cyrilzakka/clinical-trials huggingface dataset:
Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia

Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.

Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.

The investigators will enroll patients with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), not taking other hypoglycemic compounds. Patients will be randomized to take Reglicem® or placebo for 3 months, in a randomized, double-blind, placebo-controlled design. Reglicem® and placebo will be self-administered once a day, 1 tablet during the breakfast.

Eligibility Criteria:
Inclusion Criteria:

* Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
* Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)

Exclusion Criteria:

* Patients with type 1 or type 2 diabetes mellitus
* Patients with impaired hepatic function
* Patient with impaired renal function
* Patients with gastrointestinal disorders
* Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
* Patients with weight change of \> 3 Kg during the preceding 3 months
* Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Patients taking (within the previous 3 months) hypoglycemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, anti-depressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
* Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC).

This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.

ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with docetaxel.

All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.

Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.

No patients will be deprived of standard prostate cancer therapy.


Eligibility Criteria:
Inclusion Criteria:

Patients who answer TRUE to the following criteria may be eligible to participate in this trial.

* Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
* Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
* Currently receiving treatment with surgical or medical castration

Exclusion Criteria:

Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.

* Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial.
* Suffering from heart failure or had a myocardial infarction within last 6 months
* A history of epilepsy or seizures
Mixed Chimeric Transplantation for Primary Amyloidosis

To evaluate the role of nonmyeloablative allogeneic transplantation in Amyloidosis.


Eligibility Criteria:
Inclusion Criteria:

* primary amyloidosis
* adequate organ function
* matched sibling donor

Exclusion Criteria:

* evidence of multiple myeloma
* HIV positive
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia

A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.


Eligibility Criteria:
Inclusion Criteria:

* Beta-thalassemia patients, 18 years of age or older, currently undergoing chronic blood transfusion therapy and iron chelation therapy who weigh more than 40 kg.
* No clinically significant findings on physical exam, medical history, or screening laboratories.
* Serum ferritin greater than 500 ng/mL, serum creatine creatinine within the normal range and platelet count greater than 100,000/mm3.
* Willing and able to discontinue DFO or L1 for the period of study.
* Woman of child-bearing potential must have a negative serum pregnancy test at screening and use a medically acceptable form of birth control during the study and for 1 month afterward. Male patients must also use barrier contraceptives during the study and for 1 month afterward.
* Have a level of understanding and willingness to cooperate with the confinement and all procedures. Able to provide voluntary signed/dated written informed consent.

Exclusion Criteria:

* Serious medical condition unrelated to Beta-Thalassemia.
* Participation in a previous investigational drug study within 30 days preceding screening.
* Patients with a known allergy to DFO that prevents chronic administration.
Comparison Study of EAP and CG Regimens for Mobilizing Hematopoietic Stem Cells in Multiple Myeloma Patients

This is a prospective, randomized, two-arm, multicenter, exploratory study aimed at evaluating the efficacy and safety of the combination of etoposide, cytarabine and Pegfilgrastim (EAP regimen) for mobilizing hematopoietic stem cells in patients with newly diagnosed multiple myeloma (NDMM). A total of 99 NDMM patients will be enrolled and randomly assigned to receive either the EAP regimen or the GC regimen (cyclophosphamide+ G-CSF) to mobilize hematopoietic stem cells. Subsequently, the mobilization effects and adverse reactions of all patients will be observed and compared.

According to strict inclusion and exclusion criteria, 99 newly diagnosed MM patients will be selected. They will be randomly assigned in a 2:1 ratio to the EAP group or the CG group. During the hematopoietic stem cell mobilization period, comparison study will be conducted regarding the proportion of patients who achieve the ideal collection value (CD34 cells \>5×10\^6/kg) after a single collection; the proportion of patients who cumulatively achieve the target collection value (CD34 cells \>2×10\^6/kg) and the ideal collection value; the cumulative collection of CD34 cells and the average number of collections; and the hematological and non-hematological adverse reactions of the EAP and CG regimens. Special attention will be given to the proportion of patients who add Plerixafor in both regimens.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients newly diagnosed as multiple myeloma.
* 2. Indication for ASCT.
* 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
* 4. Life expectancy ≥ 3 months.
* 5. Subjects must be able to understand the protocol and sign the informed consent.

Exclusion Criteria:

* 1. Cardiac function class II or higher or cardiac ejection fraction \<40%.
* 2. Serum direct bilirubin (DBIL)\>2× upper limit of normal (ULN).
* 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× ULN.
* 4. Serum creatinine clearance rate≤30%.
* 5. Patients with active infection.
* 6. Previously received hematopoietic stem cell mobilization.
A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial)

This is parallel, Phase 4 study which consists of a 24 week (0.5 years) randomized, double blind, placebo controlled, 2-arm treatment period followed by an open label segment of 104 weeks (2 years) for a total of 128 weeks (2.5 years) to evaluate the effect of dupilumab treatment on esophageal function, and remodeling in adults with eosinophilic esophagitis.

Duration of study period (per participant)

* Screening period: Up to 12 weeks before Week 0
* Randomized double-blind period: 24 weeks
* Open label period: 104 weeks
* Post Investigational Medicinal Product (IMP) intervention follow-up period: up to 12 weeks or until the participants switch to commercialized dupilumab, whatever comes first.

There will be ten (10) site visits, and five (5) direct-to-participant IMP delivery visits (except if prohibited by local regulatory authorities or if participant is not willing. In this case, IMP will be dispensed at the study site).

The duration per participant will be up to 152 weeks.

Eligibility Criteria:
Inclusion Criteria:

* A documented diagnosis of EoE by endoscopic biopsy.
* Baseline endoscopic biopsies with a demonstration on central reading of intraepithelial eosinophilic infiltration.
* History (by participant report) of an average of at least 2 episodes of dysphagia (with intake of solids) per week in the 4 weeks prior to screening.
* Body weight ≥40 kg.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Other causes of esophageal eosinophilia or the following conditions: hypereosinophilic syndrome or eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome).
* Active Helicobacter pylori infection.
* History of achalasia, Crohn's disease, ulcerative colitis, celiac disease, and prior esophageal surgery.
* Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to10 mm upper endoscope or any critical esophageal stricture that requires dilation at screening.
* History of bleeding disorders or esophageal varices.
* Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline.
* Initiation or change of a food elimination diet regimen or reintroduction of a previously eliminated food group in the 6 weeks prior to screening.
* Participation in prior dupilumab clinical study or participants currently treated or have been treated with commercially available dupilumab or contraindicated to dupilumab per local labelling.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
China-Administration of Nicorandil Group（CHANGE）

We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and after the reperfusion with those standard therapy treated by PCI

The aim of this study was to evaluate the efficacy and safety of nicorandil in improving myocardial infarct size in patients with acute myocardial infarction through a multi-center, prospective, randomized, double-blind and parallel-controlled clinical study, providing evidence-based support for the optimization of PCI treatment strategies. The primary objective of the study was to compare whether the effect of nicorandil in combination with PCI was significantly better at reducing the myocardial infarct size than that of PCI alone in AMI patients.

Eligibility Criteria:
Inclusion Criteria:

1. Acute ST-T elevation MI patients (\<12h)
2. undergoing emergency PCI；
3. Subject has read and signed a written, informed consent form.

Exclusion Criteria:

1. SBP\<80mmHg；
2. LM stenosis
3. Aortic dissection；
4. AMI (\<6 month)
5. PCI或CABG (\<6 month)
6. Already under the treatment of Nicorandil；
7. Contraindicated or intolerable to Nicorandil
8. severe adverse effects to CMR or MRI；
9. Currently (or within one month) participating in another new drug trial.；
10. Pregnant or lactation period；
11. Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating; Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;
Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.

The purpose of this study is to provide relevant quantitative evaluation of apathy close to real life situation by means of a multimodal sensor system integrated.

The investigators try to measure the amount of goal-directed behaviour and to detect the pattern of apathy. The main objective of this pilot phase is to select the variables of goal-directed behaviour from the list of metrics providing by the multimodal acquisition system in healthy subjects and patients with frontotemporal dementia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Frontotemporal Dementia (FTD) according to diagnostic criteria reported by Rascovsky et al. (2011).
* Understanding of the instructions and capacity to realize the cognitive tasks.
* Capacity to read, to understand and to sign legal document of information
* Capacity for informed consent for research, capacity to sign consent
* MMSE score \> 20
* Absence of other cerebral pathology.
* Absence of psychiatric disease interfering with the assessment of the tests
* Absence of excessive psychotropic use
* Access to National Healthcare Insurance
* Accompanied with a caregiver

Exclusion Criteria:

* Excessive psychotropic use
* Incapacity or refusal to realize the experimental tasks
* Subject deprived of freedom by an administrative or court order
* Subject under legal protective measure.
* Incapacity for informed consent for research
* Participation in another biomedical research
* Airway obstruction risk
* Reduction of activity not attributable to another chronic pathological condition
Ticagrelor in Elderly Patients Undergoing Percutaneous Coronary Intervention

The study is an investigator-sponsored, retrospective cohort study designed to compare efficacy and safety of ticagrelor in elderly patients undergoing percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age≥75 years old;
* Treated with PCI (limited to stent implantation) ;
* Survivors and treated with DAPT (aspirin \[100 mg once daily\], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist \[clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)\]) at discharge;

Exclusion Criteria:

* Coronary artery bypass graft (CABG) or only drug conservative treatment during hospitalization;
* Concurrent use of oral anticoagulants;
* Inability to tolerate long-term antiplatelet therapy, such as active bleeding and a bleeding tendency;
* Acute infectious diseases;
* Cognitive impairment;
* Declined re-examination.
Ultrasound Guided Anterior Quadratus Lumborum Block

Percutaneous nephrolithotomy (PNL) is frequently used today for renal stones. percutaneous nephrolithotomy (PNL) procedure has become the treatment of choice for many patients with symptomatic renal stones . Patients undergoing PNL suffer from acute postoperative pain, despite a multimodal analgesic regime.

This is a randomised controlled trial efficacy of the anterior Quadratus Lumborum Block (QLB) in terms of analgesic efficacy in patients who undergo percutaneous nephrolithotomy.

Many analgesic procedures such as NSAID, opioid and regional anesthesia procedures are used as a part of multimodal analgesia for postoperative Percutaneous nephrolithotomy pain.

In this study we will use the ultrasound -guided anterior Quadratus Lumborum Block . Local anesthesic will be injected between quadratus lumborum muscle and psoas muscle with ultrasound.Analgesic effect of this block will be detected by using morphine consumption and visual analogue scale .

Eligibility Criteria:
Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent elective Percutaneous nephrolithotomy

Exclusion Criteria:

* Previous history of opioid use preoperatively,

  * Allergy to local anesthetics,
  * The presence of any systemic infection,
Immun Status at Pancreatitis Patients

Pancreatitis is a common complication especially in patients with gallbladder stones, most patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20% of patients, the disease is severe and mortality rates of up to 30% are detected in these patients. In the evaluation of acute biliary pancreatitis, many scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity and mortality of the disease.

In this study, the investigators aimed to evaluate the correlation between morbidity and mortality of acute biliary pancreatitis and serum proinflammatory cytokines with ELISA and lymphocyte subtypes with Flow-cytometry.

Pancreatitis is a common complication especially in patients with gallbladder stones, most patients with biliary pancreatitis may recover spontaneously without sequelae, but in 10-20% of patients, the disease is severe and mortality rates of up to 30% are detected in these patients. In patients with severe pancreatitis, aggressive fluid replacement, organ damage follow-up, appropriate antibiotherapy, and endoscopic sphincterotomy and radiological interventions may be of great benefit. In the evaluation of acute biliary pancreatitis, many scoring systems have been established (Atlanta, Ranson, APACHE, BISAP etc.) from past to present to determine morbidity and mortality of the disease. There are limited number of studies in the literature about the immune parameters in the evaluation of acute pancreatitis. In a studies, serum inflammatory markers such as IL-1, IL-6 and CD4, CD8 T lymphocyte and Treg population were evaluated. It was reported that inflammatory markers, especially anti-inflammatory IL-10 levels were elevated in patients with acute pancreatitis, and CRP and IL-1β levels of inflammatory markers were higher in patients with organ failure. Treg cells are reported to be an independent prognostic factor in determining the severity of acute pancreatitis. There is only one study with a limited number of patients in whom PD-1 values in T lymphocytes and PD-L1 values in monocytes were determined in the literature. In this study, it is stated that PD-L1 can be used as a new marker in determining infectious complications. In patients diagnosed with acute biliary pancreatitis, determination of the course of the disease at the time of diagnosis is extremely important for treatment and survival.

In this study, the investigators aimed to evaluate the correlation between morbidity and mortality of acute biliary pancreatitis and serum proinflammatory cytokines with ELISA and lymphocyte subtypes with Flow-cytometry.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* Diagnosis of acute biliary pancreatitis
* Sign the voluntary consent form

Exclusion Criteria:

* Being under 18 or older than 80
* Not signing the voluntary consent form
* Pancreatitis resulting from an interventional procedure (ERCP, surgery, etc.)
* Pregnant women
* Being a history of immunodeficiency
* Cancer history
Esophageal Replacement With a Decellularized Human Esophagus Graft

The aim of the study is to analyze over a 12 month-period, the safety and the efficacy of a circumferentiel oesophageal replacement of the esophagus by a decelularized human esophagus, in 24 patient with a short esophageal stenosis refractory to endoscopic dilatations.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 65
* Caustic, traumatic, anastomotic, post-operative, radiation-induced or post-endoscopic (mucosal resection, submucosal dissection) benign esophageal stricture refractory to endoscopic dilatation.
* For women: effective contraception for the entire duration of the study (from signature of consent to end of follow-up)
* Affiliated or beneficiary of a social security scheme.
* Free written consent signed by the participant and the investigator.

Exclusion Criteria:

* Weight loss \> 10% of body weight over last 3 months
* Stenosis \> 5 cm in length
* Multiple strictures
* Esophageal mouth stenosis
* Anterior surgery close to the operative zone
* Complete anterior omentectomy
* Tumour stenosis or progressive tumour pathology
* Non-stabilized psychiatric disorders
* Participation in another interventional study
* Pregnant or breast-feeding women
* Women of childbearing age without effective contraceptive measures:

All women of childbearing age must have a negative pregnancy test prior to treatment and must agree to maintain highly effective contraception using contraceptive measures from the date of consent until 12 months due to the risks associated with anesthesia during endoscopy

* Uncontrolled sepsis
* Related to the transplant procedure

  * ASA score ≥ 3,
  * Severe respiratory insufficiency (FEV1 \< 1 L),
  * Decompensated hepatic cirrhosis or presence of esophageal varices,
  * Chronic renal insufficiency (creatinine \> 1.25 N),
  * Myocardial infarction less than 6 months old or progressive heart disease,
  * WHO general condition \> 2,
  * Weight loss \>20% not recovered after renutrition.
* Contraindication to general anaesthesia, analgesics and antibiotics.
* Conditions requiring long-term immunosuppressive or corticosteroid treatment.
* Patients under curatorship or guardianship
Prospective Registry and Biobank for Long-term Observational Studies in Adult Patients with Pulmonary Hypertension

Prospective registry and biobank for long-term observational studies in adult patients with pulmonary hypertension

In a prospective registry prevalent and incident patients diagnosed with group 1 to 5 pulmonary hypertension will be enrolled. In an integrated biobank body fluid samples will be collected at enrollment and sequentially during treatment with targeted drugs for pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of pulmonary hypertension group 1 to 5
* Ability to give informed consent

Exclusion Criteria:

- Withdrawal of informed consent