cyrilzakka/clinical-trials huggingface dataset:
VATS for Resection of Mediastinal Parathyroids

Background: hyperparathyroidism (HPT) is a disease caused by hypersecretion of one or more parathyroid glands, it can be associated with ectopic mediastinal parathyroid glands (MEPA) in 2% of cases. The use of video-assisted thoracoscopic surgery (VATS) for the surgical resection of these glands is a safe, cost-effective, and low-morbidity option for patients with MEPA. We report a case series of patients with this disease managed with VATS.

Patients \& Methods: From 2008 to 2022, a retrospective study involving patients with MEPA and treated by VATS approach was performed in a tertiary hospital in Mexico City. Relevant biochemical and clinical variables such as imaging studies, pre and postoperative lab results, surgical strategy and outcomes, and pathological analyses were analyzed.

Hyperparathyroidism (HPT) is a clinical disorder characterized by an inappropriately elevated paratohormone (PTH) due to hypersecretion of one or more parathyroid glands, that may develop secondary hypercalcemia and other metabolic disturbances. This disease includes various signs and symptoms such as nephrolithiasis, osteopenia and osteoporosis, depression, mental numbness, loss of appetite, nausea, vomiting, constipation among others. The abnormal secretion of PTH is most commonly caused by a single parathyroid gland adenoma in 85% of the cases, in the other 15% is due to multiple gland hyperplasia (15-20%)(1) or rarely from a parathyroid carcinoma (\<1%). HPT occurs in both genders equally around the sixth decade(2). World HPT prevalence is estimated at 1 in every 500 women and 1 in every 2000 men(3).

Mediastinal ectopic parathyroid adenomas (MEPA) are rare tumors, constituting 1-2% of all parathyroid adenomas. These glands are inferior to the sternal notch and their location may vary from the superior mediastinum to the pericardium and diaphragm(4). The first report of a mediastinal parathyroid adenoma was in 1932 by Churchill in the patient Captain Charles E. Martell, who had 6 prior cervical explorations for his hyperparathyroidism until an ectopic gland was found in the superior mediastinum(5). Before the introduction of VATS, MEPA were usually resected by thoracotomy or a median sternotomy, currently with the daily use of minimally invasive surgery, VATS is being adopted as the procedure of choice.

The aim of this study to report a case series of patients with MEPA treated with VATS, along with a literature review.

Eligibility Criteria:
Inclusion Criteria:

* Patients with MEPA

Exclusion Criteria:

* incomplete records
Spectroscopy With Surface Coils and Decoupling

The purpose of this study is to obtain chemical information from part of your body without a biopsy. This is done using a technique called magnetic resonance spectroscopy (MRS) which is similar to magnetic resonance imaging (MRI) except that signals are detected from the chemicals (spectroscopy) naturally present in your body using radio waves. To receive this information from your body, small loops of wire (surface coils), placed near the tissue of interest, may be used to more effectively detect signals that come from the chemicals in your body. The investigators may use a second radio channel simultaneously, which will allow us to obtain greater chemical information (decoupling). The results may also help us to understand how this study can be used to help other patients with your condition.

The investigators propose to use 1H spectroscopy or 1H decoupled 31P NMR spectroscopy to obtain biochemical information about tumor metabolism in patients, both before and after antineoplastic therapy. In healthy volunteers, normal tissue metabolism will also be studied. It is hypothesized that metabolic information may be of prognostic significance, or may be useful for timing of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have suspected or documented neoplastic disease, strongly suspected or established by physical examination, history or conventional histologic biochemical or imaging techniques, or have surgical or aspiration biopsy that will be used to establish a diagnosis
* Patients with obstructive jaundice, both from malignant and non-malignant disease, will be considered for the study
* Patients/volunteers must be clinically stable and not require cardiovascular monitoring
* Patients must be 6 years of age or older and be able to cooperate for an approximately 60 minute examination
* Volunteers must be 18 years of age or older

Exclusion Criteria:

* Inability to cooperate for an MR exam
* Contraindication to MR: Pacemaker, Aneurysmal clips Any ferrous metallic implants which could be deflected by the magnet, Metal implants in field of view, Pregnant women, OR Age and mental status wherein he/she is unable to cooperate for MR study
Dose De-escalation to the Elective Nodal Sites in Head and Neck Cancer

A randomized clinical trial was initiated to investigate whether a reduction of the dose to the elective nodal sites and the swallowing apparatus delivered by IMRT would result in a reduction of acute and late side effects without compromising tumor control.

1. Study hypothesis

   Dose de-escalation in the elective nodal sites and off-target regions of the swallowing apparatus delivered by IMRT does reduce overall rate of late dysphagia and neck fibrosis comparing to the standard dose to the elective nodal sites.
2. Primary endpoint

   To estimate the difference in overall rate of late dysphagia and neck fibrosis 1 year after the end of radiotherapy in patients receiving dose de-escalation to the elective nodal sites and off-target regions of the swallowing apparatus applying IMRT.
3. Secondary endpoints

Local, regional and distant control Recurrence and site of recurrence Overall, disease-free and disease-specific survival Acute toxicity Quality of life

Eligibility Criteria:
Inclusion Criteria:

oral cavity, oropharynx, hypopharynx and larynx SCC Histolocervical lymph node metastases of unknown primary cancer Primary unresectable tumor and/or patients refused surgery Stage T2-4; T3-4 N0 Tany N1-3 for laryngeal cancer Karnofsky performance status ≥70% Age ≥ 18 years old

Exclusion Criteria:

Treatment combined with brachytherapy Prior irradiation to the head and neck region History of prior malignancies, except for cured non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease at least 5 years Distant metastases Pregnant or lactating women Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Multimodal Pain Management Following Primary TKA

The investigators plan to evaluate the length of time to discharge readiness between the groups (continuous femoral nerve blocks (cFNB) vs. liposomal bupivacaine (LB) vs. periarticular infusion cocktails (PIC) following primary total knee arthroplasty (TKA). In addition, the investigators will compare quadriceps strength recovery over time and exploratory variables between the groups.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 40 Years Old
* Scheduled for Primary Total Knee Arthroplasty

Exclusion Criteria:

* Opiate Tolerant (≥60mg/day oral morphine/equivalent for ≥1 week)
* Neuromuscular deficit affecting the lower limbs

  * Peripheral neuropathy
  * Radiculopathy/Sciatica
* Known allergy or intolerance to Bupivacaine or Ropivacaine
* Hepatic Disease
* Renal Disease/Patients needing Dialysis
* Planned unicompartmental knee replacement
* Less than 90 degree of knee flexion preoperatively.
* Patients who lack the capacity to consent or are unwilling to do so
* At the discretion of the PI, patients who may have difficulty complying with standard of care (SOC) followup may also be excluded
KN046 in Subjects With Advanced Solid Tumors and Lymphoma

This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent; willing and able to complete all required procedures of study.
2. With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
3. Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
4. ECOG performance status of 0 or 1.
5. Subject must have adequate organ function.
6. Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
7. Ability to comply with treatment, procedures and PK sample collection and the required study follow-up procedures.

Exclusion Criteria:

1. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
2. Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
3. Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
4. Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
5. Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
6. Active HBV or HCV infection.
7. Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
8. Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
9. Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter

This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.

Patients undergoing elective, neurointerventional procedures, or patient undergoing follow-up diagnostic procedures who meet all inclusion criteria and none of the exclusion criteria will be considered for enrollment. The study investigates the use of the Gentuity Neurovascular Imaging System as a diagnostic tool for intravascular imaging in the cerebrovasculature. The study evaluates the incidence and severity of device-related adverse events, clinical usability performance and technical performance of imaging quality.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure
* Patients that present with a Modified Rankin Score (mRS) ≤3
* Patients 18 years of age or older
* Patients willing and able to provide written informed consent to participate in evaluation

Exclusion Criteria:

* Patients with serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk
* Pregnant
* Patient has a known hypersensitivity to contrast media
* Patients undergoing an urgent or emergent neurointerventional procedure
* Patients that present with a Modified Rankin Score (mRS) ≥4
* Patients that present with an unresolved spontaneous subarachnoid hemorrhage and/or intracranial hemorrhage
* Participation in another clinical trial of an investigational drug or device
* Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System
5-HTR2A, DRD2,and COMT Genes Polymorphisms and Olanzapine Plasma Concentration in Treatment of Early-onset Schizophrenia

In this study,investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Blood olanzepine plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the study is to explore the predictive factors on olanzepine treatment response in EOS, which can guide the individualized treatment and improve the cure rate of EOS in clinical setting.

