cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria:

* Receipt of another investigational agent within 4 weeks
* Receipt of influenza vaccination for current season 2006/2007.
* any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
* fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
* Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
* Surgery planned during the study period
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
* Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
* History of (or current) drug or alcohol abuse
* Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Clinical Outcome After Close Rectal Ileo Pouch Anal Anastomosis for Colitis Ulcerosa(CU)

The purpose of this study is to investigate a new technique: Close Rectal Dissection (CRD) as restorative surgery for Ulcerative Colitis patients: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). Clinical outcome and quality of life will be compared to the conventional Ileo Pouch Anal Anastomosis (C-IPAA) and the Ileo Neo Rectal Anastomosis (INRA).

Ulcerative colitis (UC) is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. The surgery rate after 10 years is 30%. After (sub)total colectomy with end ileostoma patients have a choice for restorative surgery. The conventional ileo pouch anal anastomosis (C-IPAA) is the gold standard of reconstructive surgery. This is al well established technique, but still carries a significant morbidity-rate. The recent studied ileo neo rectal anastomosis (INRA) has shown to reduce reservoir-related complications with a similar functional outcome, but is a very laborious technique. Therefore, we want to investigate an alternative technique: the Close Rectal Ileo Pouch Anal Anastomosis (CR-IPAA). The CR-IPAA is conducted in the nonanatomic perimuscular plane, resulting in a reduction of reservoir-related complications. After the close rectal dissection an ileo-anal pouch anastomosis will be constructed in a similar way. The close rectal dissection (CRD) is very laborious and has therefore never been developed extensively. But recent technical development of electrothermal bipolar vessel sealer (EBVS ) and ultrasound dissection have enhanced the CRD technique enormously. This brought along new interest in the CRD and justifies the research of its application.

Eligibility Criteria:
Inclusion Criteria:

* UC patients with the CRD procedure with written informed consent.
* Age, sex and disease specific matched control group op UC-IPAA patients with written informed consent.

Exclusion Criteria:

* Pregnancy
* Malignancy
* Psychiatric disease or inability to assess follow-up
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a documented clinical history of perennial allergic rhinitis
* Patient is a nonsmoker
* Patient is in good general health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is \<8 weeks postpartum or is breast-feeding
* Patient is a current or past abuser of alcohol or illicit drugs
Letrozole and Sequential Clomiphene to Improve the Outcome of Embryo Transfer

The purpose of this study is to study the effects of letrozole and sequential clomiphene in ovulation and pregnancy in PCOS patients.

To evaluate the efficacy of letrozole and clomiphene in PCOS patients is important,especially in resistent PCOS patients. Although most medications prove the effectiveness of letrozole and clomiphene,the subjects of letrozole and sequential clomiphene in PCOS patients are rarely.The trial may provide further basis for this medication in PCOS patients in ovulation. If the medication demonstrates efficacy, the method would help the patients with PCOS to deal with the problem of infertility.

Eligibility Criteria:
Inclusion Criteria:

* Women with PCOS

Exclusion Criteria:

* •Women more than 38 years or less than 20 years

  * With infectious diseases or endocrine diseases
  * Who refuse to participate in the experiment
Communicating Human Papillomavirus Vaccine With Japanese Parents and Caregivers With Daughters Aged 12-18

This study aims to comprehensively assess confidence in and acceptance of human papillomavirus (HPV) vaccines among Japanese parents and caregivers with daughters aged 12-18 and their decision-making process.

This study will implement an experiment as a sixteen-arm randomized controlled trial in an online survey environment. Before the experiment, participants, who are Japanese caregivers with daughters aged 12-18 who have not received an HPV vaccine, will first answer a pre-experiment survey. The survey will collect information on participants' socio-demographic data and key decision-making factors for HPV vaccine acceptance and confidence. Then, the study will randomly assign the participants to view one digital communication message using a 2 × 2 × 2 × 2 between-person factorial experiment on 'components of message.' The sixteen experimental messages will be developed based on real social media messages posted between November 2021 and April 2022, when the Japanese government prepared to reinstate an active recommendation of HPV vaccines for eligible girls after eight and a half years of suspension.

The sixteen messages will assess four factors: messenger, style, content, and misinformation. Each message will be similar except for one variable in consideration. The messenger component will be whether the message is from an individual or an organization. As individual messengers, the study will set a fictional male or female with common Japanese names who actively communicate about HPV vaccines. As organizational messengers, the study will use the existing accounts of the Ministry of Health, Labour and Welfare or the Japan Cancer Society or a fictional account of an anti-vaccine group. The style component will be whether the message conveys information through storytelling or scientific data. Messages will include personal stories for the storytelling style and statistics for the scientific data style. The content component will be whether the message conveys information about the effectiveness of the HPV vaccine in preventing diseases or the safety of the HPV vaccine. The contents will be built on both factual information and misconceptions about HPV vaccine safety and effectiveness that are often mentioned in the actual social media posts. The misinformation component will be whether the message conveys misinformation or factual information. The study will debrief all respondents exposed to misinformation after the survey.

Lastly, the study will collect data as a post-experiment survey to evaluate how an online message influenced caregivers' trust, confidence, and motivation to vaccinate.

Eligibility Criteria:
Inclusion Criteria:

* Female adult caregivers, older than 20, with daughters aged 12-18 who have received none or only one shot of HPV vaccine.

Exclusion Criteria:

* Caregivers who do not agree to participate in survey, experiment, or both.
* Caregivers with daughters who have already received two or more HPV vaccines.
Prosthetic Component Relationship of the Reversed Delta III Total Shoulder Prosthesis in the Transverse Plane of the Body

Comparison of the function and mobility of the shoulder with the placement of the Delta prosthesis (anteversion and retroversion of the glenoidal and humeral components)


Eligibility Criteria:
Inclusion Criteria:

* Shoulder prosthesis

Exclusion Criteria:

* Inability to place the hand on the back in prone position
Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava

Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Based on the national cancer data in 2020, Florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the United States. Unfortunately, around 16% of adults in Florida continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies. Therefore, there is an unmet and urgent need for novel interventions to improve the success of tobacco cessation. If such an intervention can reduce tobacco-associated lung carcinogenesis, that will be more desirable. The ultimate goal of this study is to develop a safe and effective kava-based intervention to enable tobacco cessation and reduce lung cancer risk, which will improve the health of Floridians.

This study will evaluate the compliance with a daily kava regimen among active smokers who have no intention to quit smoking. This study will also investigate whether kava use can reduce tobacco use and dependence, as well as tobacco-associated lung carcinogenesis.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 21 years or above
* self-reported smoking at least 5 cigarettes/day for the past year with no intention to quit at time of screening visit
* expired carbon monoxide level of more than 8 ppm at recruitment
* willingness to participate in the proposed study, as indicated by signed informed consent
* access to a functional telephone
* expected presence in the study's geographical area for the next 4 months
* not currently enrolled in any smoking cessation programs per self-report
* female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, Intrauterine Device \[IUD\], Diaphragm, and cervical cap)

Exclusion Criteria:

* history of active cancer (other than non-melanoma skin cancer) within the past 2 years
* diagnosed with liver dysfunction or with previous liver diseases
* levels of alanine transaminase, aspartate transaminase, alkaline phosphatase, or total bilirubin over limit of normal range at prescreen
* inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report)
* are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study
* participant answered "Yes" to any of the ASQ questions 1 through 3, or refuses to answer all of the questions. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place more than12 months from screening visit then subject is still eligible.
Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study

The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy.

This will be a pilot study that will include patients with AML receiving intensive induction therapy with 7+3 +/- a third agent (for any actionable cytogenetics or mutations). All patients will have a planned mid-induction bone marrow assessment as standard of care. All patients will subsequently be observed for count recovery, regardless of bone marrow results and in the absence of peripheral blood disease proliferation, and an end of induction bone marrow biopsy will be performed either at count recovery or between days 28 and 42 in the absence of count recovery. Patients with complete remission (CR) will proceed to consolidation chemotherapy as determined by the treating investigator. Patients with refractory disease will proceed to further therapy as determined by the treating investigator. All patients will be followed for long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Adult male or female, age ≥18
2. Patients with newly diagnosed AML (de novo or secondary), treated with intensive induction chemotherapy (7+3+/-3rd agent). The 3rd agent will be midostaurin for FLT3-mutant AML or gemtuzumab ozogamicin for core-binding factor AML. Patients on clinical trial with an investigational agent added to 7+3, may be enrolled on the protocol after discussion between the investigators and medical monitors.
3. Prior use of hypomethylating agents, lenalidomide, erythropoiesis stimulating agents and growth factors as allowed for treatment of myelodysplastic syndrome. Prior treatment for AML is not allowed.
4. Cardiac function: Ejection fraction \>50-55%
5. Adequate organ function for receipt for induction chemotherapy
6. Patients with HIV and Hepatitis B or C should have controlled disease.
7. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment.

Exclusion Criteria:

1. Any other active malignancy requiring treatment or with expected survival ≤1 year.
2. Recipients of prior allogeneic stem cell transplant.
3. Patients with psychiatric illness or social situation that would limit compliance with the study requirements.
4. Patients with active CNS disease
5. Patients with APL
6. Received any investigational drugs within the 14 days prior to the first day of induction
7. Pregnant and/or breastfeeding
Evaluate the Protective Effect of Conditioning With Sevoflurane on the Myocardium

Heart surgery is a considerable source of stress for the myocardium that must be minimized.

Troponin Ic is a reliable marker to determine the level of this myocardial stress.

Studies have shown that post-conditioning with AVH has a protective effect on the myocardium, if the treatment is initiated at the start of the ischemia.

The aim of this study is to evaluate the protective effect on the myocardium (by measuring troponin levels) of the association of pre-conditioning and post-conditioning with Sevoflurane (AVH) sedation administered during and after scheduled surgery for valve replacement, via sternotomy or thoracotomy compared with total intravenous anaesthesia with Propofol.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided informed written consent.
* Aortic valve replacement via sternotomy or thoracotomy, under Cardiopulmonary bypass (CPB).
* Anterograde cardioplegia with cold blood

Exclusion Criteria:

* Adults under guardianship.
* Patients without national health insurance cover.
* Epileptics.
* Heart grafted patients.
* Patients under 18 years and pregnant or beast-feeding women.
* Aortic dissections and vascular surgery.
* Contra-indications to treatment with Sevoflurane: hypersensitivity to halogen-based anaesthetic agents, myopathy, personal or family history of malignant hyperthermia, hyper-eosinophilia, liver disease, icterus or unexplained fever after anaesthesia with a halogen-based anaesthetic agent
* Contra-indications to treatment with Propofol: known hypersensitivity to propofol or one of the constituents of the specific form used, hypersensitivity to peanuts or soja.
* pre-operative LVEF\<35%.
* Coronary artery bypass graft alone or associated.
* Mitral valve replacements.
* Warm cardioplegia.
CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer

PRIMARY OBJECTIVES:

I. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.

SECONDARY OBJECTIVES:

I. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.

II. Correlate biomarkers of response with clinical response in patients treated with this drug.

III. Determine the safety and toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the pancreas

  * Locally advanced or metastatic disease
* Radiographic evidence of disease
* No known brain metastases
* Performance status - ECOG 0-2
* More than 3 months
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
* Creatinine ≤ 1.5 mg/dL
* Creatinine clearance ≥ 50 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Fasting serum cholesterol ≤ 350 mg/dL
* Fasting triglycerides ≤ 400 mg/dL
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent uncontrolled illness
* No concurrent prophylactic hematopoietic colony-stimulating factors
* No prior chemotherapy for metastatic pancreatic cancer
* More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer

  * Must have radiographic evidence of recurrent disease
* More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer

  * Must have radiographic evidence of disease progression
* See Chemotherapy
* See Chemotherapy
* No other concurrent investigational or commercial agents or therapies for the malignancy
* No other concurrent anticancer therapy
* No concurrent combination antiretroviral therapy for HIV-positive patients
Osteoarthritis Cardiovascular Risk Factors

We analyze retrospectively the relationship between traditional cardiovascular risk factors as hypertension, obesity, dislipidemia and diabetes and hand or knee osteoarthritis and we compare the results with a control groups of patients with soft tissue disease with no other rheumatologic condition.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for symptomatic hand or knee osteoarthritis
* All patients referred in the same period for soft tissue disease
* \> 50 years old

Exclusion Criteria:

* Any other rheumatologic condition
* secondary osteoarthritis
Physical Therapy Program for Prevention of Shoulder Pain After Device Implant

This is a clinical research study to determine if a prescribed physical therapy intervention after subcutaneous implantation of an implanted cardioverter-defibrillator (ICD) or pacemaker reduces the incidence of rotator cuff tendonitis when compared to usual post procedural care.

One hundred patients who undergo subcutaneous ICD or pacemaker implant and consent to inclusion in the trial will be randomized to one of two groups. One group will receive standard of care instructions after implant. These standard instructions include: no pushing or pulling movements with arm on side of implant, no lifting over 5 lbs., and no movements above the level of the shoulder for six weeks post implant. This will be the control group. The second group, the exercise group, will be instructed verbally on a series of specific exercises (appendix A) to be completed at least three days per week for 6 weeks.

After the patient signs informed consent, a demographic form will be completed. At this enrollment visit, both groups will be asked to use a visual analog scale to report level of shoulder and/or extremity discomfort. Physical exam will include the impingement test, assessment of shoulder elevation, and measurement of the angle of abduction at which discomfort occurs. Subjects will be given the QuickDASH questionnaire (Appendix B) to complete. This questionnaire is an 11 item self-report questionnaire designed to assess the physical function and symptoms during certain activities.

At the 1 week follow-up visit, the patient will be informed of their randomization group. The patients in the control group will receive standard of care instructions. The patients in the exercise group will have specific exercises demonstrated to them and written instructions with pictures will be provided for home reference. Follow-up for both groups will occur at 1, 3 and 6 months post implant and it will include a physical exam, the QuickDASH questionnaire, and the visual analog scale. Patients in the exercise group will be asked to complete an exercise log and return it to the study staff after the 6 week of exercise is complete. In addition, telephone follow-ups will be completed for the exercise group at 2, 3, 5, and 6 weeks post implant. Patients will be asked how often they complete the exercises.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing ICD or pacemaker device implant

Exclusion Criteria:

* Prior shoulder injury or surgery
* Mastectomy on affected side
* CVA with ipsilateral arm involvement
* Inability or refusal to perform exercises as prescribed.
* Subjects who would not be able to come in for follow-up visits at one, three, and six-month intervals will also be excluded.