cyrilzakka/clinical-trials huggingface dataset:
Validation of a Sensor for Non-invasive Measurement of Stroke Volume and Cardiac Output

toSense, Inc. has developed a novel, non-invasive, body-worn sensor -CoVa Patch-that offers an alternative to invasive continuous cardiac output monitoring. To validate this new sensor's measurements of stroke volume and cardiac output, toSense, Inc. will conduct a study that compares its measurement performance to that from a pulmonary artery catheter using the thermodilution method.

This in an introductory clinical study with cardiac ICU patients featuring CoVa Patch. This is a single site, non-blinded, non-randomized study. It will employ a retrospective analysis comparing the accuracy of SV and CO. The 'test sensor', CoVa Patch, which will measure SV and CO quasi-continuously and non-invasively, approximately every 5-30 minutes for a period of time lasting approximately 12-48 hours. These measurements will be compared to those from a 'reference device', which is the pulmonary arterial catheter. It uses an invasive technique called thermodilution that will be made approximately every 4 hours. Measurements between the test and reference devices will be compared in a retrospective analysis once the study has completed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age at Visit X.
* Subject is a patient in the Cardiac ICU and meets the following criteria: pulmonary artery catheterization scheduled or completed.
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
* Subject is not pregnant at the time of consent

Exclusion Criteria:

* Pregnant in the study.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Subject is unable or unwilling to wear electrode patches as required for a period between 6 to 48 hours.
The Effect of Scapular Exercises in Patients With Stroke

There is a paucity of research on the correlation between postural control and upper extremity function. Analyzing the mechanisms of postural deficits and related problems is believed to give idea for any conceivable advance in future rehabilitation strategies in patients with stroke.

The purpose of this study was to examine the effect of scapular exercises on the scapular stability and trunk control. We hypothesized that scapular exercises correct the scapular position and improve postural control. Hence the reaching out movement can be applied in a controlled and fluent manner at the end of the treatment.


Eligibility Criteria:
Inclusion Criteria:

Diagnosed as acute stroke, being able to sit without support, presence of hemiparesis, clinical stability

Exclusion Criteria:

Shoulder joint dysfunction due to previous musculoskeletal disease, severe dementia, severe visual disturbances that could not be corrected with glasses, severe aphasia, scored ≥ 3 on the Modified Ashworth Scale and refused to participate
Prospective Study for 24-months of Physical Training Introduced in Lifestyle of Patients With FSHD : Tolerance, Sustainability and Efficiency of Unsupervised Training Program.

It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated with physiological and functional positive effects without alteration in quality of life. Van der Kooi et al. (2005) and Cup et al. (2007) studies suggest that the combination of endurance and strength trainings is even more relevant. However, only a few controlled and randomized studies have been conducted on this topic and the impact of such training programs on skeletal muscle regenerative capacities has not been addressed yet. Moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not practice of regular exercise can be maintained in patient's daily life. Also, only a few experiments report an integrative view of potential benefits of such programs on functional, biological and quality of life.

The present project is the second phase of a study for which the first phase currently financed by AFM is in progress and aims to establish a program of adapted physical training performed at the patient's home under supervision. This program was developed in order to try to meet the two following requirements: 1) to be compatible with the daily professional/social activity of patients so it can be integrated in their life routine; 2) to be intense enough so functional benefits can be induced. The first phase is a controlled and randomized study where patients with FSHD participate in a 6-months supervised training program combining aerobic and strength training sessions on an ergocycle.

This second phase of our research project aims to evaluate whether a long-term integration of this adapted training program into patients' lifestyle is possible. The same tools, same method and same measurements of training program will be used with remote monitoring, less frequent as it was in the first phase, over a period of 24 months. This second experimental work will also be based on multi-factorial evaluations, i.e. biological, physiological, functional, and quality of life questionnaires and remains collaboration between Universities of Saint Etienne (L. Féasson), Grenoble (B Wuyam) and Örebro (F Kadi) within the Rhône-Alpes Reference Centre for Rare Neuromuscular Diseases (JC Antoine).

Eligibility Criteria:
Inclusion Criteria:

* Included in the FSHD1 study
* Social Security regimen affiliated
* Consent form signed

Exclusion Criteria:

* Severe cardiac or respiratory insufficiency
* Cardiac pacemaker
* Morbid obesity (BMI upper to 35)
* Anti platelet therapy
Heart Failure Self-care With the Aid of a Smartphone Application

The purpose of this study was the development, and testing of a HF application that was used to provide self-care support to HF patients through a smartphone device. The study appraised current available literature on HF to determine best practices for promoting self-care of HF through direct communication with individuals with HF living at home. For the purpose of this study, smart phone communication was utilized. Smart phone applications allow patients to transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to healthcare providers. Using a secure website, a healthcare worker can access the information and contact the patient via the mobile phone when their data is out of normal range. This study was novel in its approach from what is traditionally offered in that it supported patient self-care decisions by promoting symptom monitoring and offered both tactical and situational skills strategies through at the point education.


Eligibility Criteria:
Inclusion Criteria:

* living in a non-nursing home setting
* primary providers of own self-care
* established diagnosis of heart failure
* cognitively intact
* able to speak/write English

Exclusion Criteria:

* not willing to use a smartphone
* not exhibiting acute decompensated heart failure symptoms
Arterial Stiffness, Blood Pressure and Cardiac Output Study

Comparison of non-invasively obtained central blood pressure using SphygmoCor and invasively recorded central blood pressure in patients with an AAA that will be treated with EVAR.

Primary objective of the first study: validation of non-invasive central pressure parameters in patients treated with EVAR against invasive measurements.

Objectives of subsequent studies: Do non-invasive central parameters change over time after EVAR? What is the influence of intraluminal thrombus (presence, amount, configuration) on non-invasive central pressure parameters (and other obtained parameters of arterial stiffness)? Prospective study with consecutive, eligible subject enrollment. All subjects will undergo the Endovascular Aneurysm repair procedure with an endovascular device. Subjects will be followed procedurally, at 6-8 weeks and 1 year post implantation.

This study is a collaboration of the following departments of the Vascular Center in the Rijnstate Hospital Arnhem: Vascular Surgery, Interventional radiology, Internal Vascular Medicine, Cardiology.

Patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair and who meet the study eligibility criteria may be screened for enrollment in the study. Up to 20 subjects will be enrolled .

Pre-procedural high resolution, contrast-enhanced CT scan evaluation to determine anatomical eligibility for enrollment will be performed within three months of the study procedure, according to standard care. Following EC/IRB approval of the study and the written informed consent form, patients will be screened for eligibility. Following informed consent, clinical characteristics will be reported (from hospital records). Per-procedural PWA measurements will be performed simultaneously with intravascular pressure measurements pre-implantation and after completion of the endocasular implantation. Subjects will be followed at 30 days and 1 year post-implantation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 18 years old;
2. Informed consent form understood and signed and patient agrees to follow-up visits;
3. Have a infrarenal abdominal aortic aneurysm (AAA) with maximum sac diameter ≥ 5.5cm, or an AAA ≥ 4.5 cm which has increased by \> 1.0 cm in the past year with a scheduled endovascular intervention

Exclusion Criteria:

1. Life expectancy \< 2 years;
2. Psychiatric or other condition that may interfere with the study;
3. Participating in another clinical study, interfering on outcomes;
4. Irregular pulse;
5. Presence of extensive peripheral arterial disease (ABI \< 0.9 or obstruction validated on imaging); dated less than 3 months prior to treatment
6. Ruptured, leaking or mycotic aneurysm;
Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy

Laser Induced Interstitial Thermal Therapy (LITT) is a "minimally invasive" procedure that uses the heat generated by a laser light (65°) to destroy brain lesions by coagulation leading to lesion necrosis under real-time MRI monitoring. The laser optical fiber is implanted into the lesion using stereotaxy. This technique, which can be performed under local anesthesia and on an outpatient basis, proved its efficacy and safety in the treatment of brain metastases for the first time in the world in 2006 (A. Carpentier et al, 2008, 2011). Since then, more than 5,000 patients have been treated in the USA, including for epileptogenic lesions (FDA device and CE cleared). Our goal is to evaluate LITT on lesions with drug-resistant epilepsy for which surgical resection is impossible. No therapeutic trial evaluating LITT in this indication has been performed to date. It is therefore necessary to study its feasibility and tolerance.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and \< 80 years
2. Patient with a medically unbalanced partial epilepsy
3. Patient with a lesional image(s) in morphological MRI responsible for epilepsy based on clinical and electrophysiological assessment, +/- PET +/- SPECT +/- MEG +/- sEEG
4. Patients for whom scheduled neurosurgical treatment with craniotomy appears difficult: Deep lesions, eloquent region lesions, patient reluctance to perform surgery.
5. Endorsement of the Multidisciplinary Meeting of Neuro-epileptology
6. Patient affiliated with a social security scheme
7. Patient who has signed prior, free and informed consent

Exclusion Criteria:

1. Pharmacosensitive epilepsy
2. Patient with poor adherence to medication, or with psychological disorders
3. Patients under legal protection
4. Patient with a contraindication to MRI (metal shards, known allergy to gadolinium, etc.)
5. Anticoagulant and antiplatelet therapy underway, cannot be stopped.
6. Severe and unbalanced psychiatric disorders
7. Pregnant women. Women of childbearing age should use oral contraception throughout the study.
8. Allergy to local anaesthetics / general anaesthesia
The Effect of Video and Traditional Laryngoscopy on Hemodynamic Response in Hypertensive and Normotensive Patients

During endotracheal intubation, it is known that la laryngoscopy has significant effects, such as tachycardia and blood pressure increase, which may be harmful, especially in those with cardiovascular disease. Different studies comparing laryngeal stimulation and there resulting hemodynamic response made with various intubation devices are available in the literature. The investigators planned to work with the hypothesis that endotracheal intubation with videolaryngoscopy would have less hemodynamic response traditional (Macintosh) laryngoscopy and the use of videolaryngoscopy would result in wider vision with less laryngeal stimulation.

In this study, in a study on endotracheal intubation under general anesthesia, a routine preparation of endotracheal intubation using video laryngoscopy or Macintosh laryngoscopy in adult hypertensive and normotensive patients between 18-75 years old, form will be written and recorded.

Patient age, weight, height, sex, operation, co-morbid conditions and vital findings, measurements used in airway evaluation, initial trial success, laryngoscope using number of procedures, intubation tube number will be recorded.

Statistical analysis was performed using statistical program to compare the hemodynamic response of hypertensive and normotensive patients using videolaryngoscope or Macintosh laryngoscope

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years.
* Underwent surgery under general anesthesia.

Exclusion Criteria:

* ASA (American Society of Anesthesiologists) IV, V patients
* Preoperative systolic blood pressure 180 mmHg, diastolic blood pressure a pressure above 110 mmHg.
* Ejection fraction is less than 40%.
* Difficult intubation history
* Mallampati 3,4
Manual Therapy to Treat Acute Whiplash Injury

The purpose of this study is to determine the short-term effects of a manual therapy protocol on pain, disability and cervical range of motion in individuals with acute whiplash injury.

Design: Randomized clinical trial. Objectives: to determine the short-term effects of a a manual therapy protocol on pain, disability and cervical range of motion in individuals with acute whiplash injury.

Methods and measures: sixty patients will be randomly assigned to 1 of 2 groups: the experimental group received a manual therapy protocol and the placebo group received two manual therapy techniques. Neck pain, disability and cervical range of motion data will be collected at baseline and 24-hr after the last manual therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome variable.

Eligibility Criteria:
Inclusion Criteria:

* To met Quebec Task Force Classification of WAD II- neck pain symptoms and musculoskeletal signs.
* No evidence of conduction loss on clinical neurological examination.

Exclusion Criteria:

* Concussion during the motor vehicle accident.
* Loss of consciousness.
* Head or upper quadrant injury during the accident.
* Sought treatment prior to their accident for neck pain.
* A previous history of whiplash
* Neck pain
* Headaches
* Psychiatric or psychologic condition
* Neurologic or circulatory disorders
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation

A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)


Eligibility Criteria:
Inclusion Criteria:

1. Singleton infants with regurgitation who are otherwise healthy
2. Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria.
3. Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days
4. Aged \> 3 weeks (21 days) and \< 9 weeks (63 days) at screening
5. Exclusively formula fed for ≥ 7 days before screening
6. Written informed consent from the parent(s) and/or legally acceptable representative(s)

Exclusion Criteria:

1. Low birth weight for gestational age and gender
2. Infants diagnosed with or suspected to have gastroesophageal reflux disease (GERD). I
3. Infants who received any of the following medication within 4 weeks prior to screening: systemic antibiotics, prokinetics and/or proton pump inhibitors and/or (other) medication to treat regurgitation
4. Infants who already consumed a thickened anti-regurgitation (AR) formula or used thickening supplements
5. Infants who already started complementary feeding
6. Infants with a gastrointestinal infection within 4 weeks prior to screening
7. Infants with a congenital condition, previous or current illness, and/or medication use that could interfere with the main study outcomes according to the investigator
8. Infants known or suspected to have: allergy for fish, soy protein, soy oil or corn; lactose intolerance; galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients and/or requiring a fibre-free diet
9. Infants known or suspected to have allergy to cow's milk protein
10. Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement
11. Participation in any other studies involving investigational or marketed products concomitantly or prior to screening
12. Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements
Monoclonal Antibody (mAb) 216 With Chemotherapy in Adult Relapsed or Refractory B-Lineage Acute Lymphoblastic Leukemia

A phase I trial in patients with relapsed or refractory leukemia of a human monoclonal antibody that kills B cell acute lymphoblastic leukemia. Trial will study safety, pharmacokinetics, and anti tumor activity of the antibody given as a single agent and with vincristine.


Eligibility Criteria:
Inclusion Criteria:

3.1.1 Age Patients must be \>= 18 years old at the time of study entry.

3.1.2 Diagnosis

3.1.2.1 Histologic Verification Patients must have had histologic verification of B-lineage ALL with bone marrow relapse or refractory disease that is unresponsive to traditional chemotherapy.

3.1.2.2 For patients WITHOUT prior allogeneic BMT:

1. Second or subsequent bone marrow relapse
2. Primary refractory marrow disease
3. M3 marrow (\>25% blasts) or \>25% leukemic blasts in peripheral blood

3.1.2.3 For patients WITH prior allogeneic BMT:

1. First or subsequent bone marrow relapse post-BMT
2. M3 marrow or M2 (\>5 % and \<25% blasts) if cytogenetic or VNTR confirmation

3.1.3 Confirmation of antibody reactivity 3.1.3.1 Patient's leukemic blasts (peripheral blood or marrow) must be documented to bind mAb 216 in vitro (Teng lab) 3.1.3.2 Patient's RBC documented to NOT express fetal "i" antigen and RBC shown to NOT bind mAb 216 in vitro (Teng lab)

3.1.4 Patient Must Not Be Eligible For Therapies of Higher Priority

3.1.5 Performance Level (See Appendix I) Karnofsky \>= 50%

3.1.6 Life Expectancy Must be at least 8 weeks.

3.1.7 Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.

1. Myelosuppressive chemotherapy: Must not have received within one week of entry onto this study.
2. Biologic, including monoclonal antibodies: At least 2 weeks since the completion of therapy with a biologic agent including monoclonal antibodies.
3. Hydroxyurea can be used up to 72 hours before study entry

3.1.8 Organ Function Requirements

3.1.8.1 Bone Marrow Function: 3.1.8.1.1 No hematologic criteria for WBC, Hgb or platelets 3.1.8.1.2 Patients with thrombocytopenia should be responsive to platelet transfusions and must not have uncontrolled bleeding.

3.1.8.2 Adequate Renal Function Defined As:

- A serum creatinine that is less than or equal to 2 x normal for age

3.1.8.3 Adequate Liver Function Defined As:

* Total bilirubin \<= 2 x upper limit of normal (ULN) for age, and
* SGPT (ALT) \<= 5 x upper limit of normal (ULN) for age

3.1.8.4 Adequate Cardiac Function Defined As:

* Shortening fraction of \>= 27% by echocardiogram, or
* Ejection fraction of \>= 50% by gated radionuclide study.

3.1.9 Regulatory

3.1.9.1 All patients must sign a written informed consent. 3.1.9.2 All institutional (IRB) and FDA requirements for human studies must be met.

Exclusion Criteria:

3.2.1 CNS 3 or refractory CNS leukemia

3.2.2 Isolated extramedullary relapse

3.2.3 Uncontrolled infection

3.2.4 Lack of mAb 216 binding to patient's leukemic blasts in vitro

3.2.5 Binding of mAb 216 to the "i" antigen on patient's erythrocytes
Photodynamic Therapy (PDT) Effect on Large Surface Photodamaged Skin

In this study, 26 patients were selected and included for full-face photodynamic therapy sessions. All patients presented signs of photoaging skin and multiple actinic keratosis. Photographs and Biopsies were taken before and after the procedure. Clinical and histological aspects as well as immunohistochemical aspects regarding neocollagen induction and tumor expression were evaluated.

Study design:

Patients and methods:

26 patients (16 females, 8 males) age 35-90 years, mean 59,4 y Skin types I-IV, severely photodamaged facial skin Multiples Aks on the face ( total 268) minimum of 3 per patient Approved by local ethical committee and informed consent given

Treatment procedure:

Prior curettage Full-face MAL application ( Metvix ®, Galderma France) 1,5 tube per treatment Incubation time 3 hs - in the first treatment session; and 1,5 h - in the 2 nd and 3 rd sessions Illumination LED (Aktilite® Photocure, Norway) 635 nm 37 J/cm2 3 treatments performed, one month apart Pain monitoring: forced air cooling device

Evaluation:

Clinical - 5 point scale based on Dover's and Zane's studies Dover JS et al. Topical ALA combined with IPL in photoaging. Arch Dermatol 2005; 141: 1247-52 Zane et al. Clinical and echographical analysis of MAL- PDT in photodamaged skin. Laser Surg Med 2007; 39: 203-9

Histological - Hematoxilin- Eosin staining

Immunohistochemical study- HP 53, Metalloproteinases, Procollagen I,

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe photodamage and at least 3 actinic keratosis on the face

Exclusion Criteria:

* Pregnancy, laser, chemical peel, imiquimod or 5-Fu treatment in the last year