cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects

The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of IVIb administered over 5-7 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between the ages of 18 and 65 years (at the time of consent).

Exclusion Criteria:

* Participants lacking good venous access in both arms.
* History of allergy or hypersensitivity to NSAIDs or any component of intravenous ibuprofen.
* Have never taken aspirin or ibuprofen
* History of abuse of alcohol or other drugs in the 2 months before CTM administration.
* Have used prescription drugs (not including oral contraceptives) within 14 days before CTM administration or have used aspirin within one week before CTM administration or over-the-counter pain relievers (NSAIDs or acetaminophen) within 3 days before CTM administration.
* Have taken investigational drugs within 30 days before CTM administration.
* Have donated blood or blood products within 30 days before CTM administration.
* Be pregnant or nursing.
* Have had breast cancer.
* Have a clinically significant laboratory test
* Presence or history of the following conditions: asthma, bleeding tendency, hypertension, heart failure, peptic ulcer disease, inflammatory bowel disease, or any other gastrointestinal disorder, renal or hepatic disease..
* Have a calculated creatinine clearance (estimated by means of the Cockcroft-Gault equation) of \< 75mL/min
* Inability to understand the requirements of the study. Participants must be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions.
* Refusal to provide written authorization for use and disclosure of protected health information
* Be otherwise unsuitable for the study, in the opinion of the Investigator.
The Evaluation of Pre-Post Smoke Evacuation Uses on Surgical Smoke and Bio-Aerosols in Operating Rooms

This study aims to evaluate the pre-post smoke evacuation uses on surgical smoke and bio-aerosols particles in operating rooms at a university hospital, Thailand.

Purpose of Project

Smoke and bio-aerosols are routinely produced by surgical instruments; eg, lasers, electrosurgical units, radiofrequency devices, ultrasonic devices, power tools. Plume and bio-aerosols contain odor-causing and odorless toxic gases, vapors, dead and live cellular debris (including blood fragments), and viruses. These airborne contaminants can pose respiratory, ocular, dermatological and other health-related risks, including mutagenic and carcinogenic potential, to patients and operating room personnel. The National Institute of Occupational Safety and Health (NIOSH) and the Center for Disease Control (CDC) have also studied electrosurgical smoke at length. Therefore, the equipment of smoke evacuation in OR needs to be used. Therefore, this study aims to evaluate the pre-post smoke evacuation uses on surgical smoke and bio-aerosols particles in operating rooms at a university hospital, Thailand.

Methodology Association of periOperative Registered Nurses (AORN) guideline is used as the conceptual framework of this study including evidence based practice for smoke and bio-aerosols evacuation systems. The study design is a quasi-experimental study (manipulation and control only, without randomization) comparing the amount of surgical smoke and bio-aerosols particles pre- post smoke evacuation uses. The samples consist of 64 cases of surgical patients who receive head-neck or breast surgery and 64 cases of surgical patients who receive abdominal laparoscopic surgery. The amount of surgical smoke and bio-aerosols' particles in the surgical field and OR environment are measured by AeroTraxTM Handheld Airborne Particle Counter Model 9306.

Eligibility Criteria:
Inclusion Criteria:

* Surgical patients who receive head-neck or breast surgery or surgical patients who receive abdominal laparoscopic surgery

Exclusion Criteria:

* Emergency cases
Safety,Effectiveness and Acceptability of Sino-implant II in DR

A study to assess the contraceptive effectiveness of Sino-implant (II).

Randomized trial to assess the contraceptive effectiveness of Sino-implant (II) and to compare levonorgestrel concentrations, safety and acceptability of Sino-implant (II) and Jadelle.

Eligibility Criteria:
Inclusion Criteria:• In good general health

* Aged between 18 and 44 years, inclusive
* Not pregnant
* Not lactating
* Not wishing to become pregnant in the next five years
* Request long-acting reversible contraception
* If previously used injectable contraceptives for pregnancy prevention, be more than 9 months since last injection of Depo-Provera and more than 3 months after the last injection of a combined injectable contraceptive
* If previously used LNG-containing oral pills or implants, be more than 1 week after last hormone intake or implant removal
* Be able to understand the information provided and to make personal decisions on participation
* Consent to participation and sign a consent form
* Agree and be able to return to the clinic for follow-up visits over five years

Exclusion Criteria:

* acute deep venous thrombosis and/or pulmonary embolism or history of thromboembolic disease
* systemic lupus erythematosus with positive or unknown antiphospholipid antibodies
* unexplained vaginal bleeding
* current or history of breast cancer
* acute liver disease or cirrhosis
* benign or malignant tumor of the liver
* use of rifampicin, and/or anticonvulsants (barbiturates, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, primidone, topiramate), and/or herbal products containing St. John's Wort (Hypericum perforatum)
* more than one sexual partner in the last 3 months
* diagnosis or treatment for a sexually transmitted infection (STI) within the past 30 days for her or partner (excluding recurrent genital herpes or condyloma)
* known HIV positive status for her or partner
* any condition (social or medical) which in the opinion of the Investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation
* BMI greater than or equal to 30 (for the sub-group of women with intensive LNG sampling)
Long-term Monitoring of Sleep with Ear-EEG in Patients with Chronic Pain

Insomnia is reported by more than 50% of patients with chronic pain. In this study, the investigators aim to advance the understanding of physiological sleep in individuals with chronic pain. To do this the investigators will monitor at-home sleep with an ear-EEG over 20 nights in patients with chronic pain and collect self-reported measures of sleep and pain. The collected data will be used to explore and characterize intra-individual variations in sleep metrics (e.g. total sleep time, time in each sleep stage (N1, N2, N3, REM), sleep latency, REM stage latency, wake after sleep onset, sleep efficiency, number of arousals and arousal index) over 20 nights.


Eligibility Criteria:
Inclusion Criteria:

For a subject to be eligible, all inclusion criteria must be answered "yes":

* Understand and write Danish.
* Pain present on most days or every day during the past 3 months.
* Pain limits daily activities or work on some days, most days or every day during the past 3 months.
* Pain intensity equal to or larger than 4 on 0-10 Numeric Rating Scale \[NRS\] within the last week.
* Informed consent obtained before any study related activities.

Exclusion Criteria:

For a subject to be eligible, all exclusion criteria must be answered "no":

* Previous stroke or cerebral haemorrhage and any other structural cerebral disease.
* Obstructive sleep apnoea (Defined as yes to 3 or more questions in the STOP-BANG questionnaire for women and 4 or more questions for men).
* Teeth grinding (bruxism).
* Pregnancy or lactation (Pregnancy is screened for through self-reporting as no risks regarding pregnancy have been identified for the described study procedures).
* Narrow or malformed ear canals or piercings, making ear-EEG infeasible.
* Allergic contact dermatitis caused by metals or generally prone to skin irritation.
* People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
Epidural Analgesia in Intensive Care Unit (APD-REA: Analgesie PeriDurale en REAnimation)

Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking. The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients.

BACKGROUND:

Epidural analgesia (EA) has been mainly investigated during the perioperative period. In the intensive care unit settings, EA should be proposed in critically ill patients, such as postoperative or trauma patients, typically. Recent findings also support anti-inflammatory, vascular or respiratory effects for EA, beyond its analgesic effects. However, data on EA safety and feasibility in the intensive care unit settings are still lacking.

DESIGN NARRATIVE:

This observational multicenter prospective clinical study will report the incidence of EA-related complications, such as infectious or neurologic complications, and the mean duration of EA in the ICU settings.

Patients admitted in three intensive care units (two from an University Hospital and one from a local hospital) and receiving EA will be included in the study, whether the EA catheter is inserted in the ICU or outside the ICU, e.g. in the operating room. Demographics, clinical and biological data will be recorded prospectively. The main goal is to evaluate the safety and feasibility of EA in critically ill patients, being assumed this technique is currently and routinely used in our intensive care units, in accordance with national and international guidelines on epidural analgesia practice.

Eligibility Criteria:
Inclusion Criteria:

* patients requiring epidural analgesia, whether the epidural analgesia catheter is inserted in the ICU or outside the ICU, e.g. in the operating room.

Exclusion Criteria:

* none (besides classic contra-indications for epidural analgesia catheter insertion, e.g. coagulation disorder, local infection...)
Promoting Atrial Fibrillation Screening in Primary Care

Atrial fibrillation is the most common sustained cardiac arrhythmia in adults. Due to the asymptomatic and paroxysmal nature (randomly and shortly occurring of atrial fibrillation, and can therefore remain unnoticed) of atrial fibrillation. Atrial fibrillation increases the risk of stroke five fold if left untreated.

