cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Electromyographic Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery

The purpose of this study will explore the advantages of electrodes used for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery

OBJECTIVES/HYPOTHESIS:

The purpose of this study will explore the advantages and applications of electrodes used for monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery. We want to know that if the monitoring system will decrease the rate of recurrent laryngeal nerve palsy.

STUDY DESIGN:

One hundred patients who undergoing thyroid surgery will be collected in this study. Patients will be intubated for general anesthesia with a Medtronic Xomed Nerve Integrity Monitor (NIM) EMG endotracheal tube (Jacksonville, Fla) that had 2 electrodes imbedded in the wall of the endotracheal tube. These wires were placed up against each vocal cord. Two grounding wires(needle No. 26) were placed up in the subcutaneous tissues of both shoulders. The electrode wires, grounding wires, and nerve stimulator were connected to a monitoring device (Medtronic NIM-Response) that recoded a visual evoked potential and audible beep to each muscle contraction of a vocal cord. A Medtronic Xomed Prass monopolar nerve stimulator wand was used to test the RLN intraoperatively and was set at 0.5mA. Direct physical touching of the RLN with nerve stimulator using pulsed current would produce an audible "beep-beep-beep".

CONCLUSION:

This study will be conducted in cooperation with Department of anesthesiology. The following subjects will be collected and elucidated:

1. If the muscle relaxant used during surgery will affect the operation of RLN monitoring system.
2. Can RLN monitoring system accurately identify the RLN
3. Can RLN monitoring system accurately predict the function of RLN
4. Can RLN monitoring system decrease the RLN palsy rate after thyroidectomy
5. Application of RLN monitoring to determine the safety and the benefit of vagal stimulation at the beginning and the end of thyroid operation
6. Application of RLN monitoring to determine whether extensive dissection of RLN increases the risk of nerve injury.

At least four papers will be written after this study with the topics as followings:

1. Influence of muscle relaxation on neuromonitoring of the recurrent laryngeal nerve during thyroid surgery
2. Intraoperative neuromonitoring of the recurrent laryngeal nerve during thyroid surgery: Plaudits and pitfalls 3. Vagal stimulation during intraoperative neuromonitoring of the recurrent laryngeal nerve in thyroid operation.

4. Does extensive dissection of recurrent laryngeal nerve during thyroid operation increase the risk of nerve injury? Our experience with the application of intraoperative neuromonitoring

Eligibility Criteria:
Inclusion Criteria:

* Thyroid disease for operation

Exclusion Criteria:

* N/A
Preliminary Testing of the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station

The study objective is to satisfy the testing requirements for the Qualcomm Tricorder XPRIZE Competition. This requires an oversight model using the Vitaliti CVSM Wearable, Vitaliti Spirotoscope, and Vitaliti IVD Station to continuously monitor the patient's five core vital signs and to detect the health conditions required by the competition.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years of age.
* English speaking
* Established diagnosis of one of the thirteen required conditions with evidence in Medical Record.

Exclusion Criteria:

* Lack of patient consent
* Has pacemaker or internal medical device
* Pregnancy
* Concurrent enrollment into a clinical trial that may affect subject treatment
* Age less than 18 or over 65
* Physical disabilities affecting vision (eyeglasses or contact lenses will be allowed), manual manipulation, or use of a computer or mobile device
Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant

The purpose of this study is to determine whether patients are able to participate in a prehabilitation program (prior to the beginning of treatment) which includes: (1) a home-based exercise program or (2) just a prehabilitation education session.

Hematopoietic stem cell transplant may have the potential for severe side effects, including functional (reduced aerobic capacity, reduced muscle strength) and psychosocial (e.g. reduced quality of life, increased fatigue) detriments.

