cyrilzakka/clinical-trials huggingface dataset:
The Use of the ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided With Lesions Smaller Than 15 mm

This will be a prospective, single-arm, single-center, open-label study to evaluate the use of the ActiSight™ Needle Guidance System in patients with lung lesions smaller than 15 mm undergoing CT-guided percutaneous chest aspiration.

Target location will be in the chest area; the procedure will be performed by a trained physician.

Subjects who are scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures will be screened for inclusion in the study.

Within an 18-day screening period, eligible subjects will be enrolled into the study and undergo percutaneous chest aspiration or percutaneous biopsy utilizing the ActiSight™ Needle Guidance system using CT to guide the needle. Subjects will be followed-up for at least one hour at the clinic for safety and preliminary accuracy evaluations. An erect chest radiograph will be performed within 90 minutes of observation after the chest aspiration to detect the majority of post procedure pneumothoraces. A follow-up visit will be conducted within 7-10 days after the procedure day for safety evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 years of age or older at the time of enrollment
* Subjects scheduled for clinically indicated percutaneous chest aspiration/biopsy procedures
* Subjects with lung lesions less than 15 mm.
* Written informed consent to participate in the study
* Ability to comply with the requirements of the study procedures

Exclusion Criteria:

* Subjects who cannot tolerate mild sedation
* Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment.
* Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study.
* Subjects who are uncooperative or cannot follow instructions
Virtual Focused ACT Groups in Primary Care

Acceptance and commitment therapy (ACT) is a transdiagnostic intervention whose aim is to reduce experiential avoidance and promote psychological flexibility, which involves engaging in values-based behaviour while accepting painful internal experiences with openness and awareness. A growing body of research supports the efficacy of brief ACT for a variety of issues, including depression, anxiety, chronic pain, and stress. Given that ACT is a transdiagnostic intervention that targets the core processes related to human suffering, this treatment may be particularly useful for implementation in primary care with diverse groups of individuals and presentations. The objective of this study is to develop and pilot test a brief, virtual, group-based ACT intervention for depression and anxiety delivered in primary care settings to determine if a future randomized controlled trial of this group treatment is both warranted and feasible. The investigators will examine (1) the feasibility and acceptability of the study procedures, (2) clinician adherence to the treatment protocol, and (3) a preliminary analysis of the treatment effectiveness. A total of 3 groups (N = 30-45) will be conducted via three primary care clinics in Winnipeg, Manitoba, Canada. The group treatment will be delivered over four 90-minute sessions. Participants will complete assessment measures at pretreatment, post-treatment, and at two follow-up time points (1-month post-treatment and 3-6-months post-treatment). All assessments and treatment sessions will be conducted virtually via videoconferencing platform.


Eligibility Criteria:
Inclusion Criteria:

* self-reported symptoms of depression and/or anxiety
* fluent in English
* access to reliable internet and a device with a webcam as well as a private/quite space from which to attend sessions
* no change in psychotropic medication for at least 6 weeks prior to the intervention
* willingness to maintain a stable medication type and dose for psychotropic medications during the intervention phase and for one month post-intervention

Exclusion Criteria:

* engagement in another psychological treatment during the intervention phase or one month post-intervention
* current psychosis
* bipolar disorder
* current substance use disorder
* cognitive/intellectual impairment
* current active suicidal ideation
Quality of Preoxygenation in Emergency Surgery

Preoxygenation prior to general anaesthesia prolongs safe apnea time. Proper preoxygenation is always a challenge in emergency surgery.

The aim of our study is to estimate problems encountered during preoxygenation, their risk factors and ways of solving them.

Factors, that are associated with compromised preoxygenation will be determined during our study. Pulse oximetry data and end-tidal oxygen concentration values will be evaluated in association with risk factors for insufficient anaesthesia face mask seal, difficult intubation, preoxygenation techniques used, comorbidities, physical status, hemodynamic and laboratory measures.

Parameters analysed:

* Preoperative: medical history, physical examination, laboratory findings, anthropometric data
* Intraoperative: preoxygenation equipment and method used (defined by anaesthesiologist in charge of the case), oxygenation and haemodynamic values recorded during preoxygenation and induction of anaesthesia, intraoperative laboratory values (if obtained)

Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* patient going for emergency surgery under general anaesthesia
* age \> 18 years

Exclusion Criteria:

* informed consent refusal
* noneligible for preoxygenation before general anaesthesia
Study of Cannabidiol for Drug-Resistant Epilepsies

The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Ages between 1 year old and 20 years old, male or female at the first visit, Week -4 (at time informed consent form is signed)
2. Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented with medical records and/or the following clinical features (must have all 3 of the following):

   1. Failure to control seizures despite appropriate trial of 3 or more AEDs at therapeutic doses
   2. An intractable childhood epilepsy including, Dravet Syndrome or Lennox-Gastaut Syndrome
   3. Must report at least 3 countable (non-countable seizures includes absence and myoclonic) seizures per month
3. Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit.
4. VNS must be on stable settings for a minimum of 3 months.
5. If on the ketogenic diet, must be on stable ratio for a minimum of 3 months.

Exclusion Criteria:

1. Epilepsies associated with neurodegenerative diseases, including neuronal ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and tumors
2. Epilepsies associated with an inborn error of metabolism, including mitochondrial disorders
3. Felbatol initiated within the past 12 months
4. Use of any Cannabis-related product (including hemp oil) in the past 12 months as assessed by parental questioning.
5. Laboratory values on comprehensive metabolic panel (CMP) and complete blood count (CBC) testing that are Class 3 or higher according to the CTCAE v4.0.
6. Positive pregnancy test.
Mental Fatigue and Industrial Work Performance

To investigate the effect of mental fatigue on industrial work performance, biomechanical determinants, (electro-)(psycho-) physiological measures and physical ergonomics. Additionally, the current project wants to evaluate whether or not the Laevo exoskeleton influences the aforementioned parameters when mental fatigue is acutely induced.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Males and Females
* 18-64 years

Exclusion Criteria:

* Musculoskeletal disorders
* Neurological disorders
* Cardiovascular disorders
* Pregnancy
Study of orBec® With Prednisone Therapy in the Treatment of Patients With Graft Versus Host Disease (GVHD)

Use of an oral topically-active glucocorticoid with limited side effects will control the gastrointestinal inflammatory process of GVHD and minimize glucocorticoid exposure.


Eligibility Criteria:
Inclusion Criteria:

* Receipt of allogeneic hematopoietic cell transplant
* Diagnosis of GI graft vs. host disease (GVHD)
* No GI infection
* Must be able to swallow tablets
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study

Exclusion Criteria:

* Significant Skin GVHD
* Liver GVHD
* Persistent vomiting
* HIV positive
* Pregnancy/lactation
Brightening Cream and Lasers in Post-sclerotherapy Hyperpigmentation

The treatment of leg veins and varicosis with sclerotherapy is one of the most frequently performed medical intervention in the western world. The most common local side effects of this treatment are hyperpigmentations caused by hemosiderin deposition in the skin as well as post inflammatory hyperpigmentation.

Although skin hyperpigmentation after sclerotherapy is a common over several months up to years lasting side-effect with a strong aesthetic impact, scanty data exist about treatment options.

Quality-Switched (QS) lasers are efficient in the removal of exogenous and endogenous pigments, such as tattoos as well as epidermal and dermal melanin deposits. The laser light is absorbed by pigment particles, leading to a fragmentation of these particles by a photothermal and photoacoustic effect. Smaller particles can be then phagocyted by macrophages, and transported via the lymphatic system into the lymph nodes. Furthermore, the positive effect of QS lasers in the management of cutaneous siderosis in stasis dermatitis and after sclerotherapy has been described in several cases.

Triple cream including hydroquinone, tretinoin and a topical corticosteroid (eg dexamethasone), is the first line therapy in the treatment of post inflammatory hyperpigmentation.

This randomized controlled study aims to evaluate the efficiency of two well-known depigmentation methods (QS laser and triple cream) for treatment of post sclerotherapy hyperpigmentation, compared with a control group performing no treatment.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick skin type I-IV
* Presence of at least 1 postinflammatory hyperpigmentation after sclerotherapy

Exclusion Criteria:

* History of adverse events related to short-pulsed laser therapy
* Pregnant or breast-feeding women
* Intention to become pregnant during the course of the study
* History of intolerance or allergic reaction to triple cream or one of its ingredients
* Prior treatment with parenteral gold therapy
* Inability to understand the study content
Proof of Concept Study of a Sucker Hemostatic Intra Uterine in Postpartum Hemorrhage After Abruptio Placenta Assisted

The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus, examination of the birth canal), begins with uterotonic treatments for invasive treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these techniques and the desire to preserve fertility required to devise new therapeutic solutions, which have recently led to the development of an innovative medical device intrauterine hemostasis.

The postpartum haemorrhage are mainly the result of weak and bleeding from the surface corresponds to the placental insertion, which is no longer localized. With the innovative medical device, our main hypothesis is that the uterine walls will append to the walls of the cup after depressurization of the latter. The actuation of the suction cup will lead to aspiration of all sides of the uterus (it is mostly the anterior and posterior that are important). The suction cup is flexible to adapt to the size of the uterus in order to be placed and removed easily from the uterine cavity.

In this study, as a first pass in Human, innovative medical device not CE marked, we did not aim to show control of the bleeding stops in the case of PPH but to prove, in a clinical situation with no foreseeable risk to the volunteers included (volunteers who have given birth without placental abruption after 30 minutes despite the directed delivery), proof of concept of using this system in these women that creates a vacuum in the Intra uterine Haemostatic vacuum and thus a joining of the walls of the uterus. This first step seems essential in order to effectively implement this medical device with serenity in emergency situations of PPH.

Eligibility Criteria:
Inclusion Criteria:

* woman between 18 and 45 years old,
* affiliation to the French social security system or equivalent,
* volunteers signed a consent to participate,
* volunteer is under loco-regional anaesthesia,
* volunteer whose the placenta has not taken off after 30 minutes despite the directed delivery.

Exclusion Criteria:

* volunteer carries uterine malformations,
* volunteer with post-partum haemorrhage (blood loss\> 500 ml),
* volunteer allergic to silicon,
* volunteer under general anaesthesia,
* pregnancy not unique,
* volunteer with fever or suspected infection during labor,
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Person hospitalized for psychiatric care
The Factors Affecting ADR of Screening Colonoscopy

The purpose of this study is to assess the impact of multilevel factors on the quality of screening colonoscopy, reflected mainly by adenoma detection rate (ADR).

The subjects will include patients who need to screening colonoscopies by 21 endoscopists between January 2019 and December 2019 were retrospectively enrolled in this unit. Multilevel factors, including patient-, proceduralist-, and procedure-level characteristics were analyzed for the relationship with ADR.

Eligibility Criteria:
Inclusion Criteria:

* Patients were retrospectively included in this study if they had undergone a completed colonoscopy.

Exclusion Criteria:

* prior colonoscopy within 3 years;
* medical history of inflammatory bowel disease (IBD), CRC, or abdominal surgery;
* fair or poor quality of bowel preparation (fair quality: some semisolid stool that could be suctioned or washed away but \>90% of mucosal surface seen; poor quality: semisolid stool that could not be suctioned or washed away with \<90% of mucosal surface seen);
* failure in cecal intubation;
* withdrawal time without removing\<6 min.
The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)

This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.


Eligibility Criteria:
Inclusion Criteria:

* The child is 4 years to 14 years of age
* The child is a non smoker
* The child has exercise-induced bronchoconstriction (EIB)

Exclusion Criteria:

* The child has active or chronic breathing disease, other than asthma
* The child has required insertion of a breathing tube for asthma
* The child had major surgery within the last 4 weeks
* The child is currently in the hospital
* The child has or had an upper respiratory tract infection within the last 2 weeks
* The child has been hospitalized or visited the emergency room or had a change in their medication for asthma within the last 4 weeks
* The child has been in a research study in the last 4 weeks
* The child has stomach, brain, heart, kidney or liver disease
* The child drinks more that 4 caffeinated drinks a day
A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in participants with Type 2 Diabetes Mellitus (T2DM).

This is a randomized, double-blind, placebo controlled study designed to evaluate the efficacy, safety, and PK of MEDI0382 administered as multiple daily SC doses to participants with T2DM. Approximately one hundred and seven participants will be enrolled across 6 cohorts. In cohorts 1-3 the participants will be randomized to MEDI0382 or placebo (2:1). In Cohort 4, participants will be randomized to MEDI0382 or placebo (1:1). In cohort 5 and 6 participants will be randomized to MEDI0382 or placebo (3:1).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM
* Must provide written informed consent
* Body mass index greater than (\>) 27 and less than (\<) 40 kg/m\^2, inclusive
* Venous access suitable for multiple cannulations
* Vital signs within normal specified ranges
* Females must be non-lactating and non-childbearing potential
* Males must practice 2 effective contraceptive measures if sexually active

Exclusion Criteria:

* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
* History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* History of cancer within the last 10 years, with the exception of non-melanoma skin cancer
* Any clinically important illness (except for T2DM), medical/surgical procedure, or trauma within 4 weeks prior to dosing
* Fasting glucose greater than or equal to (\>=) 200 mg/dL
* Positive Hepatitis B, Hepatitis C or human immunodeficiency virus test or use of antiretroviral medications at screening.
* Concurrent or previous use of a glucagon-like peptide 1 receptor agonist
* Current or previous use of systemic corticosteroids within the past 28 days prior to screening
* Use of any medicinal products or herbal preparations licensed for control of body weight or appetite is prohibited.
* Known or suspected history of alcohol or drug abuse within the past 3 years.
* Positive drug screen
Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic - MICROSHOCK - RENAL

An observational study of the state of the renal and systemic circulations in patients with early septic shock. Both macro and microvascular parameters will be assessed using echocardiography, sublingual incident dark field video-microscopy and renal contrast enhanced ultrasound. Patients will be categorised by KDIGO degree of kidney injury at Day 7 and stratified. Haemodynamic and perfusion based variables over time for these groups will be compared to assess the impact of changes in same on the development of AKI. Lab based work to quantify renal injury biomarkers will also be undertaken.


Eligibility Criteria:
Inclusion Criteria:

Age \> 18 years Within 48 hours of ICU admission Evidence of suspected or confirmed infection Serial Organ Failure Assessment (SOFA) score increase of 2 or more (assuming baseline 0 if no previous measures) Requiring vasopressor therapy to maintain a MAP \> 65mmHg Lactate \> 2 mmol/l despite initial fluid resuscitation

Exclusion Criteria:

Known intolerance to Sonovue or any other ultrasound contrast agent Acute Respiratory Distress Syndrome Pregnancy Breast Feeding mothers Patients not expected to survive 24 h in whom the intent of treatment is palliative
Comparison of PT-Cy at a Dose of 25 mg/kg/Day and PT-Cy at a Dose of 50 mg/kg/Day in GVHD Prophylaxis

This is a two arm open label phase III clinical trial. Adult patients with hematological malignancies undergoing allogeneic HSCT from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (SOPs), meet all inclusion criteria, and do not satisfy any exclusion criteria. Patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). Patients will receive PTCy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as GvHD prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have an indication for allogeneic hematopoietic stem cell transplantation

Exclusion Criteria:

* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
Correlations Between Press Ganey Hospital and Ambulatory Scores for a Neurosurgical Practice

This will be a retrospective review of MHS neurosurgeon hospital (i.e., Methodist Dallas Medical Center, Methodist Richardson Medical Center, Methodist Charlton Medical Center, and Methodist Mansfield Medical Center) and ambulatory clinics (Methodist Moody Brain and Spine Institute \[MBSI\]- Dallas, MBSI-Richardson, MBSI-Mansfield, MBSI-Sunnyvale, MBSI-Charlton, MBSI-Grand Prairie, and MBSI-Park Cities) PG HCAHPS survey results received between January 1, 2016 and December 31, 2020.

This will be a retrospective review of MHS neurosurgeon hospital (i.e., Methodist Dallas Medical Center, Methodist Richardson Medical Center, Methodist Charlton Medical Center, and Methodist Mansfield Medical Center) and ambulatory clinics (Methodist Moody Brain and Spine Institute \[MBSI\]- Dallas, MBSI-Richardson, MBSI-Mansfield, MBSI-Sunnyvale, MBSI-Charlton, MBSI-Grand Prairie, and MBSI-Park Cities) PG HCAHPS survey results received between January 1, 2016 and December 31, 2020. Patient electronic medical records will also be reviewed to identify details including: demographics, and chief complaints or indication, and/or procedure details. We anticipate completing this review by September 2021

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Completed a PG HCAHPS hospital and/or ambulatory survey between January 1, 2016 and December 31, 2020 in relation to a MHS neurosurgeon hospital and/or ambulatory visit

Exclusion Criteria:

• Patients not meeting the study inclusion criteria in section 4.1