cyrilzakka/clinical-trials huggingface dataset:
Machine Learning Assisted Differentiation of Low Acuity Patients at Dispatch

BACKGROUND:

At Emergency Medical Dispatch (EMD) centers, Resource Constrained Situations (RCS) where there are more callers requiring an ambulance than there are available ambulances are common. At the EMD centers in Uppsala and Västmanland, patients experiencing these situations are typically assigned a low-priority response, are often elderly, and have non-specific symptoms. Machine learning techniques offer a promising but largely untested approach to assessing risks among these patients.

OBJECTIVES:

To establish whether the provision of machine learning-based risk scores improves the ability of dispatchers to identify patients at high risk for deterioration in RCS.

DESIGN:

Multi-centre, parallel-grouped, randomized, analyst-blinded trial.

POPULATION:

Adult patients contacting the national emergency line (112), assessed by a dispatch nurse in Uppsala or Västmanland as requiring a low-priority ambulance response, and experiencing an RCS.

OUTCOMES:

Primary:

1. Proportion of RCS where the first available ambulance was dispatched to the patient with the highest National Early Warning Score (NEWS) score

Secondary:

* Difference in composite risk score consisting of ambulance interventions, emergent transport, hospital admission, intensive care, and mortality between patients receiving immediate vs. delayed ambulance response during RCS.
* Difference in NEWS between patients receiving immediate vs. delayed ambulance response during RCS.

INTERVENTION:

A machine learning model will estimate the risk associated with each patient involved in the RCS, and propose a patient to receive the available ambulance. In the intervention arm only, the assessment will be displayed in a user interface integrated into the dispatching system.

TRIAL SIZE:

1500 RCS each consisting of multiple patients randomized 1:1 to control and intervention arms


Eligibility Criteria:
Inclusion Criteria:

* Identification of a resource constrained situation by ambulance director (i.e., 2 or more patients awaiting an ambulance response)
* Assigned priority 2A or 2B (Low-priority ambulance response) by dispatch nurse call-taker
* Valid Swedish personal identification number collected at dispatch
* Age \>= 18 years

Exclusion Criteria:

* Relevant calls received more than 30 minutes apart
* Logistical factors (eg. the patients' geographical locations) affect the ambulance assignment decision
* On scene risk factors (eg. a patient is outdoors and risks hypothermia) or risk mitigators (eg. healthcare staff already on-scene with a patient) affect the ambulance assignment decision
THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

The purpose of this study is to demonstrate the safety and effectiveness of the THERMOCOOL® SMARTTOUCH™ Catheters with Contact Force Sensing Capability in the treatment of drug refractory symptomatic paroxysmal Atrial Fibrillation (AF) during standard electrophysiology mapping and RF procedures.


Eligibility Criteria:
Inclusion Criteria:

* Have had at least 3 atrial fibrillation episodes within 6 months of this study
* Have failed at least one antiarrhythmic drug shown by repeated atrial fibrillation episodes
* 18 years of age or older

Exclusion Criteria:

* Have had previous ablation for atrial fibrillation
* Have take amiodarone within 6 months of this study
* Have had any heart surgery within the last 60 days
* Have had a heart attack within the last 60 days
* Females who are pregnant or breast feeding
Individualized Pneumoperitoneum Pressure in Colorectal Laparoscopic Surgery Versus Standard Therapy (IPPCollapse-II)

The purpose of this study is to assess the post-operative recovery quality of the Individualized Pneumoperitoneum Pressure Therapy in Colorectal laparoscopic surgery versus standard therapy using a quality validated scale of postoperative recovery of their stay in the Post-Anaesthesia Recovery Unit.

In the last two decades laparoscopic surgery has settled as a less invasive surgical approach compared to open surgery. It is associated with lower perioperative morbidity and hospital stay. There is growing evidence that increased intra-abdominal pressure (IAP), even for short periods of time, is associated with increased perioperative morbidity (pain, increased inflammatory markers peritoneal injury worse splanchnic perfusion abnormalities hemodynamic and ventilatory ...).

The study is a prospective multicenter randomized clinical intervention trial to assess the impact of IAP individualization strategy (IPP-Individualized pneumoperitoneum Pressure) relative to a IAP standard strategy (SPP-Standard pneumoperitoneum Pressure) using a validated scale (VAS) (PQRS- Postoperative Quality of Recovery Scale). Postoperative pain in the first 24 hours (area under VAS curve , opioid rescue, referred pain to the shoulder) and surgical stress and inflammatory markers (neutrophil/lymphocyte, ratio,C-reactive protein, interleukin-6, procalcitonin) are also measured. Postoperative complications are evaluated by Clavier-Dindo classification.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Classification of the American Society of Anesthesiologists (ASA I-III)
* No cognitive deficits
* Signed informed consent prior to surgery

