cyrilzakka/clinical-trials huggingface dataset:
Early Use of Rosuvastatin in Acute Coronary Syndromes: Targeting Platelet-Leukocyte Interactions

The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be between 18 and 80 years old.
2. Subjects must be willing and able to give informed consent
3. A woman of child-bearing potential who is currently sexually active must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for up to 30 days after enrollment.
4. Subjects must have symptoms of acute coronary syndrome as defined by 2 of the 3: (a) history of cardiac-ischemia-related symptoms of at least 10 minutes duration ≤ 8 hours prior to randomized treatment assignment (b) concurrent biomarker evidence of cardiac ischemia, as defined by troponin I or T greater that upper limit of normal (ULN) or creatine kinase-myocardial band (CK-MB) greater than ULN. (c) concurrent electrocardiographic evidence of cardiac ischemia, as defined by new of presumably new ST-segment depression (≥1 mm) or transient (\<30 min) ST-segment elevation (≥ 1mm) in at least two contiguous leads.
5. Subjects must be statin naive or currently only on low dose statin (Simvastatin 20mg, Pravastatin 40mg, or Atorvastatin 10mg)

Exclusion Criteria:

* Age \<18 years
* Age \> 80 years
* Use of Crestor in the past 30 days
* GFR (estimated) \<30 ml/min
* Hemodialysis
* History of liver failure
* Unexplained liver function abnormalities
* Current or planned use of cyclosporine or gemfibrozil
* Sepsis
* Hypotension
* Dehydration
* Trauma
* Severe metabolic, endocrine or electrolyte abnormality
* Recent (within the last 2 weeks) or planned (in the next month) major surgery
* HIV/AIDS with current of planned use of HIV protease inhibitors
Combined Access Closed Tympanomastoidectomy: Microsurgery Allied to Endoscopy

Chronic otitis media is a prevalent medical condition, leading to important impact in the lives of the individuals with this condition, and a great amount of patients may need surgical intervention. The main objectives of the surgery in these cases are to restore the anatomy of the middle ear, to improve hearing and to remove the infection to avoid further complications. Still, chronic otitis media with cholesteatoma presents high rates of recurrence and residual symptoms after surgery.

The standard technique used for treatment of chronic otitis media is microsurgery. Nonetheless, with the development of new technologies that use endoscopy, it is now possible to use endoscopic surgery to improve the visualization of the cholesteatoma and ear structures by combining both techniques.

This study will evaluate the efficacy of the combined access surgery technique, which is microsurgery combined with endoscopy, for closed tympanomastoidectomy in patients with cholesteatoma. Furthermore, the study aims to compare the results of the combined access technique and the standard technique by randomizing the patients in two groups: one group will receive tympanomastoidectomy by standard technique and the other group will receive combined technique.

Patients with cholesteatoma and medical indication of closed tympanomastoidectomy will be randomized into two groups. In the first group, microsurgical tympanomastoidectomy will be performed; while combined technique will be performed in the other group. The combined technique improves the visualization of the middle ear canal and the mastoid. Herewith, the best visualization of the surgical site facilitates the full removal of the cholesteatoma. In addition to that, the combined technique is less invasive than the standard one, since less bone debridement is required to access the surgical site.

The outcomes of the study will be evaluated through follow up medical appointments and exams. The patients will be followed by monthly medical appointments with otoscopic evaluations for diagnose of possible recurrence of the disease or residual cholesteatoma. Also, audiometry exams will be performed in the third, sixth and twelfth months. Image exams such as nuclear magnetic resonance may be performed at the end of this period to evaluate relapse of the disease if the otoscopic evaluation is inconclusive.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cholesteatoma with indication for closed tympanomastoidectomy.

Exclusion Criteria:

* Patients with malformation of the temporal bone or previous surgery in the ear eligible for the study.
Different Modalities in Reducing Airborne Particulate Concentrations During AGP for Health Volunteers

Several clinical procedures have been described as aerosol generating procedure (AGP), including nebulization, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and bronchial hygiene treatment, etc. However, the understanding on the transmission risk of these treatments is still unclear, particularly the methods to reduce the airborne particulate concentrations during these treatments are still lacking. This study is aimed to compare different modalities in reducing airborne particulate concentrations during these aerosol generating procedures, in order to find the most effective method to reduce particle concentrations, ultimately to decrease the transmission risk and protect health care providers.


