cyrilzakka/clinical-trials huggingface dataset:
External Validation of Simplified 4C Mortality Score by Deleting CRP

The (Coronavirus Clinical Characterisation Consortoum) 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (Glasgow Coma Scale), urea or blood urea nitrogen (BUN) level, and C reactive protein (CRP). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability. A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use. we aim to validate a modified 4C score.

The clinical presentation and progression of COVID-19 in patients is highly variable, which makes it difficult for clinicians to triage patients and determine their prognostic risk.

The (Coronavirus Clinical Characterisation Consortoum) 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC) based on eight different parameters: age, sex, number of comorbidities, respiratory rate, peripheral oxygen saturation, level of consciousness (Glasgow Coma Scale), urea or blood urea nitrogen (BUN) level, and C reactive protein (CRP). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability. A recent validation study demonstrated that the score could be simplified by deleting CRP item which is favorable to its widespread use. The study aim to validate a modified 4C score.

Methods

This is a multicenter retrospective observational, cohort study of patients admitted to five Tunisian university hospitals (Fattouma Bourguiba Hospital Monastir, Sahloul Hospital Sousse, Farhat Hached Hospital Sousse, Taher Sfar Hospital Mahdia, Habib Bourguiba Hospital Sfax, Traumatology and Burns Center Tunis), the study included medical records of all adult patients with confirmed COVID-19 infection who were hospitalized from January 2020 and November 2022. A confirmed case of COVID-19 was defined by a positive reverse transcriptase-PCR (RT-PCR) assay of a nasopharyngeal swab associated with compatible clinical manifestations. Incomplete electronic record were excluded from the analysis.

Anamnesis, clinical, paraclinical, radiological, and outcome data were collected using a validated electronic case report form (eCRF). The primary outcomes measure was in-hospital death from any cause.

Eligibility Criteria:
Inclusion Criteria:

- admitted to one of the participating hospitals with a confirmed case of COVID-19 defined by a positive reverse transcriptase-PCR (RT-PCR) assay of a nasopharyngeal swab associated with compatible clinical manifestations

Exclusion Criteria:

* Incomplete electronic records were excluded from the analysis.
The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol

Walking is encouraged for people with type 2 diabetes but there is little evidence that performing a bout of walking can improve glucose control. Furthermore, it is unknown how participant characteristics (e.g., age, sex, medications) impact the acute glucose responses to walking in people with type 2 diabetes. The primary purpose of this study is to examine how a standardized bout of walking impacts glucose control assessed over 24 hours using continuous glucose monitoring. A secondary purpose is to determine whether responses are influenced by age, sex, and medication use.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2D for more than 6 months
* 30-90 years of age
* No contra-indications to exercise (PAR-Q+, Rose Angina questionnaire, limited ability to walk for 50 min).
* No previous myocardial infarction, stroke or diagnosed coronary artery disease
* No changes in diabetes medication in last 3 months
* Not treated by insulin or corticosteroids
* No significant change in body weight (\>5%) in last 3 months
* Blood pressure \<160/100 mmHg; resting HR\<100
* Able to understand English or French and comply with study requirements (e.g., attend visits during the day)
* Hemoglobin A1C \<9.0%
* No prior history of hypoglycaemia during activity or sleep

Exclusion Criteria:

* Chest pain during physical activity.
* Chest pain while resting (no physical activity) in the past month.
* Loss of balance or consciousness because of dizziness in past 12 months
* Bone or joint problem (for example, back, knee, or hip) that could be made worse by a change in physical activity.
* Currently pregnant or planning on becoming pregnant in the next 3 months
* Currently taking exogenous insulin
* Previous heart attack or stroke
* Any other reason that prevents ability to walk on a treadmill for 50 minutes
Spine Registration Using 3D-Scanning

The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.


Eligibility Criteria:
Inclusion Criteria:

1. Patients that require exposure of posterior bony anatomy for visualization as standard of care.
2. Patients will have had a CT scan performed prior to the procedure as standard of care, or is expected to have a CT scan intraoperatively as standard of care.
3. Clinically planned for spine surgery.
4. Able to provide written informed consent from subject, using IRB approved consent form and agrees to comply with protocol requirements.
5. Patients who do not speak English will be allowed to participate, with the expectation that the site will provide interpreter services to help with the consent process.

