cyrilzakka/clinical-trials huggingface dataset:
Peers Plus Mobile App for Treatment in HIV

This study called "Peers plus mobile App for Treatment in HIV (PATH)" is a two-arm randomized controlled trial (RCT) evaluating the efficacy of an intervention that combines peer navigation and mobile health (mHealth) technology to support HIV care outcomes among Hispanic and Black Persons Living with HIV (HBPLH).

PATH is a community-academic collaboration with a federally qualified health center serving patients in South San Diego under the Ryan White model of care.

The scientific premise of this RCT is that combining two interventions developed by this team (peer navigation + mHealth) into a single mHealth peer navigation intervention (PATH) will eliminate the need for in-person support from peer navigators, promote high impact on HIV care continuum outcomes, as well as extend broader reach to underserved communities.

The RCT will test the efficacy of PATH with 375 HBPLH (among whom \>33% will report stimulant and/or opioid use in the past 6 months).

Aim 1. Improve the primary outcomes - sustained viral suppression (i.e., suppressed viral load at both 6- and 12-month follow-up), and secondary outcomes (e.g., retention in care) compared to usual care.

Sub-aim 1: Explore subgroup differences in efficacy based on factors like race/ethnicity and substance use.

Aim 2. Examine the theory-informed mediators (e.g., self-efficacy to engage in HIV care, HIV stigma) through which PATH has the greatest impact on sustained viral suppression among HBPLH.

Aim 3. Explore whether PATH significantly affects substance-related outcomes (e.g., frequency of substance use, engagement in substance abuse treatment) when compared to usual care among those using substances (i.e., stimulants and/or opioids).

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Can read and speak English or Spanish
* Self-reported diagnosis of HIV by a physician or healthcare provider
* Currently prescribed HIV medication
* Having access to an internet browser on a home computer, tablet, or smart phone
* Does not plan to move out of the San Diego area in the next 12 months
* Meets one or more of the following medical chart verified or self-reported criteria

  * One or more detectable viral load test result (\>200 copies m/L) in the past 12-months while on antiretroviral therapy for at least 3 months
  * Having missed 1 or more scheduled HIV care appointments in the last 12 months
  * Last HIV care visit was more than 6 months ago
  * Self-reporting less than 90% antiretroviral therapy adherence in the last 4 weeks using the Wilson-3 scale
  * Report stimulant or opioid use (non-prescription) in the past 6 months

Exclusion Criteria:

* \<18 years old
* Currently enrolled in any program, intervention, or research study designed to improve antiretroviral therapy adherence or engagement in HIV care (e.g., LinkPositively)
* Members of one of the community advisory boards providing advisement on the study.
The Effects of Low Dose Ketamine on Cardiovascular Function

Low dose ketamine is used for pain management and for the treatment of anxiety and depression. Prior studies on low dose ketamine have noted short-term (minutes to hours) increases or decreases in blood pressure. Blood pressure that is too high or too low can be problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure. In fact, no prior studies have measured sympathetic nervous system activity after low dose ketamine has been given to an adult. Because sympathetic nervous system activity has a large influence on blood pressure, we need to know how exactly low dose ketamine affects these body systems. Therefore, in this research we will study how low dose ketamine affects sympathetic nervous system activity and cardiovascular function. The results from this research will inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and blood vessels.


Eligibility Criteria:
Inclusion Criteria:

* Non-obese (body mass index less than 30 kg/m2)

  \*alternatively, individuals will be permitted to participate if they have a body mass index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102 cm for males
* Systolic blood pressure \<140 mmHg
* Diastolic blood pressure \<90 mmHg

Exclusion Criteria:

* Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
* Current or previous use of anti-hypertensive medications
* Any known history of renal or hepatic insufficiency/disease
* Pregnancy or breast feeding
* Current smokers, as well as individuals who regularly smoked within the past 3 years
* Individuals with a history of drug abuse
* Individuals who have an unexplained positive urine drug screen (e.g., some agents cause false-positive results, but when the agent is abstained for hours/days/weeks, the repeated drug screen is negative. One example could be an over-the-counter supplement)
Assessing QbTest Utility in ADHD: A Randomised Controlled Trial

Attention Deficit/Hyperactivity Disorder (ADHD)is one of the most common mental health disorders of childhood. Children with ADHD often have poor attention, are restless and hyperactive and show impulsive behaviour.

It is important to detect ADHD so young people can have access to appropriate clinical interventions.

One of the most common ways ADHD is assessed is through the clinician's opinion; however, this can vary between clinicians and is thought to be one reason why ADHD may be mis-diagnosed. Using a more objective computer tasks may help improve our understanding of ADHD. One computer task is the QbTest.

The test presents different symbols to the child, and the child has to respond by pressing a button only when a target symbol appears. The test measures the child's attention, impulsivity and movement whilst doing this task.

Although the test is thought to be a valid measure, more research needs to be conducted on this measure to see whether it helps clinicians decision making.

To see whether this test helps clinicians make a diagnosis of ADHD and helps with medication decisions, children and young people will be asked to complete the task as part of their initial assessment for ADHD. Half the participants and their clinician will have access to the QbTest result; the other half will not have access to the QbTest result until the end of the study.

Participant's parents, teachers and the clinician will also be asked to complete some questionnaires about the child's symptoms and behaviour. If the child is diagnosed with ADHD and is given medication they will be asked to complete the task again on medication. The same set of questionnaires will be completed by the parents/teachers/clinicians.

The entire sample will be followed up at 6 months and asked to complete the questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Age 6-17 years (may turn 18 years during the study).
* Referred to CAMHS or community paediatrics for an ADHD assessment
* Capable of providing written informed consent (over 16)
* Parental consent (under 16)

Exclusion Criteria:

* Non-fluent English
* Suspected moderate or severe learning disability
* Previous or current diagnosis of ADHD
Outcomes After Repair of Acute Rotator Cuff Tears

Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic patients. The purpose of the current study was to investigate if delay of surgery, age at repair and the number of cuff tendons involved affected the structural and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* significant trauma to the shoulder
* sudden onset of symptoms
* asymptomatic in the shoulder before trauma
* pseudoparalysis in the shoulder after trauma
* full thickness rotator cuff tear of at least one tendon

Exclusion Criteria:

* patients with previous or gradual onset of symptoms in the traumatised shoulder
* partial rotator cuff tear
* displaced fracture
Effect of Hyperbaric Oxygen Therapy(HBOT) on Patients with Sudden Sensorineural Hearing Loss(SSNHL) and Coagulation Function

The objective of this observational study was to understand the effect of HBO on patients with SSNHL and its association with coagulation function and prognosis.

The main question it aims to answer is whether HBO therapy can improve outcomes and coagulation function in patients with SSNHL.

The prognosis of SSNHL patients receiving HBO and SSNHL patients not receiving HBO were compared


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for sudden deafness in the American Academy of Otolaryngology Head and Neck Surgery 2019 Clinical Practice Guidelines for Sudden Deafness;
* Aged 18-75 years old;
* Patients with unilateral sudden deafness for the first time, and the onset time is less than 2 weeks.

Exclusion Criteria:

* Patients with other ear diseases, such as auditory trauma, barotrauma, retrocochlear disease, bilateral hearing loss, history of chronic otitis media in the same ear, and history of surgery in the same ear;
* Patients with serious primary diseases such as heart, liver, kidney dysfunction and hematopoietic system diseases;
* Pregnant and nursing patients;
* Accompanied by serious mental illness;
* Patients with incomplete clinical data.
Effect of Injectable Platelet-rich Fibrin on the En Masse Retraction of Maxillary Anterior Teeth

The aim of this study is to investigate the effect of local injection of injectable platelet rich fibrin (i-PRF) on the rate of orthodontic en masse retraction of anterior teeth clinically and to report any associated pain as well.

Trial will be carried on 2 groups, each involve 13 participants with a total of 26 participants.

1. Subject examination to ensure he/she meets the eligibility criteria of the research.
2. Leveling and alignment using fixed orthodontic appliance.
3. Upper first premolars extraction as a part of the orthodontic treatment planning.
4. With the starting of en masse retraction, injection of the (i-prf) obtained from venous sample palatally and distally to the anterior teeth in the intervention group, and sham injection in the control group. The injection in both groups will be done just before retraction, 21 and 42 days after beginning of retraction Rate of en masse retraction will be calculated for patients in both groups at the monthly basis for for months after starting en masse retraction, data will be analyzed statistically.

Eligibility Criteria:
Inclusion Criteria:

1. Orthodontic patients with and age range (16 - 30) years.
2. Protruded upper anterior teeth requiring extraction of first premolars and anterior teeth retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.
3. Patients with full permanent dentition (with the exception of third molars).
4. Healthy dental and periodontal condition with good oral hygiene

Exclusion Criteria:

1. Patients with extensive restorations on the anterior teeth.
2. Subjects taking medication affecting inflammatory process of the orthodontic tissue reaction.
3. History of previous orthodontic treatment or trauma to the anterior teeth.
4. Syndromic patients and patients with systemic diseases.
5. Poor oral hygiene or periodontal diseases.
Reliability of Ultrasound Assisted Epidural Analgesia in Obese and Normal Weight Parturients

This study wants to investigate if ultrasound assisted epidural catheter insertion for labor analgesia is easier and safer to the standard epidural technique.

This study has four specific aims:

1. to evaluate congruity between palpatory technique and ultrasound lumbar evaluation to identify the correct spinal space;
2. to compare between ultrasound evaluation and needle measure of skin-epidural space depth;
3. to compare between longitudinal and transverse ultrasound epidural space depth in obese and normal parturients;
4. to check the reduction of complications and failure rates of epidural analgesia with ultrasound assistance.

Eligibility Criteria:
Inclusion Criteria:

* all women who request epidural analgesia for labor

Exclusion Criteria:

* all women who present contraindication for epidural analgesia
Accuracy and Precision of Different Devices for the Monitoring of Pulsed Oxygen Saturation

Hypoxemia is a frequent situation in clinical practice, particularly in intensive care units or perioperative. The mortality and morbidity increase for cardiovascular reason, due to hypoxia has been reported several times. It is therefore important to detect hypoxemia very early and with accuracy. The objective is to correct the causes quickly and thus avoid or minimize complications.

In addition to the risks associated with hypoxemia, the monitoring of Arterial Oxygen Saturation also avoids the adverse effects associated with hyperoxia. Indeed oxygen leads to the formation of free radicals, which in physiological condition are regulated by antioxidant mechanisms. However, in anesthesiology, it is common to find pathological situations (acute respiratory distress syndrome, shock, prolonged inflammatory state) where these regulatory mechanisms are overwhelmed. Oxygen administration to supra-physiological concentrations leads to a formation of excessive free radicals, aggravating the existing injury (including lung).

Oxygen therapy is a fully-fledged treatment requiring monitoring of its effectiveness and tolerance. Currently, the standard method for assessing oxygenation is the arterial blood gas analysis with the Arterial Oxygen Saturation. Its cost and the need for an arterial blood sample do not allow regular monitoring. Clinical evaluation of hypoxia is completely unreliable. there is a third method : monitoring devices that measure Arterial Pulsed Oxygen Saturation, called "pulse oximeters." Pulse oximeters have become an integral and mandatory part of the standard monitoring. It is through the measurement of Arterial Pulsed Oxygen Saturation, supposed to reflect Arterial Oxygen Saturation, that clinicians guide their therapeutic attitudes to optimize oxygenation and improve the prognosis of patients. So pulse oximetry is a method considered reliable and especially non-invasive. It is less expensive and does not require blood sampling. These qualities explain why these devices are easily used in anesthesia, intensive care and in emergency situations.

However, several studies have demonstrated the inaccuracy of Arterial Pulsed Oxygen Saturation in frequent situations resuscitation (shock, sepsis, dark skin type). Thus, it is necessary to objectify the benefits and limitations of pulse oximetry to optimize their use, especially in these situations of high risk, where a discrepancy between the values measured by the pulse oximetry and measurement of arterial blood saturation with oxygen gas can be detrimental.

It exists several pulse oximetry devices, whose accuracy seems unequal, which necessitates a comparative study.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in intensive care
* Over 18 years
* Continuous monitoring of oxygen saturation
* Susceptible oo have arterial blood gases and carrying an arterial catheter

Exclusion Criteria:

* patient protected by the law
* no social security number
* carbon monoxide Intoxication
* High methemoglobinemia.
* Therapeutic limitation
Anti-infectious Therapy of Periodontitis - Comparison of Different Clinical Strategies

It is the aim of the study to evaluate the efficiency of "One stage full mouth disinfection" according to the original protocol (Quirynen et al. 1995) in comparison to other approaches considering different scaling strategies and different disinfection concepts. Therefore, a multicenter randomized control treatment will be performed. In total, 204 patients with chronic periodontitis shall be allocated to the following treatment concepts. Group A: quadrant scaling with weekly intervals (Q-SRP; N = 51); Group B: full mouth scaling (FMS; N = 51); Group C: full mouth disinfection (FMD; N = 51); Group D: full mouth disinfection with subgingival glycine air polishing using erythritol powder (FMDP; N = 51). Evaluation of periodontopathic parameters and periodontal pathogens at baseline, 3 months and 6 months shall give evidence about the benefits of concept and the single components of FMD.


Eligibility Criteria:
Inclusion Criteria:

* patients with generalized moderate to severe chronic periodontitis
* presence of at least 18 teeth
* with at least 2 multi-rooted and / or 2 single-rooted teeth in the first quadrant with at least 6 sites with periodontal probing depth of ≥ 6 mm
* radiographic bone loss of at least 25% of the root length

Exclusion Criteria:

* subgingival scaling and root planing within the last 12 months
* antimicrobial rinsing or intake of systemic antibiotics within the last 4 months
* systemic diseases with known interactions to periodontal disease or known need for antibiotic prophylaxis
* known intolerance / allergies to chlorhexidine
* pregnancy
Changes of Dorsalis Pedis Artery Flow Pattern After Caudal Block in Children: Observational Study Using a Duplex Sonography

The purpose of this study is to determine the changes of Dorsalis Pedis Artery Flow Pattern after Caudal Block in Children: Observational Study Using a Duplex Sonography.


