cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement

This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
* patients scheduled for placement of bilateral myringotomy tubes

Exclusion Criteria:

* history of allergy to either dexmedetomidine or fentanyl
* concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.
Use of Rosuvastatin in HIV-Infected Subjects to Modulate Cardiovascular Risks

The hypothesis of this study is that 96 weeks of Rosuvastatin will be safe and effective in decreasing cardiovascular risk and bone loss in the HIV+ population.

While the use of antiretroviral therapy (ART) in recent years has had an impressive impact on mortality and disease progression in HIV-infected patients, nevertheless, cardiovascular disease is a major concern impacting morbidity and mortality in this population.

This study will assess if a potent statin, rosuvastatin, could improve endothelial dysfunction, slow carotid intima media thickness (IMT) progression and bone loss, and decrease inflammation and oxidative stress in HIV-infected ART-treated subjects with good HIV virologic control. The investigators will also see if rosuvastatin will induce beneficial changes in the prevalence of metabolic syndrome and lipid metabolism as well as improve bone turnover markers.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of HIV Disease
* Age \> 18 years old
* Receiving a stable ARV regimen for at least the last 12 weeks prior to study entry and cumulative duration of ARV for 12 months
* Fasting LDL cholesterol \< 130 mg/dl
* Fasting triglycerides \< 300 mg/dL
* hsCRP \> 2 mg/L or CD38+DR+/CD8+ \> 19%
* If on Vit D replacement therapy, stable regimen for \> 3 months prior to study entry

Exclusion Criteria:

* Women who are pregnant or breast feeding
* Any active or chronic inflammatory condition
* Cardiovascular disease
* Current or recent (within 24 weeks of study entry) therapy with omega-3 fatty acids, fibrates, ezetimibe or statins
* Uncontrolled hypothyroidism or hyperthyroidism
* Uncontrolled diabetes
* Use of systemic cancer chemotherapy of immunomodulating agents
* Use of Anabolic agents, growth hormone, growth hormone releasing factor, or any other anabolic agents, except for stable replacement testosterone.
* Use of biphosphonates or other bone therapies
* Any of the following lab findings obtained within 14 days prior to the screening evaluation including the following:

  * AST and/or ALT \> 2.5 x ULN
  * Hemoglobin \< 9.0 g/dL
  * CK \> 3 X ULN
  * Calculated creatinine clearance \< 50 mL/min
Effect of Interval and Resistance Exercise on Physiological and Psychological Parameters.

The purpose of this study is to examine the physiological and psychological effects of a sprint interval and resistance training intervention on females.

Females aged 20-65 will attend 10 weeks of exercise training consisting of sprint interval training and resistance training for 30 sessions. We will examine changes in body composition, blood panel (fasting glucose, cholesterol, triglycerides), strength (bench press and back squat), aerobic capacity and psychological parameters (hardiness, affect, enjoyment, perception and self-regulation). The effects will be measured acutely after the program and 6-months after the cessation of the program.

Eligibility Criteria:
Inclusion Criteria:

* This population consists of: females, aged 25-55, who are: sedentary (not reporting a regular schedule of exercise over the last 3 months), and able to start an exercise program (assessed by the PARQ+)

Exclusion Criteria:

* Females who are below age 25 or over age 55, who are currently exercising and have existing conditions that would exclude them from exercise.
Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously

The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* BMI of 18-30 kg/m2
* more than 50 kg bodyweight.