Early-onset schizophrenia (EOS) is the World Health Organization ranked psychosis as the third most disabling condition worldwide in youth, and may lead to obvious social dysfunction and interfere seriously with neurodevelopmental processes in a young person, which in turn has the potential to irreversibly alter the trajectory of his or her life. To improve the outcome of the patients of EOS, elaborate and individualized therapeutic regimen is urgently needed. The functional gene polymorphisms and drug (antipsychotics) plasma concentration can both influence the drug response, but few studies explore the contributions of genetic heterogeneity, drug plasma concentration and clinical features of patients to drug response together and interactions of above factors in EOS patients. In this study investigators will recruit 100 DSM-Ⅴdefined EOS Han patients, older than 7 years old and onset of illness before 17 years old, and all EOS patients will receive a 8-week systematic olanzepine titration treatment and a battery of assessments of treatment effect and safety. Blood olanzepine plasma concentration will be tested regularly and genotyping of 8 polymorphisms of 5-HTR2A, DRD2 and COMT genes will be conducted by Polymerase Chain Reaction （PCR）, Restriction Fragment Length Polymorphism (RFLP) and TaqMan probes genotyping technology. The aim of the study is to explore the predictive factors on olanzepine treatment response in EOS, which can guide the individualized treatment and improve the cure rate of EOS in clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* above 7 years old,
* age of onset ≤17 years old,
* Han or other nationality, male or female,
* in line with the diagnostic DSM-V criteria for schizophrenia, and
* negative and positive symptom scale (Positive and Negative Syndrome Scale, PANSS) score ≥70 points;
* patients are in the condition of first-episode, or relapse.

Exclusion Criteria:

* IQ \<70,
* current or previous history of traumatic brain injury,
* psychoactive substance use,
* personality disorders,
* obvious abnormalities on physical and laboratory examination,
* previous allergy or olanzapine had significant adverse reactions.
CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth

Depression in youth is a serious public health concern for which more personalized treatments are needed. This randomized controlled trial will test the effect of an intervention aimed at enhancing social cognitive capacities (e.g., ability to take another's perspective), thereby making treatment of depression in youth more efficient and effective. Participants in the R33 (N=82) will be youth between ages 13- through 17-years-old currently experiencing depression. Youth will be randomized to either an enhanced CBT intervention that teaches social cognitive skills, particularly social perspective taking and theory of mind (CBTSCT) as compared to CBT only. The primary target is improvement in both social cognitive skills and depressive symptoms at post-treatment and at a 6-month follow-up.

Depression in adolescents is a recurrent and impairing disorder. Although some treatments have shown modest effects in children and adolescents (e.g., cognitive behavioral therapy - CBT), there remains a critical need to build upon these therapies to reach even more youths with depression. One variable hypothesized to affect children's interpersonal relationships is their level of social cognitive development on abilities particularly relevant to social functioning and CBT (e.g., social perspective taking; theory of mind). This RCT will test the efficacy of an intervention aimed at increasing children's social cognitive (SC) abilities. Adolescents (ages 13-17; N=82) with depression diagnoses or clinical levels of depressive symptoms (PHQ9 \>15) will be randomized to either the social cognitive training enhanced CBT (CBTSCT) or CBT only. In the R33 RCT, investigators will conduct a trial aimed at replicating the results of the R61 with a new sample of 82 youth (ages 13-17) randomized to CBTSCT or CBT only. Youth will be evaluated regarding their social cognitive abilities (i.e., theory of mind), level of depressive symptoms, and social functioning at baseline, post-treatment, and at a 6-month follow-up. Finally, investigators will test if increases in social cognitive abilities partially accounted for the relation between treatment condition and decreases in depression. If the CBTSCT intervention significantly improves participants' social cognitive abilities and decreases depressive symptoms, then this will provide therapists with a more efficient and personalized treatment of depression in youth.

