cyrilzakka/clinical-trials huggingface dataset:
Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients

The purpose of this study is to evaluate the feasibility of administering a 20-day preoperative cognitive training intervention (Cog-Train) to a widely inclusive sample of cardiac surgical patients.

Cognitive outcomes remain poor after cardiac surgery. Data from the field of cognitive neuroscience suggests that cognitive training, which harnesses the brain's adaptive plasticity to improve, maintain, or restore function in a target area, can be used to strengthen brain resilience and improve cognitive outcomes following challenge. While its effectiveness has been demonstrated in older adults as well as in other (nonsurgical) patient populations, no training intervention like this has ever before been used in any surgical patient in the preoperative period. The purpose of this study is to evaluate the feasibility of administering a 20-day cognitive training intervention (Cog-Train) to a widely inclusive sample of cardiac surgical patients before their surgery. Data obtained will be used to design a full-scale randomised controlled trial (RCT) on Cog-Train's effectiveness in improving postoperative cognitive outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective cardiac surgery with cardiopulmonary bypass at Papworth Hospital
* Aged 60+ years

Exclusion Criteria:

* Surgery scheduled for sooner than 21 days
* 'Off-pump' surgery being considered
* Inability to obtain informed consent
* Sensory or motor impairments impeding use of task
* Communication barriers impeding administration of study procedures
* Inability to demonstrate understanding of task and/or study procedures
* Inability to make time commitment
Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL

This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics
* Age between ≥13 to ≤ 65 years
* No detectable leukaemia in the CSF (CNS-1)
* CNS leukaemia without clinically evident neurological symptoms (CNS-2; with \<5 WBC per μL and cytology positive for blasts)
* Adequate organ function as defined by a creatinine clearance \> 50 ml/min, serum total bilirubin \< 5 times the normal value, left ventricular ejection fraction \> 40%
* ECOG performance status ≤ 2
* Life expectancy \> 3 months
* Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression
* Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods
* Male patients must use highly effective contraception methods

Exclusion Criteria:

* Patients with CNS-3 leukaemia.
* Active cancer (other than B-ALL).
* Evidence of severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder.
* Presence of active autoimmune disease or atopic allergy.
* HIV serology positivity.
* Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay.
* Uncontrolled sepsis
* Pregnant / nursing female.
* Ongoing prednisolone \> 1mg/kg daily or equivalent.
* Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.
Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in the Positive COVID-19 Patient

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complication that lead to in intensive care hospitalization.

This complication determines a variable mortality from 25 to 30%. To correct hypoxemia (often severe) is often needed non-invasive or invasive mechanical ventilation.

Mechanical ventilation is not a therapeutic strategy, but it allows to extend the time-to-recovery necessary to solve COVID-19 respiratory failure cause.

Calibration of ventilatory support is essential to ensure adequate time-to-recovery without contributing to onset lung and / or diaphragmatic damage.

Basal diaphragmatic activity assessment, device for administering the oxygenation support choice and setting ventilatory support parameters are decisive.

Ultrasound is the best method for measuring diaphragmatic work. The aim of this study is to evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted to Intensive Care Unit (ICU) for acute respiratory failure and to record its function on weaning.

Hypoxemic acute respiratory failure in COVID-19 patients often leads to necessity of intubation and mechanical ventilation support. Complications may be severe as Ventilator-Induced Lung Injury (VILI) and respiratory infections. Weaning process from mechanical ventilation is based on respiratory work reduction and mechanical support to allow patient's respiratory ability to recovery. Respiratory muscle strength give an important contribute. Ultrasound diaphragmatic evaluation is essential to evaluate patients respiratory capacity as diaphragm atrophy usually suggest a difficult process and weaning failure.

COVID-19 pneumonia represent a particular type of ARDS (acute respiratory distress syndrome), in which different mechanism such as interstitial edema and diffuse alveolar damage, ventilation-perfusion mismatch, intrapulmonary shunt play a role/attend The aim of this study is to assess diaphragmatic function in weaning from mechanical ventilation in patients affected from COVID-19 respiratory failure and his implications.

Eligibility Criteria:
Inclusion Criteria:

* Hypoxemic respiratory failure in COVID-19 patients during intensive care unit hospitalization
* Age\> 18 years
* Weaning by mechanical ventilation

Exclusion Criteria:

* tracheostomy,
* unstable clinical conditions;
* agitation (Richmond Agitation-Sedation Scale (RASS)≥ + 2) or non-cooperation (Kelly Matthay scale ≥5);
* more than two organ failure
* consent refusal
Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor

When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:

* Arm 1: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
* Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs

When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:

* Arm 1: Patient will receive 1liter (L) of lactated ringers (LR) and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
* Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs Outcome variables include occurrence of maternal hypotension or Category II fetal tracings in the first hour after epidural placement.

Eligibility Criteria:
Inclusion Criteria:

* Laboring at Bethesda North Hospital Labor \& Delivery Unit
* Will receive epidural analgesia
* 37+ weeks gestation
* Singleton pregnancy
* Category 1 tracings only before epidural placement

Exclusion Criteria:

* Under 18 years old
* Does not speak English
* Unable to consent to involvement in the research study
* Diagnosed with fetal demise
* Diagnosis of pre-existing hypertension
* Diagnosis of gestational hypertension
* Diagnosis of pre-eclampsia
* Diagnosis of diabetes
* Breech presentation
* Contraindications to lower leg compression (ex: fractured bones in leg, cellulitis, lower limb amputation, etc.)
* Contraindications to receiving 1L of LR
* Blood pressure on admission systolic blood pressure (SBP)\>160 or diastolic blood pressure (DBP)\>110
* Fetal heart rate abnormalities before epidural
Registry to Monitor the Susceptibility to Aztreonam of Pseudomonas Aeruginosa Isolates From Cystic Fibrosis Patients

This is a prospective, longitudinal, 5-year study that will enroll participants from the existing Cystic Fibrosis Foundation (CFF) patient registry. Each enrolled participant will provide samples for microbiological evaluation, obtained upon enrollment and then once per year thereafter for 5 years.


Eligibility Criteria:
Key Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

* Current participant or willingness to participate in the CFF patient registry database
* ≥ 6 years of age
* Subject has CF as diagnosed by one of the following

  * Documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test, or
  * Two well-characterized genetic mutations in the CFTR gene, or
  * Abnormal nasal potential difference (NPD) AND accompanying clinical characteristics consistent with CF. For subjects who lack documentation of either a positive sweat chloride test or an abnormal NPD, and who have only one well-characterized genetic mutation of the CFTR gene, the diagnosis of CF is determined by the Investigator.
* FEV1 ≥ 25% predicted and ≤ 90% predicted.
* ≥ 2 lower respiratory tract cultures positive for PA with results documented in the subject's medical history.
* Subject must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure.

Key Exclusion Criteria:

Subjects who meet the following exclusion criterion are not to be enrolled in this study.

• Any serious active medical or psychiatric illness that, in the opinion of the Investigator, would interfere with subject assessment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by tDCS

The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal mechanism.


Eligibility Criteria:
Inclusion Criteria (MCI patients):

* right handedness
* amnestic and amnestic plus MCI with:

  1. subjective memory impairment;
  2. objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values;
  3. relatively normal performance in other cognitive domains;
  4. no constraints in activities of daily livings
  5. age: 50-90 years

Exclusion Criteria:

* severe internal or psychiatric disease
* epilepsy
* other severe neurological diseases, e.g. previous major stroke or brain tumor
* DMS-IV manifest dementia
* contraindication for MRT (claustrophobia, metallic implants, tattoos)
KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method

The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used contraceptive methods and reasons for use of Kyleena.


Eligibility Criteria:
Inclusion Criteria:

* Women requesting contraception with Kyleena. The woman's informed decision for contraception with Kyleena was made before and independently from the study as per investigator's routine practice
* Written informed consent.

Exclusion Criteria:

* Contraindications for Kyleena according to the local market authorization/SmPC
* Mental incapacity to consent and provide data during the observational study
* Women participating in an investigational program with interventions outside of routine clinical practice.
An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))

The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.

The study included a 12-week double-blind treatment phase and a 36-month open-label extension phase. Participants who completed or discontinued the initial 12-week phase of the study and who opted to participate in the open label extension phase were randomized to either losartan or enalapril at a dose of the investigator's choosing for the duration of the extension. The open label extension was designed to continue until the 100th participant completed 3 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Participant is 1 to 17 years of age
* Able to provide a first-morning urine sample each day during the study
* Documented history of proteinuria associated with chronic kidney disease of any origin
* Signed consent of parent and/or legal guardian

Exclusion Criteria:

* Pregnant and/or nursing
* Requires more than 2 medications to control high blood pressure
* Has undergone major organ transplantation (e.g. heart, kidney, liver)
* Known sensitivity to losartan or other similar drugs, or any history of angioneurotic edema
* Known sensitivity to amlodipine or other calcium channel blocker
* Requires cyclosporine to treat renal disease (kidney disease)
Non-invasive Cooling of Subcutaneous Fat

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat using the Zeltiq Dermal Cooling device.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
2. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
4. Subject is taking diet pills within the past 6 months.
5. Subject is unable or unwilling to comply with the study requirements.
6. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
7. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
8. Patient is pregnant or intending to become pregnant in the next 9 months.
9. Patient is lactating or has been lactating in the past 9 months.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera

This is a prospective observational study that will enroll patients with high-risk Polycythemia Vera (PV) with at least one Thromboembolic Event (TE) after diagnosis or up to 2 years prior to diagnosis.

This is a non-randomized study, and to ensure a sufficient number of patients in both cohorts, enrollment in each cohort will be terminated once the target of 150 patients has been reached.

All patients are already on treatment with hydroxyurea or ruxolitinib at enrollment as per clinical practice and independently of their participation in this study. In addition, the follow-up visits and the evaluation procedures required in the study protocol correspond to current clinical practice. According to local regulations related to observational studies, assessments such as blood tests are justified by the purpose and rationale of the study (i.e., the identification of possible predictive factors of TEs) and are considered current clinical practice. Data related to other procedures will be collected only if such procedures are performed as per clinical practice but are not required otherwise.

Patients in both cohorts will be followed for 3 years after enrollment and will have visits at Months 6, 12, 18, 24, 30 and 36. A time window of ± 1 month is permitted for all visits.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study.
2. Age ≥18 years.
3. Diagnosis of PV according to WHO 2008 or WHO 2016 and high-risk stratification according to European LeukemiaNet (ELN) classification.
4. At least one TE after diagnosis or up to 2 years prior to diagnosis.
5. Patients on treatment with hydroxyurea at enrollment and for at least 18 months prior to enrollment or those on treatment with ruxolitinib who started treatment up to 18 months before enrollment.
Effect of Premeal Protein-bar on Glycemic Control in Patients With Type 2 Diabetes

The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.

Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5\~35 kg/m2
* Type 2 diabetes patients
* Fasting blood glucose ≥ 126 mg/dl or
* HbA1c ≥ 6.5% or
* Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin.

Exclusion Criteria:

* HbA1c \< 6.5% or \> 10%
* Subjects using insulin other than basal insulin
* Subjects who have newly started or have changed anti diabetic drugs within 3 months
* Subjects who are allergic to grains, nuts, legumes and milk
* Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery)
* Subjects with chronic unstable disease
* Subjects with cognitive impairments who are not able to follow the study protocol
* Females who are pregnant or doing breast feeding
* Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels of higher than 3 times of upper normal ranges
* Subjects with hemoglobin level of less than 10.0 g/dL
* Subjects with alcohol addiction or drug abuse
MRI for Non-Invasive Imaging in Neonates and Children

The purpose of this study is to develop rapid MRI techniques for imaging the lung with hyperpolarized helium-3 gas as an inhaled contrast agent. These techniques will be piloted in adults and older children before testing them in younger children and infants. The purpose is to enable imaging of non-sedated infants by imaging so fast as to freeze motion.

he purpose of this study is to further develop the techniques to permit the imaging of infant lungs with hyperpolarized helium-3 MRI including techniques for acquisition in free breathing infants and infants on a ventilator. We have developed fast imaging techniques and obtained proof-of-concept data in infants as young as 2 months old. Many pediatric lung diseases including CF, bronchopulmonary dysplasia (BPD) and asthma have their origins in infancy so it would be desirable to be able to image infants with hyperpolarized gas MRI. We focused on developing fast imaging techniques to, in essence, freeze lung motion in non-sedated infants. We feel the technique will be more widely adopted if clinically useful images can be obtained without sedating the infant. Some very rapid imaging techniques have been developed for conventional proton MRI for applications such as cardiac MRI that require very short acquisition time. We modified these techniques for use in hyperpolarized gas MRI and developed a technique that permits the acquisition of the entire lung volume of an infant in less than 1 second. These techniques would also be useful for imaging infants who are still on a ventilator with the hope of increasing our understanding of lung development and neonatal lung disease.

Eligibility Criteria:
Inclusion Criteria:

* MRI sequence development (n=40): Healthy subjects and patients with CF, BPD, or asthma will be used in the development of the rapid imaging techniques. These subjects will be age 4 months to 65 years old. Healthy subjects can have no history of chronic respiratory disease. The subjects with CF or asthma must have a physician diagnosis of their respective disease.
* Proof-of-Concept Study (n=30): Ten healthy infants,10 infants with CF, and 10 infants with BPD age 4-24 months will be imaged in the proof-of-concept study. Healthy infant must have had an uncomplicated term birth and have no history of chronic respiratory symptoms. The patients with CF must have a physician diagnosis of CF and be at their baseline clinical status on the day of imaging.

Exclusion Criteria:

* Any condition for which a MRI procedure is contraindicated.
* Presence of any non-MRI compatible metallic material in the body, such as pacemakers, metallic clips, etc.
* Likelihood of claustrophobia
* Chest circumference greater than that of the helium magnetic resonance (MR) coil.
* Pregnancy, by report of subject. Clinically in the Department of Radiology at UVA, self report is used when screening patients for MR scans as well as CT scans and fluoroscopy studies. If the subject reports there is any chance of their being pregnant a urine pregnancy test will be performed prior to any imaging.