cyrilzakka/clinical-trials huggingface dataset:
Application of Artificial Intelligence Algorithm Based on CT Imaging for Muscle Parameter Measurement

To establish an artificial intelligence model for automated diagnosis of sarcopenia based on CT imaging

With the accelerating aging process, the early identification and diagnosis of sarcopenia, along with the effective prevention of its adverse outcomes, have become a focal point in medical research. However, current methods for assessing and diagnosing sarcopenia still face significant limitations, making the development of more efficient and accurate techniques for muscle mass evaluation an urgent clinical need. Although CT is considered as the most promising method for assessing muscle mass, its practical application is hindered by factors such as reliance on physician expertise and time-consuming procedures, limiting its widespread clinical adoption. In light of these challenges, this study aims to develop an artificial intelligence model for fully automated muscle mass measurement based on abdominal CT imaging and to validate its application value in assisting the diagnosis of sarcopenia.

Eligibility Criteria:
Inclusion criteria：

1. The population undergoing BIA and abdominal CT examinations;
2. Can cooperate to complete human body composition analysis, grip strength measurement, 6m walking time measurement, and questionnaire survey.

Exclusion criteria：

1. Age\<18 years old;
2. Existence of abdominal wall edema;
3. History of spinal surgery or vertebral fractures, or vertebral tumor lesions;
4. History of neuromuscular disorders.
Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty

The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.

The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne CFU and particles at the surgery site during total arthroplasty surgery.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for total shoulder arthroplasty

Exclusion Criteria:

* Prior history of infection
* Revision surgery
* Screens positive for MRSA
Cardiovascular Response to Two Manual Techniques for Neck Pain

The aim of the investigators study is to investigate whether posteriorly directed (AP) pressures and laterally directed (LAT) glides, cause blood pressure and heart rate elevation or lowering in patients with neck pain. The answer will advance the investigators understanding of why manual therapy works.

To be included in the study, these subjects with unilateral non-traumatic, non-chronic neck pain (operationally defined as neck pain with mobility deficits lasting less than 3 months) shall have numeric pain rating scale (NPRS) of between 0 and 5 out of 10 as the most painful neck movement even with passive scapular elevation, neck disability index (NDI) of between 16 and 50 out of 100%, resting systolic and diastolic blood pressure between 90/60 and 138/88, and resting heart rate between 60 and 90. Subjects are excluded if they are current smoker, over 50 years of age, has a history of fainting spells or loss of consciousness, is on blood thinners, is taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease, has a history of spinal surgeries, and has neck pain classified or associated with headache, radiating pain, and movement coordination impairments. A convenience sample of subjects will be randomly allocated to 1 of 2 groups. Both Group 1: AP and Group 2: LAT will receive posterior pressures and lateral glides respectively to one hypomobile segment. Baseline NPRS, and NDI will be collected at the initial visit. Systolic blood pressure (SBP) and heart rate (HR) will be measured with a OMRON automatic monitor recording time points: (1) 5 minutes, and (2) 7 minutes after lying supine; (3) during the 1st set, (4) 5th set of one of the glides, (5) 2 minutes after time point #4, and (6) 4 minutes after time point #4. After time point #6, a global rating of change (GROC) will immediately be collected based on the most painful neck movement. A finger pulse oximeter will be placed on the subjects' index finger to constantly monitor their pulse rate for slowing heart rate or asystole. The primary author will perform one of the techniques on all subjects. After one visit, a follow-up NPRS, and NDI will be collected again.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral, non-traumatic, non-chronic mechanical neck pain
* Numeric pain rating scale between 0-5/10 as the most painful neck movement (with passive scapular elevation)
* Neck Disability Index between 16-50/100 percent
* Resting blood pressure between 90/60 and 138/88 mmHg
* Resting heart rate between 60 and 90 beats per minute

Exclusion Criteria:

* Current smoker
* Under 18 years and over 50 years of age
* History of fainting spells or loss of consciousness
* Currently on blood thinners
* Taking medications for or have a history of diabetes mellitus, neurologic or cardiovascular disease
* History of spinal surgery
* Has neck pain classified or associated headache, arm pain, trauma/whiplash
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically

The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.


