cyrilzakka/clinical-trials huggingface dataset:
Cost-Effectiveness Analysis of a Virtual Reality-Assisted Hypnotherapy Program on Quality of Life in Patients with Chronic Low Back Pain: a Multicenter, Randomized, Prospective, Comparative, Open-Label, Parallel-Group Study

This randomized, prospective study aims to evaluate the effectiveness and cost-efficiency of a Virtual Reality (VR)-assisted hypnotherapy program on quality of life in patients with chronic low back pain. The study compares a VR-assisted hypnotherapy group to a standard treatment group. Both groups will undergo a conventional physical therapy program supervised by physiotherapists for 3 weeks (15 sessions). The VR-assisted hypnotherapy group will receive additional sessions utilizing the HypnoVR software, which delivers relaxing virtual environments. Outcomes will be assessed immediately after treatment, at 1 month, and at 3 months post-treatment. Primary endpoints include pain reduction measured by the Visual Analog Scale (VAS). Secondary endpoints include functionality, quality of life, anxiety, depression, sleep quality, healthcare costs, and treatment adherence. Statistical analyses will determine the efficacy and economic impact of this innovative therapy for chronic low back pain management.


Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 80 years.
* Chronic neck pain lasting for more than 3 month

Exclusion Criteria:

* Presence of newly developed neurological deficits.
* Existence of comorbid neurological diseases.
* Medical history unsuitable for the use of virtual reality (VR) glasses (e.g., visual impairment, epilepsy).
* Pregnancy.
* Changes in medication for chronic pain management within the last three months (e.g., Pregabalin, Gabapentin, Duloxetine, etc.).
Convalescent Plasma in Outpatients With COVID-19

The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.

This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.


Eligibility Criteria:
Inclusion Criteria:

* One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection
* Has at least one study defined risk factor for severe COVID-19 illness
* Clinical team deems stable for outpatient management without supplemental oxygen
* CP available at the site at the time of enrollment
* Duration of symptoms ≤ 7 days at ED presentation
* Informed consent from subject

Exclusion Criteria:

* Age less than 18 years
* Prisoner or ward of the state
* Presumed unable to complete follow-up assessments
* Prior adverse reaction(s) from blood product transfusion
* Receipt of any blood product within the past 120 days
* Treating clinical team unwilling to administer 300 ml fluid
* Enrollment in another interventional trial for COVID-19 illness
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
* Have an ECOG performance status of ≤ 1
* Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease
* Participants with asymptomatic or treated CNS disease may be eligible.

Exclusion Criteria:

* Have known active CNS metastases and/or carcinomatous meningitis.
* Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.
* Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction.
* Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
* Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
* Have other active malignancy unless in remission with life expectancy greater than (\>) 2 years.
Clinical Outcomes and Cost of Gram Negative Bacteremia

This study examines the clinical outcomes and healthcare costs associated with gram negative bacteremia at Duke University Medical Center from 2002-2015.

Specific Aim 1: Define the clinical impact of gram negative bacterial (GNB) bloodstream infections (BSI). In this objective, the investigators will describe the prevalence, source of bacteremia, and location of acquisition (i.e., community-acquired, healthcare-associated, hospital-acquired) of GNB BSI. The investigators will also examine the outcomes associated with GNB BSI including length of hospital stay, length of ICU stay, in-house mortality, and hospital costs.

Specific Aim 2: Describe antibiotic resistance patterns in GNB BSI, and explore associations between antibiotic resistance and clinical and economic outcomes. In this objective, the investigators will describe the prevalence and antibiotic susceptibility profiles of multidrug resistant phenotypes including MDR bacteria, which are defined by resistance to three or more drug classes, ESBL-producers, and CRE. The investigators will examine the differences in mortality, resource use (length of hospital stay, length of ICU stay), and direct medical costs between cases with and without antibiotic resistance.

Eligibility Criteria:
Inclusion Criteria:

Since January 2002, one investigator (VGF) has received daily reports from the clinical microbiology laboratory on all hospitalized patients at Duke University Medical Center with one or more blood culture(s) positive for gram negative rods. Patients were then evaluated within 36 hours of the detection of bacteremia for clinical evidence of infection

Exclusion Criteria:

Patients were excluded from the study for the following reasons: age less than 18 years, polymicrobial infection (blood culture positive for more than one pathogen), neutropenia (white blood cell count less than 1.0 x 109/L), or death prior to the return of positive blood cultures. In order to preserve the independence of observations, only the initial episode of gram negative bacteremia was included in the analysis (e.g., patients were only included once). The study was approved by the Duke University Medical Center Institutional Review Board.
Stability of Anterior Open Bite Treatment Using Extrusion Arches

This study investigated treatment effects and stability of anterior open bite cases using extrusion arches


Eligibility Criteria:
Inclusion Criteria:

* adult patients above 18 years anterior open bite 2-6 mm full permanent dentition incisors requiring extrusion

Exclusion Criteria:

* increased incisal show at rest
* gum show at smiling cleft patients patient with tempro-mandibular joint problems FMA angle above 45
Oxygen Therapy in Schizophrenia

Due to intense ATP-consuming processes in the brain, a high level of brain energy supply is required. A popular hypothesis regarding the pathogenesis and pathophysiology of schizophrenia postulates hypofunction of neuronal circuits in the prefrontal and limbic-temporal areas. An emerging body of data suggests that impaired energy metabolism due to mitochondrial dysfunction plays a role in the pathophysiology of schizophrenia.

Under normal conditions cellular metabolic rate, i.e. oxygen and glucose consumption, increases proportionally with any increase in neuronal activity. The impaired energy metabolism due to mitochondrial dysfunction and frontal lobe hypofunction might be improved by increasing O2 supply to the brain. Oxygen-enriched air inhalation has been shown to increase brain oxygen supply. Hyperoxia therapy is a useful tool in the treatment of neurological and neurotrauma deficits.

We therefore suggest a randomized double blind cross-over study of enriched inspired O2 partial pressure in schizophrenia.

It is surprising given the numerous findings on reduced energy metabolism in schizophrenia that simple treatment with inspired enriched oxygen has not been studied.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* 2 years of illness
* PANSS more than 60

Exclusion Criteria:

* unstable or serious physical illness
* suicidality
* drug abuse
* BMI above 30
* taking anti-hypertension medication
Clinical Success of Short Dental Implants Alone and Standard Dental Implants Combined With Osteotome Sinus Floor Elevation in Posterior Maxillae

The aim of this study is to determine the clinical success of short implants (6mm) alone and standard implants (10mm) combined with sinus floor elevation in atrophic maxilla.

Implant treatment in posterior maxilla is commonly faced with great challenges due to the limited residual bone height and poor bone quality. Efforts have been made to allow successful implant treatment in atrophic posterior maxillae.Osteotome sinus floor elevation (OSFE) has been proven to be a predictable surgical procedure to vertically increase the bone volume in atrophic maxilla.On the other hand, short implants (intra-bony length of 8mm or less) are being increasingly used in extremely resorbed maxilla to avoid additional surgical trauma and expense.However, still limited randomized controlled trials have compared the clinical success of short implants and standard implants combined with OSFE.

This study is designed as a prospective randomized controlled clinical study. We plan to enroll 180 patients in need of dental implant treatment in posterior maxilla. All patients will sign the informed consent form before treatment. The study is approval by the Ethics Committee of Shanghai Ninth People Hospital, China. The clinical component of the study will be initiated in May 2015 at the Department of Oral and Maxillofacial Implantology, Shanghai Ninth People Hospital, Shanghai Jiao-Tong University, China.

A block randomization sequence will be used to assign eligible patients to three groups: Group 1: short implants (6mm) alone; Group 2: standard implants (10mm) combined with OSFE. The assignment will be concealed from the clinical operators until the beginning of implant surgery. The outcome examiners and patients will be kept blinded to the assignment.

The required sample size is calculated based on the primary outcome parameter, implant survival rate. A recent study (Rossi et al. 2016) compared survival rate of short implants and standard implants (Survival rate: 86.7% VS 96.7%). If α=0.05, and 1-β =0.8, a sample size of n=116 per group is required. Assuming a drop-out rate of 10%, 125 patients per group will be required. The total required sample size will thus be n=250.

Eligibility Criteria:
Inclusion Criteria:

The following inclusion criteria are applied:

* age≧18 years, partial edentulism in posterior maxilla for at least three months from tooth loss,
* residual bone height range from 6-8mm,
* sufficient bone width in edentulous region.

Exclusion Criteria:

The patients will be excluded on the basis of:

* heavy smoker (\>10 cigarettes per days),
* uncontrolled diabetes mellitus or other systemic diseases,
* uncontrolled periodontal infection,
* insufficient bone quality to achieve implant stability and
* previous implant installation or bone grafting at surgical site.
Impact of Belt Position on the Results of PEEP Titration by EIT During ARDS

ARDS is a frequent reason for hospitalization in intensive care. In order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (VILI) that can occur. PEEP is a parameter that plays a role in the appearance of VILI, and its adjustment can be optimized by EIT. The EIT is a non-invasive, non-irradiating, real-time monitoring device, today widely used for the optimization of ventilation in patients intubated for ARDS. The positioning of the EIT belt at different chest heights could influence the result of the PEEP titration.

The aim of this study is to test the hypothesis that the position (2nd intercostal space or 5th intercostal space) of the EIT (Electrical Impedance Tomography) belt significantly influences the result of PEEP (Positive Expiratory Pressure) titration.

Eligibility Criteria:
Inclusion Criteria:

* Occurrence of moderate to severe ARDS (PaO2/FiO2 ratio ≤ 200 mmHg) within 72 hours following intubation
* Criteria for moderate to severe ARDS for less than 72 hours
* Passive ventilation in controlled assisted ventilation (no spontaneous ventilation)
* Consent of next of kin

Exclusion Criteria:

* Age \< 18 years
* ECMO
* Pneumothorax
* Pacemaker or implantable defibrillator
* Chest trauma in the last 3 months
* Skin peeling (Burned, Lyell)
* Intracranial hypertension
* Uncontrolled shock (noradrenaline \>5 mg/h)
* Pregnant woman
* Adult patient protected within the meaning of the law
* Lack of social security
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients at least 18 years of age
2. Patients with AK lesions within a contiguous 25 cm2 area on the upper extremity
3. Patients with a 25 cm2 area of normal skin on the upper inner arm
4. Female subjects must be of either non-childbearing potential or childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
5. Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
6. Ability to follow study instructions and likely to complete all study requirements
7. Obtained written informed consent prior to any study-related procedures

Exclusion Criteria:

1. Location of the selected treatment areas within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
2. History or evidence of skin conditions other than the study indication that would interfere with evaluation of the study medication
3. Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety, as determined by Investigator clinical judgment.
4. Anticipated need for in-patient hospitalisation or in-patient surgery during the study period.
5. Current participation in any other interventional clinical trial
6. Subjects who have received treatment with any non-marketed drug product within the last two months
7. Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol
8. Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding
9. Undergone cosmetic or therapeutic procedures within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
10. Use of acid-containing therapeutic products within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
11. Use of topical salves/topical steroids: within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
12. Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers, systemic medications that suppress the immune system or UVB in the last 4 weeks
13. Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas within 8 weeks prior to any screening visit
14. Use of systemic retinoids
Efficacy of SLT in Patients With Insufficient IOP Control Under Maximum Tolerated Drug Therapy (Eye Drops)

Examination and follow-up of efficacy and safety of SLT in patients with unsufficient IOP control despite maximum tolerated topical therapy. In addition, it will be examined whether medical treatment can be reduced after the SLT procedure and whether filtering surgery - as the only remaining option - may be postponed.

SLT (Selective Laser Trabeculoplasty) uses the Nd:YAG-Lasers (wavelength 532nm, Q-switched, frequency-doubled). Thanks to the low laser energy used and the short duration of treatment, only pigmented cells of the trabecular meshwork are targeted and selectively treated. Neighboring, non-pigmented cells and tissue are spared collateral and thermic damage, the architecture of the trabecular meshwork remains intact. The SLT procedure uses less than 1% of the energy of the ALT procedure with an extremely low pulsation duration.

Several studies confirm the effective IOD reduction of SLT and rate the procedure as an relatively safe and effective therapy for glaucoma. Also repeated use of the SLT procedure is considered as meaningful. Meanwhile the SLT procedure is used as primary and supplementary treatment of glaucoma and study confirmed that the SLT procedure was just as effective as administration of Latanoprost in reducing IOD in newly-diagnosed glaucoma.

Eligibility Criteria:
Inclusion criteria: Patients with

* primary open angle glaucoma (including normal tension glaucoma)
* pseudoexfoliation glaucoma
* pigment dispersion glaucoma

Exclusion criteria: previous intraocular surgery closed angle glaucoma pediatric glaucoma inflammatory or uveitic glaucoma unclear view of the trabecular meshwork
Researches About Proximal Humerus Fractures

Majority of previous classifications based on two-dimensional images to analyze these complicated 3-D fractures. Small or delicate changes in rotation and positioning can result to considerable disagreement in the interpretation of standard radiographs. Therefore, a classification system which had a better reliability and reproducibility for the fractures is warranted and helpful for orthopedic surgeons. Furthermore, CT and 3-D CT construction images with high resolution give a much clearer view of the pattern of proximal humeral fractures. Edelson proposed a new three-dimensional classification for fractures of the proximal humerus. The results concluded that it was a useful in classifying these injuries with reasonable interobserver reliability.

It could be hypothesized that patients with proximal humeral fractures would benefit from this 3D classification, but there is a scarcity of application of the classification in large samples. T


Eligibility Criteria:
Inclusion Criteria:

* Whole imaging data ;
* Clear record of demographic data;
* Three dimensional construction with mimics (with CT of B30);
* Patients older than 17 years with displaced PHF occurring less than 3 weeks before allocation and treatment.

Exclusion Criteria:

* Patients with the presence of neurological disease (syringomyelia and);
* Open fractures;
* Pathological fracture (other than osteoporotic);
* Not a resident in the hospital catchment area
A Randomized Study of a Short Duration Therapy for Candidemia

Scientific justification Candidemia is a major public health problem. In France, the 30-day mortality of candidemia varies from 30% to 50% depending on the need for intensive care and it has not decreased in 30 years.

The duration of treatment for candidemia was set at a minimum of 14 days after the last positive blood culture following the Rex trial (1) comparing the efficacy of fluconazole vs amphotericin B where the minimum duration of treatment was imposed. The risk of a too short treatment is the absence of control of the candidemia with secondary dissemination, in particular cardiac and ophthalmic.

A retrospective study looking at the risk of ophthalmologic complications after candidemia found among the 21/78 treated for less than 14 days, only one case of late endophthalmitis in a patient who had only been treated for 48 hours. In addition, the prolonged duration of antifungals exposes the risk of selection of more resistant strains with a modification of the flora, with the possibility of acquiring resistance as early as 8 days of treatment with caspofungin, and has a greater liver toxicity.

There is no prospective study on the direct impact of antifungal agents (type of antifungal agent and duration) on the mycobiota.


Eligibility Criteria:
Inclusion Criteria:

* Adults (Age ≥ 18 years old)
* With an uncomplicated candidemia defined by the absence of secondary sites requiring prolonged treatment: endocarditis, ophthalmologic involvement, thrombosed catheter, arthritis, meningitis, candida abscess that cannot be drained, pyelonephritis.
* Without expected aplasia duration greater than 7 days
* Being apyretic and having a 1st negative blood culture after diagnosis
* Removal of the vascular catheter if present
* Written informed consent from the patients or his/her relatives
* Patients with less than 7 days of aplasia predictable

Exclusion Criteria:

* Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or the presence of secondary sites of candidemia requiring prolonged treatment
* Patients with more than 7 days of aplasia
* Candida strain resistant to the antifungal used
* Pregnancy, breastfeeding
* Hypersensitivity or previous severe adverse drug reaction to the antifungal treatments.
* unwilling, in the judgment of the investigator, to comply with the protocol
* Patient under legal guardianship or without healthcare coverage
* Women with childbearing potential not using adequate contraception
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)

This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 40 years of age
* Written informed consent obtained from subject
* Female of non-childbearing potential

Exclusion Criteria:

* Any hepatitis B vaccination.
* Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg
* Pregnancy or lactating female
* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration