cyrilzakka/clinical-trials huggingface dataset:
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults

The purpose of the study is to evaluate the efficacy, tolerability and the safety of two fixed doses of vortioxetine in the treatment of major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ criteria (classification code 296.3x)
* The patient has a MADRS total score \>=26
* The patient has a CGI-S score \>=4
* The patient has had the current episode of MDE for \>3 months

Exclusion Criteria:

* Any current anxiety psychiatric disorder as defined in the DSM-IV TR
* Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR
* Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR
* Use of any psychoactive medication 2 weeks prior to screening and during the study
* The patient is at significant risk of suicide or has a score \>=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit

Other protocol-defined inclusion and exclusion criteria may apply.
Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female and male aged from 18 to 75 years, inclusively
3. History of physician-diagnosed asthma requiring treatment with medium dose ICS (\>250ug fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
4. Documented treatment with medium-dose ICS (\>250ug and ≤500ug fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 month prior to Visit 1

Exclusion criteria:

1. Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
2. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: - Affect the safety of the patient throughout the study - Influence the findings of the studies or their interpretations - Impede the patient's ability to complete the entire duration of study
3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation

The purpose of this study was to understand the biological and functional changes after one year of smoking cessation and to collect data on a broad range of biomarkers of exposure (BoExp) and biomarkers of effect (BoE).

This was a 12 month, multi-region, multi-center, ambulatory study conducted in the US, Japan and Europe. Smokers who were willing to quit smoking within the next 30 days at the Screening Visit were enrolled to reach approximately 950 subjects continuously abstinent from smoking from Actual Quit Date (AQD) onwards at week 2, in order to achieve at least 190 successful quitters expected to complete the study. Once approximately 950 subjects reached week 2, screening and enrollment were stopped.

Compliance with smoking abstinence was verified by self-reporting, CO breath tests, and urine cotinine tests. Smokers who were not continuously abstinent from smoking \[i.e., free from tobacco product use (e.g., CC, pipes, cigars, snus) or any nicotine-containing product (including electronic cigarettes) other than nicotine replacement therapy (NRT)\] from their AQD onwards were discontinued from the study. At the end of the study, 358 subjects were verified as continuously abstinent from their AQD.

Eligibility Criteria:
Inclusion Criteria:

* Current healthy smoker as judged by the Principal Investigator(s) or designee(s).
* Subject is aged from 30 to 65 years old (inclusive).
* Subject has smoked for at least the last 10 years.
* Subject smoked more than 10 cigarettes/day on average over the last year.
* Subject is willing to quit smoking within the next 30 days.

Exclusion Criteria:

* Subject has clinically relevant medical conditions that in the opinion of the Investigators would jeopardize the safety of the participant or affect the validity of the study results.
* Subject has Forced Expiratory Volume in 1 second/Forced Vital Capacity(FEV1/FVC) \< 0.7 and FEV1 \< 80% predicted value at post-bronchodilator spirometry.
* Subject with FEV1/FVC \< 0.75 (post-bronchodilator) and reversibility in FEV1 that is both \> 12% and \> 200 ml from pre- to post-bronchodilator values.
* Subject who took or is taking concomitant medication which may have an impact on the biomarkers of effect.
* Female subject is pregnant or is a breast-feeding.
Percutaneous Imaging-guided Cryoblation of the Anterior Abdominal Wall Endometriosis Scars

Endometriosis is a common condition affecting 10% of women. It is characterized by the presence of ectopic endometrial cells. This pathology most frequently develops in the ovaries, utero-sacral ligaments and pelvic peritoneum, but also in the recto-sigmoid. Rarely, these lesions are found outside the pelvis, and even more exceptionally in the abdominal wall (in 0.03 to 1% of cases).

Cryotherapy has already been used for many years to treat soft tissue tumors (kidney and prostate tumors). It has also been successfully used by interventional radiologists to treat parietal desmoid tumors. After discussions with radiologists, given the similarity of location and extension of wall endometriosis lesions with desmoid tumours, the successes observed, and the scarcity of studies in the literature, it seemed appropriate to the investigators to study this new therapy.

The aim of this study was to investigate the efficacy of cryotherapy on parietal endometriosis lesions.


Eligibility Criteria:
Inclusion Criteria:

* Adult woman (≥18 years old) Having benefited from cryotherapy of an abdominal wall endometriosis nodule between January 6, 2020 and January 2, 2023.
* Subject not objecting to the reuse of their data for the purposes of this research

Exclusion Criteria:

* Subject having expressed its opposition to the reuse of its data for scientific research purposes.
Immediate Effects of DLPFC tDCS on Attention Bias

This research is being done to test if the investigators can modify or reduce negative attention bias in depression following a single session of transcranial direct current stimulation (tDCS) over the left anodal dorsolateral prefrontal cortex (DLPFC) in patients with mild to severe depression. The study will consist of a single-session tDCS session administered onsite at the Johns Hopkins University (JHU). After the consent process, participants will complete the study (approximately one hour in duration) with the guidance of a research associate.

This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to severe depression (based on BDI-II score range 14-19 for mild and 29-63 for severe) to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression. Subjects may or may not be receiving treatment for mild-severe depression.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45
* Female
* Mild to severe depression (determined by BDI-II scores of 14-19 and 29-63, respectively)
* If taking antidepressants, medication must be stable ≥ 30 days prior to screening

Exclusion Criteria:

* Wide-Range Achievement Test-Fourth Edition (WRAT-4) Reading Subtest standard score \<85 (to ensure understanding of test procedures)
* Insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff
* Primary psychiatric disorder other than depression (based on MINI)
* Primary neurologic condition that would prevent ability to participate (as determined by study clinician).
* History of head trauma in the last year
* Medical device implants in the head or neck
* History or current uncontrolled seizure disorder
* Current substance abuse disorder
* Pregnant or lactating women
* Skin disorder/sensitive skin near stimulation locations
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children

The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing cardiac catheterization procedure for treatment or diagnosis of cardiovascular disease
* 1 day to less than 18 years of age
* Weight between 3.5 and 40 kg
* Parental or legal guardian consent and subject assent

Exclusion Criteria:

* Failure to obtain written consent
* Equal or more than 18 years in age
* Weight more than 40kg or less than 3.5kg
* Jaundice with bilirubin levels higher than the reference range
* Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent motioning of SpO2 levels during the study or placement of cerebral oximeter
Effect of Prematurity on Renal Function in 5 Years Old Children

Purpose of the study:

1. To evaluate the effect of prematurity on renal function in 5 years old children
2. To compare former premature children treated by ibuprofen in the neonatal period to controls


Eligibility Criteria:
Inclusion Criteria:

* Former premature children included at birth in a trial about ibuprofen and renal function in premature infants (ClinicalTrial.gov identifier:NCT00217191)

Exclusion Criteria:

* lack of parental consent
A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes

This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers.

Subjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.


Eligibility Criteria:
Inclusion Criteria:

* smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
* tested positive for urine cotinine (≥ 200 ng/mL) at Screening
* exhaled carbon monoxide \> 10 ppm (parts per million) at Screening

Exclusion Criteria:

* relevant illness history
* relevant medication use
* body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening
* allergy to propylene glycol or glycerin
* use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
* use of any prescription smoking cessation treatments within 3 months prior to Check-in
* smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
* planning to quit smoking during the study
* female subjects who are pregnant, lactating, or intend to become pregnant
Monitoring of Immunological Mechanisms and Biomarkers Underlying Efficacy and Toxicity of Cancer Immunotherapy

This trial is a translational, open-label, multi-site, prospective cohort study of 520 patients aiming to identify and to monitor immunological biomarkers associated with therapeutic response to immune checkpoints blockade (ICB), in patients with multiple types of advanced (unresectable and/or metastatic) solid cancers.

The study will be conducted on a population of patients receiving ICB (anti-PD-1 or anti-PD-L1 or anti-CTLA4, alone or in combination) in the context of either routine care or a clinical study protocol.

Patients with any of the following tumor types may be enrolled in the trial:

* Non-Small Cell Lung Cancer (NSCLC),
* Head and neck cancer,
* Melanoma,
* Bladder cancer,
* Other tumor types when Immuno-Oncology agent is expected to be efficient or when a clinical trial is an option.

For each included patient, tumor biopsy specimens and blood samples will be collected at different time points.

All included patients will be followed-up until progression. After this date, survival data will be collected.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years at the time of study entry.
2. Patient with histologically documented metastatic and/or unresectable solid malignant tumor (NSCLC, head and neck, melanoma (except uveal melanoma), bladder cancer or any other advanced solid tumor when I-O agent is expected to be efficient or when a clinical trial is an option).
3. Patient for which a treatment with immune checkpoint blockade including, but not limited to, anti-PD-1, anti-PD-L1 and anti-CTLA-4 mAb alone or in combination has been decided.
4. Archived tumor specimen available or feasible for pre-treatment tumor biopsy.
5. Current treatment with ICB not yet started.
6. Evaluable disease (measurable as per RECIST 1.1. or not).
7. ECOG Performance status 0-2.
8. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures.
9. Patient affiliated to a Social Health Insurance in France.

Exclusion Criteria:

1. Patient pregnant, or breast-feeding.
2. Uveal melanoma
3. Any condition contraindicated with tumor /blood sampling procedures required by the protocol.
4. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders.
6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
7. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.

