cyrilzakka/clinical-trials huggingface dataset:
Cardiac and Lung Assessment of Professional Soccer Players Following COVID-19 Disease

During this world COVID-19 outbreak, and according to the experience of team doctors, after their return, some players could have been affected by the SARS-cov2. Also, this study aims to clearly determine the condition of athletes at the end of lockdown after this COVID-19 crisis and the cardiorespiratory consequences in particular in those who have been affected by COVID-19 and the prevalence of acute myocarditis. The investigators assess in this observational study the cardiac and lung consequences of COVID-19..

The global health crisis caused by the COVID-19 virus, beginning in November 2019, initially in China, has being marked by a rapid spread, numerous severe respiratory cases and an elevated mortality rate. Although that 85% on average of patients with SARS-cov2 are not symptomatic or poor symptoms, these people were not systematically tested by PCR and spontaneously recovered. However, at the end of lockdown, the challenge for the medical staff in each first league soccer team involves to assess their clinical health conditions including clinical evaluation, COVID-19 tests, chest CT, and cardiac function in order to detect potential anomalies. Especially, physicians should be cautious about the risk of acute viral myocarditis, often asymptomatic, in patients having COVID-19 with any or poor symptoms, reported in 7 to 28%. The risk could be a myocardial dysfunction, arrhythmic complications and/or sudden death during return to exercice.

In this observational study, the investigators included the soccer player after the spring lockdown. After firstly an exhaustive interview to assess the lockdown quality of the athlete, clinical status and potential mild or poor symptoms of COVID-19 during the outbreak, and secondly COVID-19 serology and regular PCR tests.

The athletes having a positive nasopharyngeal SARS-cov2 PCR and/or positive COVID-19 serology test, with or without symptoms, were included in the study. Up to 10 days after first positive PCR, a cardiac evaluation is done including EKG, cardiac ultrasound echography and stress test in running ground and Chest Computer Tomography (chest-CT). According to the results of cardiac tests and Lung CT-scan, these athletes also require Cardiac MRI to eliminate the risk of acute myocarditis.

Eligibility Criteria:
Inclusion Criteria:

* Professional soccer player
* age over 18 years

Exclusion Criteria:

* recent muscle injury (\< 1 month)
* recent orthopedic surgery (\< 3 months)
Mortality Due to COVID-19 in the COVID-AGEBRU Study

The COVID-Age Brugmann study aims to identify the clinical predictors of mortality risk in older patients admitted to an acute care unit due to COVID-19

The COVID-19 disease has been shown to be associated to higher mortality risk and health adverse consequences. Despite of the fact that the SAR-COV2 virus has been shown that affects every populations, the negative impact is higher in older people, pointing this population as the most severely affected.

The COVID-Age Brugmann study aims to identify if comorbidity, geriatric syndromes, and health issues at admission are associated to mortality risk in older patients admitted to an acute care unit due to COVID-19

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70 and older
* Patients admitted to an acute care geriatric unit due to COVID-19
* Patients with COVID-19 by PCR, serology or CT scan suggestive of this disease

Exclusion Criteria:

* No other demographic or clinical exclusion criteria will be applied
An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)

The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects.

Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia.

Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%


Eligibility Criteria:
Inclusion Criteria:

* ≥ 19 years old, and ≤ 64 years old, and
* Female patients with breast cancer receiving chemotherapy recently covered under national health insurance (only chemotherapy regimens in the table below), and
* Patients with neutropenic events (febrile neutropenia or grade 4 neutropenia) in any previous cycle that did not use G-CSF for the prevention of neutropenia

Exclusion Criteria:

Patients with any of the followings are excluded.

* Patients with a history of allergic reactions to E-coli derived proteins, human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim
* Uses for off-label indications such as chronic myelogenous leukemia, myelodysplastic syndrome
A Pilot Project to Facilitate Dental Care and Reduce Barriers For Youth With Disabilities

This randomized clinical trial is an innovative pilot project to determine the acceptance and impact of telehealth visits on youth with intellectual and developmental disabilities (IDD), their caregivers, and dentists. The impact of the telehealth visit will be assessed by: 1) determining if the intervention group was more likely to achieve the set goals and 2) Likert scaled surveys of satisfaction of caregivers and dentists. Qualitative data will be collected to inform improvement on clinical interviews by the dentist.


Eligibility Criteria:
Inclusion Criteria:

* Have an appointment for a routine check up at the Pediatric Clinic or Pediatric Health Center at the Boston University Goldman School of Dental Medicine
* Diagnosis of Intellectual or developmental disability (IDD)
* Have a caregiver who is willing to participate in the study
* Have a dental provider who is willing to participate in the study
* English speaking

Exclusion Criteria:

* None
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps

The purpose of this study is to determine if Vitamin D supplementation improves clinical and immunologic parameters in chronic rhinosinusitis with nasal polyps.

