cyrilzakka/clinical-trials huggingface dataset:
Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia

arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.

Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. The second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.The third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. All patients will be received postoperative a tramadol i.v. patient control analgesia device. At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. NRS score, white fast track, satisfaction will be questioned.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 70 years
* American Society of Anesthesiologists I or II
* Scheduled to undergo knee arthroscopy

Exclusion Criteria:

* allergic to any medicines
* History of drug or alcohol abuse,
* Opioids or sedative medications
* History of psychiatric conditions
* Pregnant or lactating women
Long Pulse 1064 nm Nd:YAG Laser in the Treatment of Erythematotelangiectatic Rosacea and Other Erythematous Telangiectatic Facial Conditions

The goal of this clinical study is to assess the effectiveness of Nd:YAG laser 1064 nm in the long pulse mode in the treatment of signs of rosacea including the erythema of the face and telangiectasia. The used parameter of this laser was of very low energy (spot size: 5mm, fluence: 4.07 J/Cm2, energy: 800 millijoules (mJ) and frequency: 5 Hz. About 2-3 passes performed in each treatment session. Up to four sessions were performed for each patient with 2 weeks interval) and also its was expected to have minimal adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Patient with rosacea (erythemato-telangiectatic type)

Exclusion Criteria:

* Other clinical types of rosacea
* Pregnancy and lactation in females
* History of malignancies
* History of photosensitivity
* History of any other modalities of treatment of rosacea over last 6 months
The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight

The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. We further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program.

* We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals.
* We hypothesise that the commercial weight management program will lead to greater weight loss compared to control program.
* We hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food)
* We hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)


Eligibility Criteria:
Inclusion Criteria:

* BMI of 28 - 45 kg/m2
* Reporting an interest in weight loss, not actively participating in a commercial weight loss program,
* Not increased physical activity levels in the past 2-4 weeks
* Able to eat most everyday foods and fruits and vegetables
* Written informed consent to be given

Exclusion Criteria:

* Significant health problems that could cause confounding effects between intervention and control.
* Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
* Pregnant, planning to become pregnant or breastfeeding
* History of anaphylaxis to food
* Known food allergies or food intolerance
* Smokers and those who have recently ceased smoking
* Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
* Those who have previously taken part in a commercial weight loss program in the last 6 months? .
* Participants who work in appetite or feeding related areas
* Participants unable to consume foods used in the study
* Participants who have had bariatric surgery
* Participants with a history of eating disorder
* Presence of untreated hypothyroidism
* Inability to fully comply with intervention or study procedures
* Insufficient English language skills to complete study questionnaires
Comparison and Analysis of Blood Loss Formulas

Although it has been pointed that estimates are significantly inexact and different from each other, the actual accuracy of them has not been properly investigated and compared.


Eligibility Criteria:
Inclusion Criteria:

- Adults 18 - 90 yrs.

Exclusion Criteria:

* Suspected or confirmed coagulopathy (including current treatment with anticoagulants or antiplatelet agents).
* Surgical blood loss volume \< 200 ml.
* Requirement for surgical gauzes during surgery, including conversion to open surgical techniques.
* Transfusion of red blood cells (RBCs) during the perioperative period.
* Significant postoperative bleeding (\> 50 ml in surgical drains) or any other type of significant blood loss.
* Fluid infusions or vasoactive drugs after the first 24 postoperative hours.
Evaluation of Neointimal Coverage of EES and BMS After Implantation in STEMI Patients by Optical Coherence Tomography

Primary percutaneous coronary intervention (PCI) represents the preferred reperfusion strategy for patients with ST-segment elevation myocardial infarction (STEMI), since it is more effective than thrombolytic regimens in reducing adverse events, including death. Drug-eluting stents (DES) are currently being widely used in patients with STEMI. The effectiveness of DES to reduce restenosis and the need for revascularization compared with bare-metal stents (BMS) has been documented in randomized controlled trials. The first-generation DESs implanted in STEMI have been associated with delayed healing and incomplete strut coverage. Therefore, in patients with implanted DES, longer duration of dual antiplatelet therapy is needed. The second-generation DESs (ZES and EES) have been improved the drug and polymer, which have been proved to improve neointima healing compared with the first generation DESs.