L-Carnitine supplementation has been shown to boost muscular performance in several studies. In hemodialysis patients with muscular weakness, fatigue, or cramps/aches, after L-carnitine treatment, about two-thirds of patients had at least some improvement in muscular symptoms . L-Carnitine was also found to improve the left ventricular ejection fraction (LVEF) in hemodialysis patients with cardiac morbidity who had significantly reduced LVEF in echocardiography before supplementation. Moreover, L-Carnitine has been shown to improve muscular function and exercise performance in athletes in several studies


Eligibility Criteria:
Inclusion Criteria:

* Age from 21 years old or greater
* Both genders have respiratory failure either of the primary medical origin or in the post-surgical course.
* Not in need of mechanical ventilation

Exclusion Criteria:

* Renal failure on regular dialysis
* Hypothyroidism
* Seizures
* End-stage liver disease
* Mechanical ventilation
* History or discovered allergy to L-carnitine, pivampicillin, and other pivalate-conjugated antibiotics.
Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma

This study was designed to assess the effect of inspiratory and expiratory muscle training in the same cycle on respiratory muscle strength, pulmonary functions, perception of asthma symptoms in children with bronchial asthma. Fifty-one children with bronchial asthma were randomly allocated to the unloaded respiratory muscle training (Placebo training group; n = 17), inspiratory muscle training alone (inspiratory muscle training group; n = 17), or combined inspiratory and expiratory muscle training in the same cycle (combined training group; n = 17). All groups were assessed for respiratory muscle strength, pulmonary functions, and asthma symptoms.

Fifty-one children with bronchial asthma were recruited from King Khalid Hospital, Al-Kharj, Saudi Arabia. The study included children who had a confirmed diagnosis of bronchial asthma according to the Global Initiative for Asthma guidelines, aged 12-18 years, identified as being stable cases, had a baseline percent-predicted value of the peak expiratory flow rate of 60-80%, sustained stale doses of medications in the past three months. Children who had unstable asthma or exacerbated asthma symptoms, history of thoracic surgery, or cardiopulmonary comorbidities were excluded.

Outcome measures

1. Respiratory muscle strength: assessed by measuring the maximal inspiratory and expiratory pressure using an electronic respiratory pressure meter.
2. Pulmonary function: The forced vital capacity (FVC), forced expiratory volume in the first second of expiration (FEV1), and FEV1/FVC ratio, were measured in a pulmonary function test through a spirometry analyzer.
3. Control of asthma symptoms: Asthma symptoms were assessed using a translated version of the asthma control test.

All groups received the conventional respiratory re-training program, three times a week, for 12 weeks in succession. The placebo group additionally received unloaded respiratory muscle training, the inspiratory muscle training group received respiratory muscle training alone, and the combined group received combined inspiratory and expiratory muscle training in the same cycle. Interventions were conducted by a licensed physical therapist who had experience of more than 10 years of respiratory training.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of asthma according to Global Initiative of Asthma guidelines.
* Age between 12 and 18 years.
* Clinically stable asthma.
* Stable doses of medications in the last three months
* A percent-predicted value of the peak expiratory flow rate of 60-80%
* No activity limitation due to asthma

Exclusion Criteria:

* Unstable asthma
* Exacerbation of asthma symptoms
* History of thoracic surgery
* Cognitive/behavioral problems
* Cardiopulmonary co-morbidities
Assessment of Outcome of Meniscus Repair With or Without Platelet Rich Plasma

The purpose of this investigation is to determine the clinical outcome of repair of meniscus tears located in the "red/white" region using a well-known suture technique combined, when indicated, with platelet-rich plasma to enhance healing. The outcome of this operation will be determined in a consecutive group of patients with an established, rigorous knee rating system a minimum of 2 years postoperatively. Results will be determined by the analysis of subjective and functional factors, sports and occupational activity levels, a comprehensive physical examination, and a radiographic evaluation using standard plain x-rays and magnetic resonance imaging. The investigators hypothesize that meniscus repairs will significantly reduce tibiofemoral compartment pain and allow for increased knee function and activity levels. The platelet rich plasma adjunct will be used in complex meniscus tears in which a portion of the tear extends into the avascular region classified as either longitudinal, horizontal, or radial. The investigators hypothesize that the healing rate of these repairs will be superior to those previously reported in clinical studies in patients who had the suture repair technique alone.

There are many published clinical studies of complex meniscus tears in the red/white region with success rates that vary from 57% to 100%. Meniscus repairs that fail in this region usually require subsequent removal, which essentially results in loss of the majority of meniscal function and risk of future disabling osteoarthritis. This study will determine if the addition of platelet rich plasma increases the success rate of complex meniscus repairs of longitudinal, horizontal, or radial tears in the red-white region. The investigators have over two decades of experience with clinical studies of meniscus repairs in patients whose age ranged from 9 to 58 years. Those investigations revealed an average success rate in terms of retention of meniscus tissue of 80%. However, meniscus tears classified as horizontal, radial, double longitudinal, and complex multiplanar had success rates of 71-73% which prompted the need for an adjunct therapeutic measure, such as platelet rich plasma, to increase the healing potential in these cases.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for meniscus repair who provide informed consent to participate

Exclusion Criteria:

* Patients scheduled for meniscus repair who refuse to participate
* Presence of a tumor, metastatic disease, active infections, platelet count \< 10 5/hl Hgb \< 10 g/dl, pregnancy, active breastfeeding, and allergy to Bupivicaine
* Patients with preexisting thrombocytopenia, hypofibrinogenemia, or who are on anti-coagulant therapy, or who have a potential hypersensitivity to bovine products