cyrilzakka/clinical-trials huggingface dataset:
COMETS - Compare the Efficacy of Rosuvastatin With Atorvastatin and Placebo in the Treatment of Non-Diabetic, Non-Atheroscleric, Metabolic Syndrome Subjects

The purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing Low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Presence of 3 or more coronary heart disease risk factors as defined by the protocol.
* Fasting low density lipoprotein cholesterol level of \> 130 mg/dL.
* Documented history of, or high risk of coronary heart disease or other established atherosclerotic disease.
* Not previously taken statins.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse
The Body's Response to Aerobic Versus Resistance Exercise

The purpose of this study is to identify the body's response to aerobic vs. resistance exercise. Throughout this study, we will examine food intake, appetite, and physical and mental well-being before, during, and after aerobic and resistance exercise.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18-29 kg/m2
* Weight stable (\< 4.5 kg weight change within last 6 months)
* Non-smoking
* Constant habitual activity patterns within last 3 months
* Non-diabetic
* Resistive exercise training (≥ 2 times a week) based on reported physical activity levels (questionnaire)
* Aerobic exercise training (≥ 2 times a week, 30-min sessions) based on reported physical activity levels (questionnaire)
* Confirmation of acceptability of eating the study test foods (macaroni casserole)
* Approved to participate in this study by our study physician and principle investigator

The older subjects must also meet the following eligibility criteria:

* Age range: 65 years and older
* Body fat (women: \<38%; men: \<28%)
* Normal resting EKG as assessed by a Cardiologist

The younger subjects must also meet the following eligibility criteria:

* Age range: 18-29 years
* Body fat (women: \<28%; men: \<18%)

Exclusion Criteria:

* Body mass index: outside of the 18-29 kg/m2 range
* Gained or lost \> 4.5 kg within the last 6 months
* Smoker (currently or within the last year)
* Intermittently been involved in a diet and/or exercise program within the last 3 months
* Clinically diagnosed as diabetic
* Did not perform resistive exercise training (currently or within the last 3 months) based on reported physical activity levels (questionnaire)
* Did not perform adequate aerobic exercise (currently or within the last 3 months) based on physical activity levels (questionnaire)
* Study food is found to be unacceptable for consumption by the subject
* Unapproved to participate in this study by our study physician and principle investigator

The older subjects:

* Age range: \<65 yrs
* Body fat (women: \>38%; men: \>28%)
* Abnormal resting EKG (interpreted by a cardiologist) and assessed (for study exclusion) by our study physician, Arthur Rosen, MD

The younger subjects:

* Age range: outside the \>29 yrs or \<18 yrs
* Body fat (women: \>28%; men: \>18%)
Stereotactic Body Radiation Therapy in Treating Patients With Localized High-Risk Prostate Cancer

This clinical trial studies stereotactic body radiation therapy in treating patients with high-risk prostate cancer that has not spread to nearby lymph nodes or to other parts of the body. Stereotactic body radiation therapy is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Studying quality of life in patients undergoing stereotactic body radiation therapy may help identify the long-term effects of treatment on patients with prostate cancer.

PRIMARY OBJECTIVES:

I. To establish the efficacy of stereotactic body radiation therapy (SBRT) in patients with high-risk localized prostate cancer compared to historical data from clinical trials.

II. To establish the safety with physician-reported outcomes after SBRT in patients with high risk localized prostate cancer.

III. To establish the quality of life with patient-reported validated questionnaires after SBRT in patients with high risk localized prostate cancer.

