cyrilzakka/clinical-trials huggingface dataset:
To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.


Eligibility Criteria:
Key Inclusion Criteria:

* Have a primary diagnosis of schizophrenia
* History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening
* History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening
* Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Key Exclusion Criteria:

* Have an uncontrolled, unstable clinically significant medical condition
* History of suicide attempt or significant violence to others in the past 2 years
* A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse
* Current substance abuse/dependence
* Concurrent psychiatric disorder other than schizophrenia.
Chronic Presence of Epstein Barr Virus in Sulcular and Junctional Epithelial Tissue From Gingiva is Associated With Severe Periodontitis

The etiopathogenesis of periodontal disease results from complex interaction between infectious agents, mainly including bacteria, and host cellular and humoral immune responses. However it is thought that bacteria-induced pathogenesis is not sufficient alone to explain all biological and clinical features of the destructive periodontal disease. The main hypothesis is that herpesviruses, such as Epstein-Barr Virus, may participate as well by altering epithelial gingival cell biology and consequently may promote the initiation and progression of periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* Men exclusively
* 12 years minimum
* 2 patients affected by chronic periodontitis
* 2 patients affected by aggressive periodontitis
* 2 healthy patients (orthodontics extraction)
* Subject who have read and understood the information note relative under investigation and who have signed the informed consent
* Subject whose legal representative signed the parental consent (if minor patient)

Exclusion Criteria:

* Patient with contre-indication to dental extraction
* Patient witn serious blood disease
* Patient who exhibits systemic condition incompatible with the realization of the study
* Patient treated with oral retinoids, bisphosphonates, oral anticoagulants and anticonvulsivants
* Patient who presents za buccal carcinoma treated with radiotherapy
* Patient who have received during the past 6 months: anti-inflammatory drugs, anti-cancerous or immunosuppressive chemiotherapy
* Patient who presents a linguistic or psychic incapacity to understand information
* Female patient
Microwave Diathermy for Treating Nonspecific Chronic Neck Pain

This randomised controlled trial aims to compare the effect of microwave diathermy (continuous and pulsed modes) with sham microwave diathermy in nonspecific chronic neck pain patients. Every patient will also be treated by exercise and transcutaneous electrical neurostimulation (TENS). The primary endpoint is to establish whether the use of microwaves is justified in terms of pain relief or reduction of disability in this patients.


Eligibility Criteria:
Inclusion Criteria:

* to be between 18 and 65 years old
* to be diagnosed with chronic nonspecific neck pain (i.e. during more than 3 months in the absence of red flags (unexplained weight loss, fever, neurological signs, history of cancer, history of inflammatory conditions...)

Exclusion Criteria:

* pregnancy
* sick leave
* litigation
* claims because the neck pain.
Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis

Systemic Sclerosis (SSc) is an auto-immune systemic disease characterized by vascular damage, cutaneous and visceral fibrosis and a dysimmune condition.

Therapies in this disease remain insufficient and the complications resulting from organs involvement lead to strong morbi-mortality.The dermic infiltrate of the patients includes a strong proportion of Tcells. T cells and Natural Killer (NK) cells are potentially involved in the vascular damage of the SSc. However mechanisms at the onset of this endothelial cytotoxicity and its impact on the capacities of regeneration of the endothelial tissue remain poorly understood. Fractalkine is at the same time an endothelial membrane-bound adhesion molecule and a chemokine which is able to bind CX3CR1 expressed by the immune populations. The purpose of the project is to define the role displayed by cytotoxic, circulating immune populations of SSc patients in endothelial cytotoxicity as well as the role of the axis Fractalkine / CX3CR1 in mediating the interactions between the immune cytotoxic cells and the endothelium.


Eligibility Criteria:
Inclusion Criteria:

* patients affected by SSc of more than 18 years
* Healthy patients

Exclusion Criteria:

* Impossibility to take some blood
* Current infection
* Ongoing cancer
* chemotherapy or a current radiotherapy
* pregnant or breast-feeding women
Synergic Control of Posture in Peripheral Neuropathies' Patients

This is a multicenter observational study aimed to characterize multi-muscle synergy organization in relation to postural stability in individuals with Peripheral Neuropathies (PN) compared to healthy age-matched subjects and to assess the effectiveness of a rehabilitation program driven by multi-muscle synergy organization.

