cyrilzakka/clinical-trials huggingface dataset:
BEnefits of Stroke Treatment Delivered Using a Mobile Stroke Unit

The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS) to a CSC ED for evaluation and treatment (Standard Management-SM).

There are many ways that use of a MSU might prove valuable in stroke patients, but we will focus on acute ischemic stroke (AIS) and treatment with IV tissue plasminogen activator (tPA) within 4.5 hours of symptom onset since that is the most evidence based effective emergency treatment for the most prevalent stroke diagnosis. We hypothesize that the MSU pathway will result in an overall shift towards earlier evaluation and treatment, particularly into the first hour after symptom onset, leading to substantially better outcome. We also hypothesize that as a result of improved clinical outcomes resulting from earlier treatment, the costs of a MSU program will be offset by a reduction in the costs of long term stroke care and increase in quality adjusted life years, thereby supporting more widespread use of this technology. To make MSU deployment more practical, we will confirm that a Vascular Neurologist (VN) on board the MSU can be replaced by a remote VN connected to the MSU by telemedicine (TM) thereby reducing manpower requirements and costs.

The successful completion of this project will provide data on important outcomes and costs associated with the use of MSU vs SM in the United States (U.S.) that will help determine the value of integrating MSUs into the pre-hospital environment in this country. Successfully addressing our three Specific Aims (time saved/ complications encountered, utility of TM, and cost effectiveness) will provide critical information that will be needed to determine if and how a subsequent more definitive study should be conducted. We anticipate that emanating from this exploratory study would be a larger multicenter trial carried out in both urban and rural U.S. pre-hospital environments, with treatment orchestrated via TM, and having sufficient power to determine a difference in long term outcome and costs between patients managed on the two pathways, following a study design that will be tested in this exploratory trial. The present study, therefore, is the necessary first step in a process which may dramatically modify the way that acute stroke patients are managed in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* Last seen normal within 4hr 30 min of symptom onset
* History and physical/neurological examination consistent with acute stroke
* No tPA exclusions per guidelines, prior to CT scan or baseline labs
* Informed consent obtained from patient (if competent) or legal representative.

Exclusion Criteria:

-None
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents

The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.

CAIN457F2302 (Core Study): Completed Sep 9 2015

CAIN457F2302E1 (Extension study): terminated early May 26 2015, ((unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.

Eligibility Criteria:
Inclusion criteria:

* Male or non-pregnant, non-lactating female patients
* Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening
* At Baseline: Disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥6 swollen joints out of 66 with at least 1 of the following at screening:
* Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR

Rheumatoid Factor positive and with at least 1 of the following at screening:

* High sensitivity C-reactive protein (hsCRP) ≥ 10 mg/L OR Erythrocyte sedimentation rate (ESR) ≥ 28 mm/1st hr
* Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
* Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan only: 6 to 25 mg/week)

Exclusion criteria:

* Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician RA patients functional status class IV according to the ACR 1991 revised criteria
* Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
* Other protocol-defined inclusion/exclusion criteria may apply.
Preoperative Oral Carbohydrate Loading in Gynecologic Surgery

The advantage of carbohydrate loading in minimally invasive surgeries are not well established. We designed this study to evaluate whether preoperative oral carbohydrate improve postoperative recovery after laparoscopic gynecologic surgeries.

This study will be conducted in the female adult patient scheduled for laparoscopic gynecologic surgery for benign or premalignant condition. Patients with American Society of Anesthesiologist physical status classification I-II, not pregnant or on lactation will be included. Patients with underlying disease that will delay gastric emptying (GERD, history of gastrointestinal surgery, diabetes), or contraindicated to NSAID or opioid, psychiatric or mental disorders, alcoholism, or drug abuse will be excluded.

Participants will be randomized into 2 group: the control group and the study group. Randomization will be conducted via random block with stratification generated by the http://www.randomization.com with 1:1 allocation. The sequence will be kept in opaque, sealed envelopes until the day before the study date. One investigator, not involved in the outcome assessment, opened the envelope on the day before the surgery, and allocated participants in each group.

After having regular diet until the evening before surgery, participants allocate in the control group were kept fasted from midnight until surgery. Participants in the study group will receive 800 mL of carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg). The participants in the study group will freely drink carbohydrate beverage starting from the evening before surgery up to 2 hours before surgery.

