cyrilzakka/clinical-trials huggingface dataset:
NSAIDS vs Opioids in Tibial Fractures

This study will attempt to determine if there is a statistic difference between the time to union, non-union rate and post-operative pain of patients who receive opioids for pain control vs. patients who receive NSAIDs and a reduced dosage of opioids for pain management

The study will be a prospective interventional study with two randomized parallel groups.

Randomization will take place immediately following the identification of a potential participant. The control group will receive the standard of care for diaphyseal tibia fractures. The standard of care consists of intramedullary nailing and post-operative opioids for pain control. The interventional group will have the same surgical indication and intervention but will differ in the primary method of pain control. The study group will receive NSAIDs and a reduced dosage of opioids for pain control. Primary outcome measures will be time to union, non-union, and pain over the post-operative period measured by a VAS pain scale. Once the data collection of both groups is complete, the statistical analysis will begin to determine if there is a statistical difference between the control and study groups in the primary outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 105
* Diaphyseal tibia fracture (OTA/AO 42 A, B)

Exclusion Criteria:

-Tibial fractures not treated with intramedullary nails
Non-Invasive Pressure Monitor for Neonates & Infants at Risk of Developing Hydrocephalus

The goal of this clinical trial is to test a modified smart soft contact lens in neonates and infants at risk of developing hydrocephalus. The main questions it aims to answer are:

* Can the device distinguish between intracranial pressure variations in neonates and infants diagnosed with hydrocephalus and those without
* Can the device compare pressure dynamics between pre- and post-operative periods in neonates and infants who undergo surgical treatments Participants will undergo standard of care evaluations for hydrocephalus (anterior fontanelle assessment and head circumference measurement) and wear the device during standard of care evaluation; pre- and post- ventricular reservoir taps, as applicable; and/or pre- and post-operatively, as applicable.


Eligibility Criteria:
Inclusion Criteria:

* Being monitored for hydrocephalus, or healthy controls

Exclusion Criteria:

* Known hypersensitivity to materials used in the contact lens and/or adhesive
* Open/closed wounds at/near the anterior fontanelle
* Anterior fontanelle is closed
* Other conditions deemed relevant by the medical team
Discussion on the Mechanism of Acupuncture on Patients with Paroxysmal Migraine Without Aura : a Randomized Controlled Clinical Trial

Background: Migraine is common but poorly managed with drugs. Acupuncture, a non-pharmacological approach, has shown promise, yet its mechanisms remain unclear. This study aims to assess the efficacy and specificity of acupuncture for acute paroxysmal migraine without aura.

Methods: A randomized, single-blind, sham-controlled trial will recruit 60 patients from Tongji Hospital, China. Patients will receive 20 sessions of Deqi or sham acupuncture over 4 weeks and be followed for 8 weeks. Treatments will occur twice within 4 hours of headache onset. Primary outcome is complete headache remission within 120 minutes after two treatments without analgesics. Secondary outcomes include headache intensity reduction, remission rates, and adverse events. Blind assessment will be conducted after at least one session. Data will be analyzed using full and per-protocol sets.

Ethics: Approved by the Clinical Trial Ethics Committee (approval no: TJ-IRB20220573). Written consent will be obtained. Results will be published in a peer-reviewed journal.


Eligibility Criteria:
Inclusion Criteria:

* 1\\They met the diagnostic criteria of migraine without aura and had a history ofmore than 1 year; 2\\Age 18-65 years old;

  * 18.5kg/m2 ≤ BMI ≤ 30.0kg / m2,right-handed; ④ The average frequency of migraine attacks in recent 6 months was ≥ 2-8 times per month; The average number of migraine attacks per month in recent 6 months was less than 15 days; The neurological examination was negative, and the CT or MRI of the head was normal; There was no experience of acupuncture or migraine prevention and treatment in recent 3 months; Able to complete the baseline migraine diary; Agree to sign the informed consent form.

Exclusion Criteria:

* Other types of primary headache or secondary headache; It is complicated with serious primary diseases such as cardiovascular,cerebrovascular, liver, kidney, gastrointestinal, blood, nervous system, etc; Complicated with severe mental illness; In the past 12 weeks, migraine drugs were taken orally or headache treatment methods such as acupuncture and physiotherapy were received; Lactation, pregnant women and planned pregnant women; Participate in another clinical trial at the same time; Illiterate, unable to read comprehension scale; Poor compliance.
Effect of Benzalkonium Chloride Containing Eye Drops on the Conjunctival Bacterial Flora of Dry Eye Patients

Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial spectrum, it has also been shown to induce toxic effects to the ocular surface. Several studies have indicated that BAC may also have altering effects on the bacterial flora of the conjunctiva.

Since dry eye syndrome (DES) is a very common and multifactorial disease of the ocular surface and the tear fluid resulting in tear film instability, inflammation of the ocular surface, symptoms of discomfort and visual impairment, there are many different preserved as well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of DES. Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture.

Therefore, the aim of this study is to investigate the effect of artificial tear eyedrops with and without BAC on the conjunctival bacterial flora. For this 40 patients with mild or moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study will be recruited and treated either with the preservative-free "Prosicca sine" eyedrops or the BAC containing "Prosicca" eyedrops for one month. Conjunctival samples will be collected of one eye of each patient before and after the 1-month treatment period to compare the conjunctival bacterial flora of the two treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 75 years.
* Signed and dated written informed consent.
* History of dry eye syndrome for at least 3 months
* Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm and ≥ 2mm
* Normal ophthalmic findings except dry eye syndrome, ametropia \< 6 Dpt.
* Recommended use of topical lubricants, but no administration of topical lubricants 4 weeks preceding the first study day.

Exclusion Criteria:

* History or presence of ocular disease judged by the investigator as incompatible with the study.
* Any other topical ocular treatment than the study medication in the 4 weeks preceding the first study day and during the treatment period.
* Wearing of contact lenses.
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day.
* Participation in a clinical trial in the 3 weeks preceding the first study day.
* Pregnancy, lactation.
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes

This is a Phase 2, randomized two-armed, multi-site study of 138 patients with metastatic castrate sensitive prostate adenocarcinoma. Patients will be randomized 1:1 to receive the fasting mimicking diet, or usual diet. All patients will receive standard of care treatment for their prostate cancer. The fasting mimicking diet will be consumed for 5 days per month for a total of 6 months and will be monitored by trained research dietitians.

This study aims to examine the effects of a fasting mimicking diet (5 days per month eating L-Nutra products only for 6 months) vs. usual diet on response to cancer treatment of metastatic castrate sensitive prostate adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic castrate sensitive prostate adenocarcinoma (Adenocarcinoma prostate histologically confirmed by biopsy AND Metastatic disease confirmed biopsy, or MRI scan)
* Men receiving or planning to start first-line intensified ADT (within 30 days of registration) with abiraterone, apalutamide, enzalutamide, or darolutamide with or without current or prior chemotherapy
* Reads, writes, and understands English or Spanish and has telephone access for remote contact with the study dietitian.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Allergies to any ingredients listed on the Xentigen Ingredient List
* Men with diabetes who are not on stable doses of antihyperglycemic medication for at least 6 months and without physician consent that they may safely hold antihyperglycemic medication during the 5 days of FMD
* Regularly practicing a fasting diet that in the opinion of the study physician would impact study participation
* Significant co-morbidities (i.e., cardiac, pulmonary, liver disease, ongoing alcohol/drug abuse) that in the opinion of the study physician would preclude enrollment in this study.
* Body Mass Index (BMI) \<20kg/m2
* Men actively trying to lose weight OR on weight loss medications (including but not limited to Contrave, Saxenda, Xenical) or planning to receive weight loss surgery in the next six months
* Self-reported weight loss ≥ 10% in the last 6 months
A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of atopic dermatitis when applied twice daily for 6 weeks.

This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with atopic dermatitis and designed to assess the safety, tolerability, and preliminary efficacy of DRM02.

Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs.

Preliminary efficacy will be assessed through the Physician's Lesion Assessment (PLA) and the Eczema Area and Severity Index (EASI) from only the two lesions identified at the baseline visit.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 to 70 years of age.
* Clinical diagnosis of stable atopic dermatitis (AD) and with two lesions of similar size and have an identical score of at least 5 but no more than 9 on the sum of the individual components of the Eczema Area and Severity Index (EASI) at the Target Lesion scale.
* Male or non-pregnant, non-lactating females.
* Signed informed consent.