Evidence shows that exercise is considered to be an effective treatment approach in hematopoietic stem cell transplant patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exists with regard to prehabilitation exercise in hematopoietic stem cell transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Hematological cancer (e.g. Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Multiple Myeloma, Non-Hodgkin Lymphoma, etc.)
* Hematological cancer in remission
* Females and males ≥18 years of age
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG score of ≤ 2
* Scheduled for an inpatient autologous or allogeneic stem cell transplant at Penn State Cancer Institute
* ≥ 2 weeks until scheduled transplant
* Primary attending physician approval

Exclusion Criteria:

* Hematological cancer not in remission
* Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency \> NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability) for exercise
* Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
* Uncontrolled hypertension
* Receiving non-transplant related chemotherapy and/or radiotherapy
* Not fluent in written and spoken English
* Active infections, hemorrhages, and cytopenias that could place transplant patients at risk for further adverse events, deemed by the exercise interventionist, physician and/or nurse
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases

The purposes of this study are 1) to explore the association between multi-dimension facial characteristics and the increased risk of coronary artery diseases (CAD); 2) to evaluate the diagnostic efficacy of multi-dimension appearance factors for coronary artery diseases.

Previous study demonstrated the feasibility of using deep learning to detect coronary artery disease based on facial photos. However, several limitations made the algorithm hard to be utilized in clinical practice, including low specificity and lack of external validation. Adding multi-dimension facial characteristics may further increase the algorithm effect.

Thus, the investigators designed a single-center, cross-sectional study to explore the association between multi-dimension facial characteristics and CAD and to evaluate the predictive efficacy of multi-dimension appearance factors for CAD. The investigators will recruit patients undergoing coronary angiography or coronary computer tomography angiography. Patients' baseline information and multi-dimension facial images will be collected. The investigators will train and validate a deep learning algorithm based on multi-dimension facial photos.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing coronary angiography or coronary computer tomography angiography
* Written informed consent

Exclusion Criteria:

* Prior percutaneous coronary intervention (PCI)
* Prior coronary artery bypass graft (CABG)
* Screening coronary artery disease before treating other heart diseases
* Without blood biochemistry outcome
* With artificially facial alteration (i.e. cosmetic surgery, facial trauma or make-up)
* Other situations which make patients fail to be photographed
Effect of COX-2 Selective Inhibitors on Postoperative Insulin Resistance After Gastrointestinal Laparoscopic Surgery

It is well established that the resistance to the effects of insulin on glucose metabolism develops with a lot of stress hormone release after surgical trauma. This condition is known as insulin resistance (IR) characterized by hyperglycemia, hyperinsulinemia and lactic acidosis. Surgical IR not only affect glucose metabolism but also influence protein synthesis, then further exacerbate the depletion of the carbohydrate, fat and protein.

Postoperative pain is a challenging task for patients and surgeons, and it is part of the stress response to trauma and surgery, while the fear of pain can exacerbate the stress response.

The main aim of this study was to invest whether effective postoperative analgesia can reduce the stress response and insulin resistance.


Eligibility Criteria:
Inclusion criteria:

* Patients with gastrointestinal cancer scheduled for gastrointestinal laparoscopic surgery
* Patients between the ages of 18 and 70 yr
* ASA physical status I-II
* Requirements of informed consent and assent of participant, parent or legal guardian as applicable
* Consciousness and ability to cooperate

Exclusion criteria：

* History of alcohol, analgesic, or narcotic abuse
* Used analgesics, neuroleptics, antipsychotic agents, or corticosteroids within 6 hours of surgery
* A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease
* Female with positive pregnancy
* Allergy to conventional NSAIDs
Comparison of Carvedilol and Atorvastatin for Preventing of Contrast-Induced Nephropathy.

This prospective study is intended to evaluate if carvedilol has any potential protective effect over atorvastatin on the development of contrast-induced nephropathy (CIN) following cardiac catheterization in patients with moderate to high risk for CIN.

This study enrolled 150 patients planned for CC, and randomly assigned for one of the three groups. Group (A)include 49 patients who received two atorvastatin dose 80 mg 12 hours before CC and 40 mg just before CC. Group (B) include 48 patients who received 12.5 mg carvedilol twice daily for 7 days before CC and continue for 24hrs after the day of CC, Group (C) include 47 patients who only hydrated with saline. All included patients were hydrated with saline intravenous 0.9 sodium chloride (NaCl) at 0.5-1 mg/kg/hour for 4-6 hours before and 4-6 hours after cardiac catheterization. Serum creatinine(Scr), blood urea nitrogen (BUN) and estimated glomerular filtration rate were evaluated at the baseline and after 48 from CC. Serum neutrophil-associated lipocalin (NGAL) was evaluated after 4 hours from CC.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 70 years.
* Serum creatinine ≤ 1.5 mg/dL.
* Using a moderate dose of atorvastatin (40 mg or equivalent dose of other statins).
* Moderate to high-risk for CIN.

Exclusion Criteria:

* Patients suffering from ST-segment elevation myocardial infarction (STEMI)
* Patients need for immediate cardiac catheterization
* Elevated liver enzymes (Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) three times the upper limit of normal).
* Active infection.
* Any contraindication to carvedilol, or atorvastatin.
* Patients on regular use of vitamins, minerals.
* Using medication with antioxidant properties e.g., beta-carotene, vitamin E, vitamin C, selenium, theophylline or N-acetyl cysteine 7 days prior to CC.
* Hemodynamically unstable patients (defined as abnormal or unstable blood pressure, especially hypotension (blood pressure less than 90/60 mm Hg).
* Patients who required dialysis.
* Pregnancy.
* Using of carvedilol in the past three months.
* Using a nephrotoxic agent in the past 48 hours or exposure to a contrast agent in the past 7 days prior to cardiac catheterization.
Glulisine + Lantus in Type I Patients

To evaluate the efficacy (in terms of change HbA1c from baseline to endpoint) and safety (in terms of adverse events, clinical chemistry, lipids, hematology) of insulin glulisine (HMR 1964) in subjects with type I diabetes mellitus


Eligibility Criteria:
Inclusion Criteria:

* type I diabetes mellitus (onset of diabetes under the age of 40),
* an HbA1c range of \>6.5 - \<11%,
* and on multiple injection regimen (more than 1 year of continuous insulin treatment),
* body mass index \<35.

Exclusion Criteria:

* Active proliferative diabetic retinopathy,
* Diabetes other than type I diabetes mellitus,
* Pancreatectomised subjects,
* Subjects who have undergone pancreas and or islet cell transplants,
* Requiring treatment with not permited drugs during the study,
* Previous treatment (in the period not less than 1 month before the beginning of the trial) with insulin glargine,
* Hypersensitivity to insulin,
* Major systemic diseases,
* Impaired hepatic or renal function

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
AZD6423 SAD/MAD Study in Healthy Volunteers

This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers. The study includes an up to 28-day screening period, an in-house period during which AZD6423 or placebo will be administered IV, and a 4- to 10-day follow-up period after discharge.

In Part 1 of the study (single ascending dose portion), approximately 40 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 5 dosage-level cohorts (AZD6423 or placebo). Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive only one dose of either AZD6423 or placebo on Day 1. In Part 2 of the study (multiple ascending dose portion), approximately 24 subjects will be randomly assigned. Eight (8) subjects will be randomized in each of 3 dosage-level cohorts. Within each cohort, 6 subjects will be randomized to receive AZD6423 and 2 subjects will be randomized to receive placebo. Each subject will receive three doses of either AZD6423 or placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-specific procedures.
2. All male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control for the duration of the study and for 15 days after dose administration. A male subject is considered biologically capable of having children even if his sexual partner is sterile or using contraceptives.
3. Subjects must have a body mass index (BMI) between 19 and 30, inclusive and weigh between 50kg and 100kg inclusive.
4. Subjects must be fluent in English.

Exclusion Criteria:

1. A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality.
2. A clinically significant abnormality on physical examination, neurological examination, EEG, ECG, vital signs or laboratory evaluations at screen or between screen and dose administration.
3. A history of seizure.
4. A history of head trauma, including closed head injury with loss of consciousness.
5. Any history of suicide attempt or suicidal behavior, or, in the opinion of the investigator, clinically significant risk of suicide or violent behavior.
6. Urine drug screen positive for a drug of abuse
7. A family history of schizophrenia, schizoaffective disorder, or psychosis in first degree relatives.
O-GlcNAcylation Role in the Pathophysiology of Systemic Lupus Erythematosus

This study aims at defining the role of O-GlcNAcylation is in the physiopathology of systemic lupus erythematosus (SLE). O-GlcNAcylation is a metabolic pathway potentially implicated in SLE with potential for the discovery of new therapeutic strategies.

Systemic lupus erythematosus (SLE) is a rare and potentially life-threatening auto-immune systemic disease. There is an urgent need for better comprehension of the physiopathology of the disease and to discover new therapeutic pathways.

The hexosamine biosynthesis pathway, or HBP, is an important regulator of immunity and results in a post-transductional modification of proteins called O-GlcNAcylation and involved in inflammation and immunity.

There is a very unbalanced sex ratio in favor of women in SLE suggesting a role of the X chromosome in the physiopathology of the disease. The human OGT gene (a key O-GlcNAcylation enzyme) is localized on the X chromosome, near the XIST gene responsible for the inactivation of one X chromosome by methylation.

Moreover, genes encoding CD40L, CXCR3 and OGT have been shown to be demethylated and overexpressed in T cells of women with systemic systemic lupus erythematosus compared to men with the same pathology.

The investigators hypothesize that O-GlcNAcylation is increased in the effector lymphocytes of SLE patients and involved in the pathophysiology of the disease. Therefore, inhibiting O-GlcNAcylation may be a promising therapeutic option in SLE.

This study will recruit 100 patients with SLE followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected at study visit to study O-GlcNAcylation levels in immune cells. Fundamental research will be realized on patients' sample.

Clinical and biological disease activity, treatment and outcomes will be studied in correlation with O-GlcNAcylation levels. Patients will be included within their usual follow-up. No extra visit will be needed and blood samples will be drawn at the same times as those drawn for clinical purposes.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged over 18 years old
* Diagnosis of systemic lupus erythematosus
* Affiliated person or beneficiary of a social security scheme.
* Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research).

Exclusion Criteria:

* Pregnant or breastfeeding women,
* Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent)
Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in PD

This project will provide preliminary data on the feasibility and effects of exercise and VR on motor behavior and neuroplasticity in PD. Results from this work will provide insight into whether combination interventions utilizing AE and VR have parallel effects on cognition, gait, and neuroplasticity in PD.

In this pilot proof-of-concept study, the study team will recruit 25 individuals with Parkinson's disease who will perform aerobic exercise (AE) followed by virtual reality (VR). The study team will measure the effects of the intervention on dual task performance, clinical measures of gait, cognition, TMS measures and questionnaires pertaining to quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic PD (ages 18 - 85) in Hoehn and Yahr stages 1 - 3.
2. Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.

Exclusion Criteria:

1. Subjects with a history of other neurological diseases (i.e. stroke, multiple sclerosis).
2. Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis.
3. Subjects with a history of PD-specific surgical procedure such as deep brain stimulation etc.
4. Subjects with a history of head injury.
5. Subjects with a history of seizures or epilepsy,
6. Subjects who are currently pregnant
7. Subjects who use of medications that could alter corticomotor excitability or increase risk of seizure
8. Subjects with skull abnormalities, fractures, unexplained, recurring headaches.
9. Subjects who have cognitive or communication impairment that would affect participation.
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years and over.
* Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.Anticipated time between injury and treatment must be less than 3 hours.

Exclusion Criteria:

* Pain medication was taken within the 6 hours that precede randomization.Any physical impairment that would influence the study's efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.