cyrilzakka/clinical-trials huggingface dataset:
Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma

Severe hypoxemia following trauma may happen in many circumstances (aspiration, ventilation-associated pneumonia, lung contusion...), most of which are not exclusively associated with a direct injury to the lungs. Severe trauma and associated musculoskeletal injuries result in the acute release of Damage-Associated Molecular Patterns (DAMPs) in plasma, many of which are made of nucleic acids. DAMPs then bind leukocytes and trigger NETosis (Neutrophil Extracellular Traps), the release of nuclear material coated with proteolytic enzymes, which ultimately promotes remote lung injury and acute respiratory distress syndrome (ARDS).

Considering that many DAMPs and all NETs are made of nucleic acids, we hypothesize that dornase alfa, a commercially available recombinant desoxyribonuclease (DNAse) could reduce DAMPs and NETs-induced lung injury in severe trauma patients under mechanical ventilation in the intensive care unit (ICU).

The primary objective is to demonstrate a reduction in the incidence of moderate to severe ARDS in severe trauma patients during the first seven ICU days from 45% to 30% by providing aerosolized dornase alfa once during the first two consecutive ICU days and compared to equivalent provision of placebo (NaCl 0,9%).

The secondary objectives are to demonstrate, by using aerosolized dornase alfa compared to placebo:

* an improvement in static lung compliance
* a reduction in mechanical ventilation duration / an increase in ventilation-free ICU days
* a reduction in the length of ICU stay
* a reduction in the hospital length of stay
* a reduction in multi-organ failure
* a reduction in ventilator-associated pneumonia (VAP)
* a reduction in mortality at day 28


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18) patient of either sex affiliated to the National Health Service

  * Severe trauma patient (either blunt or penetrating), Injury Severity Score \> 15
  * Under mechanical ventilation for an expected duration \> 48h
  * Admitted in the ICU
  * Signed informed consent from the patient's relative
  * Patient equipped with an indwelling arterial catheter

Exclusion Criteria:

* Pregnancy or breast feeding

  * Opposition from the patient or his/her relatives
  * Protected major (Guardianship)
  * Contraindication to the use of dornase alfa
  * Known intolerance to dornase alfa
The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD

To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

* This is a 12-week, multicentre,randomized,open-label,active-controlled, paralleled-group study.
* Chinese patients aged ≥40 years with moderate-to-severe COPD are eligible for this study.

  1. If satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized Salbutamol.
  2. Patients record daily severity ratings for daytime symptoms of shortness of breath, tiredness, activity limitation, frustration with symptoms, and night-time sleep symptoms on daily cards.
  3. Each symptom is rated using 0-100 visual analog scal (VAS). For overall assessment of daytime symptoms, a combined symptom score is obtained by adding VAS scores for shortness of breath, tiredness, activity limitation, frustration with symptoms.
  4. Patients are required to be symptomatic as demonstrated by a combined daytime symptom score of 120 on at least 4 of the 7 days prior to randomization.

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  1. Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks.

     1. Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID.
     2. Salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks.
  2. A Follow-up visit will be conducted 2 weeks after completion of treatment/early withdrawal to assess for any adverse effects after discontinuing study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Chinese male or female outpatients aged 40 to 79 years, inclusive
* Patients with an established diagnosis of COPD, defined as GOLD guideline postbronchodilation FEV1/FVC ratio of \<70%, AND Postbronchodilation FEV1% predicted ranged from ≥25 to ≤70.
* A cigarette smoking history of 10 pack-years
* Use of oral theophylline, or any other inhaled medications other than LABA, LAMA, or ICS for≥30 days (e.g. SABA, SAMA)
* Patients who are able to use Accuhaler device and relief medication
* Patients willing to give informed consent to participate in the study and comply to study protocol
* Eligible female on child-bearing potentia

Exclusion Criteria:

* Patients with concurrent respiratory disorders (e.g. asthma) other than COPD
* Patients with a requirement for regular or long term oxygen therapy (\>12h/d)
* Patients who used inhaled or oral steroids within 30 days of screening
* Patients who had a respiratory tract infection requiring antibiotics within 14 days of screening
* Patients with a moderate-to-severe COPD exacerbation within 30 days of screening
* Patients with any significant medical condition or disease that would place patients at risk or interfere with the study evaluation.
* Patients who used some inhibitory agents (e.g. b blockers) within 14 days of screening
* Female patients who is pregnant or may be pregnant in the study duration
MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. A simultaneous integrated boost (SIB) will be delivered to the intraprostatic dominant lesion (if present) in this study. Besides a potential biological impact of this innovative prostate SBRT treatment, the reduced OTT offers also benefits in terms of patient convenience. The primary endpoint is clinician reported grade 2 or more acute gastrointestinal (GI) and genitourinary (GU) toxicity, assessed using CTCAE v 5.0 and RTOG, measured up to 3 months after the first treatment fraction.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y
* Histologically confirmed prostate adenocarcinoma
* Low risk: cT1c-T2a, Gleason score 6, PSA \< 10ng/mL
* Favorable intermediate risk: 1 intermediate risk factor, Gleason 3+4 or less, \< 50% positive biopsy cores)
* Unfavorable intermediate risk: \> 1 intermediate risk factor, Gleason 4+3, \> 50% positive biopsy cores)
* Limited high risk: cT3a with PSA \< 40ng/mL or cT2a-c with a Gleason score \> 7 and/or a PSA \> 20ng/mL but \< 40ng/mL
* World Health Organization performance score 0-2
* Written informed consent

