cyrilzakka/clinical-trials huggingface dataset:
Nimotuzumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Treatment Esophageal Cancer in Old Age

The research subjects of this project are mainly aimed at patients with locally advanced esophageal cancer who cannot be treated surgically, in Taixinsheng 3 months after the end of concurrent chemoradiotherapy, RECIST is pressed as based on physical examination and esophageal barium dialysis or esophageal contrast-enhanced CT Criteria assessed short-term and long-term efficacy separately. By detecting the expression of EGFR in patients with locally advanced esophageal cancer, the relationship between the efficacy of EGFR monoclonal antibody therapy and the long-term prognosis of patients was evaluated. Evaluation of safety, toxicity and side effects during treatment and in the near and long term.

It is expected that 45 patients will be enrolled, and patients who meet the enrollment criteria will undergo esophagoscopy, esophageal barium meal examination, chest contrast-enhanced CT, abdominal ultrasound, electrocardiogram, blood routine, whole body bone scan, liver and kidney function and other examinations before treatment, and esophageal ultrasound if necessary. Patients who received esophageal ultrasound were staged by esophageal ultrasound results, and those without esophageal ultrasound were mainly staged according to the cervical chest and epigastric contrast CT and esophageal barium plates, and clinical staging was performed according to the 2002 AJCC staging standard. After the combination of Taixinsheng and concurrent chemoradiotherapy, adverse reactions and efficacy evaluation were observed. The expected result is that the local control rate of EGFR monoclonal antibody combined with chemoradiotherapy is improved in patients with locally advanced elderly esophageal squamous cell carcinoma, and there is no significant increase in adverse reactions, and serological indicators such as EGFR can be used as prognostic indicators for esophageal malignancy and have certain guiding significance for treatment. EGFR monoclonal antibody can be used in locally advanced elderly esophageal cancer patients who cannot tolerate chemotherapy, with good short-term efficacy and tolerable toxic side effects, which further provides reference value for clinical guidance.

Eligibility Criteria:
Inclusion Criteria:

1. Locally advanced senile esophageal cancer that cannot be treated surgicallyr (T3-4N0 or any N+);
2. The pathological type is esophageal squamous cell carcinoma;
3. immunohistochemistry showed medium and strong expression of EGFR;
4. No signs of perforation, such as protruding spikes, niche shadow formation, twisted angles and mediastinal disorder;
5. Karl Fischer score (KPS) ≥ 70, age ≥ 70 years old, can eat a semi-liquid diet;
6. No serious comorbidities, such as severe obstructive emphysema, hypertension, coronary heart disease, diabetes and psychiatric history, etc., and no other malignant tumors;
7. All patients had not received EGFR-targeted therapy, immunotherapy, and chemoradiotherapy.

Exclusion Criteria:

-
Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty

Aspiration of gastric contents during perioperative period is a grave complication with significant morbidity and mortality. Diabetic patients have a higher incidence of autonomic dysfunction, causing gastropathy. They are known to have gastroparesis and the consequent delayed gastric emptying which predisposes them to an increased risk of aspiration than the general population. Furthermore, other common factors can influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics.

In the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee.

In the present study, we will evaluate the effect of old age, diabetes, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years
* American Society of Anestheiologist physical status classification 1, 2, and 3
* Body mass index \< 35 kg/cm2

Exclusion Criteria:

* Previous surgery of the upper gastrointestinal tract
* Achalasia
Ketamine Frequency Treatment for Major Depressive Disorder

Depression is a wide spread illness. Depression contributes most significantly to national health care costs. While the number and types of treatments used for depression have expanded over the years, even with an increased range of options, the response rate, defined as the number of subjects who have a 50% reduction in depressive symptoms, is estimated to be around 65%.

This randomized clinical trial will examine the frequency of treatment with ketamine in patients with treatment-resistant depression TRD without psychosis. It will compare two modes of the ketamine treatment; every other day ketamine, versus two active and four placebo treatments over the period of 12 days.


Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 65
* Major depressive disorder without psychotic features confirmed by a structured clinical diagnostic interview, SCID.
* Treatment resistant depression defined using the Antidepressant Treatment History Form (ATHF)
* HDRS 21 score \> 18
* Female participants of childbearing potential must be using a medically accepted means of contraception (birth control pills, spermicidal barrier)
* Ability to concur with medication standardization regiment (section as an outpatient
* Physically healthy (no chronic diseases; normal CBC, BMP, AST, ALT, and UA)
* Competent to give informed consent to all required tests and examinations and sign a consent document

Exclusion Criteria:

* Bipolar disorder
* Psychosis or any other psychotic disorder as defined by DSM-IV criteria
* Serious or imminent threat for suicide
* Pregnant or nursing female
* Presence of serious unstable medical illnesses including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, or abnormal laboratory tests (CBC, BMP, AST, ALT, and UA)
* Uncontrolled hypertension
* History of CVA
* Treatment with St. Johns wort, tramadol, phentolamine, naloxone, or anticholinergic medications
* Alcohol or illicit drug abuse for 6 months (evidence from UDS)
* Currently involved in a clinical trial or used an experimental medication within the last 30 days
* Hypersensitivity to ketamine products
Surgical Ablation for Atrial Fibrillation

Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone atrial fibrillation (AF). This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF.

Atrial fibrillation (AF) patients with a previous stroke are often at a high risk of recurrent stroke and bleeding. Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone AF. This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF. Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \> 18 years
* Patients with paroxysmal, or persistent/long-standing persistent AF according to the standard EHRA definition.
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication.
* Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)

Exclusion Criteria:

* AF secondary to a reversible cause (i.e., thyreopathy, etc.) Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.)
* Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology
* Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)
YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey

To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in terms of awareness about these tools, their utilization, knowledge and comprehension of Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional (HCP)s and patients

A total sample size of 160 to 200 HCPs and 160 to 200 patients

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* HCP experienced in the treatment of patients with the research compound and patients that have received at least one dose
Neurofeedback Training for PD

The goal of this clinical trial is to test neurofeedback training in both people with Parkinson's disease and healthy control.

The main questions it aims to answer are:

* To demonstrate that EEG based or STN LFP based neurofeedback can help patients with Parkinson's disease to volitionally modulate pathological brain activities measured non-invasively;
* To evaluate the learning effect of the neurofeedback training with multiple training sessions

Patient participants will be asked to receive the research intervention called neurofeedback training for maximal three separate sessions. During the intervention, the participants will also be asked to press a pinch meter as fast as possible in order to measure the reaction time, meanwhile, different type of brain signals will be recorded.

. This will be a within-subject cross-over study contrasting the effect of the neurofeedback training and no training.


Eligibility Criteria:
Inclusion Criteria:

* Participants with symptomatic Parkinson's disease or age-matched healthy control
* Adequate understanding of verbal explanation or written information given in English
* Able and willing to give informed consent.
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Lack of capacity to consent (judged by the researcher taking consent as not having sufficient mental capacity to understand the study and its requirements)
Early Childhood : Action Research in the Lunévillois Area (PERL)

The PERL project is a research in prevention in perinatality. The objective of this research is to offer preventive and regular care at familie's home in the Lunévillois area, while integrating it into the existing practices of the maternal and child protection, in the framework of a partnership between the PMI (Protection Maternal Infantile) and the child psychiatry.

An innovative prevention device to support the interactions and development of the child will be proposed to about sixty families, randomly recruited into the general population.

If the family agrees to participate, their will benefit from regular home visits by a pediatric nurse, accompanied on certain times by a psychologist, for a period of 4 years from the birth of the child.

This home-visits accompaniment, centered on listening and observation, focuses on three areas: baby's development, parenthood and parent-child's interactions.

A longitudinal and comparative evaluation will be carried out with a "control" group recruited according to the same conditions and at the same time as the "participants" group.

A parallel research on the processes and mechanism will be carried out in partnership with the School of Public Health in order to define and validate the intervention theory (what are the mobilized levers produced and how, what are the mechanisms linking the intervention to its results), to describe the implementation and the processes involved, and to analyze the effects of context, especially social, on processes and results.


