cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine Pharmacokinetics-pharmacodynamics in Mechanically Ventilated Children With Single-organ Respiratory Failure

Currently, dexmedetomidine is approved by the United States Food and Drug Administration (FDA) for short-term analgosedation (\<24h) in mechanically-ventilated critical care adult patients and sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Trials are underway to investigate its pharmacokinetics, clinical efficacy and safety in long-term use. Clinical experience with dexmedetomidine in the paediatric population is limited. Moreover, during childhood many developmental changes take place with consequences on drug exposure and drug response. Finally, critical illness itself can affect drug pharmacokinetics and -dynamics. Therefore, we cannot simply extrapolate adult data for use in children but we are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.


Eligibility Criteria:
Inclusion Criteria:

* patients (m/f) admitted to the paediatric intensive care unit
* expected to require at least 24h of mechanical ventilation
* patient age : 1 month-15 years
* patients with single-organ respiratory failure

Exclusion Criteria:

* patients with neurologic conditions that prohibit an evaluation of adequate analgosedation
* no arterial catheter in place at inclusion
* patients who have received another investigational drug within 30 days
* patients on continuous infusion with neuromuscular blockers
* patients with a life expectancy \<72h
* patients with a known allergy to lorazepam, midazolam and/or morphine
* heart block
* pre-existing bradycardia
* hemodynamically unstable patients (Wernovsky index \> 16 points) after full fluid replacement with crystalloid
* patients with significant renal insufficiency (creatinine plasma level 1 month-5 year : \> 1 mg/dl ; 5-10 years : \>1.2 mg/dl; \> 10 years : \> 1.5 mg/dl)
* patients with significant hepatic insufficiency (aspartate aminase \>950 UI/L and prothrombin time \< 60 or INR \>1.4)
* previous treatment with α2-adrenoreceptor agonist clonidine within 14 days
Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients

The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Unresectable and/or metastatic GIST
* Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
* For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
* Good physical functioning (ECOG Performance Status of 0 or 1)
* Generally, good function of organ such as liver and kidneys

Exclusion Criteria:

* Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST)
* Known intolerance of imatinib at a dose of 400 mg/day or higher
* Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
* Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
* Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks or who have not recovered from side effects of this therapy
Brain Tumor Patient-Caregiver Congruence, MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT)

The goal of this study is to compare patient ratings of how severe their own symptoms may be, with their caregivers' ratings of how severe they think the patients' symptoms may be. This will be compared using a questionnaire that is given to patients with brain tumors and their caregivers.

Researchers will also study any effects that these patients' neurocognitive function may have on these patients' and their caregivers' ratings of how severe the brain cancer symptoms may be.

Study Visit:

If you and your caregiver agree to take part in this study, you will both complete 2 questionnaires. You will be in separate rooms when you complete the questionnaires.

The first questionnaire is a demographic questionnaire that asks basic questions such as your age and employment status.

Your second questionnaire asks about any brain cancer symptoms that you may be experiencing, and asks you to rate how severe they may be.

Your caregiver's second questionnaire asks the same questions as yours. It asks the caregiver to rate how severe he or she believes your symptoms may be.

In total, the questionnaires should take about 10 minutes to complete.

Symptom Review:

The study staff will review the questionnaire responses right away. If you rate any symptom as severe as 7 or higher, the study staff will tell you to contact your doctor who is treating the cancer. The study staff will also contact your doctor who is treating the cancer. Otherwise, your questionnaire responses will only be used for research and there are no plans to contact your doctor.

Length of Study Participation:

After you and your caregiver complete the questionnaires this one time, your and your caregivers' active participation in this study will be over.

The study chair will also collect information from your medical record. This information will include your medical history and the results of the neurocognitive testing (routine tests of "thinking" skills such as your memory and concentration).

