cyrilzakka/clinical-trials huggingface dataset:
Determine the Effects of Prone Positioning and NO in COVID-19 ARDS by EIT

We aims to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography.

The investigators aim to investigate the effects of prone positioning and nitric oxide inhalation in adult patients who is diagnosed with COVID-19 associated acute respiratory distress syndrome by electrical impedance tomography (EIT).

The EIT assessment is performed in patients ventilated in supine position, supine position with NO inhalation for 1 hour, prone position for 1 hour, prone position for 2 hours with NO inhalation for 1 hour, prone position for 3 hours, prone position for 16 hours, re-supine position for 3 hours. Arterial blood gas (ABG) analysis results, ventilator parameters and hemodynamic parameters are also recorded at each time point.

Eligibility Criteria:
Inclusion Criteria:

* adult patients who have COVID-19-associated acute respiratory distress syndrome

Exclusion Criteria:

* patients who refuse to participate in the study; unable to use EIT, such as open-chest surgery with chest tube placement; have contraindication for prone positioning, including pregnant, post-abdomen surgery within a week; hypercapnic respiratory failure.
Comparison of a Plastic Stent Without Central Lumen With Self Expandable Metal Stents in Patients With Malignant Distal Biliary Obstruction

This is a non-inferiority randomized study to compare a plastic stent without central lumen (VIADUCT) with self-expandable metal stents for treatment of malignant obstruction of the common bile duct. It is a non-interventional study, a CE mark for the VIADUCT stent exists.


Eligibility Criteria:
Inclusion Criteria:

* histologically proven malignant biliary stenosis
* signs of biliary obstruction
* informed consent

Exclusion Criteria:

* age under 18
* Operations like Roux-Y, biliodigestive Anastomosis, BII
* life expectancy less than 3 months
* Karnfosky index less than 60%
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

This study consists of Phase 1a dose escalation, Phase 1b dose expansion in a single indication, and Phase 2a expansion in a single indication.

Primary Objectives

* All Phases: Evaluate the safety and tolerability of MDX2001 in patients with advanced solid tumor malignancies
* Phase 1 only: Identify a recommended Phase 2 dose (RP2D) for further development of MDX2001
* For Phase 1b and Phase 2: Assess the anti-tumor efficacy of MDX2001 in patients with selected advanced solid tumor malignancies

Secondary Objectives:

* Further characterize the anti-tumor activity of MDX2001 based on additional assessments of clinical benefit
* Characterize the pharmacokinetics of MDX2001
* Characterize the immunogenicity of MDX2001
* Characterize relationship of baseline target protein expression in tumor tissue and clinical benefit

The expected duration of study intervention for patients may vary, based on progression date. The median expected duration of study per patient is estimated to be 10 months (up to 1 month for screening, a median of 6 months for treatment, and a median of 3 months for long term follow-up).

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 18 years of age
* Histologically or cytologically confirmed diagnosis of metastatic solid tumors
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Adequate hematologic, hepatic and renal function
* Capable of giving signed informed consent

Exclusion Criteria:

* Any clinically significant cardiac disease
* Unresolved toxicities from previous anticancer therapy
* Prior solid organ or hematologic transplant
* Known untreated, active, or uncontrolled brain metastases
* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectious requiring intravenous treatment.
* Receipt of a live-virus vaccination within 28 days of planned treatment start
* Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.
* Participation in a concurrent clinical study in the treatment period.
* Known hypersensitivity to MDX2001 or any of its ingredients

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Intranasal Steroids and the Nasal Ocular Response

Eye symptoms of tearing, redness and itch frequently occur in patients with allergic rhinitis or hayfever. The purpose of this study is to learn whether placing allergen (the substance that causes allergies) in the nose several days in a row will cause an increase in eye symptoms and whether receiving a nasal steroid spray will prevent these eye symptoms.


Eligibility Criteria:
Inclusion Criteria

1. Males and females between 18 and 45 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin test to grass and/or ragweed antigen.
4. Positive response to screening nasal challenge.

Exclusion Criteria

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015

This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.

The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.

