cyrilzakka/clinical-trials huggingface dataset:
Diabetes Self-management With Continuous Glucose Monitoring

The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (CGM) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics.

Participants will:

* Visit the clinic twice with a 14-day interval
* Fill out a survey before the first and at the last visit
* Use CGM as usual and use smart insulin pens and an activity tracker
* Register food intake
* Answer two-three questions twice a day in REDCap

A two-centre observational study conducted in Denmark, including adults with type 1 diabetes (n=500) on multiple daily injections already using FreeStyle Libre 2.

Upon recruitment, participants will complete a survey of 11 validated questionnaires, including T1-DDS-28. For 14 days, participants will continue regular CGM use, smart insulin pens will record real-time insulin dosage, and an activity sensor will monitor physical activity and sleep. Participants will register food intake in the LibreLink app and respond to queries on quality of life twice daily through REDCap. At the end of the study, participants will complete the T1-DDS-28 and Health Literacy Questionnaire.

Our primary objectives is to investigate the association between diabetes distress (assessed by Type 1 Diabetes Distress Scale (T1-DDS-28)) and:

1. frequency of reading CGM data,
2. frequency of low glucose alarms,
3. frequency of high glucose alarms,
4. frequency of daily between-meal insulin corrections,
5. frequency of hypoglycaemic events preceded by correction of hyperglycaemia with insulin,
6. frequency of hyperglycaemic events preceded by correction of hypoglycaemia with carbohydrates, and
7. sociodemographic and psychosocial characteristics of CGM users.

Our secondary objective is to investigate the association between glycaemic metrics and the variables described above. Glycaemic metrics will be reported as CGM-metrics, including time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL), per international consensus (ATTD, 2022)

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 85 years.
2. Diagnosed with T1D over one year ago.
3. Actively using FreeStyle Libre 2 (\>80% sensor activity).
4. Used FreeStyle Libre 2 for over three months.
5. Uses multiple daily insulin injections.
6. Capable of providing written informed consent.
7. Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.

Exclusion Criteria:

1. History of allergic reactions to materials or adhesives used in CGM devices.
2. Presence of severe cognitive or psychiatric conditions that could hinder the effective use of CGM or smart caps or pens - at the investigator's discretion.
3. Current use of steroids unless part of a chronic therapy plan.
4. Daily consumption of vitamin C ≥ 500 mg.
Study of Sugammadex Versus Usual Care on Incidence of Residual Blockade at Post Anesthesia Care Unit Admission (P07981)

This study will compare the incidence of residual neuromuscular blockade in participants who undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
* Scheduled to undergo an elective abdominal surgical procedure under general anesthesia; and:

  * expected to undergo neuromuscular relaxation with rocuronium for

endotracheal intubation; and

* expected to require at least one maintenance dose of rocuronium; and
* expected to require active reversal of neuromuscular blockade; and
* expected to require clinical or subjective neuromuscular monitoring only; and
* expected to recover in the PACU

  * Arm that is accessible for measuring the TOF ratio in the PACU
  * Sexually active female patient of child-bearing potential must agree to use a

medically accepted method of contraception through seven days after receiving

protocol-specified medication.

Exclusion Criteria:

* Anatomical malformations that may lead to difficult intubation
* Neuromuscular disorder(s) that may affect neuromuscular blockade and/or trial assessments
* Dialysis-dependent or has or is suspected of having severe renal insufficiency
* Significant hepatic dysfunction
* Family history of malignant hyperthermia
* Cardiac pacemaker
* Allergy to study treatments or its/their excipients, to opioids / opiates, sugammadex, muscle relaxants or their excipients, or other medication(s) used during general anesthesia
* Toremifene before or within 24 hours of study drug administration
* Scheduled for an overnight stay (or \>12 hours) in PACU
* Expected transfer to an Intensive Care Unit after surgery
* Pregnant, intention to become pregnant between randomization and the Day 30 pregnancy follow-up visit
* Breast-feeding.
* Investigational drug(s) within 30 days of randomization on this study
* Participation in any other clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial
* Participant or family member is among the personnel of the investigational or Sponsor staff directly involved with this trial
Topical Lidocaine for Needle Insertion and Injection Pain

Skin infiltration with local anesthetic is commonly used to decrease patient discomfort during peripheral nerve blocks. Topically applied local anesthetic gel might provide analgesia while eliminating the need for additional injections. The primary objective of this study was a noninferiority comparison between the analgesia achieved with topical gel with that of skin infiltration for pain upon needle insertion and injection during administration of the interscalene brachial (ISBP) and axillary (AX) plexus blocks.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand Dutch, French or English language, purpose and risks of the study, provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
* Age \>18 at the time of informed consent
* ASA I-III physical class
* Scheduled for elective shoulder or upper arm surgery requiring a preoperative interscalene brachial (ISBP) or axillary (AX) plexus block

Exclusion Criteria:

* History of an allergy or contra-indication to a local anesthetic
* Baseline neurological deficit
* Medical condition that will make it difficult to assess sensory distribution or communicate with a staff member
* Presence of preexisting coagulation disorders
* Infection at injection site
* Concomitant opioid therapy
* Recent history (\<3 months) of drug or alcohol abuse
* Female subjects who are pregnant or currently breastfeeding, or who have a positive pregnancy test result at first visit
A Phase 2 Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Stable Type 2 Diabetes and Hypertension

To evaluate the impact of escalating doses of IW-1973 on endothelial function \[using EndoPAT to measure fingertip small vessel pulse volume\], blood pressure (BP), and heart rate.


Eligibility Criteria:
Inclusion Criteria:

* Patient is ambulatory male or female
* Patient's body mass index score is \>20 and \<40 kg/m2 at the Screening Visit
* Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
* Patient's health is stable with no clinically significant findings on a physical examination
* Patient has type 2 (ie adult onset) diabetes mellitus diagnosed by a physician or nurse practitioner \> 6 months before the Screening Visit, and an entry HbA1c that does not mandate prompt intervention for improved control
* Patient has hypertension diagnosed by a physician or nurse practitioner \> 6 months before the Screening Visit and BP within the protocol's acceptable range
* Patients must be on a stable regimen for glycemic control, and a stable regimen for hypertension control that includes an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB)
* Patient has abnormal endothelial function measured by the EndoPAT
* Other inclusion criteria per protocol

Exclusion Criteria:

* Patient has a clinically significant active or unstable medical condition that, in the opinion of the Investigator, would preclude trial participation
* Patient is on medication(s) that when co-administered with a soluble guanylate cyclase (sGC) stimulator, could increase the risk of hypotension
* Patient has evidence of severe or active end-organ damage attributable to diabetes
* Patient has severe renal insufficiency, has undergone renal transplantation, or has planned renal transplantation
* Other exclusion criteria per protocol
Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects

The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.


Eligibility Criteria:
Inclusion Criteria for all subjects :

* to be over 18 year-old,
* to be enrolled in a social security plan,
* to have underwent a pre-inclusion medical examination,
* to give a written consent.

Inclusion Criteria for volunteers with pathology :

- person with a pathology characterized by a functional and / or morphological alteration that may have an impact on the data collected (images, physiological signals, ...).

Exclusion Criteria for all subjects :

* any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, ... ),
* subject under a measure of legal protection,
* Person who refuses to be informed by a doctor in th event of a fortuitus discovery of an abnormality on the MRI examination requiring additionnal examinations or specific treatment.
Effect of Calcium Glycerophosphate (CaGP) - Fluoride Dentifrice on Dental Biofilm pH

The aim of this study was to investigate the buffering effect of a calcium glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm, respectively). The pH measurements were taken from a single-site using a microelectrode, with salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12 hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.

Although the mechanisms of action of fluoride are reasonably understood, the mechanism of calcium phosphate and calcium glycerophosphate (CaGP) are still a matter of debate. It has been suggested that CaGP increases the phosphorus content in the biofilm and, as a result, the buffering capacity of the biofilm is intensified. The pH levels of the biofilm are maintained above the 5.0-5.5 range. This is above the critical range for enamel demineralization.

Eligibility Criteria:
Inclusion Criteria:

* to live in a non-fluoridated area
* to have at least 20 natural teeth
* signed a consent form agreeing to carefully follow the research instructions

Exclusion Criteria:

* presence of active caries lesions
* periodontal disease
* use of antibiotics/medication.
Effect of Symbicort on Sleep Quality in Patients With Emphysema

This study will look at the effects of the drug Symbicort on sleep quality. Symbicort is an inhaled medication that contains 2 drugs. One is a medication that opens up the airways (formoterol). The other is a steroid to decrease airway inflammation (budesonide). Symbicort is not an experimental medication. It is approved by the Food and Drug Administration for use in patients with emphysema. Patients with severe emphysema commonly sleep poorly. The cause of poor sleep in these patients is unknown. Symbicort may improve sleep quality by opening the airways and reducing lung inflammation. It is not known for sure if these effects actually improve sleep and quality of life. It is hoped that this study will answer this question.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe emphysema (GOLD stages 2 and 3)

Exclusion Criteria:

* Use of supplemental oxygen,
* A recent COPD exacerbation within the past 4 weeks.
* A previous diagnosis of obstructive sleep apnea
* A known urinary outflow obstruction,
* Glaucoma
* History of an allergic reaction to one of the study medications.
Assessing the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa: a Study Protocol

The aim of this study is to conduct a randomized control trial (RCT) to assess the efficacy of weighted blankets (WB), on anxiety for patients with severe anorexia nervosa (AN) and avoidant restrictive food intake disorder (ARFID) in an inpatient medical setting. We hypothesize that using weighted blankets will reduce anxiety in these patient populations.

Anorexia nervosa (AN) has one of the highest mortality rates of any psychiatric disorder with anxiety being a common comorbidity. The standard of care for inpatient medical stabilization for patients diagnosed with AN is a multidisciplinary approach with emphasis on nutrition, psychotherapy, and medical management of complaints. Weighted blankets, an example of deep pressure stimulation, have been shown to reduce anxiety. However, not much is known about the effect of weighted blankets in the eating disorder population. Therefore, this randomized control trial (RCT) protocol outlines a study design for assessing the effect of weighted blankets on patients with AN.

A two-arm RCT design will be implemented for this study. A convenience sample of 24 patients will be enrolled with 12 patients in the control and intervention groups based on inclusion criteria. The control group will receive Denver Health's standard of care for patients admitted to its well-known medical stabilization unit for patients with extreme form of eating disorders, while the intervention group will receive both the standard of care and a weighted blanket. A mixed-design ANOVA will be performed to explore differences in the Beck's Anxiety Inventory and Subjective Units of Distress Scale between the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with AN-R, AN-BP, or ARFID upon admission (per Diagnostic and Statistical Manual-V criteria)
* Moderate/Major Anxiety per initial evaluation score using BAI
* OT assessment

Exclusion Criteria:

* Pregnant or nursing mothers
CT Based Definition of a Tissue Window for Acute Stroke Thrombolysis

Aim of this study is to define a CT-based "tissue window" for stroke thrombolysis. Our primary hypothesis is that

1. patients with a "tissue window" (favourable non-contrast CT (NCCT) scan and an intracranial occlusion on CT angiography (CTA) or perfusion-CT-mismatch" (area of reduced cerebral blood flow (CBF) \> area of reduced cerebral blood volume (CBV)) represent a significant proportion (\> 20%)of acute stroke patients and therefore are an important target group for future interventional studies
2. patients with a "tissue window" suffer an unfavourable outcome (\> 50 % mRS =\>4 at 3 months)if the occluded artery was not recanalized.


Eligibility Criteria:
Inclusion Criteria:

* ischemic anterior circulation stroke
* last seen normal \< 12 hours
* stroke severity =\> 3 on the National Institute of Health Stroke Scale
* multimodal CT stroke protocol performed
* informed consent obtained

Exclusion Criteria:

* premorbid modified Rankin Scale score \> 3
* contraindications to contrast media application
* pregnancy or breast feeding
* subacute stroke \> 50 % of MCA territory
* CT evidence of non-vascular cause of stroke symptoms
A Long-term Safety Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

This was an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450. This study allowed dosing of eltrombopag at an individualized dose for each subject based upon platelet count. The starting dose was based on the subject's dose at the end of the TRA115450 study. The maximum dose was 75 mg daily.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained from the subject's guardian and accompanying informed assent from the subject (for children over 6 years old).
* Subjects must be between 1 year and \<18 years of age at Day 1.
* Subjects must have enrolled in TRA115450/PETIT2 study.
* Subjects must have completed Part 1 and Part 2 of TRA115450/PETIT2 study.
* Female subjects of child-bearing potential (after menarche) must have a negative pregnancy test within 24 hours of first dose of study treatment; agree and be able to provide a blood or urine specimen for pregnancy testing during the study; agree to use effective contraception during the study and for 28 days following the last dose of study treatment, and not be lactating.
* Male subjects with a female partner of childbearing potential must agree to use effective contraception from 2 weeks prior to administration of the first dose of study treatment until 3 months after the last dose of study treatment.

Exclusion Criteria:

* Subjects with any clinically relevant abnormality, other than ITP, identified on the screening examination or any other medical condition or circumstance, which in the opinion of the investigator makes the subject unsuitable for participation in the study or suggests another primary diagnosis (e.g. Thrombocytopenia is secondary to another disease).
* Any subject considered to be a child in care, defined as one who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. This can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or who has an appointed legal guardian.
Modal Anatomy of the Ethmoid Bone

The creation of a 3D model of modal anatomy of the ethmoid could, like other parts of the body, improve anatomical, radiological and perhaps even surgical learning. Anatomical variations might constitute a "background noise" of the modal anatomy, which can be attenuated by multiplying the instances of acquisitions. The objective of this work is to establish modal anatomy of the ethmoid by the analysis of a large number of CT-scan acquisitions carried out in individuals with no acquired sinus pathology.

Non-interventional descriptive research.

Sinus CTscans (period 2016-2019) will be reviewed from the PACS database of the CHRU of Nancy and selected in individuals without sinus pathology. All CT-scans will be fully anonymized. 26 landmarks will be pointed out to enable :

1. prior images alignment (centering on the median line, realignment rotations then resizing)
2. a mean and median calculation, allowing to establish a mean and median ethmoid model
3. calculation of standard deviations for each voxel The structures obtained in this way (bone, tissue or aerial) will be described anatomically.

Eligibility Criteria:
Retrospective analysis of sinus CT scans images from individuals (period 2016-2019)

Inclusion Criteria:

All individuals (\>18 years all) with a sinus CT scan available in the CHRU database

Exclusion Criteria:

inflammatory sinus disease (eg. nasal polyposis, aspergilloma, ...) evolutive sinus tumor anatomical abnormality (e.g. post traumatic, prior sinus surgery, embryologic abnormality...)
Qishenyiqi Dripping Pill for Coronary Microvascular Disease

To investigate the efficacy and safety of Qishenyiqi in patients with microvascular angina pectoris. Long-term follow-up of 1 year will be performed to evaluate the effect of Qishenyiqi on coronary flow reserve and adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
* Coronary normal or stenosis \< 20%;
* Ischemic depression in ST segment during resting or exercise;
* Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0;
* Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

* Previous myocardial infarction or PCI or CABG treatment;
* A history of heart failure;
* Severe arrhythmia;
* Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm;
* Familial hypercholesterolemia;
* Takayasu arteritis, Kawasaki disease or coronary artery malformation;
* Pregnant or nursing, or having the intention to give birth within one year;
* Hepatic or renal dysfunction;
* Allergic to contrast agents or traditional Chinese medicines;
* Patients who participated in clinical research of other drugs within 3 months before being selected.
A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)

To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
* Patient is male or female \>=18 and \<= 65 years of age
* Patient understands the study procedures and alternative treatments available
* Patient is able to read, understand and complete study questionnaires

Exclusion Criteria:

* Patient has a history or presence of a major psychiatric disorder
* Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
* Patient has a history of seizures or is at high risk of developing seizures
* Patient has systolic blood pressure \>160mm Hg or diastolic blood pressure \> 100 mm Hg
* Patient has diabetes mellitus as defined by medical history