cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions

The LTI-01-2001 study is a double-blind, placebo-controlled, Phase 2 study to evaluate LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female ≥ 18 years of age who provide written informed consent
* Clinical presentation compatible with complicated parapneumonic pleural effusion (CPE), empyema or other type of pleural infection
* Has pleural fluid requiring drainage as determined by chest ultrasonography or by chest CT, and which is either:
* a) purulent; b) gram stain positive; c) culture positive; d) pH \< 7.2; or e) glucose \< 60 mg/dL (3.3 mmol/L)
* Failure to adequately drain pleural fluid ≥ 3 hours post insertion of patent chest tube within the pleural space, as evidenced by one or more of the following criteria:
* \> 2 cm depth of fluid by ultrasound or CT
* \< 80% drainage from chest radiograph obtained prior to chest tube insertion.

Key Exclusion Criteria:

* Current pleural infection already treated with intrapleural fibrinolytic therapy
* Evidence of ipsilateral fibrothorax (e.g. CT scan with \> 0.5 cm visceral pleural thickening)
* History of multiple thoracenteses or thoracic surgical procedures within 3 months of screening
* Previous pneumonectomy on the side of the pleural effusion
* Current bilateral pleural infections
* Known non-expandable lung prior to this pleural infection
* Known or high clinical suspicion of a malignant pleural effusion
* Existing indwelling or tunneled pleural catheter
* Current infected hepatic hydrothorax or evidence of another abdominal process (e.g. pancreatic cyst or renal cyst) communicating with the pleural space
* Active bleeding, or any condition in which bleeding is either a significant risk or would be difficult to manage
* Fully anticoagulated patients on heparin, warfarin or novel oral anti-coagulants who are not able to temporarily discontinue anti-coagulants while receiving study medication and for 2 days after last dose of study medication Note: patients receiving low-molecular weight heparin for immobilization or anti-platelet agents are not excluded.
* Presence of severe metabolic derangements that would interfere with study assessments
* Systolic blood pressure \>185 mmHg or diastolic blood pressure \> 110 mmHg at screening
* Hemodynamically unstable and/or requires use of intravenous vasopressor therapy
* Expected survival \< 3 months from a pathology other than the qualifying infected, non-draining pleural effusion (e.g. metastatic lung carcinoma)
Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase

This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single subcutaneous injection. Subjects will remain confined at the research clinic for approximately 2 days. After discharge, subjects will return to the research clinic 15 times during 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy and hypercholesterolemic subjects between the ages of 18 and 65 years.
* Healthy subjects must have fasting LDL-C \>/= 70 to \</= 190 mg/dL at two qualifying visits.
* Hypercholesterolemic subjects must be on a stable daily dose of statin for at least 45 days before dosing and fasting LDL-C must be \>/= 70 mg/dL.

Exclusion Criteria:

* Use of prescription or non-prescription drugs within 7 days or 5 half-lives (whichever) is longer prior to the first dose of study medication. For hypercholesterolemic subjects the use of statin class medication is allowed.
* Prior exposure to bococizumab (also known as PF-04950615 or RN316) or other investigational PCSK9 inhibitors.
* Treatment with monoclonal antibodies within 6 months or 5 half-lives (whichever is longer) before dosing.
Clinical Trial Ceftriaxone in Subjects With ALS

The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in amyotrophic lateral sclerosis (ALS).

It is known that nerve cells called motor neurons die in the brains and spinal cords of people with amyotrophic lateral sclerosis (ALS). However, the cause of this cell death is unknown. Researchers think that increased levels of a chemical called "glutamate" may be related to the cell death. For this reason researchers want to study drugs that decrease glutamate levels near nerves. Ceftriaxone-a semi-synthetic, third generation cephalosporin antibiotic-may increase the level of a protein that decreases glutamate levels near nerves. Studies of ceftriaxone in the laboratory suggest that it may protect motor neurons from injury.

Ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. Also, ceftriaxone has not been given to people over a long period of time, such as months or years. The goals of this study are to evaluate the safety and effectiveness of ceftriaxone as a treatment for ALS, and to determine the safety and effectiveness of long-term use of the drug in people with ALS.

A total of 600 eligible people with ALS will be enrolled in this multi-center research study. Participants will be randomly assigned to receive treatment with ceftriaxone (2/3 of participants) or placebo (1/3 of participants) for at least 12 months.

