cyrilzakka/clinical-trials huggingface dataset:
The Effect of Low Flow Anesthesia on Postoperative Emergence Agitation in Rhinoplasty

Emergence agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia; this may cause respiratory depression, nausea and vomiting, as well as an increase in blood pressure, heart rate and myocardial oxygen consumption. Although its pathogenesis remains unclear, ENT (ear, nose and throat) surgical procedures have been reported to have a higher incidence of agitation in both adults and children. In recent years, low-flow inhalation anesthesia has been widely used in adult anesthesia practice. The aim of this study is to compare the effects of low flow anesthesia and normal flow anesthesia on emergence agitation.

Emergence agitation, defined as restlessness, disorientation, arousal, and/or inconsolable crying, is a common phenomenon seen in the early phase of recovery from general anesthesia; this may cause respiratory depression, nausea and vomiting, as well as an increase in blood pressure, heart rate and myocardial oxygen consumption. Hypoxia can lead to serious complications such as aspiration pneumonia, bleeding or reoperation. Although its pathogenesis remains unclear, ENT (ear, nose and throat) surgical procedures have been reported to have a higher incidence of agitation in both adults and children.

In recent years, low-flow inhalation anesthesia has been widely used in adult anesthesia practice. Low flow anesthesia has many advantages; the consumption of inhalation agents is reduced, the temperature and humidity of the airways are maintained, the cost of anesthesia and pollution caused by atmospheric waste gases are reduced. In addition, because the temperature and humidity of the tracheobronchial tree are preserved, respiratory functions and mucociliary activities are better preserved. In low-flow anesthesia, the concentration of inhaled anesthetics changes very slowly, and their concentration gradually decreases after the administration is terminated. Since the anesthetic concentration will slowly decrease in the low-flow group during termination of anesthesia, the concentration difference between the brain and lungs will be small. In addition, it is known that a longer period between discontinuation of the administration of anesthetic agents and extubation reduces emergence agitation. This seems possible with the low-flow anesthesia technique.

The aim of this study is to compare the effects of low flow anesthesia and normal flow anesthesia on emergence agitation.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years
* ASA class I-II,
* scheduled for elective rhinoplasty surgery under general anesthesia

Exclusion Criteria:

* history of allergy to nonsteroidal anti-inflammatory drugs,
* bleeding diathesis or anticoagulant use,
* psychiatric drug use,
* previous rhinoplasty surgery
* patient refusal
Confocal Laser Endomicroscopy With Cresyl Violet for in Vivo Diagnosis of Gastric Intestinal Metaplasia

Confocal laser endomicroscopy (CLE) is a novel endoscopic system which can provide approximately 1000-fold magnification of the gastrointestinal mucosa. Previous studies have demonstrated its diagnostic value for Gastric intestinal metaplasia (GIM) with the use of a contrast agent.Recently, Cresyl violet (CV) has been used in CLE to visualize tissue architecture in human ileum, colon or myenteric plexus.No investigation has reported the characterization of GIM imaged with CLE when using CV as staining dye


Eligibility Criteria:
Inclusion Criteria:

* patients who had long-lasting upper gastrointestinal symptoms and aged 40 years or above
* patients with H. pylori infection, or known GIM or atrophic gastritis

Exclusion Criteria:

* patients with a history of GI surgery
* advanced gastric carcinoma or any other malignancy in the GI tract
* acute upper GI bleeding
* patients with contraindications to CLE examination, such as coagulopathy, pregnancy, breast feeding, impaired renal or liver function
* patients refused to provide informed consent
A Study on the Efficacy and Safety of Repeated Treatments With Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines

This is a Multi-center, Open-label Study on the Efficacy and Safety of Multiple Treatments with Recombinant Botulinum Toxin Type A for Injection in the Treatment of Moderate to Severe Glabellar Lines. The study has been designed to evaluate the long-term safety, tolerability, efficacy , maintain time and immunogenicity of multiple treatments with Recombinant Botulinum Toxin Type A for Injection (YY001) in the treatment of moderate to severe glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female 18 to 65 years (inclusive) at the time of signing the informed consent form.
2. At screening or baseline, participants who complete all visits of the REFINE study without major protocol deviations and SAEs
3. Agree to participate in the study and sign the informed consent form.
4. At the discretion of the investigator, the participants can comply with the protocol requirements.
5. Females and/or males of childbearing potential and their partners: those who should be using effective contraception and have no plans for childbearing, egg donation (females), or sperm donation (males) from the signing of the informed consent form to 3 months after the last administration. female participants of childbearing potential must have had a negative blood pregnancy test (human chorionic gonadotropin) within 7 days prior to the first administration of study drug or a Urine pregnancy test examination must be negative 3 days prior to the first administration of study drug.

