cyrilzakka/clinical-trials huggingface dataset:
Adjuvanted Influenza Vaccine in Stem Cell Transplant

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for transplant patients, studies have shown that nonadjuvanted vaccine has poor immunogenicity. There are no studies that define the effect of adjuvanted vaccine in this population. The purpose of this study is to determine if a vaccination with FLUAD® results in improved immunogenicity as compared to standard vaccine in allo-HSCT recipients. Immunogenicity will be assessed by standard quantitative antibody titer assessments and using cell-mediated immunity measurements.

The investigators plan to study the immunogenicity of two different types of the influenza vaccine in 240 allogeneic stem cell transplant patients during the 2015-2016 season. Patients will be randomized to receive either adjuvanted influenza vaccine or nonadjuvanted. Antibody titers will be evaluated by a standard hemagglutination inhibition assay. The investigators hypothesize that the patients who receive the adjuvanted influenza vaccine will reach significantly higher response to the vaccine. This study advances research on the prevention of serious viral infections in transplant recipients.

Results from this study have the potential to directly improve patient care. If the use of the adjuvanted influenza vaccine is successful, this strategy may lead to a significant reduction in burden of disease, hospitalizations, and long-term morbidity.

The co-administration of vaccine with an adjuvant is a potentially promising method of boosting immunogenicity. Two adjuvants have been used in influenza vaccines: AS03 and MF59. Both are oil-in-water emulsions. AS03 was used in the monovalent pandemic A/H1N1 vaccine in Canada and Europe. Adjuvanted vaccines have been studied in the hematopoietic stem cell transplant population with most studies done in using the AS03-adjuvanted pandemic vaccine. MF59 adjuvant has been used in seasonal influenza vaccine in Canada and Europe for people ≥65 years old. MF59-adjuvanted vaccines have not been well studied in hematopoietic stem cell transplantation but could represent a significant advance if they show greater immunogenicity than the standard non-adjuvanted influenza vaccine. Both FLUAD® and the standard 2015-2016 nonadjuvanted vaccine will contain 15 microgram antigen from each strain and will be injected in a standard dose (0.5 mL) in the deltoid muscle by trained personnel.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Greater than 3 months post-transplant
* Allogeneic HSCT

Exclusion Criteria:

* Has already received influenza vaccination for 2015-2016 season
* Egg allergy
* Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
* Febrile illness in the past one week
* Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next 4 weeks
* Unable to provide informed consent
* Unable to comply with study protocol
Artificial Intelligence Assists Surgeons' Decision Making

This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.

Anastomotic leakage is a serious and life-threatening complication after anterior resection in patients with rectal cancer, and temporary ileostomy was introduced to reduce the serious consequences due to anastomotic leakage. However, whether a temporary ileostomy is applied in the surgery depends on the surgeon's experience, and there are no clinical guidelines to follow. Recently, artificial intelligence has widely been applied in medical field and produced some exciting results, and we have developed a high-performance artificial intelligence model based on 2369 rectal cancer patients, which showed good discrimination of anastomotic leakage and may reduce the temporary ileostomy rate. Hence, this randomized controlled trail will evaluate the artificial intelligence model for guiding surgical decision-making of performing a temporary ileostomy in patients with rectal cancer who receive anterior resection.

Eligibility Criteria:
Inclusion Criteria:

1. Aged older than 18 years and younger than 85 years.
2. Primary rectal adenocarcinoma confirmed by preoperative pathology result.
3. Expected curative resection via total mesorectal excision procedure.
4. American Society of Anesthesiologists (ASA) class I, II, or III.
5. Written informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Severe mental disorder or language communication disorder.
3. Hartmann surgery or colostomy is performed intraoperatively.
4. Interrupted of surgery for more than 30 minutes due to any cause.
5. Malignant tumors with other organs
Effects of Pulsed Electromagnetic Field on Autonomic Function in Patients With Chronic Musculoskeletal Pain

Previously it has been demonstrated that exposing the heart to electromagnetic field during exercise stress test improves the recovery following the stress test. This is explained by the effect of the electromagnetic field on the sympathetic activity of the heart. In the present study we would like to further investigate the effects of electromagnetic field on autonomic nervous system function in patients with chronic musculoskeletal pain that usually have high sympathetic activity. Each patient will be exposed to 20 minutes of electromagnetic field during which the autonomic nervous system function will be measured. In addition, patient tolerability to the exposed magnetic field will be investigated. We assume that short exposure to electromagnetic field would result in decreased sympathetic activity and therefore, on the long run, could be suggested as a therapeutic tool for such patients.

Adult patients suffering from chronic muscoloskeletal pain will be recruited to this study during their weekly visits to the Department for Complementary Medicine at Sheba Medical Center. Patient will be exposed to 20 minutes of weak intensity and low frequency electromagnetic field while seated, during which heart rate variability measures will be recorded. In addition, patient tolerability to the exposed electromagnetic field will be investigated, including VAS score (pain score). This is a double blind placebo-control study by which neither the patients nor the physicians know which treatment is given to the patients. The study code will be open only at the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Chronic musculoskeletal pain

Exclusion Criteria:

* Implantable defibrillator
* Implantable pacemaker
* Active cancer
* Pregnancy
The Effect of Angiotensin II Type 1 Receptor Antagonists on the Size and Expansion Rate of Abdominal Aortas in Hypertensive Patients

Abdominal aortic aneurysm (AAA) is a common disease that develops from degeneration of the aortic wall. The natural history of AAA is gradual expansion and if left untreated may result in rupture and death. The mechanism of the development of this disease is unknown however it appears to be multifactorial and possibly related to degradation processes within the arterial wall. There is growing evidence that Angiotensin receptor blockers ( ARBS) may have an inhibitory effect on remodelling processes within the arterial wall, thus inhibiting degeneration of the vessel wall.

Study hypothesis: ARBS are associated with smaller diameters of aortas among hypertensive patients, and are associated with a lower rate of aortic expansion compared to other antihypertensive drugs.


Eligibility Criteria:
Inclusion Criteria:

* medically treated hypertensive patients, ages 50-80

Exclusion Criteria:

* pregnant women
* patients previously treated for aortic disease
* unable to sign informed consent, minors
Retrospective Study to Review Patients at Risk for VTE at Hospital Discharge

An investigator initiated study exploring VTE prophylaxis at the time of hospital discharge.

It appears likely that many patients will remain at risk for VTE at the time of hospital discharge. These risks will go unrecognized, and discharge prophylaxis orders will not be prescribed.

To test this hypothesis, we will perform a retrospective review of approximately 2,500 patients at Brigham and Women's Hospital at risk for VTE at the time of hospital discharge to determine what proportion received VTE prophylaxis. We will correlate the implementation of discharge VTE prophylaxis with the occurrence of symptomatic DVT and pulmonary embolism within 90 days of hospital discharge.

We will also conduct a substudy of this patient population to determine adherence to VTE prophylaxis among hospitalized patients.

Eligibility Criteria:
Inclusion Criteria:

* Acutely ill medical and surgical patients with a risk score of 4 or greater without prophylaxis or a risk score of 4 or greater with anticoagulation at hospital discharge.

Exclusion Criteria:

* None.
OPtimal TIming of COrticosteroids in Early-onset Fetal Growth REstriction: the OPTICORE Study

The aim of this observational study is to optimize the timing of antenatal corticosteroids administered to patients with pregnancies complicated by early-onset fetal growth restriction in order to reduce neonatal morbidity and mortality. In the Netherlands two main timing strategies of antenatal corticosteroids are commonly practiced. In this study the investigators will compare these two timing strategies regarding CCS administration in early-onset FGR on the combined endpoint of perinatal, neonatal and in-hospital mortality. In addition, the investigators aim to develop a dynamic, prediction tool, a novel technique in prediction research to predict the time-interval in days until delivery within this population. With that, the investigators aim to reduce neonatal morbidity and mortality for future FGR pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Early-onset FGR in accordance with the consensus-based definition of Gordijn et al. (19);
* Singleton pregnancy;
* Age ≥ 18 years;
* Installed active, neonatal management after counselling (thus having an indication for CCS administration in case of birth \< 34 weeks of gestational age).

Exclusion Criteria:

* Multiple pregnancies;
* Fetal congenital abnormalities or antenatal diagnosed genetic disorders;
* Patients who stated that their patient or offspring data may not be used for scientific research.
A Study Investigating Lu AG22515 in Healthy Adults

The main goal of this study is to learn more about the safety of a drug called Lu AG22515. During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a placebo (normal saline solution).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.0 and ≤32.0 kilograms (kg)/square meter (m\^2) and weight between 55 and 110 kg (both inclusive) at screening.
* Fully vaccinated against COVID-19, as evidenced by presentation of a vaccine card. The last administration of the COVID-19 vaccination must be received a minimum of 30 days and maximum 6 month prior to dosing in this study.
* Medically healthy with no clinically significant medical history, physical examination and neurological assessment, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.

Part C only:

* The participant is Japanese, defined as being born in Japan and having four Japanese grandparents as well as living a Japanese lifestyle as confirmed by the Japanese lifestyle questionnaire.

Exclusion Criteria:

* Reported history of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
* Received any vaccination in the last 30 days prior to Day 1.

Note: Other inclusion and exclusion criteria may apply.
A Study of RAY1225 in Participants With Obesity

The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with Obesity. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.


Eligibility Criteria:
Inclusion Criteria:

1. Have a body mass index (BMI) of ≥28 kilogram per square meter (kg/m²) or ≥24 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, fatty liver disease,or HbA1c ≥5.7% and \< 6.5%;
2. Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.

Exclusion Criteria:

1. Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
2. with a history of diabetes or hypoglycemia;
3. Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2 or with thyroid nodules of unknown etiology found at screening and considered clinically significant by the investigator.
4. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \>1 year prior to screening)
5. allergic constitution;
6. not suitable for subcutaneous injection.
Randomized Controlled Trial of Percutaneous and Intradermal BCG Vaccination.

An open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, in the prevention of tuberculosis during the first two years of life.

This is an open label, randomized, controlled, equivalency trial to compare the efficacy of the percutaneous route of administration with the intradermal route of administration of Japanese (Tokyo) 172 BCG, obtained from the BCG laboratory in Tokyo, Japan, in the prevention of tuberculosis, with bacteriological or histological confirmation, or meeting strict clinical criteria, during the first two years of life. The comparison of the two methods is necessary because the intradermal method is almost universally preferred, without direct evidence from a clinical trial. The intradermal method provides for more accurate dosing and produces a higher rate of tuberculin skin test conversion, but neither of these factors has been shown to correlate with efficacy of BCG vaccination. The percutaneous method is much simpler and, if shown to be equally effective, could become a preferred method. The Japanese strain was chosen because it is the one commercially available strain produced for both intradermal and percutaneous administration, and because a seed lot from this strain was previously used to produce BCG for the South African BCG vaccination program.

Eligibility Criteria:
Inclusion Criteria:

1. The child must be eligible to receive routine BCG vaccination.
2. The child must be born at one of the five hospitals taking part in the study and be a resident in the study area.
3. The mother must have had an opportunity to become informed about the study, either through pre-natal classes and a follow-up visit or, if time and the situation permits, after the mother presents at the hospital or birthing facility and before or after the child is born.
4. After being informed about the study, the mother gives consent for the infant to be enrolled and signs a consent form.

Exclusion Criteria:

1. The mother fails to give informed consent.
2. The child has a medical condition which contraindicates vaccination during the first 24 hours of life (e.g., birth weight below 2,500 grams).
3. The infant is hospitalized outside of the study area before vaccination has been given (e.g. transferred to a hospital in Cape Town because of respiratory distress).
Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia

This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.


Eligibility Criteria:
Inclusion Criteria:

* Males with moderate male-pattern baldness (androgenic alopecia)
* Females with moderate female pattern hair loss
* Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products

Exclusion Criteria:

* Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
* Use of bimatoprost or other prostaglandin analogs within 3 months
* Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
* Any prior hair growth procedures (eg, hair transplant or laser)
* Blood donation or equivalent blood loss within 90 days
* History of alcohol or drug addiction
Conventional Microneedling vs Microneedling With 5-FU (MMP) for Idiopathic Guttate Hypomelanosis (IGH) Repigmentation

The purpose of this study is to determine whether 5-FU infusion (Microinfusion of Medicine Percutaneously - MMP) is effective for Idiopathic Guttate Hypomelanosis (IGH) repigmentation compared to conventional Microneedling. MMP is a procedure done with tattoo devices using medication in place of ink.

