cyrilzakka/clinical-trials huggingface dataset:
Assessment of Prognosis and Myocardial Reperfusion in Patients with ST-segment-elevation Myocardial Infarction (STEMI) According to Coronary Atherosclerotic Burden.

In the current literature, it has been widely demonstrated that the extend of coronary atherosclerotic burden is associated with adverse long-term outcomes. Little is known about the impact of atheroma burden and either myocardial reperfusion and short-term outcomes after ST-segment elevation myocardial infarction (STEMI). Several angiographic scores have been used to measure the extend and severity of coronary atheroma. The SYNTAX score and the Gensini score have been shown to be independent predictors of cardiovascular events and mortality in stable coronary artery disease as well as in myocardial infarction.

This research therefore aims to assess the impact of overall coronary atherosclerotic burden, measured by two angiographic scores (SYNTAX score and Gensini score), both before and after primary percutaneous angioplasty, in patients with STEMI according to different clinical subgroups.


Eligibility Criteria:
Inclusion criteria:

- patients presenting with STEMI and treated with primary PCI (pPCI) at the University Hospital of Nancy between 2003 and 2023.

Exclusion criteria:

- patients with missing or incomplete coronary angiogram.
Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

The purpose of this study is to Evaluate Pathogens and Immunity to Acute Otitis Media in Healthy Children.

A prospective evaluation of bacterial pathogens Streptococcus. pneumoniae, Haemophilus influenzae, Moraxella. catarrhalis and Staphylococcus aureus and their antibiotic susceptibility when colonizing the nasopharynx and/or causing acute otitis media in the years 2015-2025. The goal will be to recruit children into a prospective group beginning at 6 months of age and followed to 36 months of age in suburban Rochester, New York. Nasopharyngeal and nasal wash samples will be obtained at each well child visit and at acute otitis media (AOM) episodes. Middle ear fluid will be obtained from every child with an acute otitis media episode who undergoes a tympanocentesis procedure. All of the nasopharyngeal and middle ear fluid samples collected will be tested by standard microbiologic techniques to identify the presence of 4 potential otopathogens (S. pneumoniae, H. influenzae, M. catarrhalis and S. aureus). All S. pneumoniae will undergo serotyping and antibiotic susceptibility testing. All samples that are culture negative will be evaluated with a multi-locus PCR test to examine for presence of potential otopathogens.

Eligibility Criteria:
Inclusion Criteria:

Healthy Children:

* Male or female age greater than/equal to 6 months or less than/equal to 36 months old.
* Parent/guardian willing to bring to all study visits

Exclusion Criteria:

* Any major illness/condition that in investigator opinion would put subject at risk during study.
* Otorrhea or tympanostomy tubes present in either ear @ time of enrollment.
* Direct descendant of study site personnel.
* Subjects \< 6 months old or \>36 months old at the time of enrollment
Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients

This is to compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye.

The subjects are the patients who underwent monocular IOL implantation before and present mild cataract in the fellow eye.Compare preoperative and postoperative the binocular functional vision and the satisfaction of patients when the patients ask for the surgery (phacoemulsification and IOLs implantation)on the fellow eye. The type of IOLs maybe according to the patients preference and the eyes condition.The subjects will be divided into three groups according to the type of the IOLs，including monofocal group,bifocal group,and trifocal group.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye
* Regular corneal topography and corneal astigmatism ≤ 0.75 Diopter

Exclusion Criteria:

* Pregnant or nursing women
* In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
* In the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logMAR after surgery (amblyopia, strabismus, keratoconus, etc.)
* Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
* Patients using systemic or ocular medication that affect visual acuity.
* Patients with history of ocular trauma or prior ocular surgery including refractive procedures
* Patients participating in other clinical trials during the study.
Supportive Oncology Care At Home RCT

This research study is evaluating a program that entails remote monitoring and home-based care for people with cancer who are receiving chemotherapy, radiotherapy, or chemoradiotherapy.

Participants receiving treatment for cancer often require multiple care visits and may experience significant symptoms and side-effects related to the cancer and the cancer treatment.

