cyrilzakka/clinical-trials huggingface dataset:
Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With T2D

The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone.

The SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.


Eligibility Criteria:
Inclusion Criteria:

1. age 20 or over
2. uncontrolled HbA1c (7\~10%) with metformin and/or sulfonylurea
3. Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m)
4. MAFLD: presence of any conditions

   1. Overweight or obese: BMI ≥23 kg/m2 (Asian)
   2. Metabolic dysregulation: at least of two of following criteria

      * Waist circumference: ≥90/80 cm in men and women (Asian)
      * Blood pressure ≥130/85 mmHg or drug treatment
      * Plasma triglycerides ≥150 mg/dL or drug treatment
      * Plasma HDL-cholesterol \<40/50 mg/dL for men and women or drug treatment
      * Prediabetes (i.e. fasting glucose levels 100 to 125 mg/dL or 2-hour post-load glucose levels 140 to 199 mg/dL or HbA1c 5.7% to 6.4%
      * HOMA-insulin resistance score ≥2.5
      * Plasma high-sensitivity CRP \>2 mg/L

Exclusion Criteria:

1. Significant alcohol consumption
2. Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes
3. Type 1 diabetes mellitus
4. medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs
5. Severe organ dysfunction

   1. liver damage: AST/ALT \>x5 UNL, albumin \<3.2, platelet \<60k, Child-Pugh-Turcotte stage B or C
   2. kidney damage: serum creatinine ≥2.0 mg/dL or eGFR \<50 mL/min/1.72m2
6. Hepatocellular carcinoma, active tumor, or metastasis
7. End-stage liver disease
Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties

The primary objective is to compare the potential for next-day residual effects of eplivanserin 5 mg/day and lormetazepam 1 mg/day by measuring the sleepiness in the morning using the patient's sleep questionnaire during 4 weeks of treatment in patients with chronic primary insomnia and sleep maintenance difficulties.

The secondary objectives are to compare the clinical safety of both products, including the potential for rebound insomnia and withdrawal symptoms after treatment discontinuation, to compare the efficacy of both products on subjective sleep parameters and to compare the effects of both products on patient's daytime functioning.


Eligibility Criteria:
Inclusion Criteria:

* Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
* At least 1 hour of wakefulness for at least 3 nights per week during the month preceding inclusion
* Disturbances of sleep maintenance criteria based on the patient's sleep questionnaire during the run-in period

Exclusion Criteria:

* Pregnant or breastfeeding women and women of childbearing potential without effective contraceptive method of birth control
* Night shift workers and individuals who nap 3 or more times per week
* Consumption of xanthine-containing beverages (i.e., tea, coffee or cola) that comprises more than 5 cups or glasses per day
* Insomnia secondary to a general medical condition

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Assessment of an iPhone Application on Glycemic Control in Type 1 Diabetes

The purpose of the study is to assess whether an electronic self-management tool, specifically an iPhone application entitled bant, can improve glycemic control in Adolescents who have Type 1 Diabetes Mellitus (T1DM).

Type 1 Diabetes Mellitus (T1DM) is among the most common chronic diseases affecting children, adolescents and adults. While intensive patient self-management can optimize Blood Glucose (BG) to near-normal levels, it is a challenge for many TIDM patients to continuously achieve this. These difficulties are compounded in the adolescent population, who struggle with daily self-management and therefore may increase their risk of T1DM complications.

Due to this observation an electronic self-management tool, in the form of an iPhone application called bant, was developed. This app guides the analysis of BG data and suggests changes in treatment, while also using social network and rewards to encourage and reinforce self-care behaviors, such as frequent self-monitoring of blood glucose levels (SMBG). By primarily measuring changes in HbA1C levels, the study will assess if bant and its features are associated with improved glycemic control in the adolescents who use it.

Eligibility Criteria:
Inclusion Criteria:

* T1DM as defined by 2008 Canadian Diabetes Association (CDA,2008)guidelines, with duration ≥ 1 year
* Age 11-16 years, inclusive at enrollment in the trial
* 2 of the participant's last 3 A1C results prior to enrollment, including the most recent, falling between 8.0% - 10.5%
* Have been followed for at least 6 months in the current diabetes clinic

Exclusion Criteria:

* Non-English speaking adolescents as the version of bant being used in the randomized control trial (RCT) is only offered in English at this time.
"Safety in Dementia": An Online Caregiver Intervention

In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.

Aim 1: To test the efficacy of Safety in Dementia (SiD) on firearm safety decision quality and behaviors, among a national sample of informal caregivers of community-dwelling people with dementia and firearm access (n=500).

Aim 2: To compare varied methods in reaching informal caregivers. Aim 3: To explore stakeholder longitudinal experiences with SiD and firearm-related decisions.

Eligibility Criteria:
Inclusion Criteria:

* Live in United States
* Speak English or Spanish
* Informal caregiver for community swelling person with dementia and firearm access
* Access to the internet

Exclusion Criteria:

* In legal custody or institutionalized
Supraventricular Tachycardia Collection Study

To collect supraventricular tachycardia (SVT) data for developing and testing sensing and detection algorithms for a subcutaneous implantable cardioverter defibrillator (ICD).

The purpose of the SVT Collect study is to collect supraventricular tachycardia episode data for developing and testing new sensing and detection algorithms for a future subcutaneous ICD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the trial is being conducted
* Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant or ICD/CRT-D change-out, OR subjects indicated for an ICD/CRT-D that are undergoing ablation or electrophysiology (EP) study (including Non-invasive EP Study \[NIPS\])
* Subjects are willing to provide Informed Consent

Exclusion Criteria:

* Subjects who are ventricular pacing dependent
* Subjects with a preexisting dual/triple chamber pacemaker or ICD who have a history of atrioventricular (AV) block with atrial pacing \< 120 beats per minute (BPM) while awake.
* Subjects who are unable to tolerate elevated ventricular rates (≥170BPM)
* Any condition which precludes the subject's ability to comply with the study requirements
* Enrollment in a concurrent study (without prior study management approval) that may confound the results of this study
* Subjects who are legally incompetent
* Subjects meet exclusion criteria required by local laws and regulations (e.g. age, breast feeding, etc).
Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture

A prospective randomized clinical trial is proposed to compare the plate fixation of proximal humerus fractures using a minimally invasive lateral approach and the traditional anterior approach.Forty five patients will be assigned to each approach (total of 90 patients) and will be assessed 7 times over a two-year period. The trial's primary objectives will be to demonstrate the efficacy of the plating technique in terms of speed of recuperation of function. The Quick DASH will be used for evaluation of function.The study will also examine secondary end-points of pain, range of motion, esthetic satisfaction and radiographic outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be based on the rates of all reported complications and adverse events at 2 years


Eligibility Criteria:
Inclusion Criteria:

1. Humeral surgical neck fracture, Neer II valgus-type Neer III
2. Patient willing to participate in the study
3. Patient available for follow-up through at least two years
4. Patient with acceptable preoperative medical clearance and free of, or treated for, medical conditions that would pose excessive operative risk
5. Patient fluent in French and/or English and able to understand his/her role in the study

Exclusion Criteria:

1. Inflammatory arthritis
2. Prior shoulder pathology
3. Active local or systemic infection
4. Neurologic or musculoskeletal disease that may adversely affect mobility
5. Participation in any other pharmaceutical, biologic or medical-device clinical investigation
6. Severe documented psychiatric disease
7. Severe ipsilateral elbow or wrist disease
8. Fracture resistant to reduction attempts through the minimally invasive lateral approach
Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis

This is a retrospectively observational study. The goal of this observational study is to analyze the risk factors of paraspinal muscles associated with the occurrence of spondylolisthesis in patients with degenerative lumbar spondylolisthesis(DLS) and to construct a predictive model. The main question it aims to answer is: Which paraspinal muscle changes are risk factors for DLS? We will collect the information of patients who have undergone lumbar MRI in our hospital and have been diagnosed with back pain ( including spondylolisthesis or no spondylolisthesis) during the period from 2022 to 2024.The collected data included gender, age, body mass index (BMI), diabetes, hypertension, occupation and imaging parameters. We will then retrospectively analyze the risk factors associated with lumbar spondylolisthesis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who presented to our hospital with back pain(the diagnosis was spondylolisthesis or no spondylolisthesis);
* Patients older than 50 years;
* Patients with complete clinical data and magnetic resonance imaging (MRI) before surgery.

