cyrilzakka/clinical-trials huggingface dataset:
Reactive Doses and Times During Oral Food Challenge to Peanut

Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food challenges (OFC). So far, consensual threshold for cutaneous test and IgE as predictor in the positivity of OFC have not been determined. Identification of reactive doses for OFC and phenotype of patients would help to personalize management of patients subgroups, with an optimal security.


Eligibility Criteria:
Inclusion criteria:

* Patients with a clinical suspicion of peanut allergy who underwent OFC to peanut
* Patients not objecting to participate in the study
* Men and women are included

Exclusion criteria:

• The patient refused to participate in the study
Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines

To better understand postpartum blood pressure changes, we are proposing a study to monitor blood pressure after delivery in 100 patients who we expect to have normal blood pressure (i.e. low-risk group), 100 patients who we expect to be at risk of new-onset high blood pressure postpartum (i.e. intermediate-risk group), and 100 patients who had high blood pressure prior to pregnancy (or very early, before 20 weeks in pregnancy) who we know are at high risk of blood-pressure related complications postpartum (i.e. high-risk group). Patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum. We expect that the daily changes in blood pressure will be different between these groups, which may allow us to better predict who is at risk, how much monitoring is needed, and when to intervene before the blood pressure abnormalities cause complications. The blood pressure device that will be given to patients is the YHE® BP Doctor Med Blood Pressure Smartwatch. This is a highly-accurate medical grade device that has not received FDA clearance. As such, the device is not being used to make blood pressure management and treatment decisions, but rather to gather data on postpartum cardiovascular physiology. Safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum birthing person 18 years of age or older
* At least 20 weeks gestation at time of delivery
* Meeting criteria for 1 of 3 risk categories for PP HTN and hypertensive morbidity
* Planned postpartum care at UCSD

Exclusion Criteria:

* Inability to give informed consent
* Institutionalization for psychiatric disorder, mental deficiency or incarcerated
* Initiation of antihypertensive therapy prior to discharge from delivery hospitalization.
Digihaler in Chronic Obstructive Pulmonary Disease (COPD)

This is a multi-center 3-month study to determine the variation in ProAir Digihaler metrics \[peak inspiratory flow (PIF), inhalation volume, number of inhalation events\] amongst COPD patients in the ambulatory setting.

The albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) (ProAir® Digihaler®) is the first and only Food and Drug Administration (FDA) approved inhaler rescue medication with a built-in sensor to detect and record inhaler use. The inhaler device measures PIF and the app groups PIF into categories that can help to highlight potential patient inhaler technique errors. This study will deploy this product in COPD patients to establish foundational data on Digihaler metrics in a COPD population at greater risk for COPD exacerbations.

Adult subjects with COPD recruited from two sites \[University of North Carolina (UNC) and Wake Forest\] will participate in a longitudinal study to collect data regarding the normal variation in Digihaler metrics (PIF, inhalation volume, number of inhalations), a daily self-assessment asking "How are you feeling?" with responses provided on a Likert scale as well as responses to a Digihaler metric algorithm-triggered digital automated questionnaire (DAQ) in a stable COPD population with history of an AECOPD, to assess correlations of Digihaler metrics to daily self-assessment and DAQ responses, correlations of self-reported to actual short acting beta agonist (SABA) use and symptoms, and the changes in inhaler parameters and SABA use around incidental AECOPD.

Eligibility Criteria:
Inclusion Criteria:

* Age \>40 years old
* History of cigarette smoking \>=10 pack-years
* Established COPD defined as physician diagnosis along with spirometry confirmation \[post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC)\<0.70\] within the last two years and an FEV1 ≤80% predicted
* Regular albuterol use (defined as at least one puff weekly for each of the last four weeks)
* Currently non-hospitalized
* Medical records confirmed history of two moderate AECOPD (defined as use of antibiotic or steroids to treat clinical event consistent with AECOPD) or one severe AECOPD (defined as emergency department/hospital visit) in prior 12 months
* Access to smart phone, tablet or computer and internet
* Willingness to switch current rescue inhaler/device to ProAir Digihaler

Exclusion Criteria:

* Allergy or inability/contraindication to use Albuterol Sulfate
* Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study
Prehabilitation Feasibility Among Older Adults Undergoing Transplantation

This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up.

This is a pilot randomized trial of older adults 60y and above planned to undergo Autologous Stem Cell Transplant for Multiple Myeloma. Eligible participants will be randomized (like flipping a coin) to one of two study conditions: 1) an 8 week long home-based prehabilitation exercise program delivered using a telehealth format or 2) an 8-week long nutrition counseling (attention control group). Assessments will occur at baseline, post-intervention (during transplant) and at 12-weeks post-transplant. Investigators will assess the feasibility and acceptability of our program as well as preliminary impact of the program on physical functioning during these time-periods.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Myeloma
* Scheduled for ASCT at UAB within 10 weeks of study enrollment
* age at ASCT ≥60y

Exclusion Criteria:

* at high risk for impending pathologic fracture using Mirels score
Mind-Body Medicine Training for Incarcerated Men and Women

The goal of this study is to learn about how effective a Mind-Body Medicine Training Program is for prisoners. The main questions it aims to answer are:

1. Does the training program increase resilience?
2. Does the training program reduce depression, anxiety, and/or stress?
3. Does the training program increase optimism?
4. Does the training program increase prisoners' belief that they can have better coping skills?
5. Does the training program increase a sense of meaning in life?
6. Does the training program increase a sense of life purpose?

Participants will attend a 2-part mind-body medicine training program (4 days for each part) and will fill out questionnaires before the training, after the training and 6 months after the training. They will also participate in group interviews after the training and 6 months after the training.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for this study will be English-speaking incarcerated individuals at the Indiana Women's Prison and and at the Plainfield Correctional Facility.

Exclusion Criteria:

1. Having any of the following before the study is completed:

1. a sentence that will end,
2. a scheduled change in security level to a minimum-security prison or,
3. a scheduled work release;

Or 2. Having conduct problems and/or emotional or mental instability that prevents safe and effective participation in the mind-body medicine training program
Effect of NanoChitosan Impregnated Calcium Hydroxide as an Intracanal Medication on Postoperative Pain Intensity and Bacterial Load Reduction

This research will study the effect of NanoChitosan impregnated Calcium Hydroxide versus Calcium Hydroxide as an intracanal medication on postoperative pain intensity measured using numerical rating scale (NRS) and bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml) in necrotic teeth.

Primary outcome: Postoperative pain measured using numerical rating scale (NRS)

1. After placement of intracanal medicament at 6, 12, 24 and 48 hours.
2. After root canal obturation at 6, 12, 24 and 48 hours.

Secondary outcome: Bacterial load reduction determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml)

1. Sample 1 (S1): after access preparation and pre-instrumentation.
2. Sample 2 (S2): post-instrumentation.
3. Sample 3 (S3): post-intracanal medicament removal at 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 25-45 years old.
2. Males or females.
3. Healthy patients who are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II)
4. Patients' accepting to participate in the trial.
5. Patients who can understand the pain scale and can sign the informed consent.
6. Mandibular Single rooted premolars, having single root canal: Diagnosed clinically with pulp necrosis.
7. Positive pain on percussion denoting apical periodontitis.(20)
8. Slight widening in the periodontal membrane space
9. Normal occlusal contact with opposing teeth

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders (ASA III or IV).
2. If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
3. Pregnant women
4. Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion
5. Patients with two or more adjacent teeth requiring endodontic treatment.
6. Teeth that require further procedural steps or multidisciplinary approach.

   1. Association with swelling or fistulous tract.
   2. Acute periapical abscess.
   3. Mobility Grade II or III.
   4. Pocket depth more than 5mm.
   5. Previous root canal treatment.
   6. Non-restorable.
   7. Immature root.
   8. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
7. Inability to perceive the given instructions.
Efficacy of an Online Program for the Treatment of Mild and Moderate Depression

iFighDepression is an online self-help programme based on cognitive-behavioral therapy that could be useful for the treatment of mild to moderate depression

Major depression (MD) is a disease with a great impact on people´s functioning and is the second leading cause of disability worldwide. It is a condition with a high prevalence, about 10% of men and 20% of women in the population will be diagnosed MD throughout their lives, and has an effect on high economic costs to health services.

While there are many effective therapeutic options for the treatment of depression, many people with depressive episodes do not receive an appropriate treatment or, in fact, do not receive any treatment at all. The social stigma, difficulties to access mental health services, to integrate therapy sessions into working life, or problems to pay for treatment are some of the main barriers to receive adequate treatment.

On-line interventions are easily accessible and low cost, and different studies suggest that these interventions have significant and lasting improvements in different mental disorders. These studies indicate that this type of treatment would be indicated for disorders that, as the case of MD, have a high prevalence and relatively low help-seeking for treatment.

iFighDepression is an online self-help programme for mild to moderate depression that has been developed in the context of the European project Preventing Depression and Improving Awareness through Networking in the European Union (PREDI-NU) which is managed by the European Alliance Against Depression (EAAD). It involves the most complete integration of the cognitive-behavioral online programs available to date, which is a format of intervention that has been proven effective in reducing depressive symptoms in several randomized controlled trials. IFightDepression is currently in pilot phase in 7 European Union countries, including Spain.

The purpose of this project is to study the therapeutic effect of the iFightDepression online programme in patients with mild to moderate depression

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder according to Diagnostic and Statistical Manual (DSM-IV-TR) criteria.
* Clinical severity between mild and moderate (according to ICG severity scale).
* A minimum of reading comprehension and knowledge of internet browsing.
* Availability to access internet during the 7 weeks of the intervention.
* Informed written consent provided.

Exclusion Criteria:

* Suicidal ideation (assessed by the HDRS and clinical interview).
* Presence of delusional ideas or hallucinations, consistent or not with the mood.
* Other concomitant psychiatric pathologies of the Axis I or Axis II according to Diagnostic and Statistical Manual (DSM-IV-TR) at the time of entry to the study.
* To be currently enrolled in a structured programme/treatment of psychotherapy.
A Study of SBRT for OligoMetastatic ESCC

The aim of this phase II trial is to assess progress-free survival, local control, overall survival, safety and tolerability of SBRT to treat patients with oligometastases in esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with metastatic esophageal squamous cell carcinoma who have received initial treatment for the primary site including surgery or chemoradiotherapy. Primary tumor site without progression at registration. The sites of allowed metastases are: peripheral lung, central lung, medistinal/cervical lymph node, liver, spinal/paraspinal, osseous, and abdominal-pelvic lymph node. All metastases not resected must be amenable to SBRT.
2. 1-4 radiographically distinct metastases of any distribution in 2 or less allowed anatomical sites. The diameters of lesions should be less than or equal to 5cm.
3. Initial treatment should be completed at least 3 months prior to study registration.
4. All the metastases treated with SBRT should not be treated with surgery, radiation, radio frequency ablation or other regional therapeutic modalities prior to study registration. The other (s) lesions should have been surgically removed.
5. Age ≥ 18. PS ECOG 0-2，wight loss\<30% during the latest 6 months.
6. Evaluation by a radiation oncologist that the patient could tolerate the treatment of SBRT.
7. Patient must provide study specific informed consent prior to study entry.
8. For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration.

Exclusion Criteria:

1. Progression of primary tumor site at time of registration.
2. Metastases with indistinct borders making targeting not feasible.
3. Known brain metastases.
4. Prior palliative radiotherapy to metastases.
5. Metastases located within 3 cm of the previously irradiated structures:

   a).Spinal cord previously irradiated \>80Gy(Biological equivalent dose with α/β=2), b).Brachial plexus previously irradiated to \> 100Gy(Biological equivalent dose with α/β=2), c).Small intestine, large intestine, or stomach previously irradiated to \> 90Gy (Biological equivalent dose with α/β=2), d).Whole lung previously irradiated with prior V20Gy \> 30% (delivered in ≤ 3 Gy/fraction), e)Metastasis irradiated with SBRT.
6. Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives.
7. Drug addiction,Alcoholism or AIDS.
8. Patients with severe organ dysfunction or Acute bacterial or fungal infection who are considered not suitable to enroll the study at the time of registration.
Remote Physical Activity Monitoring in Individuals With Metabolic Syndrome

A prospective intervention study to evaluate the effectiveness of the developed toolset for remote physical activity monitoring to improve arterial stiffness and other cardiometabolic parameters and to increase physical activity levels and the compliance to the prescribed exercise in individuals with metabolic syndrome.

At first, all subjects of the prospective study participated in the 2-month outpatient aerobic exercise program, which consisted of 40 aerobic training sessions on a cycle ergometer 5 times/week for 40 min. During all training sessions, heart rate was maintained at the targeted level, which was obtained individually by cardiopulmonary test. After 2 months, during individual motivational consultations, all participants received recommendations for home-based training and were randomly allocated to the intervention or the control group. Then only the intervention group subjects participated in the 6-month home-based aerobic exercise program using a wearable heart rate monitor, which was connected to the smartphone via Bluetooth. The intervention group subjects used a smartphone application created for the study. The control group participants were asked to exercise at home for 6 months without wearables and smartphone application. The evaluation of the study participants was performed at baseline (1st visit), after 2 months (2nd visit) and after 8 months (3rd visit).

Eligibility Criteria:
Inclusion Criteria:

* Males (40-55 years) and females (50-65 years) with metabolic syndrome, having at least three of the following five criteria: hypertriglyceridemia (triglycerides ≥ 1.7 mmol/l); high-density lipoprotein cholesterol ≤ 1.03 mmol/l for men or ≤ 1.29 mmol/l for women; abdominal obesity (waist circumference \> 102 cm for men and \> 88 cm for women); elevated blood pressure (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg or current use of antihypertensive drugs); elevated fasting plasma glucose ≥ 5.6 mmol/l;

Exclusion Criteria:

* Patients with overt cardiovascular disease (previous myocardial infarction, coronary artery bypass surgery, percutaneous coronary intervention, previous stroke)
* Patients with severe heart failure symptoms, uncontrolled hypertension
* Patients with urinary tract infection or fever for another unknown reason
* Patients who have actively exercised in the last 24 hours
* Pregnant women
Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer

This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.

It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy.

S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* More than 3 months expected life span
* Measurable lesion by RECIST criteria version 1.1
* Palliative chemotherapy naive
* Adequate organ functions
* Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

* Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer.
* Participants who had received radiation therapy for target lesions 4 weeks before study enrollment
* Participants who had received major surgery 4 weeks before study enrollment
* Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding
* Participants with central nervous system(CNS) metastases
* Participants with peripheral sensory neuropathies with impaired functional activities
* Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.
Sleep and Circadian Rhythms in Mechanically Ventilated Patients

This study examines the feasibility of assessing sleep and circadian rhythmicity in critically ill patients undergoing mechanical ventilation. Secondarily, it will examine the feasibility of reducing subject exposure to environmental light and noise and of delivering routine care according to classical day/night routines.

Over 1 million patients develop respiratory failure annually in the United States; yet, the sleep of patients undergoing mechanical ventilation has received little attention. This protocol enrolls acutely ill medical patients undergoing mechanical ventilation. The feasibility of assessing sleep and circadian rhythmicity through the use of continuous bedside polysomnography and the measurement of core body temperature and urinary hormonal levels at frequent intervals will be explored. As a secondary goal, the feasibility of delivering routine care according to classical day/night routines, and of employing various noise and light reduction strategies at night, will be explored in a subset of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing mechanical ventilation in the medical intensive care unit.

Exclusion Criteria:

* Central nervous system disease (stroke, seizure, dementia, etc)
* Metabolic or hypoxic encephalopathy
* Confirmed or suspected drug overdose
* Currently receiving neuromuscular blockers
* Coma