cyrilzakka/clinical-trials huggingface dataset:
The REMINDER Program for Older Adults Supported by Residential and Daycare Facilities

Dementia and mild cognitive impairment (MCI) deeply impact individuals' well-being and are expected to increase due to population aging, with global cases projected to rise to 152.8 million by 2050. Social isolation, accounting for 4% of dementia cases, emerges as a critical modifiable risk factor, particularly in institutionalized older adults, where it significantly raises dementia risk.

To address these challenges, the REMINDER program was developed as a tailored, multidomain intervention to reduce dementia risk, emphasizing social and cognitive engagement and advancing its adaptation and evaluation in Residential and Daycare Facilities (RDF). To assess the feasibility of REMINDER in older adults supported by RDF (recruitment, adherence, retention, acceptability, accessibility, and usability) and explore potential changes in cognitive and psychosocial outcomes.

Implementing DRR programs in RDFs presents several unique challenges, including participant diversity in educational levels, physical and cognitive health, motivation, and logistical constraints within institutional settings. A feasibility study is essential to identify and determine how to overcome these barriers. Specifically, this study explores acceptability, accessibility, adherence, and usability to optimize the REMINDER intervention for RDF settings. By addressing these practical concerns, the feasibility trial will ensure the intervention is effective and implementable, laying the groundwork for a successful full-scale RCT that meets the needs of older adults in RDFs (resulting in an adapted version, the REMINDER4Care). By creating an engaging and well-accepted tool, we look forward to amplifying the RDF tools available to reduce the risk of dementia in their residents.

Objectives

The primary objectives of this study were as follows:

1. To evaluate the acceptance rate of RDF and participants to join the research;
2. To determine the suitability of participant eligibility criteria by estimating feasible eligibility and recruitment rates;
3. To measure participant adherence and retention through attendance rates across all intervention sessions and trends over time;
4. To assess the feasibility of the REMINDER program in clinical settings, including its acceptability, accessibility, and usability.

Secondary objectives included exploring preliminary changes in cognitive and psychosocial outcomes from baseline to post-intervention while acknowledging that the study was not powered to detect statistically significant effects.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 65 years and older
* RDF users
* Those with elementary reading and writing skills.

Exclusion Criteria:

* Have a clinical diagnosis of dementia and/or MMSE scores below the cutoff for the presence of dementia (MMSE \< 22-27, depending on education level)
* Have a psychiatric or neurological condition that impairs cognition in the long term
* Have sensory and functional deficits that compromised their participation in the neuropsychological assessment and throughout the intervention sessions.
Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation

The aim is to determine the sensitivity and specificity of a screening tool to identify patients who undergo ACL reconstruction (non-copers) after 3 months of standard rehabilitation following an anterior Cruciate ligament (ACL) injury.

All included patients are referred to municipal rehabilitation to resolve effusion and range of motion deficits before the first screening (baseline screening) is completed. Hereafter the patients follow 3 months municipal rehabilitation before the second screening (3 months screening). A physiotherapist performs the screening and at the second screening, this is performed prior to consulting an orthopaedic surgeon.

Eligibility Criteria:
Inclusion Criteria:

* unilateral primary ACL injury
* Index injury no older than 6 months

Exclusion Criteria:

* Multiligament rupture
* Large cartillage or meniscus injuries
* Scheduled ACL reconstruction within 3 months
Ibuprofen Arginine and Neural Mobilization Versus Ibuprofen Arginine in the Treatment of Carpal Tunnel Syndrome

In the present investigation the pain reduction effects of a physiotherapy technique combined with pharmaceutical ibuprofen arginine treatment will be compared to those produced by ibuprofen (only) treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment) combined with a pharmaceutical oral ibuprofen arginine treatment, to those effects produced by a ibuprofen arginine (only) treatment. Additionally, effects over the functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 2 different groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
* Full understanding of written and spoken Spanish (language).
* Participants must freely consent to participate.
* The presence of positive Phalen an Tinel sings.
* The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

* The lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive)
GP Remote Consultation to Reduce Opioid Prescribing

Opioid prescribing rates are high in the North East and North Cumbria region of England. The COVID-19 pandemic has interrupted the existing regional programme that aims to reduce the use of opioid medications, and also prescribing is likely to have increased during the lockdown. Thus, it has become increasingly challenging for primary care to dedicate sustained clinical time to tackle this complex issue with patients, who may also be reluctant to seek help. A video messaging intervention based upon a GP consultation was developed to remotely explain the rationale for opioid reduction and facilitate self-initiation of support. The short video suitable for smartphone viewing is messaged using a two-way communication system. Patients can watch the video and request additional support by replying with a simple text or email response. This enables efficient delivery of a discrete offer of help to at risk individuals who often avoid service contact. The aim of this study is to evaluate the potential benefits, risks and economic consequences of 'at scale' implementation.

