cyrilzakka/clinical-trials huggingface dataset:
Laparoscopic Bariatric Surgery and Erector Spinae Plane Block

The aim of the study is to evaluate the effect of erector spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Laparoscopic sleeve gastrectomy is one of the most common surgical procedure that is chosen for bariatric surgery. Postoperative pain after bariatric surgery can de significant. Narcotic analgesics are often used to manage the postoperative pain in patients undergoing bariatric surgery. However, these drugs causes many undesirable adverse effects such as nausea, constipation, and respiratory depression.

The ultrasound (USG) guided ESP block was first defined in 2016. With the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of ESP is that spread blocks the ventral and dorsal rami to the paravertebral area. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia after bariatric surgery.

The aim of the study is to evaluate the effect of ESP block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Eligibility Criteria:
Inclusion Criteria:

* elective bariatric surgery
* American Society of Anesthesiology (ASA) II-III
* 18 - 65 years
* body mass index (BMI) 40-60 kg/m2

Exclusion Criteria:

* ASA ≥4
* under 18 years of age or over 65 years of age
* declining to give written informed consent
* have neurological and/or psychiatric disorders
* cooperation cannot be established
* accompanying laparoscopic cholecystectomy or paraumbilical hernia repair
* history of bariatric surgery
* the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
* with hepatic, neuromuscular, cardiac and/or renal failure
* history of allergy to the local anesthetics
* patients undergoing open surgery
S100B as a Marker of Brain Injury of Preterm Infants

The improvement of treatment of preterm neonates improved their survival, however there is still significant portion of preterm infants (specifically very preterm infants) that suffers from brain insults and as a result developmental deficits. The brain injury is a consequence of hypoxic ischemic events, intracranial hemorrhages, as well as, infections and metabolic crisis. The brain injury is a combination of abnormal myelination, axonal damage and neuronal death. Although there is reduction in focal brain injury, diffuse brain injury is still abundant. Several treatments has been suggested and tested in animal models to prevent the brain insults including glutamate receptor blockers, allopurinol, xenon and different types of stem cells. However, two main obstacles prevent the use of these medication, first the uncertainty of their effect on the developing brain and second the difficulty to time the brain insult. Unlike neonatal asphyxia, when the delivery time and clinical signs are used to time and grade the brain injury, in preterm infants there is no real time tool to indicate severity and timing of brain injury. The disability point out a beneficial therapeutic window is a major obstacle in the acute treatment of brain injury in preterm infants. The aim of this study is to try and delineate such therapeutic window by using brain injury biomarkers.

S100b and GFAP are well recognized biomarkers of brain injury in adults, children and infants. Serial measurements of S100b in saliva (every 2 days) and GFAP in serum (weekly) will be sampled. A database of the clinical status of the infants will be collected, as well as, head ultra sound weekly and head MRI a term age. Development will be assessed by at 18 months. Two hypotheses are stated: One, increase in the levels of S100b and GFAP in their timing will be correlated with the severity of the clinical status, Two the duration of increased level of S100b and GFAP will be associated with abnormal MRI at term findings and abnormal developmental assessment.


Eligibility Criteria:
Inclusion Criteria:

- Preterm delivery before 30 week gestational age

Exclusion Criteria:

* Dysmorphic features in initial neurological examination
* Antenatal brain injury on fetal MRI or ultrasound
* Brain malformation
* Maternal drug abuse
* Maternal use of teratogenic medications
Effects of Ginseng on Stress, Emotional and Cognitive Processing

This study aims to confirm the positive effect of the Red Panax Ginseng on the cognitive performance and regulation of stress and fatigue in adults with moderate stress level.

This study has been designed as a randomized double-blind placebo-controlled interventional study.

One hundred and fifty participants (aged between 18 and 60), presenting a moderate level of perceived stress, were randomly allocated to the control (placebo) or test (ginseng supplement) group. Participants will be supplemented during 3 weeks with those products. Cognitive performance and emotional processing will be measured with tests and questionnaires before (baseline) and at the end (3 weeks) of the intervention. Fasted blood glucose level will be measured in blood before (baseline) and at the end (3 weeks) of the intervention.

Eligibility Criteria:
Inclusion Criteria:

I.1. Healthy woman or man, aged of 18 to 60 years (inclusive); I.2. With a moderate level of perceived stress (PSS scores ranging from 14 to 26); I.3. Provision of signed and dated informed consent form; I.4. Stated willingness to comply with all study procedures and availability for the duration of the study; I.5. Speaking French.

