cyrilzakka/clinical-trials huggingface dataset:
Building Respiratory Support in East Africa Through High Flow Versus Standard Flow Oxygen Evaluation

Acute hypoxemia is common and deadly in resource variable settings. While studies in high income countries (HICs) have indicated a possible benefit to high flow oxygen as compared with standard flow oxygen, rigorous studies in low or lower middle income countries (LMICs) have not been performed. Studies in sepsis have demonstrated that interventions that improve outcomes in one context may actually be neutral or harmful in a different context.

The goal of this study is to test whether high flow oxygen results in better outcomes for hypoxemic adult patients, as compared with standard flow oxygen, in five LMIC hospitals. The main questions it aims to answer are:

1. For hypoxemic adults in these LMIC study settings, does high flow oxygen or standard flow oxygen result in lower mortality?
2. What are the facilitators and barriers to using high flow oxygen in these settings?
3. Does high flow or standard flow oxygen use more oxygen?

Participants will be randomized to receive either high flow oxygen through a large nasal cannula, or to receive standard flow oxygen, through nasal cannulas, face masks, or non-rebreather masks. Researchers will compare the outcomes for the two groups, to see if one group of patients has better outcomes than the other.

The study will also examine how much oxygen is used by the two patient groups, as well as other factors relevant to the feasibility of implementation of high flow oxygen in these sites.


Eligibility Criteria:
Inclusion Criteria:

* age\>=18 years AND
* admitted to a study site hospital within the 24 hours prior to screening AND
* SpO2\<90% at time of first assessment OR
* receiving oxygen at time of first assessment

Exclusion Criteria:

* imminent death (high clinical suspicion of death within 24 hours of admission)
* patient or caregiver refusal of study participation
* history of chronic respiratory failure (SpO2\<90% or oxygen dependence for at least three months)
* anatomical factors precluding the use of nasal cannula
* intubation or non-invasive ventilation by the clinical team prior to screening for the trial
* known hypoxemia at transferring facility for \>48 hours
* lack of availability of either SFO or HFO devices or supplies at the time of randomization.
EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan

The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL). The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline and at the 6 and 12 months after start of EYLEA treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been determined to start EYLEA treatment
* Patients who are registered to Special drug use investigation of EYLEA for AMD(Trial Number 15858)
* Patients who have agreed with the patient informed consent

Exclusion Criteria:

* Patients who have already received EYLEA
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

The purpose of this collaborative CTSA (Clinical and Translational Science Award) application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in breastfeeding mothers and their infants

The approach includes 1) development and implementation of an innovative PPAP infrastructure at participating CTSA hubs (Aim 1) and 2) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids and precision dosing in nursing mothers and infants (Aim 2).

SPECIFIC AIMS: The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in

Aim 1. Develop and implement a perioperative precision analgesia platform (PPAP) by linking genomics to opioid metabolism, Clinical Pharmacogenetics Implementation (CPIC) guidelines, precision dosing, clinical safety, and personalizing analgesia

Aim 2. Evaluate utility of PPAP in nursing mothers and their newborns following Cesarean Section The investigators hypothesize that CYP2D6 and other (ABCB1, and OPRM1) variants will explain clinical and pharmacokinetic variations of oxycodone, and PPAP implementation will reduce adverse effects in mothers and infants.

Eligibility Criteria:
Inclusion Criteria:

Adult women (\>18 yr) All races American Society of Anesthesiologists Classification (ASA) physical status: 1 to 3 undergoing elective Cesarean section that are willing to receive in-patient opioids.

Exclusion Criteria:

1. Health conditions including uncontrolled diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)
2. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes
3. Preoperative severe pain and opioid use/misuse, allergy to oxycodone
4. Allergy to oxycodone
5. Significant neurological disorders, liver and renal diseases
A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients

The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus:

* How much effect AP-306 has assessed by blood phosphorus lowering;
* How safe and tolerable AP-306 is.

Participants will receive either following treatments:

* AP-306, and
* Sevelamer carbonate.


Eligibility Criteria:
Important Inclusion Criteria:

1. On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit
2. Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit
3. Serum phosphorus within the trial-required range

Important Exclusion Criteria:

1. Pregnant or breastfeeding
2. Any history of kidney transplant
3. Any history of a parathyroid intervention
4. Any clinically significant GI disorders within 4 weeks prior to the screening visit
5. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
6. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
7. Documented history of hypersensitivity or allergic reactions to any of the excipients used by AP-306, or history of hypersensitivity or allergic reactions or intolerant to sevelamer carbonate
Habit Formation for Adherence to Statin Use and LDL Reduction

In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients with suboptimal cholesterol control who are at high risk for CVD, the study investigators propose to test the effectiveness of different behavioral economic techniques in inducing habit formation for adherence to statin use and sustained reductions in LDL cholesterol after financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to 12 months (6 months after cessation of financial incentives).


Eligibility Criteria:
Inclusion Criteria:

* Individuals at high risk of a cardiac event, specifically one of the following:
* Individuals with clinical CVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ;
* Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl;
* Individuals without clinical CVD or diabetes with LDL greater than or equal to 100 mg/dl and estimated 10-year CVD risk 7.5%;
* Individuals without clinical CVD or diabetes with LDL cholesterol greater than or equal to 190 mg/dl A prescription filled for a statin medication within the last 12 months (derived from pharmacy records);
* Medication Possession Ratio (MPR) less than or equal to 80%
* Low medication adherence on self-report completed during enrollment

Exclusion Criteria:

* Less than 18 years old
* Contraindication to further statin use or have suffered side effects from statins, such as myopathy
* Will not or cannot give consent
* History of active or progressive liver disease or abnormal liver function tests on baseline screening when applicable
* Currently participating in another clinical trial with related aims
* Co-morbidities likely to lead to death within a short-period
PARTNER II: Improving Patient and Family Centered Care in Advanced Critical Illness

This is a stepped wedged randomized controlled trial comparing the PARTNER intervention with usual care in 5 Intensive Care Units. The overarching goal of this research project to ensure patient-centered decisions about the use of intensive treatments for patients with advanced critical illness. In a prior project, the investigators developed the PARTNER program (PAiring Re-engineered ICU Teams with Nurse-driven Education and OutReach), a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs, including: 1) changing care "defaults" to ensure clinician-family meetings within 48 hours of enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings, 3) increased use of palliative care services for patients with a poor prognosis. The investigators propose to begin deployment of the PARTNER II program in the spring of 2015 enrolling 690 surrogate decision makers in 5 ICUs using a stepped wedge design. The investigators expect to achieve the following project goals:

1. To increase the patient-centeredness of end-of-life decisions, and to increase the quality of clinician-family communication.
2. To decrease the psychological burden on family members acting as surrogates.
3. To reduce total health care costs by decreasing the duration of use of burdensome, invasive treatments at the end of life.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Surrogate decision maker for ICU patient in one of 5 UPMC ICU's

Exclusion Criteria:

* Non-English Speaking
* Surrogate's loved one is for organ transplantation
* Not physically able to participate in family meeting
Assessment of Clinical & Radiographic Efficiency of Manual & Pediatric Rotary Systems in Primary Root Canal Preparation

Manual files used for the pulpectomy of primary teeth have some disadvantages such as time wastage and the occurrence of iatrogenic errors compared to rotary systems.

Little studies have been done to clinically evaluate the Kedo-S Square \& Fanta AF™ Baby rotary systems in relation to the quality of obturation, instrumentation time and postoperative pain in root canal preparation of primary molars using CBCT.

Biomechanical preparation is one of the most important steps of primary teeth pulpectomy, which are primarily targeted during canal debridement . Conventionally, hand files were used for cleaning and shaping in primary teeth with some disadvantages such as time wastage and the occurrence of iatrogenic errors such as zipping, lateral perforations, apical obstruction, and canal transportation.

The use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. Numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. Since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. As a result, there was a great need for the development of a unique pediatric rotary file system.

The Kedo-S Square rotary system is a single file system specifically designed for paediatric use. It consists of two files, one for anterior primary teeth (A1) and one for posterior primary teeth (P1) also, Fanta AF™-Baby rotary system, another specifically generated paediatric rotary file, was produced using Ni-Ti controlled memory (CM)-Wire technology.

A good root canal treatment in primary teeth is dependent on the quality of biomechanical preparation, the type of obturating material used with as few voids as possible, and the achievement of a good hermetic seal. Also, treatment time is an important aspect as reduced chairside time increases children's cooperation for dental treatment, reduces anxiety, and making the treatment protocol optimal. Another factor affecting the success of primary teeth pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into peri-radicular tissues accordingly, causing inflammation and releasing inflammatory mediators.

Eligibility Criteria:
Inclusion Criteria:

* healthy cooperative children
* non-vital posterior teeth with sufficient coronal structure
* intact 2/3rd root structure
* no mobility or external pathological root resorption

Exclusion Criteria:

* Uncooperative children
* children with systemic illness
* non-restorable primary molars
* primary molars with sever mobility, or pathological root resorption
Preparation Rich in Growth Factors (PRGF) Treatment for Osteoarthritis of the Knee

to evaluate the influence of PRGF treatment on patient suffering from OA knee

Autologous platelet-secreted growth factors (GFs) may have therapeutic effects in osteoarthritis (OA) capsular joints via multiple mechanisms. Our aim is to examine the effect of a platelet-derived preparation rich in growth factors (PRGFs) in OA knee

Eligibility Criteria:
Inclusion Criteria:

* age 40-75 years old
* diagnosed Oa of the knee more then 1 year
* no knee deformation

Exclusion Criteria:

* mental of physical disabilities
* pregnancy
* deformities of the knee
A First In Human Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics and Pharmacodynamics of Single Oral Doses Of PF-06372865

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06372865. The pharmacodynamic activity of PF-06372865 will also be assessed. The effect of food on PK and the PK of PF-06372865 administered as a tablet formulation may also be investigated. Pharmacodynamic interaction between PF-06372865 and lorazepam will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (e.g., gastrectomy).
* A positive urine drug screen.
Postoperative Oral Cryotherapy in Sore Throat and Daily Life

The purpose of this study will to evaluate the degree of postoperative sore throat and Life Impairment changes in patients with sleep apnea who underwent da Vinci robotic arm surgery as an intervention of oral cryotherapy.

An experimental study was conducted with 32 patients in the experimental group and 32 patients in the control group. The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies,and then intervened in the postsurgical period using oral cold therapy (ice lolly in the mouth),while the control group received general routine care. The control group received regular care. The assessment tools included the Pain Profile Scale and the Life Impairment Scale, and the assessment period was from the first day to the 14th day after the operation.

Eligibility Criteria:
Inclusion Criteria:

* (1)Admission age is 18 years or above, conscious, able to communicate in Mandarin and Taiwanese, and willing to be measured and fill out the questionnaire after explaining the process and purpose of the study.
* (2) The study was conducted in hospitalised patients diagnosed with sleep apnea who underwent surgery.

Exclusion Criteria:

* (1) Diagnostic diagnosis of the disease not clearly known.
* (2) Patients with unclear consciousness.
* (3) Patients who have been diagnosed with mental illness before the diagnosis of the -
* disease or recently diagnosed with mental illness.
* (4) People with paraplegia or low behavioural ability.
* (5) Patients who have suffered a stroke.
Concomitant Hybrid Versus Catheter Ablation for Atrial Fibrillation With Hypertrophic Cardiomyopathy

The goal of this clinical trial is to compare the rhythm control effect in hypertrophic non-obstructive patients with non-paroxysmal atrial fibrillation by either concomitant catheter endocardial and thoracoscopic epicardial ablation or catheter ablation alone. The study aims to see if concomitant hybrid ablation can more effectively achieve rhythm control effect than catheter ablation alone in non-paroxysmal atrial fibrillation patients with hypertrophic cardiomyopathy.

After informed consent, 66 eligible admissions will be recruited in 2 centers. Eligible participants will be randomly divided (1:1) into either hybrid or catheter ablation arms, looking for a primary outcome of 1-year freedom from atrial arrhythmias.

Eligibility Criteria:
Inclusion Criteria:

1. Patients' age is ≥18 y
2. Clinically diagnosed hypertrophic cardiomyopathy (any left ventricular wall segment thickness ≥15 mm in genetical negative (or unknown genetical status) patients or ≥13mm in genetical positive ones-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging or computed tomography)-that is not explained solely by loading conditions)
3. Non-obstructed left ventricular outflow obstruction with peak gradients \<30mmHg
4. Concomitant with persistent atrial fibrillation (7 days\<sustained episode lasting\<3 years) with drug-refractory symptoms.
5. Be able to understand the contents of the trial, and provide written informed consent to participate in this investigation.

Exclusion Criteria:

1. Patients with left atrial size \>60 mm (2-dimensional echocardiography, parasternal long-axis view)
2. Contraindicated to systemic anticoagulation
3. Left ventricular ejection fraction ≤40%
4. Concomitant with left atrium or left atrial appendage emboli
5. Concomitant with a coronary or valvular disease that indicates intervention
6. Ischaemic stroke within 2 months
7. Previous ablation history
8. Uncontrolled hyper/hypothyroidism
9. End-staged kidney failure
10. Concomitantly involved in other trials
11. Pregnant or breastfeeding, or women of childbearing age not using a reliable contraceptive method
12. Concomitant with bacteremia or at an active phase of infection
13. Anatomically not suitable for thoracoscopic surgery(history of chest surgery or radiotherapy, etc.)
14. Unwilling or unable to comply with all peri-ablation and follow-up requirements
Antithymocyte Globulin in Treating Patients Undergoing Stem Cell Transplant for Multiple Myeloma

RATIONALE: Biological therapies, such as antithymocyte globulin, may stimulate the immune system in different ways and stop cancer cells from growing.

PURPOSE: This phase II trial is studying how well antithymocyte globulin works in treating patients undergoing stem cell transplant for multiple myeloma.

OBJECTIVES:

Primary

* Determine the response rate at 4 weeks in patients with multiple myeloma treated with anti-thymocyte globulin at least 4 to 6 weeks prior to undergoing conditioning therapy for allogeneic or autologous stem cell transplantation.

Secondary

* Determine the toxicity of this drug, in terms of formation of antirabbit antibodies, in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive anti-thymocyte globulin IV over 6 hours on day 1 and over 4 hours on days 3 and 5. Treatment begins 4 to 6 weeks prior to undergoing conditioning therapy for autologous or allogeneic stem cell transplantation.

After completion of study treatment, patients are followed at 28 days.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed multiple myeloma
* Candidate for autologous or allogeneic stem cell transplantation within 1 to 3 months after study treatment
* Measurable disease, defined as serum monoclonal protein ≥ 1 g/dL OR urinary light chain excretion = 500 mg/24 hours
* No malignant CNS disease

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 6 months
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count \> 50,000/mm³
* Creatinine ≤ 2 mg/dL
* Hepatic function ≤ 2 times upper limit of normal
* DLCO ≥ 50%
* No active infection
* No hypersensitivity to rabbit proteins
* No symptomatic hyperviscosity syndrome
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

* More than 28 days since prior chemotherapy, including prednisone (20 mg equivalent/day)
* No prior anti-thymocyte globulin
* No concurrent radiotherapy
Exploring the Experience of Using a Prayer Mobile App

The goal of this clinical trial is to explore the feasibility and preliminary effects of using Pray.com on spiritual well-being and mental health symptoms in racial/ethnic minority adults. The main question it aims to answer is: What are the feasibility and preliminary effects of using Pray.com on spiritual well-being and mental health (stress, depressive and anxiety symptoms) in racial ethnic minority adults (i.e., individuals who identify as Black/African American, Latinx/Hispanic, Asian/Pacific Islander, Native American, or Multiracial)?

Participants will be given the Pray.com app and directed to use it daily. Participants will complete measures at baseline (i.e., time 1) and four-weeks (i.e., time 2). A smaller subset of participants will be asked to participate in a qualitative interview.

Participants (N = 75) will be recruited through social media and various Christian organizations that serve racial/ethnic minorities. Participants will be over the age of 18 and identify as a racial/ethnic minority (i.e., individuals who identify as Black/African American, Latinx/Hispanic, Asian/Pacific Islander, Native American, or Multiracial). Participants also must be willing to participate in a study that involves engaging in a regular Christian religious practice and are willing to download the Pray.com app.

Eligible participants will be given the Pray.com app and directed to use it daily. Participants will complete measures at baseline (i.e., time 1) and four-weeks (i.e., time 2). At the end of the study participants will be randomly asked to participate in an interview (N = 15) which will take no longer than 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Identify as a racial/ethnic minority (e.g., Black/African American, Latinx/Hispanic, Asian/Pacific Islander, Native American, Multiracial).
* Own a smart phone and be willing to download a mobile app.
* Willing to engage in a Christian-based religious practice on a mobile app.

Exclusion Criteria:

* n/a