This is a multicenter observational study of peripheral neuropathies patients aiming at characterizing multi-muscle synergy and at assessing the effectiveness of a rehabilitation program driven by multi-muscle synergy organization.

The study can be divided in two phases:

Phase 1 will included peripheral neuropathies patients and healthy age-matched subjects.

Peripheral neuropathies patients will be assessed with:

* Neurological assessment formalized via Total Neuropathy Score-clinical version (TNSc©)
* Nerve conduction studies
* Impact of PN on patients' quality of life using Short Form Health Survey 36 (SF-36)
* Functional status using Functional Independence Measure (FIM)

Peripheral neuropathies patients and healthy age-matched subjects will receive a postural evaluation recording during three different postural tasks (quiet standing, voluntary sway and shoulder flexion):

* centre of pressure (COP) displacement of force platform;
* surface muscle activation using electromyography (EMG) of 13 muscle on the right side of the body (tibialis anterior, soleus,gastrocnemius lateralis-medialis, biceps femoris, semitendinosus, rectus femoris, vastus lateralis and medialis, tensor fasciae latae, lumbar and thoracic erector spinae and rectus abdominis).

Phase 2 will included only peripheral neuropathies patients. Participants will be assessed at baseline, after a 20 session 2-3/w program of physical therapy and at a follow up of 3 months.

The evaluations of the first phase will be implemented with evaluation of mobility and balance using Six Minute Walking Test (6MWT), Mini Balance Evaluation System Test (MiniBESTest) and Timed Up and Go test (TUG).

Eligibility Criteria:
Inclusion Criteria:

* Subject suffering from peripheral neuropathy with a TNSc© score more than 4
* male and female subjects who are 18 years of age or older

Exclusion Criteria:

* orthopedic or neurologic comorbidities that can influence postural control

A control group of healthy subjects with the same demographic features of peripheral neuropathy patients wil be also included.
Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02

This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.


Eligibility Criteria:
Inclusion Criteria:

* Participation in AFF002 and AFF004

Exclusion Criteria:

* Presence or history of allergy to components of the vaccine, if considered relevant by the investigator
* Contraindication for MRI imaging
* History and/or presence of autoimmune disease, if considered relevant by the investigator
* Active infectious disease (e.g., Hepatitis B, C)
* Presence and/or history of Immunodeficiency (e.g., HIV)
* Significant systemic illness
Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases

This prospective cohort study will investigate whether progression of the interstitial lung diseases is related to specific clinical endpoints and their changes over time. Longitudinal data of patients will be compared to an age-matched control group during a follow-up of at least two years.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with interstitial lung disease:

   * Age between 40 and 75 years old upon inclusion;
   * Diagnosis of interstitial lung disease;
   * Clinical stability for at least 4 weeks prior to inclusion;
   * Absence of any comorbidity that interferes with the performance of tests;
2. Age-matched control group:

   * Age between 40 and 75 years old upon inclusion;
   * Absence of any comorbidity that interferes with the performance of tests;

Exclusion Criteria (both groups):

* Participants that present severe or unstable cardiac disease identified during the cardiopulmonary exercise testing;
* Participants with cognitive deficit that interfere with any of the tests;
Growth and Tolerance of Healthy Term Infants to a New Infant Formula

The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.


Eligibility Criteria:
Inclusion Criteria:

* in good health
* singleton full term birth
* Birth weight \> 2490 g.
* Infant is between 0 and 11 days of age
* Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
* If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
* If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
* not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study

Exclusion Criteria:

adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.
H-28 DELTA ST-C and Minima Retrospective Study.

The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.


