cyrilzakka/clinical-trials huggingface dataset:
Impact of the Assisted Ventilation Mode on Diaphragm Efficiency in Critically Ill Patients

This study evaluates the impact of the assisted mode of mechanical ventilation on diaphragm efficiency in mechanically ventilated critically ill patients. Participants will be randomized to the neurally adjusted ventilatory assist (NAVA) mode or to the pressure support ventilation (PSV) mode.

During mechanical ventilation the ventilator applies positive pressure to the respiratory system. Often in the acute phase of critical illness patients are ventilated in the control mode (CMV), where the patient is completely passive. This quickly (within 48 hours) has been shown to induce diaphragm atrophy and dysfunction (Levine et al New England Journal of Medicine, 200; 358:1327-35). To preserve diaphragm function, guidelines suggest to shift as soon as possible to the assisted mode (the ventilator applies positive pressure to assist spontaneous inspiratory effort). The synchrony between patient and ventilator is critical in this context. PSV is the classical assisted mode and applies a constant pressure whatever the patient effort. NAVA is a newer mode based on the diaphragm electrical activity (EAdi) measurement. It assist patient effort proportionally to the EAdi and hence to patient's effort. The investigator hypothesis is that NAVA would improve diaphragm efficiency more efficiently than PSV.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* oro-tracheally or naso-tracheally intubate
* had been ventilated for acute respiratory failure in control mechanical ventilation for at least 72 hours consecutively
* candidate to assisted ventilation
* Hemodynamically stable without vasopressor or inotropes (excluding a dobutamine and dopamine infusion lower than 5 gamma/Kg/min and a 3 gamma /Kg/min, respectively
* normothermia

Exclusion Criteria:

* Neurological or neuromuscular pathologies
* phrenic nerve dysfunction
* contraindications to the insertion of a nasogastric tube (for example recent upper gastrointestinal surgery, esophageal varices).
An Epidemiological Study to Assess Performance of Using Healthcare Tools to Understand Genital Herpes Simplex Virus-2 (HSV-2) in Patients ≥ 18 Years of Age in the United States and Europe.

The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe.

More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. Ultimately, this study will allow generating additional real-world evidence (RWE) on patterns of recurrences and other key parameters.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman ≥18 years old.
* Written informed consent obtained from the patient prior to performance of any study-specific procedure.
* History of at least one episode of HSV-2 genital herpes lesions in the 12 months preceding the screening, and seropositive for HSV-2 as determined by Western blot OR PCR-positive for HSV-2 (newly diagnosed patients).
* Patients who are medically stable in the opinion of the investigator.
* Patients who, in the opinion of the investigator, are able to understand and comply with the study requirements (attend regular telephone calls/study site visits/home visits/self-completion of questionnaires, self-swabbing).
* Seronegative for HIV, as determined by laboratory testing. Patients documented to be positive to HIV will not be eligible for study participation

Exclusion Criteria:

* Prior receipt of a vaccine or candidate vaccine containing HSV antigens.
* Immunocompromised patients, as per medical history and investigator judgement.
* Other genital tract disorders or sexually transmitted diseases that may interfere with the assessment of the study (as per investigator's judgement).
Evaluation of Amnion Chorion Membrane and Demineralized Bone Matrix Putty Allograft in Periodontal Intrabony Defects

A clinical and radiographic evaluation of 2 regenerative techniques, bioresorbable membrane and bone allograft for management of periodontal intrabony defects.

Twenty-two patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed had two- or three-walled intrabony defects. Patients were randomly assigned into two groups; bioresorbable membrane or bone allograft. Clinical parameters were recorded at baseline and at 3 and 6 months postoperatively. Radiographic parameters were recorded at baseline and at 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Severe chronic periodontitis patients.
* having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.

