cyrilzakka/clinical-trials huggingface dataset:
Influenza Vaccination in Cancer Patients

The purpose of this study is to determine the timing of influenza vaccination to induce higher antibody response in adult patients with non-hematologic malignancies receiving scheduled cytotoxic chemotherapy.

The participants will be stratified by the age (cut off; 60 years old) and last year influenza vaccination, and block-randomized to 2 groups; Day 1 vaccination group and Day 11 vaccination group.

Day 1 group will be vaccinated at Day 1, when the cycle of chemotherapy begins. Day 11 group will get the vaccine at Day 11, 10 days after chemotherapy begins.

As the rate of completion of study in the Day 11 group is anticipated lower than Day 1 group, we will assign the participants into Day 1: Day 11 with the different ratio; 4:5.

Hemagglutination inhibition Ab titre at pre-vaccination and post-vaccination (21-28 days after vaccination) will be examined in all participants.

All the participants will be asked if they have any contraindication for influenza vaccine by a physician before vaccination. And they will be monitored for any adverse reaction of the vaccination after 2-4 days(phone calling) and after 21-28 days (visiting the hospital).

Eligibility Criteria:
Inclusion Criteria:

1. Patients who receive the scheduled cytotoxic chemotherapy every 3 weeks because of solid cancer.

   Specific definition of each term is like following:
   * The solid cancer includes various kinds of cancer except hematologic and lymphoid malignancies.
   * Cytotoxic chemotherapy includes adjuvant, neoadjuvant or palliative purpose of chemotherapy with the planned duration at least over 3 cycles every 3 weeks.
   * Targeted therapy drugs like as monoclonal antibody, tyrosine kinase inhibitor or oral chemotherapy drugs like as Xeloda are excluded.
2. Patients who did not receive the influenza vaccination yet in the current year.
3. Older than 19 years
4. Eastern Cooperative Oncology Group (ECOG) performance status is 0, 1, or 2
5. Cell blood count meets following criteria:

   * Neutrophile count ≥ 1.5 x 10\^9/L
   * Platelet count ≥ 100 x 10\^9/L
   * Hemoglobin ≥ 8 g/dL
6. Patients who can understand and agreed with the informed consents.

Exclusion Criteria:

1. Patients who have any contraindication for influenza vaccination.
2. Patients who are supposed to receive the last chemotherapy at the enrollment
3. Patients who receive simultaneous radiation therapy with cytotoxic chemotherapy
4. Patients who receive any immunosuppressant (excluding steroid for anti-emetic effect)
5. Patients with HIV and low CD 4+ T cell count (\< 500/uL)
6. Patients with autoimmune disease who are anticipated to have a problem with immunogenicity for vaccine
7. Patients who have transplanted organ and receive immunosuppressants
8. Patients who are supposed to get prophylactic G-CSF after chemotherapy
9. Patients who are suspected to have active infectious disease.
Effects of Far Infrared Radiation on Fibromyalgia Patients

This study aimed to evaluate the effectiveness of infrared radiation in improving the various symptoms of fibromyalgia syndrome, by using a long-sleeved white shirt impregnated with a long-infrared irradiating bioceramic, as well as the adherence to it and its applicability in daily routines.

A prospective, experimental, randomized, and double-blind study was carried. The study was implemented over 7 months, with a total of 5 visits for each patient. Participants were randomly allocated in experimental or control group. Those included in the experimental group received a shirt impregnated with ceramic emitting long infrared waves while participants in the placebo group received an exactly looking shirt, but not impregnated with ceramic emitting long infrared waves. Each visit comprised clinical evaluation and self-report scales filling (WPS, SS and FIQR scales).


Eligibility Criteria:
Inclusion Criteria:

* age superior to 18 years-old
* ability to freely sign the informed consent form
* generalized pain index scores (WPI ≥ 7 and SS score ≥ 5, or WPI ≥ 3 and ≤ 6 with SS ≥ 9, presence of abdominal pain and / or with depression and / or headache, in the last 6 months, at the screening consultation).

Exclusion Criteria:

* dermatological diseases
* Other rheumatic and /or autoimmune diseases
Smart-glasses During the US-guided Radial Arterial Catheterization in Pediatric Patients: a RCT

The primary objective of the study is to evaluate the effect of smart glasses (Head-mounted display Moverio BT-300 (Epson Inc., USA)) on the first-attempt success rate of radial artery cannulation in pediatric patients. This study hypothesizes that the use of smart glasses improves the hand-eye coordination and the first-attempt success rate of radial artery cannulation. This is a single-center, randomized, placebo-controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the radial arterial cannulation in pediatric patients undergoing general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* General anesthesia
* Arterial cannulation for hemodynamic monitoring, multiple blood sample

Exclusion Criteria:

* Unstable vital sign, significant arrhythmia or hypotension, Shock
* High risk of peripheral ischemia
* Skin disease, infection, hematoma, recent cannulation at radial artery
PROMUS Element Plus US Post-Approval Study

This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.

The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length. The proposed study will compile real-world clinical outcomes data for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

Patients enrolled in this study are expected to follow antiplatelet therapy recommendations per American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines for percutaneous coronary intervention (PCI). Recommended medications include aspirin, which should be taken for 3 days prior to the procedure or as a peri-procedural loading dose and then continued indefinitely. Additionally, one of the following P2Y12 antagonists may be given in a peri-procedural loading dose and in a maintenance dose per physician discretion: clopidogrel, prasugrel, ticagrelor, or ticlopidine.

Eligibility Criteria:
Inclusion Criteria:

* The population will include consecutive, consented patients.

Exclusion Criteria:

* There are no exclusion criteria in this all-comers study.
Enhancing Resilience in Senior Community Residents

This randomized waitlist-controlled trial tests the efficacy of the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP), a mind-body intervention, to enhance resilience and flourishing among residents in continuing care retirement communities. The investigators hypothesize that participants in the SMART-3RP group will report greater increases in resilience and flourishing relative to participants in the control group.

This randomized control trial tests the efficacy of the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP) to improve resilience and flourishing among older adults residing in continuing care retirement communities relative to a wait-list control group. At enrollment, participants will be randomly assigned to the intervention group or the control group using computer generated 1:1 blocked randomization stratified by community site. The intervention group will receive the SMART-3RP program immediately upon enrollment; the wait-list control group will be invited to receive the SMART-3RP program after the final survey time point. An estimate of 360 participants will be recruited from up to nine geographically diverse Erickson Senior Living communities.

Eligibility Criteria:
Inclusion Criteria:

* Resident of an Erickson Senior Living community
* Currently residing in an Erickson Senior Living apartment home
* Sufficient English language skills to participate in study procedures

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Unable or unwilling to participate in in-person group sessions
Combined Exercise and Nutrition Intervention for Sarcopenia

This study aims to demonstrate the effect of combined exercise-nutrition intervention in old adults with sarcopenia. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-nutrition intervention with conventional medical care. Handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA, quality of life, activities of daily living, sarcopenia screening questionnaire, nutritional assessment will be evaluated on baseline, 12-weeks and 24-weeks after intervention

The definition of sarcopenia is age-related loss of skeletal muscle and physical functions.

Sarcopenia is emerging health problem and increases medical expenditure as the population ages. Sarcopenia is closely related to chronic diseases and geriatric diseases.

In particular, patients with hip fracture showed a high prevalence of muscle loss and muscle weakness.

It has been reported exercise in sarcopenia patients helped the treatment of the diseases.

Also, it is recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients.

However, there is still not established standard protocol for the combined exercise-nutrition intervention.

Therefore, the aim of this trial is to compare the effects of combined exercise nutrition intervention in sarcopenia patients with multicenter, multidisciplinary, randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 65 years and under 90 years
* patients who meet the criteria for the Asian Working Group for Sarcopenia (AWGS) 2019
* patients who had metabolic syndrome

Exclusion Criteria:

* patients with less than estimated glomerular filtration rate (eGFR) 30
* patients with musculoskeletal or chronic lung disease incapable of exercise
* patients with untreated or uncontrolled cardiovascular disease which may affect muscle mass or performing exercise
* patients less than 5 years after treatment of malignant tumor
* patients with liver cirrhosis, diabetes and other chronic disease
* patients who cannot perform combined exercise nutrition intervention for other reasons
EEG & Behavioral Predictors of Changes in Smoking Trajectories in Young Light Smokers

The purpose of the proposal is to identify new predictors of smoking progression in young light smokers (YLS: 18-25 years \& cpd \< 5) using an 18-month longitudinal design and to relate these predictors of progression to the genetic profile most highly associated with smoking progression. A number of novel predictors will be assessed in 128 YLS. Predictors will include individual differences (IDs) in EEG, reward sensitivity, attentional performance, and mood during abstinence and in response to standardized and to self-selected acute nicotine doses (ANIC), as well as genetically influenced affective traits, and smoking history. The associations of a compelling genetic functional variant polymorphism, rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking progression and the novel predictors. The study is expected to provide insights into IDs in mechanisms and predictors that contribute to smoking trajectories in YLS and thereby lead to targeted pharmacotherapy and behavioral interventions for at-risk YLS.

The purpose of the proposal is to identify new biobehavioral endophenotypes that predict smoking progression in young light smokers (YLS: 18-25 years \& cpd \< 5) using an 18-month longitudinal design and to relate these endophenotypes and progression to the genetic profile most highly associated with smoking progression. A number of novel predictors will be assessed in 128 YLS. Predictors will include individual differences (IDs) in EEG, reward sensitivity, attentional performance, and mood during abstinence and in response to standardized and to self-selected acute nicotine doses (ANIC), as well as genetically influenced affective traits, and smoking history. The associations of a compelling genetic functional variant polymorphism, rs16969968, in the alpha5 nicotinic receptor subunit will also be related to smoking progression and the novel predictors. The study is expected to provide insights into IDs in mechanisms and endophenotypes that contribute to smoking trajectories in YLS and thereby lead to targeted pharmacotherapy and behavioral interventions for at-risk YLS.

Eligibility Criteria:
Inclusion Criteria:

* smokers of 3 to 30 cigarettes per week for past 6 months

Exclusion Criteria:

* Smoking fewer than 3 or more than 30 tobacco cigarettes per week
* Never smoked more than 30 cigarettes per week
* Psychoactive drug use other than caffeine or occasional marijuana
* Current serious psychiatric diagnosis (e.g., major depressive disorder)
* Recent drug dependence
* Left-handed
* Color blind
Survey and Reduction of Mortality in Peridialysis Uremic Patients Via Intervention of Risk Factors

In patients with non-dialysis-dependent end stage kidney disease (ESKD) the common transition of care to renal replacement therapy is dialysis. Each year over 70 000 Chinese transition from non-dialysis-dependent ESKD to dialysis. Whereas dialysis therapy is intended to be life-sustaining, ESKD patients have a 10-fold or higher risk of death compared with the general population. Mortality rates are even higher upon transition and in the first year, especially in the first 3 to 6 months following the transition to dialysis, yet it remains unknown which is the contributing cause of this high death rate. Hence, there is an urgent need to examine the emerging field of Transition of Care in ESKD. We suggest the term "peridialysis period" for this transition period for ESKD patients, so that the transition of care from non-dialysis-dependent ESKD to dialysis ESKD can be more pragmatically defined and studied. In the current study, we will investigate the mortality and its risk factors of ESKD patients during peridialysis period, and improve the survival rate and quality of life of peridialysis ESKD patients by intervening the risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with end stage kidney disease (eGFR\<15ml/min/1.73m2) or newly started dialysis with 3 months at all hospitals in Yangzhou, China since January 1, 2016

Exclusion Criteria:

* Patients who have had a history of dialysis and have been transferred to Yangzhou during this period;
* patients who are transferred to a dialysis area outside Yangzhou City
* Patients who give up dialysis treatment
* patient whose renal function recover and stop dialysis treatment;
* Patient who receive kidney transplantation
Phase II/III Study of Anti-VEGF in Neovascular AMD

The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD

This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center, by percentage of classic CNV vessels: \[predominantly classic (\>50%) vs. minimally classic (1-49%) vs. purely occult (0%)\], and according to whether, or not, they have received prior PDT with Visudyne (no more than once). All patients will be re-randomized after 54 weeks of treatment to either, continue or discontinue therapy for further 48 weeks.

Eligibility Criteria:
Patients of either gender, aged 50 years or above, diagnosed with subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye, may be enrolled. Clinically significant concomitant diseases will be excluded.
Effect of Intradialytic Electrical Muscle Stimulation and Passive Leg Mobilisation on Blood Pressure and Dialysis Efficacy

Hypothesis: Intradialytic blood pressure and dialysis efficacy (in terms of urea removal) improve under electrical muscle stimulation or passive leg movement on a treadmill.


Eligibility Criteria:
Inclusion Criteria:

* Dialysis patients able to put legs on a treadmill

Exclusion Criteria:

* Dialysis duration shorter than 3 months
The Role of Patient Expectations in Traumatic Orthopedic Outcomes-TEFTOM EURASIA

Design:

Prediction trial, up to 10 sites in Asia and Europe

Goal:

To better understand the "success" or "failure" after orthopedic trauma surgery by developing a model that can be applied clinically as a user-friendly "baseline" questionnaire - capable of predicting "success" or "failure" based on a patient's pre-surgical expectations of their final outcome and to validate a novel outcomes measure (TOM).

Primary aim:

To assess the psychometric properties of predictive validity, internal consistency and reproducibility of the trauma expectation factor (TEF) in the Eurasian population.

Secondary aim:

To assess the psychometric properties of criterion validity, internal consistency,reproducibility, and sensitivity to change of the TOM in the Eurasian population.

Key questions related to patient and surgeon expectations:

* How different, or similar, are patient and surgeon expectations?
* Do expectations change over time?
* Do patient expectations predict outcomes in validated measures use today?


Eligibility Criteria:
Inclusion Criteria:

* Isolated ankle or distal tibia fracture
* Scheduled for and undergoing one of the following surgeries for their fracture:

  * Open fracture and internal fixation (ORIF)
  * external fixation (EF)
  * EF followed by ORIF
* 18 years of age or older
* Understand and read country national language at elementary level
* Able to understand the purpose of the clinical trial,
* Able and willing to conduct all follow-up visits
* Signed informed consent

Exclusion Criteria:

* Subject has previously undergone internal fixation surgery for this ankle/distal tibia fracture.
* Subject has disease entity, or condition that precludes likelihood of bony union (e.g., metastatic cancer, metabolic bone disease).
* Subject has severe dementia or other severe mental health problem that may preclude him/her from completing study questionnaires.
* Subject is participating in other competing clinical research that may interfere with participation in this research.
* Subject is unlikely to attend study related follow-up visits.
* Subject has poly-trauma (more than one organ system compromised)
* Subject has additional fracture(s) other than ankle fracture
* Subject is a prisoner
* Fracture occurred more than 28 days before surgery
A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension

To compare the intraocular pressure(IOP)-lowering efficacy of morning or evening instillations of a combination IOP-lowering therapy in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Adult patients of any race and either sex with open angle glaucoma or ocular hypertension.
A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy

The ARCH study is an open-label, single-center, Phase 1b study of sevasemtem (EDG-5506) to assess the safety and pharmacokinetics (PK) of sevasemten in adults with Becker muscular dystrophy (BMD).

Sevasemten is an investigational product intended to protect and improve function of dystrophic muscle fibers.

This open-label study will evaluate the safety, tolerability, and pharmacokinetics (PK) of sevasemten in participants with BMD who completed the first-in-human study, EDG-5506-001, as well as additional (treatment-naïve) participants from outside the EDG-5506-001 study to meet the target sample size.

All participants will receive sevasemten. On-site visits will occur approximately monthly for the first 12 months, followed by every 3 months to assess safety and measures of function. This study will have a 24 month treatment period, followed by a 4 week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who have completed Study EDG-5506-001.
2. Participants who were not from Study EDG-5506-001 must meet the following:

   1. Male sex at birth and aged 18 to 55 years inclusive at time of consent.
   2. Documented dystrophin mutation with phenotype consistent with BMD.
   3. Ambulatory at Screening (defined as ability to complete 100 meter \[m\] timed test, with or without assistance).
   4. Body weight ≥ 50 kg at the Screening visit.
   5. Body mass index (BMI) between 20 and 34 kg/m2 inclusive.

Exclusion Criteria:

1. Receipt of oral corticosteroids for \>5 days in the previous 6 months at a dose of \>5 mg equivalent per day. Lower oral doses or inhaled/intranasal steroids are permitted.
2. Receiving moderate or strong cytochrome P450 CYP3A4 inhibitors or inducers.
3. Participation in any other investigational drug study or use of use of an investigational drug within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.
4. Medical history or other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory result or abnormality that may increase the risk of study participation or, in the Investigator's judgment, make the participant inappropriate for the study. Includes venous access that would be too difficult to facilitate repeated blood sampling.
Rapid HIV Testing Program in the Emergency Department

The purpose of the study is to evaluate the feasibility of a rapid HIV testing program in the Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing program in the TUH Emergency Department is feasible. Patients presenting to the Adult TUH Emergency Department with certain conditions will be offered rapid HIV testing. Testing will be performed by oral swab using the OraQuick Advance test. Patients will receive post-test counseling.


Eligibility Criteria:
Inclusion Criteria:

One of the following conditions:

* Sexually transmitted disease evaluation or prior history of sexually transmitted disease
* Pregnancy
* Clinical condition that suggests possible immunodeficiency
* History of illicit drug use
* History of chronic viral hepatitis
* Patients with unexplained pneumonia or recurrent pneumonia
* Male patients who have a history of sex with men
* Abdominal pain in a sexually active woman or urethritis in a man
* Trauma.
* Age 18 years old or older.

Exclusion Criteria:

* Age less than 18 years.
* None of the above conditions.