Introductory Statement: Our laboratory has found that patients with chronic rhinosinusitis with nasal polyps (CRSwNP) have insufficient levels of vitamin D3. This is a proposal to conduct a placebo controlled trial on the use of vitamin D3 (5,000IU/day for 6 weeks) to determine clinical and immunologic outcomes in these patients.

General Investigational Plan: We routinely examine vitamin D levels in all patients with CRSwNP. Those that are insufficient (less than 32 ng/ml) and have agreed to undergo sinus surgery will be randomized to placebo or vitamin D3 supplementation (5,000IU/day) for 6 weeks prior to surgery. Blood will be drawn pre- and post-supplementation to examine systemic immune parameters such as dendritic cell and T cell expression and cytokine levels. Sinus tissue will be collected at the time of surgery to analyze local immune parameters (dendritic cell, T cell and cytokine levels) between supplemented and placebo groups. Clinical outcomes will be analyzed using quality of life questionnaires, endoscopic grading and nasal peak inspiratory flow pre- and post- supplementation. IRB approval for this research project is pending.

Eligibility Criteria:
Inclusion Criteria:

* Chronic sinusitis with polyps

Exclusion Criteria:

* Use of systemic steroids, or other immunmodulatory agents in preceding monthS, other immunologic, renal, gastrointestinal, endocrine or skeletal disorder (rheumatoid arthritis, immunodeficiency, cystic fibrosis, ciliary dyskinesia, malabsorption, etc.)
* Pregnancy or age less than 14 years.
OsciPulse Device for the Prevention of VTE

This is a Phase 2 safety and tolerability trial that will take place in two parts. Part one of the trial will determine the tolerability of the OsciPulse device on healthy subjects who wear the device for up to three hours. Healthy volunteers will answer questionnaires and may undergo an ultrasound test at the end of their participation in the trial.

Part two of the trial will determine the safety and tolerability of the OsciPulse device on subjects admitted to Penn Presbyterian Medical Center. Eligible subjects will be enrolled for 6 hours. In the first 3 hours, subjects will wear the standard of care intermittent pneumatic compression device or the OsciPulse device. In the second 3 hours, the subject's device will be switched and subjects will wear the alternate device not used in the first 3 hours. Subjects will answer questionnaires and may undergo an ultrasound at the end of the first 3 hours and at the end of the second 3 hours (at hour 6).


Eligibility Criteria:
Inclusion Criteria:

Part 1: Adult over the age of 40, generally healthy without a current foot or ankle injury, no history of diagnosed vascular disease including DVT, PE, VTE, post-phlebetic syndrome, or chronic venous insufficiency, mentally alert and understand English proficiently, able to give informed consent

Part 2: Adult over the age of 18, admitted to the at Penn Presbyterian Medical Center, anticipated decreased level of mobility for at least 6 hours as determined by the clinical team in collaboration with study personnel, mentally alert and understand English proficiently, able to give informed consent.

Exclusion Criteria:

Part 1: injury to the lower limbs, skin breaks, abrasion, or irritation in the area of the limb in contact with the OsciPulse device.

Part 2:

1. Inability or contraindication to applying IPC to both legs such as:

   * Evidence of bone fracture in lower extremities
   * Burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, \& ischemic limb in the legs at the site of IPC placement
   * Acute ischemia in the lower extremities
   * Severe peripheral vascular disease
   * Amputated foot or leg on one or two sides
   * Compartment syndrome
   * Severe lower extremity edema
2. Subjects anticipated to require surgical intervention within six (6) hours of admission
3. Subjects with history of VTE (DVT or PE)
4. Previous vascular surgery
5. Pregnancy or within 6 weeks of postpartum period
6. Limitation of life support, life expectancy \< 7 days or palliative care
7. Admitted to an outside hospital more than 24 hours prior to screening
8. A head-unit is unavailable for the 6 hours or more
9. At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.
Experiences of Genetics Patients With Visible Abnormalities Who Facilitate Teaching in Genetics Clinics

This study will describe the experience of patients with visible physical abnormalities in the genetics clinic when they are involved in teaching others about their condition. Information from this study may be used to enhance educational experiences in genetics clinics.

Patients 18 years of age and older with a visible physical anomaly who have been seen by a genetics professional in the past 5 years may be eligible for this study.

