cyrilzakka/clinical-trials huggingface dataset:
A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-99282 alone and in combination with anti-lymphoma agents in participants with relapsed or refractory non-Hodgkin's lymphomas.

Participants with relapsed or refractory non-Hodgkin's lymphomas (R/R NHL) who have failed at least 2 lines of therapy (or have received at least one prior line of standard therapy and are not eligible for any other therapy).

The dose escalation will evaluate the safety and tolerability of escalating doses of CC-99282 in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and/or relapsed or refractory follicular lymphoma (R/R FL) participants to determine the maximum tolerated dose (MTD) of CC-99282 as monotherapy.

The dose expansion will further evaluate the safety and preliminary efficacy of single agent CC-99282 or the safety and preliminary efficacy of CC-99282 in combination with anti-lymphoma agents in participants with R/R DLBCL and NHL.

Part B Cohort B will further evaluate the potential effects of food on the PK and safety of CC-99282.

Eligibility Criteria:
Inclusion Criteria:

* History of Non-Hodgkin's Lymphoma (NHL) with relapsed or refractory disease
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

* Life expectancy ≤ 2 months
* Received prior systemic anti-cancer treatment (approved or investigational) ≤ 5 half-lives or 4 weeks prior to starting CC-99282, whichever is shorter
* Is on chronic systemic immunosuppressive therapy or corticosteroids or has clinically significant graft-versus-host disease (GVHD)
* Impaired cardiac function or clinically significant cardiac disease

Other protocol-defined inclusion/exclusion criteria apply
Project COPE:Managing Dementia at Home

This study tests the effectiveness of an in-home intervention to reduce upset and burden among family caregivers, and decrease nursing home placement. The main hypothesis that will be tested is that compared to control group, subjects, experimental group participants will have enhanced well-being and fewer nursing home placements.

Implement a multi-component in-home intervention designed to prevent and ameliorate the troublesome behaviors that families typically confront and that often trigger nursing home placement. The intervention combines the most effective strategies that have been identified in previous caregiver research by the investigative team and best clinical practices to provide a comprehensive service approach to families and individuals with dementia including education, skills training, home safety, and stress management. To enhance its applicability to real-world practice within the aging service network, the intervention is designed to be reproducible and its components and treatment goals commensurate with the Medicaid Waiver Program. In the absence of evidence-based service protocols currently in place for this Waiver population, the intervention, if effective, would provide a systematic, evidence-based approach in the Medicaid Waiver program to help families and persons with dementia remain at home and in their communities.

Eligibility Criteria:
Inclusion Criteria:

* Care-recipients must have a MMSE score \< 24 and a diagnosis of dementia, live in the community, and either need help with one or more daily activities and/or have one or more behavioral occurrences. Caregivers must be a relative, at least 21 years of age, be English speaking, have a telephone, either live with the care-recipient (CR) or spend at least 48 hours per week in direct oversight or caring for him/her; plan to live in the area for 9 months, report upset with CR function dependence or behavioral occurrences.

Exclusion Criteria:

* The CG-CR dyad will be excluded if CR has had more than 3 hospitalizations within the past 12 months, are in treatment for life-threatening cancer, have schizophrenia or a bipolar disorder, have dementia secondary to head trauma, have a MMSE score = 0 and are bed-bound (defined as confinement to bed or chair for at least 22 hours a day for at least four of the previous seven days); or they are enrolled in a clinical trial of pharmacological treatment for agitation. Also, the dyad will be excluded if the CG had more than 3 hospitalizations within the past 12 months or is in treatment for life-threatening cancer; is involved in another clinical trial of psychosocial or educational interventions for caregivers; or plans to place their family member in a nursing home within the next 9-months.
To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study

This is a single blind, single dose, crossover study to investigate the relative efficacy of terbutaline Turbuhaler® 0.4 mg in relation to salbutamol pressurized Metered Dose Inhaler (pMDI) 200 μg in Japanese adult asthmatic patients.The secondary objective of this study is to investigate safety of terbutaline Turbuhaler® 0.4 mg in Japanese adult asthma patients by means of adverse events (AEs) and vital signs (blood pressure, pulse rate). The subject population includes Japanese patients (16 years of age or older) with asthma who need treatment with inhaled Glucocorticosteroids (ICS).


