cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

Primary Objective:

To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) in participants with active rheumatoid arthritis (RA) who were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continued treatment with MTX, were determined to be inadequate responders.

Secondary Objectives:

To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy in participants with active RA who were either intolerant of, or considered inappropriate candidates for continued treatment with MTX, or after at least 12 weeks of continued treatment with MTX, were determined to be inadequate responders, with respect to:

* Reduction of signs and symptoms of RA.
* Improvement in quality of life assessed by participant reported outcome questionnaires.

Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity) throughout the study.

Total study duration was up to 310 weeks: Up to a 4 week screening period, 24 week randomized double-blind treatment phase, 276-week open-label extension, and 6 weeks post-treatment final study visit.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of RA greater than or equal to (\>=)3 months duration.
* American College of Rheumatology (ACR) Class I-III functional status.
* Active RA was defined as:

At least 6 of 66 swollen joints and 8 of 68 tender joints, high sensitivity C-reactive protein (hs-CRP) \>=8 mg/L or ESR \>=28 millimeter per hour (mm/H), and DAS28-ESR greater than (\>) 5.1.

* Participants as per Investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with MTX, or after at least 12 weeks of continued treatment with MTX, or inadequate responders treated with an adequate MTX dose for at least 12 weeks.

Exclusion criteria:

* Age \<18 years or the legal age of consent in the country of the study site, whichever was higher.
* Current treatment with disease-modifying antirheumatic drug (DMARDs)/immunosuppressive agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after cholestyramine washout.
* Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL-6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor.
* Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Short Term Results of Pediatric Septic Hip Arthritis Management in Assiut University Hospitals

Detect short term results of pediatric septic hip arthritis and its risk factors

Septic arthritis of the hip is a true orthopedic emergency(1). In developed countries, the incidence of acute bacterial septic arthritis is estimated to be 4 to 10 per 100,000 children (2).It is caused by many microorganisms. Staph aureus is most common in children over 2 years of age . Staph aureus is gram-positive cocci in clusters and most common in nosocomial infections of neonates(3-4).Group B streptococcus is most common in neonates with community-acquired infection and exposed during transvaginal delivery(5).Neisseria gonorrhoeae is gram-negative diplococci and most common in adolescents.when the causative Organism is Neisseria gonorrhoeae ,patients usually have a preceding migratory polyarthralgia,multiple joint involvement and small red papules(6-7).Group A beta-hemolytic streptococcus is most common organism following varicella infection.HACEK organisms (Haeophilus,Actinobacillus,Cardiobacterium,Eikenella,and Kingella fastidious) are less common causative organisms(8-9).Early diagnosis and accurate treatment is key in avoiding complications such as joint destruction,joint dislocation , ankylosis, growth arrest or spread of infection leading to osteomyelitis , pelvic abscess or nerve lesions.. Treatment is started without delay after synovial fluid and blood samples have been obtained. The classical presentation of septic hip arthritis in children is a combination of a painful hip joint with limited range of motion, fever, malaise and inability to bear weight on the affected limb. Misdiagnosis or inappropriate treatment of acute septic arthritis of the hip in children can result in devastating damage of the joint and possible lifelong disability. Open arthrotomy , drainage and thorough irrigation of the joint is considered the standard treatment for septic arthritis of the hip.Empiric antibiotic treatment primarily targets S. aureus and takes into account its resistance to antibiotics(10-11). So,we want to detect short term results of pediatric septic hip arthritis at Assiut University Hospitals

Eligibility Criteria:
Inclusion Criteria:

- Children younger than 14 years old presented with septic hip arthritis only or by bilateral septic hip arthritis in Assiut University Hospitals

Exclusion Criteria:

* 1-patients with Tuberculous arthritis 2-patients whose parents refuse to participate in the study
Modified Atkins Diet and Type 2 Diabetic Patients

This randomized control trial compared the influence of an Atkins diet to that of the ADA recommended diet on Type 2 diabetic obese patients during a one-year follow-up period