Exclusion Criteria:

* Subjects who have unstable atopic dermatitis (AD).
* Significant infection at the target lesion site.
* Prior or concomitant use of systemic therapies for AD within the past 4 weeks. - Prior or concomitant use of topical treatments for AD, to within 10 cm of the target lesion within the past 4 weeks.
* Prior or concomitant use of oral retinoids for AD within the last 6 months.
* Use of biologics for AD within the past 3 months, or 5 half-lives (whichever is longer).
* Subjects who have poor skin condition within 5 cm of the target lesion.
* Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease; or are a poor medical risk because of other systemic diseases or active uncontrolled infections.
* Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.
* Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days.
* Subjects who have a clinically significant laboratory value at screening.
Ethanol-Free Clobetasol Propionate Foam 0.05% (Olux-E Foam) vs Vehicle Foam in the Treatment of Chronic Hand Dermatitis.

The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.

Topical corticosteroids have anti-inflammatory, immunosuppressive and antiproliferative properties. Clobetasol propionate foam 0.05% (Olux-E), a Class 1 corticosteroid, is formulated in an ethanol free petrolatum base that provides the benefits of a super-potent corticosteroid combined with moisturizing ingredients in the treatment of corticosteroid responsive dermatoses. The current study is designed to show efficacy and safety in the treatment of moderate to severe chronic hand dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Capable of understanding and willing to provide signed informed consent
* Male or female at least 12 years of age at time of consent and at time of first dose.
* Able to complete the study and to comply with study instructions.
* Moderate to severe hand dermatitis.
* Chronic hand dermatitis diagnosis must be at least 6 months

Exclusion Criteria:

* Female who is pregnant, trying to become pregnant, or breast feeding.
* Currently diagnosed with allergic contact dermatitis.
* Participated in a previous study of the same study product.
* Had any major illness within 30 days before the screening/baseline visit.
* Considered immunocompromised.
* Has a clinically relevant history of or current evidence of abuse of alcohol or other drugs.
* Considered unable or unlikely to attend the necessary visits.
Yoga for Adolescent and Young Adult Non-Curative Cancer Patients

Adolescents and young adults who are living with cancer are not benefiting from the same age-appropriate physical and psychosocial care, as are children and older adults. As a result, their unique needs often go unmet or unaddressed. Studies have demonstrated that a lack of age-appropriate care may be responsible for a deceased quality of life. Studies have also shown that physical activity is able to reduce many of the negative side-effects linked to cancer and its treatment (e.g., nausea, vomiting, fatigue). A light form of physical activity that is both safe and manageable for cancer patients is yoga. The purpose of this study is to examine the achievability and safety of a light 7-week home/hospice-based Hatha yoga program (available on DVD) in the adolescent and young adult non-curative cancer population. This study will also examine the ability of yoga to reduce cancer related side effects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a non-curative cancer and assigned to non-curative or palliative care
* Between 15-39 years of age
* Have primary physician/oncologist consent to participate

Exclusion Criteria:

* Experience any medical conditions that contraindicate yoga (e.g., bone metastases)
* Exhibit cognitive limitations (e.g., psychiatric disorders)
* Score below 30% on Palliative Performance Status Scale
A Study of Atherosclerosis in Patients After Radiation Treatment for Breast Cancer

The purpose of this study is to compare plaque burden in the coronary and carotid arteries 5 years after adjuvant radiotherapy in women with right sided breast cancer vs left sided breast cancer.

This study reviews case series of patients with a history of breast cancer treated with radiotherapy for at least five years. The study measures atherosclerosis by using coronary and carotid artery calcium scoring.

Eligibility Criteria:
Inclusion Criteria:

* women dx with ductal carcinoma in situ or breast cancer, stage 0 to stage IIIc, who received conservative surgery and radiotherapy at least 5 years ago
* less than or equal to age 60

Exclusion Criteria:

* hx of coronary disease prior to tx of ductal carcinoma in situ or breast cancer
Use of CBT-I in Individuals With a Concussion

Sleep disturbances have been shown to contribute to poorer recovery from a concussion. Furthermore, sleep disturbances have been associated with more frequent and severe post-concussion symptoms including headache, vertigo, anxiety, depression, and decreased short term memory reducing quality of life and productivity at work or school. Additionally, recent research indicates that individuals with a concussion who have poor sleep quality have increased levels of Neurofilament light (NfL) and tau biomarkers indicating that there may still be axonal damage after weeks or months after the initial concussion injury. Post-concussion symptoms have been associated with higher levels of these biomarkers and there has been a report of higher levels of NfL and tau years following a concussion event. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia yet it remains unclear if this treatment method is effective in improving sleep outcomes, reducing concomitant post-concussion symptoms, and biomarkers of neural injury/risk in individuals post- concussion. The central hypothesis for this project is treating sleep disturbances will yield a clinically relevant reduction in concomitant post-concussion symptoms. The objective for the proposed study is to determine if CBT-I will reduce insomnia symptoms and improve concomitant post-concussion symptoms in individuals after concussion and if symptom improvements are maintained at 6-weeks and 12-weeks after CBT-I intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 64 years old
* At least 4 weeks since concussion injury
* Self-report difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights per week since injury
* Score ≥10 on the Insomnia Severity Index to indicate clinical insomnia.
* Score ≥25 on the Mini-Mental State Examination (MMSE) questionnaire

Exclusion Criteria:

* Known untreated sleep disorder (such as sleep apnea, restless leg syndrome, circadian rhythm disorder, hypersomnia, parasomnias)
* Increased risk obstructive sleep apnea (STOP BANG Score ≥3)
* Increased risk of restless leg syndrome on RLS-Diagnosis Index
* Increased risk of circadian rhythm sleep-wake disorder (respond "Yes" to all circadian rhythm questions).
* Increased risk of parasomnia (Respond "Yes" to all questions for night mere disorder OR respond "Yes" to all REM sleep arousal disorder: Sleep walking questions, OR responds " Yes" to all REM sleep arousal disorder: Sleep Terrors questions, OR respond "Yes" to all REM sleep behavior disorder questions.)
* Active abuse or history (up to 2 years) of alcohol/ drug dependence as defined by the DSM-V criteria
* Severe mental illness such as schizophrenia or bipolar disorder
* Score of \> 29 on the Beck Depression Inventory or indication of suicidality (response of "2" or "3"to item 9)
* History of diagnosed nervous system disorder other than concussion (such as multiple sclerosis, Parkinson's Disease, Stroke)
* Currently works nightshift
Digital Media Usage With Impulsivity and Attention Deficit in Children

To explore the relationship between children's digital media usage and attention, activity, parenting pressure; to explore the relationship between family basic data factors and screen usage.

Background: Digital products are inseparable from life. Parents may feel that teaching materials are educational because of their high availability.Meaning, busy work, helping to share care or short respite, etc., and providing digital products for children, it is very important to understand children's behavior, usage habits, and the relationship between parents.According to the American Academy of Pediatrics, parents should limit their exposure to most types of screen time until the child is 2 years old , and children 2-5 years old should be less than one hour per day, and it is recommended to watch high Quality program content, accompanied by adults. The standards for screen time in various countries generally follow this policy.However, many studies have found that most children spend far more screen time than recommended guidelines. Research in Canada and the United States indicates that children aged three to five spend more than two hours a day on average. According to a tracking study, children aged three to five were surveyed on their In terms of screen use, it was found that compared with children who watched less than half an hour, children who used more than two hours a day had more significant implicit and explicit behavioral problems, namely withdrawal, nervousness, anxiety, irritability and attention deficit, and restless behavior.

Objective: To explore the relationship between children's digital media usage and attention, activity, parenting pressure; to explore the relationship between family basic data factors and screen usage.

Methods: Individual caregivers were interviewed through paper or electronic questionnaires to assess children's and families' digital media usage habits, children's activity levels, and parental stress. The following assessment tools were used. Including digital media use survey at home (refer to Surveillance of digital-Media habits in earLy childhood Questionnaire, SMALLQ™), Chinese version of parental child activity scale (Werry-Weiss Peters Activity Scale Chinese version, WWPAS), parental stress scale brief Form (Parenting Stress Index: Short form, PSI/SF)

Eligibility Criteria:
Inclusion Criteria:

* Caregivers whose children are currently receiving early treatment and who can cooperate with the questionnaire;
* The child's family has the habit of using digital media devices;
* The child's main complaints include inattention and impulsivity;
* The child's age is 3 to 6 years old.

Exclusion Criteria:

* The child has other specific diagnosed diseases, such as autism group, sensory disorder, known genetic and genetic diseases, etc.