cyrilzakka/clinical-trials huggingface dataset:
Peak Plantar Pressures While Wearing a Carbon Fiber Off Loading Orthoses

The purpose of this study is to determine the ability of carbon fiber off loading orthoses to reduce plantar pressure while providing an augmented plantarflexor power to improve walking and function. Results of this study could lead to increased use of carbon fiber off loading orthoses for patients with diabetes, peripheral neuropathy, and foot wounds as a way augmenting wound healing and preventing future recurrences of wounds.

The long term goal of this research is the successful incorporation of carbon fiber into an off loading device will provide protection to the insensate foot of people with diabetes by reducing localized peak pressures, and thus the risk of recurrence neuropathic foot wounds and fractures, while improving ankle power at push off that will allow individuals with loss of ankle muscle function to walk faster and return to dynamic activities required in their jobs and for full function in the community. The overall goal of this proposal is to determine effects of carbon fiber off loading orthoses (CFO) design characteristics (lay up and geometry of strut) on brace strength, weight, power return capacity, plantar off-loading and participant comfort using FE models, ex-vivo testing and human testing.

First, a CFO will be fabricated using geometry consistent with the current clinical standard. This representative CFO will serve as a baseline from which a finite element (FE) model will be built. The model will be altered as desired to determine the effects of variable design characteristics. The FE model will estimate brace deflection and stress when the CFO is designed with various lay up designs and brace thicknesses. We will use results from the FE model to fabricate a new CFO for study participants.

We will then measure peak plantar pressures during walking while the participants are barefoot, wearing the CFO consistent with current clinical standards, and wearing the new CFO fabricated based on the results of the FE model. We will also measure plantarflexor power during walking while the participants are wearing the CFO consistent with current clinical standards and while wearing the CFO designed based on the results of the FE model. It is believed that the FE model driven CFO design will lead to improved brace strength while reducing plantar pressure compared to barefoot and will have similar plantarflexor power as the CFO based on current clinical standards.

Eligibility Criteria:
Inclusion Criteria:

1. Daily life includes a minimum of moderate activity level (variable cadence walking)
2. Have a Gillette or carbon off loading orthosis as a result of diabetes related foot impairments
3. Diagnosis of diabetes mellitus and peripheral neuropathy
4. Ability to ambulate in the community (K-level ≥ 2)
5. Age \> 21 years

Exclusion Criteria:

1. Unable to ambulate and complete testing required for study participation.
2. Severe foot deformity of the hindfoot or any deformity of the foot with a dislocation resulting in a bony prominence on the plantar/weightbearing surface of the foot.
3. Neurological diseases that affects walking
The Effects of Sımulatıon Used in Vagınal Chıldbırth on Malpractıce Tendency And Perceptıons of Care Behavıors

H1a: The simulation-based training used to provide delivery skills have an effect on malpractice trends of midwifery students.

H1b: The simulation-based training used to provide delivery skills have an effect on midwifery students' perceptions of care behaviors.

H0a: The simulation-based training used to provide delivery skills have not an effect on malpractice trends of midwifery students.

H0b: The simulation-based training used to provide delivery skills have not an effect on midwifery students' perceptions of care behaviors.

The study was conducted as a single blind, prospective, and simple randomized controlled trial. The study was conducted in the fall semester of 2016 and in the fall semester of 2017 in the midwifery department of a university.

The study universe comprised 79 students who took the course about vaginal delivery (which is included in the midwifery curriculum) provided using simulation-based training and 90 students taking this course for the first time. The study included 120 participants, including 60 randomly selected students who agreed to participate in the study, were enrolled in midwifery, and took the course explaining vaginal delivery for the first time and 60 randomly selected students who received this education using simulation-based training.

The simulation training included the activities that midwives should do during the birth and management of vaginal delivery. Bone pelvis, fetal head, fetus, cervical dilatation-effacement, fetal descensus, maternal-neonatal birthing simulators and chicken breast model for episiotomy were used by the researchers to monitor, manage, and provide care for the progress of labor. The students in the control group received theoretical training about management and care of vaginal delivery. In addition, the researchers demonstrated them how to monitor and manage the delivery process and provide care.

Data collection tools included a personal information form, medical malpractice tendency scale in nursing, and caring assessment questionnaire.

Statistical analyses were made using Statistical Package for Social Sciences (IBM SPSS) Statistics 22 software. The findings were analyzed using descriptive statistics (average, standard deviation, frequency, and percentage). The Kolmogorov-Smirnov test was used to determine normal distribution of the data.

Eligibility Criteria:
Inclusion Criteria:

* To receive simulation based training
* Older than 18 years,
* To Voluntary to participate,
* To know how to read, write and speak in Turkish,
* To do model work
* Fully completed the data collection forms
* To continue the all course

Exclusion Criteria:

* To received theoretical training,
* Younger than 18 years,
* Refuse to participate
* Not knowing how to read, write and speak Turkish,
* Not to do model work
* Not to fill the questionnaire
* Not to continue the course
Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia

This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration.

Hyperphosphatemia is associated with abnormally high blood concentrations of phosphorus. Normally, phosphorus in the body is excreted into urine via the kidneys, but this process is impaired when renal function is reduced. Hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. High blood phosphorus concentrations trigger various complications caused by phosphorous interaction with blood calcium or parathyroid hormones, and makes patients more prone to calcium deposition in soft tissues such as the coronary arteries, increasing the risk of ischemic heart disease. ILY101 is a non-absorbed, metal-free polymer that binds phosphorus in the gastrointestinal tract, allowing for excretion of phosphorus. It is therefore anticipated to ameliorate hyperphosphatemia by reducing the absorption of phosphorus from the gastrointestinal tract.

Eligibility Criteria:
Inclusion Criteria:

* CKD patients on dialysis
* Prior successful use of phosphate binder
* Signed informed consent

Exclusion Criteria:

* Previous intolerance to polymer-based phosphate binders
* Kidney transplant planned within 3 months
* Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control
* Clinically significant liver disease
* History of bowel obstruction or other significant gastrointestinal disorder

Additional study entry criteria will be evaluated during initial screening.
Consequences of Anti-interleukin 6 Immunotherapy Treatment for Rheumatoid Arthritis on Periodontium

Rheumatoid arthritis and periodontitis are two inflammatory diseases that share many pathophysiological similarities as some inflammatory mediators like TNF-alpha, IL-1, Il-6, Il-17, Il-12 et Il-17, RANK-L, or OPG The most severe or progressive forms of rheumatoid arthritis require in 10-30% of cases, the use of biotherapies such as anti-TNF-alpha, anti CD-20 and anti-lL-6. All these treatments results in, among other things, an increased risk of infection, both viral and bacterial.

These new biotherapies could have an impact on periodontal status

* either by favouring sub gingival colonization of root surfaces by periodontal pathogenic bacteria and initiate periodontitis or exacerbate pre-existing periodontitis,
* or a positive modulation of the host response by inhibiting bone resorption of the alveolar process.

To date, very few studies have been conducted on this subject which is really a translational research, involving several medical specialties.


Eligibility Criteria:
Inclusion Criteria:

* patient over 18 years presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is prescribed.
* At least 18 permanent teeth in the mouth at least 3 teeth with a healthy periodontal status
* Having expressed their written free and informed consent

Exclusion Criteria:

* Hypersensitivity to any of the following components : tocilizumab, saccharose, polysorbate 80, phosphate disodique dodécahydrate, phosphate monosodique dehydrate
* Severe or active infections
* Systemic Pathology affecting the immune system including Sjögren's syndrome
* Surgery in the previous month
* HIV positive
* Alcoholic
* Toxicoman
* Antibiotic treatment in the last 2 months
* Legally protected patients
Optical Genome Mapping in Characterization of Multiple Myeloma

The current cytogenetic characterization of Multiple Myeloma (including chromosome and gene abnormalities identification in abnormal plasma cells) encounters some limitations. Indeed current techniques only enable to analyze a limited numbers of predefined abnormalities. New tools that will allow for characterization of abnormalities involved in multiple myeloma development are thus required. The interest of Optical Genome Mapping has already been demonstrated in other hematological diseases. The present study aims at validating Optical Genome Mapping in genetic abnormalities identification for patients with Multiple Myeloma (MM).

For this study, supplementary samples will be collected during bone marrow biopsy performed at MM diagnosis. These will be used for CD138+ Plasma Cell Isolation and sent to GENTYANE (GEnoTYpage and sequencing in AuvergNE) platform in Clermont-Ferrand for Optical Genome Mapping.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Non previously treated Multiple Myeloma (criteria from the International Myeloma Working Group)
* Presence of CRAB criteria (Calcium Renal Anemia Bone : Calcemia \> 2.75 mmol/l or \> 0.25 mmol/l higher than the Upper Limit of Normal ; serum creatinine \> 173 μmol/l or creatinine clearance \< 40ml per minute attributed to myeloma ; anemia with hemoglobin value \< 10g/dl or more than 2g/dl below the Lower Limit of Normal, bone lesions with osteolytic lesions or osteoporotic vertebral collapses attributed to myeloma)

Exclusion Criteria:

* Opposition of the patient
* Failure of myelogram
* Previous treatment of multiple myeloma (except with corticosteroids)
* Failure of FISH
* Minor or patients placed under guardianship or supervision
* Patients deprived of liberty
* Patients placed under judicial protection
* Patients that are not able to express their consent
* Pregnant and breastfeeding women
A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Overweight or Obese Participants Who Are Healthy or Have Type 2 Diabetes Mellitus (MK-5823-002)

The purpose of this study is to assess the multiple rising dose safety/tolerability and pharmacokinetics of MK-5823 in overweight/obese participants who are healthy and overweight/obese participants with Type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-childbearing potential
* A Body Mass Index between 27 and 35 kg/m\^2 and weighs at least 50 kg
* Judged to be in good health and for the T2DM Panels, good health other than the diagnosis of T2DM
* For T2DM Panels only: has a diagnosis of T2DM and is being treated with lifestyle management (e.g. diet and exercise) alone or in combination with a stable dose of metformin
* A nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

* History of stroke, chronic seizures or major neurological disorder
* History of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.
* History of clinically significant endocrine abnormalities or diseases (including type I or type II, or steroid-induced diabetes for healthy participant panel; and excluding T2DM for the T2DM Panels)
* Irritable bowel syndrome, or recurrent nausea, vomiting, diarrhea, or abdominal pain.
* History of neoplastic disease
* History of cataracts, diabetic retinopathy, macular edema, macular degeneration, vitreous hemorrhage, glaucoma, ocular surgery, ocular trauma or blindness
* Requires treatment with systemic or ocular corticosteroids
* For T2DM Panels, a history of hypoglycemic unawareness
* For T2DM Panels, active treatment with any anti-hyperglycemic drug other than metformin
* For T2DM Panels, treatment with any peroxisome proliferator-activated receptor-gamma agonist (e.g. Avandia or Actos) within 12 weeks of study participation
* Unable to refrain from using any medication beginning 2 weeks before study participation
* Consumes excessive amounts of alcohol (\>3 per day)
* Consumes more than 6 caffeinated beverages per day
* Had major surgery or donated or lost more than 1 unit of blood
* Participated in another investigational study within 4 weeks of study participation
* History of significant multiple and/or severe allergies or anaphylactic reaction
* Hypersensitivity to glucagon or insulin
* Uses illicit drugs or has a history of drug or alcohol abuse within 3 months of study participation
* Woman of child-bearing potential or is a nursing mother
* For T2DM Panels, age \>50 years
Study Evaluating Absorption, Distribution, Metabolism and Excretion (ADME) of Single Dose [14C]-BI 207127 in Healthy Male Volunteers

Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of \[14C\]-BI 207127 and to characterize the metabolic profile following single dose administration.


Eligibility Criteria:
Inclusion criteria:

* Body mass index =18.5 and BMI = 29.9 kg/m2
* Subject is willing to avoid sun exposure from the first administration of the trial drug until the end of the study
* Male subjects must agree to minimise the risk of female partners becoming pregnant from the dosing day until three months after the completion of the study. Acceptable methods of contraception for male volunteers include a vasectomy no less than three months prior to dosing or barrier contraception. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device, tubal ligation, or hormonal contraceptive for at least three months, or diaphragm with spermicide.
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion criteria:

* Participation in more than one other radiolabelled investigational study drug trial within 12 months prior to check-in. The previous radiolabelled study drug must have been received more than 6 months prior to check-in for this study and the total exposure from this study and the previous study will be within the recommended levels considered safe, per 21 CFR 361.1 (eg. less than 5,000 mrem whole body annual exposure)
* Exposure to significant radiation (eg. serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check-in
* Participation in another trial with an investigational drug within two months prior to administration of the trial drug or during the trial
* Use of drugs which might reasonably influence the results of the trial, including use of a broad spectrum antibiotic, within 10 days prior to administration of investigational medication in this trial or during the trial
* Intake of a drug with a half-life of \>24 hours within the month prior to administration of trial medication, or if administration of trial medication would occur in the time period in which fewer than 10 half-lives had elapsed
* Surgery of the gastrointestinal tract (except appendectomy or cholecystectomy)
* Current smoker or smoker in last six months; alcohol abuse (more than 40 g/day); history of illicit drug abuse within the past 2 years
* Blood donation (more than 100 mL within four weeks prior to first administration of the trial drug or during the trial)
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms); a history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* History of photosensitivity or recurrent rash
* Irregular defecation pattern (less than one bowel movement a day)
The Test-retest Effect of the "d2 Test of Attention".

The "d2 test of attention" has been used in studies regarding sleep deprivation due to night shifts in hospital staff, in order to determine whether sleep deprivation has an impact on performance. However, by repeating the test there appears to be a test-retest effect, as the participants improve when performing the test more than once. The aim of this study is to determine, whether the "d2 test of attention" has a test-retest effect.

20 surgeons and 20 surgical nurses will be included in this study. They will be asked, after thorough instruction, to perform the d2 test of attention after a designed schedule. The participants will on day 1 and 2 perform the test 3 times consecutively at intervals of 5 minutes. On day 3, 4 and 5 the test will be repeated only once. After the 5th day follows a 7-day-break. On day 13 the test will again be performed once.

Eligibility Criteria:
Inclusion Criteria:

- Nurses and surgeons at the department of Surgery, Herlev hospital. Age 22-55 years.

Exclusion Criteria:

* Known sleep disturbances and attentional deficits, previous use of the d2 test of attention, use of central stimulating drugs
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection

The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.

The title of protocol reflects the original study design. The study design section is reflecting that the design as of protocol amendment 5 is non-randomized.

Eligibility Criteria:
Inclusion Criteria:

* Medically stable on the basis of physical examination, medical history, vital signs, and triplicate 12-lead electrocardiogram (ECG) performed at screening
* Hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening: participants be either currently not treated with HBeAg positive status or virologically (nucleos\[t\]ide analog \[NA\]) suppressed with HBeAg negative status
* Hepatitis B surface antigen (HBsAg) greater than (\>) 100 International Units per Milliliter (IU/mL) at screening
* Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included
* Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
* Fibroscan liver stiffness measurement less than and equal to (\<=) 9 Kilopascal (kPa) within 6 months prior to screening or at the time of screening

Exclusion Criteria:

* Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
* History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
* History or signs of cirrhosis or portal hypertension, signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening
* Presence of coagulopathy or bleeding disorder as indicated by: (a) International normalized ratio (INR) greater than or equal to (\>=) 1.1\* upper limit of normal (ULN); (b) Partial thromboplastin time \>1.1\*ULN; (c) Any signs of prolonged bleeding (\>10 minutes)
* Presence of hemoglobinopathy (including sickle cell disease, thalassemia)
* Liver biopsy performed prior to screening that led to complications and that in the opinion of the investigator would prohibit another liver biopsy
Understanding and Improving Anticoagulation Dosing for Patients With Atrial Fibrillation

This study will survey atrial fibrillation patients to better understand patient perspective of DOAC treatment, and providers to assess knowledge, practice patterns, and beliefs surrounding anticoagulation for AF.


Eligibility Criteria:
Inclusion Criteria:

Retrospective Analysis:

1. NVAF documented in at least 2 claims between January 2015 and December 2016
2. CHA2DS2-VASc scores of 2 or higher

Prospective Analysis:

1. Patient Analysis: All patients in ResearchMatch with diagnosed AF.
2. Provider Analysis: All providers who contributed at least 25 AF patients treated with DOACs to the Symphony claims dataset. All provider specialties (i.e. cardiology, primary care, and other), as well as provider types (i.e. physician, physician extender, and nurse practitioner) will be included.

Exclusion Criteria:

Retrospective Analysis:

1. Patients with bioprosthetic or mechanical valves in the mitral position.
2. Patients with any of the following missing data: age, sex, body weight, serum creatinine, and any data required for DOAC dosing.
3. Patients with mitral stenosis.
4. Patients without 12-month follow-up data.

Prospective Analysis:

1. Provider Analysis: All providers who contributed less than 25 AF patients treated with DOACs to the Symphony claims dataset.
2. Patient Analysis: Patients unwilling or unable to consent.