cyrilzakka/clinical-trials huggingface dataset:
Paraspinal Muscle Relaxation in Spine Surgery

During anesthesia, neuromuscular blocking agents (NMBA) are routinely used for relaxation of muscles necessary for the conduction of the surgical procedure. Train-of-four (TOF) test is based on supramaximal stimulation of peripheral nerve resulting in four twitches: T1 to T4. The assessment of the NMBA blockade is performed routinely by measurement of the amplitude of compound muscle action potential (CMAP) and calculation of percentage of CMAP decrement from T1 to T4.

Train-of-four monitoring is routinely performed during spine surgery by stimulation of the ulnar nerve. Furthermore motor evoked potentials (MEPs) are routinely used in intraoperative neuromonitoring to assess the whole motor pathway from the cortical level down to the distal muscle. During anesthesia MEPs are routinely evoked by transcranial electrical stimulation with single or short train stimuli. In clinical practice even though full muscle relaxation of the hand by NMBA can be observed, utilizing the TOF test, remaining muscle tonus can be observed at the paraspinal musculature during spine surgery.

The goals of this study are to determine (1) if any differences between muscle relaxation of the hand and foot (measured by TOF test and MEPs) and MEPs of the paraspinal musculature occur; (2) how much more NMBA must be administered to achieve full muscle relaxation of the paraspinal musculature in comparison to the hand or foot.

Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until TOF 0 at the hand is achieved. TOF measurements will be performed at baseline 5 minutes after induction. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus. When TOF 0 at the hand is achieved the MEPs of the paraspinal musculature will be measured. When there is remaining muscle tonus of the paraspinal musculature another bolus of rocuronium is administered until no MEPs can be measured for the paraspinal musculature.

Eligibility Criteria:
Inclusion Criteria:

* All patients that will undergo spinal surgery with intraoperative neurophysiological Monitoring
* Age: 14 - 99 years

Exclusion Criteria:

* No intraoperative neurophysiological Monitoring
* Age \<14 year
* prior neurological diseases or deficits that may affect safety of surgery/Intraoperative neuromonitoring
* No informed consent
Evaluation of Partial and Total Femoral Replacement

Several surgical options for the reconstruction of massive bone defects have been described and include biologic methods with autografts and allografts, and the use of tumor endoprostheses (total femoral replacement, TFR). Several types of modular TFR are available, but nevertheless unpredictable outcomes and high complication rates have been described from most authors. The aim of the present study was to compare complication rates after TFR performed with modular total femur prosthesis MML (Fa. ESKA/Orthodynamics) in patients with and without malignant disease.


Eligibility Criteria:
Inclusion Criteria:

* Total or partial femoral replacement

Exclusion Criteria:

* Failure of device
IMPAACT P1107: Effects of Cord Blood Transplantation With CCR5Δ32 Donor Cells on HIV Persistence

IMPAACT P1107 will describe the outcomes of HIV-infected persons, ages 12 months and older, who undergo transplantation with CCR5Δ32 cord blood stem cells for treatment of cancer, hematopoietic disease, or other underlying disease.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV-1 infection
* 12 months of age or older
* Willing to provide written informed consent
* Pre-Transplant Cohort: Underlying disease appropriate for stem cell transplant, as determined by the transplant team as part of standard of care.
* Pre-Transplant Cohort: Availability of an appropriately matched (as determined by the transplant center) CCR5Δ32 cord blood unit (homozygous or heterozygous) and intention to proceed with transplantation. NOTE: Double cord transplants are allowed. If a double cord is used, at least one cord blood unit should be CCR5∆32 (homozygous or heterozygous).
* Pre-Transplant Cohort: Received a CCR5Δ32 homozygous cord blood or bone marrow transplant within the last two years.

Exclusion Criteria:

• Received, or planning to receive, more than one CCR5Δ32 homozygous cord blood or bone marrow transplant.
RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users

Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.


Eligibility Criteria:
Inclusion Criteria:

* Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
* Ability to consent in English

Exclusion Criteria:

* Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment
Myofascial Release or Trigger Point Injections for the Reduction of Post-Mastectomy Pain Syndrome

This clinical trial studies the effect of myofascial release in decreasing post-mastectomy pain compared to standard of care trigger point injections in patients with post-mastectomy pain syndrome. Patients who have mastectomies often experience pain that does not go away after time. This is known as post-mastectomy pain syndrome. Myofascial release is a form of physical therapy in which pressure is applied to the affected areas. Myofascial release may be an effective way of decreasing pain in patients with post-mastectomy pain syndrome without the use of medication.

PRIMARY OBJECTIVE:

I. To evaluate the change in pain score using the Numerical Rating Scale for pain on an 11-point scale (0-none to 10-worst) from implementation of myofascial release (MFR) versus trigger point injections (TPI) in the treatment of myofascial trigger points (MTP) as noninvasive therapies for post mastectomy pain syndrome (PMPS).

SECONDARY OBJECTIVES:

I. To evaluate the change in medications, particularly opiate medications in the treatment of post mastectomy pain.

II. To evaluate a patient's satisfaction with therapy or treatment throughout the course of the study at each consecutive encounter or follow up.

III. To evaluate a patient's range of motion with therapy or treatment beginning at time of screening and until the end of the study.

IV. To evaluate a patient's degree of lymphedema both subjectively and objectively in the affected extremity(ies) unilateral to the site(s) of mastectomy in response to the various forms of treatment throughout the study.

V. To evaluate quality of life measure changes with treatments used throughout the study.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive standard of care trigger point injections at baseline.

ARM II: Patients perform myofascial release for 10 minutes each day.

Eligibility Criteria:
Inclusion Criteria:

* Chronic post-mastectomy pain syndrome (\>= 3 months)
* Able to perform MFR techniques and follow basic instructions
* \>= 18 years old

Exclusion Criteria:

* Current chemotherapy
* Pending surgery during treatment
* Active infection
* Active debilitating disease
* Pregnant
* Other chronic pain diagnosis beside PMPS
* Untreated psychiatric diagnosis (not receptive to taking precautions and interventions by treating psychiatrist/psychologist/physician i.e. taking necessary medications)
* Morbid obesity (body mass index \[BMI\] \> 40)
* Allergy history of bupivacaine and/or lidocaine
The Effect and Safety of Pulsed Field Ablation (PFA) in Patients With Paroxysmal Atrial Fibrillation (PAF)

This study is aimed to evaluate the Efficacy and Safety of Pulsed Field Ablation (PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF)

This clinical trial is a prospective, multi-center and single-arm Study. It will be carried out in 3 or more clinical trial institutions, and eligible patients with paroxysmal atrial fibrillation are enrolled. For those patients recruited, pulmonary vein isolation will be performed using pulsed field ablation device (Sichuan Jinjiang Electronic Technology Co., Ltd. Chengdu, China). The safety and efficacy of pulsed field ablation(PFA) in Patients with Paroxysmal Atrial Fibrillation (PAF) will be studied using ring-shaped pulsed field ablation catheter

Eligibility Criteria:
Inclusion Criteria:

Paroxysmal Atrial Fibrillation (PAF)

Exclusion Criteria:

1. A history of atrial fibrillation ablation;
2. Left ventricular ejectfraction(LVEF)\<35%
3. Left Atrium(LA)（echocardiography）\>55mm
4. Thrombus in the left atrial or heart before surgery
5. New York Heart Association(NYHA) grade Ⅲ-Ⅳ
6. second or third degree atrioventricular block
7. Significant congenital heart defects (e.g. atrial septal defect or severe pulmonary vein stenosis, but except foramen ovale)
8. Prosthetic valves
9. Pacemakers or defibrillators (ICD)
10. Hypertrophic cardiomyopathy, chronic obstructive pulmonary disease or myxoma
11. Symptomatic carotid stenosis
12. Untreated or uncontrolled hyperthyroidism or hypothyroidism
13. Systemic active infection
14. Renal failure with obvious bleeding tendency or undergoing hemodialysis
15. Myocardial infarction or any cardiac intervention/open surgery within 3 months
16. Stroke or transient ischemic attack within 6 months
17. Obvious contraindication for interventional surgery who were determined by the investigator to be unable to undergo ablation
18. Pregnant or lactating women or those who planned to have a family during the study period
19. Have participated in clinical trials of other drugs or medical devices within 3 months
20. Unsuitable to participate in this clinical trial by the investigator
Exercise and Prediabetes After Renal Transplantation

The present clinical trial, EXPRED-II, is the continuation of EXPRED-I (NCT04489043).

Objective: to evaluate the feasibility of exercise in the reversibility of prediabetes after transplantation, as a first step to prevent Post-Transplant Diabetes Mellitus (PTDM).

