cyrilzakka/clinical-trials huggingface dataset:
Early EUS in Acute Biliary Pancreatitis

Acute biliary pancreatitis (ABP) is a potentially life-threatening condition caused by common bile duct (CBD) stones or sludge, which requires prompt diagnosis and treatment by endoscopic removal of the material. Accurate detection of CBD stones is warranted to select patients for early therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

In clinical practice the decision to perform an ERCP is often based on biochemical and radiological criteria despite they already have been shown to be unreliable predictors of CBD stone presence.

Endoscopic ultrasound (EUS) is not currently a worldwide standard diagnostic procedure early in the course of acute biliary pancreatitis, but it has been shown to be accurate, safe and cost effective in diagnosing biliary obstructions compared with magnetic resonance cholangiopancreatography (MRCP) and ERCP and therefore in preventing unnecessary ERCP and its related complications.

The investigators aim to investigate the clinical usefulness of early EUS in the management of ABP.

All consecutive patients entering the emergency department due to acute abdominal pain and showing biochemical and/or radiological findings consistent with possible ABP will be prospectively enrolled. Patients will be classified as having a low, moderate, or high probability of CBD stones, according to established risk stratification. All enrolled patients will undergo EUS within 48 h of their admission. ERCP will be performed immediately after EUS only in those cases with proven CBD stones or sludge.

The following parameters will be investigated: (1) clinical: age, sex, fever; (2) radiological: dilated CBD, (3) biochemical: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (gGT), alkaline phosphatase (ALP), amylase, lipases, C-reactive protein (CRP). Association between presence of CBD stone at EUS and the individual predictors were assessed by univariate logistic regression. Predictors significantly associated with CBD stones (p\<0.05) will enter in a multivariate logistic regression model.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients entering the emergency department for possible acute biliary pancreatitis

Exclusion Criteria:

* gastrectomy
* patient in whom the cause of biliary obstruction was already identified by US
Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits

The aim of the current report is to investigate the feasibility of transferring the free dorsal digital flap, including both dorsal branches of the proper digital nerves (PDNs), to reconstruct the volar soft tissue defect of digits. Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured.

Sensory restoration of the reconstructed digit was evaluated via static two-point discrimination (2PD). The range of motion (ROM) of the donor middle and ring fingers was measured. The data were compared with those of the contralateral, uninjured hand.

Eligibility Criteria:
Inclusion Criteria:

1. soft tissue defects in the fingertip, pulp, or volar surface of the digits;
2. a defect \> 2 cm in length;
3. unavailability of the homodigital and heterodigital island flaps because of concomitant injuries to donor fingers; and
4. the patient refuses to use tissues from the toe.

Exclusion Criteria:

1. soft tissue defects in the dorsum of the digits;
2. a defect \< 2 cm in length;
3. homodigital and heterodigital island flaps are available.
Lifestyle Intervention in Obstructive Sleep Apnoea

Obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a common disorder characterised by interrupted breathing while sleeping. It is associated with cardiovascular problems such as high blood pressure, heart attack and stroke. Furthermore, most patients with OSAHS are overweight and have impaired quality of life. Lifestyle interventions incorporating exercise training, dietary advice and behaviour change have been shown to elicit favourable changes in quality of life, body mass/composition and cardiovascular risk in a range of patient groups. However, no study has investigated the impact of lifestyle modification on such health outcomes in patients with OSAHS. This study will address this issue by investigating the effects of a lifestyle intervention on quality of life, body mass/composition and cardiovascular risk in patients with OSAHS. A total of 60 volunteers will be recruited and randomly allocated to one of the two groups. Patients in the intervention group will be offered a 12-week individualised lifestyle programme consisting of supervised exercise training, dietary advice and behaviour change counselling. Patients in the control group will receive an educational booklet detailing healthy eating and exercise guidelines but no supervised or structured intervention. The results of this study will inform the design of a larger, multi-centre randomised controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* obstructive sleep apnoea patients who have been receiving CPAP therapy for at least 6 months and are known to be adherent to the treatment (\>75% nightly use per week)
* clinically obese (body mass index \>30)
* age 18-85 years
* able to undertake exercise testing and training

Exclusion Criteria:

* patients with any contraindications to exercise (e.g. severe hypertension, unstable arrhythmias, severe musculoskeletal injuries)
* unable to undertake the requirements of the study
* non-English speaking
* already undertaking \>30 min exercise \>3 times per week
* non-compliant with CPAP
* body mass index \<30
* unable to provide written informed consent
Shotgun Mass Spectrometry-based Lipid Profiling in Chronic Inflammatory Diseases

Collect blood from patients admitted for coronary angiography to tubes with heparin, centrifuge and collect plasma. This will be frozen at -80C. Sent to the Lipotype laboratory, Dresden, Germany, for the detection and quantification of compounds derived from oxidized LDL cholesterol (cholesterol hemi-esters).