The postoperative quality of recovery (QoR) score, time to readiness to discharge, patient satisfaction, postoperative nausea and vomiting, change in body weight, and insulin resistance will be assessed.

Eligibility Criteria:
Inclusion Criteria:

age between 18 and 70 years American Society of Anesthesiologists physical status (ASAPS) classification I-II absence of pregnancy or lactation at the time of surgery.

Exclusion Criteria:

suspicious delayed gastric emptying such as GERD or gastrointestinal surgery metabolic disorders such as diabetes known contraindications to NSAID or opioid physically disabled severe psychiatric or mental disorders alcoholism, drug abuse
Diagnostic Accuracy in Sepsis

The sepsis syndrome has recently been more stringently defined as "a life-threatening organ dysfunction caused by a dysregulated host response to infection". Clinical and paraclinical tools are investigated for their ability to adequately recognize sepsis early.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old with suspected sepsis in the Emergency Department of Oslo University Hospital Oslo

Exclusion Criteria:

* Non
Real-World Evaluation of Patient Characteristics and Treatment Patterns Among Patients With CML-CP Treated With Asciminib

A retrospective, non-interventional cohort study design using data obtained from the Flatiron Health oncology electronic health record (EHR)-derived de-identified database, was used to address the study objectives.

The overall asciminib cohort included adult patients with Philadelphia positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CML-CP), with or without the T3151 mutation, who initiated asciminib in any line of therapy. The third-line or later (3L+) asciminib cohort included adult patients with Ph+ CML-CP who did not have T315I mutation and initiated asciminib after prior use of at least 2 different tyrosine kinase inhibitors (TKIs) or omacetaxine. The 3L asciminib cohort included the subgroup of the 3L+ asciminib cohort who initiated asciminib after prior use of 2 different TKIs or omacetaxine. The fourth-line or later (4L+) asciminib cohort included the subgroup of the 3L+ asciminib cohort who initiated asciminib after prior use of at least 3 different TKIs or omacetaxine.


Eligibility Criteria:
Inclusion criteria:

* Patients who initiated asciminib as identified by Flatiron through the Flatiron Health-Novartis Scemblix CML Spotlight database study.
* Patients had at least one diagnosis for CML (International Classification of Diseases, 9th Edition, Clinical Modification \[ICD-9-CM\]: 205.1x; International Classification of Diseases, 10th Edition, Clinical Modification \[ICD-10-CM\]: C92.1x).
* Diagnosed with CP as identified by Flatiron through chart abstraction.
* Had 2 or more documented clinical visits, on different days in the Flatiron data on or after 1 January 2011.
* Had evidence of treatment with asciminib on or after Food and Drug Administration (FDA) approval date (29 October 2021), with data granularity availability at least at the month level for dates of asciminib use.
* Had CML initial diagnosis date on or after 1 January 2011.
* Had 1 or more clinical activity within 6 months prior to asciminib initiation (e.g., medical visit, medication order, lab test, etc.).

Exclusion criteria:

* Patients who did not meet inclusion criteria listed above.
* Had stem-cell transplant (SCT) on or prior to asciminib initiation or unknown SCT date.
* Diagnosed with CML in accelerated phase (AP) or blast crisis (BC) before asciminib initiation, as identified by Flatiron through chart abstraction, or had blast greater than 15% or unknown blast result within 60 days prior to asciminib initiation.
* Patients had received a clinical study drug between 15 November 2017 and 4 December 2019 (randomization dates for the ASCEMBL trial).
Effectiveness of an Individualized Symptom Education Program (ISEP)

The purpose of this study is to examine whether an Individualized Symptom Education Program (ISEP) is helpful to women to manage their symptoms when they are receiving radiation therapy for gynecological cancer.

It is expected that women who participate in the ISEP program will be better able to manage their symptoms and exprience less distress than women who receive usual care.

Women who have radiation therapy for gynecological cancer may experience a number of symptoms including fatigue, pain, nausea, pelvic symptoms (urgent and frequent urination and bowel movements, vaginal discharge, vaginal itching, skin irritation), anxiety and depression. We know that individualized education programs have helped people with other types of cancer to better manage their symptoms, and we would like to find out whether such interventions are helpful to women with gynecological cancers.

This study will compare two types of education: 1) the symptom education program currently in place (usual care), and 2) an individualized symptom education program (ISEP). This study is being conducted because we do not know if one type of education in patients who receive radiation for gynecological cancers is better than the other. Both types of education are are described below.

Usual care: Usual symptom education during radiation treatment consists of receiving verbal and written education from a radiation oncologist, nurse and radiation therapist, and other members of the interdisciplinary team. The radiation therapist will see the patient everyday during her radiation treatment and her doctor and nurse will see her on a weekly basis. The patient will also see other members of the team, such as a dietitian and social worker as required.

Individualized symptom education: Individualized symptom education will include usual symptom education and also an education program that focuses on symptom management. The patient will meet with an advanced practice nurse on a weekly basis for six sessions of about 30 minutes each. The advanced practice nurse will ask about the symptoms the paient is experiencing and those that are most bothersome to her. She will be given information about specific strategies to manage those symptoms, including written education materials. These strategies will be based on published best practice guidelines.

Data on symptom experience will be collected at 3 points: at baseline, after completion of the education program (end of external beam treatment), and at 3 months following completion of the education program (3 months following completion of external radiation treatment).

Eligibility Criteria:
Inclusion Criteria:

* First time diagnosis of cancer of the uterus, cervix, vagina, or vulva
* Beginning first time radical radiation therapy to the pelvis of at least 4000cGy (with or without brachytherapy after external beam treatment and with or without concurrent chemotherapy)
* At least 18 years of age and over
* Able to speak and understand English

Exclusion Criteria:

* Receiving palliative cancer treatment
* Receiving split course radiation treatment
* Ovarian cancer
Mobile Mindfulness Training for Smoking Cessation

The purpose of this study is to assess the effectiveness of a Mobile Mindfulness Training smartphone application on smoking cessation in smokers ages 18 to 65 years.

In this study, a pilot phase will be carried out first to test feasibility and engagement of the tested intervention. Then in the randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains mindfulness for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.

Eligibility Criteria:
Inclusion Criteria:

Participants must be (a) 18-65 years of age; (b) smoke 5+ cigarettes/day, (c) \< 3 months abstinence in the past year; (d) have a smartphone; and motivated to quit smoking.

Exclusion Criteria:

There are no exclusion criteria. We aim to recruit a heterogeneous group, representative of the general population.
Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads

Determine the ability of real-time ultrasound with fusion technology of prior acquired MRI of the pelvis to guide a needle to the second sacral foramen using the posterior approach and place a interstim lead.


Eligibility Criteria:
Inclusion Criteria:

* Patient consented for Interstim lead placement

Exclusion Criteria:

* Patients requesting not to be in the study.
* Pregnant patients
Acute Impact of Different Foods and Beverages on Exercise Induced Oxidative Stress and Inflammation

The aim of this research project is to explore the acute impact of specific foods and beverages, which have been shown to be associated with inflammatory processes, mainly in epidemiological studies, on inflammatory and oxidative stress parameters in healthy humans following a high intensity physical workout.

The aim of this research project is to explore the acute impact of specific foods and beverages, which have been shown to be associated with inflammatory processes, mainly in epidemiological studies, on inflammatory and oxidative stress parameters in healthy humans following a high intensity physical workout. The choice of food will mainly be based on the food groups from the Empirical Dietary Inflammatory Index. For that purpose, seventy-two healthy volunteers will be recruited to perform several interventions in order to assess the impact of different nutrient groups or single- foods on oxidative and inflammatory markers. They will be divided into the three groups beverage consumption, plantbased foods and protein sources. The intense physical activity serves to induce a physiological stress response in the body, known to be accompanied by an increase in oxidative and inflammatory stress parameters. The idea is that anti- inflammatory or antioxidant nutrients could potentially attenuate this stress response in dependence on their anti- inflammatory or antioxidant potential. The operability of this concept has already been tested. The main benefit of this approach is to get a deeper insight into short term effects of single foods or beverages on inflammatory and prooxidative processes in humans by using short term intense physical activity as a stress model. One major practical aspect of this approach is to assess dietary components with respect to their pro- or anti-inflammatory-/oxidative stress potential regarding e.g. non-communicable diseases such as type 2 diabetes, coronary heart disease or the metabolic syndrome. Furthermore, it could help to reduce inflammation or oxidative stress during or following high intense physical exercise in order to reduce the stress response during training or competition in order to enhance regeneration and to foster the training gain in sports.

Eligibility Criteria:
Inclusion Criteria:

* female human subjects
* aged 18-40 years
* no chronical diseases
* not more than 120 minutes of physical activity per week
* no regular resistance training within the past 6 months
* BMI 18.5 - 24.99 kg/m²
* body fat percentage of at least 20%
* Exclusion Criteria:
* contraindications against physical activity
* anemia
* fructose or lactose intolerance
* smoking
* medications with influence on ROS levels or inflammation
* allergy or intolerance against intervention food/beverages.
Does a Soft Drink Mixture Improve Tolerance of Activated Charcoal in the Adult Poisoned Patient Without Affecting Efficacy

Activated charcoal (AC) is an established, effective means of gastrointestinal decontamination. Providers give it to patients who have ingested something that is thought to be potentially poisonous to prevent it from being absorbed. However, one limitation to its use is palatability of the AC for the patient, potentially limiting how much, if any, is taken.

Other studies have suggested that mixing AC with various substances improves the rating on various scales (taste, etc). An important question is whether mixing the AC with other substance effects the ability of the AC to bind to xenobiotic in the gut. This small study investigates whether mixed cola with charcoal affected its ability to prevent the absorption of acetaminophen. It also performs a survery to see if participants preferred the AC-cola mixture. The investigators hypothesize that the AC will be equally as effective with cola as without. The investigators also hypothesize that participants will prefer the AC-cola mixture.


Eligibility Criteria:
Inclusion Criteria:

* No self-reported history of any hepatic, gastrointestinal, or renal disease
* No self-reported history of alcohol or substance use disorder
* No daily prescribed medications
* Weight between 60-93 kg

Exclusion Criteria:

* pregnant,
* imprisoned
* allergy or intolerance to acetaminophen or gluten
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.

This single arm study will evaluate the efficacy and safety of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response to one or more anti-TNF therapies. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. After week 24, eligible patients may receive re-treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-80 years of age;
* rheumatoid arthritis for \>=6 months;
* receiving outpatient treatment;
* an inadequate response to at least one anti-TNF therapy;
* stable methotrexate for \>=12 weeks.

Exclusion Criteria:

* other rheumatic autoimmune disease or inflammatory joint disease;
* previous treatment with MabThera;
* concurrent treatment with any DMARD (apart from methotrexate), anti-TNF alpha therapy, or other biologic agent.
Innovative Physiotherapy in Stroke Rehabilitation

The current study has the potential to improve rehabilitation during the subacute phase of a stroke, aiming to reduce the individual's disabilities and risk of falling, enhance health promoting physical activity and independence in ADL.

The purpose of the RCT is to investigate the effects of an innovative physiotherapy intervention, called I-CoreDIST when applied in comprehensive rehabilitation after discharge from a stroke unit and throughout the rehabilitation chain.The project investigate: 1) effects on postural control and balance in various positions and functional activities. Effects on and level of physical activity, and 2) user's identifications of positive and negative features in content and coordination of physiotherapy integrated in post stroke rehabilitation. Function parameters of balance, gait and levels of physical activity at baseline and at 12 weeks will be compared to those obtained from the standard care group. Semistructured interviews will be conducted to identify patients' perceptions of key positive and negative features of content and coordination of I-CoreDIST and standard care rehabilitation after a stroke.

Eligibility Criteria:
Inclusion Criteria:

* A stroke diagnosis
* Can sit for 10 seconds without support
* Age 18-85
* Trunk Impairment Scale-Norwegian version (TIS-NV) \< 15
* Pre-stroke modified Ranking Scale (mRS) 0-3

Exclusion Criteria:

* Dementia
* Unable to cooperate in physiotherapy
* On-going substance abuse
* Severe co-morbidity preventing rehabilitation, severe neurological diseases such as Parkinson disease, Multiple Sclerosis and brain tumor.