cyrilzakka/clinical-trials huggingface dataset:
Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?

The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism.

This study tests the effects of dietary protein and calcium on calcium retention and indices of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2 Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass Index (weight in kilograms divided by height in meters squared)and randomly assigned to a high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group, and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7 weeks each. There is a 3-week "washout" between dietary periods, during which the subjects consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days by whole body scintillation counting. In addition to Calcium retention, other endpoints include urinary indices of acid excretion and urine serum indices of bone resorption.

Eligibility Criteria:
Inclusion Criteria:

* at least 3 years since last menses
* bone mineral density equal to or greater than 2.5 standard deviations from average bone mineral density for young adults,
* body mass index equal to or less than 35 kilograms/meter squared

Exclusion Criteria:

* taking prescription medication other than hormone replacement therapy
Motor Activity and Its Barriers at the Early Phase Post-stroke in Acute Care Setting.

Being active early after stroke prevents secondary complications, reduces hospital length of stay and improves long-term functional outcomes. Early mobilization and early rehabilitation are the means to achieve activity at the early phase post-stroke. Performance of out-of-bed activity at an acute care setting is partially dependent on the routines used in the acute care setting, however, knowledge the knowledge about associations between clinical routines and the characteristics of out-of-bed activity is limited. Also, there is limited knowledge about institutional barriers to such activity.

Accordingly, the goal of the current study is, in acute hospital inpatient setting, to: 1) characterize stroke patients' activity according to shifts (i.e. morning and evening), 2) test associations between out-of-bed activity and patients' clinical status and 3) identify barriers to activity.

The study is a prospective observational study that monitors physical activity in people after stroke while they in an acute stroke care setting, and records berries for out-of-bed activity including being in sitting or standing and walking.

Patients are included if they admitted to the hospital within 48 hours of symptom onset, passed routine initial neurologic and nursing examinations within 48 hours of admission, and have score of 5-18 on the National Institutes of Health Stroke Scale (NIHSS). Patients are excluded if they had hemorrhagic stroke, and if they have heart failure, acute coronary syndrome, unstable hemodynamics and fractures, or if they are terminally ill.

Not required

Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke
* Admitted to the hospital within 48 hours of symptom onset
* Passed routine initial neurologic and nursing examinations within 48 hours of admission
* Score of 5-18 on the National Institutes of Health Stroke Scale (NIHSS).

Exclusion Criteria:

* Hemorrhagic stroke
* Heart failure
* Unstable hemodynamics
* Fractures
* Terminally ill
Couple & Family Contexts

The purpose of this study is to understand the factors that lead to adolescent sexual risk behavior by investigating both the family contexts and romantic relationships that influence adolescent couples' decision-making.

In the United States, inner-city African American and Latino youth are vulnerable to the negative consequences of sexual risk behavior. Despite the fact that sexual risk behavior is a dyadic behavior, almost all of the social-cognitive theories emphasize individual-based variables to explain behavior. Little research has studied both members of an adolescent couple or has used measures from each member to predict future sexual activity of that dyad. The overall aim of the present study is to identify explanatory models of couple sexual risk behavior among a sample of unmarried, non co-habiting Latino and African American high school-aged dyads that are romantically linked. In addition, the present research also will study the parents of adolescent couples. In doing so, the present research will apply theories of cognition, emotion and emotion regulation, and a new theory of parental monitoring to the study of adolescent sexual risk behavior among couples.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents must be between the ages of 17-19
* Adolescents must currently reside in the Bronx, New York
* Adolescents must be of Latino or African American descent
* Adolescents must identify as being currently involved in romantic relationship
* Adolescent and parent must both agree to being a participant
* Adolescent and parent must be able to participate in questionnaire activities

Exclusion Criteria:

* Any cognitive or psychiatric disability that would prevent successful participation of adolescent or parent in questionnaire activities
Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives

This observational non-interventional study will assess (under conditions of clinical practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or without active promotion of lifestyle changes in hypertensive patients at high cardiovascular risk

Study Design:

Eligibility Criteria:
Inclusion Criteria:

patients with essential hypertension aged \>/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus.

Exclusion Criteria:

according to SPC
Feasibility of Immersive Virtual Reality Dietician Program in Metabolic-dysfunction Associated Steatotic Liver Disease

Metabolic-dysfunction associated steatotic liver disease, often referred to as "fatty liver disease", is a leading cause of liver failure. Dietary weight loss is a cornerstone of treating fatty liver disease, but access to traditional in-person nutritional education is often limited by cost, availability, and transportation. Immersive virtual reality (iVR) has the potential to not only overcome these barriers, but also provide an interactive learning experience, such as measuring and preparing foods. Therefore, the investigators have created and validated an iVR dietician program known as the Immersive Virtual Alimentation and Nutrition (IVAN) using evidence-informed practices from the Academy of Nutrition and Dietetics.

