cyrilzakka/clinical-trials huggingface dataset:
[68Ga] NOTA-SGC8 in the Staging of Bladder Cancer

The goal of this clinical trial is to test the imaging and diagnostic ability of \[68Ga\]-NOTA-SGC8 PET/MR in bladder cancer patients with different stages. The main questions it aims to answer are:

* Tumor specific lighting ability of \[68Ga\]-NOTA-SGC8 in bladder cancer patients with different stages.
* The safety of \[68Ga\]-NOTA-SGC8. Participants will be irrigated with \[68Ga\]-NOTA-SGC8 into the bladder for tumor imaging under PET/MR. The imaging performance of \[68Ga\]-NOTA-SGC8 on different stages of bladder tumors will be systematically evaluated by combining with pathological sections of patients. Urine accumulation and radioactivity distribution of \[68Ga\]-NOTA-SGC8 will be measured. The adverse events will be recorded.

Participants will be irrigated with \[68Ga\]-NOTA-SGC8 intravesically, with 0.05mCi/kg per person per time according to body weight, no more than 5mCi. The participants will be instructed to urinate cleanly before irrigation, and then irrigated \[68Ga\]-NOTA-SGC8 into the bladder via catheter for 30 minutes to make full contact between the injection and tumor. After 30 minutes, the injection will be withdrawn and 300ml normal saline will be injected into the bladder to maintain the shape of the bladder.

To evaluate the efficacy of \[68Ga\]-NOTA-SGC8 in imaging bladder tumors, the following indexes will be measured: specific imaging of the tumor area; specific imaging of its target PTK7 receptor protein; distribution in major organs; PET/MR imaging after administration; the absorbed dose of internal radiation based on the reference human hormone model using OLINDA software.

Tumor tissues of patients will be collected, and pathological sections of relevant patients will be analyzed after surgery. Immunohistochemistry will be used to verify the expression of PTK7 receptor in corresponding tumors. The association between PTK7 receptor protein and tumor malignancy, invasion, and stage will be evaluated by molecular imaging results.

All adverse events will be recorded within 24 hours after the administration of \[68Ga\]-NOTA-SGC8. Serious adverse events will be recorded for all subjects within 24 hours to 5 days after intravesical infusion. Blood and urine samples will be collected and the concentration of 68Ga-NOTA-SGC8 in the blood and urine will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed or previously diagnosed bladder tumors.
* At least one cystoscopy was performed within one month prior to enrollment, and the clinical diagnosis of bladder tumor was present.
* Age \> 18 years, \< 80 years
* Patients voluntarily participate and sign informed consent and are willing and able to follow protocol requirements.

Exclusion Criteria:

* Pregnancy, lactation, severe liver and kidney insufficiency and children;
* Participants who are allergic to the experimental drug, have an allergic disposition, or are allergic to multiple drugs.
Ileocecal Sphincter Reflex by Cecal Distension During Colonoscopy

The aim of the current study is to test the hypothesis that patients with IBS may have a defective ICV pressures and may have small bowel bacterial overgrowth. The goal of the current study is to identify the role and competence of ileocecal valve (ICV) in patients with irritable bowel syndrome.

The primary objective is to measure the pressure of the ileocecal valve in patients with and without irritable bowel syndrome (IBS). The Ileocecal valve reflux pressures during air insufflation of cecum will be used.

This is an outpatient study. There will be no requirement to stay overnight in the hospital. The research will be conducted in the gastroenterology section of the department of Medicine in North shore university hospital and in North shore long island Jewish medical center. Both these hospitals are tertiary care centers with adequate facilities for the safe and appropriate conduct of this research. Participants must meet all eligibility criteria and sign the consent form before enrolling in the study. This is a cohort study with 2 groups (patients with IBS and participants without IBS). Patients will be enrolled into one of these two categories based on their medical history, signs and symptoms and questionnaire. There are no controlled compounds used in this study. There is no treatment involved in this study. There are 2 study related visits per subject.

