cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of a Vaccine Against Essential Hypertension

CYT006-AngQb is a vaccine that induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Angiotensin II. The vaccine is administered by subcutaneous injection.

The objectives of the study are:

* To evaluate safety and tolerability of 5 s.c. injections of 300µg CYT006-AngQb with Alhydrogel™ in patients with mild to moderate essential hypertension (hypertension Grade I and II).
* To assess pharmacodynamic effects, i.e. anti-Ang II immune response and renin- angiotensin system (RAS) biomarkers.
* To explore the effect on blood pressure using ABPM.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate essential hypertension (Grade I and Grade II) with mean sitting office SBP =140-179 mmHg and/or mean sitting office DBP = 90-109 mmHg on 2 consecutive visits (screening and V1).
* Daytime blood pressure above threshold for definition of hypertension in the screening ABPM measurement (SBP \>135 mmHg).
* Patients without current antihypertensive therapy.
* Patients on antihypertensive therapy, which can be stopped.
* 18 to 69 years of age.
* Male patients, or female patients without childbearing potential .

Exclusion Criteria:

* Patients with "very high added risk" according to 2007 Guidelines for the Management of Arterial Hypertension (Journal of Hypertension, 2007, 25:1105-1187), i.e. those with:
* grade III hypertension (mean sitting office SBP ≥180mmHg and/or mean sitting DBP≥110mmHg)
* history or presence of established cardiovascular or renal disease:
* Ischemic stroke, cerebral hemorrhage, transient ischemic attack
* Myocardial infarction, angina pectoris, coronary re-vascularization, heart failure
* Peripheral artery disease
* Diabetic nephropathy
* Known autoimmune disease.
* Severe allergy.
* Pregnancy or breastfeeding.
* Women in childbearing age that are not surgically sterilized.
* Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C.
* Current diagnosis or history of malignancy.
* Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
* Drug or alcohol abuse within the past 2 years.
* Presence or history of relevant cardiovascular, renal, hepatic, pulmonary, endocrine, autoimmune, neurological and psychiatric disease as judged by the investigator.
* Any current or past disease or conditions (physical or mental) that would, in the opinion of the investigator, interfere with the study procedures or interpretation of the study data (e.g. workers in the night shift).
* Previous participation in a clinical trial with a Qb based vaccine.
* Use of an investigational drug within 3 months before enrolment, or planned use during the whole study period.
* Possible dependency of the patient on sponsor and/or investigator.
* Planned active immunization 2 weeks before or 2 weeks after any study medication vaccination.
* Donation or loss \>=400 mL of blood within 8 weeks prior to dosing or major surgery within past 2 months.
Cognitive Behavior Therapy for Anxiety-related Asthma in Adults.

This is a study to develop a protocol on Cognitive behavior therapy (CBT) for asthma-related anxiety that in a consecutive study can be translated to internet-delivered CBT.

Asthma is one of the most common chronic diseases around the world, with a high prevalence of anxiety disorders. Cognitive behaviour therapy (CBT) has been shown to increase psychological well-being for anxiety-related asthma. Our primary aim is to develop a standardized CBT protocol for asthma-related anxiety that can be transferred to internet-delivered CBT. Ten participants will be included in a single-subject multiple baseline design. They will all receive 10-12 sessions of CBT.

Eligibility Criteria:
Inclusion Criteria:

* asthma diagnosed by a physician
* anxiety or stress related to asthma

Exclusion Criteria:

* severe psychiatric disorder (e.g. psychotic disorder, addiction disorder, suicidal ideation).
H5N1 Vaccine Study in Japanese Elderly Population Aged 65 Years and Older

The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic influenza vaccine in a Japanese elderly population aged 65 years and older.


Eligibility Criteria:
Inclusion Criteria:

* Participant is 65 years or older at the time of screening.
* Participant is generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination.
* Participant is physically and mentally capable of participating in the study.
* Participant is willing and able to comply with the requirements of the protocol.

Exclusion Criteria:

* Participant has a history of infection with H5N1 virus or a history of vaccination with an H5N1 influenza vaccine.
* Participant is at high risk of contracting H5N1 influenza infection (e.g., poultry workers).
* Participant currently has or has a history of a significant cardiovascular (including hypertension), respiratory (including asthma), metabolic, neurological (including Guillain-Barré Syndrome and acute disseminated encephalomyelitis), hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder.
* Participant has any inherited or acquired immunodeficiency.
* Participant has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to: systemic or inhaled corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
* Participant has a history of severe allergic reactions or anaphylaxis.
* Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating.
* Participant has received a blood transfusion or immunoglobulins within 90 days prior to study entry.
* Participant has donated blood or plasma within 30 days prior to study entry.
* Participant has received any influenza or any live vaccine within 4 weeks or any other inactivated vaccine within 2 weeks prior to vaccination in this study.
* Participant has a functional or surgical asplenia.
* Participant has a known or suspected problem with alcohol or drug abuse.
* Participant has been exposed to an investigational product (IP) within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
* Participant is a family member or employee of the investigator.
* Participant has any other condition that disqualifies his/her participation in the study in the opinion of the investigator.
High-flow Nasal Cannula Oxygen Therapy With or Without NIV During the Weaning Period

Prospective multicenter randomized controlled open-label trial comparing 2 strategies of oxygenation during the post-extubation period in ICU patients at high risk of extubation failure. Patients will be randomized and assigned to one of the two groups, with a 1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* Duration of mechanical ventilation prior to extubation at least 24h
* Planned extubation decided by the physician in charge of the patient after success of a weaning trial
* Patients at high risk of reintubation according to the following criteria: patients older than 65 years, or those having any underlying chronic cardiac or lung disease.

Exclusion Criteria:

* Patient admitted for traumatic brain injury
* Periphal neuromuscular disease as reason for intubation
* Usual lon-term treatment with NIV for chronic desease
* Usual lon-term treatment with CPAP for obstructive apneas syndrome
* Contraindication to NIV
* Unplanned extubation
* Do-not-reintubated order at time of extubation
* Terminal extubation for end of life
* People under legal protection
* Opposition to participate
Comparison of Two FiO2 (1 or 0.5) for Tracheal Extubation in Post-anesthesia Care Unit

The purpose of the study is to assess the optimal fraction of inspired oxygen (0.5 or 1) for extubation or removal of a supraglottic airway device after general anesthesia.

During pre-anesthesia visit, eligible patients receive oral and written information of the study and potential risks.

In the operating room all patients giving a written informed consent will undergo at the end of surgery a screening to determine eligibility for study entry.

Before emergence from general anesthesia, patients who meet the eligibility requirements will be randomized in a open label manner to receive a 0.5 or 1 FiO2.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia, with invasive mechanical ventilation including an airway device (supraglottic airway device or tracheal tube) at their arrival in PACU.
* ASA physical status classification 1, 2, or 3 stabilized.
* Surgery performed in emergency operating room department including vascular, digestive, urological and minor trauma surgery or surgery performed in head and neck anesthesia pole block including anterior cervical spine, lumbar disc herniation, cranioplasty, nerve stimulator, vertebroplasty, narrow lumbar canal, simple arthrodesis (less than or equal to two stages), otological, ophthalmological and skin surgery.

Exclusion Criteria:

* Per-operative hemodynamic instability.
* Patients with a BMI greater than 35.
* Patients classified as difficult to intubate and / or ventilate.
* Heavy surgeries (operating time greater than 4 hours).
* Patient requiring postoperative non invasive mechanical ventilation
* Patients with diagnosed COPD
* SPO2 in room air \< 96% before the intervention.
* Any patient under guardianship.
* Pre-operative and / or intra-operative morphine intake.
* Surgical management of the upper airways (ex : tonsillectomy)
* Pregnant and lactating women.
The Safety of the 6-minute Walk Test After Acute Myocardial Infarction

Background: The six-minute walk test (6MWT) is widely used as an instrument for assessing the functional capacity of cardiac patients. It's a simple, low cost test that better reflects day-to-day activities when compared to other tests. Its use to evaluate the functional capacity of cardiac patients in the in-hospital phase after acute myocardial infarction requires further studies. Objective: To evaluate the safety of the 6MWT performed on the third day after acute myocardial infarction (AMI). Methods: It's a cross-sectional study, to be accomplished in Hospital São Paulo - Federal University of Sao Paulo. Individuals, of both genders, aged 18 years and over, will be assessed on the third day after acute myocardial infarction. The 6MWT will be performed according to the norms of the American Thoracic Society. The distance covered during the 6MWT will be measured as weel as adverse events.


Eligibility Criteria:
Inclusion Criteria:

* AMI patients

Exclusion Criteria:

* Previous history of AMI
* Recurrent or refractory pain
* Presence of neuromuscular diseases
* Acute or chronic lung diseases
* Inability to perform the functional test
The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery

The trial will be placed within an ongoing addiction recovery program at Infinite Recovery in Austin, TX. Members with any addiction enrolling in an inpatient treatment program at Infinite Recovery will be recruited into this 1-year study to evaluate the effectiveness of a plant-based diet to aid drug and/or alcohol addiction recovery. Volunteers willing to participate in the trial will be randomly assigned to a treatment or control group. Those in the treatment group will follow the standard protocol offered by Infinite Recovery, with the exception that they will be provided with only plant-based meals. Both groups will also receive nutrition education to support their dietary plan. Several health and wellbeing endpoints will be assessed as part of the standard care at Infinite Recovery, combined with a few additional measurements described within this study protocol.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Entering inpatient treatment at Infinite Recovery Addiction Treatment Facility

Exclusion Criteria:

* Pregnant
* Psychiatrically unstable.
Edoxaban in Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

This study is designed to gain real-world clinical data on the peri- and post-procedural usage of anticoagulation and antiplatelet therapy in patients with non-valvular atrial fibrillation (NVAF) undergoing successful percutaneous coronary intervention (PCI) treated with edoxaban.

The study will assess real-world evidence data of anticoagulation and antiplatelet therapy in patients with NVAF undergoing PCI treated with edoxaban. The observation period will start 4 to 72 hours after removal of the guiding catheter of successful PCI in a hospital and ends 1 year after procedure. Follow-up telephone calls will take place approximately 1 month and 1 year after PCI. Real-world data of effectiveness of edoxaban and antiplatelet therapy, clinical events of interests, safety and quality of life (QoL) data of edoxaban will be collected.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Providing written informed consent (ICF) for participation in the study
* NVAF treated with edoxaban
* Successful PCI
* No planned elective cardiac intervention for the whole duration of the study (up to 1 year)
* Capability of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year)
* Availability of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year)
* Willingness of patients for follow-up by telephone by the site for the whole duration of the study (up to 1 year)
* Not simultaneously participating in any interventional study
* Life expectancy \> 1 year

Exclusion Criteria:

* Not applicable
Chronic Multimorbidity Patterns in Relation to COVID-19 Severe Infection

The aim of the study was to analyze the patterns of chronic multimorbidity of a cohort of Covid-19 patients, and to assess the relation between the patterns and the development of severe infection or mortality.

This is a Big Data study that aims to establish the multimorbidity (MM) clusters of a cohort of Covid-19 patients, and assess their potential relation with severe infection or mortality. Databases of demographic information and complete medical records from the cohort will be provided by the Agency for Health Quality and Assessment of Catalonia (AQuAS). Data will be collected and integrated in a complete database in order to define the study variables: multimorbidity patterns, COVID-19 severe infection and COVID-19 associated mortality. The population will be stratified by sex and age (21-45, 46-65, 66-80 and 81-95 years). Diagnoses from primary care and hospitals will be filtered and classified using the Chronic Condition Indicator v.2021 and the Clinical Classification Software v.2021 \[1\], in order to identify the Chronic Conditions (CC) of the patients. CC with prevalence \>2% in each age-sex strata will be subjected to a fuzzy c-means clustering analysis. The final number of clusters in each age-sex group will be determined under the clinical criteria of the research group members. Percentages of patients that suffered severe Covid-19 infection or death in each cluster will be calculated. Bivariate statistical analysis comparing the demographic data and the cluster distribution with severe infection and mortality will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Positive results of Covid-19 laboratory tests
* Covid-19 related clinical profile verified by healthcare professionals

Exclusion Criteria:

* Male \>90 years
* Females \>95 years
ACE Inhibitors to Decrease Lymphoid Fibrosis in Antiretroviral-Treated, HIV-infected Patients: A Pilot Study

The investigators propose a proof-of-concept, pathogenesis-oriented, randomized, placebo-controlled pilot study to assess whether the addition of an angiotensin converting enzyme (ACE) inhibitor to standard Highly Active Antiretroviral Therapy (HAART) reverses lymphoid fibrosis, and whether this leads to more effective HIV-specific host immune responses and an accelerated clearance of the latent reservoir.


Eligibility Criteria:
Inclusion Criteria include:

* Stable HAART with maintenance of plasma HIV RNA levels below level of detection (\< 40-75 copies/mL) for ≥ 12 months
* \> 90% adherence to HAART within preceding 30 days

Exclusion Criteria include:

* Screening systolic blood pressure \< 110mm Hg or diastolic blood pressure \< 60mm Hg
* Current use of any ACE inhibitor, angiotensin receptor blocker, or aldosterone antagonist
* Known diabetes mellitus or cardiovascular/kidney/collagen vascular disease
* Pregnant/breastfeeding women.
Utilization of Rehabilitation Prior to Surgery Among Patients With Anterior-cruciate Ligament Knee Injury

This research aims to assess physiotherapy utilization in the treatment of patients with an anterior-cruciate ligament knee injury, when delivered before their surgery (prehab), and its potential effects on absence from work, and patients global health consumptions (before and after the surgery).

Based on the codes generated from French National health database, patients with prehab (+post-surgery rehabilitation) will be compared to patients receiving only post-surgery rehabilitation

Eligibility Criteria:
Inclusion Criteria:

- First episod of ACL-surgery

Exclusion Criteria:

* No history or previous ACL-surgery
* No rehabilitation after surgery
Ketamine Sickle Cell Disease

Sickle cell disease (SCD) often results in acute vaso-occlusive crisis (VOC), an obstruction of blood vessels resulting in ischemic injury and pain. The pain experienced during these episodes is due to a wide range of pathophysiological processes. Though recent studies have begun to unravel the underlying mechanisms of these processes, literature focused on pain management for sickle cell disease is scarce. Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) remain the predominate treatment for VOC.

However, the efficacy of these treatments has come into question. A large sub-set of patients with SCD report continued pain despite treatment with opioids. Tolerance and opioid-induced hyperalgesia (OIH) may be responsible for unresponsiveness to opioid-centric treatment modalities. New classes of drugs are being tested to prevent and treat acute pain associated with SCD, but in the meantime physicians are looking to existing therapies to bridge the gap.

The N-methyl-d-aspartate (NMDA) receptor has been implicated in both tolerance and OIH. As a NMDA receptor agonist, ketamine has been shown to modulate opioid tolerance and OIH in animal models and clinical settings. Ketamine utilized as a low dose continuous infusion could benefit patients with SCD related pain that are unresponsive to opioid analgesics. Based on limited studies of adjuvant ketamine use for pain management, low-dose ketamine continuous infusion appears safe. Further clinical investigations are warranted to fully support the use of low-dose ketamine infusion in patients with SCD-related pain.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with sickle cell anemia
* Adults aged 18 and older
* Subjects who have given written consent

Exclusion Criteria:

* Subjects who are pregnant
* Subjects younger than 18 years
* Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other similar medications
* Subjects who have a contraindication to ketamine
Improving Nicotine Patch Adherence Among Latino HIV-Positive Smokers

The goal of this study is to evaluate a smoking cessation program for Latino HIV-positive smokers focused on improving adherence to using the nicotine skin patch.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Latino
* HIV positive
* current, daily smoker
* ready to set quit date in next 30 days
* willing to try the nicotine patch

Exclusion Criteria:

* suffering from any medical condition which would prevent using the nicotine patch
* currently using other tobacco products or e-cigarettes
* currently receiving counseling or medication to quit or reduce smoking
A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis

The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)

This is a multinational, multicenter, randomized, double-blind study to demonstrate similar efficacy and safety of TVB-009 compared to Prolia® administered subcutaneously at doses of 60 mg every 26 weeks. Approximately 326 postmenopausal women with osteoporosis will be randomized to receive either TVB-009 or Prolia®. At week 52, patients in the Prolia® arm will be re-randomized 1:1 to either continue with a third dose of Prolia® or transition to TVB-009 and receive a single dose of TVB-009 in the transition period to assess immunogenicity and safety after a transition from Prolia® to TVB-009. The total treatment duration for each patient is 78 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal womeen (≥60 and ≤90 years) with a diagnosis of osteoporosis
* Body weight ≥50 kg and ≤90 kg
* Bone Mineral Density (BMD) measurement T score of less than -2.5 but not less than -4.0 by dual-energy X-ray absorptiometry (DXA) at the lumbar spine at screening
* At least 3 vertebrae in the L1 L4 region that are evaluable by dual-energy X-ray absorptiometry (DXA)

Exclusion Criteria:

* One severe or more than two moderate vertebral fractures
* History and/or presence of hip fracture or atypical femur fracture
* Any prior treatment with denosumab
* Ongoing use of any bone active drugs which can affect Bone Mineral Density (BMD)
* Vitamin D deficiency or hyper- or hypocalcemiacium at screening
* Hyperthyroidism, hypothyroidism, hypoparathyroidism or hyperparathyroidism
* Any medical condition that could jeopardize or would compromise the patient's safety or ability to participate in this study

Other Inclusion/exclusion criteria may apply