cyrilzakka/clinical-trials huggingface dataset:
Description of Septic Thrombophlebitis on Central Venous Catheter and Midline

Central venous catheters improve the tolerability and feasibility of patient care in the hospital setting by allowing the administration of hyper-osmotic, vesicant and venotoxic fluids. Despite these advantages, the long-term presence of central venous catheters is associated with thrombotic and infectious risks , including catheter-related bacteremia, which can be complicated by septic thrombophlebitis and endocarditis that can lead to death.

Septic thrombophlebitis is a complication of venous catheter infections, which increases the morbidity. It is defined by the presence of a thrombosis in the vein where the venous catheter is located, associated with a bacteremia. A distinction is made between superficial and deep thrombophlebitis.

The frequency of septic thrombophlebitis of venous catheters is variable and poorly described in the literature.

When the diagnosis of septic thrombophlebitis is made, it is recommended to extend the duration of antibiotic therapy, to remove the infected catheter and to prescribe anticoagulant treatment. However, there is no recommendation on the duration of anticoagulation for septic thrombophlebitis, whether it is deep or superficial.

Investigator proposes a prospective and descriptive interventional study to describe the ultrasound evolution of thrombus in patients with septic thrombophlebitis on central venous catheter and midline.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient hospitalised at the CHM or CHUA, with a central venous device (Implantable chamber, central venous jugular, femoral, subclavian, PICCline, dialysis catheter) or a Midline and having catheter-related bacteremia
* Catheter-related bacteremia according to the following definition (ePOPI): Positive blood cultures within 48 hours of a suspected catheter infection (or its removal) With one of the following criteria: - Before catheter removal: differential time of positivity of central/peripheral blood cultures ≥ 2 hours
* After catheter removal: positive catheter culture ≥ 103 CFU/ml, with the same organism.
* Patient transportable for ultrasound or ultrasound can be performed in the patient's bed
* Patient capable of giving consent, or consent of the trusted person for patients not capable of giving consent at the time of inclusion
* Written consent signed by the participant and the investigator
* Person affiliated to social security

Exclusion Criteria:

* Patient with a life expectancy of less than one month
* Contraindication to anticoagulation
* Patient already on curative anticoagulant therapy for any indication
* Minor or adult patient under guardianship or protected or deprived of liberty
* Pregnant, nursing or parturient woman
Antimicrobial Stewardship in UTIs in Nursing Homes

Background: The widespread inappropriate use of antimicrobial substances drives resistance development at the individual and population level all over the world. In long-term care facilities (LTCF), antibiotics are among the most frequently prescribed medications. More than one third of antibiotics prescribed in LTCFs are for urinary tract infections (UTI). Studies have shown that 30 - 40% of antibiotic courses prescribed in LTCFs were unnecessary and that more than two-thirds were inappropriate based on society guidelines.

Preliminary data: A surveillance study on healthcare-associated UTIs at LTCFs of the Geriatric Health Centers Graz revealed that guideline recommendations on antimicrobial choice were met in only 50% of patients. The most frequently used antimicrobial substances for UTI were quinolones.

Aims: Using a multifaceted bundle of antimicrobial stewardship interventions consisting of clinical practice guidelines, care pathways and local as well as web-based education and training targeting nursing staff as well as physicians we aim to improve the quality of antimicrobial prescriptions for UTIs in four LTCFs in Graz, Austria.

Design: Non-randomized cluster controlled intervention study. Setting: The Geriatric Health Centers Graz are a local institution comprising among others 4 LTCFs (total of 400 beds). These will serve as intervention group. Four LTCFs located in the surroundings of Graz will serve as control group.

Intervention: The main components of the intervention are 1) two sessions of voluntary continuing medical education on the urinary tract infection program in each LTCF for physicians and nursing staff, 2) distribution of educations materials such as written guidelines on antibiotic prescribing including a smart phone friendly version, 3) implementation of the project homepage as a platform to distribute guidelines and educational videos and to enable physicians to ask questions which will be answered by an infectious disease physician.

Outcomes: The primary outcome will be the proportion of adequate prescriptions (adequate in terms of antimicrobial choice). Secondary outcomes include proportion of adequate prescriptions (adequate in terms of decision to treat), number of cases with clinical failure, number of admissions to hospital due to UTI, number of adverse events attributed to antimicrobial treatment for UTI, percentage of extended spectrum betalactamase (ESBL) producing enterobacteria isolated from urinary cultures


Eligibility Criteria:
Inclusion Criteria:

* residents living in the participating long term care facilities who experience urinary tract infections (UTI)

Exclusion Criteria:

* residents without UTI
Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery

This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for pseudomyxoma peritonei (PMP) with predicted intraoperative blood loss of greater than or equal to (\>=) 2 liter (L). Eligible participants will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cryoprecipitate.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>= 18 years at the time of providing written informed consent.
* Diagnosis of PMP requiring CRS with HIPEC.
* Bleeding risk: Predicted intraoperative blood loss of \>=2L, assessed within 60 and 100 mins after start of study surgery (assessment made before 2 L of blood is lost)

Exclusion Criteria:

* Confirmed or suspected congenital or acquired coagulation disorder or a prothrombotic disorder
* Myocardial infarction, acute coronary syndrome, or stroke within 2 months before study surgery.
* Known history of chronic hepatitis.
* Clopidogrel or ticagrelor administration within 5 days before study surgery.
* Prasugrel administration within 7 days before study surgery.
* Oral factor Xa inhibitor administration within 2 days before study surgery.
* Glycoprotein IIb / IIIa antagonist administration within 24 hours before study surgery.
* Oral direct thrombin inhibitor administration within 3 days before study surgery.
* Vitamin K antagonists within 5 days before study surgery.
A High School Program for Preventing Prescription Drug Abuse

This project will develop and evaluate a program to prevent prescription drug abuse in high school students

This Fast-Track SBIR project is designed to address the critical need for an effective primary prevention approach for prescription drug abuse (PDA), an urgent public health crisis in the United States. The project involves developing and testing an innovative new approach to the primary prevention of PDA among high school students utilizing e-learning and small group facilitator-led intervention modalities. The intervention is an adaptation of the evidence-based substance abuse prevention approach called Life Skills Training (LST). The adapted intervention will address the relationship between PDA and alcohol, tobacco and other drug (ATOD) use and abuse; positively change social norms surrounding ATOD and PDA; discourage diversion of prescription medications; enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios.

Eligibility Criteria:
Inclusion Criteria:

* High school aged-youth

Exclusion Criteria:

* Significant cognitive impairment or severe learning disabilities, as screened by field staff at participating sites
Effect of Maternal Heart Sound on Crying Time and Pain Level in Newborns During Heel Blood Collection

This study was carried out to determine the effect of maternal heart sound listened to by newborns during heel blood collection on pain level and crying time.

The randomized controlled and experimental study was conducted with 60 newborns applied to a public family health center for heel blood collection. The infants in the experimental group (n=30) were listened to the maternal heart sound before, during, and after the heel blood collection procedure, and routine blood collection was applied to the control group (n=30). Newborn Information Form and Newborn Infant Pain Scale (NIPS) were used to collect data.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 38-41 weeks,
* Chronological age of 2-28 days,
* Without any physical, metabolic or genetic disease,
* Newborns who did not use any analgesic drugs before the procedure

Exclusion Criteria:

* Newborns whose heel blood cannot be taken at once
Effect of Rewarming Rate During Cardiopulmonary Bypass on Clinical Prognosis of Infants Undergoing Cardiac Surgery

The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.

There have been many studies indicating that rewarming management plays an important role in cardiac surgery. The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in patients undergoing cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are randomly assigned to either a slow rewarming strategy (0.24 degrees C/min) or a fast rewarming strategy (0.5 degrees C/min).

Eligibility Criteria:
Inclusion Criteria:

* Infants who had underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* Preoperative liver or kidney disease or dysfunction
* Preoperative coagulation disorder
* Palliative operation or a second operation
* Above 3 years
Awareness on Cancer in Persons With Intellectual Disabilities

Context People with intellectual disability (PWIDs), nearly 1,300,000 adults and children in France, develop as many cancers as persons in the general population. However, their tumors are different by their particular organ distribution, the age of onset, the biological background (2,000 genetic conditions are associated with an intellectual disability) and above all the unusual clinical presentation. These cancers are not well known from physicians, carers and families, and often discovered late. A recent review of the literature shows many inequalities in the prevention, monitoring, screening, diagnosis and treatment of cancer in these patients. Currently, no population study on clinical features and stage at diagnosis of cancer in PWIDs is available. No interventional research study has been conducted on this subject.

Hypothesis Investigators hypothesize that inequalities in cancer care of PWIDs do not result from a direct link between intellectual disability and cancer, but are related to diagnosis difficulties of these tumors which are not well known, and to difficulties of communication with these patients who do not express easily their symptoms, particularly pain.

The study will first evaluate characteristics of all cancers diagnosed in PWIDs in the department of Hérault (20,000 PWIDs) during the four-year period preceding the intervention. Investigators will cross the data of social network of PWIDs (CREAI Languedoc Roussillon) which covers nearly 90% of PWIDs living in this area, and the Hérault Cancer Registry. Second, during a two-year information program, physicians, mainly general practitioners, carers in and outside institutions, associations and families will be informed on cancer frequency, on cancer particularities and on cancer detection in PWIDs by the mean of documents, mails and e-mails, meetings and a website providing all available useful information on cancer in PWIDs. Third, characteristics of tumors observed during the three years after the beginning of the intervention will be statistically compared to the corresponding tumors before the intervention. This will be done especially for colon cancer and breast cancer using the TNM stage and the used therapeutic means. On the basis of the first part of the study, if a significant difference on stage at diagnosis and treatment is observed compared to the general population, other tumors will also be included in the comparison, if relevant.

Eligibility Criteria:
Inclusion Criteria:

* Persons with intellectual disabilities according to the World Health Organization definition
* Residing in the Hérault department of France
* Diagnosis of a malign invasive or in-situ tumor

Exclusion Criteria:

* Refusal of study participation following provision of information (refusal by the patient, or his/her guardian, or principal caregiver)
Pain Reduction After Cholecystectomy

To determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 mL 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.

The primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (VAS), using a VAS lineal with a slide. The patient was asked to indicate a score from 0 to 100 corresponding to his or her pain. At 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the VAS scores.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 80
* ASA I or II
* with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy

Exclusion Criteria:

* acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer,
* a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs
* pregnancy
* patients suffering from hypotension or hypovolemia
* infectious liver disease
* conditions obstructing adequate pain scoring
* patients using drugs that deduce function of the CYP3A4 or CYP1A2 system
* patients having an American Society of Anaesthesiologists (ASA) classification of three or higher.
Hearing Aid Processing and Working Memory in Realistic Spatial Conditions

The goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). We anticipate the outcomes of this study to be applicable to realistic listening conditions.

Hearing aids have specialized features to improve access to sounds for the hearing-impaired listener. The choice of appropriate hearing aid settings is integral to the hearing rehabilitative process. Researchers and clinicians have been influenced by previous work showing that individual cognitive abilities, including working memory, are associated with hearing aid benefit, especially in adverse listening conditions. However, previous research is limited to omnidirectional microphone settings and unrealistic listening conditions. Such conditions fail to recognize that most hearing aids are fit with directional processing that may improve the listening environment, and that typical environments contain speech and noise signals in a range of spatial locations. Therefore, the broad goal of this research is to understand how patient variables interact with hearing aid signal processing in realistic listening conditions in order to effectively treat hearing-impaired individuals in communications situations that are most important to them.

Eligibility Criteria:
Inclusion Criteria:

* \> =18 years of age; any sex
* Sensorineural hearing loss with pure-tone thresholds between 25-70 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
* Speak English as their primary language
* Normal or corrected-to-normal vision (\<=20/50)
* Participants will be in good health (self-report)

Exclusion Criteria:

* Clinically significant unstable or progressive medical conditions
* Participants who score \< 23 on the cognitive screening test (Montreal Cognitive Assessment)
* Evidence of conductive hearing loss or middle ear issues
* Significant history of otologic or neurologic disorders
* Evidence of significant asymmetry between ears
* Non-English-speaking or non-native English speaking
A Study of MET233 in Combination With MET097 in Individuals With Obesity or Overweight With or Without Diabetes

This study is designed to test how well the combination of MET233 with MET097 works to treat individuals with obesity or overweight with or without diabetes.

This is a randomized, placebo-controlled, double-blind, double-dummy study to investigate the safety, tolerability, PK, and PD of subcutaneous (SC) doses of MET233 co-administered with MET097 in adult participants with a BMI of 27 to 38 kg/m2, including some participants with T2DM. For Part A, after the up to 4-week screening period, the study includes 1 dose and a 12-week safety follow-up after administration. For Part B and Part C, after the up to 4-week screening period, the study includes 5 once-weekly doses and an approximately 11-week safety follow-up after the last administration. Parts A and B will include only participants with overweight or obesity without type 2 diabetes. Part C will include participants with overweight or obesity who also have type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥27 kg/m2 and ≤38.0 kg/m2 (inclusive) at screening
* For participants in Part A and B, no history of clinically significant diseases or clinically significant findings from the physical examination. For participants in Part C, no clinically significant diseases except T2DM, well controlled hypertension, and/or dyslipidemia.
* For participants in Part C, diagnosed with T2DM for at least 3 months before screening.
* For participants in Part C, T2DM includes glycated hemoglobin (HbA1c) value ≤10.5% at Screening and treated with stable therapy for at least 30 days prior to Screening/Visit 1.

Exclusion Criteria:

* Female who is lactating or who is pregnant according to the pregnancy test at Screening or on Day 1.
* Seated blood pressure higher than 160/100 mmHg at the Screening visit or prior to the first study drug administration.
* Elevated resting pulse greater than 100 beats per minute at Screening visit or prior to the first study drug administration.
* Estimated glomerular filtration rate (eGFR) \<80 mL/min at the Screening visit.
* Diagnosis of Type 1 diabetes.
* For Part A and Part B: Diagnosis of T2DM or glycated hemoglobin (HbA1c) \> 6.4% or fasting plasma glucose \>126 mg/dL at the Screening visit or history of taking any medications to lower glucose.
* For Part A and Part B: Participant reported weight-related comorbidity, including sleep apnea and cardiovascular disease.
* History of bariatric or weight loss surgeries.
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome.
* Lifetime history of acute or chronic pancreatitis or pancreatic cancer.
* Participation in a weight loss program with or without pharmacotherapy during the 3 months prior to study administration or plans to do so.
Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study

The study will investigate the effect of PL-56 on albumin leakage and renal function (glomerular filtration rate) in patients with IgA nephropathy. It will also assess the safety of treatment with PL-56.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Female or male patient \> 18 years
* Biopsy-verified IgA nephropathy
* Proteinuria: U-albumin \>500 mg/24 h
* S-creatinine \< 200 umol/L
* A minimum of four available sample results (U-albumin and S-creatinine) prior to inclusion in the study.

Exclusion Criteria:

* Severe gastrointestinal disorders which may impair drug effect, or other conditions which could modify the effect of the trial drug as judged by the investigator
* Consumption of an investigational drug within 30 days prior to enrolment
* Unacceptable blood pressure (treated or untreated), defined as a systolic value \>150 mm Hg and/or diastolic \>90 mm Hg
* Hyperlipidaemia defined as unacceptable levels of lipids according to the discretion of the Investigator
* Patients in whom an ACE inhibitor was introduced/changed during the last three months prior to enrolment
* Patients treated with immuno-suppressive drugs
* Patients unable to take oral medication
* Severe liver disease (defined as ASAT and/or ALAT and/or gamma-GT above twice the normal value).
* Uncontrolled (treated or untreated) congestive heart failure as judged by the Investigator
* Patients with diabetes
* Patients with current malignancy or history of malignancy during the last three years
* History or presence of psychological or psychiatric illness which may interfere with the patient´s ability to adhere to the protocol
* Alcohol or drug abuse (present)
* Patients unwilling to meet the requirements of the protocol
* Other medical or social reasons for exclusion at the discretion of the Investigator
* Use of drugs inhibiting the cytochrome P-450 enzyme CYP3A4 (including grape fruit juice)
* Kidney transplanted patients
* For women only: pregnant or breast feeding; unwilling to use adequate contraception during the study (only women of childbearing potential)
The Evaluation of a School Climate Videogame Intervention

A randomized control trial of a videogame intervention to assess and improve school climate.

To assess the acceptability and preliminary efficacy of a videogame intervention designed to teach teens the skills in restructuring thoughts and then empowering them to take action and improve their school climate.

For this project, the play2PREVENT Lab aims to assess the acceptability and preliminary efficacy of a videogame intervention designed to teach teens the skills in restructuring thoughts and then empowering them to take action and improve their school climate. Program and school staff will enroll participants between the ages of 14-19 years old to play our videogame during their after school programs. Before and after gameplay, participants will answer assessment questions related to self-efficacy, cognitive reappraisal, and dimensions of school climate. Questions will also assess participants' feedback on the videogame. Students not randomly assigned to the videogame intervention will only respond to assessment questions. The data will be transmitted electronically via Qualtrics data collection platform to the Lab for further analysis.

Eligibility Criteria:
Inclusion Criteria:

* Must be a current high school student
* English-speaking
* Willing to provide minor assent
* Willing to provide parental consent (if under 18 years old)
* Willing to play/use the game/tool for about 45 minutes to 1 hour after school
* Willing to answer questions about their experiences in playing the game, questions around school climate, and questions around self-efficacy on an iPad for about 30 minutes
* Willing to participate in an optional focus group for about 30 minutes

Exclusion Criteria:

* Those that do not meet the criteria above