cyrilzakka/clinical-trials huggingface dataset:
Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.

Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation.

The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables.

Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.

Eligibility Criteria:
Inclusion Criteria: Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible

Exclusion Criteria:

* history or identified risk for deep vein thrombosis or pulmonary embolism
* history of coagulation or cardiovascular disorders
* vascular diseases
* pregnancy
* current use of anticoagulation drugs
* previous orthopedic surgery in the legs.
Effect of Piezoelectric Surgery on Quality of Life and Periradicular Healing After Endodontic Surgery

This study will compare the effect of piezo Vs bur on quality of life and healing after endodontic surgery.

The goal of endodontic surgery has changed from mere reduction of periapical pathosis and preservation of periodontium to successful postoperative management of patient regarding function and esthetics, improving the quality of life of patient and their overall acceptance. Piezoelectric bone surgery is a recent and innovative technology, permitting selective cutting of mineralized tissues sparing soft tissues.In this study after thorough clinical \& radiographic examination patients will be given informed consent after explaining the treatment procedure and its associated risks and benefits. Patients are allocated into 2 groups, group 1(piezo group) in which after flap reflection bone cutting and root end cutting are performed with US6 piezoelectric insert and in group 2(control) bone and root end cutting are performed with conventional bur. Each patient will be given a questionnaire to fill out for each day starting from the day of surgery for 7 days postoperatively to assess the quality of life. They will be also requested to note down the details of analgesic intake. Hemorrhage control during surgery will be assesed. Clinical and radiographic examinations will be performed every 3, 6 and 12 months to evaluate any evidence of signs and/or symptoms and after 12 month follow up post operative CBCT taken to evaluate volume reduction of lesion postoperatively.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with no general medical contra-indications for oral surgical procedures (ASA-1 or ASA-2).
2. Patients of age 16 years and above.
3. The tooth to be treated surgically should have a periradicular lesion of strictly endodontic origin (chronic apical periodontitis).
4. The nonsurgical re-treatment was judged unfeasible or had previously failed.
5. The tooth had an adequate final restoration with no clinical evidence of coronal leakage.
6. The apical area of the root canal should be devoid of the presence of a post for at least 6 mm.
7. Patients with no acute symptoms.

Exclusion Criteria:

1. Unrestorable tooth.
2. Fractured / perforated tooth.
3. Apicomarginal defects.
4. Through \& through lesions.
5. Teeth with deep pockets.
6. Serious medical illness(uncontrolled/poorly controlled diabetes, unstable or life threatening conditions or requiring antibiotic prophylaxis).
Effects of Levosimendan, Milrinone and Norepinephrine on Left and Right Ventricular Function in Septic Shock

The aim of this study is to investigate the effects milrinon and levosimandan on n heart function in septic cardiomyopathy and how norepinephrine affects the left and right ventricular function in patients with septick shock using pulmonary artery catheter, conventional and strain echocardiography.

This is a prospective study where 30 patients with septic chock during the care in ICU, will be included. Patients with a history of previous heart disease are excluded from the study. Each patient is in need of norepinephrine infusion and on mechanical ventilation. Initially the mean arterial pressure (MAP) is randomly changed from 60 to 75 and then to 90 mmHg. Hemodynamic variables as blood pressure, cardiac output, pulmonary artery occlusion pressure (PAOP) will be registerd at each MAP-level, arterial line and pulmonary artery catheter (PAC) and the cardiac function will be assessed with conventional and strain echocardiography. Then, if the echocardiogram shows impaired LV-function will the patient be randomized to receive either Milrinone or Levosimendan. Hemodynamic variables as blood pressure, cardiac output, pulmonary artery occlusion pressure (PAOP) will be registered again, as well the cardiac function with conventional and strain echocardiography. Echocardiograms will be analysed for the determination of LV an RV strain. Potential differences between different levels of blood pressure as well as effects of Milrinone or Levosimendan on hemodynamic and echocardiographyc variables will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Septic shock.
* All patients will be resuscitated with fluids before the inclusion.
* Need of Norepinephrine infusion.
* Myocardial dysfunction in echocardiogram, either LVEF \< 50% or Global Left Ventricular Systolic strain over -15%.

Exclusion Criteria:

* History of previous heart disease or pulmonary hypertension.
* Age \< 18 years.
* Cardiac arrhythmia.
Prospective Biobanking Study in Cancer Patients Aiming at Better Understand the Link Between the Molecular Alterations of the Tumor Itself, Its Microenvironment and Immune Response (SCANDARE)

SCANDARE is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, Head and Neck Cancer, advanced stage treatment-naïve cervical cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. This study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. All patients will receive standard treatment according to the stage of the diseases and usual procédures.

Patients will have blood and +/- tumor samples at the following times :

1. if eligible for surgery :

   * at surgery (blood + tumor and nodes)
   * after surgery (blood)
   * 6 months after surgery if non recurrence (Blood)
   * before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes if possible)
   * before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)
   * at progression (blood + tumor biopsie and nodes if possible)
2. if eligible for neoadjuvant chemotherapy :

   * before neoadjuvant therapy (blood + tumor biopsie and nodes)
   * during neoadjuvant therapy (post cycle 1) (blood)
   * at the time of surgery (blood + tumor and nodes)
   * 6 months after surgery if non recurrence (Blood)
   * before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes)
   * before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood)
   * at progression (blood + tumor biopsie and nodes)

Eligibility Criteria:
Inclusion Criteria:

1. Tumor types :

   1. Newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy
   2. Newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy
   3. Newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery
   4. Newly diagnosed treatment-naïve cervical cancer patients (1) stage Ia - IIa1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥IIa2).
   5. Newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment
2. Male or female patients ≥ 18 years of age
3. Signed informed consent

Exclusion Criteria:

1. Male or female patients ≤18 years old
2. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
3. Individually deprived of liberty or placed under the authority of a tutor
4. Patients not affiliated to the Social Security System
The National Institutes of Health Measure of Healing Experience of All Life Stressors

NIH-Healing Experience in All Life Stressors (NIH-HEALS) is a 35 item self-report questionnaire developed by the NIH Clinical Center Pain and Palliative care. It assesses an individual's mechanisms for coping as a means to reach "healing" during life's difficult situations and/or life limiting challenges. The factorial structure of the tool has been recently re-examined with 200 patients. The three main factors are: Connection (including religious, spiritual, interpersonal), Reflection/ Introspection, and Trust/Acceptance.

At the Clinical Center Pain and Palliative Care Service (PPCS) we have developed a pscyho-social-spiritual measure, the Healing Experience in all Life Stressors (HEALS), that focuses on the healing experience in people with severe and life limiting illness. We have validated this tool further in order to be able to identify those individuals who may benefit from additional interventions to cope with their illness and even assist them in reaching a healing experience that is possible even in the midst of their unfavorable circumstances. Identification of vulnerable individuals as well individuals who do have transformative experience after being diagnosed with severe and life limiting illness, has far-reaching impact on the quality of patient care for the very sick patients.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 or above
* The ability to read and write in English
* The presence or history of a serious and/or life-threatening disease
Intranasal Dexmedetomidine for Pain Management During Screening for Retinopathy of Prematurity

Background: Preterm infants undergo serial eye examinations during their hospital stay to monitor for the development of a specific disease termed "retinopathy of prematurity". While those examinations are known to cause significant pain and stress, the current standard of care (sucrose and local anesthesia) is not adequate in terms of alleviation of pain.

Purpose: The goal of this clinical trial is to test the effectiveness of dexmedetomidine for pain management in preterm infants undergoing routine eye examinations.

The main questions it aims to answer are:

* Does dexmedetomidine reduce the pain scores of preterm infants during and shortly after eye assessments in comparison to placebo (saline 0.9%).
* Does dexmedetomidine cause more adverse effects than placebo.

In this crossover study participants will receive either dexmedetomidine or saline 0.9% intranasally 30 minutes before the examination, on top of the current standard of care. The participants will be monitored closely for 5 hours to note differences in adverse effects. The researchers will use video monitoring to assess the pain scores using a standardized and validated scoring system.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 31 weeks post-menstrual age, or birth weight \< 1500 grams
* Informed consent signed by one of the parents

Exclusion Criteria:

* Invasive ventilation at the time of the eye assessment
* Multiple congenital anomalies
* Chromosomal / genetic anomalies
* Infant received a sedative drug in last 5 days
* Eye examination for reasons other than retinopathy of prematurity screening
* Attending physician deemed the patient not stable enough
High-resolution Imaging of Corneal Lesions With Optical Coherence Tomography (OCT) - A Pilot Study

Corneal lesions such as corneal abrasions and corneal infiltrates are common in clinical practice. The current study seeks to investigate whether high-resolution OCT is suitable for imaging of these corneal lesions. The present study has the character of a pilot study and the results are intended to be used to develop a standardized protocol for imaging and analysis of these corneal lesions. Based on this protocol, further studies investigating the pathophysiology of corneal lesions or evaluating therapeutic success can be planned.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* Newly diagnosed corneal abrasion or corneal infiltrate

Exclusion Criteria:

* Recurrent corneal erosion
* Participation in a clinical trial in the previous 3 weeks
* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Any contraindication for topical application of Novain 0.4% eye drops for topical anesthesia or of Minims-Fluorescein Sodium eye drops for fluorescein staining
* Pregnancy, planned pregnancy or lactating
Acute Effects of Various Aerobic Exercise in Allergic Rhinitis.

This study was to investigate the comparison among acute effects of various aerobic exercise on symptoms in allergic rhinitis patients.

Fifteen patients with allergic rhinitis aged 18 - 45 years old. The experiment was a crossover design in which each participant was given three types of exercise: running, cycling, and swimming. The participant perform moderate intensity exercise 30 minutes/time. Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-and post-exercise. The dependent variables between pre-test and post-test were analyzed by a paired t-test. The dependent variables between groups were analyzed by independent t-test. One way repeated measures ANOVA was used to compare the variables among exercise. Differences were considered to be significant at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of allergic rhinitis diseases
* Clinical symptoms of persistent rhinitis (nasal congestion, sneeze, nasal itching, and running nose) for more than 4 days per week.
* Positive skin prick test (wheal diameter\>3 mm.) to house dust mite (D. pteronyssinus) and using normal saline as the negative control.
* Stopped taking all medicine before the study such as antihistamine for at least 3 days, oral steroid and nasal steroid for at least 2 weeks and luekotriene receptor antagonist for at least a week prior to the study, but the patients could take pseudo ephedrine.

Exclusion Criteria:

* Asthma, Chronic rhino-sinusitis, Hypertension, Cardiovascular diseases
* A smoking habit
Ultravist: Safety and Efficacy in Computed Tomography of Head and Body

This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician.

Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old and clinically indicated for a contrast-enhanced CT of the head or body.

Exclusion Criteria:

* Patients that are less than 18 years old and do not have a clinical indication for a contrast-enhanced CT of the head or body.
Feasibility of Gadolinium Contrast Reduced Brain MRI: the Potential of Deep Learning

MRI scans were performed using 3 different 1.5T scanners with an eight-channel head coils. Following a 3D pre-contrast T1w scan, a low-dose contrast-enhanced 3D T1w scan was obtained using 20% (0.02 mmol/kg) of the standard dosage of gadoterate meglumine.

The subjects were immediately administered the remaining 80% (0.08 mmol/kg) of the contrast agent to reach the standard dose of 0.1 mmol/kg, which served as a training ground truth for further quantitative assessment. All three acquisitions were performed during a single imaging session, with no additional gadolinium dose administered above the standard protocol.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical indications for imaging with a contrast-enhanced 3D-T1w MRI sequence including tumor suspicion, postoperative tumor follow-up, multiple sclerosis, routine brain imaging, etc.,
2. no plan for dynamic contrast administration or deviation from the standard dose of 0.1 mmol/kg body weight (e.g., sella imaging, magnetic resonance angiography),
3. no clinical contraindications to imaging prolongation (i.e., emergency, poor patient condition).

Exclusion Criteria:

1. prominent image artifacts,
2. incomplete study sequences (e.g., early termination)
3. errors related to contrast agent administration.
Effect of Food Acceptability on Appetite Hormones' Response in Normal Weight vs. Obese Male Subjects

Male subjects with specific body characteristics were recruited for the study. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions. This procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples of 5 ml were collected at fasting and after ingestion of meals. At the end, subjects were given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin and glucose levels were performed.

Male subjects were recruited for the study based on the following criteria: age between 18 and 50, body mass index normal or obese, non-smokers, non-alcoholic, and do not take medications. Subjects did an acceptability test on custard and completed a screening questionnaire. Around 30 subjects (15 with a normal BMI and 15 obese) continued the study. Subjects were randomly assigned to one of two meals. Each of the two meals was ingested after a 3-day adaptation period. The meals had similar macronutrient composition and provided energy equivalent to 30% of the subjects' resting energy expenditure. At each test day, fasting blood samples were withdrawn by a registered nurse under sterile conditions. This procedure was followed by ingestion of one of the two meals within a period of 10-15 minutes. Blood samples of 5 ml were collected at fasting and after ingestion of meals at 15, 30, 60, 120, 180 and 240 minutes. At the end, subjects were given ad lib access to cheese pizza to assess energy intake after the custard preload. Blood analysis for GLP-1, ghrelin, insulin and glucose levels were performed.

Eligibility Criteria:
Inclusion Criteria:

* Gender: Male
* Age: 18-50 years
* Body Mass Index (BMI): 18.5-24.9 kg/m2 or 30-39.9 kg/m2
* Stable body weight for at least three months before the study with the absence of any form of dieting, food restriction or other abnormal eating behaviors (to minimize the effect of weight change on ghrelin and GLP-1 statuses)
* Agreement on the acceptability levels of the two versions (high and low acceptability) of custard

Exclusion Criteria:

* Smoking
* Substance abuse such as alcohol or drugs
* Medical or psychological illness
* Previous gastrointestinal surgery
* History of weight fluctuation (weight loss of greater than 5% within the past 3 months)
The Effect of Auditory Disturbances on Human Movement

This study sets out to investigate the potential effect of auditory disturbances on human movement

Clinicians routinely investigate/test human movement but if/how this is effect by auditory disturbances is unclear. This study sets out to investigate the impact of auditory disturbances on human movement.

Eligibility Criteria:
Criteria:

Inclusion Criteria: - Healthy participants

* Pain free healthy participants
* Able to speak, read and understand Danish and English

Exclusion Criteria: - Healthy participants

* Pain from the neck, back, arm or leg during the past 6 months up to the test session
* Former surgery in neck, back, arm or leg restricting normal movement
* Current or previous chronic or recurrent pain condition
* Pregnancy
* Current or previous neurologic, musculoskeletal or mental illnesses
* Lack of ability to cooperate

Inclusion Criteria: - Pain population

* Self reported ongoing or recurring pain from neck, back, arm or leg
* Able to speak, read and understand Danish and English

Exclusion Criteria: - Neck pain population

* Current or previous chronic or recurrent pain condition
* Former surgery in neck, back, arm or leg restricting normal movement
* Pregnancy
* Current or previous neurologic, musculoskeletal (other than what is included) or mental illnesses
* Lack of ability to cooperate
Propofol-Enhanced Assessment of Ketamine for Chronic Pain and Depression

The goal of this clinical trial is to compare ketamine to a placebo when given as a single infusion during IV sedation in adults with chronic pain and depression. We do not know whether ketamine will be more effective than placebo under these circumstances.

This study aims to:

* Evaluate whether placebo is non-inferior to ketamine in treating chronic pain and depression, when delivered under propofol sedation
* Confirm that propofol sedation is a safe way to keep participants blinded to treatment
* Assess patients' comfort with the sedation process to improve future studies
* Explore whether patient expectations affects their pain and depression

Participants will:

* Need to qualify for the study based on stringent medical criteria
* Undergo sedation with propofol
* Randomly receive either a ketamine or a placebo (saline) infusion during sedation
* Complete several study assessments over 5-7 weeks

Ketamine is a dissociative anesthetic that has been in clinical use for more than 50 years. In addition to its well-known anesthetic and pain-relieving properties, ketamine has been found to have fast-acting antidepressant effects in patients with depression. However, the mechanisms underlying ketamine's ability to treat chronic pain and depression are poorly understood. A most basic question regarding ketamine's therapeutic mechanism is still unresolved: do patients need to consciously experience and recall ketamine's acute dissociative effects to receive lasting analgesic and antidepressant benefits? In this clinical trial, participants will receive either ketamine or a placebo when they are under sedation with propofol. A n=6 pilot feasibility phase will precede the fully-powered n=34 randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years old
* Comfortable speaking and writing in English
* Chronic pain present daily for at least 3 months
* Currently experiencing depression
* Able to comply with the study protocol and communicate with study personnel about adverse events and other clinically important information

Exclusion Criteria:

* Pregnant or breastfeeding
* One or more health conditions that makes study unsafe or unfeasible, determined by study physicians
* Regular use of medications that may have problematic interactions with the study drugs
* Participating in another clinical trial which may conflict with this one