cyrilzakka/clinical-trials huggingface dataset:
Comparison of Contrast Agents in Liver MR for the Detection of Hepatic Metastases

If an abbreviated HBP protocol liver MR with gadobenate dimeglumine is shown clinically comparable to standard of care liver MR with gadoxetate disodium for detecting hepatic metastasis from colorectal cancer, its use will save time, cost, and patients' effort.

The goal is to:

* Estimate and compare the diagnostic performance, including sensitivity, specificity, positive/negative predictive value, and area under the receiver operating characteristics (AUROC), of abbreviated protocol liver magnetic resonance (MR) with hepatobiliary phase (HBP) using gadobenate dimeglumine for detecting liver metastases, with 1) abbreviated protocol liver MR with HBP using gadoxetate disodium, 2) standard of care complete protocol liver MR using gadoxetate disodium, and 3) complete protocol liver MR using gadobenate dimeglumine.
* Estimate and compare quantitative measures of HBP images (liver enhancement ratio, lesion contrast to noise and signal to noise ratios \[CNR and SNR\]) for both gadobenate dimeglumine and gadoxetate disodium.
* Qualitatively assess the preference, or lack thereof, of radiologists regarding the images generated by abbreviated protocol liver MR with HBP using gadobenate dimeglumine versus abbreviated protocol liver MR with HBP using gadoxetate disodium.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer patients
* Age 18-80 years
* No prior treatment including surgery
* Prior imaging with suspected liver metastasis

Exclusion Criteria:

* Age \< 18 years or \> 80 years
* eGFR \< 30 ml/min/1.73 m2
* Previous reaction to gadolinium contrast agents
* History of claustrophobia or movement disorders likely to impact image quality
* Non-MR safe implants or metallic foreign bodies
A Trial Comparing High-Flow Nasal Cannula Versus Noninvasive Ventilation on Reintubation and Post-Extubation Respiratory Failure in High-Risk Patients With Systolic Heart Failure

This prospective, open-label randomized controlled pilot trial will enroll participants at the Yale New Haven Hospital. Patients with systolic heart failure, defined as an ejection fraction ≤40%, who require invasive mechanical ventilation (IMV) and are admitted to either the cardiac intensive care unit (CICU) or medical ICU (MICU) will be included.

Subjects meeting eligibility criteria will be randomized 1:1 to one of the two treatment groups:

* Intervention: Extubation to high-flow nasal cannula (HFNC)
* Control: Extubation to non-invasive ventilation (NIV)

The primary objective is to compare the rates of reintubation and post-extubation respiratory failure for high-risk patients with systolic heart failure extubated to HFNC or NIV. Reintubation will be at the discretion of the attending physician. In doing so, this pilot study will provide the framework for an appropriately powered randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* The patient is a male or non-pregnant female greater than or equal to 18 years of age
* The patient is ventilated for greater than 24 hours
* The patient has a systolic left ventricular dysfunction defined as an ejection fraction less than or equal to 40%
* The patient, or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Exclusion Criteria:

* Patients actively being treated for a COPD exacerbation or known hypercapnia (PaCO2\>45) on last Arterial Blood Gas (ABG)
* Patients agitated or uncooperative state
* Patients with do-not-resuscitate orders
* Patients presenting with tracheostomies or anatomical abnormalities interfering with mask fit
* Patients are prisoners
* Patient self-extubates
* Patients with pre-existing NIV prescription (e.g., obstructive sleep apnea, neuromuscular disorders, advanced COPD)
The Effects of tDCS Combined With rTMS on Post-stroke Cognitive Impairment

If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\]

The purpose of the clinical trial is to find a treatment for stroke patients with cognitive impairment, and the main questions it aims to answer are:

* \[Search for effective treatments of cognitive impairment after stroke\]
* \[Explore brain network features with functional near-infrared spectroscopy\] Participants will receive conventional treatment, tDCS treatment, or rTMS treatment, or tDCS-rTMS treatment.

And then compare cognitive function and brain function.


Eligibility Criteria:
Inclusion Criteria:

* Meet the clinical diagnostic criteria of the Expert Consensus on the Management of Cognitive Impairment after Stroke in 2021;
* 30-80 years old, right-handed, unilateral hemiplegia;
* Verbal expression can cooperate with the completion of the evaluation, sustained attention time is longer than 5 minutes;
* Simple Mental State Examination Scale (MMSE) score ≤26 points; MoCA scale score \< 26 points; Memory test (RMBT) score less than 21 points;
* patients or their family agree to sign the informed consent;
* The Ethics Committee approved the trial.

Exclusion Criteria:

* Memory dysfunction caused by other diseases, such as Alzheimer's disease, lewy body dementia, pituitary tumor surgery, hypothyroidism, etc.;
* There are contraindications of rTMS and tDCS for untreated intracranial aneurysms, severe epilepsy, intracranial metal, etc.
* Patients with severe visual, cognitive or speech impairment who cannot cooperate with treatment;
* The condition is not stable; Or other serious physical diseases.
Mobile Methods for Reducing Obesity Risk in Parents and Children

The purpose of this study is to test the efficacy of an innovative 6-month smartphone-delivered intervention using simplified monitoring of dietary intake compared to a smartphone-delivered intervention with standard calorie monitoring among parents with overweight or obesity.

This is a 6-month randomized controlled trial comparing the efficacy of two smartphone-based dietary and weight change interventions among 70 parent-child dyads with at least one child between the ages of 2 and 12 (70 adults and 70 children ages 2-12). One intervention group (Simple) will use a simplified, low-burden form of dietary tracking in the study smartphone application and the other group (Standard) will use standard calorie tracking. Components of both interventions include (1) setting personalized goals for weight, dietary intake, and daily activity (2) adaptive text message interventions based on behavior change techniques such as goal setting and in-the-moment progress feedback several times per week, (3) weekly tailored feedback updated in the study smartphone app, and (4) weekly lessons on the smartphone app. The primary objective is to promote weight loss in the parents, and the secondary objective is to determine if one or both interventions produce a ripple effect of parent dietary change onto dietary changes in the child.

Eligibility Criteria:
Inclusion Criteria (parent):

* Currently age 21-55.
* Body mass index (BMI) of 25-50 kg/m².
* Have one child between the ages of 2-12.
* Own an iPhone running at least iOS11 with a data and text messaging plan.
* Have the ability to read, write, and speak English.

Inclusion Criteria (child):

* Currently age 2-12.

Exclusion Criteria (parent):

* Lost more than 10 pounds in the last 6 months.
* Currently participating in another nutrition or weight loss program.
* Currently meeting exercise recommendations of 150 minutes per week of moderate-to-vigorous physical activity.
* Currently pregnant or breastfeeding, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
* Planning to relocate in the next 8 months.
* Will be out of town for 2 weeks or more in the next 8 months.
* Cannot attend two visits at the UNC Weight Research Program clinic.
* Pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, as determined by items endorsed on the PAR-Q (Physical Activity Readiness Questionnaire).
* Treatment of diabetes with insulin or oral medications that may cause hypoglycemia.
* History of clinically diagnosed eating disorder.
* Diagnosis of schizophrenia or bipolar disorder.
* Hospitalization for a psychiatric diagnosis within the last year.
* Report a past diagnosis of or current symptoms of alcohol or substance dependence.
* Another member of the household (family member or roommate) is a participant or staff member in this study.
Evaluation of the Child and Family Traumatic Stress Intervention

The purpose of this study is to determine the efficacy of the Child and Family Traumatic Stress Intervention (CFTSI) in preventing the development of Posttraumatic Stress Disorder (PTSD) when implemented within 30 days of a potentially traumatic event.


Eligibility Criteria:
Inclusion Criteria:

* Youth exposed to a potentially traumatic event within the last 30 days who have one new symptom on the Posttraumatic Checklist (PCL)

Exclusion Criteria:

* Already receiving mental health treatment
* Autism or Developmental Disability
* Diagnosed with psychosis or bipolar disorder
* Non-english speaking
The PERSEVERE Study

RCT of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care


Eligibility Criteria:
Inclusion Criteria:

1. Age at enrollment ≥18 years
2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery
3. High-risk class of acute PE
4. RV dysfunction, as defined RV/LV ratio ≥1.0
5. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards

Exclusion Criteria:

1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.
2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention
3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH
4. Recent stroke (\<14 days)
5. Recent cranial or spinal surgery (\<14 days)
6. Life-threatening active bleeding or hemorrhage into a critical area
7. Known intracranial tumor
8. End-stage medical condition with life expectancy \<3 months (irrespective of the severity of acute PE), as determined by the Investigator
9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated
10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)
11. Current participation in another drug or device study that may interfere with the conduct of this trial
12. Ventricular arrhythmias refractory to treatment at the time of enrollment
13. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling
14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions
15. Subject was previously enrolled in this study
16. Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization
A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis

The goal of this observational study is to draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of the dynamic evolution of endometrial carcinogenesis in 100 patients with normal endometrium, 100 patients with atypical endometrial hyperplasia, and 100 patients with endometrial cancer; and then to explore the underlying molecular mechanism, and establish the database system for the dynamic evolution of endometrial carcinogenesis.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis: normal endometrium, atypical hyperplasia endometrium, or endometrial cancer;
* Obtain pathological results after undergoing hysteroscopic surgery or hysterectomy;
* The patient voluntarily participated in this research project with good compliance and was able to complete the enrollment according to the experimental requirements;
* Sign the informed consent form and consent to the collection and use of their data, and consent to genomics, transcriptome and other tests.

Exclusion Criteria:

* Patients with malignant tumors in other parts of the body;
* Suffering from uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders;
* Poor compliance and inability to cooperate and describe treatment responders.
Decision Aids to Improve Knowledge in Patients With Prostate Cancer

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
* Prostate-specific antigen (PSA) \< 50 ng/mL
* Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
* Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
* Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
* Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
* Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures
Embryo Transfer: Direct Versus Afterloading Trial

The purpose of this study is to evaluate two types of embryo transfer procedure.

The investigators will compare direct embryo transfer against afterloading embryo transfer.


