cyrilzakka/clinical-trials huggingface dataset:
The Effect of Cigarette Smoking / Smoking Cessation on Skeletal Muscle Mass, Strength and Functional Capabilities

Tobacco smoke is probably the single most significant source of toxic chemicals that humans are exposed to. Smoking is associated with a variety of pathological conditions such as cardiovascular and pulmonary diseases. In addition to the known harmful effects of cigarette smoking, several epidemiological studies identified tobacco use as a risk factor for sarcopenia, the loss of skeletal muscle mass and strength with advancing age. Previous studies examined skeletal muscles of smokers in comparison with muscles of non-smokers and found structural and metabolic damage in muscles of smokers.

Quitting of smoking is known to be associated with weight gain. A previous study examined the effects of smoking cessation on body composition of post-menopausal women using dual-energy x-ray absorptiometry (DEXA). It was found that women who successfully quit smoking for a period of 16 months have significantly increased their body weight, fat mass, muscle mass and functional muscle mass in comparison with non-quitters women. For the first time, it was shown that smoking cessation is associated with an increase of functional muscle mass. Yet, the effects of quitting of smoking on muscle mass and muscle functional capabilities of younger subjects remain unclear. Therefore, we aim to investigate the effects of smoking cessation on muscle mass, muscle function and strength in heavy smoker's subjects. Our findings may shed light on the beneficial effects of smoking cessation regarding the status and function of skeletal muscle in heavy smokers and as a possible strategy to prevent or delay the progression of sarcopenia.

Research hypothesis: Smoking cessation among adult heavy smokers will lead to increase in skeletal muscle mass and improvement of muscle function and strength compared with continued smokers.

Body composition and muscle function were assessed at the beginning of a smoking cessation program and again after 12 months. Changes in body composition and muscle function were compared between continued smokers and quitters.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between the ages of 18-65
* Heavy smokers (smoking more than 15 cigarettes per day)
* Taking part in smoking cessation support group at "Clalit Health Services", Haifa and Western Galilee district

Exclusion Criteria:

* Medical conditions affecting skeletal muscle metabolism or function.
* Use of corticosteroids or any other medication or nutritional supplement affecting skeletal muscle
* Consuming more than two alcoholic drinks per day
Canine-Assisted Anxiety Reduction In Emergency Care

Compare the effect of a single exposure to a therapy dog and handler within the pediatric emergency department patient with anxiety by measuring the change in patient perception of anxiety before and after dog exposure using the FACES scale. We will also measure galvanic skin response (resistance to electrical current).

This study challenges current dogma by introducing a widely available, low cost method of dog therapy to reduce patient stress. The organization "Paws of Love" estimates that it has 180,000 volunteers who have qualified therapy dogs and who are generally willing to volunteer their time in emergency care. The benefits may include improved perception of wellness, less opioid use, and decreased use of physical and chemical restraints. As a further extrapolation, this secondary effect may extend to improved patient-doctor communication and patient experience. This will in turn improve patient safety in the Emergency Department, decreasing the number of adverse events, and decreasing the risk of medical malpractice by improving the patient-provider relationship. (6, 7)

Eligibility Criteria:
Inclusion Criteria:

* 4-17 years old;
* Physician or nurse with primary care responsibilities believes that the patients has a moderate to high level of anxiety

Exclusion Criteria:

- violent behavior and any reported prior fear or adverse reaction to dogs in the dog intervention group.
Ankle Dorsiflexion Changes With Assisted Stretching Device

Ankle range of motion is an important degree of freedom for performing activities of daily living. Limited range of ankle motion has been related to Achilles tendonitis, lower limb injury, and abnormal gait leading to overuse injury. While stretching and massage can help increase range of motion the amount and frequency of manual manipulation needed to affect range of motion is not accessible to an individual in their home. A new device has been developed to allow deep stretching of the ankle and surrounding muscles to help increase ankle dorsiflexion. This device can be used in an individual's home, without assistance, allowing more frequent stretching without increased visits to physical therapy. The goal of this study is to determine the effect of using this device during a course of treatment to improve ankle dorsiflexion in individuals with decreased ankle range of motion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of limited ankle range of dorsiflexion by physical therapist

Exclusion Criteria:

* Inability to perform testing activities as described in the consent form by self-report
* Inability to perform daily stretching with the device by self-report
Exploratory Research on Constructing a Computational Biological Model Based on NGS for MRD After Breast Cancer Surgery

This study will include 80 subjects after radical breast cancer resection, collect blood samples of the above subjects, observe and quantify the characteristic changes of cfDNA in the blood of breast cancer subjects after surgery, and establish a computational biological model based on next generation sequencing to monitor breast cancer MRD;

This study will include 80 subjects after radical breast cancer resection. The results of CA15-3, CEA, color Doppler ultrasound and other traditional postoperative monitoring examinations for breast cancer, as well as 5ml of peripheral venous blood, were collected on the day of enrollment/the 7th day after adjuvant treatment/the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, 24th, 30th and 36th months after surgery. We observe and quantify the characteristic changes of cfDNA in the blood of breast cancer subjects after surgery, and establish a computational biological model based on next generation sequencing to monitor breast cancer MRD;

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years old, gender not limited; 2. Obtain plasma samples from the subjects during a 3-year follow-up period; 3. The subjects fully understand the study and voluntarily sign the informed consent form; 4. Able to cooperate with a 3-year follow-up visit to the hospital; 5. The physical fitness status score (ZPS) of the ECOG scoring criteria for the subjects must be ≤ 1; 6. Life expectancy ≥ 5 years; 7. Subjects who meet the following criteria:

  1. Histopathology confirmed primary breast cancer (unlimited molecular type);
  2. Radical breast cancer resection is expected;
  3. Adopting postoperative adjuvant therapy or preoperative neoadjuvant therapy;

Exclusion Criteria:

* 1. The subject is pregnant or breastfeeding; 2. Serious mental illness or drug abuse; 3. Unable to obtain the subject\&#39;s plasma during this period; 4. If the subject has a non primary malignant tumor of the breast with a clear pathological diagnosis within 5 years before enrollment: 5. If the subject has suspected non breast malignant tumors (such as B-ultrasound, CT, etc.) on imaging within the past year of enrollment, but without pathological confirmation; 6. Clinical suspicion of distant metastatic lesions; 7. The subject has received any blood product infusion therapy within the past 30 days; 8. Known carriers of pathogenic genetic mutations;
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
* Baseline ADHD-RS-IV score \>=28
* BP w/in 95th percentile for age, gender, and height

Exclusion Criteria:

* Subject has controlled or uncontrolled comorbid psychiatric diagnosis
* Subject has conduct disorder
* Suicidal
* Under or overweight
* Concurrent chronic or acute illness that might confound results.
Individualized Metabolic Assessment and Nutritional Optimization in Children With Chronic Respiratory Insufficiency

The investigators aim to examine the feasibility of individualized diet intervention in children dependent on long-term mechanical ventilator support at home. The investigators will use a multidisciplinary model that will allow for diet modification based on comprehensive nutrition, metabolic and respiratory assessments performed in the subjects' home. the impact of this intervention (for 12 weeks) on body composition and respiratory variables will be assessed.

A strategy of individualized diet intervention and its impact on respiratory and nutritional outcomes in children on long-term mechanical ventilation has not been previously evaluated.

The investigators' objective is to assess the feasibility of individualized diet intervention in children dependent on long-term mechanical ventilator support using a multidisciplinary model. The investigators will optimize energy intake (based on indirect calorimetric measurement) and protein intake (based on recommended intake values) in this group. The subjects will be administered the modified diet for 12 weeks, and a comprehensive nutrition, metabolic and respiratory assessment will be performed before and after intervention, in the subjects' home. The investigators will examine the effect of individualized diet optimization on nutritional status, body composition, CO2 production (VCO2) and minute ventilation (MV).

The investigators hypothesize that optimizing energy and protein intake would be associated with improved nutritional status, particularly increment in LBM, and decrease in VCO2 and MV. If nutritional optimization is associated with positive outcomes in our study cohort, this concept could be generalized to a wider patient population with respiratory insufficiency.

