cyrilzakka/clinical-trials huggingface dataset:
Growth of Infants With Cow's Milk Allergy Fed an Amino Acid-based Formula Containing Two Human Milk Oligosaccharides

The main aim of this study is to provide longitudinal growth data in infants with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides.


Eligibility Criteria:
Inclusion Criteria:

1. Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
2. 2500g ≤ birth weight ≤ 4500g
3. Having obtained written informed consent form the infant's parents or legally authorized representatives (LAR).
4. Infant aged between 1 and 8 months.
5. Exclusively formula-fed at time of enrolment; or CMPA infant receiving partial breastfeeding and infant's mother having independently elected before enrolment to exclusively formula feed.
6. Infants with physician-diagnosed CMPA as per standard clinical practice:

Exclusion Criteria:

1. Previous treatment with AAF \> 72 hours
2. Known underlying medical condition that would impair growth (as per physician's assessment, e.g. unstable congenital heart disease, cystic fibrosis, metabolic disorder, chronic liver disease etc.)
3. Demonstrated chronic malabsorption which is not due to CMPA.
4. Other significant pre-natal and/or serious post-natal disease other than CMPA before enrolment (per investigator's medical decision).
5. Infants whose parents or caregivers who cannot give informed consent or who cannot be expected to comply with study procedures.
6. Treatment with systemic corticosteroids (oral or intravenous) for \>72 hours within 4 weeks before enrolment (topical corticosteroids allowed)
7. Infants taking probiotic preparations for \> 72 hour within 4 weeks before enrolment
8. Currently participating or having participated in another clinical trial since birth.
Myocardial Microvascular Disease in ESRD

Cardiovascular diseases are the leading cause of mortality in patients with end stage renal disease (ESRD). They often have myocardial ischemia (a major predictor of mortality) on non invasive testing (Stress echocardiography and/or myocardial perfusion scintigraphy) but the incidence of significant coronary stenosis (\>70%) is low. The goal of this observational study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular disease in patients with end stage renal disease scheduled or not for kidney transplantation. These patients routinely undergo non invasive detection of myocardial ischemia. Patient included in the study will be followed up for 2 years for major cardiovascular events. Patients with detected myocardial ischemia during non invasive testing are being explored by coronary angiography. During coronary angiography additional detection of myocardial microvascular disease is being performed by simultaneous measurement of Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) followed by calculation of the index of microcirculatory resistance (IMR).

Comparison of cardiovascular outcomes between patients with and without myocardial ischemia and patients with and without myocardial microvascular disease will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients age \> 18 years with end stage renal disease under dialysis and/or scheduled for kidney or kidney + pancreatic transplantation
* Having a non invasive detection of myocardial ischemia and agreeing to participate (signed informed consent document)

Exclusion Criteria:

Past medical history of

* Acute coronary syndrome
* Hypertrophic cardiomyopathy
* severe aortic and/or mitral valvular disease (grade ≥ 3)
* Known contraindications to adenosine injection: AV block grade ≥ 2 and/or sinoatrial block unless prior implantation of a pace maker, asthma, allergic reaction to adenosine.
Vagus Nerve Stimulation and Stress Reduction Training for Migraine

This study design has two components: 1) a cross-sectional assessment of brain activity and inflammation in migraine patients compared to healthy controls and 2) an assessment of 8 weeks of a combination therapy approach to treating migraine.

Chronic pain is the most prevalent and disabling medical condition, and no single therapy has proven to be completely successful for alleviating pain, such as migraine headache. It is well documented, and recommended in the recent Institute of Medicine (IOM) report, that a multimodal approach is optimal for pain management. This study will evaluate a combination transcutaneous vagus nerve stimulation and stress reduction training for migraine.

Investigators will recruit participants who have migraines and randomize to one of four potential treatment arms (real or sham stimulation + real or sham stress reduction training). Brain imaging (MRI and PET) and clinical data will be collected before and after 8 weeks of the combination therapy.

