cyrilzakka/clinical-trials huggingface dataset:
Explainable Insulin Decision-making System to Assist Physicians in Diabetes Management

The investigators plan to conduct a multi-case, multi-reader observational study with the primary objective of exploring the effects of an interpretable insulin-assisted decision-making system on physicians' (1) decision accuracy and (2) decision confidence.


Eligibility Criteria:
Case:

Inclusion Criteria:

* Patients with T2DM who were admitted to Zhongshan Hospital of Fudan University from 2022.12 to 2023.3.
* Insulin regimen is one of the following: a. Basal regimen: once a day subcutaneous injection of long-acting or ultra-long-acting insulin; b. Premixed regimen: two/three times a day subcutaneous injection of premixed insulin; c. Basal mealtime regimen: three times a day before meals subcutaneous injection of short-acting or rapid-acting insulin, plus once a day injection of long-acting or ultra-long-acting insulin.

Exclusion Criteria:

- Cases will be excluded if there is insufficient information for a valid assessment (missing data on insulin or blood glucose \>40%).

Doctor

Inclusion Criteria:

licensed medical practitioner.
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as add-on Treatment for Early Alzheimer's Disease

The aim is to examine the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) applied at the anodic left Cortex DorsoLateral PreFrontal (CDLPF) of patients with early Alzheimer's disease (AD).

This study included 15 patients treated with rTMS and whose medication reference is stabilized for 3 months by IAChE. Patients with early AD or related disease will be selected in the MCRR of Besançon and the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Mattis Clinical Demantia Rate (CDR), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI) and Hamilton Anxiety Scale (HAMA). The complete assessment takes 40 minutes. A second evaluation will be realized by a neuropsychologist takes around 120 minutes using Mattis CDR, Grober Free and Cued Selective Reminding Test, Trail Making Test (TMT), Crossing of Test (COT), Isaacs Set Test (STI) , Clock-Drawing Test (COT), Signoret's Battery of Cognitive Efficacy (BEC96), Rey-complex figure test-copy and Picture naming 80 items test (DO80).

Each rTMS session runs 20 minutes during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. A psychometric assessment will be conducted again at the end of treatment week and one month after stopping treatment. A neuropsychometric assessment will be conducted one month after stopping the treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment. Moreover a questionnaire will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and 4 weeks after stopping the sessions) using Resource Utilisation Dementia (RUD), Apathy Inventory (AI), Activities of Daily Living (ADL) scale, Instrumental Activities of Daily Living (IADL) scale, Quality of Life in Alzheimer's disease (QoL-AD) scale, Questionnaire of recent change of the personality (CP6).

The population of this study will be comprised of patients between 60 to 85 years-old with early Alzheimer's characterized according to NINCDS-ADRADA criteria. These patients will be recruited on a voluntary basis, after notification and consent in the research center. This study was conducted over a period of 15 months.


Eligibility Criteria:
Inclusion Criteria:

* subject diagnosed with early Alzheimer's disease or related diseases according to NINCDS-ACDRADA criteria.
* subject under treatment by IAChE for at least 3 months.
* CDR score ≤ 2
* psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months

Exclusion Criteria:

* CDR \> 2
* subjects diagnosed with psychiatric disorder (depression according to DSM-IV criteria, bipolar disorder, schizophrenia, addiction)
Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

Patients with a steroid dependent nephrotic syndrome will be compared to those with a non steroid dependent form of nephrotic syndrome at the end of the first manifestation. An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease. Genetics factors will be checked using a DNA chips devoted to the response to steroid therapy and viral genome of EBV, CMV, HHV7 will be searched for using PCR reaction in total blood DNA extract.

Eligibility Criteria:
Inclusion Criteria:

* children below 16 years
* first manifestation of nephrotic syndrome
* steroid sensitivity according to the recommendations of the french "pediatric society nephrology"

Exclusion Criteria:

* patients who don't stay in Paris during the study
VIDEOLARYNGOSCOPY STUDY OF THE LPEC

Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression.

Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients undergoing general anaesthesia

Exclusion Criteria:

* pregnant women
* people with facial
* oropharyngeal abnormalities
Evaluation of Barriers to Postpartum Care in HIV Infected Women

The purpose of this study is to evaluate why the majority of HIV infected women in the Harris County Health District system who are pregnant do not come to clinic for their HIV disease after they have a baby through questionaires administered prepartum and questionaires and structured interviews postpartum. The study will ask subjects questions about HIV, drug use, depression and social problems.

This study is evaluating information pre and postpartum to assess what are barriers to patients coming into care for HIV after they have a baby. We will try to evaluate recurrent themes in questionaires and interviews to try and identify the barriers to care.

Eligibility Criteria:
Inclusion Criteria: HIV infected pregnant women who

* HIV-infected women who are pregnant by confirmatory tests or an HIV positive woman who has had a baby within the last 6 months and is coming to care postpartum.
* Women who intend to get care at Harris County Hospital District.
* Subjects must be \>18 years old.

Exclusion Criteria:

* Women unable to complete questionnaires.
* Women who are unable to speak, read, or understand English or Spanish.
AI Mobile Application Versus HCP for Bodyweight Squats

To assess if an artificial intelligence (AI) mobile application can identify and improve bodyweight squat form in adult participants when compared to a Physical Therapist (PT).

Artificial intelligence (AI) is changing the way people can address their health needs. One such way related to physical exercise is AI-enabled exercise mobile application (digital coach), which uses motion tracking technology to monitor and provide real-time audio feedback on a person's exercise form. However, this AI technology has yet to be independently tested against an in-person evaluator (human coach) for its ability to improve exercise form. This study is a blinded randomized controlled trial comparing the ability of the digital coach (n=15) and a Physical Therapist (PT) human coach (n=15) to improve bodyweight squat form in 30 able-bodied volunteers age 20 - 35. Each volunteer performs 10 unassisted control squats, then 10 squats with assistive vocal feedback from either coach after each repetition, and finally 10 more unassisted test squats, all squats video-recorded. Three independent video evaluators count the number of correct squat repetitions completed by volunteers before and after intervention by the different coaches. This project is important to validate the digital coach compared to a PT human coach in a small population using a bodyweight squat for its wide applicability to daily movement patterns.

Eligibility Criteria:
Inclusion Criteria:

* Columbia University affiliate
* Aged 20 to 35 years
* Able to perform moderate bodyweight exercise for 10 minutes

Exclusion Criteria:

* Unable to provide consent
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis

Retrospective and prospective, pharmacological, multicentre, non-profit observational study.

Consecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg/day from September 2019 to December 2025 will be enrolled in the study.

Aim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg/day in patients with HDV-related compensated cirrhosis in the real-life setting.

Primary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years
* HDV-related compensated cirrhosis defined by positivity of HDV RNA for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis
* Started treatment with BLV monotherapy between September 1st 2019 and 2025

Exclusion Criteria:

* Chronic hepatitis without any evidence of cirrhosis
* Decompensated cirrhosis
* PegIFN alpha therapy
Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants

1. The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.
2. Design: non-inferiority study, prospective, controlled, randomized, multi-center.
3. Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS \>3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" during 24 hours.
4. Conditions of measurements:

   Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.

   Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 (fraction of inspired oxygen

   ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 / FiO2
5. Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
6. Study Schedule: October 2014-April 2016


Eligibility Criteria:
Inclusion Criteria:

* age\<6months
* bronchiolitis
* mWCAS \> or=3
* hospitalisation in pediatric intensive care unit
* signed consent form (2 parents)

Exclusion Criteria:

* Intubated patient
* Neurological or cardiac disease
Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors

This is a protocol to govern the prospective trial of facial nerve monitoring in patients undergoing parotidectomy with an eye towards interpreting if the facial nerve monitor provides useful information to operating surgeons and if the information provided by the facial nerve monitor can predict degrees of postoperative facial nerve paresis.

Additionally, the study will determine if performing daily facial rehabilitation exercises provides a benefit in reducing time to recovery of temporary post-parotidectomy paresis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Planned parotid gland surgery (superficial or total parotidectomy)
* Benign or malignant disease

Exclusion Criteria:

* Pregnancy
* Preoperative facial nerve dysfunction
* Revision operation
* History of preoperative radiation to the surgical field
* Entire nerve not dissected
* Intentional nerve sacrifice
* Poor signal to noise ratio during surgery
* Lack of access to device compatible with video conferencing software, or lack of access to broadband internet connection
A Randomised Controlled Trial Comparing Bone Anchored Hearing Aid With Bonebridge

The Bonebridge is a new bone conducting implantable hearing aid. The investigators plan to randomize patients to receive either the Bonebridge or a conventional bone conducting hearing device. The investigators will then compare the surgical and audiological outcomes of the two groups.

The new Bonebridge fully implanted, except for an external sound processor. It does not have any percutaneous parts like the Bone Anchored Hearing Aid. The investigators believe that this may improve wound healing and reduce problems with wound infection and skin overgrowth seen in Bone Anchored Hearing Aids.

There may also be audiological improvements by the use of the Bonebridge as the physical separation of the vibrating part from the sound processor should reduce feedback. The company also claims other audiological improvements in the Bonebridge.

The investigators wish to demonstrate whether this is actually the case by performing a study directly comparing the outcomes of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Conductive Hearing Loss within criteria for Bonebridge
* Adults

Exclusion Criteria:

* Children
* Pregnancy
The Effect of Uterine Entry in Fetoscopic Laser Photocoagulation for Twin-To-Twin Transfusion Syndrome

The purpose of this study is to evaluate whether the entry technique surgeons use to get inside the uterus to perform fetoscopic laser photocoagulation for twin-to-twin transfusion syndrome has an effect on the rates of chorioamniotic membrane separation.

Patients who choose to undergo fetoscopic selective laser photocoagulation (SFLP) at Texas Children's Fetal Center will be offered participation in this research study by study investigators. Description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. Once the patient is deemed eligible the informed consent process will be reviewed. If patients elect to participate in the study, informed consent will be obtained, and participants will be provided a copy of the signed consent.

After consent has been obtained, participants will be randomized into two groups ("direct entry" and "Seldinger technique").

Procedure: Selective laser photocoagulation (SFLP) is standard of care for the treatment of complicated monochorionic twin pregnancies. Entry into the uterus for SFLP is achieved under ultrasound guidance using one of two accepted methods, direct entry or the Seldinger technique. Intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure.

Group I - Direct entry: The surgeon will gain access to the uterus by inserting a sharp trocar through a small incision in the skin. After access has been established, the trocar is removed and a small tube called a cannula is left in place.

Group II - Seldinger technique: The surgeon will gain access to the uterus by inserting needle through a small incision in the skin and run a guide wire through the needle so a thin tube called a cannula can be placed over the wire.

Follow-Up:

Participants will be monitored after the procedure and upon discharge from the hospital they are free to resume care with their primary doctor. Investigators will collect follow-up data on the health of the participant and the babies until the babies turn one month old.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome.

Exclusion Criteria:

* Patients who do not elect to undergo fetoscopic laser photocoagulation for the treatment of complicated monochorionic-diamniotic twin pregnancies with twin-to-twin transfusion syndrome.
* Triplets and higher order multiple gestations.
Study of Peripherally Inserted Central Catheter (PICC)-Related Infections in a Tropical Area

Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter (PICC)-related infections among patients managed in the University Hospital of La Reunion for PICC setting.

Septi-PICC is a prospective single-center study of infections related to PICCs setting at the South tertiary site of the University Hospital of La Reunion over one year with a follow-up of 6 months per patient.

All the complications such as thromboembolic, are collected during the follow-up.

It is planned a convenience sample of 400 patients over 18 years of age, except pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* all patients managed for a PICC setting in the tertiary care hospital

Exclusion Criteria:

* known pregnancy
* minor
Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule

Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.

Objectives

Main objective

To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k\>0,6

Secondary objectives

To compare the sensitivity and specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* obscure digestive bleeding justifying capsule endoscopy
* complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation
* absence of concomittent ongoing study
* absence of occlusive symptoms of suspected Crohn's disease nor of previous small bowel radiotherapy
* filled inform consent
* no implanted pace maker
* patient being affiliated to the CPAM

Exclusion Criteria:

* under 18 years old
* oral iron within 8 days before capsule endoscopy
* gastroparesis
* pacemaker
* swallowing troubles
* presence of oclusive symptoms suspected Crohn's disease nor of previous small bowel radiotherapy
* pregnancy or risk of pregnancy without efficient oral contraception
* absence of written informed consent
Pharmacokinetics Study of ALO-02 and OxyContin

To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice Daily in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant diseases.
GrowWell - Responsive Bottle Feeding

The overall goal of this research is use digital health to augment the clinical encounter with Women, Infants, and Children (WIC) clinicians and prevent rapid infant weight gain among children living in low-income households. Intervening on weight gain during infancy offers an opportunity to influence lifelong obesity risk. Using personalized motivational messages and targeted skills-training resources, the intervention will support parents and caregivers in adopting responsive feeding strategies. Knowledge gained from this project will be used to develop a future, larger grant submission focused on developing healthy feeding and eating habits among mother-infant dyads.

Assess the feasibility and acceptability of a digital intervention aimed at increasing responsive infant feeding behaviors, beginning 1 month postpartum and continuing through 3-months postpartum, among a prospective cohort of women receiving WIC benefits.

Use qualitative methods to explore barriers and facilitators to participation in a digital infant feeding intervention among women receiving WIC benefits during early postpartum

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* as a smartphone and an email address
* willing to send and receive daily text messages
* can read and write in English
* child is \<=6 weeks

Exclusion Criteria:

* participating in in a different research study that, in the opinion of the investigator, would conflict or would otherwise be too problematic if the subject were to participate in this study
* planning to leave North Carolina in the next 6 months
* subjects who do not have the capacity to give legally effective consent
* any medical or congenital condition that would interfere with infant feeding or growth (ie, Down syndrome or cleft lip or palate)