Eligibility Criteria:
Inclusion Criteria:

- Children aged 1 month to 17 years will be included if they were dependent on at least 12 hours of mechanical ventilation per day via a cuffed tracheostomy tube, with a fractional oxygen requirement (FiO2) less than 0.6, and a leak less than 10% around the cuff at the time of data collection

Exclusion Criteria:

-Intercurrent illness such as fever, seizures and/or infectious disease in the 24 hours preceding the study, and/or respiratory decompensation requiring an increase in ventilator settings of \>20% from baseline in the 72 hours preceding the study
Role of Peripheral Vision in Scene Perception (PERISCE)

Despite its low spatial resolution, peripheral vision is very useful for rapidly categorizing a visual scene. Low spatial frequencies of a visual stimulus available in peripheral vision would allow a coarse categorization of the scene and objects (deciding, for example, whether it is an urban or natural landscape). This first representation would then trigger predictive mechanisms which would subsequently guide a more detailed visual analysis in central vision. The psychophysical studies that the investigators have already conducted in this scientific context has been carried out under normal vision conditions. The objective of this project is to study the influence of peripheral vision on central vision with an original approach: What are the consequences of a loss of peripheral vision on the processing performed in central vision? The project will concern patients with glaucoma. This ophthalmic pathology particularly affects the peripheral retina and thus represents a good pathological cognitive model of a visual recognition system in which peripheral vision is less important. The investigators will conduct psychophysical studies with glaucomatous patients and healthy volunteers with normal vision. All participants will be required to perform a short experiment on a computer (15 minutes) where they will look at different photographs of scenes of different luminance and spatial frequencies. Participants will have to perform various tasks on these images using the keys on the keyboard.


Eligibility Criteria:
Inclusion Criteria:

For patients :

* between 18 and 80 years old
* stable bilateral primary open angle glaucoma (POAG)
* visual acuity \> 5/10 for distant vision for the eye tested
* peripheral visual field defect on the eye tested measured through a Humphrey Visual Field Analyzer

For healthy volunteers :

* between 18 and 80 years old
* visual acuity \> 5/10
* absence of ophthalmologic disease other than Glaucoma (age-related macular degeneration, cataract except for uncomplicated cataract surgery, amblyopia, optic neuropathy, diabetic retinopathy ...)

Exclusion Criteria:

* ophthalmologic disease other than Glaucoma (age-related macular degeneration, cataract except for uncomplicated cataract surgery, amblyopia, optic neuropathy, diabetic retinopathy ...)
* treated with medication that might compromise sustained attention (benzodiazepine, narcoleptics)
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes

The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it.

The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 5 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.


Eligibility Criteria:
Inclusion Criteria:

Part A for Healthy Participants:

* Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment

Part A for Type 2 Diabetes (T2DM) Participants:

* Are participants with T2DM diagnosed greater than 1 year before enrollment,
* On basal insulin therapy, insulin glargine, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)
* Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening

Part B

* Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
* HbA1c 6% to 8.5% inclusive at screening

Part C

* Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
* HbA1c 6 to 8% inclusive at screening

All Parts

* Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)
* No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants

Exclusion Criteria:

* Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
* Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within the 6 months prior to screening

All Parts

* Cardiovascular: no significant history of cardiovascular disease (CVD)
* Gastrointestinal: have gastroparesis or have undergone gastric surgery
* Hepatic: have acute or chronic hepatitis
Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

Thyroid nodule pathologies occur frequently and represent a clinical issue for the endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The incidence of this pathology has been further highlighted by the introduction of the ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is now detected through ultrasound. The majority of nodules are benign and characterized by slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term levothyroxine treatment has, however, several well-known side effects and limitations.

During the last years, number of controlled studies have demonstrated that ultrasound guided percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid with a high level of precision, and to destroy the thyroid tissue in a predictable and repeatable fashion, without side effects.

Aim of the study:

1. to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign thyroid nodules and on nodule-related symptoms, and to compare these effects with findings in control group without active therapy;
2. to assess the eventual re-occurence of thyroid lesions (observed after other types of ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up;
3. to demonstrate reproducibility of results within different environments and under different operators;
4. to validate eventual presence of major or minor side effects.

To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up. Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.


