cyrilzakka/clinical-trials huggingface dataset:
Vytorin in the Treatment of Alopecia Areata

Subjects, non pregnant/lactating and over 18years old, with 40% alopecia areata will take vytorin (statin/ezetimibe) for 24 or 52 weeks and be monitored for hair regrowth.

The investigators hypothesize that Vytorin medication may have an effect on the inflammatory process of alopecia areata. Inactivating the inflammatory process may help in permitting hair regrowth in those subjects.

Primary objective:

To evaluate the efficacy of oral simvastatin + ezetimibe (Vytorin) in treating alopecia areata in subjects 18 years and older.

Secondary objective:

To investigate the presence of heat shock proteins in alopecia areata subjects, before and after treatment with oral simvastatin.

Subjects will be asked to take vytorin 10/40 for a period of 24 or 52 weeks and monitored for progression of hair regrowth. They will have Lipids, creatinine kinase (CK), liver function tests (LFTs), obtained on baseline visit prior to starting the medication and at visit 2, week 8. LFTs will be continuously monitored at visit 4, 7, week 24 and week 40.

In case of muscular pain or tenderness the medication will be stopped immediately. In most cases, muscle symptoms and CK increases resolved when simvastatin treatment was promptly discontinued.

All adverse events will be recorded

The investigators are going to exclude:

oChildren less than 18 years

* Pregnant women
* Lactating women
* Subjects with kidney, liver or muscle disease
* Allergy to the drug or its components. Subjects with history of uncontrolled hypothyroidism, The investigators Hypothesize that this medication may have an effect on the inflammatory process of alopecia areata. Inactivating the inflammatory cascade may help in permitting hair regrowth in those subjects.

Eligibility Criteria:
Inclusion Criteria:

* 40-80% hair loss.
* Clinical diagnosis of alopecia areata
* 18-years or older

Exclusion Criteria:

1. You are less than 18 years old
2. You are pregnant or planning to be pregnant during the next 12 months.
3. You are nursing a child.
4. You have kidney, liver or muscle disease.
5. You have an allergy to Lidocaine, the study drug or its components.
6. You are presently participating in another clinical trial
7. You are currently using, or have used within the past 3 months, the following:

   * Systemic corticosteroids. (prednisone, methylprednisolone, hydrocortisone etc.)
   * Immunosuppressant agents.(cyclosporine, efalizumab etc.)
   * Any medication that may have interaction with Vytorin (check with the study doctor for other medications you are taking).
8. You are currently using, or have used within the past 2 weeks, any topical medication for the treatment of alopecia areata
9. You have an ongoing hypothyroid problem that is not being treated. If this problem is being treated then you can participate.
Damage Control Laparotomy

Randomized study to compare outcomes of patients undergoing damage control laparotomies versus definitive closure for which there is surgeon equipoise to randomize.

Single center, prospective, randomized study involving seriously injure patients requiring an emergent laparotomy within 90 minutes of arrival to the emergency department. There are situations in which the patient is unable to be closed at the end of the emergent laparotomy (identified as damage control) and there are situations in which the injury has been treated and the incision can be closed (definitive). There are also situations where it is not clear if the patient should be kept open or closed and the result of the surgery varies based on the surgeon performing the case.

The eligible subjects for this study will be randomized toward the end of the emergent laparotomy procedure on a 1:1 basis and will be followed throughout the hospitalization for complications. Patients will also be contacted at 6 month to complete a quality of life questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Emergent laparotomy
* Patient has injuries for which surgeon has equipoise to perform a Definitive (DEF) or Damage Control Laparotomy (DCL)
* Age ≥16 years (age cut-off for admission to adult trauma service at Memorial Hermann Hospital-Texas Medical Center)

Exclusion Criteria:

* Indication for DCL for which there is no surgeon equipoise:

  * Need for gauze packing of liver or retroperitoneum for hemorrhage control
  * Immediate need to go to Interventional Radiology for hemorrhage control
  * Concern for Abdominal Compartment Syndrome - defined as physically unable to re-approximate fascia or \>10mmHg change in peak airway pressure during fascial closure
  * Hemodynamic instability - defined as persistent hypotension, ongoing transfusion requirement, or continuous vasopressor use
* Indication for DEF for which there is no surgeon equipoise:

  * Negative and non-therapeutic laparotomies
  * Isolated cystorrhaphy
* Prisoners
* Known pregnancy
* Patients with burns \> 20% of total body surface area
* Patient/legally authorized representative opted out of exception from informed consent (opt out bracelet)
* Currently enrolled in another interventional study
A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic

Prophylactic treatment in cancer patients undergoing antineoplastic therapy during the COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cancer diagnosis
* Ongoing systemic antineoplastic treatment irrespective of application route
* Age ≥ 18 years
* Life expectancy of at least 3 months
* Adequate renal, cardiac and liver function
* Corrected QT time (QTc) ≤ 450 ms
* Eastern Cooperative Oncology Group (ECOG) performance status of \< 3
* Capable of understanding the study and giving informed consent
* Negative COVID-19 test at study entry as measured by routine testing

Exclusion Criteria:

* Use of any investigational agent within 28 days prior to study start
* Patients with active opportunistic infections
* Pregnant or lactating women
* Women of childbearing potential and male subjects not willing to use adequate contraception methods during the study period
* Hypersensitivity to azithromycin or other macrolides
* Concurrent medication with ergotamine, theophylline, digitalis
* Inability to swallow tablets
Enhancing Mass Casualty Triage Through Virtual Reality Simulation

This interventional study aims to investigate whether Virtual Reality (VR) compared to traditional education and training, can enhance the correct triage abilities of nursing students in simulated mass casualty incidents (MCI). The primary research question seeks to answer if VR compared to Standard education supports students' ability to triage correctly in a simulated MCI situation. Additionally, this study aims to address the following secondary questions: Does VR compared to standard education have an effect on the time to triage in a simulated MCI situation? And, does VR compared to Standard education have an effect on theoretical knowledge retention concerning triage in MCI situations? In the interventional group, participants will utilize VR for MCI training and learning, while the control group will undergo standard education, including lectures and paper exercises. The researchers will compare the two groups of nursing students to assess whether VR yields better outcomes in MCI triage education.

A randomized controlled trial (RCT) involving nursing students from a university in Stockholm, Sweden. The students are randomly allocated in a 1:1 ratio to either VR (intervention) or standard training in triaging during a mass casualty Incident. Both groups of participants will receive the same lecture on disaster events and triage using the same method before undergoing triage training either with VR support or traditional paper-based training. To achieve a power of 0.80 and a p-value of 0.05, a total of 60 participants are required (control n=30, intervention n=30). However, all students (approximately 100) will be invited to participate in the study to avoid excluding those who wish to take part in the study. The primary outcome measure is the students' ability to triage correctly. Secondary outcome measures include knowledge and knowledge retention, as well as the time taken to triage correctly. Knowledge tests will be conducted approximately one week after training and again 3-6 months after completing the training. The knowledge test consists of a questionnaire with 20 multiple-choice questions used in previous studies.

Eligibility Criteria:
Inclusion Criteria:

Nursing students registered for a course in disaster medicine/emergency care that is conducted during their fifth semester (out of 6) in the nursing program.

Exclusion Criteria:

Does not meet inclusion criteria
Examination of Pain in Individuals With Non-Specific Lack Pain

The aim of this study is to examine the relationship between pain, and balance, proprioception sensation in the knee, erector spinae and multifidus muscle strength in individuals with non-specific low back pain.

Impaired postural control in people with non-specific low back pain; It can be affected by many factors such as pain, musculoskeletal disorders, proprioception. Postural control is important for the continuation of activities of daily living. Postural control is decreased in patients with non-specific low back pain. According to the proprioception examinations, patients with low back pain are more impaired than healthy individuals. Impaired proprioception can also reduce the ability to maintain posture, balance control and increase the load on the spine. Thus, individuals with low back pain may become more vulnerable to injuries. Weakness of the abdominal muscles and superficial trunk muscles are also risk factors for low back pain.

Weakness and fatigue may occur as a result of structural changes, which are more common in the paraspinal muscles and the multifidus muscle. This can lead to deterioration of lumbar stability. Because these muscles have an important place in providing stability.

Proprioceptive information from the hip, knee and ankle and coordination of the joints are important in maintaining and controlling balance. Regional receptors in muscles, joints, skin and tendons and proprioception in the knee joint provide the necessary joint activity and stabilization. With the decrease in balance and proprioception, pain may occur, and we may encounter a decrease in muscle strength as a result of leading a sedentary life. In this case, since the proper posture, muscle activity and balance required for coordinated movement are negatively affected, the movement is impaired. Because these activities must be performed in the correct order for the movement to occur.

In the literature, there are studies on the relationship of low back pain with muscle strength, balance and proprioception; however, the lack of sufficient studies investigating the relationship between balance and proprioception in the knee in individuals with non-specific low back pain suggests that the study to be conducted will make an important contribution to the literature and reveals the importance of our study.

Eligibility Criteria:
Inclusion Criteria:

* Having pain intensity of 3 or more according to VAS.
* Having a mini mental test score of 24 and above
* Being able to stand on one leg.
* Having low back pain for 3 months or more

Exclusion Criteria:

* Osteoporosis
* Being in the 0%-20% range on the Oswestry scale
* Pregnancy
* Being on constant painkillers for one reason or another
* Having undergone lumbar, hip, knee and ankle surgery.
* Having severe hearing, vision, speech impairment
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Histological Diagnosis of Cancer
* Hgb \</= 10
* Ongoing or Planned Chemotherapy
* Body Weight \>50kg
* Free of Active Infection
* Karnofsky Status 60% to 100%

Exclusion Criteria:

* Active infection
* Use of Multivitamins with iron within one week of entry
* Myelophthisic bone marrow involvement by tumor except hematologic malignancy
* Concurrent medical condition that would prevent compliance or jeopardize the health of the patient
* Use of any IV iron products within two months of study entry
* Blood Transfusions
* Hypoplastic bone marrow failure state
* Acute Leukemia
* Myeloproliferative syndrome
* Uncontrolled hypertension
Research on Association Between Selenium Deficiencies and Change of Thyroid Function

As one of the essential micronutrients, selenium has important biological functions. However, an effective and convenient method for evaluation of selenium nutritional status has not yet been established. Previous literature has disclosed effect of selenium deficiency on inactivating glutathion peroxidase and deiodinase, which may cause decreased conversion from thyroxine ( T4) to triiodothyronine (T3). A case-control study is designed to demonstrate the association between selenium deficiency and abnormally elevated T4 or T4/T3, which may provide more clues for establishing effective selenium assesment methods.


Eligibility Criteria:
Inclusion Criteria:

* with normal free triiodothyronine( FT3), free thyroxine (FT4) and thyroid-stimulating hormone (TSH).
* without thyroid hormone replacement therapy
* without medical history of thyroid surgery
* without iodine radiotherapy;

Exclusion Criteria:

* acute critical illness in the latest 1 year;
* weight fluctuation by more than 5% in the latest 3 months;
* eating disorders
* neuropsychological disorders
* allergy to corn or yeast
* fail to give informed consents.
Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome

Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing total knee arthroplasty

Exclusion Criteria:

* diabetes
* neurological disorders
* coagulation disorders
* rheumatoid arthritis
* chronic opioids therapy
* allergy to local anesthetic
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG-Preschool Age

Individuals with Fragile X Syndrome show differences in how they understand and learn language from infancy. They frequently have lifelong delays in speech and language as well. In addition, they experience other auditory symptoms, including being very sensitive to certain sounds as well as being more sensitive than others to loud sounds. The underlying brain activity for sound perception and speech learning in Fragile X is not well understood, especially in the infant, toddler, and preschool years. This study uses behavioral assessment of speech and language abilities, neuroimaging, and hearing tests to understand how speech and hearing are different in children with Fragile X Syndrome.

Fragile X Syndrome (FXS) is the leading monogenic cause of intellectual disability and autism and is associated with extremely high risk for early delays in speech and language. While early childhood is essential for speech and language development, neural mechanisms for language impairments have been studied entirely in older children and adults with FXS. Therefore, markers for speech and language impairments are unavailable in young children with FXS to predict severity, test potential mechanisms, and track response to intervention. The investigators have identified a hallmark brain-based phenotype of hyperresponsiveness to sounds in adolescents and adults with FXS. This fundamental alteration in cortical responses to sound could influence early language delays, but this phenotype has not been explored in infants or toddlers with FXS.

Specifically, in this study the investigators will use simultaneous EEG/fNIRS during presentation of simple speech, stories, and nonspeech sounds to quantify and localize auditory hypersensitivity and neural differentiation in 30 preschoolers with FXS. The investigators will assess specificity through comparison with 30 typically developing controls and 30 mental-age matched children with a history of premature birth and language delays.

Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of Fragile X Syndrome, Typical Development, or History of Premature Birth
* able to sit independently
* English is spoken at home

Exclusion Criteria:

* For all participants: no seizures in the past 6 months
* For typical development group and Fragile X group: not born prior to 32 weeks gestation
Effects of Soft Ball Tissue Release Exercises on Low Back Pain Secondary to Tight Hip Muscles.

It is also suggested that low back pain patients tend to have trigger point or tight muscles, i.e. Gluteus Maximus, Gluteus Medius, iliopsoas and Quardatus Lumborum, on at least one side.After approval from the university ethical committee, 23 (male, female) were enrolled in this study. All patients who presented nonspecific low back pain were included on the basis of inclusion and exclusion criteria. Demographic data of the patients were collected. Oswestry low back disability index was used to evaluate the disability level of low back. Piriformis muscle tightness was diagnosed among low back pain patients using FAIR (Flexion, abduction, internal rotation) and Freiberg's test. The FAIR test was performed on the patient in, side lying position, with the hip flexed at 60º and the knee flexed at 90º. With the hip being stabilized, a single examiner will internally rotate and adduct the hip by applying downward pressure onto the knee. Freiberg's test was performed on the patient in the supine position with the thigh extended. The leg and thigh are passively internally rotated by the examiner. If pain is registered, the test is positive. The effects of soft ball tissue release exercises on low back pain secondary to tight hip muscles


Eligibility Criteria:
Inclusion Criteria:

* Age: 35-50 years Gender: Male and Female Low back pain for at least 12 weeks. Tight hip muscles (Priformis (FAIR test), TFL (Ober's test), Iliopsoas (Thomas test).

Exclusion Criteria:

* Any anatomical or neurophysiological causes of disease (X-ray and examination by a medical doctor) of spine.

Abnormal past histories of the spine, i.e. spondylitis, fracture, etc. Neurologic diseases. Functional restrictions on the upper and lower limbs. Disc prolapse Lumber Spinal stenosis L4-5 Spondylolysthesis Any abnormality at Sacroilliac joint (Faber,Pattricks,thigh thurst, ASIS distraction, Sacral compression test)
Behavioral Weight Loss Program for Cancer Survivors in Maryland

Behavioral Weight Loss for Overweight and Obese Cancer Survivors in Maryland: A Demonstration Project

The objective of the ASPIRE Project is to design, implement, and evaluate a real-world, lifestyle-based, support for overweight or obese cancer survivors in both urban and rural areas of Maryland. The project will provide three options of support to encourage lifestyle change to achieve and maintain a healthy weight for cancer survivors:

1. Self-Directed Weight Loss: educational materials only;
2. App-Directed Weight Loss: educational materials, weight loss app with weekly e-mail support; and
3. Coach-Directed Weight Loss: educational materials, weight loss app, weekly e-mail support and one-to-one weekly telephonic coach support.

Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed with a malignant solid tumor,
* completed all required surgical, and/or chemotherapy and/or radiation curative intent therapy at least three months prior to enrollment,
* anticipated treatment-free life span of 12 months or longer.
* chemoprophylaxis with tamoxifen or aromatase inhibitors for breast cancer in women will be permitted
* anti- Luteinizing-hormone releasing therapy for prostate cancer in men will be permitted.
* BMI ≥ 25 kg/m2 (BMI ≥ 23 kg/m2 for Asians) and weight ≤ 400 lbs.
* have an email address for regular personal use

Additional criteria for participants in weight tracking (self-directed or app directed)

* willingness to record/transmit quarterly weights for 12 months

Additional criteria for App-Directed Program:

* willingness to change diet and increase physical activity and track weight, diet and physical activity
* have a smart phone for personal use
* sufficient data plan/Internet to support daily use of weight loss app\*

Additional Criteria for Coach-Directed Weight Loss Program

* willingness to lose weight by changing diet and physical activity habits
* willingness to track weight, diet and physical activity
* willingness to record/transmit quarterly weights for 12 months
* smart phone for personal use
* data plan/Internet to support daily use of weight loss app\*
* willingness to complete coaching calls (12 weekly calls and 3 monthly calls)
* sufficient call plan to support coaching calls

  * a corresponding website could be used, then daily Internet access is required for person use.

Exclusion Criteria:

* received any chemotherapy (unless anti-hormonal therapy) and/or radiation three months or less prior to the proposed program date
* women who are breastfeeding, pregnant, or planning pregnancy within the next year

Additional exclusion criteria for participants in weight tracking and/or Coach-Directed Program

* self-identification of uncontrolled concurrent medical condition likely to limit compliance with the program as determined by investigators.
* current involvement in another organized weight loss program
* current use of steroids or other medication known to affect body weight
* bariatric surgery scheduled within the next 6 months, or
* plan to move outside the continental US in the next 12 months
The Effect of Blood and Blood Products Transfusion Training Based on the Flipped Classroom Model on Nursing Students

Blood is a living tissue with many vital functions that provide perfusion of organs. Therefore, blood transfusion is a tissue transplant and a complicated treatment method that is applied very frequently. Many reactions may develop during transfusion due to application errors. In this direction, it is necessary to increase the knowledge and skills of nursing students regarding safe blood transfusion during their undergraduate education. On the other hand, self-efficacy is a more comprehensive concept that includes the concepts of knowledge and skills, and self-efficacy perception is considered important in terms of indicating a level of professional development. It is important to use effective teaching methods to increase the knowledge and skills of students and to support their self-efficacy. The flipped classroom model is a teaching method that has the potential to change teaching and learning for nursing education. In the light of this information, this study was planned to determine the effect of education based on the flipped classroom model on the self-efficacy of senior nursing students regarding blood and blood product transfusion.

The study is a non-drug clinical randomized controlled trial and was conducted between February and June 2024. The universe of the study consisted of senior nursing students of the faculty where the study was conducted. In terms of reliability of the study, control group data will be collected first. Criteria for inclusion in the study; Being a senior nursing student and being a volunteer.

Eligibility Criteria:
Inclusion Criteria:

* Being a senior nursing student
* Nursing students who volunteered to participate in the study

Exclusion Criteria:

* There are no exclusion criteria