cyrilzakka/clinical-trials huggingface dataset:
Physical Activity and Breast Cancer Risk in Postmenopausal Women:the SHAPE Study

Purpose of the SHAPE study is to examine the effects of an 1-year exercise programme on endogenous hormone levels associated with breast cancer among sedentary postmenopausal women and whether a decrease in intra-abdominal fat is associated with a lowering of these hormone levels.

Physical activity has been associated with a decreased risk for breast cancer. The biological mechanism(s) underlying the association between physical activity and breast cancer is not clear. Most prominent hypothesis is that physical activity may protect against breast cancer through reduced lifetime exposure to endogenous hormones. Another hypothesis is that physical activity prevents overweight and abdominal adiposity.

In this intervention study, 189 sedentary postmenopausal women who are aged 50-69 years are randomly allocated to an intervention or a control group. The intervention consists of an 1-year moderate-to-vigorous intensity aerobic and strength training exercise programme. Participants allocated to the control group are requested to retain their habitual exercise pattern. Primary study parameters measured at baseline, at four months and at 12 months are: serum concentrations of endogenous estrogens, endogenous androgens, sex hormone binding globulin and insulin. Other study parameters include: amount of total and abdominal fat, weight, BMI, body fat distribution, physical fitness, blood pressure and lifestyle factors.

This study will contribute to the body of evidence relating physical activity and breast cancer risk and will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer in postmenopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 50 -69 year
* \> 12 months since last menses
* Non-smokers (at least 12 months)
* Sedentary
* Knowledge of the Dutch language
* Agreement to be randomly assigned to either the exercise intervention or control group
* Informed consent to participate in all screening and study activities

Exclusion Criteria:

* Use of hormone replacement or oral contraceptives in past 6 months
* Morbidly obese (BMI \> 40)
* BMI \< 22
* Currently on or planning to go on a strict diet
* Ever diagnosed with breast cancer
* Diagnosis of other types of cancer in the past 5 years
* Diabetes mellitus or other endocrine related diseases
* Disorders or diseases (locomotor, optical, neurological, mental) that might impede the participation in the exercise programme
* Alcohol or drug abuse
* Maintenance use of corticosteroids
* Use of beta blockers
Dose Escalation Study of Cyclophosphamide in HIV-Infected Subjects on HAART Receiving SB-728-T

The purpose of the study is to evaluate the safety, tolerability and effect on HIV viral load, of escalating doses of cyclophosphamide administered 1 day prior to SB-728-T infusion.

The objectives of the study are to augment HIV-specific T-cells and to reverse or decrease the progressive destruction of CD4+ T-cells that leads to clinical AIDS. Levels of engraftment vary from negligible to about 10% of the CD4+ T-cells in the vascular compartment. Preliminary analyses of HAART TI suggest that an anti-HIV effect may correlate with the level of SB-728-T engraftment. Concurrently, non-myeloablative lymphodepletion with cyclophosphamide has been demonstrated to enhance engraftment of adoptively transferred T-cells through a variety of mechanisms. The study is being undertaken to increase SB-728-T engraftment through the administration of low non-myeloablative doses of cyclophosphamide.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older with documented HIV diagnosis within 10 years of screening.
* Must be willing to comply with study-mandated evaluations; including discontinuation of current antiretroviral therapy during the treatment interruption.
* Must have received at least 6 months of continuous HAART therapy and have had undetectable VLs for the preceding 3 months.
* On stable antiretroviral medication (no changes to treatment within 4 weeks of screening.
* CD4+ T-cell count ≥500 cells/µL.
* Undetectable HIV-1 RNA obtained at screening.
* ANC ≥2500/µL
* Platelet count ≥200,000/µL

Exclusion Criteria:

* Acute or chronic hepatitis B or hepatitis C infection.
* Active or recent (in prior 6 months) AIDS defining complication.
* Any cancer or malignancy within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin or low grade (0 or 1) anal or cervical dysplasia.
* Current diagnosis of NYHA grade 3 or 4 CHF, uncontrolled angina or arrhythmias.
* History or any features on physical examination indicative of a bleeding diathesis.
* Received HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
* Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents within 30 days prior to screening.
* Use of Aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2 week period prior to leukapheresis.
* Currently participating in another clinical trial or participation in such a trial within 30 days prior to screening visit.
* Subjects who are currently taking maraviroc or have received maraviroc within 6 months prior to screening.
Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery

Postoperative nausea and vomiting (PONV) are common complications after surgery. Patients undergoing orthognathic surgery are reported to have a high rate of PONV, especially those undergoing bimaxillary surgery. Activation of cholinergic system plays an important role in the development of PONV. Penehyclidine is an muscarinic antagonists which selectively block M1 and M3 receptors and is commonly used to decrease oral secretion. The purpose of this retrospective cohort study is to investigate whether use of penehyclidine is associated with a reduced risk of PONV in patients undergoing bimaxillary surgery.