However, the difference of strut coverage between EES and BMS implanted in STEMI patients is unknown. In this study, we assess the neointimal coverage at 3-month and 12-month follow-up in EES and BMS implanted in patients with STEMI by optical coherence tomography.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-75 years
* Acute MI with ST-segment elevation, within 12 hours from symptoms onset.
* Length of culprit lesion≤25mm.
* Vessel size in between 2.5 and 4.0 mm.
* Signed patient informed consent.

Exclusion Criteria:

* Prior administration of thrombolytic therapy.
* Cardiogenic shock.
* Renal failure (Crea≥2.0mg/dL).
* Recent major bleeding.
* Allergy to heparin, aspirin, clopidogrel, everolimus, the polymer components of the Xience V stent, stainless steel, or contrast media.
* Left main disease
* Multi-vessel lesion
* Other hemodynamically significant lesion(s) is present in the infarct vessel (or side branches)
* Angiography demonstrates the infarct lesion to be at the site of a previously implanted stent or in bypass grafts.
* No suitable anatomy for OCT scan.
The Effect of Oxytocin on Face Perception

The purpose of this study is to determine whether oxytocin affect face perception


Eligibility Criteria:
Inclusion Criteria:

* normal or corrected to normal vision

Exclusion Criteria:

* minors
* pregnancy (according to a pregnancy test taken by subjects prior to participation)
* a history of asthma or nasal polyps
* cardiac disorders
* hyponatremia
* acute or chronic renal insufficiency
* liver cirrhosis
* neurological disease
* other chronic disease
* dementia, or lack of judgment
Effects of Parent-Adolescent Joint I-Interventions for Adolescents with Adverse Childhood Experiences

The study aims to examine the effectiveness of internet-based Parent-Adolescent Joint Interventions in improving the mental health outcomes of participants, specifically by reducing symptoms of depression, anxiety, and PTSD, as measured by the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder-7 scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). Adolescents will be recruited from middle schools and randomly assigned to one of three groups: (a) psychoeducation, (b) psychoeducation + emotional skills enhancement, or (c) psychoeducation + emotional skills enhancement + positive childhood experience promotion. The school-based intervention will consist of 4-8 sessions, with assessments conducted at baseline, post-treatment, and a 3-month follow-up. Investigators will conduct multilevel models (MLMs) and structural equation models (SEMs) to investigate the impact of Adverse Childhood Experiences (ACEs), Positive Childhood Experiences (PCEs), alexithymia, and emotion regulation abilities on mental health outcomes in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Middle school students studying in school and their parents
* Capable of hearing, speaking, reading, and writing

Exclusion Criteria:

* High suicidal risks
* Severe mental disorders
Elderly Dependent Patients With Non Small Cell Lung Cancer (NSCLC)

The purpose of this study is in non small-cell lung cancer stage IV et IIIB (T4 with pleural effusion) in elderly dependent patients with evaluation of the sequence Gemcitabine first line followed by Erlotinib when progression versus Erlotinib first line followed by Gemcitabine when progression

A multicenter phase II trial,prospective,randomized,open,non comparative

Eligibility Criteria:
Inclusion Criteria:

* Age \> 65
* Comorbidities score, PS and frailty score according to table 1
* No dementia, faecal or urinary incontinence, repeated falls
* ADL = 0, IADL = 0-1
* Life expectancy at least 12 weeks
* Creatinin clearance \> = 30 ml/mn (according to Cockcrofts-Gault formula)
* Competency to give written informed consent
* Haematological functions as follows : neutrophiles count \> 1.5 x 109/l and platelets \> 100 x 109/l hemoglobin \> 9,5 g/dl - Hepatic function as follows : Bilirubin \< 1,25 LNS ASAT / ALAT \<5 x NAlcPh \<5 x N
* PS \< 3
* cerebral metastasis eligible if asymptomatic
* Histologically or cytologically confirmed NSCLC
* Stage IV/IIIB4 (T4 with pleural effusion)
* No prior chemotherapy
* relapses of previous NSCLC treated by surgery or radiotherapy are eligible, if the target is measurable out of initial radiotherapy field and if cytological or histological proof
* At least one measurable target lesion by RECIST guidelines

Exclusion Criteria:

* symptomatic cerebral metastasis
* Any severe comorbidity calculated by Charlson score according to table 1
* ADL \> 0 and IADL \> 1- performance status \>2 (ECOG)
* peripheral neuropathy grade 2 or more
* dementia, repeated falls, urinary or faecal incontinence
* contra-indication to corticosteroids
* contra indication to a product of this study
* unwilling or unable to comply with study requirements, for personal, family, sociologic, geographic or any other reason
* inability of the subject to give written informed consent
* lack of liberty following legal or administrative decision
* hypersensitivity to polysorbate
* hypersensitivity to erlotinib or any excipients of this product
* unusual hereditary disorders, as galactosemia, deficit in lactase and syndrome of malabsorption in glucose or galactose
* participation in concomitant clinical trial
* bronchioloalveolar or neuroendocrine or composite carcinoma
* superior vena cava syndrome
An Observational Study of Respiratory Syncytial Virus (RSV) Hospitalizations in Preterm Infants

Purpose of this study is to evaluate clinical, humanistic and health economic burden of Respiratory Syncytial Virus (RSV) in infants born 29 to 35 Weeks Gestational Age (wGA) hospitalized for RSV at up to 12 months of age.

This surveillance study will enroll approximately 500 eligible infants from approximately 40 study sites in the US, hospitalized for laboratory-confirmed, nosocomial or community-acquired RSV disease during the study eligibility period of 1 October 2014 through 30 April 2015 (Season 1) and 1 October 2015 through 30 April 2016 (Season 2). During these eligibility periods, infants may be enrolled:

* Prospectively at the time of their index Respiratory Syncytial Virus Hospitalization (RSVH) admission or any time prior to their index RSVH discharge, or
* Retrospectively on the basis of electronic medical record (EMR) review following discharge from the index RSVH.

Regardless of the timing of study enrollment (i.e., in relation to the date of discharge from the index RSVH), sites will identify all infants eligible for study participation, including those treated in the inpatient ward and intensive care unit (ICU). Identification of all potentially eligible infants will be ensured through the review of the EMR, or other local healthcare database deemed appropriate for study purposes by the Study Coordinating Center (SCC).

The clinical, humanistic and health economic outcomes associated with the RSV disease will be characterized in the outpatient and inpatient settings, from the onset of symptoms of RSV disease pre index RSVH to up to 4 months post index RSVH discharge date (additionally to 12 months post index RSVH discharge date in Season 1 only), on the basis of medical records and Parent/Guardian self-report. Information regarding any sequelae associated with the index RSVH, medically-attended wheezing episodes, loss of work productivity and healthcare resource utilization (HRU) related to the management of RSV-related disease will also be collected from the medical records and Parent/Guardian by telephone interview at approximately 1 month and 4 months following discharge from the index RSVH (additionally at 12 months in Season 1 only).

Eligibility Criteria:
Inclusion Criteria:

* Born at 29 to 35 wGA (i.e., 29 weeks, 0 days through 35 weeks, 6 days)
* Laboratory-confirmed, nosocomial or community-acquired RSV disease (RSV can be documented in the outpatient and/or inpatient setting during the illness that resulted in the index hospitalization)
* Hospitalized ≥24 hours for the diagnosed RSV disease (the index RSVH)
* \<12 months of age at time of index RSVH admission
* Written informed consent and any locally required authorization (e.g., HIPAA), obtained from the infant's Parent/Guardian

Exclusion Criteria:

- Receipt of RSV immunoprophylaxis within the 35 days prior to onset of respiratory symptoms associated with the index RSVH
Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥18 years
2. Performance status, Eastern Cooperative Oncology Group 0-2
3. Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
4. Plan for SSRS per the treating team
5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
6. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography/computerized tomography

Exclusion Criteria:

1. Prior anaphylactic reaction to 18F-fluciclovine
2. Evidence of leptomeningeal disease
3. Prior whole-brain radiation therapy
4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
5. Females pregnant at the expected time of 18F-fluciclovine administration
6. Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed
7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
Understanding The Effect Of A Strong CYP3A4 Inducer On Glasdegib Pharmacokinetics

The study also aims to determine the effect of a strong enzyme (CYP3A4) inducer-rifampin- on drug exposure of Glasdegib. This study will be conducted in healthy subjects given a single dose of glasdegib in each period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects of non-childbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
* Female subjects of non childbearing potential must meet at least one of the following criteria:

  1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; AND have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
  2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  3. Have medically confirmed ovarian failure.
* All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* A positive urine drug screen
* Screening supine 12 lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.
* Subjects with family history of myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias.
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of investigational product and, refrain from sperm donation for the duration of the study and for at least 90 days after the last dose of investigational product.
A Digital Lifestyle Intervention in Primary Healthcare to Prevent Cardiovascular Disease

Unhealthy lifestyle behaviors are well-established risk factors for cardiovascular disease (CVD) which is the leading cause of death globally and in Sweden. Digitalization offers new and better possibilities for healthcare to fulfil their responsibility to support healthier lifestyles, however, to ensure scalability and sustained implementation of digital tools within healthcare, digital interventions need to be systematically maintained and delivered by the primary healthcare. The aim of this project is to evaluate whether a digital lifestyle intervention, developed within Swedish primary healthcare, can improve clinically important cardiovascular health outcomes and lifestyle behaviors. In this multi-center randomized controlled trial patients, 40-60 years, in Swedish primary healthcare will be recruited and randomized to the control or intervention group. All participants will receive standard care consisting of one structured health dialogue focused on lifestyle habits. The intervention group will also receive support through the digital lifestyle intervention for creating healthy habits regarding diet, physical activity, alcohol consumption, and tobacco usage. The primary outcome is LDL-cholesterol at 6 months post-randomization. Secondary outcomes 6 months post-randomization are HDL-, total cholesterol, fasting blood glucose, triglycerides, non-HDL, blood pressure, weight, height, BMI, waist circumference, cardiovascular risk evaluation (SCORE2), dietary intake, physical activity, sleep, stress, alcohol consumption, tobacco use, and health-related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Attended a Health dialogue visit to primary healthcare for patients 40-60 years old
* Willing to change at least one lifestyle behavior regarding physical activity, diet, smoking/snus, alcohol, sleep, or stress

Exclusion Criteria:

* diabetes
* heart failure
* history of myocardial infarction
* history of stroke
* pregnancy
Canine-Assisted Profiling of Lung Cancer From Human Breath

The study aims to optimize and define a reproducible and non-invasive method for canine assisted lung cancer detection, using human breath samples from patients and controls for training and testing purposes.


Eligibility Criteria:
Inclusion criteria:

Healthy volunteers, lung cancer or other lung disease.

Exclusion criteria:

Other known malignancy.
Rivaroxaban in Type 2 Myocardial Infarctions

This trial is the pilot phase of a randomized controlled trial to test the feasibility of recruiting patients with a type 2 myocardial infarction and randomizing them to low-dose rivaroxaban to reduce the risk of major cardiovascular events.

This trial is an investigator-initiated prospective, single-center, placebo-controlled, double blinded, pilot randomized controlled trial of low-dose rivaroxaban (2.5mg oral twice daily) for 90-days following a type 2 myocardial infarction. The primary feasibility outcome is time to recruitment of 100 participants, stratified by sex.

Eligibility Criteria:
Inclusion Criteria:

1. Participant age ≥ 65years or \>45 years and an additional risk factor (smoking, diabetes mellitus, hypertension, dyslipidemia or known atherosclerotic disease)
2. Rise in troponin level, with one troponin value above the 99th percentile of the upper limit of normal deemed to be due to a type 2 myocardial infarction by the attending team within the past 30 days
3. Alive at the time of hospital discharge

Exclusion Criteria:

1. Current use of anticoagulation
2. Current use of dual antiplatelet therapy
3. Advanced kidney disease (eGFR \<15ml/min)
4. Previous hemorrhagic stroke at any time or embolic stroke within the past year
5. Previous life-threatening bleeding event
6. Life expectancy less than one year
7. Anticoagulation recommended conditions - atrial fibrillation, pulmonary embolism, deep vein thrombosis, mechanical heart valves, rheumatic mitral valve disease, left ventricular thrombosis
8. Surgery in the previous 30 days
9. Inability to provide informed consent in English
10. Pregnancy, breastfeeding or child bearing potential