Eligibility Criteria:
Inclusion Criteria:

1. Participants ages 13- through 17-years-old
2. Youth must have a diagnosis of a current depressive disorder (e.g., major depressive episode; persistent depressive disorder) or a score on the Patient Health Questionnaire (PHQ9) \> 15

Exclusion Criteria:

* ever met criteria for a diagnosis of bipolar disorder, schizophrenia, autism, or conduct disorder
* current alcohol or substance use disorder with significant impairment
* imminent risk of suicide
* reading level \< 4th grade
Delayed Primary Closure Using Negative Pressure Wound Therapy

Surgical site infection rates for contaminated or dirty laparotomy wounds can be as high as 45%. Surgical management of dirty and contaminated wounds has been controversial in the literature and between surgeons. Primary closure (PC) of these wounds can lead to multiple complications including surgical site infection (SSI), necrotizing soft tissue infection, wound and fascial dehiscence, evisceration, sepsis and hernia development. However, an alternative technique of utilizing secondary intention results in prolonged healing time and increased cost and healthcare resource utilization. Delayed primary closure (DPC) was developed to address many of these issues. Bhangu completed a systematic review and meta-analysis comparing primary versus delayed primary skin closure in contaminated and dirty abdominal wounds. They included 8 studies randomizing 623 patients with contaminated or dirty abdominal wounds to either DPC or PC. The most common diagnosis was appendicitis (77.4%), followed by perforated abdominal viscus (11.5%), ileostomy closure (6.5%), trauma (2.7%), and intra-abdominal abscess/other peritonitis (1.9%). The time to first assessment for DPC was between 2 and 5 days postoperatively. In all studies, the DPC group had significantly less SSIs using a fixed-effect model (odds ratio, 0.65; 95%CI, 0.40-0.93; P = .02). However, heterogeneity was high (72%), and using a random-effects model, the effect was no longer significant (odds ratio, 0.65; 95% CI, 0.25-1.64; P = .36). Additionally, all of the studies were found to be at high risk of bias, with marked deficiencies in study design and outcome assessment.

A recent systematic review showed improved fascial closure rates with negative pressure wound therapy (NPWT) Yet, a large national study using NPWT to perform a DPC has been shown to actually decrease the rate of closure. Access to NPWT has increased over the years and innovative wound management techniques including incisional application of negative pressure therapy have allowed clinicians to apply this method to dirty wounds following the principles of delayed primary closure. There are currently no studies available to help determine the safety and efficacy of advanced NPWT techniques to optimize surgical wound management from the open abdomen to skin closure. Within our Division, we have decided to make a practice change and develop a standard closure plan for open abdomens using the negative pressure devices available within our institution.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* undergone midline laparotomy and managed with an open abdomen for at least one day
* contaminated or dirty wound classification

Exclusion Criteria:

* Less than 18 years of age
* Prisoners
* Pregnant females
* Non-surgical patients
RELVAR Effects on Parasternal Muscle Activity, Diaphragm, and Ventilation in Severe COPD

This study examines the effect of the ultra long acting beta agonist/corticosteroid bronchodilator combination fluticasone furoate/vilanterol trifenatate, on respiratory muscles and ventilation in adults with severe bronchitis or emphysema (COPD).

In adults with severe, minimally reversible bronchitis or emphysema (COPD), there is progressive hyperinflation of the lungs with associated flattening and inefficiency of the major respiratory muscle, the diaphragm. These changes limit physical activity and exercise, and provoke shortness of breath - dyspnea.

These debilitating symptoms are often significantly lessened with ultra long acting combination bronchodilators, even in adults where the bronchodilator does not produce any measurable improvement in either airflow or lung hyperinflation.

This symptomatic improvement in adults with severe, minimally reversible COPD may occur because of a direct benefit of the bronchodilator on respiratory muscles and ventilation.

This study examines the effect of the ultra long acting bronchodilator fluticasone furoate/vilanterol trifenatate upon the upper anterior chest wall respiratory muscles (parasternals), the diaphragm, and breathing pattern.

Eligibility Criteria:
Inclusion Criteria:

* ambulatory, stable severe COPD (GOLD Class III-IV)
* on long acting bronchodilator therapy
* compliant with use of prescribed medications
* fit for minor surgical procedure including intravenous sedation

Exclusion Criteria:

* hypersensitivity to milk proteins
* hypersensitive to fluticasone furoate/vilanterol formulation
* angina or substantial cardiovascular risk
* exacerbation of COPD within the preceding 2 months
* significant non-respiratory system disease