cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale

The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of 2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously treated participants with severe hemophilia A. The secondary objectives are: to characterize the PK of rFVIIIFc manufactured at the 15K scale at the 15K baseline and after 13 weeks of treatment; to characterize the PK of rFVIIIFc manufactured at the 15K scale at 1000 IU/vial and 6000 IU/vial strengths; and to evaluate the safety of rFVIIIFc manufactured at the 15K scale.

PK assessments are in 3 phases: Pharmacokinetic Assessment 1(PK1): PK assessments following single injection of rFVIIIFc manufactured at the 2K scale. Pharmacokinetic Assessment 2 (PK2): PK assessments are made following a single injection of rFVIIIFc manufactured at the 15K scale where participants are randomized to the 1000 IU vial or 6000 IU/vial strengths. Pharmacokinetic Assessment 3 (PK3): PK assessments are made following 13 weeks of rFVIIIFc treatment manufactured at the 15K scale where participants are randomized to the 1000 IU vial or 6000 IU/vial strengths. After study completion, in countries where rFVIIIFc is not commercially available, eligible participants will be offered enrollment into a long-term safety and efficacy extension study (8HA01EXT \[NCT01454739\]).

Eligibility Criteria:
Key Inclusion Criteria:

* Have severe hemophilia A, defined as \<1 IU/dL (\<1%) endogenous FVIII as determined by one-stage clotting assay from the central laboratory at Screening.
* Previously treated subject, defined as having at least 150 documented prior exposure days (EDs) to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.
* No history of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors will not exclude the subject.
* No measurable inhibitor activity using the Nijmegen-modified Bethesda assay (\>=0.6 Bethesda Unit per milliliter \[BU/mL\] is considered positive) at Screening.

Key Exclusion Criteria:

* Current enrollment in any interventional clinical study in which an investigational drug or approved therapy for investigational use is administered within 30 days prior to the Baseline Visit OR prior participation in any of the following Biogen studies: 998HA101 (NCT01027377), 997HA301 (NCT01181128), 8HA02PED (NCT01458106), 997HA307 (NCT02083965), and 8HA01EXT (NCT01454739).
* Previous participation in this study.
* Any concurrent clinically significant major disease that, in the opinion of the Investigator or Biogen, makes the subject unsuitable for participation in the study.
* Other coagulation disorder(s) in addition to hemophilia A.
* History of hypersensitivity or anaphylaxis associated with FVIII or intravenous (IV) immunoglobulin administration.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Irony Comprehension Ability of Chinese Speaking Patients With TBI

This study aims at understanding irony comprehension ability of Chinese speaking patients with TBI through a series of self-made stories. Each story contains two characters having a conversation, and one of them would give a figurative (which is, ironic) or literal statement at the end of the story. The participants are asked to figure out its meaning.

The investigator plans to recruit TBI patients and control group whose gender and age accord with them, 15 people in each group. They would be asked to read the materials mentioned above displaying by a computer. It may take 30 minutes per time, and every participants only do once.

Eligibility Criteria:
Inclusion Criteria:

* Above 20 years old
* Chinese speaking people
* Diagnosed as TBI patients for over 6 months
* Having no other neurological and mental related problems
* Able to read with or without assistive device like glasses

Exclusion Criteria:

* Addicted to alcohol or drug morbid and postmorbid
* Having any communication disorders
A Laboratory-based Surveillance Study of Candida Bloodstream Infections (MK-0991-093)

This study will evaluate the incidence rate of Candida blood stream infection (candidemia) among people hospitalized in participating medical centers in Brazil, and will assess the antifungal drug susceptibility patterns of Candida clinical isolates. No hypotheses will be tested in the study. Candida blood stream isolates collected from people hospitalized for any reason during the study period will be sent to a core mycology laboratory for antifungal drug susceptibility testing. All people who develop candidemia while hospitalized will be considered participants in the study.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in a participating medical center
* Developed candidemia blood stream infection (confirmed by isolation of Candida species from blood culture)
Unraveling Perioperative Myocardial Injury

The aim of this study is to gain insight into the etiology of myocardial injury after non cardiac surgery. Furthermore, suspected etiologies were explored and hierarchically classified into most likely cause how this determines prognosis and what factors are associated with improved outcome.

As above

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 year of age
* Undergoing non-cardiac surgery in the Erasmus MC, with (high-sensitive) Troponin T \> 50 ng/L measured in any of the first three days after surgery.

Exclusion Criteria:

* Re-operations within the study period.
* Daycare surgery
Cyclophosphamide Drug Interaction Study In Cancer Patients

This study is designed to evaluate the potential pharmacokinetic interaction between oral GW679769 and IV (intravenous) cyclophosphamide when administered to cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of cancer.
* Undergoing chemotherapy with a cyclophosphamide regimen with a cyclophosphamide dose of 500 - 700 mg/m2 and a cycle duration of 14-28 days.
* Adequate hematologic, renal and hepatic function.

Exclusion Criteria:

* Pregnant or lactating.
* CNS (central nervous system) metastases.
* Active systemic infection or any other poorly controlled medical condition.
* Patients cannot take CYP3A4 inhibitors within 7 days of study treatment or CYP3A4 inducers within 48 days of study treatment.
Optimization of the Targeted Anticancer Therapies

The study includes an observational pharmacokinetic study and an interventional medication adherence study. The purpose of this study is 1) to describe the concentration-time profiles of targeted anticancer drugs and to characterize the concentration-effect/toxicity relationships in the target population of patients (observational study) and 2) to characterize patterns of adherence to oral targeted anticancer drugs and identify key-driver modifiable adherence factors in patients participating in an adherence program (interventional study).

Targeted anticancer therapies are often prescribed at the same dosage regimen in all patients. However, it is known that the marked interindividual variability in drug level may affect treatment outcomes. Several factors are known to modulate drug levels, such as weight, genetics host-drug and drug-drug interaction. The identification of these factors could give the possibility to propose better adjusted dosage regimens according to patient's individual characteristics. Moreover, the presence of high or low drug concentrations may partially explain toxicity or lack of efficacy of targeted anticancer drugs in some patients. The characterization of the relationship between drug levels and treatment response (efficacy and toxicity) would allow an optimized and a more individualized patient management with targeted anticancer drugs.

Oral targeted therapies must be taken on the long term and adherence issues have been shown to compromise treatment efficacy. Side effects and lifestyle management are among factors affecting treatment adherence. The characterization of adherence over time and the identification of factors susceptible to improve it will represent a great benefit for healthcare professionals and patients.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients to whom a targeted anticancer therapy is prescribed

Exclusion Criteria:

* Patients incapable of judgment or participants under tutelage
Management of Severely Atrophied Maxillary Ridge Using Quad Zygomatic Implants

This clinical study will aim to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants

The aim of this study will be to compare and evaluate zygomatic implant stability, occlusal contact, and bone level changes around dental implants and that of the atrophied maxilla rehabilitated with immediate loaded hyprid prosthesis supported by 4 zygomatic implants.

Eligibility Criteria:
Inclusion Criteria:

* All patients will have healthy healed residual alveolar ridges, Angle's class I maxillomandibular relations, available maxillary restorative space. This will be verified by tentative jaw relation records.

Exclusion Criteria:

* All detrimental bad habits like smoking, TMJ clicking or TMJ dysfunction will be excluded.
Parent Training to Enhance Social Success for Children With Autism Spectrum Disorder

Children with autism spectrum disorder (ASD) exhibit characteristic deficits in social initiation and there are no empirically validated treatments specifically for this core deficit. While parent training is known to be a critical intervention component, few social skills programs involve parents. This study will capitalize on an existing social skills group already established at the community agency Abilities United, with the goal of enhancing the program's effectiveness by adding a parent component. Specifically, the proposed study will investigate whether a novel parent mediated social skills program (Social SUCCESS), which provides parent training in conjunction with a social skills group intervention, will result in more frequent initiations during play with typically developing peers. Participants will include 50 children with ASD age 4:0 to 6:11 years. Children will be randomly assigned to either Social SUCCESS (N=25) or waiting list (N=25). Treatment will be provided for 8 weeks during a weekly 120-minute social skills group at Abilities United. The study will evaluate the effects of Social SUCCESS on areas of core social deficit including frequency of peer initiations using parent ratings, observational measures, standardized questionnaires, and a social eye tracking task. Outcomes will be compared to a waiting list control group. Findings will be disseminated through presentations and publications to aid clinicians in providing more effective social skills treatment for children with ASD and to enhance the scientific knowledge-base related to evidence-based social skills treatments. This research designed with the goal of stimulating additional scientific inquiry in the area of treatment for core social deficits in ASD and will provide a strong foundation for larger scale grants to study motivation-based interventions to improve social functioning.


Eligibility Criteria:
Inclusion Criteria:

* child aged 4.0 to 6.11 years
* child diagnosed with ASD (Autism Diagnostic Observation Schedule; ADOS-2)
* child without intellectual disability (Stanford Binet Intelligence Scales; SB-5)
* parent able to consistently participate in parent training sessions and complete study measures

Exclusion Criteria:

* child with other severe psychiatric disorder
* child with known genetic condition (e.g., Fragile X, Retts)
* child with unstable medical condition (e.g., active seizures)
A Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Characteristics of KMRC011

This trial is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic of KMRC011 injection in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

* A male whose age is between 19 and 55 years of age
* A person whose body mass index is between 18.5 and 27 kg/m2 at screening
* A person who has the ability and willingness to participate in the clinical trial
* A person who voluntarily agrees with the clinical trial after hearing and fully understanding the detailed explanation of this clinical trial

Exclusion Criteria:

* A person who has a clinically significant disease or history of liver, kidney, neuropsychiatry, immune system, respiratory system, endocrine system, hematology\*oncology system, cardiovascular system, etc.(In the case of liver disease items, it includes subjects who have hepatitis virus)
* A person who has clinical history of hypersensitivity reactions to the major components or constituents of investigational product or other clinically significant hypersensitivity reactions to drugs or foods, or those with allergic diseases requiring treatment
* A person with infectious disease or severe trauma within 21 days of the randomization date
* A person whose serum AST, ALT or γ-GT levels exceed 1.5 times the upper limit of the reference range at screening
* A person whose QTcF on the electrocardiogram exceeds 430 msec or who has a clinically significant abnormal rhythm at screening
* A person with a glomerular filtration rate less than 60 mL/min/1.73 m2 calculated from serum creatinine at screening
* A person with a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 60 mmHg, or greater than 100 mmHg at screening
* A person with thrombocytopenia or coagulopathy which should not be given intramuscular injection
* A person whose weekly average drinking amount exceeds 140g of alcohol per week
* A person whose daily average smoking amount exceeds 10 per day
* A person who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the investigational product within 14 days of the injection
* A person who has the history of substance abuse or positive urine screening test
* A person who have received a investigational product or a bioequivalence study drug within at least 90 days prior to the randomization
* A person who donated whole blood within 60 days before the randomization, or donated components of blood within 30 days
* A person who dose not have a medically approved contraceptive during the trial and has a plan to provide sperm
* A person who has clinically significant abnormalities from clinical laboratory test
* A person who is deemed ineligible for clinical trials by the investigator
Efficacy of High Flow Nasal Cannula Oxygen to Reduce Desaturation During Tracheal Intubation

Tracheal intubation of critically ill patients is associated in the intensive care unit (ICU) with significant complications and morbidity. Patient desaturation is one of the most common complications that may lead to cardiac arrest despite pre-intubation oxygenation. Preoxygenation can be improved by the use of non-invasive ventilation, but this technique can be cumbersome to implement in the context of urgent intubation and more importantly it does not insure oxygenation during intubation. High flow nasal cannula oxygen therapy is a technique that has been shown to improve patient oxygenation in the context of acute hypoxemic respiratory failure. It bears the potential to be of clinical benefit in the setting of tracheal intubation in the ICU to ensure patient safety. The purpose of this study is to compare pre- and per-intubation (during intubation) oxygenation with either a conventional high FiO2 oxygen bag reservoir facemask (current standard practice) or high flow nasal cannula oxygen therapy (new practice to be implemented in our ICU).

Pre-oxygenation is ensured in our ICU with a high FiO2 nonrebreathing facemask, except in patients already under high flow nasal cannula oxygen therapy because of acute hypoxemic respiratory failure. A nasal catheter is positioned to ensure a low oxygen flow during laryngoscopy. Whether or not all patients should benefit from high flow nasal cannula oxygen therapy for pre-oxygenation remains unknown. In order to improve quality of care delivered to our patients and in anticipation of a change in our practice, we decided to record prospectively oxygen parameters during and immediately of intubation using a facemask and to compare them with parameters obtained in patients intubated after our change in practice. The change of practice consists in the systematic use of high flow nasal cannula oxygen therapy to ensure pre and during procedure (tracheal intubation)oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* ICU patient requiring tracheal intubation

Exclusion Criteria:

* age \< 18 years
* cardiac arrest
* acute respiratory failure requiring immediate high flow nasal cannula oxygen, defined as patient with SpO2 \< 95% while under 15 L:min oxygen with a nonrebreathing facemask
An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers

A double blind, non randomized, multicenter investigation

The study consists of 2 evaluations/visits.

Evaluation/visit 1: Takes place in connection with admission to the hospital. Informed consent, inclusion and exclusion criteria are assessed as well as assessment of skin type and inspection of the entire body skin. Pregnancy test on women of childbearing potential, height, weight, blood pressure and body temperature are measured. Questions about demography, health conditions, previous illnesses, nicotine habits. Risk assessment for pressure ulcers (Modified Norton or RAPS-scale) is carried out according to the hospital usual routine. Examination with PU sensor will be performed.

Evaluation/visit 2: Takes place in connection with the discharge from the hospital or 4 weeks after visit 1 if the research subject is still hospitalized. Full body skin inspection to see possible onset of pressure ulcers. Review of the research subject's medical records as well as review of nursing notes from the hospital where the research subject has been discharged from, to find any notes about pressure ulcers. The study participation is then terminated for the research subject.

Eligibility Criteria:
Inclusion Criteria:

1. Given their written consent to participate in the study
2. Male or female between ≥18 years and ≤ 64 years with a reduced mobility, where the hospitalization may involve a risk that the person may become less active or Male or female ≥65 years

Exclusion Criteria:

1. Existing pressure ulcer or damage to the skin around the sacrum where the PU sensor plate and pillow are to be placed
2. Fever ≥38 ºC, within 30 minutes before the examination with PU sensor
3. Difficulty lying still in supine position during the examination with PU sensor, which takes 5 to 10 minutes
4. Known allergy or sensitivity to any of the materials in PU sensor that gets in contact with the skin on the sacrum
5. Body weight ≥200 kg
6. Previous participation in the study
7. Mental inability, or language difficulties that results in difficulty to understand the meaning of participation in the study and / or signing the study consent,
8. Pregnancy
Restricting the Use of Artesunate Plus Amodiaquine Combination Therapy to Malaria Cases Confirmed by a Dipstick Test: A Cluster Randomised Control Trial

Effective use of Rapid Diagnostic Test (RDT) and artemisinin-based combination therapy (ACT) depends on the accuracy and safety of RDT based treatment practices and on factors related to the health delivery system. We propose to study the accuracy and safety of RDT based diagnosis and treatment of febrile illness, health system determinants of effective use of RDTs and the public health outcomes of RDT based ACT for malaria.A cluster randomised trial of RDT based versus clinical judgment based treatment of febrile illness on the incidence of malaria in \<48 month old children will be conducted. Health Centres will be randomly allocated to RDT based treatment or clinical judgment based treatment arm and children under 2years of age from the catchment area of each health centre will be followed for 2 years. The cost effectiveness of RDT based approach will be compare with the clinical judgement based treatment.

Two-stage, four component study Stage I - Component A: Accuracy of RDT and the outcome of treatment based on RDT results Primary outcome:What is the sensitivity and specificity of Paracheck cassettes in Ghana to diagnose malaria?

Stage 1 - Component B: delivery system determinants of effective RDT based ACT Primary outcome: What are the delivery system determinants of effective RDT based ACT?

Stage 2 - Component A: effects of restricted use of ACTs based on RDT results: a randomised controlled trial Primary outcome: Incidence of malaria (fever + any level of parasite density) in \< 48 month-old children

Stage 2 - component B: Cost effectiveness analysis:

Primary outcome:What is the cost effectiveness of RDT based ACT for treatment of children under 4 years compared with ACT based on clinical judgement?

Eligibility Criteria:
Inclusion Criteria:

* All children aged less than 48mths reporting to health center with suspected malaria

Exclusion Criteria:

* Children having chronic illnesses such as severe malnutrition and heart disease will be excluded from the study.
GrandAides; a Workforce Innovation to Address Post Acute Care

Randomized controlled trial with two groups looking at post hospital care for patients who were admitted with congestive heart failure. The control group includes standard of care provided to the patients after discharge including a hospital employed community health worker. The intervention group receives a specially trained GrandAide following the GrandAide model for post acute care. Difference in ER visits and readmissions was measured.

GrandAides program is a credible messenger community health worker based program that assumes a community health worker from the community who has specialized education around a certain chronic condition will be able to support patients in the outpatient setting more effectively than current standard of care. In this study a GrandAide visited a patient discharged from the hospital in their home for 4 weeks providing education, checking vital signs, and assisting with communication with the cardiologist. The study measured the difference in hospital admissions and ER visits between the group that was assigned a GrandAid and the group that took part in standard care. The groups were assigned randomly. The difference was calculated using one and two tailed t-test results.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of heart failure Lives in 6 zipcode catchment area of Temple University Hospital Is followed by Temple Cardiology

Exclusion Criteria:

End Stage Renal Disease Housed in a Skilled Nursing Facility Substance Use Disorder Unable to give consent Doesn't speak English Under age 18