cyrilzakka/clinical-trials huggingface dataset:
Negative Beta Glucan in ICU Patients

This is a prospective study aimed at testing a strategy of early initiation of an antifungal agent to patients admitted to intensive care units (ICUs) at risk for invasive candidiasis. Score system have been developed to identify groups at very high risk for the development of candidemia/invasive candidiasis in the ICU. These scoring system have used clinical information with or without data on Candida colonization, and have shown reasonable correlation with candidemia/invasive candidiasis. More recently, a biomarker - detection of 1,3-beta-D-glucan in the serum - has been tested in the early diagnosis of candidiasis. The incorporation of biomarkers such as beta-D-glucan could help clinicians to select a group at higher risk for candidemia, and despite the fact that these tests may give false-positive results, their negative predictive value could be of great help.

Therefore, the objectives of this study are:

1. To assess the frequency of positive biomarkers in ICU patients at high risk to develop invasive candidiasis/candidemia;
2. To test the strategy of early discontinuation of antifungal therapy based on repeatedly negative blood cultures and 1,3 beta-D-glucan in the serum.

Entry criteria are: In the ICU for \>2 days AND systemic antibiotics \>2 days OR central venous catheter for \>days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.

Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.

If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (\>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for \>14 days.

Eligibility Criteria:
Inclusion Criteria:

* In the ICU for \>2 days AND

  * Systemic antibiotics on days 1-3 of ICU OR
  * Central venous catheter on days 1-3 of ICU
* AND at least 2 of:

  * Total parenteral nutrition on days 1-3 of ICU
  * Any dialysis on days 1-3 of ICU
  * Major surgery in the 7 days before admission in the ICU
  * Pancreatitis in the 7 days before admission in the ICU
  * Use of corticosteroids for at least 3 days in the 7 days before admission
  * Use of other immunosuppressive agents in the 7 days before admission in the ICU
* In addition, the patient must have at least one of the following:

  * Fever (axillary temperature \>37.5 oC)
  * Hypothermia (axillary temperature \<35 oC)
  * Hypotension
  * Unexplained acidosis
  * Unexplained elevation in C-reactive protein

Exclusion Criteria:

* Antifungal for \>3 days
* Allergy to an echinocandin
A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds for up to 4 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and over
* Patients able and willing to provide informed consent
* Patients with Surgical wounds including incisional wounds including laparoscopic
* wounds and surgical wounds healing by secondary intention.
* Patients with Traumatic wounds
* Patients must be willing to attend visits as per schedule in protocol

Exclusion criteria:

* Patients with known allergies to any of the materials used in the dressing
* Patients who require any oxidising agents such as hydrogen peroxide or hypochlorite solutions.
* Patients, who in the opinion of the investigator, is considered unsuitable for any other reason
* Patients with wounds showing signs of infection on presentation or not resolving with the use of antibiotics
Precision Medicine Study on Cardiovascular Disease (PRECISE)

Cardiovascular diseases are the leading cause of death in China and have become a financial burden on society under the traditional medical model. A new and sustainable medical model is needed to solve this dilemma, for which precision medicine models have great potential. Monogenic cardiovascular disease is the first field to be broken through in precision medicine at this stage, and it is also the field where precision medicine is most likely to be successfully transformed into clinical application, including genetic diagnosis, molecular typing, risk stratification, genetic interruption and individualized treatment.

In this study, patients with monogenic cardiovascular disease are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood, saliva, urine and feces for all patients, and myocardium for patients receive cardio myectomy surgery . Genetic testing will be performed to identify novel disease genes, genetic risk factors and potential therapy targets.

Eligibility Criteria:
Inclusion Criteria:

* Patients with monogenic cardiovascular diagnosed according current practice guideline.

Exclusion Criteria:

* Patients who refuse to sign the informed consent or decline follow-up.
The Cross-sectional Area of the Long Head of the Biceps Tendon and the Rotator Cuff Tear Position

The main aim and scope of this study is making measurement and comparison of the cross-sectional area of the long head of the biceps tendon(LHBT) in the patients suffered form rotator cuff tear with different tear positions, and making observation and comparison of the impairment type of the LHBT in the patients suffered from rotator cuff tear with different tear positions. The results may identify the influence of the tear position on the LHBT.


Eligibility Criteria:
Inclusion Criteria:

* partial or full-thickness but reparable rotator cuff tear;
* small- to large-sized rotator cuff tears being defined by DeOrio and Cofied4;
* no improvements after at least 1 month of conservative treatment such as NSAIDs or corticosteroid injection.

Exclusion Criteria:

* massive rotator cuff tears being defined by DeOrio and Cofied;
* patients with osteoarthritis of the glenohumeral joint;
* trauma or a history of surgery at the shoulder.
Telemedicine Intervention in Patients With Chronic Pain in PD

Pain is a very common and disabling symptom in Parkinson's disease, yet it is often untreated. This study will assess the impact of home-based physical and cognitive exercise interventions to reduce pain in this disease. This approach would offer an easily implemented and affordable way to encourage and maintain use of these interventions by patients virtually indefinitely through remote access technology. The study findings may help VA clinicians provide optimal care for the many Veterans with Parkinson's disease and chronic pain.

Project Background/Rationale: Pain is one of the most disabling and common nonmotor symptoms in Parkinson's disease (PD), with a prevalence of 40-85%. Research indicates that undertreatment of pain is particularly high in the PD population. Only about one-half of patients with PD who report pain receive regular pain medications. There is increasing interest in nonpharmacological treatments for chronic pain in PD to supplement pharmacological approaches. While there is evidence to support the utility of physical exercise to improve chronic pain management, relatively less is known about the role of cognitive exercise.

Project Objective: The investigators propose to conduct a pilot randomized, controlled trial in patients with chronic pain in PD to assess the impact of physical and cognitive exercise interventions on pain outcomes.

Project Methods: A total of 166 community-dwelling Veterans, 40 years of age or older, with chronic pain in mild-to-moderate PD will be randomly assigned in a 2 x 2 factorial design to one of four groups (1 - combined cognitive and physical intervention, 2 - physical intervention only, 3 - cognitive intervention only, 4 - health education). The investigators will test the effects of the interventions at 3 months for the outcome of pain severity.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of idiopathic PD
* At least 2 of the 3 cardinal signs of PD (resting tremor, rigidity, bradykinesia)
* Response to dopaminergic medication

Exclusion Criteria:

* Angina pectoris
* History of myocardial infarction (MI) within 6 months
* History of ventricular dysrhythmia requiring current therapy
Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics

Emergence agitation (EA) is a post-operative behavioral disturbance was first reported in early 1960s. EA is a term used to describe non purposeful restlessness and agitation, thrashing, crying or moaning, disorientation and incoherence during early stage of recovering from general anesthesia in children, especially those receiving sevoflurane. Generally, the incidence of EA following sevoflurane anesthesia varies from 10% to 66% and is more common in pre-school children. EA is generally short lived without obvious aftereffect. However, it still accompanies with risk of self-injury, and requires extra nursing care, which may delay the discharge and increase the cost of medical care Emergence agitation is diagnosed by a final composite score of greater than or equal to 10 on the Pediatric Anesthesia Emergence Delirium Scale (PAED).(

Sevoflurane induced anesthesia does not cause significant cardiac depression and dysrrhythmias as compared to halothane. Sevoflurane anesthesia is also easy to titrate for maintaining an adequate level of anesthesia, especially for the intubated. It also is a potent bronchodilator, which can offer an added benefit especially in children with a history of asthma. For all above reasons sevoflurane has clearly become the inhalation induction agent of choice.

The exact reasons for a higher incidence of EA with sevoflurane are not well explained. seizure activity in previously nonepileptic patients has been detected with electroencephalography during sevoflurane anesthesia.

One of the proposed treatments for EA is the use of opioids; however, it carries the risk of an extended Post Anesthetic Care Unit (PACU) stay resulting in parents' discomfort and added costs. Therefore, analgesic adjuvants with NMDA (N-methyl-D-aspartate) receptor antagonist functions, such as ketamine and magnesium sulfate have been tried to control this phenomenon in children.

Also, Dexmedetomidine, a selective a-2 adrenoceptor agonist, has sedative, analgesic, and anxiolytic effects. It was proved that α2 agonists decrease emergence agitation by their analgesic effect as well as by minimizing the anesthetic requirements.

In the review of literature this is the first study comparing the effectiveness of the three drugs ketamine, magnesium sulfate and dexmedetomidine infusions together in one study on the incidence of emergence agitation after sevoflurane induced anesthesia in children.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status II
* ages from 2-5 years.
* weight more than 6 kg.
* scheduled for cardiac catheterization procedure not exceeding 3 hours.

Exclusion Criteria:

* psychological disorder or cognitive delay.
* chronic or acute intake of any sedative drug or anticonvulsant drugs.
* Any neurological condition that will limit ability to communicate with, or understand a practitioner.
* those with coexisting renal diseases , any reported allergy to the given medications.
* legal guardian refusal .
Peritoneal 1.3-ß-D-glucan for the Diagnosis of Intra-abdominal Candidiasis in Critically Ill Patients (pBDG2)

New rapid diagnostic strategies are warranted in intra-abdominal candidiasis (IAC). A previous retrospective study showed that one measure, the day of the surgery, of peritoneal 1.3-Beta-D-Glucan ≤ 310pg/ml could rule out an IAC. This strategy was independent of the patient underlying conditions and Candida risk factors. This study aimed to confirm these results with a multicenter prospective study


Eligibility Criteria:
Inclusion Criteria:

* critically ill adult (\> 18 yrs old) admitted to ICU for intra-abdominal infection requiring surgery and possible intra abdominal candidiasis

Exclusion Criteria:

* declinate to participate,
* expected death within the first 24 hours
Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Inclusion Criteria:

* At least 18 years of age
* Scheduled to undergo elective total hip arthroplasty

Exclusion Criteria:

* Scheduled to undergo staged, bilateral hip arthroplasty \[Day -30, Day 0\]
* Pregnany or breastfeeding \[Day -180, Day 0\]
* Had active bleeding or high risk of bleeding \[Day -180, Day 0\]
* Had conditions preventing bilateral venography \[Day -30, Day 0\]
* Congestive heart failure \[Day -180, Day 0\]
* Pulmonary hypertension \[Day -180, Day 0\]
* Edema of legs \[Day -180, Day 0\]
* Substantial liver disease \[Day -180, Day 0\]
* Severe renal impairment (creatinine clearance \<30 ml per minute) \[Day -180, Day 0\]
* Concomitant use of protease inhibitors for the treatment of HIV \[Day -180, Day 0\]
Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women

Urinary tract community infections are one of very frequent reason consultation and prescription. Urinary tract represents the second site of bacterial community infection after the respiratory system. The management of the acute uncomplicated pyelonephritis was simply codified in the past recommendations of the French Agency for Safety Health Products (AFSSAPS) in 2008. Treatment is based on two main families of antibiotics, fluoroquinolones with 7 days treatment and 3rd generation cephalosporins with 10 to 14 days treatment.

The practice of a short treatment with ceftriaxone intra venous relayed by cefixime orally provides a simplified treatment for patients, a reduced use of fluoroquinolones and a probable decrease in correlation with the emergence of fluoroquinolones resistance, and finally, a decrease in the cost of treatment of acute uncomplicated pyelonephritis.

Patients will be included by investigators or coinvestigateurs, the day of consultation in the emergency adult department in Clermont-Ferrand city.

The diagnosis of acute uncomplicated pyelonephritis is established in the emergency department based on the clinical, laboratory and imaging criteria.

Clinical, biological and radiological data will gathered during this consultation :

* Clinical data: flank pain, fever, urinary symptoms,
* Biological data: urine dipstick (BU No. 1), cytobacteriological urinary (ECBU No. 1), blood prélèvements (Blood count, creatinine, CRP)
* Imagery: renal and bladder ultrasound. During the next consultations in the emergency department, respectively on day 3 (J3) of treatment and on day 9 (J9), urine tests (urinary dipsticks \[BU No. 2 and No. 3\] and cytobacteriological urinary \[ECBU No. 2 and No. 3\] will be realised. The clinical and biological management of patient will be performed by the same department to ensure a better comparability of biological results and a centralized real-time clinical data.

Patient follow-up will end with a phone call on day 37 (J37), and the rate of clinical relapses and / or biological occurred between day 9 and day 37.

Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 65 years old
* Diagnosis of Acute Uncomplicated Pyelonephritis
* Patient obliged to participate in the French national health and pensions system.
* Patient who have read, understood and signed the consent

Exclusion Criteria:

* Women who are pregnant
* Men
* One of these risk factor who define a complicated pyelonephritis:

Medical history of uro-nephrology problem Nephropathy Obstructive Uropathy Vesicoureteral reflux Post mictinal residue \> 100mL Urinary fistula Catheter vesicle and urethral Kidney transplantation Immunodeficiency Diabetes

* Recurrent pyelonephritis
* Allergy of betalactam or cephalosporin
* History of hypersensitivity reactions to antibiotic medications
* Patient in terminal care
* Trouble of cognitive function
* Patient deprive of judicial or administrative freedom
* Patient participating to another trial
* Refusal to participate to the trial
Uptake of the Antifungal Miconazole and Effect on Estrogen Metabolizing Enzymes in Humans

The purpose of this study, is to study the uptake of the pharmaceutical antifungal miconazole when used as a vaginal suppository in young women. The investigators want to know if the uptake is big enough to cause a biological effect (effect on CYP1A2 and CYP3A4 activity).


Eligibility Criteria:
Inclusion Criteria:

* Woman
* Age 18-45 years
* Healthy
* Signed consent
* Written authority to the GCP-unit

Exclusion Criteria:

* Pregnancy
* Breast-feeding
* Hypersensitivity to miconazole
* Hypersensitivity to sodium ethyl parahydroxybenzoic acid(E219)
* Hypersensitivity to sodium propyl parahydroxybenzoic acid (E217)
* Using contraceptives with hormones
* Daily consumption of alcohol
* Daily use of medicine
* Participated in a clinical trial within the last 3 months
Gemcitabine Plus Oxaliplatin in Advanced Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

Oxaliplatin is a diaminocyclohexane platinum compound, with a mechanism of action similar to that of cisplatin. Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. Gemcitabine and oxaliplatin are both active in NSCLC with no overlapping toxicity. Preclinical studies show a synergistic effect of the gemcitabine-oxaliplatin combination. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index.

The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. We are conducting a phase II study to evaluate the response rate and toxicity of the gemcitabine-oxaliplatin combination both given every 4 weeks in patients with advanced NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Histologic or cytologic diagnosis of NSCLC, Stage IV or selected stage IIIB (with positive pleural effusion or separate tumor nodules in the same lobe) according to the American Joint Committee on Cancer (AJCC).
2. No prior chemotherapy.
3. Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
4. No other forms of cancer therapy, such as radiation, immunotherapy for at least 4 weeks before the enrollment in study.
5. Performance status of 0, 1, 2 on the ECOG criteria.
6. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
7. Estimated life expectancy of at least 12 weeks.
8. Patient compliance that allow adequate follow-up.
9. Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 3,500/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, and platelet count ≥ 100,000/uLAdequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
10. Informed consent from patient
11. Males or females at least 18 years old.
12. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study registration.

Exclusion Criteria:

1. MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
2. Serious concomitant infection including post obstructive pneumonia
3. Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
4. Pregnant or nursing women
5. Psychiatric disorder that would preclude compliance.
6. Major surgery other than biopsy within the past two weeks.