cyrilzakka/clinical-trials huggingface dataset:
Nicotinamide Riboside and Metabolic Health

This study will investigate the effects of 6 week Nicotinamide Riboside supplementation (1000 mg/day) on metabolic health in healthy (pre)obese humans. The primary objective will be hepatic and whole body insulin sensitivity. Secondary objectives, to provide information about the underlying mechanism, will be muscle mitochondrial function, brown fat activity, ectopic lipid accumulation, energy metabolism, cardiovascular risk parameters, body composition and acetylcarnitine levels.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Caucasian
* Males and postmenopausal females
* Aged 45-65 years at start of the study
* Body mass index (BMI) 27 - 35 kg/m2
* Stable dietary habits (no weight loss or gain \>5kg in the past 3 months)
* Sedentary lifestyle (not more than 2 hours of sports per week)

Exclusion Criteria:

* Type 2 diabetes
* Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
* Contra-indication for MRI
* Participation in earlier research or medical examination that included PET/CT scanning
* Alcohol consumption of \>2 servings per day
* Smoking in the past 6 months
Study of T3 for the Treatment of Fibromyalgia

Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50
2. Meet american college of rheumatology criteria for fibromyalgia
3. at baseline report an average pain of 4 or more on a brief Pain Inventory.
4. can climb 2 flights of stairs without shortness of breath.

Exclusion Criteria:

1. new medication change in the last 2 months
2. any cardiac disease at all
3. known thyroid disease before or after thyroid screening bloodwork
4. unstable medical or psychiatric disease.
5. Known inflammatory or rheumatic disease other than fibromyalgia
6. substance abuse in the last year
7. suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
8. concomitant herbal medications
9. multiple severe medication allergies
10. the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
11. diabetes
12. smoking
13. Known uncontrolled hypertension
14. known uncontrolled hypercholesterolemia
A Study of Camrelizumab Combined With Rivoceranib Mesylate Versus Investigator's Choice of Regimen in Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of Camrelizumab Combined with Rivoceranib Mesylate versus Investigator's Choice of Regimen in Treatment of Patients with Hepatocellular Carcinoma (HCC)


Eligibility Criteria:
Inclusion Criteria:

1. Subject must participate voluntarily and sign the informed consent form;
2. Aged ≥ 18 years old, male or female;
3. Histopathologically confirmed hepatocellular carcinoma;
4. Has PD on treatment with prior anti-PD-1/PD-L1/CTLA-4 monoclonal antibody (mAb) administered either as monotherapy or as combination therapy.
5. No more than 2 lines of previous system treatment;
6. Be able to provide fresh or archived tumor tissue samples;
7. Patient with at least one measurable lesion (for Stage I);
8. Barcelona clinic liver cancer: Stage B or C;
9. Child-Pugh score: ≤ 7;
10. ECOG PS score of 0-1;
11. Life expectancy of ≥ 12 weeks;
12. Adequate organ function
13. Must take one medically approved contraceptive measure

Exclusion Criteria:

1. Patients with any active, known or suspected autoimmune disorder;
2. Patients who have used corticosteroids or other immunosuppressive agents for systemic treatment within 1 month prior to randomization;
3. With known severe allergic reactions to any other monoclonal antibodies;
4. Received previous camrelizumab or rivoceranib mesylate treatment;
5. Patients who discontinued ICIs treatment due to immune-related toxicity;
6. Patients with known CNS metastasis or hepatic encephalopathy;
7. Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;;
8. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before randomization;
9. Patients with other malignancies currently or within the past 5 years;
10. Patients with hypertension which cannot be well controlled by antihypertensives; history of hypertensive crisis or hypertensive encephalopathy;
11. Uncontrolled cardiac diseases or symptoms；
12. Known hereditary or acquired bleeding disorders;
13. Clinically significant bleeding symptoms or clear bleeding tendency;
14. Patients with gastrointestinal perforation or gastrointestinal fistula;
15. Patients with significant vascular invasions with a high possibility of fatal bleeding;
16. Patients with important arterial/venous thrombosis;
17. Patients experiencing toxicity caused by previous anti-tumor therapy that has not recovered to Grade ≤ 1;
18. Patients with active infection;
19. Patients with congenital or acquired immune deficiency;
20. Patients who received live vaccines within 28 days prior to randomization, or are expect to be vaccinated during the treatment period;
21. Patients with other potential factors that may affect the study results.
Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology

Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology

Establishment of Acute Lymphocytic Leukemia Data Base in the Department of Oncology

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed Acute Lymphocytic Leukemia

Exclusion Criteria:

* Patients with diagnosis other than Acute Lymphocytic Leukemia
International Programs Collaborative Studies Coordinating Center

To continue the work of the Collaborative Studies Coordinating Center (CSCC) on international studies in cardiopulmonary disease epidemiology. The work was being performed under bilateral agreements that the NHLBI had entered into with Russia, The People's Republic of China and Pakistan. The contract provided nutritional, epidemiologic and biostatistical services in support of these studies.

BACKGROUND:

Computer processing, biostatistical, and epidemiological services at the Collaborative Studies Coordinating Center (CSCC) had been funded previously as part of the NHLBI Lipid Research Clinics (LRC) contracts. In FY 1990, contract N01HV08112 was awarded separately from the LRC for the first time and provided services for collaborative studies carried out under NHLBI international bilateral agreements with the USSR, Poland, and the People's Republic of China. The assistance has provided important contributions to large-scale, international epidemiological studies resulting from bilateral agreements between the United States and other countries. The results of these efforts have provided insights into different disease patterns and trends throughout the world.

DESIGN NARRATIVE:

The CSCC coordinated data collection and data file transfer, coordinated scientific meetings, visited the collaborating countries, hosted collaborative scientists, and directed data analysis, combining data from all countries.

Eligibility Criteria:
No eligibility criteria
DNA Analysis of Blood and/or Tissue Samples From Patients With Primary Kidney Cancer Receiving Sorafenib on Clinical Trial MRC-RE05-SORCE

RATIONALE: Studying samples of blood and/or tissue in the laboratory from patients with kidney cancer receiving sorafenib may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to sorafenib.

PURPOSE: This research study is looking at the DNA in blood and/or tissue samples from patients with primary kidney cancer receiving sorafenib on clinical trial MRC-RE05-SORCE.

OBJECTIVES:

* Examine the relationship between tumor genotype, expression, and patient outcome.
* Examine the relationship between constitutional genotype and patient outcome.

OUTLINE: This is a multicenter study.

Patients undergo blood and/or tissue sample collection for laboratory studies. Laboratory studies include generation of tissue microarrays; analysis of protein expression by immunohistochemistry; tumor DNA extraction and whole genome amplification; detection of VHL or other relevant gene mutations by direct sequencing; and constitutional (lymphocyte DNA) genotyping by single nucleotide polymorphism analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed resected renal cell carcinoma

  * Clear cell or non-clear cell tumor
* Receiving sorafenib tosylate on clinical trial MRC-RE05-SORCE

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Safety Study of Levocetirizine and Fexofenadine

This Study is to comparison of Efficacy and Consistency of Action of Levocetirizine 5 mg once daily with Fexofenadine 60 mg twice daily in the histamine induced wheal, flare and itch Response.

This will be a randomized, double-blind, placebo-controlled study with intra-individual comparison of the histamine induced wheal and flare reaction. In September 2009, Fexofenadine was approved as an antihistamine against allergies in Japan and it is currently used widely. It has been approved in 120 countries, including the US, UK, France and Germany \[11\]. In Europe and the United States, fexofenadine is marketed at 120 mg once daily for allergic rhinitis and 180mg once daily for urticaria. In Japan, fexofenadine is marketed at 60 mg twice daily for both conditions. But is this dosage regimen as effective as levocetirizine, 5 mg once daily? The above described study from Takahashi et al, comparing 60 mg twice daily versus cetirizine 10 mg once daily suggests that it is not \[4\]. The aim of the study is to compare the efficacy and consistency of action of levocetirizine 5 mg once daily with fexofenadine 60 mg twice daily over a 24 hour period in the histamine induced wheal, flare and itch response. Furthermore, we would like to investigate whether a different between Japanese and Caucasian exists or not. Each volunteer will receive the study medication at time point 0 and 12 hour later. Skin Prick Test (SPT) will be performed in each volunteer using histamine (10 mg/ml), 15 minutes before drug admission (baseline) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours afterwards. Volumetric optical scanning system and infrared camera will be used for objective evaluation of the wheal- and flare reduction. Additionally, measurement of the erythema diameter with a transparent ruler will be performed. The subjective intensity of itching will be assessed using a Visual Analogue Scale (VAS). To relate the pharmacokinetics of the drugs to their pharmacodynamics, blood samples for assay of drug concentrations will be taken at baseline and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours later. Subjects will undergo the same procedure on three separate occasions to receive each treatment option. The options are: placebo at time 0 hours + placebo at 12 hours, Levocetirizine 5mg at time 0 hours + placebo at 12 hours or fexofenadine 60mg at time 0 hours + fexofenadine 60mg at 12 hours. There will be a washout period of at least 6 days between the treatments.

Eligibility Criteria:
Inclusion Criteria:

Eighteen (18) healthy male volunteers, including at least 6 persons of Japanese origin, will be recruited for this study

Exclusion Criteria:

* None of the subjects will have taken oral antihistamines, antidepressants, antipsychotics or corticosteroids or applied topical antihistamines, corticosteroids or mast cell stabilizers to the skin for 2 weeks prior to testing.
* No subject shall perform physical exercise for 4 hours prior to the skin prick testing.
* Especially, Bronchial asthma, anaphylactic reactions in the history, use of beta-blockers, skin diseases in the test field are exclusion criteria.
Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures

A common procedure in children with cancer is the spinal tap, or lumbar puncture (LP), in which a needle is inserted into the spinal canal. In this population, LPs are most commonly performed to collect cerebrospinal fluid (CSF, the liquid surrounding the brain and spinal cord) for diagnostic testing, and to inject medications including chemotherapy. Local analgesic (pain control medicine) during pediatric LP procedures is underutilized and not standardized. The first local analgesic routinely used for LP procedures was lidocaine injection. The discovery of the topical EMLA (lidocaine 2.5%/prilocaine 2.5%) cream, approved by the FDA for local skin use in pediatric patients, has provided an additional option for local LP analgesia. A comparison between topical EMLA vs lidocaine injection for LP pain control in the pediatric population has not been performed. Pediatric oncology patients often require serial LPs for diagnostics purposes and/or chemotherapy delivery. Due to a lack of standardization of LP analgesia in this population, the investigators have designed a prospective, single-blind, randomized control crossover trial to examine EMLA vs. lidocaine injection in reducing pain associated with LP in children being treated for leukemia or lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric cancer patients (aged 3-18) with a diagnosis of leukemia or lymphoma
* Patients are expected to receive serial (i.e. \> 1) LP as outpatients in Charleston Area Medical Center Children's Cancer Center in the course of 12 months for diagnostic and/or treatment purposes

Exclusion Criteria:

* Patients not in the age range
* Non-cancer patients
* Allergy to amide anesthetics
* Patients treated with class I and III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide)
* Patients with congenital or idiopathic methemoglobinemia
LGX818 for Patients With BRAFV600 Mutated Tumors

The purpose of this signal seeking study is to determine whether treatment with LGX818 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study


Eligibility Criteria:
Inclusion Criteria

* Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis of melanoma and colorectal cancer (CRC)) or hematologic malignancies and is in need of treatment because of progression or relapse.
* Patient's tumor has been evaluated and pre-identified as having a tumor with a BRAFV600 mutation at a CLIA certified laboratory.
* Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
* Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate hematological response criteria.
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

* Patient has received prior treatment with LGX818.
* Patients with Central Nerve System (CNS) metastasis or leptomeningeal carcinomatosis.
* Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
* Patients with acute or chronic pancreatitis.
* Patients with impaired cardiac function or clinically significant cardiac diseases.
* Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix.
A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine

To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.

This is a single-center, randomized, double-blind, placebo- and active-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetic profile of JNJ-10450232, administered as a single dose in capsules (250 or 1000 mg), over a 24 hour period after molar extractions. Subjects will stay at the research center for \~24 hours after administration of study drug. Healthy male subjects, ages 18 to 45 years inclusive, will be screened by medical history, vital signs, an electrocardiogram (ECG), and clinical laboratory tests. Eligible subjects will return to the clinic on the day of surgery and complete baseline vital signs and clinical laboratory tests. They will undergo dental extraction of a minimum of three third-molars and, if qualified, will be randomly assigned to one of four study treatments for pain.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18-45 years
* At least moderate dental pain assessed by a categorical scale pain intensity scale and a score of at least 5 on the 11-point (0-10) pain intensity numerical rating scale (PI-NRS) following surgical removal of three third-molars

Exclusion Criteria:

* Subjects who are not otherwise healthy
* Test positive for the urine drug screen
* Taking prohibited medications will not be allowed to participate in this study
Longitudinal Data Registry of Plasma Cell Dyscrasia

This study aims to identify clinical characteristics, response and clinical outcome of plasma cell dyscrasia (PCD) diagnosed in Zhongshan Hospital, Fudan University from May 2023. In its current version, the registry incorporates historical data (collected from 2007) and is prospectively collecting follow-up data and recording patient outcomes.

PCD is a spectrum of diseases that is being gradually understood in Asia. This study aims to observe and describe the clinical and genetic characteristics of Chinese PCD patients, and to explore the relationship between the characteristics and pathogenesis. It also aims to discover the potential distinct clonal evolution patterns among different subtype of this disease spectrum. This study is a non-interventional real-world, study. Alll registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

Patients with pathological diagnosis of PCD \[e.g.: symptomatic/asymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis) from 2007 to 2027 in Zhonshan Hospital.

Patients who had complete diagnostic, treatment and follow-up records. With fully comprehension and signature of the informed consent form (ICF) for participation.

Exclusion Criteria:

Patients who refused to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.

Patients who suffered from severe mental illness. Patients who were deemed unsuitable for inclusion by the investigator.
Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/Nephron Sparing Surgery(NSS) Performed Via Lumbotomy

42 patients age of 20 to 85, (ASA) physical status I-III undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Patients will be randomised into 2 groups - patients from the first group will undergo General Anesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) unilaterally performed under ultrasound guidance with catheter left on the side of surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. . Patients in this group will be anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 via interfascial catheter. ESP block will be performed at the level of Th7-8 after proper positioning he patient in the sitting position before GA then standard technique of catheter application will be applied. After the surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.


Eligibility Criteria:
Inclusion Criteria:

* Pts undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anaesthesiology in Warsaw
* Pts consented for the study prior to surgery
* ASA 1-3

Exclusion Criteria:

* Pts without consent for trial
* Pts ASA 4-5
* Coagulation abnormalities
* Allergy to local anesthetics
* Skin lesions in the place of needle insertion