Exclusion Criteria:

E.1. Subject with severe medical or cognitive problems which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study criteria or with participant safety; E.2. Subject with a coffee consumption of more than 5 cups per day; E.3. Subject consuming drugs and/or with historical drug addiction (\<5 years); E.4. Subject with alcohol consumption exceeding 3 glasses of wine per day, or two halves of a beer per day, or one glass of strong alcohol per day; E.5. Subject undergoing medical treatment which, in the opinion of the Principal Investigator, could interfere with cognitive and emotional processing; E.6. Subject with type 1 or type 2 diabetes; E.7. Subject participating in another intervention trial; E.8. Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, IUD, abstinence, ...).
The MAD Study of SSGJ-613 in Healthy Subjects

To evaluate the safety and tolerability of SSGJ-613 after multiple subcutaneous injections in healthy subjects.

The purposes of this study are to evaluate the safety and tolerability, PK characteristics and immunogenicity of SSGJ-613 after multiple subcutaneous injections in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
2. The body mass index (BMI) is in the range of 19.0\~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
3. Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent

Exclusion Criteria:

1. Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
2. Subjects who have or are currently suffering from any serious clinical diseases before screening,
3. Abnormal vital signs or abnormal ECGor physical examination are clinically significant
4. Clinical laboratory examinations found to be abnormal and have clinical significance
5. Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
6. Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
7. Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening
8. Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 2 weeks before administration
9. Has known or suspected pregnancy or lactation
10. Subjects who are unsuited to the study for any reason, judged by the investigators
Sepse: Critical Analysis of New Sepse Definitions and Retrospective Evaluation of Sepse Protocol at a Tertiary Hospital in Brazil

Research in the databases Lilacs, BIREME, SciELO by the terms: systemic inflammatory response syndrome (SIRS), sepsis, severe sepsis and septic shock and their equivalents in the English language. Selection of the main articles of the last five years to study and contextualize the reality presented since the implantation of the HUVR sepsis protocol. Statistical analysis of data since the implementation of the sepsis protocol in the HUVR, in July 2014 until June 2016.


Eligibility Criteria:
Inclusion Criteria:

All individuals who had a confirmed or suspected sepsis diagnosis and had a sepsis protocol completed during the study period.

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Exclusion Criteria:

Individuals with confirmed or suspected sepsis in the study period who did not complete the protocol.

Individuals under the age of 18

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Microparticles, Vector of Genetic Information During HIV Infection

The aim of the investigators study is to demonstrate in healthy subjects and a cohort of patients infected with HIV, the presence of miRNAs in circulating peripheral blood microparticles (MPs).


Eligibility Criteria:
Inclusion Criteria:

* Age of 40 +/-10 years
* Seronegativity for the HIV 2
* Patients of the group A: seropositivity for the HIV 1 confirmed in ELISA and Western Blot for at least 2 years and having never received from antiretroviral treatment, with a viral plasmatique load \> 1000 copies / ml
* Patients of the group B: seropositivity for the HIV 1 confirmed in ELISA and Western Blot for at least 2 years and under stable antiretroviral treatment for at least 6 months, with a viral load undetectable plasmatique (\< 40 copies / ml)
* patients of the group C : Matching on the age (+/-3 years) to a patient
* Be considered healthy by the Investigator after a clinical examination Seronegativity for the HIV 1 confirmed in ELISA the day of the taking

Exclusion Criteria:

group A et B

* Age of \< 30 years and \> in 50 years
* Seropositivity for the HIV 2

group C Seropositivity for the HIV 2

- Be under medicinal treatment
The Efficacy of Acupuncture and Laser Acupuncture in Treating Chemotherapy or Target Therapy-induced Hand-foot Syndrome

Chemotherapy or target therapy-induced hand-foot syndrome in cancer patients affects the quality of life. At present, there is no better treatment for this side effect of chemotherapy or target therapy. In severe cases, it is necessary to reduce the dose of chemotherapy or target therapy, which may affect the progress and effect of chemotherapy. In recent years, acupuncture has been widely used for many side effects of chemotherapy, such as numbness of hands and feet, gastrointestinal discomfort, and dizziness. There have been many studies have proved to be effective, but quite few studies explored the acupuncture treatment improves the hand-foot syndrome caused by chemotherapy or target therapy in cancer patients. Therefore, the investigators expect to evaluate the efficacy of acupuncture, and applying acupuncture or laser acupuncture to improve hand-foot syndrome caused by chemotherapy or target therapy in cancer patients in the future.

The investigators design a single-center, sham-controlled, assessor- and subject- blind, randomized clinical trial. 60 subjects will be equally and randomly divided into an acupuncture group, laser acupuncture, and sham-laser acupuncture groups in the 6-week trial. Each subject receives acupuncture, laser acupuncture, or sham-laser acupuncture three times a week for three consecutive weeks depending on their group, with a total of 9 times interventions. Outcome measures include Common adverse events evaluation standard version 5.0 (CTCAE) and Visual Analogue Scale (VAS), Dermatology Life Quality Index (DLQI) and assessment of cancer patients' quality of life questionnaire (EORTC QLQ-C30). ANSWatch and Thermal Image Camera are also used to assess those subjects. Those outcome measures will be conducted at baseline, the 3rd and the 6th week after the interventions.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients receiving chemotherapy or targeted therapy
2. Age over 20 years old
3. Western medicine diagnoses hand-foot syndrome
4. Sign the consent form

Exclusion Criteria:

1. Pregnant or planning to become pregnant
2. Serious arrhythmia (or cardiac pacemaker installed)
3. Epilepsy
4. Severe organ failure, such as heart and lung failure, liver and kidney failure
5. Psychiatric history, unable to cooperate with acupuncture and assessors
6. Those who received traditional Chinese medicine treatment for hand-foot skin reaction
Effectiveness of Modified Functional Appliance With Expander

This clinical trial compares the effectiveness of a myofunctional appliance that uses a clear and modified twin block appliance with an expander made from 2mm biocompatible polyethylene terephthalate modified with Glycol thermoplastic material with a conventional twin block appliance with an expander. The trial will be conducted on adolescent patients with class II division 1.

In a multicenter single-blinded randomized clinical trial study with two-arm parallel groups, a computer random generator will develop a simple randomization with an equal allocation ratio (1:1) and without stratification. The investigator will initially assess the patients for eligibility to be included in the study. Those who will meet the inclusion criteria, the parents will be informed about the nature of the study verbally to get the initial approval for participation. Then they will be provided with the patient information sheet and consent form.

According to the sample size calculation, 48 patients will be recruited (24 for each group), and impressions and lateral cephalometric radiography will be taken before treatment and bite registration then the appliance inserted, and the patient will be checked every two weeks for expansion and every four weeks for overjet recording. The treatment will be continuing for 6 months to take final records. The collected data will include cephalometric evaluation, clinical evaluation, scanned upper model evaluation, and finally patient satisfaction from the appliance.

Data will be analyzed using Statistical Package for Social Sciences for Windows, version 26.0 including descriptive statistic (number, mean, and standard deviation), Reliability statistic (interclass correlation coefficient), and Inferential statistics (independent samples t-test).

Eligibility Criteria:
Inclusion Criteria:

1. Patients' age at the start of treatment: at growth spurt \[in stage 2 (Acceleration) - 3 (Transition) of cervical vertebral maturation\].
2. Skeletal and dental relationships: skeletal class II with normal maxilla and retrognathic mandible. Moderate to severe dental class II division 1 malocclusion with overjet ≥ 8 mm.
3. Horizontal/normal growth pattern.
4. Convex profile with decreased or normal lower facial height (clinically and radiographically).
5. Well-aligned/mild crowding of maxillary and mandibular dental arches.
6. Good oral health free from caries and periodontal problems at the start of treatment.

Exclusion Criteria:

1. Patients with vertical growth pattern or backward mandibular rotation tendency.
2. Patients with open bite
3. Patients with obvious facial asymmetry.
4. Patients with orofacial clefting.
5. Patients with bad oral habits.
6. Active periodontal disease.
In-patient Asthma Counseling by Pulmonologist and Hospital Re-admission Rate

Prospective randomized clinical trial to assess the effect of in-hospital intensive counseling and follow-up vs. usual care, on re-admission rates of patients with Asthma.

The study population will include asthma patients admitted to internal Medicine departments and medical ICU at Soroka University Medical Center, due to asthma exacerbation.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years old.
2. Admitted to Internal Medicine at Soroka University Medical Center due to asthma exacerbation.

Exclusion Criteria:

1. Substance abuse (except for tobacco).
2. Handicapped or bed ridden patients.
3. Patients who don't speak Hebrew, English, Russian or Arabic.
4. Other significant respiratory disease such as COPD, interstitial lung disease (as decided by the PI).
Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

The goal of this randomized controlled trial is to evaluate the benefits from adding multimedia animations to a paper-based therapeutic exercise program in subjects with rotator cuff related shoulder pain. The main question\[s\] it aims to answer are:

* Does subjects improve more regarding shoulder disability and pain?
* Are the subjects more satisfied with the treatment received?
* Do the subjects adhere more to the exercise program?
* Do the subjects have greater expectations with the treatment received? Participants will perform a therapeutic exercise program within 6 months. Researchers will compare the addition of web-app animations to the classical paper-based information.


