cyrilzakka/clinical-trials huggingface dataset:
Opioid Use Disorder Treatment Linkage at Sexual Health Clinics Using Buprenorphine

This study will examine the effectiveness of opioid use disorder (OUD) treatment linkage strategies for patients seen at sexual health clinics. This 3-arm RCT will compare Usual Care vs. Patient Navigation vs. Patient Navigation + Buprenorphine Initiation (UC vs. PN vs. PN+BUP).

This study, entitled Opioid Use Disorder Treatment Linkage at Sexual Health Clinics using Buprenorphine (OUTLAST-B), will examine opioid use disorder (OUD) treatment linkage strategies for people receiving sexual health services from public clinics and health departments. This three-arm, parallel randomized clinical trial (RCT) will compare Usual Care (UC), vs. referral via Patient Navigation (PN), vs. Patient Navigation with buprenorphine initiation (PN+BUP).

The UC Arm will include standard services at the sexual health clinic / city health department.

The PN Arm will include all UC Arm services, with the addition of a Patient Navigator who will assist the participant in selecting a community OUD treatment program, facilitate an intake appointment, help to resolve barriers and coordinate OUD treatment entry, and support early retention in OUD treatment.

The PN+BUP Arm will include all PN Arm services, with the addition of meeting with the sexual health clinic's buprenorphine-waivered provider (typically a nurse practitioner) to initiate buprenorphine treatment, as a bridge until successful transfer to OUD treatment in the community.

Research assessments consisting of a structured interview battery and biomarkers for drug use and sexually transmitted infections will be conducted at baseline, 3-, and 6-month follow-up. Selected outcomes will be examined through 12-months via health record linkage methods. The study will examine participant outcomes in the domains of: (1) OUD treatment entry and retention, (2) Opioid use and related problems (including fatal and non-fatal overdose), and (3) HIV/STD-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Opioid use in the past 30 days
3. DSM-5 diagnostic criteria for OUD with physiological dependence
4. Willing to try buprenorphine treatment.

Exclusion Criteria:

1. current enrollment in OUD treatment with buprenorphine, methadone, or extended-release naltrexone
2. clinical contraindication with buprenorphine (e.g., allergy to buprenorphine or naloxone, chronic pain management with opioid agonists)
3. regular use of illicit long-acting opioid agonists (e.g., methadone; due to potential challenges with dose induction)
4. heavy alcohol use that, in the judgement of the prescribing provider, raises a safety concern that precludes eligibility for buprenorphine induction
5. high dose or intravenous benzodiazepine misuse
6. pregnancy (due to special needs; will be treated outside of the study)
7. unstable medical or psychiatric illness (e.g., psychosis or active suicidal ideation)
8. inability to provide informed consent (e.g., failure to pass consent quiz)
Paracetamol and Metamizole With SPI-guided Anaesthesia for VRS

The aim of this randomized trial is to assess the efficacy of preemptive analgesia using paracetamol or metamizole or both of them under SPI-guided anaesthesia for vitreoretinal surgery (VRS), presence of PONV (postoperative nausea and vomiting) and oculocardiac reflex (OCR) and compare Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception postoperatively.

Patients will receive general anaesthesia combined with either preemptive analgesia using preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous infusion of 1,0 g of acetaminophen or both of them together.

Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular block are routine in modern anaesthesia, whereas monitoring of analgesia still requires further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable showing the nociception-antinociception balance into abovementioned parameters constituting a novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia (AoA) or tailor-made anaesthesia.

Different options of preemptive analgesia are used to decrease the postoperative pain perception as well as diminish the rate of PONV by deceasing intraoperative consumption of intravenous narcotic analgesics

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate in the study
* written consent to undergo general anaesthesia alone or combined with different techniques of pre-emptive analgesia and vitreoretinal surgery

Exclusion Criteria:

* history of allergy to local paracetamol or metamizole
* necessity of administration of vasoactive drugs influencing SPI monitoring
* pregnancy
Evaluation Study: Obsessive-compulsive Disorders in Childhood and Young Adulthood

Obsessive-compulsive disorders are very damaging illnesses that can already manifest in childhood and adolescence. With an average prevalence from 1 - 3%, they are one of the most frequently diagnosed psychiatric illness in these age groups. With the further use of data, the treatment success can be significantly improved; causal variables/predictors can be recognized, understood and taken carefully into account. The anticipated incremental knowledge will ultimately help children and young people with obsessive-compulsive disorders to receive faster and more effective treatment.


Eligibility Criteria:
Inclusion Criteria:

* Children and young people from 8-18 years of age who fulfill the international classification of diseases tenth edition (ICD-10) , obsessive-compulsive disorder handled in our clinic.
* Good German language speaking skills
* IQ \> 75
* All study participants or their legal representative have given written permission for their experiences to be documented in the study.

Exclusion Criteria:

* Schizophrenia-related disorders (psychoses)
* Missing data
* Data sets without confirmed diagnosis
* Purely consultaive patient interview (no therapy intervention prescribed)
EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers

The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard of care.

The objective of the proposed work is 1) to monitor clinical safety of EPC Silver Wound Gel on diabetic foot ulcers, 2) to evaluate the clinical impact of EPC Silver Wound Gel in foot ulcer progression in conjunction with the standard of care 3) to quantify the changes within the wound bacterial environment as it impacts wound healing and 4) to evaluate subjective patient and clinician outcomes: satisfaction, quality of life, perceived benefit, and compliance.

Consenting subjects who qualify for enrollment will proceed with two, weekly, visits related to screening. If screen passed, ie. under the current standard of care no progression of the diabetic foot ulcer is observed in accordance with validated diabetic foot ulcer classification metrics, then the subject will proceed with two weeks of study period where twice weekly clinic and twice weekly intermediate home-based care. This may be followed by an additional two weeks of study period, if warranted in accordance with best practice, with once weekly clinic and intermediate home care visits. In total there will be up to 9 clinic visits (minimum 7 clinic visits up to 9 clinic visits) in 6 weeks (screening and trial visits; minimum 4 weeks up to a maximum of 6 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with diabetes mellitus according to definitions outlined by the American Diabetes Association
* Presenting with an active or current foot ulcer that has been identified as stalled or persistent non-healing under current standard-of-care; showing no progression in 2 weeks as per IDSA guidelines.
* Presenting with a localized mild or local infection of the ulcer as listed in the IWGDF/IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (Table 1); exceeding 0.5 cm2 in area after appropriate debridement.
* Subject must agree to adhere to all protocol procedures and must be willing and able to provide written informed consent.
* Correction or optimization of underlying medical problems (e.g. diabetes or systemic infection).

Exclusion Criteria:

* Participants exhibiting extensive gangrene, and/or immediately limb-threatening infection
* Indications of osteomyelitis identified by plain radiographs taken within 2 days prior to study entry.
* No palpable dorsalis pedis or posterior tibial pulse or a pedal systolic pressure (Doppler ultrasound) of ≤ 40 mm Hg
* Clinically significant peripheral arterial disease requiring vascular intervention
* Patients requiring renal dialysis, immunosuppressive mediation, or those with uncontrolled hypertension.
* Lymphangitis; spread beneath the fascia; muscle, joint, or bone involvement.
* IDSA-defined severe infection, including systemic toxicity or metabolic instability
* Current use of enzymatic debridement.
* Participants with known silver sensitivity
The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60

The first study of my PhD showed that acute supplementation of berry extracts can modulate cognitive behaviour in healthy adults. There is a growing body of evidence supporting an improvement in memory and learning performance in animal models following the ingestion of flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However, study 2, showed no effect on any aspects of memory in healthy young adults after supplementation of the berry extracts. It is hypothesised that the lack of behavioural effects on memory of the berry juice in study 2 was because of the cohort used. These healthy adult participants were already performing near to their peak (Salthouse et al., 2009), and unlike study one, participants were not mentally fatigued enough to reveal subtle cognitive benefits.