Exclusion Criteria:

* Pregnant
* exposure to biologic type drugs within the last 3 months
* history of allergic or anaphylactic reaction to a biologic drug
* use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day
* excessive alcohol use.
Effectiveness of Telerehabilitation Interventions in Multiple Sclerosis

Multiple sclerosis (MS) is an inflammatory, demyelinating, neurodegenerative disease of the central nervous system of unknown etiology. The most common clinical signs and symptoms are motor dysfunction, fatigue, spasticity, impaired mobility, cognitive impairment, chronic pain, depression, decreased quality of life, and bladder and bowel dysfunction. 66% of people with MS have impaired upper extremity function. As a result of the deterioration in upper extremity function, the performance of many daily living activities affects performance. As a result of this influence, there is a decrease in the functional independence of people, quality of life, and participation in activities in the community. Exercise training represents an existing behavioral treatment approach to safely manage many functional, symptomatic, and quality-of-life outcomes in MS. Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies." Telerehabilitation has proven to be useful for people with MS by increasing physical activity and reducing fatigue. In the studies, telerehabilitation and face-to-face rehabilitation services were compared, and stated that they had similar results. At the same time, it was stated that telerehabilitation provides people with gains in terms of time and cost. In addition to all these, the researchers emphasized the benefits they received from telerehabilitation from the people's statements. Therefore, the results of this study, which will be performed on MS patients, will enable the evaluation of telerehabilitation strategies from the patient's point of view.

The participants was included in the study titled 'Investigation of the Effects of the Synchronized Telerehabilitation-based Upper Extremity Training Program on Hand-arm Function, Pain, Fatigue, Quality of Life, and Participation in People With Multiple Sclerosis (ClinicalTrials.gov Identifier: NCT05073731)' will be included in this study. Questionnaires that will enable individuals to evaluate their telerehabilitation service will be administered once. Physicians and physiotherapists will make evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Having a definitive diagnosis of MS according to the 2017 McDonald criteria
* Being over 18 years old
* Volunteering to participate in the study
* To have received exercise training based on synchronous or asynchronous telerehabilitation

Exclusion Criteria:

* Having a neurological disease other than MS
* Having an MS attack 30 days before or during the study
* Cognitive disability at a level that hinders assessment and treatment.
KN035 for dMMR/MSI-H Advanced Solid Tumors

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy.

For colorectal cancer participants, who are required to have been previously treated with standard therapies , other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

Later-line therapies after failure of standard treatments for advanced colorectal and non-colorectal cancer patients are limited. Mismatch repair (MMR) deficiency or microsatellite instability-high (MSI-H) played a role of positive predictive factor, which had been documented after the pembrolizumab and nivolumab trial were reported, for PD-1 blockade monotherapy in patients with advanced colorectal and non-colorectal cancers.

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy.

For colorectal cancer participants, who are required to have been previously treated with standard therapies. For other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors.
* Confirmed MMR deficient or MSI-H status.
* At least one measureable lesion.
* Eastern Cooperative Oncology Group performance status of 0 or 1 .
* Life expectancy of greater than 12 weeks.
* Adequate hematologic and organ function.

Exclusion Criteria:

* Currently participated in a study of an investigational agent and received trial treatment, or used an investigational device within 4 weeks of the first dose of medication in this study. Patients who have had specific anti-tumor treatment within 2 weeks prior to the first dose of study.
* Patients who have not recovered to CTCAE Grade 1 or better from related side effects of any prior antineoplastic therapy.
* Has received prior therapy with an immune check point agonist/inhibitor.
* Patients who have undergone major surgery within 4 weeks of dosing of investigational agent.
* Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
* Known active central nervous system metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment.
* Patients who have known history of infection with HIV.
* Patients with evidence of interstitial lung disease.
* Patients who have known history of any major cardiac abnormalities.
* Patient who is not willing to apply highly effective contraception during the study.
* Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study.
Impact of a Brief Motivational Interview on Drinking Behaviors of At Risk Drinkers Screened in the Emergency Room

Alcohol abuse is associated with injury, chronic illness, absenteeism from work, and social costs to families and communities. The goal of this project is to translate motivational interventions successful in the primary care setting to the Emergency Department (ED) environment by implementing screening, brief intervention and referral to treatment (SBIRT) in order to reduce at-risk drinking among ED patients.