Eligibility Criteria:
Inclusion Criteria:

* Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks
* Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
* Weaning must not be underway
* Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection

Exclusion Criteria:

* Clinically significant disease state in any body system, except for the indication being treated with linaclotide
* Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility
* Participation in any other clinical investigation using an experimental drug within 90 days
A Real-World Evidence Study in China of the Catalys Precision Laser System

This study is a prospective, single-arm, observational study of the Catalys Precision Laser System in real-world clinical practice. The study will be conducted at one site at the Boao Super Hospital in Lecheng International Medical Tourism Pilot Zone of Hainan province in China. The study is being conducted to evaluate the overall performance of the Catalys Precision Laser System. One or both eyes of each subject will be included in study.

The Catalys system is used as part of cataract surgery to create LASER cuts as intended by the surgeon to aid in cataract surgery, without adversely impacting the risk to the patient.As such, the endpoints of surgeon rating of completeness of corneal incisions, anterior capsulotomy and phacofragmentation and any device related adverse events from the time of Catalys System use to 1-month postoperative follow-up should adequately cover the evaluation of the intended use of the Catalys System.


Eligibility Criteria:
Inclusion Criteria

All criteria apply to each study eye:

Note: Study inclusion and exclusion criteria will be per the Catalys system instructions for use. A few key criteria are listed below:

* Patients scheduled for cataract surgery, including treatment with the Catalys Precision Laser System for anterior capsulotomy, phacofragmentation and the creation of single plane and multi-plane arc cuts/incisions in the cornea.
* Signed informed consent and privacy protection authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment and/or medical record in the governing countries
* At least 22 years of age at the time of consent.ion Criteria

Exclusion Criteria:

All criteria apply to each study eye:

* Presence of corneal ring and/or inlay implant(s), Descemetocele with impending corneal rupture)
* Severe corneal opacities, corneal abnormalities, significant corneal edema, or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule.
* Any contraindications to cataract surgery
Bi-Axial Rotating Magnetic Field Therapy in Refractory Neuropathic Foot Pain Secondary to Diabetic Peripheral Neuropathy

The researchers will study the application of a commercial pulsed magnetic stimulating device to the feet of patients with moderate-severe foot pain secondary to diabetic peripheral neuropathy (DPN).


Eligibility Criteria:
Inclusion Criteria:

* DPN stage 2 and 3; symptomatic \> 6 months

Exclusion Criteria:

* Pacemaker in patient or mate
Survey of the Moderna COVID-19 Vaccine in People at High-Risk of Developing Severe COVID-19 Symptoms

This study is a survey of the Moderna COVID-19 vaccine in Japanese people at high risk of developing severe COVID-19 symptoms. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects of the Moderna COVID-19 vaccine in this group. This will be from the first vaccination to 28 days after the second vaccination.

The number of visits to the clinic will depend on the clinic's standard practice.


Eligibility Criteria:
Inclusion Criteria:

1. The participant is capable of understanding the contents of the investigation, recording his/her own symptoms in the health observation diary, and has obtained written consent to participate in the investigation from the vaccinee himself/herself (If minor, parent or legal guardian).
2. The participant has an underlying disease at the time of this drug vaccination that is considered to pose a high risk of aggravation of COVID-19.

Exclusion Criteria:

1. The subject has any contraindication to this drug.
Developing Computerised CBT for Adults With OCD

The study aims to pilot a new computerised cognitive behavioural therapy programme for a small case series of adults with obsessive-compulsive disorder. The investigators hypothesise that the findings will demonstrate improvements in symptomatology following the programme. The programme will have longer-term aims of being rolled out over a number of IAPT services within the NHS, reducing waiting lists and increasing therapist time.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 or over with OCD as defined by DSM-IV who are seeking CBT.
* The patient describes their OCD as their main problem and scores between 14 and 30 on the YBOCS (Goodman et al, 1989). A score above 30 is in the severe range and indicates that the CBT should probably be therapist delivered.
* Able to use self-help materials in English and answer written questionnaires.
* Able to access the internet (either at home or in a public library or drop in centre or at the clinic).
* Have a current episode of OCD of more than 6 months in duration.

Exclusion Criteria:

* Significant and complex co-morbidity (e.g. significant personality disorder, severe depression or alcohol dependence, which requires longer therapy or is more difficult to treat). Such patients are likely to be part of a Community Mental Health team or be funded by the Department of Health's National Specialist Commissioning Team scheme for severe treatment refectory OCD.
* Current active suicidal intent or severe self-neglect that requires hospitalisation.
* The patient has a primary problem of compulsive hoarding (as such patients are more complex or are more likely to be under a Community Mental Health team).
* Continuing to receive another form of psychotherapy.
* Has received CBT for OCD in the past year.
* A participant may be taking an anti-depressant for OCD but must be on a stable dose for at least 12 weeks prior to entry in the trial with no plans to alter the dose during the trial period. There must also be no plan to commence on an anti-depressant or anti-psychotic medication. (Participants excluded because of their current or planned medication may be offered a further assessment for the trial after being on a stable dose
Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in the intensive care unit of Nantes University Hospital
* Signed informed consent
* Patient with not hypercapnic acute hypoxemic respiratory failure
* Immunocompetent and immunodeficient patient

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Contra-indication to non invasive ventilation
* Allergy to xylocaine
* Coagulation troubles
* Tracheotomized patient
* Urgent indication to intubation
* Hypercapnic acute respiratory failure
* Acute pulmonary edema
* Face or nose malformation
Ketamine Tolerance in Children After Repeated Administrations During Radiotherapy Sessions

Ketamine provides a safety zone for sedated but spontaneously ventilated children especially in remote conditions such as radiotherapy units where sedation is an essential practice for children to keep calm and motionless In this study, investigators planned to analyse ketamine doses needed and the recovery times in pediatric oncology patients undergoing repeated radiotherapy sessions.

Ketamine provides a safety zone for sedated but spontaneously ventilated children especially in remote conditions such as radiotherapy units where sedation is an essential practice for children to keep calm and motionless.However, there had been a disagreement about the ketamine doses needed for a continuous and steady level of sedation during repeated radiotherapy sessions in children. In this study, investigators planned to analyse ketamine doses needed and the recovery times in pediatric oncology patients undergoing repeated radiotherapy sessions.After approval from the Baskent University, School of Medicine, Ethics and Research Committee (KA09/247) and informed consents of the patients' guardians, 33 pediatric patients undergoing radiotherapy due to oncologic disorders were enrolled to receive ketamine 2 mg/kg and atropine 10 μg/kg.Patients' demographic data such as age, gender, weight, ASA physical status and duration and total number of radiotherapy sessions were noted. Total ketamine consumption to maintain the targeted sedation level during each session, additional dose administration and the recovery time were recorded. The adverse events such as apnea, laryngospasm, bronchospasm, desaturation, respiratory depression, bradycardia, sedation levels deeper or superficial than intended to, excessive salivation, allergy, nausea and vomiting and need for emergency medication were also noted after each session. The study drugs were prepared, labelled and administered by an anesthetist according to the study protocol and data were recorded by an anesthetist blind to the amount of the study drug used.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients undergoing radiotherapy due to oncologic disorders

Exclusion Criteria:

* Patients younger than 1 year and older than 14 year,
* patients with cardiac, renal or liver function abnormalities, who were already under sedative drug treatment or allergic to the drugs to be used or the patients for whom the study drugs
Smoking Cessation Aid for Young Smokers

This study, sponsored jointly by the George Washington University School of Public Health and the NICHD, will compare the effectiveness of two self-help quit-smoking programs for young people.

Smokers between 18 and 22 years of age who are interested in quitting smoking may be eligible for this 6-month study. Candidates must be enrolled in school at least part time.

Participants are randomly assigned to one of two treatment groups. Both groups receive a brief counseling session and self-help guide, and one group also receives email counseling related to quitting smoking. All participants have three interviews-one in person at the beginning of the program, one over the phone after 2 months in the program, and one in person after 6 months, at the end of the program. The surveys cover the participant's intentions and behaviors related to smoking cessation and their opinions about the self-help materials. In addition, participants may be asked to provide saliva samples at the beginning and end of the program for verifying smoking status.

While young smokers have a demonstrated interest in quitting and make frequent quit attempts, they often fail in their quit attempts. This group may benefit from aids which promote higher rates of success in their quit attempts. The lack of promising approaches for adolescent and young adult smoking cessation is a recognized problem.

The goal of this study is to build on previous work in developing a smoking cessation kit for youth, which is based on the principles of social marketing and social cognitive theory. This study aims to test the acceptability and efficacy of the X-Pack intervention. It is our belief that with minimal assistance--in the form of the X-Pack product and supporting e-mails--the quit attempts that young people make can result in long-term abstinence.

The design of this study is a two-arm randomized trial where participants are randomized to the X-Pack condition or to the control condition. Study participants consist of current smokers between the ages of 18-22 who are interested in quitting in the next 6 months. The first 292 participants who meet eligibility criteria will be enrolled in the study and randomized to one of two conditions. Participants in the intervention condition will receive the X-Pack, an in-person counseling session, and supporting e-mails. Participants in the control condition will receive the control materials, Clearing the Air, and an in-person counseling session. Participants will be measured at baseline, 2 and 6 months.

Eligibility Criteria:
* INCLUSION CRITERIA

To be eligible for inclusion, individuals must 1) have smoked at least one cigarette/day in each of the past 7 days, 2) be 18 to 22 years old, 3) be interested in quitting smoking in the next 6 months, 4) be willing to try quitting smoking in the next month, and 5) be enrolled in school at least part-time.

EXCLUSION CRITERIA

None listed.
Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.

An optimum recovery profile after AT includes a rapid, smooth awakening without emergence agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate receptor antagonist with good analgesic properties and periprocedural amnesia.

The ketamine/midazolam combination was administered in different ways with controversial results about their effect on the EA and recovery profile.

Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery profiles regarding postoperative EA and PONV.

This study aims to evaluate the effect of premedication with an intramuscular ketamine/ midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I or II
* Children scheduled for AT under general anesthesia (GA).

Exclusion Criteria:

* Congenital cardiovascular anomalies
* Behavioral changes
* Delayed physical development
* Children receiving sedatives or anticonvulsants therapy
Dual Point-of-care Test for the Diagnosis of Yaws

A dual POC immunoassay simultaneously detecting non-treponemal and treponemal antibodies was developed for the diagnosis of infections with T. pallidum. The assay is designed for use in resource-limited settings where challenging conditions (such as lack of electricity, running water, or laboratory equipment) commonly exist. We sought to compare performance of the dual-POC assay for diagnosis of yaws infection with that of the RPR and TPHA as reference standards.

Yaws is an infectious disease caused by Treponema pallidum subspecies pertenue, a bacterium which closely resembles the causative agent of syphilis, and is spread by skin to skin contact. In the field, yaws is diagnosed on the basis of epidemiological context, evocative symptoms and signs and positive serological tests or dark field microscopy. The darkfield microscopy is not easy to perform , hence the interest in serological tests. The serological tests used to confirm yaws are the same as those used to diagnose syphilis. Yaws serologic diagnosis relies on testing for non-treponemal and treponemal antibodies. These antibodies differ markedly with respect to antigenic reactivities and kinetics during the disease process.

Historically screening for yaws has involved the use of nontreponemal tests, such as rapid plasma reagin or venereal disease research laboratory. Positive results of nontreponemal tests of specimens are then confirmed using a more specific treponemal test, such as Treponema pallidum haemagglutination. However, the equipment and personnel requirements for conducting and interpreting these laboratory-tests are rarely available in low-resource settings in developing countries where yaws occurs.

Rapid treponemal tests which detect antibodies to T. pallidum antigen have become popular for the diagnosis of venereal syphilis due to their many advantages. These tests that can be performed outside a laboratory setting with minimal training and using blood collected by a finger prick, which makes them extremely useful in remote areas where laboratories are not available. However, the rapid treponemal tests for syphilis detect treponemal antibodies, which limits their use for interpretation of the disease status since they cannot distinguish between active and past or treated infection.

A combined point-of-care (POC) test which detects both treponemal and non-treponemal antibodies has recently been evaluated for the diagnosis of syphilis, and appears promising for yaws diagnosis. The use of the dual POC test would result in the ability to both screen and confirm the serological status of patients with suspected yaws within 15 minutes and give a better indication of active disease.

Eligibility Criteria:
Inclusion Criteria:

* Children from 2 to 15 years with clinical suspicion of active yaws

Exclusion Criteria:

* Persons who are unable to sustain venipuncture; persons who do not provide an informed consent, or withdraw consent