Eligibility Criteria:
Inclusion Criteria:

* Underwent to a THA with DELTA ST-C cup and MINIMA stem in 2017 onwards
* Both genders
* Any race
* A diagnosis in the target hip of one or more of the following:

  1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis
  2. Rheumatoid Arthritis
  3. Post-traumatic arthritis
  4. Fractures of femoral neck
  5. Congenital or acquired deformity
* Patient willingness to participate

Exclusion Criteria:

* Local or systemic infection
* Septicaemia
* Persistent acute or chronic osteomyelitis
* Confirmed nerve or muscle lesion compromising hip joint function
* Vascular or nerve diseases affecting the concerned limb
* Poor bone stock (for example due to osteoporosis) compromising the stability of the implant
* Metabolic disorders which may impair fixation and stability of the implant
* Any concomitant disease and dependence that might affect the implanted prosthesis
* Metal hypersensitivity to implant materials
* Required revision of previous standard femoral stem
* Age \< 18 years old
* Any clinically significant pathology based on clinical history that the Investigator feels may affect the study evaluation including, but not limited to:

  1. significant neurological or musculoskeletal disorders or disease that may adversely affect gait and compromise functional recovery
  2. neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device
  3. known metabolic disorders leading to progressive bone deterioration
* Hip replacement on the contralateral side performed within less than one year
Cementless Oxford Partial Knee Controlled Observational Study

The purpose of this study is to evaluate the safety and effectiveness of the Cementless Oxford Partial Knee System.

The study is designed to document and compare the clinical and radiographic results of the Cementless Oxford Partial Knee System (investigational device) to those of the cemented Oxford Partial Knee System (control device).

Eligibility Criteria:
Inclusion Criteria:

* have primary diagnosis of osteoarthritis or avascular necrosis limited to the medial compartment of the knee
* signed informed consent for patients contributing to investigational or control if required
* Male or female over the age of 21 years at the time of surgery
* Undergone primary partial knee arthroplasty as unilateral arthroplasty or bilateral arthroplasty, simultaneously or otherwise
* Patients that are current residents of the United Kingdom

Exclusion Criteria:

* Evidence of infection, sepsis, and osteomyelitis at the time of surgery
* Use in the lateral compartment of the knee
* Rheumatoid arthritis or other forms of inflammatory joint disease
* Revision of a failed prosthesis, failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture
* Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device
* Partial or full thickness cartilage disease or damage to central part of the lateral femoral condyle
* Osteoporosis or insufficient bone stock
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infection which may spread to the implant site
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee
* Charcot's disease
* A fixed varus deformity (not passively correctable) of greater than 15 degrees
* A flexion deformity greater than 15 degrees
* Refuse to sign informed consent if it is required
* Patients that are not current residents of the United Kingdom
Continuation With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age

Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD


Eligibility Criteria:
Inclusion Criteria:

* The patient is a male or female child aged ≥7 and \<12 years or an adolescent aged ≥12 and ≤17 years at Baseline in Study 12712B.
* The patient must have completed extension Study 12712A immediately prior to enrolment into this extension study.
* The patient had a primary diagnosis of a MDD at entry in Study 12709A or 12710A, diagnosed according to DSM-5™.
* The patient is still indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator.

Exclusion Criteria:

* The patient has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12712A.
* The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Other protocol-defined inclusion and exclusion criteria may apply
Abscopal Effects of Stereotactic Body Radiotherapy in Metastatic Clear Renal Cell Carcinoma

Prior research has indicated that stereotactic body radiotherapy (SBRT) can effectively trigger systemic anti-tumor immune response. The goal of this observational study is to learn about abscopal effects of stereotactic body radiotherapy in patients of metastatic clear renal cell carcinoma. The primary objective was to assess the objective response rate (ORR) and complete response (CR) in non-irradiated lesions, and incidence of adverse events (AEs).


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years at the time of signing informed consent;
* Histologically confirmed, advanced renal cell carcinoma of stage IV (AJCC 8);
* Previously received SBRT treatment；
* Evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria.

Exclusion Criteria:

* Patients who cannot be adequately followed up;
* Has a known additional malignancy that is progressing or requires active treatment.
Maintaining Nonsmoking: Older Smokers - 1

The purpose of this study was to examine pharmacological and psychological interventions for smokers over 50.

The overall goals of this line of research were to prevent relapse to cigarette smoking, and to understand the processes related to smoking and relapse. The specific aims of the current study were to test a series of hypotheses about the efficacy and cost-effectiveness of long-term, tailored interventions in chronic, older smokers and the interaction of these interventions with gender and depression. Participants were 50 years or older and smoker 10 or more cigarettes per day. Baseline assessments includes measures of smoking behavior, nicotine dependence, depression diagnosis, demographics and life circumstances and measures of anger, depression and mood disturbance, stress, social support, health status, motivation for changed and drug and alcohol use.

Eligibility Criteria:
smokers of at least 10 cigarettes per day

Inclusion Criteria:

MULTIPLE

Exclusion Criteria:

MULTIPLE
Urinary Concentration and Diluting Ability in Patients With Chronic Renal Disease and/ or Hypertension

The investigators want to test the hypothesis that patients with chronic renal disease have a poorer ability to preserve water after being thirsty and a poorer ability to excrete water after a load of fluid. They presume that these abilities become poorer when renal insufficiency progresses. The investigators further hypothesize that patients with hypertension also have a decreased ability to concentrate and dilute urine.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic renal insufficiency, aged between 18 and 65, both men and women
* Creatinine clearance between 30-59 ml/min
* Patients with hypertension, aged between 18 and 65, both men and women; hypertension is defined as a mean arterial blood pressure in the daytime that is more than 140/90 mm Hg.
* Healthy volunteers, aged between 18 and 65, both men and women

Exclusion Criteria:

* Clinical signs or history of disease in the heart, lungs, liver, brain, and endocrine organs
* Cancer
* Alcohol abuse
* Medicine abuse
* Pregnancy
F-18 FDG PET/CT and CT in Initial Staging of Non-small Lung Cancer

Is to compare F-18 FDG PET/CT to routine CT in staging of non-small lung cancer and effect on change management.

* The optimal treatment of non-small cell lung cancer (NSCLC) relies on accurate disease staging that is based on the TNM system which relies on tumor size, regional nodal involvement, and the presence of metastasis.
* CT is the standard modality used to assess the intra-thoracic spread but false negative CT scans have been reported and were related to the presence of metastasis in normal sized lymph nodes and false positive findings have been related to lymph node enlargement due to benign process.

PET is most widely used in thoracic oncology because of its superiority over other imaging techniques in staging nodal and metastatic disease, however, the poor anatomic details of PET can lead to errors in diagnosis and staging.

• To solve this problem, CT is combined with PET to provide matched morphological and functional data. The diagnostic capability of PET/CT in the preoperative staging of lung cancer is superior to that of CT alone and PET alone as it has the advantage of a more accurate assignment of tumor stage (T stage) and defining the lymph node stage (N stage) as well as reduction of the number of useless thoracotomies

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically proven NSCLC who underwent initial PET/CT images.
* All patients ≥ 18 years.

Exclusion Criteria:

* Patients who had started treatment before initial PET/CT. Patients with glucose level \< 200 mg/dl. Patients with another malignant condition.
Effect of rTMS of the Dorsolateral Prefrontal Cortex on Language Production in Healthy Participants

The purpose of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) on language production.

Background:

Several studies investigating healthy or clinical populations have shown that (r)TMS applied over the dorsolateral prefrontal cortex (DLPFC) has an effect on language-related processes such as verbal working memory (Osaka et al., 2007), sentence comprehension (Cotelli et al., 2011) and language switching (Holtzheimer et al., 2005, Nardone et al., 2011).

Clinical observations and neuroimaging studies seem to confirm the role of executive functions and frontal structures in language processing in monolingual and bilingual subjects (e.g. Fabbro et al., 2000, Abutalebi \& Green 2007). However, only few studies investigated the effects of modulation of cognitive control-networks on lexical access.

Aim and procedure:

The study will investigate the role of the DLPFC and executive functioning in L1 and L2 language processing. The core question is whether rTMS over the DLPFC will influence lexical access and language production.

Each participant will take part in two sessions: 1. rTMS session 2. Sham rTMS session. After the application of rTMS/Sham rTMS, the participants will conduct two language tasks (translation, picture naming) and a non-verbal task, while the EEG is recorded.

Eligibility Criteria:
Inclusion Criteria:

* L1 French, knowledge of English as a foreign language
* 18-45 years of age
* Right-handedness

Exclusion Criteria:

* epilepsy /family history of epilepsy
* brain surgery, traumatic brain injuries
* cardiac pacemaker, metallic objects in the body
* history of neurological diseases or psychiatric disorders
* drug use (alcohol, psychoactive medication)
* developmental language disorder