The study consists of three stages. The first stage, which has completed enrollment, will look at whether ceftriaxone enters the cerebrospinal fluid (the fluid that surrounds the spinal cord, also called CSF) in amounts that are high enough to be of possible benefit. The second stage, which has also completed enrollment, will look at the safety and side effects of the study drug when taken daily for at least 20 weeks. The study is currently enrolling subjects for the third stage, which began in Spring 2009, and will determine whether the study drug prolongs survival and slows decline in function due to ALS.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be people with ALS, at least 18 years of age.
* Participants must be medically able to undergo the study procedures and have a caregiver or other individual who will be available to help with daily study medication administration.
* Participants should live within a reasonable distance of the study site, due to frequent study visits.

Exclusion Criteria:

* Participants cannot be taking any other experimental medications for ALS, or have a history of sensitivity to cephalosporin antibiotics (such as Ancef, Keflex, Ceclor, Ceftin, Lorabid, Suprax, or Fortaz).
Predict the Best Level of Care Placement for Each Child's Behavioral Health Needs - Efficacy Study

The purpose of this randomized clinical trial is to test the efficacy of a new clinical decision support tool, Placement Success Predictor (PSP). PSP will provide placement-specific predictions about the likelihood of a youth having a good outcome in each placement type using machine learning algorithms.

The primary hypothesis is that if clinical team members have access to PSP results for youth in the experimental group, these youth will have better outcomes at the 3-month follow-up compared to youth in the control group.

In 2017, a total of 669,799 children were confirmed victims of maltreatment in the United States; of the 442,733 children in foster care, 34% have been in more than one placement and 11% are in a group home or institution. Stakes are extremely high for making the best out-of-home placement choice per child because some placement types and multiple placements are associated with poor outcomes. In the past few years, legislation has been created to guide placement decisions for children. Federal law 42 U.S. Code 675 requires that children in the care of the state are placed "in a safe setting that is the least restrictive (most family like)." In addition, the Family First Prevention Services Act signed into law by the U.S. Congress in 2018 includes measures to reduce the number of children in long-term residential settings. This study is an effort to develop and test a science-based clinical decision support tool using behavioral health data collected through standard clinical practice.

A randomized controlled trial (RCT) design will be used to assess efficacy of clinical team access to Placement Success Predictor (PSP) on child welfare clients' well-being outcomes and healthcare costs.

Sample. Clients at the State of Iowa Department of Health and Human Services (Iowa HHS) are the sample for this efficacy study.

Randomization. The outcome of a single coin toss was applied to an undisclosed algorithm for the client's record number to determine who gets assigned to the experimental group (i.e., client has PSP results).

Methods. The Treatment Outcome Package (TOP), a behavioral health assessment, is a standard part of care delivered in Iowa and its completion is required by the state. Iowa HHS clinical teams will be provided PSP results for clients in the experimental condition. A request for a waiver of consent for this study was approved by the WCG IRB.

Eligibility Criteria:
Inclusion Criteria:

* Completed TOP CS assessment

Exclusion Criteria:

* None
Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran

The primary objective in this cross-sectional study is to assess the prevalence of post-thrombotic syndrome (PTS) in the two treatment arms of the RE-COVER studies (warfarin versus dabigatran). PTS will be assessed by the recently developed Patient Reported Villalta (PRV) Score.

Secondary objectives: to assess in both treatment arms the

1. Prevalence of recurrent venous thromboembolism (VTE) after the discontinuation of study treatment.
2. Prevalence of PTS determined by the standard Villalta score.
3. Health related Quality of Life (HRQoL).

In the RE-COVER- and RE-COVER II studies, 5109 patients with deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) were randomized to receive 6 months of treatment with either dabigatran (150 mg twice daily) or warfarin (once daily to maintain international normalized ratio (INR) 2.0-3.0). All patients received an initial 5-7 day phase of parenteral anticoagulant treatment. The studies were designed as double blind, double dummy trials. RE-COVER was conducted between April 2006 to November 2008 and RE-COVER II between June 2008 and October 2010; they were completed in 2009 and 2011, respectively. A substantial number of patients are expected to have developed post-thrombotic syndrome (PTS). However, since dabigatran provides a stable level of anticoagulation throughout the treatment period and knowing that the quality of anticoagulation is an important factor in the development of PTS, we anticipate that a lower rate of PTS will be seen in the dabigatran treated patients compared to warfarin.

