cyrilzakka/clinical-trials huggingface dataset:
Relevance of Isoniazid Dosage in Adults Treated for Tuberculosis

Tuberculosis is the third leading infectious killer. In 2021, an estimated 10,6 million people fell ill with tuberculosis worldwide. Drug resistance emerges with the increase of antibiotherapy use. Among the four antimicrobial drugs used for tuberculosis, isoniazid is a first line treatment. It has a bactericidal activity against the tuberculosis complex. Nevertheless, the hepatic metabolism of isoniazid shows variation between individuals. There is a real risk of hepatotoxicity and neurotoxicity induced by isoniazid. The peak measurement (Cmax) of serum isoniazid is recommended to adjust the treatment and to allow recovery. Moreover, several samples allow a kinetics of isoniazid elimination so as to distinguish slow and fast acetylators. Few data are available on isoniazid acetylation. It could be useful to know the proportion of patients treated by isoniazid at a standard dose, associated with a risk of overdosing or underdosing. Inadequate exposures should be studied to understand if there is an impact in the medical care.


Eligibility Criteria:
Inclusion Criteria:

* to be an adult,
* to have a diagnosis of tuberculosis

Exclusion Criteria:

* pregnancy,
* disagreement to participate
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. Each of these problems is characterized by difficulty sleeping at night and excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this sleepiness. The idea behind this treatment is that sleepiness that leads to napping during the day prevents a patient from being tired or sleepy enough to get good sleep at night. This study is designed to determine if the medication can "reset" participants' sleep/wake rhythm to a more normal rhythm.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
* Subjective complaint of sleep disruption, unsatisfactory sleep, early morning awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made by either the potential participant or by the caregiver.

Exclusion Criteria:

* Participation in any other clinical drug trial
* Liver failure
* Believed by the investigator to be unwilling or unable to follow the protocol
* Active liver or coronary disease
A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations

Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will assess the occurrence of skin safety events for a further two months of continuous use of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08 (NCT00702650) trial.


Eligibility Criteria:
Inclusion Criteria:

* Hypogonadal males with a qualifying general medical health who have Completed the MTE08 trial up to and including Day 120/121 in a compliant manner
* Were able to communicate with the trial staff, understand the Trial Information Sheet and sign the Written Informed Consent Forms; were willing to follow the Protocol requirements and comply with Protocol restrictions and procedures

Exclusion Criteria:

* Any clinically significant chronic illness or finding and/or laboratory testing that would interfere with the trial objectives or safety of the subject
* Any man in whom testosterone therapy was contraindicated, which included those with:

  * Known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstructions and with a International Prostate Symptoms Score (IPSS) score of greater than or equal to 19
  * Known or suspected carcinoma (or history of carcinoma) of the breast
  * Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests \>2 times the upper limit of the normal range values
  * Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions
  * Current significant cerebrovascular or coronary artery disease
  * Untreated sleep apnoea
  * Haematocrit of \>54%
  * Untreated moderate to severe depression
* Men with clinically significant prostate exam or clinically significant elevated serum Prostate Specific Antigen (PSA) level (\> 4 ng/mL) or age adjusted reference range of PSA values
* Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect Sex Hormone Binding Globulin (SHBG) or testosterone concentrations (excluding Testosterone MD-Lotion (cutaneous solution)) or metabolism such as warfarin, insulin, opiates, gonadotropin-releasing hormone analogues (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
* Men with uncontrolled diabetes (Hemoglobin A1c \[HbA1c\] greater than or equal to 10%)
* Subjects intending to have any surgical procedure during the course of the trial
* Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial
* Subjects whose partners are pregnant
High-flow Nasal Cannula Oxygenation During Rapid Sequence Induction in Children

This randomised study aims to compare the utilization of high-flow humidified nasal oxygenation (HFNO) with standard care, using apnoeic facemask oxygenation, during rapid sequence induction (RSI) of anesthesia in young children.

170 children aged less then 11 years, admitted to the operating room for surgery and with a medical indication of a RSI of anesthesia will be recruited in one university hospital (Necker-Enfants-Malades in Paris).

Children will be randomly assigned into two groups: the control group will benefit of standard care and the HFNO group will receive heated and humidified oxygen through a nasal cannula device during pre-oxygenation and apnoea time prior to tracheal intubation.

HFNO has been evaluated and showed benefits in rapid sequence induction of anesthesia in adults and prolonged apnea time before desaturation in children. To the investigators' knowledge the potential benefit of HFNO during RSI in young children remain to be evaluated.

Hypoxic events during rapid sequence induction (RSI) in children remain more frequent than during standard induction. Although the exact incidence is difficult to appreciate. However the deleterious consequences of hypoxemia during tracheal intubation procedures are well known.

HFNO is an effective technique to supplement oxygen including during apnoea. Studies in children have shown benefits both during breathing and apneic situation.

A monocentric controlled randomized study including children, aged less then 11 years, will be conducted in order to assess the potential benefits of this technique during RSI. The rate of successful tracheal intubation without oxygen desaturation is the primary outcome.

Children will be randomly assigned into two groups:

* The control group will benefit of standard RSI. Pre-oxygenation will be given through facemask with 100% oxygen during 2 minutes, with a flow of 6 to 8 L.min-1 depending on the age of the child. No oxygen will be delivered during laryngoscopy.
* The HFNO group will be given 2 L.Kg-1.min-1 of humidified and heated 100% O2 through a nasal cannula during a 2 minutes pre-oxygenation and then throughout laryngoscopy.

Adverse events will be recorded and follow-up continued until discharge from the post anesthesia care unit (PACU).

Eligibility Criteria:
Inclusion Criteria:

* child from birth until 10 years
* patient needing (elective or in emergency) surgery under general anesthesia requiring tracheal intubation and fulfilling all criteria for a rapid sequence induction
* Parents or legal guardians signed the Informed consent form
* Social insurance affiliation

Exclusion Criteria

- child having one or more contraindication to use high flow nasal oxygenation:

* Nasal obstruction
* Recent trauma of aero-digestives tracts
* Epistaxis
* Known or suspected fracture of the skull base
* Cephalo-spinal fluid leak or all other communication between nasal space and intracranial space
* Tuberculosis or other nasal or lung infection
* Pneumothorax or pneumo-mediastin documented or suspected
* Complete limitation of mouth opening
Correlation Between iXip and Final Pathology Specimen From Radical Prostatectomy: a Multicenter Prospective Trial

The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. Moreover, preliminary results from a prospective study showed that iXip could predict cancer aggressiveness, too.

Since the 90s, serum PSA has become the cornerstone of diagnosis of PCa, However, due to its proven poor specificity, the actual role of PSA testing has been largely debated, especially if used during opportunistic screening programs. leading to a significant risk of over-diagnosis and over treatment.

In order to overcome drawbacks of PSA-based diagnostic pathway several PSA-derivates has been proposed. However, they were marginally used in clinical practice because not supplied by public health care systems.

The Immune compleX Predictive Index (iXip) is a predictive tool for prostate cancer (PCa) diagnosis that integrates PSA, PSA-IgM, prostate volume and age of the patient. An algorithm processes these parameters providing the probability of prostate cancer. Several prospective studies confirmed its ability to predict prostate cancer presence at biopsy and therefore to reduce the rate of useless prostate biopsies. Moreover, preliminary results from a prospective study showed that iXip could predict cancer aggressiveness, too.

All pathological specimens are analyzed by an expert uropathologist, following ISUP reccomandations.

Before radical prostectomy a blood sample from each patients is collected. Serum PSA-IgM concentration is measured using Prostate-IC kit in duplicate. The analysis with Prostate-IC kit was performed on automated ELISA analyzer.Then the iXip index is calculated by using the online calculator (http://ixip.xeptagen.com/).

Eligibility Criteria:
Inclusion Criteria are:

* histologically proven prostate cancer,
* patients scheduled for radical prostatectomy
* paziente able to provide consent
* age \> 18 years or \< 80 years

Exclusion criteria are:

* neiadjuvant hormone therapy
* salvage radical prostatectomy
* concomitant solid or hematological tumors,
* autoimmune disorders
* or immunosuppressive therapies,
* acute bacterial or viral infections.
Neurofeedback Training for the Treatment of Substance Use Disorders

The proposed randomized controlled trial (RCT) will investigate the usefulness of electroencephalographic (EEG) biofeedback, also called neurofeedback (NF), a treatment method that can potentially prevent relapses among patients with a substance use disorder (SUD) through its calming effect on the central nervous system.

The study will examine whether NF can improve general well-being and quality of life (QoL) and subsequently its ability to play a role in relapse prevention strategies. Specifically, the effect on physical and psychological distress will be investigated.

A patient with a substance use disorder (SUD) typically requires comprehensive and individualized care across different levels of service providers, from primary care to the specialist health care services. Among the known threats to a prolonged remission are negative emotional states because they can trigger the urge to use drugs. An integrative approach is warranted aimed to address the physiological, psychological and social aspects of the disorder during the rehabilitation period.

Patients with a SUD diagnosis in an outpatient clinic will be randomized to either 1) 20 sessions of symptom-based NF training in conjunction with traditional therapy or 2) conventional counseling. The primary outcome is QoL at the end of treatment and at a 3 and 12 month follow-up. Secondary outcome measures include alcohol and drug use, mental distress, sleep quality and cognitive function. The optimal quantity of the intervention will be assessed with a cost-benefit approach.

The proposed study will provide new knowledge about how NF can be best utilized in SUD treatment, potentially improving QoL and relapse rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a substance use disorder referred to outpatient addiction treatment, aged \>18 of both genders.

Exclusion Criteria:

* Severe psychiatric disorders (e.g. psychosis) that have not been stabilized with e.g., medication (assessed as a part of the clinical process at the clinic). Severe cognitive impairment or language problems (inability to converse for interviews).
Efficacy of Indacaterol 150 µg Versus Formoterol

The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1).

Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

  * Post-bronchodilator FEV1 \<80% and ≥40% of the predicted normal value
  * Post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
* Smoking history of at least 10 pack-years

Exclusion Criteria:

* Patients who have had a COPD exacerbation in the 6 weeks prior to screening
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply
A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.

A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
* Healthy male subjects aged between 18 and 45 years (inclusive) at Screening.

Exclusion Criteria:

* Clinically relevant findings on the physical examination at Screening.
* Clinically relevant abnormalities on 12-lead ECG, measured after at least 5 min in a supine position at Screening.
* Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry) at Screening and on Day -1.
* History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed).
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Moderate or severe renal insufficiency (creatinine clearance \< 60 mL/min calculated with the Cockcroft Gault formula) at Screening.
* Total bilirubin \> 1.5 x Upper Limit of Normal at Screening.
Longitudinal Follow-up of High Viscosity Glassionomer IonoStar Plus Versus a Composite Bulk X-tra-Fil Combined With Futurabond U (Splith Mouth Study): Reunion Island, Circus of Mafate

The main objective is the longitudinal follow-up and comparison of the maintenance of the dental filling materials up to 24 months using the HVGIC IonoStar Plus versus Bulk X-Tra -Fil composite (Futurabond U adhesive system). 150 patients will be recruited in the Mafate dental health center. Patients with minimum 2 carious lesions (or multiple of 2, maximum 6) class I or II moderate not including the cusps, and touching the outside part of the middle of dentin. Assignment period will be 4 years: Inclusion period 18 months with 2 years following (6-month, 1 year and 2 years checking) and 3 months for statistical analysis and publications process Estimation of the parameters associated with a failure of the restoration at 24 months will follow the FDI scores. The Secondary objectives are to evaluate the caries risk of isolated population thanks to Cambra application and estimate the concordance of the judgment of maintaining the restoration between the expert in-situ and experts based on the images remotely.


Eligibility Criteria:
Inclusion Criteria:

* Patient with 2 carious lesions (or multiple of 2) class I or II moderate not including the cusps, and touching the outside part of the middle of dentin
* Asymptomatic tooth or with a reversible pulp syndrome tooth
* Measured by pulp test (if not possible should not prevent the inclusion)
* Patient consultant in investigative testing center
* Patient of 18 to 70 years old
* Patient able to support care
* Patient able to understand care (no language barrier)
* Collect the informed consent signed after a period of reflection
* Be affiliated to a French social security scheme or recipient of such a regime
* Tooth with criteria for pulp vitality tests of pulp sensibility

Exclusion Criteria:

* Patient under guardianship
* Pregnant or breastfeeding
* Patient at risk for infectious endocarditis
* Patient with severe periodontal disease (Pocket depth ≥ 5mm and/or mobility IV)
* Patient with an allergy to one of the materials used in the study
* Patient with an allergy to local anesthesia
* Patient with risks of infectious endocarditis
* Non-cooperative patient
* Participate in another ongoing biomedical research
The Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

Cerebral palsy (CP) is characterized by permanent or variable sensory-motor function impairments resulting from developmental anomalies or damage to the brain. Spasticity, dystonia, postural disorders, and weakened movement patterns can hinder the development of the respiratory system in children with CP. As the severity of postural disorders increases in children with CP, inadequate or improper use of respiratory muscles and insufficient ventilation reduce the mobility of the thoracic cage. The aim of study is to investigate the effects of respiratory muscle training on respiratory parameters, trunk control, walking, and functional independence in children with CP.

In this prospective randomized controlled study, participants will be divided into two groups: the Inspiratory Muscle Training (IMT) group and the control group. The IMT group will receive IMT in addition to the traditional physical therapy program, while the control group will only receive the traditional physical therapy program. Respiratory muscle strength, respiratory functions, chest expansion, trunk control, walking speed and endurance, and functional independence will be assessed before and after the training.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 4 and 12 years
* Classified as levels 1, 2, and 3 according to the Gross Motor Function Classification System (GMFCS)
* Diagnosed with spastic diplegia and/or hemiplegic cerebral palsy
* Ability to cooperate during the exercises

Exclusion Criteria:

* Presence of acute or chronic respiratory diseases
* Presence of acute medical conditions
* History of active epilepsy
* Scoliosis with a Cobb angle greater than 30 degrees
* Presence of chest deformities
* Severe visual and hearing impairments
Efficacy of Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With HIV Associated Non-Hodgkin's Lymphoma

Most treatment procedures in AIDS-related lymphomas disclose a relatively poor outcome for patients with low response rates, high number of relapses and AIDS events. The addition of rituximab to the standard regimen - CHOP could improve the outcome of these patients. The aim of the trial is to evaluate the safety and efficacy of rituximab when added to the CHOP regimen in patients with newly diagnosed AIDS-related non-Hodgkin lymphoma.

HIV infection is associated with a high incidence of AIDS-related lymphomas (ARL). Since the use of highly active antiretroviral therapy (HAART), the incidence of AIDS-defining illnesses has decreased, leading to a significant improvement in survival of HIV-infected patients. The incidence of ARL has decreased in a lower degree and lymphoma remains the major cause of death of HIV patients. Most treatment procedures disclose a relatively poor outcome of patients with low response rates, high number of relapses and AIDS events. Since the majority of HIV-associated NHL are CD20-positive the addition of rituximab to the standard regimen - CHOP could improve the outcome of these patients

Eligibility Criteria:
Inclusion Criteria:

* HIV positive with a high grade Ann Arbor stage I to IV untreated non-Hodgkin's lymphoma of B-cell origin confirmed by biopsy. The following histologies are eligible: \*Burkitt's lymphoma, \*diffuse large B-cell with standard histological diagnosis, \*Burkitt-like and high grade large cell immunoblastic lymphoma with immunophenotyping CD20 positive
* Good and intermediate prognostic group (no more than one of the following prognostic factors: \*CD4 below 100/µl, \*history of opportunistic infection, \*Karnofsky index below 60 percent or ECOG over 2)
* Written inform consent to participate

Exclusion Criteria:

* Active viral hepatitis
* Pregnancy
Lipids, Inflammation, and CV Risk in RA

The objective of this study is to elucidate the relationship between inflammation and lipoprotein atherogenicity, and to determine the relative contribution of inflammation and lipids to CV risk in RA. The central hypothesis of this study is that inflammation and lipoprotein atherogenicity is tightly linked such that both factors are important to assess CV risk in RA. Further, the investigators hypothesize that this relationship is obscured by a consideration of routine lipids alone.


Eligibility Criteria:
Inclusion Criteria:

* RA diagnosed by a rheumatologist
* Fulfills the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Criteria for RA
* Age\>35
* Active RA as defined by treating rheumatologist
* Biologic DMARD naive

Exclusion Criteria:

* Patients on statin or PCSK9 inhibitor therapy
* Corticosteroid therapy \>10mg prednisone or its equivalent as a maintenance treatment
* Pregnancy
* Unstable angina (chest pain) or shortness of breath
* Severe valvular heart disease
* Myocarditis
* Pericarditis
* Asthma with active wheezing
* History of lymphoproliferative disease or melanoma (stage two or higher), active malignancy, or cancer treatment in the last 5 years
* Active infectious disease (HIV, Tuberculosis, or Hepatitis B/C)