cyrilzakka/clinical-trials huggingface dataset:
Effect of Music During Carotid Endarterectomy

The purpose of this study is to test the hypothesis that music listening during carotid endarterectomy administered the cervical plexus block will cause less anxiety, less pain, and greater patient satisfaction.

Patients who decided to participate in the study were randomized by means of a computer-generated randomization order into 2 groups: Music Group (Group M) and Operating Room (OR) Noise Group (Group O). Randomization was independently carried out in both centers.

Preoperative and postoperative State Trait Anxiety Inventory (STAI) scores, intraoperative STAI responses, preoperative and postoperative numerical rating scale scores for anxiety, pain scores and hemodynamic parameters were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing carotid endarterectomy using cervical plexus block
* American Society of Anesthesiologists class 2 to 3
* Ability to consent

Exclusion Criteria:

* inability to communicate
* not understand the aim and objectives of the study
* not provide informed written consent
* contraindications for the block (local infection, coagulation disorders)
* hypersensitivity to the local anesthetics
* refusal of regional anesthesia
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy

The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.


Eligibility Criteria:
Inclusion Criteria:

* Has undergone primary, unilateral, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
* Experiences a pain intensity rating of moderate to severe acute pain.
* Able to provide written informed consent before any study procedure.

Exclusion Criteria:

* ASA Physical Status Classification System classification of P3 or worse.
* Has surgical or post-surgical complications.
* Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Has previously participated in another TRV130 clinical study.
Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial

Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually applied but there is no perfect choice. It depends on physician's skill and situation. The best regimen is patient-controlled analgesia, but it requires an expensive equipment. Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.

Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may provide good analgesia for 72 hours.


Eligibility Criteria:
Inclusion Criteria:

* age =\>18 years
* scheduled for abdominal surgery

Exclusion Criteria:

* ASA class \> 3
* Known allergy to fentanyl or morphine
* History of substance or alcohol abuse, and tolerance or dependence on opioids
* Combined epidural block
* Can't use PCA, abnormal renal / liver function
Chloroprocaine for Inguinal Herniorrhaphy

This study is to determine the minimum effective dose for intrathecal chloroprocaine in inguinal herniorrhaphy in outpatients using a Combined Spinal Epidural (CSE) anesthesia.

A standard CSE procedure will be conducted in which the patient is placed in an upright sitting position on the side of the operation table and a epidural Tuohy needle 18G will be inserted into L3-L4 interspace via a loss-of-resistance technique. The dura will be punctured using a 27-gauge pencil-point spinal needle and a certain dose of chloroprocaine 1% will be given. After the spinal needle is withdrawn, an epidural catheter will be placed and the epidural needle will be withdrawn. After fixation of catheter the patient will be placed in a supine position.

The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. Each time there will be added 2,5 microgram of sufentanil for prolongation of the analgesia. The testing interval is 2 mg.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients for unilateral inguinal hernia repair
* ASA I - II - III

Exclusion Criteria:

* hypersensitivity to amino-ester local anesthetics, para-aminobenzoic acid or sufentanil
* contraindications to spinal or epidural anesthesia
* bilateral inguinal herniorrhaphy
* extremes of height and weight (BMI 20 or 35 kg/m2, height 150 cm or 185 cm)
Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.

In a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at Shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc ringer.

Eligibility Criteria:
Inclusion Criteria:

* were women with singleton pregnancy
* with cephalic presentation
* who had NVD spontaneously or by induction

Exclusion Criteria:

* placenta previa
* placental detachment
* coagulation problems
* previous CS
* macrosomia
* Polyhydramnios
* and uncontrolled asthma
Prognostic Value of CD318 in AML at Assiut University Hospital.

