cyrilzakka/clinical-trials huggingface dataset:
Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate

The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which are known to contribute to both symptoms and disease progression in patients with Rheumatoid Arthritis.

This multicenter, randomized, double-blind, placebo-controlled, dose-escalating study will assess the safety, tolerability, efficacy, PK and pharmacodynamics of SCIO-469 in patients with active RA who also are receiving methotrexate. A total of 120 subjects will be randomly assigned and treated in one of seven dose groups with the total daily dose of SCIO-469 ranging from 0 to 180 mg. Dose groups will be staggered over four Treatment Periods. Safety and available PK data from a Treatment Period with lower dose groups will be reviewed prior to initiating higher dose groups in the next Treatment Period. Placebo subjects will be randomized in all Treatment Periods. Study drug will be taken for 30 days. Each subject will be followed for approximately 4 weeks after completing the 30-day Treatment Period. Safety will be assessed by way of physical examination, medical history, vital signs, orthostatic vital signs, chest radiograph, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests), purified protein derivative test for tuberculosis, neurological tests, adverse events, and concomitant medications through out the study. Study drug will be administered for 30 days at one of the following dosage strengths; 30 mg, 60 mg, 90 mg. One group of subjects will get 60 mg for one week followed by 120 for one week followed by 180 mg for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have active rheumatoid arthritis and are receiving methotrexate
* meet the revised 1987 American Rheumatism Association (ARA) criteria for rheumatoid arthritis
* has active RA as demonstrated by 9 tender and 6 swollen joints and one of the following: C-reactive protein 1.0 mg/dL, Erythrocyte sedimentation rate (ESR) 28 mm/hour, or Morning stiffness = 45 minutes. .

Exclusion Criteria:

* Patient used etanercept, infliximab, anakinra, or an experimental biologic agent within past 3 months
* Had elevation of liver enzymes within past 6 months
* Has a history of Tuberculosis
* Vertigo, inner ear, or vestibular abnormalities
* Cancer
* HIV-positive
* Abnormal electrocardiogram
* patient has chronic or acute infection
* Multiple sclerosis, neuropathy or encephalopathy
Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents

The purpose of this study is to examine the effects of a guided imagery intervention on perceived stress in pregnant adolescents.

Pregnant adolescents attending a local alternative education program will be subjects of this study. Students will participate in four, 15 minute guided imagery sessions over about a 4-6 week period. They will complete a pregnancy specific stress questionnaire before beginning and after completion of the guided imagery protocol. The students will also complete a short 9-question stress measure before and after each of the individual guided imagery sessions.

The specific aims are:

1. to evaluate whether a guided imagery intervention reduces perceived stress in pregnant adolescents; and
2. to evaluate whether a guided imagery intervention enhances well-being in pregnant adolescents.

The hypotheses are that the intervention will reduce perceived stress and enhance well-being in these subjects. The purpose of this study is to assess whether employing a guided imagery intervention with pregnant teens and education will reduce perceived stress levels and improve well-being.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate

Exclusion Criteria:

* Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.
Observation of Blood Lipid Outcomes in Lipid Clinic

Taipei MacKay Memorial Hospital will establish a Lipid Clinic for hyperlipidemic patients. In this Lipid Clinic, the physician will discuss with each individual patient and set an individualized LDL goal according to current guideline and regulation of National Health Insurance Administration (NHIA). The aim of this study is to observe blood lipid outcomes in patients who receive treatment in Lipid Clinic of Taipei MacKay Memorial Hospital.

Hyperlipidemia is a major risk factor of atherosclerotic cardiovascular disease (ASCVD), and therefore it is beneficial to prevent the risk of ASCVD by controlling the prevalence of hyperlipidemia. According to CEPHEUS Pan-Asia survey, the rate of LDL goal attainment in hyperlipidemic patients of Taiwan was suboptimal, especially in high-risk patients. 2017 Taiwan lipid guideline for high-risk patients has been published and clearly defined the treatment goal of blood LDL-C for high-risk patients. Besides, Taipei MacKay Memorial Hospital will establish a Lipid Clinic for hyperlipidemic patients. In this Lipid Clinic, the physician will discuss with each individual patient and set an individualized LDL goal according to current guideline and regulation of National Health Insurance Administration (NHIA). The aim of this study is to observe blood lipid outcomes in patients who receive treatment in Lipid Clinic of Taipei MacKay Memorial Hospital.

Eligibility Criteria:
Inclusion Criteria:

* ≥20 years-old
* Abnormal lipid profiles according to 2017 Taiwan Lipid Guideline for High-risk Patients

Exclusion Criteria

* Reject to participate in this study
* Pregnant women
* Prisoner
* Illiteracy
* HIV patients
* Individuals who are mentally retarded, homeless, and handicapped
A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food

This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients with Laparoscopic Cholecystectomy

The BACILO study was designed with the objective of having robust data on local epidemiological bacterial colonisation information on bile cultures with patients taken to laparoscopic cholecystectomy in our institution to find which predictive factors are associated with culture positivity and antibiotic resistance patterns. Secondary endpoints include evaluating demographical, clinical and surgical variables and establishing comparison between both positive and negative bile cultures and between antibiotic sensitive and resistant microorganism strain isolations.

BACILO is single-centre, observational, analytical, prospective study with a prognostic prediction model with the objective of identifying predictive factors associated with microbial and antibiotic resistance patterns in bile cultures of patients taken to laparoscopic cholecystectomy in our institution. Primary outcomes are bile culture positivity and phenotypical resistance antibiogram patterns while secondary outcomes include demographic, clinical and surgical characteristics and surgical outcomes. The main objective is to determine predictive factors using a prediction model, variables included are: Age, diabetes mellitus, C-reactive protein test, choledocholithiasis/ERCP, cholecystitis and severity of cholecystitis according to the 2018 Tokyo guidelines.This in the nature of describing the relationship between bile culture positivity and phenotypical antibiogram resistance patterns in our institution, and establish thus better treatment strategies based on higher quality local evidence.

Eligibility Criteria:
Inclusion Criteria:

* Patients included must be over 18 years of age and be taken to laparoscopic cholecystectomy between March 2024 and February 2026 in any institution of the Méderi hospital network (Hospital Universitario Mayor and Hospital Universitario Barrios Unidos), have signed the written informed consent to be included in the study and have both bile culture and antibiogram.

Exclusion Criteria:

* - Patients that will be taken to laparoscopic cholecystectomy with another concomitant surgical procedure (including but not exclusive to gastrectomy, pancreatoduodenectomy, oesophagectomy, splenectomy, abdominal wall reconstruction, colectomy, amongst others) with the exception of umbilical herniorrhaphy.
* Patients without a postoperative control appointment.
* Patients with an untreated HIV diagnosis.
* Patients with diagnosis of a malignant gallbladder or biliary tract disease documented preoperatively.
Phase 3 Multicenter Comparative Study to Confirm Safety and Effectiveness of the F(ab)2 Antivenom Anavip.

The purpose of this study is to establish if F(ab)2 antivenom (Anavip) is safe for crotalinae envenomation. Confirm its effectiveness in preventing the occurrence of delayed coagulopathies and compare the safety and efficacy with Fab antivenom (CroFab) in patients with Crotalinae envenomation.

Fewer than 200,000 crotaline envenomations occur annually in the US.Crotaline venoms contain a broad variety of toxins, venom variability and injection quantity among individual snakes and across species result in broadly variable patient presentations. Clinical consequences of crotaline envenomation include local and systemic effects, both of which may progress for hours to days.The best studied systemic consequence is coagulopathy, which may in its complexity mimic disseminated intravascular coagulation. Platelet and clotting disorders respond rapidly to administration of polyvalent antivenom.

Crotaline viper envenomation in the United States is treated with one of two licensed products: Wyeth Antivenin (Crotalidae) Polyvalent (Polyvalent), or CroFab® (antivenin Crotalidae polyvalent immune Fab, ovine). In recent years, both of these products have been in critically short supply. Use of Wyeth Polyvalent has been associated with a greater than 75% incidence of adverse reactions, including acute type 1 and delayed type 2 immune reactions.These phenomena are an inherent risk in the use of whole immunoglobulin. CroFab´s low molecular weight creates a pharmacokinetic mismatch with crotaline venom which leds to a recurrent venom effects.

Anavip is pharmacologically and pharmacokinetically different.Because of the elimination of the Fc portion of the immunoglobulin molecule, Anavip is expected to produce far fewer adverse reactions than seen with whole immunoglobulin antivenoms and unlike Fab molecules, F(ab)2 molecules exceed the size threshold for renal clearance and thus are expected to remain in circulation for a significantly longer time and substantially reduce the incidence of recurrent coagulopathy.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 2 to 80 years of age
* Presenting for emergency treatment of pit viper bite
* Informed consent document read and signed by patient (or parent/legal guardian)

Exclusion Criteria:

* Current use of any antivenom, or use within the last month
* Current participation in a clinical drug study, or participation within the last month
* Positive urine or blood pregnancy test at screening
* Breast-feeding
* Allergy to horse serum, sheep serum, or papaya
* Underlying medical conditions that significantly alter platelet count or fibrinogen; thrombocytopenia, hemophilia, familial dysfibrinogenemia, leukemia
* Use of any medication expected to affect platelet count, coagulation factors or fibrinogen: chemotherapeutic agents, warfarin, heparin
* No clinical indications of snake bite requiring antivenom for treatment
Non-invasive ONSD-based Neuromonitoring in a Neurointensive Care Setting

Intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (ONSD). The recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. Results are correlated to the parallel recorded intracranial pressure (ICP). The study aims to establish ONSD as a supplementary for raised ICP.

During the intensive care stay, patients with implemented invasive intracranial pressure monitoring will have sonographic recording of the optic nerve sheath (video clip) with a parallel recording of the underlying ICP. The obtained image material is then i) analyzed by a machine-learning algorithm and ii) manually by 2 blinded differently experienced examiners (expert, novice) with respect to the ONSD. For the manual procedure, three individual measurements are made for each eye and the mean value is determined.

Subsequently, the measured values of the two examiners and the automated procedure are correlated with the ICP recorded during the sonographic examination.

Eligibility Criteria:
Inclusion Criteria:

* Traumatic or non-traumatic (e.g. SAH) brain injury
* Established invasive intracranial pressure monitoring (either intraparenchymal or Intraventricular)

Exclusion Criteria:

* Soft tissue damage to orbital or periorbital region
* Fracture of the Orbita
* Status post decompressive craniectomy
Transversus Abdominis Plane Lock Versus Quadratus Lumborum Block in Children

Although abdominal wall surgeries are also as routinely performed on pediatric patients, postoperative pain in children has remained under-researched compared to adults. Consequently, there has been a growing need for adapting regional analgesia to this distinct population. While the Transversus Abdominis Plane Block (TAPB) and Quadratus Lumborum Block (QLB) have been established as potent sensory blocks in adult practice, data on their efficiency in pediatric abdominal parietal surgeries remain scarce.

The investigators aimed to compare the analgesic effect of lateral TAPB versus posterior QLB in children undergoing elective abdominal wall surgery.

Randomized controlled trial, including pediatric patients aged from 1 to 10 years old scheduled for an elective outpatient open sub-umbilical abdominal wall surgery.

After a standardized anesthesia induction protocol, patients were randomized into two parallel groups receiving either a lateral TAPB or a posterior QLB.

The investigators determined the time to first rescue analgesia as the primary outcome of the present trial. As for secondary outcomes, the investigators set out to comparatively assess block failure rates, intra operative hemodynamic features pain scores consisting of FLACC scale values, analgesic consumption attested by the number of administrated rescue paracetamol doses along the cumulative administered dose per kilogram of weight within the first postoperative 24 hours, as well as the incidence of side effects namely systemic local anesthetic toxicity symptoms, PONV, urinary retention, ICU admission or re-intervention for block-related complications.

