cyrilzakka/clinical-trials huggingface dataset:
CGM Use in Adults With Type 2 Diabetes on Basal Insulin

A prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period. The purpose of this study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 will improve HbA1c compared to SMBG over 16 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy.

The study will assess change in HbA1c as the primary endpoint. Other endpoints related to glycaemic control are included in the analyses. The study is split into two phases each of four months duration: participant-driven (phase 1) and HCP/therapy-driven (phase 2). Participants will be randomised to either FreeStyle Libre 3 or to continuation with their current SMBG device.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or over.
* Type 2 diabetes diagnosis for ≥1 year prior to enrolment.
* Type 2 diabetes treated with a basal insulin injection regimen and SGLT2 inhibitor and/or GLP-1.
* Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive).

Exclusion Criteria:

* Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.
* Currently participating in another study that could affect glucose measurements or glucose management.
* A female participant who is pregnant.
* A breastfeeding female participant.
* Bariatric surgical procedure within the past 12 months or is planning/scheduled for bariatric surgery within the study duration.
Extracranial Stereotactic Radiosurgery in Treating Patients With Solid Tumors

RATIONALE: Extracranial stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial is studying the side effects and best dose of extracranial stereotactic radiosurgery and to see how well it works in treating patients with solid tumors.

OBJECTIVES:

Primary

* Establish the maximum tolerated dose (MTD) of extracranial stereotactic radiosurgery in patients with isolated tumors. (Phase I)
* Determine the minimum dose required for local control. (Phase II)

Secondary

* Determine the radiographic response rate.
* Determine the median time to progression of the treated tumor.
* Evaluate the toxicity of treatment.
* Evaluate the cause of death.

OUTLINE: This is a phase I dose-escalation study followed by a phase II open-label study. Patients are stratified according to tumor size.

* Phase I: Patients undergo stereotactic radiosurgery to one lesion. Cohorts of 3-6 patients undergo escalating doses of stereotactic radiosurgery until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of patients experience dose-limiting toxicity within 3 months of treatment.
* Phase II: Patients undergo stereotactic radiosurgery to one lesion at the MTD or at the dose at which local control at 3 months is ≥ 80%, as determined in phase I.

After completion of study treatment, patients are followed at 1 month, 3 months, and then every 3 months thereafter.

PROJECTED ACCRUAL: At least 48 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Presence of well-circumscribed tumor on contrast-enhanced CT scan or MRI

  * Maximum diameter of 6 cm

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 3 months
* Not pregnant
* Fertile patients must use effective contraception
* Negative pregnancy test
* Must be able to tolerate CT scan or MRI contrast

PRIOR CONCURRENT THERAPY:

* At least 3 weeks since prior chemotherapy or immunotherapy
* No prior treatment on this study
* No chemotherapy or immunotherapy during and for 4 weeks after completion of study treatment
* No concurrent external-beam radiotherapy overlapping with the radiosurgically-treated volume (including low-dose regions)
CCK1R Function in Patient Leukocytes

The type 1 cholecystokinin receptor (CCK1R) is a potential target for the treatment of obesity, due to the ability of this GI hormone to elicit satiety. However, this receptor has been shown to be sensitive to the cholesterol content of the membrane in which it is expressed. Because some patients who might be candidates for the use of CCK agonists to treat their obesity and co-morbidities, the goal of this study is to determine how metabolic abnormalities might affect the responsiveness of this receptor to CCK. Because the normal site mediating CCK-stimulated satiety is on vagal afferent neurons that cannot easily be studied, we will collect buffy coat cells from a peripheral blood sample from patients involved in the Sangre Por Salud Biobank at Mountain Park Medical Center. Ex vivo, the CCK1R will be expressed on these cells and will be functionally characterized, and the cholesterol content of the cells will be assayed. These data will be correlated with the clinical, biochemical, and metabolic phenotypic data collected as part of the parent study.

Subjects are volunteers who provide prospective informed consent to be entered into the Sangre Por Salud Biobank at Mountain Park Medical Center. These include men and women age 18-85 of Hispanic/Latino descent, who are not pregnant or have given birth in the previous 12 months, or who are nursing, and who have not been diagnosed with cancer in the previous three years. Two groups of patients are included, representing those who have not been diagnosed as having diabetes, and those with diabetes. Subjects undergo entry physical examination and standard metabolic phenotyping, with the non-diabetics also undergoing a 2-hour glucose tolerance test. Blood samples are also banked and available for other studies, such as the one now being described.