Exclusion Criteria:

* Pregnant women
* Having any given systemic disease
* Taking any type of medication and/or antibiotic therapy during the 3 months before the study
* Received periodontal treatment within the past 12 months Current or former smokers
Efficacy and Safety Study of Polidocanol Injectable Foam for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, polidocanol injectable foam compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Eligibility Criteria:
Inclusion Criteria:

* Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
* Ability to comprehend and sign an informed consent document and complete study questionnaires in English
* Ability to record symptoms in accordance with the protocol
* Symptomatic varicose veins
* Visible varicose veins

Exclusion Criteria:

* Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP (clinical, etiologic, anatomic, and pathophysiologic) Classification of Venous Disorders).
* Leg obesity impairing the ability to access the vein to be treated and/or to apply postprocedure compression bandaging and stockings
* Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
* Deep vein reflux unless clinically insignificant in comparison to superficial reflux
* Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
* Reduced mobility
* Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
* Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
* Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
* Current alcohol or drug abuse
* Pregnant or lactating women
* Women of childbearing potential not using effective contraception
* History of DVT, pulmonary embolism or stroke
Vonoprazan-Based Triple Therapy in Comparison With Extended Sequential Therapy

This study aims to compare the efficacy of the current standard first-line anti-helicobacter pylori regimen, extended proton pump inhibitor-based sequential therapy, with that of vonoprazan-based triple therapy, through a randomized controlled trial.

Helicobacter pylori infection is a well-established risk factor for peptic ulcer disease and gastric cancer. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Extended proton pump inhibitor (PPI)-based sequential therapy as one of the most commonly used first-line regimens provides a satisfactory eradication rate of 90.7% (95% CI, 87.4% - 94.0%). Nevertheless, its complexity of the "sequential" usage is sometimes confusing to the patients and may lead to treatment failure. The emerging new regimen - vonoprazan-based triple therapy, on the other hand, is another appealing choice with simplicity, short treatment duration, and low pill burden. However, there's still no evidence regarding the use of vonoprazan-based triple therapy with high-dose amoxicillin (1000mg twice daily) as the first-line regimen. This study aimed to compare the efficacy of the current standard first-line regimen, sequential therapy, with that of vonoprazan-based triple therapy with high-dose Amoxicillin.

Eligibility Criteria:
Inclusion Criteria:

* Patients with H.pylori infection who was over 20 years old and agree to participate in the trial will be recruited.

Exclusion Criteria:

* Who had received helicobacter pylori eradication before
* Who are known to be allergic to any drug used in this trial
* Pregnant women
* Who are refuse to participate in the trial for any reason
Treatment for Nicotine Addiction in Women

The purpose of this study is to use a medication tolcapone and or placebo to test if the symptoms of nicotine withdrawal lessens , and or changes in smoking urges, and mental reasoning in female smokers over a 72 hour period.

The proposed trail will be use a double-blind, placebo-controlled design to conduct the first randomized controlled trial of the COMT inhibitor, tolcapone, in nicotine dependent women. This study will determine if tolcapone is superior to placebo by attenuation the severity of nicotine withdrawal and smoking urges during short-term abstinence. Withdrawal severity will be assessed by a self-report scale and cognitive assessment, including a sustained-attention task. Smoking urges will be assessed by a self-report scale.

Eligibility Criteria:
Inclusion Criteria:

* Must be 18yrs to 45yr old woman, read and write in English.
* Must smoke at least 5 or more cigarettes a day
* FTND score at least 4 or higher
* A CO reading of 10 or higher during screening
* Must be in good health as verified by medical history, screening exam, screen laboratory tests.

Exclusion Criteria:

* Excluded if using psychotropic medications, have contraindications to tolcapone use (e.g.. liver problems, allergy to tolcapone, history of no traumatic rhabdomyolysis or hyperpyrexia, confusion possibly related to medication), have other substance use disorder, are pregnant or breast feeding, have a current psychotic disorder, bipolar disorder, homicidal or suicidal ideation, have current (past month) substance use disorder, other than nicotine dependence, or are unable to fulfill the scheduled visits and procedures.
Gabapentin for the Treatment of Pruritus Caused by Burn Injuries in Children

Children with healing burns often suffer from pruritus that may continue for many months. Pruritus can be very distressing to the child and can interfere with sleep, activities of daily living, and rehabilitation therapy. Additionally, constant scratching of skin grafts may result in damage that requires further surgery, thus putting the patient at additional risk and adding to health care costs. Although the size of the burn injury is a risk factor for pruritus, almost 50% of patients with small burn injuries reported moderate or severe pruritus.

Gabapentin has been shown to be effective for the treatment of pruritus in adult patients with brachioradial pruritus, uraemic pruritus and pruritus of unknown origin. Although the specific mechanism is unknown, the end result is the downregulation of excitatory neurotransmitter release and decrease in neuronal hyperexcitability.

The primary objective of this study is evaluating the effectiveness of gabapentin in reducing the severity of pruritus in children with burn injuries.

