cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)

The primary objective of this study is to evaluate the effect of entospletinib (ENTO) on the best overall response rate in adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic corticosteroids as part of first-line therapy for cGVHD.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* Male or non-pregnant, non-lactating, females
* Newly diagnosed cGVHD defined by:

  * At least 100 days after receiving any allogeneic hematopoietic stem cell transplant AND
  * Receiving a new course of systemic corticosteroids (≥ 0.5 mg/kg/day) as first-line cGVHD therapy at least 1 day and no more than 21 days prior to first dose of ENTO/Placebo AND
  * Moderate to severe cGVHD as assessed by NIH cGVHD Diagnosis and Staging Criteria (NCDSC) with at least three organ systems involved OR one organ system with a score of 2 OR lung organ score = 1
* Individuals who have undergone transplant for hematologic malignancy are required to be in complete remission.
* Have either a normal ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the Sponsor

Key Exclusion Criteria:

* Inability to begin systemic corticosteroids therapy at a dose of ≥ 0.5 mg/kg/day (or equivalent)
* Uncontrolled infection within 4 weeks prior to randomization
* History of the following therapies in the post-transplant period:

  * B cell depleting biologic agents
  * CD19 CAR-T cells based therapies
  * BTK/SYK/JAK/PI3K inhibitors
  * Phototherapy-unless administered for acute GVHD
* Treatment of cGVHD with anti-thymocyte globulins (ATG), or campath within 60 days of screening visit unless used for treatment of acute GVHD
* Severe organ dysfunction manifested during screening period:

  * Requiring supplemental oxygen at more than 2 L/min
  * Uncontrolled arrhythmia or heart failure

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effectiveness of a Neuromuscular Exercise Program and Visual Feedback in the Management of Body Position for Stroke Survivors

The aim of the biomedical research is to evaluate the changes of body position management during standing and walking for stroke patients, using innovative training methods during the rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Experienced an ischemic stroke for the first time;
* Middle-aged (44-59) and elderly (60-74) by WHO classification;
* Muscle strength of the lower extremities according to the Oxford scale is 3-5 points;
* Do not have any neglect;
* Mini Mental State Examination \>12 points.

Exclusion Criteria:

* Experienced an ischemic stroke not for the first time;
* Had hip or knee replacement surgery's, which may affect gait;
* Muscle strength of the lower extremities according to the Oxford scale is 0-2 points;
* Have neglect;
* Mini Mental State Examination \<12 points.
Automated Visual Monitoring for Improving Patient Safety (VIPSafe)

After an operation many patients are in a confused mental status at the intensive care unit. In this status they possibly fall out of their bed or pull out endotracheal tubes or central venous catheters accidentally. For this, they need permanently monitoring and control through intensive care personnel.

The goal of the VIPSafe project is to develop robust techniques for automated patient monitoring, that rely on data from a small number of untethered sensors, which are nonetheless flexible enough to cope with a large variety of demands.


Eligibility Criteria:
Inclusion Criteria:

* patients with planned postoperative stay at intensive care unit after previous written consent to the study
* patients with not-planned postoperative stay at intensive care unit with written consent after admission to intensive care unit
* patients unfit to plead with admission to intensive care unit with written consent of the officially appointed agent

Exclusion Criteria:

* absent written consent
* age \< 18 years old
Effect of Structured Patient Interviews in the Preoperative Anesthesia Clinic on Recall of Relevant Information

The preanesthetic visit influences patient satisfaction and medical outcome. This study aims to evaluate whether training for a structured interview technique improves communication skills, resulting in increased recall of relevant information by surgical patients.


Eligibility Criteria:
Inclusion Criteria:

* Surgical patients in the preoperative anesthesia clinic
* Written informed consent

Exclusion Criteria:

* Inadequate comprehension of the German language
Sexual Needs of Adolescents Living With HIV Since Childhood

To improve the knowdelge about the sexual health needs of perinatally HIV-infected adolescents living in France.

