cyrilzakka/clinical-trials huggingface dataset:
Immediate Implants in Maxillary Premolar Region Using Xenograft vs Allograft

Immediate implant placement has the disadvantage of difficulty in obtaining primary stability, lack of adequate soft tissue coverage and also the control of the implant position is difficult in addition to the cost of the graft. Autogenous bone graft is considered to be the golden standard for grafting as it has osteoconductive , osteoinductive and osteogenic functions , however it has the problems of donor site morbidity , the need for two surgeries as well as post operative swelling and discomfort of the patient , so alternative bone grafts as allografts and xenografts, has been introduced.

Allograft bone is obtained from individuals of the same species, derived from human-cadaver bone that has been selected and tested to be free of HIV and transmitted diseases. The most common allograft used is dematerialized freeze-dried bone allograft (DFDBA), provide type I collagen, which comprises most of the organic component of bone. In addition, allograft contains BMPs, which stimulate osteoinduction. There are thirteen proteins have been identified (BMP1-BMP13) which are osteoinductive compounds and stimulate new bone formation. A previous study demonstrated that, a combination of osseous coagulum collected during preparation and freeze-dried bone allograft placed at immediate implant insertion and loading. Xenografts are one of the most successful and widely used grafting materials nowadays as a replacement for autogenous bone grafts. Studies showed that xenografts are very successful because of their osteoconductive properties, their denisty which provides stabilization to the graft and implant and they supply the necessary minerals for bone formation as xenograft don't resorb completely.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with badly broken teeth in upper premolar zone indicated for extraction, presence of at least 3 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony walls after extraction.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Burst Spinal Cord Stimulation for Neuropathic Pain.

This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.

SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms.

Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed below detection level. Thus, it is possible to do double-blinded sham-controlled studies.

In this study, we will study the effect of burst SCS compared with sham on pain intensity and function (Patient-Specific Functional Scale). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).

Eligibility Criteria:
Inclusion Criteria:

* History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate.
* Understand Norwegian or Swedish language (written and spoken).
* Usual pain intensity ≥ 3.5 / 10 (NRS 0-10)

Exclusion Criteria:

Absolute

* Opioid dose \> 100 mg morphine equivalents / day
* Ongoing litigation
* Mental / psychiatric disorder that may affect treatment
* Chronic generalized pain
* Pregnancy
* Hypersensitivity to local anesthetics
* Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders
* Laminectomy in or above level for planned epidural access
* Spine surgery the last 3 months

Relative

* Ongoing medication that affects coagulation or platelet function
Surrogate Markers for Sudden Cardiac Death in Patients With Diabetes Mellitus and End Stage Renal Disease

Aim: Patients with type 2 diabetes mellitus (T2DM) and hemodialysis due to diabetic nephropathy exhibit a high risk for sudden cardiac death (SCD). Preliminary data suggest that beta-blocker treatment may reduce arrhythmias and mortality in this high-risk population. However, no results from large-scale clinical outcome trials with beta-blockers exist in this patient group and a broad, scientifically unapproved use of beta-blocker treatment may not be justified due to potential harmful side-effects such as AV-block or hypotension. In addition, we are lacking identified ECG surrogate parameters for SCD in this high-risk population and on the occurrence of arrhythmias in temporary relationship to hemodialysis sessions.

Therefore, the present study will identify surrogate parameters of SCD in hemodialysis patients with T2DM and in an interventional trial investigate the suppressive effect of beta-blockers on these identified ECG markers.


Eligibility Criteria:
Inclusion Criteria:

* patients with diabetes mellitus type 2
* chronic hemodialysis at least since 3 months
* aged above 18 years
* written informed consent
* legally competent

Exclusion Criteria:

* intake of bets-blockker within the last four weeks
* pregnancy and breast feeding
* abuse of drugs and alcohol
* missing compliance
* life expectancy \< 6 month
Medical Hypnosis and Stress Reduction in Hospitalization

Patients with chronic diseases, especially rare diseases with uncertain diagnoses, have a representation of their disease and an experience of their hospitalization that is sometimes traumatic, distressing and painful. Patients hospitalized can benefit from non-medicinal techniques, such as medical hypnosis, which could improve the perceived stress in these patients and thus optimize the hospitalization experience. The aim of this study is to evaluate the impact of medical hypnosis in reducing stress and improving the experience of hospitalization comparing two groups : a group (cases) benefiting from an hypnotic technic " the place of safety " and a control group without intervention during hospitalization


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised in the internal medicine department of the Lille University Hospital
* Age\>= 18 years
* Patients having expressed their non opposition

Exclusion Criteria:

* Not covered by the social security system
* Person unable to receive informed information
* Persons deprived of liberty
* Persons under legal protection (guardianship / curatorship)
* Psychotic and/or dementia disorders
* Pregnant and breastfeeding women
Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.

Evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.

This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.

Eligibility Criteria:
Key Inclusion Criteria:

* Males and females, 46 years of age or older
* A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery
* Pseudophakic with prior uncomplicated cataract surgery

Key Exclusion Criteria:

* Angle closure, congenital, or secondary glaucoma
* Diagnosed degenerative visual disorders
* Clinically significant intraocular inflammation or infection
Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached)

The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is typically provided to children with mild to moderate sleep onset latency and/or bedtime resistance difficulties. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime resistance).

The purpose of the Family Help Sleep Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 80 children (6-12 years of age)suffering from mild to moderate sleep onset latency and/or bedtime resistance will be randomized.

The intervention is delivered from a distance, using an educational handbook and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.

Eligibility Criteria:
Inclusion Criteria:

* children 5-12 years of age
* attending grades primary-6 (Elementary School)
* sleep onset latency and/or bedtime resistance
* speak and write English
* provides parental authorization
* has access to telephone in home

Exclusion Criteria:

* any mental health disease with the exclusion of disruptive behavior disorder
* neurological conditions
* moderate to severe cognitive impairment
* has received a behavioral intervention for sleep difficulties in the past 6 months
* nocturnal enuresis
* sleep apnea
* co-sleeping
Evaluation of Accuracy and Precision of a New Arterial Blood Gas Analysis System Blood in Comparison With the Reference Standard

Evaluate the precision and accuracy of the Proxima 3® System by obtaining quantitative clinical data at various time points. Compare the methods associated with obtaining blood gas results using the Proxima 3® System device versus a conventional ABG analyse. The aim of the investigator is to evaluate the precision and accuracy of the Proxima 3® ABG system parameters (pH, pCO2 pO2, hematocrit and potassium) in clinical practices with rapid changing context.

In this study the investigator will test the applicability of the Proxima 3® ABG system in a heterogeneous patient population consisting of patients scheduled for hybrid atrial fibrillation surgery, patients scheduled for heart valve surgery, complex cardiac surgery with deep cooling, spine surgery or patients with expected major blood loss. The investigator will compare the ABG values obtained with the traditional ABG measurement system of the hospital.

The availability of a disposable patient-dedicated blood gas analyser allows rapid, frequent measurement of blood gases in theatre without the loss of theatre staff. As well as facilitating measurement in the unstable patient, this approach opens up the possibility for more frequent measurement to identify patient deterioration before a crisis occurs.

The conventional laboratory ABG method uses sensor technology for pH, pCO2, pO2, sodium, potassium, calcium, glucose and lactate levels. It measures hemoglobin concentration via spectrophotometry methodology at a set wavelength of 467-672 nm. The blood gas laboratory uses ABL90 Flex (Radiometer®). The optical system is based on a 138-wavelength spectrophotometer with a measuring range of 467-672 nm. The spectrophotometer is connected via an optical fiber to a combined hemolyzer and measuring chamber.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ≥18 years old
* Patients who have (or will have) an arterial line, which was (will be) inserted for clinical - need, will be considered for inclusion in this study
* Patients who give informed consent (or their personal/nominated consultee) to participate in the study
* Patients who are likely to have an arterial line for at least 6 hours.

Exclusion Criteria:

* Patients contraindicated for an arterial line
* Refusal of consent by a patient
* Not for use with patients with uncorrected hyperphosphataemia, hypocalcaemia or hypercalcaemia.
* The patient is considered to be unsuitable for the study by the investigator
Irreversible Electroporation(IRE) For Uterine Cervical Neoplasms

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Uterine Cervical Neoplasms.

By enrolling patients with unresectable Uterine Cervical Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Uterine Cervical Neoplasms.

Eligibility Criteria:
Inclusion Criteria:

* Uterine Cervical Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants

This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults. The study will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD), Part 2 will investigate multiple ascending doses and drug-drug interaction (MAD/MAD DDI) Part 3 will investigate single dose relative bioavailability (RBA) of a new formulation of VH4004280.


Eligibility Criteria:
Inclusion criteria:

* Participant must be 18 to 55 years of age inclusive.
* Participants who are overtly healthy.
* Male or female participants of non-childbearing potential.
* Capable of giving signed informed consent.

Exclusion criteria:

* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neurological or psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug or interfering with the interpretation of data.
* Abnormal blood pressure.
* Symptomatic herpes zoster.
* Evidence of active or latent tuberculosis (TB).
* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Breast cancer within the past 10 years.
* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* QT interval corrected for heart rate according to Fridericia's formula (QTcF) greater than (\>)450 milliseconds (msec).
* Past or intended use of over-the-counter or prescription medication including herbal medications.
* Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the study.
* Exposure to more than 4 new investigational products within 12 months prior to the first dosing day.
* Current enrollment or past participation in another investigational study.
* ALT \>1.5 times upper limit of normal (ULN), total bilirubin \>1.5 times ULN, and/or estimated serum creatinine clearance less than 60 milliliters per minute.
* History of or current infection with hepatitis B or hepatitis C.
* Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test, having signs and symptoms, or having contact with known Coronavirus Disease-2019 (COVID-19) positive person/s.
* Positive HIV antibody test.
* User of tobacco or nicotine-containing products, regular alcohol consumption and/or regular use of known drugs of abuse.
* Sensitivity to the study drug, or components thereof.
Continuous Infusion of Linezolid Versus Intermittent Dosing in the Treatment of Nosocomial Pneumonia

The investigator's goal in this study is to determine the clinical efficacy and safety of continuous infusion in comparison with standard intermittent infusion.

Prospective randomized controlled clinical trial on critically ill Pneumonic patients, included two groups, over one year period. The first group will be administered intravenous (IV) linezolid 600mg twice daily. The second group will be prescribed linezolid (IV) 600 mg loading dose followed by 1200 mg by continuous infusion. Both groups will be co-administered intravenous (IV) Meropenem 1g every 8 hours empirically.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICUs diagnosed as HAP or VAP
* Chest X-ray/ computed tomography showing new or progressive infiltrate.
* New onset of purulent sputum or change in sputum character.
* Body temperature greater than 38 ℃ or less than 35.5℃.
* White blood cell counts greater than 10000 /mm3 or less than 4000 /mm3.
* Significant quantitative pathogen cultures from respiratory secretions.

Exclusion Criteria:

* Age \<18 years, Pregnancy, Lactation
* Previous known allergic reaction to linezolid
* Creatinine Clearance (CrCl) \<10 mL/min, calculated according to the Cockcroft-Gault formula
* Thrombocytopenia (platelet count less than 80,000/mm3)
* Severe hepatic failure (Child-Pugh C)
* Concomitant treatment with other drugs that can potentially interfere with Linezolid (i.e., macrolides, serotonin modulators, omeprazole)
* Acute DIC score \> 4 points or hematological disorder
* Concurrent drug-associated Thrombocytopenia
DOORS: A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes Who Change From Dipeptidyl Peptidase-4 Inhibitor (DPP4i) Treatment to Oral Semaglutide in Italy

The purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who change their treatment from DPP4i to oral semaglutide. Participant will get oral semaglutide as prescribed by the study doctor. The study will last for about 5-6 months. Participants will be asked to complete two questionnaires. One will be about eating behaviour and the other one will be diabetes related. Participant will complete this questionnaire during the normal scheduled visit with study doctor. Participants will be asked questions about their health and diabetes treatment and lab tests as part of their normal doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to switch from DPP4i treatment to commercially available oral semaglutide has been made by the participant/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the participant in this study
* Participant with last measurement of HbA1c \>= 7.5% at informed consent and treatment initiation visit (V1) or less than or equal to (\<=) 90 days before informed consent and treatment initiation visit (V1)
* Treatment naïve to insulin. An exception is short-term insulin treatment for acute illness for a total of \< 14 days

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the informed consent and treatment initiation visit (V1) and throughout the duration of the study
* Participants with type-1 diabetes
* Participants who are pregnant or who become pregnant (or who plan to become pregnant) during the study period
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Age \< 18 years on the informed consent and treatment initiation visit (V1)
A Storage Facility for Tissues Obtained from Patients with Malignant Melanoma

This study collects and stores blood and tumor samples from patients with malignant melanoma and healthy individuals. The purpose of this study is to gain a better understanding of the causes of melanoma and how melanoma tumors behave. Storing blood and tumor samples for future research may lead to new discoveries that may ultimately help with diagnosing or treating this disease.

PRIMARY OBJECTIVE:

I. Facilitate studies aimed at investigating new prognostic markers and potentially therapeutic therapies in malignant melanoma.

OUTLINE:

Patients undergo collection of blood samples at the time of the initial diagnostic work-up, and possibly prior to the initiation of surgery, chemotherapy, immunotherapy, or radiation therapy, at tumor progression or recurrence, and annually during routine follow-up (no more than 4 blood draws per year). Patients may also undergo collection of tissue sample during standard of care surgical or radiologic procedures. Healthy individuals undergo collection of blood samples up to 4 times over 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patient with malignant melanoma or personal history of melanoma
* Normal donors
* Informed consent can be obtained
* Patients with any stage of malignant melanoma

Exclusion Criteria:

* Incarcerated individuals will be excluded from this protocol
Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex

Nicotine enhances auditory-cognitive function because it mimics the brain's system for "paying attention" to important sounds amid distractions (for example, understanding speech in a noisy environment). In part, nicotine does this by activating inhibitory neurons in the auditory cortex. Since age-related hearing deficits result, in part, from the loss of inhibitory neurons in auditory cortex, this project will determine whether nicotine's effects can compensate for reduced inhibition in the aging auditory cortex and thereby restore auditory function.

The investigators will use functional magnetic resonance imaging (fMRI) to measure the selectivity of responses in auditory cortex to tones of various frequencies. The investigators will measure the effects of nicotine (administered as chewing gum) and aging on these fMRI response properties. The investigators hypothesize that frequency selectivity will decrease with aging and increase following nicotine administration.


Eligibility Criteria:
Inclusion Criteria:

* non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency

Exclusion Criteria:

* deafness or excessive hearing loss
* smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
* history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
* regular use of prescription medications (excluding oral contraceptives)
* drug dependency