cyrilzakka/clinical-trials huggingface dataset:
Neurostructural Integration Technique for Fibromyalgia

Fibromyalgia is a common cause of widespread musculoskeletal pain. The investigators have found that our patients seem to benefit from a soft tissue physical therapy called neurostructural integration therapy (NST). The purpose of this study was to compare NST to hydrotherapy which is already used to manage fibromyalgia symptoms.

Twenty female patients who met the American College of Rheumatology diagnostic criteria for the classification of FM were enrolled in the study. Patients were randomly allocated to receive either hydrotherapy or NST. Patient evaluations were performed at baseline, six weeks, three months, and six months. Primary outcome measures included the SF-36 quality of life questionnaire, the Fibromyalgia Impact Questionnaire and the Total Myalgic Score. Duration of morning stiffness and duration of weekly aerobic exercise as reported by the participants were secondary outcome measures. Statistics analysis was performed by standard parametric and non parametric methods.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who fulfills ACR diagnostic criteria for fibromyalgia

Exclusion Criteria:

* Patients with established ischemic heart disease, uncontrolled hypertension or diabetes, hypothyroidism, severe depression
Arm Ergometer Versus Stabilization Exercises on Trunk Control and Upper Extremity Functions in cp

The purposes of the current study are to:

Define and compare between the efficacy of arm ergometer versus stabilization exercises on trunk control, hand grip power and upper limb quality of functions in children with diplegia.

Studies have shown that the cycle ergometer exercise improves several parameters, such as muscle strength and endurance, along with torso control in sitting position. However, these results are presented only in a small sample. Studies with the use of cycle ergometer in the population with CP are still few and present little information about the physiological effects .Previous studies on children with CP focused on the effect of ergometer on the upper and lower extremities functions. Limited literature is available regarding the effect of arm ergometer on trunk control among this population. The current study will be carried out to define the effect of arm ergometer versus stabilization exercises on trunk control, hand grip power, upper limb function in children with diplegia.

Eligibility Criteria:
Inclusion Criteria:

1. Age ranges from six to ten years.
2. Grade of spasticity 1 to 2 according to Modified Ashworth scale.
3. Level II and III according to gross motor functional classification system.
4. Level I-III according to manual ability classification system.
5. Able to follow verbal commands and instructions included in both test and training.

Exclusion Criteria:

1. Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
2. Structural or fixed soft tissue deformities of the upper extremities.
3. Neurological or orthopedic surgery in the past 12 months in the upper extremities.
4. Botox injection in the upper extremities in the past 6 months.
Pharmacokinetic Comparisons of Two Donepezil Formulations

To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed donepezil formulation with a conventional formulation in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

This single dose, open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover study was conducted to compare the relative bioavailability and pharmacokinetic characteristics of a newly developed formulation with a conventional formulation in healthy subjects.

For this, a single-center, randomized, single-dose, open-label, 2-way crossover study with a 21-day washout period was conducted in 22 healthy volunteers. Plasma samples for the analysis of donepezil were collected up to 240 h after drug administration. Participants received either reference or test drug formulation of 10 mg donepezil in the first period and the alternative formulation in the second period. Plasma concentrations of donepezil were determined by validated high-performance liquid chromatography coupled to tandem mass spectrometry detection. Pharmacokinetic parameters, including Cmax and AUC, were determined by noncompartmental analysis. Analysis of variance (ANOVA) was carried out using log-transformed Cmax and AUC, and the mean ratios and their 90% confidence intervals (CI) were calculated. According to regulatory requirements set forth by Korea and the US Food and Drug Administration, products meet the criteria for bioequivalence if the 90% CIs of the mean ratios for Cmax and AUC are within the range of 0.80 to 1.25.

Eligibility Criteria:
Inclusion Criteria:

* Males age 20 to 45 years
* Body weight \> 45 kg with +/- 20% of ideal body weight
* Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

Exclusion Criteria:

* subjects with acute conditions.
* presence of history affecting ADME
* Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality
* Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings
* Any other acute or chronic disease
* A history of hypersensitivity to donepezil
* A history of alcohol or drug abuse
* Participation in another clinical trial within 3 months
* smoked \>10 cigarettes daily
* consumption over 5 glasses daily of beverages containing xanthine derivatives
* use of any medication having the potential to affect the study results within 10 days before the start of the study.
Comparative Study of Polymetric Clips (Hem-o-Lok) Versus Historical Endoscopic Staplers for Laparoscopic Appendectomy

The purpose of this study is to compare the clinical outcomes and the operative costs of appendectomy performed with the Hem-O-Lok polymetric clips compared to endoscopic staplers. Prospective data will be collected before, during, and after surgery on patients undergoing a laparoscopic appendectomy that have the Hem-o-Lok ® stapler used to close the stump after the appendix is removed. Use of the Hem-o-Lok ® stapler is standard for appendectomy patients at Duke Regional Hospital. Retrospective data will be collected from patients who had an appendectomy prior to 1/2012 using a different clip as part of their surgery, or an open appendectomy to compare outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. scheduled to undergo a laparoscopic appendectomy because of a diagnosis of appendicitis based on clinical history or radiographic imaging.

Exclusion Criteria:

1. Less than 18 years of age
2. Signs of appendiceal rupture or abcess on preoperative imaging studies (CT or ultrasound)
3. Inability to provide informed consent
Dry Needle In Management of Cervicogenic Headache

Headache is an important health problem. It is the commonest type of all signs of illness in the people worldwide. Cervicogenic Headache is commonest musculoskeletal condition in physiotherapy practice. This study's main objective was to evaluate effectiveness of Dry Needle with exercise in decreasing pain and improving function in patients with Cervicogenic Headache.

50 patients were included and assigned randomly to group A and B. Group-A received Dry Needle plus exercise and group-B received Dry Needle alone. Baseline assessment was taken before and after treatment; treatment was given for four weeks twice a week. Outcome indicators were measured by Visual analog scale, Neck Disability Index and Cervical Range Of Motion.

The study findings indicate that both groups improve the symptoms of a headache. Clinically better improvement was indicated by Dry Needle plus exercise group than Dry Needle alone group. As per our results, Dry Needle plus exercise should be preferred for the management of cervicogenic headache over Dry Needle alone.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-50 years.
* Male and female both gender
* Worker in the Office.
* Employed permanently.
* Self-motivated for working continuously for rehab.
* Persistent or regular pain in the neck over a span of at least 6 months.

Exclusion Criteria:

* Cervical spine injury or surgery.
* Congenital spinal deformity.
* Participants having age less than 20 or elder than 50 years.
* Cervical radiculopathy,
* The participants had experienced any recent trauma or suffering from dizzy spells, any vascular neurological disorders.
MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity

This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity".


Eligibility Criteria:
Inclusion Criteria:

1. Male or female over 20 years.
2. Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial.
3. Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor.

Exclusion Criteria:

1. Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).
2. Subjects with fixed joint, muscle contracture, or atrophy in the treatment area.
3. Subjects with botulinum toxin treatment within 3 months before administration of the investigational product.
4. Known immunization or hypersensitivity to any botulinum toxin preparations.
5. Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics
Working Memory Training for Children With Cerebral Palsy

Cerebral palsy (CP) is the most common motor disability in childhood (2-3 per 1000 live born), and is frequently accompanied by cognitive impairments and behavioural problems. The present study is a controlled clinical trial, a multicenter-study involving three health regions, as well as the Norwegian University of Science and Technology (NTNU). Its primary research goal will be to evaluate the effects of computer-based cognitive training in children with CP. In addition, this study will be the first to conduct a comprehensive neuropsychological examination to improve our understanding of cognitive impairments as well as cognitive resources in CP children in Norway to aid in intervention planning.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral Palsy
* School age (7-15 years of age)

Exclusion Criteria:

* Not able to use computer, blind, deaf
Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis

A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index: 18-35 kg/m\^2
* Diagnosed with RA (disease duration of at least 6 months)
* Stable dose of methotrexate (5-25 mg weekly for ≥ 4 weeks)
* Immunizations up to date
* Willing to use highly effective contraception during treatment and through end-of-study

Exclusion Criteria:

* Uncontrolled, clinically significant systemic disease other than RA (i.e., diabetes mellitus, liver disease, asthma, cardiovascular disease, hypertension)
* Malignancy within 5 years
* Presence of serious infection, recurrent/chronic infections
* Class IV RA according to American College of Rheumatology/ (ACR) revised response criteria
* Diagnosed with Felty's syndrome
* Known or suspected sensitivity to mammalian cell-derived products
* History of alcohol and/or substance abuse within the last 12 months
* Receipt of rituximab at any time in the past
* Evidence of renal disease
Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.

The study is a multi-center, parallel, randomized, double-blinded study with subsequent follow-up period of two years. Eight-four subjects across twelve sites will be randomized 1:1 to receive either a corneal tissue that have been cross-linked or not cross-linked (No UVA light source). Cross-linking is a term that refers to the linking of polymers (long chain) molecules by chemical bonds. It is believed that cross-linking the cornea will make the cornea stronger and more resistant to degradation.

CorneaGen (formerly Keralink International) (Baltimore site) will supply the donor tissue and Avedro Inc (Waltham MA) will supply the riboflavin and the UV light source. Staff at CorneaGenwill administer the riboflavin with dextran solution and perform the cross-linking procedure according to one of randomization groups before shipping the masked donor cornea to study sites for Boston Keratoprosthesis (B-KPro) implantation.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Willing and able to comply with study assessments for the full duration of the study
* Age ≥ 18 years
* Candidate for a Boston Keratoprosthesis / Cornea transplant
* In generally good stable overall health
* Patients with an eye at risk for a cornea sterile ulcer which includes:

  * Autoimmune diseases (mucus membrane pemphigoid, Stevens-Johnson syndrome, systemic lupus erythematosis, rheumatoid arthritis, or other autoimmune diseases); OR
  * History of previous sterile cornea ulceration requiring a cornea transplant

Exclusion Criteria:

* Age \< 18 years
* Inability to provide written informed consent and comply with study assessments for the full duration of the study
* No or minimal tear production with evidence of keratinization of the bulbar conjunctiva
* Corneal or ocular surface infection within 30 days prior to study entry
* Ocular or periocular malignancy
* Inability to wear a contact lens due to lid abnormalities or shortened fornix
* Signs of current infection, including fever and current treatment with antibiotics
* Pregnancy (positive pregnancy test) or lactating
* Participation in another simultaneous interventional medical investigation or trial
Hypertension Management in Terms of Routine Agents

known hypertensive patients admitted to emergency department with increased blood pressure will be evaluated in terms of antihypertensive agents given at hospital, degree of blood pressure decrease, hospital stay and laboratory and imaging tests ordered. The impact of routine oral antihypertensive agents used by the patients on these parameter will be assessed.

Hypertensive patients account for approximately 1-25% of annual emergency department visits . While this figure varies by region, hypertensive patients are among the groups that contribute significantly to emergency department crowding and workload . Hypertensive emergencies constitute about 0.3-0.9% of all patients, and this number is rapidly increasing each year .

The 2017 AHA hypertension guidelines emphasize that severe elevations in blood pressure (hypertensive crisis and hypertensive urgency) do not require emergency department visits or referrals unless there is end-organ damage . It is noted that treatment in these patients typically involves dose adjustment or a change in medication .

The 2023 ESC hypertension guidelines recommend that in patients presenting to the emergency department with a hypertensive crisis, blood pressure should be gradually lowered with oral agents over a 24-48 hour period. These patients do not usually require hospital admission but can be monitored in an outpatient setting for clinical evaluation. It is noted that their blood pressure may remain elevated upon discharge from the emergency department, and follow-up in a clinic is necessary for reevaluation of chronic therapy .

Some studies have indicated that both oral and intravenous treatments are preferred for patients presenting with hypertensive crises, highlighting that the approach can vary from physician to physician .

When evaluating literature reviews, published guidelines, and conducted studies, it is observed that there are differences between European and American approaches in defining and treating hypertensive crisis, as well as variability in physician management of these patients .

In our study, we plan to evaluate the effect of emergency department treatment on lowering blood pressure in known hypertensive patients (≥140/80) without end-organ damage. Additionally, we aim to assess the impact of the antihypertensive agents that patients routinely use on their length of stay in the emergency department, as well as the frequency and effectiveness of the medications used, and the target blood pressure values achieved post-treatment according to guidelines.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 and older.
2. Blood pressure measured at ≥140/80.
3. Diagnosis of essential hypertension.

Exclusion Criteria:

1. Pregnant patients.
2. Individuals without a prior diagnosis of hypertension.
3. Patients with end-organ damage (hypertensive emergency).
4. Patients whose routine antihypertensive agents are unavailable.
5. Patients who leave the clinic without permission, making follow-up data inaccessible.
A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris

To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) to AKLIEF® Cream and both active treatments to a placebo control in the treatment of acne vulgaris

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent;
* Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3,or 4 as per the Investigator's Global Assessment (IGA)
* Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis,squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).
ChatGPT-4 for Surgical Site Infection Detection From Electronic Health Records After Colorectal Surgery.

Epidemiological surveillance is one of the eight core components of the World Health Organization Infection Prevention and Control Programmes. These include surveillance programmes for surgical site infection (SSI).

At present, for SSI surveillance, infection control teams perform a manual time-consuming work, which could make a transition to automated surveillance leveraging the new information technology.

This study aimed to evaluate the ability of ChatGPT-4o to detect surgical site infection at the three anatomical levels.

Healthcare-associated infections (HAIs) have a negative impact on patient health, represent a significant healthcare and economic burden on healthcare systems and are considered the most preventable cause of serious adverse events in hospitalised patients.

Epidemiological surveillance is one of the eight core components of the World Health Organization (WHO) Infection Prevention and Control Programmes. These include surveillance programmes for surgical site infection (SSI), which have proven to be effective in all types of surgery and in a variety of settings.

For a programme to be effective, surveillance for HCAIs must be active, prospective and continuous, comprising a surveillance period up to 30-90 days post-intervention, to cover the high rate of SSIs detected after discharge.

At present, infection control teams perform a manual, prospective, time-consuming and almost artisanal work, which should make a transition to automated or semi-automated surveillance that leverages the possibilities offered by today\&#39;s information technology.

The evolution of surveillance systems should benefit from this new possibilities offered by artificial intelligence, allowing automated detection of suspected SSI adverse events from clinical course text, microbiology reports or coding of diagnoses, procedures, complications and readmissions.

This study aims to evaluate the ability of ChatGPT to detect surgical site infections (SSI) at the three anatomical levels described by the CDC.

The study will retrospectively compare the results of the AI chatbot in diagnosing SSI, trained using the US CDC definition criteria, with a large cohort of elective colorectal surgery patients already evaluated through a nationwide nosocomial infection surveillance system, which will be the comparative gold standard.

Eligibility Criteria:
Inclusion Criteria:

* Elective colorectal resection

Exclusion Criteria:

* Emergency surgery
* Infection present at operation
* Previous intestinal stoma
Driving Ability Evaluation System to Improve the Conditional Driving License System: Safety and Feasibility Study.

The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities in healthy adults.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function and cognitive function of healthy drivers. to identify the correlation between their outcomes and the VR driving simulator's result

VR driving simulator is to evaluate the driving abilities of high-risk drivers, including the elderly and those with medical conditions, potentially prone to incapacitate driving.

It aims to evaluate whether drivers who were anticipated to have impaired driving ability can handle highly risky situations for traffic accidents. The results of this study can be used to make the drivers know their status and encourage them to take safety training. Until now, the evaluation of driving abilities could only be conducted at licensing centers. However, the use of VR technology can eliminate spatial limitations, offering a promising tool for the objective assessment of driving skills.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 19 who are currently driving.
* Individuals capable of understanding and following the researcher's instructions.
* Individuals who can understand the purpose of the research and have consented to participate

Exclusion Criteria:

* Those who have not signed the consent form.
* Individuals with a history of severe dizziness or epilepsy.
* Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes.
* Patients with severe shoulder pain.
* Patients whose range of motion in major joints is restricted by more than 50%.
* Pregnant women.
* Patients with pressure sores.
* Patients with limitations on simulator use due to heterotopic ossification.
* Patients with acute fractures.
* Other patients for whom participation in the study is expected difficult.