cyrilzakka/clinical-trials huggingface dataset:
Envafolimab Monotherapy or Envafolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer

There exists substantial evidence suggesting that patients diagnosed with MSI-H/dMMR colorectal cancer can derive benefits from immunotherapy in the management of advanced colorectal cancer. In cases of locally advanced colorectal cancer exhibiting microsatellite instability (dMMR/MSI-H), patients exhibit low responsiveness to neoadjuvant chemotherapy, resulting in minimal rates of complete tumor remission and downstaging. Nevertheless, initial exploratory studies, characterized by modest sample sizes, reveal a favorable therapeutic effect of neoadjuvant immunotherapy in this particular patient population. Envafolimab monoclonal antibody, the first PD-L1 antibody developed and manufactured in China, possesses noteworthy practical and societal value in the context of exploratory clinical research on neoadjuvant immunotherapy for locally advanced MSI-H/dMMR colorectal cancer patients. The objective of this study is to evaluate the safety and efficacy of envafolimab monoclonal antibody (PD-L1) as neoadjuvant therapy for locally advanced MSI-H/dMMR colorectal cancer through a prospective, multi-cohort phase II clinical trial. Additionally, this study aims to investigate the effectiveness and safety of envafolimab monoclonal antibody in combination with CAPEOX as a neoadjuvant treatment regimen for locally advanced pMMR colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmed rectal cancer
* Clinical stage T3-4 or T any N1
* With or without MRF positivity, with or without EMVI positivity
* R0 resection is estimated
* Age ranged from 18 to 70

Exclusion Criteria:

* Clinical stage T1-2 N0
* Distance metastasis
* Multiple primary tumor
* Cachexy
Nexplanon Application Post-Abortion (NAPA)

Women who receive Nexplanon immediately post abortion will be significantly more likely to be using the device 6 months after the procedure than those assigned to receive the device 2-4 weeks after the procedure.

Women will be contacted 6 months after their abortion to ask about contraception use and side effects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older,
* an intrauterine pregnancy \> 14 weeks and \<23 6/7 weeks gestation and desire termination of pregnancy
* desire a Nexplanon for contraception
* able to give informed consent in English
* no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D\&E

Exclusion Criteria:

* unable to give informed consent
* have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon.
* non-surgical management of pregnancy
* prior participation in this study
* breast cancer or a history of breast cancer
Viral Illness in Pediatric Critical Care: Incidence Timing & Severity of Associated Heart Dysfunction & Acute Kidney Injury

The purpose of this study is to be able to better describe the incidence, timing and severity of myocardial dysfunction and acute kidney injury (AKI) following a documented respiratory viral illness (RSV, adenovirus, metapneumovirus, parainfluenza, influenza, etc.) in pediatric patients.

This is a single-centre, prospective and retrospective, descriptive data-collection pilot study.

Prospective Data Collection:

All pediatric patients who are less than 18 years with a confirmed positive respiratory viral swab will be invited to participate.

Retrospective Data Collection:

The retrospective portion of this study will examine a 5 year period prior to the start of enrollment for the prospective study, with the intention to include all pediatric patients who are less than 18 years with a confirmed positive respiratory viral swab and admitted into the local hospital's PICU.

Eligibility Criteria:
Inclusion Criteria:

1. The parent or legal guardian of the pediatric subject must sign the Consent Form for participants in the prospective portion of the study.
2. The subject must be no greater than 18 years of age, at the time of consent.
3. The subject must be admitted to the local hospital.
4. The subject must have a confirmed positive respiratory viral swab.

Exclusion Criteria:

1. The parent or legal guardian of the pediatric subject is unavailable or unwilling to sign the Consent Form for participants in the prospective portion of the study.
2. The subject has had previous kidney injury or myocardial dysfunction prior to positive respiratory viral swab.
3. The subject has any previous problems (prior to positive respiratory viral swab) with their heart or kidneys that could compromise the results, in the opinion of the Investigator.
Peripheral Nerve Blocks for Above-the-knee Amputations

Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).

Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (LFCN), and obturator blocks to provide surgical anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing above-the-knee amputation or knee disarticulation
* Ability to understand and provide informed consent

Exclusion Criteria:

* Patient refusal or inability to provide informed consent
* True allergy, not sensitivity, to any of the following substances:
* - Local anesthetics
* - Propofol or other sedative agents
* - General anesthetic agents
* Pregnancy
* Severe hepatic impairment
* Evidence of infection at or near the proposed needle insertion site
* Any sensorimotor deficit, whether acute or chronic, as determined by the PI
* Chronic use of opioid medication
* BMI ≥ 35
Deep Brain Stimulation of the Globus Pallidus in Huntington's Disease

This is a single centre, controlled phase I study, which evaluates safety and efficacy of stimulation of lower caudal two contacts (GPI) vs. upper cranial two contacts (GPE) in Huntington´s disease (HD).

