cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis

The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24 months.
* Evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

Exclusion Criteria:

* Treatment with any of the following within the 6 months prior to Screening: natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil; intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral, or intrathecal corticosteroids for the purposes of disease modification.
* Treatment with the following within 1 year prior to Screening: cyclophosphamide or alemtuzumab.
Cardiac RadiothErapy for VEntricular Tachycardia

Objective: To explore in our center the feasibility and safety of a SBRT treatment method for VT.

Study population: Patients with ventricular tachycardia that are refractory to dose-escalated antiarrhythmic drugs and where catheter ablation has either already been performed or is deemed to be unsuccessful or associated with high risks.

Intervention: Patients will be treated with a stereotactic body radiotherapy technique as a single fraction treatment up to a dose of 25 Gy delivered to the VT substrate defined by electrophysiological mapping.

Main study endpoints: The primary aim is to explore the feasibility and safety of a SBRT treatment method for refractory VT. Secondary endpoints include an assessment of the efficacy of the treatment, quality of life, late toxicity and overall survival.

Patients will have to fill in a quality-of-life questionnaire before and after the radiotherapy treatment. The risk associated with this trial is an increase in toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years
* Presence of a structural heart disease and an implantable cardioverter defibrillator (ICD)
* Documented sustained monomorphic VT that requires ICD intervention (e.g., shock or anti-tachycardia stimulation)
* The VT is inducible by ICD via non-invasive programmed stimulation (NIPS) or during electrophysiology measurement
* Patient must have failed or become intolerant to at least one antiarrhythmic medication
* Patient must have failed at least one invasive catheter ablation procedure, or have a contraindication to a catheter ablation procedure, or have VT thought to arise from a protected location
* Ability to give a written informed consent and willingness to return for follow-up

Exclusion Criteria:

* Pregnancy or breastfeeding
* Lack of evidence of a myocardial scar triggering the VT
* Polymorphic VT or ventricular fibrillation (VF) as a clinical heart rhythm
* Advanced symptomatic heart failure defined as NYHA Class IV heart failure
* Previous radiotherapy with cardiac involvement
* Life expectancy \< 6 months, in the absence of VT, as best based on clinical judgment by the treating and enrolling physicians
* Any condition that is deemed a contraindication in the judgment of the investigators
Validation of Low Dose CT for Diagnosis of Lung Nodules

The investigators have developed an extremely low dose computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of two chest radiographs. The investigators plan to test this exam in patients with known or suspected cancer undergoing clinically indicated chest CT.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric and young adult patients (ages 4 to \<21 years)
* Known or suspected malignancy other than lymphoma
* Undergoing clinically indicated CT of the chest

Exclusion Criteria:

* Pregnancy identified by routine Department of Radiology verbal screening
* Prior enrollment in the same study (no patient will be enrolled more than once)
* Inability to provide consent and/or assent
* Lymphoma
Functional Imaging of Cerebellar Mutism Syndrome

The purpose of this study is to better understand why some children with cancer have difficulty speaking after brain surgery. Difficulty speaking may be due to known complications to the language centers in the brain. These language centers may be located in slightly different places in different people. This study will study which areas may be damaged.


Eligibility Criteria:
Inclusion Criteria:

* Subject and/or guardian is able to provide written informed consent prior to study registration
* Age ≥3 years and ≤21 years
* Newly diagnosed, untreated mass in posterior fossa, either benign or malignant
* Is being evaluated for surgical resection of the mass
* Able to perform clinical language testing in English

Exclusion Criteria:

* Claustrophobia
* Any contraindication to MRI (e.g., pacemaker, aneurysm clip, tissue expander).
* Pregnant or nursing female
* Does not speak English as a primary language (as determined by the P.I. or treating physician after discussion with a potential subject and his/her family)
* Preexisting language or developmental disorder that would limit ability to cooperate with testing (as determined by the P.I. or treating physician after interviewing potential subject and his/her family; for example, a child may be excluded if he/she has confirmed or suspected autism spectrum disorder, dysarthria, dyslexia, lisp, hypotonia, or other age inappropriate speech development)
Endoscopy in CKD With Iron Deficiency Anemia

Iron deficiency anemia is very common in CKD patients. Data about gastrointestinal lesions in Arab patients are insufficient.

