cyrilzakka/clinical-trials huggingface dataset:
Crossed Leg Sign and it's Correlation With Significant Pathology

By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology.

By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology. Therefore, by determining the sensitivity and specificity of this physical exam finding, the clinician would have a better idea of the patients clinical management, including diagnostic testing and ultimate treatment of the patient. Crossed Leg Sign will be defined in this study as: any patient observed in the Emergency Department with sustained crossed legs. To my knowledge, crossed legs have never been evaluated in regards to it's correlation with significant pathology. This could potentially add another physical exam finding to be used by the clinician.

Eligibility Criteria:
Inclusion Criteria:

* Any patient observed in the Emergency Department with sustained crossed legs.

Exclusion Criteria:

* Any patient not observed to have sustained crossed legs and is not being used as a control.
A Preliminary Clinical Usability Study for the Recovery Force DVT II Cuff

A preliminary clinical usability study to assess design, comfort, wearability, and acceptance of Recovery Force's Deep vein thrombosis (DVT) cuff

A single site, observational study will be conducted at the University of Southern California (USC) with participants who have and/or have had previous experience with DVT pneumatic cuffs. Study staff will examine participants overall experience, product functionality and perceived adherence to Recovery Force's DVT II cuff.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female Age 18-65 who have had exposure with a DVT cuff on the calf within the last 6 months from a previous or current clinical condition

Exclusion Criteria:

-
An Investigator-initiated, Explorative Trial Evaluating the Effect of SAT-008 in Healthy Adults

The purpose of this exploratory study is to evaluate the efficacy, safety, and feasibility of a novel digital device called SAT-008 in healthy adults.

This clinical study was designed as a single institution, open, controlled, and investigator-led clinical trial to evaluate the efficacy, safety, and feasibility of a novel digital device called SAT-008 in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19 to 50 years
* Received influenza vaccination the previous year
* Scheduled to receive the influenza vaccine
* Voluntarily agrees with a consent form

Exclusion Criteria:

* Current infectious disease
* History of autoimmune diseases
* Current immunological compromised diseases.
Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter

Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing arthroplastic surgery of knee or hip

Exclusion Criteria:

* Sensitivity to local anesthetics
* Other reason not to use local anesthetics
Safety, Tolerability and Pharmacokinetics of BEA 2180 BR in Healthy Male Volunteers

Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of BEA 2180 BR; additional exploration of metabolism following inhalation


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (BP, PR), 12 lead ECG measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
2. Age ≥21 and ≤50 years
3. BMI ≥18.5 and \<29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Exclusion Criteria:

1. Any finding of the medical examination (including blood pressure (BP), pulse rate (PR), and ECG measurements) deviating from normal and of clinical relevance
2. Evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
8. Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
10. Participation in another trial with an investigational drug within 2 months prior to randomisation
11. Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
12. Inability to refrain from smoking on trial days as judged by the investigator
13. Alcohol abuse (regularly more than 40 g alcohol per day for men)
14. Drug abuse
15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
16. Excessive physical activities within 1 week prior to randomisation or during the trial
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of the study centre

    The following exclusion criteria are specific for this study due to the known class side effect profile of anticholinergic drugs:
19. hypersensitivity to tiotropium and/or related drugs of these classes
20. history of narrow-angle glaucoma
21. history of prostatic hyperplasia
22. history of bladder-neck obstruction
Co-administration Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-802)(COMPLETED)

The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

The duration of treatment is 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

* Patients who have cholesterol levels within normal ranges as identified by the study
Comparison of McGrath Series 5 and Airtraq Videolaryngoscope for Double-lumen Tube (DLT) Intubation

Previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. We have compared it with traditional Macintosh laryngoscopefor double-lumen tube intubation. In this study, we will investigate its role in double-lumen tube intubation by comparison with another videolarygoscope.

The investigators designed a randomised controlled study to compare of McGrath Series 5 and Airtraq videolaryngoscope for DLT intubation in intubation time and the first attempt success rate.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Thoracic surgery required one lung ventilation

Exclusion Criteria:

* ASA physical status \>4
* Emergent operation
* planned tracheotomy
* difficult intubation predicted by a simplified airway risk index score
Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block

The purpose of this prospective, randomized, double-blind, placebo-controlled study is to evaluate the effect of preoperative administration of alprazolam on the success of the IAN block for teeth with irreversible pulpitis.

Sixty patients diagnosed with irreversible pulpitis of a mandibular molar randomly receive, in a double-blind manner, identical capsules of either 0.50 mg alprazolam or placebo 45 minutes before the administration of a conventional IAN block. Access is begun 15 minutes after completion of the IAN block, and all patients profound lip numbness. Success is defined as no or mild pain based on visual analog scale recordings during access preparation and initial instrumentation.

Eligibility Criteria:
Inclusion Criteria:

* patients with active pain in a mandibular molar
* prolonged response to cold testing with Endo-Frost cold spray
* Absence of any periapical radiolucency on radiographs
* a vital pulp while access cavity preparation
* ability to understand the use of pain scales.

Exclusion Criteria:

* patients were having allergy and sensitivity to benzodiazepines
* pregnant and breast feeding patients
* patients who had taken sedation within 24 hours before the treatment
* having pain in more than one mandibular tooth
* unable to give informed consent
Complications Associated With Partial Nephrectomy for Renal Cancer

This paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy .

This paper evaluates the initial complications and the complications two years postoperatively necessitating re-hospitalisation for three surgical procedures for renal tumour partial nephrectomy (open (OPN), standard laparoscopy (LPN) and robot assisted laparoscopy (RAPN)) in 2016-2017 in France (9119 initial hospitalisations included 4035 OPN, 1900 RAPN, 1709 LPN). The investigators have extracted for these all hospitalisations from the French national hospital data base (PMSI-MCO). The investigators concluded mini-invasive and robotic surgery had lower morbidity and a shorter initial hospitalisation.

Eligibility Criteria:
Inclusion Criteria:

* hospitalisations between the 1st January 2016 and the 31st December 2017 with one of the partial nephrectomy codes

Exclusion Criteria:

* partial nephrectomy for non-cancerous pathology
* no technical information
ALI/ARDS Clinical Sub-phenotyping Study

1. Construct a structured clinical data and biosample information platform for Chinese patients with acute lung injury/ acute respiratory distress syndrome.
2. By deciphering the heterogeneity of patients with acute lung injury/ acute respiratory distress syndrome, achieve clinical, longitudinal physiological, and biological sub-phenotyping to guide individualized precision treatment and improve prognosis.

Acute lung injury/ acute respiratory distress syndrome is one of the most common and complex critical illnesses in clinical practice, with a high mortality rate of 45% to 50%. Currently, effective therapeutic strategies for this condition are still lacking. Increasing evidence suggests that the significant heterogeneity of this disease plays a crucial role in the poor treatment outcomes and high mortality rates observed in patients. Therefore, this study aims to analyze the heterogeneity of acute lung injury/ acute respiratory distress syndrome patients and establish a clinical classification system for acute lung and extrapulmonary organ injuries.

The objectives of this study include establishing a nationwide clinical database and biobank for acute lung injury / acute respiratory distress syndrome by collecting clinical data and biological samples from various provinces. By overcoming the barriers posed by diverse and heterogeneous data sources, mathematical and machine learning models will be utilized to construct clinical, physiological, and biological classification systems for acute lung and extrapulmonary organ injuries. The proposed classification model will be validated multiple times using international public databases and prospective acute lung injury/acute respiratory distress syndrome cohorts to ensure its stability and generalizability. The mapping relationship between different classifications and patient prognosis as well as treatment responsiveness will be explored.

Moreover, a machine learning-based supervised technique will be applied to develop a bedside simplified model (Point-of-Care model) and establish a bedside clinical classification decision system. Ultimately, this research aims to provide a foundation for standardized and precision-guided clinical diagnostic and therapeutic pathways, promoting improved treatment outcomes and overall prognosis in acute lung injury/ acute respiratory distress syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for Acute Respiratory Distress Syndrome (ARDS) according to the updated global definition in 2023.
* The patient or their legal representative signs an informed consent form.

Exclusion Criteria:

* Individuals aged less than 18 years old.
* Those who refuse to participate in the study.
An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease (TED)

This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic Thyroid Eye Disease (TED).

This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as subcutaneous/SC injections every 4 weeks or every 8 weeks compared to placebo in participants with chronic TED.

Participants who do not have a meaningful response at Week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of VRDN-003.

Eligibility Criteria:
Key Inclusion Criteria:

* Must have moderate to severe chronic TED, with any CAS (0-7) on the 7-item scale, and with documented evidence of ocular symptoms or signs that began greater than 15 months prior to screening
* Must agree to use highly effective contraception as specified in the protocol
* Female TED participants must have a negative serum pregnancy test at screening

Key Exclusion Criteria:

* Must not have received prior treatment with another anti-IGF-1R therapy
* Must not have received systemic corticosteroids or steroid eye drops for any condition, including TED, or selenium within 2 weeks prior to first dose.
* Must not have received other immunosuppressive drugs for any condition, including TED, or any other therapy for TED within 12 weeks prior to first dose
* Must not have received an investigational agent for any condition, including TED, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose
* Must not have received radioactive iodine (RAI) treatment within 8 weeks prior to first dose
* Must not have had previous orbital irradiation or decompression surgery for TED to the study eye's orbit
* Must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results
* Must not have abnormal hearing test before first dose. Must also not have a history of ear conditions considered significant by study doctor
* Must not have a history of inflammatory bowel disease
* Female TED participants must not be pregnant or breastfeeding

NOTE: There are additional eligibility criteria for participants who do not have a meaningful response at Week 24 (irrespective of initial treatment arm) who may receive additional injections of VRDN-003. These are described in the protocol.
A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)

This study was evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose metabolism.


Eligibility Criteria:
Key Inclusion Criteria:

* Heterozygous for F508del and an MF mutation (F/MF genotypes)
* Forced expiratory volume in 1 second (FEV1) value ≥ 30% of predicted mean for age, sex, and height
* Abnormal glucose tolerance determined by an OGTT as either:

  * Impaired glucose tolerance (IGT) defined as 2 hour post OGTT blood glucose level ≥140 to \<200 mg/dL (≥7.77 to \<11.10 mmol/L) and fasting blood glucose level \<126 mg/dL (\<7.00 mmol/L)
  * CF-related diabetes (CFRD) defined as either fasting hyperglycemia (blood glucose level ≥126 mg/dL \[≥7.00 mmol/L\] after an 8-hour fast) or 2-hour post OGTT blood glucose level ≥200 mg/dL (≥11.10 mmol/L)

Key Exclusion Criteria:

* Clinically significant liver cirrhosis with or without portal hypertension
* Solid organ or hematological transplantation
* Lung infection with organisms associated with a more rapid decline in pulmonary status
* Type 1 or Type 2 diabetes
* Duration of CFRD ≥5 years

Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy

The object of this study is to investigate the damage to the retinal nerve fiber layer (RNFL) and ganglion cell complex layer (GCL+) in diabetic patients without retinal microangioma as detected by fundus fluorescein angiography (FFA) and to determine the kind of nerve damage more likely to indicate early injury.

Patients with type 2 diabetes mellitus and healthy volunteers will be included in our study. Patients with retinal microangioma are excluded by FFA. The parameters around the optic disc and macular area of the above two groups are measured by optical coherence tomography (OCT), and the results will be analyzed using the SPSS 22.0 software.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with T2DM
2. Patients without microangioma

Exclusion Criteria:

1. Patients with any other ocular disease that might affect retinal nerve injury
2. Patients with optic neuropathy, age-related macular degeneration, retinal and choroidal disease, and retinal artery/vein occlusion.
3. Patients with hypertension, hematopathy, neuropathy, and other systemic diseases causing retinal nerve changes.
4. Patients with keratopathy, cataract, and vitreous hemorrhage were also excluded.
Linking Novel Diagnostics With Data-Driven Clinical Decision Support in the Emergency Department

The primary objective of this study is to validate the use of an electronic clinical decision support (CDS) tool, TriageGO with Monocyte Distribution Width (TriageGO-MDW), in the emergency department (ED). TriageGO-MDW is non-device CDS designed to support emergency clinicians (nurses, physicians and advanced practice providers) in performing risk-based assessment and prioritization of patients during their ED visit. This study will follow an effectiveness-implementation hybrid design via the following three aims (phases), to be executed sequentially:

(Aim 1) Validate the TriageGO-MDW algorithm locally using retrospective data at ED study sites.

(Aim 2) Deploy TriageGO-MDW integrated with the electronic medical record (EMR) and perform user assessment.

(Aim 3) Evaluate TriageGO-MDW in steady state with respect to clinical, process, and perceived utility outcomes.


Eligibility Criteria:
Inclusion Criteria: Adult patients receiving care at a study site ED

Exclusion Criteria: None
A Validation Study of The Relationship Between ALDH2 and Aortic Dissection

The purpose of this study is to validate the impact of ALDH2 Glu504Lys polymorphism on aortic dissection.


Eligibility Criteria:
Inclusion Criteria:

* Chinese Han people diagnosed with aortic dissection in Guangdong Provincial People's Hospital

Exclusion Criteria:

* Aortic dissection based on trauma, connective tissue diseases and pregnancy
* Patients with tumor
* Patients with no written consensus
The Effect of the COVID-19 Pandemic on Primary Bladder Cancer Presentations

In this study, investigators aim to reveal how the COVID-19 pandemic process affects primary bladder cancer presentations, tumor stages and degrees, the time elapsed between diagnosis and intervention, tumor recurrence and progression, which are oncological results.

The rapid spread of the 2019 coronavirus disease (COVID-19) caused by a novel betacoronavirus known as the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has had dramatic effects on individuals and health systems around the world. Beyond those infected with SARS-CoV-2, the intense demand for limited health system resources has led to reduced capacity, rapid depletion of healthcare systems, and hospitals becoming a source of virus transmission.

Urology associations and reference centers have issued recommendations to inform urology care during the COVID-19 outbreak. It is essential that urologists give priority to patient safety. Potential delays in the diagnosis and treatment of urological conditions and the additional burden on healthcare resources must be balanced against the risks of exposure to COVID-19. While this situation aims to conserve healthcare resources, it has created the risk of delaying cancer treatment. As a result, the transformation of health services and the increasing interest of the public in avoiding exposure to the disease has led to a decrease in the number of hospital admissions.

The effects of the pandemic on patients with bladder cancer due to a decrease in emergency room and urology clinic admissions are not clear. During the COVID-19 outbreak, the EAU (European Association of Urology) panel of non-muscle invasive bladder cancer published an evidence-based guideline. According to this guideline, four priority groups were formed and a certain period of delaying treatment was defined for patients in each group according to their priorities.

Eligibility Criteria:
Inclusion Criteria:

* Primary bladder cancer

Exclusion Criteria:

* Previous history of urinary tract tumor
* Chronic kidney disease