cyrilzakka/clinical-trials huggingface dataset:
A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.

First line of treatment for vulvar intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VAIN) is not well defined. Laser vaporization and ultrasonic surgical aspiration are both accepted surgical modalities used in the treatment of vulvar and vaginal dysplasias, however no prospective study has been done to compare the two procedures. The specific aims of this research study include:

1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias in a prospective, multi-institutional, randomized clinical trial.
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present with vulvar or vaginal dysplasias or condylomas that require surgical intervention will be informed of the study by the treating physician
* Pre-operative biopsies to confirm presence of dysplasia / condyloma. Patients with dysplasias of grade 3 / CIS will be included at the discretion of the treating surgeon and will have had invasion confidently excluded by clinical exam and biopsy.

Exclusion Criteria:

* Patients under the age of eighteen or who are pregnant will be excluded
Interprofessional Pharmacogenomics (IPGx) Registry and Repository

This program collects genetic and health information to help doctors choose the right medications for patients.

This study wants to understand how genes can affect how the body responds to medicines. This information will help us determine whether changing your medicine can make you healthier and improve your life. We will study your medical history for the last year and the next five years after you join the study.

study goals include:

* Enrolling patients who take multiple medications or have harmful side effects from their medications.
* Keeping all medical information and genetic samples from patients in one place.
* Helping doctors make better decisions about which medicines to prescribe.
* Influencing insurance companies and the government to help pay for this kind of medical care for people who need to change their medicine to stay healthy.

Eligibility Criteria:
Inclusion Criteria:

* The study will invite patients who are eligible for PGX workup/PGX care to participate, provided they meet the following criteria: Use of five or more medications, including over the counter drugs, supplements, natural products, cannabis products, or other recreational drugs, or
* Individuals taking blood pressure or depression medications, even if less than five medications.
* Ability to understand and give consent.
* Able to consent to donate blood and/or urine samples and buccal swabs.
* Able to answer detailed questionnaires, including quarterly questionnaires about ADRs, cognitive testing such as serial mini-mental status exams, and or quality of life questions.
* Able to understand that their health record and changes in health status will be followed for a five-year period and shared in deidentified form with the research community.
* All genders.
* Any age over 18 years.

Exclusion Criteria:

* Individuals admitted to hospice.
* Declines to participate or interact with staff/share their medical status.
* A diagnosis of Alzheimer's disease or related dementias in a medical record as this indicates a progressive, debilitating condition that impairs memory, thought processes, and functioning.,
* Individuals who are unable or unwilling to provide consent.
* Unable to verbally communicate and comprehend English language
Biomarker Expression in Tissue Samples From Patients With Bone Sarcomas

This trial studies biomarker expression in tissue samples from patients with bone sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

STUDY SUBTYPE: Ancillary/Correlative

OBSERVATIONAL STUDY MODEL: Case-only

TIME PERSPECTIVE: Retrospective

BIOSPECIMEN RETENTION: Samples without DNA

BIOSPECIMEN DESCRIPTION: Tissue samples obtained from Cooperative Human Tissue Network (CHTN)

STUDY POPULATION DESCRIPTION: Patients enrolled on P9754 and AOST0121 clinical trials

SAMPLING METHOD: Non-probability sample

PRIMARY OBJECTIVES:

I. To determine if there is differential expression of tumor factor (TF) among patients with osteosarcoma.

II. To determine if there is an association between overall survival and disease free survival and the extent of TF expression.

III. To determine if TF expression correlates with presence of gross metastatic disease at presentation, and development of subsequent metastases.

OUTLINE:

Tissue samples are analyzed for tumor factor expression levels by immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* Tissue samples from patients with osteosarcomas obtained from the CHTN:

  * P9754 clinical trial for patients with non-metastatic osteosarcoma
  * AOST0121 clinical trial for patients with metastatic or recurrent osteosarcoma
Does Weight Loss Surgery and Probiotic Supplementation Lead to a "Lean" Gut Microbiota?

The purpose of the weight-loss study is to characterize the effect of LGG supplementation on the relative abundance of phyla in the gut microbiota of patients undergoing gastric bypass and sleeve gastrectomy surgery, and to elucidate a relationship between the gut microbiota pattern and the degree of weight-loss post-surgery.