Eligibility Criteria:
Inclusion Criteria:

* Patients in IVF/CICSI program
* Transfer day:2 or 3 after ovum pick-up

Exclusion Criteria:

* None
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-38431055 in Healthy Male Volunteers

This will be a single center study conducted in two parts. Part 1 will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of JNJ-38431055 in healthy male volunteers. Part 2 will assess the effect of food on the pharmacokinetics of JNJ-38431055.

The study includes 2 Parts and will be conducted at a single center. Part 1 is a randomized (study drug assigned by chance), double-blind (neither the volunteer or investigator knows the name of the assigned study drug), placebo-controlled (placebo is a substance that looks the same as JNJ-38431055 but contains no JNJ-38431055), single ascending dose study. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on Day 1 or three treatment periods. In Part 1, for each volunteer, the study will consist of a screening evaluation visit, 3 periods of double-blind treatment, and a final, follow-up examination. The total study duration for each volunteer will be approximately 9 weeks. Part 2 is a randomized, open-label, 2-period crossover study to evaluate the effect of administering JNJ-38431055 together with food on the pharmacokinetics of JNJ-38431055, as compared to administration in the fasting condition. In Part 2, study drug (JNJ-38431055 will be administered orally as single doses on Day 1 or two treatment periods. There will be at least 7 days between doses. In Part 1, study drug (i.e., JNJ-38431055 or placebo) will be administered orally as single doses on Day 1 of three treatment periods. In Part 2, study drug (JNJ-38431055) will be administered orally as single doses on Day 1 of two treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 (inclusive)
* Healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed
* Volunteers must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* History of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
* Smoker or tobacco user within the past 6 months
* History of recent major surgery (within 6 months of study start)
* Positive test for alcohol and/or drugs of abuse
* Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the volunteer to comply with the study requirements
* Any condition that, in the opinion of the investigator, would compromise the well being of the volunteer or the study or prevent the volunteer from meeting or performing study requirements.
Study of Ocular Torsion in Patients Suffering From Palsy of the Superior Rectus Extraocular Muscle

Retrospective medical chart and medical imaging file review of patients suffering from palsy of the superior rectus extraocular muscle


Eligibility Criteria:
Inclusion Criteria:

* Patient with unilateral muscular palsy of the superior rectus muscle
* Patient must have a binocular vision as characterized by Lang test

Exclusion Criteria:

* bilateral impairment of the superior rectus muscle
* presence of an orbital lesion (orbital trauma, tumor or pseudo-tumor)
* thyroid orbitopathy
* No binovular vision
Enhanced Nutrition for Preterm Infants

The overall objective of the proposal is to demonstrate the feasibility of providing increased calories and protein in the first week of life to very low birth weight (VLBW) preterm infants.

Infants will be randomized to receive either standard parenteral nutrition via the neonatal intensive care unit (NICU) protocol or enhanced parenteral nutrition via the Study protocol during their first week of life through higher initial macronutrient provision and faster advancement of macronutrient provision.

Eligibility Criteria:
Inclusion Criteria:

* VLBW (birth weight \<1500grams) preterm (gestational age (GA) at birth \< 32 weeks) infants admitted to the University of Minnesota Masonic Children's Hospital NICU, for which written informed consent can be secured from a parent within 12 hours of birth.

Exclusion Criteria:

* Infants who are diagnosed prenatally with a clinical condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development, who experienced severe birth asphyxia, who are enrolled in another study affecting nutritional management, or who are likely to be transferred out of the NICU will be excluded from participation.
Premixed vs Basal Bolus Insulin Therapy in Older Patients With Type 2 Diabetes

The purpose of this study is to compare efficacy and security of premixed insulin treatment vs basal bolus insulin treatment in older patients with poorly controlled type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients
* Age ≥ 65 years old
* Type 2 diabetes mellitus
* HbA1c ≥9% (74 mmol/mol)
* Previously treated with one or two doses of basal insulin and oral hypoglycaemic agents

Exclusion Criteria:

* Severe insulin-resistance
* High doses of corticosteroids
* Chemotherapy treatment
* High comorbidity
* Bad compliance of the treatment
* Frequent severe hypoglycaemia
A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor

This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Rheumatoid arthritis of \>/= 6 months duration (according to American College of Rheumatology (ACR) criteria)(according to ACR criteria)
* Inadequate response due to inefficacy of treatment (for at least 3 months) with only one approved Tumor Necrosis Factor (TNF)-agent other than adalimumab Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study
* On methotrexate treatment for \>/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks
* Disease Activity Score (DAS28) \>3.2 at baseline
* Oral corticosteroids (\</=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for \>/=6 weeks prior to baseline.

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
* Rheumatic autoimmune disease other than rheumatoid arthritis
* Prior history of or current inflammatory joint disease other than rheumatoid arthritis
* Functional class IV (ACR criteria)
* History of severe allergic reaction to human, humanized or murine monoclonal antibodies
* Known active current or history of recurrent infection (including tuberculosis)
* Primary or secondary immunodeficiency (history of or currently active)
* Body weight \>150 kg
* Previous treatment with any cell-depleting therapies
* Previous treatment with tocilizumab
* Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline.