cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Acceptability Study of My Sleep Our Sleep (MSOS) Program

The purpose of this study is to test feasibility and acceptability of a psycho-behavioral intervention on sleep in cancer patients and their partners.


Eligibility Criteria:
Inclusion Criteria:

Patients:

1. newly diagnosed with a gastrointestinal cancer (stage I to IV) 12 months or less prior to participating
2. 18 years or older
3. able to speak/read English at the 5th grade level
4. having a consistent partner who is involved in daily activities including sleep
5. having 5 or greater score on the Pittsburgh Sleep Quality Index.

Sleep partners:

1. 18 years or older
2. able to speak/read English at the 5th grade level
3. a partner of the patient who is involved in the patient's daily activities including sleep
4. having similar circadian rhythm/sleep patterns with the patient
5. having 5 or greater score on the Pittsburgh Sleep Quality Index.

Exclusion Criteria:

Patients and their sleep partners:

1. having had a diagnosis of dementia, psychotic disorder, major depressive disorder, bipolar disorder, which currently has not been treated
2. having active suicidality in the past year
3. currently having an untreated diagnosed sleep disorder (narcolepsy, restless leg syndrome)
4. currently having have a poor physical functioning status as measured by an Eastern Cooperative Oncology Group (ECOG) score of 3 or higher and Karnofsky grade of 50 or lower
5. having poor cognitive function status as measured by the Mini Mental State Examination score of 24 or less
6. unable to see or hear
7. at the end of life (life expectancy of less than a month)
8. unwilling to change their current sleep-related habits in near future.
Brain-heart Interaction in Coronary Plaque Stability and Cardiovascular Events

The effect of brain-heart interaction remains unclear. The study aims to investigate the biological interconnection between brain neural activity and coronary plaque morphological and inflammatory features, as well as their connection with clinical outcomes.

Brain neural activity assessed by resting amygdalar activity (AmygA) can predict cardiovascular events. However, its biological interconnection with plaque vulnerability i is not fully understood. Coronary computed tomographic angiography (CCTA) is a non-invasive technique that enables comprehensive assessment of morphological characteristics of coronary atheroma and estimates the level of plaque instability. Recently, perivascular fat attenuation index (FAI) enables assessment of coronary inflammation by analyzing changes of perivascular adipose tissue attenuation in CCTA.

18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including brain neural activity and hematopoiesis.

The present study aims to use ¹⁸F-FDG PET/CT to assess the AmygA, and to investigate its association with CCTA assessed plaque morphological and inflammatory features as well as their ability in predicting future cardiovascular disease events.

Eligibility Criteria:
Inclusion Criteria:

* 1) Age: greater than 20
* 2) Patients either absence of prior cancer or remission from cancer for at least 1 year prior to imaging and throughout the follow-up period;
* 3) Patients absence of acute or chronic inﬂammatory or autoimmune disease at the time of imaging;
* 4) Patients with CCTA performed within 90 days of 18F-FDG PET/CT scan as part of routine clinical practice
* 5) Patients with diameter stenosis \>30% by CCTA but without coronary revascularization

Exclusion Criteria:

* 1) Complex coronary lesion (ostial lesion, unprotected left main lesion, chronic total occlusion, grafted vessels, etc)
* 2) Coronary lesion with heavy calcification
* 3) Chronic renal insufficiency (Serum creatinine \>2.0mg/dL)
* 4) Severe liver dysfunction (aspartate transaminase or alanine transferase \> 5 times of upper normal limit)
* 5) Pregnancy or potential pregnancy
* 6) Life expectancy less than 5 year
Postoperative Analgesia After Elective Hip Surgery - Effect of Obturator Nerve Blockade

The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients for primary hip replacement in spinal anesthesia
* Age \>= 18 years
* American Society of Anesthesiologists physical status classification score I-III
* Informed consent

Exclusion Criteria:

* Lacking the ability to corporate
* Lacking the ability to speak danish
* Planned discharge on the same day of surgery
* Neuropathy of the lower extremities
* Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
* Contraindications for dexamethasone
* Chronic opioid demanding pain
* Pregnancy
* Allergy towards one or both investigatory medicinal products
* Active treatment with amiodarone
* Active treatment with verapamil
* Active treatment with corticosteroids
Endothelial Hyperpolarization in Humans

The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.