A total of 6 HD patients will be selected out of an existing larger HD patient cohort upon careful evaluation of the inclusion and exclusion criteria at month 0. Patients will be recruited if no significant cognitive deterioration is observed between month 0 and month 3. The preoperative clinical status will be evaluated twice including the United Huntington Disease Rating Scale (UHDRS), neuropsychological, neurophysiologic and neuroradiological assessments. At 4 weeks postoperatively an extensive evaluation of effects and side effects of every single contact of the bilateral quadripolar electrodes takes place.

All patients will receive a stereotactic placement of bilateral stereotactic insertion of two quadripolar electrodes into the Globus pallidus, two contacts reaching the GPE, two the GPI within both hemispheres. Surgery will be done under general anesthesia, The implantation of the stimulator (Kintera®) will take place in the same procedure. Postoperatively patients will be monitored at three and six months and regularly up to 60 months with a battery of clinical, neuropsychological, psychiatric, neurophysiological and neuroimaging tests.

We expect that this trial will provide a rational basis to conclude about the efficacy, safety, reproducibility and long-term effects of pallidal Deep Brain Stimulation (DBS) on motor symptoms of HD.

Eligibility Criteria:
Inclusion Criteria:

* clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats\>= 36)
* age: \> 18
* moderate stage of the disease (UHDRS motor\>= 30)
* predominant movement disorder
* compliance of the patient, stable cognition during a 6 months phase prior to inclusion (MDS\>/= 120)
* signed informed consent

Exclusion Criteria:

* advanced disease, precluding the ability to give informed consent
* very early stage of disease causing minor disability
* severe comorbidity that could compromise the life prognostic or preclude general anaesthesia or immunosuppression
* Mattis Dementia Rating Scale \< 120
* psychiatric or personality disturbances that might compromise the follow-up
* participation at another trial (in particular transplantation)
* severe cortical atrophy seen on CT and MRI
Catheter Ablation for Atrial Fibrillation in Preserved Ejection Fraction

Atrial fibrillation (AF) displays high prevalence in heart failure with preserved ejection fraction (HF-PEF) and compromises prognosis of affected patients. This study aims to assess catheter ablation (CA) for AF in patients with HF-PEF compared to AF-patients without systolic or diastolic dysfunction. Primary endpoints are freedom from AF and quality of life at 1 year. Furthermore, the study is designed to elucidate mechanistic characteristics distinguishing arrhythmic substrate and predicting AF-recurrence in patients with HF-PEF. For this purpose, left atrial concentrations of biomarkers for inflammation, fibrosis and neurohumoral activation are determined and hemodynamic measurements are performed periprocedurally.

Information on benefit from CA in these patients is necessary for clinical decision making and mechanistic investigations may point to tailored approaches in order to increase therapeutic efficiency.


Eligibility Criteria:
Inclusion Criteria:

* Left ventricular ejection fraction ≥50%
* Scheduled for catheter ablation of AF

Exclusion Criteria:

* Significant valvular heart disease
* Coronary artery disease with \>70% stenoses or necessary coronary Intervention at time of recruitment
* Coronary intervention 60 days before recruitment
* Coronary bypass surgery 90 days before recruitment
* Cardiomyopathy or cardiac storage disease (e.g. amyloidosis)
* Reduced left ventricular ejection fraction
* Pericardiac disease
* Significant pulmonary hypertension
* Chronic obstructive pulmonary disease with home-oxygen-therapy, oral steroids, hospitalization due to exacerbations during the last 12 months before recruitment, or suspected severe pulmonary condition based on clinical evaluation
* Other non-cardiac conditions associated with limited physical capacity (adipositas permagna, severe anemia)
* Pregnancy
* Other limitations for adequate performance of stress echocardiography (e.g. orthopedic reasons)
A Comparison of Capsules and Oral Spray Solution as Methods of Delivering Vitamin D3 and Raising Status

The aim of the study is to compare the effectiveness of a vitamin D3 oral spray solution with capsules at raising vitamin D status over winter.