Eligibility Criteria:
Inclusion Criteria:

* We included patients aged from 1 to 10 years old with American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria:

* Non-inclusion criteria were a priorly known allergy to local anesthetics, a priorly known or suspected coagulopathy, inflammation or infection at the needle injection site, cognitive impairment preventing standard pain assessment and associated circumcision or scrotal incision.
* Later on after allocation, patients were excluded for block failure or major perioperative complications
Aggressive hydraTion in Patients With ST -Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to prevenT Contrast-Induced Nephropathy

To compare the efficacy of 2 different hydration strategies, hydration according to clinical guideline and adequate hydration, on contrast-induced nephropathy in patients with STEMI undergoing primary PCI to investigate the possible beneficial role of periprocedural adequate hydration.

all consecutive patients with STEMI，age at least 18 years, who were candidates for primary PCI at our institution were considered for enrollment in the present study. Initial exclusion criteria were contrast medium administration within the previous 14 days, end-stage renal failure requiring dialysis, and refusal to give informed consent. Eligible patients were randomly assigned in a 1:1 ratio to receive preprocedure and postprocedure hydration (adequate hydration group), hydration according to clinical guideline (guideline hydration group，control group )

Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients with STEMI, age at least 18 years, who were candidates for primary PCI were considered for enrollment.

Exclusion Criteria:

* contrast medium administration within the previous 14 days or follow 72 hours,
* end-stage renal failure or renal transplantation, and refuse PCI or dead during the procedure,
* heart failure of cardiac shock or New York Heart Association class IV,
* recent acute kidney injury defined as an absolute increase of 0.5 mg/dl in serum creatinine over baseline in the past 24h
* ,the presence of lactation, pregnancy,
* malignant tumour or life expectancy less than 1 year,
* allergy to contrast, peri-procedural receipt of metformin non-steroidalanti-inflammatory drugs in the past 48h and during the study period,
* planned renal catheterization or heart valvular surgery。
The Construction and Application of Therapeutic System of Intelligent Decision-Oriented Hemodynamic Organized Therapy for Shock Patients

Patients with septic shock with norepinephrine \>0.25ug/kg/min were enrolled. Informed consent was obtained for inclusion in the study and random assignment into the combination or norepinephrine group.

Contact the research assistant to obtain patient number information and print out the appropriate labels.Notify the ward dispensing nurse to open the experimental drug cassette (placed in the refrigerator 4℃ drug cabinet).

Extract the corresponding experimental medication according to the patient label number, dispense it and send it to the ward, label it and hand it over to the bedside nurse to start using it. The time point at which the medication was connected to the patient and activated was recorded as the zero point for the start of the study.

The data were monitored according to the time points specified in the study: baseline,0h , 6h, D1, D2, and post-drug withdrawal.


Eligibility Criteria:
Inclusion Criteria:

Septic shock patients with norepinephrine\>0.25ug/kg/min

Exclusion Criteria:

1. Under 18 years of age
2. Acute coronary syndrome requiring treatment
3. have been treated with VA-ECMO
4. VV-ECMO treatment has been administered for less than 12 hours
5. Patient is on posterior pituitary hormone
6. Patients with liver failure with a Model for End-Stage Liver Disease (MELD) score ≥ 30
7. Patients requiring more than 500 mg of hydrocortisone or equivalent glucocorticoid daily as a fixed dose
8. absolute neutrophil counts below 1,000/mm3
9. Patients with active bleeding who are expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate patients with active bleeding that is expected to require (within 48 hours of study entry) transfusion of more than 4 units of red blood cell concentrate
10. malignancy or other irreversible disease or condition with an estimated 6-month mortality rate of ≥50%
11. Confirmed or suspected acute mesenteric ischemia. If the investigator believes that the patient's condition is highly suspicious but not confirmed by conventional criteria The investigator may exclude a patient if, in the opinion of the investigator, the patient's condition is highly suspicious but not confirmed by conventional criteria, or if the treating physician has initiated empiric therapy.
12. Likely death expected within 12 hours
13. Family or physician plans to implement a palliative care plan for the patient
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure;
* Male or female aged ≥ 18 years;
* Insomnia disorder according to DSM-5 criteria;
* Insomnia Severity Index score ≥ 15;
* Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;
* Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.

Exclusion Criteria:

* Body mass index below 18.5 or above 40.0 kg/m2;
* Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;
* Cognitive behavioral therapy (CBT) only allowed if, the treatment started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
* Self-reported usual daytime napping ≥ 1 hour per day and ≥ 3 days per week;
* Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
* Mini Mental State Examination (MMSE) score \< 25 in subjects ≥ 50 years;
* For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
* History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.