This is an investigational study. Up to 120 patients and 120 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Imaging consistent with a primary brain tumor or prior pathologic diagnosis of primary brain tumor
2. Referred for neurocognitive function testing as part of the plan of care
3. Age \> or = 18 years of age
4. Ability to speak, read, and write the English language
5. Caregiver Attribute: Identified by the patient as being primarily involved in the patients' care in the home setting (biologic, legal, or functional relationship)
6. Caregiver Attribute: Able to speak, read, and write the English language
7. Both patient and caregiver have to agree to participate
8. The caregiver needs to be present at the time the patient is recruited

Exclusion Criteria:

1. Patients less than 18 years of age will be excluded from this study.
2. Patients will be excluded from the study if they are unable to complete the self-report questionnaire or participate in neurocognitive testing.
The Role of Manual Twirling Acupuncture in Reducing Muscle Pain and Stiffness After Biceps Curling in Healthy Untrained Individuals

Regular physical activity can help to prevent and control non-communicable disease. WHO recommends at least in adults to do moderate-vigorous physical activity includes muscle strengthening. But regardless the importance and recommendations of physical activity, not all of the world's population does it .Biceps Curling is a popular physical exercise which easy to do , it can strengthen the muscles in the upper body. However based on the International Association for the Study of Pain (IASP) in individuals who just starting to do physical exercise may experience pain and can become a barrier to do physical activity, so an approach is needed to prevent this and acupuncture is one of them. Currently, a lot of acupuncture research has been carried out to reduce the condition pain and stiffness after weight training, but there are not many study using manual acupuncture twirling in this condition .

That's why the aim of this study Is to see the efficacy of giving manual acupuncture with twirling stimulation for pain and stiffness post weight training. The study method will be a Single Blinded Crossover Randomized Controlled Trial which will compare the efficacy of Manual Acupuncture twirling with Manual Acupuncture Sham for post-exercise pain and stiffness . The outcomes consist of Visual Analog Scale, Pain Pressure Threshold, Range of motion of elbow flexor at 24 hours, 48 hours, and 72 hours post weight training

This is a clinical trial study with cross-over design with 1 week wash out period to evaluate and compare the effects of Manual Acupuncture twirling and Manual Acupuncture sham for pain and stiffness after Biceps Curling (Weight Training) on healthy untrained subjects. The subjects are 48 males/female and will be randomly assigned to 2 groups: (1) Manual Acupuncture Twirling/Manual Acupuncture Sham and (2) Manual Acupuncture Sham/Manual Acupuncture twirling group . The subjects will receive two times treatment on day 1 and day 7. The outcome will be assessed each before treatment (baseline) at 24 hours, 48 hours, and 72 hours post weight training. Patients and the outcome assessors will be blinded to the group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Individuals with no exercise program
* Elligible for physical exercise
* Willing to take part in the study and sign informed consent

Exclusion Criteria:

* Consuming anti-inflammatory drugs, muscle relaxants and received any type of acupuncture within 7 days before the study
* Having contraindications of manual acupuncture (Pregnant, malignancy, bleeding disorders, needle phobia)
Intraoperative Different Fluid Therapy Protocols

We aimed to evaluate the relationship between different intraoperative fluid therapy protocols and postoperative renal damage and mortality.

Sixty patients who 18-65 age and underwent pancreatic surgery in our hospital were included in the study. They were divided into two groups as liberal fluid therapy (Group 1, n=30) and targeted fluid therapy (Group 2, n=30).

Eligibility Criteria:
Inclusion Criteria:

* Planned pancreatic surgery

Exclusion Criteria:

* No exclusion criteria was presetted.
Hemorrhagic Complications of Transvaginal Oocyte's Retrieval: an Update.

The goal of this retrospective analysis is to focus on peritoneal bleeding after oocyte retrieval and to further investigate factors related to this specific complication and if hemorrhagic complication rate modifications can be observed.

The main aim is to update our knowledge on oocyte retrieval complication, focusing specifically on hemorrhagic / hemoperitoneum rate.

All retrievals will be retrieved in IVF/ICSI cycles and Fertility Preservation both in oncological patients and in patients requesting oocyte storage for deferring motherhood.

Data collection goes from January 2017 to December 2022.

Eligibility Criteria:
Inclusion Criteria:

* patients that underwent a procedure of oocyte transvaginal retrieval for IVF/ intracytoplasmatic sperm injection (ICSI) cycles and fertility preservation

Exclusion Criteria:

-
Fasting Bioequivalence Study of Memantinol 20 mg Tablets Versus Akatinol Memantine® 20 mg Tablets In Normal Healthy Subjects

This study are two-way crossover, open-label, single-dose, fasting, bioequivalence study of Memantinol® (JSC "GEROPHARM", Russia) 20 mg tablets versus Akatinol Memantine® (Merz Pharma GmbH \& Co. KGaA, Germany) 20 mg tablets in normal healthy subjects

Study to evaluate the bioequivalence of orally administered memantinol preparations, film-coated tablets, 20 mg

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Healthy male and female subjects aged 18 to 45 years.
* Verified diagnosis is "healthy" according to data Standard clinical, laboratory and Instrumental methods of examination.
* Have a body mass index between 18,5 and 27 kg/m2.
* Females must have a negative pregnancy test.
* Subjects must use, with their partner, methods of highly effective contraception; if the Hormonal contraceptives was used they must canceled have at least 2 month before the study.

from the time of IMP administration until 3 months after the last dose of IMP.

