cyrilzakka/clinical-trials huggingface dataset:
The Real Life Topical Field Treatment of Actinic Keratosis Study

This non-interventional, multinational study of topical field treatment of actinic keratosis (AK) aims to collect real-life experience with ingenol mebutate as well as one or two other topical field therapies commonly used in the individual country. Physicians will report baseline characteristics, while the main study focus will be on patient reported outcomes 3-4 weeks after treatment completion (treatment satisfaction, adherence, resource utilization and Health Related Quality of Life.

Dermatology centres in Denmark, Norway, Sweden, the Netherlands, the United Kingdom and Canada will participate.

Actinic keratosis (AK) is caused by exposure to UV radiation and has the potential to regress to normal skin or to squamous cell carcinoma. AK treatment options include cryotherapy for solitary lesions and topical field therapy or photodynamic therapy for lesions in an area of sun-damaged skin. This prospective, non-interventional, multinational study aims to describe and compare in a real-life setting the treatment satisfaction, treatment adherence, resource utilization and quality of life during topical field treatment of AK with 5-fluorouracil, imiquimod, diclofenac and ingenol mebutate.

Dermatology centres in Denmark, Sweden, Norway, Canada, the United Kingdom and the Netherlands will aim to include a total of approximately 1600 patients, of which around 100 in each country will be patients scheduled to receive treatment with ingenol mebutate. In each country patients will in addition be recruited for one or two of the other treatment arms, as appropriate in the country.

Only adult patients scheduled to start treatment with imiquimod, 5-fluorouracil, diclofenac or ingenol mebutate who have given informed consent to use data from their medical records for the study and to report study data themselves will be included and followed for the duration of the scheduled treatment + 3-4 weeks.

Physician will report patient demographics and AK characteristics at baseline. Patients will at baseline report AK Quality of Life, including general attitude regarding sun damaged skin at baseline, and, if applicable, treatment satisfaction and adherence with latest previous AK treatment. At 3-4 weeks after end of treatment, the patients will report treatment satisfaction, adherence, resource utilization, health related Quality of Life.

Treating physicians report drug-related Adverse Events in accordance with national laws and regulations and normal clinical practice.

Eligibility Criteria:
Inclusion Criteria: Patients eligible to receive topical treatment with one of the following for treatment of actinic keratosis at the discretion of the dermatologist: Ingenol mebutate, 5-fluorouracil, imiquimod, diclofenac. Informed consent.

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Exclusion Criteria: Any on-going treatments at study start with ingenol mebutate, 5-fluorouracil, imiquimod or diclofenac; other topical treatment for AK in treatment area; pregnancy or planned pregnancy within treatment period.

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Teicoplanin-based Antimicrobial Therapy in Staphylococcus Aureus Bone and Joint Infection: Tolerance, Efficacy and Experience With Subcutaneous Administration

Staphylococci represent the first etiologic agents of bone and joint infection (BJI), leading glycopeptides use, especially in case of methicillin-resistance or betalactam intolerance. Teicoplanin may represent an alternative to vancomycin because of its acceptable bone penetration and possible subcutaneous administration. Various studies have shown that teicoplanin pharmacodynamic profile was superior compared to vancomycin regarding bone diffusion. Few studies have investigated the use of teicoplanin in BJI, particularly through subcutaneous administration.

The aim of this study assesses the efficacy and tolerance of teicoplanin in S. aureus BJI, especially focusing on subcutaneous use. This study is a retrospective single-center observational cohort study (2001 to 2011) including all consecutive patients managed at our institution receiving teicoplanin as part of S. aureus BJI treatment.


Eligibility Criteria:
Inclusion Criteria:

- Patients with bone and joint infection caused by S. aureus receiving teicoplanin (IV or SC) as part to treat the infection

Exclusion Criteria:

- Patients with diabetic foot- and decubitus ulcer-related BJI
ARISCAT and LAS VEGUS Risk Scores for Predicting Postoperative Pulmonary Complications After Cardiac Surgery

The goal of this observational study is to compare the, ARISCAT and LAS VEGUS scales, for predicting postoperative pulmonary complications in patients undergoing cardiac surgery. The study aims to compare the diagnostic accuracies of the two risk prediction scores in predicting postoperative pulmonary complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective heart surgery

Exclusion Criteria:

* Refusal to consent
* Patients undergoing emergency surgery
Boston Outcomes of Autism in Toddlers Study

The purpose of this research study is to learn more about the outcomes of children who received an Autism Spectrum Disorder (ASD) diagnosis when they were toddlers. The study is interested in whether an early diagnosis can help children with their cognitive, language, social, and behavioral abilities.

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in domains of social communication and restrictive and repetitive behavior. There is general agreement, in light of knowledge around optimal periods of neural plasticity, that ASD should be diagnosed as early as possible since young toddlers are at a critical stage in early development when intervention is theoretically most effective. The rate of persistence of an ASD diagnosis is heavily debated.Therefore this study attempts:

1. To determine the rate of persistence of Autism Spectrum Disorder (ASD) diagnosis and functional outcomes, as defined by cognitive level, adaptive functioning, language skills, persistence of ASD symptoms, and classroom placement at kindergarten age, among children who received a DSM-5 ASD diagnosis at \< 36 months.
2. To evaluate predictors of rate of persistence and functional outcomes among kindergarten grade level children ages 5-7 years, who received an ASD diagnosis as toddlers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Autism Spectrum Disorder as a toddler through DSM-5 at Boston Children's Hospital
* Enrolled in or just finished Kindergarten

Exclusion Criteria:

* Individuals with known genetic disorders including, but not limited to, Fragile X syndrome, Down syndrome, Tuberous Sclerosis Complex and those with 16 p deletions/duplications.
Evaluation of Safety and Performance of the Atalante System With Patients With Lower Limb Paralysis

The study is a prospective, open, bicentric and observational study. It is conducted to assess the safety and performance of the Atalante exoskeleton system with patients with lower limb paralysis.

The principal objective is to assess the performance of the Atalante system in performing ambulatory functions with motor complete SCI patients characterized by the success rate in performing a 10mWT at the last session of training with the Atalante system.


Eligibility Criteria:
Inclusion Criteria:

* Motor complete traumatic Spinal Cord Injury (AIS A and B) since at least 4 months
* Spinal Injury Level between AIS T5 and AIS T12
* Able to verticalize on a daily basis
* Height: between approximately 1.60 and 1.90 m. More specifically, Atalante is able to accommodate the following limb lengths:

  * Thigh: 380-460 mm
  * Distance between the ground and the joint space of the knee (to be measured while wearing the shoes they intend to wear with Atalante):

    * 457-607 mm for patient with an ankle dorsiflexion ≥ 16°
    * 457-577 mm for patient with an ankle dorsiflexion between 13° et 16°
    * 457-567 mm for patient with an ankle dorsiflexion between 10° et 13°
    * 457-557 mm for patient with an ankle dorsiflexion between 0° et 10° o Hip width less of equal to 460 mm when seated
* Maximum weight: 90 kg
* Patient having given his written consent

Exclusion Criteria:

* Patients whose joint centers cannot be aligned Atalante's
* Ranges of motion below:

  * Hip: 115° flexion, 15° extension, 17° abduction, 10° adduction, 10° medial rotation, 20° lateral rotation
  * Knee: 5° extension, 110° flexion
  * Ankle: 0° dorsiflexion, 9° plantar flexion, 18° inversion and eversion
* Severe spasticity (greater than 3 on the modified Ashworth scale) of the adductor muscles, hamstrings, quadriceps and triceps surae
* Pregnant or lactating woman
* Unbalanced psychiatric or cognitive status which may interfere with an appropriate use of the device
* Other neurological disorder
* History of osteoporotic fracture and/or disease or treatment responsible for a secondary osteoporosis
* Active implantable medical device
* Evolutive intercurrent disease: pressure sore, infection, venous thrombosis
* Unstable and unhealed limb and pelvic fracture
* Unstable spine
* Severe illness which may interfere with the verticalized posture and tolerance to effort
* Evolutive osteoma
* Syringomyelia
Clinical Trial In The Treatment Of Allogeneic Post-Transplant Cytopenias With Sequential Infusion Of Allogeneic Mesenchymal Cells Expanded In Vitro

The purpose of this study is to evaluate the safety and efficacy of the sequential infusion of allogeneic mesenchymal stem cells (MSC), expanded "in vitro" with platelet lysate without addition of animal products in the treatment of patients undergoing allo-HSCT who developed one or more cytopenias.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hematologic malignancies who have been subjected to allo-HSCT and that are diagnosed with one or more peripheral cytopenias with complete chimerism in bone marrow (determined by molecular-STR-studies). They may include:

  1. Patients who have received as a source of cells MO or SP
  2. Patients who have received cells from a related donor or unrelated HLA-matched
  3. Patients transplanted with myeloablative or non-myeloablative conditioning
* Adequate cardiac function assessed from a clinical point of view by the researcher, with no history of ischemic heart disease (angina or myocardial infarction) in the previous 6 months.
* Adequate pulmonary function assessed clinically without evidence of severe obstructive or restrictive lung disease.
* Patients between 18 and 70 years
* Signed informed consent

Exclusion Criteria:

* Patients whose haemopathy has not been controlled by the transplantation or is in progress at the time of treatment.
* Patients who do not have complete chimerism in bone marrow (performed within 28 days prior to baseline by molecular study -STR-).
* Patients with thrombotic microangiopathy.
* Patients with post-transplant cytopenias with toxic origin in relation to antiviral treatment (eg ganciclovir, valganciclovir) without concomitant graft against host disease.
* Patients with bacterial, viral or fungal infection that is not being controlled with proper treatment.
* Patients with a history of ischemic heart disease (angina or myocardial infarction) in the previous 6 months, and those considered by the investigator does not have adequate cardiac function, evaluated from a clinical point of view.
* Patients with poor lung function, evaluated clinically, according to the researcher.
* Patients who, in the opinion of the investigator, are not on a good position to tolerate treatment.
* Patients who do not have the required donor.
* Women pregnant or at risk of pregnancy by contraceptive measures inadequate.
* Patients \<18 or \> 70 years.
* Patients who did not sign the informed consent.
A Prospective Study of Performing MRI Simulation in Treatment Position in Spinal Stereotactic Body Radiation Therapy

To learn the usefulness of performing MRI scans in different positions and learn the best practice for spinal stereotactic body radiation therapy (spinal SBRT) planning and dose delivery.

1. Objectives

1. Assess the feasibility of performing MRI scans in the treatment position for accurate treatment planning and dose delivery in spinal stereotactic body radiation therapy (spinal SBRT).
2. Characterize the improved accuracy of image fusion between MRI and CT and its dosimetric impact when performing MRI scans in treatment position in spinal SBRT.
3. Assess the ability of MRI simulation to accurately target extended spinal targets beyond the current targeting limitations (\>3 consecutive vertebral body levels)
4. Optimize the workflow of using MRI simulation in treatment planning and dose delivery.

Eligibility Criteria:
3.1. Inclusion Criteria

1. Greater than or equal to 18 years of age
2. Pathologically confirmed diagnosis of cancer, including, but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and carcinoma of unknown primary
3. Signed informed consent
4. Willing to undergo 2 MRI simulations in one or multiple sessions, one with immobilization device, and the other without.
5. Patients undergoing spinal SBRT 3.2. Exclusion Criteria

a. Patient with a relative or absolute contraindication to MRI (such as pacemaker, etc.) b. Patients with significant instrumentation or cement at the site of interest causing artifact c. Inability to tolerate with immobilization device for greater than 30 minutes
Cabozantinib Plus Pembrolizumab for Recurrent, Persistent and/or Metastatic Cervical Cancer

Drug: Cabozantinib Drug: Pembrolizumab

This study is a multi-center, single arm, open label trial to evaluate the efficacy and safety of Cabozantinib (XL184) plus Pembrolizumab in recurrent, persistent and/or metastatic cervical cancer with PD-L1 tumor positivity.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent or persistent cervical cancer after prior systemic chemotherapy for which there is no curative intent option
* Documented histologic cervical cancer (acceptable histologies: squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma)
* Patients must have PD-L1 tumor positivity as defined as CPS\>/= 1
* Age greater than 18 and ECOG performance status of \<= 2
* Adequate organ and marrow function

Exclusion Criteria:

* Prior treatment with cabozantinib or pembrolizumab
* Receipt of any type of small molecule kinase inhibitor
* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy
* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery
* Anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel)
* Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias Uncontrolled hypertension despite optimal antihypertensive treatment, stroke
* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation
* Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose
* Active autoimmune disease requiring systemic therapy within the past 2 years
* Active infection requiring systemic therapy within the past month
* History of immunodeficiency
Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression

A Study to evaluate the efficacy of psychotherapy for easing the cardiac symptoms and improving and quality of life in patients with hypertrophic cardiomyopathy accompanied with depression

This study will use a 8 week parallel group design. 100 patients diagnosed as hypertrophic cardiomyopathy accompanied with depression will be into experimental group and control group. The experimental group received 8 times of psychological treatments for once each week; the control group did not receive any antidepressant treatment. Follow-up assessments will be performed at baseline, week 4 and 8.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as hypertrophic cardiomyopathy;
* Diagnosed as depression;

