cyrilzakka/clinical-trials huggingface dataset:
Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy

The purpose of this research is to gather information on the safety and efficacy of using a prebiotic as an adjunctive therapy to peanut oral immunotherapy. The prebiotic is not an FDA approved drug or medication rather a fiber found at local grocery stores.

By doing this study, we hope to learn if using a dietary fiber called a "prebiotic" helps increase the number of children who can tolerate eating 1043mg of peanut protein (or about 3-4 peanuts) after going through oral immunotherapy (OIT) to peanut. We are also trying to determine if this fiber will reduce the side effects of OIT and if so, we would like to find out if the reason it is working is by changing the bacteria in the gut. Participation in this research will last about five years.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 17 (inclusive)
* A convincing clinical history of peanut allergy
* Immune markers consistent with peanut allergy

  * Serum IgE to peanut of \>0.35 kUA/L and a skin prick test to peanut \>8mm greater than the negative saline control -or-
  * Serum IgE to peanut of \>5 kUA/L and a mean peanut wheal diameter on skin prick test 3 to 8mm greater than the negative saline control -or-
  * Serum IgE to peanut of \>14 kUA/L and mean peanut wheal diameter on skin prick test 3mm greater than the negative saline control
* Experience dose-limiting symptoms at or before 100mg challenge dose of peanut protein on screening double blind placebo-controlled food challenge (DBPCFC)
* Written informed consent from parent/guardian
* Written assent from subjects above the age of 7

Exclusion Criteria:

* • History of a chronic disease (other than asthma, allergic rhinitis, and atopic dermatitis) that is at significant risk of becoming unstable or requiring a change in chronic therapeutic regimen

  * History of mast cell disease
  * History of recurrent idiopathic or virally induced urticaria, angioedema or anaphylaxis
  * Any history or presence of autoimmune, cardiovascular disease, chronic lung disease (other than asthma), malignancy, psychiatric illness, or gastrointestinal inflammatory conditions, including celiac disease, inflammatory bowel disease, eosinophilic esophagitis or other eosinophilic gastrointestinal disease
  * Current participation in any other interventional study
  * Subject who has undergone any type of oral immunotherapy
  * Severe asthma or uncontrolled mild to moderate asthma
  * Uncontrolled atopic dermatitis
  * Current use of oral steroid medications
  * Use of \>1 bursts of oral steroid medications in the past year
  * Inability to eat by mouth the fiber supplementation or placebo control and peanut flour for any reason
  * Use of any therapeutic antibody (biologic medication) or any immunomodulatory medication in the past 12 month (other than a short course of oral steroids)
  * Current use of any type of immunotherapy
  * Pregnancy or lactation
  * Allergy to potato or corn oat or cow's milk
  * Unwillingness to carry an epinephrine auto-injector
  * Unwillingness to comply with activity restrictions during OIT or any other study procedure
A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin

This study will evaluate the effects of treatment with vildagliptin and metformin as initial combination in newly diagnosed patients with type 2 diabetes who have very high levels of HbA1c and/or fasting plasma glucose.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
* Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
* Body mass index 22-40 kg/meter squared
* HbA1c \> 11% and/or FPG \>270 mg/dL

Exclusion Criteria:

* Pregnant or lactating female
* History of type 1 diabetes
* Evidence of significant diabetic complications
* Treatment with insulin or any other oral antidiabetic agent

Other protocol-defined inclusion/exclusion criteria may apply.
Pre-oxygenation With Facemask Oxygen vs High-flow Nasal Oxygen vs High-flow Nasal Oxygen Plus Mouthpiece Oxygen

Pre-oxygenation increases oxygen reserves in the body to reduce the likelihood of oxygen desaturation on induction of general anaesthesia. Pre-oxygenation with facemask is the commonest method method of pre-oxygenation. High-flow nasal oxygen is a newer alternative. This study randomises participants to receive pre-oxygenation by one of three methods: facemask, high-flow nasal oxygen, high-flow nasal oxygen plus mouthpiece.

The administration of supplemental oxygen prior to induction of anaesthesia is known as pre-oxygenation. Pre-oxygenation increases oxygen reserves in the body with the purpose of delaying the time until oxygen desaturation after breathing stops (apnoea) following the administration of an anaesthetic. In the last decade, clinicians have begun utilising high-flow nasal oxygen for pre-oxygenation. However, the rationale for this is based largely on its ability to achieve ongoing oxygenation after the onset of apnoea (apnoeic oxygenation). This study isolates oxygen administration with high-flow nasal oxygen to the period when the person is breathing, without ongoing oxygen administration during the apnoea period, to quantify its effects during the pre-oxygenation period only. A third group of participants breathes oxygen through a mouthpiece in addition to receiving oxygen via high-flow nasal cannulae. The effect of these pre-oxygenation methods will be measured by the time taken until oxygen saturation levels decline to the lower end of the normal range (92%), along with other parameters such as blood oxygen levels.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* ASA 1 or 2
* Receiving a general anaesthetic for non-emergent surgery