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients age 35-75 years
* BMI 30-39.9kg/m
* HbA1C\>7%
* Not receiving insulin
* Micro-albumin excretion\<60 mg/day

Exclusion Criteria:

* Serum creatinine level \> 1.4 mg per deciliter
* Diastolic blood pressure \> 100 mmHg or systolic blood pressure \> 180mmHg
* Liver disease
* LDL cholesterol \> 160 mg per deciliter despite lipid-lowering treatment
* Use of psychiatric medications
* Osteoporosis
* Cancer
* Food allergies, and
* Low carbohydrate diet in the past 6 months.
Regional Lymph Node Metastasis and Survival Outcomes in Advanced HCC

Tumor-draining lymph nodes play an important role in anti-tumor immune responses. In patients with hepatocellular carcinoma (HCC), however, the relationship between regional lymph node metastasis (LNM) and immunotherapy-based efficacy is unclear. This study aimed to evaluate whether extrahepatic LNM is associated with worse survival outcomes as compared to other metastatic sites in patients with advanced HCC.

In patients with advanced-stage hepatocellular carcinoma (HCC), previous studies showed that transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies exhibited better efficacy (PFS and OS) as compared to the ICIs and molecular target therapies. Besides, previous studies showed that tumor-draining lymph nodes play an important role in anti-tumor immune responses in vivo and in vitro studies. However, the relationship between regional lymph node metastasis (LNM) and immunotherapy-based efficacy is unclear. Therefore, this study aimed to evaluate whether extrahepatic LNM is associated with worse survival outcomes as compared to other metastatic sites in patients with advanced HCC who received transarterial chemoembolization (TACE) in combination with ICIs and molecular target therapies. This real-world study may provide further information on treatment selection for clinical practice and trials.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
2. Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread;
3. Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
4. Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
5. TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
6. Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
7. Has repeated measurable intrahepatic lesions;

Exclusion Criteria:

1. Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
2. Unable to meet criteria of combination timeframe described above;
3. Child-Pugh C or PS \> 2 or Severe hepatic encephalopathy
Influence of Rapeseed Proteins on the Postprandial Metabolic Response

The aim of the study is to investigate the effect of rapeseed proteins on the postprandial metabolic response. Therefore, study participants will receive a meal rich in fat and carbohydrates with and without rapeseed protein or with soy protein that serves as control.

The current study is a monocentric, controlled intervention study that will be conducted as cross-over design. Three interventions are planned and participants will be invited to consume a test meal with added rapeseed protein isolate, a test meal with added soy protein isolate and a test meal without additional protein. The evening before, the subjects will receive a standardized dinner. After a 12-hour fasting overnight, a cannula will be placed. Blood samples will be taken before and after eating the test meal rich in carbohydrate and fat. The test meal consists of pasta with oily tomato sauce with either 25 g of rapeseed protein, 25 g of soy protein or no additional protein. A total of 11 blood samples will be collected over a period of 6 hours. In the meantime, the blood pressure and pulse will be measured repeatedly and information on satiety will be recorded. The interventions will be interrupted by a period of, at least, 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* healthy men and women
* age between 18 and 65 years
* informed consent
* body mass index between 18,5 up to 29,9 kg/m2
* anamnesis without diagnostic findings

Exclusion Criteria:

* acute or chronic diseases ((hypertension, coronary diseases, renal diseases, diabetes, alcohol abuse etc.)
* intake of drugs (exemption: oral contraceptive)
* pregnancy or lactation
* food intolerance or allergies to mustard, soy, tomato, wheat
* participation on another trial
* blood donation - while last 2 month before the start of the study
* extensive physical activity (competitive sports, hard physical work)
* diet procedure
* smoking
Perioperative Combination Chemotherapy Versus Chemoradiation for Locally Advanced EGJ Adenocarcinoma

Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.