Eligibility Criteria:
Inclusion Criteria:

• Ages 18-65, Male or Female

Exclusion Criteria:

* Chronic lung disease, including asthma, COPD, etc.
* Upper airway anatomical abnormities
* Pregnancy
* Uncontrolled Diabetes, hypertension, or untreated thyroid disease
* Has any of the following symptoms in the last 21 days: sore throat, cough, chills, body aches for unknown reasons, shortness of breath for unknown reasons, loss of smell, loss of taste, fever at or greater than 100 degrees Fahrenheit.
* COVID-19 test positive within 21 days.
Diabetic Foot Ulcer (DFU) Rapid Pathogen Identification

The purpose of this study is to evaluate the role of rapid diagnosis of pathogens in treatment of infection and wound healing in diabetic foot ulcers. This research is studying the use of a new device of people to learn if metagenomic next generation sequencing (mNGS) techniques technology is a feasible tool that can be used to direct targeted antibiotic therapy in infected diabetic foot ulcers.

Participant's tissue will be randomized to usual care tissue collection and cultures (standard of care) or usual care tissue collection and cultures (standard of care) plus metagenomics next generation sequencing (mNGS). The participant's will not be randomized to any treatment (i.e. antibiotic therapy).

Participants will have tissue taken per standard of care at the baseline visit. In addition, participants will complete of a comprehensive medical history questionnaire, Michigan Neuropathy questionnaires, and have assessments of the foot ulcer or wound. The study team will follow participants for approximately 12 weeks.

Initial antibiotic therapy to treat diabetic foot ulcer infections are determined by participants treating provider and are based on clinical characteristics, drug allergies or sensitivities, and suspected causative pathogen (i.e., bacteria). In this study, the identification of pathogens using mNGS will be given to the treating physician and may result in additional or different antibiotics.

The decision for antibiotic prescription(s) to treat the diabetic foot ulcer infection will be made by treating providers. The antibiotic plan will be updated according to final culture results (usually 4-6 days following culture of tissue). For those participants randomized to the mNGS cohort, the results (usually 24-36 hours following culture of tissue) will be shared with the treating physician. The treating physician may provide additional or different treatment than initially prescribed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diabetes mellitus
* Have an infected DFU with a surface area ≥0.5 square centimeter (cm2)

  o DFU Infection status will be clinically recorded at time of enrollment according to Infectious Disease Society of America (IDSA): mild, moderate, or severe infection
* Have a hemoglobin A1c\[HbA1c\] of 12% or less as measured within the last 6 months,
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Pregnant or lactating
* Uncontrolled blood glucose as demonstrated by a HbA1c of greater than 12%
* Bilateral wound or ulcer
* Current infection of Coronavirus disease 2019 (COVID19)
* Unable to provide informed consent or are unwilling to participate
Acute Medical Admissions of ELDERly Patients (ELDER)

To evaluate differences in health outcomes among elderly patients (age ≥ 75 years) treated in a Quick Diagnostic Unit (QDU) compared to the Department of Internal Medicine (DIM). A QDU is a medical Short Stay Unit (SSU).

The Danish emergency care system is undergoing major changes; Emergency Departments (ED) are now centralised at fewer hospitals, thus the ED now serve as the single point of entry for all acute patients. Another initiative, has been the establishment of a Quick Diagnostic Unit (QDU) as a subunit in the ED. The QDU is a ward for fast track diagnostics and treatment of stable medical patients that is believed to optimise in-hospital care by quicker diagnosis and shorter hospitalisations, and minimise time for patients to return to their habitual health status. However, little evidence exists on the putative benefits for elderly patients treated in a QDU setting.

In this study, we will examine the benefits and drawbacks of treatment of elderly medical patients (≥75 years) in an acute treatment system with the possibility of fast-track admission and treatment, rather than treatment in the traditional medical system. We will randomise patients to treatment in either a fast track ward/short stay unit, the QDU, or to standard treatment at the Dept. of Internal Medicine (DIM).

We hypothesise that treatment in a QDU compared to DIM offers optimised care through immediate access to clinical staff and rapid diagnostic facilities, treatment and quicker rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 75 years
2. Admitted for in-hospital treatment for an internal medicine disease
3. Green tag triaged upon arrival in the ED

Exclusion Criteria:

1. Previous participation in this trial
2. Participation in other clinical trials
3. No QDU beds available
4. Subject does not have a Danish Civil Registration Number (CPR).
5. Subject resides abroad
6. Requires help using the toilet in daily life
7. Patients not aware of date, time and location, or their own data (name, birth date)
8. Informed consent cannot be obtained
MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal

The purpose of the study is to improve image quality, increase speed of scanning and to see how well certain products test by scanning people who have an orthopedic hip or knee metallic implant.