Healthy controls will also be recruited for collection of the same baseline brain imaging and clinical data, but with no treatment or second data collection phase.

Findings from this research will help elucidate brain activity and inflammation associated with migraines and evaluate the efficacy of the combination therapy in reducing migraine.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be between 18 and 65 years of age.
2. Migraine Diagnosis and general health otherwise.
3. Willingness to attend twice- weekly treatment session at Cambridge Health Alliance for 8 weeks.
4. Able to give written consent and participate in group interventions in English.

Healthy Volunteers between the ages of 18 and 65 can participate in this study.

Exclusion Criteria:

1. Major illness, psychiatric condition, or neurological disease.
2. Previous experience with stress reduction training (such as mindfulness training, MBSR, MBCT, Relaxation Response) or more than 15 home mediation practice sessions in the past month, or more than 10 classes in yoga, Tai Chi, or Qi Gong in the past 3 months
3. Any condition that would prohibit MRI scanning

Healthy Volunteers have the same eligibility constraints with the addition of current or past history of migraine.
Evaluation of a Multi-professional Breathlessness Service for Patients With Breathlessness Due to Any Advanced Disease

Breathlessness is a common and distressing symptom in patients with advanced diseases like cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF) or lung fibrosis, which broadly impacts on patients' quality of life and may result in high burden for carers.

This single-blinded randomized controlled fast track trial evaluates the effectiveness of a multi-professional breathlessness service in patients with advanced and chronic diseases. The intervention group will get immediate access to the breathlessness service whereas the control group will receive standard care and get access to the service after a waiting time of eight weeks. Primary endpoints are mastery of breathlessness and quality of life, measured with the CRQ (Chronic Respiratory Questionnaire) as well as the reduction of symptom burden of patients and burden of carers. The evaluation of the cost effectiveness of the breathlessness service from the perspective of the German health system is a further study aim.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by breathlessness due to any advanced life-limiting and progressive disease, despite treatment of the underlying condition and
* Patients capable (in a cognitive and functional manner) to participate in the intervention including outpatient clinic and physiotherapist visits as well as self- management
* If patients are suffering from acute exacerbations of the underlying conditions, they are put on a waiting list for two to four weeks and are then entered into the trial.

Exclusion Criteria:

* Patients suffering from breathlessness due to chronic hyperventilation syndrome, asthma or any other unknown cause
* Cancer patients under concurrent initial or full dose systemic treatment or radiotherapy (except on maintenance therapy)
* Patients participating in any trial targeting the treatment of underlying conditions/ illness
Peptide-specific Vaccination in HLA-A*02 Positive Patients With Biochemical Recurrence After Radical Prostatectomy

The study evaluates the prostate-specific antigen (PSA) response in HLA-A\*02 positive patients with biochemical recurrence after radical prostatectomy treated with a prostate-specific peptide vaccine in combination with different immune-adjuvants.

Patients with a biochemical recurrence after initial therapy can be included.

Eligibility Criteria:
Inclusion Criteria:

* biochemical recurrence after Radical Prostatectomy
* no clinical metastases in CT or bone scan
* HLA-Type: HLA-A\*02 positive
* Karnofsky-Performance-Index \>70
* Age \>45 / \<80 years
* no prior or ongoing hormonal therapy
* no ongoing radiation therapy
* Serum-Creatinine \<2mg/dl; Bilirubin: \<2gm/dl
* no history of allergy or chronic obstructive lung disease (COLD)

Exclusion Criteria:

* Patients unable to consent
* Karnofsky-Performance-Index \<70
* known allergy or COLD
* presence of secondary malignancy
* prior or ongoing hormonal treatment
* ongoing radiotherapy
* immunosuppressive medication
* seizure
To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants

The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the single-dose pharmacokinetic (PK) of drospirenone and ethinylestradiol in healthy female participants.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be a female of childbearing potential with a normal menstrual cycle
* Participant must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 18.0 and 30.0 kilogram per square meter (kg/m\^2), extremes included, and a body weight not less than 50.0 kilogram (kg)
* Participant must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
* Participant must have a negative serum (beta human chorionic gonadotropin \[beta- hCG\]) pregnancy test at screening
* Participant must have a negative highly sensitive urine pregnancy test at Day -1

Exclusion Criteria:

* Participant is peri- or postmenopausal, or participant with bilateral oophorectomia
* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
* Participant has previously been dosed with simeprevir (SMV), odalasvir (ODV), or AL-335 in more than 3 single dose studies, or a multiple-dose study with SMV, ODV, or AL-335
* Participant with currently active gynecological disorders including, but not limited to, vaginal bleeding without an obvious reason and hyperprolactinemia with or without galactorrhea
* Participant with a past history of: heart arrhythmias (example, extrasystolic rhythms or tachycardia at rest). Isolated extrasystolic beats are not exclusionary; risk factors associated with Torsade de Pointes such as hypokalemia; family history of short/long QT syndrome; sudden unexplained death (including sudden infant death syndrome \[SIDS\]) in a first-degree relative (that is, sibling, offspring, or biological parent)
Different Volumes of Erector Spinae Plane Block for Breast Surgery

Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice.

The US-guided erector spina plane block (ESPB) provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations.

The aim of this study is to compare the efficacy of the different volumes of US-guided ESPB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption, and the secondary aim is to evaluate pain scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for mastectomy and axillary dissection surgery under general anesthesia

Exclusion Criteria:

* anticoagulant treatment,
* known local anesthetic allergy,
* infected skin around the block site,
* pregnancy or breast-feeding,
* back abnormalities
Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia

The researchers are trying to evaluate a newer imaging technique (Ga-DOTATATE PET/CT) to see if it is more sensitive to localize the source of the hormone, which has caused the low phosphate levels.

Subjects will be contacted (phone script attached) to inform them of the study and the imaging modality. The first 10 patients that agree to participate in the study will be asked to present to the Mayo Clinic where they can provide a written consent and perform the imaging study.

Enrolled subjects will be evaluated in the clinical practice prior to having 68Ga-DOTATATE PET/CT imaging performed. The treating endocrinologist will be informed of the imaging results and will review the results with the subject using a follow-up visit or phone call; when a tumor is localized, the endocrinologist will discuss appropriate management options.

Subjects will be follow for one year post 68Ga-DOTATATE PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or older) seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 1/1/2000 and 1/30/2018 who provide informed consent to participate in the study.

Exclusion Criteria:

* Pregnant
* Prisoners
* Subjects diagnosed with heritable hypophosphatemic rickets/osteomalacia
* Subjects who do not consent for the study or withdraw consent during the duration of the study.
* Subjects in whom tumor localization and successful resection has already occurred.
An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse

This study aimed to examine the effectiveness of the 12-week ergonomic intervention developed by Person-Environment-Occupation (PEO) model in improving musculoskeletal discomfort and muscle strength for hemodialysis nurses. The maintenance effects of the intervention were also evaluated after another 12-week follow-up.

Methods A cluster experimental design was used to conduct this study. Participants were recruited from hemodialysis units at two medical centers in Taiwan and had complaints of work-related musculoskeletal disorders (WMSDs) within the past six months. By PEO model, the 12-week intervention including ergonomic education and exercise program was designed based on the job contents of hemodialysis nurses. In the study period, we used a mobile massager app to reminder them and monitor their implementation of exercises. The outcome indicators were measured before and after intervention as well as the follow-up after another 12 weeks. A generalized estimating equations model was adopted to analyze the repeated measurements.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 65 years old, which is the legal age range of adult for work in Taiwan
* registered nurses to work full time in the hemodialysis unit more than 6 months,
* having complaint of WMSDs within previous 6 months before this study.

Exclusion Criteria:

* having no musculoskeletal disorder related to the job
* to care less than 4 patients in 4 hours, which was below the Taiwan workload reference for nurse in hemodialysis job
* to have any other consideration to keep from 12- week physical exercise program (such as pregnancy, injury, disease, leave..., etc.).
Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage

Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in patients with NVAF and prior ICH.

Methods/design: A multicenter prospective randomized open-label clinical trial with blinded outcome evaluation (PROBE design) and blinded safety outcome assessment. The active comparison LAAO is tested against medical therapy in a 2:1 stratified randomization.

Study population: Patients should have had an ICH within 12 months prior to enrollment and have NVAF with increased risk of stroke or systemic embolism, as indicated by a CHA2DS2VASc score \>2. In total 750 patients will be included. Active enrollment ensues over 3 years followed by 5 years follow-up and a long-term follow-up at 10 years.

Intervention and control: The intervention group will be treated by LAAO, using the Amplatzer Amulet device. Implantation requires a catheterization procedure using venous access and transseptal puncture and is guided by angiography, fluoroscopy and transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE). Recommended post-implant antithrombotic therapy includes aspirin (ASA) therapy for at least 6 months, with or without clopidogrel for the first 45 days after implantation. The control group will receive medical therapy, delivered according to national standards and guidelines at the treating physicians' discretion. This may include oral anticoagulation (OAC) (vitamin-K antagonists, VKA), non-VKA OAC, antiplatelet therapy or no antithrombotic therapy at all.

Main study outcomes: The primary outcome is the composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, life-threatening or major bleeding and all-cause mortality, assessed over at least two years. Secondary outcome examines various early and late safety outcome parameters.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of paroxysmal, persistent or long-standing NVAF with CHA2DS2VASc score \>2.
* Clinical and CT/MRI evidence of ICH within 12 months but not less than 4 weeks prior to enrollment.
* Age \> 18 years.
* Signed informed consent.

Exclusion Criteria:

* ICH secondary to vascular malformation or tumors
* Estimated life expectancy of less than 1 year at eligibility assessment
* mRS \> 3 at enrollment
* Prior surgical LAA excision
* Planned combined interventional procedures at the time of enrollment
Evaluation of SAMe for Hot Flashes

RATIONALE: S-adenosyl-L-methionine may help relieve hot flashes in women based upon its ability to potentially modulate serotonin.

PURPOSE: This phase II trial is studying the side effects and how well s-adenosyl-L-methionine works in treating hot flashes in women with a history of breast cancer or those who do not wish to take estrogen due to a perceived increased risk of breast cancer.

OBJECTIVES:

I. To evaluate the impact of SAMe on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.

II. To evaluate the toxicity of SAMe in this study population. III. To evaluate the effect of SAMe using quality-of-life (QOL) measures.

OUTLINE:

During the first week, participants will complete a daily, prospective hot flash diary and complete baseline questionnaires and will not be taking any study medication. After this baseline week, participants will receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer
* Bothersome hot flashes (defined by their occurrence \>= 14 times per week and of sufficient severity to make the patient desire therapeutic intervention)
* Presence of hot flashes for \>= 1 month prior to registration
* Life expectancy \>= 6 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
* Ability to complete questionnaire(s) by themselves or with assistance
* Negative pregnancy test done =\< 7 days prior to registration for women of childbearing potential only

Exclusion Criteria:

* Any of the following current (=\< last 4 weeks) or planned therapies (tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for \>= 4 weeks and must not be expected to stop the medication during the study period): antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy, vitamin E, flaxseed, and megadose vitamins (herbal teas, multivitamins, and vitamin D are allowed), warfarin (1 mg of daily warfarin is allowed for central line patency), medications interacting with SAMe (antidepressants, monoamine oxidase (MAO) inhibitors, meperidine, dextromethorphan, pentazocine, tramadol, gabapentin, and levodopa)
* Pregnant women
* Nursing women
* Women of childbearing potential who are unwilling to employ adequate contraception
* Known allergy to SAMe
* Current use or use within the past 6 months of SAMe
* Clinically significant acute or chronic progressive or unstable neurologic, psychiatric, hepatic, renal, cardiovascular, respiratory, metabolic, or systemic disease precluding participation in the study
* History of bipolar disorder or Parkinsonism