cyrilzakka/clinical-trials huggingface dataset:
Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations

We plan to compare single person short axis view with two person long axis view

Introduction: The guidelines for the use of bedside ultrasonography in the evaluation of critically ill patients published by the society of critical care medicine recommends short-axis view be used during insertion of central venous catheter (CVC) in internal jugular vein (IJV) to improve success rate1. The long axis view is considered better for cannulations as it helps in preventing posterior wall puncture but in the trials it has been found to be inconvenient for a single user2,3. We hypothesise that if two persons perform long axis cannulations i.e. one person will image the vein while the other punctures it will be equally convenient to single person doing the cannulations in short axis. The advantage we expect to see is lesser complications in long axis group.

Methodology:

Inclusion criteria: Any patient getting admitted to ICU and requiring central venous cannulations.

Exclusion: Lack of consent. Randomization: At a 1:1 ratio, to be achieved using a computer-generated random number sequence for 100 consecutive subjects Study intervention: Eligible patients will be randomized to a short-axis or long axis technique for ultrasound guided IJV cannulations. Ultrasound guidance will be performed dynamically using a single-operator technique for short axis and double operator technique for long axis view. Cannulations and USG is to be carried out by 2 trained Anaesthesiologists.

Definition:

1. Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.
2. Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.
3. Number of needle sticks: Number of time punctures were done in the skin. Complications were noted as hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax.

All the times are to be noted by a bedside nurse who is not involved in the trial or knows the study hypothesis.

Statistical Analysis: An intention-to-treat analysis was performed. Insertion time, overall procedure time and number of needle sticks, and will be compared using Mann-Whitney U tests. The success rate and complication rate will be compared using Fisher exact tests. All statistical analyses will be performed with SPSS 20.0

Eligibility Criteria:
Inclusion Criteria:

* Any patient getting admitted to ICU and requiring central venous cannulations.

Exclusion Criteria:

* Lack of consent
CE-U and MRE to Predict the Efficacy of Anti-TNF Therapy in Crohn's Disease

The value of anti-TNF therapy in intestinal strictures related to Crohn's disease (CD) has not been clearly demonstrated. The results reported by some teams suggest no beneficial effect or even an increased risk of bowel obstruction in the case of stricture, while other publications indicate a favourable action of anti-TNF in this setting. The efficacy of anti-TNF in patients with intestinal stricture related to Crohn's disease could depend on the lesions responsible for the stricture, as anti-TNF agents are probably effective in inflammatory forms and useless or even potentially harmful in fibrotic forms. In practice, the decision is currently empirical and a trial of anti-TNF therapy is often proposed.

In view of the high incidence of intestinal strictures in CD and the need for a treatment as effective as anti-TNF in this setting, it is important to more clearly define the indications of these treatments guided by the information provided by modern imaging.

The aim of this prospective study is to determine whether certain signs detected by MR enterography and contrast-enhanced ultrasonography can help to predict failure of anti-TNF therapy in patients with CD presenting a symptomatic stricture of the small bowel and scheduled to receive this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease defined according to the usual endoscopic, histological, and radiological criteria
* Small bowel (jejunum or ileum) stricture identified by radiography or endoscopy
* Obstructive symptoms greater than or equal to 3 on a scale from 0 to 6 evaluated over the last 8 weeks
* Failure of corticosteroids and/or immunosuppressives and indication for anti-TNF therapy

Exclusion Criteria:

* Nonresolving complete bowel obstruction
* Previous anti-TNF therapy
* Contraindication to anti-TNF therapy:

  * Intra-abdominal, intra-mural or extramural abscess
  * Active infection
  * Severe infection during the previous 2 months
  * Nontreated latent tuberculosis
  * Heart failure
  * Active malignancy during the previous 5 years
  * Demyelinating neurological disease
* Modification of the treatment of Crohn's disease during the previous two months: azathioprine, mercaptopurine, methotrexate, thalidomide
* Contraindication to MR enterography or contrast-enhanced ultrasonography
Novel Approaches of Advanced Neuroimaging Based on MRI Fiber Tracking to Detect Early Signs of Vascular Cognitive Impairment in Hypertensive Patients

Hypertension is the major risk factor for vascular cognitive impairment (VCI). One of the main limitations in the clinical approach to VCI is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. Thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (HT).This aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. Thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in HT, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. In order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. In particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 40 and ≤ 70 years
* patients with moderate hypertension
* written informed consent

Exclusion Criteria:

* previous IMA, stroke or TIA
* arrhythmia or severe cardiac disease
* Diabetes or renal disease
* psychiatric disease
* neurological or neurodegenerative disease
* dementia
* assumption of drugs known to interfere with cognitive function
* inability to be subjected MRI analysis
* participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.
Oregano Ointment vs. Standard Treatment for Pediatric Atopic Dermatitis

This study is designed to evaluate and compare the efficacy of 3% oregano extract ointment prepared in aqueous solution versus 1% hydrocortisone ointment, a standard treatment, in decreasing the inflammation associated with mild to moderate atopic dermatitis. We plan to recruit 40 patients on the ages comprised between 2 and 17 years old and the study duration for each of the patient is 1 month.

A single-center, investigator initiated, randomized controlled, double-blind trial will be conducted to determine the effects of an oregano extract in aqueous solution versus 1% hydrocortisone in the treatment of acute-subacute pediatric atopic dermatitis (AD). We suspect that topical oregano will serve as an effective, non-steroidal AD therapy, simultaneously offering extra benefits to pediatric patients as oregano is a natural product with antimicrobial, anti-inflammatory, and antiseptic properties that lacks reports of adverse effects associated with steroids, which children have been noted to be more susceptible to.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female subjects aged 2-17 years of age.
* Individuals must be diagnosed with acute-subacute AD regardless of the study.
* Written informed consent must be obtained from all patients or caregivers.
* Women of childbearing potential (WOCBP) must be willing to practice effective contraception for the duration of study treatment.
* Subjects must be willing and able to comply with study conditions, properly apply or have caregivers apply topical medications to the selected body sites, as well as return to the clinic for required visits.
* Subject caregivers must be willing and able to perform ADQ assessment test.

Exclusion Criteria:

* Individuals who are immune-compromised or suffering from infectious disease, malignant disease, are known to be HIV+ or present with a general reduced level of health.
* Individuals diagnosed with underlying dermatological conditions in addition to AD.
* Individuals with a chronic pre-existing disease such as diabetes mellitus or others that in the opinion of the investigator would preclude their participation in the study.
* Individuals who are pregnant, nursing mothers, or subjects planning a pregnancy during the course of the study.
* Subjects/caregivers who are unable to communicate or comply with study conditions due to language disability, poor mental development, or impaired cerebral function.
* Individuals who are simultaneously enrolled in another clinical drug or device research study.
* Individuals with a history of chronic steroid use.
* Individuals needing to concurrently use topical agents, medicinal products containing corticosteroids, or immunosuppressants.
* Individuals who have received systemically administered corticosteroids and/or antihistamines 2 weeks prior to the start of study.
* Individuals undergoing light therapy.
* Individuals who have been treated with another investigation device or drug within 30 days prior to study enrollment.
* Individuals with a known allergy to oregano.
Ascorbic Acid to Prevent Postreperfusion Syndrome in Liver Transplantation

The goal of this clinical trial is to test the efficacy of intravenous ascorbic acid in preventing the postreperfusion syndrome in liver transplantation. The main questions it aims to answer are:

* Can intravenous ascorbic acid prevent postreperfusion syndrome in liver transplantation ?
* Can ascorbic acid decrease the incidence of liver graft dysfunction after liver transplantation?
* Can ascorbic acid decreased the incidence of postoperative complications after liver transplantation ?

Participants will receive 1.5 g of intravenous ascorbic acid diluted in 100 ml of saline or 100 ml of saline alone, during the anhepatic phase of liver transplantation before reperfusion of the new graft.

Researchers will compared the incidence of postreperfusion syndrome in both groups.

Researches will compared:

* Incidence of postreperfusion syndrome in liver transplantation
* Changes in interleukin values and other inflammatory markers before and after transplantation
* Incidence of liver graft dysfunction between groups
* Incidence of acute renal failure and other complications between groups

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing liver transplantation

Exclusion Criteria:

* Pregnancy
* Allergy to ascorbic acid
* Nephrolithiasis
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Hyperoxaluria
* Hyperuricemia
* Haemochromatosis
* Sickle cell anemia
* Serum Creatinine \> 1.2 mg/dl in women and 1.3 mg/dl in men
* Split liver graft
* Acute liver failure
* Living donor liver transplantation
* Controlled donor asystolia
* Treatment with: indinavir, Vitamin B12, Cyclosporine, iron, deferoxamine, disulfiram
Effects of Low-Dose Doxycycline on Oral Bone Loss

The primary purpose of this clinical trial is to determine whether low-dose doxycycline can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient).

The primary purpose of this clinical trial is to determine whether low-dose doxycycline (LDD) can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient). The effects of LDD on alveolar bone height loss, progressive periodontal attachment loss, systemic bone mineral density, gingival crevicular fluid biochemical markers of collagen degradation and bone resorption and serum biomarkers of bone formation, bone resorption and inflammation also will be assessed. In addition, another objective is to determine if the microbial effects obtained with LDD over two years are equivalent to a placebo control. This clinical trial involves two clinical sites: the University of Nebraska Medical Center College of Dentistry and Stony Brook University School of Dental Medicine. A total of 128 postmenopausal osteopenic women with periodontitis between the ages of 45 and 70 at the time of telephone screening will be randomized to LDD or placebo groups and subjects will be followed for two years.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be female, postmenopausal and not receiving estrogen replacement therapy.
* Subjects will be 45-70 years old at the time of telephone screening.
* Subjects will have osteopenia (T-score of -1.0 to -2.5) of the lumbar spine or femoral neck as determined by dual-energy absorptiometry (DEXA) scans.
* Subjects will have a history of generalized moderate-advanced periodontitis and will be undergoing periodontal maintenance.
* Subjects will be in good general health and willing to sign the IRB-approved consent form.

Exclusion Criteria:

* Subjects will not have an allergy or hypersensitivity to tetracyclines.
* Subjects will not have diseases or take medications that affect the inflammatory or immune responses (e.g., chronic use of non-steroidal anti-inflammatory drugs) or bone remodeling (e.g., drugs such as prescription estrogens, bisphosphonates, calcitonin or steroids).
* Subjects will not have any medical condition requiring antibiotic premedication (e.g., prosthetic heart valves, prosthetic joints, and mitral valve prolapse with regurgitation) for routine dental therapy.
* Subjects cannot have diabetes mellitus.
* Subjects cannot have had active periodontal therapy (quadrant scaling and root planing or periodontal surgery) within the past year.
* Subjects cannot have osteoporosis (T-score greater than -2.5) of the lumbar spine or femoral neck.
Clinical Evaluation of a New Dual-cure Universal Adhesive

The overall aim of this study is to evaluate the clinical performance and safety of the new dental dual-cure adhesive for luting indirect ceramic restorations (inlays and onlays). The primary aim is to determine the rate of postoperative hypersensitivity occurrence after using the new adhesive for the placement of indirect restorations. The secondary objective of this study is to assess the long-term clinical performance of the new adhesive in terms of marginal quality, retention/fracture rate of the ceramic restorations, and vitality/fracture rate of the restored teeth.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* Informed consent signed and understood by the subject
* Indication for indirect restorations (inlay, onlay) in molar or premolar
* The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
* visual analogue scale (VAS)\&lt;4 (0=no pain, 10=maximum conceivable pain)
* Max. 2 restorations per participant in different quadrants.
* Vital tooth
* Healthy periodontium, no active periodontitis
* Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
* Sufficient language skills

Exclusion Criteria:

* Insufficient isolation
* Participants with a proven allergy to one of the ingredients of the materials used
* Participants with proven allergy to local anaesthetics
* High caries activity/ poor oral hygiene
* Participants with severe systemic diseases
* Pregnancy
* Tooth with irreversible pulpitis
* Indication for direct pulp capping
* Bleaching of teeth within the last 14 days
* Usage of peroxide-based disinfectants within the last 14 days
The Clinical Study on Treating Acute Gouty Arthritis Using Both Internal and External Therapy of Tonifying Spleen and Descending Turbid

This research is based on spleen trapped by dampness and turbid which is the pathogenesis of gouty arthritis.It uses effective prescription of Endocrinology of Dongzhimen Hospital.In this study, the investigators use multi-center randomized parallel controlled clinical trials.The treatment groups are afforded oral traditional Chinese medicine decoction-tonifying spleen and descending the turbid decoction as well as soaking and wet wrapping.The control groups are afforded diclofenac sodium enteric-coated tablets as a positive control drug.The outcome is evaluated by condition of symptoms remission,pain relief time, recurrence rate and laboratory index to determine the efficacy of internal and external treatment.And the research will provide optimized diagnosis and treatment program. The investigators hope this research will also get tonifying spleen and descending the turbid internal and external treatment for gouty arthritis effective clinical treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-75, and gender unlimited;
2. The patients must meet western medicine diagnostic criteria for acute gouty arthritis;
3. The patients must meet that integral syndrome differentiation conforms to the spleen beset by dampness syndrome and local syndrome differentiation conforms to blockage disease due to heat.

Exclusion Criteria:

1. Secondary hyperuricemia, such as cancer and perichemotherapy of leukemia, renal failure, cirrhosis of the liver and drug effect(such as diuretics, aspirin, antitubercular agents), et al.
2. Acute infectious diseases, stroke, acute myocardial infarction ,as well as other acute diseases and tumors, rheumatoid arthritis.
3. Patients with peptic ulcer and gastrointestinal bleeding.
Simethicone: Does it Improve Operative Field and Postoperative Pain?

Simethicone is an oral anti-foaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.

The investigators objective is to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies.

Introduction: Simethicone is an oral antifoaming agent that reduces bloating, abdominal discomfort, and abdominal pain by promoting the clearance of excessive gas along the gastrointestinal tract.

Objective: to evaluate the efficacy and safety of preoperative oral simethicone for bowel preparation in gynecological laparoscopies.

Methods: 100 infertile women will be scheduled for laparoscopy, patients randomized to receive either Simethicone (Group I) or placebo tablets (Group II). The primary outcome measure will be the overall exposure of the surgical field and pain scoring. Assessment of the overall exposure of the surgical field was done using a five-point scale (poor, sufficient, medium, good, and excellent). Visual analog score (VAS) will be used for assessment of postoperative pain and verbal analog scoring was used for assessment of patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients
* aged 20 - 40 years old
* scheduled for laparoscopy

Exclusion Criteria:

* Women were excluded from the study if patients had one or more of the following:

  * scar of previous operation, uterine mass, severe endometriosis, suspicion of malignancy, history of allergic reaction to study drugs, psychiatric disorders and patient refusal
68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)

Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.

Prospective multicenter study evaluating the prediction of histological response of pembrolizumab in combination with neoadjuvant chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.

Patients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg Q3W given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide. After definitive surgery, patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity.

The 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Female with age ≥ 18 years,
2. Patients with previously untreated, non-metastatic, centrally confirmed TNBC (stage T1c N1-2 or T2-4 N0-2 per AJCC) for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care,
3. Patients with measurable targets according to RECIST/PERCIST criteria,
4. Patients without distant metastasis based on staging 18F-FDG PET/CT,
5. Patients with tumor tissue available,
6. Patients who provided a signed written informed consent,
7. Patient ability to comply with protocol requirements,
8. Patients covered by a health insurance system.

Exclusion Criteria:

1. Pregnant and lactating women,
2. Patients with prior anti-PD(L)1 immunotherapy,
3. Patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment,
4. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent,
5. Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons,
6. Patients who are not affiliated to a social security system, or who are deprived of liberty, or under guardianship.
7. Person deprived of liberty or under guardianship
A Post Marketing Survey Study to Evaluate the Safety and Effectiveness of Prezista

The purpose of this study is to assess the safety data of darunavir in a natural clinical practice.

This is a non-interventional (a scientific study to make a clear and easy understanding of the cause and effect relationship), prospective (in which the participants are first identified and then followed forward as time passes), consecutive survey for collecting safety and efficacy data of darunavir in treatment of Acquired Immune Deficiency Syndrome (AIDS) in a natural clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are prescribed with darunavir for treatment of Acquired Immune Deficiency Syndrome (AIDS)

Exclusion Criteria:

* Known hypersensitivity to Prezista
* Prezista coadministered with medicinal products that are highly dependent on CYP3A for clearance