cyrilzakka/clinical-trials huggingface dataset:
Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption

This study is intended to quantify the effect of food on the extent of absorption of palbociclib.

The caloric content of the food and the time of the meals with respect to palbociclib administration may influence the capacity of the body to absorb the drug.

High and low calorie meals will be given to the subjects 30 minutes before palbociclib administration as 2 of the 3 conditions to compare with completely absence of food in the body when dosing (fasted).The third condition to test and compare with fasted stage will be the administration of food before and after palbociclib administration.

This information will help the program to decide wether or not the presence of food when dosing palbociclib help with its absorption and to what extent it does help. Based on the collected information, a recommendation about the administration of palbociclib with food will be provided to patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study
* Subjects who are willing and able to comply with all 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
* Any condition possibly affecting drug absorption
* Male subjects who are unwilling or unable to use a highly effective method of contraception
Efficacy of Prophylactic Negative Pressure Wound Therapy (NPWT)

The role of prophylactic negative pressure wound therapy (NPWT) is promising in reducing wound-related complications. However, the prophylactic use of NPWT in reducing wound complications in patients who underwent conventional open harvesting of the great saphenous vein has been under-investigated compering with other surgical approaches.

Therefore, this study aims to assess the effect size of the prophylactic NPWT in preventing wound dehiscence in high-risk patients who underwent conventional open harvesting of the great saphenous vein as a conduit for coronary artery bypass.

The study design is a prospective, randomized, controlled, and monocentric trial. The primary endpoint is given by the reduction of wound dehiscence as a dichotomic outcome (yes versus no).

More precisely, in the experimental group, we will use the proposed device PICO7 (NPWT); this device is certificate CE. PICO consists of a single-use (i.e., completely disposable) NPWT unit, canister, and dressing that are designed for application over clean, closed, sutured, or stapled incisions in a simple peel-and-place process. Instead, in the control group, patients will receive standard care.

Finally, patients eligible to be enrolled in this study will be blindly randomized using for the arm allocation (allocation 1:1). Randomization should take place as soon as possible after consent. Patients will be randomized on a 1:1 basis to receive either dressing.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged ≥ 50 years)
* Diagnosis of Diabetes (both type 1 and 2) as comorbidity with anamnesis during the last year of poor glycemic control (HbA1C \>7.5%)
* BMI ≥ 25 Kg/m2

Exclusion Criteria:

* Cognitive impairment
* Anamnesis of non-heling wounds
* Wagner grade 2-5 foot wound
* Osteomyelitis
* Pregnancy
* Contraindication to use PICO7 described previously.
Post-MI PET Scan Imaging of Inflammation

Restoring the patency of the coronary vessels and providing the ischemic myocardium with reperfused blood can cause additional tissue damage. A key element of ischemia and reperfusion (I/R) injury and major determinant of the evolution of damage in the affected myocardium is the inflammatory response. The main objective of the study is to evaluate the efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory response in the reperfused myocardium.


Eligibility Criteria:
Inclusion Criteria:

* The study will enroll patients 18 years old or older
* Who presented to the hospital within twelve (12) hours of the onset of chest pain -Who had ST segment elevation \> 1 mm in two contiguous limb leads or ST segment elevation \> 2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels.

Exclusion Criteria:

* Excluded patients:

  * with age \> 80 years old
  * with active inflammatory diseases, infectious diseases or known malignancy
  * under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents
  * with known hypersensitivity-allergy to colchicine
  * under chronic treatment with colchicine
  * with severe renal failure (eGFR \< 30 ml/min/1.73 m2)
  * with hepatic failure (Child - Pugh class B or C)
  * presented with cardiac arrest
  * presented with ventricular fibrillation
  * presented with cardiogenic shock
  * with stent thrombosis
  * with angina within 48 hours before infarction
  * with previous myocardial infarction in the affected territory
  * with occlusion of the left main or left circumflex coronary or the right coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)
The Application of a Mental Practice Protocol in the Acute Inpatient Rehabilitation Setting

The purpose of this randomized controlled trial is to compare the effect of audio-guided mental practice (MP) and video-guided MP on the impairment and functional abilities of upper extremity (UE) hemiparesis following a stroke. Participants are recruited from Adventist Healthcare Rehabilitation Hospital. All participants must be less than one-month post-stroke with moderate UE hemiparesis. Eligible participants are randomly assigned to an experimental group, (MP or repetitive-task practice (RTP)), or the control group.