Iron deficiency anemia without gastrointestinal symptoms needs to be assessed in patients with chronic kidney disease.

Eligibility Criteria:
* Patients with eGFR is less than 60 ml/m/1.73 m2.
* Patients with iron deficiency anemia.
* Absence of gastrointestinal symptoms.
Experimental Studies of the Effects of Caffeine on Glucose Regulation

This project contains experimental studies of the effects of the drug caffeine on glucose regulation in adults who have Type 2 diabetes. In our experiments, we are testing the hypothesis that moderate amounts of caffeine exaggerate the abnormal increases in glucose and insulin observed after meals in patients with type 2 diabetes. On separate study days subjects receive standard meals after taking capsules containing either caffeine or an inactive placebo. We measure levels of glucose, insulin, and other chemicals in blood samples drawn over the next 3 hours. In a separate study, we use continuous glucose monitoring to measure glucose levels during everyday activities on days when subjects receive caffeine or placebo.

These studies do not involve clinical treatment or disease management. However, we hope to learn whether a very popular drug impairs the clinical management of a common disease.

Pilot results suggest that caffeine, the most commonly used drug in the world, may interfere with postprandial glucose metabolism by increasing insulin resistance and/or by stimulating hepatic glucose production. This effect could have serious clinical implications for coffee drinkers who have type 2 diabetes. Early results suggest caffeine exaggerates the postprandial hyperglycemia and hyperinsulinemia present in these patients.

The experimental (non-treatment) studies in this project include double-blind placebo-controlled cross-over laboratory tests of glucose tolerance in groups of type 2 diabetic patients and prediabetic volunteers who are coffee drinkers.

The lab studies test the hypothesis that caffeine (vs. placebo) increases postprandial insulin responses and results in a potentiation of glucose responses in the type 2 group.

An ambulatory study examines the effects of caffeine administration on glucose levels during everyday activities in the natural environment. This study uses a double-blind placebo-controlled cross-over design. Ambulatory glucose data are collected with a MiniMed CGMS sensor and recorder worn for 72 hours. Caffeine and placebo are administered on separate days. Average glucose levels and glucose responses to meals are compared across treatment days within subjects.

Eligibility Criteria:
Inclusion criteria:

* 6 months or longer history of type 2 diabetes
* treatment by diet, exercise, or oral medication
* current daily consumption of 2 or more cups of coffee
* BMI \>21kg/M2 and \< 45kg/M2

Exclusion criteria:

* Required use of insulin
* Current cigarette smoking
* Current use of medications that impact glucose metabolism
* Pregnancy
* Other major medical disorders
To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Investigate the efficacy and safety of HSK16149 capsules in Chinese diabetic peripheral neuropathic pain (DPNP) following 13 weeks treatment in comparison to placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent;
2. Males or females aged 18-75 years of age inclusive;
3. Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 6 months;
4. HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening;
5. At Screening, pain scale (VAS) of ≥40 mm and \<90 mm.

Exclusion Criteria:

1. Peripheral neuropathy or pain unrelated to DPN that may confuse the assessment of DPNP.
2. Skin conditions in the area affected by neurupathy that could alter sensation.
3. Chronic systemic diseases that may affect subjects' participation in the study.
4. Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:

   1. Neutrophils \< 1.5 × 10\^9/L, or platelet \< 90 × 10\^9/L, or hemoglobin \< 100 g/L, or
   2. AST/ALT \> 2.5 × upper limit of normal (ULN), or TBIL \> 1.5 × ULN, or
   3. Estimation of glomerular filtration rate (eGFR) \< 60 mL/min / 1.73 m\^2, or
   4. Creatine kinase \> 2.0 × ULN.
5. History of substance abuse or alcohol abuse.
6. Acute complications of diabetes in the 6 months prior to screening.
7. Any active infections at screening.
8. HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive.
9. Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3).
10. Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of DPNP.
11. History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds.
12. History of suicidal behavior or attempted suicide.
13. Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period.
14. Participated in another clinical study within 30 days prior to screening.
15. Other conditions of the subjects who are unlikely to comply with the protocol.
16. Could potentially affect a subject's safety.
Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer

* this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added
* the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen)
* all patients receive all three drugs; there is no placebo

* Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible.
* Patients with brain metastases, squamous histology, or hemoptysis are excluded.
* All patients must give informed consent.
* Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy
* Stage IV disease or stage IIIB with a malignant pleural effusion
* measurable or evaluable disease
* Performance status 0 or 1 (ECOG)
* adequate renal, hepatic, and bone marrow function
* adequate recovery from previous surgery or radiotherapy
* informed consent

Exclusion Criteria:

* brain metastases
* squamous (epidermoid) histology
* hemoptysis
* central airway disease
* Pancoast tumors
* previous chemotherapy or biologic therapy for lung cancer
* prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS
* pregnant or nursing women
Tandospirone Combined With Atypical Antipsychotic Drugs in Schizophrenia

Efficacy and safety of Tandospirone combined with Atypical Antipsychotic drugs to Improve Cognitive function in Schizophrenia

With atypical antipsychotics for the control group, evaluate cognitive function in schizophrenia patients with antipsychotics combined 5-Hydroxytryptamine 1A (5-HT1A) receptor partial agonist tandospirone

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders-IV Edition (DSM-IV) diagnostic criteria for schizophrenia patients.
* 18-65 years (including 18 and 65), male or female.
* Treated with a stable dose of an AAPD for at least three months.
* Informed consent was obtained (if the patient is in the acute phase of schizophrenia, does not have the capacity, their guardians need sign informed consent).
* PANSS negative score ≤60.

Exclusion Criteria:

* Combined AxisⅠmental illness other than schizophrenia;
* Taking a mood stabilizer, antidepressants, anticholinergic or anxiolytic drugs, and other drugs improve cognitive function;
* Suicidal tendencies;
* Have severe or unstable heart, liver, kidney, endocrine, blood and other medical disease patients
* Clinically significant ECG or laboratory abnormalities were
* Glaucoma and epilepsy;
* Unsupervised or unable to take prescribed medication;
* History of alcohol and drug abuse;
* Allergic;
* Pregnant or lactating woman;
* Patients participate in other clinical trials during a month;
The Incidence and Risk Factors of Radiotherapy Induced Hypothyroidism in Head and Neck Cancer With Long Term Follow up

This is a retrospective study with long term follow up to evaluate the incidence, timing and risk factors of radiotherapy induced hypothyroidism in non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy.

For any patient, fixation was done by a thermoplastic mask. CT scan was done at 3mm thickness for the head and neck region. CT images were transferred to the planning system. Three-dimensional conformal RT, intensity-modulated radiotherapy (IMRT) or Volumetric modulated arc therapy (VMAT) was created. All patients were irradiated with once-daily fractionation at 1.8-2.0 Gy/d with 6-MV photon beams for five days a week. The gross target volume (GTV) was treated with a dose of 70Gy and the lymphatic site (CTV) and areas of high risk microscopic disease (CTV) including lymph nose levels received a radiation dose ranging from 54-66 Gy according to its risk. PTV is a circumferential margin of 5mm around CTV.

Thyroid function parameters:

The patient's serum T4, T3 and TSH levels, were measured during follow up. Clinical hypothyroidism is defined as the increase in TSH above 5.0mIu/ml with a decrease in free thyroxine levels (free T4) in the serum while elevated TSH with normal free T4 levels was labeled as subclinical hypothyroidism .As per institutional values, the normal values intervals of T4 level (7- 25 PMOL/L), T3( 1.5-7 PMOL/L),TSH (0.2-5 mIu/L).

The median time to onset of hypothyroidism was defined as the time interval between completion of radiotherapy and first abnormal recorded T3/T4/TSH value.

For all treated patients, thyroid gland was delineated and by reviewing the DVH, the V45, V50, V55, V60, V65 and V70 which means the volume of the thyroid gland receiving 45 Gy, 50 Gy, 55Gy, 60 Gy and 70 Gy respectively.

Eligibility Criteria:
Inclusion Criteria:

* Non-thyroid head and neck cancer patients who were treated with RT alone or in combination with surgery and/or chemotherapy

Exclusion Criteria:

* Patients with thyroid gland disease or abnormal thyroid hormone levels before radiotherapy
18F-FDG PET/CT for IgG4-Related Disease

This is an open-label study to investigate the diagnostic performance of 18F-FDG PET/CT (positron emission tomography/computed tomography) in evaluation of patients with IgG4-related disease. A single dose of 18F-FDG will be intravenously injected into patients with IgG4-related disease before and after treatment.

Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration. The most important feature of IgG4-RD is chronic inflammation with multiple organ involvement. However, some organ involvements are difficult to find by ultrasound, CT or MRI.

18F-FDG PET/CT is a sensitive imaging tool for inflammation. In this study, PET/CT were performed in patients with IgG4-RD both before and after glucocorticoid treatment by a single dose of 18F-FDG. Visual and semiquantitative method will be employed to assess the PET/CT images. The PET/CT image data will be used to establish a diagnostic model as well as assessment criteria for response evaluation of IgG4-RD treatments.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 18-75 years old with informed consent
* Patients with IgG4-RD:

  1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
  2. elevated serum IgG4 (\>1.35 g/L) or with histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
  3. exclusion of other diseases.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential;
* Inability to complete the examination;
* Concurrent severe and/or uncontrolled and/or unstable diseases;
* Currently under treatment using glucocorticoids.
Factors Sustaining Tobacco Abstinence in Cancer Patients Treated With Radio-chemotherapy or Radiotherapy

The TABAC STOP ORL POUMON study aims to evaluate the factors influencing long-term smoking cessation in patients with head and neck cancer (HNC) or lung cancer undergoing radiotherapy or chemoradiotherapy. This is a single-center observational study, following patients at 1, 6, and 12 months after treatment completion. The primary objective is to determine the proportion of abstinent patients at 6 months, while secondary objectives analyze factors influencing abstinence, smoking trajectories, and reasons for relapse. A total of 100 patients will be included to ensure robust statistical analysis.

The TABAC STOP ORL POUMON study is a prospective, single-center observational study aiming to understand factors influencing long-term smoking cessation in patients treated for head and neck or lung cancer. Tobacco is a leading cause of death and disease, particularly in areas like Hauts-de-France with high smoking rates.

Eligible patients, undergoing radiotherapy or chemoradiotherapy, are enrolled during the final week of treatment, completing questionnaires assessing nicotine dependence and alcohol use. Follow-ups are scheduled at 1, 6, and 12 months, through clinic visits or phone interviews.

The primary endpoint is the proportion of patients who remain smoke-free at 6 months. Secondary endpoints include factors influencing smoking cessation, reasons for relapse, and changes in nicotine and alcohol dependence. The study will enroll 100 patients, expecting 81 evaluable cases, with data quality ensured through regular checks and source verification.

Eligibility Criteria:
Inclusion Criteria :

* Patient aged 18 years or older
* Diagnosed with head and neck cancer or lung cancer
* Undergoing curative treatment with chemoradiotherapy, radiotherapy alone, or stereotactic radiotherapy
* Current or former smoker
* Patient covered by a social security scheme
* Patient informed and having given consent for data collection

Patients with human papillomavirus (HPV) may also be included

Exclusion Criteria :

* Patient receiving palliative treatment
* Patient under guardianship or curatorship

Study Exit Criteria :

- Protocol-defined exit : After the 12-month consultation

Early exit :

* Withdrawal of consent for data collection
* Death of the patient
STEM-PD Open Label Extension (OLE)

This study seeks to establish the safety and efficacy of extended twice daily treatments for treating symptoms associated with PD. Only participants who completed the STEM-PD RCT trial are eligible for the OLE.

Up to 220 participants will enter an open label extension (OLE) study during which all study participants will receive treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily treatments will be re-introduced for the final 8 weeks (56 days).

Eligibility Criteria:
Inclusion Criteria:

* Completion of the study activities in the STEM-PD RCT trial. l.
* Participants must be willing and able to give consent to participate in the study trial.

Exclusion Criteria:

* Participant anticipates being unable to attend all visits and complete all study activities in both the RCT and OLE study trial.
* Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the RCT or OLE study trial.