cyrilzakka/clinical-trials huggingface dataset:
Long-term Impact of Pulmonary Rehabilitation

This study has been designed to capture a large group of patients who undergo pulmonary rehabilitation and map their progression over a 5 year time-frame.

The outcome measures have been chosen to capture physiological, functional capacity, free-living activities plus admission and exacerbation rates thereby enhancing our understanding of the potential effects exercise and self management techniques may have on the disease progression.

Pulmonary rehabilitation has not been shown to reduce inflammation; therefore, unlike acute exacerbation's where a decrease in inflammation indicates recovery, the exact mechanisms responsible for improvement during pulmonary rehabilitation are as yet unknown.

The benefits of pulmonary rehabilitation are well documented elsewhere, however, the exact mechanisms responsible for these significant improvements and alteration of the disease progression are unexplained. Also unexplained is the apparent lack of carry over of functional capacity into free-living activities as measured by activity monitors.

There are no reported effects on decreasing level of inflammatory cytokines or C-reactive protein (CRP) post rehabilitation, however, a training response to reactive oxidative stress (ROS) after a moderate intensity pulmonary rehabilitation programme has been reported. As oxidative stress is a catalyst to inflammation, a training response to exercise induced ROS in patients with COPD may also have a secondary effect of modifying inflammation in the stable COPD patient thereby improving patient outcomes.

No studies to-date have combined free-living activities, biomarkers and standard outcome measures in patient's pre and post pulmonary rehabilitation or follow-up patients over a five year period.

Subjects referred to pulmonary rehabilitation who fulfil the GOLD criteria for COPD will be recruited on a rolling basis and randomly allocated to one of two groups. Group 1 (Control), Group 2 (Intervention).

It is a multi-centred, randomised controlled trial using the above convenience sample of patients referred to pulmonary rehabilitation who meet the inclusion/exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of COPD based on the GOLD staging of the Disease
2. MMRC score of 3 or above
3. Ability to mobilize independently
4. Willing to comply with the home exercise and inspiratory muscle training programmes
5. Willing to wear the SenseWare Armband
6. Optimal medical management
7. No adverse effects to exercise testing
8. Patient's awaiting lung transplant

Exclusion Criteria:

1. Evidence of ischemic heart disease/acute changes on ECG
2. Uncontrolled hypertension
3. Insulin dependent diabetes mellitus
4. Uncontrolled CCF / idiopathic cardiomyopathy
5. Reversible Asthma
6. A diagnosis of lung cancer/TB/recent pneumothorax/PE or pneumonia
7. Any musculoskeletal/neurological condition which would render the patient incapable of completing the course
8. Exacerbation of COPD within 4 weeks of program
9. Poor cognitive status
10. Previous attendance at a pulmonary rehabilitation program
To Investigate The Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04531083 In Healthy Male Subjects

The purpose of the study is to investigate the safety, toleration and pharmacokinetics of single oral doses of PF-04531083 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* young
* healthy
* male

Exclusion Criteria:

* elderly
* unhealthy
* female
Narrow Band Imaging (NBI): A Novel Imaging Modality in Minimally Invasive

The purpose of this study is to determine whether narrowband imaging (NBI) makes it easier for a surgeon to see cancer.

NBI is a kind of light. Normally, white light is used during surgery. White light uses many wavelengths of light. NBI only uses two wavelengths which highlight the blood vessels. This makes it easier for the surgeon to see blood vessels. Tumors often have more blood vessels than normal tissue. As a result, NBI may make it easier for the surgeon to see small tumors.

In this study the surgeon will look with both normal white light and NBI. This way a comparison can be made to determine which is superior.

Improved identification of tumors allows doctors and patients to make informed decisions about whether treatment is needed after surgery. It also provides additional information to determine which treatments may be best.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet one (or more) of the following criteria:
* Preoperative diagnosis of ovarian, fallopian tube, or primary peritoneal carcinoma (all stage, grade and histology)
* Preoperative diagnosis of grade III endometrial carcinoma (all stage, all histology)
* Preoperative diagnosis of uterine serous carcinoma (all stage, all grade)
* Preoperative diagnosis of clear cell endometrial carcinoma (all stage, all grade)
* Preoperative diagnosis of endometrial carcinosarcoma (all stage, all grade)
* Gastrointestinal carcinoma (all histology, stage and grade)
* Pancreatic carcinoma (all histology, stage and grade)
* Lung cancer (all histology, stage and grade)
* Esophageal carcinoma (all histology, stage and grade)
* Suspected or pathologically confirmed metastatic disease to the lung (all disease primaries)
* Suspected or pathologically confirmed malignant pleural effusion (all disease primaries)

Patients must meet all of the following criteria:

* Planned thorascopic robotic or laparoscopic surgical approach
* \>18 years old
* Not pregnant
* Able to give consent Participation in other research protocols does not exclude a patient from participation in this study.

Exclusion Criteria:

* None
National Survey About Trajectory and Life Conditions of HIV Trans People in France

TRANS\&VIH is a national survey that will explore condition of vulnerability and trajectory of transgender people living with HIV. To fulfill this purpose, clinical data from medical registry and socio-behavioral information collected through questionnaire, will help to explore this questions about vulnerability and condition of transgender people living with HIV.

In France, transgender still a taboo subject, and is poorly documented. There are no precise data on the number of transgender people in France or on their socio-demographic characteristics. The absence of such data reinforces their invisibility in social life and contributes to their stigmatization. Transgender people faces many social barriers in our society. These barriers accumulate in HIV seropositive transgender people (TRHIV), and most likely increase the burden of HIV infection. The main objective of ANRS TRANS\&VIH - the community-based research study presented here - is to identify personal and social situations of vulnerability for TRHIV in France, the obstacles for receiving medical care, and their healthcare needs.

ANRS TRANS\&VIH is an ongoing national, exhaustive, cross-sectional survey of all TRHIV currently followed up in HIV services in France. It is a mixed-methods study, the quantitative and qualitative components includ TRHIV women and men, respectively. Socio-behavioral and medical data are collected (start date January 2021) by community-based interviewers in participating hospital-based HIV structures in order to explore patient care pathways and living conditions of the TRHIV population with regard to transitioning and HIV. This is the first study in France to collect such data. The statistical techniques used for the data analyses will reflect the study's objectives and will be adapted to the type of data collection used: cross-sectional (questionnaires) and longitudinal (life history). Several types of analyses will be performed, including: (i) a description of the individual characteristics of transgender female TRHIV; (ii) comparative analyses between different groups of stakeholders (e.g., differences between the Ile de France region (which covers Paris and the surrounding area) and other regions); (iii) analysis of life and HIV trajectories; (iv) structural analyses using structural data collected for participating HIV structures (v) qualitative analysis of data from interviews with participating TRHIV men.

ANRS TRANS\&VIH results will be used to make recommendations to health authorities to ensure that a comprehensive healthcare package will be offered to TRHIV which takes into account this population's specific background and problems.

Eligibility Criteria:
Inclusion Criteria:

* transgender woman or transgender man
* living with HIV
* followed in hospitals in metropolitan France and the country's overseas territories
Skeletonised Versus Pedicled Internal Thoracic Artery

It is to date unknown whether Thunderbeat has a place in harvesting the left internal mammary artery (LIMA) and whether skeletonisation is superior to pedicle harvested LIMA. Though, some studies have shown improved flow-rates in the skeletonised graft while others shows compromised blood flow to the thoracic wall after pedicle harvested LIMA.

The purpose of this study is to improve the quality of life for patients undergoing coronary artery bypass graft (CABG) operations.

The aim of this study is to compare three groups of LIMA harvesting techniques: Pedicled, surgical skeletonised and skeletonised with Thunderbeat to determine the best way to harvest LIMA during CABG operations.

The study design is an experimental randomized controlled trial in a single centre.

Study population: Adult patients enlisted for elective stand-alone CABG surgery at the Department of Cardiothoracic surgery, Odense University Hospital.