Based on questionnaire we plan to recruit 25 participants who meet the criteria of IBS and 25 participants who do not meet the criteria of IBS (Total of 50 participants in the study). Patients with IBS are those who meet the criteria of IBS based on their symptoms and the responses to a validated ROME III - questionnaire. All other participants who do not meet the criteria for IBS are classified as non-IBS participants. All the participants should be having a clinically indicated colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of small bowel bacterial overgrowth or irritable bowel syndrome and who are undergoing routine colonoscopies or subjects who are undergoing routine colonoscopy and test positive for small bowel bacterial overgrowth will be candidates. If the patient has prior lactulose breath test done for clinical purposes then repeat lactulose breath test will not be required. If no prior lactulose breath test has been performed then it will be done as part of this research study. In addition patients who test negative for SBBO will be candidates for the control population.

Exclusion Criteria:

* Medications-Subjects on any medication that could affect the ileocecal valve high-pressure zone will be excluded; this includes use of prokinetic agents, current use of any antibiotics and anticholinergics. Patients will be excluded if the lactulose breath test is done on antibiotics or during the colonoscopy preparation.

GI symptoms, conditions and disorders: In addition exclusion criteria will include a history of ileocecal resection or disease affecting the colon and/or small bowel including crohn's disease, ulcerative colitis or diseases causing diarrhea.
Clinical Relationship Between Vitamin D-mediated Th17 and Treg Cells and Parkinson's Disease

The aim of this study is to detect the expression levels of vitamin D, Treg, and Th17 in the peripheral blood of patients with Parkinson\&amp;#39;s disease (PD), investigate the impact of Treg/Th17 imbalance on PD patients, and explore the effects of vitamin D intervention on Treg/Th17 imbalance and clinical outcomes. Furthermore, this study aims to delve into the potential mechanisms of vitamin D deficiency and Treg/Th17 imbalance in the pathogenesis of Parkinson\&amp;#39;s disease, ultimately providing new theoretical evidence for the research, prevention, and treatment of PD.

FromJanuary 2023 to July 2024, 50 PD patients and 50 health control groups were collected. All subjects were from the Parkinson\&#39;s outpatient clinic and ward of the Department of Neurology, Suzhou Hospital Affiliated to Anhui Medical University. This study was approved by the Medical Ethics Committee of Suzhou Municipal Hospital and signed an informed consent form. The gender, age, identity registration, place of origin, marital status, education level, occupation, smoking, drinking, occupational exposure, body mass index, home address and contact information of the patients were collected for detailed registration. Current medical history, past history, family history, medication use, physical examination, previous relevant auxiliary examination results, etc. Evaluation scales: H-Y Staging Scale, UPDRS Scale, Breg Balance Scale, MMSE Intelligence Scale, MoCA Scale, SDS Depression Self-Rating Scale, SAS Anxiety Self-Rating Scale, PDSS Parkinson\&#39;s Disease Sleep Scale. Peripheral blood of patients and control groups were sampled to determine the levels of vitamin D, Treg and Th17. PD patients were divided into vitamin D deficiency group and vitamin D non-deficiency group according to the detection of vitamin D. Vitamin D deficiency group was randomly divided into intervention group and non-intervention group. The intervention group was supplemented with vitamin D, and the non-intervention group was not treated. The above scale and peripheral blood vitamin D, Treg and Th17 levels were evaluated after 3 months of follow-up and compared with the pre-intervention and non-intervention groups. Statistical analysis was carried out using SPSS26.0 and GraphPad Prism v.9.

Eligibility Criteria:
Inclusion Criteria:

* Meets the age requirement and is in good health.

Exclusion Criteria:

* Have related vitamin D metabolic diseases (kidney failure, severe liver damage, hereditary 1α hydroxylase deficiency, etc.).
* Have an immune system disorder.
* Have a history of disabling cerebrovascular disease.
* Have a grade 1 or 2 relative with PD.
* Have severe dementia, depression, or serious mental illness.
* Failure to sign the informed consent form.
Association Between Apical Periodontitis and Psoriasis Vulgaris

The aim of the present cross-sectional study is to assess the presence of AP and caries in psoriasis vulgaris individuals and to examine whether these medications influence these oral conditions. Therefore, 154 patients diagnosed with psoriasis were included in the study and subjected to oral examination to assess for presence of periapical lesions and caries experience.