Eligibility Criteria:
Inclusion Criteria:

* Parents living in the Lunevillois area
* Mother to be 8 months pregnant
* Baby who's born from january to december 2018

Exclusion Criteria:

* No exclusion criteria
The Effect of Clamping the Indwelling Urethral Catheter Before Removal From Patients After Type III Radical Hysterectomy

The effect of clamping the indwelling urethral catheter before removal is an unsettled issue in clinical practice. No studies have done before in the patients with gynecologic cancers who received radical hysterectomy. We hypothesized that clamping the catheter would decrease the rate of recatheterization. In addition, the feeling of urination during clamping is correlated with lower rate of recatheterization after removal.


Eligibility Criteria:
Inclusion Criteria:

* patients receiving Piver III radical hysterectomy
* catheterization over 7 days

Exclusion Criteria:

* catheterization shorter than 7 days
Use of Provodine to Protect HCW Hands (Aim II.1)

The investigators will assess whether applying Provodine, an FDA-approved hand hygiene product with a long duration of anti-microbial action, to healthcare workers' hands protects against self-contamination during the removal of personal protective equipment (gloves, gowns, etc).

We will perform a two-armed pilot test among 40 front-line healthcare workers (nurses, doctors, respiratory therapists, etc) at the University of Iowa Hospitals and Clinics. Participants will serve as their own controls. First, participants will perform hand hygiene with alcohol-based hand rub as they normally would in clinical practice then don PPE. We, the research team, will contaminate participating healthcare workers' (HCW) PPE with either bacteriophage MS2 (twenty participants) or S. marcescens ATCC 14756 (twenty participants). MS2 preparation and propagation and S. marcescens culture suspensions will each be performed as previously described. The MS2 bacteriophage will be suspended in 0.01 M phosphate-buffered saline and each PPE site will be contaminated with 10\^5 plaque-forming units (PFU) of MS2 in 5 drops of 5 μL each. Aliquots of 3 mL of S. marcescens broth suspension (yielding bacterial titers of \~1 X 10\^9 CFU/ml) will be applied to each PPE site. Participants will then doff PPE using the Centers for Disease Control's (CDC) recommended protocol. We will sample their hands using the bag broth method. A research assistant will monitor participants as they wash their hands with soap and water then rinse their hands with 70% ethanol. Participants will then apply ProvodineTM to their hands and put on (don) fresh PPE. We will repeat the contamination, doffing, and sampling procedure. For MS2 recovery, we will assay the eluent using the most probable number (MPN) enrichment infectivity assay. For S. marcescens recovery, we will dilute the eluent, plate it, incubate the plates, and count the colonies as described.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be UIHC healthcare workers (doctors, nurses, etc.)

Exclusion Criteria:

* Known skin sensitivity to povidone iodine or Provodine (TM)
Response of Urticaria to Stress Intervention

Several studies have shown a relationship between psychological stress and chronic urticaria (hives). The primary objective of this study is to evaluate the effect psychological stress intervention has on chronic urticaria.

As many patients with chronic urticaria display heightened levels of stress before and/or after the onset of the urticaria, the purpose of this study is to evaluate the effect of psychological stress intervention on chronic urticaria. Intervention group participants will meet with a psychiatry resident once a week for six consecutive weeks to be educated on psychological stress intervention techniques. Control group participants will meet with a psychiatry resident once a week for six consecutive weeks for general supportive therapy, which will not provide psychological stress intervention. All participants will complete a packet of psychological and dermatological questionnaires before the first session with the psychiatry resident and one week after the final session. All participants will record daily 1) their urticaria symptoms and 2) the type and number of antihistamines taken. Blood and saliva samples will be collected before the first session and one week after completion of the final session to compare the levels of stress hormones and cytokines in order to evaluate an effect on immune dysregulation.

Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18-64 years who are inadequately controlled on H1 and/or H2-blocker therapy for chronic urticaria
* The Urticaria Activity Score must have a score of at least 2 (one point from each of the two categories: number of hives and severity of pruritus).

Exclusion Criteria:

* Urticaria secondary to vasculitis
* Use of prednisone, hydroxychloroquine, cyclosporine, or a tricyclic antidepressant (except Doxepin) within the 30 days prior to enrollment
* A history of anaphylaxis
* Non-controlled or debilitating chronic diseases (poorly controlled diabetes or congestive heart failure)
* An immune system disorder
* Deranged stress hormone level (for example, Cushing's disease)
* Ongoing omalizumab therapy
* Nocturnal employment (which would effect study measures, such as cortisol levels).
Relationship Between Albumin/Creatine Ratio, B12, Folate, and Frailty Index

In the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, CRP, procalcitonin, vitamin D, IL-1, and IL-6 has been investigated (2). In our study, the investigators aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin, hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery. By identifying the relationship among these parameters, the investigators believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

Frailty is a condition associated with a decline in physiological performance. Patients are categorized as healthy, pre-frail, or frail based on physiological and functional characteristics. Frailty is known to be influenced by various lifestyle factors such as socioeconomic status, psychological factors, diet, exercise, and genetic predisposition. With aging, there is an increase in cognitive and physical dysfunction, which correlates with an increase in frailty. Along with frailty, geriatric symptoms, mortality, and other negative health outcomes also increase in the elderly population. Therefore, early detection of frailty is crucial to implementing lifestyle changes aimed at improving cognitive and physical status. Various assessment scales are used to evaluate frailty, such as the Frailty Scale Version 9, Quality of Life Scale Short Form-36, and Modified 5-item frailty index (mFI-5) In the literature, the relationship between frailty and various blood tests such as beta-2 microglobulin, CRP, procalcitonin, vitamin D, IL-1, and IL-6 has been investigated (2). In our study, the investigators aim to investigate the relationship between frailty status assessed using frailty scale forms (Frailty Scale Version 9, Quality of Life Scale Short Form-36) and preoperative levels of Albumin/Creatinine, B12, Folate, Ferritin,hemogram, Sedimentation Rate, and CRP in patients undergoing gastrointestinal malignancy surgery. By identifying the relationship among these parameters, the investigators believe that modifiable factors contributing to frailty in patients at risk can be addressed through appropriate interventions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are over 65 years old.
* Patients classified under ASA (American Society of Anesthesiologists) risk groups I, II, and III.
* Patients with gastrointestinal malignancy undergoing surgery

Exclusion Criteria:

* Patients who are under 65 years old.
* Patients with an ASA score of IV or higher.
* Patients who refuse to participate in the study.
* Patients undergoing emergency surgeries will be excluded from the study
Investigation of the Clinical Performance of Silicone Hydrogel Contact Lenses During Continuous Wear

The primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24 months.


Eligibility Criteria:
Inclusion Criteria:

* Has had an oculo-visual examination in the last 2 years.
* Is correctable to at least 6/7.5 distance visual acuity in each eye with spherical contact lenses.
* Is a current soft contact lens wearer.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.

Exclusion Criteria:

* Has any systemic disease that might interfere with contact lens wear
* Is using any systemic or topical medications that will affect ocular health.
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures

This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.

In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will result in less total opioid administration during the randomization period compared to a fascia iliaca compartment block using 0.2% ropivacaine.

The long-term goal of this study is to provide pilot information to guide and design larger, multicenter trials which will evaluate the utility and cost-effectiveness of long acting liposomal bupivacaine as an opioid-sparring analgesic strategy in injured trauma patients. Ultimately, it is hoped that this information can improve safe and effective narcotic sparing analgesia in the awake, combat casualty, as well as serve as primary steps towards

Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years ≤ 70 years
2. Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital
3. Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident.

Exclusion Criteria:

1. \>10 hours since presentation to the emergency department
2. History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.
3. Central or peripheral neurologic deficit on presentation
4. Concern or compartment syndrome
5. Associated additional long bone fractures
6. End stage liver failure
7. Renal failure requiring dialysis
8. Pregnancy or breast feeding
9. Prisoners
10. Coagulopathy with INR \>1.5
11. Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)
12. Suspected prolonged intubation within first 12 hours secondary to respiratory failure other than peri-procedurally
13. Adults unable to consent
14. Pediatric patients \<18 years old
15. Patients exhibiting signs of shock upon admission, HR \>120 or SBP \<100 mmHg.
16. History of allergic reaction to local anesthetics
17. Administration of any other local anesthetic in the 2 hours prior to the study enrollment.
18. Distal femur fractures