For the current study, 5 ml of blood will be coded and delivered in an anonymized form. Buffy coat cells will be isolated and infected ex vivo with a viral construct including the wild type CCK1R tagged with a fluorescent tag. Cells will be placed in culture overnight and harvested for quantitation of receptor expression and determination of CCK responsiveness and cholesterol content. These data will be correlated with selected relevant clinical, biochemical, and morphometric data.

Eligibility Criteria:
Inclusion Criteria:

* volunteers

Exclusion Criteria:

* Hispanic/Latino descent not pregnant, or given birth in the previous 12 months, or currently nursing not diagnosed with cancer in the past three years
Assessment of Empathetic Process by Scanpath Study of an Artwork

Analysis of gaze patterns during social cognition tasks and standardised exploration of a specific artwork, between elderly subjects without cognitive disorders and subjects with neurodegenerative diseases such as Fronto-Temporal Dementia, Alzheimer's Dementia or Parkinson's Disease


Eligibility Criteria:
Inclusion Criteria:

* Male or Female.
* 60 years old and above.
* Sufficient written and oral expression in French.
* Benefit from French or Monaco Social security.
* Written informed consent signed by the patient.
* For the control group: voluntary subjects, without cognitive impairment.
* For the FTD / AD / PD groups: patients diagnosed with one of these diseases, and volunteers to participate in the study.

Exclusion Criteria:

* General anaesthesia within 3 months.
* Ophthalmological problems preventing a video-oculography examination.
* Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
* History of stroke.
* Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
hepatomiR cACLD Study

This study looks to gather data on hepatomiR, a CE-certified test already intended for gauging liver-related outcomes, in order to define a cut-off regarding specific decompensation events (ascites, variceal hemorrhage, hepatic encephalopathy) in chronic liver disease (CLD). Based on these data, it is aimed to advance the current understanding of factors driving decompensation, with potential repercussions for future risk management and therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Chronic liver disease (more than 6 months)
* LSM ≥ 10 kPa
* Outpatient at the Clinical Department of Internal Medicine II, University Hospital St. Pölten
* Signed patient consent form

Exclusion Criteria:

* Age older than 18 years
* Pregnancy
* Primary hepatic malignancy (hepatocellular carcinoma, cholangiocarcinoma) with portal invasion and/or extrahepatic spread
Evaluation of Raltegravir During the Third Trimester of Pregnancy

The purpose of this study is to assess the evolution of raltegravir concentration in the mother (between the 3rd trimester of pregnancy and one month post-delivery) and her neonate, when this drug is used to prevent mother-to-child HIV-1 transmission as part of a combined antiretroviral regimen.

1. Objectives

   1. Principal objective

      * To study pharmacokinetic properties of raltegravir in pregnant women infected by HIV-1, during the third trimester of pregnancy (between 30 and 37 weeks of amenorrhea) and 1 month after childbirth (between W4 and W6 postpartum), as well as in their neonate.
   2. Secondary objectives

      * Estimate the frequency of women receiving raltegravir and having indetectable viral load at delivery (and those having a strictly indetectable viral load, with no signal under the threshold of the technique used).
      * Describe the tolerance to raltegravir in pregnant women during the third trimester and in her neonates
2. Methodology

   * National multicenter pharmacokinetic study conducted among pregnant women infected by HIV-1 and exposed to raltegravir during pregnancy.
3. Statistical method

   * Method of population pharmacokinetic with 5 samples: before the drug intake, 0.5, 3, 8 and 12 hours after the intake at each of the 2 visits (between 30 and 37 weeks of amenorrhea, and 4 to 6 weeks after delivery).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman, between 30 and 37 weeks of amenorrhea
* 18 years old and over
* Infected by HIV-1
* Receiving a therapeutic combination, stable for at least 15 days before inclusion, with raltegravir at the standard dose (400 mg twice daily) which the doctor plans to maintain till the end of pregnancy and at least one month after delivery
* Informed consent signed by mother and investigator (at the latest day of pre-inclusion and before any examination conducted as part of research)
* Affiliated person or beneficiary of a social security system (medical aid of state or AME is not a social security system)
* Participant agreeing to be registered in the national file of the people who participate in biomedical researches

Exclusion Criteria:

* Infected by HIV-2
* Under 18 years old
* Receiving therapeutic association with atazanavir (Reyataz®), fosamprenavir (Telzir®), or efavirenz ( contained in Sustiva® and Atripla®)
* Currently using medication, drugs or alcohol which can interfere with the research: rifampicine, phénobarbital, phénytoïne, topical gastrointestinal, antiacid and adsorbents
* Presenting a clinical situation or acute pathology incompatible with the realisation of a pharmacokinetic study.
* Planned absence which could hinder research participation (travel abroad, moving, imminent transfer ...)
* Participating in another research, except the French perinatal survey (ANRS CO1 EPF or ANRS CO11 observatory), including an exclusion period still in progress at the pre-inclusion
* Person under guardianship, or deprived of freedom by a judicial or administrative decision
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.

This study is a randomized, blinded and controlled phase II study to evaluate the safety and immunogenicity of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Infants. A total of 600 infants aged 2 months (60\~90 days) were randomized to receive five different vaccination regimens: three experimental groups (1, 2, and 3) received three doses of sIPV with high, medium, and low D antigen content, respectively, on the month 0,1,2 schedule; two control groups (4 and 5) received three doses of conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the same schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity. Adverse events occurring within 30 days after each dose were collected to assess the safety.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer aged 2 months (60\~90 days) old without prior vaccination of poliovirus and any contraindication for vaccination;
* Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
* Complying with the requirement of the study protocol;
* Axillary temperature ≤ 37.0 °C;

Exclusion Criteria:

* Preterm or low birth weight infants;
* Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
* History of polio;
* Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
* History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
* Autoimmune disease or immunodeficiency/immunosuppressive;
* Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
* Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
* Mother of the participant has HIV infection;
* Acute illness or acute exacerbation of chronic disease within the past 7 days;
* Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
* Receipt of any subunit or inactivated vaccine within the past 7 day;
* Receipt of any live attenuated vaccine within the past 14 days;
* Receipt of any blood product within the past 3 months;
* Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).

The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.

Bezlotoxumab is administered during a course of antibiotic therapy. The dose is administered as one time treatment. Patients will receive 10 mg/kg IV over 60 minutes as a single dose via central line.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* active CDI receiving therapy
* diagnosis of IBD
* and history of CDI.

Exclusion Criteria:

* \<18 years old
* no IBD
* no CDI
* history of colectomy
* history of preexisting congestive heart failure
* pregnant or nursing women
* TCP\<50
* past cardiac history.
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600

The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written consent
* Ability and willingness to comply with the study procedures and duration requirements
* 18 years of age or older
* Consented and eligible to undergo a single unit whole blood donation

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Undergone an amputation of any upper extremity
* Diagnosed with dextrocardia
* Subjects who have a pacemaker
* Subjects with body hair density which prevents adequate application of device electrodes
Mastalgia Treatment: Is There a Role for Osteopathic Manipulative Treatment

There are many current medical treatments for mastalgia, but few have been proven effective. Our objective is to evaluate the effectiveness of osteopathic manipulative treatment as compared to a light touch protocol and standard management in the treatment of women with cyclical and non-cyclical mastalgia. We will compare duration of the pain, severity of the pain and the effect of the pain on quality of life.

Our objective is to evaluate the effectiveness of osteopathic manipulative treatment (OMT) as compared to a light touch protocol and standard management in the treatment of women with cyclical and non-cyclical mastalgia (breast pain).

A randomized placebo controlled study will be conducted at two academic health care centers. Women with breast pain will be evaluated and followed by the breast surgeon. Once a pathologic cause has been ruled out, the women will be stratified and randomly divided into three study groups. Group A, B, and C. Group A will receive standard of care treatment. Group B will receive light touch (a placebo for the OMT treatment). Group C will receive OMT directed at treating mastalgia. The treatment will continue for three months.

The subjects will fill out an initial pain questionnaire and a follow-up questionnaire each month. They will also be instructed to fill out a breast pain log daily for three months. A final questionnaire will be completed at six months. Statistical analysis will be utilized to determine whether the addition of OMT improves the severity or duration of the pain as well as quality of life as assessed by the patient.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years of age presenting with breast pain, both cyclical and noncyclical, who complain of pain despite a negative full work-up for pathology, reassurance, and use of an appropriate supportive bra.
* A pain scale questionnaire will be completed by the subject. The pain should be present for at least 7 days each month if it is mild pain or be of moderate to severe intensity for at least 3 days each month. In addition, breast pain must have been present for a minimum of 2 consecutive months preceding the date of inclusion into the study.

Exclusion Criteria:

* Women under 18 years old, women who have had recent breast surgery (\<2yrs), women who have breast implants.
* Women with bleeding risk such as those regularly taking aspirin, NSAIDs, Plavix or any other anticoagulation therapy.
* Women who are pregnant, breastfeeding or who are planning to get pregnant are excluded.
* Women with known chronic pain syndromes or structural abnormality such as osteoporosis will be excluded. When necessary bone densitometry will be performed.
* Women who are unable to complete the questionnaire.
RECOVER-AUTONOMIC: Platform Protocol, Appendix B (Ivabradine)

This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans.

This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs.

The hypothesis is that some of the autonomic dysfunction symptoms are immune-mediated, so immunotherapy and other applicable therapies will result in improvement in autonomic symptoms.

Interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix.

Eligibility Criteria:
Inclusion Criteria:

* See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)

Additional Appendix B (Ivabradine Sub-study) Level Inclusion Criteria:

1. Abnormal active standing test defined as presence of orthostatic tachycardia (an increase of 30 beats per minute (bpm) or more in HR within 10 minutes upon standing without orthostatic hypotension) and experiencing orthostatic symptoms
2. COMPASS-31 Score \> 25 and not enrolled in the IVIG appendix

Exclusions Criteria:

* See NCT06305780 for RECOVER-AUTO: Platform Protocol level inclusion criteria which applies to this appendix (or sub-study)

Additional Appendix B (Ivabradine Sub-study) Level Exclusion Criteria:

1. A person of child-bearing potential who is not taking effective contraception
2. Use of the following medications: clonidine, tizanidine, amphetamines, and serotonin and norepinephrine reuptake inhibitors (SNRIs) with the exception of modafinil
3. Use of beta-blockers (any formulation), calcium channel blockers, midodrine, pyridostigmine, fludrocortisone, and guanfacine will be excluded unless participant is on a stable dose (\>4 weeks). Participants on stable doses will be allowed to continue the medication throughout the study.
4. Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties
5. Lactating and breast-feeding women
6. Severe hepatic impairment
7. Use of drugs known to prolong the QT-interval (e.g., quinidine, disopyramide, bepridil, sotalol, amiodarone, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine
8. Concomitant use of digoxin
9. Participants who are pacemaker dependent
10. Patients with hypokalemia (serum K+\<3.5 mEq/L)
11. Patients taking potassium-depleting diuretics
12. A history of congenital or acquired long QT syndrome, with or without torsade de pointes
13. Patients with high degree AV block such as Mobitz II
Analysis of Foxp3 and Vimentin Expression in Renal Transplant Recipient

This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function, one-year graft histological analysis and incidence of acute rejection.

This observational study is designed to analyse the urinary mRNA expression of Foxp3 and Vimentin, two genes involved in tolerance and early graft dysfunction in 500 renal transplant recipients from 17 renal transplant site in France and to determine the predictive value of these gene expression on the one year graft outcome including graft function,

Eligibility Criteria:
Inclusion Criteria:

* All renal transplant recipients aged \>18 years with informed consent
* Kidney transplantation in one of the centers participating in the study all patients registered on the waiting list to the Agency of Biomedicine
* Supported by a conventional procedure
* Informed consent signed.
* No pregnancy or lactation in progress.
* Serology HIV and (HCV negative suppressed by amendment n°2)
* No contraindication for a biopsy at 1 year post transplant

Exclusion Criteria:

* Positive crossmatch, focal segmental glomerulosclerosis (FSGS) as primary nephropathy, HIV positive population
* Absence of registration on the waiting list for transplantation with the Agency of Biomedicine
* HIV-positive serology
* Chronic renal failure secondary to focal segmental hyalinosis
* Cross-match historical or cross match of the day positive T or B awareness
* Patient included in a Memorandum of industry (suppressed by amendment n°1)
* No affiliation to a social security scheme
* Patients with early failure due to immediate complications (4%) will be included but will not be considered for analysis