This study will be a mixed methods study comprising of a quasi-experimental non-randomised before-and-after study and qualitative interviews. In the first phase, the intervention arm will comprise 50 GP practices in the region using System 1 who will deliver the video to their patients. The control arm comprises 50 practices in the region using EMIS who will continue care as usual. The unit of analysis is the GP practice, with no individual-level quantitative data collected. Monthly practice level data will be accessed and followed up for 6 months. A general linear model will be used to estimate the association between the exposure (video message vs. control) and the outcome (opioid prescribing). In the second phase, semi-structured interviews will be undertaken remotely with purposively selected participants including patients who received the video and health professionals involved in sending out the videos. These interviews will be audio recorded with participants' consent, transcribed and analysed thematically.

As well as evidence and rapid insights to inform the potential accelerated implementation of the intervention within the Integrated Care System, this study will provide evidence that could underpin the future adoption of the intervention into wide scale clinical management that can be disseminated as a future national programme via the Academic Health Science Network.


Eligibility Criteria:
Inclusion Criteria:

* adults (aged 18 or over)
* registered with a mobile phone number at practices
* regularly taking opioids for more than 90 days or at a dose equivalent to \> 100 mg of codeine a day (this varies for each opioid medication) using electronic records

Exclusion Criteria:

* if they are coded cancer or palliative care.
Methodological Study of the Effect of a Lotion Containing Nature Based Microbial Extract on Atopic Skin

The purpose of the study is to test the selected methods and to explore the effect of nature-based exposure on immunological biomarkers and the condition of atopic skin. Overall purpose is to test the safety and feasibility of a new nature-exposure method on atopic skin: regular use of lotion containing inactivated microbial extract that mimics Finnish forest microbial biodiversity.

According of hygiene and biodiversity hypotheses, regular contact to nature biodiversity is beneficial for human health. Without the contact, there is risk for immune system malfunction and related diseases like atopy, allergies and inflamed bowel diseases. Regular contact to natural biodiversity, including environmental microbes, add immunological tolerance and train immune system to separate dangerous external stimuli from non-dangerous ones.

This study aim at testing if it is safe to use microbial extract in lotion on daily basis on atopic skin. Study participants are adults and they have atopic dermatitis diagnosis. Participants use the lotion with microbial extract on other arm and placebo lotion (same lotion but microbial extract is replaced with safe coloring ingredient) on the other arm two times per day for 28 days. Atopy medicines are not used on the study period and 14 days before the study. Also, other moisturizers than test lotions are not used on test areas during the study.

Study is placebo controlled, randomized and double-blinded.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65
* Legally competence
* Fullfills Hanifin \& Rajka criteria for atopic dermatitis
* Commitment to the study

Exclusion Criteria:

* Regular contact to farming environment
* Cancer or on going cancer treatments
* Use of immunosuppressive medicines
* Photo therapy, solarium or vacation abroad during the study
* Too severe eczema (not possible to keep pause from atopy medicines)
Vulvovaginal Candidiasis in Canadian Females

Vulvovaginal candidiasis (VVC; colloquially referred to as a 'yeast infection') is a prevalent mucosal infection caused by Candida spp. that affects \~75% of women at least once in their life. VVC usually responds well to treatment, yet a small but significant fraction of women experience recurrent yeast infections even with weekly treatment. A further complication in understanding the causes of recurrent infections is that approximately one in five females have vaginal yeast present without any symptoms at any given point. The link between fungi, other microbes in the vagina ("microbiome"), and the human immune system remain poorly understood in the switch from having yeast present in the vagina without any symptoms and symptomatic yeast infections. Fungi also compose a normal component of the microbiome at other sites in the body (e.g., oral, skin, gastrointestinal tract, rectum) where they may serve as a source of re-infection following treatment.