20 individual semi-structured interviews will be conducted with 20 young adults living with HIV sinc childhood and living in France. The aim of this study is to identify their sexual needs through exploring their personal experience of sexuality during their adolescence. The investigator intend to explore communication about the disease and sexuality within their families ; communication about sexual health with health care professionnals ; whether sexuality has arrose difficulties related to their chronic condition such as rejection or sadness ; whether there are differences in sexual needs regarding gender. A thematic analysis will be conducted by three researchers.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 25 yo
* HIV-1 or HIV-2 diagnosis before the age of 13
* non opposition to participate to the study
* be affiliated to a social security scheme (except Aide Médicale de l'Etat (AME))

Exclusion Criteria:

* having contracted HIV infection through sexual contact
* persons under guardianship or custodianship, or deprived of their liberty by a judicial or administrative decision
* associated illnesses or disabilities that makes participation impossible
Endocan Biomarker Level in Gingival Crevicular Fluid in Periodontitis Patients With Type 2 Diabetes Mellitus

Aim of the current study was to evaluate Endocan biomarker level in gingival crevicular fluid of patients with stage 1 or 2 (mild to moderate) periodontitis with controlled type 2 diabetes mellitus (DM) and compare it to that in DM free periodontitis patients.


Eligibility Criteria:
Inclusion Criteria:

* Probing pocket depths (PPD) ≤ 5 mm.
* Clinical attachment level (CAL) ≤ 4 mm.
* Type 2 DM, for at least the past 3 years.
* HbA1c ≤ 7%.

Exclusion Criteria:

* Uncontrolled Diabetes Mellitus.
* Systemic antibiotic or anti-inflammatory medication use in the previous 2 months.
* Non-surgical periodontal therapy in the previous 6 months.
* Surgical periodontal therapy in the previous 12 months.
* Use of calcium channel blockers, phenytoin, or cyclosporine.
* Pregnancy.
* Smokers
Fever During Labour

Pilot study to assess fever during labour.

200 parturients will be monitored for fever during labour using rectal thermometer.

Repeated measurements 1/hr during the first 6 hours will allow us to find patients developing fever.

Fever = rectal temp \>38 Celsius twice within 60 min or 39 degrees Celsius measured once .

After birth, blood samples are assessed for infection. Use of Antibiotics and other medication is Recorded. Subgroup analyses based on suspected causes of fever during birth.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years, planned vaginal birth, able to give consent

Exclusion Criteria:

* do not speak Danish or English, unable to cooperate to rectal temperature measurements,
Time-dependent Improvement of Functional Outcome Following LCS Rotating Platform TKR

The objective of this prospective study is to determine (1) the time course of patient-relevant functional outcome evaluated by the Knee injury and Osteoarthritis Outcome Score (KOOS) and (2) the time course of range of motion (ROM) the first four years following TKR using the LCS rotating platform prosthesis. Improvement of patient self-reported pain and daily function during the study period, are of particular interest.


Eligibility Criteria:
Inclusion Criteria:

* patients with knee osteoarthritis
* admitted for total knee replacement
* no rheumatoid arthritis
* no previous knee infection
* age 40-85 years

Exclusion Criteria:

-
PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases

This randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer, cardiac disease, or neurologic disease.

PRIMARY OBJECTIVES:

I. To assess and optimize image quality of PET and MRI focusing on technical artifacts and their correction.

II. To assess the accuracy of PET quantification based on MR attenuation correction (MRAC) derived from various MRI sequences and reconstruction algorithms including the effect of routinely used Gadolinium-based contrast agents on MRAC.

III. To determine the clinical and diagnostic accuracy of PET-MRI in comparison to standard-of-care diagnostic imaging.

IV. To assess the efficacy and workflow in combining PET and MRI in one single examination as compared to separate imaging studies.

V. To assess the potential for radiation dose reduction if PET-CT is substituted by PET-MRI, thus avoiding the radiation exposure from the CT-component.

Eligibility Criteria:
Inclusion Criteria:

* Clinically indicated PET/PET-CT (with or without clinically indicated diagnostic MRI)
* Presenting with one of the four conditions specified below

  * Fludeoxyglucose F 18 (FDG) avid cancers
  * Cardiac disease (cardiac viability assessment)
  * Neurologic disorders (dementia)
  * Inflammatory disease (for example fever of unknown origin, vasculitis, osteomyelitis)

Exclusion Criteria:

* Pregnancy and lactation
* Contraindications to undergo MRI
* Cardiac pacemaker and metal devices (as specified in a separate MRI Informed consent)
* Claustrophobia or inability to tolerate MRI examination (lay still for approximately 1 hour and hold breath intermittently)
* Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
* Renal insufficiency: glomerular filtration rate (GFR) \< 40ml/min/1.73m\^2 and following European Society of Urogenital Radiology (ESUR) guidelines (exclusion criterion only for contrast enhanced MRI)
* Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)
Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis

Classification of early-onset idiopathic chronic pancreatitis (EOICP) and late-onset idiopathic chronic pancreatitis (LOICP) was proposed based on bimodal distribution of age at onset of idiopathic chronic pancreatitis (ICP). However, studies of larger populations prove it may be normal distribution. Therefore, the aim of the study is to find what the distribution of age at onset of ICP is and whether the classification of EOICP and LOICP is meaningful.

Idiopathic chronic pancreatitis (ICP) patients admitted to the investigator's center from January 2000 to December 2013 were enrolled. Characteristics were compared between early-onset idiopathic chronic pancreatitis (EOICP) and late-onset idiopathic chronic pancreatitis (LOICP) patients. Cumulative rates of diabetes mellitus, steatorrhea, pancreatic stone, pancreatic pseudocyst (PPC), biliary stricture, and pancreatic cancer after the onset and the diagnosis of ICP were calculated, respectively. Different cut-off values for age at onset of ICP were set to classify EOICP and LOICP. Then differences of clinical courses between EOICP and LOICP were compared when classified by distinct cut-off values.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with idiopathic chronic pancreatitis according to Asia-Pacific consensus

Exclusion Criteria:

* Pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
* Groove pancreatitis
* Autoimmune pancreatitis
* Chronic pancreatic patients with identified etiologies
Timing of Resective Surgery After Neoadjuvant Chemoradiotherapy in Esophageal Cancer

This study compares outcomes with regard to the timing of resective surgery after neoadjuvant chemoradiotherapy (CRT) in cancer of the esophagus or gastric cardia. Patients are randomised to surgery either conventional 4-6 or 10-12 weeks after termination of CRT. The study hypothesis is that a longer delay improves histological response and decreases the risk of postoperative morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma or SCC of the esophagus or GEJ Siewert type I and II.
* Tumors should be resectable and without distant metastasis, as assessed after completed CRT.
* Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.
* Pre CRT tumor stage: T1N1-3M0, T2N0-3M0, T3N0-3,M0, T4aN0-3,M0
* Written informed consent
* Completed at least 80% of the planned chemotherapy and at least 90% of the prescribed radiotherapy dose within the neoadjuvant CRT schedule according to protocol within a period of \<36 days.

Exclusion Criteria:

* Concomitant malignant diagnosis (excluding non-melanoma skin cancer) \<5 years since current cancer diagnosis.
* Ongoing antitumoral treatment irrespective of time since diagnosis of earlier malignancy.
* Patients being unable to comply with the protocol for reasons of language or cognitive function.
* Tumor stage T1N0, T4bNX or TXNXM1.
* Carcinoma of the upper third of the esophagus (i.e. cervical and uppermost thoracic) for simplicity here defined as upper border of tumor above 22 cm from incisors at endoscopy.
* Clear radiological signs of tumor progression during CRT on CT-scan after completion of CRT. PET is not used in this decision as FDG-activity often increase due to radiotherapy induced inflammation.
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation

Cardiac allograft vasculopathy (CAV) is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. Surveillance for CAV is vital; however an ideal approach has not been established. The goal of this study is to assess whether noninvasive positron emission tomography (PET) based surveillance is non-inferior to invasive coronary angiography (ICA) surveillance.

MARINER is a Canadian multicentre prospective, randomized clinical outcomes-based trial evaluating noninferiority of a noninvasive PET strategy compared to ICA for CAV surveillance. Patients are randomized to annual PET or ICA for CAV surveillance. Non-inferiority is assessed according to a clinical composite of death, retransplant, allograft dysfunction not related to acute rejection, and angiographic CAV associated with myocardial infarction or heart failure. Secondary outcomes include the rate of new or progressive CAV, number of ICA performed, number of ICA and PET procedural related complications, EuroQol-5 Dimension assessed patient health-related quality of life and health care resource use.

Eligibility Criteria:
Inclusion Criteria:

1. Post heart transplant 2-10 years.
2. Age ≥18 years.
3. Able to provide informed consent.

Exclusion Criteria:

1. Contraindication to dipyridamole due to severe aortic stenosis.
2. Contraindication to dipyridamole due to 2:1 or greater AV block without pacemaker.
3. Contraindication to dipyridamole due to severe bronchospasm.
4. Unable to undergo coronary angiography due to allergy to iodinated contrast.
5. Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2. for non-dialysis patients as determined by local laboratory analysis.
6. Unable to undergo coronary angiography due to unsuitable vascular access.
7. Treated rejection ≤1-month.
8. Unstable angina or MI ≤7 days.
Subperiosteal Implants Constructed With Digital Technology

Atrophied jaw is a condition where there is insufficient bone quantity to place root form implants. Several treatment plans are available for treating atrophied jaws, including subperiosteal implants. Subperiosteal implants were introduced in the last century. Poor clinical results led those implants to be progressively abandoned. Recently, several Authors suggested a revival of subperiosteal implants as an alternative to regenerative procedures.

