cyrilzakka/clinical-trials huggingface dataset:
WBPS A Prospective, Method Comparison, Proof of Concept Study

The study will evaluate the accuracy of BP measurements by a new algorithm to be embedded to the existing CE-marked WinPack device, compared to two reference devices (one oscillometric and one volume-clamp device), in healthy subjects and patients undergoing a standardized physical-activity hypertensive protocol.

Current standard for patient monitoring in acute care such as intensive care units (ICU), operating rooms (OR) or emergency rooms (ER) is the use of expensive, bulky and uncomfortable monitors.

Unfortunately, once discharged from the acute care setting and transferred to a general division for example (low acuity), patients are left with manual measurements of vital signs every 4 to 6 hours, depending on the available resources in nursing. Furthermore, these measurements reflect only the results of the time the measurement is taken (spot check). The combination of manual spot checks and lack of innovative medical technology in 60% of hospital care settings (all non-ICUs and non-OR) represents an important limitation to patient follow-up, with its associated risks and costs.

In particular, when referring to the monitoring of blood pressure (BP), current monitoring practice relies on the use of occlusive pneumatic cuffs inflated around the arm. Based on oscillometric technique, occlusive cuffs not only are uncomfortable, but they provide only intermittent measurements, with the inability to provide a full view of the BP regulation landscape. Therefore, un-detected hypertensive events can be omitted, putting the patient at risk.

The continuous, comfortable and portable measurement of BP in low acuity hospital departments is a major unsolved problem of modern healthcare systems with regards to patient monitoring and safety.

Winmedical (device manufacturer) commercializes a wearable multi-parametric modular medical system, WinPack, to deliver continuous real-time monitoring and recording of vital signs, such as electrocardiography (ECG), respiration rate, BP, blood oxygen saturation, body temperature, and posture, in low-acuity departments to increase the overall clinical performance. A new algorithm to process the raw physiological signals acquired by the WinPack to provide more accurate and more continuous BP measurement is now to be tested.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Informed Consent
* Compliant and able to protocol manoeuvres

Exclusion Criteria:

* Blood pressure difference between to arms \>15mmHg
* Current or history of tobacco smoking (for the last 5 years, \> 5 cigarettes per day),
* Current alcohol or drug abuse (\>4 units per day),
* Unstable cardiac condition (myocardial infarction \< 1 week, pulmonary embolism, ventricular arrhythmia, decompensated heart failure)
* Severe anaemia (haemoglobin \<100g/l)
* Oxygen therapy
* Lesion or deficiency on left hand, preventing to perform handgrip exercises
* Lesion or deficiency on both legs, preventing to perform leg extension exercise
Epidemiology of Injuries During Crossfit Practice

This study aims to precisely describe epidemiology of injuries than occur during practice of crossfit. Each participant will complete questionnaires in order to identify injuries. The first questionnaire will be completed at the moment of the inclusion and the second questionnaire will be completed if participant has injuries every 3 months until month 12.


Eligibility Criteria:
Inclusion Criteria:

* person affiliated to a crossfit structure at Reunion Island at the beginning of the study
* personne who agrees to participate in the study

Exclusion Criteria:

* person under tutorship or curatorship,
* person whose the initial questionnaire initial is complete,
* person who can neither read nor write french.
* person planning to leave Reunion Island within 12 months after enrolment in the study
Music Mindfulness Study 2a.

Mental health vulnerability due to stress is increased in People of African Descent (PADs) in America due to disproportionate effects of racism, poverty, education, and criminal justice sentencing. Various meditation and mindfulness approaches have provided evidence of measured reductions in multiple negative dimensions of stress. However, the majority of these studies do not have an adequate representation of PADs or other marginalized groups and are not designed to be culturally relevant or community based. Music has been shown to alleviate multiple symptoms of stress and has been shown to be a preferred and effective support for meditation and mindfulness. However, its role in stress management in PADs engaged in meditation or mindfulness is seldom studied. This study aims to evaluate the effects of a virtual, community-based music mindfulness program on stress management in PAD community members with anxiety and depression during COVID19.

Music Mindfulness Study: Investigators will compare the effects of music-backed guided mindfulness mediation and guided mediation alone in alleviating anxiety and depression.

Investigators hypothesize that this intervention will lead to reductions in scores on stress scales and will provide preliminary data for studies evaluating these types of community programs as an adjunct to the standard of care.

