cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Sufentanil Administration by Paramedics in Acute Trauma

The safety and efficacy of competence of paramedics to administer sufentanil intravenously in adult acute trauma patients without presence or without phone-call consult with an emergency medical doctor will be assessed in this observational study.

Condition or disease: pain in trauma or injury. Intervention/treatment: sufentanil administered by paramedics after the phone call consultation of medical doctor versus sufentanil administered by paramedics based on their competency, without consultation of medical doctor.

The administration and indication of an opioid analgesics is carried by a medical doctor in most European emergency services. However, trips to majority of less serious traumas are realized by ambulances with paramedic crews without a medical doctor present on site.

This study will assess the new competence of paramedics to administer opioid analgesics without presence or phone-call consult with an emergency medical doctor.

This study will address the safety and efficacy of sufentanil administered by the paramedics in the field to patients with acute trauma without any consultation with medical doctors.

This study will complement the recently published data of the previous study, which, however, took place during the outbreak of COVID-19 and this lockdown situation could have distorted the frequency and nature of the observed cases.

Eligibility Criteria:
Inclusion Criteria:

* acute trauma with severe pain (VAS/NRS \> 4)
* age \> 18 years
* conscious patient (GCS = 15; alert in AVPU)
* haemodynamically stable patient (\> 100mmHg of systolic blood pressure, \> 60/min of heart rate)

Exclusion Criteria:

* EMS doctor on site
* paediatric patient (less than 18 years)
* predominantly chronic but not acute pain
* incomplete documentation
* other than traumatic reasons for opioid administration (eg. acute coronary syndrome)
Manual Therapy for Tension Headache With Psychological Disorders

Introduction. Tension-type headache is a highly prevalent disorder with a significant socio-economic impact, affecting psychological aspects. This study aims to assess aspects pertaining to anxiety, depression, headache frequency and pain intensity.

Subjects and methods. A clinical trial was conducted on 84 participants suffering from tension-type headache, divided into 4 groups, the mean age being 39.76 years (SD 11.38). The first group received suboccipital soft tissue treatment (ST); the second group was treated with articulatory technique (AT); the third group was applied a combination of both techniques (ST and AT) and a forth group which served as control group. Treatment sessions were administered during four weeks, with a post-treatment assessment, and follow-up after one month. The investigators conducted Repeated measures Analysis of Covariance (RM-MANCOVA) to evaluate the effect of treatment on between and within-subject conditions and their interaction on reported depression, anxiety, and headache pain frequency and intensity.


Eligibility Criteria:
Inclusion Criteria:

* Patients participating in this study had been diagnosed in primary healthcare centers with frequent episodic tension-type headache (ETTH) or chronic tension-type headache (CTTH) as described by the International Headache Society (IHS). Participants presented pericranial tenderness evolving over a period greater than six months and all were pharmacologically stable.

Exclusion Criteria:

* Exclusion criteria covered patients with secondary headache suffering from photophobia or phonophobia, nausea or vomiting, cases of headache aggravated by head movements, musculoskeletal disorders, previous neck trauma, vertigo, dizziness, arterial hypertension, arthritis or advanced degenerative osteoarthritis, patients with heart devices, excessive emotional tension, neurological disorders, radiological alterations, pregnancy and a positive vertebral artery test.
Cinnamon and Withania on Weight Loss

With the prevalence of obesity soaring and the absence of an effective and safe treatment that is low-cost and always feasible, the use of food supplements has gained attention for the potential benefits in the absence of significant safety concerns. Cinnamon (CC) and Withania somnifera (WS) are plant-based supplements reported to be effective in improving metabolic health and body composition, the first mainly acting on insulin resistance and the second on energy expenditure and leptin resistance, as shown in preclinical and some clinical studies. Their association, possibly synergistic leveraging different mechanisms of action, has never been studied.

This was a double-blind placebo-controlled study. Patients with overweight or obesity were prescribed a mildly hypocaloric diet with CC 300 mg plus WS 150 mg tid for 4 weeks in a cross over design and anthropometric parameters together with safety outcomes were collected.


