cyrilzakka/clinical-trials huggingface dataset:
Quantiferon for Detection of Latent Tuberculosis in Healthcare Workers

The accuracy of tuberculin skin test (TST) for detecting latent tuberculosis is limited in countries with a high proportion of population having received vaccination with the BCG. We aim to determine the cost-effectiveness of Quantiferon gold (QTFG), compared to BCG vaccine to detect latent tuberculosis in exposed healthcare workers (HCWs)

The QUANTIPS study includes two components:

1. survey of HCWs working in high-risk units (respiratory diseases or infectious diseases with at least 5 case of smear-positive pulmonary tuberculosis par year) from 14 University hospitals in France
2. Follow-up of HCWs with unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient) in 4 University hospitals Main objective: Therapeutic impact of tuberculosis screening using TST compared to QFTG. The impact is defined by the decision to treat of not a HCW with latent tuberculosis using QFTG, compared to the decision which would have been based on TST alone

Secondary objectives:

* Cost-effectiveness of replacing TST by QFTG
* Prevalence and incidence of latent tuberculosis in exposed HCWs (Part 1)
* Incidence of latent tuberculosis in HCWs exposed to an index case (part 2) Inclusion: HCWs who volunteer to participate in units with at least 5 patients with smear-positive tuberculosis each year (Group 1), HCWs exposed to a smear-positive patient non isolated at hospital admission (Group 2) Study population: 2000 (Group 1) and 600 (Group 2) HCWs Study duration: inclusion during 3 months, follow-up of one year (Group 1 ); Inclusion for one year, with a 3-month follow up (Group 2)

Study exams:

* Group 1 : TST, QFTG, chest radiography at baseline and after one year
* Group 2 : TST, QFTG, chest radiography at baseline (within 3 weeks after exposure) and after 3 months

Endpoints:

* therapeutic decision regarding tuberculosis treatment, with a cost-effectiveness analysis (Markov's modelling)
* prevalence and incidence of latent tuberculosis

Eligibility Criteria:
INCLUSION CRITERIA:

Group 1:

* Healthcare worker volunteering for the study
* Stable (expected employment in the unit \> one year)
* Working in a high-risk units for tuberculosis (at least 5 cases of smear-positive pulmonary tuberculosis per year)

Group 2 :

* Healthcare worker volunteering for the study
* With an unexpected exposure to a patient with contagious tuberculosis (delay in respiratory isolation of a smear-positive patient)

EXCLUSION CRITERIA:

* No informed consent
* Age \< 18 years
* Employment in this unit \< one year
Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis

Defining ultrasound criteria for normal uterine biometry and assessing the prevalence of repeat abortions in patients with abnormalities of the uterine cavity

Adenomyosis is a gynaecological disorder with a high prevalence in women of childbearing age and is characterised by the presence of glands and endometrial stroma within the myometrium, associated or not with hypertrophy and hyperplasia of the surrounding myometrium. Adenomyosis may cause pelvic pain and/or abnormal uterine bleeding. Transvaginal ultrasound may be considered the main non-invasive diagnostic modality for the diagnosis of adenomyosis. The aim is to optimise the ultrasound diagnosis of uterine pathology and in particular of adenomyosis by defining uterine biometric parameters (longitudinal, transverse and anteroposterior diameters and their ratios; uterine volume) allowing patients to be divided into 3 groups:

* Uterus affected by adenomyosis (group A): adenomyosis is a gynaecological condition with high prevalence in women of childbearing age and is characterised by the presence of endometrial tissue (innermost layer of the uterus) within the uterine muscle. Adenomyosis can cause abdominal pain and abnormal uterine bleeding.
* Uterus affected by fibromatosis (group B): uterine fibromatosis is a gynaecological condition characterised by the appearance of numerous fibroids in the uterus. It is a very frequent condition in the general population and its frequency increases as the age of the patients increases.
* Normal uterus (group C). Transvaginal ultrasound, although a reference diagnostic tool, still remains an operator-dependent examination to date: our secondary objective is to build models that can simplify diagnosis through the use of artificial intelligence. The aim is to create various artificial intelligence software that can 'learn to make a diagnosis'. This method has already been applied in radiology, proving capable of discriminating between benign and malignant tumours from images from different diagnostic methods with performance similar to that of experienced radiologists.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 60;
* obtaining informed consent

Exclusion Criteria:

* Hysterectomised patients;
* Virgo patients (hymenal integrity);
* Patients reporting intolerance to transvaginal ultrasound;
* Gynaecological oncology;
* Recent pregnancy or childbirth (within 6 months);
* Menopausal patients
Denosumab in Current Users of Bisphosphonates for Glucocorticoid-induced Osteoporosis

The purpose of this study is to study the efficacy of denosumab, a new drug, in the treatment of osteoporosis in patients using bisphosphonates.

There are no data on the use of denosumab in steroid induced osteoporosis. Postmenopausal women with chronic use of Glucocorticoid (GCs) are at high-risk of osteoporotic fractures. Despite bisphosphonate treatment, a certain proportion of high-risk patients using chronic GCs either do not achieve a satisfactory gain in bone mineral density (BMD) or develop new fragility fractures. Thus, more potent osteoporosis treatment is necessary for this subgroup of patients. This prompts the current study which aims to examine the efficacy of denosumab in current users of oral bisphosphonates for Glucocorticoid-induced Osteoporosis (GIOP).

Eligibility Criteria:
Inclusion Criteria:

1. Women or adult men (\>18 years of age) with various medical diseases requiring long-term prednisolone treatment. Pre-menopausal women should have no plan for pregnancy within 2 years of study entry and agree to practice contraception during this 2-year period.
2. A daily dose of prednisolone (or equivalent) of more than 2.5mg within 3 months of study entry.
3. Having received oral bisphosphonate treatment for at least 2 years.
4. Suboptimal response to bisphosphonate treatment, defined as either one of the following: (1) failure of lumbar spine, femoral neck or total hip BMD values to increase; (2) values of lumbar spine, femoral neck or total hip BMD remain osteoporotic, ie. T scores \< -2.5 or Z scores \< -2.0; or (3) development of new fragility vertebral or non-vertebral fractures despite at least 2 years' treatment with good compliance.
5. Informed consent from patients.

Exclusion Criteria:

1. Patients with previous use of denosumab or teriparatide.
2. Premenopausal women who plan for pregnancy within 2 years of study entry or who do not agree for contraception within this 2-year period.
3. Patients with known bone disorders such as osteomalacia, renal osteodystrophy, and hyperparathyroidism.
4. Patients with unexplained hypocalcemia.
5. Patients with serum creatinine level of \>=200umol/L.
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma

Single centre prospective evaluation of 68Gallium(Ga68)-FAPI-46 PET/MRI in patients diagnosed with Hepatocellular Carcinoma (HCC). 68Gallium-FAPI-46 PET/MRI and standard contrasted multiphasic MRI imaging will be acquired in patients with radiological or histological diagnosis of HCC. The PET scan results will be compared to standard imaging to evaluate its role in lesion detection, characterisation and staging in patients with HCC.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-99 years
* Diagnosis of HCC based on histological assessment, or meeting consensus radiological criteria for diagnosis of HCC based on American Association for the Study of Liver Diseases practice guidelines(18)
* No prior locoregional therapy for HCC
* Creatinine clearance \> 30ml/min based on Cockcroft Gault formula
* Able to provide informed signed consent

Exclusion Criteria:

* Allergy to 68Ga-FAPI contrast agents
* Contraindication to MRI, including but not limited to MRI incompatible metallic implants, cardiac pacemaker, claustrophobia
* Weight \> 150kg
* Known active malignancy other than HCC
* Hepatic surgery within the last 30 days.
* Active inflammatory conditions that may affect FAPI imaging in opinion of investigator. Including but not limited to active infection, IgG4-related disease, inflammatory bowel disease,
* Pregnancy (all women of childbearing age are required to undertake a urine pregnancy test)
Acute Supplementation With Beta-Alanine Improves Performance in Aerobic-anaerobic Transition Zones in Endurance Athletes

The use of beta-alanine (BA) to increase physical performance is widely documented. However, the acute effect of this amino acid on maximal tests in the aerobic-anaerobic transition zone is still uncertain. The objective of this study was to determine the acute effect of low and high-dose BA trials on maximal aerobic speed (MAS) in endurance athletes. We hypothesized that high doses of BA have a greater effect than low doses, both compared to baseline. Twelve male endurance athletes volunteered for the study. The experimental design applied was randomized cross-over, double-blind. Treatment included three 6-minute run tests (6-MRT), the first as a baseline, then randomized 6-MRT with low (30 mg·kg-1) and high (45 mg·kg-1) dose BA trials. The 6-MRTs were separated by 72 hours. The main variable of the study was the distance (m) performed in the 6-MRT. Differences between tests were established through ANOVA and Tukey's multiple comparison tests (p \< 0.05).

In this original research, we determined the acute effect of low (30 mg·kg-1) and high-dose (45 mg·kg-1) BA trials on maximal aerobic speed (MAS) in endurance athletes. At the same time, we compared the effect size with of BA.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criterion was years of training for endurance events (participants had a minimum of two years running middle-distance and long-distance events).

Exclusion Criteria:

* The exclusion criterion was the inability to perform the 6-minute run test
Cardiovascular Events in Parkinson's Disease Patients

Cardiovascular (CV) disease is a common comorbidity of Parkinson's disease (PD). The background incidence rate of CV events in a levodopa-treated PD population was assessed to better understand these comorbidities in the PD population. One objective of the study is to identify a population of prevalent PD patients with incident levodopa use within the years 2004-2010 on the Integrated Health Care Information Services (IHCIS) database. The second objective is to report the incidence of CV events overall and during intervals 0-6, 6-12 and 12-18 months after first prescription of levodopa among all new levodopa users.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with one or more prescriptions of levodopa between 1st July 2004 and 30th June 2010
* Individuals on the database with medical and pharmacy benefit for at least 6 months prior to date of first prescription of levodopa
* Individuals with one or more diagnosis codes for Parkinson's disease within the 6 months prior or 6 months post first prescription of levodopa

Exclusion Criteria:

* Individuals less than 20 years of age on date of first prescription of levodopa
* Individuals previously prescribed levodopa prior to study period
A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab

The purpose of this study is to evaluate whether the risk of serious infections in rheumatoid arthritis patients with tocilizumab is higher than in those with tumor necrosis factor inhibitors using the nationwide real-world data.

This observational, retrospective cohort study using the Korean National Health Insurance (NHI) data will evaluate whether the risk of serious infections (SIs) in rheumatoid arthritis patients treated with tocilizumab is higher than in those with tumor necrosis factor inhibitors. We will compare incidence rates between two groups and estimate relative risks of SIs in tocilizumab users using the time-dependent Cox proportional hazard regression. Various covariates potentially related to RA severity and occurrence of infection will be assessed and used for adjustment.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who had a diagnosis of rheumatoid arthritis (ICD-10 codes: M05-06) between 2013 and 2018

Exclusion Criteria:

* Individuals less than 18 years of age
* Having no records of prescription of tocilizumab or TNFi at least once between 2013 and 2018
Web-based Rehab After Acute Vertigo

Acute onset vertigo is common and entails much suffering with persisting symptoms at 3 months after onset in up to half of those afflicted. Vestibular rehabilitation to aid recovery is not readily available. The purpose of this study is to investigate the effects on vertigo symptoms of a 6-week online vestibular rehabilitation tool compared with standard care (written instructions leaflet) after acute onset vertigo.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old; and
* The subject has given written consent to participate in the study; and
* New acute onset dizziness or vertigo since ≥24 hours with pathological spontaneous or gaze-evoked nystagmus (i.e. an acute vestibular syndrome, AVS). The nystagmus as described above must be present at investigation between 24 hours and 7 days from onset, spontaneously, gaze-evoked or head-shake evoked and documented; and
* Screening and inclusion within 7 days of onset of continuous symptoms; and
* Symptomatic at inclusion

Exclusion Criteria:

* Pre-existing vestibular disease or neurological disease anticipated to affect the ability to participate in the study or the effect of the intervention. N.B: Recurring AVS with no set diagnosis before inclusion is accepted, as is past transient neurological diseases such as TIA or migraine; or
* Inability to use the online rehabilitation tool, e.g. due to not having access to a computer, tablet or smartphone, not having access to the internet or lacking in experience with such tools; or
* Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation; or
* Medical and/or physical contraindications to making the required head movements (e.g. vertebral dissection) or otherwise participating in the training and testing exercises or data collection; or
* Medication or other substance intake which can affect the ability to participate in the study or the reliability of the measurement methods. These medications include regular use of: Anticonvulsants, antiemetics/motion sickness medications, benzodiazepines, neuroleptics. Transient corticosteroid and/or antiemetic treatment related to the current vertigo is accepted.
Rates of Fetal Extractions Between Only Vaginal Touch Usually Realized and Vaginal Touch + Echography

The main objective of this study is to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.

The main objective is to compare the rate of fetal extractions between a systematic practice of an echography of presentation and the vaginal touch only one usually realized during the labor.

It is a prospective, randomized study. After randomization, the patients will be assigned to one of following both groups:

* Diagnosis of the variety of presentation of the fetal head by the usual examination, that is the only vaginal touch allowing the palpation of the sutures of the fetal head to locate the axis and the orientation of this one in the maternal pond. However, this clinical examination can be completed by an echography if the team considers that this information is necessary to optimize the coverage delivery in case of extraction by pair of forceps or suction cup.
* Diagnosis of the variety of presentation of the fetal head by the vaginal touch, confirmed by the systematic practice of an abdominal echography completed by a perineal echography from 8 cms of dilation, and made for a maximal extension of 15 minutes following the vaginal touch. This echography will be at the need repeated

  1900 patients (that is 950 by group) have to allow to detect a decrease of 25 % of the rate of deliveries assisted in the experimental group (systematic echography) with regard to the control group (TV), that is a decrease absolved from the rate from 20 % to 15 %, with a 80 % power and a risk of 5 % (bilateral test).

Duration of participation in the study: = 2 days Duration of the inclusions: 36 months

Criteria of efficiency Rate of deliveries attended defined by a composite criteria: deliveries by caesarian from a dilation of the cervix = 8 cms, and instrumental extractions by pair of forceps or suction cup.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* singleton pregnancy in head presentation
* gestational age ≥ 37 WG
* dilation of the cervix = 8 cms

Exclusion Criteria:

* caesarian antecedent, preeclampsia, praevia placental
* maternal and pregnancy pathology
* included in other trial
* absent consent
Retinal Sensitivity in BRVO After Anti-VEGF Therapy

The efficacy of anti-vascular endothelial growth factor (VEGF) therapy for branch retinal vein occlusion (BRVO) is shown, but its effect on retinal sensitivity is not fully investigated. The purpose of this study is to compare the changes in retinal sensitivity after ranibizumab therapy or combination therapy of ranibizumab and laser photocoagulation in eyes with BRVO.


Eligibility Criteria:
Inclusion Criteria:

* Treatment naive patients of branch retinal vein occlusion with visual acuity of less than 1.0 and macular edema of more than 250 micrometers in foveal thickness.

Exclusion Criteria:

* Patients with history of treatment for branch retinal vein occlusion, possibility of pregnancy, allergy for ranibizumab, intraocular infection, or severe inflammation will be excluded.
Dysfunctional Adiposity and Glucose Impairment

This is a large and comprehensively phenotyped cohort with fasting glycaemia where the predictive value of body composition and anthropometric measures of total and central fat distribution for postprandial carbohydrate intolerance are studied.

Subjects aged 18-70 years, who attended the Department of Endocrinology and Nutrition of the Clínica Universidad de Navarra from 2009-2014 for a check-up were offered to participate in the DICAMANO study. 853 subjects agreed to take part. Only those individuals with a normal fasting glucose level (≤5.5 mmol l-1) were analysed. Subjects with T2DM or severe renal, liver or thyroid dysfunction were excluded. Participants were instructed to temporarily discontinue for 48 hours any medication known to affect glucose or lipid metabolism. On the day of the study visit, each subject had a complete routine clinical assessment to evaluate the presence of cardiovascular, respiratory, renal or endocrine disorders. All patients underwent a 75-g OGTT with a concomitant anthropometric study, blood pressure monitoring and lipid profile analyses. They were classified by glucose tolerance on the basis of blood glucose levels according to ADA diagnostic criteria for T2DM (2017). Carbohydrate intolerance was defined as a 2-hOGTT glucose level ≥7.8 mmol l-1 (mg dl-1). Body composition, visceral adipose tissue, anthropometry study, OGTT-based parameters and cardiovascular risk factors are measured.

Eligibility Criteria:
Inclusion Criteria:

* Fasting glucose level ≤ 5.5 mmol l-1
* BMI ≥ 25

Exclusion Criteria:

* Type 2 diabetes mellitus
* Severe renal, liver or thyroid dysfunction
Isolated Thoracic Perfusion (ITP-F) for MPM

This is an observational study of isolated thoracic perfusion with subsequent hemofiltration to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in malignant pleural mesothelioma.

Treatment of patients with progressive malignant pleural mesothelioma (MPM) after multimodal therapy is a therapeutic challenge. Survival of the patients is low and the treatment options are sparse. This is an observational study of isolated thoracic perfusion with subsequent hemofiltration as a locoregional therapeutic strategy in this situation.

23 pts. with epithelioid MPM were included in this phase II study after informed consent. All patients had progressive disease after multiple therapies and were recommended BSC of a MDT. Following insertion of a venous and arterial 21 ch. stop flow catheter via a femoral access, the inferior vena cava was blocked beneath the right atrium, the arterial catheter was blocked in the aorta at the diaphragm. The upper arms were blocked by pneumatic cuffs. Chemotherapy was given via the arterial catheter. Chemotherapy consisted of 60mg/m2 cisplatinum and 15mg/m2 mitoxantrone q for 3 weeks until progress. After administration of chemotherapy, thoracic perfusion with blocked stop-flow catheters was maintained for 15 minutes. After de-blocking of the catheters, hemofiltration was performed for 45 min. with 5l filtrate. The endpoint of the study was overall survival.Secondary endpoint was toxicity.

Eligibility Criteria:
Inclusion Criteria:

* History of pre-treated Malignant Pleural Mesothelioma, Progress after Staging

Exclusion Criteria:

* Drug abuse, distant metastases, no bone marrow function
Different Medications to Induce Labor

This is a randomized controlled trial examining whether the use of misoprostol or pitocin, in combination with a foley catheter, is more effective at inducing labor in patients with a gravid BMI that is considered obese.

This randomized controlled trial will include patients with a BMI greater than 30 at the time of admission for their induction of labor. Patients will be randomized to either misoprostol or Pitocin to begin induction of labor, alongside the standard foley catheter, and the primary outcome of interest will be length of time from start of induction until delivery.

Eligibility Criteria:
Inclusion Criteria:

- Pregnant patient presenting to labor \& delivery for induction of labor with a BMI \> = 30

Exclusion Criteria:

- Pregnant patient presenting to labor \& delivery for induction of labor with BMI \< 30
New Approaches for the Identification and Characterization of Functional Markers of the Risk of Extension of Breast Cancer Without Lymph Node Involvement

1. Identify the tissue proteins associated with early breast cancer invasion phases without lymph node involvement .
2. Consider their role in the invasion and the risk of tumor spread .


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* CCIS
* Invasive tumors
* Breast cancer tissues available in the biobank

Exclusion Criteria:

* non availability of cancer tissue specimen