Exclusion Criteria:

1. Language problems that would prevent from properly understanding instructions in any language.
2. Patients less than 18 years of age or older than 80 years of age
3. Patients who are excluded from consideration for the surgical procedure are therefore excluded from the research study.
4. Special populations: pregnant women, prisoners.
5. Minimally invasive spine surgery that does not expose the necessary bone/s.
6. Spine surgery without posterior exposure.
7. Patients considered high risk for anesthesia, as determined by operative surgeon
Labor Analgesia With Ropivacaine and Clonidine

The aim of the present study was to examine, for pain relief during labor, the efficacy of two pharmacological approaches - the 0.125% ropivacaine alone and the 0.0625% ropivacaine added to 75 ug clonidine, both by epidural administration. The effect of the drugs on mother and newborn was also determined.


Eligibility Criteria:
Inclusion Criteria:

* Singleton healthy
* Full-term pregnancy
* American Society of Anesthesiologists physical status I or II

Exclusion Criteria:

* Patients who had received opioids
* History of hypersensitivity to local anesthetic or to clonidine
* Fetus showed signs of possible intrauterine suffering
* Fetus showed signs of possible neurological deficit
Observational Study of Ibrutinib Use in CLL

IB-RU-SCOPE is a "routine-clinical practice" oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the Russian Federation

Ibrutinib is approved in Russia for treatment of CLL patients both in first line and in relapsed/refractory setting. There is a discrepancy in reported ibrutinib toxicity profile, efficacy and tolerability between registrational clinical trials and observational studies, which to some extent may be explained by patient selection in the former. IB-RU-SCOPE is a first "routine-clinical practice" oriented cohort observational study of ibrutinib in CLL in Russia. The study is designed to include all previously untreated and relapsed/refractory CLL patients older than 18 years with active disease, who have recently started or are about to start ibrutinib (both as monotherapy and in combination), and to follow them to a minimum of 18 and a maximum of 36 months. The study is being conducted in approx. 10 Russian hematological centers and aims to include approx. 70 CLL patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 18 years.
2. Diagnosis of chronic lymphocytic leukemia, established according to iwCLL criteria (Hallek et al., 2018).
3. Presence of indications for initiating treatment as listed in iwCLL guidelines (Hallek et al., 2018) before start of ibrutinib therapy.
4. Treatment with ibrutinib per instructions for medical use of the drug, approved in the Russian Federation, is planned or this therapy has been started within 7 days before enrolment in the study (date of signing of informed consent). Simultaneously, the patient has not received ibrutinib as one of the previous lines of treatment.
5. Informed consent signed by the patient.

Exclusion Criteria:

1. Presence of contraindications for the use of ibrutinib in accordance with the instructions, approved in the Russian Federation for the medical use of the drug, namely:

* known hypersensitivity to ibrutinib (e.g. with anaphylactic and anaphylactoid reactions);
* pregnancy and the period of breastfeeding;
* age under 18 years;
* severe renal dysfunction (creatinine clearance \<30 mL/min), incl. need for hemodialysis;
* severe liver dysfunction (Child-Pugh class C);
* concomitant use with strong inducers of the isoenzyme CYP3A (e.g., carbamazepine, rifampicin, phenytoin and drugs, containing Hypericum perforatum extract);
* concomitant use with warfarin, other vitamin K antagonists, fish oil and vitamin E preparations.
LALUCA Research Platform A Prospective Analysis of Lung Cancer Diagnosis and Management in Clinical Practice

This is a prospective analysis of the diagnosis and treatment of lung cancer in a real-world setting. The aim of the project is to establish a clinical platform to collect representative data on molecular testing, sequence of systemic tumor therapy and other therapies, and disease progression of patients with lung cancer. A special focus will be on molecular biomarker testing and reflex NGS testing. Another aim of the registry is the collection of quality indicators in lung cancer care. The results of the register will be used to describe the current state of care and to develop it further for the future.

The identification of driver-mutations, whose gene product can be specifically inhibited by targeted therapies, has markedly changed the diagnostic and therapeutic landscape for this tumor entity, leading to improved outcomes for patients with metastatic NSCLC.

The use of next generation sequencing (NGS) allows for detection of a multitude of different druggable mutations. In absence of a curative treatment approach and a druggable mutation the prognosis of lung cancer remains poor.

Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-Iife practice, is crucial to evaluate and improve the quality of care for patients with lung cancer.

