cyrilzakka/clinical-trials huggingface dataset:
Classic and Modified Rapid Sequence Induction for Prevention of Gastric Content Regurgitation

Induction of anesthesia induces a loss of protective upper airway reflexes and is associated with gastric content regurgitation. Emergency surgery bears a higher risk of gastric content regurgitation because of full stomach, delayed gastric emptying, intestinal obstruction, stroke or other factors. Rapid sequence induction (RSI) of anesthesia was recommended to minimize the risk of regurgitation and aspiration. Classic RSI scheme mainly includes the use of short-acting sedatives and muscle relaxant, together with a manual pressure to the cricoid cartilage (Sellick maneuver) which aims at compressing the esophagus to avoid regurgitation. Though widely recommended, the scheme has been controversial for years. Our department modified the scheme and put it into use in day shift emergency surgery since March 1, 2018. This retrospective analysis is aimed at comparing the effect of classic and modified rapid sequence induction in prevention of gastric content regurgitation in emergency surgery under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients receive emergency surgery under general anesthesia March 1, 2015 to February 29, 2020
* Eighteen years or older

Exclusion Criteria:

* Trachea intubation status on admission
* Tracheotomy
* Bronchoscope surgery
* General anesthesia with laryngeal mask
* Awake intubation
A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV

To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with varicella-zoster viral disease who have failed or are intolerant of alternative therapy.

Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV infection.
* Cutaneous, visceral, or ocular varicella-zoster viral infection.
* Refractory or intolerant to acyclovir or foscarnet therapy.
* Consent of parent or guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Inability to take oral capsules or tolerate liquids.

Concurrent Medication:

Excluded:

* 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid.

Patients with the following prior condition are excluded:

History of immediate hypersensitivity to nucleoside analogues.

Prior Medication:

Excluded:

* 5-flucytosine, 5-fluorouracil, high-dose prednisone, or probenecid within 4 weeks prior to study entry.

Required:

* Prior acyclovir or foscarnet.
CONCEPTT Kids International Neurodevelopmental Outcomes Among Offspring of Women With Type 1 Diabetes

Neurodevelopmental Outcomes among Offspring of women with Type 1 Diabetes: A Follow up Study of the CONCEPTT Randomized Control Trial (CONCEPTT Kids International). An international, multicentre prospective cohort study of child and mother pairs. The potential number of recruits is 225 and the main inclusion criteria is child's mother who participated in the CONCEPTT Trial.

This is a multicentre, international prospective cohort study of child and mother pairs from sites in Canada, UK, Spain and Italy. The expected duration of the study is three years. Women who participated in CONCEPTT will be invited to participate in CONCEPTT Kids International. Once informed consent is obtained, mothers will be asked to complete forms and questionnaires that provide information on family socio-demographics and their children's executive functions and behaviour (i.e. social responsiveness and attention). Self-reported height and weight measures of the child and parent(s) will also be collected.

Our primary outcome measure is childhood executive function measured by the Global Executive Composite of the Behaviour Rating Inventory of Executive Function - Second Edition (BRIEF2)

The secondary outcome measures were chosen based on our systematic review and meta-analysis, which identified significant associations between maternal pre-existing diabetes, and ASD and ADHD. We will use two parent-completed questionnaires to assess symptoms associated with these disorders; the Social Responsiveness Scale-2 (SRS-2) for behaviours associated with ASD and the ADHD Rating Scale-5 (ADHD-5) for ADHD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Children of women who participated in the CONCEPTT trial at selected recruiting sites

Exclusion Criteria:

* NA
Residual Embolism Evaluated With Single Photon Emission Computed Tomography

Major progress achieved in diagnostic and therapeutic strategies has substantially improved the short-term prognosis of patients with pulmonary embolism (PE). These improvements have led to a shift from an acute to a chronic condition of venous thromboembolism, justifying the recent development of Chronic Thrombo-embolic Disease (CTED). In most of the situations, it is due to a residual pulmonary vascular obstruction (RPVO) which can be assessed by pulmonary scintigraphy.

Planar ventilation/perfusion (V/Q) scintigraphy is the gold standard, but for several months, V/Q single photon emission computed tomography (SPECT) is recommended in the guidelines.

The aim of this study is to evaluate the performances of various SPECT protocols to quantified RPVO and compared to planar scintigraphy to evaluate the RPVO.

Eligibility Criteria:
Inclusion Criteria:

* Patient addressed to nuclear medicine department of Saint-Etienne public hospital for V/Q pulmonary SPECT-CT assess to rule out perfusion obstruction, admitted for a suspicion of pulmonary hypertension (PH), or a persistent dyspnea after PE
* Patient affiliated ou beneficiary of social security.

Exclusion Criteria:

* Pregnant patient.
* Patient addressed to nuclear medicine department for acute pulmonary embolism.
* Impossibility of the entire protocol acquisitions realization.
Maintenance rTMS for Treatment-resistant Depression (TRD): a One-year Double Blind Controlled Study

number of center : 1

* duration of study : 24 months
* recruitement time : 23 months
* Aim :Principal

Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients.

Secondary

Evaluate the impact of rTMS on cognitive functions.

The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (\> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).

Eligibility Criteria:
Inclusion Criteria:

* TRD stage I Thase-Rush
* HDRS + or = 18
* Patients age 18 to 70 years.
* Negative pregnancy test and contraception for women.
* Informed Consent

Exclusion Criteria:

* Patient was treated with mood stabilizer in the previous week
* Other disorder on axis I of the DSM IV than depressive disorder.
* Patient with an addiction problem other than tobacco and caféine
* antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker
* Previous history of head trauma the previous two years.
* intracranial hypertension.
* not affiliated to the social security Patient
* patient under constraint hospitalisation
* Under legal protection measure
Virtual Pain Care Trial

The main objective of this study is to evaluate the effect on pain of Virtual Reality Therapy as add-on therapy during wound care procedures in adults.

After inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1 ratio. Randomization will not be blinded since both the provider and patient know if the patient will be wearing the VR system during wound care or not wearing the VR system.

Patients are randomly assigned to one of two groups:

Group 1 - Intervention group 1, Virtual Reality Therapy Group 2 - Control group, care as usual

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 or older with wounds receiving wound care
* Individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures
* At least 1 prior painful wound care procedure, where they have indicated a VAS ≥ 4, or patients reporting a VAS ≥ 4 before initiating the wound care procedure.

Exclusion Criteria:

* Individuals not being able to understand Dutch language at primary school level
* Individuals not being able to read or write Dutch
* Individuals diagnosed with dementia and/or cognitive impairment
* Individuals diagnosed with epilepsy
* Individuals diagnosed with migraine
* Individuals with severe dizziness and/or nausea
* Individuals with a known history of claustrophobia
* Individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide
* Individuals who have no feeling in the wound care area
* Individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the VR headgear and/or headphones
Extracorporeal Focused Shock Wave Therapy for Primary Knee Osteoarthritis

The purpose of this study is to determine whether Extracorporeal Focused Shock Wave Therapy reduces knee pain and enhance function in patients with primary knee osteoarthritis.

This study is a placebo controlled Randomized Clinical Trial (RCT) in which the primary outcome is to determine whether Extracorporeal Focused Shock Wave Therapy (ESWT) reduces knee pain comparing the VAS at baseline and one month after the end of the treatment. Function assessment and progression of pain along the treatment are the secondary outcomes. Function will be assessed with the Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne's Algofunctional Questionnaire for Osteoarthritis of Knee (Lequesne) and the Timed up and Go (TUG).

The ESWT applications will be performed once a week for four consecutive weeks, the patients will be assessed for pain and function before the beginning of the treatment and one week after every application of the ESWT.

The treatment groups will be randomized. The allocation of the patients is sealed and will not be disclosed to the patients nor to the evaluators.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiologic diagnosis of primary knee osteoarthritis (Kellgren \& Lawrence I, II or III);
* Capability to understand the Informed Consent Form;
* Chronic pain for at least 3 months prior to inclusion, measured by VAS. (VAS 4 or above);
* Absence of skin injures, infections or tumor in the target knee;
* Availability to comply with the visits.

Exclusion Criteria:

* History of spinal cord stenosis or clinical symptoms of lumbar radiculopathy;
* History or onset neurological diseases;
* Generalized pain or fibromyalgia;
* Inability to walk;
* History of knee surgery in the target knee;
* Secondary causes of osteoarthritis;
* Use of statins and quinolones in the previous year;
* Uncontrolled and ongoing psychiatric diseases;
* Invasive knee treatments with hyaluronic acid infusion, corticosteroids and anaesthetics, in the target knee, up to 6 months previous to study inclusion.
SCT Plus Immune Therapy in Average Risk AML/MDS

Allogeneic stem cell transplantation followed by targeted immune therapy with Gemtuzumab Ozogamicin (Mylotarg) will be given to patients with average risk AML or MDS.

