cyrilzakka/clinical-trials huggingface dataset:
Selection of Chronic Low Back Pain Patients for Neurotomy Surgery Radiofrequency

Chronic low back pain is one of the leading causes of disability associated with significant health care costs. One possible management of chronic low back pain of facet origin is neurotomy-radiofrequency (NT-RF) intervention. Currently, to determine whether a patient is eligible for NT-RF, two positive block tests are required.

Clinical examination with a homolateral extension-rotation-tilt maneuver of the spine (ERI maneuver) would have the potential to identify subjects with pain of facet origin. It could therefore be a simple and effective diagnostic tool in the evaluation of a patient with low back pain and help in the decision whether or not to perform a test block by local infiltration of the zygapophyseal joint prior to an NT-RF procedure.

The purpose of this longitudinal, prospective, observational, single-center study is to evaluate the performance of the combined extension-rotation-lateral tilt maneuver (ERI maneuver) in predicting the response to neurotomy-radiofrequency intervention in patients with chronic low back pain.

The included patients will answer 5 questionnaires, in addition to the usual clinical data:

* Hospital Anxiety and Depression scale (HAD) questionnaire,
* Quality of life questionnaire EQ-5D-5L,
* Brief Pain Inventory - French version: Questionnaire Concis de la Douleur (QCD),
* Functional Impotence Scale for Low Back Pain: The Quebec Back Pain Disability Scale
* Clinical Global Impression of Change (CGI-C)


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the chronic pain service at the Calot Institute with chronic low back pain for at least three months, not responding to well-conducted conservative treatment
* Age 18 - 65 years
* Patient did not object to the use of their data
* Patient affiliated to a social security plan

Non inclusion Criteria:

* Patient with a disorder of hemostasis
* Patient with a history of arthrodesis
* Patient with radiologically visible root damage
* Patient with instability of the spine
* Patient with an abnormality on dorso-lumbar MRI: MODIC 1
* Patient under legal protection :

  * Person under guardianship,
  * Person under curatorship,
  * Person under legal protection,
  * Person deprived of liberty,
* Pregnant or breastfeeding woman
Assessment of Breathing Pattern During NIV

COPD and OHS are respiratory conditions that disrupt normal breathing. Positive airway pressure, specifically Non-Invasive Ventilation (NIV), has been shown to improve breathing and reduce symptoms in patients with these conditions. Regular use of NIV can lead to better symptom management, improved quality of life, and reduced use of healthcare resources. The type of mask used for breathing support can greatly affect a patient's comfort and willingness to use it. For conditions like Obstructive Sleep Apnea (OSA), which is a physical blockage of the airway caused by the relaxation of the muscles of the throat, nasal masks are often used because they are comfortable and work well. But for breathing support in the hospital, full face masks are typically used because patients are having significant trouble breathing and tend to breathe through their mouth.

However, it's important to note that we don't yet fully understand the best way to provide breathing support for long-term NIV users, like COPD and OHS patients. The understanding of breathing route is currently only established for OSA. However, conditions like COPD affect the lungs and the overall system used for breathing, which is different from the throat blockage seen in OSA. So, the assumptions we make based on conditions like OSA may not apply to these other conditions. More research is needed to understand this better.

* Participants undergo PSG, lying on their backs while their breathing route is recorded for about 30 minutes.
* The participants are then put on their prescribed airway pressure support with the first randomized mask, and their breathing is recorded again for 30 minutes.
* The mask is switched to the second mask, and the same procedure is repeated.

Participants are then moved to the sleep laboratory for the night where they are provided with beds.

* They continue NIV therapy with the last mask used during the awake test.
* After at least 60 minutes of recording, participants are awakened to switch back to the first mask. They are then allowed to sleep uninterrupted for the rest of the night.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Prescribed nocturnal NIV for COPD or OHS
* Able to complete an overnight sleep study
* Comfortable to sleep on a standard double bed
* Capacity to complete informed consent

Exclusion Criteria:

* Uncontrolled sleep apnea (Apnea-hypopnea index (AHI) over 15 events/hour off personal NIV device data)
* Prescribed IPAP above 25 cmH2O
* Self-reported pregnancy
* Allergic to adhesive of the sensors
* Self-reported cold/flu symptoms
Inflammation and the Host Response to Injury (In Healthy Volunteers)

The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.

The body's immune response to injury or infection is very complex.Immune cell activity, the release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the body's "instructions" for making proteins (Ribonucleic Acid or RNA) and heart rate variability (HRV,the intervals between heartbeats) may affect the body's clinical response to stress such as infection.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's response to endotoxin.This will enable the investigator to better understand the mechanisms involved in the immune response as well as potential therapeutic strategies to improve outcomes in patients.

Eligibility Criteria:
Inclusion Criteria:

* Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study.
* Written informed consent prior to the performance of any study related procedure.

Exclusion Criteria:

* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
* Recent history of alcohol or drug abuse
* Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures
* Exposure to any experimental agent or procedure within 30 days of study
* Pregnancy or breast feeding
* Prior exposure to endotoxin in an experimental setting -
Assessing Clinical Trial Experiences of Patients With Osteosarcoma

Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about osteosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with osteosarcoma who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with osteosarcoma
* Patient has self-identified as planning to enroll in an interventional clinical trial
* Patient is a minimum of 18 years or older

Exclusion Criteria:

* ECOG score of 4
* Patient is pregnant
* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

As of June 4, 2024, this study is no longer accepting any newly screened participants.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast carcinoma
* Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
* Centrally confirmed PD-L1 and hormone receptor status
* Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)
* Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)
* \<=12 weeks between primary surgery and randomization
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Screening left ventricular ejection fraction (LVEF) \>= 50% and no decrease in LVEF by \>15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF \>= 55%
* Life expectancy \>= 6 months
* Adequate hematologic and end organ function

Exclusion Criteria:

* Stage IV breast cancer
* An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
* Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
* History of exposure to various cumulative doses of anthracyclines
* History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)
* Current grade \>=2 peripheral neuropathy
* History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
* History of or active autoimmune disease or immune deficiency
* Treatment with immunostimulatory or immunosuppressive agents
* Cardiopulmonary dysfunction
* Any known active liver disease
Burden Fatty Liver Among Acute Ischemic Cerebral Stroke Patients

1. Assess frequency of hepatic steatosis among patients in patients with Ischemic stroke without previous risk factors
2. Assess outcomes morbidity and mortality ischemic stroke in correlation with hepatic steatosis .

Fatty liver disease, encompassing both alcoholic and non-alcoholic variants, is a growing health concern worldwide, with prevalence rates soaring in parallel with obesity and diabetes epidemics. The estimated global incidence of NAFLD alone is 47 cases per 1,000 people, with a higher rate observed in males than females. Among adults worldwide, the estimated prevalence of NAFLD is 32%, with a higher prevalence in males (40%) compared to females (26%), making it the most common liver disorder. The hazards of fatty liver disease extend beyond the liver itself .The condition is characterized by the accumulation of excess fat in liver cells, which can progress to more severe liver diseases, such as steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma.

Early assessment and diagnosis of liver steatosis are crucial for managing and mitigating the risks associated with FLD. Non-invasive methods, such as elastography combined with the Controlled Attenuation Parameter (CAP) score, have emerged as effective tools for detecting and quantifying liver fat content. These methods offer a less invasive alternative to liver biopsies, providing reliable data to guide clinical decisions.

NAFLD is characterized by a proinflammatory and proatherogenic state that causes vascular inflammation and neurodegeneration, potentially leading to both clinical and subclinical cerebrovascular disease. Increasing epidemiological evidence links NAFLD to a higher risk and greater severity of stroke, independent of other vascular risk factors.Additionally, studies suggest NAFLD is involved in subclinical cerebrovascular diseases, such as carotid atherosclerosis which is characterized by the build-up of plaques in the carotid arteries. Patients with NAFLD exhibited greater carotid atherosclerosis .

