cyrilzakka/clinical-trials huggingface dataset:
Primary Uncemented Partly Ti-coated Total Hip Prosthesis With and Without HA, and Alumina-on-alumina Articulation

Both HA coated and certain uncoated femoral stems have good results in general. On the cup side the results are more variable, either with or without HA. HA may delaminate from the prosthesis, damage the articulation, witch may lead to osteolysis and aseptic loosening.

The investigators are investigating whether a well working uncemented hip prosthesis design with HA coating, will perform without HA in the long run, when the investigators use pure Ti macrostructure and alumina on alumina articulation.

Hypothesis: The bone ingrowth will be equal when the surface has almost equal roughness in Ti and HA version. This means that HA on Ti is not necessary with a well functioning prosthesis design.

0-hypothesis:The two prosthesis perform equal in survival, clinically (HHS),radiographic and in patient satisfaction at 2, 5, 10, 15 and 20 years.

Investigate survival of the implants and possible biological consequences. Clinical outcome with Harris Hip Score. Radiographic outcome with a modified protocol after JRC, JBJS 1990. Patient satisfaction with the hip prosthesis (five categories).

Grit blasted TiAL6V4 + pure Ti versus grit blasted TiAL6V4 + pure Ti +HA, with almost the same roughness. Screw cup, double tapered stem, partly double coated cup, proximally double coated stem.

Prospective RCT. Multicenter ( Three hospitals). Selected surgeons. Non-inferiority-design.

At present 569 hips (391 patients, 178 bilateral) are randomized into the study. Inclusion of patients into the study stopped in January 2013.

548 hips have completed follow ups at an average of 2 years, 301 hips have completed follow ups at an average of 5 years and 60 hips at 8-10 years.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary osteoarthrosis.
* Both gender, less than seventy years.
* Patients operated for FCF and patients with previous osteotomies are included.

Exclusion Criteria:

* Treatment with Prednisolon.
* Osteomyelitis.
* Serious infections illnesses.
* Cancer or metastasis.
* Rheumatoid arthritis.
* Osteonecrosis after use of alcohol or medicaments.
* Kidney illnesses.
* Metabolic bone diseases.
* Earlier hip arthrodesis.
* Allergic reactions on implants.
* Patients who do not cooperate on rehabilitation.
Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting

Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG). Roxadustat is a prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies.

This study aims to evaluate the efficacy of administration of Roxadustat before surgery in the prevention of acute kidney injury after CABG.

Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG), with a incidence of 28-38%. Renal ischemia-reperfusion injury is the main mechanism for acute kidney injury after CABG.

Roxadustat is a kind of prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies.

This study aims to evaluate the efficacy of administration of Roxadustat (before surgery) in the prevention of acute kidney injury after CABG. This is a multicenter, randomized, double-blind, placebo-controlled study.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old
* non-emergent CABG and planned cardiopulmonary bypass (CPB)
* eGFR\>15ml/min/1.73m2

Exclusion Criteria:

* pregnancy or breast feeding
* malignancy
* severe liver dysfunction
* acute kidney injury before randomization
* uncontrolled hypertension
The Relationship Between White Matter Hyperintensity With Cognition and Emotion

White matter hyperintensity (WMH) has been found to be related with cognitive and emotional dysfunction. A presumed mechanism is that WMH disrupts the structural connectivity within a large-scale brain network, thereby impairing the brain's ability to integrate the neural processes efficiently. It is not yet clear, what the pattern of brain network disruption relates to WMH and how the brain network disruption induced by WMH has an effect on cognition and emotion performance. Using multi-model magnetic resonance imaging (MRI) techniques, we aimed to explore the mechanisms of cognitive decline and depression related with brain network dysfunction in patients with WMH, and to provide objective imaging marker for early diagnosis and prevention of WMH associated cognitive decline and depression.


Eligibility Criteria:
Inclusion criteria:

1. white matter hyperintensity visible on T2 fluid-attenuated inversion recovery images;
2. age between 35 to 80 years;
3. without stroke lesion (except lacunar infarction) on current diffusion weighted images;
4. without a history of multiple sclerosis, Alzheimer's disease, Parkinson's disease and head trauma.

Exclusion criteria:

1. white matter lesions of nonvascular origin (immunological-demyelinating, metabolic, toxic, infectious, other);
2. intracranial hemorrhage;
3. with severe head motion on magnetic resonance images
Analyzing Patient Flows at the Emergency Department by Data Analytics, Simulation, and Optimization

In this project, investigators apply operations research techniques, more specifically data analytics, system simulation, mathematical modelling, and optimization, for analyzing and improving operations in the Emergency Department at the Prince of Wales Hospital. The long term goals of this project are to demonstrate that integrated approach of data analytics and systems thinking is beneficial to health service planning and to extend present work to applications in other health-service systems.

