cyrilzakka/clinical-trials huggingface dataset:
Prevention of Post-Extubation Laryngeal Edema With Intravenous Corticosteroids

Tracheal intubation is a frequent procedure in intensive care units (ICU). Post-extubation laryngeal edema is a frequent complication with potential morbidity and mortality, and may lead to urgent tracheal re-intubation. Corticosteroids have been proposed to reduce the incidence of post-extubation laryngeal edema. A few clinical studies have been conducted in adult ICU patients and have led to discrepant results. These discrepancies may be related to the time lag separating the administration of the corticosteroids and the planned extubation. Accordingly, we tested the hypothesis that pretreatment with corticosteroids initiated 12 hours before a planned extubation may efficiently prevent the occurrence of postextubation laryngeal edema in critically-ill adults who have been mechanically ventilated for more than 36 hours in the ICU.

We conducted a prospective, double-blind, placebo-controlled, multicenter trial of 12-hour-pretreatment by methylprednisolone before a planned extubation in adult patients ventilated for more than 36 hours in the ICU. Methylprednisolone (20 mg) or placebo was first administered intravenously 12 hours before extubation and continued every 4 hours until tube removal. Primary endpoint was the occurrence of laryngeal edema within 24 hours of extubation. Laryngeal edema was clinically diagnosed and considered as major when requiring tracheal reintubation.

Eligibility Criteria:
Inclusion Criteria:

* Adult ≥ 18 years
* Intubated for ≥ 36 hours
* Scheduled extubation
* Informed written consent

Exclusion Criteria:

* pregnancy
* history of postextubation laryngeal dyspnea
* laryngeal disease
* tracheotomy
* patient receiving corticotherapy prior to admission
* traumatic intubation
* participation to this study or to another trial
Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin™ Treatment in Subjects With Phenylketonuria

The primary objective is to evaluate the degree and frequency of response to Phenoptin™ (sapropterin dihydrochloride), as demonstrated by a reduction in blood phenylalanine (Phe) level among subjects with phenylketonuria (PKU) who have elevated Phe levels. A secondary objective of this study is to evaluate the safety of Phenoptin™ treatment in this subject population, and identify individuals in this subject population who respond to Phenoptin™ treatment with a reduction in blood Phe level.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 8 years
* Blood Phe level \>/= 450 umol/L at screening
* Clinical diagnosis of PKU with hyperphenylalaninemia documented by past medical history of at least one blood Phe measurement \>/= 360 umol/L (6 mg/dL)
* Willing and able to provide written informed consent or, in the case of subjects under the age of 18, provide written assent (if required) and written informed consent by a parent or legal guardian, after the nature of the study has been explained
* Negative urine pregnancy test at screening (non-sterile females of child-bearing potential only)
* Male and Female subjects of childbearing potential childbearing potential (if sexually active and non-sterile) must be using acceptable birth control measures, as determined by the investigator, and willing to continue to use acceptable birth control measures while participating in the study
* Willing and able to comply with study procedures
* Willing to continue current diet unchanged while participating in the study

Exclusion Criteria:

* Perceived to be unreliable or unavailable for study participation or, if under the age of 18, have parents or legal guardians who are perceived to be unreliable or unavailable
* Use of any investigational agent within 30 days prior to screening, or requirement for any investigational agent or vaccine prior to completion of all scheduled study assessments
* Pregnant or breastfeeding, or considering pregnancy
* ALT \> 5 times the upper limit of normal (i.e., Grade 3 or higher based on World Health Organization Toxicity Criteria) at screening
* Concurrent disease or condition that would interfere with study participation or safety (e.g., seizure disorder, oral steroid-dependent asthma or other condition requiring oral or parenteral corticosteroid administration, or insulin-dependent diabetes, or organ transplantation)
* Serious neuropsychiatric illness (e.g., major depression) not currently under medical control
* Requirement for concomitant treatment with any drug known to inhibit folate synthesis (e.g., methotrexate)
* Concurrent use of levodopa
* Clinical diagnosis of primary BH4 deficiency
A Study of Patients With Chronic Disease

TARGET-RWE is a 10-year, international, longitudinal, observational study of patients with chronic disease designed to specifically address important clinical questions that remain incompletely answered from registration trials. The protocol will follow a master protocol design in which a shared study infrastructure supports progressive development of the registry across the spectrum of chronic diseases.

The TARGET-RWE master protocol design allows shared study parameters and operational components to be organized within a centralized platform. Utilizing this platform, therapeutic area-aligned Communities with associated Disease-Specific Cohorts (DSC) can be added according to scientific merit and need to address specific research questions in patients diagnosed with chronic diseases. This design capitalizes on a shared, sustainable infrastructure across a diverse patient population, which allows for more efficient coordination and conduct than can be achieved in traditional stand-alone, independently-conducted research studies with narrowly-focused target patient populations. This master protocol design will ultimately support a dynamic program that adapts to the changing landscape of chronic disease management and allows for rapid enrollment and collection of retrospective and long-term prospective data from participants in specific disease areas of interest.