The vascular endothelium synthesizes at least four potent vasodilator substances: nitric oxide (NO), prostacyclin, carbon monoxide and endothelium-derived hyperpolarizing factor (EDHF) that contribute to vasodilator tone, and to inhibition of platelet activation and inflammation. EDHF release is stimulated by receptor-dependent agonists such as acetylcholine and bradykinin (BK), and leads to hyperpolarization of the underlying smooth muscle cells presumably by opening Ca2+-activated K+ channels. Indirect pharmacological evidence suggests that EDHF is a cytochrome P450-derived arachidonic acid metabolite, presumably an epoxide. Although the pivotal role of NO to conduit vessel dilation in response to acute increases in shear stress is well known, its' contribution to dilation with sustained increases in flow are minimal, and may be due to EDHF release.

Eligibility Criteria:
Inclusion Criteria:

* Hyperlipidemic (LDL \> 140)
* Healthy Volunteer

Exclusion Criteria:

* Pregnancy
* Diabetes mellitus
* Cardiovascular Disease
* Hypertension
* Use of any regular medications
* Renal insufficiency
* Smoking (current or within the past 5 years)
* Bleeding disorder
Effect of Intraoperative Muscle Relaxation Depth on Postoperative Sore Throat and Hoarseness After General Anesthesia

Investigators assess and compare postoperative sore throat and hoarseness in the group maintaining moderate relaxation and deep relaxation during operation.

In this sturdy, the deep block is applied when the surgeon requests for deep muscle relaxation to improve surgical field condition in the surgery such as laparotomy known that the deep block is helpful and in the other surgeries, the moderate block is maintained. The investigators assess the postoperative sore throat and hoarseness and compare the effect of muscle relaxation depth in the deep block group and moderate block group in terms of the incidence and severity of postoperative sore throat and hoarseness.

Eligibility Criteria:
Inclusion Criteria:

* Requirement for mechanical ventilation under general anesthesia

Exclusion Criteria:

* Hoarseness and sore throat existed before surgery
* Upper respiratory infection
* Known or predicted difficult airway
* Liver, renal disease
* Requirement of postoperative ventilator care
* the operation within 2hrs
* Laparoscopic surgery
* Other positions except supine during surgery
A Comparison of Language Intervention Programs

Brief Summary:

Nearly 7% of elementary school children present with difficulties learning and using language. Unfortunately, language impairments are often long lasting and may have serious social, academic, and vocational ramifications. More than 1 million children receive language intervention in the public schools each year, and many more are seen in hospitals and other clinical settings.

This randomized clinical trial compares the language outcomes of Fast ForWord to two other interventions (computer assisted language intervention without acoustically modified speech and individual language intervention) and to the outcomes of an academic enrichment (control) condition. Each year for 3 years, children will be randomly assigned to each of the four conditions at three regional sites (Austin, Texas, Dallas, Texas, and Lawrence, Kansas). The treatments will be administered in special summer programs. The primary research question is which intervention results in the most improvement in the composite language score from the Oral and Written Language Scales. Secondary questions include which intervention results in the greatest gains in conversational language,which intervention results in the greatest gains 3 and 6 months after training, which intervention results in the greatest improvement in auditory perception, and which intervention is the most cost effective.

The results of the study will have theoretical and practical value. Theoretically, the study tests the temporal processing hypothesis of language impairment. Practically, the study will describe and compare the language, communication, auditory processing and academic outcomes of different language interventions. The study will help clinicians and administrators choose the most effective and least expensive treatment for the children they serve.


Eligibility Criteria:
Inclusion Criteria:

* age 6 to 9 years
* score between 75 and 125 on the Matrices subtest of the Kaufman Brief Intelligence Test
* Speaking Quotient of 79 or lower on the Test of Language Development: Primary: 3rd Edition

Exclusion Criteria:

* Previous participation in 8 or more hours of language intervention or classroom activities using any of the Fast ForWord, Laureate, or Earobics speech-language or reading software and/or the Lindamood-Bell auditory discrimination training
* Failure of a hearing screening test
* An episode of otitis media in the previous 12 months
* Evidence of focal brain lesion, traumatic brain injury, cerebral palsy, or seizure disorder
* Abnormality of oral structure or function impeding normal language production
How Often Should We Eat

The Danish Food Administration recommends eating three main meals and three small meals a day in order to maintain a healthy lifestyle. However, there is little research to support this concept- moreover, many studies shows that fasting can have a positive impact on our health.

HYPOTHESIS AND PURPOSE The investigators hypothesize, that the number of meals per day in order to maintain a healthy lifestyle will not differ in normal weight subjects.

The investigators will include 1) healthy, normal weight subjects. The investigators will study the effects of two daily meals.

More specifically, the investigators want to better understand how the body reacts to long-term, intermittent fasting (14 h /day for 4 weeks). The investigators will assess cognitive function, dietary intake, appetite regulation, fitness, glucose and insulin responses, as well as fat and muscle composition of the body before, during, and after the study.

Our long-term goals are to compare the effects of intermittent fasting with acute fasting. All of this is in an effort to establish how our eating habits ultimately affect our health and to, perhaps, contribute to new recommendations for healthy eating in normal weight population.

BACKGROUND Obesity and diabetes are increasing health threats facing the Western world today, despite abundant research efforts and campaigns to prevent such outcomes. Throughout the years, as the incidence of both obesity and diabetes in the general population has increased, so too has the typical number of daily meals. A once common three meals per day has now increased to six meals per day, in many instances. Recent animal research has shown that intermittent fasting (one or two meals per day) over a long period of time can improve cardiovascular health and prevent chronic diseases. Biochemically, fasting leads to an activation of metabolic mechanisms designed to preserve carbohydrates and increase the dependence on energy produced by the metabolism of fat. There is little scientific evidence regarding the number of meals per day that proves to be the healthiest, and those studies that do exist have opposing conclusions. Several theories do exist regarding the number of meals per day that affect us in the most favorable way, but these are just theories. Our study is the first to assess, in both a systematic and controlled setting, how long-term, intermittent fasting affects the human body.


Eligibility Criteria:
Inclusion Criteria:

* Physically active, defined as at least 8,000 steps per day
* Regular meal frequency, i.e. energy intake=energy utilized, and eating between 3-6 meals per day

Exclusion Criteria:

* Daily medications
* Acute illness within the past two weeks (infection, fever, or surgery)
* Chronic disease, including cancer, heart, liver, kidney, and respiratory diseases, as well as metabolic diseases, such as diabetes
* Alcohol abuse or more than 14/21 units (women/men) consumed per week
* Smoking, including occasional smoking
Online Platform for Self-service of Patients With Chronic Cardiovascular Diseases

The purpose of this study is to define the requirements and characteristics of the software that will be developed for the project "Creation of a platform for self-service of people living with chronic cardiovascular diseases in an understandable, clear, complete, consistent and verifiable manner.

The project concerns the design and implementation of a long-term program of therapeutic exercise and evaluation, by exercise and health professionals, of the anatomical and functional adaptations of exercise in patients and athletes with cardiovascular diseases. Essentially, it is a program of recording and monitoring cardiovascular rehabilitation in the form of systematic exercise of the patient both at home and in sports venues, which will contribute to the prevention of cardiovascular events in conditions of fatigue and at rest as well as to the gradual rehabilitation of the patient who performs a physical activity.

Depending on the individual's functional capacity and health issues, combined with monitoring the patient's vital signs (such as blood pressure, heart rate, oxygen saturation, body temperature) the exercise professional will create an individualized, targeted exercise program with ultimate aiming at its rehabilitation with the help of physical activity and the improvement of its functional performance and by extension the quality of life of the individual. At the same time, the project will seek to motivate patients to remain committed to the physical activity program, with the aim of faster reintegration into their daily life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiovascular disease and recent myocardial infarction (\>4weeks)
* Patients shall be in a clinical stable condition.

Exclusion Criteria:

* Uncontrolled T1 or T2 diabetes mellitus.
* Comorbidities precluding exercise training (e.g., orthopaedic/neurological conditions).
* Uncontrolled arrhythmias
Rituximab in Treating Patients With Waldenstrom's Macroglobulinemia

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have Waldenstrom's macroglobulinemia.

OBJECTIVES: I. Determine the objective response, time to treatment failure, and toxicity in patients with Waldenstrom's macroglobulinemia treated with rituximab. II. Correlate expression and changes in expression of CD20 on patient plasma cells and B-cells with clinical responses.

OUTLINE: This is a multicenter study. Patients receive rituximab IV weekly for 4 weeks. Treatment may be repeated 2 months later in patients with stable disease, partial response, or complete response. Patients are followed every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Waldenstrom's Macroglobulinemia requiring therapy who have received no more than 2 prior courses of therapy; previously untreated patients with slowly progressive WM if the patient can reasonably be expected to not require chemotherapy or steroid therapy for 90 days
* CD20 positive tumor cells
* Presence of monoclonal paraprotein
* Minimum IgM level \> 2 times the upper limit of normal
* Adequate organ function: ANC\>1000/uL; PLT \> 25000/uL; serum creatinine \< 2.5; serum total bilirubin and SGOT \< 2.5 times the upper limit of normal
* 18 years and older
* Life expectancy of 6 months or greater
* ECOG performance status of 0-2
* Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 6 months after completion of treatment

Exclusion Criteria:

* Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry
* Patients who are pregnant
* Serious co-morbid disease
* Uncontrolled bacterial, fungal, or viral infection
* Active second malignancy
* Individuals who cannot provide informed written consent
A National Study in Patients With Unexplained Splenomegaly

Primary Objective:

To estimate the prevalence of Gaucher disease and of other etiologies, in patients of 15 years old or more presenting with unexplained splenomegaly after exclusion of first intention-diagnoses (e.g. portal hypertension, diagnosis or suspicion of haematological malignancy, haemolytic anemia) based on basic physical and biological exams (e.g. full blood count, liver enzymes, reticulocytes)

Secondary Objective:

To describe the exams and tests conducted for diagnosis purpose and the more frequent associations

Study duration per participant is between 1 and 12 months

Eligibility Criteria:
Inclusion criteria:

* Participants referred for the first time for splenomegaly exploration defined as :

  * Either a palpable mass on left upper abdominal quadrant, further confirmed by a ≥ 13 cm craniocaudal length on abdominal Imaging
  * Or a non palpable splenomegaly discovered on abdominal imaging and with a craniocaudal length ≥ 13 cm
* Participants with splenomegaly (as defined above) of unknown origin

Exclusion criteria:

* Participants with obvious diagnostics based on clinical exam, patient's interview and the previous initial routine biological tests :

  * Diagnosis of portal hypertension
  * Diagnosis of hemolytic anemia
  * Diagnosis of hematological malignancy
  * Known diagnosis of Gaucher Disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Surgery in Early Life and Child Development at School-entry: A Population-based Study

The central hypothesis is that surgery and anesthesia exposure in children with immature structural and functional brain development has long-term adverse effects on child development at school-entry compared with children not exposed to anesthesia.

The secondary hypothesis is that frequency of surgery and anesthesia exposure in children with immature structural and functional brain development has a dose-dependent association with worsened child development outcomes at school-entry.

The overall objective is to investigate the association between surgery/anesthesia exposure(s) in children in Ontario and major child development outcomes (physical health and well being, social competence, emotional maturity, and language and cognitive development) at school entry as measured by the Early Development Instrument.


Eligibility Criteria:
Inclusion Criteria:

* Completion of the Early Development Instrument in Ontario

Exclusion Criteria:

* Children with physical or developmental disabilities identified in the Early Development Instrument
* Not born in Canada
* Having undergone fetal interventions, radiation or brachytherapy, local pharmacotherapy, systemic cancer chemotherapeutic procedures, therapeutic interventions of the cardiovascular system
* Patients of a cardiology or cardiovascular service
The Effect of Aroma on Anxiety Among Children With Autism.

This study evaluates the effects of essential oils on anxiety scores among children who have an autism spectrum disorder. One third of the children will receive a control blend of oils, one third of the children will receive a test blend of oils, and the other third will receive a second test blend of oils.

Essential oils have been found in studies to reduce both stress and anxiety as measured by an anxiety inventory, but studies have not tested these effects among children who have an autism spectrum disorder.

The essential oils used in this study are administered each morning for a total period of four weeks, with an optional second exposure on an as-needed basis during the final two of the four weeks of the study. The oils are administered during this time to evaluate both the preventive effects and the treatment effects of the essential oils.

Anxiety is measured on an anxiety inventory, which is completed by the parent of the participant at the end of each week during the study. Parents complete this data online, allowing them to participate from anywhere in the U.S.

Eligibility Criteria:
Inclusion Criteria:

* age: 6-11 years old at enrollment
* diagnosed with an autism spectrum disorder

Exclusion Criteria:

* mast cell activation syndrome
* history of adverse response to essential oil inhalation