Study Unit: Test-days within subject and subject

The study will address two main hypotheses in CABG patients:

1. That both the surgical skeletonised and Thunderbeat skeletonised harvesting techniques of LIMA are superior to pedicled harvesting in regards to flowrates and pulsatility index (PI).
2. Skeletonized harvesting of LIMA graft compared to pedicled harvesting improves patient quality of life three days, 30 days, and six months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Stand-alone CABG (surgical removal of the left atrial appendage (LAAX) is accepted, since it doesn't affect the graft area)
* On-pump with cardioplegia (otherwise one cannot be sure of the pressure and perfusion during surgery of the graft)
* Patients aged \>18
* Elective surgery (there is a known higher risk of postoperative complications with urgent surgery)

Exclusion Criteria:

* CABG combined with other heart surgery, except from LAAX
* Previous heart surgery
* LVEF \< 40% (there is a known higher risk of postoperative complications with low LVEF)
* Known cancers (there is a known higher risk of postoperative complication)
* Thoracic radiation therapy (there is a known higher risk of postoperative complication)
* Severe chronic obstructive pulmonary disease (COPD) (there is a known higher risk of postoperative complication)
* Patients not able to understand written consent
* Urgent and emergent surgery (there is a known higher risk of postoperative complication)
An Observational Exploration of Clinical Trials Targeting Traumatic Brain Injury

Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about traumatic brain injury clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with traumatic brain injury who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with traumatic brain injury
* Patient has self-identified as planning to enroll in an observational clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* Pregnant or nursing patients
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury

Hypothesis: That SPECT brain imaging tracks and is consistent with clinical improvements in patients receiving hyperbaric oxygen therapy (HBOT) for chronic traumatic brain injury.

The study is a retrospective chart review of patients with chronic neurological, emotional, social, and cognitive deficits from mild, moderate, or severe traumatic brain injury who underwent SPECT brain imaging as part of their evaluation and treatment with hyperbaric oxygen therapy in my practice over the last two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical and cognitive testing.

Eligibility Criteria:
Inclusion Criteria:

* Adults or children with traumatic brain injury at least one year old

Exclusion Criteria:

* None
Palliation: the Effect of Education on Pain

Rationale: Although radiotherapy is an effective palliative treatment for patients with painful bone metastases with over 70% responders, pain intensity is not always sufficiently controlled. Recent analyses from the randomized Dutch Bone Metastasis Study on 1157 patients show that during weekly follow up, 35% of the patients remain above a pain intensity level of 4 on a numeric rating scale (range 0-10) despite pain medication. According to the WHO criteria, a pain intensity of 5 or higher prompts treatment. As advised in the CBO guideline 'Pijn bij Kanker' educating patients can improve patient empowerment and thereby pain control. However, the effect of a nurse-led education of patients undergoing palliative radiotherapy for painful bone metastases has not been investigated yet.

Objective: This project investigates whether nurse-led pain education in addition to standard care results in better control of pain in patients referred for palliative radiotherapy.

Study design: A national multicenter phase 3 study (n=450).

Study population: Patients with painful bone metastases referred for short schedule radiotherapy.

Intervention: Patients will be randomized between standard care or standard care with the Pain Education Program, a nurse-led pain education. The pain Education Program will be provided on the same day the radiotherapeutic treatment will start. The nurse will first assess the knowledge of a patient based on a structured interview. Thereafter, lacunas will be taught using the 'Pijninstructie Programma' (Pain Education Program). In addition, nurses will telephone patients at regular intervals during follow-up to monitor their needs.

Main study parameters/endpoints: The primary outcome of this randomized multicenter study is a decrement of the number of patients whose worst pain intensity remains above 4 at any time during the 12 weeks of follow up with regard to the control group. The secondary outcome is improvement of quality of life.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All patients will fill out the Brief Pain Inventory, the EORTC QLQ-C15-PAL and the EORTC QLQ-BM22 at baseline and, thereafter, weekly for 12 weeks after randomization.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* uncomplicated painful bone metastases
* primary malignancy is a solid tumour
* pain intensity on a numeric rating scale of 5 or higher
* indication for short-term radiotherapy
* able to fill out Dutch questionnaires
* able to follow instructions
* informed consent provided

Exclusion Criteria:

* Hematological malignancy
* Long-term schedule radiotherapy
* Life expectancy shorter than three months
* Karnofsky Performance Score of 40 or less
Platelets Study: Influence of the Antiretroviral Treatment on the Platelet Physiology During HIV Infection

HIV infection is associated with an immune activation and an inflammatory response - despite an active antiretroviral therapy - which may lead notably but not exclusively to cardiovascular diseases. It has been shown that the use of Protease Inhibitors (PI) instead of Non Nucleosidic Inhibitors (NNRTI) may increase the risk of myocardial infarction. Platelets may play a role in the occurrence of the inflammatory state: they contain big amounts of chemokines, growth factors, and adhesion proteins. Today, the contribution of platelets to the inflammatory state associated with HIV infection has been little studied. Thus, it has been shown that platelets in HIV patients are able to release interleukin (IL)-18. The group has shown with others that the platelet function could be altered during HIV infection. Inversely, it doesn't know how antiretroviral therapy interacts with platelets.

The aim of the study is to evaluate, according to the antiretroviral therapy, the impact on the platelets activation markers.


Eligibility Criteria:
Inclusion Criteria:

* Unchanged antiretroviral therapy for at least one year
* Plasmatic viral load \< 40 copies/ml.
* signature of informed consent

Exclusion Criteria:

* Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HVC) coinfection
A Study Based on Health Insurance Data About the Treatment of Patients Who Have Been Newly Diagnosed With Chronic Obstructive Pulmonary Disease (COPD)

A retrospective analysis study in COPD patients for an exact follow-up period of 12 months (in subgroup analyses: 24 and 36 months); censoring of patients will only be done in case a patient died during the respective follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* All patients who were continuously insured by the sickness fund for the entire period (01/01/2013-30/06/2018) or, in case a patient deceased after index date, for the time until death
* A patient will be included as an incident COPD patient if either a hospital documented at least one COPD diagnosis (International Statistical Classification of Diseases and Related Health Problems (ICD-10 J 44.-) or a specialist (pneumologist) documented at least 2 confirmed COPD diagnoses (above ICD-10) code) in two different quarters; the first of the above diagnoses is defined as index diagnosis; inclusion period is defined as lasting from 01/01/2014 until 30/06/2017
* Patients should not have received any COPD diagnosis (ICD-10 J44.-) or any COPD-associated medication in the 12 months pre-index period
* Patient should have, at date of incident COPD diagnosis (index date), an age of at least 40 years

Exclusion Criteria:

* Patients received , at least one confirmed inpatient asthma diagnosis or two confirmed outpatient diagnoses of asthma (ICD-10: J45) by pneumologists
Medical Records Investigation of Whether Perioperative Dexmedetomidine Will Reduce the Duration of Mechanical Ventilation or Hospital Length of Stay in Patients Undergoing Minimally Invasive Cardiac Surgery

The concept of enhanced recovery after surgery (ERAS) is utilizing in multiple specialties widely. Early tracheal extubation is one of the components of ERAS that enhances postoperative recovery and reduces the length of stay in intensive care unit (ICU).Dexmedetomidine is a highly selective, shorter-acting α2-adrenergic receptor agonist that has both analgesic and sedativeeffects.It was associated with decreased mortality, time to extubation, and hospital length of stay in cardiac surgical patients according to previous studies.The purpose of this study was to investigate the effect of perioperative dexmedetomidine on patients undergoing minimally invasive cardiac surgery(MICS) who were early extubated after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergone minimal invasive off-pump coronary artery bypass graft (CABG), valvular surgery or combined procedures at Far Eastern Memorial Hospital, New Taipei City, Taiwan between January 1, 2020 and August 31, 2020.
* Age above 20 y/o

Exclusion Criteria:

* Emergency surgery
* Postoperative mechanical ventilation more than 6 hours
* Extubated in the operating room
Dose Finding Study of a DNA Vaccine Delivered With Intradermal Electroporation in Patients With Prostate Cancer

This study will assess the feasibility and safety of vaccination with increasing doses of xenogenic DNA administered intradermally in combination with electroporation in patients with relapse of prostate cancer. The DNA encodes prostate specific antigen (PSA) from Rhesus Macaque (Macaca mulatta), a protein that is 89% homologous to human PSA. The study will also assess the safety and functionality of the DERMA VAX™ (Cyto Pulse Sciences) DNA vaccine delivery system.


Eligibility Criteria:
Inclusion Criteria:

* Male patients. Age \>18 years.
* HLA-A\*0201 positive.
* Histologically confirmed prostate cancer.
* Minimum two (2) and maximum four (4) years after treatment with curative or salvage radiotherapy.
* Serum testosterone within normal range.
* Increasing PSA from a previous reference value on two (2) consecutive occasions at least one month apart and with a minimum of 2 ng/mL above nadir.
* PSA doubling time is one (1) year or less.
* No evidence of metastatic prostate cancer.
* Karnofsky performance status ≥ 80.
* Adequate organ function:

  * AST and ALT ≤ 2.0 x upper limit of normal (ULN); total serum bilirubin ≤ 1.5 x ULN
  * Calcium ≤ 2.6 mmol/L, serum creatinine ≤ 1.5 x ULN
  * Hb ≥ 100 g/L; absolute leukocyte count ≥ 3.0 x 109 /L; platelets ≥100 x 109 /L
* Life expectancy ≥ 12 months.
* Swedish or English speaking subjects only.
* Written informed consent (subjects must be capable of providing their own informed consent).

Exclusion Criteria:

* Previous ablation of testis.
* Radiologic evidence of metastatic disease.
* Prior chemotherapy or investigational therapy/agents within 4 weeks.
* Active bacterial, viral or fungal infection.
* Carrier of HIV, HBV, or HCV.
* Immunosuppressed (post splenectomy, post stem cell transplantation) or on immunosuppressive therapy other than inhaled or replacement corticosteroids.
* Any other major illness or peripheral blood vein status that, in the investigator's judgement, will substantially increase the risk associated with sampling or participation in this study.
* Subjects with cardiac demand pacemakers.
* Any reason why, in the opinion of the investigator, the patient should not participate.
Measurement of Distinct Biological Pools of Hydrogen Sulfide in Women With Cardiovascular Disease

Cardiovascular disease which includes coronary artery disease and peripheral artery disease remains the leading cause of death among women in the United States. The impact of cardiovascular in women was not recognized by clinicians for a long time. It is now evident that, women suffer the consequences of cardiovascular at rates at least as high as those observed in men but there are still major gaps in our understanding this disease in women. Hydrogen sulfide (H2S), a gaseous mediator plays an important role in the cardiovascular system. Research has demonstrated it's critical role in animal ischemia reperfusion models. Hydrogen sulfide exists in distinct biological pools in blood. Recently, the Kevil lab has pioneered the development of new analytical techniques for accurate measurement of all biological pools of H2S. By measuring these distinct pools of H2S in women with and without cardiovascular disease the investigators hope to further understanding of role of H2S in pathophysiology of cardiovascular disease. This research will help to assess the ability of H2S and its distinct biological pools to potentially be a diagnostic marker or a therapeutic target for cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting to the cardiac catheterization laboratory for coronary or peripheral angiography.
2. Females,Age\>40years

Exclusion Criteria:

1. Inability to provide informed consent.
2. STelevationmyocardialinfarction.
3. Cardiogenicshock.

3. ABI \>1.4 (indicative of non-compressible vessel needing further evaluation to diagnose PAD), unless documented known PAD. 4. Non-atheroscleroticPAD(e.g.Buerger'sdisease). 5. Enrolment in another clinical trial with use of experimental therapeutic agents.