The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent obtained before any trial-related activities
* Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015

Exclusion Criteria:

* Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product
Evaluating VR Therapy Using Cold Pressor Test

This study is testing whether or not low-cost, virtual reality (VR) headsets for mobile phones can be used as a potential distractor from pain and thus would have clinical applications as a low-cost, non-pharmaceutical method to increase pain tolerance in patients undergoing painful or uncomfortable procedures. To do this, the investigators are asking volunteers to submerge their hand up to the wrist in cold water (Cold Pressor Test), either while playing an interactive virtual reality game on the headset, or while wearing a VR headset that is turned off as a control. The investigators will record the participants' tolerance to cold water as measured by how long the participants are able to keep their hand in the cold water.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult Mayo Clinic students and employees

Exclusion Criteria:

* Participants who are known to be sensitive to VR technology and/or have undesirable reactions to VR technology (i.e. dizziness, motion sickness)
* Participants with significant alcohol/smoking histories, sickle cell anemia, history of previous myocardial infarction and/or coronary artery disease, malignant hypertension, metabolic
* dysfunctions, pregnancy, Raynaud's disease, epilepsy, severe mental disorders, chronic pain conditions, or diseases producing neuropathic pain
* Participants that have used drugs/alcohol the day prior to the study
Assessment of Heat Generation From Low Speed Drilling Without Irrigation

ASSESSMENT OF LOW SPEED DRILLING WITHOUT IRRIGATION VERSUS CONVENTIONAL DRILLING WITH IRRIGATION REGARDING HEAT GENERATION AND PERI-IMPLANT MARGINAL BONE LOSS

Assessment of heat generation from conventional drilling speed for dental implant placement versus biological drilling (low speed without irrigation ) by thermocouples technology And measure the primary stability of dental implants placed by the two techniques by osstel device

Eligibility Criteria:
Inclusion Criteria: both sex no intraoral soft and hard tissue pathology no systemic condition that contraindicate implant placement adult patients with proper posterior mandibular ridge requires implant placement

Exclusion Criteria:

presence of pathological lesions heavy smokers more than 20 cigarettes per day patients with systemic disease that may affect normal healing Patients with no enough bone in posterior mandible for implant placement
Optimizing Metabolic Control in Type 1 Diabetes - The Automatic Bolus Calculator Flash Study

This study aims to compare the effect of flash glucose monitoring (FGM) with traditional self-monitoring of blood glucose (SMBG) with or without carbohydrate counting and automated bolus calculation, in patients with type 1 diabetes and poor metabolic control.

The investigators will include in total 200 patients recruited from 5 clinical sites in the Capital Region of Copenhagen.

The patients will be randomized into four groups; A) Standard diabetes training, i.e. group training in in general diabetes health issues, B) Group training in carbohydrate counting and automated bolus calculation, the app MySugr will be taught and downloaded, C) Group training as in group A, and instructed to use FGM, D) Group training as in group B, and besides training in the use of the app MySugr, also instructed to use FGM.

All patients are followed for 26 weeks with 6 clinical visits, group training (1 visit) and 2 telephone consultations.

The primary outcome is time spent in normoglycemia.


Eligibility Criteria:
Inclusion criteria:

* Age \>/= 18 years
* HbA1c \> 53 mmol/mol
* Type 1 diabetes more than 1 year
* Treated with basal and bolus insulin. Basal insulin can be taken once or twice daily. The percentage basal/bolus insulin should as judged by the investigator cover the patient's real need for basal insulin - if he or she is not eating and taking bolus
* Patients may or may not have knowledge on carbohydrate counting
* Patients may or may not have any experience with continuous glucose monitoring or FGM
* Patients have a personal smart phone
* Patients attend the outpatient clinic in one of the five study sites included in the study

Exclusion criteria:

* Use of an automatic bolus calculator on a daily basis within the last three months
* Daily use of continuous glucose monitoring or FGM on a daily basis within the last three months
* Use of insulin pump
* Use of Neutral Protamine Hagedorn insulin as long acting insulin (Insulatard, Humulin Retard) within the last three months
* Pregnant, breastfeeding, plan to get pregnant
* Gastroparesis
* Severe diabetes complications including proliferative retinopathy and myocardial infarction within the last six months
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation as e.g. alcohol and drug abuse
* Current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
* Inability to understand the individual information and to give informed consent
Important Factors in Integration of Vocational Rehabilitation in Mental Health

The purpose of this study is to explore, through a qualitative approach, how a group of people with serious mental illness experienced the integration of a vocational rehabilitation intervention during their admittance in hospital.

People with serious mental illness admitted to hospital face significant barriers to gain both education and employment. Norway is a high-income welfare society with low unemployment rates, but the employment rates are very high in the population with psychosis and schizophrenia. Norway have a strategy for work and mental health, and through this strategy, the government has supported some pilot projects which focus on new ways of supporting people with serious mental illness in gaining employment. This study focuses on a representative sample participating in a pilot study. The sample consists of admitted patients who have received vocational rehabilitation under admittance. The study design is qualitative in nature with open- ended questions to allow the sample to express their opinions, attitudes and thoughts about the assistance they have had during their rehabilitation stay in hospital.

Eligibility Criteria:
Inclusion Criteria:

* Formerly and present admitted patients in the Rehabilitation ward who participated in a project with vocational rehabilitation.

Exclusion Criteria:

* Mental retardation
Effects of Direct Antiviral Agents on Hepatitis C Virus Arthropathy

The prevalence of HCV infection in Egypt is 14.7%. HCV is both a hepatotropic and a lymphotropic virus, it may exert a chronic stimulus on the immune system with both T and B lymphocyte alterations. In addition to cryoglobulinaemic vasculitis, HCV may trigger different immune-mediated extrahepatic disorders. A variable combination of HCV with other unknown enviromental and/or hostgenetic cofactors may lead to different clinical phenotypes that characterise HCV syndrome. Patients who have HCV -related arthropathy are accounted for by 2 clinical subsits: Rheumatoid-like arthritis and Cryoglobulin-related arthritis. Patients with mild arthritis, conservative manegement using analgesics with anti- inflammatory activity is recommended. In patients who have contraindications to their use, short term low dose prednisone is an option. In HCV infection with concomitant RA, ACR guidelines published in 2008 provided recommendations pertaining to these of DMARDs that are based on the severity of liver disease using the child- pugh- turcotte classification. For patients with severe cryoglobulinaemia such as severe debilitating disease or systemic in improvement, a combination of immunosuppressive and antiviral therapy is preferred. It has been found that antiviral therapy with interferon immunosuppressive and antiviral therapy is preferred. It has been found that antiviral therapy with interferon improves the musculoskeletal manifestations in HCV arthropathy. The DIrect antiviral agents seems very promising in treatment of HCV arthropathy. As HCV genotype 4 is the most common genotype in Egypt, the effective optional antiviral agents are sofosbuvir, daclatasvir, ledipasvir, paritaprevir, velpatasvir, ombitasvir and simeprevir.


Eligibility Criteria:
Inclusion Criteria:

* Antiviral patients with arthropathy concomitant HCV (proved by PCR testing).

Exclusion Criteria:

* patients with child-pugh B and child-pugh C decompensated cirrhosis.
* patients more that 60 years.
* patients with chronic infection e.g.(pulmonary T.B).
* patients with organ failure e.g.( heart failure, respiratory failure).
* patients with CKD with GFR lead that 60 ml/ ministry/1.73m2.
* patients on immunosuppressive agents.
* patients with HBV- coinfection.
Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Peripheral T-cell lymphoma (PTCL）is a distinct and heterogeneous histopathologic subtype of non-Hodgkin lymphoma (NHL), accounting for \~10%. Patients with PTCL still have poor treatment response and prognosis under conventional CHOP regimen. There is no standard of care for those patients. Targeted drugs are warranted in this group of patients to improve survival. This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed peripheral T-cell lymphoma based on 2016 WHO classification with enough tumor sample for NGS
* Treatment naive
* Age ≥ 18 years
* Must has measurable lesion in CT or PET-CT prior to treatment
* ECOG 0,1,2
* Informed consented

Exclusion Criteria:

* ALCL,ALK positive, NK/T-cell leukemia, adult T-cell lymphoma/leukemia, T-LGL
* Has accepted localized or systemic anti-lymphoma treatment
* Has accepted autologous Stem cell transplantation before
* History of malignancy except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix prior to study treatment
* Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
* Primary CNS lymphoma
* Left EF≤ 50%
* Lab at enrollment (Unless caused by lymphoma): Neutrophile\<1.5\*10\^9/ L ;Platelet\<50\*10\^9/L; ALT or AST \>2\*ULN; Creatinine\>1.5\*ULN
* Other uncontrollable medical condition that may that may interfere the participation of the study
* Not able to comply to the protocol for mental or other unknown reasons
* Patients with mentally disorders or other reasons unable to fully comply with the study protocol
* Pregnant or lactation
* HIV infection
* HBV-DNA or HCV-RNA positive
Barbed Suture for Emergency Midline Laparotomy Closure

Urgency surgeries are often performed in a stressful setting with critical patient involved. In this context, laparotomy closure can sometimes be the most neglected part of the procedure. Barbed sutures, frequently used in laparoscopic procedures, have proven to be effective in maintaining traction.

The aim of this study is to describe the incisional hernia rate after emergency midline laparotomy, according to the suture utilized, evaluated at one month and one year postoperative.

A retrospective cohort study was performed including patients with urgency midline laparotomy during 2018-2019. Group A was represented by patients with slowly absorbable monofilament continuous suture, while Group B included patients with barbed suture closure.

Main variables were hernia rates one month and one year after surgery, diagnosed by physical exploration and/or imaging. Demographic characteristics, risk factors, among other descriptive determinations were registered.

A total of 128 patients were performed an emergency midline laparotomies, and 110 meet all inclusion criteria. There was equality between sex and median age was 65 years old. Significative differences were observed regarding incisional hernia at 30 days, being less frequent when barbed suture was utilized. These differences were not present at the long-term reevaluation (one year).

In conclusion, midline laparotomy closure must be performed within quality standards. The lack of studies regarding emergency laparotomy closure, the European Hernia Society stated that no recommendations can be given on this patients. Barbed suture appears as a promising option for closure in these specific circumstances, but needs further study.

Eligibility Criteria:
Inclusion Criteria:

* Emergency laparotomy
* Minimum age of 18 years old.
* Digestive surgical disease.
* Minimum survival of one month postoperatively.

Exclusion Criteria:

* Laparoscopic surgical procedure.
* Non-digestive surgical procedure (gynecology, urology...).
Phase 2 Study of EDG-5506 in Children and Adolescents with Duchenne Muscular Dystrophy Previously Treated with Gene Therapy (FOX)

The FOX study is a 2-part, multicenter, Phase 2 study of safety, pharmacokinetics, and biomarkers in children and adolescents with Duchenne muscular dystrophy previously treated with gene therapy including a randomized, double-blind, placebo-controlled Part A, followed by an open-label part B.

The EDG-5506-215 protocol was amended to include an additional dose cohort and enroll additional participants across select cohorts.

FOX is a 2-part, multi-center, Phase 2 study to evaluate the effect of sevasemten (EDG-5506) on safety, pharmacokinetics and biomarkers of muscle damage in approximately 48 children and adolescents with Duchenne muscular dystrophy treated with oral, once-daily sevasemten. This study will have up to a 4-week Screening period, a 12-week randomized double-blind, placebo-controlled treatment period (Part A), followed by a 40-week open-label extension period (Part B) .

Approximately forty-eight (48) participants aged 6 to 17, inclusive, will be randomized to sevasemten or placebo in a 2:1 ratio. Three dose cohorts (Cohort 1, Cohort 2 and Cohort 3) of approximately 12 participants each will be enrolled. Approximately 12 additional participants may be added to 1 of these cohorts following Data Monitoring Committee (DMC) review of emerging data.

Eligibility Criteria:
Key Inclusion Criteria:

* Aged 6 to 17 with a documented mutation on the DMD gene and phenotype consistent with DMD.
* Prior receipt of an AAV-based gene therapy (≥ 2 years after study drug administration in an open-label study or ≥ 3 years after randomization in a randomized study).
* Able to complete stand from supine in ≤ 8 seconds at the Screening visit and able to perform the 4-stair climb in \< 10 seconds at the Screening visit.
* Body weight ≥ 15 kg at the Screening visit.
* Treatment with a stable dose of corticosteroids for a minimum of 6 months prior to the Baseline visit.

Key Exclusion Criteria:

* Medical history or clinically significant physical exam/laboratory result that, in the opinion of the investigator, would render the participant unsuitable for the study. This includes venous access that would be too difficult to facilitate repeated blood sampling.
* Screening visit cardiac echocardiography showing left ventricular ejection fraction (LVEF) \< 40%.
* Receipt of an investigational drug (other than the AAV-based gene therapy per Inclusion criteria) within 30 days or 5 half-lives (whichever is longer) of the Screening visit in the present study.
* Receipt of an exon-skipping therapy within 6 months prior to the Screening visit.