cyrilzakka/clinical-trials huggingface dataset:
Phase IV Clinical Trial of an Influenza Split Vaccine Anflu

To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-60 years old
* Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years
* Not participate in any other clinical trials during the study
* Not receive any immunosuppressive agents during and one month prior to the study
* Be able to understand and sign the informed consent.

Exclusion Criteria:

* Woman： Who breast-feeding or planning to become pregnant during the study
* Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin
* Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
* Autoimmune disease or immunodeficiency
* Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases
* Guillain-Barre Syndrome
* Women subjects with positive urinary pregnancy test
* Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
* Axillary temperature \>37.0 centigrade at the time of dosing
* Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
Evaluation of the Blood Levels of the Drug (Lixisenatide), the Plasma Glucose Levels and Safety in Paediatric and Adult Patients With Type 2 Diabetes

Primary Objective:

- To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls

Secondary Objectives:

- To evaluate in both paediatric and adult populations:

* the blood levels of lixisenatide (pharmacokinetic) parameters in plasma after single subcutaneous ascending doses
* the maximum post-prandial glucose excursion, and on the changes in insulin, C-peptide and glucagon plasma concentrations following a standardized breakfast
* safety and tolerability.

The duration of the study for each patient is planned between 4 and 7 weeks including a screening period (25 to 30 days), 3 treatment periods 1-7 days apart, each period lasting only one day (Day 1) and an end-of-study visit between 1 to 7 days after the last dose administration.

Eligibility Criteria:
Inclusion criteria :

* Male or female patients with type 2 diabetes mellitus, as defined by WHO (fasting plasma glucose ≥ 7 mmol/L (126mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL)), diagnosed for at least 1 year (adults) and at least 3 months for paediatric population at the time of screening visit, with or without metformin (stable dose ± 10 % for at least 4 weeks prior to randomization)
* HbA1c ≥ 7% and ≤ 10% at screening
* Age eligibility for paediatric population: ≥ 10 years and \<18 years with at least 3 patients below 15 years and no more than 3 patients aged between 16 and 18 years; Age eligibility for adults: ≥ 18 and ≤ 65 years
* For paediatric population:body weight \>50kg, BMI \>85th percentile for age and gender and BMI ≤ 50 kg/m²
* For adults: BMI \> 25 kg/m2 and ≤ 37 kg/m2

Exclusion criteria:

* If female, pregnancy (defined as positive serum pregnancy test), breast-feeding
* Diabetes other than type 2 diabetes
* Positive test for insulinoma associated protein (IA2) and glutamic acid decarboxylase (GAD) autoantibodies
* Use of other oral or injectable antidiabetic or hypoglycemic agents other than metformin (e.g., alpha glucosidase inhibitor, exenatide, DPP-IV inhibitors, insulin etc.) within 3 months prior to the time of screening
* Allergic reaction to any GLP-1 agonist in the past (e.g. exenatide, liraglutide) or to metacresol
* History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
* Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™

The present trial is a follow-up of AL203 study (NCT00343889).

Primary Objectives:

To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine \[OPV\]).

Secondary Objective:

To describe the safety profile of a booster dose of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.

Study participants will receive a booster vaccination of DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).

Eligibility Criteria:
Inclusion Criteria:

* Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)
* Participated in the AL203 study and completed the three-dose primary series with either DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age
* Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
* Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received in the last 3 months
* Any vaccination in the 4 weeks preceding the trial vaccination
* Vaccination planned in the 4 weeks following the trial vaccination
* Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
* History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
* Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, or poliovirus 3 types antigen since the end of the primary series
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
* Serious adverse event related to any vaccination in the AL203 study.
Dexmedetomedine Infusion Versus Fentanyl Infusion for Donor Anlgesia During Living Donor Hepatectomy

To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion during donor hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* donors of living donor liver transplantation

Exclusion Criteria:

* patient refusal Known allergy to dexmedetomedine
A Trial of High Power-Short Duration Versus Standard Power-Long Duration Radiofrequency Ablation for Treatment of Atrial Fibrillation

This study is a prospective, randomized controlled study to compare overall clinical outcomes between High Power Short Duration (HPSD) and standard radiofrequency (RF) ablation settings for Atrial Fibrillation (AF) ablation in the treatment of subjects with paroxysmal or persistent Atrial Fibrillation.

Pulmonary vein isolation using radiofrequency (RF) ablation is a widely used treatment strategy for atrial fibrillation. Peri-procedural complications rates are estimated at between 1.5 - 6% with the two most feared complications being stroke and atrial-esophageal fistula. The risk of these complications increases with (1) longer left atrial dwell times with greater potential for clot formation and (2) esophageal heating during delivery of radiofrequency energy. 'High-power short-duration' (HPSD) is an increasingly utilized strategy to decrease procedure duration and minimize the risk of these complications. Potential mechanisms for benefit include: (1) shorter left atrial dwell times due to more efficient lesion delivery (2) rapid, but more controlled, resistive tissue heating, which avoids deeper, passive conductive heating that can reach the esophagus and cause injury. Moreover, HPSD may improve lesion efficacy and durability due to less recover of excitability after ablation. Despite being widely used and several retrospective studies, there have been no prospective randomized trials comparing outcomes between HPSD and standard RF ablation settings. Moreover, the investigators are interested to see if a shorter procedure (less time in the left atrium) is associated with a lower rate of silent cerebral infarctions (which are occasionally seen on MRI brain post RF ablation - their clinical significance is unclear).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age at their pre-operative visit.
2. Patient is scheduled to have their first AF ablation
3. Paroxysmal or persistent AF
4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Prior AF ablation
2. Stroke or transient ischemic attack (TIA) within the previous 6 months
3. Known esophageal ulcer or gastrointestinal (GI) bleed within prior 6 months
4. Intent to perform adjunctive left atrial ablation, including posterior wall isolation, left atrial appendage isolation, mitral or other linear lesions.
5. Prior rheumatic heart disease or significant mitral stenosis
6. Mechanical mitral valve replacement
7. Long lasting persistent AF \> 1 year
8. Severe left ventricular systolic dysfunction, with LV ejection fraction LVEF\<35%
9. Prior left atrial appendage (LAA) occlusion device
10. Prior septal occlusion device
11. Pregnancy
12. Pacemaker, defibrillator or any contraindication to MRI
Functionally Oriented Music Therapy (FMT) In The Treatment Of Long Term Pain

Project idea: This project aims to explore and evaluate a hitherto unexplored treatment method for people living with long-term musculoskeletal pain. The project's starting point is that it is urgent to develop evidence-based methods that can promote health and well-being, alleviate suffering and lead to an improved quality of life in the target group. The method "Functionally oriented music therapy" (FMT), to be studied in the present project, can be such a method. In FMT, music and movement are combined for health-promoting purposes, which can be assumed to lead to experiences of well- being and recovery. The method is already used in primary care in Region Sörmland, but the method is not evidence-based in the treatment of long-term musculoskeletal pain, which is why scientific evaluation is needed. The project is urgent both from a societal and patient perspective, among other things because healthcare resources need to be used more efficiently than today. To evaluate the method, both qualitative and quantitative research methodology will be used. If the results of the project are positive, i.e., if we can find evidence that various aspects of health are specifically affected/improved, then the results can contribute to evidence based FMT support for health promotion purposes for people with long-term musculoskeletal pain. If, on the other hand, the results show that FMT has no or only little effect, that in itself is an important contribution to new knowledge about treatment and recovery in people with long-term musculoskeletal pain. Today, FMT is used in, among other things, habilitation, rehabilitation and psychiatric care. However, research is needed that deals with the method's health-promoting efforts even in the case of long-term musculoskeletal pain problems.


Eligibility Criteria:
Inclusion Criteria:

* People with long-term musculoskeletal pain that occurred for at least three months.
* People over 18 years of age.
* People able to understand and speak Swedish or English

Exclusion Criteria:

* Severe hearing loss
* Visual impairment
* Cognitive impairment.

Pain conditions caused by:

* malignancy
* severe spinal pathology or
* neurological disease that severely limit the ability to perform activities.
Older HIV-infected Adults and Drug Interactions: French Cross-sectional Study

Drug interactions between antiretroviral drugs and concomitants drugs and between antiretroviral need to be studied HIV-population is ageing. The referential of interactions is the Liverpool base.

Filters in the French social security system database, 2016 :

* Code of Pathology "Human Immunodeficiency Virus (HIV) infection" Age ≥ 65 years
* Treatment with an antiretroviral between January 1, 2016 and December 31, 2016

Eligibility Criteria:
Inclusion Criteria:

* Men and women over than 65 years with an HIV infection and insured at the French Primary Health Insurance fund

No exclusion Criteria
Characterizing Spondyloarthritis With 68Ga-FAPI PET/CT

To evaluate the potential usefulness of 68Ga-FAPI PET/CT for the diagnosis, inflammation evaluation and prognosis prediction in spondyloarthritis.

Spondyloarthritis (SpA) is a chronic inflammatory rheumatic disease characterized by inflammatory back pain, enthesitis, dactylitis, and the formation of syndesmophytes, all of which significantly affect a patient's healthy functioning and general quality of life. Prevalence of underlying malignancy is high in patients with SpA. Radiographic sacroiliitis became a crucial finding in the diagnosis and classification of patients.

68Ga-FAPI has been developed as tracers specific for fibroblast-activation protein (FAP), which is overexpressed in activated fibroblasts in various type of cancers and autoimmune diseases, such as rheumatoid arthritis, IgG4-related diseases and interstitial lung diseases.

Recently the investigators have published articles of the application of 68Ga-FAPI in IgG4-related disease and rheumatoid arthritis, which showed it was more sensitive than FDG in detecting a certain type of inflammation. Increased 68Ga-FAPI Uptake in ankylosing spondylitis in a patient with rectal cancer has also been reported in a case report, indicating the potential utility of FAP-targeted PET/CT imaging for diagnosis and disease assessment in spondyloarthritis.

Thus, this prospective study is going to investigate utility of 68Ga-FAPI PET/CT in diagnosis of spondyloarthritis as well as inflammation assessment in joints including the sacroiliac (SI) joints, spine and peripheral joints. Also, this study aims to investigate potential utility of 68Ga-FAPI PET/CT in predicting treatment response and disease prognosis such as formation of syndesmophytes and erosive changes.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of SpA according to the ASAS (Assessment of Spondyloarthritis International Society) classification criteria for SpA.
2. Adult men or women 18 and ≤ 65 years of age at the time of signing the informed consent (ICF).
3. participants who were able to provide informed consent (signed by participant or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

1. Pregnancy;
2. Breastfeeding;
3. known allergy against FAPI;
4. any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Follow up Protocol to the Phase I/II Study of OPN-305 in Second-line or Third-line Lower Lower Risk Myelodysplastic Syndrome

This protocol is a follow-up for patients receiving continuation of OPN-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and HMA naïve parts of the main study OPN-305-106.


Eligibility Criteria:
Inclusion Criteria:

* Completion of the OPN-305-106 study
* Principal Investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor HI-E response" or "major HI-E response" and in the opinion of the Principal Investigator the patient may benefit from continued treatment with OPN-305 monotherapy or combination treatment with azacitidine.
* Provide written informed consent for the follow up protocol.

Exclusion Criteria:

* Refusal to provide written informed consent
* Withdrawal from the OPN-305-106 study prior to the final EOT visit
* Plan to be included into another interventional investigational study.
* Progression of disease
Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

This single-blind, randomized controlled trial studies how well inhaled essential oils work for common quality of life concerns in patients who are undergoing cancer treatment such as chemotherapy, targeted therapy, and/or immunotherapy given through the vein (intravenously). Aromatherapy using essential oils, such as ginger essential oil, German chamomile essential oil, and bergamot essential oil, may improve quality of life issues such as nausea, anxiety, loss of appetite, and fatigue in patients undergoing treatment for cancer.

PRIMARY OBJECTIVES:

I. To determine if aromatherapy, specifically inhaled essential oil, is beneficial for side effects related to cancer treatments involving chemotherapy, targeted therapy, and/or immunotherapy administered intravenously.

II. To describe the effect of inhaled ginger essential oil, German chamomile essential oil, and bergamot essential oil on nausea and anxiety of patients receiving chemotherapy, targeted therapy, and/or immunotherapy administered intravenously.

III. To describe the effect of decreased levels of nausea and/or anxiety on levels of appetite and/or fatigue.

IV. To evaluate the acceptability of using a personal inhalation bottle for inhalation of essential oils.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP I: Patients inhale 7 drops of bergamot essential oil using a personalized inhalation bottle three times daily (TID) (morning, midday, and evening) for up to 7 days. Patients also use a journal to document symptoms, time of inhalation, and medication use TID for up to 7 days.

GROUP II: Patients inhale 7 drops of chamomile essential oil and complete journal as in group I.

GROUP III: Patients inhale 7 drops of ginger essential oil and complete journal as in group I.

GROUP IV (CONTROL): Patients inhale 7 drops of almond essential oil and complete journal as in group I.

Eligibility Criteria:
Inclusion Criteria:

* Gastrointestinal cancers, neuroendocrine cancer, or melanoma or other skin cancers
* Receiving chemotherapy, targeted therapy, and/or immunotherapy
* Not naive to the treatment
* Must be able to read and write English

Exclusion Criteria:

* Allergies to ragweed, chrysanthemum, chamomile, ginger, bergamot, citrus fruits, tree nuts, perfumes
* Asthma diagnosis
* Patients receiving only octreotide injections
* Patients receiving floxuridine (FUDR) via hepatic artery infusion (HAI) pump only
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

This is an ambispective, multi-surgeon, single site, consecutive case series taking place in the United States. Once a subject is identified and informed consent is obtained from that subject, retrospective data will be collected from the subject's electronic medical record (EMR), and prospective data will be collected from subject-provided PROM's. A minimum of 16 and maximum of 23 subjects will participate in the study.

Eligibility Criteria:
Inclusion Criteria:

* The subject underwent a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques
* The subject signs a written informed consent form (ICF)

Exclusion Criteria:

* None
Autonomic Responses During the Valsalva Maneuver and Deep Breathing Test Depend on the Experimental Setup

The purpose of this study is to determine the effects of procedural differences during the Valsalva maneuver and deep breathing test in autonomic nervous system testing.


Eligibility Criteria:
Inclusion Criteria:

* male
* ≥ 18 year
* normal ECG-12

Exclusion Criteria:

* any known disease
* smoking
* any intake of regular medicine
A Randomized Trial Evaluating Personalized vs Guideline-based Well Follow-up Strategies for Patients With Early-stage Breast Cancer

After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.

After breast cancer patients complete the acute phase of their treatment (i.e. surgery, chemotherapy and/or radiation therapy), they are routinely followed in clinic every 3-6 months for several years. Multiple guideline recommendations exist with no consensus on the optimal follow-up schedule due to lack of randomized data to support any particular follow-up recommendation. The frequency of follow-up varies between and within different institutions. To date, no de-escalation strategy has appropriately evaluated patient reported outcomes such as quality of life or perception of care. There has been a growing body of evidence that de-intensification of follow-up is safe, effective and reduces costs for both patients and the health care system. Therefore the investigators propose a randomized trial evaluating personalized vs guideline-based well follow-up strategies for patients with early-stage breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Being referred to the Wellness Beyond Cancer Program (WBCP) for routine follow-up after completion of acute phase of treatment for invasive breast cancer

Exclusion Criteria:

* History of prior invasive breast cancer, recurrent brest cancer or metastatic breast cancer
* Currently receiving zoledronate, LHRH (Gonadotropin-releasing hormone) or abemaciclib