cyrilzakka/clinical-trials huggingface dataset:
Randomized Trial of Intraoperative IV Versus Preoperative Oral Acetaminophen During Ambulatory Lumbar Discectomy

Effective non-opioid analgesics are of particular interest in ambulatory surgery, as providers may be able to reduce pain while avoiding perioperative opioids that can delay same day discharge. The value of maintaining an efficient flow of patients from the perioperative area to discharge is an important metric for same day surgery centers, and an improvement in efficiency with IV acetaminophen could potentially offset the increased cost of the medication while providing a more pleasant surgical experience for patients. The goal of this study is to compare the efficacy of intraoperative IV administration vs. preoperative oral administration of acetaminophen on postoperative opioid utilization, patient-reported pain scores, opioid-related adverse effects, and time to recovery and discharge from the post-anesthesia care unit (PACU) after ambulatory lumbar discectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years-old
* Weight greater than 50 kg body weight
* ASA physical status I-III
* English-speaking

Exclusion Criteria:

* Weight less than 50 kg
* Pregnancy or breast feeding
* revision surgery
* Contraindications to the administration of acetaminophen (e.g. allergy, liver failure, etc)
* Chronic pain conditions unrelated to back pain
* Opioid tolerance ( defined as taking greater than oxycodone 20 mg daily for a week during the past month).
Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema

The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 years or older
* Type 1 or type 2 diabetes
* BCVA score of \>24 and \<78 letters
* Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) \>250microns

Exclusion Criteria:

* Anti-VEGF intravitreal treatment in last 4 weeks
* Intravitreal steroid treatment in the last 8 weeks
* PRP or Focal laser in last 4 months
* Active iris neovascularization
CardioBBEAT - Randomized Controled Trial to Evaluate the Health Economic Impact of Remote Patient Monitoring

The primary endpoint is the incremental cost effectiveness ratio (ICER), defined as the combined clinical endpoint "days alive and not in hospital nor stationary care per days in study" and the change in total cost compared to that of the control group.

Between January 2010 and June 2013, 621 patients with left ventricular ejection fraction (LVEF) ≤ 40% were enrolled and randomly assigned to two study arms comprising usual care and a home telemonitoring group. The 302 patients enrolled in the intervention group are supported by an interactive bi-directional home telemonitoring system (Motiva®) that collects and transfers patient's vital sign data to a dedicated telemedicine data centre. All patients were to remain in the study for one year with an examination at the beginning and both, after 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Chronic Heart Failure (CHF) based on European Society of Cardiology (ESC) guidelines
* Symptoms corresponding to New York Heart Association (NYHA) functional class II-IV
* Left Ventricular Ejection Fraction (LVEF) ≤ 40%
* American Heart Association (AHA) classification stage C or D
* Age \> 18 years
* Discharged after hospitalisation for worsening Chronic Heart Failure (CHF) within the last twelve months
* Able to understand the German language
* Sufficient eyesight to understand and follow the instructions communicated by the Motiva® platform
* Willing and able to use the required hard- and software and maintain a patient diary
* Residing within geographical reach of one of the ten study sites in order to receive additional treatment if required as well as follow-up consultation
* Willingness to provide informed consent regarding benefits and risks related to the trial, and to sign a participation agreement for the installation of the telemedicine platform Motiva®

Exclusion Criteria:

* Myocardial infarction within the past four weeks
* Heart surgery or any coronary intervention within the past eight weeks
* Cardiogenic shock within the past four weeks
* Intended cardiac surgery within the next six months or priority status on a waiting list for organ transplantation
* Severe chronic and pulmonary illness with an immediate impact on the main outcome measures
* Renal failure requiring dialysis
* Dementia or other severe cognitive impairment
* Psychiatric disorders rendering patients unable to participate in the trial
* Discharged to or living in a geriatric clinic or a nursing home
* Participation in another clinical trial
Tenofovir to Prevent HBV Reactivation

The purpose of the study is to determine how effective preemptive tenofovir therapy is in preventing the re-activation of Hepatitis B infection, in patients who are receiving rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation will be compared between patients who receive preemptive tenofovir and patients who receive tenofovir as needed.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
3. HBsAg negative, anti-HBc positive

Exclusion Criteria:

1. Current therapy with known activity against HBV
2. Screening ALT \> 10 x ULN
3. Screening ALT \>2 and \<10 xULN with HBV DNA \> 2000 IU/mL (indicates active HBV infection despite HBsAg negative and require antiviral therapy)
4. Life expectancy \< 3 months
5. HBsAg positive
6. HIV co-infection
7. Active HCV co-infection (HCV RNA positive)
8. Creatinine clearance \<50 mL/min
9. Intolerance to tenofovir
10. Women of child-bearing potential unwilling to take contraception during the study period
Sonoelastography of the Supraspinatus Tendon

This study aims a determine the responsiveness of sonoelastography in the tendinopathy-affected supraspinatus tendon.

