cyrilzakka/clinical-trials huggingface dataset:
Effect of Vitamin D3 and Omega-3FA on Estradiol

The effect of vitamin D3 and omega-3 Fatty acids on estradiol levels.

The data about effect of vitamin D3 (VD3) and omega-3 fatty acids (omega-3FA) on serum levels of estradiol (E2) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the E2 levels.

This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on serum E2 levels in premenopausal females with vitamin D deficiency (VDD).

This randomized, placebo-controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks, separately and with each other, on the mid-follicular serum levels of E2 and 25-hydroxy vitamin D (25OHD). This study was conducted during winter in 86 healthy premenopausal Jordanian females with VDD with a mean age of (32.8 ± 8.9) years. Fasting serum levels for 25OHD, E2, PTH (parathyroid hormon), calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal females
* Medical diagnosis of vitamin D deficiency (VD \< 30 ng / ml)

Exclusion Criteria:

* Women previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation. Women who are pregnant, breastfeeding or using hormonal contraceptives were also excluded.
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.


Eligibility Criteria:
Inclusion criteria:

1. Aged 2 months (42 to 98 days) at time of enrollment.
2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion criteria:

1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by S pneumoniae.
7. Major known congenital malformation or serious chronic disorders.
8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
11. Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Effect of Fluid Challenge on Glycocalyx

Interventional study comparing effect of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery on glycocalyx by using perfused Boundary Region in sublingual microcirculation.

Effect of two regimes of fluid challenge on GCX in patients with sepsis and during elective surgery under general anesthesia.

Hypothesis to be tested: Administration of 500 ml of balanced solution as a bolus impairs GCX more than prolonged administration.

The aim of the study: Comparison of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery.

Type of the study: Open, randomized, interventional.

Subjects:

Part A: Patients with sepsis within 48 hours before admission to ICU requiring fluid challenge based on clinical or echocardiographic assessment.

Part B: Patients during major elective surgery requiring fluid challenge based on clinical or echocardiographic assessment.

Sample size calculation (based on expected difference in PRB, alpha error I =0,05 and study power = 0,99) = 52 patients. Investigators plan enrolment of 60 patients for each part, totally 120 patients.

Intervention:

* 500 ml of balanced crystalloid solution within 5 minutes (group "fast")
* 500 ml of balanced crystalloid solution within 30 minutes (group "slow") Data to be recorded and analysed: Demographics, severity score, fluid response assessment, sublingual microcirculation by SDF imaging will be recorded at time points: baseline, after intervention, after 60 minutes, after 120 minutes, plasma syndecan-1 will be analysed before intervention and 120 minutes thereafter, microcirculatory data and Perfused Boundary Region.

Eligibility Criteria:
Inclusion Criteria:

arm A: age over 18, diagnosis sepsis, fluid bolus administration indicated, arm B: age 18-70, ASA status I-III, major surgery

Exclusion Criteria:

none.
Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients

A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose.

The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.

In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)


Eligibility Criteria:
Inclusion Criteria:

* Diabetes, type 1 or 2
* Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb.
* No options for target limb revascularization.

Exclusion Criteria:

* Cancer antecedent in the last two years
* Current limb infection or limb gangrene
Multicenter Outcome Registry of AnaLgesic Effect of SCS(MORALES) Registry Protocol

The objective is to provide information to help the physician community decide the most effective type of device/therapy that would work for their patients, based off of the etiology of pain, the location of the pain for sustained pain relief.

This registry will enroll patients that qualify for an SCS implant, for approved pain areas, as defined by medicare guidelines, and follow these patients for up to 12 months for denovo implants. For patients who have lost their pain relief over time, with a prior implanted device, this registry will follow a change out to another vendor/therapy, and follow those patients for up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* FDA approved indications for SCS implants, for commercial and government(medicare, medi-cal etc) approved payors

Exclusion Criteria:

-
A Phase I Safety and Immunogenicity Trial of UBI HIV Lipopeptide Immunotherapeutic P3C541b in HIV-1 Seropositive Human Subjects

To evaluate an HIV lipopeptide immunotherapeutic, P3C541b, at two dose levels administered subcutaneously in HIV-seropositive patients.

Patients are randomized to receive P3C541b or placebo within each of two study groups. Enrollment in the first group will be independent of HLA type, whereas all but two of the patients enrolled in group 2 must have one or more HLA types A33, B8, B27, or Bw62. Treatment in group 2 will not begin until those in group 1 have reached day 14 without serious toxicity.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positivity.
* CD4 count \>= 500 cells/mm3.
* No evidence of AIDS, persistent diarrhea, fever, oral hairy leukoplakia, herpes varicella-zoster (multidermatomal), oral candidiasis, opportunistic infections, severe cytomegalovirus infection, or disseminated or chronic herpes simplex.
* Successful establishment of EBV transformed B lymphoblastoid cell line.

NOTE:

* Most patients in group 2 must possess one or more HLA types A33, B8, B27, or Bw62.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active syphilis.
* Positive circulating hepatitis B virus antigen.
* Active clinically significant medical problems.
* Evidence of psychiatric, medical, or substance abuse problems that would affect ability to participate on study.
* Occupational or other responsibilities that would prevent completion of study.

Concurrent Medication:

Excluded:

* Other HIV immunotherapeutic.
* Zidovudine or analog.
* Investigational therapies for HIV.

Patients with the following prior conditions are excluded:

* History of cancer unless surgically excised with reasonable assurance of cure.
* History of anaphylaxis or other serious adverse reactions to vaccines.
* History of serious allergic reaction to any substance that required hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasms, or hypotension).
* History of autoimmune disease or use of immunosuppressive medications.
* History of suicide attempts or past psychosis.

Prior Medication:

Excluded within the past 6 months:

* HIV immunotherapeutic.
* Zidovudine or analog.
* Investigational therapies for HIV. Illicit drug use within past 30 days.
The Effects of Virtual Reality Greenspace on Stress Among Adults With Mobility Impairments

The purpose of this project is to examine the effects of virtual reality greenspace exposure on physiological and affective acute stress responses among adults with mobility impairments.

Exposure to greenspace is known to yield numerous mental and physical health benefits such as improved mood, decreased stress, and increased levels of physical activity. Regular access to greenspace however is difficult for various segments of the population including individuals with disabilities or chronic health conditions. Numerous factors contribute to this difficulty including architectural barriers, shortage of accessible trails, and limited transportation options. These challenges have led to a growing interest in exploring the use of virtual reality (VR) greenspace environments. Studies have demonstrated that VR greenspace exposure can reduce stress and improve mood and mental well-being in various populations but has not been tested among individuals with mobility impairments who experience high levels of stress. During a single lab visit, participants will be randomized to VR greenspace activity or control, undergo the Trier Social Stress Test. The VR group will then engage in a series of nature-based VR activities. The Control group will sit quietly. Assessments will be collected at 4 timepoints. Physiological stress responses will be measured via changes in BP, HR, and two saliva measures (salivary alpha-amylase, salivary cortisol). Affective response (stress, affect, anxiety) will be assessed using self-report surveys. This study will provide insight into the influence of VR greenspace exposure on stress recovery (physiological and affective responses), among individuals with mobility impairments.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* A self-reported lower extremity mobility impairment (e.g., cerebral palsy, spinal cord injury, multiple sclerosis, stroke) with partial or full use of the upper extremities.

Exclusion Criteria:

* Impairment in visual acuity as measured by a Snellen eye chart \<20/70 after correction
* Regular engagement (\>20 minutes/week) in virtual reality greenspace activity
* Having an endocrine disorder (that can affect cortisol levels)
* Taking oral corticosteroids
* Score below 24 on the Mini Mental State Exam
Pilot Study of AdvanStep in Improving Balance in at Risk Elderly

Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive training exercise and balance device. The use of the AdvanStep will bring about a measurable improvement in the individuals balance in standardized measures.

1. Feasibility study, assessing usability of the system and receiving feedback from the volunteers.
2. Structured treatment sessions twice per week after an initial assessment of balance and mobility on standardized tests.
3. Reassessment of balance and mobility after completion of 15 treatment sessions.
4. Treatment sessions will be supervised by physical therapists.

Eligibility Criteria:
Inclusion Criteria:

* Age 65-80
* History of 2 falls in past 5 years, not requiring medical attention
* No acute orthopedic or neurological disorders
* No cognitive impairment affecting daily function.
* Adequate vision and hearing to see the computer screen and follow verbal commands.
* Unilateral stance test - inability to remain in unilateral stance for 25 seconds

Exclusion Criteria:

* Congestive heart failure or angina that limits physical activity
* Need for interventional medical treatment
The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies

Use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable We will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at the time of initial diagnosis or relapse. These patients will receive a targeted dye to aid in the resection of these metastases. We plan to assess ICG as it relates to:

1. Diagnostic accuracy using pathologic correlation as gold standard measure
2. Short and long term event free and overall survival

Patients diagnosed with solid malignancies or metastatic lesions who require clinically indicated resection will be identified by their Oncologist. The oncologist will inform the subject/family about the study and ask if they may be interested in participating. If the subject/family demonstrates potential interest in the study, the Pediatric Surgery Research team will discuss the risks and benefits of pre-operative ICG administration with the patients and enrollment.

Study subjects: All patients diagnosed with solid malignancies as well as those with metastatic disease distant from the primary tumor will be potentially eligible for the study. Diagnosis will be made:

1. In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI, CT scan, etc), and sometimes biopsy.
2. Prior to definitive surgical resection of the newly diagnosed malignancy

Eligibility Criteria:
Inclusion Criteria:

All patients with newly diagnosed solid, primary malignancies or their related metastatic lesions.

Diagnosis of primary or metastatic malignancy will be made by combination of:

1. Clinical evaluation and physical exam
2. Radiologic study including ultrasound, CT scan, and/or MRI
3. Pathologic diagnosis after biopsy

Exclusion Criteria:

1. Those patients and parents/guardians unwilling to provide consent/assent.
2. Pregnant and/or women who are breast feeding.
3. Patients with Iodine allergies
Randomized Population-Based Study on Chlamydia Trachomatis Screening

30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.

The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.


Eligibility Criteria:
Inclusion Criteria:

* born in 1974, 1974 or 1976 AND living in Aarhus County October 1007

Exclusion Criteria:

-
Functional Magnetic Resonance-Based Observations of Brain Networks in Moyamoya Disease Patients Under Anesthesia

Moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. Perioperative circulatory management of patients with smoky vessels to ensure perfusion of brain tissue and integrity of brain network during surgery to minimize postoperative impairment of neurological functions, including motor, sensory, emotional and cognitive functions, is the key point of perioperative circulatory management of moyamoya disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network connectivity. The purpose of this study is to observe the changes in cerebral blood flow, cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas under anesthesia to provide a basis for exploring anesthesia management to improve cognitive function and cerebral network connectivity in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moyamoya disease scheduled for direct or indirect intracranial and extracranial revascularization surgery
* Age between 18-65 years
* Obtain written informed consent.

Exclusion Criteria:

* Patients with preoperative claustrophobia, sensory or motor aphasia that are unable to understand and cooperate with the examination
* Preoperative cranial imaging suggesting cerebral infarction lesion diameter \>15mm
* Patients allergic to anesthetic drugs
* Metal implants in the body
* Undergoing other experimental drug or instrumentation trials
Effects of Exercise Training on Cognitive Function and Neurotrophic Factors in Overweight Adults

The BrainFit Study aims to examine acute effects of High Intensity Interval- vs Resistance or Combined program has benefits on Cognitive Function as well as on secretion and regulation of neurotrophic factors or neurotrophins in a cohort of sedentary, overweight adults (aged 18-30 years) from Bogota, Colombia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Interested in improving health and fitness.
* Central obesity: waist circumference ≥90cm
* Body mass index ≥ 26 kg/m(2)

Exclusion Criteria:

* Systemic infections.
* Weight loss or gain of \>10% of body weight in the past 6 months for any reason.
* Currently taking medication that suppresses or stimulates appetite.
* Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
* Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
* Asthma.
* Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
* Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
* Any active use of illegal or illicit drugs.
* Current exerciser (\>30 min organized exercise per week).
* Indication of unsuitability of current health for exercise protocol (PARQ).
Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial

The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.

This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies presenting for preinduction ripening. Patients will be randomized to receive either TFC alone (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of oxytocin and labor was managed according to routine obstetric protocols. This study is powered to detect a 20% difference in the proportion of patients delivered within 24 hours, the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of induction, complications, and pain management.

Eligibility Criteria:
Inclusion Criteria:

* singleton gestation
* presenting for induction as determined by their primary obstetrical provider
* with fetuses in cephalic presentation
* gestational age greater than 23 weeks

Exclusion Criteria:

* any condition precluding vaginal delivery
* estimated fetal weight \>4500 grams
* a previous attempt at ripening or induction during the pregnancy
* clinically significant cervical or vaginal infection
* chorioamnionitis
* HIV
* hepatitis B or C
* unexplained vaginal bleeding
* low-lying placenta
* abnormal cervical anatomy or cervical cerclage
* latex allergy