cyrilzakka/clinical-trials huggingface dataset:
Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a significantly better immunologic response to boosting can be elicited in patients previously vaccinated with PPV.


Eligibility Criteria:
Inclusion Criteria for HIV positive subjects:

1. At least one prior PPV ≥ 3 and \< 8 years ago, while HIV positive. There is no upper limit to the number of previously received PPVs.
2. HIV-positive (except 25 HIV-negative persons as control group).
3. Age between 18 and 60 years of age.
4. Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.

Exclusion Criteria for HIV positive subjects:

1. Prior allergic reaction to the PPV
2. Allergic to components of PCV, including diphtheria toxin.
3. Pregnant or lactating females as defined by history or positive HCG urine test.
4. History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
5. History of splenectomy
6. Temperature of \>38C
7. Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
8. Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
9. Patients diagnosed with HIV wasting disease
10. Viral load over 50,000 copies/ml.
11. History or evidence of recent illicit drug or alcohol abuse.
12. Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.

Inclusion Criteria for HIV negative subjects:

1. HIV-negative by HIV ELISA within the last 12 months
2. Age between 18 and 60 years of age.
3. Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.

Exclusion Criteria for HIV negative subjects:

1. Prior PCV and/or PPV vaccination.
2. Prior allergic reaction to the PPV
3. Allergic to components of PCV, including diphtheria toxin.
4. Pregnant or lactating females as defined by history or positive HCG urine test.
5. History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
6. History of splenectomy
7. Temperature of \>38C
8. Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
9. Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
10. History or evidence of recent illicit drug or alcohol abuse.
11. Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.
12. Works in chain of command of primary/associate investigators.
Culturally Specific Interventions: African American Smokers

The investigators expect that a culturally specific group intervention targeting African American smokers will result in greater smoking cessation rates compared to a standard intervention.


Eligibility Criteria:
Inclusion Criteria:

1. self-identification as African American
2. current smoker of ≥ 5 cigarettes/day or expired CO level of ≥ 8 ppm;
3. age 18-65;
4. able to speak and read English;
5. permanent contact information;
6. access to transportation by public transit or car;
7. no current behavioral or pharmacological treatment ;
8. interest in quitting smoking; (9) have availability to attend sessions.

Exclusion Criteria:

1. enrolled in another cessation program,
2. do not speak and read English,
3. do not have access to transportation by car or bus to attend sessions,
4. do not have childcare during session times,
5. have contraindications for patch use (pregnant/breastfeeding),
6. if they are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse),
7. if they endorse active addiction to another substance (e.g., illicit drugs or alcohol),
8. if they have been diagnosed with an acute cardiac or respiratory condition;
9. people identified as having a severe mental illness
Xanthohumol As an Adjuvant in the Treatment of Septic Shock

Septic shock (SS) is a life-threatening condition resulting from excessive inflammatory response to bacterial, viral or/and fungal infections. It is associated with dysregulation of the immune system, activation of immune cells, and massive release of cytokines, commonly known as the cytokine storm (CS). The clinical manifestations of SS depend on the initial site of infection. However, the classic symptoms are associated with severe dysfunction of the respiratory and cardiovascular systems, which are observed from the early phase. Respiratory insufficiency frequently requires different forms of oxygen supplementation, including mechanical ventilation and even extracorporeal oxygenation. The severity of respiratory and other organ dysfunction depends on the inflammatory response to the infection and circulating toxins, which correspond to excessive cytokine release. In the past years, several studies documented that reduction of SS-related inflammatory response and CS improved organ function and alleviated the clinical course of SS. Unfortunately, an effective strong anti-inflammatory without side effects medications has not yet been found. Therefore, the use of natural anti-inflammatory and antioxidant substances seems very promising.

Xanthohumol (Xn) is a natural prenylated chalcone extracted from the female inflorescences of hop cones (Humulus lupus) and possesses strong anti-inflammatory and antioxidant properties. It is widely used as a supplement to diet. Xanthohumol inhibits CS and has been showed to be an effective medication for reducing the severity of lung injury. It has been documented that Xn inhibits proinflammatory pathways in a different manner. A decrease in cytokine production and release can affect endothelial function and correct inflammatory-related vascular hyperpermeability, reducing uncontrolled water shift to extravascular space and then tissue edema. Clinical observation showed that administration of Xn alleviated clinical course, improved respiratory function, and reduced mortality in critically ill COVID-19 patients. Xanthohumol is safe and well tolerated by humans, and no adverse effects have been reported yet. Based on its strong anti-inflammatory and antioxidative properties, it can be speculated that the use of Xn can effectively reduce the inflammatory response and improve the clinical course in SS patients.


Eligibility Criteria:
Inclusion Criteria:

* a septic shock in the early, acute phase,
* respiratory insufficiency required mechanical ventilation with PaO2/FiO2 \< 150,
* bacterial infection,
* procalcitonin higher than 5 ng/mL and interleukin 6 higher than 100 pg/mL,
* no allergy to hops or their derivatives,
* hemodynamic instability requiring vasopressor infusions

Exclusion Criteria:

* lack of agreement
* septic shock treated for more than 1 day,
* history of severe chronic cardiac, pulmonary and/or liver diseases
Naltrexone for Relapse Prevention

This study is to evaluate the safety and effectiveness of an injectable slow releasing preparation of naltrexone to reduce alcohol consumption and risk of relapse in alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection for a total of three months, with two subsequent followup visits spanning a 6- month period.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence.
* Abstinent from alcohol for a period of at least 3 days prior to beginning of study.
* Able to read English and complete study evaluations.
* Females who are postmenopausal, have had surgical sterilization, or use reliable means of birth control.

Exclusion Criteria:

* Meets criteria for dependence on a psychoactive substance other than alcohol and nicotine and/or cannabis.
* Prior history of opioid dependence.
* Regular use of psychoactive drugs including anxiolytics and antidepressants.
* Prior treatment with naltrexone.
* Current use of disulfiram.
* Psychotic or otherwise severely psychiatrically disabled (e.g., suicidal, current mania).
* Significant underlying medical conditions such as hepatic, cerebral, renal, thyroid, or cardiac disease.
* Abstinent longer than 28 days prior to randomization.
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke

This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.


Eligibility Criteria:
Inclusion criteria:

1. Age: Adult subjects ≥ 50 (men) or ≥ 55 (women) to ˂ 80 years of age (either sex) and meeting lipid criteria
2. Low-density lipoprotein cholesterol (LDL-C) ≥ 90 mg/dL (≥ 2.3 mmol/L) or non-high-density lipoprotein cholesterol (non-HDL) ≥ 120 mg/dL (≥ 3.1 mmol/L), or apolipoprotein B ≥ 80 mg/dL (≥ 1.56 µmol/L)
3. Evidence of at least one of the following at screening (without prior myocardial infarction or stroke):

   A. Significant coronary artery disease (CAD) B. Significant atherosclerotic cerebrovascular disease C. Significant peripheral arterial disease D. Diabetes mellitus
4. At least 1 high-risk feature

Exclusion criteria

* MI or stroke prior to randomization
* Coronary artery bypass grafting (CABG) ˂ 3 months prior to screening
* Estimated glomerular filtration rate (eGFR) ˂ 15 mL/min/1.73 m²
* Uncontrolled or recurrent ventricular tachycardia in the absence of an implantable-cardioverter defibrillator.
* Atrial fibrillation or atrial flutter not on anticoagulation therapy (vitamin K antagonist, heparin, low molecular weight heparin, fondaparinux,or non-Vitamin K antagonist oral anticoagulant)
* Triglycerides ≥ 500 mg/dL (5.7 mmol/L) measured up to 3 months prior to screening. The most recent results must be used.
* Last measured left-ventricular ejection fraction ˂ 30% or New York Heart Association (NYHA) Functional Class III/IV
* Planned arterial revascularization
A Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT

To compare computed tomography (CT) images (pictures) of the coronary arteries using the General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients referred for an x-ray coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective diagnostic catheterization OR
* Elective diagnostic catheterization has been performed within the past 2 weeks but no less than 24 hours prior to the coronary CTA procedure with no intervention performed or change of the patient clinical status.
* Age ≥18 years but ≤75 years.

Exclusion Criteria:

* Prior coronary stent implantation
* Prior coronary artery bypass grafting or other heart surgery
* Prior pacemaker or internal defibrillator lead implantation
* Prior artificial heart valve
* Biochemical renal insufficiency (CrSerum \> 1.6) or on dialysis
* Resting HR \> 100 at the time of enrollment
* Contraindication to β-blockade or calcium channel blocker

  * NYHA-IV
  * High-grade atrioventricular (AV) block
  * Systolic blood pressure \<90 mm Hg
  * Severe asthma or active bronchospasm and/or chronic obstructive pulmonary disease
* Atrial fibrillation
* Inability to provide informed consent
* Evidence of ongoing or active clinical instability

  * Acute chest pain (sudden onset)
  * Acute myocardial infarction
  * Cardiac shock
  * Acute pulmonary edema
Safety and Efficacy of Fibrinogen Concentrate in Aortic Arch Surgery Involving Moderate Hypothermic Circulatory Arrest

Bleeding is a common complication of cardiac surgery, especially aortic arch surgery involving moderate hypothermic circulatory arrest. Fibrinogen concentrate is increasingly used to treat coagulopathic bleeding in cardiac surgery, although its effectiveness and safety are unknown.