Eligibility Criteria:
Inclusion Criteria:

1. Children with partial or deep thickness burn
2. Children receiving triple antihistamines for treatment of pruritus
3. Children with a pruritus score ≥ 2 (Appendix 1) despite triple antihistamine therapy
4. Children who are tolerating liquids by mouth or nasogastric tube

Exclusion Criteria

1. Children with a medical condition for which gabapentin is contraindicated including children who have demonstrated a hypersensitivity to gabapentin or any of the components of the formulation.
2. Children with seizure disorders
3. Children with a pre-existing behavioural or developmental disorder
4. Children with renal impairment
5. Children with severe burns requiring PICU admission
A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors

N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin. This study will test the safety and effects of ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.


Eligibility Criteria:
Inclusion criteria:

* Signed written informed consent
* Male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists
* Clinically or radiologically documented measurable disease.
* Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
* Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)

Exclusion criteria:

* Receipt of ADH-1 prior to this clinical study
* Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
* History of primary brain tumors or brain metastases
* History of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days before study entry.
* Stroke, major surgery, or other major tissue injury within 30 days before study entry
* History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states
Correlation Between the Pulmonary Function Parameters and the Circulatory Parameters (PSV, EDV, RI) of Retrobulbar Blood Vessels (CRA, PCA, and OA) in 48 T2DM Patients Did Not Combinate With DR

Objective: The main target of this study was to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels in patients with type 2 diabetes (T2DM) without diabetic retinopathy (DR).

Method: T2DM patients without DR were choose to research the correlation between the pulmonary function and the circulatory parameters of retrobulbar blood vessels. The primary endpoints were the pulmonary function parameters; The secondary endpoints were the HbA1c, FPG, 2hPG, WC, and BMI. The tertiary endpoints were the blood-fat; In addition, the retrobulbar circulation in the retrobulbar blood vessels were evaluated using color doppler imaging (CDI).

Pulmonary function parameters (VC%, FVC%, FEV1%, PEF%, MVV%, TLC%, FEV1/FVC%, DLCO%, and DLCO/VA%); the retrobulbar circulation (PSV, EDV, RI);retrobulbar blood vessels (CRA, PCA, and OA);blood-fat(TC, HDL-C, LDL-C, and TG).

Pulmonary function was measured by spirometer which was provided by Jaska Corporation in Japan, model number: HI-101; The CDI recordings were taken using a Powervision SSA-380A (Toshiba, Japan) using a 7-MHz transducer.

Eligibility Criteria:
Inclusion Criteria:

1. The patients were diagnosed with T2DM according to the guidelines of the American Diabetes Association;
2. No smoking history, pulmonary disease nor pulmonary infection within a fortnight;
3. Did not have hepatopathy, nephropathy, and gastrointestinal disease; and
4. Likely to have good compliance and able to visit our hospital for periodic assessments.

Exclusion Criteria:

1. T1DM, gestation and lactation;
2. Renal inadequacy, a serum creatinine \>132 µmol/L (male), or a serum creatinine \>123 µmol/L (female);
3. hypohepatia, the liver enzyme was two times higher than normal;
4. Intensive care with insulin treatment;
5. The patients combinated with DR and hypertension (antihypertensive drugs were used);
6. Patients with other eye conditions that could affect the blood flow, such as high degree myopia, maculopathy of any origin, glaucoma, and those with a history of laser treatment or introacular surgery;
7. New York Heart Association class III or IV heart failure, a history of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months; 8) Cholesterol-lowering drugs can not control the blood-fat (TC \> 250 mg/dl, HDL-C \< 30 mg/dL, LDL-C \> 170 mg/dl, TG \> 200 mg/dl) adequately; and

9) Use of systemically injected glucocorticoids within 3 months prior to our study.
MSB11022 in Healthy Subjects

This is a phase I, randomized, double-blind, parallel-group trial to compare Investigation Medicinal Product (IMP) MSB11022, US- Reference Product (RP), and EU- Reference Medicinal Product (RMP) (Humira®) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and healthy female subjects of non-childbearing potential aged 18 to 55 years, inclusive.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Concurrent or history infections such as opportunistic infections, including sepsis, pneumonia, and fungal infection.
* Individuals with history of tuberculosis or diagnosed with tuberculosis by interview, chest X-ray examination, or interferon-gamma release assay.
* Concurrent or history of demyelinating disease (multiple sclerosis, etc.).
* Concurrent or history of congestive cardiac failure.
* Concurrent or history of allergic symptoms such as asthma bronchial, drug-induced rash, and urticaria, which, in the judgment of the investigator, may affect participation in this clinical study.
* Concurrent or history of cardiac, hepatic, renal, gastrointestinal, respiratory, and/or hematological function disorders, which, in the judgment of the investigator or any of the sub investigators, may affect participation in this clinical study.
* Other protocol defined exclusion criteria could apply.
Ultrasound Assessment of Rheumatoid Arthritis Patients Who Changed Diet

The purpose of this research study is to evaluate if a weight loss intervention will improve your rheumatoid arthritis disease activity.

