cyrilzakka/clinical-trials huggingface dataset:
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.

Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD-involved, excluding the scalp.

In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA, excluding the scalp, and must complete all PK assessments to be included in the PK analysis. Of these subjects, at least 3 subjects who are less than 9 months of age will be enrolled. Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments. Only selected study sites will participate in the PK assessment.

Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28 days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination), Day 36, and Day 57 (end of study).

Eligibility Criteria:
Inclusion Criteria:

Aged ≥ 3 months at the screening visit to \< 24 months on baseline/Day 1, diagnosed with AD

Exclusion Criteria:

Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)
Use of Antibacterial Cement in Infected Dentin

Dental materials with antibacterial properties can prevent the harmful effects caused by oral cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of antibacterial cement for sealing infected dentin in atraumatic restorations of primary molars.

The study enrolled 45 children (45 teeth) between 5 and 8 years of age, of both genders, divided into two groups. In group A (GA; n=22), the cavities were lined with conventional glass ionomer cement (Vidrion F®) and in group B (GB; n=23), with antibacterial cement (Vidrion F® containing 1% each of metronidazole, ciprofloxacin, and cefaclor). Both groups were restored with Ketac Molar Easymix®. Molars with carious lesions on the inner half of dentin without clinical or radiographic pulp damage were selected. Patients were evaluated clinically (for pain, fistulas, or mobility) and radiographically (area of caries, periapical region, and furcation of teeth) after 1, 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* signed consent from a parent or guardian;
* primary molars with carious lesions on the inner half of dentin;
* access of caries lesions to dentin spoons.

Exclusion Criteria:

* damaged pulp determined clinically (for pain, fistulas, tooth mobility);
* damaged pulp determined radiography (bone or dental pathology);
* children taking antibiotics;
* children who refused the treatment;
* children had systemic disease.
Objective Physical Activity Assesment in Postmenopausal Women

The purpose of this study is to accurately assess weekly physical activity levels of postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.

This observational study aims to accurately assess weekly physical activity levels of postmenopausal women using lactate thresholds to individualize the accelerometer cut-points.

Postmenopausal women will be recruited from local advertisements in public health centers. Each woman will perfom on different days a progressive discontinuous submaximal walking-running test and several constant speed tests wearing an accelerometer to identify the individual lactate threshold (LT), the maximal lactate steady state (MLSS) and the corresponding accelerometer activity counts/min (cpm). Participants then will wear an actigraph accelerometer (wGT3X-BT) for seven days.

Linear regression equations will be developed for each participant to determine accelerometer activity counts for each intensity level: 1) sedentary behaviour (\<200 cpm), 2) light intensity (200 cpm to activity counts at LT), 3) moderate intensity (activity counts between LT and MLSS) and 4) vigorous intensity (activity counts \>MLSS). Physical activity levels will be measured using both, individualized approach and Sasaki, Jonh and Freedson´s (2011) absolute cut-points obtained through walking and running activities eliciting 3-6 MET intensities (2689-6166 cpm), considering it a "moderate" effort.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 70 years
* Surgical or natural menopause (no menstrual periods during at least the last 6 months)

Exclusion Criteria:

* Body mass index less than 39kg/m2 (obesity class III)
* Osteoporosis
* Presence of low-trauma fractures or severe arthrosis at hip, knees or feet
* Functional limitation to walk fast or altered gait patters and instability
* Presence of any chronic disesase that would impair the cardiovascular (e.g. myocardial infarction, stroke, chronic heart failure), musculoskeletal (osteoporosis, low-trauma fractures) and respiratory systems (COPD) or any disease or medication known to affect bone metabolism (glucocorticoids)
Mood Disorders in Multiple Sclerosis Patients

This study investigates the frequency of unipolar and bipolar mood disorders in patients with multiple sclerosis. MS is a chronic condition that affects the central nervous system, and previous research suggests that mood disorders, such as depression and bipolar disorder, may occur more frequently in MS patients compared to the general population.

A retrospective analysis of 85 patients diagnosed with MS was conducted, evaluating lifetime experiences with mood disorders using structured clinical interviews. The goal is to better understand the prevalence of these mood disorders and to raise awareness of the importance of mental health care in patients with MS. The findings highlight that mood disorders, particularly bipolar disorder, are more common in MS patients than previously thought. This information can help healthcare providers improve screening, diagnosis, and treatment for MS patients suffering from mood disorders.

This study is a retrospective cohort analysis designed to examine the lifetime prevalence of unipolar and bipolar mood disorders in patients with multiple sclerosis. MS is a chronic, demyelinating condition of the central nervous system that leads to varying degrees of neurological impairment. Previous studies have shown that mood disorders, particularly depression and bipolar disorder, are more prevalent in patients with MS than in the general population.

Data from 85 patients (45 females and 40 males) diagnosed with MS were analyzed, focusing on psychiatric history through structured clinical interviews. The study evaluated the presence of mood disorders, including major depressive disorder, bipolar disorder types I and II, dysthymia, and unclassified mood disorders. Data were collected using DSM-IV criteria to ensure consistency in diagnosis.

The results demonstrate that mood disorders, especially bipolar disorder, are more frequent than previously reported in this patient population. These findings underscore the need for improved mental health screening and treatment for MS patients, as managing psychiatric comorbidities can significantly enhance overall quality of life. The study emphasizes the importance of integrating psychiatric care into routine MS management.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Multiple Sclerosis: Participants must have a confirmed diagnosis of multiple sclerosis (MS) by a qualified neurologist.
* Age Range: Participants must be between 18 and 65 years of age.
* Informed Consent: Participants must provide informed consent to participate in the study.
* Geographic Location: Participants must reside in Tehran, Iran.

Exclusion Criteria:

* Other Neurological Disorders: Individuals with a diagnosis of any other neurological disease (e.g., epilepsy, Parkinson's disease) will be excluded.
* Head Trauma: History of head trauma that resulted in impaired consciousness or memory loss.
* Seizures: A history of seizures that could affect mood.
* Substance Dependence: A history of substance dependence as per DSM-IV criteria.
* Other Physical Illnesses: Any systemic or physical diseases that could lead to mood symptoms.
The Influence of Covid-19 on the Audio-vestibular System

the study's porpuse is to examine whether Covid-19 causese a reduction in sensorineural hearing and vestibular function in recovered pateints - compared to healthy controls.

Both study groups will undergo audiometry, tympanometry, Video Head Impulse testing, Subjective Visual Vertigo testing and Video-Nystamography.

Previous audiometry results will also be aquired.


Eligibility Criteria:
Inclusion Criteria:

* ages 18-80 performed audiometry testing in the last two years

Exclusion Criteria:

* known inner ear dysfunction - Sudden sensorineural hearing loss; autoimmune disease (Cogan's syndrom, SLE, ect.), familial/genetic sensorineural hearing loss, excessive noise exposure.

knowm conductive hearing loss (Air-bone gap\>10dB) prior ear surgery chronic tympanic membrane perforation.
fMRI of Hypothalamic Responses to Taste, Temperature and Glucose

The study will consist of five occasions with one week in between. BOLD signal intensity of the hypothalamus will be measured using fMRI. Measurements will be done before and after drinking 300 ml plain water or water to which glucose and/or ethyl butyrate will be added.

The hypothalamus is known to be important for control of feeding behaviour as well as the regulation of temperature. Functional magnetic resonance imaging (fMRI) is a non-invasive method, which detects transient haemodynamic changes in the brain, using blood oxygen level dependent (BOLD) signal differences.

In order to investigate the role of hypothalamic neural activity in response to taste, glucose and temperature, fMRI will be performed before, during and after ingestion of 300 ml plain water or water with added ethyl butyrate (pineapple flavour), added glucose or added ethyl butyrate plus glucose. All beverages will be consumed at 22 °C and the combination will also be drunk at 0 °C.

The study uses a randomised cross-over design in 16 healthy male subjects with a normal body weight. There will be an interval of at least one week between the five occasions.

