cyrilzakka/clinical-trials huggingface dataset:
The Influence of the Ribs on the Gravity of Burst Thoracic Spine Fractures

The purpose of this study is to analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures.

To analyse the anatomic influence of the ribs related to the incidence and severity of burst spine fractures, with the measurements of kyphosis, vertebral collapse and vertebral canal narrowing

Eligibility Criteria:
Inclusion Criteria:

* burst fractures in thoracic spine

Exclusion Criteria:

* fractures that were not burst fractures in thoracic spine
Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use

The purpose of this study is to determine the effectiveness of a medication called suvorexant in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.

Preclinical research has established important functions for the orexin system in mediating arousal/sleep, stress, and cue-induced reinstatement of drug taking (e.g., relapse). The role of stress/anxiety and drug cue reactivity in human drug relapse is well established, but to date, the role of the orexin system in modulating these phenomena has not been examined in humans with substance use disorders (e.g., cocaine). The goal of the present first-in-human study will be to examine the effects of an orexin antagonist (suvorexant) on interactions among stress/anxiety, sleep, and drug-cue reactivity. The study will utilize a battery of highly sensitive, drug-specific, laboratory measures of drug cue reactivity (a relapse risk model), and well-established metrics of stress/anxiety and sleep. The hypothesis is that antagonism of the orexin system will attenuate the link between (1) stress/anxiety and drug cue reactivity, and (2) sleep and drug cue reactivity. These results will elucidate a unique biochemical mechanism for understanding relapse, and provide a potential medication target for relapse prevention.

Eligibility Criteria:
Inclusion Criteria:

* meet current DSM-5 criteria for cocaine use disorder (CUD) of at least moderate severity (≥4 symptoms)

Exclusion Criteria:

* current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
* have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
* significant current suicidal or homicidal ideation
* medical conditions contraindicating administration of suvorexant (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal EEG, severe liver or kidney disease, seizure disorder, or sleep disorder - particularly narcolepsy)
* taking medications known to have significant drug interactions with the study medication(s) (e.g., MAO inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and all sedatives)
* currently or recently (last 3 months) treated for substance use \[other than cocaine or nicotine\] or another psychiatric condition
* conditions of probation or parole requiring reports of drug use to officers of the court; (8) impending incarceration
* pregnant or nursing for female patients
* inability to read, write, or speak English \[required for lab tasks and psychometric scales\]
* unwillingness to sign a written informed consent form
* subjects with alcohol use disorders or are drinking \> 7 alcoholic drinks per week. All subjects who are excluded will be given referral information to other local treatment programs.
Suprapatellar Versus Infrapatellar Nailing in Tibial Fractures: A Pilot Study

This study compares two techniques for the fixation of tibial fractures. The techniques are the suprapatellar (above knee)or infrapatellar (below knee) approach to tibial intramedullary nailing. Null hypothesis: There is no difference in 1) residual post-operative pain levels, 2)knee function, 3) healing and alignment of the tibia, or 4) trochlear changes in the patello-femoral cartilage between patients who are randomized to receive tibial nail insertion through either a suprapatellar nail entry portal or a standard patellar tendon approach.

Patients undergoing tibial fracture repair will be consented and randomized into one of the two techniques, with arthroscopic photos taken before and after nail insertion to study the condition of the patello-femoral cartilage. Enrolled patients will be followed for one year in clinic.

Eligibility Criteria:
Inclusion Criteria:

* Tibial shaft fractures amenable and indicated for repair with intramedullary nails, with or without the use of reaming
* Acute tibial fractures within 4 weeks of injury
* Closed or open tibial fractures after appropriate irrigation and debridement
* Fractures must be within metaphyseal/diaphyseal junctures defined as middle 3/5 of tibia
* Skeletally mature patient
* Age 18 and above.

Exclusion Criteria:

* Tibial shaft fractures that require articular reconstruction with plates
* Any tibial fracture extending \> 1 cm into the proximal or distal 1/5 of tibia
* Tibial plateau fractures
* Pilon fractures
* Periprosthetic fractures
* Non-unions
* Prior knee surgery
* History of gout or rheumatoid or osteoarthritis
* Concomitant injury to same limb (including any traumatic injury to ipsilateral knee, femur or foot, and knee dislocation)
* Spinal injury
* Prisoner or high likelihood of incarceration
* Not likely to follow-up in the estimation of surgeon
* Pregnant females
Remission Rates of New Type 2 Diabetes With Weight Loss and Exercise

This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of \< 6.5%.