Eligibility Criteria:
Inclusion Criteria:

* The presence of a single nodule or dominating nodule;
* A solid or mixed echo-structure with less than 20% fluid volume;
* A lesion volume between 5 and 18 ml (greatest diameter \> 3.0 cm and \<= 4 cm);
* Thyroid hormone and TSH serum levels within the normalcy value;
* 2 cytologically negative examinations for suspected neoplasia (British Thyroid Association, Second class THY)within the last six months;
* Calcitonin values within the normalacy value;
* Anticoagulant treatment suspension and antiaggregation treatment suspended for at least 72 hours.

Exclusion Criteria:

* Hyperfunctioning lesion (99mTc scintigraph);
* Autoimmune thyreopathy or elevation of autoantibodies;
* Active anticoagulant treatment or antiaggregation treatment.
Paperless Partograph for Management of Low Risk Labor

Paperless partograph is a technique used for monitoring the progress of labor before delivery, and arriving at the accurate time to intervene for ensuring a safe delivery.

The study will be carried out to find out the effectiveness of paperless partograph in management of labor and its effect on maternal and neonatal outcomes


Eligibility Criteria:
Inclusion criteria:

1. Age: 18 to 40 years
2. Gestational age 38-42 weeks
3. Singleton pregnancy
4. Vertex presentation
5. Women who will accept to participate in the study

Exclusion criteria:

1. Malpresentation
2. Induced labour
3. Multiple pregnancy
4. Medical diseases with pregnancy
Implantation of Markers for the Radiotherapy of Lung Cancer Patients

This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.

OBJECTIVES:

* To acquire experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors in patients with stage I-IIIB non-small cell lung cancer.
* To characterize the potential side effects involved in the use of markers in these patients.
* To analyze the positional stability of lung markers in these patients over a radiotherapy series.
* To acquire experience in the use of markers for treatment planning and radiotherapy in these patients.

OUTLINE: Patients undergo implantation of ≥ 1 small radio-opaque Visicoil™ marker into or close to the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo x-rays to document marker location, detect potentially dropped markers, and diagnose operation-related side effects (i.e., pneumothorax). After marker implantation, patients undergo stereotactic or conventionally fractionated radiotherapy for 30-33 daily fractions.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of non-small cell lung cancer

  * Stage I-IIIB disease
* No prior surgical tumor resection
* Respiration-induced tumor motion \> 5 mm
* Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals

PATIENT CHARACTERISTICS:

* Not pregnant
* No insufficient lung function or other parameters prohibiting a bronchoscopy
* Not a prisoner or institutionalized

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Concurrent chemotherapy allowed
Ablation of the Pulmonary Veins for Paroxysmal Afib

The purpose of this trial was to investigate and confirm the safety, efficacy, and efficiency of the Ablation Frontiers® Cardiac Ablation System when used in the treatment of paroxysmal atrial fibrillation. (PAF)

This trial was a non-randomized, multi-center, prospective study of subjects with symptomatic, paroxysmal atrial fibrillation (PAF). The purpose of this study was to investigate and confirm the safety, efficacy and efficiency of the Medtronic Ablation Frontiers® Cardiac Ablation System when used for the treatment of paroxysmal AF. The trial was conducted over a 2 year period with enrollment occurring between 4 October 2007 and 1 December 2008.

Eligibility Criteria:
Inclusion Criteria:

History of symptomatic paroxysmal atrial fibrillation defined as:

* Self terminating AF lasting no more than 7 days
* AF events demostrating spontaneous conversion back to sinus rhythm
* Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year
* AF symptoms defined as the manisfestation of any of the following: Palpitations, Fatigue, Exertional dyspnea, effort intolerance
* Age between 18 and 70
* Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study

Exclusion Criteria:

* Structural heart disease of clinical significance
* Prior ablation for arrhythmias other than AF within the past three months
* Prior left sided AF ablation
* Enrollment in any other ongoing arrhythmia study protocol
* Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
* Active infection or sepsis
* Any history of cerebral vascular disease including stroke or TIAs
* Pregnancy or lactation
* Untreatable allergy to contrast media
* Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
* History of blood clotting (bleeding or thrombotic) abnormalities
* Known sensitivities to heparin or warfarin
* Severe COPD (identified by an FEV1 \< 1)
* Severe co morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)