Participants will be screened, consented, and enrolled into either a 2-week pilot study (to test the feasibility of the experiment) or an 8-week full length study. The focus of this registration is the 8-week full length study.

Upon completion of the study, participants will be asked to take part in a focus group that will provide valuable feedback on their experience with the mindfulness intervention.

Eligibility Criteria:
Inclusion Criteria:

* symptoms of anxiety or depression assessed by PHQ9 (\>9) and GAD7 (\>9)

Exclusion Criteria:

* Component 2a
* PHQ-9 \<9, GAD7 \< 9
* regular meditation practice of at least once a week
* has taken meditation course or intervention in the past year
* any hospitalizations in the last 6 months
* suicidal ideation, self-injurious behavior, or homicidal ideation at screening
* active audio-visual hallucinations or other signs of psychosis
* diagnosis of a seizure disorder or other neurological disorder that precludes outpatient participation
* history of thyroid or cardiovascular disease
* current substance use disorder
Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
* Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject's parent/guardian.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
* History of hypersensitivity to any vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
* Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
* Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Single Incision Versus Conventional 3-Port Laparoscopic Appendectomy

A randomized trial to study the null hypothesis:" single incision appendectomy does not take longer operation time when compared to conventional 3-port appendectomy". The study will be carried out in a tertiary referral center in Hong Kong with a catchment population of 1 million.

Since the introduction of single incision laparoscopic surgery (SILS), this approach has become more popular and various case series and reports had described its feasibility in many general surgical procedures including appendectomy, cholecystectomy, and colectomy. Despite this, strong evidence in support of SILS to be equivalent or even superior to conventional multi-port approaches remain scarce, although there are case series and comparative studies with promising results in cholecystectomy and colectomy. There are many case series available stating that single incision appendectomy may be a feasible alternative to conventional approach, but may be at the expense of a longer operating time and a higher post operative wound pain score. A recent randomized trial by St. Peter et al. was the first to test the feasibility of this approach to standard 3-port approach in appendectomy in children. Under randomized settings of this trial the single incision appendectomy produced longer operating times and resulted in greater charges. However, the primary outcome measure in this trial was wound infection and the result showed no significant differences between the two approaches. The answer to whether single incision appendectomy produces a longer operating time when compared to conventional 3-port approach remained undetermined, in particular the adult population, and therefore a randomized trial design based on operating time as its primary outcome is desired.

Eligibility Criteria:
Inclusion Criteria:

* appendicitis score \>5, imaging showed no complication from appendicitis

Exclusion Criteria:

* pregnancy, mentally incapacitated, previous surgery
fMRI Analysis of Aging and Awareness in Conditioning

Cathodal Transcranial direct current stimulation (tDCS) was administered to the right parietal region in order to determine if this stimulation could disrupt awareness of the conditioned stimulus (CS) - unconditioned stimulus (US) relationship in a classical conditioning experiment.


Eligibility Criteria:
Inclusion Criteria:

* Educational attainment of at least eight years and English as the native language
* Mini-Mental State Examination (MMSE) score of 26
* Normal episodic memory (i.e., CERAD word List Recall \> 5)
* Informed consent; 5) age of 20-30

Exclusion Criteria:

* Disturbed consciousness
* Other neurological or systemic disorder which can cause dementia or cognitive dysfunction
* Prior history of a major psychiatric disorder
* History of definite stroke
* Focal lesion on MRI exam
* Use of anxiolytic, antidepressant, neuroleptic, or sedative medication
* Predominately left-handed
* Has MRI contraindication such as pacemaker, implanted pumps, shrapnel, etc. (full MRI screening form will be filled out).
Motivational Parameters Associated With Physical Activity and Sedentary Behaviors Among Persons With Chronic Diseases

The principal aim of these researches is to explored the role of motivational parameters, including: automatic and controlled psychological processes and self-regulatory capacities, in physical activity and sedentary behaviors adoption and maintenance. Precisely investigators are interested in change in motivational and self-regulatory processes during rehabilitation programs and their prospective influences on self-reported and objective behaviors among persons with chronic diseases.

Automatic processes refered to implicit attitudes measured through the implicit association test (IAT) and single category (SC-IAT). Controlled processes refered to the variables of the Theory of Planned Behavior measured by questionnaire. Self regulatory capacities refered to the concept of impulsivity measured by questionnaire and executive functions measured through the STROOP task and Wisconsin Card Sorting Task.

Physical activity and sedentary behaviors are measured by questionnaire and accelerometry.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Under health care coverage

Exclusion Criteria:

* medical contra-indication to exercise
* concerned by acute health procedure
* enable to completed computerised tests and questionnaires
* Under psychiatric treatment
Post Market Clinical Follow-Up Study in Patients Treated with the On-X Ascending Aortic Prosthesis (AAP)

The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.

In this study patients will be observed that receive an On-X AAP implant for the treatment of a diseased, damaged, or malfunctioning native or prosthetic heart valve. The On-X AAP will be implanted at the discretion of the treating physician. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the On-X AAP. Written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient in Europe and every patient that is alive in the US prior to data collection where required. In Europe, every patient will be enrolled prospectively prior to the intervention.

In the US, patients can be enrolled retrospectively after the intervention or prospectively prior to the intervention. The data from patients who have died following their implant will be recorded in the database without the requirement for written informed consent after IRB approval.

The period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the surgery for each patient.

Echocardiography images at prior to discharge, at 12 months, 60 months will be evaluated by a CoreLab. All adverse events defined in the Clinical Event Committee (CEC) charter will be adjudicated by the CEC.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age at time of On-X AAP implant
* Patient understands and has signed the Informed Consent Form:

  * Prior to implant of On-X AAP or
  * Post implant (US only) or
  * Patient died prior to enrollment (US only)
* Patient is willing and able to participate in follow-up

Exclusion Criteria:

* Patient unable to tolerate anticoagulation therapy
* Patient with active endocarditis at the time of his / her On-X AAP implant
* Patient participates / participated in another clinical investigation which may interfere / may have interfered with the effectiveness of anticoagulation therapy
* Patient has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
* Patients in which On-X AAP is implanted in combination with AMDS or FET
* Patient's life expectancy is less than 3 years in the opinion of the Investigator
A Study to Evaluate the Effect of Mipomersen on Cardiac Repolarization Conducted in Healthy Subjects

To assess the electrocardiogram (ECG) effects of mipomersen administered as a 200-mg subcutaneous (SC) therapeutic and a 200-mg intravenous (IV; \[2-hour infusion\]) supra-therapeutic dose relative to placebo in healthy adult male and female subjects; and to evaluate the safety and pharmacokinetics (PK) of mipomersen when administered as a single therapeutic (200 mg) SC and a single, supra-therapeutic (200 mg) IV dose.

This will be a randomized, double-blind, single-site, crossover study in healthy male and female subjects to determine if mipomersen administered as a single therapeutic (200 mg) SC and a single supra-therapeutic (200 mg) IV dose delays cardiac repolarization as determined by the measurement of QT/corrected QT (QTc) interval. A total of 60 healthy male and female subjects will be enrolled in this 4-way crossover study, randomly assigned to 1 of 8 treatment sequences, and cross over into 4 treatment periods where each subject will receive both a single SC injection and a single IV infusion during each period.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided before any study-related procedures are performed.
* Body mass index (BMI) of 19 to 32 kg/m2 inclusive.
* Subjects can not have consumed nicotine or nicotine-containing products for at least 6 months before Screening.
* Subjects are nonpregnant and nonlactating, surgically sterile, postmenopausal, abstinent, or subject or partner is willing to use a reliable method of contraception during the study and 5 months after the last dose of investigational product.

Exclusion Criteria:

* History of risk factors for Torsades de Pointes, known Long QT Syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments or family history of Long QT or Brugada Syndrome.
* Abnormal screening ECG that is interpreted by the Investigator to be clinically significant.
* Use of concomitant medications (prescribed or over-the-counter), without the approval of the Investigator and Sponsor, within 7 days before the first dose of investigational product.
* Clinically significant abnormal findings on the physical examination, ECG, blood pressure, heart rate, medical history, or clinical laboratory results at Screening or before dosing.
* History of clinically significant allergies or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Positive test for HIV antibody, hepatitis C antibody, or hepatitis B surface antigen.
* Positive test for drugs of abuse, alcohol, or cotinine at Screening or before dosing or history of drug or alcohol abuse or dependence within 1 year before Screening.
* History of cancer, with the exception of basal cell carcinoma.
Ileal Interposition With Sleeve Gastrectomy for Control of Diabetes

Ileal interposition shifts a segment of ileum proximally to achieve maximal meal stimulated Glucagon-Like Peptide-1 secretion and coupled with a limited/complete sleeve gastrectomy (depending on the Body Mass Index), for Ghrelin reduction, helps in achieving good glycemic control in Type 2 Diabetes patients.

Laparoscopically, using 6 ports, the ileum is tarnsected at 30 cms proximal to ileo-caecal junction and at 200 cms proximal to Ileo-Caecal junction;this ileal segment of 170 cms is interposed into proximal jejunum between 20-50 cms distal to Ligament of Treitz. Endo-GIA staplers and hand-sown closure was used for the 3 anastomoses. The mesenteric gaps defects were closed with 3/0 prolene sutures. Sleeve gastrectomy was done starting from antrum/body upto angle of His with a sizing bougie ranging from size 32--58 Fr.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes (as defined by American Diabetes Association criteria)of more than 1 year duration
* Body Mass Index 21 - 55 kg/m\^2
* Poor glycemic control (HbA1c \> 8%) despite maximal use of Oral Hypoglycemic Agents and Insulin; or good control(lower HbA1c) but requiring progressively higher drug doses.
* Gives Informed Consent for the surgery
* Postmeal C peptide \> 1.0 ng/mL
* Age 25 - 75 years
* Stable weight for more than 3 months

Exclusion Criteria:

* Type 1 Diabetes
* Postmeal C peptide \< 1 ng/mL
* Pregnancy
* Significant nephropathy requiring dialysis
* Coexisting systemic disease
* Previous gastric or intestinal resection surgery
* Obesity due to organic illness
Non-invasive Ventilation in Patients With Interstitial Lung Disease - a Feasibility Study

The efficiency of non-invasive ventilation (NIV) in hypercapnic patients with chronic obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous studies. There is only a limited number of therapeutic options for patients with severely progressed interstitial lung disease (ILD). The question whether chronic hypercapnic ILD-patients are able to profit from nocturnal NIV and thus increase their performance in physical training has been left unknown. Therefore, this study aims to evaluate the feasibility of the initialization of a NIV for hypercapnic ILD-patients during pulmonary rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of Interstitial lung disease
* Hypercapnia defined as carbon dioxide partial pressure ≥45 mmHg (at rest, night or activity)
* already existing but not sufficient and regular use of non-invasive ventilation (≤3h/24h)
* patients consent to participate in this trial

Exclusion Criteria:

* acute pulmonary insufficiency (ph\<7.35)
* acute, clinically relevant heart disease
* already existing and sufficient use of non-invasive ventilation (≥3h/24h)
* Body-Mass-Index\>30
* obstructive sleep apnea
* Intolerance to perform non-invasive ventilation
* acute infection
A Placebo-Controlled Study of MK0634 in Patients With Overactive Bladder (0634-007)

Overactive bladder is very prevalent in postmenopausal women. The current study is designed to investigate whether a new drug may offer safe and effective treatment.

Clinical development of MK-0634 was discontinued. Study MK-0634-027 was a safety follow-up study to determine if there were any ocular effects of MK-0634 in participants from the United Kingdom who were exposed to MK-0634 during the 007 study.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal females (ages 40-74) with predominantly urge urinary incontinence overactive bladder episodes.
* Patients must meet minimum eligibility requirements (e.g., average number of micturitions/day) based on screening diary cards.

Exclusion Criteria:

* Patients must not suffer from diabetes insipidus
* Hyperglycemia
* Hypercalcemia
* Orthostatic hypotension
* Active/recurrent urinary tract infections (\>6 episodes per year)
* Patients must be willing to discontinue their current OAB medication therapy.
Evaluation of the Practice of Three Morning Sputa on Separate Days for Diagnosis of Mtb

Obtain sputum smears within one day to rule out TB


Eligibility Criteria:
Inclusion Criteria:

* All subjects admitted to Bellevue Hospital for evaluation of possible TB

Exclusion Criteria:

* Unable to produce spontaneous or induced sputum
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?

Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating "cancer cell/macrophage" hybrid cells in the peripheral blood.

The study will be conducted on a population of patients with sarcoma and treated in the context of routine care.

For each included patient, blood samples will be collected during baseline visit and after the initiation therapy.

At the end of the 2nd blood collection, the patient will have completed his participation in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
2. Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
3. Age ≥ 18 years old.
4. Localized or metastatic disease or recurrent disease.
5. Patient who has not yet initiated specific treatment for sarcoma.
6. Patient affiliated to a Social Health Insurance in France.
7. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria:

1. Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.
2. Associated pathology(s) that may prevent the proper conduct of the procedure under consideration.
3. Pregnant or breastfeeding woman.
4. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
5. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).