TARGET-RWE currently includes the TARGET-RWE.LUNG Community, with open DSCs for Asthma, COPD and Idiopathic Pulmonary Fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Adults and children being managed or treated for a chronic disease under study. Diagnosis is based on the clinical judgement of the care provider.
* Patient is anticipated to have continued management of their chronic disease at the participating site.

Exclusion Criteria:

* Inability to provide informed assent/consent.
Pilot Study of Infrared Imaging of Cutaneous Melanoma

Design: this is a pilot study of infrared imaging of cutaneous lesions in patients and volunteers with and without clinically detectable melanoma, and with one or more palpable cutaneous lesions eligible for this imaging study. Participants will be evaluated with infrared camera imaging at cutaneous sites with known melanoma deposits, suspected melanoma deposits that are to be biopsied, or at cutaneous sites with other lesions, including other skin cancers, benign inflammatory lesions, benign neoplastic lesions (lipomas, epidermal cysts, dermatofibromas, scar, healing wound, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Patients or volunteers with or without a history of melanoma.
* One or more palpable skin or subcutaneous lesions for which at least one of the following is true:

  * A tissue diagnosis has been made for the lesion(s) in question, by prior cytologic or histologic evaluation (Category A1).
  * A tissue diagnosis will be obtained for the lesion(s) in question by cytologic or histologic evaluation (Category A2).
  * A tissue diagnosis is not available, but a clinical diagnosis of melanoma or benign lesion is available with a high degree of confidence. Examples are hemangiomas, skin tags, seborrheic keratoses, dermatofibromas, lipomas, or growing pigmented skin lesions that are comparable to other cutaneous metastases of melanoma in the same patient (Category B).
* All patients must have the ability and willingness to give informed consent and must be age 18 years or older at the time of study entry.

Exclusion Criteria:

* Known or suspected allergy to the adhesive skin markers or water-soluble ink used for the labeling of lesions.
* Very fragile skin that may be susceptible to injury from adhesive markers.
* Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
Effects of an OT Workstation Intervention on Knowledge, Self-efficacy, and Habit Formation

The study aims to determine whether a face to face ergonomic workstation intervention has any advantage over an online instructional training program for acquisition of knowledge, self-efficacy, and habit formation.

Thirty participants will be recruited from the staff of Virginia Commonwealth University via recruitment fliers distributed through the Staff Senate. Potential participants will be informed that participation in the study will require them to work with the research team at their computer workstations outside of designated working hours, e.g., before or after work, during lunch break, or on a weekend. Potential participants will be reminded that they may need to obtain approval from direct supervisors to use university equipment, i.e., their computer workstations, during non-working hours. All participants will be asked to complete knowledge, self-efficacy, and habit formation survey regarding computer workstation ergonomics via REDCap.

Participants will receive an email with the link to the REDCap surveys.

Those participants randomly assigned to the control group will complete the OSHA Computer Workstations eTool, available at (https://www.osha.gov/SLTC/etools/computerworkstations/wkstation_enviro.html). The eTool consists of 5 sections: 1) Good Working Positions, 2) Workstation Components, 3) Checklists, 4) Work Process, and 5) Workstation Environment.

Those participants who are assigned to the intervention group will be contacted by the investigators to schedule face to face visits at their computer workstations. Face to face intervention will consist of educating the participant on points of computer workstation ergonomics, direct observation of the participant working at her/his workstation, evaluation of workstation characteristics, instruction on how to alter workstation features, and instruction on best practices for exercise and scheduling of breaks to prevent pain, discomfort, and injury.

All participants will be contacted via email 2 weeks following the interventions to complete the post-test knowledge, self-efficacy, and habit formation survey on RedCap.

Eligibility Criteria:
Inclusion Criteria:

* 21 years old or older.
* Work at computer workstation at least 30% of a typical day.

Exclusion Criteria:

-
Bronx MBCT-Migraine

This randomized clinical trial aims to examine the effect of a standardized 8-week course of Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people with migraine.


Eligibility Criteria:
Inclusion Criteria:

* ICHD-3 beta headache diagnosis of migraine,
* self-reported and diary-confirmed 4-20 headache days per month
* aged 18-65
* ability to read English
* capacity to consent.

Exclusion Criteria:

* no ICHD-3 beta headache diagnosis of migraine
* fewer than 4 or greater than 20 headache days per month
* under 18 or over 65
* inability to read English
* lacking the capacity to consent
* utilization of new preventative pain treatments within four weeks of the baseline assessment, or a plan to utilize new preventive pain medications during the duration of the study
* severe psychiatric illness that would interfere with participation in the treatment
Effect of Iron Versus Multiple Micronutrient Supplementation on Anemia in Preschool Children of Malaria-Endemic Area

Some micronutrients are likely to interact with malaria parasite, leading to either synergistic or antagonist effect on malaria morbidity and therefore on hemoglobin response.