The purpose of this project is to set up a clinical platform to document representative data on molecular testing, sequence of systemic treatment and other treatment modalities, and course of disease in patients with lung cancer. A particular focus is on molecular biomarker testing and NGS of patients before the start of first-line treatment. The data shall be used to assess the current state of care and to develop recommendations concerning topics that can be improved.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Histologically confirmed lung cancer
* Age ≥ 18 years
* Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments

Exclusion Criteria:

-
Effects of PFC tDCS on Cognitive Control, Attention Lapses and Coordinated Neural Activity in the Theta and Alpha Bands

The purpose of this study is to better understand the neural correlates of higher-order cognition, both in the healthy brain and in schizophrenia, and to determine how these mechanisms are modulated by transcranial direct current stimulation (tDCS) at frontal and occipital scalp sites. Testing the effects of tDCS at these scalp sites on cognitive task performance will help us understand the roles of the brain regions corresponding to these sites during higher-order cognitive processing (language comprehension, cognitive control, and related attention and memory processes). Behavioral and electrophysiological (EEG) measures will be used to assess cognitive performance. Our overarching hypothesis is that stimulating prefrontal circuits with tDCS can improve cognitive control performance, and ultimately performance on a range of cognitive tasks, as compared to stimulating a different cortical region (occipital cortex) or using sham stimulation.

This study is solely intended as basic research in order to understand brain function in healthy individuals and individuals with schizophrenia. This study is not intended to diagnose, cure or treat schizophrenia or any other disease.


Eligibility Criteria:
Inclusion Criteria:

* between ages of 18 and 50
* ability to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks
* ability to give valid informed consent

Exclusion Criteria:

* no history of head trauma
* no current or previous history of treatment with psychotropic medication
* corrected vision 20/30 or better
* tDCS/MRI contraindications, including: pregnancy, ferrous metal in any part of the body, serious medical conditions, claustrophobia, metallic implants, skin damage, conditions such as eczema at electrode sites, cranial pathologies
Assuring Patient-centered Literacy Promotion for Underserved Children Study

This study tests whether an enhanced primary cared based literacy promotion intervention consisting of a video and text message will increase shared reading occurrences between parents and children compared to the standard version.

This is a randomized controlled trial aimed at assessing the effectiveness of an enhanced intervention consisting of a video and a series of text messages in promoting shared reading between parents and children. Participants will be randomized to one of two study arms (1) the enhanced intervention consisting of a video in the waiting room, standard guidance on shared reading, and a series of text messages (2) regular care which includes standard guidance on shared reading. The primary outcome will be shared reading occurrences. Secondary outcomes will include receipt of intervention, measure of the cognitive home environment, developmental screening results, and measure of parent reading beliefs.

Eligibility Criteria:
Inclusion Criteria:

1. primary caregiver of a child age 6-15 months,
2. primary language English or Spanish,
3. cell phone ownership,
4. age ≥18 years,
5. willing to receive text messages, and
6. willing to accept randomization

Exclusion Criteria:

1. Individuals unable to provide consent
2. Individuals who do not meet inclusion criteria
Effect of Light Meal on Pharmacokinetic and Pharmacodynamics of Aliskiren in Patients With Mild to Moderate Hypertension

The purpose of this study is to determine the effect of a light meal on the pharmacokinetics and pharmacodynamics of aliskiren in patients with mild to moderate hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients, 18 to 65 years of age with mild to moderate hypertension
* Patients who are eligible and able to participate in the study

Exclusion criteria:

* Severe hypertension
* Secondary form of hypertension.
* Type 1 or type 2 diabetes mellitus
* Serum potassium out side laboratory reference range
* Any history of hypertensive encephalopathy or cerebrovascular accident

Other protocol-defined inclusion/exclusion criteria may apply
The Effect of an MBSR Course on Medical Trainee and Medical Academic Faculty Stress and Burnout

The study team is seeking to evaluate the efficacy of the Mindfulness Based Stress Reduction (MBSR) course at reducing stress and burnout. This will be done through the collection of brief anonymous online surveys (the Perceived Stress Scale and the Mini Z) before the MBSR course and at 2 weeks, 6 months, and 12 months following the end of the course. Participation is completely voluntary and will not affect anyone's ability to take this course, and the course instructors will have no knowledge of who has or has not participated in the study.

The study is a pre- and post- survey design with the 8-week MBSR course as the intervention. MBSR is an evidence-based curriculum with a greater than 40-year history, that has been taught at Mount Sinai since 2018. Study participants will be those who have voluntarily signed up to take the course in response to an email describing the course that was sent by the office of the Mount Sinai Graduate Medical Education (GME). The study participants will be separated into two groups: faculty and trainees, and the study will span approximately two weeks prior to the start of the course (9/13/2023) (the "pre-" period) and six months after the completion of the course 5/31/2024) (the "post-" period). The course will be delivered by Zoom, but the participants will be joining from all Mount Sinai locations. The MBSR course itself involves didactics (i.e., stress physiology, review of mindfulness research, mindful communication practices), group discussions based on individual experiences with the mindful practices taught in the course, and the teaching of meditation practices including sitting and moving meditation practices. Home practices are offered as guidance each week but are not required. There is no planned control group at this time.