Patients will be interviewed and examined by the investigator if they accept to attend a clinic visit. Otherwise, a telephone interview will be performed if the patient refuses to meet up. PTS will be determined using Patient Reported Villalta (PRV) Score form. However, those who will meet for consultation will in addition be assessed for PTS by the standard Villalta score.

The primary endpoint will be the prevalence of PTS determined by Patient Reported Villalta (PRV) score. The secondary endpoints are 1- objectively verified DVT or PE after the discontinuation of treatment, 2- prevalence of PTS determined by the standard Villalta score, 3- health related quality of life (HRQOL) determined by EQ-5D (www.euroqol.org) and Venous Insufficiency Epidemiological and Economic Study quality of life and symptom (VEINES-QOL/Sym) questionnaires.

The investigators will recruit the subpopulation of patients who were included into the RE-COVER studies in the Norway, Sweden and Canada.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with DVT (±PE) treated in the RE-COVER studies.
2. Signed written informed consent.

Exclusion Criteria:

1. Patients who refuse to participate
2. Deceased patients
Mixed Local for Sciatic Block

Choice of local anesthetics is the major determinant of the characteristics of a peripheral nerve block. Short acting local anesthetics while provides faster onset suffer from shorter duration. On the other hand, long acting local anesthetics while provides long duration suffered from long onset time. The ideal local anesthetics should provide faster nerve block onset while providing reasonable duration to provide sustained postoperative analgesia. Mixing short and long acting local anesthetics for nerve blocks may appear to be the solution however previous published studies have demonstrated similar onset time to long acting local anesthetics and with reduced duration. Recently, the London Health Sciences Centre established an ambulatory surgical centre. Fast onset peripheral nerve block is desirable. Previous studies have not looked at popliteal sciatic block and anecdotally we feel addition of short acting local anesthetics appear to speed up onset. We are therefore interested in conducting a randomize trial to determine whether mixing short and long acting local anesthetics can speed up onset of surgical quality block.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old)
* Scheduled for elective below-knee surgeries such as ankle arthroscopy, lower limb fracture fixation, toe surgeries, etc
* Capable of providing informed consent

Exclusion Criteria:

* History of allergic reaction to local anesthetics
* Pre-existing neurological disorders affecting lower limbs
* Significant renal or hepatic impairment
* Pregnancy or breastfeeding
* Less than 60kg
* Inability to provide informed consent
MiRNAs Evaluate the Prognosis of Sepsis by Dynamic Study

Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which regulate mRNA expression. The present study was designed to observe the selected miRNA expression which evaluate the sepsis prognosis in the progression of sepsis in order to be a new target for the treatment of sepsis.

The study is a non-intervention observational study. Purpose of this study is to observe some selected miRNA expression which evaluate the sepsis prognosis in the progression of sepsis . The investigators will collect serum samples from patients with sepsis in SICU, RICU and EICU on the 1st、3rd、5th、7th、10th、14th day of 301 Hospital since November 2011 , and then use mirVana PARIS kit extract total RNA and use qRT-PCR detect miRNAS expression in serum which can evaluate the prognosis of sepsis, and statistical analysis the miRNAS expression correlation with SOFA score.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of sepsis
* Patients who agree with the study

Exclusion Criteria:

* Aged \<18 years;
* Into the group who died within 24 hours;
* Agranulocytosis (\<0.5 × 109 / L);
* Combined HIV infection.
The Learning Outcome of Resuscitation Teamwork Training in Postgraduate Year Doctors and Nurses

It is challenging for healthcare team to manage emergency patient effectively. Most of these critical patients have medical conditions and need complex medical managements. Research findings have shown that poor healthcare teamwork would result in poor communication, missing information, and insufficient situation monitoring and thus compromise patient safety. Simulation has been proved as an effective method to develop teamwork competency. However, comparing to traditional training model, simulation requires more resources such as funding, spaces, time, administration staffs, schedule, facilitators, and equipment. It would not be easy to delivery in various professional departments. Game-based learning was a known effective and learner-centered learning model which required less resources. Researchers have shown that game-based learning has higher acceptance for the learners and can improve learners' knowledge, attitude, motivation, and performance. Therefore, the aim of this study was to explore the learning effectiveness of resuscitation teamwork training of board game-based learning, simulation-based learning and lecture-based learning in PGY doctors and nurses.

