cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Exposures of Lofexidine and Its Major Metabolites in Subjects Seeking Buprenorphine Dose Reduction

The purpose of this study is to evaluate the relative exposures of lofexidine and its major metabolites in subjects seeking buprenorphine dose reduction.

This is a Phase 1, open-label, inpatient study in male and female subjects seeking at least a 4 mg reduction of their buprenorphine maintenance dose. The purpose of this study is to assess the relative exposures of lofexidine and its 3 major metabolites in subjects tapering from buprenorphine maintenance treatment. Lofexidine is an alpha-2 adrenergic agonist under development for the treatment of acute withdrawal from short-acting opioids.

Eligibility Criteria:
Inclusion Criteria:

* Have current dependency such that the subject is maintained on a daily dose between 8 and 24 mg of buprenorphine and is seeking reduction of their buprenorphine dose by at least 4 mg.
* Urine toxicology screen positive for buprenorphine at Screening.
* Agree to collection of blood samples for genotyping of CYP2D6 metabolizer status.
* If female and of childbearing potential, subject must have been using birth control for at least 30 days and must agree to use an acceptable form of birth control through at least 30 days after the last dose of study drug.
* If male, must agree to use an acceptable form of birth control throughout the entire study period and for 90 days after the last dose of study drug. Must not donate sperm for 90 days after the last dose of study drug.

Exclusion Criteria:

* Be a female subject who is pregnant or lactating.
* Have a very serious medical illness not under control.
* Have participated in an investigational drug study within the past 30 days.
* Received any drugs that are known strong, moderate or weak inhibitors of cytochrome P450 (CYP) enzymes CYP1A2, CYP2C19, or CYP2D6, within 14 days or 5 half-lives (whichever is more) before Day -1.
* Abnormal cardiovascular exam at Screening.
* Subjects requiring the following will be excluded: Tricyclic antidepressants, which may reduce the efficacy of imidazoline derivatives; Beta-receptor blockers, to avoid the risk of excessive bradycardia.
4D CT Scan Versus 3D CT Scan Concerning Cardiac Dosimetry Assesment for Left Sided Breast Cancers Radiotherapy

To establish if the cardiac radiation dose assesment is well aproximated with routine 3D CT scan compared to 4D CT experimental scan with respiratory gating (breath motion monitoring). The study population relates to left side breast cancers female patients that require a radiation therapy treatment.

As a standard of care, the postoperative breast cancers radiation therapy is generally based on a 3 dimensions CT scan that does not incorporate the breathing motion by definition.

Meanwhile, the patients must commonly receive the treatment in free motion breathing condition.

More of that, the Cardiac dose, especially the LAD (left anterior descending artery) dose has been established as the main cause of radiation induced ischemic heart disease (RIHD) and should be consider in the first place.

In more concrete terms, the higher the LAD dose is, the greater the RIHD relates: arise the LAD dose by 1 Gy means a 7.4% higher risk to cause a RIHD during the next 5 years.

That being said, to determine if the cardiac dosimetry and the dose-volume histograms (specifically for the left side breast cancer treatments including or not the internal mammary artery) obtained from a 3D CT scan reflect well or not the reality (which is widely subject to the breathing motion).

Finally, because it has been established that a 4D CT scan can monitor the breathing motion, it seems definitely interesting to compare it with the average 3D CT scan to address this concern.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 yo
2. Sex=female
3. Patients diagnoses with a left side breast cancer for which a radiation therapy is indicated and confirmed in a multidisciplinary consultation meeting.
4. Be able to understand and give her personal free consent, no judicial protection measure.
5. Written or oral consent, in compliance with the clinical investigation rules and regulation.
6. Patient affiliated with social security system
7. Treatment expected to be realized in Saint Quentin Hospital

Exclusion Criteria:

1. Patient \< 18 yo
2. Pregnant women.
3. Breastfeeding women.
4. Consent not given
5. Claustrophobia
6. Incapacited subject or judicial protection measure
7. Other research with exclusion period time ongoing
8. All the inclusion criteria not met
Interventions in Mathematics and Cognitive Skills

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

To achieve this goal, investigators will use a theoretically-motivated integrated symbolic/non-symbolic (iSNS) intervention with a randomized controlled design to enhance cross-format mapping between symbolic and nonsymbolic representations of quantities. The investigators will develop innovative computational models to investigate individual differences in latent cognitive processes and brain plasticity that contribute to learning, long-term retention, and transfer in children.

The investigators will assess performance in several areas and investigate cognitive and neural mechanisms that support numerical skill acquisition in children with differing levels of math learning abilities.

Eligibility Criteria:
Inclusion Criteria:

1. Elementary school aged children starting from first grade (6-12 years old)
2. IQ: Participants with a Full Scale IQ \> 70 on the Wechsler Abbreviated Scle of Intelligence (WASI-II).
3. Identification of Mathematical Learning Disabilities: Scores below the 35th percentile percentile on symbolic number processing test in Numeracy Screener and two or more Wechsler Individual Achievement Test (WIAT-IV) math subtests
4. Identification of typically developing children: Scores at or above the 35th percentile percentile on symbolic number processing test in Numeracy Screener and all WIAT-IV math subtests
5. Normal or corrected-to-normal vision and no hearing impairments
6. Inclusion in MRI scan session: Right-handed

Exclusion Criteria:

1. History of neurological or psychiatric disorder (i.e., schizophrenia, psychosis, depression, or attention deficit hyperactivity disorder.)
2. History of trauma involving head injury
3. Consistent psychiatric medications
4. Exclusion from MRI scan session: No major contraindication for magnetic resonance imaging (MRI) - braces, metal implants, pacemakers, vascular stents, metallic ear tubes, consistent exposure to metal, claustrophobia)
A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy


Eligibility Criteria:
Inclusion Criteria:

* Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
* Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
* subjects must have good or fair diabetic control (Hgb A1c \< 10%)

Exclusion Criteria:

* Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain i.e. peripheral arterio-vascular disease.
* Subject receives treatment for seizures.
* Subject has had any amputations other than diabetically-related toe amputations.
* Subject has major skin ulcers.
* Subject has clinically significant ECG abnormalities.
* Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties.
* Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
* At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.
* subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.
Methadone vs Magnesium in Spinal Fusion

Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects.

The current study would use a prospective, randomized trial investigating the efficacy of one of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along with a third control group. The patients would be randomized to receive remifentanil plus a single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of magnesium; or remifentanil alone. In addition, the two medications being studied might make it easier to determine the efficacy of neurophysiologic monitoring including somatosensory evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA) required to elicit the response.

The purpose of this study would be to explore the effects of intraoperative methadone vs magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of desflurane, remifentanil, and the need for intraoperative supplemental agents to control blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 12, and younger than 19 years of age undergoing posterior spinal fusion for idiopathic scoliosis
* American Society of Anesthesiologist (ASA) physical status I or II
* Parents/Guardian willing and able to authorize informed consent
* Patients willing and able to authorize assent

Exclusion Criteria:

* Patients presenting with neuromuscular scoliosis
* Patients deemed at increased risk of adverse reactions due to the presence of pre-existing severe organ system dysfunction, including debilitating lung disease, severe obstructive sleep apnea, severe congenital or acquired heart disease, and/or severe renal impairment
* Patients who are both being currently treated for a psychological disorder and have a history of hospitalization for said disorder
Study to Evaluate an Implant With a Sloped Top in Patients With a Sloped Jaw Bone

The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.

The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Aged 18-75 years at enrolment
* A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site
* History of edentulism in the study area of at least 3 months
* Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement.
* In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position)
* Deemed by the investigator as likely to present an initially stable implant situation

Exclusion Criteria:

* Uncontrolled pathological processes in the oral cavity
* Known or suspected current malignancy
* History of radiation therapy in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Uncontrolled diabetes mellitus
* Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Smoking more than 10 cigarettes per day
* Present alcohol and/or drug abuse
* Current need for bone grafting in the planned implant area
* Previous enrolment in the present study
* Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months
* Involvement in the planning and conduct of the study (applies to both Sponsor staff or staff at the study site)
* Unlikely to be able to comply with study procedures, as judged by the investigator
A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis

The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis


Eligibility Criteria:
Inclusion Criteria:

* Completion of a previous D2E7 study
* Subject is in good health (Investigator discretion) with a recent stable medical history

Exclusion Criteria:

* Former enrollment in this trial (DE018)
* Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast feeding or considering becoming pregnant.
Clinical Significance and Diagnosis of Sarcopenia in Cardiac Patients

Obesity sarcopenia, characterized by the coexistence of excess fat and muscle mass reduction, may contribute to the pathophysiology of exercise intolerance in patients with heart failure with preserved ejection fraction (HFpEF). The project will examine the impact of selected circulating miRNAs on processes that may form the pathophysiological basis for HFpEF development and obesity sarcopenia in correlation with biochemical markers, echocardiographic assessment and non-invasive assessment of hemodynamic parameters. In addition, the impact of LDL and HDL on these diseases will be assessed. Determinations of selected adipokines and asymmetric dimethylarginine will also be carried out and their effects on the cardiovascular system will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* control group: healthy volunteers
* study groups: patients with HFpEF. Patients in which the results of BNP/NT-proBNP did not confirm the diagnosis of HFpEF were classified as hypertensive group.

Exclusion Criteria:

* coronary artery disease
* unstable hypertension
* heart failure class IV NYHA
* condition after percutaneous or surgical revascularization
* pulmonary hypertension in echocardiography
* obstructive or restrictive lung diseases
* congenital heart disease
* arrhythmias (including atrial fibrillation)
* pacemaker or implantable cardioverter defibrillator
* hyperthyroidism or hypothyroidism
* pregnancy or lactation
* hemodynamically significant acquired heart defects
* cardiomyopathies
* GFR \<60 ml/min/1.73 m2
* other medical conditions such as: cancer, significant anemia, diabetes, alcohol and drug abuse, chronic inflammatory diseases and other
* the patient's inability to cooperate and / or give informed consent to participate in the study
Fluorescence Surgery for Sentinel Node Identification in Melanoma

Sentinel node biopsy is a surgical procedure used to find melanoma lymph node metastasis (i.e. groin/axilla) in very early stages. This study aims to add a new technology over the standard procedure - a fluorescent contrast (indocyanine green) using special light (near infra-red) - looking for more precise diagnosis of the presence of the lymph node metastasis.

The main objectives of this study is perform a new technique added to the usual procedure for sentinel lymph node biopsy for cutaneous melanoma. The fluorescence surgery consists in a injection of indocyanine green around the primary tumor, or, when already excised (excisional biopsy), the biopsy site at the beginning of the surgery. Patient performs, in a standard fashion, the lymph scintigraphy prior the surgery and is injected at the same time a blue die similarly the indocyanine green. Immediately after the indocyanine infusion, the injection site is massaged and a near infra red light (NIR) is focused over it. An appropriated infra red camera is positioned over the lymphatic pathway, searching for the fluorescence and localizing the sentinel node at the basin. The skin is opened and the sentinel node is resected. The success or not in localizing the sentinel node is pointed and the standard techniques are applied - gamma probe and surgical location of a blue lymph node. All sentinel node characteristics are noted as number, which technic identified it, time, location. Later information will be gathered as histological status, surgical complications, recurrence and survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for sentinel node biopsy in standard care

Exclusion Criteria:

* Previous neoplasia
* Previous surgery or scar in the lymph node basin or primary tumor, except primary tumor biopsy
* Local recurrence
* Hypersensibility or allergy history to indocyanine or Iodine-based contrast media
Histones and Free-plasma DNA After Cardiac Arrest

To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones in cardiac arrest patients.


Eligibility Criteria:
Inclusion Criteria:

* Out of hospital cardiac arrest of presumed cardiac cause
* Return of spontaneous circulation (ROSC)
* Glasgow Coma Score \< 8
* Age \> 18 years and \< 80 years

Exclusion Criteria:

* \>60 minutes from the circulatory collapse to ROSC
* Time interval \> 4 hours from cardiac arrest to initiation of targeted temperature management
* Terminal illness
* Coagulation disorder
* Unwitnessed asystolia
* Cerebral performance category 3-4 before the cardiac arrest
* Severe persistent cardiogenic shock
* Pregnancy
* Persistent cardiogenic shock (systolic blood pressure \< 80 despite inotropic treatment)
* New apoplexy or intracerebral hemorrhage
* Lack of consent from the relatives
* Lack of consent from the general practitioner
* Lack of consent from the patient if he/she wakes up and is relevant
The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus

Neurofilament Light Chain Protein (NfL) has been found by many studies as a sensitive biomarker of neuronal damage from several reasons, e.g. neurodegenerative diseases (Alzheimer's disease, Multiple Sclerosis, etc.), inflamation (HIV) or trauma. Its role as biomarker thus offers a possibility to predict and manage diseases associated with neuronal damage. Therefore our aim is to investigate the changes in level of NfL in hydrocephalus and to find its role in management of treatment in hydrocephalus.