Exclusion Criteria:

* Emergency surgery
* Pregnancy or lactation
* Immune disorders
* Kidney or liver disease or advanced-stage cardiopulmonary
* Patient refusal to participate in the study
* Patients under 18 years or inability to consent
* Associated neuromuscular disorders, contraindication for the use of rocuronium/ sugammadex, allergy or hypersensitivity to rocuronium / sugammadex
Bendamustine-based Combination Therapy for PCNSL

This pilot study will i) evaluate the efficacy and the safety of bendamustine-based combination chemotherapy and ii) investigate the pharmacokinetics (PK)of bendamustine in plasma and CSF when given as salvage treatment for patients with relapsed or refractory primary central nervous system lymphoma (PCNSL).

A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. Based on the demonstrated activity and proposed additive mechanisms of the chemotherapeutic agents included in the bendamustine-based combination regimen, the efficacy and safety of R-B(O)AD will be evaluated for treatment of relapsed/refractory (R/R) primary CNS lymphoma. Evidence from previous preclinical tissue distribution studies and single agent intravenous drug therapy trials in CNS malignancies suggests that bendamustine penetrates brain and tumor tissue, however there are no clinical data available on the PK of bendamustine in the CSF. This study will evaluate the PK of plasma and CSF drug levels through a population based nonlinear mixed-effects model approach in a R/R PCNSL cohort with the goals to define the currently unknown PK profile of bendamustine in the CSF and to further characterize the relationship between plasma and CSF drug levels, and the influence of exposure on response to therapy.

Eligibility Criteria:
Inclusion Criteria:

1. PCNSL of diffuse large B-cell lymphoma (DLBCL) with a CNS lesion by tissue biopsy
2. Age ≥ 19 years old
3. Relapsed or refractory PCNSL after frontline combined chemotherapy or radiation
4. ECOG performance status 0-2
5. Absolute neutrophil count ≥ 1000/uL
6. Platelets ≥ 100,000/uL
7. Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
8. Aspartate aminotransferase (AST) ≤ 3 x ULN
9. Creatinine ≤ 2.0 x ULN

Exclusion Criteria:

1. PCNSL of other than DLBCL or T-cell lymphoma with a CNS lesion by tissue biopsy
2. Any of the following: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception
3. Uncontrolled infection
4. Therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration
5. Persistent toxicities ≥ grade 3 from prior chemotherapy or biologic therapy regardless of interval since last treatment
6. History of thromboembolic episodes ≤ 3 months prior to registration
7. Active hepatitis B or C with uncontrolled disease
8. Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
9. Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
10. Major surgery ≤ 4 weeks prior to registration or have not recovered from side effects of such therapy
Aveir VR Real-World Evidence Post-Approval Study

The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.

This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.

Eligibility Criteria:
Eligibility Criteria:

* Implanted with an Aveir VR leadless pacemaker
* Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period
* Ability to link with Medicare fee-for-service data
mSEP: Testing of Physiological and Immune-metabolic Blood Markers for Maternal Sepsis

A prospective observational cohort study investigating physiological parameters vs biological markers of whole blood in septic and non-septic pregnant woman to predict systemic immune health

The altered physiology of pregnancy makes the signs and symptoms of sepsis less distinctive in the pregnant population. This can lead to both over treatment (with antibiotics) and late identification of sepsis. The progression of sepsis can be rapid in this population, resulting in severe morbidity and mortality. The mortality associated with sepsis in the general population is over 10%, while septic shock can increase this figure up to 30%. A study looking at maternal mortality due to sepsis recognised that the time from the onset of infection to death was less than 24 hours in 50% of patients. A review of the literature shows that half of the fatal cases of maternal sepsis could have been prevented with early detection of sepsis.

The unmet need is therefore a diagnostic bedside tool that can be performed on women identified as high risk via physiological parameters. The tool needs to be quick and easy to use whilst accurate at diagnosing sepsis.

Study Objectives

To evaluate the effectiveness of physiological parameters in predicting maternal sepsis.

To evaluate the effectiveness of alternative biomarkers in diagnosing maternal sepsis including a genomic sepsis-test.

Investigation of the systemic immune health of women undergoing an uncomplicated pregnancy and labour.

Eligibility Criteria:
Inclusion Criteria:

Pregnant with viable pregnancy confirmed on ultrasound at dating scan and over 18 years of age Able to provide informed consent (a translation service will be provided for women where English is not the first language);

Women recruited into Cohort B will have deferred consent taken to avoid interference with clinical care.

Exclusion Criteria:

* Pregnant woman under the age of 18 or wishing not to consent, withdrawing consent or lacking capacity.
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics

In people who develop asthma after the age of 12 and who are also overweigh, there can be an increased burden of asthma symptoms, more flare-ups, and poorly-controlled asthma when compared to normal weight asthmatics. Certain factors are more abundant in the blood of individuals who are obese. One such factor is derived from the metabolism of an amino acid found in your diet, which is known as L-arginine (Amino acids are most commonly known as the building blocks of proteins, the same as the proteins found in food). This factor is called asymmetric dimethylarginine or ADMA. The balance of L-arginine to ADMA may be important to the health of subjects with asthma. The balance between L-arginine and ADMA plays an important role in producing nitric oxide (NO) in the airways. NO is normally produced in the lung and plays a major role in maintaining airways open and functioning normally. Our research has shown that in subjects with asthma who are overweight and developed asthma later in life, the combination of low L-arginine and high ADMA, may lead to lower NO levels. We are asking participants in this study to take L-citrulline, which is converted to L-arginine by your body, as a supplement for a period of one week. We anticipate that L-citrulline will restore NO levels in the airways, by increasing the ratio of L-arginine to ADMA


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, 18-75 yrs old, from all racial/ethnic backgrounds
* Diagnosis of asthma for \>1 yr
* BMI ≥ 30
* Baseline pre-bronchodilator FEV1 between 60 and 90% predicted with a 12% or greater bronchodilator response to 4 puffs of albuterol
* Smoking history \<20 pack years and no smoking in the last year
* Able to identify age of asthma onset

Exclusion Criteria:

* Respiratory tract infection within the last 4 weeks;
* Oral CS burst within the last 4 weeks or regular systemic CS use
* Hospitalization within the last 3 months
* ER visit within the 4 weeks
* Significant or uncontrolled concomitant medical illness including (but not limited to) heart disease, cancer, diabetes
* Current smoking or within the previous 12 months
* Current use of statins for the past 30 days (Statins lower ADMA levels)
* Pregnancy
* Intolerance or allergy to L-arginine or L-citrulline
* Phosphodiesterase inhibitors
* Taking oral nitrates
Feasibility, Effectiveness, and Patient Experience of Online Acceptance and Commitment Therapy Plus Exercises for Older People With Chronic Low Back Pain

No study has investigated the effects of online ACT on community-dwelling older adults. Given that clinical practice guidelines have recommended exercise therapy for treating people with CLBP, a combination of ACT and exercise therapy may yield better clinical outcomes than exercise alone among community-dwelling older adults with CLBP.

A double-blinded (participants and statistician) pilot randomized controlled trial (RCT) will be conducted to evaluate the feasibility and the relative effects of online ACT plus back exercise training as compared to exercise alone in improving psychological flexibility, physical well-being, and quality of life of community-dwelling older people with CLBP at different time points. The clinical outcomes will be measured at baseline, immediately after the 4-week treatment, and at the 3- and 6-month post-treatment follow-ups. Further, a qualitative research study will be conducted to understand the experiences of participating in online ACT and back exercise training in older people with CLBP (including identifying facilitators and barriers to participation).

Recruitment posters will be displayed in five Hong Kong community centers. A total of 40 older people with LBP will be recruited and randomized to either a 4-week online ACT-plus-back-exercise group or a 4-week online spine care education-back-exercise control group. All participants will be screened for eligibility.

After providing the informed consent, participants will undergo baseline assessments. Then they will be randomized into either group. Immediately after the 4-week treatment and at 3- and 6-month post-treatment, participants will be invited to complete another set of questionnaires that are identical to their baseline questionnaires to evaluate the effects of interventions on their pain, physical function, psychological well-being, and quality of life.

Semi-structured interviews will be conducted to collect the user experience of participants in both groups by purposive sampling. The interviews will be conducted immediately post-treatment and at the 6-month post-treatment follow-up to evaluate the perspectives at different time points.

Eligibility Criteria:
Inclusion Criteria:

1. have non-specific LBP in or near the lumbosacral spine with or without leg pain that lasts for at least 3-months in the last 12 months
2. have sought some medical or healthcare professional treatments for CLBP
3. able to read and write at an adequate level of proficiency in Chinese
4. Mini-Mental Status Examination (MMSE) scores 23 or above

Exclusion Criteria:

1. people with malignant pain or lumbar spinal stenosis
2. confirmed dementia
3. severe cognitive impairment
4. serious psychiatric or psychological disorders
5. Mini-Mental Status Examination (MMSE) scores below 23
BOL-DP-o-04 in Patients With Low Back Pain and Sciatica

The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.

A Prospective, Single-Center, Double-Blind, Placebo-Controlled Trial of BOL-DP-o-04 in Patients with Low Back Pain and Sciatica. The study is aimed to evaluate the pain-relieving effect of BOL-DP-o-04, in addition to SOC, on Low Back Pain and Sciatica.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Mild to Severe Low Back Pain and/or Sciatica
3. Imaging studies (CT or MRI) supporting anatomical abnormality that could be the cause of the symptoms
4. Must be physically and mentally willing and able to comply with the treatment regimen and understand the informed consent and study procedures
5. Signed and dated Informed Consent Form (ICF)
6. Non-responsive to standard therapy for at least 1 month

Exclusion Criteria:

1. VAS Pain Subscale score at Screening is less than 6 (with 0 being no pain and 10 being worse imaginable pain)
2. Known allergy to cannabis or its components
3. A patient who is pregnant or intends to become pregnant during the study
4. A patient who is nursing or intends to nurse during the study
5. A patient suffering from a mental disorder precluding administration of study drug
6. Prisoners
7. A Patient is unable to sign an informed consent form
8. Unstable angina pectoris
9. Cardiac insufficiency precluding cannabis administration
10. Immunosuppressed patients unless BOL-DP-o-04 administration is deemed safe by the treating physician
11. Known Aspergillus infection
12. Panic attacks or anxiety unless a psychiatrist allowed BOL-DP-o-04 following intake interview
13. Any mental/psychiatric illness in first-degree relative in a young patient \< 30-year-old.
14. Patient with congestive heart failure
15. Subjects who get the following medications: opiates, Primidone, Phenobarbitol, arbamazepine, Rifampicin, Rifabutin, Troglitazone, and Hypericum perforatum
Lingual Muscle Training in Late-Onset Pompe Disease (LOPD)

This study is being done to test the effects of Lingual Muscle Therapy (LMT) in patients with Late-Onset Pompe Disease (LOPD) who have tongue weakness. The results of this study will help design future research studies about LMT in LOPD.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 12 years
* Lingual weakness as measured by quantitative muscle testing (≤ 5% lower limit of normal for stratified age)
* Confirmed diagnosis of LOPD
* On enzyme replacement therapy for ≥ 26 weeks at pretest
* Able to follow directions for study participation
* Able to complete a home-based LMT regimen
* Access to reliable internet connection
* Access to use of electronic device that allows for FaceTime, Jabber, or WebEx use

Exclusion Criteria:

* Neurodegenerative conditions (e.g. stroke, dementia) or other serious neurologic condition that would prevent meaningful study participation as determined at the discretion of the principle investigator
* Any current or past history of seizures.
* Head and neck cancer or radiation treatment to head/neck
* Inability to tolerate IOPI device tongue bulb
* Inability to give legally effective consent
* Inability to read and understand English
Study to Analyze the Surgical Site Infections in a Group of Patients Who Were Randomly Applied a Negative Pressure Therapy Dressing Versus Conventional Dressing

Surgical site complications generate a series of consequences that prolong hospital stay, increase interventions and procedures, and consequently considerably increase healthcare costs. Hence, the importance of studying measures to reduce these complications and the most feared of them is surgical site infection. The objective of the study is to analyze the complications of the surgical site in a group of participante with risk factors for developing them after undergone abdominal surgery in the period described.

All non-consecutive participants operated on in a hospital were included, both those who, based on a protocol prepared by the investigators unit, were classified as having no risk of developing complications, low risk or high risk. Partfipants classified as low and high risk, after their consent to participate in the study, entered to form part of it. This participanta were classified before surgery according to the risk factors of themselves and of the procedure, and those at risk were randomized to treatment with a negative pressure therapy dressing or no treatment, and a cure was performed with a conventional dressing. The participants classified as not at risk of complications were not included in the study. In this way the investigators tried to analyze if the intervention with the negative pressure therapy dressing reduced the complications of the surgical site.The primary objective was to analyze the reduction of surgical site infections in participants treated with negative pressure therapy compared to those treated with conventional dressing. As secondary objectives the investigators proposed to measure other complications in both groups and the hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* patients with risk factors for developing surgical site complications
* undergo abdominal surgery
* consent of the patient to participate in the study

Exclusion Criteria:

* non-consent of the patient to participate in the study
* patients without risk of developing surgical site complications
A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.

All tumor types are now closed for enrollment:

Triple Negative Breast Cancer

Gastric Cancer

Pancreatic Cancer

Small Cell Lung Cancer

Bladder Cancer

Ovarian Cancer

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types:
* Triple Negative Breast Cancer
* Gastric Cancer
* Pancreatic Cancer
* Small Cell Lung Cancer
* Bladder Cancer
* Ovarian Cancer
* Subjects must have measurable disease
* Eastern Cooperative Oncology Group (ECOG) of 0 or 1
* Adequate hematological and organ function as confirmed by laboratory values

Exclusion Criteria:

* Active brain metastases or leptomeningeal metastases
* Subjects with active, known or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
* Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting T cell is also prohibited