Fibrinogen concentrate was administered to 54 patients when the fibrinogen level was below 1.5 g/L after protamine reversal. Additionally, 30 patients were enrolled as the non-FC-treated group.

The aim of this prospective study was to investigate the safety and efficacy of fibrinogen concentrate in patients with acute type A aortic dissection.

Eighty-four acute type A aortic dissection patients undergoing emergency aortic arch surgery involving moderate hypothermic circulatory arrest were included. The clinical data, standard laboratory tests and plasma fibrinogen levels were obtained at 5 time points.

The investigators analyzed the standard laboratory tests, the plasma fibrinogen levels, the volumes of cumulative postoperative drainage and transfused allogenic blood products in 84 patients.

The primary and secondary end points were determined and considered.The primary endpoint (efficacy endpoint) included the volumes of individual allogeneic blood products, volumes of cumulative drainage within 24 h and 48 h and 5 days volumes after infusion of fibrinogen concentrate as well as the rates of reoperation due to bleeding. The secondary endpoint (safety endpoint) for the study was the incidence of serious adverse events from infusion of fibrinogen concentrate to day 45. The serious adverse events defined for the evaluation of safety of fibrinogen concentrate were death, pulmonary embolism and other thromboembolic or ischemic events (myocardial infarction, paraplegia and cerebral infarction).

Eligibility Criteria:
Inclusion Criteria:

* The participants aged 18 years or above who were undergoing emergency aortic arch surgery involving moderate hypothermic circulatory arrest for an acute type A aortic dissection

Exclusion Criteria:

* The participants with congenital or acquired coagulation disorders, previous surgery at the same site, death prior to planned surgery, stroke or myocardial infarction within 2 months before surgery and use of aspirin, clopidogrel or vitamin K antagonists within 2 to 5 days before surgery.
Use of Homeopathy in Patients Suffering From Long COVID-19

In some patients, coronavirus (COVID-19) can cause symptoms that last weeks or even months after the infection has gone. The aim of this study was to describe the effect of adjunctive individualized homeopathic treatment delivered to Long-COVID-19 patients with previously confirmed symptomatic SARS-CoV-2 infection.

All patients had been tested positive for SARS-CoV-2 before having developed Long-COVID-19 symptoms. Several testing methods were carried out in each patient to analyze a SARS-CoV-2 infection. For a confirmed infection, at least 3 out of these 5 tests had to be positive. Tests for the orthomyxoviruses influenza A and B, human metapneumovirus (hMPV) and paramyxoviruses were negative unless stated otherwise.

The homeopathic physician treated all Long-COVID-19 patients by individualized homeopathy. Repertorization of the symptoms of the current pandemic and a search in the current homeopathic literature on COVID-19 was performed using computer program. All available homeopathic medicinal products (HMPs) could be chosen by the treating physician.

Modified MONARCH criteria were assessed post hoc by all authors. Deviations were solved by discussion in person. Clinical outcome of case reports was evaluated using the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory". Eight points is assumed as the limit for potential correlation between homeopathic therapy and amelioration of the symptoms or healing in chronic cases.

Eligibility Criteria:
Inclusion Criteria:

Long COVID-19 symptoms following recovery from SARS-CoV-2 infection

Exclusion Criteria:

Patients not signing informed consent
Fractional Photothermolysis for the Treatment of Burn Scars

The aim of our study is to determine the effect of fractional photothermolysis laser in the treatment of burn scars.

One of the main problems in the management of burned patients is the treatment of post-burn scarring. Frequently this scars cover large areas, tend to retract, present pigmentary changes and are disfiguring, producing significant life quality impairment.

Unfortunately, there are very few therapeutic options for treating these scars, which can be secondary to reconstructive surgery or after spontaneous healing. In the last decades most reports in scar treatment have included, pressure garments, chemical peeling, dermabrasion, ablative and non-ablative laser therapy and surgery with varying degrees of success. There is only one report treating burn scars with fractional laser, with good results.

The aim of our study is to determine the effect of of a second-generation erbium-doped 1,550-nm fractional photothermolysis laser (Fraxel SR laser, Reliant Technologies Inc.) in the treatment of burn scars.

Eligibility Criteria:
Inclusion Criteria:

* Burn scars should be located on the anterior thorax or abdomen with at least 4 months of evolution.
* The scar should be slightly elevated, with erythema and with no signs of keloid formation.
* Maximum scar dimension: 0.2 - 1% body surface area.
* Acceptance of informed consent for laser treatment.

Exclusion Criteria:

* Previous non-surgical treatment (i.e. dermabrasion, laser, peelings, bleaching agent. etc).
* Previous surgical treatment (i.e. graft)
Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time

The purpose of this study is to investigate the link between the lungs and rheumatoid arthritis (RA). Additionally, to understand why RA patients get lung disease, how to treat, and prevent the disease.

This study is to learn more about the risk factors for the development of lung disease among patients with rheumatoid arthritis (RA), an auto-immune disease. Additionally, those at heightened risk of developing RA such as in the pre-RA period. This is a prospective and retrospective study, which 420 patients will be enrolled into the study. In-person participation will be up to 4 years, completing different standard of care assessments yearly. Additionally, quality of life questionnaires will be completed every 6 months at 4 time points. Lastly, an extended follow-up will be performed yearly for an additional 6 years, an overall 10 year participation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 80 years

Exclusion Criteria:

1. Subjects who do not speak English
2. Subjects without the capacity to sign the informed consent form (ICF)
3. Pregnant women
Parameters of Acceptability, Compliance and Efficacy of Fulvestrant in Post-menopausal Patients With Advance Breast Cancer

The objectives of this study is to obtain information of Faslodex use in the treatment of breast cancer in the clinical practice in Argentina.

In Argentina, Faslodex is indicated for treating postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-oestrogen therapy or disease progression during anti-oestrogen treatment. This study will provide information regarding the acceptability and compliance of Argentina patients to Faslodex and will provide information regarding the efficacy of this treatment in local population.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer with recurrence during or after adjuvant anti-estrogen therapy or disease progression during anti-estrogen treatment, currently receiving Faslodex
* Signature of the informed consent

Exclusion Criteria:

* Any contraindication to Faslodex administration
The Health of Competitive Fitness Athletes

Fitness athletes emphasize the value of staying lean, muscular and defined, and motivates and inspires followers through social media. We want to study the effect of such lifestyle on selected aspects of psychological and physical health in female fitness athletes, and compare the outcomes to a healthy, physically active female population.

Little is known about the mental and physical health effect from following the modern, idealized fitness lifestyle. The lifestyle is characterized by selective and restrictive eating behavior, strength training and use of supplements. The athletes emphasize the value of staying lean, muscular and defined, and motivates and inspires followers through social media. This study will recruit and observe a group of competitive female fitness athletes over their typical 3 month dieting period when preparing for contest. Before their contest diet is initiated, the athletes will be screened on selected aspects of psychological and physical health. The screening is repeated two weeks prior to their first seasonal contest, and then finally one month post-contest season. During the diet period of 3 months, the athletes answers brief questionnaires by email on eating- and training behavior and on mood, while also reporting dietary intake by telephone interview.

Recreational physically females, not planning to do any fitness contest, will be recruited to serve as a parallel control group. They will perform the same physical and psychological screening, and answer the same questionnaires throughout the fitness contest diet period.

Eligibility Criteria:
Inclusion Criteria:

* Fitness athletes: planning to compete in fitness sport during spring or fall 2017
* Controls: being regular physically active (exercise \>2 times/week during last year) with a BMI between 17,5-30

Exclusion Criteria:

* Controls: having competed in fitness sports previously or planning to do in the future, or working as a personal trainer.
* Not able to meet at the Norwegian School of Sport Sciences for baseline and follow up screenings.
* Being pregnant or nursing
* Metabolic related diseases
Glycaemic Response to a Liquid Meal Tolerance Test

The purpose of this study is to assess whether added food ingredient(s) affect glycaemic responses to a liquid meal tolerance test (LMTT).


Eligibility Criteria:
Inclusion Criteria:

1. Male or female (not less than 40% Male)
2. Aged 18 - 55 years
3. Non Smokers
4. Have a body mass index between 18.5 to 29.99 kg/m2
5. Healthy, non-diabetic, no gastric bypass surgery
6. Not allergic to dairy, or soy
7. Have a fasting plasma glucose (finger-stick) \<100 mg/dl (\<5.5 mmol/L)
8. Willing and able to provide written informed consent
AI Assisted Reader Evaluation in Acute Computed Tomography (CT) Head Interpretation

This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838).

The purpose of the study is to assess the impact of an Artificial Intelligence (AI) tool called qER 2.0 EU on the performance of readers, including general radiologists, emergency medicine clinicians, and radiographers, in interpreting non-contrast CT head scans. The study aims to evaluate the changes in accuracy, review time, and diagnostic confidence when using the AI tool. It also seeks to provide evidence on the diagnostic performance of the AI tool and its potential to improve efficiency and patient care in the context of the National Health Service (NHS). The study will use a dataset of 150 CT head scans, including both control cases and abnormal cases with specific abnormalities. The results of this study will inform larger follow-up studies in real-life Emergency Department (ED) settings.


Eligibility Criteria:
Inclusion Criteria:

* Radiologists/Radiographers/ED clinicians who review CT head scans as part of their clinical practice

Exclusion Criteria:

* Neuroradiologists.
* Non-radiologist groups: Clinicians with previous formal postgraduate CT reporting training
* Emergency Medicine group: Clinicians with previous career in radiology/neurosurgery to registrar level