To evaluate the effectiveness of SBIRT in the emergency room setting, ED patients meeting NIAAA criteria for high risk drinking were recruited from 14 sites nationwide (control group-Spring, 2004; intervention group-Summer, 2004). 26% of screened ED patients met inclusion criteria. All enrollees received a list of local referral resources. Intervention group patients also participated in a 15 minute negotiated interview and ED staff referred them directly for treatment if indicated. Enrollees completed 3-month follow-up surveys with a telephone Interactive Voice Response (IVR) system. A total of 1137 patients were enrolled across 14 sites (561 intervention, 576 control), with 62% male, 37% Black, and 38% White, and a mean age of 37. At baseline intervention-i and control-c groups were similar in demographic characteristics and number of drinks on a typical day (mean-i 5.00, mean-c 5.12) and maximum drinks on a given day in the past month (mean-i 7.51, mean-c 7.33). The 3 month follow-up rate was 62% (n=687); the 6 month follow-up rate was 52% (n=567). The 12 month follow up is currently underway.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Communication in English or Spanish
* Met NIAAA criteria for "at-risk drinking":

  * for Men: 15 or more drinks/week, or 5 or more drinks on a single occasion
  * for Women: 8 or more drinks/week, or 4 or more drinks on a single occasion
  * Age 65 or over: 8 or more drinks/week or more than 1 drink per day

Exclusion Criteria:

* Requests detox or already in alcohol treatment program
* Abnormal mental status
* Too ill to give consent
* Unable to provide consent for other reasons
* Suicidal
* Employee or student of site institution (where required)
* Prisoner
* Inability to follow up
Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

IND numbers: 79,599; 101,943

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages ≥18 years of age
* Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment
* Subjects should have chronic hepatitis C (CHC) as documented by:

  1. Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or
  2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)
* HCV genotype 1a, 1b or 4 only
* HCV RNA viral load of ≥10,000 IU/mL at screening
* Have one of the following:

  1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
  2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
  3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis
* Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
* Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening

Exclusion Criteria:

* Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures)
* History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
* Documented or suspected hepatocellular carcinoma (HCC)
* Positive for hepatitis B surface antigen (HBsAg)
* Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies
* Alanine transferase (transminase) (ALT) \>5x upper limit of normal (ULN)
* Total Bilirubin ≥2 mg/dL
Treatment of Post-traumatic Stress Disorder With High Doses of Escitalopram

The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of chronic post-traumatic stress disorder (PTSD) in adult civilian survivors of traumatic events.

Forty survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve weeks

Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks.

The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or the last meeting with the patient - Last Observation Carried Forward).

The secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.

The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of chronic post-traumatic stress disorder (PTSD)

Forty adult survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve weeks

Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks.

The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or the last meeting with the patient - Last Observation Carried Forward).

The secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.

Eligibility Criteria:
Inclusion Criteria:

* Adult survivors of traumatic events with chronic PTSD

Exclusion Criteria:

* Individuals with past history of psychotic disorder, bipolar disorder, opiate or stimulants abuse.
* Individuals currently on anti-depressant therapy.
* Individuals with past history of a failure to respond to escitalopram
* Pregnant Women
* Medical condition excluding the treatment with escitalopram (e.g., renal or hepatic insufficiency). Current, life threatening medical illness. History or severe side effects with escitalopram (e.g., hyponatremia)
Efficacy of a Physical Activity Counselling on the Severity of Chronic Low Back Pain in Patients With Cardiovascular Risk

Objective: To determine the influence of a counseling of physical activity (PA) versus usual care (UC) in the magnitude of chronic pain (CP) in patients diagnosed with chronic low back pain (CLBP).

Methods: A total of 64 subjects with (CLBP) and older were randomly divided into two groups: an experimental group (UC) + counseling of (AF) and control group (UC). Each group consisted of 32 participants and were evaluated twice (pre and post-intervention), being spaced one month, both groups received telephone follow-up for their participation. The primary endpoint was the magnitude of the (CP) measured by the tool grading scale of chronic pain (EGDC), while as secondary were considered the cardiovascular risk factors, catastrophism, kinesiofobia, disabled by back pain, quality of life, anxiety and depression and the (FA).


Eligibility Criteria:
Inclusion Criteria:

* Patients with low back pain more than 3 months
* Age over 18 years old
* Low or Medium Cardiovascular Risk

Exclusion Criteria:

* Cardiovascular Risk Factors ≥ 5
* Quirurgic procedures at spine last 10 years
* Past of Cancer, or Fibromialgia
Irrigating Fluid and Blood Coagulation

Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation. However, little is known about the dose-response relationships of hemodilution. The investigators have therefore performed the present study to measure the effect of a mixture of 2.7% sorbitol-0.54% mannitol solution on the coagulation pathway according to the hemodilution level using a rotational thromboelastometry (ROTEM®) tests.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* age: 20 to 65 years
* Body weight \> 50 kg
* Volunteers who provided informed consent

Exclusion Criteria:

* Hematologic disease
* Anticoagulant medication
Biological Evaluation of a Novel Anti-inflammatory Treatment in Immune-mediated Inflammatory Diseases

The aim of the study is to investigate in vitro the impact of a novel anti-inflammatory treatment on costimulatory molecules expressed on monocytes.


Eligibility Criteria:
Inclusion Criteria:

* Immune-mediated inflammatory disease (non-ST segment elevation myocardial infarction, Rheumatoid arthritis, Chronic obstructive pulmonary disease, Idiopathic pulmonary fibrosis, Crohn's disease, Ulcerative colitis, Cystic fibrosis, Psoriasis, Multiple sclerosis or major depressive episode)
* Patient able to understand the reason of the study
* Patient not opposed to the conservation of biological samples for scientific research

Exclusion Criteria:

* Pregnant woman
* Subject without health insurance
The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis

Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the lungs, and then the airways become blocked, leading to difficulties with breathing. It is the most common reason why children are admitted to hospital, with 1-3% of all children admitted to hospital during their first winter, creating enormous strains on NHS services. The majority of those admitted with the condition are under six months of age and the associated stress for parents is considerable. After forty years of research the best treatment we have is supportive care and oxygen.

Recent research suggests that salt water, sprayed as a mist so that the children can breathe it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis. Scientists think that the salt water changes the mucus which blocks the airways so that it can be cleared more easily. Three small research studies all suggested that a child's time in hospital could be reduced by a quarter by using this treatment. If this was true, it would be good for children, their families and the children's wards trying to cope with the large numbers admitted with bronchiolitis every year.

To decide whether this treatment should be used throughout the NHS, we need to run a randomised controlled trial of hypertonic saline in a large number of children. The trial will tell us if adding saline to usual care reduces distress in both children and parents, as well as whether it reduces the length of time they stay in hospital. We will then know if the treatment is the best thing for children with bronchiolitis and whether it provides the NHS with good value for money.


Eligibility Criteria:
Inclusion Criteria:

* Previously healthy infants under 1 year of age
* Admitted to hospital with a clinical diagnosis of acute bronchiolitis, following the UK definition of an infant with an apparent viral respiratory tract infection associated with airways obstruction manifest by hyperinflation, tachypnoea and subcostal recession with widespread crepitations on auscultation
* Requiring supplemental oxygen therapy on admission

Exclusion Criteria:

* Wheezy bronchitis or asthma - children with an apparent viral respiratory infection and wheeze with no or occasional crepitations
* Previous lower respiratory tract infections
* Risk factors for severe disease \[gestation \<32 weeks, immunodeficiency, neurological and cardiac conditions, chronic lung disease\]
* Subjects where the carer's English is not fluent and translational services are not available
* Requiring admission to high dependency or intensive care units at the time of recruitment