This will be a prospective, longitudinal, and randomized controlled trial design. A total number of 180 PGY doctors and nurses will be enrolled from a teaching hospital in northern Taipei City. They will be randomized into board game-based learning group, simulation-based learning group, and lecture-based learning group. Three groups will receive "Emergency Medical Response Teamwork" training and all of these contents were developed according to America Heart Association Guidelines for Cardiopulmonary Resuscitation and ECC and TeamSTEPPS curriculum from Agency for Healthcare Research and Quality. We will collect the professional demography, the professional medical knowledge for medical management, the concept of knowledge for teamwork, team performance, team attitude, medical management, course survey, and cognitive load scales. We will compare the learning effectiveness between three groups in pretest, posttest, and three-months follow up. Statistical methods used included descriptive and inferential statistics, χ2 chi-square tests, Kruskal-Wallis H test, Friedman test, Wilcoxon test, generalized estimating equations, and text mining.

Eligibility Criteria:
Inclusion Criteria:

1. Postgraduate Year doctors who is 20 years old and work in primary care.
2. Postgraduate Year nurses who is 20 years old and work in primary care

Exclusion Criteria:

1. Participant do not work in primary care provide.
2. Healthcare provider do not delivery in relative adult care department, such as pediatric department, obstetrics department, and psychiatry department so on.
A Study to Compare PK, PD and Safety of the AD-214 and AD-2141

A study to compare safety, pharmacokinetics and pharmacodynamics of AD-214 to AD-2141 in healthy volunteers.

This study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of AD-214 compared with administration of AD-2141 in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age 19\~50 years in healthy volunteers
* BMI is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
Post-operative Thoracic Epidural Analgesia and Incidence of Major Complications: a Large Retrospective Dual Center Experi-ence

A retrospective observational dual center study investigating side effects and major complications after thoracic epidural insertion according to local safety protocols.

Abstract: (1) Background: Thoracic epidural analgesia is considered the gold standard in post-operative pain management following thoracic surgery. This study was designed to explore the safety of thoracic epidural analgesia and to quantify the incidence of its post-operative side-effects in patients undergoing thoracotomy for major surgery, such as resection of lung malignancies and lung transplantation. (2) Methods: This is a retrospective, dual-center observa-tional study implementing patients that underwent major thoracic surgery including lung trans-plantation and received concurrent placement of thoracic epidural catheters for postoperative an-algesia. An electronic system of referral and documentation of complications was used, and information was retrieved from our electronic critical care charting system. Side effects such as nausea and vomiting , itching, catheter related issues and also major complications such as epidural haematoma, abscess, or permanent nerve damage were investigated.

The study aims to highlight the importance of a solid documentation and recording system alongside with the implementation of safety protocols.

Eligibility Criteria:
Inclusion Criteria: 1. All patients undergoing major thoracic surgery ASA1-3 2. All patients undergoing lung transplantation

Exclusion Criteria: 1. Active bleeding 2. Coagulopathy 3. High inflammatory markers 4. SIRS 5. Lack of patients' consent for throracic epidural insertion

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A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin

The purpose of this study is to assess the potential for a drug interaction between GDC-0853 and midazolam, itraconazole, rosuvastatin, and simvastatin.

This will be a 4-part study, with each part being an open-label fixed-sequence evaluation conducted in healthy adult participants. Approximately 64 participants will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Within body mass index range of 18 to 31 kilograms per square meter, inclusive
* Females will be non-pregnant, non-lactating, and either postmenopausal or surgically sterile
* Males will either be sterile or agree to use an approved method of contraception

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic/immunologic/immunodeficiency, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Participation in any other investigational study drug trial in which receipt of any investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check in
* History of malignancy, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 3-year disease-free follow up
* Any acute or chronic condition or any other reason that, in the opinion of the investigator, would limit the participant's ability to complete and/or participate in this clinical study
A Multi-Center, Observational Registry of Subjects With Secondary Hyperparathyroidism (HPT) and Chronic Kidney Disease (CKD)

Objectives include description of current practices; assessment over time of K/DOQI goals, clinical outcomes, health resource utilization(HRU) and patient reported outcomes (PRO) and the impact of Sensipar® on these parameters


Eligibility Criteria:
Inclusion Criteria:

* 3 month history of Stage 4 or Stage 5 CKD
* A PTH value within 3 months of enrollment
* If relevant, completion of Sensipar® study prior to enrolling in Registry Exclusion Criteria:
* Females who are pregnant or breast feeding