This is a pilot 12-week RCT (Randomized Clinical Trial) in 60 obese RA (Rheumatoid Arthritis) patients to evaluate if a weight loss intervention will improve PDUS (Power Doppler Ultra Sound), traditional disease activity measures (DAS28, Disease Activity Score - 28), and adipokine/MBDA (Multi-Biomarker Disease Activity) assessments. While there have been observational weight loss RA studies, none were RCTs and they did not utilize objective measures (PDUS or MBDA).

Eligibility Criteria:
Inclusion Criteria:

1. Patient must meet 1987 ACR (American College of Rheumatology) criteria
2. Age \> 18 years of age
3. Baseline DAS28/ESR\>3.2 (ESR-erythrocyte sedimentation rate)
4. Stable DMARDs or biologic therapy for at least 12 weeks, or stable off RA therapy 12 weeks.
5. Willingness to participate in a weight loss program
6. BMI \> 30
7. Prednisone ≤ 10 mg
8. Patient has provided informed consent

Exclusion Criteria:

1. Major surgery (including joint surgery) within 8 weeks prior to baseline or planned major surgery within 3 months after baseline
2. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
3. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (as this may falsely elevate biomarkers)
4. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of baseline or oral antibiotics within 2 weeks prior to baseline
5. Pregnant women or nursing (breast feeding) mothers
6. Neuropathies or other conditions that might interfere with pain evaluation unless related to primary disease under investigation
7. History of an eating disorder
8. History of bariatric surgery
9. EKG results deeming patient to unsafe for study intervention
10. Allergy to study intervention
Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: an International, Multi-centric, Prospective Study

Background Three-dimensional (3D) imaging and subsequent 3D virtual treatment planning are becoming state of the art in orthognathic surgery. However, current available software is still too time-consuming. KLS Martin (Tuttlingen, Germany) has currently completed the preclinical and the single surgeon (GS) closed beta-phase of their novel 3D virtual planning software, IPS (Individual Patient Solutions) CaseDesigner (IPSCD).

Objectives The investigators aim to test pre-release versions of the IPSCD software under real-world working conditions in strictly selected university, general and private hospital settings. In specific, they aim to demonstrate that the IPSCD will ensure a significant reduction in treatment planning time.

Study design closed beta-phase; international, multi-centric, prospective study Patients presenting at the division of maxillofacial surgery at the different hospital centers, for an orthognathic-related problem will receive a complete routine work-up, including a cone-beam CT (CBCT) according to the IPSCD protocol. The same surgeon and/or orthodontist will run all the virtual planning steps with the novel software. Timing of the eight major steps will be measured with a digital chronometer.

One hundred and eight patient cases will be planned with the IPSCD software in the participating centers over a period of three months, in the order of respectively one, three and five cases per month per participating center.

Investigators will register anonymized patient demographics (age, gender, clinical diagnosis, type of surgery), and provide feedback regarding the required time to complete the different surgical planning steps, regarding the number of failed alignments, and the occurrence of software bugs. Intergroup comparison of virtual planning time between the different centers will be analyzed. In addition, the learning effect will be examined through comparison of the different cases planned by the same surgeon and/or orthodontist, or in comparison to the initial beta-testing phase results by GS.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages
* Patients of both genders
* Patients should present themselves at the division of Maxillofacial surgery or Orthodontics, at the participating hospital centers for orthognathic surgery
* Patients should receive standardized cone-beam computed tomography (CBCT) image acquisition, according to the IPSCD protocol
* Preoperative 3D virtual planning should be performed by the same investigator per center with the IPSCD software

Exclusion Criteria:

* All patients that do not fit the abovementioned description
* Patients with posttraumatic deformity
* Patients with congenital deformity
* Patients with pre-prosthetic indication