cyrilzakka/clinical-trials huggingface dataset:
The Initiation of Swallowing Can Indicate the Prognosis of DOC

This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it is a good item as a stimulus and to detect the relationship between the initiation of swallowing act and the prognosis of DOC patients.

Studies suggest that the initiation and patterning of swallowing of the pharyngeal phase is also under active cortical control for both spontaneous as well as volitional swallowing in awake humans and non-human primates. A recent study found that most patients of disorders of consciousness (DOC) would recover their swallowing ability quickly. And there is no study about detecting the initiation of swallowing act in DOC patients. This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it is a good item as a stimulus and to detect the relationship between the initiation of swallowing act and the prognosis of DOC patients. DOC patients were recruited (standard diagnosis procedure is 4 times CRS-R testing within 2 weeks). The different four stimuli were as follows: 1) One command (as recommended in CRS-R) which was "open your mouth". 2) Put a spoon in front of the patient's mouth without a command. 3) One command with a spoon in front of the mouth, the command is "there is a spoon and open your mouth". 4) One command with a spoon full of water in front of the mouth, the command is "there is a spoon with water and open your mouth". We presented these stimuli orderly in front of the patient's mouth and presented any one of them over 4 trials at 15 second intervals.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* no administration of central nervous system stimulant, neuro-muscular blocking agents, or sedative within the prior 24 hours
* a diagnosis of VS or MCS-, based on the behavioral assessment of standardized CRS-R
* periods of eye opening (indicating preserved sleep-wake cycles).

Exclusion Criteria:

* documented history of prior brain injury
* premorbid illness resulting in documented functional disabilities up to time of the injury
* acute illness (e.g., pyrexia, pneumonia, diarrhea)
* receiving hyperbaric oxygen treatments within 2 hours
* fracture of the mandible.
A Pilot Study of Collaborative Assessment and Management of Suicidality With Suicidal Children ("CAMS-4Kids")

The purpose of the study is to assess the feasibility and acceptability of CAMS-4Kids for children with suicidal ideation and/or behavior. During this open pilot trial, we will enhance treatment procedures, refine adherence measures, and develop a treatment manual. Our study sample will include 10 children, ages 5 - 11 years old, seeking outpatient services for suicidal ideation and/or behavior.

The Collaborative Assessment and Management of Suicidality (CAMS-Jobes, 2006; 2016) is an evidence-based, therapeutic framework for addressing suicide risk in the adult population. CAMS-4Kids, the research intervention used in this study, is a 10-session developmentally-sensitive adaptation of CAMS for children ages 5 - 11 years old.

Within the CAMS framework, clinicians treat patient-identified issues that contribute to their suicidal thoughts and/or behavior called "suicidal drivers." A "clinical road map" is provided through the Suicide Status Form (SSF) that guides treatment as an assessment, treatment planning, tracking and clinical outcome tool. Clinicians and children engage in the assessment and treatment planning sections of the SSF - Initial Form at the outset of treatment. A CAMS Stabilization Plan is also collaboratively developed which focuses on reducing access to lethal means, coping strategies, decreasing interpersonal isolation, and ways to address potential barriers to care.

Subsequent CAMS-4Kids sessions include ongoing assessment and treatment plan reviews using the SSF - Interim Sessions Form. The CAMS Stabilization Plan is also reviewed and updated as clinically indicated. Treatment involves clinical interventions most appropriate to treat the patient's "suicidal drivers." Clinical interventions may include coping cards, "Hope Journal," behavioral activation, Virtual Hope Box, increasing social support, guided imagery, DBT relaxation skills, positive self-talk, and other cognitive-behavioral techniques.

The conclusion of CAMS-4Kids occurs after 3 consecutive sessions of effectively managing suicidal ideation and behavior. The SSF Outcome/Dispositional Final Session Form is completed at the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* children between the ages of 5 - 11 years old, inclusive, at the time of consent;
* current suicidal ideation and/or behavior;
* resides with primary caregiver who has legal authority to consent to research participation
* client of outpatient Behavioral Health Services
* Outpatient or Mood and Anxiety Program visit scheduled at least 4 weeks from the diagnostic assessment and/or discharge from the Crisis Stabilization Unit.

Exclusion Criteria:

* the inability to understand study procedures (e.g. developmental disabilities, severe cognitive impairments, actively psychotic)
* inability of the child and/or parent to speak or read English
* current participation in weekly therapy sessions with outpatient Behavioral Health Crisis Team
Barrier Function Measurement in Dry Eye Patients After Using Systane Ultra for 30 Days

The primary objective is to determine if there is a correlation between reductions in corneal staining and improvements in corneal barrier function.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have moderate corneal staining and exhibit a need to use artificial tears.

Exclusion Criteria:

* Patients can not participate in any other ophthalmic drug or device clinical trial within 30 days of the baseline visit.
BONAMI (BOne Marrow in Acute Myocardial Infarction)

Emerging evidence suggests that stem cells and progenitor cells derived from bone marrow can be used to improve cardiac function in patients after acute myocardial infarction. In this randomised trial, we aim to assess whether intracoronary transfer of autologous bone-marrow cells could improve myocardial viability at 3 and 12 months' follow-up.

After successful percutaneous coronary intervention (PCI) for acute myocardial infarction, 100 patients are randomly assigned to either a control group (n=50) who receives an optimal medical treatment, or a bone-marrow-cell group (n=50) who receives an optimal medical treatment and intracoronary transfer of autologous bone-marrow cells 7•10 days after PCI.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18-75 years.
* Acute myocardial infarction
* Absence of viability in the infarcted zone and LVEF \<45%.

Exclusion Criteria:

* History of prior myocardial infarction
* Significant stenosis in another coronary territory than the acutely treated vessel
Effect of RIC on 2,3-BPG in Erythrocyte (RIC-BPG)

Under hypoxia or high-altitude hypoxia ,it has been found that 2,3-bisphosphoglycerate(2,3-BPG) in erythrocyte increased and facilitated oxygen release to tissues.Remote Ischemic Conditioning(RIC) can also cause hypoxic conditions in local limbs.Thus,we hypothesize that whether RIC could also increase 2,3-BPG in erythrocyte.

RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently and has been proved to be effective in ischemic stroke and myocardial infarction(MI).The possible mechanisms of RIC protection is complicated.RIC leads to local ischemia and hypoxia and has been demonstrated to play a role in vital organs through hypoxia inducible factors(HIF) against stroke and MI.Besides HIF, hypoxia or high-altitude hypoxia could also change glycolytic process in erythrocyte through adenosine or sphingosine-1-phosphate(S1P).Accompanying with alternating glucolysis, 2,3-diphosphoglycerate(2,3-BPG) in erythrocyte increases and it also facilitating oxygen release to tissues.Thus,we hypothesize that whether RIC could also increase 2,3-BPG in erythrocyte.There are 8 arms in this trial: All arms are RIC treatment. The level of 2,3-BPG in erythrocyte will be assessed by ELISA before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-65 years old
2. Healthy adults

Exclusion Criteria:

1. Individuals with various chronic diseases.
2. Individuals with various acute diseases.
3. Individuals who take any medicines
4. Individuals who have taken health supplements for more than 2 weeks.
5. individuals with BMI\<18.5 or BMI≥24
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone & Formoterol Administered Alone in Patients With Asthma

To compare the efficacy and safety of the fixed combination asthma drug Flutiform HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, in adult and adolescent patients with mild to moderate asthma.


Eligibility Criteria:
* Ages eligible for study: 12 years and above
* Genders eligible for study: both
* Prior steroid use: steroid-requiring or steroid-free

Inclusion Criteria:

* History of asthma for at least 12 months
* For steriod-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit
* For steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to Screening Visit
* Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit
* Documented reversibility of 15% within 12 months of Screening or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration)
* Symptoms of asthma during Run-in
* Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile, or using acceptable methods of contraception.
* Must otherwise be healthy
* Provide written informed consent. Wishes of minors must be respected.

Exclusion Criteria:

Patients will not be eligible for the study if they meet any of the following criteria:

* Life-threatening asthma within the past year or during the Run-In Period.
* History of systemic corticosteroid medication within 3 months before the Screening Visit.
* History of omalizumab use within past 6 months.
* History of leukotriene receptor antagonist use, e.g., montelukast, within past week.
* Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
* Upper or lower respiratory infection within 4 weeks prior to Screening Visit or during Run-In Period.
* Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis).
* Known Human Immunodeficiency Virus (HIV)-positive status.
* Smoking history equivalent to "10 pack years".
* Current smoking history within 12 months prior to Screening Visit.
* Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening Visit.
* Patients who are confined in institution.
Young Patient With Aortic Dissection or Aneurysm: A Prospective Observational Cohort Study

Aortic dissection or aneurysm is unusual in young patients, and frequently associated with unusual presentations. However studies about this area is scarce. Besides, the treatment option is not clare. The prognosis of this cohort is also unclear.

