cyrilzakka/clinical-trials huggingface dataset:
Exercise Training Effects on Metabolic Syndrome: Interactions With Medication

To analyze the effects of different exercise training modalities (continuous, intervallic, and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome patients when this training interacts with their habitual medication.

Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity, the effects of different modalities of exercise training on cardiorespiratory and metabolic fitness. The main objective is to weight the effects of exercise training separately and in conjunction with the subject's habitual pharmacological treatment to identify the best combination of drug and exercise.

Methods and design: Randomized, pretest-posttest control group experimental design. Project developed in a single center with the collaboration of the regional public health system.

Subjects: Will be referred by their primary care physicians to our study unit. Up to 40 subjects all of them with metabolic syndrome will be recruited (at least 20% women).

Measurements:

1. Specifically, the investigators, will study cardiovascular adaptations that increase, i) maximal aerobic capacity measured by VO2max, ii) anaerobic and respiratory compensation point ventilatory thresholds, iii) arterial stiffness, measured by pulse wave velocity (SphygmoCor System), v) central and peripheral blood pressure, and iv) biological markers of endothelial dysfunction using reactive hyperemia with a laser Doppler fluxmeter in central and peripheral blood vessels.
2. The metabolic adaptations under study will include, i) insulin sensitivity by HOMA-IR, ii) fat oxidation by indirect calorimetry

Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome patients diagnosed according to the International diabetes federation consensus of 2009 (Alberti, et al., Circulation).
* 18-65 years old

Exclusion Criteria:

Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise.

* Respiratory failure
* Patient ends
* Pregnancy
An Open-Label Study to Evaluate Retreatment With LIPO-202

Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Provided consent
* Healthy male or non-pregnant female subjects
* BMI \< 30 kg/m2
* Stable diet and exercise routine
* Central abdominal bulging that is at least "Slight Bulge, Not Flat"

Exclusion Criteria:

* Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen
* Plan on starting a weight loss or exercise program during the study.
* Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
* Known hypersensitivity to study drugs
* Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202
Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy

Patients with partial-onset seizures seen in community-based practices were to be included in this therapeutic use study

* to assess the safety and tolerability of Keppra (Levetiracetam) and to confirm the favorable safety of the drug found during clinical development
* to obtain further information about optimal dosing in daily clinical practice. Compared to previous registration trials, the study population corresponded more closely to that seen in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Male and female older than 16 years;
* Epilepsy with partial onset seizures, with or without secondary generalization;
* At least one concomitant marketed anti-epileptic drug

Exclusion Criteria:

* Safety reasons
Quadratus Lumborum Block for Postoperative Analgesia After Colostomy Closure

Patients undergoing abdominal procedures often require multimodal postoperative pain controls. Truncal blocks such as quadratus lumborum (QL) block may be used adjunctively as a part of it. The investigators hypothesized that the ultrasound-guided QL block with transmuscular approach can provide adequate pain relief for colostomy closure as part of a multimodal pain control.


Eligibility Criteria:
Inclusion Criteria:

* A physical status between ASA I and III
* 20 - 75 years of age
* Patient has signed an informed consent
* Without contraindication of QL block

Exclusion Criteria

* American Society of Anesthesiologists (ASA) Physical Status ≥ 4
* Any contraindication to nerve blocks (including coagulopathy, abnormal anatomy, infection at the planned QL injection site, and amide-type local anesthetic allergy) pregnancy or breast-feeding
* Severe obesity (body mass index≥ 35 kg/m2)
* Patients with a history of significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease
* Allergy to NSAIDs
* Infection at the QL injection site
* Patients with major psychosis or drug and alcohol abuse
* Patient unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia pump
AcoArt III / Arterio-venous Fistula in China

This trial is aimed to evaluate the safety and efficacy of DCB in treating AVF stenosis in chinese population.

For years, first-line treatment of AVFs stenoses has been percutaneous transluminal angioplasty. However, restenosis and reintervention rates remain incredibly high and occur, according to recent studies, in up to 60% and 70% of patients at 6 and 12 months, respectively. Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia and drug-coated balloons,therefore, it represents an attractive option for AVF stenoses.

Eligibility Criteria:
Inclusion Criteria:

* Age during 18-85 years old
* Arteriovenous fistula is matured and has undergone one or more hemodialysis sessions
* Venous stenosis of the AV fistula
* target lesion has stenosis ≥50% evidenced by angiography. and have at least one symptom of these：1,the venous pressure increased significantly during dialysis. 2,abnormal physical examination. 3,Decrease in blood flow
* the length of target lesion ≤100mm
* Patient able to give informed consent
* residual stenosis ≤30% after predilation

Exclusion Criteria:

* Women who are breastfeeding, pregnant or are intending to become pregnant
* AVF located at lower limbs
* two or more than two stenosis at the target vessel.
* Obstruction of central venous return
* ISR
* AVF with acute thrombosis requiring lysis or thrombectomy in 30 days
* vascular access has surgery in 30 days or intending to undergo a surgery
* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* Patients undergoing immunotherapy or suspected / confirmed vasculitis
* Patients with history of blood coagulation dysfunction and history of thrombocytopenic purpura
* Vascular access infection or systemic active infection
* patients's life expectancy is less than 12 months
* Renal transplantation has been planned or converted to peritoneal dialysis
* Other medical conditions that lead to researchers who believe that patients may not be able to follow the trial program
* involved in other drugs, biology, medical device research, or has been involved in other similar products clinical Test
Evaluation of Gluma Desensitizer in Post-treatment Sensitivity in Posterior Composite

To evaluate the effect of Gluma desensitizer in controlling immediate post-treatment sensitivity in posterior occlusal composite restorations.

The primary objective of this study is to observe the effect of gluma desensitizer application in controlling the post-treatment sensitivity in posterior occlusal composite restoration in molar teeth using 2 adhesive bonding strategies.

The secondary objective is to evaluate the difference in the post-treatment sensitivity on application of Gluma desensitizer either prior to or after acid etching.

The different adhesive gluma desensitizer application groups are randomly divided into 6 groups,

1. Total etch control group (No gluma desensitizer application)
2. Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
3. Total etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching
4. Self etch control group (No gluma desensitizer application)
5. Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application prior to acid etching
6. Self etch group Gluma (Kulzer GmbH, Germany) desensitizer application after acid etching

Eligibility Criteria:
Inclusion Criteria:

* Occlusal cavitated caries in maxillary and mandibular first and second molars

Exclusion Criteria:

* Occlusal caries with axial or proximal extension
* Teeth with periodontal treatment within last three months
* Teeth with cracks
* Teeth to be taken as abutment for prosthesis
* Patients with psychiatric treatment
* Patients in orthodontic treatment or going to need orthodontic treatment
* Patients under dentin hypersensitivity or using desensitizer treatment
* Patients not willing for post treatment follow up
* Patients having any other teeth with pain or sensitivity symptoms
* Caries excavation with pulp exposure and post treatment sensitivity due to occusal interference in restoration
A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
* Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure
* Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable)

Exclusion Criteria:

* Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study
* Systemic fungal, bacterial, viral, or other infection that is not controlled
* Active autoimmune disease requiring immunosuppressive therapy
* Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen

Other protocol-defined inclusion/exclusion criteria apply
Tislelizumab or Tislelizumab Combined With Lenvatinib Neo-adjuvant Treatment for Resectable RHCC

This non-randomized phase II clinical trial aimed to explore the efficacy and safety of Tislelizumab or Tislelizumab combined with Lenvatinib as neoadjuvant treatment for resectable RHCC patients

Hepatocellular carcinoma (HCC) patients have about 70% of 5-year recurrence rate after curative treatment. Only 30% of recurrent HCC (RHCC) patients are resectable when diagnosed. Neoadjuvant treatment may reduce tumor burden and recurrence rate after surgery for RHCC patients. Immune checkpoint inhibitors combined with or without antiangiogenic agents have already been reported effective in advanced HCC patients as first-line therapy, and in several early-stage solid tumors as neoadjuvant therapy. According to several preclinical results, immune infiltration and the expression of PD-1 were higher in RHCC tumors than in paired primary tumors. So, immune checkpoint inhibitors combined with or without antiangiogenic agents might have a better response in RHCC patients than primary HCC patients. Herein, we designed this phase II clinical trial to explore the efficacy and safety of Tislelizumab (PD-1 inhibitor) or Tislelizumab combined with Lenvatinib as neoadjuvant treatment for resectable RHCC patients. Enrolled resectable RHCC patients will be divided into two non-randomized seperate arms, sequentially (arm 1: neoadjuvant tislelizumab; arm 2: neoadjuvant tislelizumab and lenvatinib). Each arm was estimated to enroll 40 patients. We have already enrolled 17 patients in arm 1, and have terminated the enrollment of arm 1 due to modest treatment responses. The enrollment of arm 2 is ongoing.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as recurrent hepatocellular carcinoma after curative treatment;
2. The criteria for resectability is met;
3. Has at least one evaluable lesion according to the RECIST 1.1 standard and has not received local treatment;
4. Eastern Cooperative Oncology Group score 0-1, Child-pugh score 5-7;
5. Agree to biopsy and blood sample collection;
6. Adequate organ and marrow function.

Exclusion Criteria:

1. Previously received any transarterial chemoembolization and immune therapy and other local or systemic liver cancer treatments, except for curative ablation;
2. Extrahepatic metastasis;
3. History of gastroesophageal varices or active cardia ulcers associated with a high risk of bleeding;
4. History of autoimmune disease or need to take immunosuppressant drugs for a long time;
5. History of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS);
6. Abnormal organ function
Functional Magnetic Resonance Imaging of Brain Activity in Patients With Painful Diabetic Neuropathy

Patients with painful diabetic neuropathy (PDN) often combine with anxiety and depression. However, the pathogenesis of PDN is unclear, especially the mechanism associated with central nervous system. The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism.The investigators evaluated the symptoms, signs and mental conditions of patients with PDN and non-pain neuropathy. The brain Blood Oxygen Level Dependent (BOLD) fMRI scan was performed in patients together with some gender and age matched healthy controls. Maybe this study can find that patients with PDN have abnormal brain activity, indicating central nervous system may contribute to painful diabetic neuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Voluntary participation and signing informed consent
* 18 to 60 years old with junior high school education or above
* meeting the 1999 WHO type 2 diabetes diagnostic criteria: having symptoms of diabetes (polydipsia, polyphagia, polyuria and unexplained weight loss) plus one of the following 3 items: (1) random blood glucose more than 11.1 mmol/L; (2) fasting blood glucose more than 7 mmol/L; (3) after 2 hours glucose load, the blood sugar more than 11.1 mmol/L
* The diagnosis of diabetic peripheral neuropathy (at the same time meets the following three items, of which painful neuropathy patients have pain symptom): (1) neuropathy occurs not earlier than the diagnosis of diabetes; (2) having clinical manifestations of pain, numbness, and abnormal sensation; (3) any abnormality in the following 5 examinations: ankle reflex, vibratory sensation, pressure sensation, temperature sensation, and acupuncture pain

Exclusion Criteria:

* left-hand writers
* neuropathy caused by other causes, such as cervical spondylosis, cerebral infarction, Green Barre syndrome; severe arteriovenous disease; neurotoxic changes caused by drugs and renal insufficiency
* patients with severe cerebral vascular disease
* diagnosed mental disorders such as depression, anxiety and Alzheimer's disease
* patients who can't accept head magnetic resonance imaging, such as those with metal (stents, metal dentures, internal fixation plates, etc.), and claustrophobic space phobias
Quantitative Sensory Testing of the Lower Lip After Inferior Alveolar Nerve Block, and Evaluation of the Role of the Contra-lateral Inferior Alveolar Nerve

The purpose of this study is to determine the contribution of the innervation of the contra-lateral mandibular nerve for the innervation of the lower lip area.

The investigators hypothesis is that the sensation of the lower lip is contributed by both mandibular nerves (from both sides of the jaw).


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no systemic diseases, chronic medication, past nerve injury, or sensory complaint.

Exclusion Criteria:

* Hypersensitivity/allergy to local anesthetic materials
* Systemic diseases, Chronic medication
* Past nerve injury
* Congenital or acquired deformity in the lower jaw
* Past fractures/neoplasm of the lower jaw
* Past surgery to the lower lip
A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers

This single-center, non-randomized, open-label study will assess the pharmacokinetics of aleglitazar after administration of single and multiple oral doses in healthy Chinese volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening and a 2-week follow-up, is up to 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female and male Chinese volunteers, 18 to 45 years of age inclusive at screening
* Subjects have to be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory measurements performed at screening
* Body mass index (BMI) 19 to 24 kg/m2 inclusive
* Female subjects who are not surgically sterile must be willing to use effective method of contraception as defined by protocol throughout the study and for 30 days after the last dosing

Exclusion Criteria:

* Any significant allergic reactions or multiple allergies
* Diagnosed or treated malignancy (except for treated cases of basal skin cancer or in situ carcinoma of the cervix) within the past 5 years
* Any major illness within 2 months prior to first dosing or febrile illness within 14 days prior to first dosing
* Positive for hepatitis B, hepatitis C or HIV infection
* Any clinically relevant history of alcohol and/or other substance abuse or addiction within the last 2 years
* Pregnant or lactating women, or women who have a positive pregnancy test
* Regular smoker with consumption of more than 10 cigarettes per day or equivalent amount of tobacco
* Participation in an investigational drug or device study within 3 months prior to the first dosing
Learning Curve of External Pop Out as a New Technique for Lower Uterine Segment Support

Cesarean section represent the most significant operative intervention in all of obstetrics, its development and application have saved lives of countless mothers and infants. the frequency with which its carried out continues to rise and has in many hospitals and health regions reached rates in excess of 30%(


Eligibility Criteria:
Inclusion Criteria:

1. Singleton term pregnancy
2. Cephalic presentation
3. Women who will accept to participate in the study

Exclusion Criteria:

1. Non-cephalic presentation
2. Congenital fetal anomalies
3. Multiple pregnancy
4. Preterm caesarean \< 37 weeks
5. Cases with marked adhesions obscuring the lower uterine segment thickness
Efficacy and Safety Study of Sulfonylureas in Neonatal Diabetes Mellitus

The aim of our trial is to try to switch patients with permanent neonatal diabetes mellitus due to a Kir6.2 or SUR1 activating mutation from subcutaneous insulin to oral glibenclamide therapy.

Neonatal diabetes mellitus, characterized by hyperglycaemia requiring exogenous insulin therapy appearing during the first months of life, is a rare condition with an estimated incidence of 1 in 400000 newborns and is permanent in only one-half of the patients\[1\]. Several studies have identified heterozygous activating mutations of the coding sequence of KCNJ11 or ABCC8 in patients having a permanent neonatal diabetes mellitus \[5,6,7,8\]. These genes encode for the 2 type of subunits Kir6.2 or SUR1 of the pancreatic β-cell ATP-sensitive K+ channel (KATP channel) which plays a central role in glucose-stimulating insulin secretion. These channels are also found on muscle and nervous cells, and this may explain the neurological features sometimes associated with permanent neonatal diabetes mellitus. Some sulfonylureas, as the glibenclamide, stimulate insulin secretion by binding to SUR1 subunit and closing KATP channels by an ATP-independent mechanism. The glibenclamide is used efficiently in type 2 diabetes but also recently in replacement of subcutaneous injected insulin in children with a Kir6.2 or SUR1 activating mutation \[7,8,11-13\].

The aim of our trial is to try to switch patients with permanent neonatal diabetes mellitus due to a Kir6.2 or SUR1 activating mutation from subcutaneous insulin to oral glibenclamide therapy. This study will stand at Necker-Enfants Malades Hospital in the Endocrinology and Diabetology Unit of the Professors Robert and POLAK. It will include 20 patients, most of them already identified. This study has two purposes: therapeutic by switching the patients from subcutaneous insulin to oral glibenclamide therapy, and cognitive by a complementary evaluation and understanding of the mechanisms of insulin secretion and of glibenclamide efficiency. To do so, we will assess continuously the capillary glycaemia for three consecutive days and evaluate the insulin secretion under insulin and sulfonylureas. Furthermore, we will rate the neurological and developmental status of the patients to seek for a potential improvement under glibenclamide therapy.

If oral glibenclamide therapy for these patients is proved to be successful, the systematic search for a Kir6.2 or SUR1 activating heterozygous mutation in newborns with permanent neonatal diabetes mellitus could be recommended in order to start early oral glibenclamide therapy and thus extend the indications for the sulfonylureas.

Eligibility Criteria:
Inclusion Criteria:

* coding sequence of KCNJ11 or ABCC8 in patients having a permanent neonatal diabetes mellitus
* written informed consent

Exclusion Criteria:

* hypersensibility of sulfonylureas
* severe renal failure (clearance of creatinemia \< 30 ml/min)
* severe hepatic failure (Prothrombin rate \< 70 %)
* Porphyria
* imidazol treatments
* pregnancy
* no social security affiliation
Isoniazid Dosage Prediction Model Development

Isoniazid (INH) is an essential component of first-line anti-tuberculosis (TB) treatment. However, treatment with INH is complicated by polymorphisms in the expression of the enzyme system primarily responsible for its elimination, N-acetyltransferase 2 (NAT2), and its associated hepatotoxicity. The objective of this study was to develop an individualized INH dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot study.


Eligibility Criteria:
* Eligible participants were patients newly diagnosed with active TB
* Who underwent standard four drug treatment for 6months: isoniazid (5 mg/kg, usually 300 mg), rifampin (450 mg for \<50 kg or 600 mg for 50 kg body weight), ethambutol(15mg/kg), and pyrazinamide (20 - 30 mg/kg)
* Given daily for two months and followed by isoniazid and rifampin with or without ethambutol for four months.
* Those patients with abnormal hepatic function on laboratory testing (increased serum aspartate aminotransferase, alanine aminotransferase, or total bilirubin) before anti-TB treatment, underlying liver disease or systemic illness such as congestive heart failure, acute life-threatening disease, or alcoholism, or disease that was resistant to INH at the start of treatment were excluded.