cyrilzakka/clinical-trials huggingface dataset:
Deep Brain Stimulation for Alzheimer's Disease

Background: Deep brain stimulation (DBS) is used to modulate the activity of dysfunctional brain circuits. The safety and preliminary efficacy of nucleus basalis of Meynert (NBM)-DBS in Alzheimer's disease (AD) is proved in a recent phase 1 clinical trial, yet, the mechanism still unknown.

Objective: 1. To compare the brain structure and functional circuits between a) AD patients with optimal drug treatment (ODT) plus NBM-DBS, b) AD with ODT and c) normal age-and sex-matched control. 2. To evaluate the clinical effectiveness of NBM-DBS in AD patients 60-75 year-old. 3. To evaluate the abnormal functional circuitry response to acute and chronic NBM-DBS in AD.

Methods: A total of 30 subjects (10 subjects of AD with ODT plus NBM-DBS; 10 subjects of AD with ODT and 10 subjects of normal age-and sex-matched subjects) will be enrolled in this prospective, with normal control, Phase II study. Study tools will include clinical rating batteries, structure and functional imaging of magnetic resonance (MR) and positron emission tomography (PET), and electroencephalogram (EEG).

Expected Results: NBM-DBS will be proved to be an safe and effective treatment modality in AD patients 60-75 year-old. Through multi-modal images and EEG analysis, the possible action mechanisms of NBM-DBS on memory circuit will be discussed. The study results may shed a light on this helpless neurodegenerative disease of dementia.


Eligibility Criteria:
Inclusion Criteria:

For groups (AD with/ without DBS)

1. Confirmed Alzheimer's dementia diagnosis
2. Regular medications taking for at least 3 months
3. Clinical Dementia Rating: 0.5 - 2
4. Mini Mental Status Examination: ≦ 26
5. Amyloid PET: positive
6. Informed consent signed by patients or families

For normal control group

1. No cognitive impairment (Mini Mental Status Examination)
2. Amyloid PET: negative
3. Informed consent signed by patients and families

Exclusion Criteria:

For groups (AD with/ without DBS)

1. Structural lesions identified by Magnetic resonance imaging (ex: stroke, brain surgery)
2. Other neurodegenerative/ neuropsychiatric diseases
3. Systemic medical diseases with cognitive impairment (ex: anemia, thyroid disease)
4. Can't have regular follow-up visit

For normal control group

1. Structural lesions identified by Magnetic resonance imaging (ex: stroke, brain surgery)
2. Dementia/ neurodegenerative/ neuropsychiatric diseases
3. Systemic medical diseases with cognitive impairment (ex: anemia, thyroid disease)
4. Can't have regular follow-up visit
Decision Support for Parents Receiving Information About Child's Rare Disease

The birth of a child with a disorder of sex development (DSD) is stressful for parents and members of the healthcare team. The "right" decisions about gender assignment (is it a boy? a girl?) and the best course of action (e.g., should there be surgery? what kind? when?) are not obvious. While there have been large advances in diagnostic assessments like genetic and endocrine testing, the tests do not always show what caused the DSD. And, even when the tests do reveal an explanation for the DSD, knowing what happened genetically or hormonally does not usually lead to a single "correct" treatment plan. Instead, it is likely that there are different acceptable treatment options - and parents will need to make decisions based, in part, on their personal preferences, values, and cultural background. Adding more stress to the situation is knowledge that many of the decisions that need to be made by parents early in a child's life are irreversible and exert life-long consequences for the child and the family.

To support parents becoming actively involved in making such decisions, and to reduce the likelihood of future worry and regret about decisions that have been made, the investigators will create a decision support tool (DST). The DST will help educate families about typical and atypical sex development of the body, the process by which DSD are diagnosed (especially how to interpret genetic test results), and possible relationships between diagnostic/genetic testing, decisions about care, and known consequences of those decisions on their child and entire family. The DST will be used by parents of young children together with their child's health care provider.

The investigators will bring together a network of researchers, health care providers, representatives of patient support and advocacy organizations, and parents of children with DSD to share their experiences. Participants of this network will be involved at each stage of creating the DST, revising it, and putting it into practice. At the end of this project, the investigators will have a fully formed DST that will be available for parents to use with their child's healthcare team as they are first learning their child may have a DSD.


