cyrilzakka/clinical-trials huggingface dataset:
HEART Pathway Implementation

The purpose of this study is to determine the effectiveness of the HEART Pathway, a clinical decision aid for the care of patients with chest pain, in a "real-world" clinical setting. This will be accomplished through the building of a transformative collaboration between research, education, and health systems operations to more effectively and efficiently provide patient care.

Millions of patients with chest pain are seen in Emergency Departments (EDs) every year. Over half of ED patients with chest pain are admitted to the hospital to undergo further testing. Despite high testing rates, less than 1 in 10 patients with chest pain are ultimately diagnosed with an acute coronary syndrome (ACS) at estimated annual cost of $13 billion. Current care patterns for acute chest pain fail to focus health system resources, such as hospitalization and cardiac testing, on patients most likely to benefit.

The HEART Pathway, which combines a clinical decision aid, with two serial troponin measurements, has been developed to identify patients with chest pain who can safely be discharged without objective cardiac testing (stress testing or angiography). Prior retrospective and observational studies have established that use of the HEART Pathway reduces cardiac testing by \>20%, while maintaining an acceptably low adverse event rate. We now seek to integrate the HEART Pathway into "real-world" clinical settings to determine effectiveness.

The goal of this proposal is to build a transformative collaboration bridging the gap between research, education, and health systems operations to more effectively and efficiently provide patient care. The vanguard for this collaboration seeks to improve quality of care for patients with acute chest pain by integrating the HEART Pathway into cardiovascular care delivery at Wake Forest Baptist Health (WFBH). This project will build on our prior work and provide a model for using the education and operational strengths of US academic medical centers to disseminate initiatives to improve care delivery.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 21 years of age at the time of Emergency Department (ED) visit
* Chest discomfort consistent with possible Acute Coronary Syndrome (ACS) as indicated by the treating physician obtaining an Electrocardiogram (ECG) and cardiac biomarkers for the patient's evaluation.

Exclusion Criteria:

* New ST-segment elevation in contiguous leads on any electrocardiogram (\>/= 1 mV)
A Pilot Study of the Bioavailability of Nasal Naloxone

The overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. These data will be used to design a well justified protocol for the final estimation of these parameters:

* Preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers
* Preliminary estimation of the maximum serum concentration (Cmax) of this formulation
* Preliminary estimation of the time to maximum serum concentration (Tmax) of this formulation
* Safety of the formulation


Eligibility Criteria:
Inclusion Criteria:

* healthy (adequate organ function is determined by electrocardiogram (ECG), liver and kidney clinical chemistry, and a standard clinical examination/interview. For safety reasons we may ask for urine sample for analysis of opioids)
* informed consent

Exclusion Criteria:

* history of liver disease
* taking any medications including herbal medicines the last week history of drug abuse
* any local nasal disease or nasal surgery or recent cold for the last week
* any history of drug allergies
Intravenous Lidocaine and Quality of Recovery After Cesarean Delivery

When given intravenously, the local anesthetic lidocaine has been shown to decrease the amount of pain medication patients require when recovering from several types of surgeries. Cesarean delivery is a very common surgery in the United States, effecting more than 1 million women each year. The investigators hypothesize that lidocaine, given during and immediately after a patient undergoes a cesarean section, will help improve a mother's overall recovery experience, as well as positively influence bonding with her new baby.

Pain after Cesarean delivery is a common occurrence on the labor and delivery unit. The increased use of neuraxial anesthesia has allowed the administration of neuraxial opioids to help with postoperative pain control. Many patients, however, still require IV and oral opioids in the post anesthesia recovery unit (PACU), and on the postpartum nursing floor. Post Cesarean delivery pain not only has the usual adverse effects common to all postoperative pain (i.e. increased risk for deep vein thrombosis, pulmonary embolism, coronary ischemia, pneumonia, poor wound healing, and psychological dysfunction) but also has the potential to adversely affect mother-baby bonding, time spent in skin-to-skin contact and success of initiating effective breastfeeding.

Systemic administration of lidocaine has been shown to decrease opioid consumption, improve recovery of bowel function and promote a better recovery after inpatient procedures. Lidocaine has been shown to have analgesic, antihyperalgesic and anti-inflammatory properties. It also has an excellent safety profile when given by a low-dose infusion.

Assessing a patient's quality of recovery has become an important outcome in several studies. The patient's capacity to return to her normal activities and effectively care for her newborn is one of the most important signs of a successful surgical procedure, and it has significant economic, sociological and psychological implications.

Quality of recovery -40(QoR-40) is a validated 40-item instrument to assess the quality of post-operative recovery (10). Myles et al. have concluded that the QoR-40 would be a useful outcome measure to assess the impact on changes in health care delivery, but anesthesia studies underutilize this instrument.

This study will evaluate the effect of perioperative systemic lidocaine in the postoperative quality of recovery of patients undergoing Cesarean delivery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Class II
* English speaking
* Scheduled Cesarean delivery

Exclusion Criteria:

* Allergy to local anesthetics
* Chronic opioid use
* Greater than 2 prior cesarean deliveries
* Prior myomectomy
* Prior classical cesarean incision
* BMI greater than 40
* History of cardiac disease
A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)

This is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of treatment with Peg-IFN and RBV.


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive
* Chronic, compensated HCV GT1 infection
* Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis
* No evidence of cirrhosis or hepatocellular carcinoma by biopsy or noninvasive testing (e.g. FibroScan and/or FibroTest)
* Must agree to use two acceptable methods of birth control from at least 2 weeks prior to first dose and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations

Exclusion Criteria:

* Non-GT1 HCV infection, including a mixed GT infection (with a non-GT1) or a non-typeable genotype.
* Documented to be Human Immunodeficiency Virus (HIV) positive or co-infected with hepatitis B virus
* Hepatocellular carcinoma (HCC) or under evaluation for HCC
* Participating in or has participated in a study with an investigational compound or device within 30 days of signing informed consent
* Diabetic and/or hypertensive with clinically significant ocular examination findings
* Current or history of central nervous system trauma, seizure disorder, stroke or transient ischemic attack
* Chronic pulmonary disease
* Current or history of any clinically significant cardiac abnormalities/dysfunction
* Active clinical gout within the last year
* History of gastric surgery or history of malabsorption disorders
* Active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)
* Pregnant, lactating, expecting to conceive or donate eggs, or male participant planning to impregnate or provide sperm donation or with a female partner who is pregnant
* Current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric disorders
* Evidence or history of chronic hepatitis not caused by HCV
Investigating the Effectiveness of Vimida

This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-COVID-19 fatigue. Inclusion criteria are: male, female or non-binary, age ≥18 years, diagnosis of post-COVID-19 fatigue, ≥3 months since the last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the Chalder Fatigue Scale (CFQ-11), consent to participation, and sufficient German language skills. Exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of COVID-19.

Patients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (TAU; n=80), or to a control group, in which they will receive access to TAU only (n=80).

The primary endpoint will be fatigue symptoms with three months post-allocation (T1) being the primary time point for assessment of effectiveness. Six months post-allocation (T2) will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.


Eligibility Criteria:
Inclusion Criteria:

* male, female or non-binary
* age ≥ 18
* diagnosis of post-COVID-19 fatigue (ICD-10 U08.9, or U09.9 in conjunction with G93.3), secured via a telemedical visit
* ≥ 3 months since COVID-19 infection that preceded fatigue symptoms
* elevated levels of fatigue: cut-off of ≥ 16 on the CFQ-11
* consent to participation
* sufficient knowledge of the German language

Exclusion Criteria:

* known somatic or psychiatric condition that can explain the fatigue (e.g., cancer, multiple sclerosis, severe depression)
* current participation in a multidisciplinary rehabilitation program aimed at ameliorating the consequences of COVID-19
Pre-procedural Ultrasound Techniques Versus Conventional Landmark Technique of Spinal Anesthesia in Elderly Patients

Traditionally, spinal anesthesia is performed using the palpation of bony landmark to identify the level and point of entry of the spinal needle. Recently, ultrasound imaging has become an increasingly popular procedure among anesthesiologists to guide neuraxial blockade. Most of the studies on pre-procedural ultrasound-guided neuraxial techniques are limited to a midline approach using a transverse median views. The parasagittal oblique view consistently offers better ultrasound view of the neuraxis compared to the transverse median view. However, it is still not evident whether these superior parasagittal oblique views will lead to an easier paramedian needle insertion. In the literature, there are no studies directly comparing the US-guided paramedian approach using the parasagittal oblique (PSO) view, the US-guided midline approach using the transverse median view, and the conventional landmark midline approach to perform spinal anesthesia in the elderly patients, in particular for the teaching of novice anesthesia residents.

The aim of this study is to find out the optimal technique to perform spinal anesthesia by residents in training. Thus the investigators will compare preprocedural ultrasound-guided paramedian technique using parasagittal oblique view vs preprocedural ultrasound-guided midline technique using transverse median view vs landmark-guided midline technique of spinal anesthesia in the elderly population. Our hypothesis is that both preprocedural US-guided techniques are superior to the conventional landmark-guided midline technique with regard to ease of performance defined as success rate at first attempt, number of puncture attempts, spinal procedure time, and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery amenable to spinal anesthesia, aged more than 60 years, with American Society of Anesthesiologists physical status 1 to 4.

Exclusion Criteria:

* Patients who are unable to give consent, refuse spinal anesthesia, have spinal abnormalities (including scoliosis and previous spine operations with instrumentation) or have contraindications to spinal anesthesia, including allergy to local anesthetics or a bleeding diathesis
Study of Hemostasis in Patients With Congenital Disorder of Glycosylation

The purpose of this study is to investigate the coagulation balance in a cohort of congenital disorder of glycosylation (CDG) patients using conventional tests combined with an integrated approach of their coagulation disorders in using TGA in the absence or presence of sTM. Thus, investigators aimed to define if the hemostatic balance in CDG patients, is preserved despite of combined deficiencies in both procoagulant and anticoagulant factors.

In CDG, coagulation abnormalities, affecting both pro and anticoagulant factors, could account for onset of acute microvascular events in these patients. In line with this hypothesis, a previous study reported a correlation between low activity of anticoagulant factors and thrombosis, although stroke-like episodes, the most frequent event, were not analyzed in this study. Moreover, the hemostatic balance is usually investigated by global coagulation tests such as the prothrombin time (PT) and the activated partial thromboplastin (aPTT). However, these tests have serious limitations. First, they explore only 5 % of the whole generated thrombin, enough to clot the plasma. In addition, global tests are insensitive to the coagulation inhibitors, especially the PC system which cannot be mobilized in the absence of thrombomodulin (TM). The thrombin generation assay (TGA), is also a global coagulation assay, but it allows exploration of the whole thrombin formation process from its generation to its inhibition. Moreover, combining different analytical conditions, all the anticoagulant systems could be investigated, including antithrombin in basal conditions and the PC system in the presence of soluble TM (sTM)

Eligibility Criteria:
Inclusion Criteria:

-Clinical diagnosis of Congenital Disorder of Glycosylation (CDG)

Exclusion Criteria:

- no exclusion criteria
Polycystic Kidney Disease 1 (PKD1) Gene Variant Groups in Autosomal Dominant Polycystic Kidney Disease

The purpose of this study is to estimate the prevalence, demographic, and clinical characteristics of PKD1/2 gene variant groups in the ADPKD population.


Eligibility Criteria:
Key Inclusion Criteria:

* Estimated glomerular filtration rate (eGFR) greater than or equal to (≥) 30 milliliter per minute (mL/min)/1.73 m\^2
* Willing and able to comply with scheduled visits and other study procedures
* A pre-existing diagnosis of ADPKD as defined in the protocol

Key Exclusion Criteria:

* History of kidney disease other than ADPKD that in the opinion of the investigator would independently impact the natural history of ADPKD
* History of solid organ or bone marrow transplantation or nephrectomy
* Ongoing renal replacement therapy or planning to start renal replacement therapy less than or equal to (≤)12 months from the Genotyping Visit in Part A

Other protocol defined Inclusion/Exclusion criteria will apply.
Temozolomide as a Prophylaxis Against Brain Recurrence in Participants With Metastatic Breast Cancer (P05225 AM2)

The purpose of this study is to determine whether temozolomide can be used as a prophylaxis against brain recurrence in participants with metastatic breast cancer.

Breast cancer is the second most common cause of brain metastases. Overall survival after the development of brain metastases tends to be poor (6-8 months). Over-expression of Human Epidermal Growth Factor Receptor 2 (HER-2/neu), negative estrogen receptor, and young age at diagnosis seem to be indicators of high risk for brain metastases. Temozolomide may be a good candidate for prophylactic chemotherapy because of its ability to cross the blood-brain-barrier, achieving high concentrations in the central nervous system (CNS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of metastatic breast cancer.
* Participants must have completed first line of metastatic chemotherapy and have achieved complete or partial response or disease stability for at least 6 months from the first confirmation of disease stabilization.
* No clinical sign of brain progression.
* At least one of the following 3 conditions: HER2 +++, Young age (\< 50 years), and/or estrogen receptor (ER)-/progesterone receptor (PgR)-
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
* Life expectancy ≥3 months.
* Neutrophils ≥1.5 x 10\^9/L, platelets ≥100 x 10\^9/L, hemoglobin ≥9 g/dL, lymphocytes ≥1 x 10\^9/L.
* Bilirubin level either normal or \<1.5 x ULN (upper limit of normal).
* AST (aspartate aminotransferase) and ALT (alanine aminotransferase) ≤2.5 x ULN (≤5 x ULN if liver metastases are present).
* Serum creatine \<1.5 x ULN.
* Effective contraception if the risk of conception exists.

