cyrilzakka/clinical-trials huggingface dataset:
Correlation Between Somatic Growth and Number of Erupted Deciduous Teeth

This investigation seeks to build upon existing evidence that a relationship exists between body mass and timing and the number of erupted teeth.

Alteration in the order of teeth eruption denotes a disorder in normal development of the teeth, rather than delayed or accelerated growth. The more time deviation of teeth eruption from normal, the more possible the presence of a problem in development of teeth. For these reasons having a non-invasive tool such as body mass index to determine if development will be slower than average, could be helpful to the practitioner.

Eligibility Criteria:
Inclusion Criteria:

- Healthy infants aged 5-36 months. 2-Absence of medical and congenital diseases. 3-Full term infants. 4-Residents of Cairo governorate.

Exclusion Criteria:

* Presence of natal and neonatal teeth.
Efficacy and Safety of Adalimumab in Adult Chinese Subjects With Active Ankylosing Spondylitis

Study of the efficacy and safety of adalimumab compared with placebo in adult Chinese participants with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Adults with active ankylosing spondylitis (AS) were randomized in a 2:1 ratio to receive treatment with adalimumab 40 mg every other week (eow) or matching placebo, given subcutaneously (SC), in the 12-week double-blind (DB) phase. Randomized participants received one SC injection of the appropriate DB study medication (adalimumab 40 mg or matching placebo) at Week 0 and then eow until Week 10. Participants who completed the DB phase could enter the 12-week open-label (OL) phase, during which all participants received treatment with adalimumab 40 mg eow, starting at Weeks 12 through 22. No study drug was administered or injected at the final study visit (Week 24). A follow-up visit occurred 70 days after the last dose of study drug (in DB or OL phases) to obtain information on any ongoing or new adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 65 years
* Has a diagnosis of ankylosing spondylitis (AS) based on the Modified New York Criteria
* Has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits:

  * BASDAI score at least 4 cm
  * Total back pain on a visual analog scale (VAS) at least 40 mm
  * Morning stiffness at least 1 hr
* Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as defined by the Investigator

Exclusion Criteria:

* Has total spinal ankylosis (bamboo spine)
* Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to Baseline
* Has extra-articular manifestations (i.e., psoriasis, uveitis, inflammatory bowel disease) that is not clinically stable, as defined by the Investigator's best clinical judgment, for at least 28 days prior to Baseline
* Has received intra-articular joint injection(s), spinal or paraspinal injection(s) with corticosteroids within 28 days prior to Baseline
* Has prior exposure to any biologic therapy with potential therapeutic impact on AS, including anti-TNF (tumor necrosis factor) therapy
Disrupt CAD III Post-Approval Study (PAS)

The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.

Subject Population: Patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study. Approximately 1000 patients in the CathPCI Registry® (including a minimum of 30 patients with permanent pacemakers \[PPM\] or implantable cardioverter defibrillators \[ICDs\]) will be enrolled. Subjects will be followed through discharge.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥18 years of age
2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
3. Left ventricular ejection fraction \>25% within 6 months
4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
5. LAD, RCA or LCX (or of their branches) with:

   * Stenosis of ≥70% and \<100% or
   * Stenosis ≥50% and \<99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR \<0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²
6. The lesion length must not exceed 40 mm
7. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
8. Evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location

Exclusion Criteria:

1. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
2. New York Heart Association (NYHA) class III or IV heart failure
3. Renal failure with serum creatinine \>2.5 mg/dL or chronic dialysis
4. Subjects in cardiogenic shock or with clinical evidence of acute heart failure
5. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
6. Previous stent within target lesion (in-stent restenosis)
Metabolites of Tear Fluid

The pilot trial evaluates the use of modified Schirmer strips and is designed to evaluate inter-individual range of metabolites in tear film.

The variability of tear film metabolites should be investigated in a sample of ophthalmologists in preparation for a pilot study in patients eye diseases.

The easy accessibility of the tear fluid and the lack of invasiveness of the study make it promising and sensible to determine the concentration of various tear film metabolites. Because attention has so far focused primarily on the quantitative and qualitative analysis of tear film proteins, many metabolites have so far only been shown to be contained in tears.

However, before the suitability of the measured values as a predictive parameter of the ocular surface for pathologies can be examined and assessed, it is necessary to determine the scattering variables in a sample of healthy volunteers. Thus, reference areas are to be defined for later investigations in order to enable reliable case number planning thereafter.

Repeated determinations at different times and on different days make it possible in particular to detect a time-dependent relationship in view of the dynamic variability of the tear film. The functional significance of certain metabolites can not yet be assessed in the establishment phase. However, the data may provide important information for the interpretation of a later, planned feasibility study with diseased patients or the influence of applied eye drops.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects at age \> 18 years

Exclusion Criteria:

* in the case of subjects with a mental disability or legal guardianship, due to possible conflicts for the caregivers, a data evaluation and recording should in principle be dispensed with.
* subjects who have had any eye drops within the last 4 weeks, e.g. lubricants were used
* subjects undergoing clinical examination for symptoms of wetting disorder or morphological changes related to eye disease
Buy 1 Get 1: Role of Grocery Coupons in Promoting Obesogenic Home Food Environments and Eating Behaviors

The prevalence of overweight and obesity among older adults has reached an all-time high, which puts this age group at high risk for associated comorbidities such as type 2 diabetes, cardiovascular disease, and certain forms of cancer. Confronted with declining incomes and economic uncertainty, many middle-aged and older Americans tried to save on their food purchases during the 2007-2009 recession. Grocery coupons, available through newspapers, mail, and increasingly online, are one of several promotional tools that supermarkets and warehouse clubs use to promote sales. It is estimated that nationally 27% of households are frequent grocery coupon users who shop at a variety of retailers. Despite the increasing popularity of grocery coupons, little is known about the extent to which they may promote obesogenic home food environments and eating behaviors. Many coupons advertise the purchase of large quantities of prepackaged and processed foods and often reward shoppers by adding 'free' products if they purchase certain quantities. Availability and easy accessibility of large portions of energy dense foods in the home has been shown to promote increased intake. The proposed study seeks to examine the effects of frequent grocery coupon usage on dietary intake, weight status, and home food availability among middle-aged and older adults. A second aim of this study is to test, in a randomized-controlled trial, the effects of incentivizing grocery coupon use for the purchase of healthy foods on 3-month changes in dietary intake, body mass index/waist circumference, home food availability, and grocery coupon use among frequent coupon users and non-coupon users.


Eligibility Criteria:
Inclusion Criteria:

* 40 - 70 years of age
* frequent grocery coupon users
* non-coupon users

Exclusion Criteria:

* dieting
* medication use or medical conditions known to affect food intake and weight
Impact of a Lifestyle Program on Quality of Life in Pemphigus Patients

The aim of this study is To evaluate the impact of lifestyle modifications, including dietary changes and regular exercise, on skin-related quality of life in patients with pemphigus by assessing changes in Skindex-16 scores over a three-month period.

The skin, the body's largest organ, serves as a critical protective barrier against environmental hazards and plays a pivotal role in immune defence.

Autoimmune diseases arise when the immune system erroneously targets the body's own tissues, leading to chronic inflammation and tissue damage. Globally, the prevalence of these disorders is on the rise, significantly impacting patient morbidity and healthcare systems.

Pemphigus is a rare autoimmune blistering disorder characterized by the production of autoantibodies against desmogleins-proteins essential for cell-to-cell adhesion within the epidermis.

Epidemiologically, pemphigus vulgaris (PV) is the most common subtype, with incidence rates varying geographically. Higher incidences are observed in regions such as the Middle East, with Iran reporting up to 5 cases per 100,000 people annually. In the Arab world, PV predominates in countries like Egypt, Sudan, and Morocco.

Complications of pemphigus are multifaceted. Patients are susceptible to secondary bacterial, viral, and fungal infections due to compromised skin integrity, which can escalate to sepsis. Oral mucosal involvement often leads to painful erosions, causing difficulties in alimentation and subsequent nutritional deficiencies.

The psychological burden of pemphigus is considerable. Chronic pain, visible lesions, and social stigma contribute to elevated rates of anxiety and depression among patients. Studies indicate that approximately 30.7% of individuals with pemphigus experience anxiety or depressive disorders, underscoring the need for comprehensive psychosocial support in this population.

Therapeutically, systemic corticosteroids remain the cornerstone of pemphigus management, often supplemented with immunosuppressants and biologic agents like rituximab. While effective, these treatments carry risks; long-term corticosteroid use is associated with adverse effects such as osteoporosis, increased infection risk, and metabolic disturbances.