The MP groups will perform either audio-guided MP or video-guided MP, five days a week, with 20 repetitions of the following tasks: wiping a table, picking up a cup, brushing hair, and turning the pages of a book. The RTP group physically performed the same tasks. The control group received traditional stroke rehabilitation.

The investigators hypothesize that video MP will have greater improvements in UE impairments and functional abilities than audio MP, RTP, and/or traditional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of stroke
* Less than one-month post-stroke
* Hemiparesis of one upper extremity
* Moderate upper extremity impairment

Exclusion Criteria:

* History of prior stroke
* Comorbidities (severe neurological, orthopedic, rheumatoid, or cardiac impairments)
* Severe spasticity
* Severe cognitive impairments
* Inability to perform mental imagery
* Severe aphasia based on speech therapist evaluation
* Low English proficiency
* Severe pain
Sleep Habits and AMI and Gensini Score

This study was to examine the effects of sleep habits on acute myocardial infarction (AMI) risk and severity of coronary artery disease (CAD) in Chinese population from two centers. A total of 873 patients were recruited from the inpatient cardiology department of the Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical University. Investigators used a 17-item sleep factors questionnaire (SFQ) to evaluate sleep habits comprehensively by face-to-face interview.

Growing evidence indicates that poor sleep harms health. Early to bed and early to rise is considered as a healthy lifestyle in Chinese population. The current study aimed to examine the effects of sleep habits on acute myocardial infarction (AMI) risk and severity of coronary artery disease (CAD) in Chinese population from two centers. A total of 873 patients including 314 with AMI were recruited from the inpatient cardiology department of the Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical University. 559 controls included 395 CAD cases and 164 non-CAD cases. Investigators used a 17-item sleep factors questionnaire (SFQ) to evaluate sleep habits comprehensively by face-to-face interview. The severity of CAD was assessed by Gensini score in AMI and CAD groups. The effects of sleep factors on AMI risk and Gensini score were examined by unconditional logistic regression. The timing of sleep (24:00 and after), sleep duration (\<6h) and frequency of night-time waking (3 times) increased the risk of AMI. In subjects with age ≤60 years, daytime napping reduced the risk of AMI. The correlation between sleep quality and AMI became insignificant after subgroup analysis by age. Short sleep duration also increased the risk of high Gensini score.

Eligibility Criteria:
Inclusion Criteria:

1. underwent coronary angiography;
2. can complete sleep factors questionnaire.

Exclusion Criteria:

1. mental diseases;
2. sleep apnea;
3. chronic obstructive pulmonary disease;
4. stroke sequelae;
5. arthritis;
6. renal failure;
7. tumor and a history of revascularization.
Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings

Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Both gender ≥ 18 years old
* From Medium to High exuding wound

Exclusion Criteria:

* Known allergy or hypersensitivity to any of the treatment dressings
* Pregnant or lactating females
* Subjects with a target wound that is ≤1 cm2
* Subjects with a target wound that is a full thickness burn
* Subjects with a target wound that is a full thickness pressure ulcer
* Subjects with known immunodeficiency
* Subject taking systemic antibiotics for wound infection
* Subject were the target wound is located on an infected limb interfered by minimal blood flow in the opinion of the investigator
* Subject with a target wound with unexplored enteric fistula
* Subjects who in the opinion of the investigator, will have problems following the protocol
* Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
* Previously enrolled in the present investigation
* Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
* Involvement in the planning and conduct of the clinical investigation
Aveir DR i2i Study

Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.

The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker.

Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have at least one of the clinical indications before device implant in adherence with ACC/AHA/HRS/ESC dual chamber pacing guidelines
2. Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
3. Subject has a life expectancy of at least one year
4. Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams
5. Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC

Exclusion Criteria:

1. Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor
2. Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period
3. Subject has presence of anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could confound the assessment of the investigational device and/or implant procedure, limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results
4. Subject has a known allergy or hypersensitivity to \< 1 mg of dexamethasone sodium phosphate or any blood or tissue contacting material listed in the IFU
5. Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis
6. Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)
7. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device
8. Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular leadless pacemaker)
9. Subject is implanted with an electrically-active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)
10. Subject is unable to read or write
Effect of Erchonia Laser on Erectile Dysfunction

This study is to see if applying low-level laser light can provide improvement in erectile dysfunction