Eligibility Criteria:
Inclusion Criteria:

* On ICS for at least 3 months from Visit 2 and with a prescribed constant dose during the 4 weeks prior to Visit 2
* Forced Expiratory Volume in 1 Second (FEV1) of at least 50 % of predicted normal value pre-bronchodilator
* Reversible airway obstruction according to reversibility test performed at Visit 2, defined as an increase in Forced Expiratory Volume in 1 Second (FEV1) ≥12% relative baseline at 15-30 minutes after inhalation of in total 400 μg salbutamol

Exclusion Criteria:

* Treatment with oral, parenteral or rectal GCS (Glucocorticosteroids)within 4 weeks or depot parenteral GCS (Glucocorticosteroids) within 3 months prior to Visit 2.
* Change in prescribed asthma medication due to exacerbation of asthma within 4 weeks prior to Visit 2 or being hospitalized due to exacerbation of asthma within 8 weeks prior to Visit 2.
Acetaminophen/Naproxen Sodium Dose Ranging Study

Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.

This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:\[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo\] following surgical extraction of four third molars.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females 17-50 years old
2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
3. Surgical removal of three or four third molars, of which, two must be mandibular impactions
4. Meets requirements for post-surgical pain level
5. Females of childbearing potential and males agree to contraceptive requirements of study
6. Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

1. Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, oxycodone or other opioids;
3. Not able to swallow whole large tablets or capsules
4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
5. Use analgesics 5 or more times per week
6. History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
7. Use of any immunosuppressive drugs within 2 weeks of screening
8. History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years
Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital

The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital.

The primary aim is to determine the incidence of delirium and to determine risk factors for this group of patients to develop a prediction model.

A secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation.

According to Dutch law, the need to obtain informed consent was waived by the Committee on Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).


Eligibility Criteria:
Inclusion Criteria:

* all adult patients (18 years and older) admitted at the critical care unit of our hospital

Exclusion Criteria:

* not able to understand Dutch
* patients with serious hearing and visibility disabilities
* mentally retarded patients
Pregabalin vs. Gabapentin on Reducing Opioid Usage

This is a single-center, randomized, open-label, Phase 4 clinical trial investigating the efficacy of multiple-dose administrations of Pregabalin or Gabapentin in combination with traditional opioid pain medications to decrease the amount of opioid pain medication usage in single-system orthopedic trauma patients.


Eligibility Criteria:
Inclusion Criteria:

1. Nurse Practitioner service admissions
2. 18 years of age or older
3. Patients enrolled within 36 hours of admission
4. Anticipated duration of hospitalization \> 24 hours from time of consent
5. Active order(s) for opioids in place at the time of enrollment

Exclusion Criteria:

1. Clinician discretion based on patient care management
2. Intubated patients
3. Patients with epidural
4. Patients with pregabalin/gabapentin as home medications
5. Patients receiving pregabalin/gabapentin upon admission
6. Traumatic brain injury patients
7. CrCl\<30ml/min or on HD
8. Unable to take enteral medications
9. On Patient Controlled Analgesia (PCA)
10. Patients with complicated wound closure
11. History of epilepsy
12. Documented history of substance use disorder
Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
* No prior chemotherapy for locally advanced or metastatic breast disease.
* Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
* Adequate bone marrow, liver and kidney function
* RECIST criteria for disease status

Exclusion Criteria:

* Prior treatment with pemetrexed
* Pregnant or breast feeding
* Brain Metastasis
* unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
Trial for the Early Identification of Acute Kidney Injury

Previse is a novel, software-based clinical decision support (CDS) system that predicts acute kidney injury (AKI). Previse uses machine learning methods and information drawn from the electronic health record (EHR) to identify the early signs of acute kidney injury; by doing so before the clinical syndrome of AKI is fully developed, Previse can give clinicians the time to intervene with the goals of preventing further kidney damage, and decreasing the sequelae of AKI. It has been demonstrated in retrospective work that Previse can predict AKI with high accuracy at long prediction horizons, but the tool has yet to be validated in prospective settings; therefore, in this project, the clinical utility of Previse will be assessed through an individually randomized controlled multicenter trial.

The trial is designed as an individually randomized, controlled, and non-blinded multicenter prevention trial with a baseline period and a primary endpoint of proportion of patients meeting one or more criteria for the Major Adverse Kidney Events within 30 days (MAKE30) composite of death, new renal replacement therapy, or persistent creatinine elevation ≥ 200% of baseline, all censored at the first of hospital discharge or 30 days. The trial will evaluate the efficacy of a machine learning algorithm for AKI prediction, in approximately 8,574 patients aged ≥ 18 years admitted to one of three participating study hospitals. Individual patient randomization will be performed at the time of the alert with a 1:1 allocation ratio. Patients will be evaluated for inclusion in the trial upon admission, and will be automatically enrolled upon meeting inclusion criteria. Because data collection will be conducted through noninvasive procedures that are routinely employed in clinical practice, it will require a waiver of informed consent. Trial efficacy will be assessed at regularly scheduled study visits, and safety will be monitored on an ongoing basis for all patients. Safety will be assessed through the collection of adverse events, laboratory tests, vital signs, and physical examinations throughout the study. An independent Data Monitoring Committee (DMC) will be formed to assist in the periodic monitoring of safety, data quality, and integrity of study conduct. In addition, the DMC will review the interim efficacy analysis performed to determine whether the primary endpoint has been met. Total trial duration is expected to be approximately 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years admitted to a participating study hospital

Exclusion Criteria:

* ﹤18 years of age
* ESRD diagnosis code
* Stage 4 or Stage 5 CKD diagnosis code
* Initial creatinine ≥4.0mg/dl
* Nephrectomy during admission
* Admission to hospice service
* Admission to observation status
* Any organ transplant (including kidney transplant) within 6 months
* Dialysis order prior to AKI onset
* Dialysis order within 24 hours of admission
* Prior admission in which patient was randomized
Insulin in Treatment of Diabetes Mellitus With Pregnancy

The prevalence of diabetes melilites is rapidly increasing over years and consequently during pregnancy. In 2017, there were 21.3 million pregnant women who experienced hyperglycemia, of which 86.4% of them were diagnosed with gestational diabetes melilites.

Pregnancy in women with diabetes is associated with an intensification in adverse maternal, fetal and perinatal outcomes including spontaneous abortions, congenital malformations, preterm labor, and macrosomia. Several studies have confirmed that poor glycemic control in women with either gestational, type 1 or type 2 diabetes during pregnancy is associated with poor pregnancy outcomes. In the same line, proper glycemic control before, early, and through all pregnancy markedly improves both maternal and fetal outcomes.

Insulin therapy is the standard treatment of diabetes melilites with the pregnancy if dietary control and exercise fail. However, insulin therapy has its difficulties like approaches to mimicking postprandial insulin release, providing adequate background insulin, balancing insulin dosage, food, activity, hypoglycemic episodes, overall glycemia. This is always a struggle for doctors and patients and much affecting their lifestyle


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 - 45 years old,
* Women with pre-gestational diabetes.
* Those who were under premixed insulin therapy prior to pregnancy.
* women pregnant between 14 weeks up to 28 weeks of gestation

Exclusion Criteria:

* History of recurrent miscarriage
* multiple pregnancies
* chronic hypertension
* severe heart, liver, and kidney disease.
* women how got pregnant after assisted reproduction
* those with advanced retinopathy, hypersensitivity to insulin.
* Women who developed bleeding in early pregnancy and those diagnosed to have any major anomaly during the first-trimester scan.
Is a Woolen Cap Effective in Maintaining Normothermia in Preterm Infants During Kangaroo Mother Care?

The aim of the present study is to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during Kangaroo Mother Care (KMC).

Background: Neonatal hypothermia is an important challenge associated with morbidity and mortality. Preventing neonatal hypothermia is important in high resource countries, but is of fundamental importance in low resource settings where supportive care is limited.

Kangaroo mother care (KMC) is a low-cost intervention that, whenever possible, is strongly recommended for temperature maintenance. During KMC, the World Health Organization (WHO) guidelines recommend the use of a cap/hat, but its effect temperature control during KMC remains to be established.

In the hospitals participating to the projects of the non-governmental organization CUAMM, KMC represents a standard of care, but the head of the babies often remains uncovered due to local habits or to the unavailability of a cap.

Objective: The aim of the present study will be to assess the effectiveness and the safety of a woolen cap in maintaining normothermia in low birth weight infants (LBWI) during KMC.

Methods: This is a multicenter (three hospitals), multi country (three countries), prospective, unblinded, randomized clinical trial of KMC treatment with and without a woolen cap in LBWI. After obtaining parental consent, all infants with a birth weight \<2500 g and candidate to KMC will be assigned to KMC with woolen cap or to KMC without cap group in a 1:1 ratio according to a computer-generated randomized sequence. The primary outcome measure will be the temperature in the normal range (36.5-37.5°C) in course of KMC during the first week of life. In all participants, axillary temperature will be measured with a digital thermometer 4 times per day. In addition, maternal and room temperature will be recorded. Secondary outcome measures will be: episodes of apnea; sepsis; mortality before hospital discharge; in-hospital growth; age at discharge.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \<2500 g (and)
* Candidate to KMC treatment (and)
* Parental consent; a written informed consent will be obtained by a member of the neonatal - Team involved in the study from a parent or guardian before KMC treatment

Exclusion Criteria:

* Major congenital malformations
* Twins
* Parental refusal to participate to the study
Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers

To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.


Eligibility Criteria:
Inclusion Criteria:

* HV aged between 18 - 60 years

Exclusion Criteria:

* history of psychiatric disease or a positive first degree psychiatric family history
* pregnancy or lactation
* concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, ...)
* medication affecting esophageal motility
* significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
* prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
* history of gastrointestinal disease
Follow-up of Malnutrition Screening in USINV

This aim of the study is to set up a procedure for screening for undernutrition in the neurovascular intensive care unit. This screening procedure follows a specific work concerning undernutrition in thrombolyzed patients (NCT03303820). This work was motivated by the fact that, despite a high frequency of undernutrition in the hospital (at least 30% of patients), undernutrition in neurovascular unit is studied very little. A cohort of thrombolysed patients in 2014 was studied retrospectively. Patients malnourished at the entrance had a non-significant, less good recovery of their stroke (+ 1 Rankin score point at 3 months in malnourished patients at the entrance).

The main objective of this project is to assess, prospectively, the frequency of undernutrition at the entrance to the neurovascular intensive care unit and to evaluate the implementation of the undernutrition screening procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patient whose age ≥ 70 years
* Patient hospitalized in Neurovascular Intensive care Unit following a stroke (infarction or cerebral hematoma)
* Francophone patient

Exclusion Criteria:

* Patient hospitalized in Neurovascular Intensive care Unit following a transient ischemic attack
* Patient whose age ≤ 70 years
* Patient hospitalized in Neurovascular Intensive care Unit for another reason than neurovascular disease
* Patient opposing the use of his data
The Effectiveness of Metoprolol in the Prevention of Syncope Recurrence in Children and Adolescents

The purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.

Syncope is often a frustrating clinical problem seen in pediatric patients. Most pediatric syncope is benign, and vasovagal syncope (VVS) is the most common type of syncope seen in children . The diagnosis of VVS is established by history, often confirmed by tilt tests. A wide range of drugs has been proposed for VVS , with β-adrenergic blocking agents being first-line therapy. However, clinical studies have shown conflicting results in terms of therapy effectiveness. β-blockers have been claimed to be effective for 60% to 100% of young patients in many uncontrolled studies but not in most short- and long-term controlled studies . Sheldon et al., in a recent multicenter, double-blinded, placebo-controlled, randomized study of adult patients, reported that metoprolol was not effective in preventing VVS. To our knowledge, no pediatric randomized controlled trials with long-term follow-up have demonstrated the efficacy of β-blockers for the prevention of syncope.

Eligibility Criteria:
Inclusion Criteria:

* Children with a history of syncope were included if they had had at least three syncopal episodes per year and had a positive head-up tilt test result.

Exclusion Criteria:

* Patients were excluded if they had:

  * Other causes of syncope;
  * Cardiovascular and/or systemic disease;
  * Systolic blood pressure \>130 mm Hg or diastolic blood pressure \>90 mm Hg； or
  * History of asthma, impaired liver function, Ⅱ to Ⅲ degrees of atrioventricular block, sinus bradycardia \< 40 beats/min, or other contraindications for β-blockers.