the immune responses are non-inferior to the immune responses induced by the clinical lot. The study will be conducted in Singapore and Malaysia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between, and including 6-12 weeks of age at the time of the first vaccination.
* Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
* Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward.
* Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
* Born after a gestation period of \>= 36 to \<= 42 weeks.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
* Concurrently participating in another clinical study, at any time during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
* A family history of congenital or hereditary immunodeficiency.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
* History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* History of any neurological disorders or seizures.
* Major congenital defects or serious chronic illness.
* Acute disease at the time of enrolment.
* Gastroenteritis within 7 days preceding the study vaccine administration.
* Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
The Safety and Effectiveness of Taneasy and Actein in COPD Patients

To evaluate the safety and efficacy of Taneasy 600mg granules and Actein effervescent tablets 600MG administered twice daily for 14 days in treatment of COPD Disease.

The study will enroll 40\~60 patients and complete 40 patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged older than 20\~75 years old.
2. Able to sign informed consent prior to the study.
3. Subjects have COPD.

Exclusion Criteria:

1. Subjects with known hypersensitivity to Acetylcysteine preparations.
2. Subjects with other serious medical diseases that are judged by the attending physician to affect the evaluation results (such as: tuberculosis, pneumonia, bronchial asthma, bronchiectasis, cor pulmonale, lung cancer, acute myocardial infarction, acute hepatitis, renal failure, etc.)
3. Pregnancy or breast-feeding woman.
4. Female subjects or their sexual partners do not use contraception during the trial.
5. Joining any drug clinical trial within 3 months prior to dosing.
6. Investigator considered to be inappropriate for enrollment.
7. Phenylketonuria (PKU).
Identification of Take Home Message in Lecture Based Learning

Medical education involves the acquisition of a large quantity of information. Lecture-based learning (LBL) is the best known of conventional teaching methods. Two thirds of critical care junior doctors identified at best only one of the three main take-home messages of a lecture, suggesting that knowledge transfer is poor during passive format learning.

The investigators assess the impact of an intervention including the identification of take-home message of lecture with slides calling "Learning Objectives", "Message", "Conclusion", in the identification of take-home message in critical care junior doctors.

Medical education involves the acquisition of a large quantity of information. Lecture-based learning (LBL) is the best known of conventional teaching methods. The main purpose of a lecture is knowledge transfer \[1\] and its great advantage is that of transferring knowledge from one individual to several or many. Knowledge transfer via LBL is still widely used in international medical congresses, in continuing medical education online via downloading of lectures offered by leading medical schools, and in postgraduate medical education in several countries. We showed that in prospective study of 13 lectures that two thirds of critical care junior doctors identified at best only one of the three main take-home messages of a lecture, suggesting that knowledge transfer is poor during passive format learning.

In this study, we assess the impact of an intervention including the identification of take-home message of lecture with slides calling "Learning Objectives", "Message", "Conclusion", in the identification of take-home message in critical care junior doctors.

6 lectures are performed by professor without specific orders. 6 lectures are performed by professor with the intervention. Both groups of professors do not know this study The critical care juniors do not know the intervention. We compare the take-home messages of students with those of lecturer, 1 month after the lecture.

Eligibility Criteria:
Inclusion Criteria:

* critical care junior who attends lecture

Exclusion Criteria:

* refusal
* critical care junior who do not speak french
Early Magnetic Resonance Imaging Response of the Dominant Intraprostatic Lesion After Online Adaptive Stereotactic Body Radiotherapy for Localized Prostate Cancer and Correlation with Prostate Specific Antigen Response

The aim of this phase II study is to determine the early multiparametric magnetic resonance imaging response of the dominant intraprostatic lesion and correlate these findings with prostate specific antigen response in patients with intermediate to (very) high risk localized prostate cancer treated with online adaptive stereotactic radiotherapy without intraprostatic fiducial markers.

Background: Stereotactic body radiotherapy (SBRT) is an established standard of care treatment for localized prostate cancer. Recent pathological studies suggest the presence of a dominant intraprostatic lesion (DIL) within the prostate, which serve as a central driver of tumor aggressiveness and recurrence after treatment. Prostate-specific antigen (PSA) monitoring is the cornerstone of follow-up, though time to PSA nadir after SBRT can extend to 3 years.

Methods: This phase II observational study aims to evaluate the correlation between PSA response and early multiparametric magnetic resonance imaging (mpMRI) changes of the DIL(s) at 6- or 9-months following online adaptive SBRT for intermediate to (very) high risk localized prostate cancer. The primary outcome is the achievement of local control as assessed by mpMRI at 6 months post-SBRT or, if necessary, at 9 months post-SBRT (in case of image non complete response at 6 months). A complete imaging response is defined as the disappearance of all morphological and functional mpMRI changes of PIRADS (Prostate Imaging Reporting and Data System) ≥3 lesion(s) correlating with Gleason ≥7a pathology. No confirmatory biopsies will be conducted. The required sample size for this study will be 28 patients, assuming a complete response rate of 80% at 6 months, targeting an acceptable margin of error with 95% confidence, and a margin of error of 15%.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed localized prostate cancer who are planned for CT- or MRI-adaptive SBRT for prostate cancer;
* Presence of PIRADS ≥3 lesion(s) in a mpMRI correlating with Gleason ≥7 score at diagnosis;
* Intermediate to (very) high risk localized prostate cancer (≤ cT3b and cN0);
* ECOG performance status of 0-2;
* Age ≥ 18 years;
* PSMA PET ≤3 months is compulsory for high-risk prostate cancer (as part of clinical routine);
* Written informed consent.
* Willingness and ability to comply with schedule

Exclusion Criteria:

* Previous (≤10 years) local therapy of the prostate including transurethral resection of the prostate (TURP),
* Contraindication for MRI;
* Previous (≤10 years) radiotherapy in the pelvis;
* Lymph node metastases or distant metastases (i.e. no localized prostate cancer);
* Participation in a clinical trial which might influence the results of this project;
* Claustrophobic anxiety;
* Uncontrolled intercurrent illness;
* Relation to investigator (family or professional)
Trospium Chloride XR in Obese Female Patients With Overactive Bladder

This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.


Eligibility Criteria:
Inclusion Criteria:

* OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
* Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
* Obese

Exclusion Criteria:

* Chronic kidney failure
* Abdominal bypass surgery for obesity
* Moderate or severe memory impairment
* Uncontrolled narrow angle glaucoma
* Uncontrolled systemic disease
* Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia
Safety and Efficacy of Using GlucoSat Technology For Non-Invasive Glucose Measurement

This study is a prospective, open label, controlled, single center study. 40 patients will be recruited for the study, according to patients' inflow and meeting eligibility criteria.

Primary Goal

\* To evaluate the safety of the GlucoSat technology as a non-invasive blood glucose level measurement technology.

Secondary Goal

\* To assess the efficacy of the GlucoSat technology as a non-invasive blood glucose level measurement technology.

Primary Endpoint Parameter

• Primary study endpoint will be to establish the safety of using the GlucoSat technology as a non-invasive glucose level measurement technology. Safety will be established by paucity of adverse events. Adverse Events occurrence will be documented throughout the study.

Secondary Endpoint Parameters

Efficacy of the GlucoSat technology will be assessed by:

* Proving the accuracy and precision of the GlucoSat technology by comparing the glucose level measured by the GlucoSat device to the glucose level observed by any certified for clinics invasive device. Inter device variability should be within 15%.
* Patient satisfaction questionnaire.
* Physician satisfaction will be assessed by questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female aged 18 and up.
* Subject was diagnosed as a diabetes patient or healthy subject.
* Subject able to comprehend and give informed consent for participation in this study.
* Signed Informed Consent Form

Exclusion Criteria:

* Pregnancy or breast feeding.
* Patients treated with steroid.
* Concomitant Coumadin use
* Recent (within the last 3 months) myocardial infarction or CVA (stroke).
* Any chronic unstable disease within the last 3 months.
* Acute bleeding disorders.
* HIV positive.
* Hepatitis B/C positive.
* BMI\>37
* Needing emergency surgery
* Known cognitive or psychiatric disorder
* Physician objection
* Concurrent participation in any other clinical trial