cyrilzakka/clinical-trials huggingface dataset:
Ultrasonographic Identification of the Proximal Humerus Landmarks

Evaluate whether discrete landmarks of the proximal humerus can be identified using ultrasound in patients with various body habitus and BMI.

There are three main forms of vascular access: peripheral intravenous (PIV), Central venous (CV) and intraosseous (IO). Of the different types of vascular access PIV and CV access have drawbacks when used during resuscitation, because they can be difficult to obtain when patients are volume depleted as in cases of trauma. Attempting CV access has numerous risks with complications occurring in up to 33% of attempts. These include failed placement (22%), arterial puncture (5%), catheter malposition (4%), pneumothorax (1%) and asystolic cardiac arrest (\<1%). Attempting to obtain CV access may also disrupt chest compressions in cases of cardiac arrest. Intraosseous access has been used in scenarios where PIV and CV access is difficult or impossible to obtain. Pharmacokinetic studies and standard practice support the bioequivalence of intraosseous and intravenous administration of common medications. Intravascular depletion does not hinder attempts at IO access, and as the insertion sites are peripheral to the heart, insertion can be done avoiding interruptions in chest compressions. Obtaining proximal humerus interosseous (PHIO) access may also be faster than obtaining both PIV and CV access with a relatively low complication rate. In one survey, complications of IO included difficulty in identifying correct anatomical site (3%), extravasation (3.7%), displacement after insertion (8.5%), and very rarely late complications including compartment syndrome (0.6%), osteomyelitis (0.4%) and skin infection (0.3%).

Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age or older undergoing general, cardiac, thoracic or vascular surgery.
* BMI \>= 18.5 kg/m\^2

Exclusion Criteria:

* Limited mobility/ range of motion of arms
* Prior surgical intervention on shoulder or humerus
* History of arm dislocation with internal rotation
* History of arm fracture
* BMI in ranges: 25.1 - 29.9, 35.1 - 39.9
Retrospective Analysis of 68Ga-PSMA-PET in Patients With Prostate Cancer: Experience From Brazil

Gallium-68-prostate-specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) has been increasingly used in the management of PCa in Brazil. Thus, the detection of metastatic lesions is improved over traditional methods e.g. MRI and the diagnosis of mCSPC patients has been proportionally increasing. Due to a lack of guidelines and clinical trials including 68Ga-PSMA-PET imaging, the management of these patients is extrapolated from data based on conventional imaging. Treatment decision and duration of treatment for mCSPC patients based on 68Ga-PSMA-PET imaging is currently unknown. 68Ga-PSMA-PET allows a diagnosis of a different set of low volume oligo-metastatic prostate cancer patients. Based on that, a new gap has been built up, since there are no standards of how those patients are managed and how they respond to conventional therapies, to metastasis direct therapy or even if they could be spared of any treatment, reducing costs and toxicities. This patient population has not been included in clinical trials and its critical to generate information on the diagnosis, treatment and outcome of these patients in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age of at least 18 years at study entry;
2. Histologically confirmed adenocarcinoma of the prostate;
3. 68Ga-PSMA-PET exam performed between October 2015 and January 2021;
4. 68Ga-PSMA-PET performed in one of the following situations:

   * localized disease at diagnosis in patients with no detection of extra-prostatic disease in traditional imaging such as CT scan, MRI and bone scan;
   * biochemical recurrence (according to PCWG3 or defined by the investigator) in patients with no detection of prostatic or extra-prostatic disease in traditional imaging such as CT scan, MRI and bone scan;
5. Traditional imaging (pelvic and abdominal CT or MRI and bone scan) with negative results (no extra-prostatic disease, for localized and biochemical recurrence disease; no prostatic for biochemical recurrence disease) performed within 8 weeks before 68Ga-PSMA-PET;
6. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records.

Exclusion Criteria:

1. Patients with no disease characteristics accessible in medical records;
2. Cancer diagnosis other than prostate cancer in the last 5 years;
3. Disease detected by traditional imaging techniques (bone scan, CT and/or MRI), meaning extra-prostatic disease, for localized and biochemical recurrence disease; or prostatic disease for biochemical recurrence disease.
Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

RATIONALE: Prinomastat may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase II trial to study the effectiveness of prinomastat plus temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.

OBJECTIVES: I. Compare the one year survival rate and progression free survival of patients with newly diagnosed glioblastoma multiforme treated with prinomastat (AG3340) or placebo and temozolomide following radiotherapy. II. Compare the safety of these regimens in these patients. III. Compare the quality of life in these patients on these regimens.

OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive oral prinomastat or placebo twice daily in combination with oral temozolomide daily on days 1-5. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Newly diagnosed glioblastoma multiforme Must have completed all appropriate subtotal or total surgical procedures (surgical biopsy alone not eligible) Must have received prior external beam radiotherapy No multifocal glioblastoma multiforme No radiographic disease progression during post surgical radiotherapy

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Stable steroid therapy for at least 2 weeks prior to study Radiotherapy: See Disease Characteristics No prior interstitial brachytherapy or radiosurgery Surgery: See Disease Characteristics No prior radiosurgery
Integrating Behavioral Therapy in the Management of Temporomandibular Disorders: A Comprehensive Evaluation Using DC/TMD Axis II Criteria

This study evaluates the efficacy of behavioral therapy, including Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback, in managing Temporomandibular Disorders (TMD). It aims to address both the physical and psychological aspects of TMD, focusing on pain reduction, improved jaw function, and alleviating psychological distress such as anxiety and depression. Participants are randomized into two groups: an intervention group receiving behavioral therapy and a control group receiving standard care. Outcomes will be assessed using validated tools to measure pain intensity, jaw function, and psychological well-being at baseline, post-treatment, and at a 6-month follow-up. This research seeks to establish the role of behavioral therapy as a key component in the comprehensive management of TMD.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-65 years.
* Diagnosed with Temporomandibular Disorders (TMD) based on DC/TMD Axis I and Axis II criteria.
* Presenting with symptoms such as jaw pain, limited jaw movement, or psychosocial distress (anxiety, depression).
* Willing and able to provide informed consent.
* Able to comply with the study protocol and attend all follow-up visits.

Exclusion Criteria:

* Severe systemic diseases or other neurological conditions that could interfere with treatment or outcomes.
* History of psychiatric disorders unrelated to TMD, such as schizophrenia or bipolar d disorder.
* Pregnant or lactating women.
* Use of medications or treatments within the past month that could influence study outcomes (e.g., corticosteroids, strong analgesics).
* Individuals with severe dental or maxillofacial conditions requiring immediate surgical intervention.
* Non-compliance with previous medical advice or treatment for TMD. Participants unable to understand or follow the study procedures due to language barriers or cognitive impairments.
Fiber and Insulin Sensitivity

Based on previous research of the investigators group, the investigators hypothesize that slowly fermentable fibers with a high degree of polymerization that increase SCFA specifically in the distal colon are expected to have higher potential for influencing host metabolism and metabolic health by improving adipose tissue function, preventing lipid overflow and hepatic as well as skeletal muscle fat accumulation thereby improving insulin sensitivity.

The objective of this randomized clinical trial is to test, whether the a dietary fiber product containing different physiological acting fibers reverses peripheral and hepatic insulin resistance in overweight/obese insulin resistant participants.


Eligibility Criteria:
Inclusion criteria:

Overweight/obese insulin resistant/prediabetic participants (age 45-70 y, BMI ≥ 28 kg/m2 \< 35 kg/m2)

Exclusion criteria:

* Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L and 2h glucose ≥ 11.1 mmol/L)
* Gastroenterological diseases or abdominal surgery;
* Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life expectancy shorter than 5 years;
* Abuse of products; alcohol and drugs, excessive nicotine use defined as \>20 cigarettes per day;
* Plans to lose weight or following of a hypocaloric diet;
* Regular supplementation of pre- or probiotic products, use of pre- or probiotics 3 months prior to the start of the study;
* Intensive exercise training more than three hours a week;
* Use of any medication that influences glucose or fat metabolism and inflammation (i.e. NSAIDs);
* Regular use of laxation products;
* Use of antibiotics in the last three months (antibiotics use can alter substantially the gut microbiota composition).
* Follow a vegetarian diet.
* Metal objects such as implants present in the body (e.g. electronic implants, pacemakers, metal fragments in the eyes, skin or body)
* The use of permanent make-up (eyeliners, eyebrows) or tattoos on the head, shoulders, breast or neck
* Claustrophobia
Pilot Study: Echocardiographic and Hemodynamic Effects of Esmolol in Septic Shock Patients

After initial hemodynamic stabilization, 36 septic shock patients with heart rate \> of 90 bpm and requiring norepinephrine to maintain mean arterial pressure (MAP) more than 65 mmHg will be randomised into two groups, esmolol group and control group. Patients allocated to esmolol group will receive a continuous esmolol infusion to maintain a lowering of heart rate of 10%. Norepinephrine will be titrated to achieve a MAP more than 65 mmHg. To investigate myocardial performance, the investigators will assess Tissue Doppler imaging by echocardiography and hemodynamic measures. Data will be obtained at baseline ,after esmolol infusion once achieved the predefined heart rate threshold and 72hours after esmolol infusion.

primary outcome were determined according to our previous study of tissue doppler.