The aims of the study are to examine if acute supplementation of two berry extracts in an older population can augment memory, attention and executive function. Secondly, the time course of these behavioural effects will be measured by multiple cognitive assessments throughout the day after consumption of the extracts.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-smokers
* Aged between 40 and 60 years

Exclusion Criteria:

* History of neurological, vascular or psychiatric illness.
* BMI greater than 35 kg/m2
* Current diagnosis of depression and/or anxiety.
* History or current diagnosis of drug/alcohol abuse.
* Anaemia.
* Any heart disorder.
* Hypertension
* Any respiratory disorder.
* Diabetes.
* Food intolerances/sensitivities.
* Phenylketonuria.
* Use tobacco products or have ceased in the last 6 months.
* Currently taking, or have taken in the last 2 weeks, any prescribed, illicit or herbal drugs and food supplements.
* Any known active infections.
* HIV antibody positive.
* Currently have, have ever had, or may be at risk of hepatitis.
* Have suffered from jaundice within the last year.
* Have haemophilia or any similar clotting disorder.
* History of head trauma
* History of migraines
* History of learning difficulties
* Any Issues with giving blood samples.
Temperature Variation During Meditative Practices

The temperature on selected points of the hands has been monitored during meditative practices. The practitioner is in complete rest for the time of the measure, and only mental activity is carried out. The purpose is to verify if the heat sensation, that is normally felt, is a real, measurable physiological effect, or if it is just a subjective feeling. Quantitative data analysis is foreseen.

Qigong is a traditional Chinese method for wellness and healing. During practice, which is based on the Qi circulation, it is usual to feel warmth, especially at the hands. The main purpose of this study is to verify if the sensation of heat is not just a subjective feeling but is a real, measurable physiological effect. Quantitative information will be hopefully derived from a simple data analysis. The study will be extended also to deep prayer meditation.

The measurement sessions will consist of two periods of practice separated by one pause period, to ensure that the temperature variation is not due to spurious effects.

T type thermocouples will be used for the temperature measurements, with sensors in the form of small copper disk. The thermocouples will be connected to a data logger, and the results analyzed. The sensors will be positioned in different points of the hands, either on the palm and on the dorsum. The Laogong (PC8) acupuncture point will be preferentially chosen, because is a very important point, from the energetic point of view, of the Traditional Chinese Medicine. and because the sensation of heat is more acute in this point. Other points will be also measured, and compared with the Laogong.

Eligibility Criteria:
Inclusion Criteria:

. Experience in meditative practice

Exclusion Criteria:

-
Pre-frailty and Rehospitalization in Cardiac Surgery

Background: It has been demonstrated that pre-frailty has more adverse outcomes after cardiac surgery, however, data on prognosis and long-term evolution in pre-frailty patients after cardiac surgery without postoperative complications are still scarce. Design: To evaluate the impact of pre-frailty on functional survival in patients after cardiac surgery without complications.

A three-year retrospective study based on a physiotherapy database was conducted, and a sample of 453 patients over 65 years of age was enrolled. All of them had an established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass \[CAB\], valve replacement or valve repair). Patients with prior neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data were excluded.

According to the hospital protocol, frailty was assessed by the Clinical Frailty Score (CFS) 24 hours before the scheduled elective surgery. We assigned patients into two groups based on this score: non-frail (frailty score 1\~3) and pre-frail (frailty score 4) according to their CFS.

If patients experienced adverse cardiovascular events-both during surgery or at the ICU- such as stroke, infection, prolonged mechanical ventilation time of more than 24 hrs, ICU stay of more than 48 hrs or in-hospital death, they were excluded. We decided to exclude these patients as our objective was to evaluate patients without any surgical complications as our group recently had demonstrated that pre-frail patients had worse outcomes after cardiac surgery in a short period of time.

All included patients were analysed for 3 years using data from the hospital and physiotherapy database, which included medical appointments every 6 months after hospital discharge and major adverse cardiovascular events (atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death).

This retrospective study was approved by the Institutional Ethics Committee (number 2.352.465).

Eligibility Criteria:
Inclusion Criteria:

* established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or Doppler echocardiography, and all had surgical interventions (coronary artery bypass \[CAB\], valve replacement or valve repair).

Exclusion Criteria:

* neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data
Supporting Refugee Parenting Community and Family Mental Health in Tijuana

The goal of this study is to better understand and support parenting practices and family mental health among migrant parents in Tijuana, Mexico. the main questions it aims to answer are:

1. What parenting skills are most needed for learning?
2. How can we teach them in a participatory way respecting cultural values and norms?
3. How does this parenting program affect parental and child interactions and mental health?

Participants will

1. have the opportunity to give their opinions on the priority parenting skills needed and on which curriculum to use for learning these skills;
2. participate in small group learning sessions twice a week for 4 weeks;
3. be asked to complete a few surveys before and after the learning sessions, and 2 months after they complete the learning sessions.

Researchers will compare parents randomly assigned to parenting sessions group with waitlist control group (starting learning sessions 1 month later) to see if the group learning benefits parent-child interactions, parental stress, and parental confidence in parenting.

Month 1:

The researchers will use a participatory research model to convene focus groups engaging community stakeholders in two large shelters in Tijuana to prioritize 3-5 parenting skills.

Month 2:

The researchers will recruit participating parents until reaching a sample size of 120, divided into 8 groups of 15. All participants will vote for 1-2 interventions from a list of 5 to revise and adapt to the local context through small group discussions and consensus building.

Month 3:

Participants will complete baseline questionnaires anonymously. Half of the participants (Group 1, N=60) will be randomized to receive the adapted learning curriculum in groups of 15, twice a week for 4 weeks. At the conclusion of month 3, all participants will complete the same questionnaires as pre-intervention. These data will serve as post-intervention data for Group 1 and a second baseline for the remaining participants (Group 2). During month 3, Group 2 will receive a two-page handout on childhood nutrition in Spanish. They will serve as the "control group" for the first wave of intervention.

Month 4:

Group 2 will receive the same intervention as group 1 in month 3. At the conclusion of month 4, participants will complete the same questionnaires as pre-intervention. They will also complete open-ended feedback interviews.

Month 5:

Researchers will analyze all anonymous data and share preliminary results with the community through peer leaders.

Month 6-7:

Researchers will conduct a phone follow-up for all available participants (2 months post intervention) and collect data anonymously.

Month 8:

Researchers will again analyze the aggregate data and share results with the community.

Month 9:

Researchers will draft a manuscript, share final results with the community and nonprofit/academic partners.

Eligibility Criteria:
Inclusion Criteria:

* all consenting parents staying at refugee shelters in Tijuana

Exclusion Criteria:

* known date of leaving Tijuana in less than 3 months
A Study Comparing Safety Of Abacavir And Lamivudine Administered Once-Daily As A Single Tablet Versus The Same Drugs Administered Twice-Daily As Separate Tablets (ALOHA Study)

This study was designed to evaluate if subjects who took 600 mg of abacavir and 300 mg of lamivudine once-daily as a single tablet were just as likely to have adverse events compared to subjects who took 300 mg of abacavir and 150 mg of lamivudine administered as separate tablets twice-daily.

A phase IIIB randomized, open-label, multicenter, parallel-arm study to evaluate the short-term safety and tolerability of the abacavir/lamivudine fixed-dose combination tablet administered once-daily or the separate abacavir and lamivudine tablets administered twice-daily, as part of a three or four-drug regimen, in antiretroviral naive HIV-1 infected subjects.

Eligibility Criteria:
Inclusion Criteria:

* Have HIV-1 infection.
* Had not received any prior HIV treatment for more than 14 days.
* At least 1000 copies of HIV-1 RNA.
* Willing to provide signed informed consent.

Exclusion Criteria:

* Enrolled in other investigational drug studies.
* Female subjects who are pregnant or breastfeeding.
* History of allergy or hypersensitivity to abacavir or lamivudine.
* Certain medical conditions that would make subjects ineligible.
Evaluation of a New Dermal Cryotherapy System

A pilot study to evaluate the feasibility of altering skin pigmentation using the Dermal Cooling System.

This non-significant risk study is being performed to test the hypothesis that a new treatment concept, controlled localized cooling of the epidermal layer, can be used to lighten areas of the skin.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject is willing to have up to 40 test sites treated on aesthetically discreet skin.
3. Subject is willing to use photoprotection (e.g., sun avoidance) of the treated areas during the duration of the follow-up period.
4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Fitzpatrick skin type VI.
2. Physician prescribed, medical or surgical treatment in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery)
3. Artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period
4. Dermatological conditions or scars in the location of the treatment sites
5. History of melanoma, personal or first degree relative
6. Known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, Reynaud's disease.
7. History of abnormal wound healing or abnormal scarring
8. Inability or unwillingness to comply with study requirments.
9. Current enrollment in a clinical study of any other unapproved investigational drug or device.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.