cyrilzakka/clinical-trials huggingface dataset:
A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Platysma Prominence

The purpose of the study is to evaluate the safety and effects of onabotulinumtoxinA (BOTOX) for the temporary improvement in the appearance of platysma prominence.

Study doctors will randomize participants into 1 of the 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 400 participants will be enrolled in the study across approximately 35 sites in USA, Belgium, Canada, Germany and the UK.

Participants will receive a single treatment of intramuscular injection of onabotulinumtoxinA (BOTOX) or placebo on Day 1 during this 4 month long study.

Participants will attend regular monthly visits during the study at the study site.


Eligibility Criteria:
Inclusion Criteria:

* Participants must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study specific procedures
* Are willing and able to comply with procedures required in the protocol
* Adult male or female, at least 18 years old at the time of signing the informed consent
* Good health as determined by medical history, physical examination, vital signs, and investigator's judgment

Exclusion Criteria:

* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
* Anticipated need for surgery or overnight hospitalization during the study
* Females who are pregnant or breastfeeding and are considering becoming pregnant or donating eggs during the study
* Known immunization or hypersensitivity to any botulinum toxin serotype
* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months
* Lower facial and neck hair, scarring (e.g., acne), or other abnormal variations that may interfere with photography (such that photograph is not acceptable)
* Tattoos, jewelry, or clothing that cannot be removed, and that obscure the target area of interest
Drains and Surgical Site Infections

This prospective observational study examines the associations of presence, duration, type, number and location of surgical drains with the risk of surgical site infections in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.

Surgical site infections (SSI) represent the most common type of nosocomial infection amongst surgical patients. They cause morbidity and mortality.

Surgical Drains are commonly inserted at the end of many surgical procedures. In contrast to potential benefits, drains are also thought to potentially serve as a conduit of bacteria into the wound and hence may increase the risk of SSI. Patterns of use of drains vary widely across surgical disciplines and individual practices. There are no uniform guidelines and standards are often rather based on tradition than on evidence. The aim of this large prospective study was to examine the association of presence, duration, type, number and location of drains with the risk of SSI in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients
* Age 18 years or older
* General, orthopedic trauma and vascular procedures
* Surgical antimicrobial prophylaxis

Exclusion Criteria:

* outpatient surgery
* Presence of a contraindication for cefuroxime and/or metronidazole
* preexisting antibiotic therapy within 14 days prior to surgery
* cognitive impairment
* combined operations including other than the above specified surgical divisions
* Emergency procedures with planned incision within 2 hours after indicating the procedure.
Stomach Cancer Exosome-based Detection

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. This study will develop and validate a blood assay to facilitate the non-invasive detection of gastric cancer.

Gastric cancer continues to have a poor prognosis primarily due to the inability to detect it in its early stages. Because conventional endoscopy is invasive and costly, gastric cancer is currently not considered to be screenable at a population level. However, if one could find less invasive and cheaper tools that accurately detect gastric cancer in its early stages, it could make a significant difference. Accurate biomarkers could help identify patients with gastric cancer before it becomes incurable.

This study aims to develop a non-invasive test to detect gastric cancer early. It consists of four phases:

1. Discovering potential biomarkers with a comprehensive and genome-wide transcriptomic sequencing analysis that will involve gastric cancer tissue, normal tissue, and serum samples from patients with gastric cancer, as well as samples from people without the disease.
2. Using machine learning to develop a combination "signature" of cell-free (cf) and exosomal (exo)-miRNA in serum specimens from a training cohort.
3. A validation of this signature in an independent cohort to confirm its accuracy.
4. An evaluation of the temporal trend of this signature in paired samples collected pre-surgery and post-surgery to investigate their potential and specificity as indicators of minimal residual disease.

In summary, this study aims to develop a highly accurate and cost-effective blood test for detecting gastric cancer early. Success could lead to significant improvements in clinical practice by catching cancer when it is most treatable. By combining different genetic markers (cell-free microRNA and exosomal microRNA) for accuracy, this study has the potential to reduce gastric cancer deaths and could lead to new screening methods in the future.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of stage I, II, III, IV gastric cancer (TNM classification, 8th edition) (cases).
* Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
* Confirmed cancer-free status at the time of study inclusion (Non-disease controls).

Exclusion Criteria:

* Lack of written informed consent.
* Systemic therapy before sampling.
* Synchronous gastric and non-gastric cancer diagnosed at or before surgery.
Conventional Follow-up Versus Mobile App For Post-Operative ACL Reconstruction Patients

Background: Telemedicine is increasingly used to overcome distance between patients and physicians. Preliminary studies suggest that mobile app follow-up care for ACL reconstruction patients is feasible, can avert in-person follow-up care, and is cost-effective.

Objective: To avert in-person follow-up through the use of a mobile app in the first six weeks after surgery.