Design and subjects The current study requires time stamps for which patients start and end activities in the department. Personally identifiable information is not needed in this study. Investigators will collect the data from the computer system of the Department. The data will be used for data analysis and the development of simulation and optimization models. With current models, investigators investigate the effects of queueing policies, study workforce planning, and conduct a cost-effectiveness analysis for strategic planning.

Study instruments Data analytics tools and simulation and optimization softwares are needed in this research.

Interventions With simulation and optimization models, investigators examine the impacts of different operational strategies on the performance of the Emergency Department. The Computational experiments will not disturb the actual operations but will provide insights into the effectiveness of the various intervention policies.

Main Outcome Measures Investigators will derive insights from computational experiments and deliver useful recommendations for managing emergency department operations in Hong Kong.

Eligibility Criteria:
Inclusion Criteria:

* All the patients attended to the Emergency Department of Prince of Wales Hospital in the period of July 2017 to June 2018 will be included in this study.

Exclusion Criteria:

* No patient will be excluded in this study
YOOMI: Effect of Gamified Physical Therapy Exercise Software on Inpatient Mobility

Patients admitted to the hospital often develop functional impairments due to being in bed most of the day. Each day of bedrest leads to significant muscle loss. As a result, many patients become dependent on others or require rehabilitation at a facility to improve mobility and function prior to returning home. Staff in the hospital is limited and often unable to mobilize patients every day while hospitalized. The investigators are testing a new experimental gamified physical therapy exercise software to see if it can be a fun, enjoyable way to help mobilize patients without the assistance of staff. The primary aim of this pilot/proof of concept study is to determine whether gamified physical therapy software can help inpatients exercise within the safety of their own beds and preserve pre-hospitalization function.


Eligibility Criteria:
Inclusion Criteria:

* \>= 65 years of age
* English-fluency in reading and speaking
* Capacity to consent
* Enrolled in HELP program
* Attending physician confirms there are no medical contraindications to in-bed exercises

Exclusion Criteria:

* Unstable Psychiatric Illness
* Unstable/Critically Ill Patients requiring ICU-level of care
* Surgical tube present (e.g. JP drains)
* Surgery during the hospitalization
* Bed Rest Activity Order
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis

The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
* Must have documented diagnosis of UC of at least 3 months' duration prior to screening
* Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

Exclusion Criteria:

* Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile \[C. difficile\])
* Stool positive for C. difficile toxin at screening visit
* Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation

Other protocol-defined inclusion/exclusion criteria apply
Analgesic Territory Assessment of the Spinal Erector Block Using Pupillometry

Few works have studied the area of analgesia covered by the spinal erector block in an objective manner, especially on the cephalo-caudal spread. The available data are dissection works or subjective data such as thermoalgesic or epicritic sensitivity.

This information would however be relevant in order to propose a better analgesia. Indeed, it could explain certain failures by insufficient diffusion of the block. The use of a multistage block could be relevant, especially in the case of osteosynthesis on several vertebral levels.

Pupillometry makes possible to monitor analgesia based on the pupillary dilation reflex to pain. The goal is to establish an objective mapping of these type of analgesia from these data.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving erector spinae block for pain management of spinal osteosynthesis

Exclusion Criteria:

* Patient refusal
* Known allergy to local anesthetics
* Contraindication to locoregional anesthesia (haemostasis disorder, infection, peripheral neuropathy)
* Technical impossibility to perform a spinal erector block
* Pathology with dysautonomia altering the pupillary reflex: diabetes mellitus with diabetic retinopathy, multiple sclerosis, systemic amyloidosis, uncontrolled hypertension, glaucoma
* Current treatment likely to alter pupillary dilation reflex to pain : antiemetic (droperidol, metoclopramide), alpha-2 agonist (clonidine)
* Serious psychiatric history
* Drug abuse
* Pregnancy
Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study

The goal of this study is to present the Jakarta Surgical Uterine Conservation (JSICA) technique and its perioperative outcomes in Placenta Accreta Spectrum patients. Participants are all patients undergoing standard hysterectomy or the Jakarta Surgical Uterine Conservation (JSICA) technique. Researchers will compare both groups to see if there are any differences in the perioperative outcomes.