In addition to the commonly prescribed 'first choice' antifungal drug fluconazole, a second-line treatment, boric acid, has shown promise in the literature and has been used locally with success at increasing the time between recurrent infections. A drawback of this therapy, however, is cost, as it is a compounded medication, and patients have to pay out of pocket. The purpose of this study is to understand how the yeast and bacterial microbial communities differ for females with recurrent infections from females with their first yeast infection and females with vaginal yeast present without any symptoms, and to track yeast diversity following treatment with either boric acid or fluconazole. The investigators hypothesize that they will identify multiple subpopulations of yeast at multiple anatomical body sites in females with VVC and recurrent VVC. They anticipate finding evidence for recurrent infection from secondary sites by linking genomic diversity of vaginal yeast strains during symptomatic infection to strains from other body sites. They hypothesize that yeast isolated from females with recurrent infections will exhibit different drug response phenotypes than yeast from females with asymptomatic vaginal yeast. They hypothesize that the vaginal microbiome of post-treatment patients treated with boric acid will differ from that of fluconazole. Combined, they hypothesize that post-treatment response will differ between the drugs, indicating that treatment specifics influence the vaginal environment.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Between ages of 18 and 50 years.

Exclusion Criteria:

* Currently pregnant
* Trying to get pregnant
* Have had a hysterectomy
* BV infection
Ocular Finding in Alopecia Areata

Alopecia areata (AA) is a common, idiopathic and sometimes recurrent non-scarring type of hair loss.

Several etiological factors, including psychological, trauma-related, genetic and autoimmune factors have been considered as possible etiological factors . A T cell-mediated autoimmune mechanism in genetically vulnerable individuals is the most acceptable etiology.

Alopecia areata presents clinically with well demarcated patches of non cicatricial hair loss in any hair bearing area with no remarkable gender preference.

Although AA may occur at any age, incidence is high among younger age groups. In fact, it is the most common form of alopecia seen in children. Various clinical patterns of alopecia have been described as patchy, diffuse, reticulate, ophiasis and ophiasis inversus. Depending on the extent of hair loss, it can be classified into alopecia subtotalis, alopecia totalis (complete loss of scalp hair), and alopecia universalis (complete loss of body hair).

National Alopecia Areata Foundation has devised "Severity of Alopecia Tool Score" (SALT score) as a measure of disease severity. Scalp is divided into 4 areas, namely, Vertex-40% of scalp surface area; right and left profiles-18% each and posterior scalp aspect-24%. SALT score is the sum of percentage of hair loss in the above mentioned areas.

Alopecia areata is now considered a systemic autoimmune disease that may have other serious comorbidities, such as cardiovascular and ocular. However, the results of studies of ocular findings in AA are controversial.

Several ocular alterations have been previously reported in patients with AA ranging from minor punctate opacities to cataract. However, there are contrasting opinions on the significance of these lenticular changes. In addition, Horner syndrome, pupil ectopia, iris atrophy, fundus changes , bilateral keratoconus, iris changes and retinal changes have been reported in AA.

Dermoscopy is a noninvasive, diagnostic tool which visualizes subtle patterns of skin lesions not normally visible to the unaided eye. Characteristic dermoscopic finding of AA included black dots , tapering hair corresponding to " exclamation mark hairs " , broken hairs , yellow dots , and clustered short vellus hairs ( shorter than 10 mm).

Since ocular affection can be a profound morbidity factor in patients with AA, we will search deeply in this study about this correlation in order to conclude the value of ocular screening in each and every patient with AA.

Eligibility Criteria:
Inclusion Criteria:

* patients of alopecia areata will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.

Exclusion Criteria:

1. Patients with documented eye disease.
2. Patients with any systemic illness.
3. Patients who received any systemic treatment with possible ocular implications in the last three months.
The Impact of Circadian Misalignment on Colonic Barrier Homeostasis in Ulcerative Colitis

The purpose of this study is to investigate if circadian malalignment (unusual sleeping patterns), such as night shifts (sleeping during the day and being awake during the night time), worsens the inflammation of the gut. We hope to look at patients with Ulcerative Colitis and Healthy Controls.


Eligibility Criteria:
Inclusion Criteria:

UC patients:

* M/F, 18-50 y/o
* Inactive Disease (Mayo Score ≤ 2)
* Stable medications with no disease flares for the \> 3 months
* Left-sided UC (Montreal E1 or E2)
* Normal psychological evaluation and negative drug screen (See Below)

Healthy Controls:

* M/F, 18-50 y/o, age ± 3y sex, race, and BMI match with UC subject
* No clinical evidence of any medical illness
* Normal psychological evaluation and negative drug screen (See Below)

Exclusion Criteria:

UC patients:

