cyrilzakka/clinical-trials huggingface dataset:
Dual Energy Computerized Tomography (DE-CT) in Patients With Crohn's Disease

This study aims to evaluate the accuracy of dual energy computerized tomography (DE-CT) in predicting the need for surgery in patients with Crohn's disease and intestinal lesions with obstructive symptoms.

Patients with known Crohn's disease which were scheduled to perform abdominal CT for obstructive symptoms preformed it in a dual energy protocol and then followed for an outcome of surgery. DE-CT parameters were then compared between patients who underwent surgery and those who did not.

INTRODUCTION Intestinal strictures are common in patients with Crohn's (CD) disease and may result in intestinal obstruction. Current available imaging studies can usually identify and locate the stricture, but can not reliably differentiate the patients who will require surgery from those who will respond to medical therapy.

Dual Energy computerized tomography (DE-CT) uses two energy sources using high and low tube voltage, thus creating two data sets. Dedicated software creates overlay of the low and high energy images, in which enhancement of tissues with iodine can be better appreciated and quantified compared to standard CT. The investigators hypothesize that dual energy can better visualize the iodine uptake in bowl wall as a marker of inflammation within intestinal lesions, and may help in identifying the patients who will or will not require surgery.

AIM To evaluate the efficacy of DE-CT studies in predicting need for surgery within 3 months.

METHODS Patients with known CD undergoing abdominal CT for possible obstructive presentation prospectively underwent a DE-CT using intravenous iodinated contrast material, and were followed for 3 months for an outcome of surgery.

The DE-CT was interpreted by a radiologist blinded to the clinical outcome, and the attending physicians of the patients were blinded to the interpretation of the DE-CT. DE-CT parameters were then compared between patients who underwent surgery and those who did not. Receiver operating characteristic (ROC) curve analysis was used to find the optimal cut off point to distinguish between patients which did or did not eventually underwent surgery. Based on the cut off points found from the ROC analysis, the negative and positive predictive values were calculated.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years,
* known Crohn's disease (at least 3 moths prior)
* obstructive symptoms
* scheduled for abdominal CT for evaluation of symptoms (regardless of participation in the study)

Exclusion Criteria:

* Pregnancy
* Contraindication to perform CT with IV contrast media
Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis

The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months).

The primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Chronic rhinosinusitis with Nasal Polyps
* Olfactory loss
* Clinical indication for treatment with Dupilumab

Exclusion Criteria:

Patients with olfactory loss from other causes such as:

* Sinonasal malignancies
* Trauma
* Idiopathic olfactory loss
* Use of cocaine
* COVID-19 related olfactory loss
* Pregnancy
Diaphragmatic Paralysis in Arthroscopic Shoulder Surgery

This study aims to assess consequences and causes of hemidiaphragmatic paralysis for ambulatory arthroscopic shoulder surgery in patients with BMI ≥ 30 kg/m².

This prospective observational study will screen patients with body mass index (BMI) ≥30 kg/m² undergoing acromioplasty or supraspinatus tendon repair. Occurrence of post-operative hemidiaphragmatic paralysis will be observed using M-mode ultrasonography and its consequences on patient ventilation: arterial oxygen saturation, dyspnea, success of ambulatory procedure. Causes of diaphragmatic paralysis will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* All patients with body mass index ≥ 30kg/m², undergoing ambulatory arthroscopic shoulder surgery (acromioplasty and supraspinatus tendon repair) will be screened.

Exclusion Criteria:

age \<18 years, brachial plexus neuropathies, severe bronchopulmonary disease, acute respiratory distress, coagulopathies, systemic glucocorticoid use, pregnancy, routine use of opioid medications, intolerance for one or more medications of the study protocol and diabetes.
A Study of LY2484595 on the Electrical Activity of the Heart

The purpose of this study is to evaluate the effect on the electrical activity of the heart as measured by an electrocardiogram (ECG) after dosing with 10 days of LY2484595 compared to 10 days of placebo in relation to a single dose of moxifloxacin. Information about any side effects that occur will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* Body mass index (BMI) of 18.5 to 29 kilograms per square meter (kg/m²)
* Reliable and willing to be available for the duration of the study and are willing to follow study procedures
* Provided written informed consent

Exclusion Criteria:

* Known allergies to LY2484595 or moxifloxacin
* Personal or family history of long QT syndrome, heart failure, or low blood potassium (hypokalemia) a family history of sudden death, or unexplained syncope within the last year
* Positive findings on urinary drug screening
* Cigarette smokers
Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

This phase 1/2 combination trial of tipifarnib, a farnesyltransferase inhibitor, and alpelisib, a PI3K inhibitor in participants with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress the HRAS protein and/or are PIK3CA-mutated and/or PIK3CA-amplified.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age.
2. Histologically confirmed head and neck cancer of squamous histology not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
3. Documented treatment failure from at least 1 prior systemic therapy in the R/M setting, unless determined not appropriate.
4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
5. Has a tumor that is dependent upon HRAS and/or PIK3CA.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. Acceptable liver, renal, endocrine, and hematologic function.
8. Must be able to swallow alpelisib whole tablet or oral suspension containing crushed tablets. Feeding tube may not be used for alpelisib administration.
9. Other protocol defined inclusion criteria may apply.

Exclusion Criteria:

1. Histologically confirmed salivary gland, thyroid, (primary) cutaneous squamous or nonsquamous histologies (eg, mucosal melanoma).
2. Ongoing treatment with certain anticancer agents.
3. Prior treatment (at least 1 full treatment cycle) with an FTI or PI3K, mTOR, or AKT inhibitor.
4. Received treatment for unstable angina, myocardial infarction, and/or cerebro-vascular attack within the prior 6 months.
5. Non-tolerable Grade 2, or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
6. Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.
7. Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
8. Participant with an established diagnosis of diabetes mellitus Type 1 or not controlled Type 2.
9. Participant has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs based on Investigator discretion.
10. Participant has currently documented pneumonitis/interstitial lung disease.
11. Participant has a history of severe cutaneous reaction, such as Stevens-Johnson Syndrome (SJS), Erythema Multiforme (EM), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
12. Other protocol defined exclusion criteria may apply.
Randomized Comparison of Low and Conventional Irradiance PDT for Skin Cancer

This study aims to examine whether the pain of topical photodynamic therapy (PDT) is significantly different when using low irradiance ambulatory light emitting diode (LED) devices compared with conventional higher irradiance hospital based LED light sources when used for superficial non-melanoma skin cancer. The investigators are also investigating the phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.

A randomized assessor-blinded comparative study of low irradiance ambulatory LED devices with conventional hospital-based LED devices for superficial non-melanoma skin cancer. Preliminary observations suggest that low irradiance LEDs cause less pain but are as effective, so the investigators are examining this in a clinical trial of patients with lesions \</= 2cm diameter of non-melanoma skin cancer (Bowen's disease and superficial basal cell carcinoma). Patients with these conditions referred to the PDT clinic will be invited to participate and if they are eligible and consent to treatment then they will be prospectively randomized to either ambulatory PDT or conventional PDT. Pain and phototoxicity scores will be recorded and clinical efficacy will be assessed up to one year after the last treatment. Computer-generated block randomization will be performed and at 90% power to detect as significant at the 5% level a mean difference in pain score of 2 in one group compared with 4 in the other, 36 patients will be needed, and as the participants will often be elderly and frail the investigators will aim for a safety margin of recruiting 50 participants to account for drop-outs. Participants will receive two treatments of either arm at a one week interval and will be assessed clinically at three months and if residual disease remains then the two treatments a week apart are repeated. Pain assessed using a visual analogue scale (VAS) score and phototoxicity on a semi-quantitative scale are recorded at 7 days when the participant returns for their second treatment. Follow up for clinical assessment is at 6 months and one year after treatment. Participants also give their opinion of treatment at one year follow up. Assessors of adverse effects and efficacy will be blinded. Data recording and analysis will be undertaken by the study statistician Dr Robert Dawe and analysis will be on an intention to treat basis using appropriate statistical tests comparing the pre-planned outcome measures, with pain as primary outcome and outcome, efficacy and patient satisfaction as secondary outcomes

Eligibility Criteria:
Inclusion Criteria:

* Bowen's disease or superficial basal cell carcinoma referred for PDT and lesion not greater than 2.4cm diameter

Exclusion Criteria:

* Unable to give consent, \>2cm diameter, lesions on highly curved surfaces where ambulatory device would not adhere
Validation of Minimally Invasive Ultrasound Indicator Dilution Technique in Critically Ill Children

A novel method to measure cardiac index based on ultrasound indicator dilution technology (UIDT) has been developed by Transonic Systems Inc. (Ithaca, NY, USA). The method overcomes many of the limitations that have plagued the existing techniques used to measure cardiac index in critically ill children.

In the proposed investigation, the investigators hope to validate a novel application of an existing technology in critically ill infants and children. The primary aim of this study is to determine the accuracy of cardiac index measured by UIDT when compared to the gold-standard Fick technique. The primary hypothesis is that the average of three consecutive measurements of cardiac index by UIDT will be accurate when compared to the Fick technique. Secondary aims will be to determine the precision of the measurement, the feasibility of the technique with regards to time required and any complications encountered. An exploratory secondary aim of this study is to determine whether central blood volume (CBV) derived from indicator transit time (ITT) correlates with central venous pressure (CVP) and echocardiography derived measures of preload.


Eligibility Criteria:
Inclusion Criteria:

* Age: less than 18 years.
* Admission to the CICU (Cardiac Intensive Care Unit) (8S) or MISICU (Medical-Surgical Intensive Care Unit) (7S) of the Children's Hospital Boston.
* Presence of a central venous catheter with its tip in the superior vena cava or a catheter in the pulmonary artery, documented by radiography.
* Requirement for mechanical ventilation via an endotracheal or tracheostomy tube.
* Presence of an arterial catheter.
* Patients must have a two ventricle circulation.

Exclusion Criteria:

* Endotracheal tube leak of greater than 10%.
* A significant air leak around the endotracheal tube makes VO2 impossible to measure.
* Presence of relevant intracardiac shunt.
* Intracardiac shunt will decrease the area under the arterial dilution curve unpredictably, making cardiac index calculations unreliable.
* A patent foramen ovale and a single ventricular septal defect less than or equal to 2mm or an atrial septal defect less than or equal to 3mm will be considered irrelevant for the purposes of this study.
* Previous enrollment in an incompatible research study.
* Current or prior diagnosis of heparin induced thrombocytopenia.
* A small amount of heparin is required to flush the extracorporeal AV (Arteriovenous) loop that is required for the measurements.
* Pneumothorax with ongoing air leak.
* An air leak will invalidate the measurement of VO2.
Prevalence Assessment and Characterization of Psychological Disorders Associated With Hypobetalipoproteinemia

Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic of LDL-C metabolism. Clinical manifestation range from asymptomatic patients to metabolic (fatty liver, diabetes) or psychiatric disorders still unrecognized. HYPOPSY research, aims to evaluate prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric disorders.

Familial hypobetalipoproteinemia (FHBL, OMIM # 1707730) is a genetic disorder heterozygotic of LDL-C metabolism (Low Density Lipoprotein - Cholesterol) whose incidence is measured from 1: 500 to 1: 1000. These heterozygous individuals may be asymptomatic or present some clinical (fatty liver, diabetes) or psychiatric manifestations still unrecognized. Moreover, these individuals have mostly a longevity syndrome and cardiovascular protection. The FHBL is often due to mutations of the APOB (APOlipoprotein B), major component of LDL, VLDL (Very Low Density Lipoprotein) and chylomicrons, and in some cases, loss-of-function mutations of the serine protease PCSK9, endogenous inhibitor of the LDL receptor.

HYPOPSY research, aims to evaluate, in a population with psychiatric disorders, the prevalence of hypobetalipoproteinemia, and to characterize specific related psychiatric disorders.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in mental Disorders Unit in Nantes University Hospital

Exclusion Criteria:

* Minor patient
Influence of Central Nervous Insulin Sensitivity on Insulin Secretion

Insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. The tissue in which it manifests are mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is independent of insulin, this organ has traditionally not been studied in this regard. In animal experiments, however, knockout of the insulin receptor in the brain leads to obesity and peripheral insulin resistance. This finding of insulin action in the brain could also be confirmed in human studies.

The investigators intend to investigate whether central nervous insulin action affects insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15 minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion. Insulin sensitivity of the brain is measured by a an established protocol with functional magnetic resonance imaging before and after nasal insulin administration.


Eligibility Criteria:
Inclusion Criteria:

* HbA1c ≤6.0%
* normal glucose tolerance during 75g oral glucose tolerance test (OGTT)

Exclusion Criteria:

* Not removable metal parts in or on the body
* manifest cardiovascular disease
* claustrophobia
* recent surgery (less than 3 months)
* Simultaneous participation in other studies
* Acute disease or infection within the last 4 weeks
* neurological and psychiatric disorders
* treatment with centrally acting drugs
* hemoglobin Hb \<13g / dl
* Hypersensitivity to any of the substances used
Application of SERS Technology Based Intraoperative Navigation System in Lung Cancer

This study aims to explore the application of Surface-enhanced Raman Scatting (SERS) technology in lung cancer surgery and clarify its mechanism through multi-omics mass spectrometry platform, and then further prove the clinical transformation value of this technology.

This study intends to apply the intraoperative navigation system based on Surface-enhanced Raman Scatting (SERS) technology to detect the PH of lung tissue, and to evaluate the benign and malignant resection margins of lung tissue based on this. In order to clarify the discrimination mechanism, a multi-omics mass spectrometry platform is planned to study the internal small molecules and pathway changes. In addition, the patients were followed up for five years to explore the correlation between the prognosis of patients and the PH of lung tissues and lymph nodes, which could prove the clinical transformation value of this technology.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in clinical research; Fully understand and informed the study and sign the informed consent form (ICF); Be willing to follow and be able to complete all trial procedures.
2. Male or female aged 18-75 years or more when signing ICF.
3. Extended tumor resection was performed to remove the lung tumor tissue, and the resection margin was ≥2cm from the tumor margin.
4. The effective measured diameter of all the lung tissues to be measured was greater than 0.5cm.
5. The patient had not received previous systemic therapy for cancer.

Exclusion Criteria:

1. Unresectable lung cancer patients.
2. Patients had received previous systemic therapy for lung cancer.
3. Patients with other active malignant tumors within the past year or at the same time.
4. The patient had a known history of psychotropic drug abuse or drug use; She had a history of alcohol abuse.
5. According to the investigator's judgment, the patient had other factors that may lead to the early termination of the study.
Transcutaneous Electrical Nerve Stimulation (TENS) in Chronic Pain, Responders and Non-Responders?

* Transcutaneous electrical nerve stimulation (TENS) is a frequently applied therapy in chronic pain. Although evidence regarding the effectiveness of TENS in chronic pain is inconclusive many patients continue using TENS on long term in daily practice. An important question is therefore why some patients respond well and others don't at all. In chronic pain evidence for abnormal pain processing (sensitization) has been found in several patients groups. The process of sensitization might influence effectiveness of TENS as the theoretical working mechanism of TENS is based on the modulation of the transmission of nociceptive impulses form peripheral receptors throughout spinal nerve system into the brain. In this study we want to study the effect of TENS on pain transmission, as measured by contact heat evoked potentials (CHEPS), between 'responders' and non-responders' after a two weeks TENS treatment. 'Responders' will be defined as patients with a pain reduction of ≥ 30% on a VAS after a two week treatment period with TENS. Non-responders are patients with a pain reduction \< 15%.
* Objective: a) Is pain reducing effect TENS in responders based on modulation of pain transmission and perception, as measured by CHEPS? b) Is the ability of TENS to modulate pain transmission and perception influenced by abnormal pain processing?
* Prospective cohort study
* Patients with chronic non specific pain (duration \> 6 months), above 18 year, will be included. Patients are referred from the Pain Clinic of the University Hospital Maastricht (MUMC). Exclusion criteria are: a) pain due to cancer, b) the use of a cardiac pacemaker, c) pregnancy, d) neurological sensory deficits, e) language and/or cognitive inability to complete the health assessment questionnaires f) previous TENS for pain relief.
* Patients receive a two week treatment period with TENS-treatment, as regular, at home after instruction. The frequency is set at 100 Hz and pulse duration at 250 μ sec. Patients have to use the TENS daily (minimal 4 times a day for 30 minutes).

Main study parameters/endpoints are decrease in amplitude of CHEPS in responders versus non-responders.


Eligibility Criteria:
Inclusion Criteria:

* referred for TENS treatment by a pain physician,
* duration of pain \> 6 months,
* age above 18,
* no current other treatment for pain besides pain medication. Patients are allowed to continue their regular pain medication (as described by physician) prior to the TENS treatment

Exclusion Criteria:

* pain due to cancer,
* the use of a cardiac pacemaker,
* pregnancy,
* neurological sensory deficits,
* language and/or cognitive inability to complete the health assessment questionnaires
* previous TENS for pain relief.
Accessing Innovative Mental Health Services for Depression in Vietnam

This stepped wedge, randomized controlled trial (RCT) will test the effectiveness of a digital mental health intervention (VMood) adapted from an evidence-based in-person intervention. The in-person intervention is based on principles of Cognitive Behavioural Therapy and uses a supported self-management approach consisting of a patient skills workbook and supportive coaching by a non-specialist provider. It was developed in Canada and shown to be effective in the Vietnamese context in a previous RCT conducted by the research team. The digital adaptation (VMood) is delivered via a Smartphone app the research team developed in Vietnam, in close collaboration with the Institute of Population, Health and Development (PHAD) in Vietnam.

The digital intervention will be delivered at the community level in 8 Vietnamese provinces, with remote coaching provided via the app by social workers. The primary outcome measure for the study is the Patient Health Questionnaire (PHQ-9), which screens for depression caseness. The investigators will also include the Generalized Anxiety Disorder(GAD-7) measure, as symptoms of anxiety commonly co-occur with depression. Secondary outcome measures will include the WHO Quality of Life-Brief (WHOQUAL-BREV), FAST Alcohol Screening Test (FAST), the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) adapted to assess tobacco use only. The investigators will also conduct a cost-effectiveness analysis (CEA) using the 5-level EQ-5D (EQ-5D-5L), the Health Economic Assessment (HEA) adapted for the Vietnamese health context, and Work Productivity and Activity Impairment Questionnaire: Depression (WPAID:D). Finally, the System Usability Scale (SUS) will be used to assess VMood usability.


Eligibility Criteria:
Inclusion Criteria:

* Score of \>4 on PHQ-9 indicating depression caseness
* consent to participate and complete all measures

Exclusion Criteria:

* Cognitive disturbance
* Psychotic symptoms