The goal of this study was to better understand the characters, treatment option and prognosis of young patient with aortic dissection or aneurysm.

To understand the clinical characteristics, treatment options and prognosis of aortic dissection or aneurysm in young people，the study plan will include young people younger (≤50 years) with aortic dissection or aneurysm from 2020.6. Then collect their clinical data and conduct follow-up studies, in order to understand younger aortic dissection or aneurysm patients.

Eligibility Criteria:
Inclusion Criteria:

* young patients with aortic dissection or aneurysm

Exclusion Criteria:

* Aortic dissection or aneurysm due to traumatic
Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions

We seek to determine if the use of the SafeSeal(TM) topical hemostasis patch is associated with reductions in time to hemostasis and time to ambulation compared to standard manual compression after arterial sheath removal following percutaneous coronary and peripheral intervention. We further seek to assess the safety of the SafeSeal patch compared to manual compression.

A variety of topical hemostasis pads containing procoagulant materials are currently available to accelerate hemostasis after removal of the arterial introducer sheath following coronary and peripheral arterial angioplasty procedures. The effectiveness and safety of these pads, however, remains poorly understood. A total of 150 patients undergoing coronary or peripheral vascular angioplasty through a 6 French arterial sheath will be randomized to sheath removal using manual compression alone or manual compression combined with use of the SafeSeal(TM) hemostasis patch. Sheaths will be removed at an activated clotting time (ACT) of \<250 seconds, and patients will be kept at bedrest for 2 hours after hemostasis is achieved. The primary endpoint will be time to hemostasis. Secondary endpoints witll include time to ambulation and frequency of bleeding complications.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥ 18 years old
2. Coronary or peripheral vascular intervention
3. 6 French arterial sheath used
4. Overnight hospitalization following procedure

Exclusion Criteria:

1. Hematoma or persistent bleeding around the vascular sheath
2. Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery
3. History of bleeding diathesis or coagulopathy
4. Hemoglobin level \< 9 g/dl
5. Inability to ambulate at baseline
6. Known allergy to any of the materials used in the SafeSeal
7. Female patients known to be pregnant or lactating
8. Evidence of ongoing systemic or cutaneous infection
9. Uncontrolled blood pressure following PCI (systolic blood pressure \> 180 or diastolic blood pressure \>110)
10. Current enrolment in another ongoing investigational drug/device trial.
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)


Eligibility Criteria:
Inclusion Criteria:

* Positive antinuclear antibodies (ANA) at Screening (Visit 1)
* Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
* Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
* Active moderate to severe SLE disease as demonstrated by SLEDAI total score.
* On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria:

* Subjects who are breastfeeding, pregnant, or plan to become pregnant
* Subjects with active, severe SLE disease activity which involves the renal system
* Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
* Subjects with the evidence of an immunosuppressive state
* Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
* History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
* Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
* Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
* Subjects with substance abuse or dependence or other relevant concurrent medical condition
* Subjects with history of thromboembolic events within 1 year of screening Visit.
* Subjects with significant hematologic abnormalities
* Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
* Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
* Subject has previously participated in this study or has previously received epratuzumab treatment.
Soft Tissue Assessment in Screw-Retained Maxillary Complete Denture With Electric Welded Framework Versus Casted

comparing the changes in the soft tissue around the implants that will be joined by a metal framework either with electric welding or with the conventional casting method

as joining multiple implants by a metal framework considered a solid solution for edentulous arches , but in the same time the conventional method to weld this metal framework to the implants by casting technique in lab usually involves a several disadvantages eg. cost and time consuming in addition to laboratory errors, Thus , this study aims to find another method to weld the metal framework intraorally by an electric welding device

Eligibility Criteria:
Inclusion Criteria:

* Ages range from 45 to 65 years old.
* Absence of any medical disorder that could complicate the Surgical phase or affect osseointegration.
* The patients must be completely edentulous.
* The patient must have enough bone height for implants minimum length of 10mm and a minimum diameter of 5 mm.
* Patients with good oral hygiene.
* Complete denture wearer.
* Adequate inter arch space for screw retained prosthesis.
* Absence of any intra-oral pathological condition.

