cyrilzakka/clinical-trials huggingface dataset:
Using Automated Calls To Improve Compliance With Acute Coronary Syndrome Best Practice Guidelines

The purpose of this study is to determine whether interactive voice response (IVR) technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best practice guidelines (BPGs).

The study hypothesis is that ACS patients who are contacted by IVR technology will be more likely to receive care as recommended in the BPGs than those followed by usual care.

Acute coronary syndrome (ACS) is a significant public-health problem in Canada and worldwide with 20,000 Canadians dying of myocardial infarction and 42,000 dying of coronary artery disease in 1999. Large clinical trials have provided evidence for the development of standardized best practice guidelines (BPG) and compliance with these guidelines have significantly improved survival. Despite the development and dissemination of BPG, their application in patients with ACS is suboptimal. This randomized control trial will use 2 groups: IVR and usual care. Patients in the IVR group will receive 5 automated calls at 1,3,6,9 and 12 months consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Responses are captured in a database allowing for interventions to maintain patients on BPG as needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients discharged from the UOHI with ACS (acute myocardial infarction, STEMI or NSTEMI)
* Patients who have a land line telephone service at home
* Patients who speak English or French

Exclusion Criteria:

* Patients discharged to a care facility or transferred to another health care institution
Parent-supported Social Skills Training for Teens With Autism Spectrum Disorders (PEERS-K)

This study aims to develop a parent-assisted social skills training program for adolescents with autism spectrum disorder(ASD) and verify therapeutic effects of the program through case-control study.

1. Both the case and the control of this study shall be a high-functioning group consisting of adolescents aged 11 to 18 years with ASD and an IQ of 80 or over. A total of 40 adolescents will be recruited and divided into two groups of twenty. One will be the case group and the other will be the waitlist control group. Again, the case will be divided into two sub-groups of ten and carry out this new developed program for both parents and adolescents. That is, the program will be carried out two times in each of both groups. The waitlist control group will be allowed to receive personal outpatient treatment and general therapeutic intervention from community while waiting.
2. Effects of the program will be measured both at the case and the control by using a scale which measures social interaction, quality of peer relationship, disposition of autism and social anxiety. Equal assessments for both the case and the control will be conducted right before the beginning of the program and right after the completion of the program and some of the survey will be retried in order to see mid- and long-term effects three months after the completion of the program.


Eligibility Criteria:
Inclusion Criteria:

* 11 to 18 years with ASD and an IQ of 65 or over

Exclusion Criteria:

* Adolescents who are hard to understand the content of treatment and carry out the task due to their IQs or limited linguistic abilities
* Adolescents who are uncooperative in the treatment, lack motives and are hard to participate voluntarily
* Adolescents who have behavior problems so clinically significant that they affects the therapeutic procedure or problems in controlling their emotion
Influence of COVID-19 on Vascular Endothelial Function

Rationale: Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) 2 could result in endothelial dysfunction with increased risk of arterial thrombotic events by downregulating the expression of angiotensin converting enzyme 2 (ACE2). Endothelial function can be easily and non-invasively determined by carotid artery reactivity (CAR) testing.

Objective: To investigate the predictive value of endothelial dysfunction, measured by carotid artery reactivity testing, for 1-year cardiovascular events in patients with past COVID-19 infection.

Study design: A prospective observational longitudinal cohort study.

Study population: Patients recovered from confirmed infection with SARS-CoV2.

Main study parameters/endpoints: macrovascular endothelial function measured by carotid artery reactivity testing.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed SARS-CoV2 infection by polymerase chain reaction on nasopharyngeal swab, sputum or bronchoalveolar lavage.
* At least 6 and no more than 20 weeks after resolution of COVID-19 related symptoms
* ≥ 16 years old

Exclusion Criteria:

* Recent (\<3 months) angina pectoris, myocardial infarction, stroke, or heart failure
* Raynaud syndrome, scleroderma, complex regional pain syndrome of the upper extremity or presence of arteriovenous fistula or open wounds on both the upper extremities.
Peak Cough Flow and Cough Clearance in Patients With Muscular Dystrophy