In a tape-recorded telephone interview, patients are asked about the following:

* Their experiences when visiting the genetics clinic
* The circumstances under which they have been approached to participate in teaching others
* Their perspective on specific teaching behaviors used in genetic consultations, and how this perspective is affected by their perception of their own visible difference
* The benefits and downsides of being involved in teaching others
* The circumstances under which they feel comfortable being approached by genetics providers to help teach others about their condition
* The conditions or circumstances that make some individual teaching experiences better or worse than others

It is common for genetics patients to facilitate teaching of others during the course of their genetics exam. Patient response to serving as a teaching case has been studied only on a limited extent. This study proposes to qualitatively explore the ways in which taking on a teaching role in a genetics clinic is experienced by patients with visible differences.

Qualitative telephone interviews with approximately 30 genetics patients with visible differences will be conducted. The interviews will be semi-structured and an interview guide will be loosely followed. Interviews will be recorded and transcripts of the interviews will be coded for analysis. A typology of common themes will be compiled and reported. Information collected through these interviews will improve understanding of the phenomenon of patients in educator roles, relate experiences to patient expectations and will fill a gap in the published literature. It is additionally hoped that results of this study may inform the development of new recommendations to enhance educational experiences in genetics clinics.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Seen in a genetics clinic or by a genetics professional in the past 5 years.
  2. Self-reported obvious physical difference or deformity.
  3. English speaking.

EXCLUSION CRITERIA:

1. Younger than 18 years.
2. Non-visible or absent physical difference of deformity.
3. Cognitively-impaired or incompetent.
Thoracic Intervertebral Foramen Block

The investigators hypothesize an alternative way to perform thoracic paravertebral block, by placing the needle tip over and behind the transverse process of vertebra, via the thoracic intervertebral foramen. This anesthetic procedure is called thoracic intervertebral foramen block.

The study aims to verify the spread of dye on to the the nervous structures of retropleural space (the ventral rami, the communicating rami, and the sympathetic trunk), and into the thoracic paravertebral space and epidural space. To accomplish this, a prospective cadaveric study was designed.

This is a prospective cadaveric study. The anesthetic procedure is performed on 2 corpses for which autopsy is requested, in accordance with Italian Low.

Before performing the autopsy, the corps is placed in the left and then in the right lateral position, to perform bilateral block. The anesthetic procedure is performed at second (T2), fifth (T5), ninth (T9), and twelfth (T12) thoracic vertebra. The ultrasonography is performed by using a high-frequency linear-array US transducer. A Tuohy needle is inserted in-plane to the ultrasound beam in a lateral-to-medial direction gently to contact the spinous process, into the skeletal muscle plane of the erector spinae muscle. Then, the needle tip is moved to reach the angle between the transverse process and spinous process. Subsequently, the needle tip is gently inserted and advanced for 2 mm along with the superior limit of the vertebral pedicle, until losing contact with the bone. Five ml methylene blue 1% dye (MB) were subsequently injected. The anesthetic procedure is bilaterally performed. Two continuous catheter sets are used and threaded 1 cm from the needle tip, for a bilateral continuous block. The catheters are inserted from the caudal to the cephalic direction.

At the end of the anesthetic procedure, a second look ultrasound scan of thoracic paravertebral space was performed. Subsequently, the corps is put in supine position, and autopsy is started.

Eligibility Criteria:
Inclusion Criteria:

* corps for which autopsy is required

Exclusion Criteria:

* corps under Legal custody of Italian Low
Evaluation of 2 Doses of Intravenous Droperidol in the Prevention of Postoperative Nausea

In this prospective, randomised, placebo-controlled study, the researchers determined whether 0.625 mg or 2.5 mg of IV droperidol given 30 min before emergence from general anaesthesia reduces the incidence of immediate and delayed post operative nausea and vomiting (PONV) in thyroid surgical female population. Two hundred and forty six female patients receiving general anaesthesia for thyroid surgery received either droperidol 0.625 mg or droperidol 2.5 mg or placebo before emergence.

* Principal Objective : Our study examined one main question: Are there difference in efficacy between droperidol IV 0.625 mg or 2.5 mg for the treatment or prophylaxis of PONV to surgical patient undergoing thyroid surgery when they receive it 30 min before emergence from general anaesthesia?
* Secondary Objective :

  * comparison of the % of patients in every group:

    * having a complete control of their nausea
    * requiring secondarily the appeal to another anti-emetic treatment in postoperative
    * presenting an Adverse event
  * Compare score of sedation in ach groups
  * Evaluate electrocardiograph
  * Compare the morphine consumption
* Study design : Prospective, randomized, monocenter, double-blind study
* Inclusion criteria :

  * Female
  * More than 18 years old
  * Patients scheduled for thyroid surgery
  * Simplified Apfel score ≥ 2
  * ASA score : 1-2
  * Informed consent obtained from the patient
  * the women in age of procreate must have a reliable contraceptive method
* Exclusion criteria :

  * age \< 18 years old
  * male
  * obesity
  * present a severe depressive syndrome
  * pregnancy women
  * trouble of cardiac rate
  * alcoholism
  * contra-indication for Droperidol prescription
* Study plan: three parallel groups will receive 2 different doses of Droperidol or placebo at the end of surgery.