Intermediate risk factors: T2b-T2c, Gleason 7, PSA 10-20 ng/mL

Exclusion Criteria:

* Transurethral resection (TUR) \< 3months before SBRT
* International Prostate Symptom Score (IPSS) \> 19
* Prostate volume \> 100cc on transrectal ultrasound (TRUS)
* Stage cT3b-T4
* N1 disease (clinically or pathologically)
* M1 disease (clinically or pathologically)
* PSA \> 40ng/mL
* inflammatory bowel disease
* immunosuppressive medications
* prior pelvic RT
* contra-indications for MRI
Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)

Until now there is no medical treatment and/or intervention that can slow, stop or reverse the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to demonstrate "Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in humans".

Specific Aims:

1. Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB function by dynamic contrast-enhanced MRI (DCE-MRI).
2. Evaluate effect of EVOO on cognitive function and on selected biomarkers


Eligibility Criteria:
Inclusion Criteria:

Men and women, experiencing mild cognitive impairment with:

1. Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level
2. memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI
3. Clinical Dementia Rating (CDR) score 0.5.

Exclusion Criteria:

1. Subjects with contradictions for MRI include: the presence of metal or electronic devices such as metallic joint prostheses, artificial heart valves, an implantable heart defibrillator, a pacemaker, metal clips, cochlear implants, a bullet, shrapnel or any other type of metal fragment; breathing problems or disorders, claustrophobia, inner ear disorders, vertigo or dizziness, tattoos or permanent makeup that contains metal, and body piercing jewelry that cannot be removed.
2. Subjects will be excluded if they are smokers
3. Subjects who have have clinically important medical or neuropsychiatric comorbidity.
4. Subjects who have renal problems or are allergic to the MRI contrast agent.
A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors

An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Participant with histologically confirmed advanced solid tumor.
* Participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
* Participant must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Participant has archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue available for analysis.
* Participant has adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

* Participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABBV-399.
* Participant has known uncontrolled metastases to the central nervous system. Participants with brain metastases are eligible after definitive therapy provided they are asymptomatic off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of ABBV-399.
* Participant has unresolved clinically significant adverse events \>= Grade 2 from prior anticancer therapy except for alopecia or anemia.
* Participant has had major surgery within 21 days prior to the first dose of ABBV-399.
Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer

A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.

Phase 1b is AMG 820 dose determining and aimed at assessing the safety and tolerability of the selected starting dose of AMG 820 in combination with pembrolizumab. Phase 2 of the study will further evaluate safety and tolerability and additionally test whether AMG 820 can enhance the anti-tumor activity observed historically with pembrolizumab alone and/or overcome lack of response to pembrolizumab monotherapy in subjects with select solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment.
* Measurable disease per RECIST 1.1 guidelines.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* Adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests.
* Availability of recent tumor tissue within 3 months prior to enrollment, when feasible.

Exclusion Criteria:

* Has known active central nervous system metastases and/or carcinomatous meningitis.
* History of other malignancy with the past 2 years with some exceptions
* Evidence of active non-infectious pneumonitis/interstitial lung disease
* Evidence of other active autoimmune disease that has required prolonged systemic treatment in past 2 years.
* Evidence of clinically significant immunosuppression such as organ or stem cell transplantation, any severe congenital or acquired cellular and/or humoral immune deficiency, concurrent opportunistic infection.
* Receiving systemic immunostimulatory agents within 6 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment (except ant PD-1/PD-L1 treatment if recruited into Group 4a or 4b).
* Evidence of active infection within 2 weeks prior to first dose of study treatment.
* Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment
* Currently participating or has participated in a study (treatment period only) of an investigational agent or used an investigational device within 28 days of enrollment
* Received live vaccine within 28 days prior to enrollment
* Adverse event due to cancer therapy administered more than 28 days prior to enrollment that has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or better.
* Positive for human immunodeficiency virus (HIV), Hepatitis B or C
* Women planning to become pregnant or who are lactating/breastfeeding while on study through 4 months after receiving the last dose of study drug.
The Effectiveness of the Wim Hof Method

The Wim Hof Method is a multi-disciplinary approach to physical and mental well-being combining cold exposure, breathing exercises, and meditation. This study evaluated the effects of a 15-day WHM intervention on cardiovascular parameters at rest and during a cold pressor test, as well as on various psychological parameters.

The Wim Hof Method (WHM) is a multi-disciplinary approach to physical and mental well-being combining cold exposure, breathing exercises, and meditation. This study evaluated the effects of a 15-day WHM intervention on cardiovascular parameters at rest and during a cold pressor test (CPT), as well as on various psychological parameters.

42 participants were randomized into an intervention (IG) and a control (CG) group. Throughout the 15-day intervention, the IG performed the WHM daily. The intervention followed the guidelines provided by Wim Hof. The intervention comprised three components: cold water exposure, breathing exercise, and meditation. The participants were instructed to perform the WHM daily over the course of 15 days. The participants could choose when to do so throughout the day, however, the components were to be performed in a strict, sequential order: breathing exercises, followed by meditation, and then cold exposure. Participants were asked to complete a daily log in which they documented whether they performed the procedure and for how long. Altogether, the procedure lasted about 15 minutes. The CG did not receive an intervention throughout the intervention period.

Before and after the intervention, systolic (SBP) and diastolic blood pressure (DBP), pulse wave velocity (PWV), heart rate (HR), root mean sum of squared distance (RMSSD), and standard deviation of intervals between successive heartbeats (SDNN) were assessed at rest and during a CPT. Furthermore, perceived stress (PSS), positive affect (PANAS+), negative affect (PANAS-), and subjective vitality (trait (SVSt) and state (SVSs)) was determined.

Eligibility Criteria:
Inclusion Criteria:

* Being male
* No underlying health conditions
* Not using antihypertensive or other cardiovascular medications
* Not engaging in regular exercise training
* Written informed consent

Exclusion Criteria:

* Having prior experience with any of the components of the intervention (breathing, meditation, or cold exposure)
Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above (6 Months After Two Doses)

To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV.


Eligibility Criteria:
Inclusion Criteria:

1. Axillary temperature ≤37.0 ℃.
2. aged 18 years and above, after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.
3. Proven legal identity, could come each visit.
4. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.

Exclusion Criteria:

1. Persons with a clear history of SARS-CoV-2 infection.
2. Using blood products after basic immunization or receiving immunosuppressive therapy.
3. Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
4. Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
5. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
6. Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
7. Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
8. Immunization with any vaccine within 14 days.
9. Any other situations judged by investigators as not suitable for participating in this study.
Evaluation of the Effect on Glucose Control of AC2993 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two AC2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (metformin) throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 diabetes mellitus
* Treated with metformin within a defined dose range for at least 3 months prior to screening
* BMI= 27-45 kg/m2
* HbA1c value between 7.5% and 11%

Exclusion Criteria:

* Treated with oral anti-diabetic medications other than metformin within 3 months of screening
* Patients treated previously with AC2993
* Patients presently treated with insulin
A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™

This was a 24-month, open-label extension study that followed an 8-week double-blind study (Study LOV111859/OM5) and an 8-week, open-label extension study (LOV111860/OM5X). Study LOV111859/OM5 was conducted to evaluate whether combination therapy with Lovaza (omega-3-acid ethyl esters) and Antara (fenofibrate) would result in a greater reduction in serum triglyceride levels in hypertriglyceridemic subjects than treatment with fenofibrate alone. This second extension of 24 months was to assess the continued efficacy of adjunctive Lovaza (omega-3-acid ethyl esters) \[formerly known as Omacor\] therapy in hypertriglyceridemic subjects treated with Antara (fenofibrate) in lowering serum triglyceride (TG) levels.

Three studies comprise this program. Study LOV111859/OM5 (double-blind study) was followed by two open label extensions - LOV111860/OM5X (1st open label extension - 8 weeks) and LOV111821/OM5XX (2nd open label extension - 24 months).

Studies LOV111859/OM5 and LOV111860/OM5X are outlined in NCT00246636.

Eligibility Criteria:
Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation.

Eligibility for entry into this study was based on the inclusion/exclusion criteria described of the double-blind LOV111859/OM5 protocol.

Subjects were men and women who had successfully completed the previous open-label extension study (LOV111860/OM5X) and had met all inclusion and exclusion criteria for the original double-blind study (LOV111859/OM5) and throughout LOV111860/OM5X, or who had a renewed waiver of a previously approved protocol deviation. The main eligibility criteria for LOV111859/OM5 were,

* 18 to79 years of age (inclusive) at screening
* fasting serum TG levels ≥500 mg/dL and \<1300 mg/dL
* BMI ≥ 25 kg/m2 and ≤43 kg/m2.

Subjects enrolled directly from the end of LOV111860/OM5X into LOV111821/OM5XX.
Behavioral Interventions for Chronic Pain and Opioid-Related Problems

The purpose of this study is to examine the effects of Mindfulness-Oriented Recovery Enhancement versus a social support group (supportive counseling) intervention for chronic pain patients receiving long-term opioid pharmacotherapy for pain.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60+
* Current chronic pain condition
* Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for \>90 days

Exclusion Criteria:

* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention
* Active suicidality, schizophrenia, psychotic disorder, and/or severe substance dependence (other than opioid dependence)
* Opioid misuse as determined by Current Opioid Misuse Measure