This research study is evaluating if a program that involves remote monitoring and home-based care may improve the quality of life, ability to manage symptoms, and overall care of individuals during cancer treatment. Remote monitoring is broadly defined as a way of monitor outside of conventional clinical settings (e.g. in the home) that often utilizes technology to increase access to care.

Eligible participants will be randomized into one of two groups:

* Usual Care or
* Supportive Oncology Care at Home

It is expected that about 300 people will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible, patients must be: age 18 or older
* Receiving definitive treatment (i.e. neoadjuvant chemotherapy and/or chemoradiation with curative intent) for pancreatic, gastroesophageal, rectal, head and neck cancer, or lymphoma
* Within two weeks of starting treatment
* Planning to receive care at Massachusetts General Hospital (MGH)
* Verbally fluent in English
* Residing within 50 miles of Massachusetts General Hospital

Exclusion Criteria:

* Patients with uncontrolled psychiatric illness or impaired cognition interfering with their ability to understand study procedures and provide written or electronic informed consent.
Does Medicinal Mushroom Agaricus Blazei Protect Against Allergy and Asthma?

Asthma and allergy is increasing in Norway and Western countries. Treatment is still mostly symptomatic. Extracts of the immunomodulatory and edible mushroom Agaricus blazei, such as Andosan™, have been shown to protect against asthma and allergy in murine models by changing the T helper cell 1(upregulation)-T helper cell 2 (downregulation) balance in the immune system. Andosan™ is produced in Japan and approved as food (mushroom juice) in Norway. Blood donors and possibly patients with pollen-derived allergy and asthma will be included in the study.The aim is to examine whether Andosan™ i) has similar clinical effects against allergy and asthma in man as it has in mice, and ii) reduces drug use and increases frequency of blood donations. Blood donors or patients who are recruited with informed consent will be given Andosan™ or placebo orally as add-on treatment to ordinary treatment for 7 weeks during the Birch pollen season, and specific IgE will be measured before, during and after the intervention, in addition to basophil activation testing and filling out of a questionnaire.

Blood donors at Oslo University Hospital (OUH) Blood Bank with self-reported birch pollen allergy and/or asthma were recruited for the study during last 4 months of 2015 and first 2 months of 2016. They signed an informed consent form for the study and were randomized into Andosan™ and placebo Groups. The PI (MD) had the study key and the participants in the study were handled by other staff (nurses and bioengineers) at the blood bank. The participants were given a questionnaire that was filled out before and after the study. Before, during and after the study also blood samples were taken for allergy testing (IgE, BAT) or cytokine profiles. When the participants visited the blood bank after 3.5 weeks, they brought the study medicine vessel (plastic container) that was controlled for remaining study medicine (all should have been used) and given new study medicine for the remaining study period (3.5 weeks). The participants were also asked about possible side effects of the study medicine. In the intervention arm, Agaricus blazei-based mushroom extract Andosan™, was given, which is produced as Health food in Japan and imported as food to Norway and provided for the study by Immunopharma company, Norway. Data were collected and analyzed together after the study. Statistical help was solicited from an OUH statistician.

Eligibility Criteria:
Inclusion Criteria:

* Blood donors with birch pollen-derived allergy and asthma

Exclusion Criteria:

* Blood donors with other types of allergy and blood donors with Birch pollen allergy who are would not be in Southern Norway during most of the pollen season
Effects of High-intensity Interval Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke

Hemiplegia is one of the most common sequelae of stroke. Stroke is the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen.

The purpose of this study is to Determine the effect of Aerobic exercise training on Balance, Walking capacity and quality of life in sub-acute stroke.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age.
* Ischemic Stroke that occurred in the recent 3 months.
* Who can walk independently or by using assistive device.
* Have a minimum Chedoke McMaster Stroke Assessment (CMSA) leg impairment score of 3 but less than 7.

Exclusion Criteria:

* Patients were excluded from the study if they have a stroke that occurs more than 3 months.
* Hemorrhagic Stroke.
* If resting blood pressure more than 160/100 even after taking medications
* Have by-pass surgery in recent 3 months.
* Other musculoskeletal problems which restrict the patient's ability to do aerobic activity.
Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.

The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox.