Exclusion Criteria:

* Patients with left ventricular ejection fraction (EF) ≦ 30%;
* Renal dysfunction with serum creatinine ≧451umol/l;
* Severe heart failure and New York Heart Association (NYHA) Heart Failure Grade III;
* Combine with any type of malignant tumor;
* Combine with other serious mental illnesses such as bipolar disorder, schizophrenia, schizophrenia-like illness, severe dementia, etc.;
* Have received medication of antidepressant or psychotherapy;
* Patients with major depression; Patients with a serious risk of suicide or have had suicide attempts;
* Pregnant women and lactating women, or women who are planning to become pregnant or breastfeeding during the study period;
* Other circumstances in which the researcher judges that it is not suitable as a research object.
Adherence Monitoring For Substance Abuse Clinical Trials

The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 to 60
* Ability to give informed consent.
* Be willing and able to use the study-provided phone for taking and transmitting capsule photos.

Exclusion Criteria:

* Unwilling or unable to use a cell phone.
* Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.
Non Invasive Evaluation of Bronchial Inflammation in Infants : a Study of the Sputum Cellularity After Hypertonic Saline Induction

* Background: Infantile asthma is composed of various phenotypes, however the definition is still based on the clinics. Namely, the infants could be classified as transitory, peristent or late and persistent asthma. Some risk factors for the persistent asthma phenotype are recognized as atopy. However all peristent asthma are not related to atopy. Regarding the pathophysiology, little is known on airways inflammation in these infants, and the current data are mostly based on the BAL analyses, or on biopsies. Consequently, BLA and biopsies should be justified by the need of an indicated fiberbronchoscopy, and therefore limited to severe infantile asthma. Airway secretion could be also collected after hypertonic saline induction and chest physiotherapy. This method has been validated in the children, but has not in the younger.
* Aim : Analyses of cell profiles regarding the severity of infantile asthma.
* Methods : This descriptive study compared 3 groups of infants, the first with acute exacerbation, the second with uncontrolled asthma and the third with controlled asthma. Accounting 25% of failure, the number of 40 infants per groups has been calculated. The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended. Safety will be evaluated.
* Inclusion criteria : Any infants suffering of infantile asthma (at least 3 episodes of wheezing during the 2 first years of life), aged between 6-12months.Asthma control was evaluated on the last 4 weeks, allowing to classify the infants . Control asthma was aimed when neither exacerbation nor persistent symptoms were observed. Uncontrolled asthma was defined whether the infant presented any symptoms during the last 4 weeks. Exacerbation was defined as any acute symptoms, as cough, dyspnoea or wheezing.
* Feasibility : A preliminary study has been presented in the Vienna ERS congress.


Eligibility Criteria:
Inclusion Criteria:

* Age between 6 and 36 mo.
* Ambulatory or hospitalized.
* With %SaO2 ³ 95%
* Parents information and non-opposition from the parents

Exclusion Criteria:

* Any underlying chronic disease
* Been given oral corticosteroid during the last four weeks
* Known adverse events with nebulized saline solution
* With cold during the 4 last weeks for the controled group.
* With %SaO2 \< 95%
Ongoing Registry of Deep Venous Reconstructions

Ongoing registration of deep venous obstructive disease patients treated by means of percutaneous transluminal angioplasty (PTA) and stenting with or without endophlebectomy (surgical desobstruction, also termed endovenectomy) of the common femoral vein and/or arteriovenous fistula creation.

Literature has shown endovenous reconstructions to be safe en effective in treating deep venous obstructive disease. Deep venous obstruction can develop in cases of (iliac) vein compression syndromes (e.g. May-Thurner syndrome) or in cases of post-thrombotic syndrome. In patients with both significant complaints (objectively measured) and venous obstruction objectified on imaging (duplex ultrasonography, magnetic resonance venography, CT-venography) stenting is indicated.

In cases of extensive post-thrombotic damage to the veins of the lower extremity endophlebectomy (surgical desobstruction) of the common femoral vein can be warranted. This operation is generally combined with the creation of an arteriovenous fistula.

Data of patients treated in our tertiary medical centre are entered in a prospective digital database, and continuously updated.

Eligibility Criteria:
Inclusion Criteria:

* Venous obstruction/occlusion in the femoral vein, common femoral vein, external iliac vein, common iliac vein or inferior vena cava

Exclusion Criteria:

* Intolerance to anticoagulant medication
* A life expectancy \<1 year