cyrilzakka/clinical-trials huggingface dataset:
The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)

The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative .

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative. HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.

Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.

This is a randomized, blind phase 3 clinical trial. Total 1200 adults (above ages 36 months ) were selected, randomized to two groups \[Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600\], adults in each group will be vaccinated with one dose of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, age above 36 months ;
* Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
* Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
* Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
* Axillary temperature ≤37℃.

Exclusion Criteria:

* Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
* Low platelet or bleeding disorder do not allow vaccination into the muscle;
* Have damaged or lower immunological function;
* Received blood, plasma or immunoglobulin treatment since birth;
* Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
* Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
PET Detection of CCR2 in Human Atherosclerosis

: Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis

Using 64CUDOTA-ECL1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..

Eligibility Criteria:
Inclusion Criteria: Normal Volunteers: 18-40 years of age, non smoker, no history of diabetes, hypertension, or hyperlipidemia. Patients: 50-89 years of age, adequate nutritional status, with or without smoking history, diabetes, hypertension, and hyperlipidema. Both asymptomatic and symptomatic patients with known carotid artery atherosclrosis \>70% and scheduled to undergo surgery. Advanced peripheral artery disease.

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Exclusion Criteria:Inability to receive and sign informed consent. Currently enrolled in another study. Patients who have type 1 diabetes or are in septic shock, receiving steroid therapy, recent history of heavy alcohol consumption, (male \>2 drinks per day, and female \> 1 drink per day. following extreme diets like Atkins or South Beach diet or with Stage 4 chronic renal failure. Patients with unstable clinical condition that in the opinion of the PI precludes participation in the study. Inability to tolerate 60 minutes in a supine position with arms down at sides. Contraindications to MR imaging, (pacemaker, brain aneurysm clips, shrapnel, etc. Positive pregnancy test or lactating. Have another conditions such as cancer or autoimmune/inflammatory diseases, e.g. rheumatoid arthritis or multiple sclerosis that are known to have increased expression of CCR2.

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Effects Of Acute Supplementation Of Citrus Aurantium L. On The Recovery Of Autonomic And Cardiovascular Activity After A Sub-Maximum Aerobic Exercise Session In Healthy Individuals

INTRODUCTION: Non-pharmacological interventions for the treatment of cardiovascular and metabolic disorders have been investigated. In this context, Citrus aurantium L., popularly known as Bitter Orange, rich in synephrine (p-synephrine), a phenylethylaminic alkaloid that is present in the bitter orange peel, has been used as an adjunct in metabolic disorders. Given the effects, the components of Citrus aurantium L. diverge from other thermogens by being able to activate metabolism and lipolysis without interfering with the performance of the cardiovascular system, making this an advantage for its use in diets. In studies, it has been observed that the activation of β-3 receptors plays an important role in the regulation and activation of other receptors, modulating and, when they are stimulated in excess, and thus, it presents effects that in addition to not causing overload in the cardiovascular system. OBJECTIVE: To evaluate the effect of supplementation of Citrus aurantium L. in combination with submaximal aerobic exercise on autonomic and cardiovascular parameters of physically active. METHODOLOGY: This is a prospective, randomized, placebo-controlled, double-blind crossover trial. 40 physically active volunteers will participate in the study. They will be qualified for the voluntary study of the male gender, who are aged between 18 and 30 years old and have a Body Mass Index (BMI) between 18.5 kg / m² and 29.9 kg / m². Do not use any medication that may interfere with cardiac autonomic modulation and do not have skeletal muscle damage. They will be considered as exclusion criteria for clinical patients, as well as those who have already used anabolic steroids or who have cardiorespiratory, neurological disorders and other known impairments that prevent the subject from performing the procedures. EXPECTED RESULTS: Speculated that the protective effects of flavonoids and their antioxidant properties found in Citrus aurantium L., optimize autonomic recovery after aerobic exercise. In addition, HRV can be used to ascertain its SNA activation effects and validate the safety of the applicability of this supplement for overweight populations, considering that it is used for this purpose.


Eligibility Criteria:
Inclusion Criteria:

* Male volunteers, aged between 18 and 30 years and with a Body Mass Index (BMI) between 18.5 kg / m² and 29.9 kg / m² will be considered eligible for the study.

Exclusion Criteria:

* Smoking patients will be considered as exclusion criteria. As well as individuals with cardiorespiratory, neurological disorders and other known impairments that prevent the subject from performing the procedures.
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C

This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver and leads to inflammation).


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy)
* Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak)

Exclusion Criteria:

* Other causes of liver disease (eg, alcoholic liver disease, HBV \[serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results\], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis)
* Participants having liver diseases associated with infection with any other hepatitis virus
* Detectable HCV RNA at screening
* Child-Pugh score \> 6
* Model for End-Stage Liver Disease score \>12
* Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP \> 100 ng/mL (\> 82.6 IU/mL) OR AFP ≥ 50 and ≤ 100 ng/mL (≥ 41.3 IU/mL and ≤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging \[MRI\] or computed tomography; based on local assessment), or ultrasound
* Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc
* Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk

Other protocol defined inclusion/exclusion criteria could apply
the Effect of coenzymeq10/Collagen Hydrogel on Bone Regeneration in Extraction Socket

To investigate the effect of CoQ10 in soft tissue healing and bone regeneration after extraction in diabetic patients seeking dental implants. Methods: This study will be a randomized controlled clinical trial, 18 patients will be divided equally into three groups. In-vitro studies will be performed to investigate the release of CoQ10 from collagen, swelling ratio, and evaluation of gelation behavior. The patients will undergo tooth extraction and filling of the socket with either collagen or CoQ10/collagen. Empty sockets will serve as a negative control. The bone regeneration of the socket will be determined by radiography, histology, histomorphometry, and polymerase chain reaction (PCR) for bone markers.


Eligibility Criteria:
Inclusion Criteria:

* Age 30-60 years including both males and females .
* Controlled Type II diabetic patients glycosylated hemoglobin (HbA1C) levels less than 7
* Good oral hygiene
* No history of bruxism/ para-functional habits
* Patients accept to sign the informed consent .
* Single or multiple Mandibular teeth requiring extraction.

Exclusion Criteria:

* Uncontrolled diseases that may contraindicate the surgery.
* Somkers patients.
* Osteoporosis.
* Hypersensitivity.
SHR1701 Alone or in Combination With SHR2554 in Relapsed or Refractory Classical Hodgkin Lymphoma

This is an open-label, phase I/II dose escalation and expansion trial. The primary objective of dose escalation phase I study is to evaluate the safety and feasibility of SHR1701 in patients with relapsed or refractory classical Hodgkin Lymphoma. The primary objective of open-label, randomized, phase II study is to assess the antitumor effect of SHR1701 alone or in combination with SHR2554 in patients with relapsed or refractory classical Hodgkin Lymphoma.

In phase I study, patients received intravenous SHR1701 30-150 mg/kg every 3 weeks. Sequential patient groups received the following doses of SHR1701: 30 mg/kg, 60 mg/kg, 90 mg/kg, 120 mg/kg, or 150 mg/kg in a 3+3 design with the intention of determining the recommended dose for phase 2. Toxicities are graded according to the Common Terminology Criteria for Adverse Events, version 5.0.

In phase II expansion study, based on the recommended dose of SHR1701 from phase I study, patients are treated with SHR1701 alone if CR rate is satisfactory, or randomized to SHR1701 monotherapy group or SHR2554 plus SHR1701 combination group to assess the clinical efficacy of SHR2554 plus SHR1701 combination therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
2. 12 to 75 years of age.
3. ECOG performance of less than 2.
4. Life expectancy of at least 3 months.
5. Subjects with lymphoma must have at least one measureable lesion \>1 cm as defined by lymphoma response criteria.
6. Subjects must have received two or more lines of previous therapy, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months. Previous treatment with anti-PD-1/PD-L1 antibodies or cytotoxic T lymphocyte associated antigen 4 (CTLA-4) inhibitors are allowed, and must be off therapy for at least 4 weeks.
7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
4. Prior organ allograft.
5. Women who are pregnant or breastfeeding.
6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Impact of Keeping a Personal Recovery Diary on Upper Extremity Disability

Primary null hypothesis:

• Keeping a personal diary has no effect on upper-extremity disability (assessed w/ PROMIS \[Patient Reported Outcome Measurement Information System\] upper extremity) 8 weeks after injury.

Secondary null hypotheses:

* Keeping a personal diary has no effect on avoidance of painful activities (assessed w/ PROMIS pain interference) 8 weeks after injury.
* Keeping a personal diary has no effect on symptoms of depression (assessed w/ PROMIS depression) 8 weeks after injury.
* There are no factors associated with upper-extremity disability 8 weeks after injury.

Recovery from injury can be counterintuitive and taxing. It is natural to feel protective and prepare for the worst. Healthy exercises can seem unwise. It can seem like things are taking too long or getting off track. We have noticed that small improvements such as being able to resume a cherished activity (e.g. knitting or swimming) or achieving some success with exercises (e.g. obtaining full supination after fracture of the distal radius), can help patients feel like things are going to be okay. That feeling seems to make it easier to do exercises and resume function activities.

We wonder if awareness of this process (mindfulness) would help patients recover more rapidly. Keeping a journal is one method for encouraging mindfulness. It allows patients to express themselves and tell their stories. There is evidence that such "narrative medicine" can be healing. We anticipate that patients who perceive little or no progress will be able to look back on how they were feeling earlier on and appreciate that things are moving in the right direction. We also hope that their journal material might be useful for other patients that are having trouble seeing the "light at the end of the tunnel", so as part of this study, we will get permission to use their quotes anonymously in future patient care materials and future research. To our knowledge, research on the impact of keeping a personal diary/journal of recovery is scant, particularly pertaining to recovery from upper extremity trauma.

Explanatory variables:

* Diary or no Diary
* Diagnosis (fracture, sprain, contusion, skin laceration, complex laceration \[tendon, nerve\])
* Location (hand, wrist, forearm, elbow, arm, shoulder)
* Sex
* Age
* Education
* Work status
* Insurance (worker's compensation, private, public, other)
* Visit type
* Prior treatment received
* Other pain conditions
* Smoking status
* Marital status
* Physical or Occupational Therapy

Eligibility Criteria:
Inclusion Criteria:

* All new patients (\>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion)
* English fluency and literacy
* Able to take informed consent

Exclusion Criteria:

* Pregnant women
A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)

The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time when MK-8527 is given alone and with the medication CBZ.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria include, but are not limited to:

* Is a healthy, adult, male or female of non-childbearing potential only, 18-55 years of age, inclusive
* Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

* Has a history or presence of:

  * Seizures (except for febrile seizure), or is at an increased risk for seizures
  * Family history of severe dermatologic reactions including toxic epidermal necrolysis and Stevens-Johnson syndrome
  * Clinically meaningful hematologic diseases, bone marrow disorders, or hematologic adverse reactions to other medications
  * Depression, unusual changes in mood or behavior or suicidal thoughts or behavior
  * Hypersensitivity reaction to anticonvulsant therapy (including phenytoin, primidone, and phenobarbital)
  * Clinically significant eye disease
* Shown to carry or be positive for HLA-A\*11:01, HLA-A\*31:01, HLA-B\*15:02, HLA-B\*15:08, HLA-B\*15:11, HLA-B\*15:21, HLA-B\*15:30, or HLA-B\*15:31 alleles.
HEME Home Transfusion Program

This research study is evaluating whether a new care delivery program that provides access to home blood transfusions in hospice (i.e, HEME-Hospice) compared to regular standard of care improves quality of life, mood, and end-of-life health care utilization for patients with hematologic malignancies.

Lack of access to blood transfusions is a key barrier to timely hospice use for patients with blood cancers. Refractory anemia and thrombocytopenia are common for patients with blood cancers and result in debilitating fatigue, shortness of breath, and bleeding. Transfusions palliate these symptoms and improve quality of life (QOL); yet, most hospices do not provide access to transfusions. Patients are thus faced with the agonizing choice of preserving access to vital palliative transfusions versus accessing quality home-based hospice care. Patients with blood cancers and their caregivers report that transfusions are vital for their quality of life, and that access to transfusions is a key factor in deciding whether to opt for hospice care.

The study team has thus developed a new model of care (HEME-Hospice) that provides access to palliative home transfusions to patients with hematologic malignancies who are enrolled in hospice. The purpose of this study is to determine whether access to HEME-hospice versus usual care improves hospice enrollment rates, quality of life (QOL), mood, and end-of-life healthcare utilization for patients with hematologic malignancies as well as QOL and mood of their caregivers. This study is a cluster randomized trial in which hematologic oncologists will be randomly assigned to access to HEME-Hospice versus usual care. Participants in this study will have access to HEME-hospice or usual care based upon the strategy to which their hematologic oncologist has been assigned.

Eligibility Criteria:
Inclusion Criteria for Patient Participants:

* Diagnosis of a relapsed/refractory hematologic malignancy
* Age ≥ 18 years
* Receipt of primary oncologic care at DFCI (at least 2 outpatient visits in 12 months prior to enrollment)
* Has received at least one red blood cell (RBC) or platelet transfusion since blood cancer diagnosis in the clinic or hospital setting without a severe transfusion reaction
* Patient resides within catchment served by Care Dimensions Hospice
* Physician-estimated prognosis of six months or less

Inclusion Criteria for Caregivers:

* Identified informal caregiver of enrolled patient with hematologic malignancy
* Age ≥ 18 years

Exclusion Criteria for Patient Participants:

* Age \< 18 years
* Already enrolled in hospice
* Resides in nursing home or assisted living facility
* History of previous serious adverse transfusion reaction

Exclusion Criteria for Caregivers:

-Age \< 18 years
Police COVID-19 Serosurvey

The investigators aim to determine the immune status of the employees of the cantonal police of Bern against SARS-CoV-2 over a period of 1 year, and to investigate the risk profile of the study participants and their risk of SARS-CoV-2 exposure in their working and private environments, as well as to evaluate the use of personal protective equipment at potential exposure instances.

i) To determine the extent of infection with seroprevalence data in the special population of police officers of the canton Bern.

ii) To determine risk factors for infection by comparing the proportion of seropositivity (infected versus noninfected individuals). The investigators hypothesize that police officers with fieldwork activity will have a higher seroprevalence than will office and administration personnel. The investigators hypothesize that working in the city of Bern will be associated with a higher seroprevalence than will working in other geographic areas of the canton (i.e. rural area).

iii) To monitor COVID-19 antibody titres and neutralizing capacity over time and to associate them with reinfection rates and infection-free intervals in police officers after accidental contact with a proven COVID-19 case. The investigators hypothesize that in seropositive individuals, there will be a decreasing dynamic of antibody titres over the one-year study period, and hence, a decrease of neutralizing capacity.

Eligibility Criteria:
Inclusion Criteria:

* Police officers of the cantonal police of Bern volunteering to participate in the study.

Exclusion Criteria:

* Refusal or inability to give informed consent or contraindication to venepuncture.
Improving Housing Outcomes for Homeless Veterans

Many homeless Veterans with serious mental illness (SMI) enroll in the VA's Supported Housing (VASH) program but struggle to obtain and sustain housing. Social skills are an important-but underappreciated-determinant of housing outcomes for homeless adults. The investigators hypothesize that homeless Veterans with SMI who participate in a social skills training program, tailored for housing-related social skills, will obtain housing quicker, retain housing longer, and show improved mental health outcomes compared to Veterans with similar needs not participating in such a program.


Eligibility Criteria:
Inclusion Criteria:

* Identified by VA Greater Los Angeles homeless program staff as a participant in Housing Skills Training:

  * Must have a history of homelessness
  * Must be a Veteran over the age of 18 years
  * Must have a serious mental illness (mood disorder, anxiety disorder, psychotic disorder)

Exclusion Criteria:

None
Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis

For proving the potential of tropical medicaments on clinical parameters of periodontitis, a comprehensive assessment is required between therapeutic medicaments. The main aim of the study was to clinically evaluate and compare the efficacy of indocyanine green mediated photodynamic therapy (PDT) and aleo vera (AV) extract when used as an adjunct therapy to scaling and root planning (SRP) for treatment of chronic periodontitis.

One hundred and fifty patients included in this study were randomly distributed in three treatment groups Group I (SRP), Group II (SRP+PDT) and Group III (SRP+AV). Four clinical parameters plaque index (PI), bleeding on probing (BoP), periodontal (PD) pocket depth and clinical attachment level (CAL) were evaluated at three time points baseline, 3rd and 6th month respectively. Additionally the amount of three inflammatory cytokines IL-6, IL-8 and TNF- α in gingival crevicular fluid (GCF) was identified using enzyme linked immune-sorbent assay (ELISA) technique.


Eligibility Criteria:
Inclusion Criteria:

* age of ≥ 30 years;
* ≥ 20 natural teeth; and
* chronic-periodontitis (≥ 3 mm of CAL and PD pocket depth respectively on at least 30% of dental sites).

Exclusion Criteria:

* chronic systemic diseases;
* PD therapy during last 6 months;
* habitual use of chewable and non-chewable tobacco (smoking);
* alcohol consumers; or
* use of particular medications during last three months (steroidal and non-steroidal drugs/ anti-biotic/ anti-depressants)