cyrilzakka/clinical-trials huggingface dataset:
Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)

Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).

Procedural ischemic myocardial injury remains the most frequent complication after coronary angioplasty. Recently it was reported that pretreatment with atorvastatin reduce the myocardial damage compared to placebo. Thus, we will evaluate the difference of pretreatment of pitavastatin compared to standard therapy on the reduction of myocardial damage in patient who is scheduled elective PCI for stable angina pectoris.

Eligibility Criteria:
Inclusion Criteria:

* Patients with LDL ≥ 100mg/dL
* Patients who are scheduled an elective PCI for stable angina

Exclusion Criteria:

* Acute myocardial infarction (\<3 months)
* Unstable angina
* Previous treatment with statins (\<6 months)
* Increase in CK-MB above upper normal limit
* Increase in liver enzymes (AST/ALT) above 2 times of upper normal limit
* Increase in serum creatinine above 2 times of upper normal limit
* Left ventricular ejection fraction \<30%
* Previous treatment with glycoprotein Ⅱb/Ⅲa receptor inhibitor (\<4 weeks)
Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-dose (SD), QIV high-dose (HD) \[adults ≥ 65 years of age only\], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.

Study duration is approximately 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years on the day of inclusion (US) and aged 21 years on the day of inclusion (Puerto Rico)
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:

  * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
  * Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Previous history of myocarditis, pericarditis, and / or myopericarditis
* Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
* Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
* Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management

The investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management.

After obtaining written informed consent of 10 trainee anesthetists with non less than 24 months and not exceeding 60 months residency, use of the King Vision aBlade videolaryngoscope was demonstrated by presenting a 2 min instruction video. First endotracheal intubation by each trainee anesthetist was randomly allocated to either direct (DL) or King Vision aBlade videolaryngoscopy (KingVL). Then order of laryngoscopy type was alternating at least each trainee anesthetists performed 10 DL and 10 KingVL endotracheal intubations.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 to 2
* written informed consent from both legal guardians
* children who were scheduled for nonemergency surgery with requirement of endotracheal intubation

Exclusion Criteria:

* known or predicted difficult airway
* increased risk for pulmonary aspiration
Function Preserving Gastrectomy for T1/2 Gastric Cancer Patients

The real world based multi-cohorts study aims to evaluate the safety and effectiveness of function preserving gastrectomy including pylorus-preserving distal gastrectomy, proximal gastrectomy and wedge gastrectomy for T1 and T2 gastric cancer patients.

Gastric cancer patients with clinical stage T1/2 will be screened for the study. For the patients enrolled, a multidisciplinary discussion will be performed to evaluate the proper gastrectomy for the patients and functional preserving gastrectomy will be considered for the indicated patients. For patients not proper for functional preserving gastrectomy, standard gastrectomies will be suggested. After surgery, a close follow up will be performed. During the study, a thorough data collection will be performed to evaluate the safety and effectiveness of functional preserving gastrectomy and recovery and postoperative function of remnant stomach.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky performance over 70%
* Histologically proven gastric or gastroesophageal joint adenocarcinoma with clinical stage T1-2N0-3M0
* No severe comorbidity with estimated survival less than 5 years

Exclusion Criteria:

* pregnancy
* Signs of distant metastases
* received chemotherapy, radiotherapy, immune therapy
* received gastrectomy
* other malignant tumors within 5 years except for cured skin cancer and cervical caner in situ.
* uncontrolled epilepsy, central nervus system disease or mental disease that affect the compliance of treatment and follow-up
* severe heart disease
* organ transplantation that needs immunosuppressor
* emergency surgery due to hemorrhage, perforation and ileus of gastric cancer
Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).

An interventional, double-blind, randomized, placebo-control design will be used to test safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in 70 subjects ≥ 18 and \< 65 years of age with documented cystic fibrosis. There will up a screening period of up to 28 days, 84 days treatment period, and 28 days follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of a CF diagnosis as evidenced by 1 or more clinical features consistent with the CF phenotype and 1 or more of the following criteria:

  1. Sweat chloride equal to or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test;
  2. Two well-characterized mutations in the CFTR gene
* FEV1 ≥ 40% predicted corrected
* Stable treatment of CF for 14 days before Visit 1

Exclusion Criteria:

* Severe or unstable CF, such as:

  1. Intravenous antibiotic treatment within 14 days before Visit 1
  2. Treatment with any corticosteroids \> 10 mg per day or \> 20 mg every other day oral prednisone or equivalent within 14 days before Visit 1
* Any one of the following values for laboratory tests at Screening:

  1. A positive pregnancy test (or at Visit 1);
  2. Hemoglobin \< 10 g/dL
  3. Neutrophils \< 1.0 x 10\~9/L
  4. Platelets \< 75 x 10\~9/L
  5. Creatinine clearance \< 50 ml/min according to modified Cockcroft-Gault equation
  6. Serum transaminases \> 2.5 x upper normal limit
  7. Total bilirubin ≥ 1.5 x upper limit of normal
* Any other condition that, in the opinion of the Principal Investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
EARLY-MYO-CMR Registry

The purpose of this registry is to depict the myocardial tissue characteristics in STEMI patients by CMR and other cardiac imaging modalities and to assess the prognostic value of imaging-derived indices. Information will be collected prospectively in about 1000 STEMI patients in 10 sites. Subjects will be followed for up to 5 years.

This is a prospective, multi-center, non-randomized, observational registry study of STEMI patients that undergo CMR examination. Information of other cardiac imagings and clinical outcomes are also prospectively collected in the database. This project will establish a prospective registry of 1000 STEMI patients in 10 sites with follow-ups of up to 5 years.

The aim of the project will be as following:

1. To investigate myocardial tissue features and functional changes in STEMI patients.
2. To identify CMR-derived indices that are associated with adverse clinical outcomes.
3. To compare CMR with other alternative cardiac imaging modalities (i.e., echocardiography or SPECT) on prognostic prediction in STEMI patients.
4. To compare myocardial tissue characteristics and functional changes in STEMI and NSTEMI patients (data derived from EARLY-MYO-CMR II Registry).

Eligibility Criteria:
Inclusion Criteria:

STEMI patients who have had CMR imaging performed and have provided written consent.

1. Patents older than 18 years old with myocardial infarction diagnosed by:

   1. typical ischemic symptom,
   2. New ischaemic ECG changes;: ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads ;
   3. elevated cardiac troponin value with at least one value above 99th percentile upper reference limit(UPL);
   4. confirmed by coronary angiography (CAG) or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischaemic aetiology.
2. Patients who have had CMR imaging performed and have agreed to comply with the follow up requirements.

Exclusion Criteria:

1. Patient who is unable to comply with the follow-up schedule.
2. Patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study.
3. Patient has a life expectancy of less than 6 months due to any condition.
Dynamic Whole-body PET/CT Imaging in Clinical Oncology

The goal of this clinical trial is to to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times in patient with oncologic pathology .

The main question\[s\] it aims to answer are:

* \[question 1\]
* \[question 2\] Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\].

Whole body hybrid PET/CT imaging, making use of the standardized uptake value (SUV), is well established in clinical setting for diagnosis and staging, treatment response monitoring and radiation therapy treatment planning of a wide range of oncologic malignancies. However, the SUV metric derived from static PET data does not capture the dynamics of the PET probe biodistribution in the body.

The present work proposes to fill in this notable gap: namely to merge whole-body and dynamic PET/CT imaging, to achieve robust quantitative whole- body parametric imaging in clinically feasible scan times. Our proposed approach has the potential to significantly enhance diagnostic, prognostic and treatment response monitoring capabilities of PET/CT and to fundamentally alter routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Patients clinically indicated for whole-body PET evaluation.
2. Patient must agree to lie still in the camera.
3. Patient must be able to comply with study procedures.
4. Patient must be able to provide informed consent.

Exclusion Criteria:

1. Patients \< 18 years of age.
2. Pregnant women are excluded.
RAC Pilot - The Feasibility and Effectiveness of a Brief Preventive Intervention Following Psychological Trauma

The investigators proposed to compare a modified Prolonged Exposure intervention to treatment as usual within a hospitalized injured trauma survivor sample, to determine with this intervention could prevent the development of PTSD.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive motor vehicle crash (MVC), industrial accident, and physical assault trauma survivors (i.e. victims of gunshot wounds, stab wounds), ages 18-75, to include both men and women, without evidence of serious cognitive impairment, admitted to the trauma surgery service at Froedtert Hospital beginning at the start of the funding period will be considered for recruitment.

Exclusion Criteria:

* Individuals who:

  1. have evidence of moderate to severe cognitive impairment secondary to trauma-related head injury,
  2. have self-inflicted injury,
  3. are more than 2 weeks post-trauma,
  4. do not meet the DSM-5 definition of a traumatic stressor for PTSD,
  5. screen positive for a current substance abuse problem ((i.e. intoxication and memory loss upon arrival or a current substance use diagnosis),
  6. are non-English speaking,
  7. are not medically stable,
  8. cannot identify a support person to attend a session with them
  9. do not score a 2 or more on the 5-item PTSD subscale of the 9-item screen.
Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals

RP3128 is a calcium release activated calcium (CRAC) channel modulator. The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending dose(s) of RP3128 in healthy volunteers and to evaluate the effect on late phase asthmatic response to allergen challenge in patients with mild asthma.

The study consists of three parts; Part 1: single ascending dose (SAD), Part 2: multiple ascending dose (MAD) in healthy volunteers and Part 3: proof of concept (POC) study in mild asthmatics. There will be 5 cohorts in SAD and 3 cohorts in MAD, the doses used in the MAD will be based on emerging safety, tolerability and pharmacokinetics (PK) from Part 1 (SAD). POC is a randomized, placebo- controlled, double blind, two period cross-over, proof of concept study in male and female of non child bearing potential with history of mild asthma. the highest identified dose of RP3128 in Part 2 (MAD) will be considered for POC

Eligibility Criteria:
Inclusion Criteria:

* Male and non-childbearing female subjects (SAD/MAD) and male and non-childbearing female patients with mild asthma;
* Healthy subjects as determined by past medical history, vitals, physical examination and 12-lead ECG, clinical laboratory tests.
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥50 kg;
* Non-smokers or ex-smokers
* Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the subject; able to comply with protocol requirements and or study procedure;
* Negative screen for drugs of abuse and alcohol at screening and on admission.
* Male subjects should agree not to donate sperm for 3 months post dose; and
* Female partners (of child bearing potential) of male subjects should use 2 methods of highly effective contraception for 3 months post last

Additionally for POC

* Pre- bronchodilator Forced expiratory volume in 1 sec( FEV1) of \> 70% (adjusted for age, sex and race)
* Steroid naïve subjects with history of mild asthma that satisfy the Global Initiative for Asthma (GINA) definition of asthma, but otherwise healthy.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant medical history.
* History of tuberculosis (TB) and/or a positive Tuberculin Skin Test and/or QuantiFeron- TB®-Gold test.
* Use of any immunotherapy within 3 months prior to screening.
* History of serious adverse reaction, severe hypersensitivity or allergy to any drug/drug substance (except house dust mite, pollen allergens or cat dander allergy in asthmatics) or in any other circumstance (e.g. anaphylaxis);
* Abnormal liver function
* Positive screen on hepatitis-B surface antigen (HBsAg), antibodies to the hepatitis C (HCV) or antibodies to the human immunodeficiency virus (HIV) 1,2;
PEP Flute-selfcare in COVID-19

Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease.

The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up.

The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.

It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group.

Finally, potential subgroup effects by gender, age, comorbidity and BMI at study entry will be explored for all outcomes.

Based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. Based on the present testing strategy and COVID-19 incidence, current expectations are that two months should be enough to recruit 400 patients. The investigators will allow for recruitment to the end of December 2020, but will terminate enrolment at n = 400.

Link to detailed protocol paper will be added once published.

Eligibility Criteria:
Inclusion Criteria:

* Positive SARS-CoV-2
* Symptoms of SARS-CoV-2 infection e.g. fever, cough and shortness of breath.
* Access to use a smartphone
* Can reply to a questionnaire (sent on email, text messages or via telephone interview) in Danish
* Given informed consent

Exclusion Criteria:

* Age \< 18 years.
* Any condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as psychiatric disorders.
* Hospitalised patients or citizens living in nursing homes
Multi-center Prospective Study on E-NOTES for Myomectomy With Traction of Multidirectional Sutures

Primary objectives : To investigate technical feasibility and postoperative morbidity after E-NOTES for Myomectomy with Traction of Multidirectional Sutures

Secondary objectives : To investigate postoperative pain after E-NOTES for Myomectomy with Traction of Multidirectional Sutures by clinical variables such as incision size, type of port, size and number of myoma, or operation time.

* Leiomyoma is a common benign tumor of the smooth muscle cells of the myometrium.1 It can cause several symptoms such as abnormal vaginal bleeding, pain, or urinary symptoms according to size and location. Steadily, lesser invasive surgeries have been preferred for such benign disease (laparotomy, laparoscopy, and then single-port surgery).2,3
* However, these minimal approaches, laparoscopic morcellation of preoperatively suspicious leimyoma, have the potential risk of peritoneal seeding of postoperative diagnosed leiomyosarcoma in the pathological examination.4 Currently, safe morcellation is also required during myomectomy while using a lesser invasive surgical approach such as single-port surgery or natural orifice transumbilical endoscopic surgery (NOTES).
* During single-port surgery or embryonic NOTES (E-NOTES) via an umbilicus, handling of myoma into different directions could be quite a big challenge. Fortunately, myoma is enough hard to pull with string and has a tendency not to rupture during manipulation of these strings.
* These concepts lead to traction of anchoring sutures during E-NOTES for myomectomy applied in the current case. Safe morcellation could be guaranteed, because direction morcellation via an umbilicus is possible in an endobag.
* This useful and safe surgical approach needs to be confirmed in multi-centers in terms of feasibility and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Women who are surgically candidate for myomectomy
* Age \> 20 years

Exclusion Criteria:

* Contraindications for laparoscopic surgery and/or general anesthesia.
* Greater than five fibroids sized of 3cm or more
* Uterus extending beyond the umbilicus
* Major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
* Patients undergoing concomitant complex surgical procedures at the time of myomectomy (such as resection of severe endometriosis etc.)
* Pregnancy
* Patients with any suggestion of malignancy in the pelvis
* Patients with cooperation of another main surgical procedures such as severe adhesiolysis or low anterior resection
* Patients who are severely anemic or who have significant medical conditions such as cardiac or pulmonary disease
* Patients who refuse to participate or give consent to the procedures
HYZAAR vs. Ramipril for Diabetes (0954A-245)(COMPLETED)

A study to test the safety and efficacy of HYZAAR as compared to Ramipril in patients with type 2 diabetes mellitus (high blood sugar) and hypertension (high blood pressure).


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years old, has been diagnosed with type 2 diabetes mellitus

Exclusion Criteria:

* Patient has renal disease, malignant hypertension, uncontrolled type 2 diabetes mellitus, history of stroke, TIA (Transient Ischemic Attacks) , or heart disease
Alternations of Intestinal Microbiota and Health Impact in CKD

This study is aimed to evaluate the impact of dietary pattern, gut microbiota and their interactions on clinical outcomes among patient with CKD stage 3-5.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CKD stage 3-5 defined as eGFR \<60 ml/min/1.73 m2 calculated with the use of the four-variable Modification of Diet in Renal Disease formula who have not yet on dialysis therapy.

Exclusion Criteria:

* Patients with active cancer
* Patients with liver cirrhosis
* Patients have taken antibiotics within three months before screening for inclusion.
* Patients with a cardiac pacemaker or metallic implants,
* Patients are amputees
* Pregnant women
* Patients with inherited renal diseases