cyrilzakka/clinical-trials huggingface dataset:
Detection of Silent Aspiration Events Utilizing pH/Impedance Probes in Hospitalized Patients

Monitoring and quantification of reflux events in high risk critically ill inpatients and lower risk general medical/surgical inpatients, with comparison to relevant clinical variables.

The investigators will conduct a pilot prospective cohort study of the incidence of reflux of gastric contents into the esophagus and the correlation with clinically evident aspiration events. The investigators will demonstrate that an esophageal multichannel pH/impedance probe can be used safely and effectively in an inpatient population to monitor reflux of acidic and non-acidic contents into the esophagus. The investigators will determine the frequency and severity of reflux events in a 24 hour period in two hospitalized patient populations: general medicine patients on the wards and critically ill patients in the intensive care unit. The investigators will then examine the relationship between the documented reflux events and clinically apparent aspiration events. The incidence of these silent reflux events in hospitalized patients is currently unclear.

Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years
2. Admitted to medical-surgical floor or medical intensive care unit

Exclusion Criteria:

1. Patients with contraindication to nasogastric tube placement (facial trauma, active epistaxis, abnormal nasopharyngeal or facial anatomy, esophageal stricture or injury, esophageal varices)
2. Patients requiring non-invasive positive pressure ventilation
3. Patients with uncontrolled vomiting
4. Patients with planned or anticipated airway or esophageal procedure within the 24-hour monitoring period
5. Patients not expected to survive for 24 hours or those receiving hospice/palliative care
The Safety and Effectiveness of Bis-POM PMEA in HIV-Infected Patients

To study the safety, tolerance, single and multiple dose pharmacokinetics, and anti-HIV activity of bis-POM PMEA ( adefovir dipivoxil ) versus placebo when administered orally on a daily basis for 2 weeks to HIV-infected patients.

Patients are randomized to receive bis-POM PMEA at one of three fixed dose levels or placebo daily for 2 weeks. At each dose level, nine patients receive bis-POM PMEA and three patients receive placebo.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone, provided a stable regimen has been maintained for at least 4 weeks prior to study entry.

Patients must have:

* HIV seropositivity.
* CD4 count \>= 100 cells/mm3.
* p24 antigen (immune-complex dissociated) \>= 50 pg/ml.
* Life expectancy of at least 6 months.

Prior Medication:

Allowed:

* Prior prophylaxis with aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active, serious infection (other than HIV infection) requiring parenteral antibiotic therapy.
* Malignancy other than cutaneous Kaposi's sarcoma.
* Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* Gastrointestinal malabsorption syndrome.
* Inability to take oral medication.

Concurrent Medication:

Excluded:

* Any parenteral antibiotic therapy.
* Diuretics.
* Amphotericin B.
* Didanosine (ddI).
* Fluconazole.
* Foscarnet.
* Ganciclovir.
* Interferon-alpha.
* Interferon-beta.
* Isoniazid.
* Aminoglycoside antibiotics.
* Ketoconazole (topical allowed).
* Itraconazole.
* Rifabutin.
* Rifampin.
* Stavudine (d4T).
* Zalcitabine (ddC).
* Zidovudine (AZT).
* Lamivudine (3TC).
* Any investigational agents (except with sponsor approval).
* Systemic therapy for Kaposi's sarcoma.

Patients with the following prior condition are excluded:

History of lactose intolerance.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Any parenteral antibiotic therapy.
* Diuretics.
* Amphotericin B.
* Didanosine (ddI).
* Fluconazole.
* Foscarnet.
* Ganciclovir.
* Interferon-alpha.
* Interferon-beta.
* Isoniazid.
* Aminoglycoside antibiotics.
* Ketoconazole (topical allowed).
* Itraconazole.
* Rifabutin.
* Rifampin.
* Stavudine (d4T).
* Zalcitabine (ddC).
* Zidovudine (AZT).
* Lamivudine (3TC).
* Any investigational agents (except with sponsor approval).

Excluded within 4 weeks prior to study entry:

Systemic therapy for Kaposi's sarcoma. Active substance abuse (including alcohol) as determined by questionnaire or positive drug screen.
The Multifunctional Image Guided Therapy Suite (MIGTS) in Emergency Multiple Trauma Care

Controlled clinical intervention study comparing the treatment of multiple trauma patients in a newly developed combined diagnostic and operation room, the multifunctional image guided therapy suite (MIGTS) versus controls. The MIGTS proved to significantly accelerate the procedure and led to more satisfied team members.

Objective: Pilot evaluation to which extend the implementation of a newly developed combined diagnostic and operation room, the multifunctional image guided therapy suite (MIGTS) may influence the emergency treatment of multiply injured patients.

Summary Background: Controlled data on the impact of modern technology integration in multiple trauma management and involved care providers are lacking.

Methods: Quasi-randomized clinical intervention study comparing the treatment of multiple trauma patients (injury severity score, ISS \>16) in the MIGTS versus controls.

Eligibility Criteria:
Inclusion Criteria:

* multiple trauma with
* at least two abbreviated injury scoring (AIS) regions involved and
* injury severity score (ISS)\>16
* primary hospital treatment at University Hospital Basel

Exclusion Criteria:

* monotrauma or
* ISS \< 16 or
* prior treatment in another hospital
Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method

The more effective use of ultrasound in regional anaesthesia techniques has made different block applications possible. Lumbar plexus block is also used for post-operative analgesia and surgical anaesthesia. Currently, in-plane ultrasound-guided LPB is widely used in short-axis imaging and Shamrock imaging.

The purpose of this use is to investigate the effectiveness of lumbar plexus block application applied with in-plane and out-of-plane methods accompanied by Shamrock imaging.

Eligibility Criteria:
Inclusion Criteria:

* 18-90 years old
* ASA (American Society of Anaesthesiologist) Score I-III risk class
* Patients who will undergo femoral neck fracture operation.

Exclusion Criteria:

* Local Anaesthetic Allergy
* With Bleeding Diathesis Disorder
* Mental Disorders
* Allergic to the medicines used
* Previous Cerebrovascular Disease
* Body Mass Index above 30
Evaluation of the Effect of Music Medicine Application on Menstrual Symptoms

In this study, the "Music Medicine Application" method was chosen in line with the literature and guidelines and it is aimed to determine whether it is effective in reducing the symptoms experienced by female students with "Music Medicine Application" during the menstrual period.

This study aims to determine whether the application of music medicine is effective in reducing the symptoms experienced by female students during the menstrual period. The type of research was planned as a prospective, randomized controlled experimental study with a pretest-posttest control group. The research will be conducted with female students studying at Pamukkale University Faculty of Health Sciences. The data of the research will be collected between March 2024 and February 2025. Personal Information Form, Visual Analogue Scale and Menstruation Symptom Scale will be used to collect data. It was determined that a total of 62 people should participate in the research, 31 in the experimental group and 31 in the control group. As the randomization method, "simple randomization" will be used to ensure an equal number of samples in the experimental and control groups. Randomization will be done using the www.randomizer.org application. The data will be analyzed using the SPSS (23.0) package program. Continuous variables will be given as mean ± standard deviation and categorical variables will be given as number and percentage. Significance Test of Difference Between Two Means in comparing independent group differences when parametric test assumptions are met; When parametric test assumptions are not met, Mann-Whitney U test will be used to compare independent group differences.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteering to participate in the research
2. Menstrual cycle length has been within normal limits (21-35) for the last 3 months
3. Not using oral contraceptives for the last 3 months
4. Not having any psychiatric problems and not receiving any treatment for this in the last 3 months.
5. Not using painkillers or any pharmacological agents or methods that reduce symptoms during the study.
6. Participants who marked 1.1-10 according to Visüel analog scala

Exclusion Criteria:

1. Presence of chronic diseases or serious medical conditions
2. Presence of another physical or psychological disorder that may affect menstrual symptoms
3. Presence of psychiatric or psychological disorders
4. Active drug use or hormone therapy
5. Having given birth
6. Answering survey questions incompletely or not answering them
7. Participants who marked 0-1 according to Visüel analog scala
8. Not applying music medicine for the experimental group
Spontaneous Regression in Metastatic Melanoma and Renal Cell Carcinoma

The purpose of this study is to collect blood and clinical data from patients with metastatic melanoma and renal cell cancer who have experienced spontaneous regression for studies of immune response and other factors that may influence these occurrences.

