cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

Trial for annual approval of interpandemic influenza vaccines


Eligibility Criteria:
Key Inclusion Criteria:

* 65 years of age or older
* Mentally competent
* Willing and able to give written informed consent prior to study entry
* Able to comply with all the study requirements
* In general good health

Key Exclusion Criteria:

* Any serious chronic or acute disease
* History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g. to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate);
* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
* Receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease
* A bleeding diathesis or condition associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
* Within the past 12 months, they have received more than one injection of influenza vaccine
* Within the past 6 months, participants had laboratory confirmed influenza disease; received influenza vaccine
* Within the past 4 weeks participants had received another vaccine; any investigational agent
* An acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the past 14 days
Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study

Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.

Background of the study:

Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.

Objective of the study:

To optimize DCE-MRI, T2\* MRI and DWI in pancreatic cancer at 3T and investigate its reproducibility.

Study design:

In the first part of the study, patients with pancreatic cancer will undergo an MR measurement protocol once at 3T, to optimize MR techniques (DCE-MRI, T2\* MRI and DWI). In the second part of the study, to assess reproducibility patients will undergo the MR measurement protocol twice within one week before start of any treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on CT imaging.
* Any tumor with a size ≥ 1cm
* WHO-performance score 0-2
* Written informed consent

Exclusion Criteria:

* Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
* Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or an aneurysm clip in their brain; patients with severe claustrophobia.
* Renal failure (GFR \< 30 ml/min) hampering safe administration of Gadolinium containing MR contrast agent.
* For the reproducibility part of the protocol: surgery, radiation and/or chemotherapy foreseen within the timeframe needed for MRI scanning.
AQT90 FLEX NTproBNP2 Test Kit Matrix Comparison and Sample Stability Verification Study

The purpose of this study is to establish the correlation between sample matrices, and to determine the sample stability for the NTproBNP2 Test Kit on the AQT90 FLEX analyzer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
* Subjects must be 18 years of age or older.
* Subjects with expected NT-proBNP concentrations within the measuring range of NTproBNP2 Test Kit.

Exclusion Criteria:

* Subjects known to be pregnant or breast-feeding.
* Subjects previously enrolled in the study.
* Subject, who has withdrawn consent.
Pelvic Exenteration in Treating Patients With Recurrent Cervical Cancer

This phase II trial is studying how well pelvic exenteration works in treating patients with recurrent cervical cancer. Pelvic exenteration may be effective in treating recurrent cervical cancer.

PRIMARY OBJECTIVE:

I. Correlate progression-free survival and overall survival with tumor size, time interval between primary cancer management and pelvic exenteration, and presence or absence of pelvic sidewall fixation by clinical examination in patients with recurrent cervical cancer treated with pelvic exenteration.

SECONDARY OBJECTIVES:

I. Determine quality of life of patients treated with this procedure. II. Correlate quality of life with reconstructive technique (e.g., no ostomy or ≥ 1 ostomy) in patients treated with this procedure.

OUTLINE:

Patients undergo pelvic exenteration within 14 days after study entry. Quality of life is assessed at baseline and at 6, 12, and 24 months after surgery. After completion of study treatment, patients are followed within 30 days, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cervical cancer

  * Any histology
  * Documented or suspected central pelvic disease with or without pelvic sidewall fixation from tumor and/or radiation fibrosis
* Meets 1 of the following stage criteria:

  * Recurrent disease, defined as reappearance of disease after a complete clinical response lasting ≥ 1 month
  * Persistent disease, defined as presence of disease by biopsy ≥ 3 months after completion of primary therapy
* Must have received prior primary treatment, including any of the following:

  * Surgery with or without post operative radiotherapy with or without chemotherapy
  * Primary radiotherapy with or without chemotherapy
  * Neoadjuvant chemotherapy followed by surgery
  * Neoadjuvant chemotherapy followed by surgery with or without radiotherapy or chemotherapy
* Plans to undergo pelvic exenteration to remove the pelvic disease within 14 days after study entry