* Patients with other forms of colitis such as Crohn's disease (CD) or indeterminate colitis
* Patient with active UC (Mayo \> 2)
* Pancolonic UC (colitis past the splenic flexure, Montreal E3))
* Use of biologic or immunomodulatory medications (i.e. Infliximab, Adalimumab, azathioprine, Vedolizumab, methotrexate, etc.)
* Gastrointestinal surgery
* Other GI diseases or systemic diseases (cardiac, renal failure, cirrhosis)
* Shift work in the last 6 months
* Antibiotic use within last 12 weeks
* Patients who have used anti-diarrheal agents such as Lomotil or Imodium within 3 days of the study
* Prednisone use the last 30 days
* Significant Depression (score ≥ 14 BDI)
* Significant Anxiety (score ≥ 40 STAI)
* Use of probiotic supplement in last 4 weeks except yogurt.
* Intentional change in diet.
* Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed.
* Chronic Alcohol use. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
* Have children under 6 months

Healthy Controls:

* History of drug abuse, gastrointestinal (GI) surgery, GI diseases, or systemic diseases such as renal (creatinine\>1.2 mg/dl), liver, cardiac, or diabetes (Hgb-A1c\>8%)
* Antibiotic use within last 12 weeks
* Shift work in the last 6 months
* Use of probiotic supplement except yogurt in last 4 weeks.
* Atypical American diet with daily fiber ≥ 16 grams or daily saturated fat ≤ 11 grams by Food Frequency Questionnaire
* Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
* Chronic Alcohol use. A washout period of 3 weeks is needed before the subject could be enrolled into the study.
* Significant Depression (score ≥ 14 BDI)
* Significant Anxiety (score ≥ 40 STAI)
* Regular use of medications that affect intestinal permeability, intestinal motility and/or endogenous melatonin including metoclopramide, NSAIDs, antibiotics, beta blocker, psychotropic medication, hypnotics and exogenous melatonin products during 4 weeks prior to the study
* People who crossed more than 2 time zones in the previous month
* Inability to sign an informed consent form.
* Have children under 6 months
Effects of Mills Manipulation and Nirschel Exercises in Patients With Lateral Epicondylitis

To find effects of mills manipulation versus NIRSCHL EXERCISES on pain ,strength and function in patients with lateral epicondylitis.

Lateral epicondylitis is also known as tennis elbow, an overuse injury that is characterized by pain and tenderness over the lateral epicondyle. The exact etiology has not been well identified, however its commonly associated with repetitive micro trauma from excessive gripping, wrist extension radial deviation or forearm supination. Extensor carpi radialis brevis is the most affected muscle. The aim of this study is to access the effects of mills manipulation versus Nirschl exercises on pain, strength, and function in patients with lateral epicondylitis.

This study will be a Randomized Clinical trial and will be conducted at Pakistan society for rehabilitation of disabled and Mayo Hospital in Lahore. Patients of aged 20-40 years having insidious onset of lateral elbow pain with positive cozens test, Mills test and Maudsley test will be taken. Patients with radial nerve entrapment, cervical radiculopathy and those receiving injections of corticosteroids in last 4 weeks are excluded. The study will include 32 patients randomly divided into two groups A and group B. The study will be completed within the time duration of 10 months after approval of synopsis. Group A will receive mills manipulation while Group B will receive Nirschl exercises. myofascial release therapy will be given to both groups as baseline. both groups will receive 3 sessions per week for 4 weeks (12 sessions), data will be taken by using numeric pain rating scale for pain, hand dynamometer for grip strength and Patient rated tennis elbow evaluation for evaluation of function, at the start of treatment and the end of treatment session. Data will be analysed on SPSS-25.

Key words: lateral epicondylitis, mills manipulation, Nirschl exercises, Patient rated tennis elbow evaluation

Eligibility Criteria:
Inclusion Criteria:

* Pain on lateral epicondyle of humerus when palpated, in the age group of 40-60 years
* Both male and female are included
* Unilateral symptomatic lateral epicondylitis
* Tenderness over palpation of extensor carpi radialis brevis muscle muscle (ECRB)
* Patients with positive cozens test (resisted wrist extension and radial deviation is painful) ,mills test (passive elbow extension \& wrist flexion is painful) and maudsley test(resisted middle finger extension is painful)
* Patients having symptoms of lateral epicondylitis for \> 3 months

Exclusion Criteria:

* Radial nerve entrapment
* Cervical radiculopathy
* Corticosteroid injection within 4 weeks
* Had received any conservative treatment for lateral epicondylitis in last 4 weeks before entering the study
* Post-surgery patients of lateral epicondylitis
* Radiological findings of extensor tendon calcification