Split body design. Each upper limb will receive a different intervention (experimental or placebo)

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, between ages 30 and 70
* Photodamaged skin on upper limbs with IGH lesions meeting aforementioned criteria and excluding differential diagnosis
* Fitzpatrick skin types III - V
* Apt and willing to comply with the entire program as well as appointments, treatment and examination
* Capable of understanding and providing a written informed consent
* Fertile women will have to use a viable birth control method for at least 3 months prior to entry and throughout the entire study

Exclusion Criteria:

* Pregnancy, intention to become pregnant during the course of the study, less than 3 months after delivery or less than 6 weeks after breastfeeding cessation.
* Uncontrolled comorbidity or any disease that, in the investigator's opinion, may interfere with the treatment, healing or cure.
* Present symptoms of hormonal disturbances, as per the investigator's criteria.
* Constitutional photosensitivity or due to metabolic disfunction, or due to use of external agentes (pharmaco, natural products, etc.) prior to initial treatment or during the study.
* Use of oral isotretinoin 6 months prior to initial treatment or during the course of the study.
* Prior treatment in target área 3 months prior to initial treatment or during the course of the study.
* Adverse reaction to any external agentes (gel, lotions or anesthetic creams) required during the study in case no alternative is available for such agent.
* History of keloids or other type of hypertrophic scar formation or poor wound healing in a previously injured area of skin.
* History of collagen disease.
* Displastic nevus or suspicious carcinogenic lesion in área to be treated.
* Hemmorragic disorder or under anticoagulant medication, including the use of aspirin not permitting a minimum 10-day suspension prior to each treatment period (in accordance with the criteria of the patient's physician).
* Skin frailty of sensitivity, favoring hemmorrage.
* History of immunosuppresion / immunological deficiency disorders (including HIV infection) or use of immunosuppressant medication.
* Participation in a study involving medication or another device three months prior to the study or during enrollment herein.
* Any condition which, in the investigator's opinion, would jeopardize the study or its participants, such as acute psychiatric disorders, panic syndrome or any aversion to needles or to the procedure.
* Hypochromiant dermatoses such as vitiligo, pitiriasis, versicolor, albinism.
* Dermatoses that evolve like Koebner's phenomenon.
* Cutaneous infectious process at the application site.
Casein Glycomacropeptide in Healthy Subjects

Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

The investigators now wish to evaluate the effects in healthy subjects by studying the anti-inflammatory and microbiome modulating properties and by assessing possible changes in gastrointestinal symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians
* Body Mass Index 18.5-25.0

Exclusion Criteria:

* Within 3 months: Acute intestinal disease (diarrhea more than 3 days in a week or bloody stools), hospital admission or antibiotic treatment.
* Chronic inflammatory disease or intestinal disease, including Crohn's disease, ulcerative colitis, celiac disease, rheumatoid arthritis or any other autoimmune joint disease, multiple sclerosis or any intestinal surgery apart from appendectomy.
* Pregnant or nursing.
* Unable to speak and understand Danish.
A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma

This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of hepatocellular carcinoma (HCC)
* HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
* Stage B (not applicable for transarterial chemoembolization \[TACE\]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
* At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
* Child-Pugh score A
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
* Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within normal limits. (control by thyroid replacement therapy is acceptable.) Participants with T3, free T3 or free T4 abnormalities at screening who are asymptomatic can be eligible
* Adequately controlled blood pressure
* Adequate renal function
* Adequate bone marrow function
* Adequate blood coagulation function
* Adequate liver function
* Males or females age ≥ 18 years at the time of informed consent
* Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion Criteria:

* Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
* Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
* Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
* Active infection (any infection requiring systemic treatment). Hepatitis B or C \[HBV/HCV\] is allowed
* Participants with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy \[WBRT\], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment