cyrilzakka/clinical-trials huggingface dataset:
Impact of a Pharmaceutical Care Model in the Management of Chronic Myeloid Leukemia Patients

Owing to effective treatment with tyrosine kinase inhibitors (TKIs), chronic myeloid leukemia (CML) has become a chronic disease with a rising prevalence globally. Although the possibility of stopping TKI therapy in CML patients who have achieved deep molecular responses is a topic of active debate and investigation, life-long treatment remains the current standard of care. It has been estimated that 3% to 56% of CML patients are not adherent to their prescribed TKI therapy. Poor adherence to TKIs could compromise the control of CML, and contributes to poorer survival. CML patients on long-term TKI therapy are prone to developing certain medication-related issues such as adverse reactions and drug interactions.Occurrence of adverse reactions even at low grades, has been shown to impact CML patient's health-related quality of life (HRQoL) and adherence to treatment. However, there is no prospective high quality evidence showing adherence to TKIs and the associated clinical outcomes can be improved in CML patients. Therefore, the investigators hypothesize that medication management intervention by pharmacist might improve adherence to TKIs, and translate into better disease response and HRQoL in CML patients, when compared to control arm who receive standard pharmacy service.


Eligibility Criteria:
Inclusion Criteria:

* has a confirmed diagnosis of Philadelphia chromosome positive CML
* has a detectable BCR-ABL1 mRNA
* has been taking TKI for at least 3 months
* able to speak and read English, Malay or Mandarin

Exclusion Criteria:

* with cognitive deficit or psychiatric disorders
* in advanced phase of CML where TKI is transitory to hematologic stem cell transplant
* history of hematologic stem cell transplant
* pregnant or plan to conceive in the next 1 year
Study of XL999 in Patients With Multiple Myeloma

This clinical study is being conducted at multiple sites to determine the activity, safety, and tolerability of XL999 when given weekly to patients with relapsed or refractory multiple myeloma. XL999 is a small molecule inhibitor of cellular factors including VEGFR, PDGFR, and FGFR that may be involved in multiple myeloma.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with a diagnosis of MM based on bone marrow aspirate and biopsy with ≥10% plasma cells (or biopsy of a tissue with monoclonal plasma cells), M protein level in the serum or urine, and evidence of end organ or tissue impairment (hypercalcemia, renal insufficiency, anemia, or lytic bone lesions), as defined by The International Myeloma Working Group Criteria (2003), at initial diagnosis (before initiation of chemotherapy)
* Measurable disease defined as serum and/or urine M component by electrophoresis
* Refractory to or relapsed after 2 prior treatment regimens (chemotherapy, biologic or hematopoietic stem cell transplantation)
* Concurrent therapy with a bisphosphonate is acceptable
* ECOG performance status of 0 or 1
* Life expectancy ≥3 months
* Adequate liver function
* No other malignancies within 5 years
* Signed informed consent

Exclusion Criteria:

* Nonsecretory myeloma, monoclonal gammopathy of uncertain significance (MGUS), or smoldering myeloma
* Anticancer therapy including chemotherapeutic, biologic, or investigational agents, including dexamethasone, within 30 days of XL999 treatment
* Hematopoietic stem cell transplantation within the previous 6 weeks
* Radiation to ≥33% of bone marrow within 30 days of XL999 treatment
* Subject has not recovered to grade ≤1 or to within 10% of baseline from adverse events due to investigational or chemotherapeutic drugs that were administered \>30 prior to study enrollment
* Uncontrolled and/or intercurrent illness
* Pregnant or breastfeeding females
* Known HIV
Compassionate Use of Ceftriaxone in Patients With Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis is a uniformly progressive and fatal neurodegenerative disorder for which there is no known cure. In a novel attempt to widen the search for potential therapeutic agents, a NINDS- led cooperative group performed an in-vitro screening program of 1040 FDA approved drugs in over 28 assays relevant to various neurodegenerative disorders. Several cephalosporins showed hits in ALS relevant assays. Efficacy was noted in models suggesting increased expression of the astrocytic glutamate transporter, EAAT2, as well as models of superoxide dismutase mediated toxicity. Ceftriaxone is a third generation cephalosporin with good CNS penetration, a long half-life, and was effective in both types of ALS assays. Ceftriaxone has calcium binding activity, antioxidant properties, and rescues motor neurons in culture from chronic glutamate toxicity. Since completion of the original NINDS screen, Ceftriaxone has been shown to increase by three fold EAAT2 activity in rodent brains, due to ceftriaxone's ability to increase EAAT2 promotor activation This program is for the use of ceftriaxone in ALS for compassionate care. Currently ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. However, there is an ongoing phase I study -by NEALS Consortium and the National Institute of Health- with three cohorts -a placebo group and two groups receiving either 2 or 4 grams of ceftriaxone daily-. Unfortunately there are only a limited number of patients being enrolled and the next phase of the project will not be undertaken until next year. At this point there are ALS patients unable to participate in this Phase I trial and unlikely to be alive when the next phase of study begins. Some of these patients want to receive the drug and are willing to pay for the drug and nursing care. We are therefore requesting a compassionate use protocol for these patients who request the medication and are willing to pay for the drug and nursing care to administer it. Dr. Terry Heiman-Patterson will supervise the administration and safety monitoring including labs for renal and hepatic function as well as IV site inspection.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite or probable ALS by the El Escorial Criteria
* Participants must be medically able to undergo the study procedures
* Subjects must have a registered nurse who can administer the drug daily and also inspect the IV site
* Not Pregnant
* Willing to pay for the cost of drug, administration, and safety testing
* Able to give informed consent

Exclusion Criteria:

* Patients who are not diagnosed with ALS by a physician
* Patients unable to give informed consent
* Patients who have a history of sensitivity to cephalosporin or penicillin antibiotics (such as Ancef, Keflex, Ceclor, Ceftin, Lorabid, Suprax, or Fortaz).
Risk Assessment of Carotid Plaques Using 3D Contrast-Enhanced Ultrasound

This is an open-label, non-randomized study conducted at Thomas Jefferson University comparing pressure-gradient estimates (obtained between a carotid plaque and the carotid artery) to imaging and histology markers of plaque vulnerability. There is an inverse relationship between the subharmonic signal magnitude from contrast-enhanced ultrasound microbubbles and ambient pressure. This pressure estimation technique (referred as SHAPE) will be used to estimate the pressure gradient across the carotid plaque cap noninvasively in vivo.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old and willing and able to participate. Patients with atherosclerosis scheduled for carotid endarterectomy

Exclusion Criteria:

* • Pregnancy or breast-feeding at the time of the scan

  * Patients with known hypersensitivity or allergy to any component (including perflutren) of Definity (Lantheus Medical Imaging, Billerica, MA).
  * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:

    * Patients on life support or in a critical care unit.
    * Patients with unstable occlusive disease (e.g., crescendo angina).
    * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
    * Patients with uncontrolled congestive heart failure (NYHA Class IV).
    * Patients with recent cerebral hemorrhage.
    * Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
  * Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) or respiratory distress syndrome.
  * Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
  * Patients who have received any contrast medium (X-ray, MRI, CT or ultrasound) in the 24 hours prior to the research ultrasound exam
Comparison of Gas Consumption From Two Different Anesthesia Machines

Low flow anesthesia (LFA) is used less than desirable, partly because one has considered that there might be danger of underdosing of anesthesia gas and thus risk of awareness under anesthesia.LFA has several advantages such as reducing loss of moisture and heat in the inhaled air under anesthesia and to reduce the consumption of anesthetic gas. A few anesthesia machines include an automatic gas control system: the Aisys machine, by GE Healthcare (Madison, WI, USA), and the Flow-i machine, by Maquet (Sweden).

