cyrilzakka/clinical-trials huggingface dataset:
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Primary objective:

To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants, aged from 6 weeks through full 7 weeks,
* Consent form signed by at least one parent or by the legal representative properly informed about the study,
* Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

* History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,
* Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,
* Known or suspected impairment of immunological function,
* Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),
* Prior administration of any rotavirus vaccine,
* Prior administration of any vaccine within the 28 days prior to randomisation,
* Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,
* History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
* Clinical evidence of active gastrointestinal illness,
* Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,
* Infants residing in a household with an immunocompromised person,
* Prior receipt of a blood transfusion or blood products, including immunoglobulins.
PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma

Given the growing importance of anti-angiogenic therapies in the treatment of metastatic renal carcinoma, it is expected that this trial will establish the preliminary data needed to apply for funding of a larger clinical investigation of the potential role of PET perfusion imaging in management of renal carcinoma, and potentially other cancers.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign a witnessed, informed consent and authorization for the release of health information.
* Patients with a diagnosis of relapsed Stage IV renal cell cancer that are medically unresponsive to prior treatment or surgically unresectable and with metastases that fall within the PET/CT field-of-view that can include the heart.
* Being considered for systemic therapy with Sunitinib

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or of childbearing potential and not using birth control
* Having no telephone or a reliable way in which study personal can contact them
* Subjects who are claustrophobic and cannot tolerate imaging procedures
* Subjects who weigh \> 350 lb. (upper weight limit of scanner beds)
The Effect of Gladskin on Disease Severity and the Skin Microbiome, Including Staphylococcus Aureus, in Patients With Atopic Dermatitis

Colonization with Staphylococcus aureus is related to inflammation in atopic dermatitis. Gladskin is a product for topical use containing the proprietary enzyme Staphefekt SA.100, which has the ability to specifically lyse the cell wall of S. aureus. The investigators hypothesize that Staphefekt decreases S. aureus colonization of the skin and consequently decreases symptoms of atopic dermatitis.The goal of this study is to determine the effect of Staphefekt on the use of topical corticosteroids in patients with atopic dermatitis. Secondary goals are to retrieve information about the effect on clinical symptoms, quality of life, growth characteristics of Staphylococcus aureus and the further microbiome.

This is a multi center intervention study with a placebo controlled, double blind and randomized design. After standardization of corticosteroid treatment (triamcinolone acetonide 0.1% cream), patients will be randomized in a 1:1 fashion to either treatment with Staphefekt SA.100 for 12 weeks or treatment with a placebo for 12 weeks. Topical corticosteroid use will be evaluated 2, 6, 12 and 20 weeks after start of the intervention. Swabs of the skin, nose and throat will be collected at baseline, week 2, 12 and 20.

Eligibility Criteria:
Inclusion Criteria:

* Atopic dermatitis of moderate and severe severity. Defined by EASI score of 7.1 to 50 performed by the researcher at visit 1
* Topical corticosteroid use (of any type)
* 18 years or older
* Able to read patient information and provide informed consent

Exclusion Criteria:

* Use of systemic antibiotics or corticosteroids in the previous 2 months
* Use of Methotrexate or oral immunosuppressive agents in the previous 3 months
* Use of topical antibiotics in the previous 7 days
* Use of light therapy in the previous 3 months
* Use of Gladskin in the previous 7 days
* Contact allergy to components of the study drug (e.g., propylene glycol and glycerol)
* Clinically infected atopic dermatitis
* Existence of another skin condition, such as folliculitis or psoriasis that could interfere with the assessment of the eczema severity
Safety and Efficacy Pilot Study of AzaSite® (Azithromycin) in Subjects With Blepharitis

The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of moderate to severe chronic blepharitis
* if female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

* had ocular surface surgery (LASIK, refractive, etc.) within the past year
* unwilling to discontinue the use of contact lenses during the study
* have glaucoma
* unable or unwilling to withhold the use of lid scrubs during the study
* have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
* currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation
Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis

The objective of this study is to evaluate how well the study product, Crest Daily Whitening Serum, alleviates Xerostomia and perceived halitosis over 1 week of use.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age.
* Can produce an unstimulated salivary flow rate of 0.18mL/min. or less.
* Score of 3 or more on question 1 of the VAS dry mouth scale (How severe is your dryness right now?), evaluated in the Pre-Product Use Dry Mouth \& Sensitivity Questionnaire.
* Evidence of currently taking a stable dose (3 months or more) of Xerostomia-inducing medication such as, antihypertensives, anti-anxiety agents, psychiatric remedies, antihistamines and etc.