The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing heart surgery

Exclusion Criteria:

* None
The Impact of Pharmacist Recommendations on Quality of Care in Diabetic Patients

The goal of this study is to investigate a comprehensive provider-focused intervention to improve the quality of care for diabetic patients in a large primary care practice at Brigham and Women's Hospital. This will be accomplished through pharmacist recommendations provided to primary care providers prior to routine scheduled office visits for diabetic patients.

Type II diabetes mellitus is an increasingly common condition among adults in the United States and is associated with substantial morbidity and mortality. The microvascular and macrovascular complications of diabetes lead to significant disability and early mortality, in addition to tremendous costs to the healthcare system. It has been clearly demonstrated, that both microvascular and macrovascular complications can be reduced through specific interventions that can be carried out by office-based primary care physicians. Despite the accumulation of evidence regarding specific interventions that can reduce diabetes-related morbidity and mortality, multiple studies have shown that the care provided for diabetic patients frequently falls short of recommended standards.

The researcher's goal is to investigate a comprehensive, provider-focused intervention to improve the quality of care for diabetic patients in a large, primary care practice at Brigham and Women's Hospital. This will be accomplished through pharmacist-delivered recommendations provided to primary care providers prior to routine scheduled office visits for diabetic patients.

Adult diabetic patients age 18 years and older receiving primary care in the Brigham Internal Medicine Associates (BIMA) practice will be randomized to intervention and control groups, based on the practice subset (Suite) within BIMA in which they receive their ongoing care. Patients who receive care from providers in Suites A, B, E, and F will be assigned to the intervention group, while patients who receive care from providers in Suites C, D, G, and H will be assigned to the control group. Patients will not be contacted regarding the study; providers who practice in the intervention Suites will receive specific written recommendations regarding optimal diabetes care parameters from our study pharmacist prior to each patient's visit. Providers who practice in the control Suites will not be contacted. Pre- and post-intervention compliance with multiple diabetes quality-of-care measures (eg, Hemoglobin A1c measurement, LDL cholesterol measurement, pneumococcal vaccination, etc.) will be assessed in the intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of diabetes
* Age 18 years or older
* Identifiable primary care physician (PCP)
* Attendance at index appointment with PCP

Exclusion Criteria:

* No assigned PCP
* Non-attendance at PCP appointment
A Safety, Tolerability, Pharmacokinetic Study of SHR-6934 Injection in Healthy Subjects

This study was a randomized, double-blind, single-dose and multi-dose, placebo-controlled phase Ⅰ clinical trial. Six dose groups were planned for the SAD part of the study and four dose groups were planned for the MAD part. A total of 88 healthy subjects were included.


Eligibility Criteria:
Inclusion Criteria:

1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
2. Male or female aged 18-60;
3. Females must have a negative pregnancy test at the Screening Visit;
4. Body mass index (BMI) between 19 and 28 kg/m2;
5. Normal Electrocardiogram (ECG);
6. Men and women of childbearing potential must agree to take effective contraceptive methods.

Exclusion Criteria:

1. History of any clinically important disease or disorder;
2. History of drug or other allergies, or who, in the judgement of the investigator, may be allergic to the study drug or any component of the study drug;
3. Prior history of risk factors for Torsades de Pointes, such as unexplained syncope, definite long QT syndrome (including family history), heart failure, myocardial infarction, angina pectoris;
4. Systolic blood pressure (SBP)≥140 mmHg or \<90 mmHg, diastolic blood pressure (DBP) ≥90 mmHg or \<60 mmHg;
5. Patients with orthostatic hypotension;
6. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
Efficacy of Oral Versus Intravenous Acetaminophen for Primary Pediatric Cleft Palate Repair

The purpose of this investigator-initiated study is to determine whether acetaminophen is an effective pain reliever for primary cleft palate repair in children and possesses opioid sparing effects. Additionally, the investigators will determine if patients who receive acetaminophen have less opioid related side-effects. The study will have three study groups based on whether the patient receives Ofirmev® and opioids (Fentanyl and Morphine), oral acetaminophen elixir and opioids (Fentanyl and Morphine), or opioids (Fentanyl and Morphine) alone. Total opioid (Fentanyl and Morphine) consumption will be tracked for the intraoperative period and 24 hours after surgery for all patients within the study and converted to morphine equivalents.


Eligibility Criteria:
Inclusion Criteria:

* Children 5 months to five years of age
* ASA physical status I or II
* primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.?

Exclusion Criteria:

* Repeat/revision cleft palate repair
* Contraindications to acetaminophen administration (liver or renal dysfunction, allergy)
* Chronic pain medications
* Diagnosis of chronic pain syndrome
* Contraindications to morphine (renal impairment, allergy)
* Seizure disorders and/or taking anti-seizure medications
* Contraindications to oral midazolam (liver dysfunction, allergy)
* Allergy to local anesthetics
Neuromuscular Balance in Low Back Pain

The research was an interventional study with a quantitative board, fulfilled in a private clinique specialized in trauma service; it was formed between august to October of 2006. The objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The 12 patients, with age between 20 and 55 years, whose did five consultations, with 100% presence, got relief of the pain and increase of movement of hips' articulation which was the most painful movement with 91,66% graduation. All the patients presented the shorting test positive and it kept positive in 7 patients. There was a significant improvement in pain relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for a more effective rehabilitation and prevention of repetition of the symptoms. It was concluded that the neuromuscular balance relieved quickly the pain, being essential for effective rehabilitation of low back pain, with the inclusion of others manual techniques.

The low back pain is a symptom presented in muscle-skeletal change on lumbar region, preferring young adults, in economic active fase. The neuromuscular balance was developed by Soulier when he met the "activator methods" which was a pen that create vibrations and consist in a vibration or a micro thrust to reduce the articulation and spinal problems through a non manipulative correction. The research was un interventional study with a quantitative board, fulfilled in a private clinique specialized in trauma service; it was formed between august to October of 2006. The objective was to investigate the effectiveness of neuromuscular balance in lumbar pain. The 12 patients, with age between 20 and 55 years, whose did five consultations, with 100% presence, got relief of the pain and increase of movement of hips' articulation which was the most painful movement with 91,66% graduation. All the patients presented the shorting test positive and it kept positive in 7 patients. There was a significant improvement in pain relief (p=0,001,) comparing the first and the fifth consultation, and hip articulation movement. Even after the relief of the pain, 7(58,3%) of the patients kept the treatment for a more effective rehabilitation and prevention of repetition of the symptoms. It was concluded that the neuromuscular balance relieved quickly the pain, being essential for effective rehabilitation of low back pain, with the inclusion of others manual techniques.

Eligibility Criteria:
Inclusion Criteria:

* Patients with low back pain between 20 and 55 years old, submitted to a physical therapy treatment.

Exclusion Criteria:

* Patients with no miofascial low back pain
Safety of Remdesivir Treatment in COVID-19 Patients Requiring Hemodialysis

The FDA approved the antiviral drug remdesivir for use in adults for the treatment of COVID-19 requiring hospitalization.

There are only limited data about the safety of the drug in hemodialysed patents. Chronic kidney disease is a risk factor in COVID-19 for developing severe disease.

The aim of our investigation is to observe the safety of remdesivir among hemodialysed patients requiring hospitalization for COVID-19.

We are going to compare two group's data:

1. Hemodialysed COVID-19 patients requiring hospitalization because of pneumonia and need of oxygen supplementation, and admitted after 12/Apr/2021 - these patients received remdesivir.
2. Hemodialysed COVID-19 patients requiring hospitalization because of pneumonia and need of oxygen supplementation, and admitted before 12/Apr/2021 - these patients did not receive remdesivir.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients at least 18 ys. of age
* Ability to understand and sign informed consent form
* End stage kidney disease of any cause, requiring hemodialysis
* COVID-19 disease (with at least one positive SARS-CoV-2 RT-PCR or COVID-19 antigene quick test)
* Radiologic evidence for pneumonia
* Need for oxygen supplemental oxygen

Exclusion Criteria:

* Hemodynamically unstable patients (systolic blood pressure \<90Hgmm; heart rate\>120/min)
* Significant liver enzyme elevation at screening (ASAT or ALAT \>2.5×ULN)
* QTc \> 470 msec at baseline ECG (Bazett formule)
* Need for mechanical ventilation or intensive care unit admission
* Limited life expectancy (\<3 months)