Since these machines were introduced, only a few studies have reported their functionality and effect on gas consumption. 20 to 55% reduction of gas consumption was found. The potential reduction may have been underestimated because in the majority of cases a FGF higher than 1 l/min was still used.

In this study the consumption of anesthetic gas (desflurane) delivered by two different anesthesia machines (Aisys and Flow-i) will be compared, with and without gas control delivery systems. Gas consumption and the time needed to reach the target level of anesthetic gas concentration will be assessed. Data needed will be collected directly from the anesthesia machine, PICIS ( Electronic anesthesia record) and EPJ (Electronic patient journal). The results of this study are of interest for intraoperative ventilation and of economic and ecological interest

.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robot assisted laparoscopic prostatectomy, robot assisted laparoscopic cystectomy or robot assisted laparoscopic gynecological surgery

Exclusion Criteria:

* Cognitive failure, which compromises the ability for an informed consent.
* Pregnancy
* American Society of Anesthesiologists physical status classification system (ASA) IV-VI

Patients who are included in the study can be excluded for the following reasons:

* surgical technical problems (for example surgically impossible to complete the operation with robot assisted surgery)
* technical problems with the anesthesia machine
Effects of Good Behavior Game in a Swedish Sample

This project seeks to study the impact of Good Behavior Game (GBG), a behavior management program, on classroom environment and problem behavior in K-3 classrooms.

The goal of this randomized trial is to study the impact of Good Behavior Game (GBG), a behavior management program, on classroom environment and problem behavior in K-3 classrooms in Sweden. The main question it aims to answer is:

• Does GBG decrease problem behaviors in K-3 classrooms?

Teachers in the intervention group will be trained in GBG and asked to implement it in their respective classrooms. Teachers in the comparison group will provide usual practice.

Background: Early conduct problems are prevalent and a prominent risk factor for several adverse health-related and psychosocial outcomes in later life. Good Behavior Game (GBG) is a promising school-based behavior management program with the potential of reaching many children in their formative years.

Primary objective: To study the effectiveness of Good Behavior Game in reducing problem behaviors in Swedish K-3 classrooms under real-world conditions.

Secondary objectives: To investigate changes in problem behaviors in common school areas, classroom climate, teacher collective efficacy, on-task behavior, and behavioral management practices as a result of teacher training in GBG. The study also seeks to investigate implementation as a moderator, as well as potential barriers and facilitators in regards to implementation.

Type of trial: Cluster-randomized controlled trial

Trial design and methods: Recruitment of schools in a Swedish municipality started early 2021. In May 2021, 5 schools were randomized to either intervention group or wait-list (service-as-usual). Data collection started in August 2021 and ended in June 2022. The intervention group received training in GBG from September 2021 to May 2022 by certified trainers who also collected fidelity data through observations throughout the school year. Teacher ratings and observer data was collected at baseline (August 2021), along with a first (November 2021) and second follow-up (May 2022, primary endpoint) throughout the first school year of implementation.

Statistical methodology and analysis: Statistical analysis will primarily include frequentist intent-to-treat analysis, and comparisons of estimates with a corresponding Bayesian model using weakly informative priors.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility is based on school or classroom level factors. Schools must have at least one classroom with a group of students enrolled in grades K, 1, 2, or 3.

Exclusion Criteria:

* Special education classrooms are not eligible, though inclusive classrooms with a minority of students needing special education can be included.
Curative Efficacy of Secondary Prevention for Patients With Ischemic Stroke Through Syndrome Differentiation of TCM

The purpose of this study is to assess the efficacy and safety of Naoxintong Capsule in the secondary prevention of ischemic stroke by the multi-center, randomized,double-blind，placebo-controlled trial design project.

The research employs a random, double-blind, multicenter, placebo parallel and controlled design to observe the clinical effect of Naoxintong capsule in the treatment in ischemic stroke of the blood stasis syndrome on the secondary prevention，which is funded by Science and Technology Commission of Shanghai Municipality.The therapeutic drug of the research is Naoxintong capsule on the market for treatment and prevention of stroke, applicable to stroke patients caused by qi deficiency, blood stasis and venation stasis.The research will be carried out in 24 hospitals.It is a total number of 2200 volunteers，who will meet the inclusion criteria other than the exclusion criteria and agree to participate in the research.Volunteers will be randomly assigned to the experimental group or the control group. The trial drug for the experimental group is Naoxintong capsule, while that for the control group is a kind of placebo capsule.Volunteers will be regularly followed up during the experimental period of 2 years. It will be to evaluate the clinical efficacy of Naoxintong capsule on the secondary prevention by the stroke recurrence and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Adult volunteers aged ≤ 90 years old, ≥18 years old；
* Conforming to the diagnostic criteria of cerebral infarction under the 2010 version of Chinese Guidelines for Treatment of Acute Ischemic Stroke；
* Conforming to diagnostic criteria of the stasis type of TCM on the ischemic stroke；
* The onset of acute cerebral infarction ≥ 10 days；
* Consciousness awake；
* Volunteers agree to accept the program and sign informed consent.

Exclusion Criteria:

* Excluding the patients of the yin deficiency type of ischemic stroke.The diagnostic criteria of Yin deficiency type of ischemic stroke is that sudden onset of disease；being signs or symptoms of of neurological deficit；CT or MRI examination showing intracranial ischemic lesions；Scarlet tongue；
* The volunteers with severe heart diseases, cardiac insufficiency, hepatosis, renal insufficiency, respiratory failure, malignant tumour, alimentary tract hemorrhage, etc. who may fail to complete the two-year follow-up；
* Psychiatric patients；
* Pregnants and lactating women；
* Volunteers in other clinical trials；
* Volunteers who are not suitable for this clinical trial according to the researchers for other reasons.
Optimal Duration of Stretching of the Hamstring Muscle Group in Elderly: A Randomized Controlled Trial

identification of optimal duration for hamstring muscle stretch by using 3 different time of stretch 15,30,60 seconds .100 subjects will be participated in this study divided into 4 group one control and 3 experimental groups according to stretch time.

Abstract:

OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.

DESIGN: Randomized controlled trial Participants: In this trial, 100 participants will participate in the study diagnosed with tight hamstring muscles (defined as the inability to extend the knee to less than 20° of knee flexion) were randomly assigned to the control group or one of the 3 intervention groups Interventions: The three experimental groups will stretched 5 times per week for 4 weeks for 15, 30, and 60 seconds, respectively the control group did not stretch Main Outcome Measures: The neurophysiological outcome measures included peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary outcome measures included knee ROM. All outcome measures will be assessed immediately after the treatment session and 24 hours after the treatment session.

Eligibility Criteria:
Inclusion Criteria:

* Subjects had to demonstrate "tight" hamstring muscles, defined as inability to extend the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of hip flexion while the person was positioned supine. Subjects were also screened to rule out knee joint flexion contractures by checking knee extension ROM, while they were lying in a prone position

Exclusion Criteria:

* Using of medical aids, and suffering from any neurological or cognitive impairment, limiting cardio-respiratory conditions, or had undergone recent surgery (within the past 12 months). Having any hip or knee replacements or any history of pathology in the low back, hips, or knees for the 3 months prior to the study
Noninvasive Brain Stimulation for Pain Relief

Non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial focused ultrasound (FUS), is be applied to healthy human subjects, acute pain patients, and chronic pain patients to investigate their uses for pain relief.

The research team will be using non-invasive brain stimulation techniques, transcranial magnetic stimulation (TMS) and transcranial focused ultrasound (FUS) to investigate their uses for pain relief in humans: healthy human subjects, acute pain patients, and chronic pain patients. Magnetic Resonance Imaging (MRI) and electroencephalogram (EEG) recordings will be collected to achieve the following objectives:

Objective 1 aims to determine the effects of noninvasive brain stimulation on the pain-related brain activities during pain processing. We hypothesize that noninvasive brain stimulation approaches will increase or decrease cortical activity upon processing painful input.

Objective 2 aims to determine the effects of noninvasive brain stimulation on pain intensity and/or pain-related behavioral assessments. We hypothesize that noninvasive brain stimulation will influence pain-intensity and/or pain-related behavioral assessments.

Objective 3 aims to investigate the correlation between brain activity and pain relief after noninvasive brain stimulation. We hypothesize that noninvasive brain stimulation will suppress cortical activity in pain-related brain areas, reduce pain intensity, and/or improve pain-related behavioral assessments.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between 18 and 80 years of age.
* Chronic and Acute pain patients: must have an MRI (for ultrasound targeting)

Exclusion Criteria:

* Direct report to the study team member
* History of brain surgery
* History of seizure
* Pregnant
* Have alcohol consumption exceeding 50 drinks/month
* Have history of opioid abuse (all subjects), or any recent opioid use (healthy controls)
* Have implant like pacemaker and aneurysm clip
* Current of psychiatric disease such as anxiety or depression, which is not optimally treated
* Current infection
* Current wound on the skin of upper and lower extremities
* Chronic pain patients: current chronic pain is not optimal controlled by pain medications (i.e. Pain VAS \>5)
Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

This study aims at investigating the possible effect of alpha-lipoic acid on endothelial dysfunction and atherosclerosis in children with type 1 diabetes mellitus.

Endothelial dysfunction and alterations in vascular structure are early indicators of future cardiovascular events. The atherosclerotic changes begin much earlier than the appearance of clinical disease. Endothelial dysfunction in diabetes may be the result of a combination of multiple stressors. In the patients with type 1 diabetes, a significant increase in the concentrations of endothelial markers was already observed at the early stages of the disease including vascular cell adhesion molecules (VCAM-1), intercellular adhesion molecules (sICAM-1), soluble E- selectin E (sE-Selektin), asymmetric dimethylarginine (ADMA), plasminogen activator inhibitor 1 (PAI-1) because their concentrations increase rapidly in states of cellular stress. Increased carotid intima-media thickness (CIMT) is a structural marker for early atherosclerosis that correlates with cardio-vascular risk factors.

Alpha -lipoic acid supplementation may have role in Improving Endothelial Dysfunction and early Atherosclerosis due to its oxidative and anti-inflammatory effect.

Eligibility Criteria:
Inclusion Criteria:

* Children with T1DM on insulin therapy ≥ 0.5 IU/kg/day.
* Age range between 12 and \< 18 years old.
* Both sex.
* Duration of diabetes ≥ 3 years.
* Glycated hemoglobin of ≥ 7.5%
* Patients who are previously evaluated for endothelial dysfunction and atherosclerosis.

Exclusion Criteria:

* Clinical evidence of heart failure, coronary artery disease, systemic hypertension, rheumatic fever, cardiomyopathy.
* Concurrent use of any medication other than insulin known to affect cardiac function (such as digitalis, angiotensin converting enzyme inhibitor, or β-blocker, etc...).
* Concurrent use of hyperlipidemia agents (Statin, fibrate).
* Concurrent use of antioxidants as selenium, vitamin C, vitamin E, etc..
* Patients with inflammatory conditions.
* Patients with conditions predispose to oxidative stress (obesity, COPD, etc...).
* Patients with liver disease.
* Patients with thyroid disease.
* Patients with seizures.
Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index

Offering renal protection in systemic inflammatory response syndrome by atorvastatin


Eligibility Criteria:
Inclusion Criteria:

* Patients ( male and female) with systemic inflammatory response ( total leucocytic count \>12,000 mm3'. temperature \>38 C, Heart rate \>90 b/min and respiratory rate\>20 cycle).

Exclusion Criteria:

* Hemodynamic instability
* Pre-admission chronic kidney disease.
* Intra-vascular coagulopathy
* Patients with myopathy.