Eligibility Criteria:
Inclusion Criteria:

* Presence of rotator cuff related shoulder pain, diagnosed as unilateral shoulder pain, located in the anterior and/or lateral deltoid region, which is reproduced by active elevation and/or lying on ipsilateral side, and with at least one the following orthopaedic tests: Neer, Hawkins-Kennedy and/or empty can.
* Pain lasting from at least 3-months.
* Pain intensity at rest, during movement, and sleeping ≥ 3/10 points on a numeric pain rating scale.
* To have a mobile phone, tablet or computer with internet connection.
* To understand written and spoken Spanish language.

Exclusion Criteria:

* History of major trauma or surgery on the shoulder, elbow, or cervical spine.
* Signs of other shoulder pathologies such as instability, frozen shoulder, calcific tendonitis, severe arthrosis, or neuralgic amyotrophy.
* Presence of full-thickness rotator cuff tears on ultrasound imaging.
* Signs and/or symptoms of neck-related shoulder pain and/or radiculopathy or radicular pain.
* Systemic diseases such as cancer, rheumatic disorders, sclerosis multiple, neurological disorders, etc.
* Severe psychiatric disorders.
Phase IIa Proof of Concept Study of M5717-Pyronaridine in Adults and Adolescents With Acute Uncomplicated Plasmodium Falciparum Malaria (CAPTURE 1)

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria. Pyramax (Artesunate/Pyronaridine) will act as an internal control providing reference safety data and a benchmark for the efficacy evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Participants with microscopic confirmation of acute uncomplicated Plasmodium falciparum using Giemsa-stained thick and thin film
* P. falciparum parasitemia of 1,000 to 50,000 asexual parasites/microliter of blood in Part A and P. falciparum parasitemia of \>1,000 to \<= 150,000 asexual parasites/microliter of blood in Part B
* Axillary temperature \>= 37.5 degree Celsius or tympanic temperature \>= 38.0 degree Celsius (use as per Coronavirus disease 2019 (COVID-19) protocols at the site \[only at Screening\]), or history of fever during the previous 24 hours (at least documented verbally)
* The Investigator confirms that each participant agrees to use appropriate contraception and barriers, if applicable
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Mixed Plasmodium infections as per thin film microscopy results
* Signs and symptoms of severe malaria according to World Health Organisation (WHO) 2021 criteria (WHO 2021)
* Known liver abnormalities, liver cirrhosis (compensated or decompensated), known active or history of hepatitis B or C (testing not required), underlying hepatic injury or known severe liver disease, known gallbladder or bile duct disease, acute or chronic pancreatitis, or severe malnutrition
* Known history or evidence of clinically significant disorders such as, cardiovascular, respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological \[including known Human Immunodeficiency Virus-Acquired Immunodeficiency Syndrome (HIV-AIDS)\], neurological (including auditory), endocrine, infectious, malignancy, psychiatric, history of convulsions, or other abnormality (including head trauma)
* Previous treatment with pyronaridine as part of a combination therapy during the last 3 months
* Prior antimalarial therapy or antibiotics with antimalarial activity within a minimum of their 5 plasma half-lives (or within 4 weeks of Screening if half-life is unknown)
* Participants taking medications prohibited by the protocol
* Other protocol defined exclusion criteria could apply
Efficacy of Urinary Follicle-Stimulating Hormone (FSH) Among Poor Responders

We proposed to compare outcomes in women with DOR undergoing ART with rec-FSH + u-HMH with those with u-FSH only in GnRH antagonist protocols.


Eligibility Criteria:
Inclusion Criteria:

* At least one trial with adequate ovarian stimulation resulted by 4 or less oocytes retrieval.

Exclusion Criteria:

* High responder patients
Vitamin and Unsaturated Fatty Acid Supplements in Healthy and Uveitis Human Subjects

The goal of this clinical trial is to learn if dietary supplements containing vitamin and unsaturated fatty acid works to intervene T cell inflammatory factor expression in patients with uveitis and healthy subjects in adults.


Eligibility Criteria:
Inclusion Criteria:

* healthy or with uveitis volunteers age 19-65 years.

Exclusion Criteria:

* abnormal blood glucose, blood pressure, blood lipids, or other systemic diseases should not participate in the study