cyrilzakka/clinical-trials huggingface dataset:
The Natural History of Wheat Hypersensitivity in Thai Children

Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance is exceedingly difficult and imposes major dietary restriction. The purpose of this study were to determine the rate of oral tolerance and identify clinical and laboratory predictors of tolerance development in Thai children who allergic to wheat.

All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by both a detailed medical examination and collection of medical history. Blood sample was taken for baseline determination of ImmunoglobulinE antibodies to wheat and to omega-5-gliadin. The oral wheat challenge were performed in all study subjects to identify a case of wheat outgrowing. The primary outcome was the development of oral tolerance to wheat. Oral wheat challenge were generally performed at least every 1 years if the child did not have an interval history of symptoms with unintentional exposure.

Eligibility Criteria:
Inclusion Criteria:

* children 1 to 15 years
* History of IgE-mediated wheat allergy

Exclusion Criteria:

* Parents refused to sign the consent
* Patient has the underlying disease: congenital heart disease, uncontrolled asthma or life-threatening condition.
Somatosensory Evoked Potentials and Pain Thresholds in Term and Preterm-Born Adolescents After Early Exposure to Pain; a Quantitative Study

Background: Several studies have indicated that infants who had undergone postnatal painful procedures appear to be hypersensitive to pain, with a lower threshold to tactile stimulations later on life.

Objective: To study the effect of early exposure to pain on cerebral somatosensory evoked potential (SEP) response to thermal stimulation (550C), in preterm and full term born adolescents (15-18 years old), who have undergone painful procedures during their neonatal period. As well as to study the effect of early exposure to thermal and tactile sensory thresholds and pain thresholds to thermal and tactile stimuli, by using the TSA and von Frey hairs.

Design: Case-control study.

Participants: Four groups of 20 adolescents (aged 15-18 years), two of which are full term and preterm-born who were exposed to painful procedures during the neonatal period. The other two groups are term and preterm-born adolescents who were not exposed to such procedures.

Main Outcome Measures: Cerebral SEP response (P300, Medoc Ltd., Israel) to thermal stimulation (550C). Warm-sensation threshold (WST), heat-pain threshold (HPT), Cold sensation threshold (CST) and cold pain threshold (CPT) by using Thermal sensory analyzer (TSA-2001,Medoc Ltd., Israel). Pain threshold to tactile stimulation will be measured by using Von-Frey hairs.


Eligibility Criteria:
Inclusion Criteria:

For all:

* Age 15-18
* Appropriate weight for gestational age (AGA)
* Informed consent signed by the parent
* Presence of one parent during the examination

Premature groups:

* Preterm-born (32-34 weeks of gestation)
* Admitted to the NICU (ventilated vs. non-ventilated)

Full term groups:

* Completed 37 weeks of gestation Pain groups (premature and full term)
* Admitted to the NICU
* Mechanically-ventilated during the first week of life
* Mechanically-ventilated for at least 48 hours

Exclusion Criteria:

* Current use of analgesia
* A chronic illness with current medical treatment
* Cognitive impairment
Noninvasive Preimplantation Genetic Testing for Aneuploidy

The study is conducted to evaluate the sensitivity and specificity of non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) using cell free DNA into spent culture medium (SCM).

Our study is a diagnostic study, recruit 218 biopsied blastocysts from couples undergoing intracytoplasmic sperm injection (ICSI) with Preimplantation genetic testing for aneuploidy (PGT-A) or Preimplantation genetic testing for structural rearrangements (PGT-SR) indication.

Oocyte retrieval, ICSI and embryo culture are performed by routine protocol.

On day 3, each embryo was washed and cultured in single droplets. TE biopsy was conducted and 10μl SCM of biopsied embryos are collected on day 5 or day 6. Both sample types undergo whole-genome amplification (WGA) using Quanti Flour ONE dsDNA system and DNA analysis by next-generation sequencing (NGS) using NextSeq High output 150 cycles kit.

Comparison of NGS results from trophectoderm (TE) biopsy and SCM is done to identify the sensitivity and specificity of the test.

A sample size of 218 day 5/day 6 embryos will be needed.

Eligibility Criteria:
Inclusion Criteria:

* Assisted Reproductive Treatment with ICSI indication
* Having PGT-A or PGT-SR indication
* Having an agreement to be enrolled into NiPGT-A study
* Having blastocyst to biopsy

Exclusion Criteria:

* In vitro maturation cycle
Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice

This registry will collect real-world clinical evidence on the performance, safety, and usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved labeling in a European commercial setting. Up to 60 subjects will have Fractional Flow Reserve (FFR) measurements of coronary lesions attempted with the CPM System and NAVVUS Catheter. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

There are no protocol-specific procedural requirements for this registry. Enrolled subjects will undergo a diagnostic angiography procedure including an FFR measurement with the CPM System and NAVVUS Catheter according to the center standard of care and the Instructions for Use of the CPM System and Navvus Catheter. Participants will be followed for the duration of hospital stay, an expected average of 1 day.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years of age or older in whom FFR measurement is indicated to guide percutaneous coronary intervention (PCI) strategy and use of the ACIST CPM System and Navvus Catheter is attempted.

Exclusion Criteria:

-
Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis

A population of 100 patients randomised to rotating and fixed PE inlays in the Columbus knee prosthesis received a navigated TKR. Knee Society Score as primary endpoint, Oxford Score, and postoperative ROM after one year will be compared.

Mobile bearing tibial platform designs are advocated to improve functional results of total knee replacement (TKR), and to reduce wear in the longer term. This study investigates short term functional results with two patient groups who are systematically different in the fixed or mobile tibial bearing only.

Methods: 100 knees in 97 patients are stratified according to age and gender and randomized into two groups fixed bearing (FB) with 52 knees and mobile bearing (MB) with 48 knees. All receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and follow an identical rehabilitation regime. Physical examinations are performed in a double-blinded manner before the operation and three, six and twelve months thereafter, using the Oxford and Knee Society scoring systems.

Eligibility Criteria:
Inclusion Criteria:

* Indication for elective TKA
* agreement to participate in this study
* Patient age between 40 and 90 years

Exclusion Criteria:

* Malalignment of the knee to be operated of more than 20° varus or 15° valgus
* Former operations on the concerned knee (except diagnostic or therapeutic arthroscopy with only meniscus refixation or cartilage smoothing)
* Joint replacement of another joint of the same leg
* Infections in the operated joint during the follow-up period
* Thromboses during the follow-up period
* Preoperative classification according to ASA 4, 5 or 6
Narrative or Fact-Based Videos in Increasing Colorectal Cancer Screenings in African American Communities

This randomized clinical trial studies narrative or fact-based videos in increasing colorectal cancer screenings in African American communities. Informational videotapes may help increase the number of participants who engage in colonoscopy screenings. It is not yet known whether narrative videos may be more effective than fact-based videos in increasing colorectal cancer screenings.

PRIMARY OBJECTIVES:

I. Assess both individual and environmental factors that guide decisions and behaviors to engage or not engage in colonoscopy screenings for African Americans in the two communities.

II. Using a Community-Based Participatory Research (CBPR) approach, develop and pilot a peer-led, narrative-based colorectal cancer behavioral intervention for increasing colonoscopy screening behaviors in African Americans.

III. Examine the efficacy of a narrative communication-style group intervention compared to a didactic intervention to influence African Americans' engagement in colorectal cancer screening, including examining the degree to which the community interventions impact cognitive and affective decision making factors about health care seeking.

IV. Examine and explore contextual factors that may influence the process of behavior change to better understand colorectal cancer (CRC) screening and health care seeking behaviors.

OUTLINE: Program locations are randomized to 1 of 2 arms.

ARM I: Participants view videos with information about CRC and screening delivered by personal narrative.

ARM II: Participants view videos with information about CRC and screening delivered by informative fact-based message.

After completion of study, patients are followed up at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Participants in each component (focus groups, surveys and educational programs) will be 18 years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program
* EDUCATIONAL INTERVENTION:
* Currently non-adherent to colorectal cancer screening
* Self-identify as African American
* Are 50 years of age or older
* Have the ability to provide informed consent in English
* FOLLOW-UP ASSESSMENTS:
* Must be non-adherent for CRC screening at the time of the educational program
* Have telephone service (mobile or landline), to participate in the follow up interviews
* Agree to providing consent for release/review of their medical record

Exclusion Criteria:

* Non-English speaking
Evaluation of a Closed-Loop Control System for Administering Patient-Specific Anesthesia

Numerous efforts have focused on the development of closed-loop systems to control anesthesia using the electrical activity of the brain (EEG) and EEG-based parameters as surrogate measures of anesthetic depth. New systems have been recently developed to considerably improve anesthetic control using model-based, patient-adaptive methods. The purpose of this study is to evaluate the clinical efficacy of a new intelligent software, ReinLoop, in delivering closed-loop, patient-specific hypnosis.


Eligibility Criteria:
Inclusion Criteria:

1. 18-45 years of age
2. Body mass index (BMI) lower or equal to 25 m2/kg
3. Subjects must be able to comprehend spoken and written English

Exclusion Criteria:

1. Any type of psychiatric, neurological, or neuromuscular disorder
2. Thyroid disease
3. History of smoking
4. Alcohol consumption which exceeds 2 drinks per day and /or drug abuse. Volunteers will be asked the question: How many drinks are you drinking on your typical day?
5. Allergy to study medication (propofol), soy, or egg proteins.
6. History of drug abuse
7. Chronic or acute use of opioids, or other medications affecting the CNS
8. Pregnancy
A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure

Objective The objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction.

Method The study is a crossover cluster randomized trial. Each heart failure clinic in Denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. The planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. Endpoints will be assessed through Danish National Registries.


Eligibility Criteria:
Inclusion Criteria:

* all patients registered in the Danish Heart Failure Registry who has a baseline left ventricular ejection fraction \<40% and who has filled in a prescription for an aldosterone antagonist

Exclusion Criteria:

* patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the Danish Heart Failure Registry
Evaluation of the Effect of Saffron (Crocus Sativus) on Pain Control After Root Canal Therapy in Teeth With Vital Pulps

The purpose of this study is to determine whether saffron is effective in the pain control after root canal therapy in vital teeth.

Among patients refer to endodontics department of Zahedan Faculty of Dentistry whom with moderate to severe pain in a single canal tooth will be selected and randomly divided in 2 groups of saffron and placebo. After root canal therapy each patient in each group will receive a box of 8 similar capsules. They will use 1 capsule exactly after treatment completion and then each 6 hours up to 48 hours. Patients will record their pain intensity in each time period according to Visual Analog Scale(VAS)and finally mean pain intensity will be compared between 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* patients who have at least one vital tooth with one root canal and moderate to severe pain

Exclusion Criteria:

1. teeth with periapical lesions
2. patients with history of:

   * allergy to saffron
   * diabetes mellitus
   * cardiovascular disorders
   * kidney and liver diseases
   * blood and hormonal disorders
   * electrolyte imbalance
3. women in pregnancy or breast feeding period and
4. use of analgesics or opioids during 4 hours before treatment
Nurse PIV Insertion Success With and Without Assistive Devices in Patients 0-12 Months of Age

The purpose of this study is to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods.

Obtaining peripheral intravenous (PIV) access is a nearly universal procedure for medical management of the hospitalized pediatric patient. In children, PIV placement can often be difficult due to the inability to identify peripheral veins (Wilson, 2007). Many assistive devices have been used or promoted to improve vein visualization with the intention of increasing PIV insertion success. Limited research was found to support this assumption regarding nursing PIV insertion success in children. This study is a randomized, controlled trial to determine if the use of a vein identification assistive device increases nurse PIV insertion success within the first two attempts in children 0-12 months of age when compared to unassisted methods. Patients admitted to Children's Hospital \& Medical Center (CHMC) Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/ Intermediate Care Unit, up to 12 months of age requiring non-emergent PIV placement as part of their medical plan of care will be eligible. Following consent subjects will be randomized into one of three vein identification method study groups (1) Wee Sight Transilluminator - a hand held light emitting device held adjacent to or under the patient's extremity to visualize the venous anatomy; (2) VeinViewer - uses near infrared light to view hemoglobin and projects an image of venous anatomy onto the skin; and (3) Unassisted Methods - traditional techniques of vein visualization and palpation. Based on study group assignment the nurse will use the appropriate vein identification method during the first two PIV insertion attempts. Evaluation of vein identification methods will be based on PIV insertion success or failure.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Children's Hospital \& Medical Center Emergency Department, 4th floor medical-surgical unit, or 5th floor medical-surgical/Intermediate Care Unit
* Require non-emergent PIV placement as part of medical plan of care
* Less than or equal to 12 month birth date

Exclusion Criteria:

* Greater than 12 month birth date
* PIV not required
* PIV inserted by practitioner other than RN
* PIV inserted by RN not employed by study areas
* Ward of state
* Require emergent PIV placement
* Primary language is not English or Spanish
Financial Incentives for Medication Adherence

This study is a pilot study. The investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that many patients do not take their medications as prescribed by their doctors. This contributes to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and death. The investigators hypothesize that use of a financial incentive will motivate patients to improve their medication adherence and ultimately their control of their chronic diseases.

The investigators plan to identify patients who get Primary Care at Boston Medical Center who still have high blood sugars more than a year after their diabetes diagnosis, and randomize them to a control arm, or one of two intervention arms. Subjects will be approached at the time of a regularly-scheduled appointment with their Primary Care doctor and offered the opportunity to participate in the study. All subjects who agree to participate in the study will meet with a Clinical Pharmacologist to review their medications in detail, and then undergo randomization. Subjects in the first intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month. Subjects in the second intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators will enroll a total of 100 subjects in the study, and anticipate an observational cohort of approximately 1,000 patients.

All patients who are eligible for the study but who are not enrolled in the study and have not declined to participate in the study will become the observational cohort for the study. The observational cohort will be used to determine whether randomization to the control arm of the study has a negative, rather than neutral, effect on patients.

At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to have their blood pressure checked and to have their blood drawn so that their blood sugar and cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel, systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and macrovascular complications, and death.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Speaks English, Spanish, or Haitian Creole
* Established patient in Boston Medical Center Section of General Internal Medicine Primary Care Practice
* Uses Boston Medical Center Pharmacy
* Diagnosed with diabetes for more than one year
* Prescribed medications for diabetes
* Last hemoglobin A1c \> 7.9

Exclusion Criteria:

* Pregnant
* History of Brittle Diabetes
* Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c
Cognitive Effects of a Dietary Supplement with PQQ, GABA, Caffeine, and B-Vitamins in Healthy Postmenopausal Women: a Randomized Controlled Trial

Various food supplements have been shown to improve cognitive function. However, there is limited data on the impact of these supplements on postmenopausal women. Millions of women experience difficulty with concentration, and memory lapses during menopause. Research shows that up to 60% of women report cognitive changes related to menopause, severely impacting their quality of life and professional performance. Women are significantly more likely to develop dementia and other cognitive dysfunction. The specially formulated Cortexium with four key ingredients aims to support cognitive function in women:

* PQQ (Pyrroloquinoline Quinone) is a redox coenzyme with high antioxidant potential and is considered to affect the brain function by increasing mitochondrial production and activation, nerve cell protection, and enhanced production of nerve growth factor.
* GABA (gamma-aminobutyric acid) is an important neurotransmitter that helps induce calm and relaxation in the brain. Its positive effects include reducing stress and anxiety, which promotes mental clarity and concentration, thus enhancing mental performance. Additionally, it can help combat fatigue by supporting restful sleep, which, in the long term, boosts brain function efficiency.
* B-VITAMINS (B1, B2, B3, B5, B6, B7, B9, B12) are essential for brain function and energy production. They support the synthesis of neurotransmitters that improve mood, memory, and concentration, and help combat stress and mental fatigue. Together, they contribute to protecting brain cells and maintaining cognitive performance.
* CAFFEINE: The stimulating and invigorating effects of caffeine on the brain and nervous system have been known for centuries. Caffeine is a mild psychostimulant with invigorating effects. It also alleviates symptoms of fatigue and enhances work capacity. Moreover, moderate amounts of caffeine are known to have a stimulating effect on the cerebrocortical fields responsible for thinking: it enhances mental activity, improves cognitive functions, and accelerates mental associations. In this way, caffeine's stimulating effect can also lead to an improved sense of well-being Our aim is test the hypothesis that Cortexium dietary supplement improves cognitive function in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Good general health.
* Education level at least completed elementary.
* Menopausal status with minimum 1 year from the last menstrual period and based on the criterion of follicle-stimulating hormone (FSH) level (FSH \> 30 mlU/ml) or a history of bilateral oophorectomy.

Exclusion Criteria:

* Active cancerous disease within the period of 5 years before recruitment.
* Mental diseases in medical history, including depression.
* Addiction to drugs and alcohol.
* Symptoms of dementia or history of neurological treatment or neurocognitive disorder.
Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using Two Femoral Block Techniques

In this study, we will be comparing two approaches to the femoral block. The first or classical approach and one that is the most popular in our institution is used by combining ultrasound guidance and neurostimulator to do the block. The second is performed with the ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and injecting. The primary endpoint of the study is the sensitive cutaneous block distribution using both techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for an elective surgery for which the anesthesiologist planned to do a single shot or continuous femoral nerve block.

Exclusion Criteria:

* Any contraindication to the femoral nerve block (coagulopathy, infection, pre-existing neuropathy, local anesthetic allergy and refusal of local anesthesia).
* Refusal to participate in the study
* Inability to understand or communicate the effect of local anesthesia secondary to the femoral nerve bloc.