cyrilzakka/clinical-trials huggingface dataset:
Lateral Positioning and Prone Position

Lateral (30°) and alternating positioning (change of side every 30 minutes) carried out on specific beds, could be an alternative or complement to decubitus positioning ventral (DV). It has been (little) studied in supine position (DD), very little in the field of Syndrome Acute Respiratory Distress (ARDS). Some recent work carried out during the pandemic COVID-19 suggest that lateral positioning could improve overall ventilation of lungs of patients in the supine position. The combination of lateralization in prone position has not been studied. The dynamic created by lateralization could allow better overall ventilation during the prone position (additive or synergistic effect with the DV which itself increases pulmonary aeration), thus making it possible to further improve the gas exchanges and, in particular, oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* An age of at least 18 years
* ARDS evolving for less than 5 days with a PaO2/FiO2 ratio (P/F ratio) \< 150 after optimization of the PEEP (P/V curve, R/I ratio), curarization and without use prior to the DV since oro-tracheal intubation.
* Obtaining written consent from the patient, one of his relatives or the person of previously designated trust. As soon as possible, the patient will be informed and written consent will be obtained
* Beneficiary of health insurance coverage
* Possibility of participating in any other studies whose evaluation criteria do not interfere not with those in the study

Exclusion Criteria:

Refusal to participate

* Pregnant, parturient or breastfeeding women
* Intracranial pressure \> 30 mm Hg or cerebral perfusion pressure \< 60 mm Hg
* Severe chronic respiratory disease with oxygen therapy or mechanical ventilation at home (except CPAP/BIPAP for sleep apnea)
* Chronic interstitial lung diseases
* Patients on ECMO
* Morbid obesity \>1 kg/cm
* Severe liver disease Child-Pugh score 12-15
* Pneumothorax
* SAPS II score \> 75 at inclusion
* Unstable spine fracture17
* Contraindications of TIE (pacemaker, implantable defibrillator, skin lesions between 4th and 5th ribs).
* Decision to limit therapeutic acts
* Any other reason which, in the opinion of the investigator, could interfere with the evaluation of the objectives of the study
* Person under judicial protection (guardianship, curatorship, etc.)
* Person deprived of liberty by a judicial or administrative decision
Effects of VR in Children With DCD: Randomized Controlled Trial

The aim of the study is to examine the effect of VR application on motor, cognitive and sensory-perceptual skills, and activity and participation levels in children with DCD.

The hypotheses on which the study proposal is based are as follows:

1. H0: VR application has no effect on motor skills in children with DCD. H1: VR application has an effect on motor skills in children with DCD.
2. H0: VR application has no effect on cognitive skills in children with DCD. H1: VR application has an effect on cognitive skills in children with DCD.
3. H0: VR application has no effect on sensory-perception skills in children with DCD.

   H1: VR application has an effect on sensory-perception skills in children with DCD.
4. H0: VR application has no effect on the functional independence levels in daily living activities in children with DCD.

   H1: VR application has an effect on the functional independence levels in daily living activities in children with DCD.
5. H0: VR application has no effect on participation levels in children with DCD. H1: VR application has an effect on participation levels in children with DCD.

Within the scope of our aims;

* To determine the gross motor skill levels of children with DCD and to obtain the effect of VR application on gross motor skill levels.
* To determine the executive function skill levels of children with DCD and to obtain the effect of VR application on executive function skill levels.
* To determine the sensory-perception skill levels of children with DCD and to obtain the effect of VR application on sensory-perception skill levels.
* To determine the functional independence of children with DCD in daily life and to obtain the effect of VR application on their functional independence levels.
* It is aimed to determine the participation levels of children with DCD and to obtain the effect of VR application on their participation levels.

Eligibility Criteria:
Inclusion Criteria:

* Being between 5-8 years old,
* It is to get 15-46 points from the Developmental Coordination Disorder Questionnaire for ages 5-7 and 15-55 points for ages 8.