Note:

1. Women of childbearing potential are those who have experienced menarche, have not undergone sterilization (hysterectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation), and are not in a state of post-menopausal (defined as absence of menstrual bleeding for 12 months prior to screening, without any other medical reason).
2. Effective contraceptives include: vasectomy, abstinence, intrauterine devices, hormones \[oral, patch, ring, injections, implants\], barrier methods \[diaphragm, cervical cap, sponge, condom\].

Exclusion Criteria:

1. Use of medications or treatments prohibited by the REFINE study protocol.
2. Any condition that required permanent discontinuation of study treatment during the REFINE study.
3. Use of nonsteroidal anti-inflammatory drugs including aspirin or anticoagulants within 1 week prior to baseline.
4. Abnormal laboratory tests that, in the assessment of the investigator, are not appropriate for participation in this study: including, but not limited to: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range (×ULN), creatinine ≥ 2 ×ULN, urea/urea nitrogen ≥ 2 ×ULN.
5. Female who is pregnant or breast feeding.
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF

Sensorum Health (Sensorum) is conducting a pilot study to determine if Sensorum's proprietary passive sensor network can be used to identify signals of early health decompensation in subjects prior to a hospitalization for chronic disease exacerbation or other ambulatory care sensitive conditions. Successful early detection would provide a window of opportunity to intervene outside of the acute setting in future interventional studies.


Eligibility Criteria:
Inclusion Criteria:

* Current Patient at Weill Cornell Medicine
* Aged 55 years or older
* Able to consent
* Documented diagnosis of congestive heart failure (CHF)
* At least 1 of the following prior hospital utilization events in the past 12 months
* Inpatient admission for any reason
* Facility observation stay for any reason
* Emergency Department visit for any reason

Exclusion Criteria:

* Significant cardiac valvular disease
* End-Stage Renal Disease (ESRD)
* End-Stage CHF
* End-Stage COPD
Hispanic Men Building Respect Education and Safety/ HoMBRES Manteniendo Respeto, Educacion y Seguridad.

The overall objective of this project is to adapt and enhance HoMBReS (Hispanic Men Building Respect, Education, and Safety within Families /Hombres Manteniendo Respeto, Educacion y Seguridad de Familia), a Center for Disease Control (CDC)-identified best-evidence HIV behavioral intervention designed to reduce substance abuse, family violence, and HIV/AIDS (SAVA) among sexually active heterosexual Latino seasonal farmworkers (LSFWs) in rural areas.

The HoMBRES de Familia project study (HoMBRES) examined the efficacy of a culturally adapted group intervention program with fathers from a seasonal farm working community and an Urban community in South Florida. The HoMBRES intervention study adapted and tested the efficacy of an intervention that can be adopted, implemented, and sustained with Latino fathers who live or work in the farm industry, construction, services, self employed or any other work industry in the semi-rural areas and urban areas of Miami Dade County. The HoMBRES intervention seeked to reduce risk for the SAVA (Substance Abuse, Violence, and HIV/AIDS infection) syndemic among this group of men and their adolescent sons.

The intervention HoMBRES consisted of four sessions remotely facilitated via a well-tested video platform accessible by a link sent to the participants' telephone, computer, tablet or IPad (approximately 1.5 hours each session). Staff scheduled the times when participants will watch the videotaped sessions in order to be available for their questions. Intervention videos were followed up with a telephone call to discuss presentation and respond to any questions participants may have had about the sessions and clarify (if needed) the material covered in the videos via telephone. Video sessions were completed within two weeks time period. Participants in the control group received one single video on diabetes prevention. Both groups were followed up six months post baseline interview.

Eligibility Criteria:
Inclusion Criteria:

* male
* adults (age 18 or above)
* living in semirural and urban areas of Miami Dade
* Latino
* understand and speaks Spanish
* has an eligible son ( 11-17 years old)

Exclusion Criteria:

* father does not provide consent and permission for his son
* son does not provide assent
VR Ultrasound Guided Breast Localization

To determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast localization procedure (traditional wire, savi scout or a radiofrequency identification tag).

Needle localizations for breast cancer surgery are required to identify cancerous tissue before surgery. Currently this procedure is done with or without a local anesthetic. Patients report anxiety regarding cancer and cancer-related procedures. Different types of needle localization may have different pain and anxiety based on their duration, complexity, and invasiveness. This research is designed to determine if VR simulated environment can reduce pain and anxiety.

Our aim is to study the efficacy of a virtual environment in reducing pain and procedural anxiety. It is intended for patients undergoing an ultrasound guided breast localization procedure that have had an abnormal breast biopsy. The overall aim is to discover an efficacious nonpharmacologic method to lower pain and anxiety during a standard of care procedure.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent is obtained from the patient
* Females ≥ 18 years of age
* Patient is schedule for preoperative ultrasound guided breast localization procedure

Exclusion Criteria:

* Patient is scheduled for or switched to a stereotactic localization procedure
* The patient has motion sickness
* The patient has severe cognitive disabilities or language barriers that inhibit study form completion in English
* Refusal of patient to sign consent
DMT310-001 Topical in the Treatment of Acne Vulgaris

The objective is to evaluate the tolerability, safety, and efficacy of DMT310 topical powder mixed with diluent in male and female patients with moderate to severe facial acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or non-pregnant female at least 18 years of age.
* Clinical diagnosis of moderate to severe acne vulgaris as determined by:

Investigator's Global Assessment (IGA) at Randomization Patient has at least 20 but not more than 50 inflammatory lesions on the face Patient has at least 20 but not more than 100 noninflammatory lesions on the face

* Patient is willing to apply the Investigational Product as directed
* Patient is willing and able to comply with the protocol

Exclusion Criteria:

* Patient is pregnant or planning to become pregnant
* Patient is taking a topical therapy on the face which may affect the patient's acne
Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System

Randomized Controlled Study to determine if preservation of ligaments provides increased functional ability post-operatively in comparison to traditional TKA which sacrifices soft tissue.

Randomized Controlled Study to compare clinical and patient reported outcomes of the Vanguard XP Bicruciate Total Knee System to the Vanguard CR Knee System through 10 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* cemented application of components
* bilateral subjects randomized by knee
* patients with pre-existing contralateral knee surgery
* painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
* correction of varus, valgus, or posttraumatic deformity
* sufficient soft tissue surrounding the knee, including the Anterior Cruciate Ligament

Exclusion Criteria:

* cementless application of components
* BMI greater than or equal to 40
* use of Anterior Stabilized Bearings
* patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
* correction or revision of previous joint replacement procedure on index knee
* infection
* sepsis
* osteomyelitis

Relative exclusion criteria:

* uncooperative patient or patient with neurological disorders who is incapable of following directions
* osteoporosis
* metabolic disorders which may impair bone formation
* osteomalacia
* distant foci of infections which may spread to the implant site
* rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* vascular insufficiency, muscular atrophy, neuromuscular disease
* incomplete or deficient soft tissue surrounding the knee, including the anterior cruciate ligament
Study of BAY1834942 in Patients With Solid Tumors

This is an open-label, Phase 1, first-in-human, dose escalation and expansion study designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and tumor response profile of the anti-Carcinoembryonic-antigen-related-cell-adhesion-molecule-6 (CEACAM6) antibody BAY1834942 in patients with advanced solid tumors known to have a prevalence for CEACAM6 expression.

The study consists of dose escalation and a tumor type-specific expansion.

The primary objectives of the study are to evaluate and characterize the tolerability and safety profile of repeated doses of BAY1834942, and to characterize the pharmacokinetics of BAY1834942 after single dose.

Secondary objectives are to evaluate the tumor response profile, pharmacodynamics, pharmacokinetics and immunogenicity after multiple doses of the drug.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged ≥ 18 years
* Patients with histologically confirmed advanced/ metastatic solid tumors: Dose escalation: solid tumor types with a expression of CEACAM6 (gastric/ GEJ cancer, esophageal cancer, NSCLC, CRC, pancreatic cancer, cervical cancer, breast cancer, bladder cancer, head and neck squamous cell cancer, bile duct cancer); Dose expansion: advanced adeno NSCLC, CRC and gastric/ GEJ adenocarcinoma.
* ECOG-PS of 0 to 1.
* Adequate organ function (bone marrow, liver, kidneys).
* Adequate coagulation function.
* Adequate cardiac function

Exclusion Criteria:

* Patients with active symptomatic or untreated brain metastases; possible exceptions for patients with treated asymptomatic central nervous system metastases
* Active autoimmune disease
* History or evidence of active pulmonary fibrosis, organizing pneumonia, or pneumonitis.
* Risk factors for bowel obstruction or bowel perforation
* History of cardiac disease
* Uncontrolled arterial hypertension despite optimal medical management
* Clinically relevant findings in electrocardiogram
* HIV infection
* Active HBV or HCV infection
Connection to Health for Smokers

The goal of the study is to develop and test Connection to Health for Smokers (CTHS), a comprehensive program to support smokers to quit and improve smokers' general health. The program will be designed for implementation by health educators in community health centers.

The investigators will use a participatory approach to develop and test the feasibility and acceptability of CTHS in community health center sites in Contra Costa County. Development of the program will be informed by active engagement with a patient advisory group composed of current smokers and clinical team members who serve current smokers in community health centers. Feasibility and acceptability will be assessed by implementing the CTHS program for patients in 3 clinical sites, using the RE-AIM evaluation framework. Primary outcomes will include the number and proportion of enrolled smokers who create at least one health-related action plan with a health educator, and stated intention of clinical teams to continue using CTHS after the research. The investigators will enroll 90 smokers in CTHS and 90 additional smokers in Enhanced Standard of Care (ESC) which will be the active comparison group. Participants will be randomly assigned. Smoking status will be reassessed after 3 months. Primary outcomes will include number of 24-hour quit attempts, and 7-day smoking abstinence, as well as changes in self-efficacy and readiness to quit smoking among participants who do not quit. Results of this pilot program will inform further development of the CTHS program for testing in larger scale clinical trials.