BOLD signal intensity of the hypothalamus will be continuously measured for 21 minutes (5 minutes baseline, 4 minutes during drinking and 12 minutes after drinking).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age between 18 and 25 years
* BMI between 20 and 23 kg/m2
* Length between 170 and 190 centimetres

Exclusion Criteria:

* Diabetes or history of other disturbances of glucose metabolism (eg impaired glucose tolerance, hypoglycaemia).
* Any genetic or psychiatric disease (e.g. fragile X syndrome, major depression) affecting brain
* Any significant chronic disease
* Renal or hepatic disease
* Recent weight changes or attempts to lose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Smoking (current or last 6 months)
* Alcohol consumption of more than 21 units per week or use of recreational drugs at present or in the last year
* Recent blood donation (within the last 2 months)
* Recent participation in other biomedical research projects (within the last 3 months), participation in 3 or more biomedical research projects in one year
* Contra-indication to MRI scanning:

  * Claustrophobia
  * Pacemakers and defibrillators
  * Nerve stimulators
  * Intracranial clips
  * Intraorbital or intraocular metallic fragments
  * Cochlear implants
  * Ferromagnetic implants
Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation

The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents.

Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately, indwelling ureteral stents commonly cause significant pain and discomfort due to irritation to the urinary system. Many studies have looked at methods to reduce these uncomfortable symptoms ranging from altering stent designs to pharmacologic therapies attempting to alleviate stent-discomfort. However, stent-related discomfort continues to be an issue and is often the cause of their removal earlier than planned. While the efficacy of certain alpha blockers and anticholinergics in treating stent-related symptoms have been studied, the data for the use of hyoscyamine in this setting is lacking. A literature search yielded no studies evaluating the use of hyoscyamine in this setting to date. The investigators hypothesize that hyoscyamine (brand name Levsin) is equivalent to tamsulosin in treating lower urinary tract symptoms in patients with indwelling double-J ureteral stents due to its anticholinergic properties. Furthermore, the investigators hypothesize that patients in the hyoscyamine arm will not require additional pain medications (e.g. Pyridium, narcotics) to help control stent-related discomfort compared to the tamsulosin arm.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older
* Patient must require placement of a ureteral stent(s), per standard of care, following routine urological procedures including, but not limited to, ureteroscopy, stone extraction, or management of upper tract transitional cell carcinoma
* Patient must agree to abstain from other clinical studies during the study period

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients with chronic or pre-existing indwelling stents
* Patients currently receiving anticholinergic or alpha blocker therapy
* Patients with chronic opioid or analgesic usage
* Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia
* Patients with an active untreated urinary tract infection
* Patients who are currently pregnant or nursing
* Patients with allergies or contraindication to either tamsulosin or hyoscyamine
* Patients on active chemotherapy
* Patients currently receiving other investigational therapy
* Patients who are unable to sign consent/answer questionnaire due to compromised mental capacity or language barrier (the questionnaire is not validated in other languages)
* Patients who have a stent placed emergently for an obstructing stone or septic stone without immediate stone removal,
* Any stents placed that will stay in for longer than 2 weeks
Physical Activity Monitoring in Frailty and Falling

BioSensics has developed a Physical Activity Monitoring System (PAMSys) that consists of a single wearable motion sensor that is worn on the torso. The objectives of this observational study are the following: 1) to test the efficacy of PAMSys for objectively assessing a persons risk of falling based on activity data measured during activities of daily living and 2) to test the efficacy of PAMSys for identifying precise early physical activity or functioning indicators of frailty in those who are pre-frail or frail as compared to non-frail controls.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling ambulatory men or women ages 65 and above

Exclusion Criteria:

* Mental Status Mini Exam score \< 23
* Those who are unwilling or unable to comprehend informed consent
Efficacy and Safety of Nitazoxanide 600 Mg in the Outpatient Treatment of COVID-19 and Influenza

2. Participants will:

* Take nitazoxanide 600mg (or placebo) orally twice daily for 7 days, for a total of 14 doses.
* Visit the clinic on the 7th day of treatment for a check-up and safety tests.
* Keep a diary of their symptoms and other medications used


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form;
* Male or female;
* Age ≥ 18 years;
* COVID-19 or influenza diagnosed by rapid test, with symptom onset less than 48 hours ago;
* Clinical condition compatible with outpatient treatment.

Exclusion Criteria:

* Known hypersensitivity to nitazoxanide;
* History of cardiomyopathies, hepatopathies, or nephropathies;
* Antineoplastic treatment with chemotherapy or radiotherapy;
* Severe autoimmune diseases with immunosuppression;
* Transplant recipients;
* Any uncompensated systemic disease at the investigator's discretion;
* Participation in clinical studies in the last 12 months;
* Pregnant or breastfeeding individuals;
* Suspected bacterial coinfection or prescription of antibiotic therapy at enrollment;
* Diagnosis of neurological disease (traumatic brain injury, stroke, Parkinson's disease, Alzheimer's disease, other dementias);
* Diagnosis of developmental disorder (ADHD, ASD, learning disabilities, intellectual disability, Rett syndrome);
* Significant hearing or vision impairment.
Effect on Teeth and Gum Cleaning in Patients With Gum and Kidney Disease

The main aim and objective of this study was to evaluate the effects of Non- surgical periodontal therapy on the subgingival microbiota and biochemical parameters in patients with chronic kidney disease and chronic periodontitis.

The study was designed as a Non randomized prospective, interventional clinical trial. The sample size for the study was 40 individuals aged between 35-75 years, equally divided into two groups.

Group I--- Patients with Chronic kidney disease and chronic periodontitis (Test) Group II--- Patients with Chronic periodontitis only (Controls) At baseline both the groups were analyzed for clinical, microbiological and also biochemical parameters and underwent Non-surgical Periodontal treatment (i.e. scaling and root planning). All parameters were reassessed again after 3 months.

A total of 20 patients attending the outpatient wing of Hyderabad Kidney Centre , Malakpet,Hyderabad who were diagnosed clinically with Chronic Kidney disease and willing to participate in the study were included in the study.

Another 20 patients attending the outpatient wing of Department of periodontics, Panineeya Mahavidyalaya Institute of Dental Sciences \& Hospital, Hyderabad, diagnosed with Chronic Periodontitis and willing to participate in the study were taken.

Biochemical parameters considered included -serum creatin \& urinary albumin: creatin ratio.

Microbiological assay was done by Polymerase chain reaction test (PCR) i.e., pooled plaque samples were taken from both predialysis as well as chronic periodontitis patients.

Eligibility Criteria:
Inclusion Criteria:

* A total of 20 patients diagnosed with Chronic kidney disease, (having abnormal Glomerular filtration rate(GFR) and serum Creatinine levels.) and chronic periodontitis (with at least 15 teeth remaining, and with the presence of ≥4 sites in 3 different teeth having clinical attachment loss (CAL) of ≥ 4mm and bleeding on probing). (Group I)
* 20 patients diagnosed with chronic periodontitis only. (GroupII)

Exclusion Criteria:

* Patients with HIV infection, pregnancy, lupus erythematosus, rheumatoid arthritis, any systemic disorder, periodontal therapy in the preceding 6 months, or on any course of antibiotic prophylaxis for periodontal procedures were excluded from the study
Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19

Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 infection / COVID 19

Exclusion Criteria:

* invasive ventilation
* respiratory failure at admission
Regaining Confidence After Stroke a Feasibility Randomised Controlled Trial

The Regaining Confidence after Stroke Course (RCAS) is a group therapy intervention to evaluate the feasibility of conducting a definitive trial, aimed to facilitate adjustment for people with stroke discharged from rehabilitation, compared with usual care. The study also aimed to evaluate the feasibility of improving mood and coping in carers of the course participants.

The Regaining Confidence after Stroke Course (RCAS) is an is an eleven week group intervention that is designed to help stroke survivors when they have finished rehabilitation to improve confidence in daily life. This feasibility study aimed to evaluate the acceptability of the course in improving confidence, mood, adjustment and increasing activity levels in stroke survivors as well as improving mood and coping in their carers.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of stroke within two years
* Discharged from all other rehabilitation therapies
* Not involved in trials of other psychological interventions
* Not previously attended an RCAS course

Exclusion Criteria:

* Score of \<10 on the Barthel Index (sufficiently independent to cope in a group setting)
* Score \<8 on the Sheffield Screening test for Acquired Language Disorders so that participants would be able to understand the materials being presented
* Unable to speak English
* Unable to give informed consent