The aim of the study is to evaluate the prevalence of apical periodontitis (AP) and caries in subjects with psoriasis vulgaris. 152 patients with psoriasis vulgaris were included in the study. The severity and extent of psoriasis were assessed according to The Psoriasis Area Severity Index (PASI), the Body Surface Area (BSA), and the Physician's Global Assessment Scale (PGA). Periapical status was assessed through dental examination and periapical radiographs. Data regarding Periapical Index (PAI), caries experience expressed as the Decayed, Missing, Filled Teeth Index (DMFT), and psoriasis medications were recorded. A predictive logistic regression model for the presence of AP and a linear regression model were then built to relate the severity and extent of AP to the type of drug therapy taken for psoriasis and to the severity and extent of the skin disease.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70
* Ability and willingness to give written consent;
* Presence of at least 6 teeth.
* Diagnosis of Psoriasis Vulgaris
* Other systemic diseases apart from psoriasis

Exclusion Criteria:

* diagnosis of periodontitis
* inability or unwillingness to give informed consent;
* periodontal treatment within the previous 6 months;
* ongoing immunosuppressive treatments or antibiotic therapy for other systemic diseases;
* pregnant or on lactation;
* additional comorbidities
* non endodontic lesions in maxilla/mandible;
* AP diagnosed on teeth with inadequate endodontic treatments and coronal restorations
Efficacy and Safety of Belimumab in SLE Patients

Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. Data showed that treatment with belimumab on the background of standard therapy was effective in active SLE patients. However, the efficacy of low-dose belimumab for prevention of disease flares in SLE patients with low disease activity is to be explored.

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with the incidence of about 70/100,000 in China. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Its pathogenesis is still unclear, but B cells have been confirmed to play a vital role in it. Belimumab, a B-lymphocyte stimulating factor (Blys) inhibitor, was the only FDA-approved biological agent for SLE. BLISS-52 showed that more active lupus patients had their SELENA-SLEDAI score reduced by at least 4 points during 52 weeks with belimumab 10 mg/kg (58% vs 46%, p=0·0024) than with placebo. But there was limited data about belimumab in SLE patients with low disease activity. Our previous study indicated that even these patients still have an annual flare rate of 30-40%. Therefore, we try to explore whether low-dose of belimumab could prevent the disease flares in SLE patients with low disease activity.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years;
2. Patients with low disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one B;
3. A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/leflunomide/tacrolimus) for at least 30 days.
4. Sign the informed consent;

Exclusion Criteria:

1. Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits;
2. Creatinine clearance rate \< 60ml/min;
3. Exposure to cyclophosphamide within past 6 months before screening;
4. Exposure to any B cell targeted therapy (Rituximab/belimumab) within past 1 year before screening;
5. History of Malignancy;
6. History of herpes zoster with past 3 months before screening.
7. Chronic HBV/HCV hepatitis；
8. Current infections (HIV/tuberculosis)
Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation

The aim of our study is to Estimate the reduction of LDL by ezetimibe in hypercholesterolemic patients on simvastatin.Investigate the effect of LDL lowering by ezetimibe on platelet activity and LDL tendency to peroxidation in hypercholesterolemic patients on simvastatin therapy

The hypothesis is that:

1. LDL lowering by ezetimibe on-top of simvastatin in patients on fixed dose of simvastatin can reduce platelet aggregation, due to the potential decreasing of cholesterol content in the platelet membranes.
2. LDL lowering by ezetimibe can lower LDL tendency to peroxidation.


Eligibility Criteria:
Inclusion Criteria:

1. Hypercholesterolemic patients on stable simvastatin dose for at least one month.
2. Age ≥18 years on stable AHA step 1 diet.
3. Patients without CHD or with one risk factors ; LDL \> 130 mg/dL and for Patients with CHD or CHD risk equivalent(clinical manifestations of non-coronary forms of atherosclerotic disease) or with 2 risk f actors (cigarette smoking, hypertension (BP ≥140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (\<40 mg/dL), family history of premature CHD;LDL\>100 mg/dL
4. Patients 'on at least simvastatin treatment of 20 mg per day.
5. CPK, ALT and AST \< 1.5 X upper limit of normal at baseline.

