cyrilzakka/clinical-trials huggingface dataset:
Transversus Abdominis Plane (TAP) Block Laparoscopic Hysterectomy

The transversus abdominis plane (TAP) block involves the sensory nerve supply of the anterior -lateral abdominal wall where the T7-12 intercostal nerves, ilioinguinal, iliohypogastric and the lateral cutaneous branches of the dorsal rami of L1-3 are blocked with an injection of local anesthetic between the internal oblique abdominal muscle (IOAM) and the transverse abdominal muscle(TAM)This technique allows sensory blockade of the anterolateral abdominal wall via local anesthetic deposition superficial to the transversus abdominis muscle. It was first described by McDonnell et al. as a landmark technique to provide analgesia for lower abdominal surgery.

Hebbart et al. subsequently described an ultrasound guided technique for the TAP block which they named posterior TAP block. The ultrasound allows identification of the external oblique abdominal muscles (EOAM),IOAM and TAM. Previous studies about ultrasound -guided regional anesthetic techniques suggest improved block quality and safety, which is primarily due to direct visualization of the relevant anatomy, the tip of the needle, and the spread of the local anesthetics.

Clinical trials of the single shot posterior TAP block have shown a significant reduction in morphine consumption during the first 24-36 hours after surgery. More recently, El-dawlatly et al. demonstrated that ultrasound guided TAP block in patients undergoing laparoscopic cholecystectomy reduced perioperative opioid consumption by more than 50%.

This is the first study to evaluate the effect of TAP block in the quality of recovery in patients undergoing laparoscopic hysterectomy and may help the pathway to make this an outpatient procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-64 years
* Surgery: Laparoscopic Hysterectomy surgery
* ASA status: I and II
* Fluent in English

Exclusion Criteria:

* History of allergy to local anesthetics
* History of chronic opioid use
* Pregnant patients
* BMI greater than 30

Drop-out criteria:

* Patient or surgeon request
* Complications related to the procedure
How Does 4 Weeks of Increased Fast Food Intake Affect Metabolism?

Objective: To study the effect of fast food-based hyper-alimentation on liver enzymes and hepatic triglyceride content (HTGC)and metabolism.

Design: Prospective interventional study with parallel control group. Setting University Hospital of Linköping, Sweden. Participants: 12 healthy men and six healthy women with a mean (SD) age of 26 (6.6) years and a matched control group.

Intervention: Subjects in the intervention group aimed for a body weight increase of 5-15% by eating at least two fast food-based meals a day with the goal to double the regular caloric intake in combination with adoption of a sedentary lifestyle for four weeks.

Main outcome measures: Weekly changes of serum aminotransferases and HTGC measured by proton nuclear magnetic resonance-spectroscopy at baseline and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-obese subjects

Exclusion Criteria:

* General diseases, obesity.
Effect of Papillary Epinephrine Spraying for the Prevention of Post-ERCP Pancreatitis in Patients Received Octreotide

Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) is the most common complication with high costs, significant morbidity and even mortality. The major mechanisms of PEP is the papillary edema which is caused by manipulations during cannulation or endoscopic treatment. The papillary edema may cause temporary outflow obstruction of pancreatic juice, and then increase ductal pressure, resulting in the occurrence of pancreatitis. Nitroglycerin can reduce the Oddis sphincter tension, the internal pressure of the biliary tract and the pancreatic duct. Therefore, it is widely used in clinical to prevent and treat pancreatitis. Many studies found nitroglycerin might be effective in preventing PEP. And topical application of epinephrine on the papilla may reduce papillary edema by decreasing capillary permeability or by relaxing the sphincter of Oddi. There are reports that epinephrine sprayed on the papilla may be effective to prevent PEP.

The investigators therefore designed a prospective randomized trial to determine whether routine using papillary epinephrine spraying in patients received octreotide can reduce post-ERCP pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

1. ERCP surgery is required
2. Signed inform consent form and agreed to follow-up on time.

Exclusion Criteria:

1. Acute pancreatitis.
2. Pregnancy or history of allergy to epinephrine.
3. Serious liver, kidney, heart and coagulation disorders
4. Unwilling or inability to provide consent
Comparison Between Three Types of Prosthetic Feet

One Solid Ankle Cushion Heel (SACH) and two Dynamic Elastic Response (DER) prosthetic feet will be tried six times in random order by the patient. The patient will be an active prosthetic foot user who walks several kilometers per day and was amputated at the trans-tibial level because of injury. Gait pattern will be rated in comparison with the patient's previous prosthetic foot by a physiatrist, physiotherapist, prosthetist and the patient. One-leg standing and 10-meter walking tests will also be performed.

The prosthetic feet will be: one SACH foot (by Otto Bock - foot C, advertised for activity category 1) and two DER feet (Dynamic Motion by Otto Bock - foot B, advertised for activity category 2-3; and Triton by Otto Bock - foot A, advertised for activity category 3-4).

All the prosthetic feet are of the same size and chosen for the patient's weight. They will be covered so that neither the patient nor professionals will be able to see which prosthetic foot is being used.

The study is blinded because the prosthetist designated for changing the prosthetic feet will be the only one who will know which prosthetic is being used. The orientational sample size calculation and the randomisation plan were prepared by a statistician.

The first trial will be performed using the patient's own prosthetic foot in order to establish a baseline. The patient will then have to to compare the prosthetic feet with his own existing prosthetic foot and rate the ability to walk on even terrain (100m), uneven terrain (grass, 100m), decline and incline (i.e., slope), and up and down the stairs (one floor) on a five-point Likert-type scale (-2 much worse, -1 slightly worse, 0 the same, 1 slightly better, 2 much better). After each trial he will also perform the one-leg standing test (with three repetitions) and the 10-meter walking test. Before each trial, the patient will be given 15 minutes for adaptation to each new prosthetic foot without the presence of the assessors.

The three expert observers will be: a physical and rehabilitation medicine specialist physician, a certified prosthetist-orthotist, and a physiotherapist. Each has got over 20 years of experience in rehabilitation of patients after amputation and observation of their gait. They will be blind to the currently used prosthetic foot. They will follow the patient and assess his walking using the same rating scale in comparison with the initial trial as the patient.

Eligibility Criteria:
Inclusion Criteria:

* active prosthetic foot user who walks several kilometers per day
* amputation at the trans-tibial level \>5 years ago

Exclusion Criteria:

* other medical problems
Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty

Observational retrospective registry to compare effectiveness of paclitaxel-coated vs. non coated balloon angioplasty proximal to a Chronic Total Occlussion (CTO) after failed revascularization. Primary objective is to determine success rate after repeated percutaneous coronary intervention of a CTO 3 to 6 months after paclitaxel-coated balloon angioplasty proximal to the persistent lesion.


Eligibility Criteria:
Inclusion Criteria:

* Failed recanalization of a CTO in patients with clinical indication for the percutaneous procedure.
* Patient willing to participate in the study providing signed informed consent.
* J-CTO Score ≥2.

Exclusion Criteria:

- Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.
A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects

This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.

This is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled KIT2014 administered via nebulizer to healthy adult participants. The study will be conducted in 2 parts, Part A (single ascending dose, SAD) and Part B (multiple ascending doses, MAD).

Eligibility Criteria:
Major Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening.
3. BMI ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females.
4. Medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities.
5. Normal spirometry results at Screening based on FEV1 ≥ 80% of predicted, FVC ≥ 80% of predicted and FEV1/FVC ratio ≥0.7.

Major Exclusion Criteria:

1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the PI to be clinically relevant.
2. Any respiratory infection or relevant respiratory problem within 14 days of Day 1.

Other inclusion/exclusion eligibility criteria apply.
Paramedic - Norwegian Acute Stroke Prehospital Project

The main aim of the study is to show that patients with suspected acute stroke met by the emergency medical service and assessed using the eSTROKE model including prehospital NIHSS and a mobile application will identify a higher number of patients with stroke, than those who receive conventional prehospital care.

Primary aims:

In patients with suspected stroke

1. The proportion of patients hospitalized with a suspected acute stroke and discharged with a stroke diagnose is significantly increased using the ParaNASPP model compared with conventional prehospital care
2. Time from onset to hospitalization is significantly reduced with the ParaNASPP model
3. The ParaNASPP model identifies patients eligible for direct transportation for comprehensive stroke center

Eligibility Criteria:
Inclusion Criteria:

* All patients with suspected acute stroke met by emergency medical services (ambulance and rapid response car)
Apples in Night Shift

Background: Emergency doctors face a highly stressful work environment during night shifts. Long-term night shift work can lead to sleep deprivation, fatigue accumulation, and disruption of the biological clock, which may affect doctors' work efficiency and physical and mental health. There are various health interventions for night shift doctors, one of which is an interesting practice of carrying an apple as a symbol of the "night shift deity" to relieve anxiety and improve work efficiency. Although this behavior is not supported by sufficient scientific evidence, it has become a common habit among some doctors during night shifts due to its simplicity, low risk, and ritualistic nature.

Objective: To assess whether carrying an apple during night shifts can significantly reduce fatigue, decrease work intensity, and enhance work experience for emergency doctors.

Design: Single-center, open-label, randomized controlled trial.

Participants: several doctors with a total of 60 emergency working night shifts.

Primary Outcome: Average number of patients per night shift.

Sample Size: The study plans to recruit several doctors with a total of 60 emergency night shifts and randomly assign them to the experimental group and the control group. One doctor can be randomized for many times.

Background: Emergency doctors face a highly stressful work environment during night shifts. Long-term night shift work can lead to sleep deprivation, fatigue accumulation, and disruption of the biological clock, which may affect doctors' work efficiency and physical and mental health. There are various health interventions for night shift doctors, one of which is an interesting practice of carrying an apple as a symbol of the "night shift deity" to relieve anxiety and improve work efficiency. Although this behavior is not supported by sufficient scientific evidence, it has become a common habit among some doctors during night shifts due to its simplicity, low risk, and ritualistic nature.

Objective: To assess whether carrying an apple during night shifts can significantly reduce fatigue, decrease work intensity, and enhance work experience for emergency doctors.

Design: Single-center, open-label, randomized controlled trial.

Participants: several doctors with a total of 60 emergency working night shifts.

Primary Outcome: Average number of patients per night shift.

Sample Size: The study plans to recruit several doctors with a total of 60 emergency night shifts and randomly assign them to the experimental group and the control group. One doctor can be randomized for many times.

Eligibility Criteria:
Inclusion Criteria:

Doctors who have a night shift in the emergency department of gynaecology with at least two weeks experience.

Exclusion Criteria:

Doctors who refuse to join the study
The Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization on Patients With Chronic Migraine

In this study, it was aimed to examine the effects of two different treatments applied to the neck region, which have been popular in recent years, on migraine.The study included 45 female patients aged 20-50 years with migraine complaints. The patients were divided into 3 randomized groups: control group (n=15), Instrument-Assisted Soft tissue Mobilization (EDYDM) group (n=15) and on Occipital nerve TENS (OTES) group(n=15).Each group was given home exercise to their treatment. Home exercises applied 1 time per day for 5 weeks. Each exercise in the exercise program was performed with 10 repetitions


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 20-50
* International Classification of headache disorders, Third Edition (beta), using the criteria to be diagnosed with migraine without aura,
* migraine with a history of being at least an annual,
* VAS neck pain to be on Level 4,
* the hit-6 score is greater than 56

Exclusion Criteria:

* receiving pharmacological or non-pharmacological treatment regularly in the last three months,
* using a pacemaker,
* being an epileptic or severely psychiatric patient,
* conducting a surgical operation from the neck region,
* cervical disc degeneration or prolapse, the presence of different diagnoses of headaches
High Molecular Weight Hyaluronic Acid, α-lipoic Acid, Magnesium, Vitamin B6 and Vitamin D, in the Prevention of Spontaneous Abortion

The study aims to verify if the association of high molecular weight hyaluronic acid, α-lipoic acid (ALA), magnesium, vitamin B6 and vitamin D, reduces the risk of miscarriage in patients at risk.


Eligibility Criteria:
Inclusion Criteria:

* two or more previous spontaneous first trimester abortions without apparent risk factors (idiopathic polyabortion)
* Endocrinopathies
* Autoimmune diseases
* Thrombophililic or coagulation diseases

Exclusion Criteria:

* Multiple pregnancies
* Presence of genetic abnormalities of one or both partners leading to increased risk of fetal aneuploidies
* Presence of Mullerian abnormalities in the uterus
* Symptoms present at recruitment such as pelvic pain or metrorrhagia
MAGIK for Femoral/Tibial Shaft Fractures

The purpose of this phase 2 randomized control trial will be to evaluate the effect of glucose-insulin-potassium (GIK) therapy in the setting of lower extremity trauma to reduce short- and long-term muscle damage, acute rhabdomyolysis, and acute kidney injury. The study will consist of 40 patients with femur or tibial shaft fractures randomized to the GIK arm (using a well-described systemic GIK protocol; n = 20) or the control arm (using isotonic saline; n = 20). The use of systemic GIK is expected to decrease the overall amount of lower extremity muscle cell death and result in improved muscle function in the postoperative period. Additionally, the investigators hypothesize that GIK will lead to less severe rhabdomyolysis and a concomitant decrease in the incidence of AKI that results from the byproducts of muscle cell death.


