cyrilzakka/clinical-trials huggingface dataset:
Effect of High Intensity Exercise Rehabilitation on Liver Function and Insulin Sensitivity in Patients With MASLD

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease worldwide, and is associated with obesity and the metabolic syndrome. Physical activity and lifestyle interventions are among the most recommended treatments for individuals with MASLD.

In this RCT, we will evaluate the effect of combined exercise training "strength and aerobic training" versus "strength and high intensity training (HIIT)". The main outcome parameter is the severity of liver steatosis. Patients will be recruited at the fatty liver clinic of the UZ Gent.

Physical activity and lifestyle interventions, including exercise, are recommended for individuals with metabolic dysfunction-associated steatotic liver disease (MASLD). Weight loss has been found to improve MASLD histologically, but exercise alone can also reduce liver fat accumulation, even without significant weight loss. Exercise has positive effects on chronic inflammation, type 2 diabetes mellitus (T2DM), and mitochondrial function in MASLD patients. Studies suggest that both aerobic and resistance exercise are effective in reducing fat content and liver enzyme levels in MASLD, and thereby generate positive effects on insulin sensitivity and cardiovascular risk. The potential of high-intensity interval training (HIIT) is large in various settings, but was never explored in this population. Moreover, the combination with strength training can have additional health effects which remain to be explored.

All subjects are recruited in the liver steatosis outpatient clinic of the university hospital in Ghent by the physicians and researchers of this study. After patient selection and obtaining informed consent, they will be screened in the rehabilitation center for cardiorespiratory fitness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MASLD by ultrasound, CAP and/or biopsy
* Age between 18 and 75 years old
* No significant liver fibrosis (Fibroscan \< 7.5 kPa; if it is between \>7.5 and \<10, there must be absence of liver fibrosis in the biopsy)

Exclusion Criteria:

* Presence of other liver diseases that may contribute to the clinical presentation in the patient
* Severe cardiovascular, orthopedic, physical or other illnesses that make it impossible to participate in the study's exercise rehabilitation program or where safety cannot be guaranteed
* Pregnancy
* Pharmacological treatment that directly affects MASLD (e.g. GLP-1 analogues)
* A change in medication in the last three months before the study that affects metabolic disease stability
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* Be between the ages of 4 and 67 years old.
* Have a diagnosis of traumatic brain injury with a potential for concussion.
* Subjects must have baseline vision correctable to within 20/500 bilaterally.
* Subjects must have intact ocular motility.
* Subjects must have ability to provide a complete ophthalmologic, medical and neurologic history as well as medications/drugs/alcohol consumed within the 24 hours prior.

Exclusion Criteria:

* ER visit has been more than 2 weeks since the injury which may have caused the concussion.
* Have received penetrating trauma or have a head CT demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
* Suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability.
* Blind (no light perception), are missing eyes, do not open eyes.
* It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.
* Previous history of: ocular motility dysfunction or extensive prior eye surgery.
* Any physical or mental injury or baseline disability rendering task completion difficult.
* Obvious intoxication or blood alcohol level greater than 0.2.
Study of CMAB009 to Treat KRAS Wild Type Metastatic Colorectal Cancer

The primary purpose of this study is to evaluate the clinical response and safety of CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients

CMAB009 is a recombinant, human/mouse chimeric monoclonal antibody (mAb) that binds specifically to the extracellular domain of EGFR. It is composed of the Fv regions of a murine anti-EGFR antibody with human IgG1 heavy and k light chain constant regions and it is expressed by Chinese hamster ovary cells. It has the same amino acid sequence as cetuximab (C225, Erbitux®) , but it has slightly different abilities for glycosylation and other post-translational modifications, and it is developed by Shanghai Zhangjiang Biotechnology Limited Company and produced by Biomabs. Phase I study results suggest that CMAB009 showed well-tolerated safety profile and primary efficacy. This multicenter, open-label study was to determine whether adding CMAB009 to irinotecan increased the response rate and prolongs survival in patients with KRAS wild-type metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed metastatic colorectal adenocarcinoma
* KRAS wild-type tumors, EGFR-expressing or EGFR-nonexpressing by immunohistochemistry;
* has measurable lesion, at least 1cm in diametre by CT or MRI, at least 2cm diametre by physical examination or other iconography
* ECOG performance status 0 to 1
* Failure (disease progression/discontinuation due to toxicity) of fluoropyrimidine and oxaliplatin treatment,stop at least one month thereafter, irinotecan-naïve

Exclusion Criteria:

* Previous irinotecan or anti-EGFR therapies
* hematologic function: hemoglobin, less than 90g per liter; neutrophil count, less than 1500 per cubic millimeter; and platelet count, less than 100,000 per cubic millimeter
* liver function: bilirubin, more than 1.0 times the upper limit of normal; aspartate aminotransferase and alanine aminotransferase, more than 5.0 times and 2.5 times the upper limit of normal with hepatic metastasis or not
* Renal function: serum creatinine, more than 1.5 times the upper limit of normal
* Patients with symptomatic central nervous system metastases
PROCLAIM: CX-072-002: Study of PD-L1 Probody Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors

To obtain evidence of antitumor effect of CX-072 in combination with anticancer therapy in adult patients with solid tumor based upon overall response rate by Response Evaluation Criteria in Solid Tumors (RECIST)


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Measurable disease as defined by RECIST v1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
4. Agree to provide tumor tissue and blood samples for biomarker assessment

Exclusion Criteria:

1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study treatment.
2. Prior therapy with a chimeric antigen receptor T cell-containing regimen
3. History of active autoimmune disease(s) including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, type 1 insulin-dependent diabetes mellitus
4. History of myocarditis regardless of the cause
5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
6. History of any syndrome or medical condition that required treatment with systemic steroids (≥10 mg daily prednisone equivalents) or immunosuppressive medications.
7. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
Study of Welltang- a Cell Phone-based Diabetes Management Application's Effect on Blood Glucose Control

The aim was to assess the impact of a cell phone-based diabetes management application (Welltang) on HbA1c, blood glucose, lipids, physical activity, weight, and blood pressure during 3 months. And hypoglycemic events, the satisfaction of the patients with Boyibang, their diabetes knowledge and self-care behaviors were also evaluated.

At baseline, all patients completed the Diabetes Self- Care Behavior Questionnaire and a Diabetes Knowledge Survey. Health, medical and demographic history, height and weight, waist and hip circumferences, and blood pressure were recorded. HbA1c and low-density lipoprotein cholesterol (LDL-C) level were tested. All of these data were measured 3 months later at the conclusion of the study intervention.

Eligibility Criteria:
Inclusion Criteria:

* All diabetes, aged more than 18 years old. No limit for HbA1c was defined

Exclusion Criteria:

* patients have any severe complications such as end phase of diabetic nephropathy or proliferative retinopathy. patients who cannot use smart phone.
ACCURATE Study for Subjects With Dry Eyes

To determine treatment and imaging outcomes in bilateral ocular surface disease management with an intracanalicular dexamethasone (0.4 mg) insert compared to standard topical over-the-counter artificial tears lubrication management

This study will evaluate the benefit of treatment with a physician administered intracanalicular dexamethasone insert and patient administered artificial tears prn compared to patient administered artificial tears prn (control) in patients with bilateral ocular surface dry eye disease. The study is a self-controlled design and includes multiple objective, measureable, and quantifiable endpoints to best determine an objective response to treatment in patient eyes randomized to either the insert plus prn artificial tears or artificial tears prn control. To aid in ensuring best possible masking, DEXTENZA is best visualized with blue light and yellow filter and therefore visualization will not be assessed until final visit following all measures.

Eligibility Criteria:
Inclusion Criteria:A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

* Age 18 years and older
* Demonstrate objective signs of Ocular Surface Disease (OSD) or
* Demonstrate symptoms of OSD determined by a standardized questionnaire
* No other corneal pathology to create unknown variability

Exclusion Criteria:A patient who meets any of the following criteria in either eye will be excluded from the study:

* History of using topical steroids or other anti-inflammatory drops within 6 months of the study
* History of corticosteroid implant (Ozurdex or Iluvien) or intravitreal steroid use for macular disease in last 12 months
* History or current use of oral steroids or immunosuppressants
* Active ocular infection
* History of HSV
* History corneal refractive surgery
* Uncontrolled Glaucoma
A Study of Brexanolone for Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease 2019 (COVID-19)

The purpose of this study was to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ARDS) due to COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Participant was confirmed positive for the novel coronavirus responsible for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection as determined by polymerase chain reaction (PCR) at Screening
* Participant had a presumptive diagnosis of ARDS at Screening and partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen \[PF ratio\]) less than (\<) 300 prior to randomization
* Participant was intubated and receiving mechanical ventilation prior to randomization
* Participants must had initiated mechanical ventilation within 48 hours prior to screening, or had an immediate clinical plan for such intervention at time of screening
* Participant was likely to survive, in the opinion of the investigator, for at least 72 hours from the time of screening

Exclusion Criteria:

* Participant had fulminant hepatic failure at Screening
* Participant had end stage renal disease at Screening
* Participant had a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection
* Participant was concurrently participating in another clinical trial for an investigational product or device at screening
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals

This study aims to determine whether people living with HIV (PLHIV) with suboptimal medical adherence can achieve better viral suppression with long-acting antiretrovirals (LA) compared to all-oral antiretrovirals.

This is an open-label, multi-center, randomized, active-controlled, superiority trial on 40 adult subjects who had been diagnosed to have HIV infection for at least 12 months before enrollment but with suboptimal viral suppression despite antiretroviral treatment (ART), with the latest HIV-1 viral load ≥ 200 copies/mL. Participants' eligibility will be assessed through a review of their medical records, and individuals with established resistance to cabotegravir or rilpivirine will be excluded. Enrolled participants will then be randomized 1:1 to either "Delayed Switch to LA Treatment Group" or "Immediate LA Treatment Group" on enrollment. The "Delayed Switch to LA Treatment Group" will also switch to LA on week 24. The proportion of participants with HIV-1 RNA \<200 copies/mL at week 24 in the two study groups will be compared. Psychologic assessments including self-stigma and depression assessment will also be performed on day1, at week 24 and week 52.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign the written informed consent form for male and female participants aged 18 and above.
* At the time of enrollment, diagnosed with HIV infection for a minimum of 12 months.
* Under oral antiretroviral treatment (ART), which can be irregular or interrupted, with the most recent viral load ≥ 200 copies/mL.
* Body weight ≥ 35Kg.
* Willing to maintain contact with the research team throughout the study (provide accurate and reachable phone numbers, social accounts like Line, or reliable contact information of family or friends).
* Willing to receive gluteal (buttocks) drug injections.
* Willing to transition back to oral medication or follow the recommended treatment prescription according to the then-current national treatment guidelines after discontinuation of long-acting injectable drugs.

Exclusion Criteria:

* For those currently undergoing oral antiretroviral therapy, who have started or restarted oral ART for less than six consecutive months before screening.
* Previously undergone HIV drug resistance testing and known to have resistance mutations to either cabotegravir or rilpivirine.
* Unable to commit to maintaining contact with the research team throughout the study.
* Individuals who cannot receive treatment for hepatitis B during the period of transitioning to long-acting injections, if they are hepatitis B carriers.
* Individuals with buttock fillers.
* Women who are planning to become pregnant, pregnant, or currently breastfeeding.
Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD

This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Chronic Obstructive Pulmonary Disease Diagnosis: Subjects with an established clinical history of COPD for more than 1 year at Screening, according to the COPD GOLD guidelines.
* Current or former smokers with a history of ≥10 pack years of cigarette smoking.
* Post-bronchodilator FEV1/FVC ratio of \<70%.
* Pre-bronchodilator FEV1 must be \<80% predicted
* Women of non-child bearing potential (ie., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or women of child bearing potential, has a negative serum pregnancy test at Screening and agrees to acceptable contraceptive methods for the duration of the study.

Exclusion Criteria:

* Pregnancy: Women who are pregnant or lactating.
* Significant diseases other than COPD, ie., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
* Primary diagnosis of asthma.
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea.
* Poorly controlled COPD (hospitalization due to poorly controlled COPD within 3 months of Screening or requiring treatment with corticosteroids or antibiotics in the 6 week interval prior to Screening or during Screening.
* Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of Randomization.
* Clinically significant abnormal ECG.
Effect of Myofascial Release on Post-Exercise Recovery in Water Polo Athletes

Objective: To assess the acute effect of a myofascial release protocol applied to the adductor muscles of the thigh on functional, biomechanical, and physiological variables. Methods: This study is a randomized, double-blind, two-arm crossover clinical trial that will analyze male water polo athletes aged 16 to 25 years recruited from a sports training center in the city of Bauru. Data related to the following parameters will be collected for the physical evaluation: functional performance, through the jump test; biomechanical, through maximum isometric torque of hip adductors, electromyography of the hip and gluteus medius muscles; and physiological, through the analysis of serum markers of muscle damage and inflammation, and heart rate variability. After the initial evaluation, the participants will be randomly divided into two groups: intervention group and sham group. Then, all participants will perform a game simulation. After the game, the participants will receive the intervention designated for each group. For the intervention group, a manual therapy protocol will be applied, based on myofascial release in the thigh region that presents trigger points. For the Sham group, a manual technique, called classic massage, will be applied, with superficial pressure, used to reach only subcutaneous tissues, without acting on muscles and fascia. This protocol will be repeated at four different times, always after the games. After a washout week, the participants will change groups and the data collection protocol will be applied again.


Eligibility Criteria:
Inclusion Criteria:

1. Male athletes;
2. Age 16 to 25 years old;
3. Have at least one year of experience in the sport;
4. Perform a training load of at least 10 hours per week in the sport;
5. Participate in at least regional level competitions

Exclusion Criteria:

1. Have no reports of muscle injury in the thigh in the three months prior to the study,
2. Joint injuries in the hip, such as femoroacetabular impingement or tendinopathies of the tendons of the hip muscles or trochanteric, iliopectineal or ischial bursitis diagnosed by a clinician;
3. Do not present a drop in -performance for more than four weeks that could characterize the occurrence of non-functional overreaching or signs of overtraining syndrome
Survival and Prognostic Factors of Squamous Cell Carcinoma of the Nasal Vestibule

The goal of this observational study is to learn about survival and prognostic factors in patients who underwent surgical treatment for primary squamous cell carcinoma of the nasal vestibule. The main questions it aims to answer are:

* what is the prognosis of patients affected by squamous cell carcinoma of the nasal vestibule?
* are there any specific factors that could influence prognosis?
* is it possible to elaborate a new staging system, able to overcome the limitations of the currently used ones? Data about patients, tumour and type of surgery performed will be collected. Participants will be followed-up for a minimum 6 months period after surgery.

This study will address the survival of patients with squamous cell carcinoma of the nasal vestibule (NV-SCC), and it will analyze factors influencing it.

In particular, apart from demographic features of the patient, data regarding the origin of the tumour and its extension will be collected and the lesion will be restaged according the the three classification systems used at present (Wang's classification, AJCC for nasal cavity cancers, AJCC for non-melanomatous skin cancer of head and neck region), given the current controversy regarding the best staging system. Furthermore data related to the surgery and the final histology will be collected.

All collected data will be analyzed in order to investigate any possible factor related to overall survival, disease specific survival and disease free survival.

Patients will be followed for a minimum of 6 months up to 5 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of squamous cell carcinoma of the nasal vestibule
* underwent upfront surgical treatment with curative intent
* availability of clinical and radiological data for cT reassessment
* availability of histological samples for pT reassessment
* follow-up of at least 6 months after surgery.

Exclusion Criteria:

* patients initially referred for disease persistence or recurrence
* patients affected by tumour involving the nasal vestibule but originating from other sites (eg. nasal cavities, skin of the nasal pyramid or upper lip)