The trial will include 20 patients diagnosed with supraspinatus tendinopathy from one orthopaedic shoulder clinic in Denmark.

The intervention will consist of an exercise program including lowload exercises with elastics and dumbbells, targeting the rotator cuff in a 12 weeks home-exercise program with two control visits at a physiotherapy department at the hospitals.

Tissue elasticity (measured by sonoelastography) is used as the primary outcome and is measured 12 weeks post baseline

Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand Danish
* Shoulder pain \> 3 months
* Positive on 3/5 clinical tests (full can, empty can, resisted external rotation, neers, hawking)
* Tendinopathy (MRI)

Exclusion Criteria:

* BMI \> 30
* Bilateral shoulder pain
* Supraspinatus full thickness rupture (US)
* Biceps rupture (US)
* Calcification in supraspinatus (X-ray)
* Pregnancy
* Glenohumeral arthrosis (X-ray)
* Frozen shoulder
* Shoulder symptoms originating from neck
* Shoulder fracture, operation or luxation
* Known neuromuscular disease, rheumatoid arthritis, cancer, fibromyalgia, spondylarthropathy or psychiatric disorders
* Labrum lesion (MRI)
* Tear (˃1/3 of supraspinatus, vertical height) (MRI)
Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients

Current guidelines lack definitive evidences about the relative benefits of locoregional surgery for the primary tumor in de novo stage IV breast cancer. The aim of this study (SYSBTC-001) was to investigate the role of locoregional surgery for primary tumor in de novo stage IV breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Operable stage IV breast cancer patients,whose primary lesion is invasive breast cancer confirmed by pathology, and metastases can be confirmed by pathology or imageology examination.
* ECOG-PS 0-2.
* Bone marrow, liver and kidney should be fully functional.
* Patients received the locoregional surgery of the primary tumor in de novo in our center, or didn't received the locoregional surgery of the primary tumor in de novo.
* For the patient who accepted systematic treatment before operation, the systematic treatment must be administered within a year since diagnosed.

Exclusion Criteria:

* Accompanied with other primary malignant tumors.
* Patients who can't plan for follow-up effectively and regularly.
* Multiple liver metastasis and ALT/AST four times higher than normal at patients' first diagnosis.
Integrated Mindfulness for Provoked Vestibulodynia

This study aims to test the efficacy of a 4-session intervention (Group psychoeducational treatment) using a randomized study design. Participants will be randomized in to 'immediate treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session IMPROVED treatment, just as women randomized to the experimental group, after the end of their wait-list period.


Eligibility Criteria:
Inclusion Criteria:

* must be a patient at the British Columbia Centre for Sexual Medicine
* diagnosis of provoked vestibulodynia (PVD)
* 19 years of age or older
* premenopausal
* fluent in English

Exclusion Criteria:

* not at patient at the BC Centre for Sexual Medicine
* unprovoked vulvar pain, other pathology causing pain with penetration, or chronic pelvic pain
* being uncomfortable and unwilling to participate in a group setting.
To Demonstrate the Relative Bioavailability of Diclofenac Sodium 75 mg Enteric-Coated Tablets Under Non-Fasting Conditions

To demonstrate the relative bioavailability of Diclofenac Sodium 75 mg enteric-coated tablets under non-fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Quality of Life in Patients Undergoing Radiation Therapy for Primary Lung Cancer, Head and Neck Cancer, or Gastrointestinal Cancer

RATIONALE: Gathering information about patients' quality of life during radiation therapy for cancer may help doctors plan the best treatment.

PURPOSE: This randomized clinical trial is studying quality of life in patients undergoing radiation therapy for primary lung cancer, head and neck cancer, or gastrointestinal cancer.

OBJECTIVES:

* To determine if patient-reported quality of life (QOL) can be improved by the real-time use of QOL data in patients with primary lung, head and neck, or gastrointestinal cancer undergoing radiotherapy.
* To obtain preliminary estimates for effect sizes on differences in key QOL domains between patients receiving real time QOL data and those not receiving QOL data.
* To obtain preliminary estimates of differences in patient satisfaction between patients receiving real time QOL data and those not receiving QOL data.
* To determine whether the availability of real-time QOL assessments in a radiation oncology practice increases the acceptance and utilization of QOL data by a clinical oncology team.
* To evaluate clinician attitudes towards the incorporation of real-time QOL data into oncology patient management.
* To evaluate the use of a set of clinical pathways for the incorporation of real time QOL data into oncology patient management.
* To evaluate the potential impact on the quality of the patient-physician relationship with real-time use of QOL data compared to interactions where quality of life data are not utilized.
* To obtain preliminary estimates of whether the real-time use of QOL data in a radiation oncology practice significantly increases the duration of the weekly on treatment visit.

OUTLINE: Patients are randomized to 1 of 2 groups.

* Group 1 (control): Patients complete QOL assessments (e.g., the Linear Analog Self Assessment \[LASA\]) at weeks 1, 3, and 5 during treatment and the last week of treatment. They also complete the Interpersonal Patient-Provider Relationship Scale (IPPRS) and Was it Worth It (WIW) questionnaires on the final day of treatment. Data is not shared with the physician, the patient, or any other clinical assistant that may be supporting the physician (e.g. nurse, or nurse practitioner).
* Group 2 (active): Patients complete QOL assessments (e.g., LASA) and the IPPRS and WIW questionnaires as in group 1. Information from the questionnaires is shared with the physician, nurse, and/or nurse practitioner and the patient immediately prior to the on-treatment visit.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following:

  * Primary lung cancer
  * Head and neck cancer
  * Gastrointestinal cancer
* No evidence of distant metastasis
* Receiving ≥ 5 weeks of definitive or adjuvant radiotherapy at Mayo Clinic Arizona

PATIENT CHARACTERISTICS:

* Able to complete computer based questionnaires
* Able to complete quality of life questionnaires in English
* Willing and able to comprehend and provide informed consent

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Study of JMKX003142 Injection in Chinese Healthy Subjects

To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003142 Injection Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Doses in Chinese Healthy Adult Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects aged 18-45 years (including boundary values).
2. Able to sign a written informed consent form.
3. Physical examination, clinical laboratory examination value, Virology examination, vital signs and ECG examination are confirmed by the researcher to be normal or abnormal without clinical significance
4. The subjects have a thorough understanding of the study content, process, and potential adverse effects, and are willing to complete the study according to the requirements of the experimental protocol

Exclusion Criteria:

1. Had or currently have serious clinical diseases related to circulatory system, respiratory system, digestive system, nervous system, endocrine system, blood lymphatic system, genitourinary system or psychiatry, as well as habitual constipation, gastrointestinal bleeding history, which is judged to be inappropriate for the study by the investigators
2. Participants in any other clinical study within 3 months prior to the first administration of this study
3. The investigators believe that the subject has other factors that are not suitable for participating in this experiment
4. Pregnant or lactating women
Assessment of Biomarkers in Pregnancy on Unknown Location and Ectopic Pregnancy

To further develop the patient care pathway for women classified with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP).

Purpose and design-There is a need for the patient care pathway to evolve in order to aid and improve the diagnosis and management of women with a pregnancy of unknown location (PUL) and ectopic pregnancy (EP). There is potential for this to be achieved by the incorporation of a statistical model that uses one or more novel markers identified by this study.

Recruitment-1000 patients. Inclusion: Patients attending the Early Pregnancy Unit (EPU) in the first trimester with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18-50 years. Exclusion: Patients diagnosed with cancer, presence of acute medical condition, patients aged less than 18 years, patients who cannot give fully informed study consent.

Consent - Posters will advertise the study. Patients in EPU will be invited to the study by a member of the clinical care team. Written consent will be required.

Confidentiality - The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. Patient consent forms will be stored securely within the study file. All patient identifiable information, where required, will be stored electronically on National Health Service (NHS) approved computers, accessible only by personnel involved in the study via password.

Conflict of interest - None involved in the study have a conflict of interest. Dissemination of results - No patient identifiable information will be included in the research report or publication. Anonymised results will be disseminated to scientific community by means of publication in peer-reviewed literature and presented at national and international meetings.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending the Early Pregnancy Unit in the first trimester of pregnancy (≤14 weeks gestation) aged between 18-50 years old and categorized as having a PUL or ectopic pregnancy

Exclusion Criteria:

* Younger than 18 years of age
* Women who in the opinion of the researcher by virtue of language or learning impairment would be unable to give fully informed consent to the study
* Viable intrauterine pregnancy (the presence of a fetal pole with a fetal heartbeat within the uterine cavity)
* Miscarriage
* Presence of an acute medical condition
Effects of Pomegranate Juice on Oxidative Stress in Patients With type2 Diabetes

Introduction: Diabetes mellitus a chronic diseases, is the most common and important metabolic disease in human. Increased free radicals production due to hyperglycemia produces oxidative stress which worsens the disease and its complications. Pomegranate juice has antioxidant and antiatherosclerotic properties. The present study was planned to evaluate the effects of pomegranate juice consumption on glycemic control, lipid profile,blood pressure and oxidative stress in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Age of 40-65 years
* Body Mass Index 18.5-30
* Fasting blood glucose ≥ 126 mg/dl

Exclusion Criteria:

* Smoking
* insulin for blood glucose control
* taking estrogen or progesterone (if female)
* Taking antioxidant supplements
* suffering from any other chronic diseases
* Participants are also excluded if they missed more than 10% of their pomegranate juice packs
Evaluation of Mitochondrial Function in Myofascial Trigger Points Cohort Pilot Study Using High-resolution Respirometry

This pilot study established a minimally invasive biopsy technique to obtain high-quality MTrP tissue samples to evaluate mitochondrial function via high-resolution respirometry.

Myofascial trigger points (MTrPs) are hyperirritable areas in the fascia of the affected muscle, possibly related to mitochondrial impairment. They can result in pain and hypoxic areas within the muscle. This pilot study established a minimally invasive biopsy technique to obtain high-quality MTrP tissue samples to evaluate mitochondrial function via high-resolution respirometry. Secondary objectives included the safety of the biopsy procedure assessed via clinical wound healing (number of patients with signs for local infection and inflammation). For this purpose, twenty healthy males participated in this study, 10 with a diagnosis of myofascial pain in the musculus (m.) trapezius MTrP (TTP group) and 10 with a diagnosis of myofascial pain in the m. gluteus medius (GTP group). The affected muscle was biopsied followed by a biopsy from the vastus lateralis to be used as a control. Measurements of oxygen consumption were carried out using high-resolution respirometry.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 18-45 years
* Clinical diagnosis of myofascial pain syndrome within the region of the shoulder-neck muscles or the lumbogluteal region and the presence of an MTrP, defined as a firm palpation of a hard, tender nodule resulting in a spontaneous pain complaint
* with symptoms present for 1 to 12 months

Exclusion Criteria:

* Signs that the participant's prescriptive compliance was not expected (e.g., lack of cooperation)
* Disorders of the respiratory tract
* Neurological disorders, in particular neurodegenerative and neuromuscular diseases
* Disorders of the cardiovascular system or the musculoskeletal system
* Civil servants and military service personnel.
Remifentanil in Extracorporeal Shock Wave Lithotripsy

The purpose of this study is to compare the analgesic efficacy and side effects induced by administration of two different infusion rates of remifentanil, 0,05 mcg/ Kg/ min versus 0,1mcg/ Kg/ min, in order to determine which one is the most appropriate analgesic treatment to face extracorporeal shock wave lithotripsy.

Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific blood and tissue esterases . This feature vouches for a predictable pharmacokinetics and makes this drug suitable for administration in continuous intravenous infusion in order to achieve patient conscious sedation during non-invasive surgical procedures. Remifentanil could be particularly useful in day surgery setting, thanks also to its faster elimination than other oppioids. This property ensure a swift recovery from conscious sedation, reducing the period of time during which patient remains in recovery room and decreasing also the incidence of side effects, like PONV and respiratory depression. Conscious sedation with remifentanil can provide patient comfort and cooperation during surgical procedure, since the verbal contact with the patient is kept up. Extracorporeal shock wave lithotripsy (ESWL) is a non-invasive procedure, contemplated as the first-line treatment for renal and upper ureteral stones, if stone diameter is ranged from 5 to 20 mm . It can grind calculi into fine particles, that are expelled through micturition. Although many studies have been published in regard to continuous intravenous infusion of remifentanil, a small number of them focuses on which is the most appropriate infusion rate for ESWL procedure.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of anaesthesiology) physical status between the I and class II
* Body mass index (BMI) between 18 and 30.

Exclusion Criteria:

* Patients who were unable to give informed consent or with diagnosis of depression
* Concurrent treatment with antidepressant
* Anxiolytic or with opioids or with history of abuse and dependence from these substances
* Allergy or intolerance to drugs administered in this study
* Severe cognitive deficits or psychiatric disorders
* Liver or renal impairment (aspartate aminotransferase \> 40 UI/L alanine aminotransferase \> 40 UI/L, creatinine \> 2mg/dL)
* Abnormal values of coagulation (International normalized ratio \> 1,2), platelet(\< 100.000/µL), arrhythmias and / or defect of atrioventricular conduction.