This is a study of the effects of weight loss and exercise training on glucose control as measured by the Hemoglobin A 1 C in individuals with recently diagnosed Type 2 Diabetes. Study outcomes are measured at 6 months. The primary outcome is the HBA1c at 6-months. Secondary outcomes include body weight, fitness, lipid profiles and HS-CRP, a measure of inflammation. The study hypothesis is that the program of weight loss and exercise will put \>50% of individuals into "remission" of their type 2 Diabetes as measured by a HBA1c of \< 6.5%.

The study replicates the clinical situation where selected patients with new type 2 diabetes, who are motivated to try an intensive lifestyle intervention, might replicate our study intervention if we are able to show a high remission rate (e.g. \> 50%) for individuals in the study.

Eligibility Criteria:
Inclusion Criteria:

* new diagnosis of type 2 diabetes since 12 months
* BMI\>27
* HBA1c \> 6.5, , 8.0

Exclusion Criteria:

* HBA1c \>8.0
* BMI\< 27
Plain Magnetic Resonance (MR) in the Assessment of Patients With Acute Abdomen

At present, CT is the gold standard in the assessment of patients with acute abdomen. Yet, one CT of the abdomen exposes patients to a radiation dose equivalent to several years of background radiation. MR can be expected to yield the same information without ionizing radiation, but tends to be more time consuming. In this study, patients with nontraumatic acute abdominal pain referred to CT of the abdomen by the department of surgery will also have performed an additional MR scan covering the entire abdomen with few fast imaging sequences in approximately 15min. CT is the diagnostic test. The MR scan is only used for scientific purposes. It will be evaluated by a radiologist blinded for the results of the CT scan. Fourteen days after admission, a final diagnosis is established based on clinical, peroperative, pathological and lab. findings. The performance of CT and MR will then be compared. The investigators hypothesize that MR can provide a diagnostic accuracy comparable to CT.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Age \> 18 years old
* Nontraumatic acute abdomen
* Weight \< 120kg
* Can keep apnoea for 15s
* Surgeon in charge considers patient fit for participation in study

Exclusion Criteria:

* Contraindications of MRI
* Suspicion of acute vascular disease
* Severe cardial or pulmonal insufficiency
* Pregnancy
* Untreated psychiatric illness
Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings for the Diagnosis of Either Acute Kidney Injury or Chronic Kidney Disease in Routine Practices (NEPHROCT)

Kidney biopsy play a key role for the investigation of either acute kidney injury or chronic kidney disease. Despite possible complications due to the invasive nature of the biopsy, such procedure is still essential in a number of clinical situations to improve the diagnosis specificity of kidney disease, better inform about its prognosis and guide the management of a future treatment. Pursuing the idea to improve both performance and rapidity associated with the histopathological analysis of kidney biopsy, with a possible recourse to artificial intelligence-based renal pathology, the present study intends to assess the impact of direct histopathological examination of kidney biopsy with dynamic full-field optical coherence tomography in routine practices for the diagnosis of either acute kidney injury or chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years of age with suspected acute kidney injury requiring biopsy in the nephrology department
* patients \> 18 years of age with suspected chronic kidney disease requiring biopsy in the nephrology department

Exclusion Criteria:

* inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy
A Study to Support the Development of the Enhanced Fluid Assessment Tool for Patients With Acute Kidney Injury

Acute Kidney Injury (AKI) is the sudden and recent reduction in kidney function. This can be detected by measuring a rise in blood creatinine level or from a reduction in urine. Reasons for developing AKI, include dehydration, low blood pressure, medication and infection. When the kidneys stop working, there can be a build-up of toxins and fluid. It is extremely important to identify a patient's fluid status as too little can cause further damage to the kidneys and too much can be harmful. Assessment is varied and often inaccurate and there needs to be a standard approach to fluid assessment.

Acute Kidney Injury (AKI) is the sudden and recent reduction in kidney function. This can be detected by measuring a rise in blood creatinine level or from a reduction in urine. Reasons for developing AKI, include dehydration, low blood pressure, medication and infection. When the kidneys stop working, there can be a build-up of toxins and fluid. It is extremely important to identify a patient's fluid status as too little can cause further damage to the kidneys and too much can be harmful. Assessment is varied and often inaccurate and there needs to be a standard approach to fluid assessment.

Aim:

To develop an Enhanced Fluid Assessment Tool for patients with AKI.

Workstream 1:

Aim: To identify what methods are useful to assess fluid in a patient with AKI. The fluid assessment techniques that are useful and are used, bioimpedance and patient reported signs and symptoms.

Workstream 2:

Aim: To identify the best methods of determining fluid status in a patient with AKI The findings from Workstream 1 will be used to rank the most useful fluid assessment techniques. This will lead to the development of the enhanced fluid assessment tool.

Workstream 3:

Aim: To assess if the tool is practical and clinically useful in determining a patient's fluid status.

The terminology and language will be reviewed and the tool will be used to assess patients and to determine the patients fluid status.

Eligibility Criteria:
Inclusion Criteria:

* Workstream 1 and 3 (phase 3):

Patients who will be included in the study will be Adult patients (over 18 years old) identified as having an acute kidney injury (AKI) within 72 hours of admission to hospital.

Workstream 2:

Experts in fluid assessment (Doctors, Nurses and AHPs). Persons included will be experts in their field of practice and have a recognised expertise in fluid assessment.

Workstream 3:

Phase 1: Experts in fluid assessment (Doctors, Nurses and AHPs). Phase 2: Staff nurses currently working on a clinical ward.

Exclusion Criteria:

* Patients who have kidney failure requiring dialysis or who are being conservatively managed.
* Patients who are receiving end of Life (EoL) care.
* Patients who have a pacemaker as this interferes with bioimpedance (WS1+3).
* There is no baseline creatinine.
* The patient has acquired an AKI 72 hours after admission to hospital.
* The patient has acute coronary syndrome
The Ratio of Hypnotic to Analgesic Potency of Volatile Anesthetics

The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and isoflurane at equi-minimum alveolar concentration using EEG analysis.

Anesthetic agents vary in their relative hypnotic potency. Recent studies demonstrated that equi-minimum alveolar concentration of various volatile anesthetic agents may produce different spectral entropy or bispectral index values. However, there is no study that demonstrate the difference between analgesic potency of volatile anesthetics. The aim of this clinical trial is to evaluate the ratio of hypnotic to analgesic potency of sevoflurane and isoflurane at equi-minimum alveolar concentration using EEG analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing general anesthesia using volatile anesthetics and intubation
* patients with american society of anesthesiologist physical status I, II
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any psychiatric or neurological disease
* patients who had received any medication affecting the central nervous system
* patients who had received medication affecting the sympathetic or parasympathetic nervous systems
* patients undergoing supraglottic airway for airway management
* pregnant women
Endoscopic Evaluation After Esophagectomy

Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.

Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and strictures. However the evaluation and prevention before developing gastric conduit ischemia have been established. The investigators have built a hypothesis that the evaluation for gastric mucosal ischemia in early phase after esophagectomy predict the complication of gastric conduit. Thus, the purpose of this study is the safety and efficacy of endoscopic evaluation about reconstructive organs after esophagectomy. The investigators evaluate endoscopic predictions using classifications in acute phase after esophagogastrostomy.

Eligibility Criteria:
Inclusion Criteria:

* Malignant or end-stage benign esophageal disease.
* Esophagectomy with reconstruction by a gastric pull-up.

Exclusion Criteria:

* Severe heart failure and pulmonary dysfunction
* Severe renal and liver dysfunction
* Allergenic history
* Pregnancy
FRENCH THERAPEUTIC EDUCATION PROGRAM AIMING TO IMPROVE LARYNGECTOMIZED PATIENTS' AND THEIR FAMILY CAREGIVER'S QUALITY OF LIFE

The therapeutic education of patients and their close relations is, as yet, poorly developed in France in the field of oncology (Pérol2007), in particular for cancers of the upper aerodigestive tract (Allison2010). In the case of pharyngeal and laryngeal cancer, total laryngectomy associated with radiotherapy remains a reference treatment for advanced stage cancers. This mutilating surgical procedure has a major impact on the patient's life, due to its physical and functional sequelae: phonatory (loss of physiological voice), feeding, olfactory and aesthetic (tracheostomy). Its psychosocial consequences are also important, owing to the biographical disruption and the identity-related metamorphoses associated with illness and its treatment, which alter the quality of life not only of patients, but also of their close relations. Indeed, transformation is not only at individual level, it also impacts the life of close relations, in particular spouses, who share the day-to-day lives of patients (Babin 2010). Currently, care for laryngectomized patients consist essentially in informing and educating them on certain technical procedures (cannula replacement, mucosity aspiration, tracheostomy or phonatory implant cleaning) during hospital admission. Such education may be formalized and dispensed within the context of a therapeutic education program.

The issue of this study will be to determine what therapeutic education program we should offer patients and their close relations in order to accompany them throughout their experience of laryngectomy and to reduce its impact on social and professional aspects of life.


Eligibility Criteria:
Patient inclusion criteria

* Patients over 18 having been treated by total laryngectomy for cancer of the larynx, pharynx or cervical esophagus.
* Patients accepting to participate in the study (informed consent form explained and signed).
* Patient having not been undergone a PTE
* Person affiliated with an appropriate social security system.

Close relation inclusion criteria

* Person over 18 designated as being a close relation by the laryngectomized patient (confidential person, spouse, parent, natural support person or any person whose quality of life may be impacted by the patient's laryngectomy).
* Close relation accepting to participate in the study (informed consent form explained and signed).
* Person authorized by the patient to be contacted by the investigator, in order to propose his/her participation in the research study.
* Person affiliated with an appropriate social security system.

Patient exclusion criteria - Physical, psychical, psychiatric or cognitive incapacity to answer to questions or participate in interviews/sessions.

Close relation exclusion criteria

- Physical, psychical, psychiatric or cognitive incapacity to answer to questions or participate in interviews/sessions.
Effects of an Immersive Virtual Reality Intervention

Some recent studies demonstrated caregivers may experience negative emotions such as anxiety and sadness, which may also affect normal treatment during the epidemic. As the pandemic continues, mental health support, encouragement , and a sense of purpose are needed to support healthcare workers.


Eligibility Criteria:
Inclusion Criteria:

* Registered nurses (RN) who work in target departments were included. The target departments mainly included internal medicine, surgical, emergency department, where nurses had direct mutual engagement with patients.

Exclusion Criteria:

* Nurses who have not been involved in the COVID-19 volunteer service.
Safety Study of Homeo-GH (Bone Marrow Derived Clonal Mesenchymal Stem Cell) to Treat Acute/Chronic Graft Versus Host Disease (GVHD)

Official Title: Five-Week, Multi-center, Phase I Clinical Trial to Evaluate Safety of Homeo-GH after Intra Venus Administration for the Treatment of Graft versus Host Disease Patients

Sponsor: HomeoTherapy Co.,Ltd

Study Design: Single Group, Open Label, 5 Week, Safety Study

This study is designed to evaluate the safety of ex-vivo cultured adult human clonal mesenchymal stem cells (cMSC) derived from human bone marrow in subjects experiencing acute or chronic graft-versus-host disease (GVHD).

Study Type: Interventional

Allogeneic MSCs being used in current human clinical trials are nonclonal, i.e., such MSCs may have other types of cells in the final stem cell product. Some concerns exist about the heterogeneity of these nonclonal MSCs that are isolated and expanded by the conventional density-gradient centrifugation method. Recently, we developed a new protocol, called the subfractionation culturing method (SCM), to generate single-cell-derived clonal MSC (cMSC) lines from whole bone marrow aspirate without employing any centrifugation step for mononuclear cells and enzyme treatment process. This method allowed us to rapidly establish single-cell-derived human clonal MSC (hcMSC) lines from raw bone marrow aspirates and to establish a library of these hcMSC lines (Song et al., 2008).

The goal of this study is to evaluate the safety of allogeneic cMSCs established by the SCM and manufactured in GMP facility. This phase I clinical trial is a multicenter, single dose study of cMSC (1 x 10e6 cMSCs/Kg recipient's bodyweight). Clonal MSCs will be infused to acute or chronic GVHD patients via an intravenous injection. Every patients will receive the same treatment

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained from patient
* Patients with ages greater than 18 years
* Neutrophill count \> 1,000 cells/mm3
* Adequated cardiac function with no evidence of cardiac disease
* Patients who had complete remission after bone marrow transplantation
* Patients who can sign an informed consent form by him- or her-self or legal representative

Exclusion Criteria:

* Patients with unstable transplant after bone marrow transplantation
* Patients with unstable vital sign
* Patients with positive penicillin skin test
* Patients who had transplantation to treat solid tumor
* Patients with bacterial, viral or fungal infection not being controlled by the adequate treatment (more than moderate infection)
* Patients who, in the investigator's point of view, are not in proper state for the treatment
Transperineal Laser Ablation for Low- and Intermediate Risk Prostate Cancer: a Single Cohort Analysis

The goal of this prospective study is to test the efficacy of Echolaser transperineal focal therapy in patients with low- and intermediate risk prostate cancer. The main question it aims to answer are: 1. short and intermediate term oncological outcomes after laser focal therapy, 2. functional outcomes and quality of life after treatment. Participants affected by low risk prostate cancer will undergo trans perineal laser focal therapy. Multiparametric prostate MRI will be perform after 3 and 12 months for oncological control. Re-fusion biopsy will be perform after 12 months. Functional outcomes and quality of life will be assess at 3, 6 and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with low- and intermediate risk prostate cancer classified as International Society for Urological Pathology, ISUP 1-2.

Exclusion Criteria:

* patients diagnosed with urothelial cancer
* contraindications for MRI
* Multifocal prostate cancer