Exclusion Criteria:

* History of serious allergic problems/events
* Medicinal intolerance.
* History of allergic reactions to memantine or investigator's product components
* Any acute and chronic diseases of the cardiovascular system, cardiovascular, bronchopulmonary, neuroendocrinal systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
* Acute infectious diseases in less than 4 weeks before the start of the study.
* Subjects who have taken medication 4 weeks preceding before the study.
* Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication (examples of inducers: barbiturates, omeprazole, etc.).
* Donation of plasma (450 mL or more) within 2 month prior to administration of the study medication.
* History of significant alcohol or drugs abuse or any indication of the regular use of more than 10 units of alcohol per week (1 Unit = 200 mL of wine or 500 mL of beer or 50 mL of alcohol 40%).
* Smokers.
* Participation in other clinical training is less than than for 3 months before the study.
* Lack of signed informed consent form.
* ECG or vital signs abnormalities (clinically significant).
* Positive testing for alcohol, drugs, pregnancy.
Knee Osteoarthritis and Rehabilitation

Osteoarthritis (OA) is a chronic degenerative disease of articular cartilage that causes hypertrophic changes in bone. OA is a non-inflammatory progressive musculoskeletal disease and is one of the most common degenerative diseases in the general population. OA is characterized by progressive cartilage destruction in load-bearing joints, subchondral sclerosis, osteophyte formation, and some biochemical and morphological changes in the synovial membrane and joint capsule. Common symptoms of knee osteoarthritis are; Knee pain that increases with activity, limitation of normal joint movement of the knee, edema, and knee pain that begins with prolonged sitting.

The aim of this study is to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received PRP.

OA is a non-inflammatory progressive musculoskeletal disease; damage begins in the cartilage and causes changes in the joint structure over time. Although intra-articular injection approaches have been frequently used in the treatment of OA recently, intra-articular injections known as Platelet Rich Plasma (PRP) have also started to be used frequently. Today, the areas of use of laser therapy have increased. When the laser beam is applied, it is absorbed by the tissue or scattered back. Laser has photochemical, thermal and ionizing effects on tissues. Laser has an analgesic effect by increasing endorphin synthesis and reducing C nerve fiber activation. Laser indirectly increases microcirculation by increasing temperature in the tissue. Although there are various studies on treatment options for OA in the literature, no studies have been found to investigate the effectiveness of laser treatment applied in addition to conventional treatment after PRP. In our study, we aimed to evaluate the effects of laser treatment applied in addition to conventional physiotherapy on pain, function, muscle strength and balance in patients with knee osteoarthritis who received PRP.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being diagnosed with knee OA by a specialist physician
* Having had PRP injection applied by a specialist physician
* Having unilateral knee OA
* Being stage I-stage III in the Kellgren-Lawrence OA classification
* Being between the ages of 18-65

Exclusion Criteria:

* Being stage IV in the Kellgren-Lawrence OA classification
* BMI being more than 40 kg/m2
* Patients who do not cooperate well
* Patients with neurological or neuromuscular disease
Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft

To compare the aortic pulse profile before and after stent-graft implantation to prove that endovascular AAA repair using non-compliant stent-graft changes the aortic pulse profile.

This study will assess hemodynamic changes in aortas of patients after treatment of their abdominal aortic aneurysm (AAA) with an FDA approved stent-graft (Zenith). This study does not require any change in clinical protocol to the the way the AAA procedures are currently done. Utilizing the catheters already employed in this procedure, intravascular blood pressure measurements will be documented at various times and at various anatomic levels prior to and after deployment of the stent-graft.

As the compliant aortic aneurysm acts as a capacitor, expanding during systole and contracting during diastole, it is our hypothesis that endovascular AAA repair using a non-compliant stent-graft changes the aortic pulse profile.

Eligibility Criteria:
Inclusion Criteria:

* Abdominal Aortic Aneurysm with planned treatment using Zenith Endovascular Stent-Graft
Intratympanic Steroid Treatment For The Prevention Of Inner Ear Toxicity Associated With Systemic Treatment With Cisplatin.

In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

Cisplatin is a potent and widely used antineoplastic drug. Ototoxicity is a serious and dose-limiting side effect. The ototoxic effect of cisplatin is characterized by irreversible, progressive, bilateral, high-frequency, sensorineural hearing loss with tinnitus. 60-80% of patients treated show elevations of hearing thresholds and nearly 15% sustain significant hearing handicap. There are currently no clinical interventions that have been shown to prevent cisplatin ototoxicity in humans. Glucocorticoids have significant potential for otoprotection. Glucocorticoids are in use for treatment of a variety of cochlear disorders such as autoimmune inner ear disease, Meniere's disease and sudden sensorineural hearing loss. Intratympanic administration of drugs is a contemporary, safe method of locally treating inner ear disorders, allowing diffusion across the round window into the inner ear. This method achieves much higher steroid levels within the inner ear compared to oral or parenteral routes. Local administration prevents the common systemic side effects of steroids. Previous animal studies have shown protection against cisplatin-induced ototoxicity after intratympanic steroid injection. Asa far as we know, there are yet no studies in humans examining the otoprotective effect of intratympanic steroids in patients treated with cisplatin. In this study we will aim to determine if cisplatin ototoxicity can be prevented by intratympanic administration of corticosteroids.

Eligibility Criteria:
Inclusion Criteria:

* adults 18 years old at least who are candidates for Cisplatin treatment
* agreement to participate in the study
* have signed an informed consent.

Exclusion Criteria:

* refusal to participate
* steroid treatment during the past month
* external or middle ear disease not enabling intratympanic treatment
* inner ear disease causing hearing loss
* severe hearing loss for any reason
* conductive hearing loss
An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty

Leg length discrepancies following total hip arthroplasty have been associated with nerve palsies, gait abnormalities, and lower back pain. Leg length discrepancies are related to poorer functional outcomes and patient dissatisfaction. Failure to restore femoral offset following total hip arthroplasty has been linked to decreased range of motion and abductor muscle strength, impingement, limping, higher dislocation rates, increased polyethylene wear, and loosening of implants. Computer navigation has shown to improve the accuracy of leg length and hip offset during total hip arthroplasty. The investigators research objective is to prove the accuracy of the Intellijoint HIP™ system for determining leg length and hip offset. The investigators hypothesis was that Intellijoint HIP™, an imageless intraoperative intelligent instrument, could improve the accuracy of leg length and hip offset during primary total hip arthroplasty. The investigators plan to study this hypothesis in humans by comparing the leg length and hip offset discrepancies produced with Intellijoint HIP™ to the standard at the investigators institution, which is a pin and outrigger system.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who is undergoing a primary total hip arthroplasty at Mount Sinai Hospital.

Exclusion Criteria:

* Pre-operative flexion contracture \>30°, infection, or inability to achieve rigid fixation of instruments intra-operatively.
A Chatbot Intervention for Reducing HPV Vaccine Hesitancy

The goal of this project is to test the efficacy of a chatbot intervention for reducing HPV vaccine hesitancy among African American parents. An online experiment will be conducted to test the effectiveness of the chatbot intervention with African American parents. Results of this project will inform future communication interventions for reducing vaccine hesitancy among African American parents.

The goal of this project is to test the efficacy of a chatbot intervention for reducing HPV vaccine hesitancy among African American parents. An online survey-experiment will be conducted. In the survey-experiment, participants will first answer questions related to their attitudes toward childhood vaccines and see a brief CDC message about HPV vaccine. Then they will be directed to interact with a chatbot designed to deliver personalized HPV vaccine messages (tailored to the participant's personality) or a similar chatbot with non-personalized messages. There will also be a control condition where participants will see the brief CDC message about HPV vaccine but will not interact with any chatbot. All participants will answer questions related to their attitudes toward HPV vaccination, intentions to vaccinate their children, as well as other message response measures.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Self-identify as Black or African American
* Parents of children under 18 years old
* Access to computer/laptop/mobile device and the Internet

Exclusion Criteria:

* Under 18 years
* Does not self-identify as Black or African American
* Not a parent of at least a child under 18 years old
* No access to computer/laptop/mobile device or the Internet