OUTLINE:

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 5 years, and then every 12 months thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary non-metastatic adenocarcinoma of the prostate
* Risk-group classification into the Dâ€™Amico or National Comprehensive Cancer Network (NCCN) â€˜high-riskâ€™ group, as defined by the presence of any one of the following high-risk factors:

  * Pre-biopsy prostate-specific antigen (PSA) \>= 20
  * Biopsy Gleason score 8-10
  * Clinical stage T3
* No pelvic nodal metastases (based on computed tomography \[CT\] or magnetic resonance imaging \[MRI\] findings)
* No distant metastases, based upon:

  * CT scan or MRI of the pelvis within 120 days prior to registration
  * Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis
* Karnofsky performance status (KPS) \>= 70
* Ability to understand, and willingness to sign, the written informed consent
* Patient will have opted for SBRT among definitive treatment choices

Exclusion Criteria:

* Patients with any evidence of distant metastases
* Hormonal therapy (luteinizing hormone-releasing hormone \[LHRH\] agonist or oral anti-androgen) exceeding 4 months prior to registration
* Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
* Prior pelvic radiotherapy
* History of Crohnâ€™s disease or Ulcerative colitis
Improving Adherence to Web-Based Cessation Programs: A Social Network Approach

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT.

This study will compare the efficacy of an interactive, evidence-based smoking cessation website (WEB) alone and in conjunction with 1) a theory-driven, empirically-informed social network (SN) protocol designed to integrate participants into the online community, and 2) access to a 4-week supply of free NRT. Using a 2 (SN integration, no SN) x 2 (access to free NRT, no access) randomized, controlled factorial design with repeated measures at baseline, 3, and 9 months, this study will recruit N=5,000 new members of a Web-based smoking cessation program and randomize them to: 1) WEB, 2) WEB+SN, 3) WEB+NRT, or 4) WEB+SN+NRT.

Aim 1: To evaluate the comparative efficacy of WEB+SN, WEB+NRT, and WEB+SN+NRT versus WEB alone with regard to self-reported 30-day point prevalence abstinence at the primary endpoint of 9 months and at secondary endpoint of 3 months. Hypothesis 1a: All three intervention conditions will outperform WEB. Hypothesis 1b: WEB+SN+NRT will outperform WEB+SN and WEB+NRT.

Aim 2: To examine whether the impact of treatment condition on cessation is mediated by greater adherence to problem solving/skills training tools, social support, and pharmacotherapy. Hypothesis 2: WEB+SN+NRT will have the greatest impact on treatment adherence, which will yield higher quit rates than the other treatments.

Exploratory Aim: To advance theory and identify the processes through which social network integration and provision of free NRT influence treatment adherence. Specifically, exploratory analyses will examine whether social support and social norms are active elements in the pathway to adherence, along with other known mediators of abstinence such as self-efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Current smoker
* Registered user on BecomeAnEX.org

Exclusion Criteria:

* Pregnant or breastfeeding
* Cardiovascular conditions
* Current use of any stop smoking medication
Outcomes Following Pre-marking of Episiotomy Location

To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.

Purpose: To compare short- and long-term outcomes of women following episiotomy during the second stage of labor, following marking of episiotomy location during the first stage of labor with those of women who underwent episiotomy without marking.

Hypothesis: Women following episiotomy following pre-marking of the location will suffer from fewer short- and long-term complications compared to those without pre-marked episiotomy location.

Study type: prospective randomized-controlled trial

Eligibility Criteria:
Inclusion Criteria:

* women 18 years of age or older who present in active labour to our center and consent to participate in the study

Exclusion Criteria:

* women under 18 years of age or those who do not or are unable to provide informed consent to participate in the study
Effect of EIT-guided PEEP Titration on the Prognosis of Patients with Moderate to Severe ARDS

Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes.

This is a prospective, multicenter, single-blind, parallel-group, adaptive randomized controlled trial (RCT) with intention-to-treat analysis which aims to determine the effects of PEEP setting guided by EIT on the clinical outcomes for moderate or severe ARDS patients ventilated with lung protective ventilation strategy. Adult patients with moderate to severe ARDS less than 72 hours after diagnosis will be included in this study. Patients in the intervention group will receive PEEP titrated by EIT with a stepwise decrease PEEP trial, whereas patients in the control group will select PEEP based on the FiO2-PEEP table. Other ventilator parameters will be set according to the ARDSnet strategy. The primary outcome is 28-day mortality. The secondary outcomes include ventilator-free days and shock-free days at day 28, length of ICU and hospital stay, the rate of successful weaning, proportion requiring rescue therapies, compilations, respiratory variables, and Sequential Organ Failure Assessment (SOFA). This study will also perform the interim analysis and subgroup analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years
2. Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen \[PaO2\]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O)
3. Diagnosis of ARDS less than 72 hours

Exclusion Criteria:

1. Expected to be mechanically ventilated for less than 48 hours
2. Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV
3. Undrained pneumothorax or subcutaneous emphysema
4. Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment
5. Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
6. Severe neuromuscular disease
7. Hemodynamic instability
8. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome
9. Severe other organs dysfunction with a low expected survival (7 days) or palliative care
10. Solid organ or hematologic tumors with the expected survival time less than 30 days
11. Participating in other clinical trials within 30 days
12. Pregnancy
13. Refusal to sign the informed consent
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna™ Gene Signature Assay

The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.

Eligibility Criteria:
Inclusion Criteria:

* Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)

  * Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive.
  * HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
* Postmenopausal women defined as:

  * Natural Amenorrhea \> 12 months, regardless of age
  * Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
  * Radiological castration with amenorrhea \> 3 months, regardless of age
  * Hysterectomy and postmenopausal blood levels
* Able to give consent
* Eligible for treatment of breast cancer with adjuvant chemotherapy
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Tumor size T3-T4
* Non-invasive breast cancer (e.g., Paget's disease, DCIS)
* Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+)
* Tumors that are estrogen-receptor negative or HER2 positive
* Have metastatic disease
* Unable to give informed consent
* Unable to complete patient reported outcome surveys
* Have contraindications for adjuvant chemotherapy

  * Age, performance status, significant comorbidities
* ECOG performance status \> 1
Ibudilast in the Treatment of Medication Overuse Headache

The purpose of this study is to determine if ibudilast is effective in reverting patients with medication overuse headache suffering chronic daily headache back to their original episodic headache pattern.

It has been established that excessive intake of medications used to treat primary headaches, particularly those containing opioids, can induce a form of secondary headache, known as medication overuse headache (MOH). Despite the significant clinical impact of this condition the mechanisms behind MOH remain poorly understood, guidelines for treatment are lacking, and relapse is common.

Recently, it has been recognised that repeated opioid exposure can facilitate pain by activating glia, the immunocompetent cells of the central nervous system, resulting in opioid-induced hyperalgesia (OIH).

The investigators hypothesise that MOH represents a form of OIH in this susceptible patient group - repeated activation of nociceptive pathways by frequent headaches interacts with the opioid induced pro-inflammatory actions of activated glia to produce chronic daily headache (CDH).

This double-blind, randomised, placebo controlled pilot study will investigate the use of ibudilast, a know attenuator of glial activation, in the treatment of medication overuse headache.

Eligibility Criteria:
Inclusion criteria:

* Regular use, for at least 3 months, of opioid-containing analgesics on ≥ 10 days/month
* Headache present on at least 15 days/month, for at least 2 months
* Headache developed or markedly worsened during medication overuse
* Primary indication for analgesics is headache disorder

Exclusion criteria:

* Unable to provide written informed consent
* Age \< 18 years at time of screening
* Unable to read and write in English
* Receiving tramadol regularly
* Taking triptans \> 4 days/month
* Taking opioids for reasons other than headache (e.g. other pain conditions, cough, bowel motility)
* Severe psychiatric disorders
* Other chronic pain conditions likely to interfere with qualitative sensory testing (e.g. trigeminal neuralgia, arthritis)
* Diabetic neuropathy
* Recent or current active infection, determined to be clinically significant by the Principal investigator
* Known active inflammatory diseases such as rheumatoid arthritis
* History of cerebrovascular disorder
* Recent history of significant trauma, as determined by the Principal Investigator including major surgery within the previous 2 months
* Recent history of drug or alcohol abuse
* Spinal cord injury
* Any clinically significant findings on screening blood sample results
* Current malignancy
* Known hypersensitivity to ibudilast or excipients in Pinatos® formulation
* Renal or hepatic impairment, defined as baseline GFR (as calculated by the Cockcroft-Gault equation) of \< 60 mL/min or LFTs \> 3 times the upper limit of normal
* For females of childbearing potential:

  * Pregnancy
  * Lack of adequate contraception (abstinence, double barrier method, intrauterine device, surgical sterilization (self or partner), hormonal contraceptive methods (oral, injected, or implanted)
  * Breastfeeding
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease

A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to \<18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa).


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of Protocol PB-06-002 or PB-06-005
* The subject, parent(s) or legal guardian(s) signs an informed consent and/or assent

Exclusion Criteria:

* Currently taking another investigational drug for any condition.
* Presence of neurological signs and symptoms characteristic of Gaucher disease with complex neuronopathic features other than longstanding oculomotor gaze palsy.
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the subject's compliance with the requirements of the study.
A Study to Compare Levels of Capsaicin After Intra-Articular Injection and Topical Application in Patients With Painful Knee Osteoarthritis

This is a Phase 1b, open-label, two-period, randomized crossover study in adult male and female participants with painful knee osteoarthritis.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) between 18.0-35.0 kg/m\^2
* Subject has moderate to severe painful osteoarthritis in one knee while walking (index knee); contralateral knee may or may not have osteoarthritis, pain should be none to mild in the non-index knee
* Confirmation of the OA of the index knee: American College of Rheumatology (ACR) diagnostic criteria
* Subject has intact skin at the location of the dosing sites (patch or injection)

Key Exclusion Criteria:

* Subject has any other form of arthritis, such as, but not limited to, rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematosus, etc.
* Subject has a dermatological condition that may contraindicate participation, including any compromise in skin integrity at the CNTX-4975-05 injection site or the Qutenza® skin application site, e.g., severe or cystic acne, psoriasis, eczema, atopic dermatitis, active or treated cancer, etc.
Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen

At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis B virus infection (CHB)

Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in combination with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach

Part B sub study is Open Label

Eligibility Criteria:
Inclusion Criteria:

* Infection with the hepatitis B virus (HBV) and positive for the hepatitis B e antigen
* Between the ages of 18 and 70
* Have not been previously treated with an interferon
* HBV nucleos(t)ide-naive

Exclusion Criteria:

* Not infected with the hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
* Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease
* Able to tolerate oral medication
Enhancing Therapy Process With Movement Strategies

Several studies have noted the benefits of exercise programs in improving both mood and anxiety symptoms. Additionally, single bouts of exercise have been shown to improve mood and anxiety. Business applications report ancillary benefits of exercise as well. For example, individuals spontaneously report better ability to approach stimuli and cope with emotional experiences if doing it while exercising.

The current study aims to investigate exercise during a therapy session as a potential intervention for enhancing therapeutic learning, particularly ability to better cope with emotional topics and experiencing intense emotions. In this study, patient participants will complete a therapy session while using an exercise machine and a separate therapy session while using a worry stone (control). Both patient participants and therapist participants will make ratings of a variety of items, including ability to discuss emotional topics and comfort in experiencing emotions.

Investigators hypothesize that patients will report better ability to discuss emotional topics and more comfort in experiencing emotions following the exercise condition as opposed to the worry stone condition. Investigators also hypothesize that therapist ratings will similarly indicate that patients were better able to discuss emotional topics and experience emotional content during exercise sessions.

The current study aims to investigate exercise during a therapy session as a potential intervention for enhancing therapeutic learning, particularly ability to better cope with emotional topics and experiencing intense emotions.

Eligibility Criteria:
Inclusion Criteria:

1. Adults over the age of 18
2. Ability to read and provide informed consent
3. Current patient or therapist at the Center for Anxiety and Related Disorders (CARD)
4. Ability to complete exercise (e.g. no physical injuries)

Exclusion Criteria:

1. Participants considered high risk based on the ACSM risk stratification guidelines (derived from PAR-Q)
2. Participants with current knee, ankle, hip, or foot injuries that could impede exercise on the machine or participants with current hand or wrist injuries that could impede use of the worry stone