Exclusion Criteria:

* Those who are receiving any other therapy program,
* have vision (other than glasses) or hearing problems,
* Children with any neurological disorder will not be included in the study.
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy

This is an Italian, Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter longitudinal observational study. Parents or guardian and subjects (when applicable) will provide their Informed Consent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving SAIZEN® via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To identify adherence subject profiling
* To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Over the age of \>2 years
* Under \<18 years of age, or over 18 without fusion of growth plates
* Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the Summary of Product Characteristics (SmPC)
* Use of an investigational drug or participation in another interventional clinical study
PillCam Colon 2 Capsule Endoscopy (PCCE) After Incomplete Colonoscopy

Purpose of study:

To evaluate the efficacy of PillCam Colon2 in subjects with an incomplete standard colonoscopy

Study design: 4 centers, prospective, cohort study Number of subjects: 74 subjects

Subject population: Patients that are indicated for colonoscopy, who are suspected or known to suffer from colonic diseases and had an incomplete standard colonoscopy

Control group: None Procedure Duration: Approximately 10-12 hours Duration of Follow up: One week follow up Duration of study: 12 months

Primary objectives: Evaluation of the efficacy of PillCam Colon2 to visualize the colon segment not reached by an incomplete standard colonoscopy Evaluation of distribution of excretion of capsules over time


Eligibility Criteria:
Inclusion Criteria:

* Subject is \>/= 18 years
* Subject is suspected/known to suffer from large bowel disease and was clinically referred for colonoscopy.
* Standard colonoscopy could not be performed completely in spite of adequate bowel cleansing and in the absence of a relevant colonic or rectal stenosis. Reasons for incomplete colonoscopy: adhesions, elongated colon, repeatedly forming loops, difficult procedure(time to reach the cecum \>45 min), adverse reaction to sedation requiring termination of colonoscopy

Exclusion Criteria:

* Subject has dysphagia or any swallowing disorder
* Subject has severe congestive heart failure or renal insufficiency
* Subject with high risk for capsule retention
* Subject has a cardiac pacemakers or other implanted electromedical devices
* Subject has any allergy or other contraindication to the medications used in the study
* Subject is expected to undergo MRI examination 7 days after capsule ingestion Subject has any condition, which precludes compliance with study and/or device instructions.
* Women who are pregnant or nursing at the time of screening and/or during the study period, or are of child bearing potential without medically acceptable methods of contraception
* Subject suffers from life threatening conditions
* Subject currently participating in another clinical study
* Colonoscopy had been performed by a physician who has experience of \<1000 complete colonoscopies
* Exchange of the endoscope had been performed because complete colonoscopy was impossible with the standard endoscope
* Time interval between incomplete colonoscopy and capsule endoscopy \>30 days
Modified Hospital Elder Life Program at Intensive Care Unit

Delirium, a form of acute brain dysfunction, occurs in up to 81% of patients receiving mechanical ventilation in the intensive care unit (ICU). Delirium occurring in the ICU is associated with increased functional dependency, cognitive impairment, longer length of hospital stay, and mortality. This study aim to develop a nursing-driven ICU delirium intervention to reduce incidence of delirium, increase the delirium-and coma-free days (DCFDs), and improve ICU patients' function, cognition, and mortality outcomes 3 months following their ICU admission. The "modified Hospital Elder life Program at the ICU (mHELP@ICU)" will be provided to ensure critically ill patients are cognitively engaged, physically active, and nutritionally well-fed.

This three-year study is divided into two phases. The first phase aims to ensure the accuracy of delirium assessment using the Intensive Care Delirium Screening Checklist (ICDSC) by ICU nurses of three participating ICUs. The ICDSC records assessed by ICU nurses will be abstracted from medical records and compared with a gold standard ICDSC evaluation by a well-trained, independent assessor. Cohen's kappa will be reported to represent the consistency of the ICDSC assessment between delirium data from medical records and the independent assessor. When the Cohen's kappa is less than 0.8, a 3-month bedside teaching and real-time feedback education program will be implemented at three ICU units to improve the accuracy of ICDSC assessment by ICU nurses. The second phase will be a clinical trial using a stepped-wedge cluster randomized controlled trial design. Adult (18 years and older) critically ill patients receiving mechanical ventilation will be consecutively enrolled from three mix-medical ICUs at a studied medical center. Estimated 266 participants will be cluster-randomized into the intervention and control groups. Participants in the intervention group will receive a 14-day mHELP@ICU, provided by a trained mHELP nurse, while the participants who received the usual care will serve as controls. Effects of mHELP@ICU will be evaluated using the daily delirium and coma data (max 14 days, or until death or ICU discharge) retrieved from the medical records, along with the participants' mortality, cognitive, and functional outcomes, which a blinded outcome assessor will assess at 48 hours, 14 days, 30 days, and 90 days after ICU admission.


Eligibility Criteria:
Inclusion Criteria of the second phase

* participants who are 18 years old or older.
* participants who receive oral endotracheal intubation with mechanical ventilation and are expected intubation greater than 48 hours.
* participants are free from delirium or coma before ICU admission.

Exclusion Criteria of the second phase

* participants who are placed on droplet or contact precautions (e.g., Open TB, SARS, COVID-19 )
Complement Activation During Hemodialysis in Atypical Hemolytic Uraemic Syndrome as Underlying Kidney Disease

Atypical hemolytic uraemic syndrome is caused by defects in the regulating factors in the alternative pathway of the complement system. Triggering can cause an uncontrolled complement activation with endothelial damage and thrombotic micro-angiopathy, especially in the kidneys. This can result in endstage renal failure. Complement activation during hemodialysis has been described as a result of contact between blood and the dialysis membrane. Our hypothesis is that patients with atypical hemolytic uraemic syndrome have a stronger complement activation during hemodialysis than patients with another underlying kidney disease. This could be a reason to treat patients with endstage renal failure due to atypical hemolytic uraemic syndrome preferentially with peritoneal dialysis instead of hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* cases: endstage renal failure due to atypical hemolytic uraemic syndrome treated with hemodialysis.
* controls: endstage renal failure due to a non complement consuming nephropathy treated with hemodialysis.
Epigenetic Determinants of Peritoneal Fibrosis

Peritoneal dialysis (PD) is a type of kidney replacement therapy for patients with chronic kidney disease where the peritoneal membrane is used to filter the blood. Exposure to PD fluid results in scarring of the peritoneal membrane and increased blood vessel growth. This condition can progress even when peritoneal dialysis is stopped. Therefore, the investigators hypothesize glucose in the dialysis fluid may result in DNA modifications called epigenetic changes. These changes modify how genes are expressed and how cells function. The investigators want to study these epigenetic changes and the effect on peritoneal membrane scarring, blood vessel growth and peritoneal membrane function.

There is considerable evidence that epigenetic changes in effector cells underlie the progressive nature of fibrogenic diseases. The investigators have developed an ex-vivo mesothelial cell culture system based on work by Aroeira and colleagues. Ex vivo cell cultures were treated with the DNA methyltransferase inhibitor 5-AZA for 72 hours. Overall, the investigators found that 11 of 14 patients' cells showed an increase in the E-Cad/alpha-SMA ratio with treatment to 5-AZA, indicating a return to a more epithelial-like phenotype and supporting an epigenetic mechanism of progressive fibrosis. The investigators hope to identify DNA methylation patterns associated with glucose exposure and peritoneal membrane solute transport in PD patients.

The investigators will take the peritoneal effluent from an overnight dwell from patients within one month of initiation of dialysis. The overnight effluent is centrifuged and the pellet is washed and cells are grown in DMEM medium. At confluence, cells are passaged into 2 flasks then taken for DNA and RNA. At 12 months, a second overnight peritoneal effluent sample will be obtained. The investigators will also gather demographic data (patient's age, diabetes, occurrence of peritonitis, cumulative PD prescription including total glucose exposure, use of icodextrin, and the results of a peritoneal equilibrium test carried out for clinical purposes between 3 and 12 months from the start of peritoneal dialysis). The investigators will use whole genome DNA methylation analysis to assess epigenetic changes in mesothelial cells from incident PD patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with end stage renal disease recently started on peritoneal dialysis. Patients will be over the age of 18.

Exclusion Criteria:

-
Proximal Effects of Alcohol on Same-Sex Intimate Partner Violence

We will recruit sexual and gender minority couples to complete 56 days of daily surveys in order to evaluate (1) the impact of COVID-19 stress and sexual and gender minority stress on heavy episodic drinking and intimate partner violence (IPV) perpetration, and (2) a brief, mobile-phone delivered text messaging intervention to mitigate the effects of these stressors. This project has high potential to inform how pandemic stress contributes to etiological models of alcohol-related IPV perpetration in sexual and gender minority couples and inform a culturally-sensitive, low burden, and easy to disseminate intervention to mitigate these effects critical during a pandemic when access to care is limited.


Eligibility Criteria:
Inclusion Criteria (applies to both partners):

* Both partners must identify as cisgender and sexual minority or at least one partner must identify as a gender minority (i.e., one's gender identity is non-congruent with their sex assigned at birth)
* 21 years or older
* In an intimate relationship lasting at least one month in which there are at least 2 days of face-to-face contact each week
* Consumption of 4 (assigned female at birth) or 5 (assigned male at birth) alcoholic drinks on at least three days in the past year

Exclusion Criteria:

* Seeking treatment or being in recovery for an alcohol or substance use disorder.
* Endorsement of severe physical IPV (e.g., use of a weapon) in the past year.
* Women who self-report that they are trying to get pregnant, that they are currently pregnant, or that they are currently breastfeeding .
UV Dosimetry Feedback in NMSC Patients

This study aims to characterize UV exposures among NMSC patients (those with a history of skin cancer) and to pilot an innovative behavioral intervention to decrease modifiable UV exposures. It will use UV dosimeters to objectively measure UV exposure and provide time and activity specific UV data on an individual level. These data will be used to develop a targeted and personalized behavioral feedback plan with counseling aimed at effective sun exposure behavior change

The study will focus on helping to prevent NMSC and its associated morbidity through learning when patients are unintentionally exposed to extreme UV radiation. It will then help to create manageable and realistic behavioral interventions to reduce exposure, while also educating patients of the dangers of abundant sun exposure.

Eligibility Criteria:
Inclusion Criteria:

* Patients between ages 18 and 50.
* Must be diagnosed with non-melanoma skin cancer.

Exclusion Criteria:

* Patients, who at the discretion of the clinician, are too ill or sick.
* Non-English speaking patients.
Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke

The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with ischemic or hemorrhagic stroke diagnosis and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease)
* Ability to reach 60 degrees in the shoulder flexion
* Minimal cognitive ability to understand commands
* No current use of antiepileptic drugs for seizures

Exclusion Criteria:

* Painful shoulder, adhesive capsulitis or glenohumeral subluxation
* Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire
Real World Data Collection and Analysis on the Anterior Cervical Spine Surgery

This observational study aims to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease

This observational study is an ambispective cohort designed. Patients who are diagnosed cervical degenerative disc disease will be selected to join in this study. Visual Analogue Scale, Japanese Orthopaedic Association Scale, Neck Disability Index, SF-36, and device related or procedure related adverse events will be recorded and compared to evaluate the efficacy and safety of anterior cervical spine surgery in patients with cervical degenerative disc disease

Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years old
2. Clinical symptoms and imaging support cervical degenerative disc disease；
3. Failed a minimum of 3months conservative treatment
4. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) anterior cervical spine surgery
5. Written informed consent given by subject

Exclusion Criteria:

1. Patients with non-degenerative (e.g., trauma, tumor, and infection) or neuromuscular diseases (e.g., motor neuron disease) were excluded
2. Patients with cervical spine X-ray film and CT scan contraindications
3. Women who are lactating and pregnant
Long-acting Biomedical HIV Prevention in Transgender Women

Transgender women (TW) have unique challenges related to HIV prevention medication adherence. Left unaddressed, these challenges will prevent TW from accessing the promising long-acting HIV prevention tools in the development pipeline. This study will develop a replicable process to tailor the delivery of these tools and an adherence intervention (that will include an mHealth app) to the needs of TW, using the example of inert injectable cabotegravir. Work builds on a pilot study to identify tailored methods to deliver injectable cabotegravir in TW, such as self-injection and injection by a healthcare provider at at "drop-in" clinic. The investigators will use qualitative methods (e.g., interviews, group discussions called "Design Sessions") to design the adherence intervention and the mHealth app. Then, investigators will execute a partially randomized patient-preference trial to determine if TW are able to use tailored injection strategies (self-injection or injection by a healthcare provider at "drop-in clinics") to improve adherence, compared to a control group of TW who will engage a protocol based on HPTN-083/084. This will serve as a "proof of concept" for the future R01 that will test this on a larger scale. Research and training will take place at NYSPI/Columbia, in affiliation with, 1) Project AFFIRM, a study of transgender identity (R01HD079603; PI: Bockting), that will provide infrastructure for critical research activities (e.g., recruitment), and 2) SLAP-HIV, a clinical trial to produce a long-acting form of cabotegravir (e.g., injection; UM1 AI120184; PI: Hope). SLAP-HIV will provide clinical oversight (e.g., ensure tailored delivery strategies are feasible).


Eligibility Criteria:
Inclusion Criteria:

* HIV-negative
* self-identified transgender woman (or woman assigned male at birth)
* at least 18 years old
* willing to complete injections
* own a smartphone that uses apps
* speak English or Spanish
* willing to take an HIV test
* live in the NYC/tri-state area
* report receptive or penetrative genital-to-genital sex with another person in the last 3 months

Exclusion Criteria:

* HIV-positive
* does not identify as a transgender woman (or woman assigned male at birth)
* younger than 18
* unwilling to complete injections
* does not own a smartphone that uses apps
* does not speak English or Spanish
* refuses HIV test
* lives outside of the NYC/tri-state area
* has not had receptive or penetrative genital-to-genital sex with another person in the last 3 months