Postoperative nausea and vomiting (PONV) are one of the most frequent complications after surgery, and are associated with patients' dissatisfaction after anesthesia and surgery. Orthognathic surgery is widely performed for the correction of dentofacial deformities. PONV is common after orthognathic surgery. Despite of improved anti-emetic prophylaxis, patients undergoing orthognathic surgery are reported to have a high incidence of PONV, especially those after bimaxillary surgery.

It is known that activation of central cholinergic system plays an important role in the development of PONV. Muscarinic antagonists such as scopolamine can block muscarinic receptors in the cerebral cortex and produce anti-emetic effects. Penehyclidine is a new muscarinic antagonists which selectively block M1 and M3 receptors. It has fewer adverse effects compared with other anticholinergics. The purpose of this retrospective cohort study is to investigate whether use of penehyclidine is associated with a reduce risk of PONV in patients undergoing bimaxillary surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥16 years;
* Underwent elective bimaxillary surgery under general anesthesia.

Exclusion Criteria:

* Age \<16 years;
* Missing data.
How Does Your Genetic Make-up (Profile) Influence Your Glaucoma?

Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic nerve. Research has shown that certain genes may cause glaucoma in some cases. So far, research has only been able to find the genes responsible for glaucoma in a small percentage of people who have glaucoma. The purpose of this project is to study the genes in patients with and without glaucoma to find additional genes that may be responsible for causing glaucoma.

Four tubes of blood will be taken from 100 people. Of those, half will have primary open angle glaucoma (POAG) and the other half will be controls (normals), half will be caucasians and the other half will be african americans, half male and half female. All groups will have a routine ophthalmic eye exam, color vision, snellen vision, and visual field done.

Eligibility Criteria:
Inclusion Criteria:

* 40 yrs
* Caucasian or African American
* Male or female with POAG, PACG, PXFG,
* Normal

Exclusion Criteria:

* Other ophthamic co-morbidities
* Other ethnic groups
* Unable to understand and give informed consent
MyHealthKeeper: Clinical Trial Study Based on Personal Health Record Healthcare Management

In order to study the effectiveness of personalized healthcare intervention for lifestyle-related diseases, investigators designed this study using mobile application and clinical feedback from clinicians


Eligibility Criteria:
Inclusion Criteria:

* Study participants must agree to support by him/herself at enroll time
* Patients without severe cardiopulmonary disease, cancer, or other acute diseases
* Patients must be over BMI \> 23 kg/m2

Exclusion Criteria:

* Patient who did not agree with this study
* Patients with severe cardiopulmonary disease, cancer, or other acute diseases
* Patients who were pregnant
Paramedic Experiences and Perceptions of Training for Participation in Research: the PREPARE Study

The investigators are currently conducting a research study, called PRESTO, in the pre-hospital environment where the investigators are asking paramedics to talk to patients about participating in the research study, interpret a heart tracing (or ECG), take a blood sample and record some study specific information. Apart from ECG interpretation, these are activities that the paramedics would not normally do and so the investigators had to provide training in order to ensure that these activities were carried out to the same standard across the four ambulance services that were involved, all of who have different working practices.

In order to do this, the investigators provided a training package based around four subject areas - blood sample collection, heart tracing interpretation, background to the study and the importance of conducting the study activities to a high standard (called Research Fundamentals). These were presented to the paramedics either as online training or in a face-to-face session. There has been a mixed response to both the uptake in training across the four ambulance services and the engagement from paramedics in following PRESTO with a potential participant.

As more research is being done in the pre-hospital environment the investigators feel that it would be beneficial to try to find out why paramedics may or may not have taken part in the PRESTO training. To do this the investigators will be sending out a survey to each of the four ambulance services which will contain questions around whether the paramedics thought the training package for PRESTO was suitable, whether the paramedics felt confident following PRESTO with a potential participant after the training and what the paramedics think the main barriers are to participating in research. Up to 30 paramedics will also be approached to participate in an interview, which will explore these ideas further.

This should allow the investigators to identify potential barriers that prevent paramedics from taking part in training for research studies. It should also allow the investigators to offer insight to future researchers about the type of training that should be provided for paramedics for a research study and how it should be delivered.


Eligibility Criteria:
Inclusion Criteria:

* Staff that are employed by one of the four ambulance services involved in the PRESTO study

Exclusion Criteria:

* Staff that are not employed by one of the four ambulance services involved in the PRESTO study
Dabigatran Versus Warfarin Anticoagulation Before and After Catheter Ablation for the Treatment of Atrial Fibrillation

Both warfarin and dabigatran have been used for stroke prophylaxis at the time of catheter ablation of atrial fibrillation. Although the risks of thromboembolism and bleeding with warfarin are well established, the relative risk and benefit of dabigatran in this setting are unknown. The purposes of the study are to assess the efficacy of warfarin versus dabigatran in the prevention of stroke and other systemic embolic complications before and after catheter ablation for AF, and to compare the prevalence of serious bleeding complications with the two OAC agents.

