cyrilzakka/clinical-trials huggingface dataset:
Diabeloop for Kids

An open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up home study phase, crossover study comparing Diabeloop closed-loop (CL) system and sensor-augmented pump (SAP) therapy.

The follow-up home study phase will be done only in French centers for a sub study. During this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote monitoring follow-up by specialized nurses, under supervision of a diabetologist. A visualization of glucose CGM curves, insulin delivery, meal and physical activity announcements will be available online through secured website, and the system will send automated message in case of predetermined situations as persistent too high or too low Blood Glucose (BG). Custom settings will be possible by the nurses during the follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Prepubescent children (Gender: both) aged between 6 to 12 years old (Tanner stage 1) at time of screening
* Type 1 diabetes as defined by WHO for at least 1 year or confirmed C peptide negative
* An insulin pump user for at least 3 months.
* Subject having a Glycosylated hemoglobin (HbA1c) blood value \< 9% at time of screening visit-based on analysis from local laboratory within 3 months.
* Subject having a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
* Subject and his parent/guardian willing to spend 3-overnight in hospital.
* Subject willing to wear the system continuously throughout the study
* Subjects and his parent/guardian must be able to speak and be literate in French or Flemish as verified by the investigator

Exclusion Criteria:

* Children who are in pubertal stage
* Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening: - Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) - Coma - Seizures
* Subject having sever DKA in the 6 months prior to screening visit.
* Known or suspected allergy against insulin
* Any other physical or psychological disease, or medication likely to interfere with the conduct of the study and interpretation of the study results as judged by the investigator.
* Subject is unable to tolerate tape adhesive around the sensor or pump placements
* Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
* Subject having took any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the study.
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.


Eligibility Criteria:
Inclusion Criteria:

* 30 years or older
* SAP 2 times ULN
* Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).
* 90 days washout calcitonin
* 180 day washout bisphosphonate

Exclusion Criteria:

* Allergic reaction to bisphosphonates
* History of upper GI disorders
* History of iritis, uveitis
* Calculated creatinine clearance \< 30 ml/min at baseline
* Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.
A Brief Alcohol Intervention for Incarcerated Women

The purpose of this study is to examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women.

Hazardous alcohol use continues to be a problem of major significance throughout the United States. Alcohol use is a prevalent condition that independently acts as an important behavioral cofactor for HIV infection in women, contributing to both sexual and drug risk. The rationale for a brief intervention with incarcerated women who hazardously use alcohol and have HIV risk behaviors is compelling. For such women, we believe that the negative effects of drinking may be increased. An intervention that successfully connects alcohol use with HIV risk behaviors may be sufficient to tip the decisional balance in favor of reducing risk-prone alcohol consumption. If alcohol consumption is reduced more generally in a person's life, this may improve judgment in pursuing behaviors which risk other negative consequences. Hazardous alcohol, and high-risk drug and sexual activities may be manifestations of a general behavior pattern among incarcerated women, and strategies that engage such individuals are needed. Given the strong association between hazardous alcohol use and high HIV risk sexual and drug activities, interventions that attempt to lower the prevalence of HIV drug and sexual risk activities by lowering alcohol consumption are well justified. Brief alcohol interventions have been efficacious in reducing alcohol use across many populations over the past decade.

Comparison(s): Participants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation.

Eligibility Criteria:
Inclusion Criteria:

* incarcerated women
* current hazardous drinking
* current HIV risk behavior

Exclusion Criteria:

-
a/LCI-OCT Pilot in Esophagus

This study will test a newly developed dual modality probe, including optical coherence tomography (OCT) and angle-resolved low-coherence interferometry (a/LCI), in the human esophagus to determine 1) whether adequate tissue contact can be attained by the probe to acquire high quality images, and 2) to identify if these images can discern whether the imaged tissue is squamous or Barrett's Esophagus (BE) epithelium. This pilot study will test the operating characteristics of the probe and collect data for further optimization of the a/LCI-OCT device.


Eligibility Criteria:
Inclusion Criteria:

* Presenting to University of North Carolina (UNC) for routine care upper endoscopy
* Meet one of the following criteria:

  1. Current dysplastic or non-dysplastic Barrett's Esophagus of any length OR,
  2. History of dysplastic or non-dysplastic Barrett's Esophagus after treatment with endoscopic eradication therapy (EET) OR,
  3. Normal asymptomatic controls without any history of dysplastic Barrett's Esophagus
* Aged 18 to 80
* Able to read, comprehend, and understand the informed consent document

Exclusion Criteria:

* Prior esophageal surgery (uncomplicated nissen fundoplication OK)
* Pregnant women
* Unable to provide written informed consent
Effects of Vitamin D on Gut Microbiota, Intestinal Barrier in IBS-D Patients

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disease. Evidence suggests that the concentration of serum VD is decreased in IBS patients, particularly in IBS-D. After giving a supplementation of VD, some symptoms of these patients were relieved to a certain degree. However, the specific mechanism still remains unclear.

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disease, which is due to the gut microbiota disturbances, intestinal mucosal barrier dysfunction, and brain-gut axis dysfunction. Vitamin D (VD), a fat-soluble vitamin, has been found to be associated with gut microbiota, intestinal mucosal barrier and NLRP3 in inflammatory bowel disease, nonalcoholic fatty liver disease and other diseases. The concentration of serum VD is decreased in IBS patients, particularly in IBS-D. And the symptoms of IBS patients seems to be connected with the level of serum VD. After giving a supplementation of VD, some symptoms of these patients were relieved to a certain degree. However, the specific mechanism still remains unclear.We designed a study to figure out the effects of serum VD on gut microbiota, intestinal mucosal barrier and in patients with IBS-D.

Eligibility Criteria:
Inclusion Criteria:

* ①IBS-D patients meeting the Roman IV diagnostic criteria: recurrent abdominal pain, averaging at least 1 day per week in the last 3 months, with 2 or more of the following: associated with defecation, accompanied by changes in defecation frequency, accompanied by changes in fecal properties or appearance. (Symptoms have been present for at least 6 months before diagnosis, and meet the above diagnostic criteria in the last 3 months; \>1/4 (25%) stools were Bristol Stool Scale type 6 or 7, and \<1/4 (25%) stools were Bristol Stool Scale type 1 or 2); ② The age ranged from 18 to 65.

Exclusion Criteria:

* ① History of other gastrointestinal diseases, such as inflammatory bowel disease, infection, cancer, abdominal radiation or surgery, hepatobiliary and pancreatic diseases; ② Taking vitamin D drugs, calcium, contraceptives, glucocorticoids, probiotics, antibiotics, antidepressants, etc.; ③ Pregnancy and lactation; ④ Diabetes mellitus, thyroid disease, osteoporosis, etc.; ⑤ Complicated with serious heart, liver, lung, kidney, blood, serious mental diseases and other systemic diseases; (6) Boston Intestinal Preparation Scale score \<6; The cecum was not detected by endoscopy. ⑦ Unwilling to participate or unable to give informed consent.
Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants

The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome

Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of noninvasive high frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age (GA) is from 26 to 37 weeks;
2. Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
3. Respiratory distress syndrome Silverman score \>5;
4. Informed parental consent has been obtained.

Exclusion Criteria:

1. Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7;
2. Major congenital malformations or complex congenital heart disease;
3. Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
4. Cardiopulmonary arrest needing prolonged resuscitation;
5. transferred out of the neonatal intensive care unit without treatment.
Evaluation of qSOFA in Neurosurgical Patients

The aim of the study is to look if Quick Sequential Organ Failure Assessment Score score in detecting a eary Sepsis is afflicted by neurosurgical disorders


Eligibility Criteria:
Inclusion Criteria: one of the following diseases

* Subarachnoidal Bleeding
* Traumatic brain injury
* Spondylodiszitis

Exclusion Criteria:

* intubated before income
* Age under 16
Butyrate Adjuvant Therapy for Type 1 Diabetes

The investigators are interested to evaluate the effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy on metabolic control in type 1 diabetes (TID) subjects.

This study will test effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy in type 1 diabetes (TID) Subjects on metabolic control in this population. Insulin sensitivity, glucose control (variability) and triglycerides will be measured after 8 weeks of treatment and compared to baseline.

Eligibility Criteria:
Inclusion Criteria:

1. All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are \> 20 and \<80 years of age recruited from the Mayo Clinic Endocrinology Clinic;
2. Will also meet HbA1c level of 6.4-8.9% and BMI of \< 30 kg/m2 at week -4.

Exclusion Criteria:

1. Except for the use of insulin, no other treatments for T1D will be permitted.
2. Pregnancy
3. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
The Effectiveness of Hyperbaric Oxygen Therapy on Pneumonia Complicating Stroke

To investigate the evidence for the integration of hyperbaric oxygen therapy (HBOT) as part of interdisciplinary stroke rehabilitation.

Pneumonia complicating stroke is very difficult to manage and has a very poor prognosis, leading to a significantly higher risk of death. Oral opportunistic pathogens have been reported to be associated with the incidence of pneumonia among non-stroke immunocompromised subjects. Preliminary studies found that patients with stroke had higher carriage rates of oral opportunistic pathogens than healthy subjects. Therefore, investigators hypothesize that pneumonia complicating stroke is associated with oral opportunistic pathogens, and hyperbaric oxygen therapy may reduce the incidence of pneumonia complicating stroke by increasing the flow of saliva, which can affect the species and relative abundance of oral opportunistic pathogens. In order to prove this, investigators need to (1) firstly conduct a randomized controlled trial to confirm whether hyperbaric oxygen therapy is able to reduce the levels of plaque, and the incidence of pneumonia complicating stroke at clinical level; (2) secondly employ metagenomics analysis to compare oral rinse samples and respiratory samples, and to identify pneumonia-associated "oral opportunistic pathogens group"; (3) finally elucidate how hyperbaric oxygen therapy influences the species and relative abundance of oral opportunistic pathogens. This proposed study will provide evidence for the integration of hyperbaric oxygen therapy as part of interdisciplinary stroke rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* New stroke events within 1-3 months (confirmed by CT and MRI)
* Moderate to severe disability (Barthel Index \< 70)
* The patient is conscious, breathing autonomously, not undergoing tracheotomy or tracheal intubation for ventilator-assisted respiration
* No concurrent lower respiratory infections and other lung diseases
* The condition is relatively stable
* Cognitive function is normal to moderately impaired (Mini-Physical State Exchange, MMSE score\>18)
* The Gugging Swallowing Screen (GUSS) shows swallowing difficulties
* No systemic and local use of antibiotic-containing mouthwash

Exclusion Criteria:

* A mild disability (Barthel Index \> 70)
* The swallowing function is normal
* Indwelling nasogastric feeding tube
* The neurological status of the patient was significantly dynamically altered (significantly improved or worsened) in the short term prior to inclusion in the trial
* The patient had been treated with hyperbaric oxygen for other indications
* Had a chest condition and cannot withstand the pressure changes caused by hyperbaric oxygen therapy
* Have an inner ear disease
* Claustrophobia
* Communication barriers and inability to give informed consent
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer

Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative MBC.

This is a Phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573 in combination with an AI in adult subjects with HR+, HER2-negative MBC. This study has 2 phases: a dose-evaluation phase (Phase 1b) and a randomization phase (Phase 2).

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed MBC not deemed amenable to curative surgery or curative radiation therapy
* Tumors are positive for ER, PgR, or both
* Tumors must be negative for HER2 (by FISH, CISH or IHC)
* Female gender and age ≥ 18 years at time of study entry
* Postmenopausal
* Karnofsky Performance Status ≥ 70
* Life expectancy of ≥ 6 months

Exclusion Criteria:

* Subjects who received prior chemotherapy, hormonal therapy, immunotherapy or biologic therapy for advanced or metastatic disease with the following exceptions:

  * Prior adjuvant therapy with an AI and/or tamoxifen is allowed, provided treatment ended at least 2 weeks prior to the first dose of MEDI-573
  * Prior neoadjuvant and/or adjuvant chemotherapy for breast cancer is allowed
* Extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor, or disease that is considered by the investigator to be rapidly progressing or life threatening (eg, subjects who are intended for chemotherapy)
* Active brain metastases with the exception of subject has been treated and are asymptomatic and there has been no evidence of CNS progression for at least 4 weeks of first dose of MEDI-573
* Evidence of ongoing spinal cord compression or leptomeningeal carcinomatosis
* Unresolved toxicities from prior therapy with the exception of alopecia that have not resolved to ≤ Grade 1 at the time of starting study treatment
* Previous treatment with agents that target the IGF receptor
* History of allergy or reaction attributed to compounds of chemical or biologic composition similar to those of MEDI-573 or AI
* History of another invasive malignancy within 5 years except for curatively resected nonmelanoma skin cancer or carcinoma in situ of the cervix
* Poorly controlled diabetes mellitus
A Drug-drug Interaction (DDI) Study to Assess the Effect of INC280 on the Pharmacokinetics of Digoxin and Rosuvastatin in Patients With cMET-dysregulated Advanced Solid Tumors

the study aim to assess the effect of INC280 on the pharmacokinetics of digoxin and rosuvastatin in patients with cMET-dysregulated advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

Patients must have:

* advanced solid tumors and have confirmed cMET dysregulation
* at least one measurable lesion as defined by RECIST 1.1.
* recovered from all toxicities related to prior anti-cancer therapies
* adequate organ function
* ECOG performance status (PS) of 0 or 1

Exclusion Criteria:

Patients must not have:

* known hypersensitivity to any of the excipients of INC280
* prior treatment with cMET or HGF-targeting inhibitor
* known hypersensitivity to digoxin or rosuvastatin or its excipients
* symptomatic central nervous system (CNS) metastases who are neurologically unstable
* presence or history of carcinomatous meningitis
* history of another primary malignancy that is currently clinically significant or currently requires active intervention
* Clinically significant, uncontrolled heart diseases, including QTcF ≥ 450 msec (male patients), ≥ 460 msec (female patients) on the screening ECG
* Thoracic radiotherapy to lung fields ≤ 4 weeks prior to starting INC280
* Major surgery within 4 weeks prior to starting INC280
* Patients receiving unstable or increasing doses of corticosteroids.
* Impairment of GI function or GI disease that may significantly alter the absorption of INC280
* Patients who have received, or are expected to receive digoxin or rosuvastatin within 21 days prior to the beginning of the DDI phase (Day 1) and for the duration of the DDI phase.

Other protocol-defined inclusion/exclusion criteria may apply
Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood transfusions and may be an effective treatment for myelodysplastic syndrome or chronic myelomonocytic leukemia.

PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.

OBJECTIVES:

* Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol.
* Determine the toxicity profile of this drug in these patients.
* Determine the time to progression and overall survival of patients treated with this drug.

OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic myelomonocytic leukemia

  * No more than 20% blasts by bone marrow biopsy
* Must meet at least 1 of the following criteria:

  * Anemia

    * Hemoglobin less than 11 g/dL over a 2-month period
  * Thrombocytopenia
  * Neutropenia

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* See Disease Characteristics

Hepatic

* ALT and AST less than 1.5 times upper limit of normal
* Bilirubin less than 3 mg/dL
* Albumin greater than 3.0 g/dL

Renal

* Creatinine clearance greater than 50 mL/min
* No history of hypercalcemia
* No renal stones within the past 5 years

Cardiovascular

* No clinically significant heart failure
* No uncontrolled hypertension

Pulmonary

* No clinically significant pulmonary failure

Other

* Not pregnant
* Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

* At least 4 weeks since prior growth factor or cytokine therapy

Chemotherapy

* At least 8 weeks since prior cytotoxic chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* Concurrent transfusion support allowed
A Post-Market Study to Evaluate Adverse Event Incidence Rates in Patients With Skin of Color Undergoing Correction of Nasolabial Folds With Hylaform, Hylaform Plus and Captique.

To assess the likelihood of keloid and scar formation, pigmentation disorders and hypersensitivity reactions in patients with skin of color undergoing correction of facial soft tissue contour deficiencies with Hylaform, Hylaform Plus or Captique.


Eligibility Criteria:
Inclusion Criteria:

* bilateral nasolabial folds with severity score 3 or 4 on the 6-point grading scale

Exclusion Criteria:

* pregnant/lactating women
* patients who previously received permanent facial implants or using over-the-counter products