This randomised crossover trial will aim to recruit a total of 22 healthy participants for a total of two 4-week interventions separated by a 10-week washout.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy
* Over the age of 18

Exclusion Criteria:

* Those that intend to consume a supplement containing vitamin D at any point during the study
* Those under the age of 18.
* Individuals that are on prescribed medication that is known to affect vitamin D metabolism
* Those following a vegan diet
* Sun-bed users
* Participants that are planning a sun holiday during the study
A Prospective Study of LessRay Enhanced Versus Standard Fluoroscopic Visualization in Surgical Placement of Spinal Cord Stimulator

The purpose of this study is to gather information comparing LessRay Enhanced fluoroscopy with the current standard of fluoroscopy. This research is being conducted to demonstrate the utility and effectiveness of LessRay Enhanced fluoroscopy during surgical placement of a spinal cord stimulator epidural array.

The purpose of this prospective, randomized single center study is to assess the ability of LessRay to decrease overall radiation exposure during surgical placement of a spinal stimulator. A secondary objective is to analyze the efficacy of utilizing enhanced low radiation imaging in a fluoroscopically intensive pain procedure.

The population group will be 65 patients from Duke University Medical Center and Duke Raleigh Hospital who meet the medical criteria for the surgical placement of a spinal cord stimulator epidural array. They will be divided equally into 2 arms: Research and Control and randomized by a non-surgeon on the study team. That information will be recorded and placed in a sealed envelope. On the day of surgery the envelope will be delivered to the OR and opened following "time-out". At the time the envelope is opened in the OR the patient is acknowledged to be evaluable for failure or success of LessRay during the surgical procedure if they are in the research arm. The control arm cohort will proceed with the surgery as typical without LessRay.

The data from the two groups (Research vs. Control) will be analyzed using a two tailed t-test with p\<.05. The risks associated specifically with the implementation of this study are with respect to loss of confidentiality. Every effort will be made to keep the information confidential

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults of any ethnicity
* At least 18 years-old but without an upper age limit
* Subject is willing to provide informed, written consent to participate in this study
* Subject meets the medical criteria for surgical placement of a spinal cord stimulator epidural array (e.g. not pregnant)

Exclusion Criteria:

* Less than 18 years of age. For both physicians involved in the study, standard of care Spinal Cord Stimulator placement is not done for those patients under 18 years of age as the literature does not show that the procedure helps in back pain of this cohort of patients
* Unable to provide informed, written consent
* Pregnant women as pregnancy makes them ineligible to undergo a surgical placement of a spinal cord stimulator
* Prior placement of a spinal cord stimulator epidural array or previous thoracic spine surgery, which could potentially make placement more difficult
* Enrollment in another study, which would prohibit participation in this study
Clinical Evaluation of the Safety and Efficacy of FID 120947A

The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.


Eligibility Criteria:
Inclusion Criteria:

* Successful history of silicone hydrogel or other soft contact lens wear (except for daily disposable lenses) in both eyes during the past 3 months and history of at least 5 consecutive days of successful DAILY wear in both eyes at Visit 1;
* Best spectacle corrected distance visual acuity greater than or equal to 0.8 (decimal visual acuity) in each eye;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the investigational products or affect the results of this study;
* Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Use of a daily cleaner and/or enzyme cleaner to care for lenses at least 7 days prior to Visit 1 (use of lens rewetting drops is acceptable);
* History of intolerance or hypersensitivity to any component of the investigational products;
* Unwilling or unable to abstain from use of all over-the-counter (OTC) or prescribed topical ocular medications (except for rewetting drops) within 7 days prior to Visit 1 and for the duration of the study;
* Moderate (grade 3) or severe (grade 4) corneal edema, corneal staining, injection (limbal hyperemia, bulbar conjunctival hyperemia), tarsal abnormalities, or "other" findings;
* Corneal vascularization that is mild (grade 2) or higher;
* Conjunctival or structural lid abnormalities or abnormal corneal opacities at Visit 1;
* Current or history of ocular infection, severe inflammation or disease within 6 months prior to Visit 1;
* Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
* Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
* Ocular or intra-ocular surgery and/or ocular trauma within the last 12 months (excluding placement of punctal plugs);
* Participation in any investigational clinical study within 30 days of Visit 1;
* Other protocol-specified exclusion criteria may apply.
School-Home Program for Mexican Children With Attention and Behavioral Concerns

A school-based behavioral intervention for Mexican youth with attention/behavior concerns (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y Tareas para el Éxito \[CLS-FUERTE\]:) will be pilot-tested in a mixed-method investigation with four Mexican elementary schools.