Eligibility Criteria:
Inclusion Criteria:

- A physician in The Mount Sinai Hospital System

Exclusion Criteria:

- none
Safety, Tolerability, and Antiviral Activity of ANA598 Administered in Combination With Pegylated Interferon and Ribavirin for the Treatment of Genotype-1 Chronic HCV Infection

The purpose of this study is to assess the safety, tolerability and effectiveness of ANA598 when administered with pegylated interferon and ribavirin (Standard of Care \[SOC\]) compared to placebo + SOC.

The safety, tolerability and antiviral activity of ANA598, administered orally at 200 mg BID or 400 mg BID for 12 weeks in combination with pegylated interferon and ribavirin (SOC) will be compared to placebo + SOC. Treatment-naïve patients with genotype 1 infection will be eligible for enrollment. Patients randomized to ANA598 will receive a loading dose of 800 mg q 12 hours administered on the first day of dosing. Patients with undetectable HCV RNA at week 4 and week 12 will be randomized to receive either an additional 12 or 36 weeks of SOC alone.

Ninety patients will be randomized into 2 cohorts. The forty-five patients in each cohort will be randomized as 30 active: 15 placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ages 18 to 65 years
* Documented chronic HCV infection, genotype 1a or 1b
* Treatment-naïve

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding
* Infection with non-genotype 1 HCV
* Previous treatment for HCV infection
* HIV or HBV positive
* Any medical contraindication to Peg-IFN or RBV therapy
* History of any other known cause of liver disease
Efficiency of Patellar Taping in Treatment of Patellofemoral Pain Syndrome

Patellar subluxation is a common disorder that may cause patellofemoral pain syndrome. The efficiency of patellar taping in the treatment of patellofemoral pain syndrome has been reported good outcomes in most patients. However, some studies reported less effective in patients with higher body mass index, larger lateral patellofemoral angle, and smaller Q angle. The investigators hypothesized that femoral internal rotation is a negative factor to the patellar taping. The investigators enroll consecutive 100 patients with anterior knee pain and radiographic evidence of patellar subluxation. The investigators determine femoral rotation via physical examination. The visual analogue scale was evaluate to compare the result between the those with and without femoral internal rotation.

Consecutive 100 patients with anterior knee pain and compatible with inclusion criteria. Before treatment, an independent physiotherapist evaluates whether femoral internal rotation or not via physical therapy, and another studying nurse records the visual analog scale and measures Q angle. After evaluation, McConnell taping is applied to these patients. Two weeks later, outcomes are recorded including visual analog scale, satisfactory, and complication. The outcomes are compared between those with and without femoral internal rotation.

Eligibility Criteria:
Inclusion Criteria:

* anterior knee pain
* radiographic evidence of patellar subluxation

Exclusion Criteria:

* history of patellar dislocation
* osteoarthritis of ipsilateral knee
* pregnancy
* history of knee injury
* BMI \> 35
* allergy to taping
Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance

The investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility.

The investigator's purpose is to study the population pharmacokinetics of meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility. In this study, the investigator will detect drug concentration in both plasma and cerebrospinal fluid to construct population pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

* Children have been diagnosed with bacterial meningitis with augmented renal clearance (eGFR ≥ 160 mL/(min\*1.73m2));
* Age: 2 months-18 years;
* Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and/ or linezolid used as part of regular treatment;
* Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid was administered intravenously.

Exclusion Criteria:

* Patients who die within the treatment cycle;
* Severe congenital malformation;
* Receive other systemic experimental drug therapy;
* Other factors that the researchers consider unsuitable for inclusion.
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients

This was a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12 - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
* Chronic spontaneous urticaria diagnosis for 6 months

Key Exclusion Criteria:

* Weight less than 20 kg
* Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
* Evidence of parasitic infection
* Any other skin diseases than chronic spontaneous urticaria with chronic itching
* Previous treatment with omalizumab
* Contraindications to diphenhydramine
* History of anaphylactic shock
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
* History of hypersensitivity to omalizumab or to drugs of similar chemical classes
* Pregnant or nursing (lactating) women