We will focus on the prognostic value of CD318 in acute myeloid leukemia patients at Assiut University Hospital

Acute myeloid leukemia (AML) is a disease with high mortality and variable prognosis . It remains a disease with a highly variable outcome depending on the exact footprint of the AML .Although many patients with AML have a response to induction therapy ,refractory disease is common and relapse represents the major cause of treatment failure .In 2016 the World Heath Organization published revisions to classification of Myeloid Neoplasms and Acute leukemias .Well-established prognostic factors are cytogenetic aberrations such as t(8;21), inv(16), and t(15;17) as well as mutated IDH1/2, NPM1, and FLT3 genes but only few markers can specifically predict the outcome after HSCT .Immunophenotyping via flowcytometry comprises an additional fast technique to predict outcome in AML, although only few markers are yet established as prognostic factors in clinical routine diagnosis, despite the fact that new and rapidly available markers are needed to improve the treatment decisions in AML patients. This is even more since starting therapy in AML patients must be initiated immediately after diagnosis . Overall mortality from AML is high and treatment should be initiated within hours after first diagnosis . In hematopoietic cells,CD318 has been identified as stem cell marker for both benign and malignant progenitor cells. CD318+ bone marrow or cord blood-derived cells have been shown to be capable to initiate multi-lineage hematopoiesis in vitro and in vivo .CD318 (CUB domain containing protein-1, CDCP1) is a highly glycosylated single pass transmembrane protein express endomesenchymal and neural stem cells and fibroblasts and hematopoietic.Overexpression of CD318 has been recently correlated with poor overall survival(OS) in colonic ,breast ,renal, hepatocellular ,and pancreatic Carcinoma.possibly due to its role in metastasis formation via interaction with integrins and anti-apoptotic signaling via Akt. Of AML blasts, pronounced CD318 expression has been observed on the immature CD34+CD133+ leukemic cells subset implicated to be enriched for leukemic stem. However, the impact of CD318 on survival in hematological malignancies has so far not been analyzed. Study done by Jonas S et al showed 57% of AML patients expressed relevant CD318 levels and a significant correlation of CD 318 surface levels with prognosis was observed . In our study investigators will use flowcytometry to detect CD318 on AML blasts and correlate it with disease course and outcome.

Eligibility Criteria:
Inclusion Criteria:

1. newly diagnosed AML patients
2. Age more than 18 years
3. Patients not starting chemotherapy yet
4. Primary AML
5. Secondary AML on top of MDS or myeloproliverative noeplasms

Exclusion Criteria:

1. Refractory AML patients
2. Relapsed AML patients
A Feasibility Study Investigating Chemotherapy-induced Neuropathy Using Multi-frequency Tactilometry and Patient-reported Outcomes (PRO)

Chemotherapy induced peripheral neuropathy (CIPN) is among the most feared side effects to cancer treatment. The development of CIPN can lead to discontinuation or omission of antineoplastic drugs, possibly affecting efficacy of cancer treatment. There is a lack of knowledge about the natural course of CIPN and to this date, there are no available methods for the early detection of CIPN. With no effective prevention or treatment options, the condition has severe impact on patient quality of life and healthcare expenditure.

This study will investigate the natural course of paclitaxel- and oxaliplatin induced peripheral neuropathy using novel diagnostic techniques. Multi-frequency vibrational technology has provided an objective method for the early detection of diabetic neuropathy. Our study will test the feasibility of this method within the field of clinical oncology and CIPN.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* A diagnosis of cancer.
* Fulfil the criteria for starting chemotherapy.
* Scheduled to undergo at least 4 courses of paclitaxel- or oxaliplatin-based chemotherapy.
* No prior paclitaxel, oxaliplatin or other neurotoxic chemotherapy.

Exclusion Criteria:

* Unable to complete PRO measures.
* Previous neurotoxic chemotherapy.
Extraction of the Compromised First Permanent Molars

Compromised first permanent molars (FPM), whether diagnosed with severe molar incisor hypomineralization (MIH), irreversible pulpities, or necrosis, require frequent re-treatment consequently entering the restorative cycle, which leads to their inevitable extraction and implant placement. Extraction of compromised first permanent molars in 8-10-year-old children allows the mesial migration of the second permanent molars during their eruption, thereby favoring spontaneous space closure as a permanent solution.

Extraction of compromised first permanent molars in children decreases the burden of repeated restorative procedures for theses molars, which will eventually need frequent repair. This will end in their inevitable extraction with its consequences. The extraction of the FPM will be delivered by Nour Wahba, Dina Darwish, and Basma Nagi, lecturers in Pediatric Dentistry and Dental Public Health Department, faculty of Dentistry, Ain Shams University.All patients will be recalled for follow-up yearly for three-years. The first follow-up will be done after 6months to perform the Quality of life questionnaires. The position of the second permanent molar will be checked clinically and radiographically to evaluate the space between second premolar and the second molar.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients\&#39; class I according to the American Society of Anesthesiologists (ASA class I)
* Age: 8-10 years
* Angle class I occlusion
* The radiographic presence of the second premolar
* The radiographic stages of development E or F for formation the second permanent molar.
* First permanent molar that is severely affected by MIH, signs of necrosis, signs of irreversible pulpitis or non-restorability.

Exclusion Criteria:

* Refusal of the parents to sign the informed consent.
* Signs of reversible pulpitis of first permanent molar.
* Patients with severe malocclusion.
Open-Label Rollover Study for Continuing Valbenazine Administration for the Treatment of Chorea Associated With Huntington Disease

This is a Phase 3, open-label study to evaluate the long-term safety and tolerability of valbenazine, and to provide participants continued access to valbenazine for the treatment of chorea associated with Huntington disease.

After completion of Week 156/early termination visit, participants in the US will be given the option to continue into an extended maintenance period for up to 104 weeks and participants in Canada will have the option to participate in a separate open-label study (Study NBI-98854-HD3022).

Eligibility Criteria:
Inclusion Criteria:

Either #1 or #2 must be met for inclusion eligibility.

1. Have participated in Study NBI-98854-HD3005 and

   a. Study drug dosing completion of Study NBI-98854-HD3005, as demonstrated by completed study drug dosing through the follow-up visit or early terminated Study NBI-98854-HD3005 for administrative reasons due to COVID-19 (for example, site closure related to COVID-19)
2. Did not participate in Study NBI-98854-HD3005 and

   1. Have a clinical and genetic diagnosis of Huntington Disease (HD) with chorea
   2. Be able to walk, with or without the assistance of a person or device
3. Be able to read and understand English and capable of providing consent to study participation or have a legally authorized representative providing consent and the participant providing assent
4. Participants of childbearing potential must agree to use contraception consistently while participating in the study until 30 days after last dose of the study treatment

Exclusion Criteria:

1. Have difficulty swallowing
2. Are currently pregnant or breastfeeding
3. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular (AV) block, uncontrolled bradyarrhythmia, or heart failure
4. Have an unstable or serious medical or psychiatric illness
5. Have a significant risk of suicidal behavior
6. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
7. Have received gene therapy at any time
8. Have received an investigational drug in a clinical study (other than valbenazine) within 30 days before the baseline visit or plan to use such investigational drug (other than valbenazine) during the study
9. Have had a blood loss ≥550 mL or donated blood within 30 days before the baseline visit
10. Have a history of severe hepatic impairment or history of protocol specified hematologic abnormalities during the course of the NBI-98854-HD3005 study
11. Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome
12. Have a known hypersensitivity to any component of the formulation of valbenazine
13. For participants who did not participate in NBI-98854-HD3005: have a history of VMAT2 inhibitor use within 30 days of baseline
Nicotinamide Riboside Impact on Extracellular Nicotinamide Adenine Dinucleotide (NAD+)

The investigation is a clinical study in which the impact of taking the dietary supplement nicotinamide riboside (NR) on the concentration of extracellular nicotinamide adenine dinucleotide (eNAD+) in human plasma over time will be determined. The study will be conducted in a randomized, double-blinded, and placebo-controlled manner.

The significance of nicotinamide adenine dinucleotide (NAD+) in promoting a healthy life is currently under intense research. Despite an increasing number of research groups focusing on NAD+, there is no validated measurement method for extracellular NAD+. With this research project, the investigators aim to address this research gap.

The coenzyme NAD+ is one of the central regulators of metabolism, existing mostly in its oxidized form, NAD+, and its reduced form, NADH, in a dynamic equilibrium. NAD+ is indispensable for various metabolic processes, and is especially key in ATP generation. It also enables gluconeogenesis, ketogenesis, pentose phosphate production, heme and lipid synthesis, and the elimination of oxygen radicals.

To validate the NAD+ assay as a robust and reliable quantification method of extracellular NAD+, a controlled increase of the measured metabolite in blood plasma is required through NAD+ precursor administration.

Multiple studies have already demonstrated that oral NR intake can increase NAD+ levels in mammalian cells, rodent tissues, and peripheral blood mononuclear cells (PBMCs) in humans. However, this relationship has not been explored in the extracellular space due to the lack of reliable quantification of eNAD+ levels. Now, using the NAD+ assay, the investigators aim to examine the increase of eNAD+ after oral NR intake and provide initial data on the effects of a 1000 mg/day dosage.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Normal nutritional status and
* Age \>18 years.

Exclusion Criteria:

* Pregnancy and/or lactation, or
* Severe psychiatric disorders, or
* Conditions that involve attention deficits, or
* Severe medical conditions, or
* Withdrawal of consent by the participant.
BRInging the Diabetes Prevention Program to GEriatric Populations

Over 24 million Americans are over 65 years and have prediabetes. Prediabetes can be addressed using a public health approach: among the 20% of participants in the Diabetes Prevention Program (DPP) who were ages 60 and over, the diet and physical activity intervention conferred a 71% risk reduction of diabetes after an average follow-up of 3 years. The population of older adults is projected to more than double from 52.5 million in 2019 to \~100 million by 2060, and if projections hold, about half (48.3%) will have prediabetes. The proposed hybrid effectiveness implementation type 1 design will compare a DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) to an in person DPP tailored for older adults (DPP arm) using a randomized, controlled trial design (n=230). The preliminary data suggests DPP-TOAT is a feasible and acceptable way to deliver the DPP to older adults, and this will be the first study to compare the effectiveness and implementation of two strategies (telehealth versus in-person) to deliver a tailored DPP for the unique needs of the growing population of older adults.

Eligible patients will be recruited through electronic health records (Epic and MyChart) and randomized to the 12-month DPP-TOAT or the in-person DPP program. Primary effectiveness outcome will be 6-month weight loss and implementation outcome will be attendance. A pragmatic approach will be used in order to inform future studies conducted in community-based and rural settings. Findings will inform best practices in the delivery of an evidence-based intervention that could reach the 30+ million adults aged 65 and over with prediabetes.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 65 years and older
* Diagnosis of pre-diabetes (A1c between 5.7-6.4%, fasting glucose between 100-125 mg/dL, or oral glucose tolerance test between 140-199 mg/dL within past 12 months)
* BMI of greater than or equal to 30
* English-speaking
* Under the care of a Primary care provider (PCP) in the NYU Langone Health system
* Able to travel to NYU Langone for in-person evaluations
* Access to a telephone
* Informed consent

Exclusion Criteria:

* Prevalent diabetes or end-stage renal disease
* Prior participation in the Diabetes Prevention Program
* A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD) -10 codes
* Taking FDA-approved weight loss medications
* PCP stating that patient should not participate
* Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
* Severe visual impairment that precludes completion of assessments and/or intervention
Food Allergy Registry at a Single Site

This is a registry of participants who are interested in being screened for clinical trials at a single site.

This registry will be maintained on a secure database and will include name, gender, age, disease, medical information, other information (via questionnaires), and date of consent. It will be overseen by our regulatory manager at our site and will not be shared with others outside of our site-specific trained individuals.

Eligibility Criteria:
Inclusion Criteria:

* Any interested party from 0-100 yrs of age to enter their information in registry

Exclusion Criteria:

* Any individual who does not consent
Effect of Different E-cigarette Cooling Flavors on Adults' Sensory Experience TCORS 3.0

This pilot sensory experiment will examine cooling from comparable concentrations of WS-3 and menthol to determine appropriate concentrations to use in the main study.

This pilot study will establish low and high concentrations of both WS-3 and menthol concentrations to test in the main study. An anticipated 30 adult e-cigarette users will participate in one laboratory session during which participants will be exposed to e-liquids containing five different concentrations of two different cooling flavors without nicotine (10 e-liquids total). Participants will rate "coolness" using the generalized Labeled Magnitude Scale (gLMS). Using averages of participant ratings, we will select a low concentration of each constituent that is rated as more than "barely detectable" but less than "moderate" to ensure that cooling is weak but clearly perceptible. For the high concentration of each constituent, we will select a concentration that on average falls between "strong" and "very strong" to identify a strong cooling sensation while avoiding sensations that would also be uncomfortable.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to read and write
* Used e-cigarettes containing nicotine
* Use e-cigs in past 30 days

Exclusion Criteria:

* Known hypersensitivity to propylene glycol
* Pregnant or lactating females
* Uncontrolled asthma
* Nut/e-liquid flavorant allergy
* Current marijuana (tetrahydrocannabinol) vaping + E-cigarette or vaping use Associated Lung Injury (EVALI) symptoms