cyrilzakka/clinical-trials huggingface dataset:
Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block

Fractures of the femur are common orthopaedic emergency especially in the geriatric population and central neuraxial blocks are the preferred technique for providing anaesthesia. However, limb immobility and extreme pain are the deterrents for ideal positioning for these procedures. postoperative pain is a nightmare so adequate analgesia has been advocated to reduce the pain. in this study, Facia Iliaca compartment block will be compared to anterior Quadratus lumborum block, both will be done Ultrasound-guided using Bupivacain0.25% for postoperative analgesia at the end of the surgery.

In this prospective, randomized, comparative study patients will be equally divided into two equal groups; GroupI: patients will receive Ultrasound-guided Facia Iliaca compartment block with 50 ml 0.25%bupivacaine at the end of surgery Group Q: patients will receive Ultrasound-guided anterior Quadratus lumborum block with 50 ml 0.25%bupivacaine at the end of surgery

Eligibility Criteria:
Inclusion Criteria:

* ASA II to IV
* Both sexes
* scheduled for fracture femur surgeries

Exclusion Criteria:

* patients with bleeding disorders and coagulopathy
* infection at the injection site
* known allergy to local anaesthetics
* patients with multiple fractures
* patients with pre-existing myopathy or neuropathy
* patients with significant cognitive dysfunction
* patients who receive long-acting opioids preoperatively
COMT Polymorphism and Entacapone Efficacy

Entacapone is an antiparkinsonian drug which block L-dopa metabolism, inhibiting the C-O-methyltransferase (COMT) enzyme. There is an individual variability of the COMT activity determined by a genetic polymorphism. The aim of this study is to investigate whether the genetic variability influences entacapone efficacy in Parkinson's disease.

COMT protein is dependent of a single autosomal locus with two co-dominant alleles with a high activity (allele H) and a low activity (allele L) form of the enzyme. L and H allele frequency in the Caucasian population is around 50%. This is a monocentric randomized blinded cross-over study comparing acute challenge of L-dopa + placebo versus L-dopa + 200 mg entacapone, in Parkinson's disease patients with HH and LL genotypes.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease
* wearing off

Exclusion Criteria:

* atypical parkinsonism
* neuroleptic use
Immuno Monitoring in Patient With Epithelial Ovarian Cancer Eligible to PARP Inhibitors

This study concerns the creation of a biological collection (blood samples) in patients with Epithelial Ovarian Cancer in in order to describe the immune response with PARP inhibitors.

The aim is to assess the impact of anti-PARP on peripheral immune populations and the amount of DNA circulating; to correlate these data with tumor infiltration, with the initial clinical characteristics and with the clinical course; compare the immunogenic effect of different anti-PARPs.

Eligibility Criteria:
Inclusion Criteria:

1. Patient over 18 years
2. Patient treated for epithelial ovarian cancer
3. Eligible for anti-PARP therapy and in one of the 2 cohorts below:

   * Cohort 1: Maintenance treatment of adult patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (FIGO stages III and IV) with or without BRCA1/2 mutation, who have had a partial or complete response to first-line platinum-based chemotherapy.
   * 2nd cohort: single-agent maintenance treatment of adult patients with platinum-sensitive, recurrent primary epithelial ovarian, fallopian tube or peritoneal cancer who have responded (completely or partially) to platinum-based chemotherapy.
4. Patient having signed the informed consent form.
5. Patient fit and able to comply with the protocol for the duration of the study, including visits, scheduled sampling and follow-up.
6. Patient affiliated to the social security system.

Exclusion Criteria:

1. Non-epithelial tumour of the ovary
2. Patient unable to understand, read and/or sign informed consent.
3. Current or previous use of immunosuppressive medication within 14 days prior to inclusion (except intranasal corticosteroids, systemic corticosteroids in physiological doses not exceeding 10 mg daily of prednisone or its equivalent, corticosteroids used as premedication for hypersensitivity reactions.
4. Patient participating in other research that may modify the systemic treatment administered in the cohort in which she will be included.
5. Pregnant or breast-feeding women.
6. HIV and/or HBV and/or HCV serology positive.
7. Patient refusal.
8. Person benefiting from a system of protection for adults (including guardianship, curatorship and safeguard of justice).
9. Inability to undergo medical follow-up for geographical, social or psychological reasons.
A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

