cyrilzakka/clinical-trials huggingface dataset:
PET/MR Scan With [68Ga]Ga-PentixaFor (CXCR4) vs Standard of Care (SOC) for Initial Staging and Follow up in Multiple Myeloma (MM)

Multiple myeloma is a disease mainly located in participants bones. Usually a participants physician arrives at this diagnosis by doing blood tests and ordering standard of care imaging tests (18F-FDG PET/CT and maybe additional MRI) to see how many bones (and/or other organs) are affected. While these two imaging tests are already very good, recent research indicates that even more precise imaging methods could be used to diagnose participants disease more precisely.

The purpose of this study is to learn if a combined PET/MR scan with a new radiotracer, \[68Ga\]Ga-PentixaFor, can provide more accurate and precise diagnostic information in patients with Multiple Myeloma, a type of cancer primarily affecting the bones.

This study aims to improve the accuracy of diagnosing and monitoring Multiple Myeloma using more advanced imaging techniques.

The investigators will be focusing on Multiple Myeloma patients, a disease mainly located in the participants bones. The goal of this clinical trial is to evaluate the diagnostic and prognostic value of CXCR4-targeted PET/MR imaging in patients with Multiple Myeloma (MM), comparing it to the standard 18F-FDG-PET/CT and MRI imaging for the initial staging, follow-up, and treatment decision-making. The study will focus on newly diagnosed MM patients and those who may undergo stem cell transplantation.

The investigators will compare the performance of \[68Ga\]Ga-PentixaFor PET/MR to standard imaging methods (18F-FDG-PET/CT and MRI) to see if CXCR4-targeted imaging offers improved accuracy, better tumor detection, and a greater influence on treatment decisions.

This study aims to establish whether combining CXCR4-targeted PET/MR imaging could become a comprehensive diagnostic tool for MM, enhancing disease monitoring, guiding therapeutic decisions, and reducing patient burden by eliminating the need for multiple imaging sessions.

Eligibility Criteria:
Inclusion criteria

* Patient older than 18 years of age
* Clinical diagnosis of (nonsecretory, oligosecretory, suspicion for extramedullary MM) MM. MM diagnosis is based on IMWG (International Myeloma Working Group) criteria.No treatment received beyond first course of

Exclusion criteria

* Any contra-indications for MRI or 18F-FDG PET/CT imaging according to institutional guideline
* Pregnancy (will be ruled out as per institutional protocol)
* Inability to lie still in prone position in MRI for at least 30 min or PET/CT for at least 30 min
* Patients or unwilling to use contraception during study and breastfeeding women can also not partake in this study
* Inability to provide consent
* Any hypersensitivity or known allergy to any component of the investigational product (\[68Ga\]Ga-PentixaFor)No concomitant other malignant hemato-oncological disease being diagnosed (i.e. additional lymphoma or leukemia)
High Versus Standard Volume Hemodiafiltration in Asia

Online hemodiafiltration (HDF) may improve clinical outcome in end-stage renal disease. The supported mechanism is the improved clearance of uremic toxins by convective transporter. However, It has not been elucidated which convection volume is optimal, especially in Asia. A total of 60 participants receiving conventional hemodialysis will be randomly assigned to receive either high dose convective volume (33-43 L/treatment) post-dilution online HDF or standard dose (16.8-21.5 L/treatment) for 24 weeks. The primary outcome is the change of serum β2 microglobulin levels between baseline and after 24 weeks. The secondary outcomes will include changes in the nutritional markers, inflammatory markers, and blood pressure from baseline to after treatment.

This would be the first multicenter prospective, randomized controlled trial to determine whether large convective volume improves the treatment efficacy in Korean patients undergoing post-dilution online HDF.


Eligibility Criteria:
Inclusion Criteria:

* Patients on thrice-weekly standard hemodialysis for \> 3 months
* Patients with a vascular access capable of delivering consistently a high blood flow rates ( ≥ 300 mL/min)
* Patients willing to provide written informed consent.

Exclusion Criteria:

* Patients with active infectious or uncontrolled inflammatory disorders
* Patients with any uncontrolled malignant disease
* Patients with recent major cardiovascular disease during the last 6 months
* Patients who are likely to receive kidney transplant within the following 1 year
* Patients whose life expectancy \< 12 months
* Patients considered by investigator to have difficulty in participation
Surveillance for Adverse Events Following Pandemic H1N1 Immunization

Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) or with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine. While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000 people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical trials before the mass campaign was launched. With this small number, adverse events occurring at a rate \< 1% will not be detected by these clinical trials.

Considering that most cases of pH1N1 to date have been relatively mild, it will be imperative to rapidly detect adverse events serious enough to reconsider the use of the vaccine. Passive surveillance is collecting notifications of adverse events but the sensitivity of this system is not high and its timeliness is not necessarily optimal.

In Canada, healthcare workers (HCW) are among those who were offered the new pandemic vaccine in priority. Because they were offered the vaccine early in the campaign and because they constitute a well-defined group in good general health, this group of people may be well suited for monitoring the safety of the pH1N1 vaccine.

The main objective of this project was to estimate in HCW vaccinated against pH1N1 the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation.

The active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City (Quebec): 3 hospitals, (3) Toronto


Eligibility Criteria:
Inclusion Criteria:

* To be a health care worker from one of the three Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax.
* To have been immunized with the pH1N1 vaccine.
* To have an email address.
* To be 18 years old and older.

Exclusion Criteria:

-
Ciprofloxacin on Burned Patients

This was a non randomised, multi center, italian study performed in burn patients receiving an antibiotic (ciprofloxacin) in order to treat an active infection. The aim of the study was to validate a pharmacokinetics model useful to verify if a standard dose regimen of ciprofloxacin, given to patients with a compromised metabolism, is a correct dose or instead is over or under dosed.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe burnt patients defined as burning of 20 to 60% of total body surface according to rule of nine, II deep degree and III degree according to Full-Thickness Burn model,
* Hospitalization for burning injury since at least 72h during hyper metabolic phase
* Active infections microbiological confirmed
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating female patients
* Previous history of tendinopathy
* Knowing syndrome of QTc prolongation
* Impairment renal function
* Hepatic insufficiency
* Convulsion
* Limited life expectancy
A Study to Evaluate Endoflip Normal Ranges Data in Healthy Volunteers

The purpose of this research is to establish the normal range of diameter and distensibility of pylorus and the fasting and postprandial antro-pyloric motility in healthy adults.

An Endoflip catheter will be placed through the mouth into the stomach in order to measure distal antral contractile activity and pyloric diameter and distensibility during fasting and after the ingestion of a standard meal

Eligibility Criteria:
Inclusion Criteria:

* Females and males.
* Between the ages of 18 and 65 years.
* Body mass index between 18 and 35 kg/m\^2.

Exclusion Criteria:

* Heartburn, regurgitation, or symptoms suggestive of gastroparesis such as nausea, early satiety, postprandial bloating, and upper abdominal pain.
* Pregnant
Effects of Intensive Antiplatelet Therapy for Patients With Clopidogrel Resistance After Coronary Stent Implantation

Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.


Eligibility Criteria:
Inclusion Criterial:

* aged 35 to 75 years
* acute coronary syndromes
* underwent successful coronary stent implantation
* informed consent

Exclusion Criteria:

* contraindications to antiplatelet therapy
* history of intracranial bleeding
* known bleeding disorders
* severe liver or kidney disease
* pregnancy
* left main coronary artery disease
* planned non cardiac surgery within 1 year
* end stage of other serious disease with life expectancy less than 1 year
* heart failure with NYHA grade 3 to 4
Disease-Modifying Antirheumatic Drugs Cycle Combination Therapy Research

This study was intended to assess the efficacy and safety of different Disease-Modifying Antirheumatic Drugs cycle combination regimen using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) in managing active adult rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

RA patients：

* Male and female patients aged 18 - 75 years (inclusive).
* Body weight between 50 and 100 kg (inclusive).
* Post menopausal or surgically sterile female patients are allowed. Female patients of child-bearing potential may participate if they are already on a stable dose of methotrexate. Additional birth control details to be provided at screening. Male patients must use an effective contraception method during the study and at least for 2 months following the completion/discontinuation of the study.
* Diagnosis of RA, classified by American Rheumatism Association 1987 revised criteria.
* Active disease evaluation (DAS 28 \> 3.2).
* Patients who using steroids before enrollment, the dose should not be more than 30mg/d, and remain unchanged for more than 30days.
* Without use of other disease activity controlling drugs.
* Get the informed consent.