Eligibility Criteria:
Inclusion Criteria:

* Must be a parent/caregiver of a patient who is newborn through 5 years old (i.e., 5.9 yrs).
* Patient clinical diagnosis of ambiguous genitalia (eg, 46,XX,Prader 2+; proximal hypospadias with uni/bilateral undescended testes) or sex chromosomes discordant with genital phenotype.
* Condition must be newly ascertained where decisions regarding surgical procedures (internal or external genitalia), diagnostic testing, and/or other aspects of clinical management have yet to be made.

Exclusion Criteria:

* Turner syndrome, Klinefelter syndrome, bladder or cloacal exstrophy.
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)

This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of HIV-1 infection

This study is ongoing for collection of safety follow-up of infants born to mothers participating in the study. The present results are based on the Week 68 interim analysis.

Eligibility Criteria:
Inclusion Criteria:

* Is in general good health with acceptable laboratory values at screening
* Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
* Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable)
* Use contraceptives consistent with local regulations
* Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP)
* A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.

Exclusion Criteria:

* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has an active diagnosis of hepatitis due to any cause
* Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to Day

  1 through the duration of the study.
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to Day1 through the duration of the study.
* Has previously been randomized in a study and received islatravir (MK-8591).
* Female is expecting to conceive or donate eggs at any time during the study
* Has QTc interval (using Fridericia correction) \>450 msec (for males) or \>460 msec (for females) or deemed clinically abnormal by the investigator.
Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine

Acute headache is one of the most common reasons for presentation to the emergency department (ED), accounting for 2-3% of all emergency visits. Migraine is a disorder of the central nervous system characterized by a moderate or severe headache, which is generally associated with nausea and/or sensitivity to light and sound, interfering with daily activities.

Study objective: The objective of this study is to determine the analgesic efficacy and safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to the emergency department (ED).

Methods of Measurements:

This single-center, randomized, double-blind study will be conducted in a tertiary care ED. Eligible patients who met the migraine criteria of the International Headache Society will be randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen trometamol, or 50 mg dexketoprofen trometamol + 10 mg metoclopramide.

Subjects reported pain intensity on both a 100-mm visual analogue scale (VAS) (limited by 'no pain' and 'the worst pain') will be used for pain measurement at baseline, after 15 and 30 min. The primary outcome measure is the changes in the VAS scores at the 15th and 30th minutes of treatment. The secondary outcome measures are the presence of adverse effects and the requirement of rescue medicine.

Primary Data Analysis:

The study was planned as a superiority trial. The difference in the VAS values between the groups was assumed to detect 21.4 mm and the standard deviation (SD) value as 2.8 mm, and thus the minimum required the number of patients for each group was calculated as 27 at the alpha-critical value of 0.05 and power of 80%. All the analyses were implemented according to the intention to treat analysis. Differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).

Eligibility Criteria:
Inclusion Criteria:

-Patients aged 18 and over with acute headache who met the diagnostic criteria of the International Headache Association (9) for the diagnosis of migraine

Exclusion Criteria:

* Patients who refused to participate in the study
* Patients that took any analgesic medication within six hours before presentation to ED Patients with any additional organic pathology (e.g., hypertension, hypoglycemia, chronic kidney failure, and intracranial masses) pregnant women hemodynamically unstable patients patients with an allergy to the drugs used in the study
Comparison of Self-assessment vs. Assessment by Others of Critically Ill Patients

We will test the results of standardized questionnaires for patients admitted to intensive care assessed by relatives/caregivers compared to the patient itself. Furthermore we will compare results with patients not admitted to intensive care.


Eligibility Criteria:
Inclusion Criteria:

* patient with a postoperative risk to be admitted to intensive care
* signed informed consent

Exclusion Criteria:

* patient who is not able to fill out the questionnaires alone and independent
* patient without relatives or a caregiver who could answer the assessment after surgery
Effectiveness of Intraoperative Exparel for Postoperative Pain Control in Total Knee Arthroplasty

Does the use of periarticular Exparel in total knee arthroplasty prove to more effectively manage post operative pain control than another local analgesic, Ropivacaine, when both are used as part of a multimodal pain management approach?

The investigators hypothesize that Exparel, a bupivacaine liposomal injectable suspension, will improve total knee arthroplasty postoperative pain with significant improvement of early function outcomes.

The investigators use a double blind, controlled, randomized study to examine the effectiveness of periarticular Exparel in total knee arthroplasty postoperative pain control as well as effect on early mobilization and length of hospital stay when compared to another local analgesic (Ropivacaine) when both are used as part of a multimodal pain management approach.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing Total Knee Arthroplasty with Dr. J.H. DeClaire
* 18 years of age or older
* Primary diagnosis of osteoarthritis of the knee
* Opioid naïve patient (according to FDA guidelines)

Exclusion Criteria:

* Prior knee replacement
* Prior use of narcotics for chronic pain management
* Inflammatory arthritis (Rheumatoid arthritis, Lupus, etc.)
* Unicompartmental knee replacement
* Bilateral Total Knee Arthroplasty
* Opioid Tolerant as defined by the FDA: Patients who are taking, for one week or longer, at least:

\> 60 mg oral morphine/day \> 25μg transdermal fentanyl/hour \> 30 mg oral oxycodone/day \> 8 mg oral hydromorphone/day \> 25 mg oral oxymorphone/day
Shared Decision-Making Structured Team Model for Critical Maternal Care in OB-GYN ICU

A randomized controlled trial was conducted with 100 critically ill pregnant women admitted to our hospital's obstetrics ICU between January 2023 and December 2024. Participants were allocated via random number table to either the control group receiving conventional multidisciplinary resuscitation care (n=50) or the observation group receiving the structured team model with shared decision-making (n=50). Comparative outcomes included resuscitation efficiency indicators (pre-hospital response time, intrahospital transport duration, emergency supply preparation time), complication rates, family psychological status measured by Hospital Anxiety and Depression Scale (HADS), and family satisfaction assessments


Eligibility Criteria:
Inclusion Criteria:

* Meeting diagnostic criteria for critical obstetric conditions:

  1. Amniotic fluid embolism
  2. Postpartum hemorrhage
  3. Emergency cesarean section was performed, etc
* Age ≥18 years
* Gestational age \>20 weeks
* Patient's family/legal representative capable of normal communication and providing signed informed consent

Exclusion Criteria:

* Pre-existing primary hematologic disorders:
* Fetal congenital anomalies confirmed by prenatal imaging
* Active malignant tumors (except carcinoma in situ)
* Severe organ dysfunction:
* Altered mental status (GCS ≤12) or documented psychiatric disorders
The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation

The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients.

The study is designed to help detect if there is an advantage in giving one type of resuscitative fluid versus another in the setting of post-operative pediatric cardiac patients. The two types of fluid being compared are crystalloid solution (normal saline) and colloid solution (5% albumin). The primary outcome measurement will be how much volume of each type of fluid will be required in order to maintain hemodynamic stability as determined by mean arterial blood pressure within predetermined parameters. Other secondary outcomes will include determinations of lactate clearance, inotropic support requirements, urine output, peripheral and pulmonary edema that occurs post-operatively, and the over all costs for each fluid based on number of required boluses and number of hours on mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Congenital heart defect with two ventricle anatomy and physiology
* Ages: 0 - 36 months of age

Exclusion Criteria:

* History of bleeding disorder
* History of renal disorder
Evaluation of Thermographic Images of the Knee in Patients With Anterior Cruciate Ligament Reconstruction Outcome

The Thermo-LCA study is a diagnostic interventional study for assessment of knee temperature of asymptomatic patients with ACL reconstruction compared with unoperated healthy contralateral knee. The aim of the study is to analyze thermographic images obtained from the knees of asymptomatic patients with ACL reconstruction that occurred between the previous 2 and 5 years, to assess the presence of inflammation in the knee with reconstructed ACL compared with the contralateral.

Thermo-LCA study involves recruitment of thirty volunteers with unilateral ACL reconstruction Will be enrolled subjects aged 18 to 40 years, with no history of previous surgery or chronic gonalgia in the contralateral knee. Once the patient's Informed Consent has been obtained, the patient will wait sitting 10 minutes inside the temperature-controlled room of 23°C, a thermographic assessment will then be performed using a FLIRT1020 thermal imaging camera. Photographs will be acquired in anteroposterior, right lateral, left lateral, and posteroanterior views of both knees. The patient will then perform a knee flexion-extension exercise against resistance for 2 minutes using a 2 kg weighted ankle monitor. The speed at which this exercise is performed will be constant for all subjects, with one repetition per second per leg. Following this exercise, four more thermographic images identical to the first will be acquired. Basal thermographic assessments will be performed at 5', 10' and 20' minutes after the end of the exercise.Once the images are acquired these will be analyzed using ResearchIR software, regions of interest of the knees will then be constructed and their temperature change over the various acquisitions and how it changes after physical exertion will then be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged between 18 and 40 years;
2. Asymptomatic at the time of evaluation (IKDC ≥95);
3. No history of previous surgery or contralateral knee fractures;
4. No history of direct or indirect trauma in the previous six months to either knee;
5. Absence of gonalgia (VAS pain equal to 0) at evaluation;
6. BMI between 18.5 kg/m2 and 29.9 kg/m2.

Exclusion Criteria:

1. Patients who are incapacitated or have neurological disorders that may invalidate the research protocol;
2. Diagnosis of leukemia, known presence of metastatic malignant cells, current or planned chemotherapy;
3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis;
4. Patients with uncontrolled diabetes mellitus;
5. Patients with uncontrolled thyroid metabolic disorders;
6. Patients abusing alcoholic beverages, drugs, or medications;
A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications

A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no SafeBreak Vascular) to determine SafeBreak Vascular's impact on IV clinical care and complications.

This randomized clinical trial's goal is to determine SafeBreak Vascular's impact, a break-away connector that separates when a harmful force is placed on a peripheral IV line, on IV clinical care and complications.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted into the participating hospital units
* Patients of any gender may participate
* Participants able to provide informed consent or have a legally authorized representative immediately available to provide informed consent
* Patients must have peripheral IV catheter access or need and are planned to have peripheral IV catheter access placed that is anticipated to last a minimum of 24 hours.
* Patients must be receiving intermittent or continuous infusion or have immediate plans to begin an intermittent or continuous infusion
* The patients must be at least 18 years of age with no upper age limit

Exclusion Criteria:

* Unable to obtain informed consent or without an available Legally Authorized Representative or Next of Kin to provide surrogate informed consent
* Age less than or equal to 17
* Patient on comfort care only
* Predicted to have an IV infusion that lasts less than 24 hours
* Patient admitted from the Emergency Department refuses to have new peripheral IV catheter placed by IV team
* Patient has two or more peripheral IV catheters at the same time
* Patient enrolled in a subject drug or device study at the time of enrollment
* Investigator discretion that patient is not suitable for the study
* Patient is COVID-19 positive
* Patient is receiving an IV infusion with gravity tubing
Celebrex Premedication in Teeth With Symptomatic Irreversible Pulpitis

Assessing the efficacy of Celebrex premedication on pain during and after endodontic treatment in teeth with symptomatic irreversible pulpits

Owing to the painful nature of endodotnic treatment in teeth with irreversible pulpits, administration of an analgesic and anti-inflammatory could help to lessen the perception of pain, hence decreasing the patient apprehension.

Previous clinical trials have shown that the use of NSAIDS as a premedication prior to endodontic treatment was effective in reducing the pain and increasing the anesthetic success, since as high as 80% of the patients with pre-operative pain experience pain after endodontic treatment.

In this study, Celebrex (Celecoxib) 200mg will be given to the patients 1 hour before initiation of the treatment, and its effect on reducing the pain will be compared with a placebo.

Celebrex being a selective COX-2 inhibitor, it will spare the physiological tissue prostaglandin production while inhibiting the inflammatory prostaglandin production thus allow for effective analgesia with fewer side effects than Non-Selective NSAIDS (nsNSAIDS).

Eligibility Criteria:
Inclusion Criteria:

* Medically free patients
* Patients able to understand Visual Analogue Scale and sign the informed conset

Mandibular molar teeth with:

* Preoperative sharp pain
* Vital pulp tissue
* Normal peripaical radiographic appearance or slight widening of the lamina dura

Exclusion Criteria:

* Patients allergic to NSAIDS
* Pregnant females
* Patients having significant systemic disorder
* Patients with psychological disturbances
* Patients with bruxism or clenching

Teeth that have:

* Associated with swelling or fistulous tract
* Acute or chronic periapical abscess
* Greater than grade I mobility
* Periodontitis
* No possible restorability
* previous endodontic treatment