cyrilzakka/clinical-trials huggingface dataset:
Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects

To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the ChimeriVax™ dengue tetravalent vaccine

Primary Objectives:

* To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.
* To describe the immune response against dengue before and after one injection of ChimeriVax™ dengue tetravalent vaccine

This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or YF vaccine.

Eligibility Criteria:
Inclusion Criteria :

* Aged 18 to 40 years on the day of inclusion.
* Informed consent form signed.
* For a woman, inability to bear a child or negative serum pregnancy test.
* Completed the one-year follow-up of Study DIV12.
* Able to attend all scheduled visits and to comply with all trial procedures.
* For a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least four weeks after vaccination.

Exclusion Criteria :

* History of thymic pathology (thymoma), thymectomy, or myasthenia gravis.
* Breast-feeding.
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
* Previous flavivirus vaccination, e.g. Japanese encephalitis or yellow fever.
* Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Planned participation in another clinical trial during the present trial period.
* History of flavivirus infection (confirmed either clinically, serologically or microbiologically).
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy.
* Chronic illness at a stage that could interfere with trial conduct or completion.
* Blood or blood-derived products received in the past three months.
* Vaccination planned in the four weeks following the trial vaccination.
* Flavivirus vaccination planned during the present trial period.
* Planned travel during the present trial period to areas with high dengue endemicity.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent.
* Participation in another clinical trial in the four weeks preceding the trial vaccination.
* Any vaccination in the four weeks preceding the trial vaccination.
* Human Immunodeficiency Virus (HIV), Hepatitis B (Ag HBs) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
* Laboratory abnormalities considered clinically significant upon the Investigator's judgement in blood sample taken at screening.
* Positive flavivirus serological test in blood sample taken at screening (for Controls only).
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea

The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).


Eligibility Criteria:
Inclusion Criteria:

* Korean patients aged ≥ 20 years of age at the day of obtaining the informed consent
* Patients with histologically confirmed diagnosis of the following:

  * PTCL, not otherwise specified (PTCL-NOS)
  * Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
  * Angioimmunoblastic T-cell Lymphoma (AITL)
* Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)
* Have at least 1 evaluable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy of at least 3 months
Autonomic Modulation Recovery After Acute Resistance Exercise

To analyze the autonomic behavior in recovery post-acute resistance exercise performed in different intensities and body segments.

Resistance training (RT) is recommended to people with different health condition. RT is recognized as safe and effective method of increasing muscle strength, physical fitness, muscle mass, and overall cardiovascular health. The magnitude of the RT effects is associated with the structure of the training program. Understanding these aspects may provide guidance for the RT prescription while reducing potential risk of cardiovascular events associated with the recovery period after exercise. The objective of the study is to compare the acute responses of the Autonomic Nervous System post RT performed with different intensities (endurance and strength) in different body segments (UL and LL). Our hypothesis is that different intensities and body segments influence the acute responses of the ANS in the post RT recovery period.

Eligibility Criteria:
Inclusion Criteria:

* Graduate students,
* Age between 18 to 30 years
* Healthy men, the Physical Activity Readiness Questionnaire (PAR-Q) was used to determine safety and possible risk of exercising based on participants' health history, the according American College of Sports Medicine, 2010.
* Trained men, the International Physical Activity Questionnaire (IPAQ) was used to determine participants' physical activity level.

Exclusion Criteria: Participants who did not attend all the RT protocols and those with HR record with error higher than 5% (ectopic beats) will be excluded.

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Artificial Intelligence (AI) Technology May Help Patients to Understand Bowel Preparation Better Before They go for Colonoscopy.This Study Attempts to Leverage AI Chatbot in Counselling Patients to Improve Bowel Cleanliness, Reduce Anxiety as Well as Increase Procedural Satisfaction

Traditional pre-colonoscopy counselling requires significant time from healthcare workers to explain procedures, limiting efficiency and patient turnover. Inadequate bowel preparation exacerbates this issue, leading to repeat procedures and increased costs. However, no study has yet evaluated the effectiveness of AI in improving the Boston Bowel Preparation Scale (BBPS) for colonoscopy preparation. By addressing this gap, AI chatbots could provide personalized guidance, reduce healthcare worker burden, improve preparation quality, and enhance patient experience.This research attempts to evaluate the effectiveness of using Artificial intelligence (AI) chat bot to improve bowel preparation, anxiety level and patient's satisfaction among colonoscopy patients in Hospital Tuanku Muhriz (HCTM), compared to conventional instructions