  • At screening, participants may present the prescription bottle, a picture of the prescriptions bottle or medical records showing the prescription.
* Subject not currently using any teeth whitening or desensitizing products that contain potassium nitrate such as Sensodyne, Pronamel etc.
* Subject willing to comply with the study regimen and products.

  * Not consume alcohol for 24 hours prior to their visit.
  * Not brush their teeth for 1.5 hours prior to their visit.
  * Not have had anything to eat or drink (including chewing gum or eating candy) for 1.5 hours prior to their visit). Water is acceptable to drink up to 1 hour prior to the study visit.
  * Not smoke 1.5 hours prior to their visit

Exclusion Criteria:

i. Subjects who are currently pregnant (self-reported). ii. Unstimulated salivary flow rate of more than 0.18mL/min iii. Subjects that have ever received therapeutic radiation in the head and neck area.

iv. Subjects with a diagnosis of conditions that would affect salivary flow such as Sjogren's Syndrome per the investigator's expert opinion.

v. Subjects with a condition the investigator believes not suitable for the study, such as autoimmune diseases and radiation therapy to head and neck region that impact salivary flow.

vi. Subjects that currently use whitening toothpaste, desensitizing toothpaste, or any other products causing similar results.

vii. Subjects currently participating in any other research studies. viii. Subject unable to provide consent (e.g. Cognitively impaired adults). ix. Non-English speaking
Efficacy and Safety of TELMINUVO to Stage 2 Hypertension

The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.

* In patients with Stage 2 hypertension to determine the efficacy and safety of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 8 weeks.
* This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(8 weeks_double blind).

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* at the screening visit

  * antihypertensive drugs not taking: 160mmHg ≤ sitSBP \< 200mmHg
  * antihypertensive drugs taking: 140mmHg ≤ sitSBP \< 180mmHg
* at the randomization visit(160mmHg ≤ sitSBP \< 200mmHg)
* willing and able to provide written informed consent

Exclusion Criteria:

* mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
* for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
* known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
* has severe heart disease(Heart failure NYHA functional class 3, 4), ischaemic heart diseases status need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
* has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
* Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) \> 8%)
* known severe or malignant retinopathy
* defined by the following laboratory parameters:

  * hepatic dysfunction(AST/ALT \> UNL X 3)
  * renal dysfunction(serum creatinine \> UNL X 1.5)
  * hypopotassemia(K \< 3.0mmol/L) or hyperpotassemia (K\>5.5 mmol/L)
* acute or chronic inflammatory status need to treatment
* need to additional antihypertensive drugs during the study
* need to concomitant medications known to affect blood pressure during the study
* history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
* known hypersensitivity related to either study drug
* history of drug or alcohol dependency within 6 months
* any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding)
* administration of other study drugs within 4weeks prior to screening
* premenopausal women(last menstruation \> 1year) not using adequate contraception, pregnant or breast-feeding
* history of malignancy including leukemia and lymphoma within the past 5 years
* in investigator's judgment
Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response

To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-38 years old
2. BMI 18-28
3. Antral follicle count (AFC) \> 9 or Anti-mullerian hormone (AMH) \>1.1 ng/ml
4. 1st or 2nd ovarian stimulation cycle for IVF/ICSI
5. Planned to undergo ovarian stimulation with 150IU of rFSH in a fixed GnRH antagonist protocol

Exclusion Criteria:

1. Antral follicle count (AFC) \<9 and AMH\<1.1 ng/ml
2. PCOS patients according to the Rotterdam criteria
3. Patients undergoing in vitro maturation (IVM)
4. Untreated endocrine abnormalities
The Effects of Aerobic Exercise in Microvascular Endothelium Function in Patients With Cardiovascular Diseases

This study evaluates the effects of different volumes of aerobic exercise training in cardiovascular parameters of patients with cardiovascular diseases enrolled in a cardiac rehabilitation program.