This study is to determine whether physiologic measures (peak cough flow, measures of respiratory muscle strength including MIP, MEP ,SNIP, and spirometry) can predict spontaneous cough clearance (as measured by a nuclear medicine study) in children with neuromuscular disease. It will also determine whether airway clearance is augmented by high frequency chest wall oscillation.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-21; able to cooperate with study procedures
* Duchenne Muscular Dystrophy OR Becker Muscular Dystrophy

Exclusion Criteria:

* Need for mechanical ventilation during the day
* Recent (within 2 weeks) lower respiratory tract infection
Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function

To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with AMD, or
* Patients diagnosed with DME
* Age over 18 years
* Inform consent

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations
* Glaucoma
* Dilatation of the pupil \< 5 mm
Prediction of Left Ventricular Adverse Remodeling and Major Adverse Cardiovascular Events in Patients with Acute Myocardial Infarction Though Plasma Multiomics Analysis.

To identify plasma multi-omics biomarkers that predict left ventricular adverse remodeling (LVAR) and major adverse cardiovascular events (MACE) in patients with acute myocardial infarction, and to investigate the molecular pathways linked to LVAR and MACE.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Diagnosis of AMI (STEMI or NSTEMI) confirmed by clinical criteria, electrocardiogram (ECG), and cardiac biomarkers (e.g., troponin).
3. Willingness to provide informed consent.

Exclusion Criteria:

1. Prior surgery or trauma.
2. Renal failure with glomerular filtration \<30 ml/min.
Patient-Reported Efficacy of Subcutaneous (SC) Abatacept in Rheumatoid Arthritis (RA) - South Africa

Research question: what are the patterns of patient-reported changes in physical function among adult patients using SC abatacept with moderate to severe RA since commencement of the compassionate use program (CUP).


Eligibility Criteria:
Inclusion Criteria:

* The global clinical trials and associated long-term extension phases imposed inclusion and exclusion criteria. Only patients that completed the clinical trials and the long-term extension phase were eligible for inclusion in the CUP
Trial of Pre-operative Chemoradiotherapy Followed by Surgical Resection in Pancoast Tumors (JCOG 9806)

The purpose of this study is to evaluate the safety and efficacy of the trimodality (concurrent chemoradiotherapy followed by surgical resection) approach in superior sulcus tumors.

Pre-operative radiotherapy has long been the community standard in Pancoast, or superior sulcus tumor. However, both complete resection rate (-50%) and long-term survival (-30%) are poor and unchanged for 40 years. Concurrent chemoradiotherapy has been shown to be beneficial in unresectable stage III non-small cell cancer. Surgery after induction chemoradiotherapy thus is a promising treatment strategy, and in fact, SWOG reported favorable results of this trimodality approach in superior sulcus tumor. The current trial is a Japanese, cooperative, multi-center, prospective one to evaluate its safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, pathologically documented non-small cell lung cancer (NSCLC)
* Invasion to the first rib or more superior chest wall
* Age: 15-74 years old
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Ample organ function
* No prior chemo- or radiotherapy
* Signed informed consent

Exclusion Criteria:

* Metastasis to, or involvement of, mediastinal node (N2)
* Distant metastasis or dissemination to pleura/pericardium
* Active concomitant malignancy
* Unstable angina, recent myocardial infarction, heart failure
* Uncontrolled diabetes or hypertension
* Pregnant or lactating women
* Other severe complications
Study to Evaluate Adverse Events and Change in Disease Activity When Intravenous (IV) Infusion of ABBV-927 is Administered in Combination With IV Modified FOLFIRINOX (mFFX) With or Without IV Budigalimab Compared to mFFX in Adult Participants With Untreated Pancreatic Cancer Metastasis

Metastatic Pancreatic Cancer Disease is one of the most aggressive and deadliest forms of cancer with very poor survival. This study will evaluate adverse events and change in disease activity in participants 18 to 75 years of age with a body weight greater than or equal to 35 kg with Metastatic Pancreatic Cancer Disease treated with Intravenous (IV) infusion of modified FOLFIRINOX (mFFX) combined with IV infusions of ABBV-927 with or without Budigalimab.

ABBV-927 and Budigalimab are the investigational drugs being developed for treatment of Metastatic Pancreatic Cancer Disease. In this study, doctors will enroll participants between 18 and 75 years of age with a body weight greater than or equal to 35 kg diagnosed diagnosed with Metastatic Pancreatic Cancer Disease in 4 different groups, called treatment arms. Each group will receive different treatments. Approximately 129 adult participants will be enrolled in the study across approximately 27 sites worldwide.

Participants will receive ABBV-927 and Budigalimab as Intravenous (IV) Infusion in Phase 1b on day 3 of every 28 day cycle, modified FOLFIRINOX as IV Infusion in Phase 1b on Day1 and Day 15 of every 28 day cycle up to maximum of 2 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Study study was terminated before the Phase 2 portion of the study began.

Eligibility Criteria:
Inclusion Criteria:

* Body weight \>= 35 kg.
* Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with metastatic disease.
* Measurable disease per Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1).
* Prior history of or clinically stable concurrent malignancy are eligible for enrollment provided the malignancy is clinically insignificant, no treatment is required, and the participant is clinically stable.

Exclusion Criteria:

* Participants with locally advanced disease.
* Participants with neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma.
* Prior radiotherapy, surgery, or systemic anti-cancer therapy for the treatment of metastatic pancreatic adenocarcinoma.
* Prior radiotherapy, surgery, or systemic anti-cancer therapy in the adjuvant setting, or earlier, within the last 4 months.
* Prior radiotherapy to any measurable metastatic lesion at any time.
* Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion).
* Known metastases to the central nervous system (CNS).
Guided Self-determination - Promoting Self-management in Type 1 Diabetes

Background: 50% of people with diabetes are living with too high blood sugars and increased risk of diabetes related complications together with poor quality of life. The need to improve diabetes care by better enabling patients to utilise their individual and local resources to self-manage the condition is widely recognized, yet there is a lack of access to evidence-based patient-centred healthcare interventions. At present the individual patient's judgement of own concrete situation mostly remains unexplored and insufficiently used in decision-making causing that problems perceived by the patient in living with the illness remain unrecognised and insufficiently resolved.

Aim and Methods: Guided self-determination (GSD) is an educational method developed to promote patient autonomy, participation, skills building and intrinsic motivation. In this evidence-based group-intervention the main objective is to implement and evaluate GSD through a randomised controlled trial. GSD methods will be performed seven times for the intervention group. The control group will receive traditional out-patient consultations - 'care as usual' Outcome measures will be performed at baseline, after 9 and 18 months. The project will focus on adults with type 1 diabetes (18-55 yrs) where an improvement will be highly cost-effective in preventing late complications and enhanced psychosocial health. GSD is presumably an intervention providing psychosocial support applicable in busy clinical practice.

An alliance is established between Haukeland University Hospital, Norway and Steno Diabetes centre, Copenhagen, Denmark, Centre of Evidence-Based Practice, Bergen University College, and Bergen University to conduct this intervention and thus make the best possible use of interrelated knowledge within the issue.


Eligibility Criteria:
Inclusion Criteria:

Diabetes type one, HbA1c \>= 8%

Exclusion Criteria:

Pregnancy, decreased cognitive function and/or serious mental health disturbances, language barriers to the Norwegian language
Bileacid Malabsorption and GLP-1 Secretion

The aim of this study is to examine the influence of BAM on postprandial GLP--1 secretion and glucose homeostasis, both with and without bile acid sequestration.


Eligibility Criteria:
Inclusion Criteria:

* Northern European origin
* Normal haemoglobin
* Age above 18 years and below 70 years
* Informed and written consent
* BMI \> 23 kg/m2 and \< 35 kg/m2
* Normal fasting plasma glucose (FPG) \< 6.5 mM) and glycated haemoglobin (HbA1c) \< 48 mmol/mol

Exclusion Criteria:

* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \>2 times normal values) or history of hepatobiliary disorder
* Gastrointestinal disease (except BAM), previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
* First-degree relatives with diabetes
* Nephropathy (serum creatinine \>150 µM and/or albuminuria
* Treatment with medicine that cannot be paused for 12 hours
* Hypothyroidism or hyperthyroidism
* Treatment with oral anticoagulants
* Active or recent malignant disease
* Any treatment or condition requiring acute or sub-acute medical or surgical intervention
* Lack of effective birth control in premenopausal women
* Any condition considered incompatible with participation by the investigators
A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.

This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection.

The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.

Eligibility Criteria:
Inclusion Criteria:

1. The patient volunteered to participate in the study, and signed the Informed Consent
2. Age 18-70 years old, male or female
3. Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
4. r/r lymphoma patients who received prior CD19 CAR-T therapy
5. At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
6. No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
7. No mAb treatment within 2 weeks before C-CAR066 infusion
8. Adequate organ and bone marrow function
9. No contraindications of apheresis
10. Expected survival time \> 3 months
11. ECOG scores 0-1

Exclusion Criteria:

1. Have a history of allergy to cellular products
2. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
3. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
4. Patients with active CNS involvement
5. Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
6. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
7. Live vaccination within 4 weeks before apheresis
8. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
9. Have a history of alcoholism, drug addiction and mental illness
10. Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
11. Patients with severe fludarabine or cyclophosphamide hypersensitivity
12. The patient has a history of other primary cancers, except for the following:

    1. Non-melanoma such as skin basal cell carcinoma cured by resection
    2. Cured carcinoma in situ such as cervical, bladder or breast cancer
13. The investigators believe that there are other circumstances that are not suitable for the trial
Esmolol Pretreatment on Pain During Injection of Propofol

Pain on injection of propofol is a common side effect. The present study was designed to investigate the effect of esmolol on pain on propofol injection and to compare it with remifentanil and placebo.

In a double-blind, prospective trial, 120 patients scheduled to undergo elective surgery were randomized to receive normal saline (n=30), remifentanil 0.35 μg/kg (n=30), esmolol 0.5 mg/kg (n=30), or Esmolol 1mg/kg (n=30) as pretreatment. Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after propofol had been given at the rate of 0.5 ml/sec pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).

Eligibility Criteria:
Inclusion Criteria:

* patients aged 19-60 years, American Society of Anesthesiologists (ASA) physical status I and II, scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* Patients with cardiovascular, neurological or psychiatric disorder problem, patients who received the analgesic or sedative medications within the last 24 hours, and pregnancy were excluded
Effect of Different Colistin Doses on Clinical Outcome of Pediatric Cancer Patients With Gram Negative Infections

Prospective randomized study comparing different colistin dosing regimens in paediatric cancer patient with MDR gram-negative infection or sepsis

The aim of this study is to:

1. Evaluate the clinical outcome of two different dosing regimen of IV colistin in the treatment of children with multidrug resistant gram-negative infections or sepsis.
2. To estimate the frequency of colistin associated adverse effects.
3. To correlate the serum colistin concentration and MIC to microbiological clearance and clinical outcome

Eligibility Criteria:
Inclusion Criteria:

1. Age between one year and 18 years
2. All paediatric cancer patients who are prescribed intravenous colistin due to:

   * Sepsis due to MDR or minimally susceptible gram-negative bacteria
   * History of MDR gram-negative infection or sepsis due to organisms sensitive to colistin.
   * Culture result consistent with MDR gram negative for this febrile neutropenic episode.
   * Patient in sepsis and colistin was administered empirically to increase antibiotic coverage.

Exclusion Criteria:

1. Age less than one year or over 18 years
2. Patients with renal impairment
3. Colistin use less than 72 hours
A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin

The Thelin Patient Safety Registry is a post-marketing program in the European Union (EU) that is designed to supplement the reporting of spontaneous adverse events (AE) and better characterize known and potential safety signals for Thelin. The registry is a secure, restricted access, electronic system which collects anonymous, pre-defined, patient-level data on demographic variables, safety monitoring measurements (i.e. liver function tests, haemoglobin and international normalized ratio (INR) measurements), concomitant medications, information on AEs and Thelin drug discontinuation. Regular review of the data is conducted to assess the frequency of identified safety risks and to monitor for the emergence of new safety signals at monthly pharmacovigilance meetings, quarterly signal detection meetings, and for each Periodic Safety Update Report (PSUR).

Non-probability sample

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document by the patient indicating that he/she (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion.
* Additional inclusion criteria reflect the approved label for Thelin as outlined in the SmPC.

Exclusion Criteria:

* There are no specific exclusion criteria for enrollment in the Thelin Patient Safety Registry, with the exception of those reflected in the approved label for Thelin as outlined in the SmPC.