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ischemic cerebral stroke exceeding of window phase without obvious risk factors.
* patients above 18 years.
* patients below 60 years.

Exclusion Criteria:

* patients have obvious risk factors including: smoking, DM , Hypertension ,renal patients , cardiovascular diseases (AF , valvular disease ,reduced systolic function ,chronic HCV ,HBV).
* patients below 18 years.
* patients above 60 years.
* patients refused to contribute to this study.
Treatment of Refractory Status Epilepticus

The purpose of this study is to determine whether propofol or barbiturates should be preferred in the treatment of status epilepticus (continuous seizure activity) refractory to 2 standard antiepileptic agents.

Refractory status epilepticus (SE) develops in 31%-44% of patients with SE, with a mortality of 16%-23%. Coma induction is advocated for its management. Propofol and barbiturates are the most used agents, but no comparative study has been performed. In consideration of the uncertainty regarding the relative effectiveness, despite several retrospective data, a prospective investigation is needed.

The objective is to assess the effectiveness (SE control, adverse events) of a first course of propofol versus barbiturates in the treatment of refractory SE, in adults with refractory SE not due to cerebral anoxia.

Comparison: Coma induction with standardized doses of propofol or barbiturates titrated towards burst-suppression on EEG, then assessment of the proportion of patients achieving a control of SE.

Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory status epilepticus not due to cerebral anoxia, needing coma induction for clinical management.

Exclusion Criteria:

* Age \< 16 years old.
* Known pregnancy.
* Cerebral anoxia as SE etiology.
* Epilepsia partialis continua (simple partial SE).
* Known intolerance to the study drugs.
* Known mitochondrial disorder, hyperlipidemia, or significant rhabdomyolysis.
A Multi-centre, Open Labelled, Multiple Dosing Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-2021 Administered Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

This trial is conducted in Europe. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC 0172-2021 administered subcutaneously to healthy male subjects and subjects with haemophilia.

The present phase 1 trial has been terminated due to the need for changes in the trial design requiring a new re-designed multiple dosing phase 1 trial. Initiation of this new trial awaits additional non-clinical data.

Eligibility Criteria:
Inclusion Criteria:

* For haemophilia subjects only: Subjects diagnosed with haemophilia A with a baseline level of Factor VIII or Factor IX below 2% without inhibitors

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Thrombocyte count below the lower limit of normal range at screening
* Any clinical signs or known history of thromboembolic events, or subject considered at high risk of thromboembolic events as judged by the investigator or subjects at increased risk of cardiovascular disease as judged by the investigator
Effect of Primer Application on the Lingual Retainer

Background: The aim of this study was to examine the effect of self-etch primer (SEP) application on the bond failure rate of a mandibular bonded lingual retainer over 24 months.

Materials and Methods: After the removal of the orthodontic appliances, the lingual retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter, wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will performed using a split-mouth design. In the study group, the SEP will be administired to the teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive remnant index (ARI) scores.

The chi-square test will be used to compare the bond failure rates and ARI scores between the groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test. The significance level will P \< 0.05.


Eligibility Criteria:
Inclusion Criteria:

1. Individuals who will continue to the retention phase after fixed orthodontic treatment,
2. Presence of all mandibular incisor and canine teeth,
3. Good oral hygiene,
4. No caries,
5. No fractures,
6. Healthy periodontal condition,
7. No restorations,
8. No previous bonded retainer,
9. No traumatic parafunctional habits such as bruxism.

Exclusion Criteria:

-
BEADI - The Bliss Cluster Randomised Control Trial on the Effects of Active Dissemination of Information (BEADI)

BEADI is a dissemination trial, on standards of care of premature babies. The main objective of BEADI is to assess whether an innovative 'active' strategy for the dissemination of neonatal information (evidence reviews, interactive training workshop, benchmarking and feedback, and ongoing support) is more likely to lead to changes in policy and practice than the traditional (more passive) forms of dissemination in English neonatal units.

BEADI will focus on three areas of neonatal care for premature (22+0 to 26+6 weeks' gestation) babies born in England: timing of surfactant therapy, staffing for resuscitation at delivery, and temperature control (in line with the main Project 27/28 findings ). However, the approach is applicable to a wide variety of clinical policies and practice.

The BEADI study has been granted ethical approval by MREC to use a subset of data collected by EPICure2 up until 31st December 2006 (pre-intervention data). For the post-intervention data, ethical approval has been granted for CEMACH to continue data collection against the three clinical areas using a subset of data items captured in the PN:E2 form, for the three month period between 1st January - 31st March 2007. Local research and development departments of each trust have also been contacted.


Eligibility Criteria:
Inclusion Criteria:

* Hospital staff : Lead neonatologist for clinical governance in each maternity hospital in England.
* Babies born in England before 27 weeks gestation between January 2006 - 31st March 2007
Home Monitoring Vs. Hospitalization for Mild Acute Pancreatitis

Acute pancreatitis accounts for a large number of hospital admissions every year. Some studies have shown that early oral feeding protocols are safe, and one previous study suggests the possibility of home care for mild acute pancreatitis.

Approximately 80% of all cases of acute pancreatitis are mild and only require supportive care for pain and nausea control and an adequate fluid replacement. Currently, all patients in our setting diagnosed with mild acute pancreatitis are admitted to a conventional hospitalization ward under the supervision of the Digestive and General Surgery Department or the Gastroenterology Department. Symptomatic treatment is administered, and abdominal ultrasound is performed to assess the cause of pancreatic inflammation. The remaining 20% fulfill the severity criteria from its onset onwards and require intensive care support.

We will conduct a multicenter randomized controlled clinical trial to compare two different approaches to mild non-alcoholic acute pancreatitis: hospital admission and outpatient management.

Eligibility Criteria:
INCLUSION CRITERIA

Patients diagnosed with mild acute pancreatitis based on at least two of the three following criteria:

* Abdominal pain
* Amylase or lipase 3x ULN (in blood/urine)
* Imaging tests (Ultrasound/CT scan) suggestive of acute pancreatitis.

Age ≥18 years and \<80 years

Absence of potential pancreatitis-related severity criteria:

* No evidence of SIRS in the emergency room
* C-Reactive Protein levels \<150mg/dL
* Marked increase in the White Blood Cell Count
* Absence of coagulopathy (INR \<1.4)
* Hematocrit \< 44%
* Creatinine \< 170 µmol/L
* BISAP score ≤2 at the time of randomization.

Patients with good pain response to 12-hour supportive care in the ER (VAS \<4) or adequate oral feeding tolerability.

Absence of local or systemic complications of acute pancreatitis on imaging tests.

Adequate cognitive capacity and without any previous diagnose of psychiatric disease.

Patients who meet each participating hospital home care criteria. Patients who give their written informed consent to participate.

EXCLUSION CRITERIA

Past medical history of pancreatic disease:

* Known or newly diagnosed chronic pancreatitis (Wirsung dilation or pancreatic calcifications in previous imaging tests)
* Patients with recurrent acute pancreatitis (\>3 episodes/year) or an episode of acute pancreatitis \<1 month ago.
* Acute pancreatitis after endoscopic retrograde cholangiography.
* Hyperbilirubinemia \>3x ULN

Comorbidities that required previous hospitalization (myocardial infarction, liver cirrhosis, chronic kidney disease, or chronic lung disease).

BMI ≥35 Kg/m2 Patients who refuse to participate in the study.
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)

Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).

NOTE: Detailed Description : data not entered

Eligibility Criteria:
Inclusion Criteria:

1. Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104.
2. Patients must be deemed by the investigator to benefit from continued secukinumab therapy.

Exclusion Criteria:

1. Plans for administration of live vaccines during the extension study period.
2. Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab.
3. Any patient who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms.

All other protocol related inclusion/exclusion criteria will apply.