The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing improvement in erectile dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Male between 40 and 80 years old
* Known or suspected vasculogenic ED based on clinical history
* In an active sexual relationship with a minimum of 2 sexual attempts per month for at least one month prior to enrollment
* Suffering from ED for at least 6 months
* Testosterone level between 300 - 1000ng/dL within one month prior to enrollment
* Hgb A1C less than or equal to 8% within one month prior to enrollment
* Total IIEF-EF scores between 8-25
* EHS score greater than or equal to

Exclusion Criteria:

* ED due to radical prostatectomy, prior pelvic surgery, or radiation therapy to the pelvis within 12 months prior to enrollment
* Men with known neurogenic or psychogenic ED
* Anatomic malformations of the penis including Peyronie's disease
* Testosterone greater than 300ng/dL or 1000ng/dL
* Hgb A1C greater than 8%
* International Normalized Ratio greater than 2.5, and men on any blood thinners other than 81mg aspirin
* Active testicular or prostate cancer
Endomysial Fibrosis, Muscular Inflammatory Response and Calcium Homeostasis Dysfunction in Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is the most common and devastating form of muscular dystrophy, caused by an X-chromosome gene mutation resulting in the absence of the protein dystrophin. Gene therapy by exon skipping or stop codon read-through and cell therapy are at the stage of clinical assays with very promising results. Nevertheless, they will not allow a complete cure of DMD patients and they will concern only specific types of mutations. It is therefore crucial to develop other therapeutic strategies related to the natural history of the disease and targeted not on the dystrophin itself, but on the consequences of its absence.

Another crucial pathophysiological pathway in DMD is muscle cell calcium homeostasis, particularly via the ryanodine recepteur (RyR1).

Our study focus on the relationship between endomysial fibrosis, abnormal inflammation response and calcium homeostasis dysfunction which are not entirely established in DMD.

The identification of the biological mechanisms that play a role in the severity of the phenotype, particularly endomysial fibrosis, should allow the development of targeted pharmacotherapy as a complementary strategy for the future treatment of DMD.


Eligibility Criteria:
Inclusion Criteria:

* Boy between 2 to 15 years old.
* Lack of any infectious disease in the last week before the study.
* Consent form signed by parents.

Inclusion Criteria for DMD infant

* Clinical suspicion of Duchenne Muscular Dystrophy

Inclusion Criteria for Control healthy Infant

* Lack of any antecedent of congenital cardiac, pulmonary or muscular disease including DMD.

Exclusion Criteria:

* Subjects who are unable or unwilling to tolerate study constraints
* Parents of the subject unable or unwilling to undergo informed consent
* Subject with no rights from the national health insurance programme
Determine the Effect of Intraocular Pressure (IOP), Optic Nerve Imaging, Venous Congestion in Volunteers Prone Position 5 Hours

The purpose of this study is to provide data that would give the investigators a better understanding of the physiologic changes that occur and may contribute to post operative blindness. An improved understanding may lead to the development of protocols or devices that reduce the chance of catastrophic visual loss.

Post operative vision loss resulting from nonocular surgery is a devastating, poorly understood and potentially preventable complication. Ischemic optic neuropathy, affecting both the anterior or posterioir portions of the optic nerve, is the most common cause of postoperative vision loss(POVL). Other, less common causes include retinal artery occlusion, retinal vein occlusion, retinal embolism, and cortical blindness. The estimated incidence of POVL in patients undergoing general anesthesia is 1/60,000. The incidence dramatically increases in cardiopulmonary bypass and prone spine surgery with estimates at 1/1600 and 1/1100, respectively. The etiology is unknown but it is thought to be multifactorial, and several potential risk factors have been identified, including degree of hypotension, preoperative hematocrit, external compression of the eye, blood loss and prone position. The investigators are proposing eight volunteers in two different sessions of 5.5 hours each. The first session the volunteer will lie prone of the flat Jackson table and the second session the volunteer will spend 5 hours prone on the Jackson table with a table elevation of 6 inches. The following measurements will be done: Intraocular Pressure (IOP) with a device called the Tonopen-XL, the Nidex NM 200 to visualize the retinal optic nerve imaging, refractometry, ultrasound, corneal thickness pachymetry, measurement of proptosis, measurement of pupillary reflex, The volunteers do not receive anesthetic medications or intravenous fluids and will provide a baseline for comparision with patients enrolled in the prospective study.

Eligibility Criteria:
Inclusion Criteria:

* subjects willing to consent

Exclusion Criteria:

* individuals unable to tolerate prone position for 5 hours
* individuals unable to tolerate contact lens placement
* females who are pregnant
* individuals with a sensitivity to proparacaine hcl 0.5% or tropicamide 1%
* individuals who are unable to have repeated mesaurements of intaocular pressure
Developing Artificial Intelligence-based Algorism to Predict Side Effects and Symptoms From Chemotherapy

In this study, the investigators obtain wearable disease based biomarkers from patients diagnosed with cancer and undergoing chemotherapy, and simultaneously measure patient self-reported adverse events through an app to evaluate chemotherapy completion rates, emergency room visits, and frequency of CTCAE adverse events.

The investigators will develop an artificial intelligence-based algorism that can predict patients' side effects based on biomarkers alone.

In this study, patients diagnosed with lung, head and neck, and esophageal cancers and undergoing chemotherapy will be measured for self-reported side effects using a wearable device to collect biomarkers through an app, and the association between patient quality of life and side effects and biomarkers obtained from the wearable device will be analyzed. On the other hand, blood (EDTA 3cc) for pharmacogenomics testing will be tested once at any point during the study period as an indicator associated with side effects after chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 20 years of age or older
* Must have diagnosed with lung, head and neck, or esophageal cancer,

  1. scheduled to receive their first treatment in preoperative or postoperative chemotherapy.
  2. scheduled for systemic chemotherapy due to recurrence or metastasis.
* Eastern Cooperative Oncology (ECOG) performance status of 0 to 2.
* Patients who have access to a smartphone and can use the mobile app on their own.
* Understand the purpose of the study and agree to participate in the study.

Exclusion Criteria:

* Patients who, in the judgment of the researcher, have difficulty using the application.
* Patients who are judged by the medical staff to be unable to participate in the study.
Compare Different Response Evaluations to Neoadjuvant Chemotherapy for Gastric Cancer

RATIONALE: Neoadjuvant chemotherapy has been proved effective for locally advanced gastric cancer, yet the best pattern of response evaluation remain unknown.

PURPOSE: Compare different pattern of response evaluation for Gastric Cancer.

OBJECTIVES: I. Find the best pattern for response evaluation for gastric cancer. II. Assess the factor associated with this pattern.

OUTLINE: Neoadjuvant chemotherapy.

PROJECTED ACCRUAL: Up to 150 patients will be accrued over approximately 2 years.

Eligibility Criteria:
Inclusion Criteria:

* sign written informed consent form
* age ≥ 18 years
* pathologically confirmed gastric or GEJ adenocarcinoma
* disease at clinical stage of locally advanced gastric cancer by CT/EUS(cT2+NanyM0)
* No prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
* Adequate organ function as defined below:

Hematologic ANC ≥ 1.5\*109/l Hemoglobin ≥ 9 g/dl Platelets ≥ 100\*109/l Hepatic Albumin ≥ 30g/l Serum bilirubin ≤ 1.5×ULN AST and ALT ≤ 2.5×ULN ALP ≤ 2.5×ULN TBIL ≤ 1.5×ULN Renal Serum Creatinine \< 1.5 ULN

* KPS ≥ 70
* Adequate lung and heart function
* Negative serum or urine pregnant test within 7 days prior to randomization for child-bearing age women
* Sexually active males or females willing to practice contraception during the study until 30 days after end of study.

Exclusion Criteria:

* Refuse to provide blood/tissue sample；
* With distant metastasis diagnosed by CT/EUS；
* Sexually active males or females refuse to practice contraception during the study until 30 days after end of study.
* History of organ transplantation（including autologous bone marrow transplantation and Peripheral stem cell transplantation）；
* Prior long term steroid therapy (excluding short term steroid treatment which is completed prior to \> 2 weeks of study enrollment)；
* Patients with central nervous system(CNS) disorder or peripheral nervous system disorder or psychiatric disease；
* Concurrent severe infection；
* Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety (including current active hepatic, biliary, renal, respiratory disease, uncontrolled diabetes hypertension et al)；
* History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible；
* Known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, or congestive heart failure, or cardiac infarction within 6 months prior to study enrollment, or cardiac insufficiency；
* Person with no capacity (legally) or inappropriate to continue study treatment for ethics/medical reasons.