Exclusion Criteria:

1. Women currently receiving cyclical hormones.
2. Treatment with psyllium, other fiber based laxatives, phytosterol margarines, or other OTCs that affect serum lipids, unless treated with a stable regimen for \> 6 weeks and the patient agrees to continue this regimen for the duration of the trial.
3. Oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and a stable regimen for at least 6 weeks.
4. Lipid lowering agents including fish oils and QUESTRAN taken within 6 weeks.
5. Active coronary heart disease: unstable angina, acute myocardial infarction, CABG or PTCA within the last 3 months.
6. Women with childbearing potential unless on safe contraception.
7. Psychiatric disease with defect in judgement.
8. Severe renal or hepatic disease.
9. Uncontrolled hypo- or hyperthyroidism.
10. Contraindication for ezetimibe or simvastatin treatment. The patients will continue on their treatment with simvastatin for 6 weeks, and then the patients will be treated by the same dose of simvastatin combined with ezetimibe 10 mg/day for other 6 weeks.
INtensity of OVarian Stimualtion and Euploid Embryos

This randomized trial was designed as a no-inferiority trial aiming to evaluate if the intensity of stimulation (a milder vs a more intense approach) may have an impact on the number of euploid embryos and the morpho kinetic parameters in advanced age women undergoing PGT-A with a PPOS protocol.


Eligibility Criteria:
Inclusion Criteria:

* Infertile patients with indication for IVF
* Undergoing preimplantation genetic screening cycles
* AMH \>= 1.5 ng/ml and \< 3.5 ng/ml (AMH result of up to one year will be valid)
* BMI 18.5 - 30 Kg/m2

Exclusion Criteria:

* Severe male factor requiring TESE (testicular sperm extraction)
* AMH \< 1.5 ng/ml or \>= 3.5 ng/ml
* Administration of any other drug potentially interfering with the treatment
* Contraindication for hormonal treatment
* Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
* Monogenic disease to be detected with PGT-M
Creatine or Vitamin D Supplementation in Persons With Spinal Cord Injury Undergoing Resistance Training

The purpose of this study is to determine the effects of creatine monohydrate or vitamin D supplementation on strength gains following a traditional resistance training program for adults with spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury
* Minimum time since injury: 3 months

Exclusion Criteria:

* Participation in resistance training programmes in the previous 6 months
* Creatine or vitamin D supplementation in the previous 6 months
A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417)

This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study. Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study. Patients in this study will be described in terms of demographic and disease characteristics.

Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.

Exclusion Criteria:

* episodic treatment with infliximab
Motivational Interviewing for Medication Adherence in Asthma

The high burden of asthma appears to be related to poor asthma control, which is associated with more frequent asthma symptoms, greater bronchodilator use and functional impairment, and worse pulmonary function. Despite the availability of effective treatments, more than 58% of asthmatics are poorly controlled. Daily adherence to inhaled corticosteroid (ICS) regimens is considered by experts to be one of the most important behavioral factors linked to achieving optimal asthma control. However, there is a paucity of research on interventions specifically designed to improve ICS adherence among adult asthmatics. The vast majority of intervention studies to date used atheoretical interventions to target behavior change, relying mainly upon educational approaches which have been criticised for "failing to translate knowledge into action." This may be due to the fact that most education-based approaches do not specifically address or help patients overcome ambivalence about behavior change, which is necessary for ensuring daily adherence. Motivational interviewing (MI) is a client-centred intervention that focuses on enhancing intrinsic motivation to change a particular behavior, and exploring and resolving ambivalence about behavior change. Brief MI sessions (e.g., 1-5 x 15-30 minute sessions) have been shown to improve a variety of health behaviors (e.g., reduce alcohol consumption, improve dietary habits, increase exercise behaviour, and improve medication adherence) and health outcomes (reduce blood pressure, body mass index, and cholesterol levels). However, no studies to date have assessed the efficacy of using MI to improve ICS adherence in asthmatics. This study aims to assess the efficacy of using MI to improve daily medication (ICS) adherence in a sample of poorly controlled, non-adherent asthmatics. It is hypothesized that patients randomized to the MI condition will exhibit significantly improved ICS adherence at 6 and 12-months post-intervention, independent of baseline levels and covariates, relative to patients randomized to the usual care control condition.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Primary diagnosis of moderate-severe persistent asthma (as per GINA)
* Prescribed inhaled corticosteroid medication (min dose of 250 µg fluticasone equivalent per day) for at least 12 consecutive months
* Uncontrolled asthma (≤ 19 on the Asthma Control Test)
* Covered by a drug insurance plan (e.g., RAMQ)
* Non-adherent to ICS medication (based on having filled less than 30% of their prescriptions over the last year)
* Able to speak English or French.

Exclusion Criteria:

* Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer)
* Severe psychopathology (e.g., schizophrenia)
* Apparent cognitive or language deficit
* Are or plan to become pregnant or move outside of Quebec over the course of the study.