The purpose of this study is to investigate the effect of supplementation with iron or multiple micronutrients on anemia while integrated with malaria management in rural Burkinabe young anemic children with high prevalence of malaria.

This is a community-based randomised double-blind trial. Children aged 6-23 months are randomised to receive either iron (n=91), iron and zinc (IZ, n=90) or MMN (n=89), 5 days/week for 6 months. Supplements are manufactured by Nutriset (Malaunay, France) as specifically fortified "plumpy-nut". They are presented in 90 ml boxes coded A, B and C each lot of boxes contained in white packing labelled A, B and C respectively. Malaria is managed in concordance with the national malaria program standards. All mothers receive one insecticide-treated bed-net (PermaNet®, Vestergaard Frandsen Disease Control Textiles) and instruction for effective utilization for children. All children with positive smear for Plasmodium falciparum are artemether+lumefantrine-treated (Coartem®, Novartis Pharma S.A.S., France) regardless of the clinical status. Children aged of at least 12 months receive 200 mg albendazole, one week prior to the supplementation starting.

Data collection involves:

* a questionnaire addressed to mothers at baseline,
* a medical examination of mothers and children at baseline: A general practitioner examines mothers for goiter determination according to the International Council for the Control of Iodine Deficiency Disorders (ICCIDD) definition and classification, and children for splenomegaly that is classified according to Hackett. Anthropometrical measurements are performed on children and mothers by a nutritionist, in agreement with the WHO recommendations. Children's capillary blood is obtained by lab technicians through a finger stick for hemoglobin measurement and malaria blood smear preparation. Hemoglobin is measured using a HemoCue® machine (Hemocue HB 201+, Angelholm, Sweden) to the nearest 1g/L.
* malaria microscopic detection at baseline and monthly during the study: blood smears intending to detect malaria infection are stained with Giemsa, and read in duplicate at the local hospital laboratory,
* a daily record of supplementation and morbidity data (diarrhoea, fever, cough).

The endpoints considered for analysis are change of hemoglobin (final haemoglobin minus baseline haemoglobin concentration) and final anemia status that are analysed by multiple linear regression and logistic regression respectively.

Eligibility Criteria:
Inclusion Criteria:

* age of 6-23 months
* hemoglobin concentration range of 70-109 g/L

Exclusion Criteria:

* severe wasting (weight-for-height z-score \< -3)
Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes

This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1\*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype

This is a Phase 1, open-label, nonrandomized study to determine the PK profiles of belinostat in patients with relapsed/refractory solid tumors or hematological malignancies who have heterozygous and homozygous UGT1A1\*28 genotypes and wild-type UGT1A1 gene. Enrolled patients will be assigned to 1 of 3 cohorts (A, B, or C) based on their UGT1A1 genotype

Enrollment into all cohorts will occur simultaneously rather than sequentially. Belinostat will be administered via a 30-minute infusion once daily from Day 1 to Day 5 of one 21-day cycle. Clinical safety will be monitored in each patient. Blood samples for PK analysis will be collected from Day 1 to Day 3, and urine samples for PK analysis will be collected from Day 1 to Day 4.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is diagnosed with advanced solid tumors or advanced hematological malignancy that is relapsed/refractory, for which no standard salvage therapy exists.
2. Patient must have received at least 1 prior systemic therapy for the current malignancy and has recovered from any toxicity of the prior therapy at screening.
3. Patient has adequate hematological and hepatic functions.

Exclusion Criteria:

1. Patient is taking UGT1A1 inhibitors (eg, atazanavir, gemfibrozil, indinavir, ketoconazole, sorafenib) at screening.
2. Patient has HBV or HCV
3. Patient has a known HIV positive diagnosis.
4. Patient has congestive heart failure Class III/IV
5. Patient has had previous exposure to belinostat.
Physical Activity Variety's Impact on Physical Activity Participation

The primary purpose of the proposed study is to examine the effect of a home-based physical activity variety intervention on objectively measured physical activity in an eight-week randomized intervention trial.

The primary purpose of the proposed study is to examine the effect of a home-based physical activity variety intervention on objectively measured physical activity in an eight-week randomized intervention trial. Early research on physical activity variety has observed increased physical activity participation, motivation, and enjoyment as a result of physical activity variety. However, previous studies examining variety have not included home-based interventions, objective measures of physical activity, or cardiovascular fitness classes.

Forty low-active college students will be randomly assigned to either an eight-week physical activity variety intervention (n=20) or a physical activity consistency comparison condition (n=20). Physical activity will be assessed via an accelerometer (e.g., Actigraph) at baseline and eight weeks, and psychosocial variables at baseline, four weeks, and eight weeks (i.e., post-intervention). Affect will be assessed at one, four, and eight weeks. Participants will receive counseling sessions and access to a website containing workouts appropriate to their condition.

Eligibility Criteria:
Inclusion Criteria:

* Engaged in no or low levels of physical activity (less than 90 minutes of moderate to vigorous intensity physical activity per week)
* Capable of completing a 30-minute session of physical activity
* 18-25 years of age old

Exclusion Criteria:

* Pregnant individuals
* Cannot read in English
* No access to the internet
* Healthcare providers have instructed them not to be active
* Any medical condition that would make physical activity unsafe or unwise
Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease

The purposes of this study are to collect and store samples including blood, normal and tumor tissue from patients with colorectal cancer or gastric cancer, to collect and store samples including blood and/or normal gastrointestinal tissue (if available) from patients with non-malignant disease (including, but not limited to, inflammatory bowel disease (IBD), gastric ulcer, hemorrhoids or hernia), and to create a database for the collected samples and allow access to relevant clinical information for current and future protocols.


Eligibility Criteria:
Inclusion Criteria:

* Any patient diagnosed with colorectal cancer, gastric cancer, non-malignant disease that requires undergoing surgery.
* Must be willing and able to provide informed consent.

Exclusion Criteria:

* Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.
Efficiency of Everolimus for the Treatment of Kidney Transplanted Patients Presenting a Missing Self-induced NK-mediated Rejection

Background:

Long-term success of organ transplantation is limited by the inexorable loss of graft function due to rejection. Prevalent dogma defends that allograft rejection is exclusively mediated by the adaptive immune system: T cells are responsible for cellular rejections and B cells producing Donor Specific Antibodies (DSA) are responsible for humoral rejection. Recently, we demonstrated that innate NK cells could be implicated in the generation of chronic vascular rejections lesions by sensing the absence of expression of self Major Histocompatibility Complex (MHC) class I molecules ("missing self") on graft endothelial cells with their Killer cell immunoglobulin-like (KIR) receptors. Using human in vitro and murine in vivo models, we also showed that Mammalian Target Of Rapamycin (mTOR) inhibitors could efficiently prevent this new kind of rejection.

Objective:

The aim of our project is therefore to test in a cohort of kidney transplanted patients the efficiency of mTOR inhibitors to treat this new kind of rejection

Methods:

A cohort of 20 kidney transplant patients with a missing self on their graft responsible for a NK-mediated rejection will be established prospectively. An mTOR inhibitor will be introduced in these patients for 6 months in association with a calcineurin inhibitor and corticosteroids. Graft function, histological lesions and NK activability will be monitored following this modification of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged \> 18 years
* Kidney transplanted patient
* Having microvascular inflammation lesion on his graft biopsy associated to mild chronic lesions
* In absence of donor specific antibodies
* In presence of a missing self

Exclusion Criteria:

* Proteinuria/urinary creatinin \> 100 mg/mmol
* Antecedent of poor tolerance or hypersensibility to everolimus or sirolimus
* Severe chronic lesions
* Presence of donor specific antibodies
Negative Pressure Wound Therapy vs Standard Care Dressing

A comparison between the efficacy of negative pressure wound therapy and the efficacy of standard care dressing

The aim of our study is to compare the efficacy of negative pressure wound therapy (Prevena) and standard clinical dressing in terms of prevention of postoperative surgical site infection, length of hospital stay, and total cost of hospitalization among vascular, plastic and general surgery patients.

Eligibility Criteria:
Inclusion Criteria:

* Consent for participation from the patient or his legal representative

Exclusion Criteria:

* Currently infected wounds
* Patients with history of immunosupression
* Pregnancy
Lurasidone Non-Interventional Study in Schizophrenia Patients

The study is a multicentric, national, non-interventional, prospective, single arm study.

The main goal of this study is to gather information about the effects, in a real-life setting, of lurasidone treatment on patient's reported outcomes, in terms of patient's treatment satisfaction, Quality of Life and functioning changes after 6 weeks from lurasidone treatment initiation in schizophrenia patients naïve to lurasidone.

Important aim of the study is to investigate, aspects related to effectiveness, safety and tolerability at 3 months' lurasidone treatment in a routine practice in Italian clinical settings.

Only patients with primary diagnosis of schizophrenia who are prescribed lurasidone was evaluated for inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥18 years) male or female subjects;
* Primary diagnosis of schizophrenia
* Patients not previously treated with lurasidone. The choice to initiate lurasidone treatment is independent of being included in the study;
* Patients legally capable of giving their written consent for participation in the study and for personal data processing.

Exclusion Criteria:

* Concomitant participation in a clinical trial