Plasma samples were obtained from a total of 427 individuals. Baseline characteristics are outlined in Table 1. Control (n = 85) were taken from the population of the Coimbra and Lisbon, Portugal, regions. They satisfied the criterion that they had never had any CVD- or SLE-related health complaints. The CVD patients (n = 238) were divided into 6 groups. CVD1 (n = 61) contains individuals who went to the hospital with chest pain but had no indicators for stable angina pectoris, unstable angina pectoris or myocardial infarction. CVD2 (n = 82) are patients with stable angina pectoris (SAP). CVD1 and CVD2 are defined according to the ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guidelines. CVD3 (n = 20) contains patients with unstable angina pectoris, CVD4 (n = 34) are patients who suffered an acute myocardial infarction with no ST-elevation in ECG, and CVD5 (n = 20) are patients who suffered acute myocardial infarction with ST-elevation in ECG. CVD3, CVD4, and CVD5, together, may be classified as patients with an acute coronary syndrome (ACS). CVD1 through CVD5 groups were all obtained from Hospital Santa Cruz, Carnaxide, Portugal. Acute ischemic stroke (IS) (n = 21) were patients admitted at the emergency room of the Centro Hospitalar de Lisboa Ocidental, Lisbon, Portugal, who suffered from acute ischemic stroke. The SLE cohort (n = 104) were patients from Hospital Dr. Fernando Fonseca, Amadora, Portugal. The inclusion criteria were all patients diagnosed with the pathology and above 18 years old. The exclusion criteria were the existence of serious renal and hepatic pathologies, cancer or existence of infectious diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for coronary angiography due to suspected coronary disease (silent ischemia, stable angina and acute coronary syndromes)

Exclusion Criteria:

* Patients unable to give informed consent
Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions

The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy cooperative children
* Aging from 3-5 years old child
* Both genders
* Primary teeth with active WSLs on buccal or labial surfaces
* Patient and parent acceptance to treatment and maintenance of good oral hygiene

Exclusion Criteria:

* Restored teeth
* White spot lesions due to fluorosis
* Teeth with hypoplasia
* Lesions that require an invasive treatment
* Any pathology or concomitant medication affecting salivary flow or causing dry mouth
Effects of Home Based Stabilization and Kegel Exercises on Postnatal Females

To compare the effects of home based stabilization exercises and kegel exercises on low back pain, disability and quality of life in postnatal females.


Eligibility Criteria:
Inclusion Criteria:

* Cesarean delivery.
* Multi gravida females.
* Postpartum low back pain last for 1 year

Exclusion Criteria:

* Low back pain before pregnancy.
* Urogenital infections.
* History of pelvic floor or lumber surgery.
* Malignancy.
* Pelvic or lumber fractures
Functional Assessment and Muscle Evaluation Through Exercise Trial

The purpose of this study is to decrease rates of urinary incontinence in older women by building strength in the pelvic and lower body muscle through exercise and rehabilitation.

This study will provide data on benefits of combination the multimodal strengthening and aerobic conditioning rehabilitation program with pelvic floor muscle training and will help to characterize changes in pelvic floor and lower extremity muscles in older women with urinary incontinence.

The study focuses on a patient-centered approach to improve overall physical function in older women. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from pelvic floor muscle training. We anticipate that this approach will decrease rates of urinary incontinence because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women.

The study will evaluate the pathophysiology of urinary incontinence in older women through evaluation of pelvic floor and lower extremities muscles with an innovative MRI protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Women ≥ 65 years older
2. Symptomatic UI
3. Symptoms ≥ 3 months
4. Episodes of UI on 3-day bladder diary
5. Stress, urgency, and mixed UI

Exclusion Criteria:

1. Women unable to have functional assessment and/or complete bladder diary
2. Impaired mental status (MMSE \<25)
3. Post-void residual ≥ 150 ml
4. Non-ambulatory (wheelchair bound), unable to complete mobility assessments
5. Hematuria
6. Urinary tract infection
7. Continuous Incontinence
8. Pelvic Organ prolapse \> stage 2
9. Fecal impaction (no BM within 1 week), severe congestive heart failure (leg swelling edema 2+), uncontrolled diabetes (positive urine glucose Dipstick test)
10. Women with significant neurological or musculoskeletal conditions that compromise mobility (stroke, multiple sclerosis, amyotrophic atrophic lateral sclerosis, severe rheumatoid arthritis)
11. Women with contraindications to undergo MRI including claustrophobia.
Study to Assess MEDI -578 in Patients With Osteoarthritis (OA) of the Knee

The purpose of this study is to evaluate the safety and tolerability of a single intravenous dose of MEDI-578, a monoclonal antibody, in patients with osteoarthritis of the knee. It will also be evaluated how MEDI-578 is absorbed and distributed through the body.


Eligibility Criteria:
Inclusion Criteria:

* Patients with painful osteoarthritis of the knee.
* The pain from the knee must exceed pain experienced from any other condition.
* Patients must be willing and able to discontinue all current analgesic treatment.

Exclusion Criteria:

* Any other form of arthritis than osteoarthritis.
* Presence of neuropathic pain, or fibromyalgia, or wide spread chronic pain not related to osteoarthritis.
* Significant abnormalities on the clinical examination that may interfere with the study or present a safety risk to the patient, as judged by the investigator.
Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.


Eligibility Criteria:
Inclusion Criteria:

* Given written informed consent
* Healthy male and female subjects. Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure (systolic ≤140 mmHg, diastolic ≤90 mmHg), pulse rate (within 45-95 bpm), ECG assessment, and clinical laboratory results
* Body mass index (BMI) between ≥18 and ≤28 kg/m², and a body weight ≥60 kg

Exclusion Criteria:

* History or current evidence of specified diseases
* History of malignancy in the past 5 years
* Gain or loss in body weight of more than 5% within the last 2 months or use of weight-loss medication within the last 3 months
* ECG abnormalities of clinical relevance
* Suspected hypersensitivity to the trial medication
* Positive virology tests indicating acute or chronic infections
* Clinically relevant laboratory parameters outside a specified range
* Use of specified medications within certain time frames or use of certain co-medications
* Abuse of alcohol or drugs
* Dietary habits that would prevent from taking standardised meals
* Female subjects: positive pregnancy test; lack of medically reliable methods of contraception during the trial
* Donation of blood
* Smoking within the last 3 months
Pneumatic Compression Stockings During Hemodialysis

This study aims to determine the effect of pneumatic compression devices (PCDs) on central blood volume in hemodialysis patients. We hypothesize that PCDs will help maintain central blood volume, and therefore prevent sudden decreases in blood pressure during hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* on hemodialysis at least 3 months
* on hemodialysis at least 3 times per week

Exclusion Criteria:

* dialyzing with a central venous catheter
* vascular access dysfunction
* peripheral vascular disease
* active medical issue
* unable to provide informed consent
Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects

1. Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects.
2. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects.
3. Evaluate the potential effects of repeat doses of varenicline on cognition in healtly non-smoking elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

Healthy, Elderly (65-85 years inclusive), Non-smoker

Exclusion Criteria:

Creatinine Clearnace \< 30 ml/min, Evidence or history of clinically significant, unstable diseases
Virtual Reality Videos in Improving Bowel Preparation Quality of Colonoscopy

Colonoscopy is the most important method to screen for colorectal cancer and precancerous lesions, whose efficacy is closely related with the quality of bowel preparation, requiring consuming purgatives and restricting the diet. Compliance to bowel preparation is highly dependent on patient education. In most cases, such education is offered only once at the time of colonoscopy scheduling by either oral or written instructions. However, about one in fourth patients still cannot achieve satisfactory bowel preparation quality. Various methods, including booklet, telephone or message reminders, smartphone applications, social media, online videos, have been used to aid patient education and prove effective. These methods can increase patient activation, which is an independent factor related to bowel preparation quality. Virtual reality(VR) videos are used in this study, giving patients direct impressions of colonoscopy. This study aims to explore whether VR videos can increase patient adherence and experience, as well as improve bowel preparation quality, compared with conventional patient education methods.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients indicated for elective colonoscopy: 1) For screening purposes: asymptomatic patients with average or high risk for colorectal cancer\[1\]; 2) For diagnostic purposes: patients presented with abnormal imaging or lower gastrointestinal symptoms including bloody stool, chronic diarrhea and abdominal pain\[2\].
* Never undergo colonoscopy before.
* Age 18-75 years.
* Written informed consent.

Exclusion Criteria:

* History of bowel surgery
* Comorbidity disorder (ascites, congestive heart failure, chronic renal failure, coronary vessel disease within the last 6 months)
* Drug use (eg, constipation drugs, laxatives, or anti-diarrheal agents)
* Pregnancy
* Severe constipation (\<3 bowel movement/week)
* Inflammatory bowel disease
* Unable to watch VR videos (eg, blindness)
A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects

An open label study to evaluate an interaction between maraviroc and raltegravir in healthy subjects.

Drug interaction study

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between 18 and 55 years of age.

Exclusion Criteria:

* Evidence or history of clinically significant disease or clinical findings at screening
Safety and Efficacy Study of Angiotech Central Venous Catheter to Prevent Bacterial Catheter Colonization

The main purpose of this study is to determine if the Angiotech central venous catheter (CVC) is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing bacterial catheter colonization. Other objectives of this study are to determine if the Angiotech CVC is equal in effectiveness to a CVC coated with chlorhexidine and silver sulfadiazine in preventing catheter-related local infection, and catheter-related bloodstream infection. This study will also assess the safety of the Angiotech CVC.

Central venous catheters are widely used for hemodynamic monitoring and the administration of fluids, drugs, and nutrition. The most frequent life-threatening complication of central venous catheter use is septicemia. Normal cutaneous flora may invade the intracutaneous tract during or after catheter insertion. The colonizing bacteria subsequently disseminate along the catheter surface and ultimately seed into the blood stream.

In the United States, a total of 250,000 cases of central venous catheter-related infections are estimated annually. Costs per infection are estimated as high as US$56,000. It is clinically imperative that effective measures be found to decrease catheter infection rates while minimizing the risk of the development of microbial resistance.

Primary Objective: The primary objective of this study is to determine the non-inferiority of the Angiotech Central Venous Catheter (CVC) when compared to the ARROWgard Blue® CVC to prevent bacterial catheter colonization.

Secondary Objectives: The secondary objectives of this study are to determine the non-inferiority of the Angiotech CVC when compared to the ARROWgard Blue® CVC to prevent:

1. catheter-related local infection; and
2. catheter-related bloodstream infection.

Safety Objectives: This study will assess the safety of the Angiotech CVC.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* Be initially hospitalized in an intensive care setting
* Require insertion of a triple-lumen central venous catheter for an anticipated period of up to 28 days
* If female and of child-bearing potential, provide evidence of a negative pregnancy test

Exclusion Criteria:

* Has a life expectancy of less than one month
* Is pregnant
* Has a history of anaphylactic reactions, including reactions to contrast dyes
* Has a history of allergy to 5-fluorouracil (5-FU) or chlorhexidine
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants

To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals' Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly administered with Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), with respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP) after a three-dose primary vaccination course.

Randomized study with five groups to receive one of the following vaccination regimens: One of the three formulations of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups) GSK Biologicals' Tritanrix™-HepB + GSK Biologicals' Hiberix™ GSK Biologicals' Tritanrix™-HepB mixed with GSK Biologicals' Hiberix™ + Wyeth Lederle's Meningitec™

Eligibility Criteria:
Inclusion Criteria:

* Healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (OPV).
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Hepatitis B and Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or meningococcal disease with the exception of a birth dose of hepatitis B vaccine.
Psychological Impact of COVID19 Among Women Undergoing Infertility Treatment

In France, one couple in eight encounters difficulties to conceive. The diagnosis of infertility frequently leads to symptoms of anxiety and depression. These symptoms appear to be higher than in the general population.

Some recent studies have looked at the relationship between anxiety and depression in ART cares.

Results are controversial, but it appears that patients with lower levels of anxiety and depression have higher pregnancy rates. Moreover, in couple, women seem to have more symptoms of anxiety and depression than men.

First epidemiological studies related to the COVID 19 pandemic have shown strong psychological impact on the general population with an anxiety rate estimated at more than 30%.

With COVID 19 pandemic and cessation of ART, it is highly likely that psychic symptoms of anxiety or even depression may have appeared or worsened in women undergoing infertility treatment.


Eligibility Criteria:
Inclusion Criteria:

* Consulting the center between 01/01/2020 to 12/31/2020
* Email address in the medical records
* All causes of infertility

Exclusion Criteria:

* Women followed for:
* Preservation of fertility
* Oocyte donation
* Women who do not speak or read French