  * Deemed to be a good surgical candidate

    * No evidence of distant disease or disease that is felt to be unresectable by physical examination
    * Patients with suspicious pelvic or para-aortic nodal disease as the only site(s) of extrapelvic disease are eligible at the discretion of the surgeon
  * Patients whose surgery is planned solely for managing complications (e.g., rectovaginal fistula, vesicovaginal fistula) of disease or prior therapy are not eligible
  * Patients whose surgery is planned as a prophylactic measure due to a slow or suboptimal clinical or radiographical tumor response during the course of primary therapy are not eligible
* No distant site of metastases by CT scan or MRI of the abdomen/pelvis OR positron-emission tomography
* No noncervical primary tumor
* No prior anterior or posterior pelvic exenteration
The Place of Men in Arrested Pregnancies

An terminated pregnancy is defined as the cessation of cardiac activity before 14 weeks of amenorrhea. This early interruption of gestation can be induced by pathological, traumatic or idiopathic causes. In any case, it remains a physically and psychologically trying event for the woman, the couple as well as for the man.

Indeed, the loss of this embryo, which measures only a few millimeters, corresponds to the loss of a child for the triad: woman, man, couple. The termination of this pregnancy is experienced as a bereavement for the future parents.

The stopped pregnancy has always been a taboo in the society. The proof being that it was not until the 1980s that this was considered mourning and its psychological consequences were studied.

Following these studies, psychological follow-ups are democratized and are thus offered to women. However, when is it men? The investigators have always put the woman at the center of the care process. Which is legitimate. However, the man is often seen as "the person who influences the woman". This default categorization marginalizes the man who would like to be an actor in the care of his partner. In fact, men are increasingly asking to support women in their gynecological care procedures. Unfortunately, for lack of measures put in place. The men are more than abandoned.


Eligibility Criteria:
Inclusion criteria:

* Age ≥18 years old
* male
* Speaking French
* The progenitor of the pregnancy and whose partner is affected by an aborted pregnancy

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under safeguard of justice
* Subject under guardianship or guardianship
* Subject under guardianship, curatorship or safeguard of justice
Tear Film Break-up Time After Instillation of Artificial Tears

This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.

Subjects with varying degrees of dry eye syndrome were enrolled in a randomized, controlled, double masked, single site study. A new formulation of an artificial tear containing glycerin 1% as an active with polylysine-graft-polyethylene glycol as an excipient was compared against a leading commercial product with propylene glycol (0.3%) and polyethylene glycol (0.4%) as active ingredients with hydroxypropyl-guar as a gelling agent. The primary outcome was a comparison of tear film stability after eye drop instillation.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* symptoms of dry eye
* no other history of ophthalmic problems

Exclusion Criteria:

* Use of any ocular lubricant or ointment in the past 36 hours
* use of contact lenses or excessive eye lid cosmetics on the study day
Effects of Dietary Protein on Musculoskeletal Health During Calorie Deficiency

Military personnel face many physiological challenges, including sustained physical activity and prolonged periods of negative energy balance. Chronic energy deficiency often results in a loss of skeletal muscle mass and can reduce overall bone health. Recent evidence suggests that dietary interventions that provide protein in excess of the current national dietary recommendation may confer protection against the negative effects of energy deficiency on the musculoskeletal system. The primary objective of this randomized, controlled study is to assess the effects dietary protein intake spanning the current acceptable macronutrient distribution range on musculoskeletal health following prolonged energy deficiency. Findings from this investigation will improve current understanding of dietary conditions necessary to reduce the damaging effects of caloric deficiency on musculoskeletal health in warfighters. Furthermore, given the rise in obesity in military populations, findings may aid in the development of nutritional weight management strategies that promote healthy weight loss without compromising musculoskeletal health.


Eligibility Criteria:
Inclusion Criteria:

* Weight stable with body mass index 22-29 kg/m2
* Physically active
* Refrain from NSAIDS and other aspirin containing medications
* Refrain from alcohol and nicotine

Exclusion Criteria:

* Metabolic or cardiovascular abnormalities, gastrointestinal disorders
* Disease or medication that affects metabolism and/or exercise
* Allergies or intolerance to foods, vegetarian practices, or medications to be used in the study
* Anemia and Sickle Cell Anemia/Trait; abnormal PT/PTT test or problems with blood clotting
* Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
* Musculoskeletal injuries that compromise the ability to exercise
* Blood donation within 8 weeks of beginning the study
* Pregnancy and women not on contraceptives
Participatory Research to Promote Physical Activity

Secondary schoolgirls have the most unhealthy profile regarding physical activity and sedentary behaviour of all age groups. Since both behaviours independently contribute to various health outcomes, an effective intervention to promote physical activity and to reduce sedentary behaviour needs to be developed.

Many interventions fail to induce changes in health behaviour, as they often use a top-down approach with limited input from the end-users (i.e. the secondary schoolgirls) of the intervention programmes. This project uses a participatory health research approach by actively involving the girls in the entire research process. A co-creation group was set up per intervention school (n=3), including girls and a researcher which co-created a school-specific intervention, tailored to the needs and interests of those girls.

The effect of participatory process were evaluated via a clustered randomized controlled trial using an intervention and control condition and a pre- and post-test design. Effects on physical activity and related determinants (e.g. self-efficacy, attitude, etcetera) were evaluated. The hypothesis was that girls from the intervention condition would improve their physical activity levels and related determinants compared to no changes among girls from the control schools. The process was evaluated as well using focus group research and the hypothesis was that girls who participate in the co-creation groups would be positive about the process and will feel empowered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, female pupils of secondary schools (aim: 10th grade) who volunteer to participate in the study
Dextenza With ILUX for Treatment of MGD

To evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert in evaporative dry eye disease (DED) patients with meibomian gland disfunction (MGD) and underlying inflammation undergoing iLUX MGD Treatment System.

This prospective study will use a fellow-eye design for 30 participants, (2 groups of 15) equating to 60 eyes. All eyes will receive bilateral iLUX MGD Treatment System. The most symptomatic eye will be selected to receive DEXTENZA® insertion on the day of the procedure (study eye). In group 1, the other eye will be assigned to receive prednisolone acetate 1% on a 4,3,2,1 month taper schedule (active comparator). In group 2, the other eye will receive punctal "sham" dilation (control eye). If there is no obvious symptomatic difference, the right eye will receive the intracanalicular insert. The study group will consist of 30 eyes receiving DEXTENZA® insertion. The control group will consist of 15 eyes receiving prednisolone acetate 1% and 15 eyes receiving sham punctum dilation. Thus, for every eye in the study group, there will be a paired eye with similar baseline characteristics in the control group sourced from the same participant. This fellow-eye design allows for greater control of potential confounders tied to participants' systemic and ocular health.

Eligibility Criteria:
Inclusion Criteria:

* A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

  * 18 years of age or older
  * Evaporative DED with MGD and clinically significant inflammation
  * Willing and able to comply with clinic visits and study related procedures
  * Willing and able to sign the informed consent form

Exclusion Criteria:

* A patient who meets any of the following criteria will be excluded from the study:

  * Patients under the age of 18.
  * Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
  * Active infectious systemic disease
  * Active infectious ocular or extraocular disease
  * Altered nasolacrimal flow of either acquired, induced, or congenital origin
  * Hypersensitivity to dexamethasone
  * Patient being treated with either topical, oral, or intravenous steroids
  * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer

The purpose of this trial is to determine that sort term calorie restriction will affect tumor biology in biopsy proven breast, endometrial or prostate cancers, which will positively impact biomarkers including miR-21, an onco-miR known to impact cancer outcomes.

PRIMARY OBJECTIVES:

1) Investigate if caloric restriction will change serum micro ribonucleic acid (RNA) 21 (miR-21) expression in patients with prostate, endometrial or breast cancer.

SECONDARY OBJECTIVES:

1. Investigate measurable changes induced by caloric restriction on both patient (host) and tumor characteristics from caloric restriction.
2. Investigate the adherence of the patient to the diet.

4) Weight, height, and body composition will be assessed via BodyMetrix. BodyMetrix uses ultrasound technology to measure subcutaneous fat.

5) Patients will have psycho-social evaluation using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) test (prostate cancer), FACT-Breast (B) test (breast cancer), or the FACT-Endometrial Cancer (En) test (endometrial cancer) and the Patient Reported Outcomes Measurement Information System (PROMIS) cancer fatigue short form at baseline, midway through diet, and at the conclusion of the diet.

6) Patient's nutritional status (Mini Nutritional Assessment \[MNA\] form) will be assessed, and their caloric needs will be calculated.

7) Local recurrence, progression free survival, distant metastases and overall survival will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Histological documentation of cancer of the endometrium, prostate or breast.
2. Candidate for definitive cancer surgery as determined by treating physician
3. The ability for the definitive cancer surgery to be scheduled within 4-12 weeks post initiation of dietary intervention as determined by the enrolling physician (not from diagnosis - but from start of diet).
4. No other malignancy within the past 6 months unless it was a non-melanomatous skin lesion
5. BMI ≥21
6. ECOG Performance Status of 2 or less
7. Patient must not be on anti-retrovirals since they may alter patient metabolism

Exclusion Criteria:

1. Patient is not a candidate for definitive cancer surgery
2. Definitive cancer surgery can not be performed within 4-12 weeks post study enrollment as determined by the enrolling physician.
3. Body Mass Index \< 21
4. Another malignancy within the past 6 months that was not a non-melanomatous skin lesion
5. ECOG Performance Status \>2
6. Patient on anti-retrovirals since they may alter patient metabolism
Ketostix® and Keto-Diastix® Performance Study

Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products. The products are: Ketostix and Keto-Diastix.

Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products.

1. Demonstrate that untrained PWDs can successfully read the Instructions for Use and use Ketostix and Keto-Diastix reagent strips for Urinalysis with no training. Urine samples from the PWDs will be collected and then tested by the PWD and will be compared to the reference assay results.
2. Demonstrate Ease of Use by PWDs with a Labeling Evaluation Survey for Ketostix and Keto-Diastix reagent strips. Participants will respond to a survey using a 5 point Likert scale with 5= Strongly Agree, 4= Agree, 3=Neutral, 2=Disagree, 3=Strongly Disagree.
3. Demonstrate that persons with diabetes (PWDs) can successfully test urinalysis control solutions.

Eligibility Criteria:
Inclusion Criteria:

* Males and females over 18 years of age.
* Diagnosed with Diabetes Mellitus (Type 1 or Type 2)
* Able to speak, read and understand English (subjects must demonstrate ability to read a paragraph from the first page of the package insert to qualify for the study).
* Willing to complete all study procedures.

Exclusion Criteria:

* Physical, visual, or neurological impairments that would make the person unable to perform urine collection and testing with the urine strips as determined by the PI.
* Intake of Vitamin C supplements (multi-vitamins are permitted)
* Prior experience testing glucose or ketones in urine with Ketostix and Keto-Diastix Reagent strips.
* Currently taking compounds such as mesna (Mesnex)
* Currently taking any medications containing azo dyes (e.g., Pyridium, Gantrisin, Gantanol), nitrofurantoin (Macrodantin, Furadantin).
* Currently taking medications such as levodopa.
* Working for a medical laboratory, hospital or other clinical setting that involves training in the urinalysis lab or use of urinalysis test strips.
* Working for a competitive medical device company (Urine Strip manufacturer) or having an immediate family member or living with someone who works for such a company.
* A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the study form).
MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin

Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of type 2 diabetes mellitus
* Glycosylated Hemoglobin (HbA1c) between 6.5 and 10% (inclusive)
* Current therapy with ACEi or ARB at stable dose for 10 weeks
* Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the previous 12 months or detected at Screening.
* Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min.
* Age between 18 and 80 years.

Exclusion criteria:

* Dual or triple blockade of the Renin Angiotensin System (RAS)
* Uncontrolled hyperglycaemia
* Mean arterial blood pressure \> 110 mmHg
* Known hypersensitivity or allergy to the investigational product, or their excipients (including matching placebos).
* Treatment with a glitazone within 6 months prior to informed consent.
* Treatment with a DiPeptidyl-Peptidase 4 (DPP-4) inhibitor, a Glucagon Like Peptide-1 (GLP-1) agonist, a Sodium/Glucose coTransporter 2 (SGLT2) inhibitor, a dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or premixed insulin within 10 weeks prior to informed consent.
* Treatment with anti-obesity drugs 10 weeks prior to informed consent.
* Alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake in the opinion of the investigator.
* Current treatment with systemic steroids (glucocorticoids) at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
* Participation in another trial with an investigational drug within 2 months prior to informed consent.