cyrilzakka/clinical-trials huggingface dataset:
Remote Temperature Monitoring of Patients At Risk for Developing Fever

The purpose of this program is to evaluate remote temperature monitoring in cancer patients at risk of fever and infection due to chemotherapy treatment. The main questions it aims to answer are:

* does remote temperature monitoring reduce the number of days spent inpatient
* what out-of-pocket cost can a patient expect to incur for participating in remote temperature monitoring
* the number of billable CPT codes that will be generated by providing remote temperature monitoring

Researchers will compare compliant and non-compliant patients to assess if compliance with remote temperature monitoring is associated with a decrease in the number of days spent inpatient.

Patients will

* wear the thermometer for the duration of their participation in the study
* have their temperature monitored continuously
* receive alerts on their phone when their temperature exceeds a threshold for a sustained duration, configurable by their physician
* respond to texts or calls from remote monitors when an alert is triggered


Eligibility Criteria:
Inclusion Criteria:

* Subject is at risk of a fever post discharge.
* Subject is ≥ 18 years or older.
* Subject has an iOS or Android phone, or is able to operate an AION provided smartphone device.
* Subject is willing to install the TempShield app on his/her phone.
* Subject is willing to allow AION to send text reminders to take temperature or complete surveys.
* Subject is willing to take an oral temperature as directed by their care plan.
* Subject is willing to configure the phone to ensure these notifications are delivered, even when phone is in a "no notification" mode.
* Subject or subject caretaker is able and willing to complete subject surveys.
* Subject is willing and able to provide written informed consent in English.
* Subject is willing and able to comply with all program procedures, requirements, assessments, visits, and complete questionnaires.
* English speakers

Exclusion Criteria:

* Unable to provide informed consent
* Subjects with a history of Medical Adhesive-Related Skin Injury (MARSI)
* Subjects with no available placement that avoids open wounds or traumatized skin (burns. Blisters. Etc.)
* Non-English speakers: The mobile application is only currently available in English. Future development will include other languages.
* Subjects receiving prophylactics that could induce fever.
* Subjects with a silicon allergy
* Subject does not have iOS or Android phone, and is unable to operate an AION provided smartphone device.
* Subjects who are not willing to take an oral temperature per their care plan.
Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population

Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.

Demographics data, clinical indications, ultrasound diagnosis, and ultrasound measurements will be recorded and stored on an database. Ultrasound measurements will be analyzed to define the normal range of values of Superior Mesenteric Artery (SMA) angle and Superior Mesenteric Artery - Aorta (SMA-A) distance in the pediatric population according to age, Body Mass Index (BMI), and fat parameters.

Eligibility Criteria:
Inclusion Criteria:

* Male and female children
* Age ranging from10 to 15 years, included
* Abdominal ultrasound examination to be performed for indications other than gastrointestinal evaluation
* Signed Informed Consent

Exclusion Criteria:

* Presence of a disease that could distort the anatomy around the SMA (e.g., abdominal mass, lymphadenopathy, severe scoliosis, free abdominal fluid)
* Oncologic patients at risk of neoplastic cachexia.
Audiovisual Consultations in Prehospital Emergency Care: Randomised Controlled Trial

This study investigates safety and efficacy of the use of audiovisual consultations of emergency medical service (EMS) doctor by paramedics for low urgency events in areas covered with paramedic crews only from emergency medical service stations with distant access to hospital.

The study will be realized on Karlovy Vary EMS areas covered with paramedic crews only from emergency medical service stations with distant access to hospital. Each call on emergency line during 6 weeks study period will be assessed for eligibility. If deemed as low urgency, the event will be randomised into 3 groups. CONTROL group: routine operation of paramedic crew with optional consultation with a doctor over the phone. In the PHONE group and in the VIDEO group, there will be a mandatory consultation of a doctor over the phone or by audiovisual constultation, respectively. The primary outcome of the study is the percent of patients treated on site without the need of hospital transfer. The secondary safety outcome is to evaluate repeated ambulance trips within 48 hours after the patient had been treated at home. Moreover, a qualitative analysis of subjective perception of the event by the patients, paramedic and consulting doctor using the Likert scales will be performed by survey at the end or immediately after the event.

Eligibility Criteria:
Each call on emergency line (in action radius of actual position of 11 of 19 Karlovy Vary EMS paramedic crews) will be assessed for eligibility by EMS call-taker in Karlovy Vary region.

Inclusion criteria are:

1. the call is evaluated as low urgency event (by criteria of Karlovy Vary EMS call-taker manual; the event is dedicated for paramedic crew only, without dispatchig doctor on site),
2. the case is determined for and will be served by one of 11 for study dedicated of total 19 paramedic crews in Karlovy Vary EMS,
3. dedicated doctor of Karlovy Vary EMS will be available for consultation during his shift.

Exclusion criteria are:

1. need for escalation of the care: paramedics' requirement for the doctor to arrive at the scene of intervention,
2. consulting doctor is not available for the study at the moment of randomisation,
3. consultation with other than trained and for study dedicated doctors,
4. patient - crew language barrier,
5. study refusal by the patient or legal representative, or refusal of audiovisual consultation,
6. technical, logistic or other (agressive patient, patient detained by police) problems evaluated by paramedic crew (not to conduct a study in PHONE and especially VIDEO group)
Skin Barrier Dysfunction and the Role of Skin Barrier Restoration

The objective of this exploratory study is to gain an understanding of cutaneous and systemic inflammation and how restoration of the skin barrier through the use of moisturizer may restore the skin barrier function and reduce systemic inflammation in elderly humans compared to the young. The exploratory study will consist of three visits per subject. Subjects will be instructed to apply a moisturizer (Vanicream Moisturizing Skin Cream) over the entire skin surface from the neck down twice daily for up to 30 days.


Eligibility Criteria:
Inclusion Criteria:

Aged group (\>70 years old)

* In good general health
* Body mass index (BMI) preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
* Fitzpatrick skin types I-V
* Disrupted skin barrier defined as transepidermal water loss (TEWL) \>5 g/m2/h on the upper arms or \>3 g/m2/h on the buttocks
* Clinical signs of skin dryness as determined by the investigator.
* No disease states or physical conditions that would impair evaluation of the biopsy sites
* Signed, written and witnessed informed consent form
* Willing to comply with study procedures

Young group (18-30 years old)

* Good general health
* BMI preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
* Fitzpatrick skin types I-V
* Disrupted skin barrier defined as transepidermal water loss (TEWL) \>5 g/m2/h on the upper arms or \>3 g/m2/h on the buttocks
* Clinical signs of skin dryness as determined by the investigator
* No disease states or physical conditions that would impair evaluation of the biopsy sites
* Signed, written and witnessed informed consent form
* Willing to comply with study procedures

Exclusion Criteria:

* Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol (determined by self-report; if subjects are unsure of their pregnancy status, they will be excluded).
* Frailty as determined by research study nurse
* History of inflammatory skin conditions such as psoriasis or atopic dermatitis.
* History of uncontrolled inflammatory or autoimmune disease.
* History of keloids or any other condition that would complicate wound healing
* History of allergic reactions to local lidocaine
* Frequent nonsteroidal anti-inflammatory drug (NSAID) use (not including low dose aspirin) and unwilling/unable to discontinue NSAIDS for 2 weeks prior to enrollment to the end of the study.
* Systemic steroids (excluding inhaled steroids for asthma) and unwilling/unable to discontinue systemic steroids for 3 weeks prior to enrollment to the end of the study.
* Topical corticosteroid use within 2 weeks of enrollment.
* Topical immunomodulation use such as calcineurin inhibitors within 2 weeks of enrollment
* Other anti-inflammatory or immunodulatory medications (immunosuppression)
* Received an experimental drug or used an experimental device 30 days prior to admission to the study.
BIPAP in the Management of Acute Respiratory Distress Syndrome

Evaluation of biphasic positive airway pressure as a new mode of ventilation in management of acute respiratory failure constituted in ARDS as a category of hypoxaemic respiratory failure in comparison to conventional ventilation.

Biphasic positive airway pressure (BIPAP) is a mode of mechanical ventilation that allow unrestricted spontaneous breathing independent of ventilator cycling, using an active expiratory valve. BIPAP mode is pressure-limited and time-cycled, Ventilation occurs via the time-cycled switching between two set pressure levels. In the absence of spontaneous breathing, this mode resemble conventional pressure controlled ventilation.

A proposed advantage of BIPAP compared to conventional pressure-controlled ventilation is the improved distribution of gas to dependent lung regions as the result of spontaneous breathing enabled during the inspiratory and expiratory time cycles, so prevents atelectasis and promotes alveolar recruitment resulting in an improved ventilation-perfusion matching.

ARDS is an acute diffuse, inflammatory lung injury, leading to increased pulmonary vascular permeability, increased lung weight, and loss of aerated lung tissue with hypoxemia and bilateral radiographic opacities, associated with increased venous admixture, increased physiological dead space and decreased lung compliance.

In patients with ARDS, BIPAP with spontaneous breathing contributes to improved pulmonary gas exchange, systemic blood flow and oxygen supply to the tissue. This is reflected by clinical improvement in the patient's condition, which is associated with significantly fewer days on ventilatory support, earlier extubation and a shorter stay in the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* All intubated Adult ARDS patients
* ARDS is diagnosed according to berlin criteria.

Exclusion Criteria:

* Age \< 18 years.
* Cardiac or respiratory arrest on admission.
* Morbid obesity with BMI \> 40.
* Acute exacerbation of IPF.
* Cerebrovascular or neuro muscular disorder. 6. Diabetic ketoacidosis. 7. Hepatic or renal disease. 8.Cardiac disease.
Gut Microbiota in Patients With Limb Lymphedema and Recurrent Lymphangitis

Lymphedema is a chronic and progressive disease of the lymphatic vessels which affects about 300 million people worldwide. Patients may experience recurrent soft tissue infection of the limb affected by lymphedema, in terms of erysipelas, lymphangitis or cellulitis. No previous study has ever investigated the possible role of the gut microbiota in the genesis of acute infectious/inflammatory episodes in these patients. Our hypothesis is that lymphedema patients with recurrent soft tissue infections are characterized by pro-inflammatory changes in the microbiota.


Eligibility Criteria:
Inclusion Criteria (Group A):

* 18-85 years
* primary or secondary, upper or lower limb lymphedema, I-II-III stage ISL
* at least 3 episodes of soft tissue infection in an year, in the last 2 years
* consent to participate in the study

Inclusion Criteria (Group B):

* 18-85 years
* primary or secondary, upper or lower limb lymphedema, stage I-II-III (ISL)
* no episodes of soft tissue infection in the last 2 years
* consent to participate in the study

Exclusion Criteria:

* No compliance to perform limb compression and skin hygiene
* Antibiotic therapy in the last 15 days
* Diabetes mellitus
* Immunodeficiency
* Ongoing neoplastic pathology
* Taking immunosuppressive drugs
* Unavailability to follow-up for at least 24 months post-enrollment.
Treatment for Aerobic Vaginitis by Using Bofukang Vaginal Suppository

Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.To evaluate the efficacy and safety after treatment.

Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.

Group 1: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 7 days.

Group 2: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 14 days.

The efficacy and safety will be evaluated 7\~14 days after treatment and 35\~42 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

Aerobic vaginitis diagnosed based on present ：

1. Vaginal dischareg ;
2. pH \> 4.5;
3. Donders score≥3;

Exclusion Criteria:

1. Patients with other vaginitis, cervical erosion, or suspected gonorrhea, herpes simplex virus infection and other vulvar diseases;
2. Patients received systemic or vaginal antifungal or antibiotic treatment within two weeks before admission.
3. Pregnancy, lactation and intentional pregnancy;
4. Women with liver and kidney dysfunction, low immune function, diabetes, psychosis or other serious diseases;
5. Allergic constitution and patients allergic to drug ingredients in this study;
6. Those with poor compliance.
A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

This is a phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age
* Able and willing to provide informed consent
* Able and willing to comply with protocol visits and procedures
* Target ulcer duration of ≥4 weeks

Exclusion Criteria:

* Ulcer of a non-diabetic pathophysiology
* Known or suspected allergies to any of the components of MEBO
* Malignancy on target ulcer foot
* Non-compliance in the screening or run-in period
Trametinib Combined With Everolimus and Lenvatinib for Recurrent/Refractory Advanced Solid Tumors

To study the clinical effect of Trametinib combined with Everolimus and Lenvatinib in the treatment of Recurrent/Refractory advanced solid tumors.

The tumor diameter was measured and the efficacy was evaluated after treatment with Trametinib combined with Everolimus and Lenvatinib.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent/Refractory advanced solid tumors
* Age between 18 and 85 years
* Expected life expectancy is greater than three months

Exclusion Criteria:

* Benign tumor
* Life expectancy is less than three months
* Serious medical commodities
* others
Characterize Metzker Pigmentary Disorders

Metzker pigmentary disorders are frequent cause of consultation in pediatric dermatology. The investigators can describe 4 patterns. They must be differentiated from mosaicisms because they aren't associated with neurologic disorders and don't require any follow up.


Eligibility Criteria:
Inclusion criteria:

* Metzker pigmentary disorder, age between birth and 18 years old

Exclusion criteria:

* None
Multimodal Postoperative Analgesia Following OSA Surgery

Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) for postoperative analgesia following multilevel OSA surgeries


Eligibility Criteria:
Inclusion Criteria:

* physical status of American Society of Anesthesiologists (ASA) II
* age between 30 - 50 years
* OSA patients diagnosed by polysomnography and stop-bang questionnaire
* enrolled for multilevel OSA surgery

Exclusion Criteria:

* history of allergy to the study drugs
* history of hepatic, cardiopulmonary or renal disease
* history of any chronic pain on medication
* history of substance abuse
* psychiatric disorder
* lack of patient cooperation.
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease

Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Study AMAG-FER-CKD-252 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Study AMAG-FER-CKD-251 (NCT01155375) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The enrollment number (n=14) includes the number of participants for both AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, combined.

Participants were enrolled by age cohorts in a stepwise manner following a safety review by the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest. Randomization was stratified by the following age cohorts: 12 to \<18 years, 6 to \<12 years, 2 to \<6 years, and 6 months to \<2 years.

Eligibility Criteria:
Key Inclusion Criteria for this study include:

1. Males or females 6 months to \<18 years of age
2. Nondialysis dependent CKD, including kidney transplant recipients
3. Has iron deficiency anemia defined as: a) hemoglobin level \<11.0 grams (g)/deciliter (dL) and b) transferrin saturation level \<20%
4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria for this study include:

1. History of allergy to either oral or IV iron
2. Allergy to two or more classes of drugs
3. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 3 months postpartum, or have a positive serum/urine pregnancy test
4. Hemoglobin level ≤7.0 g/dL
5. Serum ferritin level \>600 nanograms/milliliter
Goal of Open Lung Ventilation in Donors

The primary goal of this study is to assess whether ventilation of deceased organ donors with an open lung protective ventilatory strategy will improve donor lung utilization rates and donor oxygenation compared to a conventional ventilatory strategy.

Deceased organ donors are maintained on life support including mechanical ventilation during the time between brain death and organ procurement. The optimal mode of mechanical ventilation for deceased organ donors has not been definitively established. Since deceased organ donors may develop atelectasis leading to impaired oxygenation, an open lung protective ventilatory strategy with higher positive end expiratory pressure (PEEP), lower tidal volume and recruitment maneuvers has been hypothesized to be beneficial. Favorable outcomes were observed in a European clinical trial comparing open lung protective ventilation (OLPV) to a conventional ventilatory strategy in terms of donor oxygenation and lung utilization for transplantation (Mascia L et al, Journal of the American Medical Association 2010). However, donor management procedures in Europe are much shorter in duration compared to the US and it is not clear that these findings are generalizable to the US donor management environment.

The GOLD trial will test the effect of an OLPV strategy compared to conventional ventilation (CV) in the US donor management environment. This multi center trial will enroll 400 brain dead organ donors randomized into 1 of 2 treatment arms. After randomization, mechanical ventilation will be protocolized according to treatment arm with one arm receiving control ventilation (CV) utilizing standard Donor Network West (DNW) protocols and the other arm receiving the OLPV strategy with higher positive end expiratory pressure (PEEP) and lower tidal volume compared to CV. The primary outcomes is donor lung utilization for transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Brain death
* Authorization for research
* ≥13 years of age

Exclusion Criteria:

* Arterial/Inspired oxygen ratio (PaO2/FiO2) ≤ 150 mmHg
* PaO2/FiO2 ≥ 400 mmHg
* BMI \> 40
* Hepatitis B surface antigen positive
* Hepatitis C positive
* Failure to complete donation process
* Hemodynamic instability
A Food-Effect Study of BPI-16350 in Healthy Subjects

This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350.

Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects aged 18\~45 (including 18 and 45 years old);
* Male body weight ≥ 50kg, female body weight ≥ 45kg, body mass index (BMI) within the range of 19 \~ 26kg /m2;
* Clinical laboratory evaluations within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
* The subjects should took effective contraceptive measures voluntarily from informed consent until 3 months after Study Completion；
* Able to comprehend and willing to sign an informed consent form.

Exclusion Criteria:

* History of significant hypersensitivity to any drug compound or food；
* Significant history or clinical manifestation of any significant cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, musculoskeletal,hematological disorder；
* Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody is positive；
* Family history of long QTc syndrome; History or presence of an abnormal ECG；
* Drug abusers, smokers or alcoholics；
* Use of any medications within 14 days prior to the first administration；
* Donation of blood ≥ 200 mL or receipt of blood products within 3 months before enrollment, or plan on blood donation during the study period；
* Participation in any other investigational drug study or receive any vaccine within 3 months before enrollment；
* Female subjects who are pregnant or lactating；the serum HCG test of women with fertility is postive at Screening.