cyrilzakka/clinical-trials huggingface dataset:
Direct Observation Study of Kratom Product Effects Among Regular Consumers

The goal of this observational clinical study is to is to learn more about how commercial kratom products affect healthy adults who consume them regularly. The main questions it aims to answer are:

1. What are the acute physiological, subjective, and cognitive effects of kratom following participant self-administration of a single oral dose of the participants usual kratom product at the participants typical dose?
2. What are the physiological, subjective, and cognitive effects associated with kratom product discontinuation among adults who use regularly?
3. What are the pharmacokinetics of kratom products consumed by adults who use regularly? On the first study day: Under direct observation, participants will self-administer a single oral dose of the participants own commercial kratom product that that is regularly taken and will consume it at the participants self-selected typical dose/serving. Following this, serial blood draws and urine collection will occur along with administration of validated questionnaires, tests, and continual monitoring. After this first study day, participants will no longer be permitted to use any of the participants kratom product during the study. On study nights/days 2-3: participants will reside a clinical research unit and be observed and evaluated for kratom withdrawal syndrome.


Eligibility Criteria:
INCLUSION CRITERIA:

1. \>21 years
2. reporting kratom use \>5 times per week for \>3 months prior to study screening
3. English language proficiency
4. Willingness to provide requested samples of the kratom product being currently taken

EXCLUSION CRITERIA:

1. Reports any acute adverse, unexpected, or otherwise sudden health event related to the typical kratom product dose that occurred within 30 days of screening
2. Having ever sought medical attention for an acute adverse health event as a result of taking any kratom product.
3. Cannot or will not provide kratom product samples in the form of an unopened package of kratom that is clearly labeled with at least the product and vendor name.
4. Self-reports using kratom products by any other route than orally swallowing.
5. Current physical dependence on alcohol, benzodiazepines, or opioids
6. Reports use of fentanyl within the past month and/or has a fentanyl positive drug screen.
7. Discordance between self-reported substance use and drug screen results obtained during screening.
8. Lifetime or current psychotic disorder
9. Current untreated major depressive or bipolar disorder
10. Pregnancy or nursing
11. Physical, psychiatric, or environmental conditions considered by study team to increase risk or undue burden (e.g., untreated hypertension, high BMI, etc.).
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada. 100 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable, in the opinion of the investigator
* CVC occlusion
* Able to have fluids infused at the volume necessary to instill study drug into the CVC

Exclusion Criteria:

* Able to have 3 mL of blood (patients weighing ≥ 10 kg) or 1 mL of blood (patients weighing \< 10 kg) withdrawn from the selected study CVC following patient repositioning
* Selected study CVC inserted \< 2 days prior to treatment
* Selected study CVC known to be dysfunctional for \> 7 days
* Selected study CVC implanted specifically for hemodialysis (HD)
* Use of a power injector on the selected study CVC during the study
* Evidence of mechanical, non-thrombotic occlusion of the selected study CVC (e.g., kink in the catheter or suture constricting the catheter)
* Previously treated in this study or any tenecteplase catheter clearance trial
* Use of any investigational drug or therapy within 28 days prior to treatment
* Use of a fibrinolytic agent (e.g., alteplase, tenecteplase, reteplase, or urokinase) within 24 hours prior to treatment
* Known to be pregnant or breastfeeding at screening
* CVC with known or suspected infection
* History of any intracranial hemorrhage, aneurysm, or arteriovenous malformation
* Use of heparin (unfractionated or low molecular weight) within 24 hours prior to treatment, except for use of intermittent or low-dose, continuous infusion of heparin to maintain catheter or vessel patency
* Use of warfarin within 7 days prior to treatment, except for low-dose warfarin used for prophylaxis
* Initiation of or increase in dose of Plavix® (clopidogrel bisulfate) within 7 days prior to treatment
* At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard
* Known hypersensitivity to tenecteplase or any component of the formulation
Dose-Escalating Study Of SB-485232 Administered Intravenously Every 28 Days To Adults With Solid Tumors Or Lymphomas

SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Safety evaluations, including blood sampling for various laboratory tests, will be conducted. Additional blood samples will also be taken to measure the amount of drug in the body at specific times.


Eligibility Criteria:
Inclusion criteria:

* Histopathological confirmation of cancer limited to a solid tumor malignancy or follicular lymphoma.
* Advanced or metastatic disease.
* Measurable disease.
* Females of child-bearing potential must use adequate birth control.
* Karnofsky Performance Status of 70% or greater.
* Predicted life expectancy of at least 12 weeks in the estimation of the physician conducting the study (Principal Investigator).
* Adequate laboratory results.
* Subjects with history of coronary artery disease must have a stress test without clinically significant abnormalities.
* Subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy, must have a MUGA (Multiple Gated Acquisition) scan which demonstrates a left ventricular ejection fraction equal to or greater than 40%.
* Signed informed consent form

Exclusion Criteria:

* Female subject is pregnant or nursing (lactating).
* Active, chronic or uncontrolled infections requiring systemic antibiotic therapy.
* Serious medical or psychiatric disorder that would interfere with the subject''s safety or ability to sign the informed consent.
* Leptomeningeal disease or evidence of prior or current metastatic brain disease.
* Receiving concurrent chemotherapy, immunotherapy, radiotherapy, corticosteroid therapy, or investigational therapy.
* Received chemotherapy, radiotherapy, immunotherapy, hormonal therapy or biological therapy for cancer or underwent a surgical procedure (except for minor surgical procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks in case of nitrosureas or mitomycin C).
* Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of SB-485232.
* Severe concurrent disease or condition, including clinically significant autoimmune disease, which in the judgement of the physician conducting the study (the principal investigator) would render the patient inappropriate for study participation.
* History of ventricular arrhythmias requiring drug or device therapy.
* An unresolved or unstable, serious toxicity from prior administration of another investigational product.
* Psychological, familial, sociological, or geographical limitations that do not permit compliance with this protocol.
* Received prior SB-485232 therapy.
* Poor venous access.
Musical Intervention During IV-line Placement in Neonates

The goal of this clinical trial is to test the effect of music in reducing the pain felt by newborn children during an intravenous line procedure. An intravenous line is a small tube brought into a vein by using a needle. The main questions it aims to answer are:

1. Does playing a lullaby during intravenous line procedures affect the vital signs and behavior of a newborn, compared to not playing music?
2. How do parents and medical staff experience the music that's being played? Participants will all receive the same care and treatments as usual. The only difference being about half of the participants will be randomly assigned to the group that gets music.

Researchers will compare the music group to the non-music group to see if there is any difference in vital signs and behaviors of the child.

After inclusion, a participant will be randomized by drawing a sealed, opaque envelope, the contents of which will be either group A: no music, or group B: music. The outcome assessor will then perform a baseline measurement of vital signs and Neonatal Infant Pain Score. Then, Brahms Lullaby will be played from a speaker. When the needle is first introduced into the skin, a second measurement will be performed. For every attempt needed to succesfully place the intravenous line, an additional measurement will be done. Finally, after succesful placement of the intravenous line is confirmed by NaCl flush, a final measurement will be done. Afterwards, a short questionnaire will be filled in by the parents and the medical staffmember(s) that performed the intravenous line.

The study groups will be compared to each other in outcome measures, and there will be statistical correction for demographic and clinical confounders, which will be collected from medical files. The research hypothesis is that group B will show a smaller increase in vital signs and NIPS on average during the procedure, compared to group A.

Eligibility Criteria:
Inclusion Criteria:

* connected to a monitor that records vital signs
* receives an IV-line

Exclusion Criteria:

* has hearing impairment
Targeting Glutamine Metabolism to Prevent Diabetic Cardiovascular Complications

Experimental data suggest that glutamine catabolism in involved in the activation of macrophages by generating TCA(Tricarboxylic acid) intermediates that promote the pro-inflammatory polarization of macrophages. The project investigates the possible link between glutaminolysis, monocytes polarization and diabetes related cardiovascular complications in humans

The aim of the study is to investigate the role of glutamine metabolism in the pro-inflammatory activation of macrophages in diabetes and related cardiovascular complications.

The study focuses on 3 adult patients' population with different diabetic status and level of cardiovascular risk:

* Patients with uncomplicated type 1 or type 2 diabetes and low cardiovascular risk
* Patients with uncomplicated type 1 or type 2 diabetes and high cardiovascular risk
* Patients with complicated type 1 or type 2 diabetes

Participants (n=975) will be recruited at clinical sites, in the diabetes and cardiology departments (APHP, Bichat - Claude-Bernard Hospital and APHP, Lariboisière Hospital), over a 2-year period.

The study will consist in a single visit. During a scheduled hospitalization or consultation as part of the follow-up of their diabetes or as part of the follow-up of their cardiological problems, clinical data will be collected as well as additional blood and urine samples for analyses and biobanking. There will be no other intervention specific to the study.

Eligibility Criteria:
Inclusion criteria General inclusion criteria applying to the five populations are the following:

* Age above 18 years
* BMI between 25 and 40 kg/m²

Inclusion criteria according to study group are listed below.

Group 1: Patients with uncomplicated diabetes and low cardiovascular risk, additional inclusion criteria are:

* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* no history of cardiovascular event, diabetic microvascular complications (kidney function normal and albuminuria/creatininuria \< 30 mg/g)
* Coronary artery calcium score \< 100 (assessment \< 12 months)

Group 2: Patients with uncomplicated diabetes and high cardiovascular risk, additional inclusion criteria are:

* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* no history of cardiovascular eventand diabetic nephropathy no more than stage 2 (i.e. GFR ≥ 60 ml/min by MDRD or CKD-EPI formula and albuminuria/creatininuria ≤ 30 mg/g)
* Coronary artery calcium score \> 400 (assessment \< 12 months)

Group 3: Patients with complicated diabetes, additional inclusion criteria are:

* 5 or more years of diabetes
* 6% \< HbA1c \< 10%
* A history of cardiovascular event (myocardial infarction, stroke, peripheral vascular disease, or angioplasty) at least 3 months ago

Exclusion Criteria:

* Solid organ or bone marrow transplant patient
* Pregnant or breastfeeding woman
* Absence of free and informed consent
* Non-affiliation to a social security regimen or CMU (universal health coverage)
* Subject deprived of freedom, subject under a legal protective measure
A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients

This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice daily \[BID\]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Treatments are described as follows:

Treatment A: Multiple oral YPL-001 80 mg doses (1 x 80 mg tablet + 1 x 1 YPL-001 80 mg matching placebo tablet) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.

Treatment B: Multiple oral YPL-001 160 mg doses (2 x 80 mg tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56.

Treatment C: Multiple oral matching placebo (2 x 1 YPL-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. Only the morning dose will be administered on Day 56. In all treatments, one tiotropium (Spiriva® HandiHaler®) 18 μg capsule will also be administered QD every morning prior to study drugs administration. Albuterol will be administered on an as needed basis. Each dose of Treatments A, B and C will be administered orally with approximately 240 mL of water.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and/or females, 30 to 85 years of age (inclusive).
* History of COPD for at least 12 months prior to screening.
* Diagnosed with COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD for at least 12 months prior to screening.
* Classified as moderate to severe COPD based on the current severity classification GOLD Stage 2-3 disease in terms of post-bronchodilator spirometry at screening
* etc.

Exclusion Criteria:

* History of life-threatening COPD including respiratory arrest, intensive care unit admission and/or requiring intubation.
* History of more than 2 hospitalizations for COPD within 12 months prior to screening.
* Presentation of an acute exacerbation of COPD that will be associated with increase sputum volume or change in sputum color within 4 weeks before Day 1 of the Run-in Period.
* Evidence of pulmonary heart disease, or clinically significant pulmonary hypertension.
* etc.
EPOS Discoid Meniscus (DiMe) Project

The aims of this Discoid Meniscus (DiMe) project are to analyze DM tears characteristics in the pediatric European population to describe current treatment options in symptomatic DM, and to evaluate clinical outcomes. To reach these objectives, a prospective database including symptomatic DM and variables associated with DM characteristics, type of tears, treatment, imaging, and clinical follow-up will be implemented. Data collection platform will provide future studies to understand the best treatment option for skeletally immature patient with symptomatic DM according to their history and lesion characteristics.

This is a multicentric international prospective cohort study. All eligible consecutive patients will be identified prospectively by the local participating clinical teams according to Inclusion/Exclusion Criteria. Prospective data entry is mandatory.

Data collection will be conducted in three phases:

* Phase 1 will register patients to the study, document symptomatic DM, collect the details of patient demographics, sport characteristics, PROMS, imaging classification and consent of the patient's legal representatives. Once the patient has reached the age of majority, the date of his/her own consent will be recorded.
* Phase 2 will register surgical treatment and arthroscopic video and photographs collected during surgery, collect intraoperative DM instability, arthroscopic classification, and surgical details. Post-operative complication will also be collected.
* Phase 3 will collect short-, medium- and long-term outcome data. Short follow-up data collection will plan at 1 month follow-up then 3 and 6-months follow-up. Then annual data collection will be performed.

The foreseen timeframe of follow-up will be 15 years for each patient. At the end of the 15-year follow-up, the data will be stored for an additional 10 years before being deleted. Data will be recorded if the patients are willing to comply with the annual data collection. Should the DiMe Project be terminated at one stage, the data will be stored for 10 years after termination of the project before being deleted.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic DM confirmed by a senior orthopedic surgeon based on physical examination and MRI
* age less than eighteen years
* informed consent freely granted and acquired before the start of the study from legal representative

Exclusion Criteria:

* concomitant or previous knee surgeries
* concomitant ligament knee injury that requires a surgical treatment
* concomitant fractures
* inflammatory or arthritic diseases.
High-Resolution PET-CT Imaging for Surgical Margin Visualization

Imaging will be exploratory and be used intraoperatively. There have been no discovered risks associated with the device to be used in this study, and none are anticipated given the diagnostic and non-invasive, 'ex vivo' nature of device use. Of note, the surgical resection will proceed as per standard of care and will not be affected by the research protocol.

Potential Benefit: Imaging intra-operatively will ensure surgeons to identify at risk resection margins.

Time Commitment: There are no additional visits that will be asked of you to partake in this study.

Drug is FDA approved and Exposure to Radiation is minimal.

This pilot study explores the use of high-resolution PET imaging to identify surgical margins in solid tumors after removal. It evaluates the feasibility and potential of using PET-CT to assess tumor specimens and ensures radiation safety with a low-dose 18-FDG injection (20% of the standard dose). Previous studies have shown good tumor visualization in breast, pancreatic, prostate, and head and neck tumors, supporting the method's proof-of-concept. This research aims to gather insights into its clinical usefulness across different cases

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed diagnosis of any solid malignancy
* Diagnosis of any T stage, any subsite that are scheduled to undergo definitive en bloc surgical resection. Patients with recurrent disease or a new primary will be allowed.
* Planned standard of care oncologic surgery with curative intent
* Male or female patients age ≥ 18 years
* Have life expectancy of more than 12 weeks
* Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
* Have acceptable glucose status (\<200 mg/dL) at Day of Surgery prior to 18F-FDG injection

Exclusion Criteria:

* General or local contraindications for resective surgery
* Women who are pregnant or breast-feeding
* Blood glucose level over 200 mg/dL prior to 18F-FDG infusion
* Any participation in other clinical trials or research study that involved a radiation exposure of more than 1 mSv in the past year. If the participant had radiation exposure greater than 1 mSv as SOC, they would not be excluded unless the Principal Investigator determines that patient could be at risk.
A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"

The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. We also assume that positive predictive value and negative predictive value for identification of presence or absence of metastases in sentinel lymph nodes (SLN) will be high enough for preoperative diagnosis of SLN metastases in breast cancer patients. This study will use CT lymphography with periareolar injection of iopamidol and standard protocols of sentinel lymph nodes biopsy using intraoperative indocyanine green (ICG) fluorescence.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Signed informed consent;
* Histologically confirmed breast cancer

Exclusion Criteria:

* Iodine allergy;
* Presence of distant metastases of breast cancer;
* Body mass index more than 40;
* Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.)
* Suspected pregnancy;
* Severe hypothyroidism;
* Bronchial asthma in the stage of decompensation;
* Decompensated diabetes;
* Kidney or hepatic failure.
Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic Asthma

This study will assess further the safety and tolerability of long-term treatment with omalizumab by extending omalizumab treatment by 1 year for those patients with allergic asthma who successfully completed study CIGE25011E2.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of severe allergic asthma who completed the treatment period of CIGE250011E3 protocol, without experiencing any significant drug-related adverse events
* Male or female patients 12-75 years of age who have given written informed consent approved by the ethical committee

Exclusion Criteria:

* Patients who had not received study medication for greater than 84 days since visit 38 of study CIGE240011E3
* Pregnant females or nursing mothers
* Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs

Other protocol-defined inclusion/exclusion criteria may apply