Screening in old populations above age 65 years is helpful to find more atrial fibrillation cases. However, screening for atrial fibrillation is not well implemented in China. Thus, this project aims to promote atrial fibrillation screening in primary care centers in China. We will develop an intervention program (SEARCH-AF) and examine the effects (including the clinical effects and implementation effects) of program.

Six health care centers in Guangzhou China will be included. We will adopt a stepped-wedge randomized trial design. Two health care centers will be randomly selected to receive the SEARCH-AF program at each step (a total of three steps).

The SEARCH-AF program will include opportunistic screening among those who aged 65 or above and screening promoting strategies. The A total of 4800 old adults will be screened for atrial fibrillation using a handheld single-lead ECG tool upon their visit to family doctor, with 800 for each health care center. The promoting strategy will be developed based on the Consolidated Framework for Implementation Research and include leadership engagement, policy support, providing screening resources, staff training on atrial fibrillation screening and management.

The whole study will last for 18 months. We will examine the intervention effects including clinical effects (atrial fibrillation detection rate, anticoagulation rate, atrial fibrillation related hospital visits, and stroke related end points) and implementation effects (cost-effectiveness of the intervention, compliance to atrial fibrillation screening ).

Eligibility Criteria:
Inclusion Criteria:

* aged 65 years or above
* living in community

Exclusion Criteria:

* with a previous confirmed diagnosis of atrial fibrillation
* with implanted ICD or pacemaker
* unable to provide consent
* involving in other atrial fibrillation screening program
Study of Motexafin Gadolinium (MGd) in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The primary purpose of this study is to determine if motexafin gadolinium may be an effective treatment for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Secondly, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening will be evaluated. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t\[11;14\] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following: 1) Refractory disease- progressive disease while on therapy, or 2) Relapsed disease progressive disease after at least one treatment course of therapy with disease response or stabilization
* ECOG performance status score of 0, 1, or 2
* Willing and able to provide written informed consent

Exclusion Criteria:

Laboratory Values of:

* Platelet count \< 30,000/µL
* AST or ALT \> 2 x ULN (upper limit of normal)
* Total bilirubin \> 2 x ULN
* Creatinine \> 2.0 mg/dL

and

* Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (\> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
* Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
* Uncontrolled hypertension
* Known history of porphyria (testing not required at screening)
* Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency (testing not required at screening)
* Known history of HIV infection (testing not required at screening)
* Pregnant or lactating (pregnancy test is required for all female patients of childbearing potential)
* Woman of childbearing potential or sexually active man unwilling to use adequate contraceptive protection
* Physical or mental condition that makes patient unable to complete specified follow-up assessments
Oculomotor Response While Using a Helmet Display Incorporating an Accommodation-vergence Stress Reduction Algorithm

Operational military personnel are increasingly using virtual or augmented reality headsets in the field or in training. However, these devices cause a conflict between accommodation (focus to see clearly) and vergence (alignment of both eyes on the object being viewed) that can be a source of visual fatigue and altered visual and perceptual abilities. Although techniques exist to limit this conflict for screen-based stimuli, the use of helmet visuals (or immersive headsets) adds technological complexity. Indeed, since accommodation on the screen of the helmet visual is impossible (i.e., distance too small) for the human visual system, lenses are used to virtually shift the image (referred to as a collimated image) so that accommodation can occur much further away. However, this material configuration also modifies the vergence, thus causing a conflict between accommodation and additional vergence that persists regardless of the attenuation technique used.

In this study, the investigator proposed to modify the image display to take into account the technical features of the helmet to correct this techno-dependent conflict. This study is aimed at determining whether the setting recommended by the algorithm developed by the investigator limits visual fatigue better than the conventional setting recommended by manufacturers or a subjective setting controlled by the user.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Non-presbyopic
* Stereoscopic acuity ≤ 60 min of arc

Exclusion Criteria:

* Accommodative insufficiency (APP ≤ 13-"age"/4, in diopters)
* Accommodative inertia (+ and - block in binocular)
* Compensation by orthokeratology
* Present or past binocular pathology: strabismus or amblyopia
Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo

To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo

Approximately 5-20 per 100,000 persons are afflicted with SSHL annually, and nearly 20-60% of SSHL patients complain of simultaneous vertigo.The aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(SSHL) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of SSHL with vertigo.

Eligibility Criteria:
Inclusion Criteria:

1. A rapid onset sensorineural hearing loss of more than 30 dB for at least three contiguous audiometric frequencies within a period of 3 days, according to standard AAO - HNS;
2. Within 10 days from onset;
3. Without other virus infectious disease within three months.

Exclusion Criteria:

1. BPPV; Meniere's disease and vestibular migraine.
2. With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc
Impact of Stigma on Compliance to Medication in Functional Dyspepsia

To date, no study exists that evaluates whether functional dyspepsia patients experience stigma and how stigma may influence adherence. Thus, the investigators aim to evaluate the relationship between functional dyspepsia and stigma, and explore possible ways to improve treatment adherence.

Due to the functional but refractory nature of functional gastrointestinal diseases (FGIDs), large number of patients who suffer from FGIDs may not be able to fully understand their diagnosis, especially when they were told that they had no organic disease and their symptoms had a psychosomatic origin rather than a gastrointestinal one. Moreover, subjects with FGIDs have concerns and negative perceptions about medications, particularly in the presence of psychiatric comorbidity. Fearing of being labeled as insane or incapability, many patients with psychosomatic symptoms choose to conceal their illness to family, colleagues and doctors. These factors may affect willingness to initiate neuromodulator regimens and treatment adherence.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old;
* met the ROME IV criteria for FD;
* absence of abnormalities in physical examination, laboratory tests (including a routine blood test, blood glucose, and liver function examination), abdominal ultrasonography and upper GI endoscopy within 6 months;
* absence of H. pylori infection;
* Generalized Anxiety Disorder Scale (GAD-7) ≥ 1 or Patient Health Questionnaire Depression Scale (PHQ-9) ≥ 5

Exclusion Criteria:

* any evidence of organic digestive diseases;
* other FGIDs such as IBS;
* severe psychological symptoms with GAD-7 ≥ 11 or PHQ-9 ≥15;
* pregnancy or breastfeeding; recent myocardial infarction or cardiac arrhythmias;
* previous gastric surgery;
* use of PPIs, psychoactive drugs or other drugs that might affect gastric function within 6 months
Study of Adherence and Effects of Balance Exercices (SIEL BLEU Associatio)

The purpose of this study is to measure the adherence to "Siel bleu" balance exercises in patients with Alzheimer's disease, while taking into account the disease stages.

The practice of physical activity, more specifically postural balance exercises, is an intervention that improves gait performance in the elderly. Among patients with Alzheimer's disease, it seems that physical exercice also improves cognitive performance, reduces the loss of autonomy and independence in activities of daily living. All these effects may reduce the caregiver burden.

Despite several initiatives in France, no study has been carried out to test the adherence to postural balance exercises and to examine the benefits on older AD patients and their caregiver.

The main objective of this study is to measure the adherence to "Siel bleu" balance exercises in patients with Alzheimer's disease, while taking into account the disease stages.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's disease (AD) (DSM-IV/NINCDS-ADRDA criteria)
* Age ≥ 65 years old
* Mild AD (Mini-Mental State Examination score between 21 and 25), moderate AD (Mini-Mental State Examination score between 10 and 20) and severe AD (Mini-Mental State Examination score between 3 and 9)
* Able to walk without any aid on 15 meters.
* Near visual acuity ≥ 2
* Absence of severe depression (score of the 15-item Geriatric Depression Scale ≤ 10)
* Written consent form to participate in the study (or trustworthy person or legal representative for severe AD)
* Being affiliated to a social security regime

Exclusion Criteria:

* Musculoskeletal disorders not related to Alzheimer's disease
* Near visual acuity \< 2
* History of cerebrovascular accident or other cerebro-spinal pathology
* Poor workmanship of the written or oral French language
* Refusal to be informed on possible hanging bare anomaly during study
* Score of Mini-Mental State Examination \< 3
* Presence of severe depression (score of the 15-item Geriatric Depression scale \> 10)
* Use of walking aid
* Subject suffering from pre-existing impellent disturbances
* Refusal to participate (or trustworthy person or legal representative)