Eligibility Criteria:
Inclusion Criteria:

1. Femoral shaft fracture or tibial shaft fracture
2. Survival \> 72 hours after definitive femur fracture fixation

Exclusion Criteria:

1. Pregnant women as the safety of GIK therapy in pregnant women has not been studied.
2. Age below 18 years
3. Survival \< 72 hours after definitive femur fixation.
4. Pathologic fracture
5. Low energy bisphosphonate related atypical fracture
6. Patients with a contraindication to any of the medications on the study list
7. Patients with prior extremity weakness resulting from stroke or other neurological condition
8. Patients with absolute contraindications to undergoing MRI (implanted defibrillator or pacemaker, implanted deep brain stimulator, bullets or gunshot pellets near great vessels or vital organs, cerebral aneurysm clips, cochlear implants, magnetic dental implants).
Proton Therapy Patient Registry

The purpose of this study is to establish a database (or "registry") of patients treated with proton beam therapy at the University Hospitals (UH) Proton Therapy Center. By keeping track of the patients treated it will allow the investigators to periodically evaluate the outcomes of patients.

The primary objective of this non-therapeutic registry study is to create a secure longitudinal database of patients treated with proton therapy at the UH Proton Therapy Center. This will allow reporting patient, tumor, and treatment characteristics as well as outcome data pertaining to disease control and complications for this relatively rare radiation modality.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with proton beam at the UH Proton Therapy Center
* Patients who have the ability to understand and be willing to sign a written informed consent document

Exclusion Criteria:

* Patients or legal guardians who are unable to understand informed consent document
Safety and Efficacy of Two Tetanus-Diphtheria Vaccines for a Donor Hyper Immunization Program

Many plasma donation centers have Tetanus immunization programs that are implemented in order to collect plasma with high levels of tetanus antibodies. The immunization program requires participants to receive multiple tetanus vaccinations over a period of time with the goal of hyper-immunizing them to tetanus. Their antibody-rich plasma is then used to manufacture a tetanus immunoglobulin product which helps with the prophylaxis and treatment of tetanus disease.

The Tetanus vaccine previously used for these programs is no longer being manufactured. Therefore, we must evaluate the safety and efficacy of a different vaccine when used for this purpose. The only other FDA approved Tetanus vaccines currently available for adults in the US are combination vaccines that also immunize against Diphtheria and/or Pertussis.

In this study, the investigators will evaluate two vaccines that are combinations of Tetanus and Diphtheria (Td). Investigators will not evaluate any vaccines containing Pertussis antigen. The vaccines to be evaluated are manufactured by MassBiologics and Sanofi Pasteur (Tenivac).

The package insert for these vaccines indicates they should be administered to previously vaccinated people once every 10 years. However, this study will evaluate whether they are safe and effective for dosing every 90 days.

The investigators hypothesize that at least 25% of study subjects will have a positive response to at least one of the five planned doses. Each vaccine will be evaluated separately.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18\* years of age at Visit 1.
2. Subject has met all suitability criteria that would allow donation as a Normal Source Plasma donor
3. Subject has not been immunized for tetanus within the prior three (3) months
4. Subject is not participating in any other immunization program
5. Subject possesses a pre-existing antibody for tetanus of at least 0.15 IU/mL

Exclusion Criteria:

1. Pregnant.
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Subject has a hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.)
4. Subject has history of a severe reaction to any immunization
5. Subject has a history of Guillain-Barré Syndrome
6. Subject is unable to read and/or write due to illiteracy or a physical impairment.
7. The Investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for adverse event assessment

   * Or legal adult according to local law. Participants in NE limited to individuals age 19-69 years due to age of majority laws in NE.
Sedation and Ease of Weaning From Mechanical Ventilation

Daily interruption of sedation is one of the modalities which is known to enhance early weaning and separation from mechanical ventilation . Daily sedation interruption is also known to help decreasing incidence of ventilator associated pneumonia. The new modality is no sedation.

there is an increase of incidence of chronic obstructive lung disease associated respiratory failure which necessitates invasive mechanical ventilation. It is well known that one of the bundles for enhanced recovery of such cases is the daily interruption of sedation . Recently studies have demonstrated the feasibility of just using sedation for initiation of mechanical ventilation, then utilization of no sedation technique as a more this offers less side effects .

Eligibility Criteria:
Inclusion Criteria:

* Obstructive lung disease
* Respiratory failure
* Invasive mechanical ventilation

Exclusion Criteria:

* Neurological deficit
* Cognitive dysfunction
* Extensive malignancy
* septic Shock
The Effectiveness of Low Calorie Low Salt Lunch for Weight Reduction of Workers of a Health Promoting Hospital

The aim of this study is to evaluate the effectiveness of Low Calorie Low Salt Lunch for Weight Reduction in overweight or obese workers of a health promoting hospital.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese
* Hospital workers

Exclusion Criteria:

* History of major medical problems such as heart disease in the last 6 months
* Orthopaedic or joint problems that would be a barrier to physical activity
* Pregnancy
* Recent weight change of ≥10% of baseline weight
* Taking medications that might affect body weight
* Participation in other program about weight control
* Alcohol or substance abuser
* Other uncontrolled psychiatric problems
* Eating disorders