Spontaneous regression in patients with metastatic cancer is an incredibly rare event. It has been described after infection in cancer patients and also rarely in patients with renal cell cancer (usually after resection of the renal primary) and, less commonly, in patients with metastatic melanoma.

Primary Objective To collect peripheral blood from patients with metastatic melanoma and renal cell cancer and spontaneous regression for studies of immune response and other studies.

Secondary Objective To collect clinical data from subjects registered to this study. Clinical data collection will include demographics and cancer characteristics, history and treatment.

Eligibility Criteria:
Inclusion Criteria

1. ≥ 18 years old at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Patients must have metastatic melanoma or renal cell cancer with spontaneous regression.
4. Willingness to undergo phlebotomy for research blood samples

Exclusion Criteria

1. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety
2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
Efficacy and Tolerability of Topical LFX453 for External Genital Warts

The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%.

During the study the patients received either LFX453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken for safety, pharmacokinetics (PK), and biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Circumcised male 18-60 years
* Clinical diagnosis of external genital warts
* Agree to remain abstinent or to use condoms during intercourse for the duration of the study
* Agree to digital photographs of treated area

Exclusion Criteria:

* Any treatment of genital warts within one month of treatment start
* HPV vaccination
* presence of warts larger than 200 mm2
* Genital herpes within one month of treatment start
* History of Bowenoid papulosis
* significant illness within 2 weeks of treatment start
* use of other investigational drugs
* known hypersensitivity to study drugs or constituents
* history of ECG abnormalities
* History of significant heart conditions
* Impaired renal function
* Abnormal liver function
* History of immunodeficiency disease
* Drug or alcohol abuse
* Immunosuppressive therapies
* Malignancies in the past 5 years
* hypertrophic scarring
Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus

Patient's with High Grade Dysplasia, Carcinoma in situ or Early Adenocarcinoma in Barrett's Esophagus are injected with HPPH and one day later are endoscopically treated with light from a laser.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have biopsy proven high-grade (severe)dysplasia, carcinoma-in-situ or early stage adenocarcinoma
* Patient may have received prior therapy; e.g.Nd-YAG laser, radiation therapy or chemotherapy. At least one-month must have elapsed between prior treatments and PDT
* Tumors (HGD/CIS or early adenocarcinoma) can be primary or recurrent, Stage 0 or I N0M (any)
* Patients must have no contraindication to endoscopy
* Male or female patients must be 18 years old or older. Female patients must not be pregnant and must be practicing a medically acceptable form of birth control or be sterile or post-menopausal. A Pregnancy test is required and must be negative.
* Patients must sign an Informed Consent according to FDA guidelines and be acceptable to the RPCI IRB
* Patients must have a Karnofsky status 50 or above.
* Patients with early invasive adenocarcinoma will be included only if they are considered poor surgical risks, have failed or refused XRT/chemo, or refused surgery.
* If the patients has had cancer other than non-melanoma skin cancer, their treating physician must deem them disease-free.

Exclusion Criteria:

* Patients with tumors of grade greater than T-1.
* Porphyria or hypersensitivity to porphyrin or porphyrin-like compounds
* WBC\<4000; platelet count\<100,000; prothrombin times 1.5 times above upper normal limit.
* Patients with impaired renal and/or hepatic function (total serum bilirubin \> 3.0 mg/d, serum creatinine\>3 mg%, alkaline phosphatase (hepatic) or SGOT\> 3 times the upper normal limit.
* Patients on concurrent chemotherapy or radiation therapy will be excluded as well as those having received prior treatment for the esophageal cancer within 4 weeks of enrollment.
An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma

This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL).


Eligibility Criteria:
Inclusion criteria:

* Males and females greater than or equal to (\>=)18 years of age (at the time consent is obtained)
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 or 2
* Diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or NHL
* Presence of evaluable disease
* Adequate organ function (as defined in the protocol)
* Reproductive criteria (as defined in the protocol).

Exclusion Criteria:

* Malignancy attributed to prior solid organ transplant
* Leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (CNS)-specific treatment in the opinion of the Investigator (for example \[e.g.\], for symptomatic disease)
* History of a second malignancy, excluding non-melanoma skin cell cancer within the last three years
* Evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
* Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
* Select cardiac abnormalities (as defined in the protocol)
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
* History of optic nerve neuropathy or neuritis.
An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide.

The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones.

The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. .


Eligibility Criteria:
Inclusion Criteria:

1. Men diagnosed with prostate cancer.
2. Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation
3. Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time
4. Age ≥ 18 years at treatment start
5. At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months.

Exclusion Criteria:

1. Evidence of metastatic disease before or 30 days after treatment start
2. Prior history of other primary cancers
Using mHealth to Improve Emotional Recovery After Pediatric Injury

Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Trauma centers in the US have good outcomes for survival and physical recovery, but they typically do not have programs to address the emotional and behavioral needs of families. The purpose of this project is to develop a service that achieves this and that can serve as a good model for trauma centers to use. This project will develop, evaluate, and test CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) to address the behavioral and emotional needs of caregivers and children.

This project consists of three main study aims. The first aim is to finalize the CAARE model and research protocol in preparation for the open trial (Aim 2). To complete this study Aim, CAARE will first be refined guided by preliminary work led by the PI with caregivers after pediatric traumatic injury (PTI). Then, we will conduct usability testing and refine the mHealth components of CAARE with about 10 caregivers in preparation for the open trial (Aim 2). Finally, we will debug the research protocol via implementation of the full CAARE intervention with approximately 5 families prior to conducting the open trial. Aim 2, the open trial, is described in more detail in the Arms/Intervention section.

Aim 3 is to assess CAARE implementation feasibility with families, trauma center leaders, and program managers. This will be conducted through qualitative interviews with (1) \~20 caregivers who participated in the open trial - diverse with respect to race, child age, and mental health status - to assess their reactions to CAARE; (2) \~15 pediatric trauma center directors and \~15 pediatric trauma program managers to identify perceived barriers and facilitators associated with implementing CAARE in pediatric trauma centers.

Eligibility Criteria:
Inclusion Criteria:

* caregivers of children who experience pediatric traumatic injury
* children younger than 12
* caregivers older than age 18.

Exclusion Criteria:

* caregiver's primary language is not English
* self-afflicted injury
* injuries resulting from caregiver abuse or neglect
Fetal Nasal Bone Length Nomogram at 11-13wk+6days in Upper Egyptian Pregnant Women

establish a reference values for the fetal nasal bone length (NBL) in upper egyptian pregnant women at 11-13wk+6 days

By using ultrasound measure fetal nasal bone length at 11-13wk+6days in Upper Egyptian pregnant women in mid-sagittal view in single pregnancy

Eligibility Criteria:
Inclusion Criteria:

Normal antenatal women of gestational age between 11 to 13week +6days. Single pregnancy. Viable fetus. No fetal malformation. No previous history of fetal malformation

Exclusion Criteria:

Medical diseased women . Multiple gestations . Fetal malformations . Missed abortion .
Radiographic Assessment of Glass Ionomer Restorations With and Without Prior Application of Nano Silver Fluoride in Occlusal Carious Molars Treated With Partial Caries Removal Technique

eligible teeth will be randomly divided into two groups to be treated with incomplete caries excavation (A), where (A1) represents teeth to be treated with application of Nano silver fluoride solution on remaining carious dentin prior to final permanent glass ionomer restoration application, (A2) represents comparator group to be restored without Nano silver fluoride application prior to restoration. Every participant will receive both the intervention and control treatment. Image of radiographic density of remaining carious dentin will be evaluated using PSP plate at baseline immediately after restoration and after 6 months after restorative procedures.

The null hypothesis tested is that application of Nano silver fluoride solution prior to glass ionomer restoration will not increase radiopacity of the underlying dentin treated by incomplete carious removal technique compared to that of direct glass ionomer restoration without prior application of Nano silver fluoride.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with at least 2 teeth with active carious lesions limited to the occlusal surface of molars at risk of pulp exposure during direct complete excavation (primary caries lesion involving more than half of the entire dentin thickness determined radiographically).
* Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test
* Absence of apical pathosis, clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues.

Exclusion Criteria:

* Teeth with spontaneous pain or sensitivity to percussion.
* Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
* Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
* patients with systemic medical conditions
* pregnant females