Methods: This will be a single-center, prospective randomized controlled trial

Results: Data to be analyzed from 72 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ACL reconstruction at Women's College Hospital (WCH), between the ages of 18-70.
* Patients must be able to use a mobile device and communicate in English.

Exclusion Criteria:

* Patients who are smokers, as they carry increased rates of complications.
* Patients must not:

  * Suffer from chronic pain
  * Be taking narcotic (morphine-like) medication for pain on a regular basis, and
  * Have an allergy to local anesthetics or morphine-like medications

    * Pain scores captured in the VAS and QoR-9 are important for judging post-operative recovery. Pre-existing pain or inability to take narcotics post-operatively would compromise the reliability of these measures.
Effect of a Simulated Flight in Patients With Type 2 Diabetes and Healthy Volunteers

Diabetes is an increasingly common condition which affects millions of people in the United Kingdom. Patients with type 2 diabetes are at increased risk to develop severe heart disease and vascular complications and these can result in death. A cornerstone of the treatment is lifestyle and diet.

The number of travellers is increasing quickly and there are more people than ever travelling by airplane. During a commercial flight the pressure of the air is lower than the pressure on the surface and that results in lower concentration of oxygen in the air we are breathing while flying. Also the humidity is very low inside an aircraft.

The aims of this study are to show if we can use a simulated flight as a method to look at how the endothelial cells react and to see if this is different between patients with type 2 diabetes mellitus and healthy volunteers.

A sub-study is also incorporated to look at different dietary interventions in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

Diabetes group:

* Diagnosis of type 2 diabetes
* Patients on stable medication (for their diabetes metformin being the only treatment if any), for 3 months prior to entry into the study
* Age between 45-75 years at the start of the study; women need to be postmenopausal and not undergoing hormone replacement therapy (HRT)

Healthy volunteers group:

* No current disease or medication which would have effect on the safety of the subjects or interfere with the study results
* Age between 45-75 years at the start of the study; women need to be postmenopausal and not undergoing HRT

Exclusion Criteria:

* For both groups:

  * Patients with concurrent illness or any medication in the last 3 months that would interfere with the study based on the investigator's judgement
  * Acute coronary syndrome in the last 3 months or any major clinical event in the previous 3 months that would effect the study based on the investigator's judgement
  * Patients not wishing to allow disclosure to their general practitioner (GP)s.
  * HbA1c \>9%
  * Smokers
  * Pre-menopausal women or post-menopausal women on HRT
  * Claustrophobia, panic attacks in the anamnesis
  * Subjects must not have been subjected to a commercial flight within 4 weeks of the study
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).

Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:

* mFOLFOX6 alone,
* mFOLFOX6 with bevacizumab, or
* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
* Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory

  * If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
* HER2+ disease as determined by a tissue based assay performed at a central laboratory.
* Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
* Radiographically measurable disease per RECIST v1.1 with:

  * At least one site of disease that is measurable and that has not been previously irradiated, or
  * If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:

  * No evidence of brain metastases
  * Previously treated brain metastases which are asymptomatic

Exclusion Criteria:

* Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.

  * Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \>6 months prior to enrollment
* Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
* Previous treatment with anti-HER2 therapy
* Ongoing Grade 3 or higher neuropathy
* Active or untreated gastrointestinal (GI) perforation at the time of screening.
Multicenter Investigation of Limitation of Infarct Size (MILIS)

To assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.

BACKGROUND:

The study of methods for minimizing the mass of ischemic infarcted myocardium associated with a myocardial infarction was identified as a topic of research priority in the 1973 Report of the Panel Chairman for the Preparation of the National Heart, Blood Vessel, Lung, and Blood Program. In September 1976, the Institute convened a workshop involving 32 investigators active in this field, respondents to past solicitations, experts on the topic of collaborative clinical trials, members of previous review committees, and several members of the Cardiology Advisory Committee. The attendees were enthusiastic about the practicality and timeliness of a collaborative clinical trial in this field. The concept of collaborative clinical trials to protect ischemic myocardium was discussed by the Cardiology Advisory Committee in its meeting of September 22, 1976, and was recommended affirmatively and enthusiastically. This trial was part of the Institute's initiatives and was reviewed and favorably recommended by the National Heart, Lung, and Blood Advisory Council at its December 1976 meeting. The trial consisted of five clinical centers, six central laboratories, a clinical coordinating center, and a data coordinating center.

DESIGN NARRATIVE:

Randomized. Group A patients were randomized to propranolol therapy, hyaluronidase therapy, or control therapy; patients assigned to Group B (propranolol contraindicated) were assigned to hyaluronidase or control therapy. Single-blind for propranolol therapy, double-blind for hyaluronidase or control therapy; fixed sample. Detailed follow-up of clinical status and endpoints for a six-month period; annual health status follow-up thereafter.

The study completion date listed in this record was obtained from the "End Date" entered in the Query View Report (QVR).

Eligibility Criteria:
Men and women, under age 75. Documented myocardial infarction which could be treated within 18 hours of onset of ischemic symptoms.
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy

This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy


Eligibility Criteria:
Inclusion Criteria:

* Female patients must be of non-childbearing potential
* Carotid stenosis between 60% and 90% and to be scheduled for CEA surgery
* One or more of the following clinical features: Prior history \>4 weeks of cerebrovascular accident (CVA) or transient ischemic attack (TIA) consistent with North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria or prior history of amaurosis fugax occurring at any time
* Diabetes haemoglobin (Hb) A1c between 7.0 and 11% or a history of two or more fasting blood glucose levels \>6.9 mmol/L
* Baseline hsCRP \>2 mg/L
* Echolucent plaque

Exclusion Criteria:

* Acute CVA or TIA within 4 weeks of enrollment or the presence of ulcerated or unstable plaque requiring urgent carotid endarterectomy
* Renal insufficiency defined as creatinine \>1.5 x upper limit of normal (ULN)
* Cirrhosis, recent hepatitis, alanine aminotransferase (ALT) \>1 x ULN (i.e., above the normal range) or positive screening test for hepatitis B (hepatitis B surface antigen) or hepatitis C (by ELISA)
* Uncontrolled diabetes mellitus within 1 month prior to study screening, defined as HbA1c \>11% at screening
* Congestive heart failure (CHF) defined by the New York Heart Association as functional Class III or IV
* Recent acute coronary syndrome event or coronary artery bypass graft (CABG) surgery (within 4 weeks of enrollment)
* Current atrial fibrillation
* Planned cardiac intervention
* Acetaminophen use in any form in the 7 days before enrollment
Topical 0.5% Timolol Solution for Healing Lower Extremity Wounds

Topical timolol, a β2-Adrenergic receptor (B2AR) antagonist, has demonstrated promise in wound healing over the past several years. The majority of the literature has evaluated the use of topical timolol to shorten wound healing time in chronic wounds of non-surgical etiologies. To date, there are no prospective randomized clinical trials evaluating the role of topical timolol for shortening wound healing time in acute open surgical wounds.

Therefore, the purpose of this study is to determine whether or not topical timolol solution decreases time to wound healing in patients with defects after Mohs Micrographic Surgery (MMS) that cannot be closed with sutures and are left to heal by second intent. The research team also will look to determine if there is a difference in cosmesis of wounds treated with topical timolol compared to those treated with the standard of care. The present study will primarily focus on wounds in the distal lower extremity as these are most commonly left to heal by secondary intent


Eligibility Criteria:
Inclusion Criteria:

* Be scheduled to undergo MMS at 234 East 85th St for a skin cancer that is deemed Mohs
* Appropriate by the Mohs surgery appropriate use criteria
* Have an open surgical wound \< 4 cm and \> 0.5 cm
* Be ≥18 years of age
* English-speaking
* Provide a signed and dated informed consent form
* State willingness to comply with all study procedures

Exclusion Criteria:

* Age less than 18 years of age
* Open surgical wound \> 4 cm
* If tumor clearance cannot be achieved with MMS
* Pregnant women
* Breastfeeding women
* Patients who are taking oral beta-blockers (ie oral timolol, metoprolol, carvedilol, propranolol, atenolol)
* Patients who are currently taking any of the following medications: clonidine, digoxin, methyldopa, quinidine, fluoxetine and paroxetine, bupropion
* Patient currently taking a calcium channel blocker AND has pre-existing heart failure as defined by a reduced ejection fraction
* Patients with pre-existing hypotension
* Pre-existing diagnosis of sinus bradycardia
* Pre-existing diagnosis of second or third degree atrioventricular block
* Congestive heart failure
* Pre-existing diagnosis of severe asthma
* Pre-existing diagnosis of chronic obstructive pulmonary disease
* Any known hypersensitivity to 0.5% timolol solution
* Patients who have a wound where primary closure is feasible and desired by the patient
* Defect size \<0.5 cm
* Prior sensitivity or known allergy to timolol
Target Engagement and Response to Oxytocin

This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.

The study will determine whether oxytocin (OT) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (SCST) program, and it will test a possible mediator of this effect. Subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with training control condition. Target engagement will be measured in an OT challenge (placebo versus OT one week apart) prior to baseline assessment. The measure of target engagement will be EEG mu suppression while observing biological motion. A social cognition battery will be administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at 12 weeks. The battery will include measures of social cue identification and mentalizing.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective disorder
* stable on an antipsychotic medication

Exclusion Criteria:

* positive pregnancy test history of head injury