cyrilzakka/clinical-trials huggingface dataset:
Feasibility of a New Ambulatory Multi-vital Signs Monitor

The purpose of this research is evaluate vital signs (VS), which include non-invasive blood pressure, pulse rate, respiratory rate and Oxygen Saturation (SpO2) using a portable wrist monitoring device called a Caretaker. This device has been cleared by the Food and Drug Administration (FDA) for use and allows the study team to check vital signs in a participant's normal setting.

Participation in this study will involve wearing this portable device at 2 different time points:

1. for up to 24 hours immediately during and after the participant's preoperative visit to obtain baseline vital signs during normal activity and during sleep and
2. after surgery up to 24 hours while participant recovers prior to discharge from the hospital

Anesthesiologists and surgeons examine vital signs such as heart rate (HR), respiratory rate (RR), oxygen saturation (SaO2) and blood pressure (BP) in an effort to detect extremes of altered VS and remediate these alterations prior to surgery and anesthesia. In most preoperative clinics, however, these VS are measured once and no further assessments are made until they arrive for their surgery. Patients with cardiac and pulmonary disease, however, can have highly variable VS.

The Caretaker device is a wrist device designed to measure relatively continuous VS over a period up to 24 hours. The device is accompanied by a finger cuff that measure pulse and respiratory rate, along with a non-invasive blood pressure detector and pulse oximeter. In an effort to detect VS that may not be recognized with the usual one-time measurement in the clinic, the study team plans to monitor ambulatory preoperative VS in patients who meet the study criteria, for up to 16-24 hours preoperatively. They will then return their device on the day of surgery.

Postoperatively, the study team will place a CareTaker device once again and measure these same VS in the same patients for up to 24 hours prior to discharge.

Eligibility Criteria:
* Inclusion Criteria

  * Age\>18 years
  * Scheduled for surgery from an outpatient setting and scheduled for a pre-admission PAC appointment
  * Risk stratification placing them in the top 25th percentile using our internally-validated PAC Risk Score.
* Exclusion Criteria

  * Surgery on the day of admission (same-day surgery)
  * Any upper extremity surgery
Effect of Attentional Touch in Stabilometric Assessments

Postural balance has been studied in the literature and ideal body mass distribution has been shown to provide stability to the body in an upright position. The use of stabilometry to assess posture is a standard in clinical practice and medical research. In the literature we find osteopathic treatment evaluated with stabilometry in specific pathological conditions. We will experiment on asymptomatic volunteers how attentive touch is effective compared to non-attentive touch and compared to an untreated group by measuring specific parameters that indicate postural balance.

Stabilometry measurements will be taken on asymptomatic volunteers before and after several specific treatments, in particular to measure whether the variance in sway speed is reduced after the treatments. The effect of attentional versus non-attentional touch will be compared in the other two groups, in addition to a control group that receives no treatment.

Eligibility Criteria:
Inclusion Criteria:

• aymptomatics

Exclusion Criteria:

* serious illnesses
* balance disorders
* recent trauma (within 2 years) to the lower limbs
Effects of Coordinative Warm-Up Exercise Protocols on the Technical and Cognitive Performance of Soccer Players

The aim of this study is to evaluate the effects of 12 weeks of warm-up protocols administered to elite soccer players on technical-coordination performance and levels of cortisol, adrenaline, noradrenaline, and dopamine, measured before and after the intervention.

The warm-up protocols included coordination exercises using different types of balls, with combined activities involving both the upper and lower limbs

Eligibility Criteria:
Inclusion Criteria:

* elite soccer players

Exclusion Criteria:

* no injuries in the previous 6 months;
* no adherence to other training protocols;
* no use of prohibited drugs and/or supplements that could affect the test results and exercises
Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy

The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.

Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines.

The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position

Exclusion Criteria:

* cerebrovascular disease
* uncontrolled hypertension, asthma, COPD
* neuromuscular disorder
* patients who have had abdominal surgery
* morbid obesity (body mass index \> 35 kg/m2)
Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk

This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).

This is a pilot study that aim to enroll 60 subjects with high bleeding risk.

All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1 randomization either to NSE predilation or NC balloon predilation using a randomization schedule.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo IVUS before DCB treatment. Data and images will be collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test;
* Coronary artery disease (CAD) patients with high risk of bleeding

Exclusion Criteria:

* Previous coronary artery bypass graft (CABG) patients
* Stent implantation in the target vessel
* Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
* Acute ST segment elevation myocardial infarction (STEMI) within 48 hours
* Contraindications to contrast media, antiplatelet therapy, or paclitaxel
* Cardiac shock
* Pregnancy
* Expected life less than 12 months
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.

Eligibility Criteria:
Inclusion Criteria:

* A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.

Exclusion Criteria:

* History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
* Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination
Prevalence of PE in ED Patients With Isolated Syncope

Syncope is a rapid onset, transient, loss of consciousness with a short duration. This symptom has been reported to be a specific presentation of patients with pulmonary embolism. However, the prevalence of pulmonary embolism in patients with syncope remains debated. This prospective cohort study will recruit patients presenting to the emergency department with a syncope, who will systematically undergo formal workup for pulmonary embolism. The main objective of this study is to assess the prevalence of pulmonary embolism in ED patients with syncope

Syncope is a rapid onset, transient, loss of consciousness with a short duration. This symptom has been reported to be a specific presentation of patients with pulmonary embolism. However, the prevalence of pulmonary embolism in patients with syncope remains debated. This prospective cohort study will recruit patients presenting to the emergency department with a syncope, who will systematically undergo formal workup for pulmonary embolism. The main objective of this study is to assess the prevalence of pulmonary embolism in ED patients with syncope

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years visiting the Emergency Department,
* history of syncope in the past 24 hours: loss of consciousness, rapid onset, short duration (\<1 min), transient, with spontaneous and rapid recovery without post event confusion
* With or without prodromes
* Without any other obvious cause
* Informed written consent
* Affiliation to a social security system (AME Excepted)

Exclusion Criteria:

- Other criteria for PE suspicion : Acute onset of dyspnea Acute severe chest pain,

* Pregnancy
* Concurrent anticoagulation treatment
* Other obvious cause of syncope : Seizure, Stroke, Traumatic brain injury , toxic intake , Atrioventricular block type 3
Community Implementation of KEEP: Fidelity and Generalization of Parenting

The primary goal of this study is to examine the fidelity and generalization of parenting effects of the KEEP foster parent training intervention as it is being delivered within a child welfare system of care by a community mental health provider.

The primary goal of this study is to utilize this opportunity as a real-world platform for addressing three key questions that need to be answered prior to wide-scale implementation of the KEEP intervention. First, do the effects of the KEEP parent training generalize (concurrently) to other children currently in foster and kin intervention homes and lead to reductions in overall levels of behavior problems? Second, does the KEEP intervention continue to have effects after the completion of the intervention and generalize (temporally) to new children who enter the homes of these families at a later point in time? Finally, as the KEEP intervention is being implemented by a community agency in a real-world system of care, can the intervention be delivered and maintained in a manner that preserves the goals and quality of the intervention?

Children in foster care, between the ages of 5 and 12, will be randomly assigned to one of two conditions - the KEEP intervention or a "services as usual" condition. In the KEEP intervention condition, foster and kin caregivers will participate in 16 weekly group meetings. Outcomes to be assessed include child problem behavior (of the focal child and other children in the household), child functioning, parental stress, family functioning, use of mental health services, child placement changes (e.g., reunification with biological parents, move to another foster home), and foster parent retention rates. In addition, for a year following the completion of the intervention, new children entering the home of foster/kin caregiver will be included in the assessments, along with the impact of these additional children on parental stress and family functioning. Finally, several dimensions of intervention fidelity (e.g., facilitator adherence and group engagement) will be assessed and examined in relation to child, family, and system outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Any child between ages 5 and 12 in relative or non-relative foster care

Exclusion Criteria:

* Only medically fragile children
Vaccine Therapy in Preventing Flu in Children With Acute Lymphoblastic Leukemia

RATIONALE: Flu vaccine may help the body build an immune response and decrease the occurrence of flu in children who are receiving chemotherapy for acute lymphoblastic leukemia.

PURPOSE: Clinical trial to study the effectiveness of vaccine therapy in preventing flu in children who have acute lymphoblastic leukemia.

OBJECTIVES:

* Determine the immune response, in terms of the formation of protective antibody titers to influenza, in children with acute lymphoblastic leukemia treated with split-virus trivalent influenza vaccine.
* Correlate the formation of protective antibody titers following immunization with the absolute neutrophil counts and absolute lymphocyte counts in these patients at the time of vaccination.

OUTLINE: This is a multicenter study. Patients are stratified according to current treatment for acute lymphoblastic leukemia (consolidation chemotherapy vs maintenance chemotherapy vs off therapy for the past 6 months).

Patients receive split-virus trivalent influenza vaccine intramuscularly once or twice at 4 weeks apart for 2 doses.

Patients are followed at week 5. Patients receiving 2 doses of vaccine are also followed at week 9.

PROJECTED ACCRUAL: A total of 175 patients (50 receiving consolidation therapy, 75 receiving maintenance therapy, and 50 off therapy) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia

  * In first remission after completion of induction chemotherapy
  * Currently on active treatment OR
  * Completed treatment within the past 6 months

PATIENT CHARACTERISTICS:

Age:

* 1 to 20 at time of diagnosis

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Pulmonary:

* No acute respiratory distress

Other:

* No history of Guillain-Barre syndrome
* No history of hypersensitivity to chicken eggs, egg products, or components of influenza virus vaccine, including thimerosal
* No febrile illness with fever over 100.4 degrees F
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* At least 7 days since prior antibiotic or antiviral therapy except prophylactic antibiotics
The Lymphocytic Infiltrate of Lung Tumors.

The study is configured as a monocentric observational transversal biological study.

The main objective of the study is the reconstruction of the molecular organization of tumors of the thoracic cavity, in particular non-small cell lung cancer (NSCLC).

The study involves the collection of clinical data and biological material (blood and tumor tissue) from 70 subjects diagnosed with thoracic tumors.

Inclusion criteria:

The study population will include all patients with the following characteristics:

* Ability to provide informed consent
* Men and women over the age of 18 years old
* Patients candidates for surgical treatment diagnosed with thoracic tumors

The procedures to which the patient will undergo during the study follow the standard of clinical practice for the treatment of pathology.

Exclusion criteria:

* Previous chemotherapy for any cancer within the last 6 months
* Pregnant and/or breastfeeding women
* Immunosuppressive state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments)

The time of observation of the patient for the purposes of the study is limited to the time of hospitalization and the surgical procedure, the patient will therefore perform a single visit to the hospital and there is no provision for the collection of further data following discharge. The study involves a single timepoint of data collection and samples.

The study will have a total duration of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent;
* Men and women over the age of 18;
* Patients candidates for surgical treatment diagnosed with thoracic tumors

Exclusion Criteria:

* Previous chemotherapy for any cancer within the last 6 months;
* Pregnant and/or breastfeeding women;
* Immunosuppressive state (states of immunosuppression or ongoing immunosuppressive/immunomodulatory treatments)
Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain

The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.


Eligibility Criteria:
Inclusion Criteria:

* Oral surgical procedure having removed 2 third molars (unilateral).
* Pre-dose pain intensity score (100 mm Visual Analog Scale \[VAS\]) \>50 mm within 5 hours of oral surgery.
* Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.

Exclusion Criteria:

* Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder.
* Prior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
* Recent history of chronic analgesic or tranquilizer dependency.
* Active dental infection at the time of surgery.
* Any significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting \> 30 minutes.
* Subjects who are smokers.
The Effect of Asthma Flare-up Clinic After Exacerbation

The goal of this interventional study is to examine the effect of asthma flare-up clinic follow-up in adult subjects after an asthma flare-up. This study aim to answer the following questions:

1. Does a follow-up in a flare-up clinic improves disease outcomes?
2. Does a follow-up in a flare-up clinic improves disease management?

Participants in the intervention group will take part in a structured follow-up at the asthma flare-up clinic at three time points. Each visit will include questionnaires, pulmonologist examination and consultation, laboratory tests and spirometry. The control group will undergo phone-call follow-up with a research coordinator in similar time frames as the intervention.

Researchers will compare the two groups to see if the clinic follow-up affects the study outcomes.

The primary outcomes will be analyzed as total exacerbations during the time frame and as a time-dependent variable (time to exacerbation) using Kaplan Meier survival analysis. Additional sub-analyses will be made for the type of inclusion setting (ED/hospitalization), number of prior exacerbations, and eosinophil count. Additional analyses will be made for all secondary outcomes. Analyses relevant only for the intervention group (such as spirometry and IOS) will compare results to the first follow-up visit. A cost-effectiveness analysis will be made, comparing the follow-up cost and the cost saved by exacerbation reduction based on the final results.

Sample size calculation - The invetigators assume based on previous research that the intervention will lead to a 20% decrease in exacerbations during the 12 months from first follow-up. To achieve an alpha of 0.05 and a power of 80%, there is a need for 88 patients in each group. Assuming a loss-to-follow-up rate (missing to complete at least 2 clinic visits or loss to phone follow-up) of 20%, the study will need 115 patients in each group (230 overall).

Eligibility Criteria:
Inclusion Criteria:

* Prior asthma diagnosis based on clinical and spirometry accepted criteria.
* Acute exacerbation of asthma as the main reason for ED arrival.
* Ability to perform in-person and telephone follow-up.
* Agree to participate, with a signed or verbal informed consent, according to the study group.

Exclusion Criteria:

* Uncontrolled comorbidity.
* Cognitive dysfunction.
* Patients under 18 years or above 75 years.
* Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer

This study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial.

The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (IDC) patients by high-resolution specimen Positron Emission Tomography/Computed Tomography (PET/CT) imaging.

The rationale of this study is to examine the non-inferiority of intraoperative high-resolution specimen PET/CT imaging in early-stage breast cancer for the identification of all positive margins of the invasive component during Breast Cancer Surgery (BCS) as compared to standard-of-care gross pathology evaluation.

The PET/CT specimen imager is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard.

Eligibility Criteria:
Inclusion Criteria:

* females with an age over 18 years;
* confirmed breast cancer with indication to undergo BCS (stage I-II with tumor ≤2.5 in greatest dimension);
* vacuum-assisted core breast biopsy is allowed for non-invasive tumors only;
* able to understand treatment protocol and informed consent form;
* estimated by the investigator to be compliant for study participation.

Exclusion Criteria:

* general or local contra-indication for BCS;
* previous breast surgery;
* inflammatory breast cancer;
* radiotherapy of the ipsilateral breast;
* vacuum-assisted core breast biopsy for all patients with invasive tumors (vacuum-assisted core breast biopsy is allowed for patients with non-invasive tumors as long as the residual tumor size on mammogram is at least 1.0 cm);
* pregnancy or lactation;
* participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year;
* active bacterial, viral or fungal infection.
Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change

The aim of this study is to compare the tooth colour changes caused by retainers made of stainless steel wires and fiber reinforced in long term

30 patients who were planned to use lower fixed retainer after fixed orthodontic treatment, were included in the study and divided into 3 groups. (n=10) (Group 1: Bond a braid retainer, Group 2: Ribbond retainer, Group 3: EverStick Ortho retainer). Colour measurements will be made with spectrophotometer (Vita easyshade) after debonding (T1), after retainer application (T2), in 1 month, 3 month, 6 month and finally 1 year from 6 lower anterior teeth. The Commission Internationale de I'Echairage L\*a\*b\* system will be used to determine the tooth colour. ∆E values measured at different times will be compared.

Eligibility Criteria:
Inclusion Criteria:

* patients with no anomalies of lower incisors and canine teeth

Exclusion Criteria:

* patients drinking more then 3 cups of coffee per day
* smoker patients