cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effect of Preemptive and Post-operative Erector Spina Plane Block on Intraoperative Opioid Consumption and Postoperative Analgesia in Patients Who Will Undergo Elective Thoracotomy Surgery, Guided by the Nociception Level Index (NoL)

The patients who will participate in the study will be determined and informed according to the inclusion and exclusion criteria, and the patients who signed the informed consent form will be included in the study.52 patients who will undergo elective thoracotomy surgery will be divided into double-blinded 2 sided as preemptive and postoperative erector spina plane block.

Intraoperative pain status of the patients will be determined by the "Nociception Level Index" device and analgesia will be provided with fentanyl. The primary aim of the study is to compare the intraoperative opioid consumption of two groups with plan block at different times.

In the postoperative period, patient-controlled analgesia device will be given to both groups for rescue analgesia. The opioid consumption of the patients will be controlled in this way in the postoperative period and their pain status will be determined. The secondary aim of the study is to examine the effect of plan block application time on the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years
* ASA classification \<4
* No history of allergy or hypersensitivity to the drugs we use throughout the procedure
* BMI ≤ 35
* No history of neuropathy
* Surgeries other than emergency surgery
* Volunteer for the study
* No presence of infection at the injection site
* No any pyschiatric disease that would prevent the evaluation of the pain score

Exclusion Criteria:

* Under the age of 18 or over the age of 65
* ASA classification ≥ 4
* History of allergy or hypersensitivity to the drugs we use throughout the procedure
* BMI \> 35
* History of neuropathy
* Undergoing emergency surgery
* Not be a volunteer for the study
* Presence of infection at the injection site
* Having a pyschiatric disease that would prevent the evaluation of the pain score
* Pregnancy
* Undergo surgery again during the postoperative follow-up period for any reason
Validation of a New Hand Held Light Emitting Diode Device for the Determination of Minimal Erythema Dose (MED)

The purpose of this study is to validate a new hand held light emitting diode (LED) device for the measurement of minimal erythema dose (MED) for narrow band Ultraviolet B (UVB) radiation by comparing to the traditional approach of measurement of the minimal erythema dose.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18 years.

Exclusion Criteria:

1. Pregnancy
2. Lactation
3. History of photosensitivity disorder
4. Photosensitizing medications
5. Personal history of melanoma or non-melanoma skin cancer.
6. Skin disease on the back
The Impact of Experienced Endoscopy Nurse Participation on Polyp and Adenoma Detection During Colonoscopy

The purpose of this study is to determine whether experienced endoscopy nurse participation during screening colonoscopy could increase polyp and adenoma detection rate.


Eligibility Criteria:
Inclusion Criteria:

* age 40-70 average risk screening colonoscopy

Exclusion Criteria:

* GI Bleeding ;
* history of colorectal surgery ;
* inflammatory bowel disease ;
* colorectal cancer,or polyposis syndrome
Psychological Impact of COVID-19 Pandemic in Healthcare Workers

Background. The current coronavirus disease (COVID-19) has a great impact worldwide. Healthcare workers play an essential role and are one of the most exposed groups.Information about the psychosocial impact on healthcare workers is limited.

Methods. 3109 healthcare workers completed a national, internet-based, cross-sectional 45-item survey between 9 and 19 April 2020. The objective is to assess the psychological impact of the COVID-19 pandemic in Spanish healthcare workers. A Psychological Stress and Adaptation at work Score (PSAS) was defined combining four modified versions of validated psychological assessment tests (A) Healthcare Stressful Test, (B) Coping Strategies Inventory,(C) Font-Roja Questionnaire and (D) Trait Meta-Mood Scale.

PSAS (Psychological Stress and Adaptation at work Score) is a self conducted questionnaire designed to assess psychological impact in healthcare workers to match times of crisis and when the time is scarce. PSAS has a range between 0 and 105, and higher scores represent higher stress detected.

Eligibility Criteria:
Inclusion Criteria:

* Active healthcare workers in any private/public hospital \> 18 years old

Exclusion Criteria:

* Refusal to participate
Vaccine Therapy in Treating Patients With Stage I or Stage II Pancreatic Cancer

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to and kill tumor cells. Combining vaccine therapy with surgery may be an effective treatment for pancreatic cancer.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with stage I or stage II pancreatic cancer that has been surgically removed.

OBJECTIVES: I. Study the safety of autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) in patients with resected pancreatic adenocarcinoma. II. Examine the immune response to HSPPC-96 in this group of patients.