Exclusion Criteria:

* Concurrent chronic systemic immune therapy not indicated in the study protocol.
* Any investigational agent(s) within 4 weeks prior to entry.
* Participants that have completed 2nd, 3rd, or 4th line metastatic chemotherapy or participant in active chemotherapy treatment.
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months.
* Acute or sub acute intestinal occlusion or history of inflammatory bowel disease.
* Known Grade 3 or Grade 4 allergic reaction to any of the components of the treatment.
* Known drug abuse/alcohol abuse.
* Legal incapacity or limited legal capacity.
* Medical or psychological condition which in the opinion of the investigator would not permit the participant to complete the study or sign meaningful informed consent.
* Women who are pregnant or breastfeeding.
* Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix (participants with a previous malignancy but without evidence of disease for ≥5 years will be allowed to enter the trial).
Duloxetine for Post Laparoscopic Shoulder Pain

Despite recent advances in minimal invasive surgery, postoperative pain control remains a challenge for both surgeons and anesthesiologists . Currently, laparoscopy has an obvious favor for both diagnostic and therapeutic procedures of pelvic and abdomen; while it is minimally invasive, has less pain, and needs less postoperative analgesic use compared with open surgeries . Shoulder pain is a frequent problem following laparoscopic procedure

Many patients may feel much more discomfort from their shoulder pain than incision pain . Post laparoscopic shoulder pain is caused by irritation and/or injury of the diaphragm and phrenic nerve by local acidosis and irritative effect of carbon dioxide during pneumoperitoneum or distention forces on the diaphragm. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant . It is used to treat major depressive disorder in adults. Duloxetine is also used to treat general anxiety disorder. It is also used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain). Duloxetine is also used to treat diabetic neuropathy. Previous studies focused on the use of gabapentin and pregabalin (both are antineuropathic pain medications) to prevent post laparoscopic shoulder pain after laparoscopic ovarian cystectomy and laparoscopic cholecystectomy showed favorable results and since duloxetine is an antineuropathic pain medications we assume its use will ameliorate diaphragmatic irritation and hencepost laparoscopic shoulder pain.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal females
* Patient consent
* Patients with ASA class I-II
* Elective gynecological laparoscopy

Exclusion Criteria:

* Body Mass Index ≥ 40
* Consuming any pain killers routinely within 48 hours before the surgery
* Smoking, drug abuse
* Patients with major psychiatric disorders, epilepsy or history of convulsion
* Any known kidney or hepatic disorders
* History of any other pervious laparotomy, laparoscopy, or other pelvic manipulation or pathology except normal vaginal delivery
* History of chest or mediastinal surgery or pathology
* Recent flu (six weeks before surgery)
* Suspected to malignancy as pathology
* Those who complained from shoulder pain just before surgery in the first Visual Analog Scale assessment.
Prevalence of Tooth Wear and Its Association with Oral Health-related Quality of Life

The aim of this study is to detect the prevalence of tooth wear (All forms of cumulative surface loss of mineralized tooth substance loss due to physical and chemico-mechanical process according to the definition of the European Organization for Caries Research (ORCA) and the International Cariology Research Group for Dental Research (IADR) i.e.: attrition, erosion and abrasion) among middle aged adult patients attending educational hospital at the Faculty of Dentistry, Cairo University and to analyze the distribution of lesions by gender and age, frequency of acidic foods and drinks consumption, medicine usage, chewing habits, systemic diseases, tooth brushing habits, and family socio economic status. Moreover, to evaluate the quality of life among middle aged elderly patients in relation to existence of tooth wear.

The study focuses on middle-aged adult patients (31-45 years) attending the Faculty of Dentistry at Cairo University during 2025-2026. It is an analytical cross-sectional study aimed at assessing the prevalence and risk level of tooth wear using the Basic Erosive Wear Examination Index (BEWE). The BEWE categorizes tooth wear into four levels (0 = no wear, 3 = severe wear), and risk levels are determined by the cumulative score.

Primary outcome: the prevalence of tooth wear and associated risk levels. Secondary outcomes: identifying predictive risk factors and assessing the Oral Health Impact Profile (OHIP) for patients diagnosed with tooth wear. All participants will be examined, and those with a BEWE score above 0 will be considered affected. Risk levels will be stratified as no risk, low, medium, or high.


Eligibility Criteria:
Inclusion Criteria:

* 1- Patients whose age between 31 to 45 years old. 2- Egyptian 3- Males \&amp; Females 4- Provide informed consent 5- Ability to comprehend asked questions

Exclusion Criteria:

* 1- Patients under or over the selected age group 2- Patients using fixed orthodontic appliances, 3- Patients with special needs