Eligibility Criteria:
Inclusion Criteria:

* In group A:

  * Patients with diagnosed communicating hydrocephalus
  * MMSE \> 10 points
  * Absence of any structural laesion on MRI or CT
  * Accepted Informed consent
* In group B:

  * MMSE \> 10 points
  * Absence of any structural laesion on MRI or CT
  * Accepted Informed consent
  * Elective spinal surgery without affecting dural sac and the spinal cord
  * Surgery shorter than 120 minutes of lasting the general anesthesia

Exclusion Criteria:

* Non-communicating hydrocephalus
* Structural laesion on MRI or CT (tumour, contusion, aneurysm)
* MMSE \< 10 points
* Life-expectancy shorter than 1 year
* Pre-existing other type of demetia (m. Alzheimer, vascular dementia)
* Surgery lasting more than 120 minutes
* Blood loss more than 500 ml
* Opening of dural sac (liquororhea)
* Adverse events during general anestesia: MAP\<60 mm Hg more than 5 minutes, arythmia with need for farmacological treatment
Effect of Musical Auditory Training on Subjects With Tinnitus Disorder

Among the theories of tinnitus generation, there is that of central neuroplastic changes, which reports the association between changes and reorganization that occur in central auditory pathways and impacts on associated areas due to the altered neural signal. Auditory training modifies these altered pathways through auditory exercises, which provoke positive neuroplasticity. Musical auditory training is a proposal to stimulate auditory, cognitive and metalinguistic skills with activities focused on musicality. Therefore, the objective of this study is to verify the effect of musical auditory training (MAT) on the neuroplasticity of the auditory system and the perception of tinnitus disorder in young adults.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes aged between 18 years and 55 years;
* Complaint of chronic tinnitus (minimum perception of six months) unilateral or bilateral;
* Hearing thresholds within normal limits bilaterally or even mild sensorineural hearing loss in the four-tone average (500, 1000, 2000 and 4000Hz);
* Annoyance score of at least four on the Visual Analogue Scale, considered a moderate symptom discomfort;
* Have normality in the Mini Mental State Examination (cognitive screening).

Exclusion Criteria:

* Apparent speech, psychiatric or neurological changes;
* History of head or brain trauma;
* Objective tinnitus (somatosensory and vascular);
* Present symptoms and/or diagnosis of middle ear involvement;
* Having started a new treatment (pharmacological or therapeutic) or having been diagnosed with a disease of any origin in the last month.
* Be carrying out another intervention for tinnitus during the research;
* Use of electronic assistive hearing devices.
Effect of Pentoxifylline on Anemia in Hemodialysis Patients

The primary goal of this clinical trial is to evaluate the promoting effect of pentoxifylline on anemia correction in hemodialysis patients, and involvement of the hypoxia-inducible factor-2 alpha. While, the secondary aim is to evaluate the effect of pentoxifylline on inflammation, hepcidin and other markers of iron homeostasis in these patients. Participants in this trial will be selected to be age and sex ratio matched and will be randomly assigned into two groups. Patients in group I will receive their regular doses of erythropoietin stimulating agents and other routine treatments plus 400 mg pentoxifylline tablets twice daily with meals for 6 months. While, patients in group II will receive their regular doses of erythropoietin stimulating agents and other routine treatments.


Eligibility Criteria:
Inclusion Criteria:

* Both sexes of HD patients
* Age \>20 years
* Patients who have adequate hemodialysis for at least 6 months
* Hb level ≤ 10.5 g/dl

Exclusion Criteria:

* Recently dialyzed patients (less than 6 months)
* Patients with known sensitivity to theophylline or other xanthine derivatives
* Severe iron deficiency with serum ferritin \< 100 µg/dL and/or TSAT \< 20%
* Planning for pregnancy, pregnancy, or lactation
* Patients with severe liver disease or other organ failure
* Previous renal transplantation, noncompliance with medication or HD prescription, or inability to oral drug administration
* Malignancy within last 3 months