OUTLINE: This is a dose escalation study. Six weeks after surgery patients are given autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) subcutaneously once a week for 4 weeks. Five patients are initially enrolled at each of two dose levels. An additional three patients may be enrolled at each dose level to determine the optimal dose of HSPPC-96. Patients are followed at weeks 1, 4, and 12 after treatment.

PROJECTED ACCRUAL: A maximum of 16 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven, resected, stage I or II pancreatic adenocarcinoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Lymphocyte count at least 700/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No clinically significant heart disease Other: No other serious illness No active infections requiring antibiotics within past 2 weeks Not pregnant or nursing Fertile patients must use effective birth control No known immunodeficiency No active bleeding

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiation therapy Surgery: Must undergo Whipple procedure or distal pancreatectomy at Memorial Hospital Must not have undergone splenectomy Other: No investigational treatment within 2 months of surgery No immunosuppressive therapies
Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery

Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. The incidence of postoperative delirium in patients undergoing cardiac surgery is high. Postoperative delirium is a manifestation of brain function injury. The effect of postoperative delirium on postoperative cardiac function in patients undergoing cardiac surgery is worthy of further discussion.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing valvular surgery
* Age between 60 to 75

Exclusion Criteria:

* Have a history of cerebral infarction before operation
* Cardiac function was seriously impaired before surgery
* Neuropsychiatric disorders were present before surgery
Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections

This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults


Eligibility Criteria:
Inclusion criteria:

* Subjects with a diagnosis of complicated skin and skin-structure infections (cSSTI) defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalization and intravenous antimicrobial treatment
* Infection to be due to Gram-positive bacteria
* Hospitalized subjects
* Written informed consent
* Female patients of childbearing potential must have a negative pregnancy test urine or serum at baseline and must use effective contraception throughout the study period.

Exclusion criteria:

* Complicated skin and skin-structure infections of the following categories:
* Infected burns
* Severely impaired arterial blood supply
* Decubitus ulcers
* Infected diabetic foot ulcers associated with osteomyelitis
* Infected human or animal bites
* Perirectal abscess
* Necrotising fasciitis or gangrene
* Infections expected to require more than 14 days of intravenous antimicrobial therapy
* Skin and/or skin structure infection that can be treated by surgery alone
* Infections associated with a permanent prosthetic device that will not be removed within 2 days of study enrollment
* Uncomplicated skin or soft tissue infection
* Documented bacteremia at baseline
* Concomitant infection nearby the site of infection at baseline, potentially interfering with the evaluations
* Hospitalization for conditions related to rhabdomyolysis
* Human immunodeficiency virus (HIV) with cluster of differentiation (CD) \< 200 or \< 14%
* Immune function alterations
* Lack of sufficient purulent material for culture and Gram test
* Systemic or local antibiotic administration with known anti-Gram positive activity in the preceding 48 hours
* Complicated skin and soft tissue infections (cSSTI) known or believed to be related to fungal, parasitic or viral infection
* Pneumonia
* Local or systemic known or suspected allergy to daptomycin
* Creatinine clearance \< 30 mL/min
* Severe liver damage (Child-Pugh class C) or Alanine transaminase (ALT) and/or Aspartate aminotransferase (AST) \> 3 x Upper limit of normal (ULN) and/or bilirubin \> 1.5 x ULN
* Use of any experimental drugs in the preceding 30 days
* Severe medical conditions that in the investigator's opinion could counter indicate participation in the study
AMO CROC Study: Self-medication and Dental Pain of Pulpal and Peri-apical Origin. Qualitative Study

Adult patients with dental anxiety or phobia constitute a population for which access to dental care is difficult and this situation is often associated with am low socio-economic status. According to the literature, these patients avoid conventional care, make greater use of emergency services, and self-medicate when experiencing dental pain. Moreover, little is known in the literature about the use of self medication in France, although it is known that in the general population does self medicate a lot. The objective of this study is to better understand the self-medication behaviors of patients in order to improve their care. This work aim at characterizing a population of adults in need of treatment for dental pain of pulpal or periapical origin and anxious or phobic adults in need of for dental treatment under general anesthesia. Self-medication behaviors will be studied in qualitative research during recorded interviews.


Eligibility Criteria:
Inclusion Criteria:

* Adults visiting the odontology unit for dental pain due to acute pulpitis or in need of dental treatment under general anesthesia
* Speaking French
* Able to give his/her informed consent
* Affiliated to the health social security system

Exclusion Criteria:

* Adults under guardianship or curatorship
* Adults refusing to participate
The Effect of Balance Training on Neuromuscular Control in Subjects With CAI

The goal of this study is evaluate the effect of uni-axial versus multidirectional balance training on muscle reaction time in subjects with chronic ankle instability. Muscle reaction time is measured on a trapdoor simulating an inversion sprain before and after a 6 week lasting balance training protocol.


