cyrilzakka/clinical-trials huggingface dataset:
Trigger Point Electroacupuncture Treatment in Patients with Chronic Low Back Pain

Electroacupuncture is an application of acupuncture combined with electrical stimulation of acupuncture points through acupuncture needles to achieve faster pain relief than acupuncture. Recently, research has shown that Trigger point acupuncture has a significant effect in reducing pain better than acupuncture on acupoints in patients with chronic low back pain. However, no research has compared the pain relief effect between Trigger Point electroacupuncture and electroacupuncture on acupoints in patients with chronic low back pain. This study was conducted to address this question.

Participants and Methods: A blinded randomized controlled clinical trial was conducted involving 60 chronic low back pain participants, randomly divided into two groups (A and B): 30 receiving electroacupuncture at the Trigger point (group A) and 30 receiving electroacupuncture on the meridian (group B) for 10 sessions. The primary outcomes were visual analogue scale (VAS), BPI index, and Trigger point count.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 or older who consented to participate in the study;
* Individuals experiencing LBP persisting for more than 3 months with an average VAS score of 5 cm or over;
* Patients displaying trigger points in back

Exclusion Criteria:

* Major trauma or systemic disease such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Scheuermann disease;
* Systemic symptoms such as weight loss, fever of unknown origin, anorexia, personal history of malignancy, diffuse pain and joint stiffness;
* Symptoms of infection such as fever, meningeal irritation signs, photophobia;
* Symptoms of central motor neuron damage such as Hoffmann sign, Babinski sign, hyperreflexia, spasticity, incontinence, sexual dysfunction;
* Symptoms of serious acute diseases such as myocardial infarction (chest pain, sweating, shortness of breath), arterial dissections (tearing sensation, headache, blurred vision);
* Conditions unsuitable for acupuncture such as inflammation of skin in need of acupuncture, weak or exhausted patients, severe comorbidities;
* Being treated with other methods. Elimination criteria: Patients experiencing adverse events from the intervention leading to their discomfort and withdrawal from the study
Efficacy and Speed of Action of a Product to Control Gastric Hydration and Gastroesophageal Reflux

A Randomised, Placebo-Controlled Clinical Trial off the Efficacy and Rapidity of Action of a Product Containing Sodium Alginate, Calcium and Magnesium Salts, Hyaluronic Acid and Aloe Vera to Control Oesophageal-Gastric pH and Reduce Symptoms of Gastric Reflux and Hyperacidity.

The investigators will include patients with gastroesophageal reflux disease and heartburn (more than 3 weekly episodes of heartburn for at least 4 consecutive weeks) not related to medication intake and don't use proton pump blockers or H2-receptor antagonists.

This is a multicentre clinical trial with two-phase design:

Phase I: A double-blind, randomised, placebo-controlled clinical trial to assess the efficacy and rapidity of action of the medical device to reduce clinical symptoms of gastric reflux and hyperacidity under normal conditions of use. This phase I will be performed in primary care clinics.

Phase II: A non-comparative, non-controlled clinical trial to objectively assess, using continuous pH monitoring, the magnitude and rapidity to control gastric and oesophageal pH after taking the product. This phase II will be performed at the Department of Gastroenterology of Medic Center.

The study will begin with the baseline visit (day 0) in which the inclusion and exclusion criteria will be confirmed, the signing of informed consent will be obtained, GERD-Q Questionnaire will be done and treatment will be prescribed, followed by a home recording where patients will record data on episodes of acidity and heartburn occuring during the follow-up week. A face-to-face visit will be at 7 days after to recollect information about total number of daytime and nighttime episodes of acidity/heartburn since the previous visit and repeat the GERD-Q Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes over 18 years of age
* Patients with gastroesophageal reflux disease and heartburn (more than 3 weekly episodes of heartburn for at least 4 consecutive weeks) not related to medication intake
* Patients not on proton pump blockers or H2-receptor antagonists
* Patients able to understand the study implications and who sign the informed consent.

Exclusion Criteria:

* Pregnant or nursing women
* Patients who are currently using or have used other medications or antacid products for the treatment of reflux and hyperacidity symptoms within 7 days prior to enrolment in this study.
* Patients treated with antihypertensive drugs, calcium channel blockers or non-steroidal anti-inflammatory drugs (NSAIDs)
* Patients with hypercalcaemia, hypertension, renal failure or other conditions in which the use of the components of the investigational product is not recommended.
* Patients with serious diseases that, in the physician's opinion, could interfere with the results of the study or prevent their participation in it.
An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position

The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in measuring position changes of hospitalized patients.


Eligibility Criteria:
Inclusion Criteria for Laboratory Subject:

1. Signed and dated informed consent by subject
2. Male or female of any race
3. At least 18 years of age
4. Willingness to have study device attached during study participation
5. Willingness to participate in all aspects of the study

Exclusion Criteria for Laboratory Subject:

1. Implanted pacemaker or defibrillator
2. Allergy or sensitivity to ECG leads or similar types of adhesive
3. History of hospital admission or a surgical procedure in the 60 days prior to study enrollment
4. BMI \> 30.0

Inclusion Criteria for Hospital Subjects:

1. Signed and dated informed consent by subject
2. Male or female of any race
3. At least 18 years of age
4. Expected hospitalized admission on the general care floor for at least three days
5. At risk for hospital-acquired pressure ulcers as defined by score on the Braden Scale of \< 18
6. Willingness to have study devices attached during study participation
7. Willingness to participate in all aspects of the study

Exclusion Criteria for Hospital Subjects:

1. Implanted pacemaker or defibrillator
2. Allergy or sensitivity to ECG leads or similar types of adhesive
3. Subject will be sleeping in a chair or spending the majority of time in a chair
4. BMI \> 39.9
A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia

The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.

This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with schizophrenia
* Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
* Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
* Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
* Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study

Exclusion Criteria:

* Serious unstable medical condition, including known clinically relevant laboratory abnormalities
* Judged to be at high risk for adverse events, violence or self-harm
* Inability to swallow the study medication whole with the aid of water (patients may not chew, divide, dissolve, or crush the study medication)
* Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
* Patients with a current use or known history (over the past 6 months) of substance dependence
* Positive urine drug examination
Rate of Catheter Colonization and Risk of Bloodstream Infection During Use of Two Different Central Venous Catheters (CVC)

The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Certofix® protect is a catheter with a surface modified in order to reduce colonization by bacteria. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.

Central venous catheters are an essential part of patient management in the ICU (Intensive Care Unit). The use of these catheters is associated with infectious complications that are an important iatrogenic source of morbidity and mortality. Many catheters become colonized with bacteria but only a proportion of colonised catheters go on to cause bacteriemia and sepsis. It is currently impossible to prospectively identify which of the catheters will become colonized and lead to sepsis. Various types of antiseptic or antimicrobial vascular catheter coatings have been developed. Studies showed that the coated catheters were effective in limiting the catheter colonization rate and that they may decrease the risk of catheter-related bloodstream infections. The "Certofix protect" was developed by B.Braun to reduce the risk of catheter related infections. It is a catheter with a modified surface that consists of a high molecular weight polymer which is non-covalently linked to the polyurethane catheter material. This clinical trial is performed to compare the safety and efficacy of the coated central venous catheter, Certofix® protect, with that of the non-coated standard catheter Certofix®.

Eligibility Criteria:
Inclusion Criteria:

* Patients with probable ICU stay
* Patient's first or second catheter placement during actual hospital stay
* Anticipated indwelling central venous catheter period \>= 3 days (jugular vein, subclavian vein)
* \>= 18 years of age
* Written informed consent of patient or independent physician prior to the participation; in this case: written informed consent after recovery if possible

Exclusion Criteria:

* The catheter will not be placed in the femoral vein
* Inflammation of the skin at the site of puncture prior to puncture
* Known hypersensitivity to any of the components (i.e. polyhexanide or related substances such as chlorhexidine)
* Participation in another clinical trial
* Emergency insertion of catheter in the field
Evaluation of the Analgesia Nociception Index and Videopupillometry to Predict a Child's Post-tonsillectomy Morphine Prescription

Some surgeries, such as tonsillectomies, are particularly painful postoperatively because they are not very accessible to a complementary technique of loco-regional anesthesia and require the use of opioids in the postoperative period.

The use of opioids, in combination with usual analgesics, is common after this surgery. However, some risks are associated with the use of morphine in children, including more frequent respiratory distress, nausea and vomiting, and can cause hemorrhagic complications and lengthen the duration of hospitalization. Decreasing the consumption of morphine drugs is therefore a real challenge.

Although there is no randomized controlled study on the use of standard analgesics with or without morphine to date, a number of studies suggest that the use of morphine should not be systematic after a surgery.

The need for opioids after tonsillectomy as well as the level of pain vary between patients. Some teams use morphine at the end of general anesthesia to prevent pain on waking and others use it only if needed, once the child is awake.

Pain assessment scales are used in the Post-interventional Monitoring Room (PIMR) to adapt these analgesic therapies according to the intensity of pain. One of the validated and frequently used scales in pediatric PIMR is FLACC (Face Legs Activity Cry Consolability). Monitoring tools are also available to evaluate the quality of intraoperative analgesia in unconscious children :

* the analysis of the pupillary variation in response to a painful stimulus by videopupillometry,
* and the ANI (Analgesia Nociception Index) which consists of estimating the sympathetic-parasympathetic balance by a complex analysis of cardiac rhythm variability.

These two types of monitoring could predict which children will require post-operative morphine treatment.

To date, no study has demonstrated the relationship between videopupillometry and postoperative morphine consumption. The average ANI has already been evaluated in children as correlated with FLACC but both monitoring devices have never been compared for a predictive purpose.

The investigators hypothesize that the use of the PPI® (Pain Pupillary Index) scale of Algiscan® and the average ANI measured by the PhysioDoloris® monitor in children still sedated at the end of the intervention could have a prognostic value on post-operative morphine prescription.


Eligibility Criteria:
Inclusion Criteria:

* Any child for whom tonsillectomy is programmed ≥ 2 years and up to 7 years inclusive
* Consent written and signed by at least one holder of exercise of parental authority

Exclusion Criteria:

* Eye disease
* Cardiac pathology
* Neurological pathology
* Chronic opioid treatment
* Any treatment interfering with the autonomic nervous system
* Any contraindication to NSAIDs
A Study to Determine the Safety and Efficacy of an Ultrasound Device in the Management of Acute Acne Lesions

The purpose of this study is to find out how effective and safe an experimental ultrasound device is for treating Acute Acne lesions.

Acne vulgaris is a disease that occurs when oil and dead skin cells clog the pores of the skin. When the skin's pores are clogged, red spots and bumps known as pimples are formed, usually on the face, neck, chest, and back. In adolescents and adults, acne vulgaris is commonly called "acne." Many factors have been associated with acne. One of the factors is the increased production of fatty substances from an enlarged sebaceous gland ("oil gland").

The experimental ultrasonic device uses sound waves (called ultrasonic waves) to heat the acute acne lesion and the surrounding sebaceous ("oil") glands deep in the skin without affecting the surface of the skin. We hope that heating the sebaceous glands will reduce their size and reduce the symptoms of inflamed acne. Using ultrasonic waves to treat acne is investigational.

This is a pilot study. A pilot study is done on a small group of subjects to learn if the device will be effective and safe, before the device is used on a larger group of subjects.

Eligibility Criteria:
Inclusion Criteria:

* female or male subjects,
* greater than 18 years age,
* with acute acne on the face.

Exclusion Criteria:

* pregnancy,
* concomitant skin diseases,
* severe acne,
* antibiotic therapy.
A Pathophysiological Study of the Postprandial Human Liver (PLS)

Fatty liver disease is a globally widespread disease The identification of valid biomarkers and targets for potential treatments requires in-depth knowledge about the pathophysiology of the postprandial liver. The study will consist of five work packages (WP) including blood tests and liver biopsies taken after fasting or ingestion of a standardized meal in: healthy controls (WP 1), patients with NAFLD (WP 2), and patients with cirrhosis (WP 3) ; before and after a standardised meal in healthy controls (WP 4), and before and after glucagon in healthy controls (WP5)


Eligibility Criteria:
Healthy participants (WP 1 , WP 4 , WP 5 )

Inclusion criteria: Healthy adults, 20 - 40 years old, non-smoker, BMI 20-25 kg/m2 , no chronical illnesses, no medication.

Exclusion criteria: Blood donation within the past 3 months, acute illness within 2 weeks

NAFLD ( WP 2)

Inclusion criteria: Patients with clinical diagnosis of NAFL and indication for liver biopsy Exclusion criteria: Malignant disease, acute illness within the past 2 weeks.

Cirrhosis (WP 3)

Inclusion criteria: Patients with clinical diagnosis of cirrhosis and indication for liver biopsy.

Exclusion criteria:Malignant disease, acute illness within the past 2 weeks.
Tongji-Ezhou Study

Tongji-Ezhou study (TJEZ) is a prospective cohort study launched at 2013 in EZhou city, Hubei province, with the goal of recruiting and assessing 10,000 individuals and then following them for at least 2 decades. In addition, blood samples would be collected every 3-5 years among 6000 of them to investigate the nutritional biomarkers and potential determinants of chronic diseases such as obesity, type 2 diabetes, metabolic syndrome, and cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* (i) permanent residence in Ezhou district (minimum of 9 months); (ii) written informed consent; (iii) age ≥ 20 years old at the time of enrolling in the study.

Exclusion Criteria:

* (i) with chemotherapy or radiotherapy for cancer and other severe diseases.
The Influence of the Sleep Apnea on the Neurological and Functional Recovery

The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after stroke. The association of the sleep respiratory troubles with a reserved functional prognosis is debated. The purpose is to find out the frequency of the sleep respiratory troubles after stroke in a PRM department and to study their relationship with functional and neurological recovery.

The sleep respiratory troubles (central apnea or CHEYNES-Stokes dyspnea) are frequent after stroke. The association of the sleep respiratory troubles with a reserved functional prognosis is debated. The purpose is to find out the frequency of the sleep respiratory troubles after stroke in a PRM department and to study their relationship with functional and neurological recovery.

Forty-five patients with the average of 58,2 years had been included in this prospective MONOCENTRICAL study. The detection of the sleep respiratory troubles was realised using a nocturnal oxymetry device and measuring the inspiratory flow, gathering the index of apnea-hypopnea.

The NIHSS, the FIM and the FUGL-MEYER scales were used at the moment of inclusion and two months AFTERWORDS.

Eligibility Criteria:
Inclusion Criteria:

Patient's or one family member's agreement for participation in the study Being aged over 18 years Stroke history in the past 6 months (ischemic or hemorrhagic) Hospitalisation in PRM department and participation to a rehabilitation program during study Patient belonging to the social security system

Exclusion Criteria:

Patient having a sleep apnea syndrome known prior to inclusion Patient presenting a cardiorespiratory INSUFIENCY Patients being INABLE to carry-out the tests or presenting a mental disorder Patients who started already their rehabilitation program before in another PRM center or department
Study Determining Gastric-Retentive and Modified Release Properties of Prototype Capsules in Healthy Subjects

To assess how long modified release (MR) memantine hydrochloride prototype capsule formulations stay in the stomach as determined by magnetic resonance imaging (MRI).

This is a single center, open-label, single dose, 5-period study in 24 healthy male and female subjects, with an optional Period 6, if required. It is expected the study will be executed in 3 cohorts of 8 subjects, with each cohort participating in up to 2 study periods (total of up to 6 study periods). Cohort 3 may be conducted in parallel with Cohort 2.

Subjects will be dosed in a sequential manner, as appropriate. Each subject will be administered up to 2 regimens (2 different prototype capsule formulations) across 2 study periods. There will be a minimum 35-day interval between each dose administration.

Subjects will have an MRI scan performed on Days 2, 4, 7, 10 and 14 of each period to assess the gastric retentive properties of the formulation.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female subjects.
2. Body mass index of 18.0 to 32.0 kg/m2.
3. Subjects must demonstrate their ability to swallow a test capsule at screening.
4. Must provide written informed consent.

Exclusion Criteria:

1. Subjects who have received any investigational medicinal product in a clinical research study within the previous 3 months.
2. Subjects who have previously been enrolled in this study.
3. History of any drug or alcohol abuse in the past 2 years.
4. Current smokers and those who have smoked within the last 12 months.
5. Individuals with clinically significant medical history relating to the gastrointestinal tract and potential for complications, thereof
6. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
7. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
8. Individuals with contraindication to MRI imaging.

Other protocol defined criteria may apply.