The investigators hypothesize that LGG administration will result in a "leaner" pattern of gut microbiota that will lead to higher weight loss at 3 months post-surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Able to give informed consent and report on side effects
3. Tolerating an oral/enteral diet
4. Stable comorbid conditions
5. Outpatient

Exclusion Criteria:

1. Inpatients
2. Pregnancy (urine test done on all patients routinely pre-op)/ unwilling to comply with contraceptive requirement after gastric bypass surgery
3. Known use of LGG or another probiotic (not including yogurt) within the previous 30 days
4. Presence of an active bowel leak, acute abdomen, active intestinal disease, or significant bowel dysfunction
5. Presence of an absolute neutrophil count less than 500 per cubic mm (must have had a Complete Blood Count within the last 6 months) or anticipation post chemotherapy that the absolute neutrophil count will fall below 500 per cubic mm.
6. History of adverse reaction to product containing lactobacillus
7. Active colitis (\*see definition below)
8. Known or suspected allergies to probiotics, lactobacillus, milk protein, or microcrystalline cellulose
9. Structural heart disease, history of endocarditis or valve replacement, implanted cardiac device, congestive heart failure
10. Positive baseline stool culture for LGG
11. Recent or planned chemotherapy or radiation therapy
12. Solid organ transplant within the prior year
13. Stem cell transplant within the prior year
14. On active immunosuppressive medication \[anti-rejection, injectable immunosuppressive drugs for autoimmune disease, or corticosteroids (greater than ½ mg per kg body weight of prednisone or its equivalent) not including inhaled or topical steroids\]
15. Allergy or intolerance to or contraindication to two or more of the rescue antibiotic regimens (ampicillin, clindamycin, moxifloxacin)
16. Participating in another clinical trial
17. Uncontrolled psychiatric illness
Effect of Open Kinetic CKE Exercises With NES in Patients With Post-ACL Reconstruction Surgery

"Anterior cruciate ligament (ACL) reconstruction is a commonly performed surgical procedure for restoring knee stability in patients following ACL injuries. Despite surgical success, postoperative rehabilitation remains crucial for improving functional outcomes, addressing quadriceps strength deficits, and reducing recovery time.

This study investigates the combined impact of open kinetic chain (OKC) knee extension exercises and neuromuscular electrical stimulation (NMES) on the functional recovery of post-ACL reconstruction patients. This randomized clinical trial involves 58 patients, divided into two groups: an experimental group receiving OKC knee extension exercises combined with NMES and a control group receiving OKC exercises alone. Functional outcomes, range of motion (ROM), and patient-reported outcomes (PROs) are assessed using validated tools.

Eligibility Criteria:
Inclusion Criteria:

* Both genders aged 18-45 years
* Subjects who have undergone unilateral primary ACL reconstruction surgery
* Subjects who are exactly 4 weeks post-surgery at the start of the study
* Subjects who received a hamstring tendon autograft or patellar tendon graft for ACL reconstruction
* Subjects cleared by a physician to begin open kinetic chain exercises in their rehabilitation program
* Subjects who are generally healthy with no significant comorbidities that could interfere with rehabilitation
* Willingness to provide informed consent and commit to the entire duration of the study

Exclusion Criteria:

* Presence of additional knee injuries (e.g., meniscal tears, collateral ligament injuries) that might affect rehabilitation
* History of prior ACL injury or reconstruction on the same knee
* Patients who underwent reconstruction of other ligaments along with the ACL
* Presence of conditions (e.g., rheumatoid arthritis, osteoarthritis, uncontrolled diabetes) that could influence recovery
* Any significant injury or surgery to the opposite knee within the last six months
* Factors that indicate a high risk of non-compliance with the rehabilitation protocol, such as poor availability, or lack of commitment to follow the exercise regimen
* Conditions affecting neuromuscular control that could interfere with exercise performance or rehabilitation response
Pilot Testing for Midline Measuring Device

Identifying the exact middling on the patient's head during the planning phase of surgery is crucial yet can be challenged by patient's head position and hair. The investigators have invented a device that uses anatomical landmark to quickly and gracefully identify the midline on a patient's head. The device is a U-shaped instrument equipped with a laser pointer at the midline. The instrument also has smooth spheres that can be positioned over the patients' ears bilaterally. The midline laser pointer will identify the midline on the patients' head. this measurement procedure is typically done after the patient is placed under anesthesia. The standard way of determining the midline on the skull is simply by surgeon's vision without any measurements. This new technique will be contrasted against the standard way. The device was invented by investigators in neurosurgery (led by Dr. Matthew Howard III). This is not patented it at this time. There is no company involved in manufacturing (assembly was completed with the help of the hospital's machine shop).


Eligibility Criteria:
Inclusion Criteria:

* Patients with normal pressure hydrocephalus who are scheduled to undergo a ventriculoperitoneal shunt surgery

Exclusion Criteria:

* Patients who are not able to consent
Laser-assisted Hyaluronic Acid Delivery by Fractional CO2 Laser in Facial Skin Remodeling

The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional CO2 laser.

Fractional CO2 lasers are already used in skin remodeling. They can also create vertical channels to enhance topical drug delivery deep into the dermis. Combining the efficacy of fractional CO2 laser to laser-assisted hyaluronic acid delivery has not yet being studied, the combination of these two techniques could improve facial skin remodeling.

The main endpoint will be to evaluate the efficacy of laser-assisted hyaluronic acid delivery by fractional CO2 laser in facial skin remodeling. The secondary endpoint will be to confirm the safety of this protocol compared to a standard treatment by fractional CO2 laser.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the Laser Center for facial skin remodeling,
* aged from 30 to 70 years old,
* with phototype I to IV (Fitzpatrick scale),
* agreeing to participate in this study, signing the informed consent form
* not fitting in any non-inclusion criterion

Exclusion Criteria:

* Pregnancy or breastfeeding,
* active infection, history of oral or genital herpes
* suspected neoplasia,
* active inflammatory or infectious facial dermatitis,
* oral retinoid treatment in the last 6 months,
* phototype V or VI (Fitzpatrick scale)
* age \<30 years or\> 70 years,
* patients under guardianship or curatorship,
* hemostasis disorders, thrombolytic or anticoagulant therapy, c
* ongenital methaemoglobinaemia,
* porphyria,
* known hypersensitivity to hyaluronic acid, local anesthetics of the amide group or to any other component of Anesderm cream Ge 5%
Contained Hepatic Vascular Injuries Following Liver Trauma

Background: For thirty years, a major shift in the management of liver trauma has been seen. Contained hepatic vascular injuries (CHVI), including pseudo aneurysms and arteriovenous fistula, are often feared due to their risk of secondary bleeding. Nonetheless, knowledge of CHVI is scarce and no guidelines on their management have been set. The investigators aimed to validate the risk factors of CHVI, identify associated morbidities, and establish a management protocol.

Study Design: A retrospective study on 318 liver trauma from a level 1 trauma center over the last 15 years, comparing the presence or not of CHVI. Univarious and multivarious analyses were performed. A comparison of the management of CHVI was also performed.


Eligibility Criteria:
Inclusion Criteria:

* presence of liver trauma
* age above 15 years old
* a full contrast abdominal CT

Exclusion Criteria: none
Establishment of Prevention and Control System of Central Nervous System Infection

Central nervous system (CNS) infection is a common nervous system acute and severe disease, mainly manifested as encephalitis, meningitis and meningoencephalitis, but also manifested as brain abscess and brain granuloma et al. The basis for the diagnosis of CNS infection lies in the detection of pathogens from brain parenchyma or cerebellar spinal fluid (CSF). However, CSF is relatively difficult to obtain and the sample size is small, which limits the rapid and definite diagnosis of CNS infection pathogens. In addition, CNS infection usually has non-specific clinical manifestations, so it is difficult to identify the pathogen for about half of CNS infection. Metagenomic next generation sequencing (mNGS) and biochip technology provide new means to identify the pathogens of CNS infection. This study analyzes the incidence and epidemic characteristics of CNS infection in China, to standardize the CSF sample processing process, shorten the detection time, increase the sensitivity and specificity of pathogen detection, reduce the detection cost, identify the common pathogens of CNS infection, and establish a standardized rapid diagnosis system, effective prevention and control system.


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspected encephalitis or meningitis; onset time within 1 month; modified Rankin Scale (MRS) \< 2 points before onset; informed consent of patients; patients who can not express their personal wishes due to aphasia, disturbance of consciousness and other reasons need to obtain the informed consent of their authorized relatives.

Exclusion Criteria:

* Non.
Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome in Intensive Cardiac Care Unit

There was no MACE in both groups, but there was stroke-major adverse vascular event lower in brief supportive psychotherapy group. There was neutrophil-lymphocytes ratio change better in brief supportive psychotherapy group and significantly in acute coronary syndrome patients without chronic heart failure or coronary arterial disease, also there was psychological symptom (depression) change better in brief supportive psychotherapy and significantly in acute coronary syndrome patients with chronic heart failure or coronary arterial disease.


Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome
* 》 18 years old
* have got pharmacological treatment in cardiology standard with or without anxiolytic drug and had got or had not yet got PCI
* be able to communicate and ready to have interview, fill the questioners and psychotherapy

Exclusion Criteria:

* stroke
* cardiogenic shock at admission time
* psychosis
* reject to involve in study
To Assess the Efficacy and Safety of HD-6277 in Adult Patients With Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding, Phase 2 Study to Assess the Efficacy and Safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise

This trial is a phase 2 study to evaluate the efficacy and safety of HD-6277 in Adult Patients with Inadequate Control of Type 2 Diabetes Mellitus by Diet and Exercise.

This is multi-center, double-blind, placebo-controlled, parallel-group, dose-finding phase 2 study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T2DM with HbA1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 8 weeks prior to screening.

Exclusion Criteria:

* Type 1 diabetes or another immune-mediated diabetes syndrome
* BMI: \> 40 kg/m2
* C-peptide: \< 0.5ng/mL
Brain Trauma Outcomes in Nova Scotia Study

The goals of this study are to identify outcome indicators of optimal care for brain injury patients, including pre-hospital care, prompt delivery to neurosurgical care and access to early rehabilitation services. Nova Scotia's centralized Neurosurgical services and integrated provincial Emergency Health Services provide a rich opportunity to construct a cohesive, integrated data management system. This system will allow us to answer important research questions related to the outcomes, care and prevention of brain trauma.

Retrospective data collection The retrospective arm of the BTO study has created full data sets and care pathways from multiple sources covering the continuum of brain trauma care. Investigators continue to analyze this large amount of data and prepare it for publication.

Prospective data Collection Patients with a major head injury (initial GCS 3-12), have been considered for enrollment in the BTO study.The prospective arm of the BTO study has 52 patients enrolled. Screening and Enrollment was complete on June 30, 2007. These patients are participating in long term follow up at 6, 12 and 24 months post injury for assessment of qualitative and quantitative outcomes. Completion of patient follow up will be in June 2009.


Eligibility Criteria:
Retrospective Arm Cohort 1: AIS ≥ 3, head +/- other injuries Cohort 2: AIS ≥ 3, isolated head injury (cohort 2 is a subset of cohort 1)

Inclusion Criteria:

1.patient treated in at least one facility prior to arrival at QEII.

Exclusion Criteria

1. injured out of province
2. time from injury to 1st facility presentation known to be \> 24 hours
3. time arrival at 1st referring facility to time arrive at QEII known to be \> 24 hours
4. direct ground or air scene transport

Prospective Arm:

Inclusion Criteria:

1. have a head injury requiring hospital admission
2. able to provide informed consent or have next- of -kin able to provide consent on patients' behalf

Exclusion Criteria:

1. unwilling or unable to provide consent
Enhancing Exercise in Breast Cancer Survivors

This study will examine whether or not providing early stage breast cancer survivors with tips on making exercise more enjoyable promotes greater levels of moderate to strenuous exercise.


Eligibility Criteria:
Inclusion Criteria:

* no health restrictions on performing moderate to strenuous physical activity
* must be 18 years or older and able to give legal consent

Exclusion Criteria:

* may not be participating in another research study regarding exercise
* restrictions on performing physical activity
Feasibility Study to Improve AF Outcomes Using a Digital Application for CV Risk Reduction

The pilot portion of this study is to determine the feasibility of utilizing AF CARE to provide lifestyle modification support to patients with atrial fibrillation (AF).

The prospective, RCT portion of this study compare cardiovascular risk factors (CVRF), AF knowledge, AF Symptom Severity and Burden, and QOL between and within the wait list group and the AF CARE group at baseline, 3, 6, and 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. BMI \> 28 kg/m2 AND one additional CVRF using LS7
2. Access and willingness to engage in digital technology
3. Has a valid email address and a cell phone number
4. Able to ambulate
5. Able to speak/read English

Exclusion Criteria:

1. Class III/IV heart failure
2. MI or cardiac surgery in prior 3 months
3. Severe renal/hepatic disease
4. Active malignancy
5. Current/recent (within 6 months) enrollment in weight loss program
Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients

The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.

Current criteria for risk stratification of patients in risk of sudden cardiac death are mainly based on left ventricular ejection fraction and NYHA class. This criteria are too robust, approximately 2/3 of ICD recipients do not profit from this treatment in the following 5 years, especially those with non-ischaemic cardiomyopathy. We plan to sub-stratify this group of patients with both ischaemic and non-ischaemic cardiomyopathy by: non-linear heart rate variability analysis, microvolt T-wave alternans, QRT-T angle and character and amount of left ventricular scarring assessed by magnetic resonance imaging. Pre-implantation values will be correlated with numbers and character of ICD therapy (both anti-tachycardial pacing and ICD discharge). The results may allow to decrease the number of patients, who do not profit from ICD treatment.

Eligibility Criteria:
Inclusion Criteria:

* LVD (left ventricular dysfunction) d/t MI (Myocardial infarction), LVEF 30% or less, NYHA (New York Heart association class) II, III
* LVD d/t MI, LVEF 30% to 35%, NYHA II, III
* LVD d/t MI, LVEF 30% to 40%, NSVT, positive EP study
* LVD d/t MI, LVEF 30% or less, NYHA I
* NICM (non-ischaemic cardiomyopathy), LVEF 30% or less, NYHA II, III
* NICM, LVEF 30% to 35%, NYHA II, III
* NICM, LVEF 30% or less, NYHA I
* signed informed consent

Exclusion Criteria:

* metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
* severe claustrophobia may not be able to tolerate an MRI scan
* heart rhythm device in place before enrollment
* atrial fibrillation in time of enrollment
* ICD implantation indicated from secondary prevention of SCD (sudden cardiac death)
* NYHA or CCS class IV
* PCI or CABG in last 3 months
* CMP/TIA in last 3 months
* syncope of unknown etiology