Eligibility Criteria:
According to the consensus statement of the International Ankle Consortium

Inclusion Criteria:

* History of an ankle sprain
* Repetitive ankle sprains AND feelings of instability AND giving way
* Ankle functionality is documented (not as inclusion criteria)

Exclusion Criteria:

* Fracture
* Surgery
* equilibrium disorder
Effects of Deep Stripping Versus Kneading on Pain, Range of Motion and Function in Knee Osteoarthritis

This is a randomized controlled trial, 44 participants selected based on inclusion criteria from physical therapy department of Surriya Azeem Surgical Hospital, Pattoki. Participants randomly recruited into two groups, 22 in deep stripping group receiving deep stripping with conventional physical therapy and 22 in kneading group receiving kneading with conventional physical therapy. Pain, range of motion and functional mobility are the primary outcomes measured by numeric pain rating scale, universal goniometer and lower extremity functional scale. Data collected at the baseline, at the 6th session, and the 12th session.

In this randomized controlled trial, 44 individuals with knee osteoarthritis (II-III grade of Kellgren-Lawrence scale) pre-diagnosed by an orthopedic, were assessed for eligibility from the physical therapy department of Surriya Azeem Surgical Hospital, Pattoki. Participants with any other musculoskeletal disorder, cognitive problem and receiving any treatment within the past three months were excluded from the study. The participants were randomly recruited into two groups with 22 participants in each group. Group A received deep stripping along with conventional physiotherapy and group B received kneading along with conventional physiotherapy. Both the deep stripping and kneading technique applied on the quadriceps muscle group, hamstring muscle group and around the knee joint. Data collected by a blinded assessor at the baseline, at the 6th session, and the 12th session.

Outcome measures were pain (measured by Numeric Pain Rating Scale), range of motion (measured by Universal Goniometer), and functional mobility (assessed by Lower Extremity Functional Scale). After collecting the data, normality of the data will be entered and analyzed in Statistical Package for the Social Sciences and than the statistical test will be applied to compare the within group analysis and between group analysis.

Eligibility Criteria:
Inclusion Criteria:

* Chronic osteoarthritis (more than 3 months) with pain in one knee joint (unilateral)
* A prior medical diagnosis having radiographic evidence of grade 2 and 3 of Kellgren and Lawrence criteria for knee osteoarthritis by an orthopedic.
* Pain intensity level more than 3 points of the numeric pain rating scale.

Exclusion Criteria:

* Any acute inflammation, contracture, or surgery affecting the knee joint.
* Any cognitive problem.
* Participants taking non-steroid anti-inflammatory drugs, intra-articular injection, or physical therapy within the last three months for the knee joint.
* Participants having a lumbar spine and/or any other lower limb impairment and/or surgery affecting knee joint.
The Comparison of Semiconductor Embedded Therapeutic Arm Sleeves for the Treatment of ECRB Tendinopathy

This study seeks to identify patient reported and clinically measured outcomes for pain management and elbow function with application of semiconductor embedded fabric combined with PRP+ASC injections in the affected area.

Extensor Carpi Radialis Brevis (ECRB) tendinopathy, also known as lateral epicondylitis or tennis elbow, is the most prevalent elbow soft tissue injury and affects 1-3% of the population. Repetitive overloading of the tendon and ligaments in the elbow lead to microtraumas, causing abnormal angiofibroblastic remodeling and increased pain. Microtearing occurs most commonly at the origin of the extensor carpi radialis brevis (ECRB) tendon. The main symptoms include a loss of grip strength, a burning sensation near the ECRB origin site, and pain during daily activities such as grasping objects or shaking hands. Both conditions present a significant injury and treatment burden on the population and effective treatment and pain management approaches with minimal side effects are needed.

Novel nonsurgical treatment approaches for ECRB tendinopathy include platelet-rich plasma (PRP) injections and stem cell therapy. Ultrasound-guided PRP and adipose-derived stem cells (ASCs) injections have shown to be an effective treatment option for patients with chronic ECRB tendinopathy.

The proposed study seeks to assess the effect of non-compressive semiconductor embedded arm sleeves in combination with PRP + ASC injections, throughout a 6-month rehabilitation course for patients with ECRB tendinopathy. Outcome measures will be collected at standardized intervals to evaluate and compare treatment groups.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with ECRB tendinopathy as determined by radiographic assessment or ultrasound imaging.
2. Patients age 18-65
3. Patients who are willing and able to adhere to follow-up schedule and protocol guidelines.
4. Patients who are willing and able to sign corresponding research subject consent form.

Exclusion Criteria:

1. Patient has a history of neurological conditions, including multiple sclerosis or Parkinson's disease
2. Patient has severe medical condition, including recent myocardial infarction, unstable angina, heart failure, severe anemia
3. Patient has had prior surgical treatment of the elbow in the last 5 years or injection treatment(s) in the last 2 years
4. Patient has complete tear of ECRB tendon or other surgical indication
5. Patient has chronic pain conditions unrelated to elbow condition
6. Patient has auto-immune or auto-inflammatory diseases
7. Patient has used tobacco within the last 90 days
8. Patient is not within the ages of 18-65
9. Patient has a history of metabolic disorders
10. Patient has an active infection (local or systemic)
11. Patient is unwilling or unable to sign the corresponding research subject consent form
12. Patient meets any other criteria or has any other condition that, in the opinion of the investigator, would prevent them from completing the study or that, in the opinion of the investigator, would confound study results.
Relative Bioavailability of NXP001 Compared to Emend® in Healthy Volunteers

This study will compare the relative bioavailability of both an oral capsule formulation and an oral suspension formulation of NXP001 to Emend® in healthy male volunteers in the fasted state.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males
2. Body mass index (BMI) of 18.0 to 35.0 kg/m2 as assessed at screening
3. Must be willing and able to communicate and participate in the whole study
4. Must provide written informed consent
5. Must agree to use adhere to the contraception requirements of the study

Exclusion Criteria:

1. Subjects who have received any IMP in a clinical research study within the previous 3 months prior to first dose
2. Subjects who are study site employees, or immediate family members of a study site or sponsor employee
3. History of any drug or alcohol abuse in the past 2 years
4. Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type)
5. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening
6. Current users of e-cigarettes and nicotine replacement products and those who have smoked these products within the last 12 months
7. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
8. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
9. Confirmed positive drugs of abuse test result
10. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
11. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory, psychiatric or gastrointestinal (GI) disease as judged by the investigator
12. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
13. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
14. Donation or loss of greater than 400 mL of blood within the previous 3 months
15. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 14 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
16. Subjects who have taken any CYP3A4 inducers in the 30 days prior to IMP administration.
17. Failure to satisfy the investigator of fitness to participate for any other reason
Burn Out and Quality of Life at French General Practioners

The suffering of caregivers is constantly increasing. General medicine, because of its primary role in primary care, is particularly exposed to the risk of burn-out and must protect itself. The aim of this study was to find an inverse relationship between health-related quality of life and being severely burned by French general practitioners.

descriptive quantitative cross-sectional study

Eligibility Criteria:
Inclusion Criteria:

* french general practitioner in liberal activity

Exclusion Criteria:

* retired doctor
* junior general practioner
Improving Diabetes Outcomes: a Couples Intervention

Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. However, diabetes programs rarely involve the partner. This is a study to develop and test an intervention that helps partners and patients who have type 2 diabetes better support each other. The intervention will be delivered over the telephone to reach more people. Our hypothesis is that an intervention that targets the couple has a greater effect on health and well-being of patients than one that targets the individual patient alone.

Research has shown that diabetes affects both the patient and family, and that support from family and partners helps diabetes patients manage their illness better. However, diabetes programs rarely involve the partner. This is a pilot proposal to develop and test an intervention that aims to both enlist the support of partners of diabetes patients, and enhance and improve the quality of that support. We believe that the intervention will help the relationship and also will have a positive impact on medical (e.g.,blood sugar control), behavioral (e.g., increased exercise, better diet) and emotional (e.g., depression) outcomes. The intervention will be implemented by telephone, in order to enhance the project's ability to reach a broader sample of patients.Forty-five couples will be recruited in which one partner has type 2 diabetes. After initial testing and basic diabetes education, they will be assigned to one of three comparison groups. For those in the intervention groups they will participate in 11 telephone contacts with a diabetes educator and a counselor and will receive education about diabetes, behavior change, emotional issues/couples communication, and problem solving techniques. A manual will include readings, structured homework assignments, and self-monitoring logs. They will be re-tested 2 weeks and 3 months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* greater than 21 years of age.
* diagnosed with type 2 diabetes for at least 1 year.
* have no severe complications (on dialysis, blindness, amputations, history of stroke)
* able to speak, read and hear English.
* married or cohabiting for \> 1 year.
* have a telephone.

Exclusion Criteria:

* have a diagnosed psychiatric disorder.
* refuse audiotaping or other study procedures.