Eligibility Criteria:
Inclusion Criteria:

* age range: 25-75 years
* overweight or obesity (BMI range: 26-35)

Exclusion Criteria:

* heart failure
* congenital cardiomyopathies
* episodes of tachy/brady-arrythmias
* acute myocardial infarction within 3 months from the enrollment
* inability or unwillingness to provide informed consent
* pregnancy
Duragen Versus Duraguard in Chiari Surgery

The study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured during application. The study compares these two materials used for duraplasty of patients undergoing Chiari surgery in a prospective randomized fashion to check the rate of surgical complications associated with each material, patient's outcomes, length of surgery and the hospital stay, etc.

The study is aimed at comparative analysis of two frequently used duraplasty materials: one is made out of bovine pericardium, and the other - from bovine collagen derived from bovine achilles tendon. Both materials are routinely used form this intervention (duraplasty), but the question of superiority of one over the other remains open. This study follows patients with Chiari malformation from the time of surgery to the time of their discharge from the hospital and then another 3 months of follow up care.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Chiari malformation

Exclusion Criteria:

* Presence of ventriculoperitoneal shunt
* Pregnancy
RAPID-RF: Remote Active Monitoring in Patients With Heart Failure

The RAPID-RF Registry aims to characterize LATITUDE® Patient Management's alert feature: LATITUDE Active Monitoring™ by evaluating type and frequency of alert notifications and alert-related medical interventions. This registry will also assess clinical outcomes including quality of life and New York Heart Association Class changes over time, mortality, hospitalizations and heart failure-related event rates.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meet current indications for a Guidant RF-enabled CRT-D device (e.g. CONTAK RENEWAL 3 RF family of CRT-D devices) which is compatible with the LATITUDE Communicator. Indications include: NYHA Class III, IV; EF of ≤ 35%; QRS duration of ≥ 120 ms; and optimized pharmacologic therapy
* Patients who have an analog telephone line compatible with the LATITUDE Communicator. The LATITUDE Communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
* Patients who receive the study components including the LATITUDE Communicator, weight scale, and blood pressure monitor
* Patients who are willing and capable of providing informed consent prior to implant and willing to participate in the RAPID-RF Registry
* Patients who remain in the clinical care of a RAPID-RF investigator at approved centers

Exclusion Criteria:

* Patients who are expected to receive a heart transplant during the course of the study
* Patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
* Patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular ICD)
* Patients whose life expectancy is less than 12 months
* Patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the RAPID-RF Registry. Contact Guidant's Clinical Application Research Study (CARS) department to determine eligibility.
* Patients who are younger than 18 years of age
* Patients who are pregnant or plan to become pregnant during the study
* Patients who are unable or refuse to comply with the protocol requirements
The Effects of Whole Versus Processed Orange Consumption on Satiety

This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.

This is a human dietary intervention study that is randomized and crossover in design with 4 treatment arms consisting of control, orange juice,whole orange, and processed whole orange to investigate the satiety effects of the treatments in healthy volunteers. Self reported hunger and fullness scores by Visual Analogue Scale (VAS) form were collected at different time points prior to and post consumption of each treatment.

Eligibility Criteria:
Inclusion Criteria:

* Gender: male or female(postmenopausal women only)
* Age at start of the study: males ≥ 21and ≤ 65 years and females ≥ 50 and ≤ 65 years
* Body Mass Index (BMI) ≥ 18.5 and ≤ 27 kg/m2
* Apparently healthy: measured by questionnaire, no reported current or previous metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet, used to eating 3 meals a day
* Reported intense sporting activities ≤ 10h/w
* Reported alcohol consumption ≤21 units/w
* Informed consent signed
* Recruitment form filled out

Exclusion Criteria:

* Smoking
* Dislike, allergy or intolerance to test products
* Possible eating disorder (measured by SCOFF questionnaire score \>1)
* Eating habits questionnaire score \>14
* Reported medical treatment that may affect eating habits/satiety
* Pre menopausal women
The Molecular Pathogenesis of Late-onset Fuchs' Endothelial Corneal Dystrophy

The purpose of this study is to gain further insights into the molecular pathogenesis of Fuchs' endothelial corneal dystrophy (FECD), to identify targets for potential specific drug therapy.


Eligibility Criteria:
Inclusion Criteria:

* FECD
* normal corneas (including enucleations for uveal melanoma)
* non-FECD oedematous corneas

Exclusion Criteria:

* prior irradiation therapy for uveal melanoma
* corneal extension of uveal melanoma
Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia

The purpose of this study is to determine whether supplementation of compound nutrients,including folic acid, vitamin B6, vitamin B12, betaine and zinc, will decrease the level of plasma homocysteine in Chinese adults with hyperhomocysteinemia.


Eligibility Criteria:
Inclusion Criteria:

1. People aged 18-65 years.
2. The level of plasma homocysteine is 15-100μmol/L.
3. Free from products which could decrease plasma homocysteine for at least one month.
4. Willing to participate in the study, consume the test product and perform all measurements.

Exclusion Criteria:

1. pregnant or lactating women.
2. severe diseases need to control.
3. people who unconsciousness and can not complete questionnaire.
4. long-term regular use of vitamin or mineral supplements.
Lymphedema Treatment Registry

Patients with breast cancer related lymphedema (clinical stage 0-2) will include in this study. Patients will take their demographic and clinical history and will evaluate with measurements of extremity volumes, body mass index, quality of life status and image studies (lymphoscintigraphy, Ultrasonography (USG), Indocyanine Green (ICG) Lymphograph or magnetic resonance imaging (MRI)) before and after the complete decongestive therapy. Outcome measurements such as limb volume, quality of life questionnaire and USG will repeat every 6,12,18, 24 months.

Patients with breast cancer related lymphedema (clinical stage 0-2) will include in this study. Patients will take their demographic and clinical history and will evaluate with measurements of extremity volumes, body mass index, quality of life status and image studies (lymphoscintigraphy, USG, ICG or MRI) before and after the complete decongestive therapy (CDT). Outcome measurements such as limb volume, quality of life questionnaire and USG will repeat every 6,12,18, 24 months.

Group 1: CDT Group 2: CDT + PO ketoprofen +Local ketoprofen gel Group 3: CDT + Local ketoprofen gel

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* Lymphedema more than 6 months
* Lymphedema stage 0-2
* Completed treatment (CT-RT)

Exclusion Criteria:

* Stage 3 lymphedema
* Cardiovasculary disease
* Hepatic disease
* Kidney disease
* Cerebrovascular event
* Metastasis
* Gastritis
* Infection
* Smoking
* Active cancer
* Bleeding history
The Effect of Energy Drink on Cardiovascular Variables: A Randomized Controlled Trial

Many adults in the United States regularly consumer energy drinks. Currently, the safety of energy drinks is still questionable and there are many reports associating energy drinks with adverse events including hospitalizations and deaths. Previous research shows that energy drink can affect heart rhythm and elevate blood pressure. However, these studies use a higher volume (32 ounces) of energy drinks than those available in the market (24 ounces). The purpose of this study is to study if 24-ounce energy drinks can significantly affect heart rhythm and elevate blood pressure when compared to a placebo.

The study is a randomized, double blind, controlled, crossover study comparing the effect of energy drinks and placebo on cardiovascular parameters including heart rhythm and blood pressure.

Subjects who contact the PI for interest in study participation will be scheduled a time to study facility for initial evaluation on eligibility criteria. At initial evaluation, participants will be informed about the study details, presented with Informed Consent Document (ICD), and be asked to sign the appropriate forms voluntarily if they decide to participate. Once consented, participants will be asked a series of questions and screened for blood pressure and heart rhythm parameters to determine eligibility to enroll. If patient is eligible to enroll, they will be allocated a randomized identification number.

Participants will be randomly assigned to consume either two-12 oz bottles of energy drink and two-12 oz bottles of control drink on 2 separate days. The study will occur over approximately 8 days with each session taking about 5 hours per day. Each session will have 6 days between each other.

Participants will be expected to refrain from any products containing caffeine or alcohol 48 hours and fast 10 hours before each study visit. At the beginning of each study visit, baseline measurements of ECG, blood pressures, and heart rate will be obtained prior to consuming study drinks. Repeat measurements will be obtained every 60 minutes after consumption over 4 hours.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female adults 18-40 years old
* Participants must be willing to refrain from caffeine and alcohol use 48 hours prior to each study day
* Participants must be willing to fast 10 hours prior to each study day
* Participants must have health insurance

Exclusion Criteria:

* Corrected QT (QTc) interval greater than 450 milliseconds (ms). QTc will be determined on the ECG obtained during initial screening appointment.
* Blood pressure at initial screening appointment greater than 140/90 mmHg.
* Presence of any known medical condition confirmed through participant interview
* Concurrent use of ANY medication taken on a daily basis, to include herbal products or supplements (exception include oral contraceptives that will be allowed if taking for longer than 1 month)
* Current smokers or those who have smoked any cigarettes within the past month
* Pregnant or currently breastfeeding
Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705

GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects;
* Between the ages of 18-55 years, inclusive
* Body mass index within the range 18.0 to 30.0 kg/m2.
* Non-smokers
* Adequate venous access for intermittent cannulation
* A signed and dated written informed consent is obtained from the subject
* The subject is capable of giving informed consent
* Available to complete the study

Exclusion Criteria:

* Any clinically important abnormality identified in the following: at the screening medical assessment
* A mean QTc(B) value at screening \>450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
* A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
* A mean heart rate outside the range of 40-90 bpm at screening.
* History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
* The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
* The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort.
* The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
* The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
* The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.

This is a single center, investigator initiated study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE).

Women with symptomatic stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to either the laser-arm or the PFE-arm.

There are 3 visits (with a maximum of 6 visits) where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.

The primary objective is to evaluate the effects of VEL treatment for the subjective cure or improvement of SUI.

The secondary objectives are to measure objective outcomes, to register any adverse events, and to determine for how long the effects of laser are sustained, with a maximum of two years.


Eligibility Criteria:
Inclusion Criteria:

* The presence of mild (score 1-2) to moderate (3-6) SUI with wish for treatment. The patient can have concomitant urge urinary incontinence (UUI), but that should not be the leading factor. Incontinence severity will be categorized by the four-level Sandvik severity index score (SIS). Scores are from 0 to 12. The higher the score, the more severe the urinary incontinence (mild=1-2, moderate= 3-6, severe=8-9, very severe=12).
* Voluntary informed consent

Exclusion Criteria:

* Any previous PFE-treatment in the last year for the same problem
* Previous surgery for incontinence or prolapse
* Severe (Sandvik SIS ≥8) SUI or insensible loss, high suspicion of intrinsic sphincter deficiency (ISD)
* Prolapse grade III or more
* Pregnancy
* Vaginal bleeding, injuries or infection in the treated area
Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.

This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate glycemic control on their current sulfonylurea monotherapy to give treating physicians a guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is not sufficient to reach glycemic control.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of type 2 diabetes mellitus.
* Contraindicated or intolerant to take metformin.
* HbA1c of ≥ 7.0% and ≤ 8.5%
* Current sulfonylurea (glimepiride) monotherapy and judged by the investigator to be inadequately controlled
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* Patients who are taking any other anti-diabetes drug (oral or injection) other than an SU component in the preceding 12 weeks.
* Acute metabolic conditions such a ketoacidosis, lactic acidosis or hyperosmolar state within the past 6 month
* Patients taking sulfonylurea for longer than 5 years
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
* pregnancy
* Other protocol-defined inclusion/exclusion criteria may apply
Biomarker Expression in Samples From Young Patients With Anaplastic Large Cell Lymphoma

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

PURPOSE: This research trial studies biomarker expression in tissue samples from young patients with anaplastic large cell lymphoma.

OBJECTIVES:

* To determine the expression of immunoregulatory proteins including CD4, FOXP3 and CD276 in anaplastic large cell lymphoma (ALCL).
* To correlate the expression of these proteins with the levels of anaplastic lymphoma kinase (ALK) autoantibodies in patient of ANHL0131.

OUTLINE: Archived tissue microarray samples are analyzed by mass spectrometry and validated by Western blotting, flow cytometry, and IHC.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of anaplastic large cell lymphoma
* Tissue microarray samples available from the Cooperative Human Tissue Network (CHTN)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified