cyrilzakka/clinical-trials huggingface dataset:
Development and Validation of a Simple Diagnostic Tool Predictive of the Aseptic Character of Joint Effusion

Development and validation of a simple diagnostic tool predictive of the aseptic character of joint effusion in the primary care setting.

In accordance with guidelines and because of the potential gravity that this situation could represent, any joint effusion must be considered as a septic arthritis until proven otherwise, thus justifying an arthrocentesis and an adequate treatment. Nevertheless, because of epidemiology in primary care, this pragmatic attitude is quite commonly obscured and practices vary according to the experience of the doctor and his personal habits. As a result, the arthrocentesis is not commonly performed and anti-inflammatory treatment, whether based on NSAIDs or corticosteroids, is even sometimes administered to the patient despite the contrary guidelines. Although usually effective, this attitude is however not without risks. In this context, it seems interesting to develop a simple, reproducible and applicable diagnostic tool in a primary care setting for predicting the risk of septic arthritis.

This study is therefore aimed at the development and validation of a predictive score based on simple clinical and paraclinical data (such as the macroscopic appearance of the synovial fluid removed) in a patient with an effusion, whatever either the clinical presentation, whether isolated or integrated in a more complex clinical presentation, whether associated with locoregional inflammatory or general signs or not.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age ≥ 18 years)
* Hospitalized in the conventional hospitalization unit or day hospitalization unit or received in consultation within the Rheumatology or Infectious Diseases units at the Le Mans General Hospital
* presenting at least one joint effusion at clinical examination
* Interesting a native, nonoperated joint, accessible to a puncture based on clinical markers, determined by palpatory anatomy
* Affiliated to social security
* No opposition expressed after written information

Exclusion Criteria:

* General antibiotic therapy in progress or completed less than 15 days before
* Failure to perform the arthrocentesis
* Person subject to a legal protection measure, not allowing his compliance with the study
* Participant already included in another study (exclusivity clause)
Analysis of the Microbiome in the Healthy Smokers and COPD Patients

This study is to build a microbiome cohort by collecting sputum and fecal samples every few months for three years from healthy smokers and chronic obstructive pulmonary disease (COPD) patients. The aim of this study is to analyze the composition of microbiome of various samples (e.g. sputum, feces) and describe the difference between healthy smokers and COPD patients.

After the introduction of the gut-lung axis theory, extensive studies revealed the diversity of microbiomes among healthy smokers and COPD patients form the respiratory samples or lung tissues. In the previous study, distinct difference in composition of microbiome in lung tissue between healthy smokers and COPD patients was reported. This study is to build a microbiome cohort by collecting sputum and fecal samples every few months for three years from healthy smokers and chronic obstructive pulmonary disease (COPD) patients who are being followed up by Asan Medical Center. The aim of this study is to analyze the composition of microbiome of various samples (e.g. sputum, feces) and describe the difference between healthy smokers and COPD patients. This study would help establishing gut-lung axis model in humans.

Eligibility Criteria:
Inclusion Criteria:

* Patients with smoking history at least 10 pack-year
* Patients with persistent airflow limitation that was not fully reversible (e.g. post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \<0.7)

Exclusion Criteria:

* Patients with co-existing illness that would interfere with study results (e.g., malignancy, congestive heart failure, cerebrovascular disorders, chronic renal failure, diabetes with severe complications, or uncontrolled hypertension)
* Patients with respiratory disease other than obstructive lung disease (e.g., previous pulmonary resection, tuberculosis-destroyed lung, and bronchiectasis)
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban

Exclusion Criteria:

* Legal lower age limitations (country specific)
* Indication for VKA other than DVT and/or PE
* Patients in whom anticoagulant treatment for their index PE or DVT should be continued
* Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate \< 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP \[Committee for Proprietary Medicinal Products\]/ICH \[International Conference on Harmonization\]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
Characterization of the Postural Habits of Wheelchair Users Analysis of the Acceptability of International Recommendations in the Prevention of Pressure Sores Risk by Using a Connected Textile Sensor

Spinal cord injuries and people with Duchenne Muscular Dystrophy or Infant Spinal Muscular Atrophy (ISA) are prone to pain and pressure sores associated with prolonged sitting. For this reason, it is recommended that people with spinal cord injuries release pressure every 15 to 30 minutes and motorized wheelchair users use the electric positioning functions at least 1 minute every hour.

The aim is to prevent and/or reduce pain and pressure sores. These devices could help to observe daily the variability of users' pressure maps, their impact on occupational performance, the link with pain and redness and could propose customized adjustments.

The main objective of this study is to evaluate the impact of an algorithm that characterizes the cruro-ischiatic fingerprints used in daily life and that issues an alert in case of detection of a pressure sore risk defined by the literature on the occupational performance of the subjects.

The resulting assumption is based on the following points:

* The algorithms implemented in this device are able to calculate and isolate a number of cruro-ischiatic fingerprints used during the day during priority activities and active or passive position changes.
* They may, in the event of a risk position, issue alerts based on the recommendations.

This will allow us to analyze the impact of these alerts on the changes in position and relief actually performed by the subject, analyze the consequences on the MCRO score (psychosocial impact on occupational performance) and verify the impact of visual biofeedback on chair positioning.

Eligibility Criteria:
Inclusion Criteria:

* Men or women over 18 years of age,
* Daily user of a FR (more than 3 hours per day):

  * Persons with Duchenne Muscular Dystrophy (DMD) or DMB using an FRE,
  * People with Infant Spinal Muscular Atrophy (ISA) using an FRE,
  * WB persons using an MRA with sensitivity disorders (ASIA A).
* FRE allowing a switchover of at least:

  * 25° of the seat and 120° of the backrest,
  * 45° of sitting in one block,
* Patient who has signed an informed and written consent,
* Affiliation to a social security scheme (beneficiary or beneficiary).

Exclusion Criteria:

* Refusal of the patient to participate in the study,
* School level lower than cycle 3 not allowing to understand the use of the embedded device,
* Severe incontinence,
* BM without sensitivity disorders,
* Participant in another study or therapeutic trial,
* Patient under guardianship or curatorship,
* Pregnant women.
EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:

- Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.

Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.

In this study the investigators want to compare the Endodrill instrument with FNA (both modalities EUS-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper GI-tract. Patients diagnosed with suspected submucosal tumors in the upper GI-tract will be enrolled to this study. They will first go through examination with EUS. If the suspicion of a submucosal tumor is confirmed, the investigator will perform both EUS guided FNA and Endodrill biopsies in the same patient.The harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy

Exclusion Criteria:

* Mental illness
* Extreme co-morbidity
Zoladex Plus Tamoxifen in Breast Cancer

The purpose of this study is to compare Zoladex plus tamoxifen with tamoxifen alone as adjuvant hormonal therapy in pre- or perimenopausal women with early-stage breast cancer in terms of breast density, estrogen levels, lipidemia, endometrial thickness and ultrasonographic abnormalities.

After the completion of primary treatment(surgery and/or adjuvant chemotherapy, radiotherapy could be given concurrently with study medication), eligible patients will be randomized to receive Zoladex plus tamoxifen or tamoxifen alone. The duration of study medication along with the follow-up will be 18 months, or until disease recurrence,or discontinuation of study therapy (as a result of an adverse event, a patient's request, or an investigator's decision), further treatment will be at investigator's discretion.

During the study period, contralateral mammograms and transvaginal ultrasound will be undertaken at baseline and after 6, 12 and 18 months of study medications. Mammographic density assessment will be undertaken by a single radiologist. Serum measurements including estrogen levels and lipidemia will be obtained at baseline and after 3, 6, 12 and 18 months of study medications.

Eligibility Criteria:
Inclusion Criteria:

* provision of informed consent
* histologically proven HR+ operable invasive breast cancer
* completion of surgery and chemotherapy(if given).
* women defined as pre- or perimenopausal according to all of the following: aged 50 years or younger, at least one menstrual period during the last months.

Exclusion Criteria:

* clinical evidence of metastatic disease
* pregnancy or breast-feeding
* bilateral oophorectomy;
* radiation of the ovaries
* patients who, for whatever reason(eg, confusion, infirmity,alcoholism),are unlikely to comply with trial requirements
* patients whose chemotherapy was started more than 8 weeks after completion of primary surgery or whose chemotherapy was completed more than 8 weeks before starting the study treatment. Chemotherapy, if given, should have been given post-operatively, ie, patients who received neoadjuvant chemotherapy are ineligible
* patients who have not received chemotherapy and whose primary surgery was completed more than 8 weeks before starting the study treatment
* previous hormonal therapy as adjuvant treatment for breast cancer
* patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop
* previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
* treatment with a non-approved or experimental drug during 1 month before entry into the study
* history of hypersensitivity to active or inactive excipients of tamoxifen and Zoladex
* history of bleeding diathesis (ie. Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin )
* leukopenia and/or thrombocytopenia
* history of ocular fundus diseases
* history of thromboembolic diseases
Iraqi Trial for Lung Cancer Screening

Lung cancer is a global problem. Worldwide, 1.2 million people die of lung cancer each year. In Iraq, lung cancer is the most common malignancy after breast cancer and the leading cause of cancer-related death. Tobacco smoking plays a major role in lung cancer; it is reported in 85-90% of lung cancer patients yet environmental tobacco smoke, environmental and domestic air pollution, work-related risk factors, radon exposure, and viruses may also have an impact on lung cancer incidence rates. Early detection of the disease before patients develop symptoms considers the best way to improve patient outcomes. IT LUCAS is designed to evaluate the utility of low-dose computed tomography (LDCT) screening in early detection and management of lung cancer in high-risk people.

Background Lung cancer is a global problem. Worldwide, 1.2 million people die of lung cancer each year. In Iraq, lung cancer is the most common malignancy after breast cancer and the leading cause of cancer-related death. Tobacco smoking plays a major role in lung cancer; it is reported in 85-90% of lung cancer patients yet environmental tobacco smoke, environmental and domestic air pollution, work-related risk factors, radon exposure, and viruses may also have an impact on lung cancer incidence rates. Early detection of the disease before patients develop symptoms considers the best way to improve patient outcomes. Screening for lung cancer using low dose computed tomography (LDCT) has been the subject of research studies since the 1990s. It has been reported to be superior to CXR and septum cytology for small tumors detection.

Aim of the study IT LUCAS is designed to evaluate the utility of LDCT screening in early detection and management of lung cancer in high-risk people in Iraq.

Study design 500 healthy participants aged 50-75 years with a history of smoking of at least 30 pack year of smoking were recruited from Ministries of Oil and Transport. They were offered Low dose CT of the chest. Nodules with suspicious (Lung RADs 4A or 4B) findings were classified as positive and referred to the Respiratory Department for further workup and biopsy. Nodules with Lung RADS 3 features are reviewed after 6 months while those with Lung RADS 2 offered a LDCT after 12 months.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* aged between 50 and 75
* smokers or ex-smoker
* tobacco exposure of more than 30 pack-years

Exclusion Criteria:

* History of cancer within the last 5 years other than non-melanoma skin cancer or carcinoma in situ,
* heart or respiratory severe co-morbidity with contraindications to thoracoscopy
Assessment of EGFR Genomic Alterations as Prognostic Markers in Cervical Cancer

The Tissue Repository will search for cases, pull slides, Paraffin-embedded tissue (PET) blocks.

This study is done to gather preliminary data for determining the best way to test EGFR expression in patients with cervical cancer who will receive treatment with EGFR inhibitors in the future.

This study is designed to obtain preliminary data of genomic and phenotypic alterations of the EGFR pathway in high grade cervical intraepithelial lesions (HG-SIL) and invasive cervical cancers (CC) to be used later for therapeutic guidance and to evaluate genomic (over-expression, amplification, point mutations, etc.) and phenotypic alterations of other transduction pathways interacting with the EGFR pathway.

Eligibility Criteria:
Inclusion Criteria:

* Samples from patients diagnosed with HG-SIL (n=300) and CC (n=300) with a follow-up of at least 24 months, existing at the Department of Pathology will be retrieved by the Tissue Repository, de-identified them and provided with code numbers that will not be linked to patient's data.

Exclusion Criteria:

* None Specified.
Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.

Assess the prevalence of medico-psychological characteristics at the time of placement (M0), their appearance / disappearance and during the two years following placement (M12 and M24) by age group in children / adolescents in Child Protective Services and placed full-time in the structures of Seine-Maritime and Eure as well as in nursery in Le Havre or Rouen


Eligibility Criteria:
Inclusion Criteria:

* Minor adressed to child protective services
* Minor placed full time

Exclusion Criteria:

* Non affiliation to social security system
* Non accompanied minor
* Minor and/or parfents not understanding french
* Minor informed and refused participation
* Parents or tutor having refused participation of their child
Natural History of MTBI-related Convergence Insufficiency & Effectiveness of Vision Therapy for MTBI-related CI

The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of office-based vergence/accommodative therapy with movement (OBVAM) for mTBI-related convergence insufficiency.

The design of this project is a pilot study, a type of feasibility study conducted in preparation for subsequent RCTs that will assess the effectiveness of interventions or therapies. In this application, we refer to this pilot and feasibility study as a pilot clinical trial (PCT). This feasibility PCT aims to identify potential challenges, logistical issues, and unforeseen complications. To do this, we will examine various feasibility aspects, including recruitment and retention, randomization, intervention protocols, outcome measures, ethical considerations, safety monitoring, resource availability, and stakeholder feedback. By conducting this PCT, we can test our procedures and gather preliminary data. The primary objectives of this feasibility PCT are to 1) Determine the feasibility of conducting future full-scale RCTs by evaluating the effectiveness of a novel vergence/accommodative/move (OBVAM) therapy program for young adults with mTBI-CI and 2) Better understand the progression and stability (i.e., natural history) of mTBI-CI over the 6 weeks following enrollment.

Eligibility Criteria:
Inclusion Criteria:

* • Age 18 to 35 years inclusive

  * Medical diagnosis of mTBI or concussion \> 1 month ago and no longer than 6 months ago
  * Convergence Insufficiency Symptom (CISS score) ≥ 21
  * Best-corrected VA of 20/25 or better in both eyes at distance \& near
  * Willingness to wear refractive correction, if indicated
  * Random dot stereopsis of 500 arcsec or better (Randot Stereo Test)
  * Receded NPC of ≥6 cm
  * Insufficient PFV (\< 15∆ or PFV blur point less than twice the near exophoria magnitude)
  * Wearing refractive correction for cycloplegic refractive errors of:
  * ≥ +1.25 D SE hyperopia or ≥ -1.00 D SE myopia in either eye
  * ≥ 1.25 D astigmatism in either eye, ≥ 1.00 D SE anisometropia
  * Astigmatism axis within ±10 degrees if magnitude is ≤1.00 D and within ±5 degrees if \>1.00 D

Exclusion Criteria:

* • No previous treatment for CI

  * No previous diagnosis of CI from an ophthalmologist or optometrist
  * No medications known to affect accommodation or vergence
  * Investigator \& patient willing to forgo all other CI treatment other than that assigned by randomization
Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.


Eligibility Criteria:
Inclusion Criteria:

* Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP \< 90mmHg.
* Patients with or without current treatment for hypertension
* Angiographic evidence of coronary artery disease
* At least 2 qualifying Cardiovascular risk factors at Visit 1

Exclusion Criteria:

* Baseline IVUS determined unacceptable
* Patients requiring treatment with disallowed study medications
* Patients with clinically significant heart disease
* Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of \< 25%
* Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:

  * Angiotensin converting enzyme inhibitors
  * Angiotensin receptor blockers
  * aldosterone receptor blockers or a direct renin inhibitor.
* Other conditions may apply
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVaxTM-JE and JE-VAX

The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVax™-JE and JE-VAX® to the respective homologous virus strain and several wild types strains after completion of vaccination course.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained.
* Aged ≥18 to \<49 years.
* In good general health.
* Available for the study duration, including all planned follow-up visits.
* Females must have negative pregnancy test and be using adequate form of contraception

Exclusion Criteria:

* Clinically significant abnormalities on laboratory and vital sign assessments.
* Anaphylaxis or other serious adverse reactions
* Administration of another vaccine within 30 days of study treatment period.
* Physical examination indicating any significant medical condition.
* Intention to travel out of the area prior to the study visit on Day 56.
* Seropositive to Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) or positive for Hepatitis B Surface Antigen.
* Pregnancy.
* Excessive alcohol consumption, drug abuse.
* Involvement in another clinical study within 60 days preceding the screening visit and during study treatment period.