Methodology: a total of 50 patients with prediabetes beyond 12 months after transplantation with capacity to perform exercise will be randomized to standard life-style recommendations as per clinical practice (n=25) or to a stepped ad-hoc designed training intervention (n=25). Prediabetes will be diagnosed based on fasting glucose levels and an Oral Glucose Tolerance Test (OGTT). Patients randomized to exercise will start with aerobic exercise training 5 times/week, 30 min/day for 12 months which may be gradually increased to 60 min/day or combined with strength exercise in the last increment in case of prediabetes persistence. The reversibility/persistence/relapse of prediabetes will be measured with fasting glucose and OGTT every 3 months. The study will last 12 months.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* ≥ 12 months post kidney transplant
* Stable renal function in the last 3-6 months
* Prediabetes (abnormal fasting glucose 100-125 mg/dl and/or glucose intolerance 140-199mg/dl)
* Ability to perform exercise

Exclusion Criteria:

* Infection, cancer, acute cardiovascular disease, advanced kidney disease, pulmonary hypertension and uncontrolled chronic liver disease.
* Inability to understand the protocol
* Severe psychological illness
* PTDM and/or DM prior to transplantation
* Morbid obesity
Studying the Analgesic Mechanism of the "Cough-Trick"

The aim of the trial is to study the possible mechanism of the pain reducing effect of CT at peripheral venipuncture


Eligibility Criteria:
Inclusion Criteria:

1. Male volunteers aged 20-40 years, height 165-190 cm.
2. Physical status I according to American Society of Anesthesiologists (ASA) classification.
3. Straight run of the vein on the dorsum of the non-dominant hand at least 4 cm long and 3 mm thick
4. No analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol

Exclusion Criteria:

1. History of peripheral neuropathy
2. Abnormal skin conditions (infection, scars, psoriasis, eczema)
3. Unsuccessful venipuncture
4. Inflamed site of VP within 1 week after VP
Continuous Lumbar Plexus Block With and Without Parasacral Block in Patients Undergoing Total Hip Replacement

The purpose of this research study is to evaluate the analgesic efficacy of adding a single shot parasacral (sciatic) nerve block to a continuous lumbar plexus block in patients undergoing total hip replacement.

This prospective study is intended to assess the efficacy of placing a parasacral (sciatic) nerve block in addition to a lumbar plexus block for postoperative analgesia following total hip arthroplasty. Although the placement of a lumbar plexus block alone has become accepted as the standard of care at UPMC for postoperative analgesia following total hip arthroplasty, the addition of a parasacral (sciatic) nerve block may provide the advantage of blocking the superior gluteal nerve and nerve to the quadratus femoris which both supply small articular sensory branches to the posterior hip capsule.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has signed and dated an Informed Consent Form.
2. Subject is classified as a ASA (American Society of Anesthesiologists) status I-III
3. Subject is age 18- 75 years old.
4. Subject is having primary total hip arthroplasty
5. No contraindication to peripheral nerve catheter ( local infection or hypocoagulable state)
6. Patient willing to receive spinal anesthesia as operative anesthesia
7. No known drug allergies to study medications
8. Patients not expected to receive therapeutic anticoagulation in the postoperative period.

Exclusion Criteria:

1. Subject inability to provide adequate informed consent.
2. Age younger than 18 years or older than 75 years
3. Any contraindication to the placement of lumbar plexus catheter, including local infection, hypocoagulable state.
4. ASA (American Society of Anesthesiologists) physical status of IV or greater
5. Any chronic painful conditions
6. Preoperative opioid use
7. Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
Electronic Stethoscope Use During Intubation in Full Personal Protective Equipment

To investigate the feasibility of auscultation to confirm the endotracheal tube position by using electronic stethoscope for clinicians who wear the full personal protective equipment.

After the pandemic outbreak of Coronavirus disease 2019 (COVID-19) in many countries, the number of critical ill patients are rapidly growing. Critical ill COVID-19 patients inevitably require endotracheal intubation for ventilator support. The chest X-rays, ultrasound, and stethoscope are three tools that can detect whether or not bronchial intubation has occurred. Auscultation by using the stethoscope is the routine first-line tool for this purpose. However, clinician who wears the full personal protective equipment (PPE) is very difficult to perform adequate auscultation with conventional stethoscope. In addition, the X-ray machines and ultrasound are very difficult to enter the negative-pressure isolation room and may raise the risks of infection spread. By using the electronic stethoscope amplified by the Bluetooth speaker, the clinician with full PPE may still hear the proper lung sound. In addition, electronic stethoscope has a good portability that can be easily brought into the isolation room. For patients undergoing surgery with general anesthesia, endotracheal tube is often mandatory and auscultation with stethoscope is routinely applied. Therefore, the investigators can simulate the circumstance that clinician with a full PPE to use the electronic stethoscope for confirmation of the proper endotracheal tube position. In addition, patients undergoing thoracic surgery require the single-lung ventilation which could be a proper simulation scenario for detection of bronchial intubation by using electronic stethoscope for clinicians with PPE.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing thoracic surgery in general anesthesia with endotracheal tube insertion and bronchial blocker.

Exclusion Criteria:

* Previous lung surgical history
* Patients with organs dysfunction, such as impaired liver function, eg. Aspartate Aminotransferase or Alanine Aminotransferase \>100; liver cirrhosis \> Child B class; impaired renal function, calculated glomerulus filtration rate\< 60 ml/min/1.73 m2; cardiac dysfunction, such as heart failure \> New York Heart Association class II, coronary arterial disease
The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer

In patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy molecular breast imaging (MBI) is an accurate test for assessing response rate to neoadjuvant therapy.

The investigators propose to evaluate Molecular Breast Imaging in patients undergoing neoadjuvant therapy for breast cancer with the aims to document that 1) the change in uptake of 99mTc-sestamibi prior to initiation of neoadjuvant therapy, after 3-5 weeks of neoadjuvant therapy and at completion of neoadjuvant therapy prior to breast cancer surgery will be a reflection of the tumor response to neoadjuvant therapy.

2) Tumor response at 3-5 weeks of neoadjuvant therapy is predictive of tumor response at completions of neoadjuvant therapy.

3) Post-neoadjuvant tumor size as determined by MBI corresponds to size found at surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy and who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery. MRI of the breast for accurate tumor size evaluation is recommended but not necessarily required for study inclusion.
* Are able to return for a 3-5 week follow-up MBI study and for the final MBI study at completion of the neoadjuvant therapy.
* Patient age \> 18

Exclusion Criteria:

* Unable to understand or sign a consent form
* Pregnant or lactating
* Physically unable to sit upright and still for 40 minutes
Effect of Flax in Yogurt on Blood Cyanide Levels

A randomized, controlled, cross-over post-prandial trial in healthy human volunteers will be conducted at the IH Asper Institute to determine the effect whole ground flaxseed, roasted then ground whole flaxseed, whole intact flaxseed and flaxseed hulls mixed into yogurt on blood cyanide levels.

Participants will receive yogurt containing the following flaxseed products in a random order:

1. 40 g ground flaxseed, untreated;
2. 40 g ground flaxseed, roasted before grinding;
3. 40 g intact whole flaxseed;
4. 28 g flaxseed hulls;
5. 0 g flaxseed.

Venous blood will be collected at the following time points: 0 (before consumption of test product), 15, 30, 45, 60, 75, 90, 120, 150, 180 min.

Urine will be collected prior to consumption of test product and 180 min.

Primary endpoints: 1) Peak blood level of cyanide and incremental area under the curve (iAUC) for cyanide in blood over a 3h postprandial period. Secondary endpoint: 1) cyanogenic glycoside and thiocyanate concentrations in plasma and urine over a 3h postprandial period.

Tertiary endpoints: 1) metabolic profile in plasma and urine over 3 h postprandial period.

Eligibility Criteria:
Inclusion Criteria:

1. Generally healthy adult, 18 years or older;
2. Willing to provide informed consent;
3. Willing/able to comply with the requirements of the study.

Exclusion Criteria:

1. Pregnant or lactating;
2. Medical history of disease that is currently under treatment;
3. Active treatment for any type of cancer within 1 year prior to study start;
4. Presence of a gastrointestinal disorder, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks;
5. Plasma concentration of vitamin B12 \< 148 pmol/L;
6. Complete blood count outside normal range;
7. Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥3 times the upper limit of normal (ULN));
8. Fasting blood glucose ≥6.1 mmol/L and/or HbA1c ≥6.0%;
9. Fasting plasma total cholesterol \>7.8 mmol/L;
10. Fasting plasma HDL \<0.9 mmol/L;
11. Fasting plasma LDL \>5.0 mmol/L;
12. Fasting plasma triglycerides \>2.3 mmol/L;
13. Systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg;
14. Major surgery within the last 3 months;
15. Smoking, use of tobacco, vape or cannabis (within the last week);
16. Allergies to flaxseed or yogurt;
17. Aversion or unwillingness to eat study foods;
18. Participation in another clinical trial, current or in the past 4 weeks
Volatile Non-Invasive Biomarkers of Epileptic Seizures

Breath and sweat samples will be collected from people who have been admitted to hospital after a potential seizure and analysed by the team. The researchers then hope to identify a pattern of small molecules that can distinguish seizures from other events, and perhaps determine the severity of the seizure.

Determining whether someone has had an epileptic seizure, or another event, can be challenging and result in the wrong diagnosis. A 'seizure test' used after the event would therefore be very helpful.

Researchers have used small molecules released from the body in breath and sweat to detect cancers and other diseases; this study will determine whether a similar method can be used to detect whether someone has had an epileptic seizure.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been admitted to either University College London's Queen's Square EEG-telemetry unit or Chalfont Centre for Epilepsy, for diagnosis of seizure events.
2. Patients aged 18 years or above

Exclusion Criteria:

1. Patients with active infection or who have taken antibiotics within 4 weeks
2. Patients on immunosuppressive medications
3. Patients with co-morbidities preventing breath collection
4. Patients unable to provide informed consent.