* Data from patients collected from 4 US and 1 Canadian medical center
* Retrospective record review of all patients that had undergone catheter ablation of atrial fibrillation during the time period beginning with the initiation of dabigatran therapy for stroke prophylaxis at each center and ending in November 2011.
* Dabigatran study group comprised of all patients that received dabigatran for stroke prophylaxis during the study time period.
* Warfarin comparison group to be selected from all patients that received warfarin for stroke prophylaxis during the identical study time period.
* Warfarin patients will be numbered sequentially
* A subgroup of warfarin patients identical in number to the dabigatran patients at each center will be selected using random number generator.

Patient data sets will be de-identified and compiled

* Master data set to be stored in Excel file
* Statistics to be performed with SAS (Cary, NC)
* Continuous data to be expressed as means ± S.D., compared with unpaired t-tests
* Categorical data will be compared with Fisher's exact test or Chi-square
* Complications including any thromboembolic events or any bleeding events will be recorded and the prevalence compared.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing catheter ablation for atrial fibrillation

Exclusion Criteria:

* none (retrospective trial)
Tolerance, Efficacy, revAlidation, Myostim

Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament.

The food supplement (MYOSTIM®) has been developped and is supplied as food bars and composed of pomegranate, leucine, creatine, proteins and D vitamin. The aim of this exploratory study is to assess the efficacy and tolerance of MYOSTIM® on muscle performance after ACL reconstructive surgery and in postoperative revalidation phase.


Eligibility Criteria:
Inclusion Criteria:

* Male between the age of 18 and 40
* BMI (Body Mass Index) ≤ 27
* Candidates for ACL reconstruction surgery of DIDT (Droit Interne et du Demi Tendineux) type
* Able to follow the instruction of the study, to go to the postoperative visits to the investigator, to go to the isokinetic and to the MRI visits
* Having signed an informed consent

Exclusion Criteria:

Related to the pathology:

* Patient who have undergone previous ACL reconstruction surgery on the same knee
* Patient who have participated to a therapeutic clinical study 3 months before inclusion
* Patient who plan to follow a workout or a revalidation program after surgery different from classical physiotherapy prescribed by the orthopedic surgeon
* Contralateral limb suffered from trauma, surgery, fracture, tear, tendinopathy, sepsis or immobilization for more than 3 weeks during the last 5 years

Related to treatment:

* Patient who have eaten doping substances or food supplement building mass and muscle strength during 3 months before inclusion excepted for creatine and beta-alanine for which the washout period is of 6 month before inclusion
* Patient who were treated with antibiotics in the month preceding the inclusion
* Patient treated with pharmacologic agents like statins, immunosuppressors or anti-malaria
* Patient taking androgens (steroids...)
* Patient under treatments which may interfere with the neuromuscular system
* Patient who were treated with analgesic or non-steroidal anti-inflammatory drugs (NSAIDS) 24 hours before inclusion visit

Related to associated diseases:

* Patient with associated uncontrolled severe disease: severe liver or kidney disease, severe and uncontrolled cardiovascular disease, HIV, B or C hepatitis, tumor
* Patient with thromboembolism disorders
* Patient with inflammatory bowel disease
* Anorexic patient
* Diabetic patient
* Patient with traumatic, neurologic or rheumatic history of the lower limbs

Related to patient:

* Allergy or contraindication to soy, milk, gluten, nuts or wheat
* Forecasting a high protein diet during the study
* Under guardianship or judicial protection

Related to MRI counter-indication:

* Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump
* Patient with a ferromagnetic splinter in the body, or having wire sutures
* Serious mobility problem (Parkinson, tremors)
* Claustrophobia

Related to impedancemeter test:

• Patient with a metal plate at the right ankle
Remote Device Interrogation In The Emergency Department

A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the Emergency Department (ED). Two sites will enroll up to 100 patients total.

Expected duration of the study is 6 months. Once enrolled the patient will participate in the study for the duration of the Emergency Department stay, until discharged or admitted to the hospital.


Eligibility Criteria:
Inclusion Criteria:

1. Present to Emergency Department with an implanted pacemaker or defibrillator.
2. Are 18 years of age or older, or of legal age to give informed consent specific to state law.
3. Are willing and able to provide informed consent for study participation.

Exclusion Criteria:

* None
The Microbiological Spectrum in Acute Dacryocystitis

Acute dacryocystitis in adults can be a very painful disease and may not respond well to medical therapy.

