cyrilzakka/clinical-trials huggingface dataset:
Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil

The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics.

This open-label study will evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics following a single 1 mg oral dose of UT-15C SR in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening.
* Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
* Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.

Exclusion Criteria:

* Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
* Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
* Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.
Effect of Preoperative Anxiety on Postoperative Delirium in Elderly Patients Undergoing Orthopaedic Surgery.

Postoperative delirium is a common and important complication in patients. The aim of this study was to investigate whether preoperative anxiety predicted onset of postoperative delirium in elderly patients undergoing orthopaedic surgery, so as to help develop preventive approaches.


Eligibility Criteria:
Inclusion Criteria:

* aged 65 or older
* patients undergoing elective orthopaedic surgery
* ASA I-III

Exclusion Criteria:

* history of craniocerebral trauma surgery or severe central nervous system disease
* inability to read or understand the informed consent documents
* too physically or psychologically ill
The Analgesic Effect of Nitroglycerin Patch for Postoperative Pain After Total Knee Replacement

Patients who undergo general anestheesia for total knee arthroplasty pften have sever postoperative pain which hinders their rehabilitation. Nitroglycerin patches have been found to cause alleviation of pain especially when used in conjuction with morphine. Therefore we propose placement of a nitroglycerin patch after total kneee arthroplasty surgery and see how it affects pain scores or causes less nedd for morphine after surgery.

Patients undergoing total knee arthroplasty will be randomized into two groups: control and placebo.

Eache patient will undergo total knee arthroplasty under general anesthesia. Both groups will get the same anesthetic protocal. At the end of surgery, before awakening patients will recieve either a nitroglycerin or placebo patch on their back. Both the participant and the investigator will be blinded to the group assisignment. At the end of surgery both groups will recieve morphine for postoperative pain. In the recovery room they will be given patient controlled analgesia with morphine. An investigator blinded to study assisignment will record pain scores, sedation scores, nauseau and vomiting. Patients will be given patient controlled analgesia for 24 hours and they will be followed for pain levels, morphine use, sedation and nauseau levels. The nitroderm or placebo patch will be removed after 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients undergoing total knee arthroplasty

Exclusion Criteria:

* Pshychiatric disorder
* Allergy to nitroglycerin or morphine
* Chronic renal failure
* Migraine headaches
* Hypotension
Comparison of Skin Substitutes Used in Burn Care

The purpose of this study is to determine if using a DERMAL LAYER under skin grafts:

1. will reduce scar formation of skin grafts
2. will reduce burn wound contractures
3. will improve functional outcome of joints requiring grafts

Compare scarring outcome of Dermal products

Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Burn injury requiring grafting
* 0 years-90 years

Exclusion Criteria:

* Partial thickness burns only
Body Temperature Changes and Early Postoperatıve Pressure Sore

This study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation.

BACKGROUND: Intraoperative hypothermia for a prolonged period increases the risk of hospital-acquired pressure sores.

PURPOSE: This study aims to determine effect of body temperature changes during total knee arthroplasty surgery on early postoperative pressure sore formation.

METHODS: This experimental study was performed with experimental-control group (N=122) patients. Data were collected with "Personal Information Form", "Body and Ambient Temperature Record Form", "Braden Risk Assessment Scale". Experimental group participants were covered with a wool blanket, and control group was given standard care.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-85 years
* Hospitalized for at least four days and accepted to participate were included in the study.

Exclusion Criteria:

* Under the age of 20 - over 85,
* Pregnant and having comorbid diseases,
* Spinal cord injuries,
* Skin problems in areas where there is a risk of pressure loss,
* Undergoing hemodialysis,
* Having creatinine and serum albumin levels higher than 3 mg/dl,
* Having immobility, incontinence, anemic, having malignant tumor(s),
* BMI \<19 or BMI \>40,
* Hemoglobin level below 10 g/dl,
* Infection,
* American Society of Anesthesiology (ASA) score of 3 or more,
* Experiencing friction, tearing and shearing,
* Undergoing more than one surgical intervention,
* Having conditions requiring the use of non-normal anesthetic agents and sedation,
* Using vasoconstrictive drugs,
* Using positioning devices,
* Undergoing prolonged surgical intervention,
* Having arterial pressure lower than 32 mmHg,
* Having diabetes mellitus requiring insulin therapy.
Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study

The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration
* Written informed consent

Exclusion Criteria:

* Time of diagnosis more than 6 months before study recruitment
* Ocular surgery of the study eye within 1 month before study recruitment
* Extensive subretinal fibrosis or retinal atrophy of the study eye
* Significant opacification of optical media of the study eye
* Uncontrolled glaucoma of the study eye
* Active ocular inflammation of the study eye
* Best-corrected visual acuity of the contralateral eye below 20/200
* Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs
Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women

The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for the prevention of osteoporosis.

The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.


Eligibility Criteria:
Inclusion Criteria:

1. Women 40-60 years of age.
2. Must be postmenopausal (0.5\~5 years post cessation of menses) or ovariectomized or hysterectomy women who have documented elevated Follicle Stimulating Hormone FSH (\>30mIU/ml) with low serum estradiol (\<20 pg/ml).
3. The lumbar vertebral BMD T-score is between -1and -2.5 SD.
4. The body mass index (BMI) is between 19 and 29 kg/m2.
5. Completed informed consent and signed informed consent form.

Exclusion Criteria:

1. Have diseases which may affect bone metabolism, e. g., hyper-or hypocalcemia, hyperthyroidism, osteogenesis imperfecta, malignancy, chronic gastrointestinal disease, extensive Paget's disease, alcoholism, and renal or hepatic impairment.
2. Has taken drug therapy for osteoporosis within the previous six months (excluding calcium supplements) prior to this study.
3. Chronic or continued use of hormone replacement drugs or medications that may affect bone calcium metabolism, for example, phosphate-binding antacids, many diuretics, adrenal or anabolic steroids, heparin, anticonvulsants, fluoride in excess of 1 mg/day and supplements of vitamin D or A in excess of RDAs.
4. Vitamin D deficiency (1, 25-dihydroxyvitamin D is lower than the normal range of: 25.1 pg/mL \~ 66.1 pg/mL).
5. Patients with fracture history.
6. Patients who can not promise to keep from taking stimulant drinks (for example, coffee, tea, alcoholic drink, and Coke) that may cause loss of bone calcium, during the study period.
Efficacy Study of Maintenance IT-101 Therapy for Ovarian Cancer Patients.

This study will assess the effect of IT-101 on delaying cancer progression in patients with platinum sensitive ovarian cancer.


Eligibility Criteria:
Key Inclusion Criteria:

* Women between the age of 18 and 78, inclusive;
* Evidence of platinum-sensitive ovarian cancer following the patient's primary treatment(\>= 6 months);
* Received a 2nd line platinum-based chemotherapy regimen (4-6 cycles) without evidence of progression;
* May have measurable or unmeasurable disease;
* Eastern Cooperative Oncology Group (ECOG) 0 or 1;
* Ability to understand and the willingness to sign a written informed consent document.

Key Exclusion Criteria:

* Women who are pregnant or lactating;
* Prior treatment with a topoisomerase inhibitor;
* Patients with unacceptable organ and/or hematologic reserve at screening;
* Urine protein of \> 500 mg/day or active nephropathy;
* Electrocardiogram (ECG) with evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator;
* History of pancreatitis within the last 12 months;
* Patients treated with previous high dose chemotherapy or stem cell transplant within the last 5 years;
* Use of any investigational agents within 4 weeks of study enrollment;
* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, psychiatric illness or other co-morbidity that presents a risk to the patient as determined by the investigator.
Clinical Study of Jaktinib in the Treatment of Patients With Moderate and Severe Atopic Dermatitis

The purpose of this study is to evaluate the efficacy and safety of Jaktinib in participants with moderate to severe atopic dermatitis.

The study is divided into two stages, the first stage test (1-12 weeks): the main test; the second stage test (13-24 weeks): the extended test.

The main test：The trial set up 4 treatment groups, including 3 dose exploration groups, Jaktinib 50mg Bid, 75mg Bid, 100mg Bid group and 1 placebo control group.

The extended test：Subjects in the placebo group were randomly assigned to receive Jaktinib 50mg Bid, 75mg Bid, and 100mg Bid treatments at a ratio of 1:1:1 (randomized in a blinded state and completed by IWRS in the background), the main test group (50mg Bid, 75mg Bid, 100mg Bid group) subjects still maintain the original dose after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Meet the Chinese diagnostic criteria for atopic dermatitis (Zhang's criteria) and be diagnosed as atopic dermatitis.
* Participants must have moderate to severe AD at screening and randomization.
* Participants must have inadequate response to topical medications within 6 months of screening.
* Agree to use emollients daily

Exclusion Criteria:

* Received prior treatment with any oral Janus kinase (JAK) inhibitor less than 4 weeks prior to randomization.
* Have received certain types of vaccinations.
* Participants who do not agree to use adequate contraception during the trial and within 4 weeks after the last dose.
* Any Participants whom the investigator deems inappropriate for participation in this clinical study
A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment

The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

Hepatic Impaired Participants:

* Participants have mild, moderate, or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
* Participants have mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by Child-Pugh Score.

Matched Healthy Participants:

* Participant must be free of any clinically significant disease that would interfere with the study evaluations.
* Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.

Exclusion Criteria:

All Participants:

* History of chronic pruritus or dermatologic syndromes that may be confounded with reactions to mezigdomide.
* Contraindication or intolerance to first-generation antihistamine medications.

Hepatic Impaired Participants:

-Clinical laboratory test results:

* Platelet count lower than 30,000/microliter (μL) at screening or Day -1.
* Absolute neutrophil counts lower than 1,500/μL at screening or Day -1.

Matched Healthy Participants:

-History of or suspected benign ethnic neutropenia.

Other protocol-defined inclusion/exclusion criteria apply
Ultrasound in Evaluating Muscle-Glycogen Content in Cancer Patients

This trial studies how well an ultrasound procedure (non-invasive MuscleSound technology) can be used to learn about levels of glycogen (a type of sugar) in cancer patients during inpatient rehabilitation. The ultrasound information will be processed to represent the energy storage in the muscle. The energy storage in the muscle may help future research to look for dietary plans that can help to increase energy storage, patient exercise tolerance, and functional improvement.

PRIMARY OBJECTIVES:

I. Determine feasibility of using non-invasive MuscleSound technology to determine glycogen stores in cancer patients.

EXPLORATORY OBJECTIVES:

I. Determine the baseline glycogen storage in two different groups of cancer patients, who are undergoing inpatient rehabilitation: (1) those with cachexia; (2) those without cachexia.

II. Determine the rate of depletion of muscle-glycogen stores by calculating the "Fuel Rating" score (FRS) at baseline, after 10-min of exercise and then again after 20-min of exercise.

III. Determine if there is any correlation between muscle-glycogen (at baseline and its depletion rate over time) and other factors including cancer type, cancer stage, patient age, patient sex, current body mass index (BMI), presence or absence of cachexia, functional measures and patient reported outcomes.

OUTLINE:

Patients undergo ultrasound via MuscleSound technology over 3 minutes at baseline and immediately after each of 2 physical therapy sessions comprising cycling or walking over 10 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Participants are willing and able to give written informed consent and to comply with study procedures.
* Patients with a biopsy-confirmed solid malignant neoplasm with at least one neurologically-intact lower extremity, who fit into one of the following groups:

  * Group 1: Patients with cachexia, defined by loss of \> 5% of body weight over the preceding 6-months (in absence of simple starvation defined as intentional weight loss) or weight loss \> 2% with BMI \< 20.
  * Group 2: Patients without cachexia, as defined above.
* Patients who have a record of weight or BMI over preceding 6-months.
* Patients must be receiving rehabilitation that includes exercise under the direction of a physical therapist.

Exclusion Criteria:

* Non-English speaking patients.
* Patient with neurological compromise of both lower extremities causing muscle atrophy.
* Underlying unstable medical condition (i.e: cardiac, pulmonary, or hematological) or musculoskeletal injury, which in the opinion of the investigator, limits participation in exercise of the measured lower extremity.
* Patients who are unable to understand or follow through with study instructions.
Recognition of Heart Failure With Micro Electro-Mechanical Sensors (REFLECS) FI

In this study the ability of smartphone sensors (accelerometer and gyroscope) to identify patients with heart failure will be studied.

Heart Failure (HF) is a condition where heart is unable to maintain adequate volume of blood in circulation corresponding to prevailing physiological demand. Gyrocardiography is a technique that utilizes micro electromechanical sensors (MEMS), accelerometer and gyroscope, to detect vibrations and rotation of thorax caused by cardiac motion. The main purpose of this study is to test the ability of an app of a smartphone with embedded motion sensors, positioned on the chest which measures the movements and function of the heart, to identify patients with different types of heart failure and their characteristics, as compared with clinical diagnosis. Echocardiography will also be used to confirm changes in cardiac cardiac mechanics including strain, cardiac torsion, diastolic filling characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients visiting hospital for heart failure, either outpatient clinic or cardiac ward
* Signed informed consent as an acceptance to participate to the trial

Exclusion Criteria:

* Age \<18 years

  * Severe cardiac valve disease
  * Previous prosthetic cardiac valve
  * Major adverse cardiovascular event or surgery within 6 weeks of planned study enrollment
  * Patients with pacemaker
  * Informed consent form not signed.
The Mobile-based Training System in Peritoneal Dialysis Patients

The mobile-based training system can effectively improve the knowledge and technical correctness of peritoneal dialysis patients.

Use mobile-based training system in peritoneal dialysis patients' retraining programs and continuously monitor the effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have received peritoneal dialysis for more than 3 months; patients who have received peritoneal dialysis for less than 3 months but have recovered from peritonitis or catheter-related infection; patients who are conscious and have no mental illness.

Exclusion Criteria:

* Patients who are unable to perform peritoneal dialysis independently; illiterate; suffering from peritonitis or catheter exit site infection.
Mucorales PCR Screening in At-risk Hematology Patients

Patients with leukemia are treated with intensive chemotherapy and often have to undergo a stem cell transplantation which makes their immune system extremely vulnerable. This puts them at risk for invasive fungal infections, of which invasive mucormycosis (IM) is one of the most dangerous ones. Treatment of IM is complex and mortality rates are still extremely high, ranging from 40% to 80% and sometimes even higher if the central nervous system is involved. Mucormycosis requires immediate intervention due to the rapidly progressive and destructive nature of the infection. But the diagnosis is often made too late...

Better survival can be achieved with a faster diagnosis. A new test has recently been developed for detection of Mucorales DNA by PCR. The polymerase chain reaction (PCR) is a method that allows to quickly make millions of copies of, for example, Mucorales DNA in order to detect it in the blood at an early stage. Because blood can easily be obtained, without an additional burden on the patient, the test could be interesting for screening for these infections, which then offers the opportunity to start an adequate treatment more quickly.

However, the test is now only performed if there is a clinical suspicion of IM. But at that point, precious time has already been lost, and often the patient can no longer be cured. In this study the utility of the Mucorales PCR as a possible screening test in at-risk patients is assessed. The participants, hospitalised patients with leukemia, will be screened twice weekly with a Mucorales PCR test during their most vulnerable period. If the study shows that the test helps in diagnosing IM faster, this could have an important impact on the treatment and survival of these at-risk patients.


Eligibility Criteria:
Inclusion Criteria:

* Underlying disease:

  * Start of remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months; OR
  * Start of myeloablative conditioning regimen to prepare for a first allogeneic hematopoietic cell transplantation (HCT).
* Expected prolonged neutropenia (ANC\< 0.5 x 109 /L for ≥ 7 days).
* Planned hospital admission for the duration of the neutropenic phase.
The Living Experience of Hong Kong Chinese Adolescents With CHD.

This study aims to explore the impacts of CHD and its limitations on adolescents and the living experience of adolescents living with CHD.

Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and quality of life than their healthy counterparts. Qualitative study is therefore needed to explore how CHD may impact on the adolescents' psychological well-being and quality of life.

A qualitative study was adopted. Purposive sampling of 30 adolescents with CHD were done. Thematic analysis was used for data analysis. The participants unfold negative impacts of CHD and its treatments, and the challenges they were facing with their relationship with others.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese adolescents
* aged 12 to 18
* able to read and write Chinese
* attending outpatient clinic of Department of Pediatric Cardiology

Exclusion Criteria:

* adolescents with non-structural heart disease
* with developmental delay or comorbid medical conditions