A school-based behavioral intervention for Mexican youth with attention/behavior concerns (the Collaborative Life Skills Program for Latinos/Familias Unidades Empezando Retos y Tareas para el Éxito \[CLS-FUERTE\]:) will be pilot-tested in a mixed-method investigation with four Mexican elementary schools.

Participants will include 24-32 students (n = 6-8 per 4 schools) in participating schools. School personnel will help identify students with and at-risk for Attention-Deficit/Hyperactivity Disorder (ADHD) with at least one caretaker and teacher able to participate in the intervention. Students must be in 1st-6th grade at a participating school and must demonstrate clinically significant attention/behavioral concerns and related impairment as rated by caretakers and teachers. Caretakers and teachers must be able to attend program sessions held at the child's school over an approximately 6-week period. Through a school-clustered random assignment design, two schools will be selected to receive CLS-FUERTE during the fall of the 2016-2017 school year and two schools will be selected to receive school services as usual while waiting to receive CLS-FUERTE the spring of the 2016-2017 school year. Caregivers and teachers of students will complete questionnaires about child behavior and family functioning and caregivers will participate in focus groups at 4 time points regardless of treatment assignment: Pre (prior to random assignment), Post 1 (following CLS-FUERTE in the fall cohort), Post 2 (following CLS-FUERTE for in spring cohort), and Follow-up (at the end of the school year).

Feasibility and acceptability of CLS-FUERTE will be examined via participation enrollment, attendance, and engagement ratings and focus group feedback. Improvement in satisfaction with school services and youth outcomes will be examined and estimates of effect sizes will be used to support future scaled-up investigation.

Eligibility Criteria:
Inclusion Criteria:

* Caretakers and teachers of children must each describe at least 3 symptoms of ADHD as occurring "often" or "very often," as well as 1 impairment domain of ADHD as affecting the child "quite a bit" or "a lot" on a symptom screening interview.

Exclusion Criteria:

* Inability of caretakers or teachers to attend groups and meetings.
Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial

Clinically and radiographically by cone beam CT evaluate the regenerative potentials of silk fibroin (SF) nanofiber membrane, using minimally invasive surgery, for the regenerative treatment of intrabony periodontal defects.

Periodontitis is a bacterially induced chronic inflammation of the periodontium that extends beyond the gingiva and involves progressive and irreversible destruction of the connective tissue attachment of the teeth.The treatment involves debridement of the tooth surface and the adjacent areas employing scaling, root planing and periodontal flap surgery. While scaling and root planing are non-surgical treatment modalities and are conservative; periodontal flap surgery gains access to the underlying bone for complete debridement achieving pocket depth reduction, periodontal regeneration, and maintenance of periodontium in healthy condition feasible by routine home care methods by the patient.

Guided tissue regeneration (GTR) therapy is playing a key role in the management of intrabony defects. Current resorbable and non-resorbable membranes act as a physical barrier to avoid connective and epithelial tissue down-growth into the defect, favoring the regeneration of periodontal tissues. However, these conventional membranes possess many structural, mechanical, and bio-functional limitations and the "ideal" membrane for use in periodontal regenerative therapy has yet to be developed. Based on a graded-biomaterials approach, we have hypothesized that a biologically active and spatially designed and functionally graded nanofibrous material that mimics closely the native extracellular matrix ECM could succeed as the next generation of GTR membranes for periodontal tissue engineering. In the current study, using a minimally invasive surgical approach, we will compare a novel silk fibroin (SF) nanofiber membrane to collagen membrane as a regenerative treatment of intrabony periodontal defects.

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years old. 2. Patients with periodontitis Stage III Grade C. 3. Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible. 4. Probing depth (PD) ≥5 mm at the site of intraosseous defects 4 weeks following initial therapy. 5. Periodontal 2- or 3-wall intrabony defects (IBDs), measuring ≥3 mm from the alveolar crest to the defect base, estimated by radiographic evaluation (Periapical X-ray). 6. Absence of a history of periodontal surgery at the involved sites in the last 6 months. 7. History of compliance with oral hygiene instructions and periodontal recall. 8. Full mouth plaque score and bleeding on probing score ≤20% after phase I therapy.

Exclusion Criteria:

* 1. Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.24 2. Pregnant and lactating women 3. Current use of any form of tobacco.