Exclusion Criteria:

* The patient has previous spinal surgery;
* Patients with lumbar tumor,lumbar infection and lumbar tuberculosis;
* Patients with incomplete MRI sequence.
The Effects of Time-Restricted Eating Model

There is increasing evidence of the effects of the time-restricted diet model based on the daily intake of energy within a period of 8-12 hours on body weight control and metabolic parameters. There is no study on the potential effects of this nutritional model, which is thought to be an effective strategy in struggling with metabolic syndrome, on individuals' eating behavior and impulsivity levels. This study, which aims to evaluate the effects of time- restricted diet strategy on food intake, eating attitude and behavior and impulsivity level in adults, is a mixed method, randomized controlled intervention study. Thirty adult individuals between the ages of 18-65 will be included in this study, which will be carried out between 31.05.2021-31.12.2021 in Istinye University. Participants will be divided into 2 groups: the intervention group (n = 15) will apply a time-restricted nutrition model for 4 weeks, and no intervention will be applied to the control group (n = 15). Participants' food intake before and after the intervention period will be evaluated with a 3-day food intake record, their eating attitudes will be evaluated with the Eating Attitude Test (EAT-26), their impulsivity levels will be evaluated with the Barratt Impulsiveness Scale-Short Form (BIS-11-SF) and Go / NoGo test, and their eating behaviors will be evaluated with the Three Factor Eating Questionnaire (TFEQ-R21). At the end of the research, all individuals in the intervention group will be interviewed in depth and their experiences regarding the process will be recorded. IBM SPSS 22 program will be used in the analysis of all quantitative data, and the MAXQDA-12 program will be used in the analysis of qualitative data. The data obtained from this research will clear up the applicability of the time- restricted diet model and its effects on eating behaviors of adults.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Body mass index (BMI) ≥ 18.5 kg/m2,
* Routine eating window ≥10 hours (including all energy-containing meals and drinks),
* To agree to participate in the research voluntarily.

Exclusion Criteria:

* Age \<18 or \>65,
* BMI \<18.5 kg/m2,
* To have applied nutritional therapy for weight loss or medical treatment in the last 6 months,
* Being in pregnancy or lactation period,
* Working the night shift or the partner working the night shift (if it affects the participant's sleep and nutritional status),
* Having a known neurological or psychological disorder,
* Declaring that have a history of eating disorder in the last 3 months,
* Weight change of ≥ 5 kg in the last 3 months,
* Having an uncontrolled medical problem (cardiovascular, pulmonary, rheumatological, hematological, oncological, gastrointestinal, psychiatric, endocrinological, etc.)
* Receiving medical treatment that may have a significant impact on glucose metabolism, appetite or energy balance,
* Being on antidepressant treatment,
* Having a history of bariatric surgery,
* Having celiac, crohn's or ulcerative colitis.
Idiopathic Generalized Epilepsy Syndromes

The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.

According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis.

the Long-term prognosis include the rate of drug-resistent epilepsy, relapse after drug withdrawn, common comorbidities such as mood disorders, attention deficit hyperactivity disorder (ADHD) and learning disabilities.

Eligibility Criteria:
Inclusion Criteria:

* Patients are consecutively and prospectively enrolled from epilepsy center, with newly diagnosed epilepsy or established epilepsy.
* Patients have a diagnosis of idiopathic generalized epilepsy (IGE), according to the 2022 diagnostic criteria.
* Comprehensive clinical information is collected, and 24 hour video-electroencephalography is performed.
* Sign the informed consent forms.

Exclusion Criteria:

* Other epilepsy syndromes are considered during follow-up, such as genetic generalized epilepsy.
* Lost to follow-up
A Phase 3 Study of Obexelimab in Patients with IgG4-Related Disease

This study aims to examine the efficacy and safety of obexelimab for the prevention of flare of IgG4-related disease (IgG4-RD)

This study consists of a 1-year randomized control period (RCP), followed by an additional 2-year open label extension (OLE) period.

To enter the Screening Period (Day -28 to Day -1), patients must have active IgG4-RD signs/symptoms (i.e., flare) that require steroid therapy. On Day 1, patients will be randomized in a ratio of 1:1 to receive either obexelimab or placebo administered as subcutaneous (SC) injections. All patients will begin a steroid taper on Day 1 to discontinuation by Week 8.

Patients will be monitored for flares during scheduled in clinic visits and any unscheduled visits. The primary endpoint is time to first IgG4-RD flare that requires initiation of rescue therapy in the opinion of the investigator and the Adjudication Committee (AC).