Despite advancements in therapeutic strategies, there remains a paucity of research focusing on lifestyle modifications as adjunctive measures in managing pemphigus. This study aims to explore the potential benefits of integrating lifestyle interventions to enhance patient outcomes, reduce treatment-related complications, and improve overall quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 1. Adults aged 18-65 years diagnosed with pemphigus. 2. Willingness and ability to adhere to prescribed lifestyle modifications.

Exclusion Criteria:

* 1. Presence of severe comorbidities that could impede adherence to dietary interventions and regular exercise 2. Pregnancy or lactation
Impact of Early Goal-directed Fluid Therapy in Hypovolemic Patients Undergoing Emergency Surgery

This study compares the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in trauma patients requiring emergency surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years
* Severe hypovolemic condition°
* Need for emergent interventional procedure under general anesthesia with an expected duration \> 120 min.

Exclusion Criteria:

* Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC
* Neurotrauma (Glasgow Coma Score \< 12) and/ or medullar trauma
* Known pregnancy or diagnosed by US or Ct-scan (\> 14 weeks)
* Sustained cardiac arrhythmia (see Logbook P8)
* Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)
* Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8)
* Burn injury \> 10%
* Needed emergency thoracotomy or ABC resuscitation protocol
* Pre-existing severe liver dysfunction(Child-Pugh class C)
* Do-not-resuscitate order, died within 48h of admission
* Ultra-emergent surgery with no further diagnostic investigation.
Demodex Blepharitis Treatment Study

This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis (reducing ocular demodex counts and achieving the clinical improvement with minimal or no irritation).

Demodex blepharitis is one of the most common causes of chronic blepharitis. The investigators preliminary clinical study showed that lid scrub with TTO was effective in resolving chronic blepharoconjunctivitis; however, it was not convenient for self-administration and caused irritation in some patients. Preclinical safety studies have verified that T4O is less irritant. In this study, the investigators will determine the optimal regimen of T4O Pads.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
* Age range: 15-80 years old.
* Both genders and all ethnic groups comparable with the local community.
* Able to understand and willing to sign a written informed consent
* Able and willing to cooperate with the investigational plan.
* Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

* Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
* Children under 15.
* Pregnant women or expecting to be pregnant during the study.
* Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
* Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
* Concomitant use of systemic antibiotics or steroids.
* Contact lens wear (unless discontinued for ≥ 30 days before randomization)
* Active ocular infection or allergy
* Unable to close eyes or uncontrolled blinking
* Presence of aqueous tear deficient dry eye defined by the Fluorescein Clearance Test as less than 3 mm wetting in 1-minute Schirmer test with anesthesia.
* Previous allergic reaction to TTO-containing products or cosmetic fragrance.
Somnodent vs Herbst in Mild and Moderate OSA Patients

Obstructive sleep apnea (OSA) is a common chronic sleep disorder that often requires lifelong care. The prevalence in the Netherlands is estimated around 300.000 patients. Due to longer life expectancy and increase in weight in the general population, its prevalence is expected to rise. Patients with mild and moderate OSA are treated primarily with an oral appliance at present time. Different oral appliances are available, but most used is the mandibular advancement device (MAD). This study focuses on two different types of MAD: the classic Herbst appliance, which is attached to the mandible and the maxilla and has an iron bar to regulate the open space; and the Somnodent, which consists of two separate splints, fixed on the mandible and the maxilla, but has no iron bar attached.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Ability to speak, read, and write Dutch.
* Ability to follow-up.
* Ability to use a computer with internet connection for online questionnaires.
* Diagnosis with symptomatic mild or moderate OSA (5 \< AHI \< 30).
* Expected to maintain current lifestyle (sports, medicine, diet, etc.)

Exclusion Criteria:

* Untreated periodontal problems, dental pain, and a lack of retention possibilities for an MAD.
* Medication used/related to sleeping disorders.
* Evidence of respiratory/sleep disorders other than OSA (eg. central sleep apnea syndrome).
* Systemic disorders (based on medical history and examination; e.g. rheumatoid arthritis)
* Temporomandibular disorders (based on the function examination of the masticatory system).
* Medical history of known causes of tiredness by day, or severe sleep disruption (insomnia, Periodic Limb Movement Disorder, Narcolepsy).
* Known medical history of mental retardation, memory disorders, or psychiatric disorders.
* Reversible morphological upper airway abnormalities (e.g. enlarged tonsils). - Inability to provide informed consent.
* simultaneous use of other modalities to treat OSA.
* Previous treatment with a MAD.
Resistance Exercise, Recovery Drinks and Appetite

Whilst the effects of manipulating the macronutrient content of foods on appetite and energy intake has been relatively well studied at rest, little is known about these responses in a post-exercise context. The effect of post-exercise nutrition on recovery from or adaptation to exercise has been well studied. However, many exercisers do so for weight management and thus any post-exercise nutrition might impact on energy balance and might need to be carefully considered. This study will examine the impact of manipulating the composition of a recovery drink consumed after resistance exercise on subsequent appetite and energy intake.

Subjects perform a bout of lower body resistance exercise lasting \~50 min and immediately post-exercise they consume one of two recovery drinks over a 5 min period. Over the next 60 min subjective appetite responses will be measured and then 60 min after drink ingestion, subjects will consume an ad-libitum meal.

Eligibility Criteria:
Inclusion Criteria:

* Generally fit and healthy
* Use resistance exercise as part of weekly training
* Weight stable in previous 6 months

Exclusion Criteria:

* Smoker
* History of gastric, digestive, cardiovascular or renal disease
* Lactose, dairy, gluten intolerances or allergies
Cluster-RCT Collective Nasopharyngeal COVID-19 Testing Amongst Pupils

Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?

In order to control the outbreak of cluster infections on school during the COVID-19 pandemic, regular rounds of collective nasopharyngeal swab testing were organized. However, it is unclear under which circumstances nasopharyngeal swab testing is better accepted by young children. Due to the closing of schools, and the different logistic situations in schools, a natural pragmatic RCT formed. In some cases, children could observe their peers before having their own test, while for others the view was blocked. Also, sometimes parents would be present during a test procedure when the school was closed, while they were not present when the school was open. To date, it is unclear whether these two variable elements influence a child's resistance to be tested. Therefore a cluster-randomized controlled trial with testing site as the unit of randomisation will be set-up. Four conditions will be tested. On the individual level, the resistance of their peers before their own testing will be taken into account. The aim of the study is to compare whether (1) the visibility of nasopharyngeal swab testing on their peers and (2) the presence of their parents impacts a child's resistance towards the test. Additionally, the impact of whether or not their peers resisted the test impact predicts the likelihood of their own resisting behaviour.

Eligibility Criteria:
Inclusion Criteria:

* undergoing a nasopharyngeal COVID-19 swab test

Exclusion Criteria:

-
The Effect of Eyelid Surgery on Dry Eye - a Prospective Study

The investigators aim to assess the effect of blepharoplasty with or without muller muscle resection on the symptoms of dry eye syndrome. this will be an observational study in which patients undergoing the aforementioned surgeries will be followed up and monitored for dry eye symptoms.

Patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in the investigators institution, will be offered to participate in the study. After filling and informed consent form, patients recruited will fill in a questionnaire about dry eye symptoms, and will be examined by an ophthalmologist for visual acuity, intra ocular pressure, anterior segment examination using a slit lamp biomicroscopy, schirmer test, tear break up time assessment and tear osmolarity. These are all standard examination in ophthalmology. The surgical procedure planned to correct the eyelid pathology will not be affected by the results of these examinations.

The same combination of ophthalmic examination will by done on postoperative follow-up examination 1 week, 1 month and 3 months after the surgery. Dry eye questionnaire will be filled in by the patients on postoperative follow-up examination 1 month and 3 months after the surgery.

This data will help us assess the effect of these common surgical procedures on dry eye symptoms.

Eligibility Criteria:
Inclusion Criteria:

* patients who are referred for blepharoplasty with or without muller muscle resection in the oculoplastic clinic in our institution
* no other ophthalmic procedures planned for the patient in study period
* ability to undergo full ophthalmic examination as stated in the study protocol
* Ability to complete the dry eye questionnaire
* ability to sign an informed consent form

Exclusion Criteria:

* previous eyelid surgery
* other orbital or lacrimal gland disease
* concurrent use of contact lenses
* concurrent use of Restasis
* previous glaucoma surgery
* use of punctual plugs
* pregnant or nursing women