The goal of this project is to translate the IVAN program from human and patient research to practice and community research. The investigators plan to accomplish this by performing a randomized clinical trial evaluating the effect of the IVAN program in combination with synchronous audio/video dietary counseling on self-reported dietary intake and weight compared to in-person counseling. Concurrently, the investigators will provide a survey assessing implementation outcomes to both groups as well as the dietician at each study visit, and crossover the intervention at study completion so all participants assess the IVAN program. Additionally, the investigators will have clinic health care providers experience the IVAN program and assess implementation outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults age \>18 years
* MASLD identified on imaging
* Possession of a smartphone

Exclusion Criteria:

* Inability to provide informed consent
* Institutionalized/prisoner
* Pregnant
* Other causes of hepatic steatosis or chronic liver disease
* Severe medical/psychiatric comorbidities at the study PI's discretion
Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy

Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Electroacupuncture is based on obtaining the needling sensation manually and applying electrical stimulation of different frequencies and intensities, aiming to enhance the intensity of acupoint stimulation to improve the effect. As a kind of acupoint stimulation therapy, electroacupuncture has shown analgesic effects in animal experiments. However, at present, the clinical evidence of electroacupuncture applied in the treatment of LDHR is still insufficient. Therefore, this randomized, single-blind, sham electroacupuncture controlled trial aims to evaluate the efficacy and safety of electroacupuncture as a treatment for LDHR.


Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 70 years old.
2. With intervertebral disc protrusion confirmed by a MRI or CT, accompanied by radicular pain in the lower extremities.
3. With a NRS score ≥ 4 points for both low back pain and leg pain, and the pain lasts for at least 3 months;
4. Voluntarily participating the trial and signing the informed consent form.

Exclusion Criteria:

1. Previous surgical treatment of the spine.
2. Received any physical therapy for lumbar disc herniation within the recent 3 months.
3. Complicated with diseases that can cause low back and leg pain.
4. Symptomatic foraminal stenosis caused by severe degenerative diseases, accompanied by severe nerve injuries.
5. Previous severe mental illness, organ failure, or malignant tumor.
6. Planned spinal surgery or other major surgeries within the next 3 months.
7. Pregnancy or lactation.
Tart Cherry Juice for Sleep in Older Adults with Insomnia: a Pilot Study of Feasibility and Comprehensive Mechanisms

The purpose of this research study is test if a study that asks older adults with sleep problems to consume tart cherry products is feasible and determine if it can change sleep patterns. This study is a total of 12 weeks. Participants will be asked to consume tart cherry juice for 4 weeks and the placebo juice for 4 weeks, while wearing a digital monitor that measures sleep. Blood (about 3 teaspoons) and urine (about 2 tablespoons) samples will be taken before and after consuming both juices to measure certain biological markers related to sleep.

The overall goal of this study is to determine feasibility of a tart cherry juice intervention in older adults, and generate preliminary data of outcomes and mechanisms related to sleep. We propose a 2-arm randomized, double-blind, cross-over study in 20 older adults with self-reported insomnia. Participants will consume 240 mL of tart cherry juice or placebo (calorically matched to the tart cherry juice beverage, but theoretically devoid of melatonin, tryptophan, magnesium and flavonoids), twice/evening for 4 weeks in a randomly assigned order.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥65 years
* Self-reporting insomnia (e.g., trouble sleeping approximately 3 nights a week for at least 6 months and/or an Insomnia Severity Index score ≥ 10 points)
* Usual bed-time between 8:00 pm and 1:00 am

Exclusion Criteria:

* Unwilling to follow the study protocol
* Inability to properly use the wearable device, complete smartphone-based surveys, or follow the intervention protocol
* Self-report of medically diagnosed sleep disorders except insomnia (e.g., sleep apnea)
* Current and consistent use of sleep aids or hypnotic prescriptions (e.g., trazadone)
* Self-report of cognitive impairment, dementia, or other neurological disorder
* Are on unstable medications (i.e., change within the last 3 months) for other conditions
* Have an allergy to the intervention products
* Self-report history of diabetes
* Current alcohol (Alcohol Use Disorders Identification Test ≥4 points33,34) or drug use disorder (Drug Abuse Screening Test,35,36 DAST-10\>2 points)
* Are excessive caffeine drinkers (\>5 cups of caffeinated beverages a day)
* Any other reason/condition the PI and investigative team believe this intervention would be unsafe
Efficacy and Safety of Ryanodex® (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)

Study EGL-4104-C-1502 is a phase 2, single-site, open-label, randomized, 2-arm parallel study of Ryanodex for the adjuvant treatment of exertional heat stroke (EHS) administered intravenously (IV), to current standard of care (SOC). SOC for the treatment of EHS is defined as effective body cooling, which should be implemented as quickly as available after diagnosis of exertional heat stroke.

The study will take place at emergency medical facilities.

Due to the life-threatening nature of exertional heat stroke (EHS), rapid assessment for inclusion into the study and subsequent immediate treatment must occur. Following initial triage and primary assessment of a subject, the subject's baseline status should be documented, and once a diagnosis of EHS is obtained, SOC treatment will be initiated immediately, the subject will be randomized to one of two treatment arms (SOC only or SOC plus Ryanodex).

Patients will be remain hospitalized for up to 72 hours after administration of the first dose of study drug and implemented SOC and will receive all necessary supportive measures until resolution of symptoms.

Study duration: 72 hours

Eligibility Criteria:
Inclusion Criteria:

* Subjects may be entered in the study if they have a core body temperature obtained rectally of ≥ 40.0°C (104°F)
* Recent history or suspected recent history (prior 24 hours) of performing intense physical activity (exertional activity)
* The subject has an impaired consciousness level as evidenced by a GCS score \< 13
* The subject has tachycardia (heart rate ≥ 100 bpm)

Exclusion Criteria:

* The subject is diagnosed with or is suspected of having an acute clinically severe infection, which in the opinion of the Investigator may increase the subject's risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments
* The subject has severe hyperthermia secondary to a condition other than heat stroke (e.g., serotonin syndrome, thyrotoxicosis, pheochromocytoma, or brain hemorrhage)
* There is likelihood of head trauma in the past 6 months, or other significant cardiovascular, pulmonary, hepatic, endocrine, or renal illness that in the opinion of the Investigator may increase the subject's risk for participating in the study and/or may impair the ability of performing and/or interpreting study assessments
* A female subject has a positive pregnancy test (urine) or evidence of active lactation
* Reported known use of potent CYP3A4 inhibitors
* A known history of allergy or hypersensitivity to dantrolene
* A history of chronic and ongoing assisted mechanical ventilation prior to the onset of EHS via an established artificial or supported airway (e.g., for severe chronic obstructive pulmonary disease \[COPD\], upper airway disease, impaired respiratory function). Note: Endotracheal intubation and mechanical ventilation as part of supportive measures for the treatment of EHS are allowed
Recruitment Maneuver After Intubation

The purpose of this study is to evaluate the safety and efficacy of a recruitment maneuver immediately after intubation in hypoxemic patients.

In the intensive care unit (ICU), acute respiratory failure is a common problem. Airway management in critically ill patients usually requires endotracheal intubation after rapid sequence induction. Induction of anesthesia is a well known cause of dramatic changes in respiratory mechanics and gas exchange. Moreover, when the intubation is for respiratory failure, the underlying pathology increases these modifications. The reduction in lung volume results in a deep hypoxemia after intubation. Moreover, mechanical ventilation applied on a collapsed lung increases the risk of ventilator induced lung injury. Recruitment maneuver, which consists of a transient increased in inspiratory pressure, decreases anesthesia-induced lung collapse and hypoxemia. During early acute respiratory failure, RM increases oxygenation and lung volume and may reduce lung oedema. Some authors have suggested the potential benefit of an early RM after induction of anesthesia in operating room. To date, no study has evaluated the short term effect of a recruitment maneuver performed early after intubation in critically ill patients. Therefore, our aim was to ascertain whether RM, performed immediately after intubation, is safe and more effective at reducing hypoxemia than usual management, in hypoxemic patients requiring intubation for invasive ventilation in the ICU.

Eligibility Criteria:
Inclusion Criteria:

* adults who met acute respiratory failure requiring intubation
* adults who met hypoxemia, defined by a PaO2 less than 100 mm Hg under a high FiO2 mask driven by at least 10 L/min oxygen.

Exclusion Criteria:

* encephalopathy
* coma
* cardiac resuscitation
* hyperkaliemia (\>5.5 mEq/L)
* acute brain injury and recent thoracic surgery
A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)

In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. The investigators wish to determine whether using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment decision, a reduction in the total number of scans and investigative operations, fewer outpatient attendances and a reduction in healthcare costs.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients suspected of lung cancer on CT scan
* Written informed consent
* Able to tolerate bronchoscopy and thoracic surgery

Exclusion Criteria:

* Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial
* Any disorder making reliable informed consent impossible
* Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion
Endoscopic Lung Volume Reduction Coil Treatment in Patients With Chronic Hypercapnic Respiratory Failure

Endoscopic lung volume reduction coil treatment is a treatment option for selected patients with severe emphysema. In the advanced stages, emphysema may lead to chronic hypercapnic respiratory failure. In this observational study the safety and efficacy of endoscopic lung volume reduction coil treatment in patients with chronic hypercapnic respiratory failure is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients with emphysema (chronic obstructive pulmonary disease with forced expired volume in one second (FEV1) \< 50% predicted and residual volume (RV) ≥ 200% predicted) in whom endoscopic lung volume reduction coil treatment is performed
* Chronic hypercapnic respiratory failure (PaCO2 ≥ 50 mmHg)
* Informed consent

Exclusion Criteria:

* Therapeutic anticoagulation
* Anti-platelet therapy exceeding the use of acetylsalicylic acid
* Severe pulmonary hypertension
Enrichment & Purging of Stem Cells in Non-Hodgkin's Lymphoma

To evaluate the role of purging the hematopoietic cell graft on outcomes for non-Hodgkin's Lymphoma.

To study the use of peripheral blood stem cells which have been treated in an effort to remove tumor cells. The researchers hope to learn whether or not this will be more effective in removing the tumor cells as compared to other methods of purging (the removal of cancer cells).

Eligibility Criteria:
Inclusion Criteria:- relapsed NHL Exclusion Criteria:- liver dysfunction
Comparison of the Effects of Physical Therapy With and Without Magnetic Field Therapy in People With Low Back Pain

A randomized and controlled trial to people with low back pain who are divided into 2 groups of treatment: 1- people treated with a protocol of physical therapy techniques without magnetic field therapy; 2- people treated with the same protocol of physical therapy techniques adding a magnetic stimulation treatment. The interventions are conducted in 3 sessions provided during 3 weeks.The lumbar pain and disability are assessed before and after the intervention, and lumbar flexion and extension pain are assessed before and after each session in all the participants.

This study is a randomized controlled trial evaluating clinical effects of a protocol of Physical Therapy Treatment (PTT), via manual therapy and active mobilization, adding or not a magnetic field therapy in people with non-specific low back pain lasting at least 6 weeks. Participants were randomized to receive either a PTT protocol including a magnetic stimulation treatment or the same PTT protocol with a sham magnetic intervention. The interventions are conducted in 3 sessions provided during 3 weeks.

Intervention:

A description of the 2 groups of treatment:

1. - Experimental group 1: a protocol of physical therapy treatment including:

   * Manual therapy techniques for inhibition of piriformis, quadratus lumbar, and paravertebral muscles in prone position and bilaterally.
   * 2 functional techniques applied to the sacrum in prone position.
   * A myofascial release of ligaments inserted to the sacrum in prone position and bilaterally.
   * Manual therapy technique for inhibition of psoas-iliacus muscle in supine position and bilaterally.
   * Stretching techniques of piriformis, gluteal and paravertebral muscles in supine position and bilaterally.
   * Active gluteus maximus contraction in supine position bilaterally.

   To this protocol, a 15 minutes of magnetic field therapy treatment applied to the lumbosacral region in prone position is added.
2. - Experimental group 2: the same Physical Therapy Treatment protocol with a sham magnetic intervention applying in the same region with a disconnected device during 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were individuals aged between 18 and 65 years with a diagnosis of non-specific low back pain, with or without lower limb irradiation, lasting at least 6 weeks.

Exclusion Criteria:

* Pregnancy, spinal tumor or infection, diabetes, spinal fracture or previous spine surgery.
* Patients with a history of rehabilitation treatment for back pain within the preceding month
* Unstable medical disorder not controlled by standard treatment and those with a cardiac pacemaker or using any other electrical devices or prosthesis.
Efficacy and Safety of Pactimibe in Patients With Atherosclerosis

The effect of pactimibe on the reduction of atherosclerosis in the carotid artery will be assessed using carotid ultrasound


Eligibility Criteria:
Inclusion Criteria:

* Increased cardiovascular risk (i.e. history of myocardial infarction, stroke, diabetes mellitus, left ventricular hypertrophy)
* Intima-media thickness greater than or equal to 0.8 mm as measured by ultrasonography
* Negative pregnancy test for females

Exclusion Criteria:

* Whole blood donation (greater than or equal to 450 ml) during the last three months before study start
* Unstable angina, congestive heart failure or uncontrolled hypertension
* Renal disease including nephrectomy and/or renal transplant
* Hepatic disease or abnormal liver function parameters
* Drug abuse or alcohol addiction