The technology comprising Magnetic Resonance (MR) imaging systems and accessories is under continuous development in order to improve the quality of images, speed of acquisition, and usability of MR devices applied to image subjects with metallic orthopedic implants. Collection of in vivo human data throughout the product development and maintenance lifecycle plays an important role in enabling the technology to be investigated, optimized, and validated.

This is a pre-market investigation involving commercially available devices, investigational devices, and commercial devices modified with investigational components. The Study will be conducted for three years, over which time a number of endpoints will be collected for various devices under development.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age; and
* Must have an in-place knee or hip orthopedic implant; and
* Must have a metallic orthopedic implant that is labeled as "MR safe" or "MR Conditional" by the implant manufacturer; and
* Must be able to provide sufficient documentation of the implant such that study staff can confirm its compatibility with the specific MR environment per the implant labeling; and
* Must be able to provide written documentation or attestation of the date their orthopedic implant was placed; and
* Must be able to hear and understand English without assistive devices; and
* Must provide written informed consent; and
* Must provide the name and contact information for his/her Physician

Exclusion Criteria:

* Any implant more than 5 years old
* Any implant that is investigational
* Any implant which cannot be verified with a manufacturer's label
* Any implant implanted outside of U.S.A.
* Any implant associated with a recall
* Any history of pathology associated with an in-place orthopedic implant
* History of pain at implant site, in the past 30 days
* Known or suspected complication, defect, or concern regarding an in-place orthopedic implant
* Surgery related to an orthopedic implant within the past 120 days
* Potential for metal to be in body due to a previous injury involving metallic objects
* Pregnancy or late menstrual period
* Any non-orthopedic implant
* Any type of prosthesis (eye, penile, heart valve, etc.)
* Any other type of metal implant other than knee or hip implant
* Presence of tissue expander (breast)
* Intra-uterine device, diaphragm or pessary
* Loose dental fillings or dental fillings in the last 30 days
* Tattoo or permanent make up
* Breathing problem or motion disorder
* Claustrophobia or panic attacks
* Hearing Aid
* Body piercing jewelry
* Dentures or partial plates
* External medical hardware (example: orthopedic braces, orthodontic appliance)
* Known or past allergic reactions to latex
Relative Bioavailability Study to Compare Inhalation of Terbutaline Sulphate 1,5mg Via Turbuhaler M3 With Turbuhaler M2

Relative bioavailability study to compare inhalation of Terbutaline Sulphate 1,5mg via current version of Turbuhaler with inhalation via a new version

An Open-label, Single-dose, 2-period Cross over Study in Healthy Male and Female Volunteers to Assess Relative Bioavailability of Terbutaline Sulphate 1.5 mg after Inhalation via the M3 Turbuhaler (New Version) Compared with the M2 Turbuhaler (Current Version)

Eligibility Criteria:
Inclusion Criteria:

1. Female and male volunteers aged between 18 and 65 years, both inclusive
2. Healthy as judged by the Principal Investigator after medical history, physical examination, 12-lead ECG, laboratory tests (including HIV, HBsAg and hepatitis C antibody tests) and assessments of pulse rate and blood pressure
3. Ability to use a Turbuhaler according to the provided instructions, as judged by the Principal Investigator or the study nurse
4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weighing at least 50 kg and no more than 100 kg -

Exclusion Criteria:

1. History or presence of respiratory, gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs (except for cholecystectomy)
2. Current smokers or those who have smoked or used nicotine products within the previous 3 months should be excluded
3. Plasma donation within 1 month of screening or any blood donation or blood loss of more than 500 mL during the 3 months prior to screening
4. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Principal Investigator or history of hypersensitivity to terbutaline (or drugs of a similar chemical structure or class) or inhaled lactose
5. Positive screen for drugs of abuse and/or alcohol and/or cotinine at screening (Visit 1) or on admission to the study centre (Day -1) prior to administration of the investigational medical product (IMP) on Day 1 -
Safety and Performance of the TFCC FastFix in the Wrist

Assess safety and performance post-market of the TFCC FastFix in the wrist.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone TFCC repair using the TFCC FastFix Device
* Patients aged 18 years and older
* Patients that are \> 12 months post-operative.

Exclusion Criteria:

* Subjects who are \< 12 months post-operative
* Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.
Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer

To evaluate the safety profile of Genexol PM combination with carboplatin for patients with newly diagnosed ovarian cancer. We hypothesized Genexol PM can be safely administered to newly diagnosed ovarian cancer patients compared to conventional paclitaxel/carboplatin combination therapy. Therefore, we will compare the prospective cohort with a historical comparison with patients administered paclitaxel/carboplatin and paclitaxel/carboplatin/bevacizumab combination therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Patients consented to participate
* Pathologically diagnosed ovarian cancer FIGO stage IC-IVB
* ECOG 0-2
* Patients with an expected survival of 3 months or more

Exclusion Criteria:

* History of paclitaxel or carboplatin hypersensitivity
* Inadequate bone marrow function (Neutrophil\<1500/mm3, Platelet \<100,000/mm3)
* Pregnancy or breast-feeding state
* Metachronous or synchronous malignancy
* Galactose intolerance, Lapp Lactase deficiency, or glucose-galactose malabsorption patients with genetic problems
* Other patients who were judged difficult to be included in this investigation by the investigator in charge
Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism

The primary objective of this study is to estimate the percent change in baseline bone mineral density (BMD) starting at one year after parathyroidectomy and all the following available dates in patients presenting with primary hyperparathyroidism. The secondary objective is to identify patient factors associated with change in BMD.

The research plan is for a retrospective review to be performed of a prospectively maintained parathyroid database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center. The patient cohort for this study consists of all patients with primary hyperparathyroidism who underwent parathyroidectomy and also had pre- and post-operative DEXA studies performed. The database will be reviewed to obtain patient and disease characteristics, laboratory values, DEXA imaging results, and surgical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. The patient cohort for this study consists of all patients within the prospectively maintained parathyroid database within the Department of Surgical Oncology at the University of Texas MD Anderson Cancer Center.
2. Patients with a diagnosis of primary hyperparathyroidism who underwent parathyroidectomy during the period of September 27, 1990 to December 31, 2013 were considered.
3. All patients who had a preoperative and one year post-operative DEXA study over the time period will be included.

Exclusion Criteria:

N/A
Inclisiran Effectiveness in China: a Pragmatic Randomized Trial

The current study will be conducted to evaluate the real-world effectiveness of inclisiran relative to standard of care (SoC) in Chinese patients with coronary heart disease (CHD), not only with the low-density lipoprotein cholesterol (LDL-C) change in 1 year, but also the LDL-C Test on Target for 1 year. This study further aims to assess the adherence, treatment patterns and satisfaction, and safety of inclisiran among Chinese patients.

The study is a multicenter, randomized, parallel, open-label, pragmatic trial, to assess the effectiveness of inclisiran in the real-world compared to SoC, in patients with CHD in China who did not achieve LDL-C goal despite maximally tolerated statin therapy for ≥4weeks stable using. CHD patients include patients with acute coronary syndrome and patients with chronic coronary syndrome.

After granting informed consent, being screened, and confirmed eligible for the study, participants will be randomized to 2 arms (inclisiran or SoC) in a 1:1 ratio.

Following the randomization, participants start inclisiran or SoC adaptation (which means switching to or adding on another/other lipid-lowering therapies (LLT\[s\]). This start date is defined as Day 0.

During follow-up, each participant will follow routine care, and the results of LDL-C tests will be collected for each Visit (every 3 months), with an allowable window of ±1.5 months. Each patient will be followed up until his/her end of study (EOS), which is the earliest of the end of follow-up period (Visit 4: approximately 12 months following Day 0), lost to follow-up, consent withdrawal, death, and participating in another interventional trial.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Documented diagnosis of CHD prior to screening, including acute coronary syndrome (ACS) and chronic coronary syndrome (CCS)
3. Aged ≥18 years at randomization
4. Despite maximally tolerated statin therapy for ≥4weeks stable using prior to screening, LDL-C result at screening not at goal (≥1.8 mmol/L).

The maximum tolerated dose of statins also includes patients with statin intolerance or contraindication.

Exclusion Criteria:

1. Received inclisiran during the 2 years prior to the screening.
2. Received proprotein convertase subtilisin-kexin type 9 (PCSK9) mabs during the 3 months prior to screening.
3. Participating in an interventional trial at enrollment
4. Having severe liver disorder (Child-Pugh class C)
5. Any other condition that may put the participant at significant risk if the participant participate in the current study, according to investigator's (or delegate's) judgment.

Other protocol-defined inclusion/exclusion criteria may apply.
Antagonist Protocol in IVF

The antagonist protocol in a novel method of stimulation in the in vitro fertilization (IVF) patients. It has been tried in poor responders, polycystic ovary (PCO) patients and normal females undergoing IVF. Can it be used with the same efficacy in all patients?


Eligibility Criteria:
Inclusion Criteria:

* age: 20- 44 years
* Poor responder females according to Bologna criteria
* Polycystic ovarian disease females according to Rotterdam criteria
* Females with infertility causes other than poor responders, or PCO; male factor or tubal block

Exclusion Criteria:

* refusal to get enrolled in the study
* cases of infertility due to severe male factor