Eligibility Criteria:
Inclusion Criteria:

* Twenty (ASA status I) unpremedicated children, ages 1 to 5 yr old, who were scheduled for a day-case urologic surgery

Exclusion Criteria:

* if there were contraindications for caudal block including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
The Study of CM310 in Patients With Atopic Dermatitis

This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).

The secondary objective of the study is to assess the immunogenicity of CM310 in patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following:

   1. Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit.
   2. Participation in CM310AD002 and met one of the following：i: Received study treatment and adequately completed the assessments and completed the EOS(V12) visit. ii:Treatment termination due to other reasons other than poor compliance or AE related to CM310 , completed the EOS visit .
2. Provide signed informed consent

Exclusion Criteria:

1. Patients who, during their participation in a previous CM310 clinical trial, developed a SAE/AE deemed related to dupilumab\*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with CM310.
2. Not enough washing-out period for previous therapy.
3. Pregnancy.
4. Other
Donepezil Therapy and Changes of Symptoms and Glucose Metabolism in Patients With Dementia With Lewy Bodies (DLB)

The purpose of this study is to evaluate change of cerebral glucose metabolism by donepezil therapy and to associate change of glucose metabolism and symptoms.


Eligibility Criteria:
Inclusion Criteria:

DLB patients:

* who fulfill the diagnostic criteria of DLB
* 60 to 85 years old
* right-handed
* Clinical Dementia Rating (CDR) ≧ 0.5
* Mini Mental State Examination (MMSE) score from 10 to 26

Normal Controls:

* who are independent
* who have no subjective or objective cognitive impairment
* 60 to 85 years old
* right-handed
* MMSE score over 24

Exclusion Criteria:

DLB patients:

* who have diabetes mellitus
* who have pathological change on MRI other than brain atrophy
* who have complication or history of dementia other than DLB, psychiatric disease, and physical disorder that affect brain function
* who have severe complication of cardiovascular, hepatic, renal, or other diseases unable to secure the safety
* who have severe digestive ulcus
* who have severe bronchitic asthma or obstructive lung disease
* who have no caregiver who knows patient's condition well

Normal Controls:

* who have diabetes mellitus
* who have taken donepezil before
* who have abnormal findings on MRI
* who have complication or history of brain injury, psychiatric disease, and physical disorder that affect brain function
Topical Cannabis for Chronic Musculoskeletal Pain

Our proposal objective is to evaluate if state-regulated topical CBD-based products relieve chronic musculoskeletal pain and/or absorb into the bloodstream.

The goal of this study is to learn more about the analgesic efficacy of state-regulated topical cannabinoid products (creams, lotions, salves, etc) and to determine if these topical products are absorbed systemically and can be detected in blood samples. Given that state-regulated dispensary products cannot be brought onto the university campus, this observational study design utilizes a Mobile Pharmacology Laboratory that will go to study participants' homes. Blood samples and other assessments will taken in the mobile lab prior to use of a topical cannabinoid product and at several time points afterwards (4 hours, 24 hours, and 2 weeks). Participants will also collect microsamples of blood using a small device at home at three time points during the first 2-72 hours after application of the product.

Eligibility Criteria:
Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Inclusion Criteria:

* Chronic peripheral joint pain
* Desire and intent to use a topical cannabinoid product containing cannabidiol (CBD) or a combination of CBD and tetrahydrocannabinol (THC) to alleviate this pain

Exclusion Criteria:

* Current or prior use of topical cannabis
* Unwilling or unable to discontinue other (non-topical) cannabis use for four weeks prior to and during study participation through week two
* Intent to use a THC-predominant topical product (ratio greater than 1:1 of THC to CBD)
* Current or history of substance use disorder
* History or diagnosis of schizophrenia, bipolar or a psychotic disorder
* Surgery on the affected musculoskeletal location within the 3 months prior to enrollment
* Planned surgery or procedure on the affected musculoskeletal location during participation in the study
* Allergy or prior severe adverse reaction to cannabis (cardiovascular event, psychosis, etc)
* Current or prior cannabis abuse/dependence
* Cognitive disability that interferes with ability to provide consent or understand study procedures
* History of seizure disorder
* Pending legal action or workers compensation
* Pregnant females or females intending to become pregnant during the study period
* Lactating females
* Chronic/severe medical illness (renal disease, liver disease, cancer, significant cardiovascular disease, or history of myocardial infarction)
* Active component military