The purpose of this prospective non-randomised study is to determine the microorganisms causing acute dacryocystitis and the antibiotic sensitivities of these organisms.

The study also aims to correlate the microbiological findings to the severity of clinical manifestations and evaluate the effectiveness of our current practice of aspiration and empiric systemic antibiotic therapy in treating patients with acute dacryocystitis and hence review whether there is a need to alter current management strategy.


Eligibility Criteria:
INCLUSION CRITERIA:

* Painful localised fluctuant induration just inferior to the medial canthal tendon of less than 2 weeks duration.

EXCLUSION CRITERIA:

* Non-fluctuant lacrimal sac swelling
* Uncooperative patient
* Unwilling Patient
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study

The oximeter is used to monitor intensive care patients undergoing oxygen therapy. It indicates pulsed oxygen saturation (SpO2), a reflection of arterial oxygen saturation (SaO2) which enables detection of hypoxemia and hyperoxia, both deleterious state. Current SpO2 recommendations aim to reduce both risk of hypoxemia and hyperoxia. SpO2 is considered the 5th vital sign.

Current recommendations for SpO2 targets do not consider the variability of oximeters used in clinical practice. This variability and lack of specification represent an obstacle to an optimal practice of oxygen therapy.

Thus, this study aims to compare the SpO2 values of different oximeters (General Electric-GE, Medtronic, Masimo and Nonin) used in clinical practice with the SaO2 reference value obtained by an arterial gas in order to specify the precision and the systematic biases of the oximeters studied. This data will also make it possible to refine the recommendations concerning optimal oxygenation


Eligibility Criteria:
Adult population

Inclusion Criteria:

* ≥ 18 years old (adult population) -
* Patients admitted to the Intensive Care Unit
* Artery catheter already installed

Pediatric population

* Below 18 years old
* Patients admitted to the Intensive Care Unit
* Artery catheter already installed

Exclusion Criteria:

* No or poor signal with the usual pulse oximeter/based on clinician judgment
* High dose of vasopressors or inotropes (epinephrine or norepinephrine ˃ 1mcg/kg/min), shock state (lactates above 3 mmoles/L)
* Pigmented nails or nail polish
* Methemoglobinemia history
* Hemoglobin below 80 g/L
* Patient in isolation (multi-resistant bacteria, C-Difficile, SARS-COV-2...)
* Prone position, Extra Corporel Membrane Oxygenator
The Use of Virtual Reality During Breast Ultrasound-Guided Biopsy Procedures

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.

Breast biopsies for patients with abnormal mammograms are required to identify cancerous tissue. Currently this procedure is done with or without a local anesthetic. Patients report anxiety regarding potentially having cancer and the possibility of cancer-related procedures. Different types of biopsies may have different pain and anxiety based on their duration and complexity. This research is designed to determine if VR simulated environment can reduce pain and anxiety.

The aim is to study the efficacy of a virtual environment in reducing pain and procedural anxiety. It is intended for patients undergoing an ultrasound guided breast biopsy procedure that have had an abnormal mammogram. The overall aim is to discover an efficacious nonpharmacologic method to lower pain and anxiety during a standard of care procedure.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained from the patient
* Females who are 18 years of age
* Patient is scheduled for preoperative ultrasound guided breast biopsy procedure

Exclusion Criteria:

* Patient is scheduled for a stereotactic biopsy procedure
* The patient has motion sickness
* The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English
* The patient has a history of seizures or epilepsy
* Refusal of patient to sign consent
A Retrospective Study to Collect the Data From the Patients Who Had the Perimount Heart Valve Replacement Surgery in China During 2001 to 2007

The objective of the study is to obtain the clinical data from patients who had the Perimount Heat Valve (Type:6900P and 2900) Replacement Surgery in Guangdong General Hospital during 2001-2007 in order to evaluate the performace of this heart valve prothesis and collect the patients' post-operation infomation including the current living status, mortality rate, and the possibility of re-operation，bleeding and thrombosis.

This is a retrospective , observentional clinical study to be conducted in Guangdong General Hospital in China. This study will enroll up to 200 patients.


Eligibility Criteria:
Inclusion Criteria:

* The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China
* The patients agree to join the study and sign the ICF

Exclusion Criteria:

* No specific exclusion criteria
Effect of Mechanical Ventilation on the Incidence of Pneumothorax After Subclavian Vein Catheterization

The purpose of this study is to determine whether mechanical ventilation influences the incidence of pneumothorax after subclavian venous catheterization.


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing neurosurgery that requires the placement of subclavian venous catheterization

Exclusion Criteria:

* infection over the puncture site
* history of prior clavicular fracture
* anatomical anomaly of subclavian vein
* Pneumothorax