Following the 52-week RCP, patients will have the opportunity to continue in an OLE period where all patients will receive obexelimab. Patients who do not wish to enroll into the OLE period will return for an in-clinic safety follow-up visit 8 weeks after the Week 52 visit (i.e., Week 60).

Including screening and follow-up, the maximum duration of participation in this study for an individual patient is 172 weeks (i.e., 28-day screening, 52-week RCP, 104-week OLE, and an 12-week follow-up).

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, ≥ 18 years of age
2. Clinical diagnosis of IgG4-RD
3. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD
4. Patients must have active IgG4-RD signs/symptoms (i.e., flare) that require the initiation of GC therapy or the increase in background long-term GC therapy
5. Other inclusion criteria apply

Exclusion Criteria:

1. Has disease in only 1 organ system whose primary manifestation is fibrosis
2. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening
3. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 4 weeks prior to screening
4. Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or \< 5 half-lives of the investigational treatment, whichever is shorter, prior to screening
5. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening
6. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
7. Use of B cell depleting or targeting agents within 6 months of randomization
8. Other exclusion criteria apply
Nab-TPC vs GP Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

We expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (TPC vs. GP) with combination therapy of Camrelizumab.

The therapeutic effect of patients with metastatic nasopharyngeal carcinoma has been further improved. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) have strong activity in treated metastatic nasopharyngeal carcinoma patients, with an objective response rate (ORR) of 20-34%. In addition, immunotherapy has also achieved good results in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. In 2021, the clinical results of a study on the treatment of recurrent/metastatic nasopharyngeal carcinoma with pembrolizumab were published. The median PFS of the pembrolizumab combined with chemotherapy group was 9.7 months, significantly prolonging PFS, with an HR value of 0.54, and reducing the risk of disease progression by 46%. Based on this, the 2022 CSCO guidelines will use pembrolizumab combined with GP chemotherapy as a new first-line treatment for metastatic nasopharyngeal carcinoma.We conducted a study comparing the efficacy of GP regimen and nab TPC regimen, and found that nab TPC regimen significantly improved the survival of patients with metastatic nasopharyngeal carcinoma compared to GP regimen, and the nab TPC regimen group had milder grade 3-4 toxic side effects.This study aims to design a prospective phase III clinical trial on the safety and efficacy of GP combined with Carilizumab compared to nab TPC regimen combined with Carilizumab chemotherapy for recurrent and metastatic nasopharyngeal carcinoma

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years.
2. ECOG score of 0-1.
3. Expected survival of at least 12 weeks.
4. Recurrent/Metastatic Nasopharyngeal Carcinoma.
5. At least 4 weeks since the previous chemotherapy.
6. At least one (according to RECIST) measurable lesion, lesions that have been previously irradiated can not be considered target lesions.
7. had adequate organ function
Diagnosing Acute Onset Insufficient Intestinal Blood Flow (Bowel Ischemia) With a Novel CT Technique Called Dual-energy CT (DECT). This Observational Study Seeks to Evaluate Whether DECT Can Improve the Diagnosis of Bowel Ischemia and How the DECT Findings Correlate With Intraoperative Findings

The aim of this study is to evaluate the performance of dual-energy CT (DECT) in the diagnosis of acute bowel ischemia (ABI). ABI is a condition characterised by inadequate blood supply to portions of the intestine. ABI is a relatively rare condition, but is associated with a high mortality rate.

DECT is an emerging field within radiology. Few reports have reported an increased conspicuity for ABI using DECT compared with conventional CT, which is the current preoperative golden standard.

The investigators hypothesize that DECT increases conspicuity of ABI compared with conventional CT and that DECT image findings correlate with the intraoperative findings.


Eligibility Criteria:
Inclusion Criteria:

* Referred on the suspicion of acute bowel ischemia

Exclusion Criteria:

* Patient not scanned with DECT
* Patient does not undergo abdominal surgery
Optimal Index for Pediatric Distal Forearm Fractures

This is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.The patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females 3 to 12 years old.
2. Any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting.

Exclusion Criteria:

1. Children with compound fractures (those with unacceptable initial reduction, fracture dislocations, and fractures with physeal separation) will be excluded from the study, as those will be treated with Kirschner wires.
2. Children whose casts is split will be excluded.