Exclusion Criteria:

* Advanced patients with severe joints disability.
* Pregnant or breast- feeding female patients.
* Patients with severe primary disease or impairment of heart, brain, lung, liver (ALT or AST \> 1.5 normal value), kidney (sCr \> normal value), endocrine, and hematology system.
* Concomitant with other rheumatic disease.
* Alcohol taken or drug abusing patients.
* Patients with congestive heart failure, QT prolongation syndrome or poorly controlled diabetes mellitus. Patients with a history of QTc prolongation will be excluded.
* Patients who have received intra-articular or systemic corticosteroid injections having been required for treatment of acute RA flare (not being part of a regular therapeutic regimen) within 4 weeks prior to randomization.
Ivermectin Role in Covid-19 Clinical Trial

Because ivermectin is being used to treat COVID-19 with insufficient evidence, the investigator conducted a randomized clinical trial to investigate the efficacy and safety of ivermectin in comparison to hydroxychloroquine and placebo in severe COVID-19 patients. The study was conducted in Shebin-Elkom teaching hospital and recruited patients from December 6, 2020, to January 31, 2021.

This study is an adaptive, randomized, double-blinded, controlled trial to evaluate the safety and efficacy of therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a single-center trial that will be conducted in Shebin Elkom teaching hospital. The study will be a series of 3-arm comparisons between two different investigational therapeutic agents (Ivermectin and Hydroxychloroquine) and a placebo. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about the successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.

Eligibility Criteria:
Inclusion Criteria:

1. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
2. Understands and agrees to comply with planned study procedures.
3. Agrees to the collection of OP swabs and venous blood per protocol.
4. Male or non-pregnant female adult ≥18 years of age at time of enrollment.
5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
6. Severe cases according to WHO definition.

Exclusion Criteria:

1. ALT/AST \> 5 times the upper limit of normal.
2. Mortality within 12 hours of admission.
3. Pregnancy.
4. Anticipated transfer to another hospital within 24 hours.
5. Allergy to any study medication commercial or public health assay in any specimen prior to randomization.
6. Mechanically ventilated on admission
Exogenous Melatonin in Postmenopausal Women with Insomnia

The aim of the study is to assess the effect of exogenous melatonin, 2 mg SR, 60 minutes before bedtime for 15 days, on the sleep and circadian rhythms of postmenopausal women with insomnia in a randomized crossover placebo-controlled study.

Eligible participants will be contacted by the research team to provide informed consent for the study. Once the screening phase is completed, they will be ready to start the study consisting of:

A) a \~2-week ambulatory phase at home with melatonin or placebo treatment; B) a 2-week wash-out period; C) same as A with the opposite treatment;

Part A: The research project will start with a 16-day ambulatory data-collection period during which participants will receive either melatonin or a placebo. They will take 2 mg of exogenous melatonin in a slow release formulation (or placebo), 60 mins prior to bedtime for 15 days. Participants will be instructed to go to bed at a regular time and stay in darkness for 8 consecutive hours each night, trying to sleep.

Part B: Throughout this period, all participants will stop taking their melatonin/placebo pills. After at least 2 weeks, they will prepare to participate to the other study condition.

Parts C: Repetition of Ambulatory phase 1 (Part A) except that participants who received the active treatment will now receive placebo and vice versa.

Eligibility Criteria:
Inclusion Criteria:

* Insomniac women will meet the diagnostic criteria for persistent insomnia as described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). They will report subjective sleep onset and/or maintenance difficulties associated with impaired daytime functioning at least 3 times a week, for at least 3 months. Sleep disturbances will be coincident with the onset of the menopausal transition.
* Postmenopausal women will have amenorrhea for at least 12 months.
* Participants will be drug-free at the time of study, and will have a history of only moderate or no use of coffee (≤3 cups/day), tobacco (≤ 10 cigarettes/day), alcohol (≤ 15 drinks/week), or other compounds.

Exclusion Criteria:

* Evidence of psychopathology on the Structured Clinical Interview for DSM-5, the Seasonal Pattern Assessment Questionnaire, the Beck Depression Inventory, and the Spielberger State Trait Anxiety Inventory.
* A history of prior gynecological pathology or medical condition that can affect the study results, including bilateral oophorectomy or endocrinopathy, and will not have used investigational drugs within 4 weeks of the study.
* A history of night work or transmeridian travel (across \>2 time zones) in the 2 months prior to the study.
* Evidence of sleep apnea (apnea/hypopnea index \> 15 per hour of sleep) or restless legs, or periodic limb movements during sleep (number of PLMs \>15 per hour of sleep).
Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.

The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.

This is a multi-country, multi-site retrospective chart review study that will use data extracted from the medical charts of SLE patients who participated in the anifrolumab EAPs AMANA or ATUc in France, Germany, Greece, Israel, Italy, Portugal, Spain, and the UK. Patient level data will be captured longitudinally for each patient over a 12- to 18-month period. The study period will include retrospective data collection covering a minimum 6- month baseline period prior to the index date and retrospective data collection covering a minimum 6-month FU period from the first Anifrolumab infusion. The index date is defined as the date of first anifrolumab infusion during the indexing period. The indexing period is between the earliest date of patient enrolment into the EAP and the date of last new patient enrolment into EAP. The EAPs have closed by end of February 2023 in all countries included in the ERYTHRO study. One data extraction will be performed per patient.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at time of enrolment into AMANA or France ATUc program, and
* Have at least 6 months of data from medical charts available prior to the initiation of anifrolumab through the EAP, and
* Have been initiated on anifrolumab at least 6 months before enrolment into ERYTHRO study, and
* Informed consent obtained (where required as per country regulations) to participate in ERYTHRO

Exclusion Criteria:

* Participated in anifrolumab clinical trials, NCT02794285 (D3461C00009) and / or NCT01753193 (D3461C00003), prior to enrolment into AMANA or France ATUc program, or
* Participated in any SLE clinical trial during the baseline period and / or the FU period of ERYTHRO, or
* Patients who were pregnant during the baseline period and / or the FU period of ERYTHRO
A Bioequivalence Study Comparing Amodiaquine Tablet (Pfizer) To Amodiaquine Tablets (Arsuamoon-Guilin China) In Healthy Subjects

The study will determine if amodiaquine tablet (Pfizer), an antimalaria agent, is pharmaceutically equivalent to a comparator product (Arsuamoon-Guilin China).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
* BMI of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs).
* An informed consent document signed and dated by the subject or a legally acceptable representative.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities.
* A positive urine drug screen, history of regular alcohol consumption.
Evaluating Race Specific AGE Accumulation As a Behavioral Biomarker Prostate Cancer Survivors

The purpose of this study is to show that reduction in advanced glycation end-products (AGEs) is associated with the beneficial regulation of receptor for AGE (RAGE) mediated tumor response which may correlate with improved quality of life in PCa survivors. AGEs are produced by the body and are affected by lifestyle, weight and diet.


Eligibility Criteria:
Inclusion Criteria:

1. Patient diagnosed with non-metastatic Stage I-III Prostate Cancer
2. Age 45 years and older
3. Within 12 months of first histologic prostate cancer diagnosis.
4. Completed planned chemotherapy and/or radiation therapy 4 weeks or more prior to study.
5. BMI \> 25
6. ECOG Performance Status 0 or 1.
7. Access to a telephone.
8. Able to read and understand written and spoken English.
9. Participants must be accessible for treatment and follow-up and must sign informed consent.
10. Subjects with known diabetes are permitted. However, they must be under active treatment for this condition.
11. Participants must past the cardiac rehabilitation center stress test.

Exclusion Criteria:

1. Planned enrollment in other formalized physical activity or diet counseling program during the 12 weeks of study
2. Received chemotherapy or radiation therapy within 4 weeks of enrollment
3. Had previous weight loss surgery (e.g. gastric bypass, sleeve gastrectomy and biliary pancreatic diversion).
4. Previously participated in Cardiac-Rehab
5. Have constrained mobility secondary to problems with balance, bone and/or joint disease
6. Have unstable angina or cardiovascular disease that prohibits exercise.