Eligibility Criteria:
Inclusion Criteria:

- Must have smoked cigarettes in the last 7 days

Exclusion Criteria:

- Speaking languages other than English or Spanish
Preventing Cigarette Use Among Urban Youth Via an M-Health Primary Care Preventive Intervention

The study aims to develop tobacco modules to be included in an innovative mobile-health (mHealth) intervention (hereon referred to as S4E) and to determine the feasibility and preliminary efficacy of the updated version of S4E in an urban youth-centered community health clinic in Southeast Michigan.

Tobacco use remains a significant public health concern in the US, and youth are disproportionately affected. Among high school youth , 38% report lifetime cigarette use, and 9.3% report having smoked a whole cigarette before the age of 13. In Southeast Michigan, African-American youth are at disproportionate risk of engaging in tobacco use and co-occuring substance use and other risk behaviors. To address these significant public health concerns, we developed Storytelling 4 Empowerment (S4E), a targeted and tailored mobile-health (mHealth) application (app) intervention to be delivered in health clinic settings. The proposed research aims to develop culturally congruent and developmentally appropriate modules focused on tobacco use prevention and risk reduction to be included as part of the S4E mHealth app. The proposed research will also determine the preliminary efficacy of S4E in reducing tobacco use, alcohol and other drug use, sexual risk behaviors, and improving HIV/STI testing in a sample (n=50) of youth ages 13-21 living in Southeast Michigan.

Eligibility Criteria:
Inclusion Criteria:

* Female, Male, and Transgender adolescents
* Adolescents 13-21 years of age
* Adolescents must live in Southeast Michigan
* Adolescents must provide assent and consent

Exclusion Criteria:

* Report of a prior psychiatric hospitalization by adolescent or caregiver
* Adolescent reports (tentative or firm) plans to move out of the Southeast Michigan area during the study.
Study of the Efficacy and Safety of Pegnano Plus Barivir (Ribavirin) in Treatment-naïve Patients With Chronic Hepatitis C at KienGiang General Hospital

This study presents a clinical study on the efficacy and safety of Pegnano combined with Barivir (Ribavirin) in treating treatment-naïve patients with Chronic Hepatitis C at Kien Giang General Hospital. The study aims to provide affordable treatment options while evaluating the virological response and side effects associated with the therapy

This study evaluates the efficacy and safety of Pegnano (Peginterferon alfa-2a) combined with Barivir (Ribavirin) in treatment-naïve patients with chronic hepatitis C (HCV). Conducted at Kien Giang General Hospital from March 2011 to March 2013, this uncontrolled clinical trial enrolled 100 outpatients aged 18-65 with HCV RNA \>80 IU/mL and compensated liver disease. Patients received Pegnano (180 mcg, subcutaneous, weekly) and Barivir (15 mg/kg daily, oral) for 24 weeks (genotypes 2, 3) or 48 weeks (genotypes 1, 4, 5, 6), with possible extension to 72 weeks for genotype 1 with late virological response. The primary goal is to assess virological responses (rapid, early, end-of-treatment, and sustained at 24 weeks) by genotype and IL28B rs12979860 polymorphism, alongside safety through adverse event monitoring. Efficacy is measured via HCV RNA levels using real-time PCR, while safety is evaluated through clinical and paraclinical assessments every 4 weeks. The study aims to provide evidence for affordable HCV treatment options in Vietnam using locally produced drugs

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C.
* Age 18-65 years.
* No previous treatment with interferon or peginterferon.
* HCV RNA serum baseline \>80 IU/mL.
* Compensated liver disease (total bilirubin \<25.6 µmol/L, INR \<1.5, serum albumin \>3.4 g/dL, no ascites or hepatic encephalopathy).
* Normal hematological and biochemical parameters (hemoglobin \>12 g/dL for males, \>11 g/dL for females; neutrophils \>1500 cells/µL; platelets \>75,000 cells/µL; serum creatinine \<1.5 mg/dL or \<132 µmol/L).

Exclusion Criteria:

* Depression.
* Autoimmune hepatitis or other autoimmune diseases.
* Unstable hyperthyroidism or hypothyroidism.
* Severe medical conditions (e.g., hypertension, congestive heart failure, angina, uncontrolled diabetes, COPD).
* Decompensated cirrhosis.
* Co-infection with HIV or hepatitis B.
* Pregnant women or those unwilling to use effective contraception.