This study uses data from Cipto Mangunkusumo General Hospital's Placenta Accreta Case Register. This register includes all patients with a confirmed placenta accreta spectrum diagnosis. Data collected includes demographic characteristics, risk factors, surgery characteristics, and perioperative outcomes. In this study, researchers would like to evaluate the perioperative outcomes of the JSICA technique in comparison to a standard hysterectomy.

Eligibility Criteria:
Inclusion Criteria for JSICA:

1. Focal accreta invasion ( \< 50% anterior wall)
2. Anterior invasion
3. No parametrial or bladder invasion
4. Residual tissue or healthy myometrium min 3 cm above the OUI or cervix
5. Good uterine contraction post-repair (with or without compression sutures)
6. Hemodynamically stable

Exclusion Criteria:

-
Optimal Concentration of Dermatophagoides Pteronyssinus (Dp) Allergen Extract for Skin Prick Test (SPT) of Thai Population

The purpose of this study is to determine the appropriate concentration of diagnostic reagent of house dust mite (Dp) to be used in diagnostic allergy skin prick test among Thai population with allergic rhinitis.

The current allergy diagnostic reagent of house dust mites marketed in the USA is at 10,000 AU/ml. This is based on the IDEAL50 concept put forth by Turkeltaub et al, almost 3 decades ago. Such concentration has been shown to give large degree of false positives even in the US population.

In Thailand, it was anecdotally observed that at such concentration, sizes of positive tests among atopic subjects were quite large and could lead to discomfort and a possible anaphylaxis in certain allergic individuals. Moreover, up to 40% of normal individuals could give positive reaction to this concentration.

It is therefore desirable to reexamine the appropriate concentration of diagnostic reagent of house dust mites among the Thai population and will be the main objective of this research.

Eligibility Criteria:
Inclusion Criteria:allergic rhinitis

* clinical diagnosis of allergic rhinitis
* has skin prick test positive to standard Dp extract (wheal diameter 3 mm. or greater)
* not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)

Inclusion Criteria:healthy subject

* no underlying disease
* not take any medications that interfere the tests (skin prick test and nasal allergen provocation test)

Exclusion Criteria:

* has skin prick test positive to standard Dp extract with wheal diameter more than 10 mm.
* has chronic disease eg. HIV infection, neurological diseases, hypertension, cardiac diseases, pulmonary diseases, hepatobiliary diseases, renal diseases, endocrinological diseases, congenital malformation, malignancy
* if has asthma, uncontrolled asthma symptom or PEF \< 70%
* during pregnancy or lactation
* has chronic skin disease
* participate other project within 30 days
* has abnormal anatomy of the nose
Retrospective Safety Survey In Patients Included In NV1FGF Clinical Trials

The objective of this study is to collect retrospectively long term safety data in patients who have participated in the previous phase I-II trials conducted with the compound.


Eligibility Criteria:
Inclusion criteria:

* Patient randomized, treated and alive at the end of the phase I-II study participation, irrespective of their treatment group,
* Who signed the TALISMAN survey informed consent (or for deceased patients, the informed consent was signed the legal representative/family member as per national regulations - except in countries where Ethics Committee approval only is required for retrospective data collection).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
CT 327 in the "Atopy Patch Test" Model

A Randomized, Double-Blind, Phase I, Single-Center Study on the Efficacy and Safety of CT 327 in the Atopy Patch Test model.

The study population will include subjects with atopic dermatitis (AD) and a positive atopy patch test (APT) test at study screening. Positive responders to the APT test will enter into a treatment period of ten days during which all subjects will have three test compounds (CT 327, Placebo or an active comparator) administered twice daily to three test fields marked on patient's back. A fourth test field will act as untreated control. A challenge with the relevant aeroallergen to which the subject is responding most strongly, as assessed at screening, will take place on Day 10. Readings of APT scores will be performed at 48 and 72 hrs after the challenge and the subjects will have a end-of-study visit 2 weeks later. Local and systemic tolerance of CT327 will be assessed during the study, in addition to its potential absorption into the systemic circulation. The effects of CT327 on modulating the immune response to aeroallergens and on the expression of immunological and inflammatory markers on biopsies of the treated areas will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 and \< 66 years of age
* Able to give informed consent
* Diagnosis of atopic dermatitis and a positive atopy patch test to at least one of the following(Dermaphagoides pteronyssinus, cat dander, grass or birch pollen)

Exclusion Criteria:

* Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
* Have a positive response to petrolatum
* Be immune-compromised
* Have any clinically significant abnormal clinical laboratory test results at Screening
* Have a history of malignancy except basal cell carcinoma of the skin.
* Have an active intercurrent infection
* Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 14 days prior to study entry.
* Have received antibiotic treatment within 1 week prior to study entry
* Within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
* Have received any investigational drug or been part of any clinical study within the last three months before study entry.
* Have a history of hypersensitivity or allergic reactions to any ingredient in the CT 327 formulation or to the selected active comparator or to polyethyleneglycol.
* If female, are pregnant or lactating, or intend to become pregnant during the study period
* If female, and of child-bearing potential, not taking adequate contraception to avoid pregnancy during and three months after the study.
* History of drug, alcohol or other substance abuse or other factors limiting the ability to cooperate and to comply with the study protocol
Pharmacogenetics of VOD in Children With HSCT

This project aims to identify common pharmacogenetic biomarkers predisposing children with cancer to develop hepatic VOD during their cancer treatment including HSCT. The impact of VOD occurrence and significant biomarkers will also be evaluated on outcome at day 100 and one year after HSCT. It should help to highlight factors that can contribute to the initiation of hepatic VOD.

Understanding mechanisms of this toxicity and to know individual parameters of disease susceptibility becomes an important issue in the care of these children. The ultimate goal of research in this area would be to develop a personalized predictive medicine and, hopefully, prevent the occurrence of VOD from a therapeutic adaptation to each patient according to his pharmacogenetic profile (adapted prophylaxis, dose adjustment, drug combinations ...). A prospective identification of patients at risk of hepatic VOD will increase the safe use of anticancer.

Hematopoietic stem cells transplantation (HSCT) in children with cancer is source of veno-occlusive disease (VOD). This complication is unpredictable and serious by involving the vital prognosis of the child. In addition, this complication may affect the patient's quality of life and have serious long-term sequelae. The incidence varies from 15 to 60% and the mortality is greater than 60% after severe VOD. The risk factors of occurrence of these complications are, to date, unknown except for a susceptibility to some therapeutic (busulfan, radiotherapy ...). Pharmacogenetic aspects of hepatic VOD susceptibility are supposed and targeted screening supported this hypothesis. But pharmacogenetic predisposition to VOD was never explored with as many polymorphisms and considering the whole exome.

Eligibility Criteria:
Inclusion Criteria:

* Children with cancer aged less than 18 years old treated for their first HSCT between 2000 and 2011 in France.
* Patients are selected from the database ProMise regarding pediatric patients treated in any center of the French Society of Stem Cell transplantation (SFGM).
* Clinical data (age, sex, initial pathology, conditioning treatment, type of graft cells, VOD occurence or not, survival status at 100 days and 1 year after transplantation) were extracted from this database.

Exclusion Criteria:

-
Comparison of Dynamic Radiographs in Determining Fusion Level in Adolescent Idiopathic Scoliosis Correction

The purpose of this study is to identify the flexibility radiograph(s) that can most accurately predict the curve behaviour after surgical correction of AIS. With these findings, the investigators hope to give further guidance for the selection of fusion levels and to incorporate different dynamic radiographs into the Lenke Classification, leading to a more universal application that can consistently lead to good surgical and clinical outcome.

The Lenke Classification is the most widely-accepted classification for Adolescent Idiopathic Scoliosis (AIS) in the world. Its recommendations for fusion of the minor curves depend on its structurality. It defines a minor curve as structural if there is inflexibility on side-bending more than 25 . However, a recent Delphi survey from a panel of experts in AIS management showed that there was no consensus as to which type of dynamic radiograph was optimal. Up to two thirds of the surgeons did not use side-bending as a routine, and hence they cannot apply the Lenke Classification accurately in clinical practice nor follow its recommendations for fusion.

Furthermore, the current classification does not give specific recommendations regarding the selection of fusion levels and does not take into account the clinical appearance of the patients which impact on treatment. Consequently, there are still controversies regarding the Upper Instrumented Vertebra (UIV) and Lowest Instrumented Vertebra (LIV) selections, and following the recommendations may not allow fusion of the least number of segments nor give best clinical results eg shoulder balance.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with AIS who reach the threshold for surgical correction.
* Patients aged 10 to 18 years

Exclusion Criteria:

* Neuromuscular deformity
* Prior fusion or spine surgery
* Spinal tumor diagnosis
* Congenital anomalies
Handy Hygiene of Children: Understanding the Effect of Live Feedback on Handwashing Behavior

Objective of the randomized controlled trial is to assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens / elementary schools will see live instructions and feedback on their current hand washing activity while washing hands. We hypothesize that the digital intervention will improve hand hygiene practices of children in kindergarten / elementary school.


Eligibility Criteria:
Inclusion Criteria:

* children aged between 2 and 7 years of age
* children attending kindergarten

Exclusion Criteria:

* none