Reduced intensity conditioning regimen of Busulfan (Bu) and Fludarabine (Flu) + Anti-Thymocyte Globulin (ATG ) (unrelated donors only) or reduced toxicity conditioning regimen of Bu/Flu/alemtuzumab, or reduced hepatic toxicity regimen of melphan/Flu/alemtuzumab and AlloSCT, followed by Gemtuzumab Ozogamicin consolidation in patients with average risk AML/MDS meeting eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

Disease Status:

* AML 1st CR with a matched family donor
* AML 1st CR with unrelated donor
* AML 2nd CR or CRP
* MDS and \< or = 5% bone marrow myeloblasts at diagnosis

Disease Immunophenotype:

* Disease must express a minimum of \> or = 10% CD33 positivity for patients with AML

Organ Function:

* Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function

Exclusion Criteria:

* Patients with active CNS AML disease at time of preparative regimen
* Secondary MDS
* Poor cytogenetics
* Female patients who are pregnant
* Karnofsky \<70% or Lansky \<50% if 10 years or less
* Age \>25 years
* Seropositive for HIV
TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)

Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).

Primary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD

Number of patients : 210 patients, in 14 sites (only one investigator per site), 15 patients per site, 5 patients per grade of transmural healing based on the appraisal of a local reader pair (a gastroenterologist and a radiologist).

Recruitment period : 2 years

Primary Endpoint : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD

Secondary Endpoints :

* To analyze intra- and inter-observer variability of radiological findings.
* To analyze intra- and inter-observer variability of TH definitions in CD.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.
* Indication for MRE based on routine clinical practice validated by the treating physician
* Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab...), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate...).
* The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study.
* A subject can be enrolled into the study only if the grade of TH (assessed by the LRP) corresponding to the subject is not already fulfilled.

Exclusion Criteria:

* Pregnancy during the study
* People unable to give consent (because of their physical or mental state)
* Absence of written consent
* Ulcerative colitis or unclassified IBD
* Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy.
* Less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve)
* Severe obstructive symptoms
* Symptomatic intra-abdominal abscess
* Contraindication for MRI
* Isolated perianal disease without luminal location
* MRE images of poor quality, based on previously defined criteria
Feeling Hot 2: Penile Skin Temperature Measurements of Nocturnal Erections

The Feeling Hot studies focus on the proof-of-principle of using temperature sensing as a tool to detect nocturnal erections. In the Feeling Hot 2 study the penile skin temperature is investigated during nocturnal erections during overnight ambulatory measurements. Simultaneous measurements with the RigiScan will be performed to detect the nocturnal erections and validate the principle of temperature measurements for erectile dysfunction diagnostics.

Differentiation in nature of erectile dysfunction (ED) is currently made by nocturnal erection detection with the RigiScan. The RigiScan uses outdated software, measurements are user unfriendly and system components are out of stock. In the search of modernizing erectile dysfunction diagnostics, the question has arisen whether temperature measurements can function as a tool for nocturnal erection detection. With the absence of a pressure component, the patient experience should improve. Literature and mathematical modelling studies have shown that the penile temperature increases significantly during erection. However, no studies have used penile skin temperature measurements to detect nocturnal erections. The Feeling Hot 2 study explores the validity of this measurement set-up for overnight ambulatory measurements of nocturnal erections in the search of modernizing erectile dysfunction diagnostics.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer without (a history of) erectile dysfunction
* Male
* Aged 18 - 29 years

Exclusion Criteria:

* Test subjects who are unwilling to sign informed consent
* Test subjects with erectile dysfunction
* IIEF-5 score of below 17
* (History of) sickle cell aneamia, atherosclerosis and diabetes type I or II.
* (History of) REM-sleep behavior disorder or other sleep disorders such as restless legs syndrome, insomnia, and sleep apnea
* Usage of sleeping pills or benzodiazepines.
A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth

The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.

The study will be a multi-centre, randomised, parallel group, double-blind, placebo-controlled study in pregnant women with threatened preterm labour between 34\^0/7 and 35\^6/7 weeks of gestation.

The study will be in 2 parts as follows:

* from screening until the day of delivery (including a treatment period up to seven days)
* a maternal and neonatal follow-up period from the day of delivery until 28 days post expected term date (or until 28 days post-delivery should this be later).

In addition, there will be an observational, safety follow-up of the infants for 2 years to evaluate developmental outcome.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age (GA) between 34\^0/7 and 35\^6/7 weeks.
* Subjects with symptoms of preterm labour.
* Subjects with a singleton pregnancy.

Exclusion Criteria:

* Foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the current pregnancy.
* Any contraindications for the mother or the foetus to stop labour or prolong pregnancy or any maternal or foetal conditions likely to indicate iatrogenic delivery.
* Use of cervical cerclage or a pessary in situ in the current pregnancy.
* The Subject has any condition which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial.
Improving the Sleep of Cancer Patients Using an Internet-Based Program

The purpose of this study is to determine whether an Internet-based program, Sleep Healthy Using the Internet (SHUTi, or "Shut-Eye"), can help to improve the sleep of people who are in remission from cancer and experiencing symptoms of insomnia.

The purpose of this study is to test the feasibility of using an Internet program to improve the sleep of cancer patients with insomnia. Participants will receive access to the Internet program (called SHUTi, or "Shut-Eye") as well as to self-hypnosis recordings designed to improve sleep. SHUTi provides an online, tailored educational program to individuals who are experiencing sleep difficulties, including those having difficulty falling asleep, waking in the middle of the night, and waking too early in the morning.

Eligibility Criteria:
Inclusion Criteria:

* Age = At least 21 years old
* Regular access to the Internet, including e-mail
* Cancer patient

  * Any type of cancer (EXCEPT non-melanoma skin cancer)
  * In remission from any stage of cancer (active treatment completed at least one month prior to enrollment)
* Insomnia diagnosis (combined from DSM-IV and ICSD):

  * Subjective complaints of poor sleep for at least 6 months
  * Sleep difficulties ≥3 nights/week
* Difficulty falling asleep (≥30 minutes to fall asleep) OR
* Difficulty staying asleep (≥30 minutes awake in the middle of the night)

  * ≤6.5 hours sleep/night
  * Poor sleep causes marked distress or significant impairment in daytime functioning (e.g. fatigue, performance deficits, mood disturbance)
* Participant feels that the insomnia was caused/aggravated by cancer or cancer treatment

Exclusion Criteria:

* Having a sleep disorder other than insomnia (e.g. sleep apnea, RLS, narcolepsy, parasomnias)
* Having a medical condition other than cancer that causes insomnia
* Experiencing a psychiatric disturbance (major depression, psychosis)
* Experiencing substance abuse
* Currently undergoing psychotherapy or counseling
* Changing sleep/anxiety/depression medication within the past month
* Having an "unusual" sleep pattern

  * Normal bedtime is after 2am OR
  * Normal wake time is after 9am
* Working as a shift worker (that is, having a schedule that requires working through the night)
* Participants reports that she is pregnant or intending to get pregnant in the next 4 months
Effects of AHCL Insulin Pump on Glycemic Control and Psychosocial Outcomes in Pediatric Patients With Type 1 Diabetes

Prospective, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (AHCL) system insulin pump in pediatric patients with type 1 diabetes

This trial consists of baseline phase of 3 weeks sustaining the treatment previously maintained by the patient, followed by study phase of 12 weeks of AHCL system application.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is age 7-19
2. The subject with one or more of the below

   * serum c-peptide ≤ 0.6 ng/mL at diagnosis
   * positive glutamic acid decarboxylase (GAD) antibody
   * positive islet cell antibody
   * positive anti-Insulin antibody
   * positive anti-islet Antigen-2 (IA-2) antibody
3. The subject was diagnosed with type 1 diabetes ≥ 1 year
4. The subject has been continuously treated at least for 8 weeks at the start of the study, by one of the existing insulin treatment methods \[insulin multi-injection (MDII), general insulin pump (CSII), sensor-linked insulin pump (SAP), or 770G insulin pump (HCL system)\]
5. The subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study

Exclusion Criteria:

1. Any systemic treatment with drugs known to interfere with glucose metabolism within 8 weeks prior to trial
2. Subjects with underlying hematologic disorders that can affect the HbA1c levels
3. Subjects with underlying medical disorders that can affect glucose metabolism
4. Subjects with a neuropsychiatric disorder such as depression or eating disorder
5. Subjects with underlying thyroid disorders and abnormal thyroid function