An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions that reported on subperiosteal implants management of patients with severely atrophied jaws in completely and partially edentulous population.

The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.

Eligibility Criteria:
Inclusion Criteria:

* population with partial or fully edentulous arches, in particular Cawood and Howell class (IV-VI);

Exclusion Criteria:

* Articles were excluded if complex reconstructive surgery including bone grafts, barrier membranes, jaw osteotomies, sinus lift, alveolar ridge distraction, and zygomatic implants was recommended for treatment
Assessment of Biomarkers for Recurrent HCV Infection Post-liver Transplantation

The purpose of this study is to learn about how different immunosuppressant therapies impact on recurrent hepatitis C virus infection in the new liver after liver transplant. We will be evaluating if Cyclosporin A has a superior effect against recurrent Hepatitis C virus (HCV) infection than Tacrolimus.

We will address the hypothesis that CSA has a superior antiviral effect against HCV than Tacrolimus by assessing serial HCV RNA levels in serum. We plan to address the hypothesis that CSA is more efficient in limiting viremia than Tacrolimus and that viremia is predictive of long-term clinical outcome of hepatic fibrosis that is known to impact on both graft and patient survival

Eligibility Criteria:
Inclusion Criteria:

* About to undergo a primary liver transplant (including living donor, split liver) and are HCV positive.
* Willing and capable of giving written consent for study participation
* Expected to be capable of study participation for full 24 months post-transplantation.
* Allograft biopsies will be possible
* Expected use of calcineurin inhibitor (Neoral or Tacrolimus) as primary immunosuppression An immunosuppressive regimen consisting of a calcineurin inhibitor (Neoral or Tacrolimus) in combination with Simulect and MYCOPHENOLATE SODIUM

Exclusion Criteria:

* This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
* This is a liver transplant from a non-heart beating donor.
* This is an ABO incompatible transplant.
* Patients with serum creatinine level \> 250 umol/L.
* The recipient is seropositive for human immunodeficiency virus (HIV) antibodies.
* Fulminant liver failure is the reason for transplant.
* Patient is participating in other clinical trial involving exploratory drug
* There is a known malignancy, or a history of malignancy, other than successfully treated non-metastatic basal or squamous cell carcinoma of the skin, or hepatocellular carcinoma less than 5 cm meeting Milan criteria for transplantation5.
* The patient is being transplanted for hepatic malignancy with greater than 5 known lesions.
* Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
* A female transplant candidate is pregnant, lactating or of childbearing potential and not practicing an acceptable method of contraception.
* An unlicensed drug or therapy has been administered within one month prior to study entry or if such therapy is to be instituted post-transplantation.
Magnetic Resonance Imaging in Cerebral Small Vessel Disease

Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) may represent as a sensitive and robust tool to detect early changes in brain subtle structures and functions. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.

Cerebral small vessel disease (cSVD) accounts for 20% of ischemic strokes and is the most common cause of vascular cognitive impairment. Early identification of cSVD is critical for early intervention and improve clinical outcomes. Magnetic resonance imaging (MRI) is sensitive to change in white matter structure and subtle vascular function alternation which correlates with cognition impairments in cSVD. MRI manifestation may also represent as useful surrogate marker. Development of advanced MRI technologies promotes their invaluable application in brain and vascular qualitative and quantitative assessment. The study is to investigate the comprehensive evaluation of brain structures and vascular functions by using advanced MRI technologies in early diagnosis and management of cSVD.

Eligibility Criteria:
Inclusion Criteria:

* Clinical evidence of cerebral small vessel disease or MRI evidence of lacunar infarcts and white matter hyperintensity
* No disability (modified Rankin's scale \< 2)
* No dementia (MMSE \> 24 and absence of dependence in daily activities)
* Able and willing to consent

Exclusion Criteria:

* Contraindications to MRI
* Standard MRI of bad quality due to movement artefacts
* Pregnant
* Unable to tolerate MRI