Eligibility Criteria:
Inclusion Criteria:

* septic shock
* fluid optimization
* with a cardiac index \> 3 l/min/m2
* Heart Rate \>90 /min

Exclusion Criteria:

* Cardiogenic shock
* Bradycardia
* History of Severe Asthma
* Indications against Esmolol
Evaluation of Efficacy of Comprehensive Genomic Tumour Profiling (CGP) from Liquid And/or Tissue Biopsy in Patients with Locally Advanced And/or Metastatic Solid Cancer

The aims of this study are

* to evaluate the efficacy of comprehensive genomic tumour profiling (CGP) from liquid and/or tissue biopsy in patients with locally advanced and/or metastatic solid cancer.
* to evaluate and describe the impact of treatment decisions based on CGP on individual progression free survival in patients with locally advanced and/or metastatic solid cancer
* to evaluate and describe similarities and differences between the treatment suggestions based on CGP/IHC (immuno-histochemistry) of tissue biopsy and liquid biopsy.

In patients with locally advanced and/or metastatic carcinoma the primary efficacy objective of the study is, to observe and describe the PFS (progression-free survival) of the matched treatment compared to the PFS of the most recent therapy.

The SOUND study will be exploring the treatment rates and outcomes of CGP-driven targeted treatment in patients with advanced or metastasized cancer. It will use a substantially larger gene-panel than previous studies in Austria. Departing from the routine clinical practice, study patients will have the opportunity to have CGP from liquid and/or tissue biopsy. The treatment decision will be discussed within a molecular tumour board consisting of experts in clinical oncology, human genetics and pathology. The treatment decision process will be supported and documented by a software.

Data from the SOUND study will cover the whole analysis process, the reasons for the treatment decision, reasons for getting or not-getting a matched treatment as well as the outcome, treatment and hospitalisation costs. The SOUND study will give valuable insights into the clinical practice of CGP-driven therapy in Austria and describe the experience and the possible restrictions. Considering the differing conditions in Austria, the SOUND study will generate data that might be useful for best practice sharing with other countries in the future.

Eligibility Criteria:
Inclusion Criteria:

* Initial diagnosis of histologically confirmed locally advanced and/or metastatic solid cancer
* Radiologically confirmed progression under the most recent therapy
* No further evidence-based drug treatment is established, or no satisfactory alternative treatments are available for the locally advanced and/or metastasized carcinoma
* Further therapy is medically feasible
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Life expectancy of at least 12 weeks
* Written informed consent and willingness to cooperate during the course of the study
* Capability to understand the intention and the consequences of the study

Exclusion Criteria:

* Untreated CNS (central nervous system) metastases. Patients with treated CNS metastases are eligible if they are clinically stable with regard to neurologic function
* Pregnant or breast feeding
* Other malignomas, diagnosed \< 5a before inclusion (except localized squamous cell carcinomas of the skin, surgically curable melanomas of the skin, basal cell carcinomas of the skin)
The Association Between Variation in Oxygen Saturation (ScO2) and Incidence of Postoperative Cognitive Dysfunction (POCD) in a Population of Elderly Patients Admitted for Emergency Surgery.

There is no study of the association between ScO2 and POCD in non-cardiac, thoracic or vascular surgery. The few studies found in cardiac, thoracic and vascular surgery show an incidence up to 50% with a variation of the ScO2 threshold which varies between 15 and 25% according to the studies.

Age is the main risk of OCDD. The management of this pathology should be early to avoid loss of autonomy of the patient. Finding a relationship, if it exists, would therefore significantly improve the mortality and morbidity of the said patient.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years
* Non-cardiac, thoracic and vascular emergency surgery
* Surgery under general anesthesia
* ASA I, II or III
* Simple information without consent
* Patient affiliated to social security

Exclusion Criteria:

* Inability to understand
* Patient under tutelage, or curatorship or deprived of public right
* ASA IV
* History of severe dementia MMSE \<20
* Personal or familial history of malignant hyperthermia
* History of allergy or hypersensitivity to anesthetic products used
* Contra-indication to Cisatracurium®: myasthenia gravis
* Contra-indication to Sevoflurane®
* Contra-indication to local anesthetics
* Indication of use of a Ketamine®-type hypnotic (modification of the BIS)
* Indication of use of nitrous oxide
* History of cranial trauma
* Neuromuscular pathology
* Spinal anesthesia
* Cardiac, thoracic or vascular surgery
* Surgery not performed in emergency
* Neurochirugia in the context of cranial trauma
* Any surgery that does not allow the use of the NIRS (impossibility of positioning of the electrodes by the location of the surgical field).
Cold Vibratory Stimuli on Pain Perception Governing Infiltration Anesthesia in in Children

Local anesthesia injections are sometimes painful, resulting in antagonistic cooperation, fear, and anxiety in children. This study aims to investigate the effectiveness of vibratory and cold stimulation before the injection to reduce pain. Purpose of the study: Evaluate the effectiveness of Buzzy® in pain reduction during local anesthesia administration compared to the traditional topical anesthetic gel in pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are in need of extraction of maxillary posterior teeth.
* Children free of any systemic disease or special health care needs (ASA I).
* Children with no learning disabilities.
* Positive or definitely positive behavior during preoperative assessments according to the Frankl Scale.
* Patients whose parents will give consent to participate.

Exclusion Criteria:

* Having active sites of pathosis in the area of injection that could affect the anesthetic assessment.
* Signs of reversible pulpitis.
* Restorable tooth.
* Patients allergic to local anesthesia or having a family history of allergy to local anesthesia.
* Patients with acute oral or facial infection (swelling and/or cellulites )
Exploratory Study on Safety of PEEK Knee Prosthesis

In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.

According to the involved person's biomedical research ethics review method "(national health and family planning commission (11)) and the medical and health institutions to carry out the researchers launched a clinical research management method" (draft) on request, for national key development plan required for research and development production of PEEK knee prosthesis for clinical trials. In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.

Since this study is an exploratory study, all subjects will be retrospectively studied one year after the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 55 years of age or older and less than 74 years of age, younger subjects should have urgent need for surgery.
* Subjects skeletal maturity.
* Subjects appropriate for total knee replacement, such as noninflammatory degenerative joint diseases (such as osteoarthritis, traumatic arthritis, or ischemic necrosis); Inflammatory degenerative joint diseases (including rheumatoid arthritis); Correction of functional deformity.
* The diseased side knee appropriate for primary total knee arthroplasty .
* Subjects or guardian is willing and able to sign the informed consent form .

Exclusion Criteria:

* Subjects with knee instability or abnormal gait caused by neuromuscular insufficiency.
* Subjects with bilateral knee joint disease who are expected to require replacement of both knees during the course of the study (i.e., within the next 12 months) .
* Alcoholics, drug addicts and drug abusers.
* Subjects with severe diabetes (fasting blood glucose \> 10mmol/L)
* Body Mass Index, BMI\>35.
* Female subjects who are pregnant or lactating.
* Subjects have disease limited their participation in the investigation or have an existing condition that would compromise their participation and follow-up in this clinical investigation.
* In the month before inclusion, subjects who participated in clinical studies of other drugs, biological agents or medical devices and failed to meet the main research endpoints.
* Other conditions, in the opinion of the Investigator, are inappropriate for participation in this clinical investigation.
Neuropsychological Indicators of SCD Progression

Some patients with subjective cognitive decline (SCD) progress to neurocognitive disorders (NCD), whereas others remain stable; however, the neuropsychological determinants of this progression have not been identified. The investigators objective was to examine baseline neuropsychological indicators that could discriminate between people in whom the SCD progressed to a mild or major NCD and people in whom the SCD remained stable.

The investigators retrospectively included patients consulting for SCD at a university medical center's memory center (Amiens, France) and who had undergone three or more neuropsychological assessments at least 6 months apart. The relationship between domain-specific scores and the global cognitive score (GCS, as a function of final status (stable SCD vs. progression toward a mild or major NCD)) was examined using a generalized linear mixed model.


Eligibility Criteria:
Inclusion Criteria:

* patients who had been referred to the memory center at Amiens University Medical Center (Amiens, France).
* patients who had undergone three neuropsychological assessments at least 6 months apart, from 2005
* patients who met the criteria for SCD.

Exclusion Criteria:

* patients who didn't meet the criteria for SCD
Gene Expression Changes In Young and Geriatric Skin

This study does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. There is evidence that in response to ultraviolet B radiation (UVB), which are the burning rays of sunlight, young adult skin responds differently than geriatric skin. In fact, researchers feel that this difference in how the skin reacts to UVB is why skin cancers are found in older skin. Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1), whereas geriatric skin has very little. The current study will test how young adult versus geriatric skin responds to UVB, and if geriatric skin treated with an injection of small amount of IGF-1 drug will then act like young skin.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female
* White skin (Fitzpatrick types I and II)
* Age 21-30 or 65 and older
* Able to comprehend procedures/risks

Exclusion Criteria:

* Known photosensitivity
* Currently on photosensitizing medications
* Diabetes Mellitus
* History of abnormal scarring
* History of skin infections
* Known allergy to lidocaine local anesthetic
* Pregnancy or nursing
* Other serious health issues