cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Safety, Immunogenicity of Bivalent mRNA Vaccine RQ3027 and RQ3025 as a Booster Dose in Healthy Adults

This clinical trial aimed to gather safety and immunogenicity data in COVID-19 vaccine-experienced healthy adults. The main questions it aims to answer are:

* The neutralizing antibodies levels of bivalent mRNA vaccines RQ3027(Alpha/Beta+Omicron XBB.1.5) and RQ3025(Alpha/Beta+Omicron BA.2/4/5) and monovalent mRNA vaccine RQ3013 against the current SARS-CoV-2 circulating variant.
* The safety profile of RQ3027 and RQ3025 given as a second booster dose to COVID-19 vaccine-experienced participants 18 through 55 years of age.
* Explore the protective efficacy by documenting confirmed COVID-19 cases after vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
* Participants 18 through 55 years of ages.
* Participants who have received at least 3 doses COVID-19 vaccine.
* Participants with the last prior dose being 90 or more days before Visit 1(Day 0) or recovered from COVID-19 at least 28 days.
* Participants able to comply with all scheduled visits, laboratory tests and investigator's instruction.

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
* Enrolling in or planning to participate other interventional clinical study.
* Has received systemic immunoglobulins or blood products within 3 months prior to the day of screening.
* History of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine.
* Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
* Continued using anticoagulants such as coumarin and related anticoagulants (i.e., warfarin) or oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran, and edoxaban).
* Having coronary heart disease, hypertension, diabetes, chronic respiratory diseases, tumors and poorly controlled.
* Immunocompromised or having immunosuppressive therapy.
* Suspected or confirmed alcohol/drug dependence.
* Investigator decide unsuitable factors for participating in clinical trials in the investigator's judgment
A Study To Test The Safety, Amount And Effects Of PF-06282999 In Healthy Overweight Adults And A Study To Test The Effects Of PF-06282999 On The Amount Of The Approved Drug, Midazolam, In Healthy Adults

Part A of the study will test the safety, the amount of drug in the body, and effects of the drug in the body after multiple doses. This will be conducted in healthy overweight adults. Part B of the study will test the effects of multiple doses of the investigational drug on the amount of midazolam, an approved drug, in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Women must be of non childbearing potential.
* Body Mass Index (BMI) of 27.0 to 35.0 kg/m2 (Part A) or 17.5 to 30.5 kg/m2 (Part B); and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subject with any contraindication to midazolam according to the country specific labeling or subject with previous intolerance or allergy to benzodiazepines (applicable to Part B of study only).
* Subjects who were enrolled in Part A are excluded from participation in Part B of this study.
* Subjects who have previously participated in a study with PF-06282999.
Effect of Sirolimus on Molecular Alterations in Cerebral Aneurysms

The objective of this study is to explore the effects of Sirolimus on the underlying molecular alterations of cerebral aneurysms.


Eligibility Criteria:
Inclusion Criteria:

1. Undergoing one of the following procedures at Jackson Memorial Hospital:

   * Clipping of an unruptured cerebral artery aneurysm
   * Endovascular treatment of unruptured cerebral aneurysms (including those receiving coiling)
2. ≥ 18 years of age
3. Willing and able to give informed consent

Exclusion Criteria:

1) Subjects meeting any of the following criteria will be excluded:

* Dissecting, traumatic, or mycotic brain aneurysm.
* Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test.
* Women who are breastfeeding.
* Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol.
* Patients with known Human Immunodeficiency Virus (HIV) infection or other known immunodeficiency.
* Patient with renal or liver failure
* Interstitial pneumonitis
* History of lymphoma
* History of skin cancer
* Hypersensitivity to sirolimus
* Severe or unstable concomitant condition disease or chronic condition, which in the opinion of the investigator could affect assessment of the safety or efficacy of study intervention.
Prehabilitation to Revolutionize Oncology: Telehealth Exercise for Cognitive Triumphs (The PROTECT Trial)

The investigators propose to deliver a pilot randomized controlled trial to 40 women newly diagnosed with breast cancer and scheduled to undergo chemotherapy. The current objectives are: 1) to evaluate the preliminary efficacy of the prehabilitation physical activity (PA) intervention delivered by a physical therapist and 2) assess the intervention's feasibility, acceptability, and appropriateness. The long-term goal is to scale this intervention for implementation into the standard of cancer care to prevent, mitigate, and treat cancer-related cognitive decline (CRCD).


Eligibility Criteria:
Eligibility Criteria:

* Diagnosis of breast cancer (stage I-III).
* Female.
* At least 18 years old.
* Scheduled to receive curative-intent chemotherapy.
* English speaking.
* Deemed fit to participate in a PA intervention by their oncologist.
* Not currently participating in another physical activity research study.
* Low active, defined by self-report as no more than 2 times per week of regular physical activity in the last six months
* Able to understand and willing to sign an IRB-approved written informed consent document.
Effectivity of Dermatix in Promoting Scar Maturation

The purpose of this research is to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

The healing of deep thermal injuries is always associated with scarring. The healing process can lead to the formation of large scar bundles (e.g. hypertrophic scars). The scars can be discomforting, disfiguring and restrict motion if situated over or near joints. Evidence for effectivity of treatment for reduction of hypertrophic scars or the prevention of them is limited.

Different treatments are used such as intralesional injected steroids, topically used oily creams, silicone sheets or occlusive dressings. Compression garments are also frequently used. There is some evidence as to the effectivity of silicone sheets for recuction of hypertrophic scarring, however, these sheets cannot be used easily on all anatomical locations.

Valeant Pharmaceuticals International has developed a silicone based scar remodelling gel, Dermatix®, which has been empirically shown by others to have potential to reduce hypertrophic scars.

Primary objectives are to demonstrate effectivity of Dermatix in promoting maturation of the scar, versus a control region that will be treated with an indifferent cream.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with hypertrophic scarring and/or ropes, stable for at least 3 months before inclusion.
2. Written informed consent
3. Scar size enabling the definition of two distinct scar areas, with similar scar characteristics at inclusion, preferably symmetric scars.
4. Patients of 18 years or older

Exclusion criteria:

1. Known sensitivity for occlusive dressings or silicone containing products
2. Any patient condition that may influence the compliance of the treatment negatively.
Food as Medicine Project

Causes' Fresh Produce Program (FPP) in Durham County has addressed barriers to food security related to transportation with an innovative delivery model, but lacks evidence regarding the impact of food supplementation on chronic diseases like hypertension, which is prevalent in historically excluded populations in Durham County. The goal of this research study is to determine the efficacy of the modified Dietary Approach to Stop Hypertension (DASH) diet in Black/African American and Hispanic/Latinx participants with chronic hypertension who identify as food insecure using a randomized controlled trial. This research will leverage FPP's innovative distribution system to deliver medically-tailored produce bags and provide education workshops to the experimental participants relative to their experimental group. The study population group intends to include members of the Durham community and surrounding areas that identify as members of either the Black/African American or Hispanic/Latinx populations. Success will be measured in pre- and post-intervention biomarkers and qualitative participant experience data. Recognizing the risk of using Protected Health Information of Durham community members, many of whom are members of historically excluded populations that have been subjugated to harmful and extractive research practices, steps will be taken to ensure that collected information about research participants' personal and health information is protected and used only for the purposes of research. Ultimately, this research aims to work directly with the community to address hypertension outside of the clinic using food and education delivered directly to participants. The success of such an intervention could lead to expansion of delivering medically and culturally tailored foods to the larger FPP population and beyond.


Eligibility Criteria:
Inclusion Criteria:

1. Adult parent/legal guardian (age 18 or older)
2. Documented essential hypertension (systolic BP \>140 and/or diastolic BP \>90, at least two documented clinical measurements)
3. Self-reported African American or Latino

Exclusion Criteria:

1. Hypertension due to secondary cause (e.g. renovascular hypertension, hyperthyroidism, Cushing's disease etc.)
2. Homelessness or insecure/transitional housing
3. Inability to prepare or cook food for themselves
4. Participants not living in Durham County, N.C.
5. Pregnant women
Nano MRI on 7 Tesla in Rectal and Breast Cancer

This study evaluates the diagnostic accuracy of an USPIO contrast agent (ferumoxtran-10) in combination with 7 Tesla MRI to detect lymph node metastases in rectal and breast cancer.

The Presence of lymph node metastases in cancer is a key factor for determining prognosis and forming an adequate treatment plan. Determining lymph node status, however, is a challenge. Ferumoxtran-10, an ultrasmall superparamagnetic iron oxide (USPIO) particle has proven to be a valuable contrast agent for detecting lymph node metastases using magnetic resonance imaging (MRI) in various types of cancer (also called nano-MRI). For small lymph node metastases (\<5mm) the diagnostic accuracy of this technique does, however, drop substantially. Most of the studies that have been performed with these particles used a 1.5 Tesla or 3 Tesla MRI scanner. The investigators would like to increase the resolution of nano-MRI by using a 7 Tesla scanner, such that the investigators can increase the sensitivity of this technique for small lymph nodes. With this study the investigators would like to validate the results of this technique with pathology in rectal and breast cancer. In these cancer types many patients undergo a surgical lymph node dissection by bulk excision of tissue including the nodes, enabling a node-to-node comparison between MRI and pathology to validate our nano-MRI results . If successful this technique would form a non-invasive alternative to the current lymph node staging techniques such as surgery. Additionally (if metastatic nodes are present), it could complement image guided focal therapies on lymph node metastases such as radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

General criteria:

* Age \> 18 years

Inclusion criteria rectal cancer patients:

* Patients with recently histologically proven rectal cancer, who are planned to undergo a total mesorectal excision without neo-adjuvant radiotherapy.

Inclusion criteria breast cancer patients:

* Patients with recently histologically proven breast cancer (Stage II), who are planned for surgery with sentinel node procedure, but will receive no neo-adjuvant therapy or will undergo an axillary lymph node dissection without prior sentinel node procedure and will receive no neo-adjuvant therapy.

Exclusion Criteria:

General exclusion criteria:

* BMI \> 30 kg/m2
* Pregnancy
* Karnofsky score \<= 70
* Contraindications for 7T MRI:

  * Epilepsy
  * Inability to provide informed consent
  * Metal implants that are not compatible with 7 Tesla MRI
* Contraindications to USPIO based contrast agents:

  * prior allergic reaction to ferumoxtran-10 or any other iron preparation
  * prior allergic reaction contributed to dextran or other polysaccharide, in any preparation
  * prior allergic reaction to contrast media of any type
  * hereditary hemochromatosis, thalassemia, sickle cell anemia;

Exclusion criteria for rectal cancer:

* Inflammatory diseases of the abdomen (such as Crohn's disease)
* Previous abdominal surgery or radiotherapy

Exclusion criteria for breast cancer:

* Prior radiotherapy or surgery to axillae
Intermittent Theta Burst Stimulation of the Precuneus

The purpose of the study is to compare the effectiveness of stimulation of the left precuneus by intermittent Theta Burst Stimulation to placebo stimulation on the severity of schizophrenia symptoms.

This is an interventional, prospective, randomized, double-blind, multicenter study, comparing iTBS treatment (experimental group) of the precuneus to placebo stimulation (control group) of patients suffering from resistant schizophrenia and having been exposed to childhood trauma.

The study population will be patients aged 18 to 40 years old exposed to childhood trauma, presenting with schizophrenia resistant to antipsychotic treatments.

This study will be implemented in 4 investigative centers. Each patient will participate for a period of 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed patient aged 18 to 40 years inclusive;
* Patient presenting schizophrenia as defined in the Diagnostic and Statistical Manual-5;
* Patient under antipsychotic treatment in accordance with the recommendations of the High Authority of Health, at a stable dosage and without modification of psychotherapeutic treatment for at least 4 weeks;
* Patient on mono or dual antipsychotic therapy.
* Patient presenting residual symptoms, i.e. absence of remission defined by the criteria of the "Remission criteria of the Schizophrenia Working Group Consensus";
* Patient having been exposed to at least one type of trauma in childhood and having a score higher than the threshold values of the childhood trauma questionnaire: emotional neglect, physical abuse, emotional abuse, physical neglect, sexual abuse;
* Patient having signed an informed consent form to participate in the study.

Exclusion Criteria:

* Patient with a contraindication to magnetic resonance imaging or intermittent Theta Burst Stimulation (presence of a metallic body, pacemaker, implantable defibrillator or other implantable metallic device, epilepsy, stroke or recent head trauma);
* Patient who is not French-speaking or cannot read and write;
* Patient under guardianship;
* Patient in forced care (psychiatric care upon decision of the State representative and psychiatric care at the request of a third party);
* Pregnant woman or likely to be pregnant (of childbearing age) without effective contraception or breastfeeding;
* Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
* Patient who is not a beneficiary of a social security system.
* Patient who, according to the assessment of the investigator, risks not being compliant or diligent in the study procedures.
Using Glialia for Treating Persistent Perceptual Postural Dizziness

This pilot study will involve 30 participants recruited from the Santa Lucia Foundation IRCCS, including 20 patients diagnosed with Persistent Perceptual Postural Dizziness (PPPD), and might or might not have previously contracted Sars Cov2 infection. They who will be randomly assigned to receive either the Glialia supplement or placebo. Additionally, 10 control participants who have recovered from COVID-19 will receive Glialia to help assess the influence of previous COVID-19 infection on neuroinflammation levels. The study aims to compare baseline neuroinflammation levels between PPPD patients and controls, measure changes in neuroinflammation in all groups after treatment and to determine if the reduction in neuroinflammation is more significant in the Glialia group compared to the placebo group. The trial will be conducted in a triple-blind manner, ensuring that neither participants nor researchers know the treatment assignments. Each participant will receive sachets to be taken daily for 60 days, with the study providing both the Glialia supplement and placebo at no cost.


Eligibility Criteria:
Inclusion criteria for all groups:

-Age between 18 and 65 years.

Inclusion criteria for the PPPD-glialia group:

* Diagnosis of PPPD;
* Recovery from COVID-19 infection or absence of previous infection.

Inclusion criteria for the PPPD-placebo group:

* Diagnosis of PPPD;
* Recovery from COVID-19 infection or absence of previous infection (matched to the PPPD-glialia group).

Exclusion criteria for all PPPD-group:

* Presence of concurrent neurological and otological disorders other than PPPD;
* Pregnant women.

Inclusion criteria for the control group:

-Previous COVID-19 infection (matched for timing to the PPPD-glialia group).

Exclusion criteria for the control group:

* Presence of neurological and otological disorders;
* Pregnant women.
Metagenomic Analysis of Gut Microbiome in Preterm

This is single center study. The investigators will try to know that relationships between intestinal microbiome and mortality in preterm infants and what relationships is between intestinal microbiome in preterm infants and morbidity, mortality.

Microbiome is the collection of all the microorganisms living in association with the human body which are consist of eukaryotes, archaea, bacteria and viruses. Microbiome in an average human body number are ten times more than human cells and have about 1000 more genes than are present in the human genome. There are symbiotic relationships between human and microbiome. If investigators are able to know about relationships between newborn and intestinal microbiome, mortality and morbidity in preterm infants may be improved. The investigators will collect the first and weekly stool of participants and analyze DNA of microbiome thorough Metagenomic anlysis. The results between 3 groups(preterm, late preterm and full-term infants) will be compared. The investigators expect that a mean distribution of intestinal microbiome in newborns(preterm, late preterm and full-term) is defined and that relationships between mortality, morbidity and intestinal microbiome.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants who were born at gestational age of less than 36 weeks from approval date to Feb 28th 2019
* full-term infants who were born at gestational age of greater than 37 weeks from approval date to Feb 28th 2019

Exclusion Criteria:

* newborns with congenital anomaly
* newborns with genetic syndrome
* newborns without consent of parents
Relationship Between Biological Phenotype, Clinical Severity of Sickle Cell Disease, and Blood Coagulation

Sickle cell disease is characterized by chronic hemolytic anemia and blood rheological alterations. In addition, blood coagulation abnormalities have been reported in patients with sickle cell disease and hemolysis-derived products could be involved. The investigators hypothesized that patients with sickle cell disease and severe hemolysis (Lactate Dehydrogenase level \&gt; 484 IU/L) could have an increased risk of hypercoagulable state and subsequent thromboembolic complications.


Eligibility Criteria:
Inclusion Criteria:

* Aged 8 years or older
* Under clinical follow-up for a diagnosis of sickle cell disease, specifically genotypes S/S, S/beta0, or S/C
* Patient covered by a social security or equivalent health insurance plan
* Collection of the non-opposition for adults
* Information of the minor and collection of the non-opposition from both parents

Exclusion Criteria:

* Patient who has undergone a transfusion or therapeutic phlebotomy within the 3 months prior to inclusion
* Patient participating in another interventional research protocol that may interfere with the present protocol (at the investigator\&#39;s discretion)
* Patient under guardianship, curatorship, or legal protection
* Patient subject to a legal protection measure
* Person admitted to a health or social care institution for purposes other than research
A Study of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to evaluate the safety of Guselkumab in participants with Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Have Crohn's Disease (CD) or fistulizing CD of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
* Have moderate to severe CD as assessed by CDAI components of stool frequency (SF), and abdominal pain (AP) scores, and endoscopic evidence
* Have screening laboratory test results within the protocol specified parameters
* A female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline
* Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD

Exclusion Criteria:

* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation
* Unstable doses of concomitant Crohn's disease therapy
* Receipt of Crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted time frame as specified in the protocol
* Prior exposure to p40 inhibitors or p19 inhibitors
* Any medical contraindications preventing study participation