Exclusion Criteria:

* ASA score ≥3
* BMI ≥ 30 kg/m2
* Nasal obstruction
* Baseline SpO2 ≤95% on room air
* Anticipated difficult airway management
* Requirement for awake intubation
* Pregnancy
* Positive PCR test for coronavirus.
The Effect of Electromyogram (EMG) Activity on Anesthetic Depth Monitoring

Currently, a lot of equipments based on Bispectral index (BIS) is used clinically in order to measure the depth of anesthesia. Although BIS is used for the measurement of the presence of consciousness or degree of sedation during general anesthesia, it could be influenced by factors that affect or interfere with the activity of EEG because it is a numerical value which is measured by analyzing EEG. The BIS electrode for EEG analysis should be attached to the patient's forehead and the EEG signal is 0.5 - 30 Hz, the EMG signal is 30 - 300 Hz, and the BIS analyzes the 0 - 47 Hz signal. Therefore, 30 -47 Hz EMG signal may influence the BIS value and the BIS value may differ from the actual. In patients with complete muscle relaxation, the change in BIS varies in proportion to the concentration of anesthetic, but in a state with less muscle relaxation or arousal period of anesthesia when recovery of muscle relaxation occurs, BIS value may not accurately reflects the change in the depth of anesthesia. Although there is a study on the influence of the degree of muscle relaxation on BIS value, there is no study on whether phase lag entropy (PLE) measuring anesthesia depth based on different mechanism from BIS is affected by status of muscle relaxation. After measuring BIS and PLE at the same time, I will compare both of them and investigate the reliability of the measurement of the depth of anesthesia of PLE and how electromyogram activity affects PLE.

Intravenous administration of 2% propofol and remifentanil would be done for total intravenous anesthesia. After intravenous injection of rocuronium 0.6 mg/ kg for muscle relaxation, endotracheal intubation would be performed. Then, anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and adheres the neuromuscular monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously monitor the state of consciousness and muscle relaxation before, during and after surgery. Before the end of surgery, the degree of neuromuscular relaxation should be within deep block (TOF count \<2) and the concentration of 2% propofol should be adjusted for maintaining BIS between 50 and 60. Reversal of muscle relaxant could be performed by intravenous injection of sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case of shallow muscle relaxation degree under neuromuscular monitoring. After then, monitor and record the values of BIS, phase lag entropy monitor (PLEM) 100, and neuromuscular monitoring in 1 minute increments for 5 minutes.

Eligibility Criteria:
Inclusion Criteria:

* The patient who is scheduled for operation requiring general anesthesia and whose American Society of Anesthesiologists (ASA) status is I or II.

Exclusion Criteria:

* Who has neuromuscular disease
* Who takes medicines related neurologic system
Overdiagnosis of Thyroid Cancer in the Marne and Ardennes Departments of France From 1975 to 2014

Introduction - Incidence of thyroid cancer has increased considerably in France in recent years, but the mortality rate has declined only slightly. Part of this increased incidence could be attributable to overdiagnosis. We aimed to estimate the contribution of overdiagnosis to the incidence of papillary thyroid cancer.

Material and methods. - Incidence rates were calculated based on data from the specialised Marnes-Ardennes thyroid cancer registry, for cancers diagnosed between 1975 and 2014, by age category and by five-year period. The population was divided into two groups according to pTNM classification at diagnosis (i.e. localised or invasive). Overdiagnosis was defined as the difference in incidence rates between the invasive cancer and localised cancer groups. This rate was then divided by the incidence rate in the localised cancer group for the most recent period (2010-2014) to obtain the proportion of cancers attributable to overdiagnosis.

Introduction - Incidence of thyroid cancer has increased considerably in France in recent years, but the mortality rate has declined only slightly. Part of this increased incidence could be attributable to overdiagnosis. We aimed to estimate the contribution of overdiagnosis to the incidence of papillary thyroid cancer.

Material and methods. - We included all subjects living in the Marne or Ardennes Departments of France and who were diagnosed with papillary thyroid cancer between 1975 and 2014. We recorded socio-demographic variables, i.e. age at diagnosis and sex. Cancer characteristics were also recorded, namely year of diagnosis, International Classification of Diseases (ICD) 10th revision code associated with the papillary cancer, and the pTNM 2002 status. Incidence rates were calculated based on data from the specialised Marnes-Ardennes thyroid cancer registry, for cancers diagnosed between 1975 and 2014, by age category and by five-year period. The population was divided into two groups according to pTNM classification at diagnosis (i.e. localised or invasive). Overdiagnosis was defined as the difference in incidence rates between the invasive cancer and localised cancer groups. This rate was then divided by the incidence rate in the localised cancer group for the most recent period (2010-2014) to obtain the proportion of cancers attributable to overdiagnosis.

Eligibility Criteria:
Inclusion Criteria:

* clinical doagnosis of papillary thyroid cancer
* living in the Marne or Ardennes departments of France

Exclusion Criteria:

- cancer stage not determined
the Effect of Acupoint Application Combined With Ear Acupoint Embedding in Patients After Esophageal Cancer Surgery

To study the effect of acupoint application combined with ear acupoint seeding on the discomfort symptoms of nasal catheter in patients after esophageal cancer surgery

From January to December 2021, 200 patients after esophageal cancer surgery with nasal catherterization in an affiliated hospital of Soochow will be selected as the research objects, and they will be divided into experimental group (100 cases) and control group (100 cases) by random number table method. The control group will receive routine nursing care, and the experimental group will implement a precision nursing program of acupoint application combined with ear acupoint embedding on the basis of the control group. The thirst, throat pain, comfort, sleep, and unplanned extubation rate will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

Meet the diagnostic criteria for esophageal cancer; Age 50-70 years old; Undertake radical surgery for esophageal cancer, and place a tube through the nose after surgery; The patient communicates well with no cognitive impairment; Informed consent for this study, signed informed consent .

Exclusion Criteria:

Patients undergoing mechanical ventilation after surgery; Serious complications and death after surgery; Patients with external ear diseases and skin damage; Participating in other clinical research projects.
Multi-Level HIV Prevention for Pregnant Drug Abusers

This 5 year study, targeting Pregnant Drug Abusers in treatment, is a randomized trial of an Enhanced Behavioral Skills Training (E-BST) intervention compared to a time-and attention-matched Health Promotion Comparison (HPC) condition. E-BST is an adaptation of the original BST intervention (Eldridge, St. Lawrence et al., 1997), designed to strengthen relationship-based social competency skills of the original BST that were crucial in sustaining adherence to protective behavior.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* a recent history (within the past year) of using illicit substances
* 12-32 weeks pregnant and not planning to terminate the pregnancy
* able to read English Informed Consent form; understand and provided written informed consent
* have competency in conversational English which is required to complete assessments and to participate in the intervention groups
* have a stable living arrangement and provide contact information
* currently not cognitively impaired since cognitive impairment may compromise the ability to comprehend and participate in the assessment and intervention
* currently not showing symptoms of a major psychiatric disorder/ including psychosis, or a high risk for suicidality
* report at least one episode of unprotected vaginal/anal sex since becoming pregnant
* answer "Yes" to this question: "Do you plan to be in the area for the next 12 months?"
* agree to a urine test at the time of each interview to detect the presence of drugs

Exclusion Criteria:

* under age 18 years
Evaluation of the Quality of Life of Patients Requiring Intestinal Cleansing Using Oral Medications to Imaging Procedure by Patient Reported Outcome

Objective: The primary objective of this study is to assess the quality of life of people treated with oral phosphate compared with polyethylene glycol + electrolytes to imaging procedures, according to the outcome variables reported by patients.

Type of study: A non-interventional observational analytic prospective cohort study.

Sample: We will include people who need bowel cleansing for the realization of imaging tests

Exposures: - oral sodium phosphate normal regimen

* Oral sodium phosphate with modified diet
* Polyethylene Glycol + electrolytes

Follow-up time: 8 days after the bowel preparation

Outcomes: Boston Scale measure Safety Differences between groups in blood test (Sodium, Potassium, Calcium)


Eligibility Criteria:
Inclusion Criteria:

* Patients which have order for an imaging procedure that requires bowel cleansing
* Older than 18 years and younger than 65 years old
* Accept to participate in this study
Parkinson's Disease in African American and Caucasian Patients

More than 10 million people worldwide are living with Parkinson's disease (PD). While the actual number of African American (or Black) patients with PD is unknown, it is clear that there are racial disparities in the access to health care, diagnosis, treatment and survival of PD. The lack of clear knowledge on the possibly lower PD prevalence among African Americans compared to Caucasians further calls for more research in this field. The University of Chicago Medicine is an ideal facility to study this topic, due to its location on the South Side of Chicago with a large African American (or Black) population. By analyzing the demographics, socioeconomics and clinical features of PD patients in our Center for Research Informatics in African American (or Black) patients compared to the Caucasians of similar geographical area, the investigators aim to work toward a better understanding of the unique features of PD in American American (or Black) population, which might help improve the healthcare among this population in the Chicago and possibly nationwide as well.

The first portion of the study will be a large medical electronic data based search and analysis of patients with PD on demographics, socioeconomic status and clinical features of PD patients. Specifically, we will retrospectively identify PD patients on both races from the electronic medical database spanned from 1/1/2006 to 10/31/2017 and compared demographics, socioeconomic status (educations, incomes and insurances), co-morbidities (all categories, including mood, cognition and psychosis), treatment (medications for parkinsonism and major non-motor symptoms, and frequency and locations of healthcare) and survival, and identified factors associated with medication usage and survival.

The second portion was designed to collect more detailed clinical assessments for information not available in the database and blood draws for genetic or candidate gene mutation analysis. Unfortunately, this part of the study could not be carried out due to the COVID-19 pandemic, which began shortly after completion of the first portion of the study. These assessments and analyses would have helped determine if there are significant differences in the clinical and genetic profiles between the African American (or Black) and Caucasian PD patients that account for their differences in clinical features and PD prevalence in these two populations.

Eligibility Criteria:
Inclusion Criteria:

* 15 years and older, confirmed diagnosis of PD, African American (or Black) or Caucasian race

Exclusion Criteria: Non-PD

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A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur

This study will determine the incidences of infections and malignancies among JIA patients treated with abatacept


Eligibility Criteria:
Inclusion Criteria:

* Two diagnoses of JIA (ICD-9 code 714.3x) within 90 days
* Age less than 18 years at the time of second of the two diagnoses
* Index date is the date of initiating treatment with abatacept

Exclusion Criteria:

* Greater than or equal to 18 years of age
Bilateral Erector Spinae Plane Block as an Opioid Sparing Technique for Selective Dorsal Rhizotomy in Pediatric Patients With Spastic Cerebral Palsy

This study aims to evaluate the efficacy of bilateral erector spinae plane block as an opioid-sparing technique for selective dorsal rhizotomy in pediatric patients with spastic cerebral palsy.

Cerebral palsy (CP) is the most common physical disability affecting children. Selective dorsal rhizotomy (SDR) is a neurosurgical procedure that permanently reduces lower limb spasticity in children with CP by selectively targeting and removing sensory rootlets with aberrant activity.

Postoperative pain is often distressing for patients and their families and can result in complications, delayed participation in therapy, and poor functional recovery. Erector spinae plane block (ESPB) is a newly described interfascial plane block. ESPB is effective on both visceral and somatic pain.

Eligibility Criteria:
Inclusion Criteria:

* Age from 6 to 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status II, III.
* Patients with spastic cerebral palsy undergoing selective dorsal rhizotomy.

Exclusion Criteria:

* Allergy to local anesthetics.
* Severe fixed joint deformity.
* Previous orthopedic surgery.
* Patient with abnormal liver/kidney function.
* Patient with skin damage or infection at the proposed puncture site.
Improved Successful Retrieval Rate of HydroMARK Plus Breast Biopsy Site Marker in Comparison to HydroMARK as Well as Improved Surgeon Satisfaction

The purpose of the study is to test how successful the retrieval rate of the new HydroMARK Plus Breast Biopsy Site Marker in comparison to HydroMARK.

Study objectives

Primary objective

Assess the successful retrieval rates of the HydroMARK Plus clip

Secondary objective

Determine the level of satisfaction of the surgeon with the retrieval of the HydroMARK Plus clip

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy clips scheduled for surgery with SCOUT localization

Exclusion Criteria:

* Patients who didn't have surgery, patients younger than 18 years old
* Patients older than 90 years old
* Inmates
* Non-English speakers
Radiolabeled Folic Acid and Imaging to Detect Ovarian Cancer

RATIONALE: Diagnostic procedures using the drug radiolabeled folic acid and imaging may be effective in detecting ovarian cancer.

PURPOSE: Diagnostic trial to study the effectiveness of radiolabeled folic acid plus imaging in detecting ovarian cancer.

OBJECTIVES: I. Evaluate the effectiveness of folic acid conjugated with indium In 111 to diagnose ovarian cancer and locate metastatic disease.

OUTLINE: This is a diagnostic study. Patients receive an injection of folic acid conjugated with indium In 111. The patient then undergoes imaging studies at various time points (e.g., 1, 4, and 24 hours). Patients then undergo exploratory surgery, the results of which are then compared to the imaging studies.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Suspected ovarian cancer OR Recurrence of ovarian cancer Scheduled for exploratory surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dL SGPT and SGOT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN No acute hepatitis Renal: Creatinine no greater than 1.4 mg/dL BUN no greater than 1.5 times ULN No known or suspected kidney disease Cardiovascular: No history of congestive heart failure No unstable angina No myocardial infarction within 6 months Other: Not pregnant or nursing No septicemia or severe infection No medical condition that would preclude the administration of large fluid volumes over a short period of time

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 months since prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 months since prior radiotherapy Surgery: See Disease Characteristics Other: At least 2 days since prior folic acid supplements At least 5 days since nonsteroidal antiinflammatory medications