Eligibility Criteria:
Inclusion Criteria:

* informed consensus of the enrolled patients
* from 18 to 75 years old
* proven to be primary adenocarcinoma of EGJ
* pre-operative staging cT3-4N+M0
* no prior other chemotherapy and/or radiation against the disease
* normal function of all other vital organs including heart,liver ,kidney and so on
* Eastern Cooperative Oncology Group performance status: 0\~2

Exclusion Criteria:

* history of other malignancy
* allergic reaction to capecitabine or oxaliplatin
* enrolled in other clinical trials
* abnormal GI tract function
* dysfunction of other organs
* pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy
* other situations judged as not adaptive to the study by investigators
Methylene Blue for Cognitive Dysfunction in Bipolar Disorder

While many bipolar patients treated with mood stabilizing medications experience improvement in their symptoms, some continue to have ongoing difficulties with concentration and memory. The purpose of this study is to look at whether these symptoms can be improved by adding the compound methylene blue to the treatment plan of patients who are already taking lamotrigine.

Methylene blue is an available 'over the counter medication' in Canada. It has been studied in the long-term treatment of mood symptoms in bipolar disorder. Several clinical studies done in bipolar disorder report that methylene blue has had positive effects on both cognition and mood. It is important to do further research in this area as we know that, for patients who continue to have ongoing cognitive difficulties, there is no recognized standard of care for bipolar patients who experience these type of deficits.

This is a double blind cross-over study. There are two dose ranges in this study. A cross over design means that some patients will start at one dose range and others with another. About half way through the study, patients will then be switched over to the other dose range. Patients partially stabilized on lamotrigine will be randomized to either subtherapeutic (16mg) or therapeutic (200mg) dose of methylene blue. This design is necessary because methylene blue stains urine and thus it is not possible to use a traditional placebo. Double-blind means that neither the doctor nor the patient will know which strength of study drug the patient will be on at what point in the study. The study will be conducted in three centres, each recruiting 20 subjects over a two-year period. The duration of the study is 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between the ages of 18 and 65 who meet both RDC and DSM-IV criteria for bipolar I or bipolar II disorder will be recruited.
* All subjects will be interviewed using SADS interview (40) with added questions as to arrive at DSM-IV diagnoses as well.
* The patients will be treated with lamotrigine as their main mood stabilizer. Patients recruited for the study will show at least partial response to prophylactic treatment with respect to the mood symptoms.
* HAM-D (17 item) scores at study entry will be 15 or lower and Y MRS scores will be less than 15.

Exclusion Criteria:

* Patients not able to give informed consent
* Patients with active substance abuse or dependence or a history of such within the past two years
* Physical illness, mainly liver and kidney disorders and G-6-PD deficiency
* Subjects previously treated with methylene blue
* Pregnant or breast-feeding women
* Subjects who have had ECT within the past two years
* Patients with known brain injury or loss of consciousness of duration greater than ten minutes
* Subjects taking concurrent medications that are known to have cognitive effects (eg. beta blockers)
Examining Effects of Domain Specific Episodic Future Thinking on Cannabis Use

The overarching goal of this online study is to compare the efficacy of six (weekly) sessions of Domain-Specific Episodic Future Thinking (DS-EFT) relative an active control condition on improving the ability to value future rewards and reducing cannabis use (grams and days of use), tobacco use, and alcohol use among.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 or older
* reside in the U.S.
* report wanting to reduce cannabis use (4 or higher on scale of 1-10 with higher scores indicating greater desire to reduce use)
* report using cannabis at least 10 days in the last month
* report using cannabis at least 100 days in their lifetime
* Data quality checks passed

Exclusion Criteria:

-
Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions

The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to fluoride.

All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and one with fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.

Eligibility Criteria:
Inclusion Criteria:

1. Two approximal carious lesions on different teeth with at least one tooth in between
2. Both study lesions must not require an invasive treatment
3. Size and form of the lesions: the lesions must be fully visible and assessable on radiographs
4. The two carious lesions must fall into classes:

   * D2 (inner half of enamel)
   * D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)
5. Able and willing to observe good oral hygiene throughout the study
6. Age ≥ 18 years and ≤ 65 years
7. Willing and able to attend the on-study visits
8. Willing and able to understand all study-related procedures
9. Written informed consent before participation in the study

Exclusion Criteria:

1. The two study test lesions are located on adjacent teeth
2. Fluoride varnish application \< 3 months prior to study treatment
3. Tooth with numerous carious lesions
4. Evidence of tooth erosion
5. History of head and neck illnesses (e.g. head/neck cancer)
6. Any pathology or concomitant medication affecting salivary flow or dry mouth
7. Any metabolic disorders affecting bone turnover
8. Patient suffers from diabetes
9. Concurrent participation in another clinical trial
10. Women who are breast-feeding, pregnant or who plan a pregnancy during the study
11. Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
A Novel Pathway to Detect Muscle-invasive Bladder Cancer Based on Integrated Clinical Features and VI-RADS Score on MRI

This study investigates the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, that correlate with muscle-invasive bladder cancer (MIBC). It found that VI-RADS scores, along with other factors, were independent predictors of muscle invasiveness.

The purpose of this study was to determine the clinical, pathological, and radiological features, including the Vesical Imaging-Reporting and Data System (VI-RADS) score, independently correlating with muscle-invasive bladder cancer (BCa), in a multicentric national setting. Patients with BCa suspicion were offered magnetic resonance imaging (MRI) before trans-urethral resection of bladder tumor (TURBT). According to VI-RADS, a cutoff of ≥ 3 or ≥ 4 was assumed to define muscle-invasive bladder cancer (MIBC). Trans-urethral resection of the tumor (TURBT) and/or cystectomy reports will be compared with preoperative VI-RADS scores to assess accuracy of MRI for discriminating between non-muscle-invasive versus MIBC. Performance will be assessed by ROC curve analysis. Two univariable and multivariable logistic regression models were implemented including clinical, pathological, radiological data, and VI-RADS categories to determine the variables with an independent effect on MIBC.

Eligibility Criteria:
Inclusion Criteria:

* a primary diagnosis of bladder tumor,
* positive urinary cytology,
* suspected bladder neoplasm identifed by ultrasound of the urinary tract and/or cystoscopy and/or CT scan of the abdomen-pelvis.

Exclusion Criteria:

* history of prior urinary tract neoplasms,
* impossibility of achieving appropriate bladder distension,
* concomitant diagnosis of carcinoma in situ (CIS),
* no detectable lesion on MRI
* any contraindication to MRI (low renal function, MR unsafe medical devices etc.)
* any contraindication to spinal and general anesthesia.
Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal without fluoroscopy

Patients This study recruited patients who suspected/confirmed CBDS from clinical manifestation, liver function tests and imaging studies. With CBD sized between 5 and 15 millimeters, which measured from transabdominal ultrasonography (US), computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasonography (EUS). The exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. All patients were informed and wrote informed consent for the procedure.

Procedures Non-fluoroscopic CBDS removal was performed by experienced endoscopists, using standard side-viewing duodenoscope. After identified major papilla, the investigators performed bile duct cannulation with guidewire assisted technique. Successful cannulation confirmed by visualized bile aspiration. If the patients had difficult cannulation, double guidewire technique was used. After the successful bile duct cannulation, the investigators performed endoscopic standard sphincterotomy (EST). Precut sphincterotomy was not used in this study. Non fluoroscopic balloon extraction was performed. The balloon was pushed up to hilum then the investigators sweep until suspected complete CBD clearance. After that the investigators used digital SpyGlassTM to confirm the complete clearance of CBDS. If SpyGlassTM showed residual CBD stone, the investigators repeat balloon extraction. If SpyGlassTM showed complete clearance, the investigator proceed to perform final cholangiogram as reference standard for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically suspected/confirmed CBDS
* CBD caliber 5-15 mm

Exclusion Criteria:

* History of bile duct surgery
* History of bile duct tumor
* History of bile duct stricture
* Severe comorbidity
* Unstable vital signs
* Pregnancy
* Coagulopathy