The purpose of this study is to demonstrate that treatment with BMS-986012 in combination with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and will improve progression-free survival compared with carboplatin, etoposide, and nivolumab alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV \[T any, N any, M1a, M1b, or M1c\], or T3-4 due to multiple lung nodules that are too extensive or tumor or nodal volume that is too large to be encompassed in a tolerable radiation plan)
* Participants taking part in the separate PET tracer sub-study must provide a fresh tumor biopsy from any disease site (primary or metastatic)
* Archived tumor specimens, in the form of blocks or sectioned slides, are mandatory for all participants except those participating in the separate PET tracer sub-study for whom the archived tumor specimen is optional
* Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
* At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria
* Adequate hematologic and end organ function
* Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Women who are pregnant or breastfeeding. Japan only: participation in the study is not allowed even if breastfeeding is suspended
* Prior chemotherapy, radiation therapy, or biologic therapy for SCLC. Previously treated limited stage SCLC (LS-SCLC) participants are also excluded
* Symptomatic brain or other central nervous system (CNS) metastases
* Paraneoplastic autoimmune syndrome requiring systemic treatment
* History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
* Grade ≥ 2 peripheral sensory neuropathy at study entry
* Significant uncontrolled cardiovascular disease
* Active, known or suspected autoimmune disease or inflammatory disorder

Other protocol-defined inclusion/exclusion criteria apply
Effect and Associated Factors of the Clinical Pharmacy Model in the Incidence of Medical Errors

Medication errors are considered by WHO to be a subject that requires attention at all levels of care, in order to reduce the serious and preventable damage related to medication.

These strategies are aimed at the patient's safety policy. In Colombia, at the regulatory level there is no standardized clinical pharmacy model where the role of the clinical pharmacist is described extensively and in detail, and in addition, data are unknown of the scope or direct effect of the incorporation of this model in the assistance in the results of health care.

The Hospital Pablo Tobón Uribe, it is a highly complex institution in Medellin (Colombia), certified by Join Comission International (JCI), which requires the continuous interaction of the pharmacist in patient care, in order to avoid medication errors and contribute to patient safety indicators. In this sense, the hospital structured and implemented a clinical pharmacy model that establishes the activities of the pharmacist incorporated into the care team in the patient attention. Today this model is applied in the institution, however, it is necessary to know the effect of its application in the solution of drug-related problems (DRPs) or a negative outcome related to medicine. The objective of this study is to know the effect on patient safety of a clinical pharmacy model in a hospital of high complexity and framed in the WHO initiative to reduce these errors of medication.

A randomized controlled clinical trial of stepped wedge will be performed. Patients will be admitted according to the inclusion criteria. Randomization will be done at the cluster level (group) and the result measured in the participants within the cluster.

Eligibility Criteria:
Inclusion Criteria:

* To be hospitalized in the Hospital Pablo Tobón Uribe a minimum of 24 hours.
* Patient with at least 5 drugs in their pharmacological therapy

Exclusion Criteria:

* Patients with only surgical procedures.
A Trial to Evaluate the Safety and Efficacy of PS433540 to Treat Hypertension

The purpose of the study is to see if PS433540 lowers blood pressure better than placebo and to see how safe PS433540 is compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 30 - 80 years
* Mean seated Systolic Blood Pressure (SBP) ≥ 150 - ≤ 179 mmHg and mean seated DBP \< 110 mmHg at two consecutive qualifying visits. The mean difference in SBP between the two consecutive qualifying visits must be ≤ 10 mmHg.
* Mean daytime (8AM - 4PM) ambulatory SBP must be between ≥ 140 - ≤ 179 mmHg and mean daytime (8AM - 4PM) Diastolic Blood Pressure (DBP) ≤ 110 mmHg
* Subjects must have a usual daytime schedule. Night shift workers are excluded from participation.
* Women of child-bearing potential (WOCBP) and male subjects must use two reliable forms of contraception if sexually active. Alternatively, female subjects must be postmenopausal (for at least 1 year)

Exclusion Criteria:

* Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of PS433540, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic, hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
* Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or New York Heart Association (NYHA) class II-IV heart failure within the last 6 months.
* Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
* Subjects with diabetes mellitus (type I and type II).
Web-based Interactive Health Communication Application (IHCA) for Successful Home Dialysis

This study involves Chronic Kidney Disease patients that must choose the type of dialysis therapy they ultimately wish to perform. These patients receive education regarding dialysis types from nurses and Nephrologists at a Kidney Function Program. The investigators have developed a web-based Interactive Health Communication Application that could provide more education and support to patients about their dialysis choices. The investigators will compare patients that will receive usual care dialysis education versus patients that will receive additional education through this web-based application. The investigators feel that this tool may increase the proportion of patients who start home dialysis, which offers advantages such as improvement in quality of life and deceased overall healthcare costs, over hospital hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in Kidney Function Program (KFP)
* previously received KFP-administered dialysis modality education
* personal access to a home computer (ie. either their own or a close friend/family member) with internet access
* most recent eGFR \< or = 20mL/min/1.73m2

Exclusion Criteria:

* inability to provide informed consent
* inability to use a home computer or internet
* inability to understand English (written or spoke)
* severe visual or auditory impairment
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide Versus Insulin Glargine in Subjects With Type 2 Diabetes Mellitus

This trial is conducted globally. The aim of the trial is to compare the efficacy and safety of insulin degludec/liraglutide versus insulin glargine in subjects with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria: - Type 2 diabetes mellitus - HbA1c 7.0-10.0% \[53-86 mmol/mol\] (both inclusive) by central laboratory analysis - Current treatment with insulin glargine for at least 90 days prior to screening - Stable daily dose of insulin glargine between 20 units and 50 units (both inclusive) for at least 56 days prior to screening. Total daily dose should be within the range of 20-50 units, both inclusive, on the day of screening, but individual fluctuations of plus/minus 10 procent within the 56 days prior to screening are acceptable - Stable daily dose of metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening - Body mass index (BMI) below or equal to 40 kg/m\^2 Exclusion Criteria: - Any use of oral antidiabetic agents (OADs) (except for metformin) within 90 days prior to Visit 1 (screening) - Current use of any drug (except metformin and insulin glargine) or anticipated change inconcomitant medication, which in the investigator's opinion could interfere with the glucose metabolism (e.g. systemic corticosteroids) - Previous and/or current treatment with any insulin regimen other than basal insulin, e.g. prandial or pre-mixed insulin (short term treatment due to intercurrent illness includinggestational diabetes is allowed at the discretion of the investigator) - Previous and/or current treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (e.g. exenatide, liraglutide) - Impaired liver function, defined as ALAT (alanine aminotransferase) above or equal to 2.5 times upper normal range (UNR) - Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (1.4 mg/dL) for females, or as allowed according to local contraindications for metformin - Screening calcitonin above or equal to 50 ng/L - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) - History of chronic pancreatitis or idiopathic acute pancreatitis
Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

In population of intensive care unit (ICU), most studies compared atypical antipsychotics such as quetiapine with the traditional haloperidol in delirious patients of various forms and etiologies. The role of such agents in patients with hyperactive is not fully understood.

This study compares the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in the intensive care unit, and mortality in critically ill patients.

A common complication in the intensive care unit (ICU) that has recently been identified is delirium. Defining delirium as a "sudden deterioration in attention, awareness, and cognition, which is not explained by any pre-existing neurocognitive disorder, but because of another medical condition," the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) clarified the definition of delirium.

A dibenzothiazepine derivative with a novel and distinctive pharmacologic profile is quetiapine. The limbic system is overactive in delirium, which is one of its pathophysiologies. By obstructing the mesolimbic dopamine D2 receptors specifically, quetiapine may be able to regulate this hyperactivity.

The objective of this study is to compare the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in ICU, and mortality in critically ill patients.

This research will not receive any grants, funding, or financial aid (NOT FUNDED STUDY). Collaborators declare that they have no conflicts of interest.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are diagnosed with hyperactive form of delirium during their ICU stay using CAM-ICU tool (the confusion assessment method for the intensive care unit)

Exclusion Criteria:

* Suspected substance-induced delirium
* Previous use of antipsychotics
* Known allergy or intolerance to the study drugs
* Pregnancy or breast feeding
* Acute renal injury
* Hepatic failure
* Inability to tolerate oral drugs
Sharable Knowledge Mining Platform

As a result of increasing adoption of health information systems in hospitals, more and more health records can be gathered and accumulated in the healthcare data repository. For this reason, the opportunity of analyzing and mining the healthcare data for quality improvement is increasing and becoming more and more important.

The purpose of the project is to gather the clinical data relevant to liver cancer, and adopt the knowledge discovery and mining modules in information technology (IT) for analyzing and discovering the knowledge from the gathered clinical data.

We can analyze the gathered clinical data for comparing the outcomes of different treatment strategies, finding out new diagnosis and staging criteria and factors, and other hidden knowledge included in the clinical data.

Afterwards, the discovered results and the mining algorithms can be shared though the sharable knowledge mining platform provided by our project.


Eligibility Criteria:
Inclusion Criteria:

* Clinical data of patients with liver cancer. (ICD9 Code is 155.0)
* Males and females
EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation

IVUS will be used to evaluate the ratio of false lumen to occluded segment, the ratio of false lumen to stent length, the location characteristics of false lumen and its prognostic value for perioperative complications, 1-year late lumen loss and MACCE events in patients with coronary CTO.

At present, novel technologies of CTO interventional therapy become mature. These technologies usually artificially cause dissection of coronary artery. The events such as collateral vessel loss, vascular injury and tear, perforation, pericardial tamponade caused by false lumen may theoretically affect the perioperative and long-term prognosis of patients. In this study, intravascular ultrasound (IVUS) was used to evaluate the characteristics of true lumen and false lumen in CTO segment, so as to determine its impact on the prognosis of patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old;
* be diagnosed with CTO;
* CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5mm;
* comply with all the evaluations and follow-up protocols.

Exclusion Criteria:

* suffered from acute myocardial infarction within the previous 3 months;
* rheumatic valvular disease;
* severe arrhythmia;
* lesions unsuitable for PCI;
* severely abnormal hematopoietic systems, such as platelet counts \<100\*10\^9/L or \> 700\*10\^9/L and white blood cell counts \< 3\*10\^9/L;
* with active bleeding or bleeding tendencies(active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency);
* severe coexisting conditions, including severe renal function dysfunction \[Glomerular filtration rate less than 60ml/min • 1.73 m2), severe hepatic dysfunction \[glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference\], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders; tumors; surgery within 3 months;
* a life expectancy less than 12 months;
* pregnancy or planning to become pregnant;
* history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents;
* cannot tolerate dual antiplatelet treatment;
* unable to communicate due to cognitive impairment, auditory, or visual impairment;
* participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention.
A Trial Evaluating Efficacy of AGA2118 in PostMenopausal Women with Low Bone MasS (ARTEMIS)

The primary objective of this study is to determine the effect of treatment with AGA2118 versus placebo at Month 12 on lumbar spine bone mineral density (BMD) in postmenopausal women with low bone mass.

This Phase 2 dose-finding study will evaluate the safety, tolerability, and efficacy of AGA2118 at a range of dosing regimens in postmenopausal women with low BMD at the lumbar spine, total hip, or femoral neck and no prior history of fragility fractures.

This study includes a 12 month blinded treatment phase where participants will be randomized 1:1:1:1:1:1:1 to receive double-blind dosing regimens of AGA2118 or placebo. At Month 12, participants who have completed the double-blind portion of the study will continue on to a 12 month open-label period where they will be re-randomized based on their prior dosing regimen to either continue their current dosing regimen, receive a new dosing regimen, or discontinue treatment and be actively surveilled throughout Months 12 to 24.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory, postmenopausal women age ≥ 55 to ≤ 80.
* BMD T-score of ≤ -2.5 to \> -3.5 at the lumbar spine, total hip, or femoral neck.

Exclusion Criteria:

* History of vertebral fracture, or fragility fracture of the wrist, humerus, proximal femur, or pelvis.
* Vitamin D deficiency.
* Known intolerance to calcium or vitamin D supplements.
* Untreated hyper- or hypothyroidism.
* Current hyper- or hypoparathyroidism.
* Elevated transaminases.
* Significantly impaired renal function.
* Current hypo- or hypercalcemia.
* Positive for HIV, hepatitis C virus, or hepatitis B surface antigen.
* Malignancy within the last 5 years.
* Diagnosis of a familial cancer syndrome or known genetic mutation that increases risk of cancer.
* Myocardial infarction or stroke within the past 12 months.
* Use of agents affecting bone metabolism.