Aerobic exercise training is well known to improve endothelium dependent vasodilatation in the microcirculation. However, the impact of exercise frequency on this response in patients with coronary artery disease remains unclear.

Eligibility Criteria:
Inclusion Criteria:

* sedentarism for at least 6 months;
* clinical diagnosis for coronary artery disease (occurrence of any acute coronary syndrome, including ST elevation or non-ST elevation myocardial infarction or unstable angina or by the diagnosis of obstructive coronary artery disease on coronary angiography in patients with stable angina).

Exclusion Criteria:

* nephropathies;
* decompensated cardiovascular diseases;
* liver diseases.
Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

Several attempts have been made to reduce these failure rates and improve return to sports rates in high-risk populations, and one of these approaches has been postoperative bracing. A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL reconstruction. Currently, however, there is no clear consensus on whether functional bracing following ACL reconstruction leads to lower failure rates, improved stability or better patient-reported outcomes when compared to ACL reconstruction without bracing.

Given the increased popularity in quadriceps tendon graft, the biomechanical advantages of postoperative functional bracing, and the graft elongation that occurs predominantly with soft tissue grafts, there might be a role for functional bracing following quadriceps ACL reconstruction. Additionally, no studies to date have assessed the role of psychological readiness of return to sport, kinesiophobia and return to sport rates with and without functional bracing following ACL reconstruction (ACLR).

The purpose of this randomized controlled trial is to assess the 2-year outcomes of psychological readiness, patient-reported outcome measures (PROMs), clinical stability, return to sport and failure rates following quadriceps autograft ACL reconstruction with and without functional bracing in the postoperative phase in younger athletic patients and military patients with a higher risk of failure or not returning to sports or duty, respectively, in a randomized study: the Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy trial (BRACE-trial).

Eligibility Criteria:
Inclusion Criteria:

* patients with unilateral complete ACL injury
* patients involved in sports and the desire to return to sports
* patients undergoing quadriceps autograft ACL reconstruction
* must be 14 to 39 years old

Exclusion Criteria:

* multiligamentous knee injuries defined as two ligaments requiring surgical stabilization
* concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction
* concomitant femoral, tibial, or patellar fracture(s)
* patients with significant osteoarthritis
* concomitant ipsilateral knee dislocation or patellar dislocation
* significant lower leg malalignment requiring correcting osteotomies
* prior ACL surgery, including contralateral knee
* pregnancy during injury or surgery
* unable to provide consent
* prolonged use of prednisolone or cytostatics
* comorbidities (e.g., muscular, neurological, vascular) that influence rehabilitation
Education Program for Family Caregivers

The purpose of this evaluation was to determine the effectiveness of an educational program designed to assist family caregivers to learn the knowledge and skills to take better care of their frail elder relatives and themselves.

Spouses, children, and other family members typically care for frail elderly persons. These family caregivers attempt to provide care for their relative in the home, despite the potential for excessive stress to themselves. This care may extend over many years, involving unrelenting management of their relative, which puts the caregiver at risk for the development of physical and mental health consequences. The stress of caring for a frail elder may result in the institutionalization of the care receiver due to declining health or abilities in the caregiver as caregivers frequently continue to provide care at the expense of their own health. The goal of the education program is to fill an important need, that is, assist caregivers to become empowered, hardier, and have the ability to cope with the stress associated with caregiving. The aim is to investigate whether this educational intervention improves selected outcomes for family caregivers of frail elders. The selected outcomes are knowledge of caregiving, hardiness, quality of life, physical health, depressive symptoms, burden, and coping.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* family member participating in care of a frail elder (60 years and older)

Exclusion Criteria:

* unable to speak or read English (materials are written in English)
Study to Evaluate Symptoms in Patients Treated With Nebivolol or Metoprolol Extended-release (ER) for Hypertension

The purpose of this study was to compare the tolerability of nebivolol to metoprolol ER in a general population of patients with mild to moderate hypertension receiving hydrochlorothiazide (HCTZ)

This study was an 18-week study to evaluate the tolerability of nebivolol compared to metoprolol ER in outpatients with mild to moderate hypertension taking HCTZ. It is a multi-center, randomized, double blind (DB), active-control, parallel-group study, starting with a 4-week HCTZ run-in phase, followed by a 12-week DB treatment phase. Patients meeting the entry criteria at the end of run-in are randomized to one of two treatment groups, nebivolol or metoprolol ER. Up-titration of dose of study drug will occur if needed during the first 4 weeks of the DB phase, after which there is an 8-week stable-dose period of treatment. A 2-week double-blind withdrawal phase follows, during which tapering off study drug occurs.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ambulatory outpatients
* History of hypertension being treated with two medications, one of which must be HCTZ and the other of which must not be a beta-blocker or clonidine
* SBP of 135-155 mm Hg and/or DBP of \>85 mm Hg at screening (Visit 1)
* SBP of 140-165 mm Hg and DBP \> 90 mmHg at randomization (Visit 3)

Exclusion Criteria:

* Treatment with a beta-blocker or clonidine within 6 months of screening (Visit 1)
* Clinically significant respiratory disease (e.g., bronchial asthma, reactive airways disease, chronic obstructive pulmonary disease)
* Coronary artery disease requiring treatment with a calcium channel blocker or nitrates
* Clinically significant cardiovascular disease (e.g., myocardial infarction, cerebrovascular event, significant arrhythmia) within 6 months of screening (Visit 1)
* History of severe mental illness (including Major Depressive Disorder, psychosis, dementia, bipolar disorder) within 6 months of screening (Visit 1)
* Use of antipsychotic medication (e.g., dopamine receptor antagonists, serotonin dopamine receptor antagonists) or antidepressants
* Diabetes mellitus, type I or II
* Participation in a previous investigational study of nebivolol at any time
* Receipt of treatment with an investigational study drug within 30 days of screening (Visit 1)
* History of hypersensitivity to nebivolol, metoprolol ER, other beta-blockers, HCTZ, or other sulfonamide-derived drugs
Bosentan for Severe Mitral Valve Dysfunction

Vasoconstrictive signaling via endothelin receptors is not limited to primary pulmonary arterial hypertension, but has also been documented in secondary pulmonary hypertension due to congestive heart failure, including cardiac valve disease. The investigators aim to examine the clinical and physiologic effects of bosentan therapy in patients with secondary pulmonary hypertension due to severe, inoperable cardiac valve disease, using a single-center, prospective, open-label, non-randomized study of oral bosentan in outpatients with severe mitral stenosis due to childhood rheumatoid fever. Primary end-point will be exercise capacity at six months determined by six-minute walking distance and cardiopulmonary exercise testing. Secondary end-points will be symptomatic relief, echocardiographic left ventricular function and pulmonary pressure, serum pro-brain natriuretic peptide, and adverse events at six months.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* \> 60 Yrs Old
* \< 85 Yrs Old
* Stable disease
* Congestive heart failure NYHA IIIB/V
* Inoperable mitral stenosis due to childhood rheumatoid fever
* Mean pulmonary artery pressure \> 40 cm H2O

Exclusion Criteria:

* Prior treatment with endothelin receptor antagonist(s)
* Hospitalization (exacerbation)
* Cardiac valve surgery
Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards

A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized in the medical department. The first approach is called basal-bolus in which 4 insulin shots are given daily ( 3 short acting before meals and one long acting before bed time). The second approach is called sliding scale in which short acting insulin alone is given before meals and before bed time according to the patient's glucose values. The aim is to keep fasting glucose between 140-180 mg/dl.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to internal medicine ward with blood glucose (BG) between 140-400 mg/dl.
* Known history (\>6months) of diabetes.
* Aged 18-80 years old.
* Previous therapy including either diet alone or any combination of oral hypoglycemia agents, glucagon-like peptide 1 (GLP-1) analogs and long acting insulin analogs or Neutral Protamine Hagedorn (NPH).

Exclusion Criteria:

* Pregnancy
* Patients with ketoacidosis
* Patients with unknown history of diabetes
* Patients with type 1 diabetes mellitus
* Patients with clinically relevant hepatic disease or renal impairment ( serum creatinine≥2.5 mg/dl)
* Use of corticosteroid therapy
* Patient with any mental disorder preventing him to cooperate and give informed consent.
* Patients on multiple daily doses of insulin regimen.