Eligibility Criteria:
Inclusion Criteria:

* All scheduled colonoscopy with indication
* Adequate digital literacy
* Adequate language literacy with Malay and English language

Exclusion Criteria:

* Patients with memory impairment due to previous stroke, dementia or Alzheimer's disease
* Diagnosed with clinical anxiety
Effect of Diacerein in the Metabolic Control of Patients With DM Type 2 and Secondary Failure to Metformin

Considering that, Diacerein is on the market for almost 20 years, being used continuously in elderly patients with osteoarthritis without present significant side effects, and considering the anti-hyperglycemic effect and the improvement in the insulin resistance observed in animal models of type 2 diabetes and in a previously study from Mexico. The aim of our study is to investigate the effect of Diacerein, a medication with anti-osteoarthritic properties and moderately analgesic activity, anti-inflammatory and antipyretic, which demonstrates inhibit properties for the synthesis of pro-inflammatory cytokines such as interleukin 1 (IL-1). Administered for 12 weeks and the effect in the glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment.

This proof of concept study aims to access the metabolic control in patients with type 2 diabetes mellitus and secondary failure to metformin.

The Study is a Phase II, Multicenter, National, Prospective, Randomized, Double blind, Parallel Groups, Placebo Comparative Trial. UNICAMP (Hospital of Unicamp) is the coordinating center and we have the participation of the State University of Feira de Santana and the Center for Diabetes and Hypertension in Fortaleza.

Study Objectives: To investigate the effect of Diacerein administered for 12 weeks; glycemic and metabolic control in patients with diabetes mellitus 2 and secondary failure to metformin treatment. The Total Number of patients will be approximately 60, 30 patients in each group.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus (DM) type 2 between 6 months to 10 years of disease
* Body mass index between 25 and 35 kg/m2
* Fasting glucose between 120 and 250 mg/dL
* Glycated Hb A1c greater than 7,5 %
* Taking Metformin (dose above 1700 mg/day) with or without other secretagogue.

Exclusion Criteria:

* Subjects with DM1
* Subjects with DM2 using insulin
* Subjects with DM2 with chronic complications that already have clinical consequences
* Subjects with other types of diabetes
* Creatinine serum greater than 1.4 mg/dl (female) and 1.5 mg/dl (male)
* History of heart disease and/or severe concomitant diseases such as liver, coronary artery, renal
* History of severe psychiatric or neurological disorders
* History of alcohol abuse and/or illegal drugs or psychotropic medicines in the past six months
* Hypersensitivity to any component of the of study drug and placebo formulation.
Effect of Fenofibrate Conversion on Triglyceride Levels in Patients on Statin Therapy

The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides.

Hypothesis: Study subjects receiving fenofibrate 54mg will maintain similar triglyceride levels as patients on 160mg of fenofibrate.

The primary objective of this randomized trial is to measure the impact of converting patients on statin therapy from fenofibrate 160mg to 54mg per day compared to patients who continue fenofibrate 160mg per day for triglycerides. Secondary objectives include evaluating effect of the dosage change on low-density lipoprotein (LDL), HDL, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and serum creatinine (SCr), and the potential cost savings associated with prescribing 54mg instead of 160mg. Electronic medical records will be used to identify subjects and gather data on demographics, comorbid conditions, and concomitant lipid lowering therapy. Subjects will be recruited for enrollment via telephone by the principal investigator (PI), co-principal investigators (Co-PIs), or provider referral after eligibility screening and approval from their primary care physician. Subjects must provide written informed consent and Health Insurance Privacy and Accountability Act (HIPAA) privacy rule authorization prior to participation in this study. Subjects will be randomized to either the intervention arm (conversion to 54mg of fenofibrate) or to the control arm (remain on 160mg of fenofibrate). Subjects in both study arms will have fasting lipid panels, ALT/AST, and SCr evaluated at baseline. All subjects will have repeat labs approximately 8 weeks after enrollment. All subjects will continue to receive standard care based on lipid values. The study period will begin approximately October 29, 2010 and run to June 30, 2011.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Patients actively taking fenofibrate 160mg and statin therapy
* A fasting lipid panel within the past 9 months with most recent triglycerides levels less than 200mg/dL
* Primary care physician approves participation and fenofibrate conversion

Exclusion Criteria:

* Impaired renal function defined as creatine clearance ≤ 50ml/min
* Current enrollment in other studies or clinical trials
* Previous fenofibrate 54mg use
* A history of pancreatitis or known previous triglyceride levels \>1000mg/dL
* Pregnancy
* Members with plan benefits that include a deductible for lab services at Kaiser Permanente
Body Mass Index and Growth Parameters Evolution in Children Treated With Hybrid Closed Loop System for Type 1 Diabetes

Overweigth and obesity are commonly diagnosed in children with type 1 diabetes, and frequently an increase of wiegth and BMI is observed after diagnoses. Hybrid cloosed loop system are new system where insulin is continually adapted to glycemia (using an algorythme). The weight and growth trajectory of children treated with this system is poorly described.

Unlike type 2 diabetes, which is a frequent metabolic complication of obesity, type 1 diabetes is not a consequence of overweight or obesity, or of an excessively sweet or unbalanced diet.

However, more and more studies are linking type 1 diabetes to obesity. An international study with 23 026 children suffering from type 1 diabtes has shown that 22.3% of boys and 27.2% of children have overweight, and 6.8% and 6.3% respectively obesity . Several hypothesis are made to explain this trend : a consequence of intensive insulinotherapy, the fear of hypoglycemia with unnecessary glucose intake, the increase of caloric intake and the decrease of physcial activity. Moreover, subcutaneous insulinotherapy leads to modification in body composition with a increase in fat mass . Nevertheless, some studies highlights a possible role of obesity in the type 1 diabetes development( familial history of type 2 diabetes more common in children with type 1 diabetes , inverse relation with age at diagnosis and BMI suggesting that children with higher BMI will be diagnosed early in age .

Hybrid closed-loop systems, in which the insulin flow rate is adjusted almost instantaneously to the blood glucose level by using an algorithm with a CSII and a CGM, are new systems that have gradually been used in current practice . These systems are significantly associated with an improvement in glycemic control (HbA1C and TIR)\[17\], a reduction in the time spent in hypoglycemic states , and with an improvement in quality of life.

Nevertheless, the impact of this new treatment on weight evolution has been poorly described. A previous study with 50 children included did not show a BMI modification after 1 year of treatment. Individually, some patients following in our center have shown a reduction of BMI after treatment of type 1 diabetes with with hybrid closed loop system.

This leads us to perform an observational study in order to describe the trajectory of BMI and growth parameters of children suffering from type 1 diabetes (expressed in standard deviations (SDS) after 6 months, 1 year and 2 years of treatment with hybrid closed loop system in the university hospital of Nancy. The second objective is to identify potential factors associated with the positive evolution of BMI at 6 months, 1 year and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* children between 6 and 18 years at the beginning of treatment with HCL
* type 1 diabetes
* follow up in University Hospital of Nancy between 01/01/2021 - 31/12/2023
* treatement with HCL since 6 months

Exclusion Criteria:

* parental opposition for the study
* pregnancy
PEG-rhG-CSF in Secondary Prevention of Nab-Paclitaxel Combined With S-1 in Advanced Pancreatic Cancer

A prospective, open, single-arm clinical study to evaluate the efficacy and safety of jinyouli（PEG-rhG-CSF） in the first-line treatment of advanced pancreatic cancer with nab-paclitaxel combined with S-1.Chemotherapy regimen: (1) chemotherapy: nab-paclitaxel, 260mg/m2, intravenous infusion for 30 minutes, D1, Q3W. S-1, 80-120mg, PO BID, D1-14, Q3W. (2) patients who met the eligibility criteria were given jinyouli injections 24 hours after the end of intravenous infusion of nab-paclitaxel during the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years, ≤70 years;
* Patients with Advanced Pancreatic Cancer diagnosed by histopathology，the expected survival time is more than 3 months;
* Neutropenia of ≥2 degree occurred with the nab-paclitaxel + S-1 regimen in the previous cycle.
* KPS score≥70;
* The peripheral blood routine of the patients was normal: ANC ≥ 2.0x10\^9/L, platelet count ≥ 90x10\^9/L, HB ≥ 80g/L before enrollment, and there was no bleeding tendency;
* Patients volunteered to participate in the trial, signed a written informed consent, willing to be followed up.

Exclusion Criteria:

* There are uncontrollable infections at the moment or systemic antibiotic treatment within 72 h of chemotherapy；
* Any abnormal bone marrow hyperplasia and other abnormal hematopoietic function；
* Patients who had received bone marrow or hematopoietic stem cell transplantation within 3 months；
* Patients with other malignancies that have not been cured or with brain metastases；
* Total bilirubin(TBIL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \>2.5 ULN, or \>5 ULN if there is liver metastasis;
* Serum creatinine (Cr) exceeded the upper limit of normal value；
* Allergic to this product or other biological products derived from genetically engineered escherichia coli；
* Suffering from a mental or nervous system disorder, without self-awareness or coordination；
* Patients expected to have a short survival or have difficulty tolerating chemotherapy；
* Pregnant or lactating female patients；
* Patients using other drugs of the same category or in clinical trials of other drugs；
* Not suitable for participation at investigators' discretion.
Role of Aprotinin in Glucagon Degradation, Measurement by Radioimmunoactive Method (RIA) I125

The aim of the study was to investigate the role of the Trasylol in glucagon prevention in degradation using radioimmunoactive method with I125. Additionally different incubation time was introduced in human plasma samples after oral glucose stimulation, also in fasted and hypoglycemia blood samples from patients' type 2 diabetes. Since, the structure and the techniques for the glucagon measurement are well described nowadays.


Eligibility Criteria:
Inclusion Criteria:

* Caucasians 18 years or older with Type 2 diabetes (WHO criteria)

Exclusion Criteria:

* HbA1c \>9 %
* Liver disease (ALAT/ASAT \>2 x upper normal limit)
* Diabetic nephropathy (s-creatinine \>130 µM or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Severe arteriosclerosis or heart failure (NYHA group III og IV)
* Anemia
* treatment with medication not applicable to pause for 12 hours
* pregnancy or lactation
* Fasting plasma glucose \>15 mM on screening day.
Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)

This study will test the hypothesis that many human heart rhythm disorders are caused by small localized sources, where brief ablation may successfully eliminate the heart rhythm disorder.

The investigators will enroll patients with documented rapid heart rates from the bottom chambers of the heart (ventricular tachyarrhythmias).

During electrophysiological study, the investigators will map the localized sources of these heart rhythm disorders.

1. The 'active' group will prospectively receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM).
2. The control group will be a historical cohort who have received traditional ablation for this disorder.

All patients will be followed for up to 1 year to ensure that they have no recurrent arrhythmias.

Eligibility Criteria:
Inclusion Criteria:

1. Documented ventricular tachyarrhythmias.
2. Undergoing clinically indicated EP study with ablation.

Exclusion Criteria:

1. Unwillingness or inability to provide informed consent.
Multidisciplinary Approach and Counseling of the Obese Patient Before and After Bariatric Surgery

The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.

The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. We will do a benchmarking and also qualitative analyses of the interviews using Nvivo 10.

This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* All the members of the obesity team should be prepared to participate in the study
Routine Application of Ostenil® Mini in Patients with Rhizarthrosis

PMCF study to observe the routine application of Ostenil® Mini in the treatment of pain and restricted mobility in degenerative and traumatic changes of the CMC joint.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age and in good general health condition
* Signed informed consent
* Existing Ostenil® Mini recommendation for the treatment of rhizarthrosis

Exclusion Criteria:

* Known hypersensitivity to one of the Ostenil® Mini components
* Known pregnancy or lactating females
* Presence of coagulation disorder
* Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts
* Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language)