  * Group 1: 0,625mg of Droperidol at the end of surgery
  * Group 2: 2,5mg of Droperidol at the end of surgery
  * Group 3: Placebo at the end of surgery
* Number of subjects : 246

Eligibility Criteria:
Inclusion Criteria:

* Female
* More than 18 years old
* Patients scheduled for thyroid surgery
* Simplified Apfel score ≥ 2
* ASA score : 1-2
* Informed consent obtained from the patient
* Women able to procreate must have a reliable contraceptive method

Exclusion Criteria:

* Age \< 18 years old
* Male
* Obesity
* Has a severe depressive syndrome
* Pregnancy women
* Trouble with cardiac rate
* Alcoholism
* Contra-indication for Droperidol prescription
Investigations Regarding B-cell Subsets in Humans

The aim of this research is to define the human equivalent of mouse B1 cells.

The specific aim of this research project is to define the human equivalent of mouse B1 cells. This will be done by evaluating IgM secretion, surface markers, functional characteristics, V gene usage, N-region addition, and phosphorylation status of intracellular proteins, gene expression, sequencing of immunoglobulin genes, determination of antigenic specificity, replication history, and response to different stimuli.

The goal of this project is to begin to the translation of decades of basic science research and research in the mouse model into the human system. It is believed that properly defining this B cell subset in humans will lead to better therapeutics, prognostics and prevention for a number of disease including infections, autoimmune disease, and cancer.

Eligibility Criteria:
Inclusion Criteria:

* Subject is considered by the physician to be a healthy adult.

Exclusion Criteria:

* Subject is under the age of 18
* Subject has an infection or is currently ill
Study Comparing the Efficacy of Two Ibuprofen Formulations

This is a study of healthy volunteers to compare how quickly different ibuprofen products relieve dental pain.


Eligibility Criteria:
Inclusion criteria :

* Outpatients with post-operative pain following surgical extraction of third molars,
* examined by the attending dentist or physician and medically cleared to participate in the study,
* in general good health and have no contraindications to the study or rescue medication.

Exclusions criteria:

* any serious medical condition,
* acute localized dental infection at the time of surgery ,
* females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception.
Efficacy and Safety of Bevacizumab Versus Pulvis Talci in Malignant Pleural Effusion

Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Background： Patients with Malignant pleural effusion can be diagnosis advanced cancer. Currently recognized as the most reliable method to control malignant pleural effusion is pleural fixed or thoracic catheter drainage. The most effective pleural fixed agent is pulvis talci, but there are about 30% relapse rate. Thoracic drainage can lead to some complications, such as chest infections, catheter migration and blockage etc. The investigators need a reliable methods to solve dyspnea and other symptoms caused by malignant pleural effusion, and improve quality of life. The purpose of this study was to determine the efficacy and Safety of intrapleural Bevacizumab versus pulvis talci as treatment for malignant pleural effusions (MPE) in patients.

Methods:

A unblended, randomized study to compare the inhibition of two treatment methods in malignant pleural effusion. Consecutive 183 patients were randomly assigned to two groups, A group is Bevacizumab200mg by intrapleural administration; B group is injected pulvis talci with closed thoracic drainage.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnose malignant pleural effusions by:

   * Diagnose malignant pleural neoplasms by histopathology
   * Recurrent pleural effusion, Histologically or cytologically confirmed diagnosis of cancer
2. Written informed consent

Exclusion Criteria:

1. \<18years of age
2. Expected survival \<3 months
3. Chest infection, chylothorax, pleurodesis or ipsilateral lung surgery once
4. Planned chemotherapy
5. Pregnancy or breast-feeding (women of child-bearing potential)
6. Not signed informed consent or non-compliance with treatment protocols
Sleep Disorders After TIPS

The Purpose of a study to investigate the incidence of postoperative sleep disorders in patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the relationship between risk factors and prognosis of sleep disorders.


Eligibility Criteria:
Inclusion Criteria:

1. History of cirrhosis (clinical or by liver biopsy)
2. Portal hypertension patients with defined indications for TIPS treatment
3. Aged 18-75 years old
4. Signed written informed consent

Exclusion Criteria:

1. mental or nervous system diseases
2. Patients with alcoholic cirrhosis who are still drinking
3. Accompanied by serious heart, lung, brain and kidney diseases
4. Preoperative diagnosis of sleep disorder
5. Patients who are illiteracy
6. The total score of the preoperative Hamilton anxiety scale was greater than or equal to 14 points, and the total score of 17 points of the Hamilton depression scale was greater than or equal to 18 points