Exclusion Criteria:

* Patients with recent extraction(less than three months).
* Patients with inflamed ridge or candida infection.
* Patients with flappy ridge.
* Parafunctional habits.
Device Accuracy of Non-invasive Glucose Measurements in Ethnic Skin

This clinical study has been launched to collect spectral raman data paired with validated glucose reference values in private homes of subjects.

The subjects enrolled in this protocol will dedicate 30 days of home-based measurement, scheduled within a 40 days' time frame. For reference measurements, subjects will be equipped with a blood glucose meter (Contour Next One, Ascenia). Optical measurements are collected with the investigational medical device. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a blood glucose meter and two investigational medical device measurements.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 40 years of age.
* Have a diagnosis of diabetes mellitus.
* Distribution of skin phototype: 50-70 % of enrolled subjects phototype IV, 20-40 % of enrolled subjects phototype III, 5-15 % of enrolled subjects phototype II, 5-15 % of enrolled subjects phototype I.
* Be willing to perform a minimum of 8 finger sticks per day during the study.
* Be willing to perform a minimum of 8 optical measurements per day during the study.
* Be willing to provide written signed and dated informed consent.

Exclusion Criteria:

* Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only).
* Subjects not able to understand and read English.
* Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.
* Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease).
* Diagnosed with cardiovascular diseases.
* Reduced circulation in right hand evaluated by Allen's test.
* Subjects receiving anticoagulants, active cancer treatment, tetracyclines and other medication/topical agents increasing photosensitivity.
* Radiotherapy for the past six months.
* Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
* Known allergy to medical grade alcohol used to clean the skin.
* Systemic or topical administration of glucocorticoids for the past 7 days and under investigation.
* Subjects undergoing dialysis treatment.
* Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff.
* Medical history or any condition that may, in the opinion of the investigator, compromise subject's ability to participate.
* Subjects currently enrolled in another study.
The Efficacy of Aspirin in the Postoperative Period in Vascular Surgery

The purpose of this study is to determine the incidence of aspirin resistance in the population of vascular surgery patients; and to evaluate the changes in the efficacy of aspirin in the first five postoperative days.

About 15% of the general population shows resistance to the antiplatelet effects of aspirin, due to genetic polymorphisms and other factors. This resistance is a cause of increased myocardial infarction and death in patients undergoing percutaneous coronary interventions. Aspirin resistance can be detected by whole blood impedance aggregometry using the Multiplate® analyzer. The population of patients undergoing vascular surgery is at particular risk of suffering myocardial infarction in the perioperative period because of the high prevalence of risk factors. Most of these patients are treated by aspirin, as a measure of primary or secondary prevention. In this study we aim to establish baseline aspirin efficacy, as measured by the Multiplate® analyzer, in this high-risk population and evaluate the changes in aspirin efficacy over the first five days of the postoperative period. It is our hypothesis that the state of chronic inflammation, accompanying severe, generalized atherosclerosis results in a higher incidence of aspirin resistance in this population. Also, the surgical trauma and postoperative thrombocytosis may reduce the efficacy of aspirin in the postoperative period, partially explaining the increased incidence of postoperative myocardial infarction in this population.

In whole blood impedance aggregometry, the electrical impedance of the blood sample is measured by placing two electrodes in the recipient. After the addition of a platelet activator, the impedance will increase as platelets accumulate on the electrodes surfaces. Several activators, testing the patency of different platelet receptors can be used.

In this study, blood will be drawn on the day of surgery, and daily until the fifth postoperative day. Arachidonic acid, ADP, TRAP-6 and collagen will be used as activators. The first specifically tests the platelets reactivity to thromboxane A2. Aspirin inhibits this pathway, and the increase in impedance should therefore be limited in patients treated by this drug. The three other tests will be performed to evaluate the evolution of overall platelet reactivity in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing peripheral vascular or abdominal aorta surgery.
* Patient aged 18 years or older.
* Patient treated by aspirin.

Exclusion Criteria:

* Incapacity to understand and consent to study.
* Patient undergoing emergency surgery.
* Patient treated by a cox-inhibitor other than aspirin.
* Patient treated by omega-3-fatty acids.
* Patient treated by ADP or GPIIb/IIIa receptor inhibitor.
* Known coagulopathy, thrombopenia, thrombopathia or congenital or acquired thrombasthenia.
* Terminal renal insufficiency.
* Hepathic insufficiency.