cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP16001 After Oral Administration in Healthy Male Volunteers

This is a dose block-randomized, double-blind, placebo- and active-controlled, single and multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of DWP16001 after oral administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adults aged 19 to 50 at the time of screening test.
2. Body weight between 50.0 kg and 90.0 kg and Body Mass Index (BMI) between 18.0 and 27.0.
3. Written consent on voluntary decision of participation prior to the screening procedure after being fully informed of and completely understanding this study.
4. Eligible to participate in the study by discretion of the investigator following medical examination by interview, physical examination, and clinical examination.

Exclusion Criteria:

1. Presence of a clinically significant hepatic, renal, nervous, respiratory, endocrine, blood•tumor, cardiovascular, urogenital, psychiatric disorder or prior history.
2. Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of surgery (except for simple appendectomy or hernia surgery) that may affect safety and PK/PD assessment.
3. Hypersensitivity to a drug containing an ingredient of the investigational product (DWP16001), Dapagliflozin or similar ingredient or other drugs (e.g., aspirin, antibiotics, etc.) or medical history of clinically significant hypersensitivity.
4. Following laboratory abnormalities identified during the screening test:

   * AST (SGOT), ALT (SGPT) \>1.5 upper limit of normal range
   * Creatinine clearance calculated by the MDRD equation \< 90 mL/min
   * Repeatedly confirmed QTc interval \> 450 ms
   * Fasting serum glucose \> 110mg/dL or \< 70mg/dL
   * Serum HbA1c \> 6.5 mg/dL
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Parents' Satisfaction Level and Anxiety

The study was planned as a prospective randomized controlled study and was carried out in the Training and Research Hospital burn unit outpatient clinic between 05.7.2021-1.04.2022. The population of the study consisted of the parents of children aged 5-10 years who applied to the burn unit polyclinic for dressing between the dates of the study. A total of 52 people were included in the research group. Data were collected by using the "Survey Form" consisting of 10 questions, "Newcastle Nursing Satisfaction Scale" and "Beck Anxiety Scale".

In this study, the "Beck Anxiety Inventory" was applied to the parents before and after the burn dressing, while the "Newcastle Satisfaction with Nursing Scale" was applied only after dressing.

Control Group (n=26): "Parent Information Form" and "Beck Anxiety Inventory" were completed by the researcher nurse after obtaining the consent of the family and the children in the control group. After filling out the form, the parent and child were taken to the dressing room, and the researcher nurse was with both the child and the parent throughout the dressing and answered all the questions that the parent and child had. After the dressing, the child was taken to the waiting room and it was waited for the child to calm down, and "Beck Anxiety Inventory" and "Newcastle Satisfaction with Nursing Scale" were applied to the parent by the researcher nurse.

The Intervention Group (n=26): "Parent Information Form" and "Beck Anxiety Inventory" were completed by the researcher nurse after obtaining the consent of the family and the children in the intervention group. Then, the parent and child were taken to the dressing room and the child was put on virtual reality headsets and he/she watched a cartoon he/she liked. During this time, all the questions that both the child and the parent had have been answered. After the dressing, the virtual reality headsets were removed, the child was taken to the waiting room and the "Beck Anxiety Inventory" and "Newcastle Satisfaction with Nursing Scale" were applied to the parents. During all these processes, procedures were carried out in accordance with the protocols and principles established within the scope of the "COVID-19 Pandemic Measures" published by the Ministry of Health.

Eligibility Criteria:
Inclusion Criteria:

* parents
* read and write,
* understand Turkish,

Exclusion Criteria:

* under the age of 18
* do not want to participate in the study
* cannot be pregnant
Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma

RATIONALE: Determination of genetic markers for soft tissue sarcoma or rhabdomyosarcoma may help doctors identify patients who are at risk for therapy-related leukemia.

PURPOSE: Clinical trial to study genetic testing of children with soft tissue sarcoma or rhabdomyosarcoma to identify children who are at risk of developing leukemia from the chemotherapy used to treat sarcoma.

OBJECTIVES:

* Identify genetically susceptible patients to therapy-induced myelodysplastic syndrome or acute myelogenous leukemia (t-MDS/AML) prior to initiation of high-dose chemotherapy for sarcoma.
* Identify patients who are at increased risk of t-MDS/AML during or after therapy.

OUTLINE: Blood is collected from patients at diagnosis (preferably before chemotherapy or transfusion), at end of therapy, and at 6 months, 1 year, 2 years, and 3 years after therapy.

Blood specimens are examined by clonality analysis (HUMARA), variant cell frequency (glycophorin A assay), GST NAT2/CYP1A1 genotyping, microsatellite instability, and ras mutation detection (single strand conformation polymorphism and sequencing of mutant alleles).

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 321 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of sarcoma including:

  * Rhabdomyosarcoma
  * Ewing's sarcoma
  * Primitive neuroectodermal tumor
  * Fibrosarcoma
  * Malignant peripheral nerve sheath tumor
  * Synovial cell sarcoma
  * Osteosarcoma
  * Other soft tissue sarcoma
* Must be currently receiving intensive or high-dose chemotherapy for sarcoma

PATIENT CHARACTERISTICS:

Age:

* Children

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder

The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.

It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.

Exclusion Criteria:

* Patients with at least 2 previous prolapse surgeries
* Patients who are pregnant or planning to have a pregnancy
Impact of Tracheotomy on Procalcitonin

Procalcitonin (PCT) is a reliable biomarker of infection and sepsis. The investigators aimed to determine whether tracheotomy influences PCT concentrations in patients without sepsis, and to assess whether operative duration and procedure affect the peak PCT level.

Procalcitonin (PCT), a soluble protein composed of 116 amino acids with a sequence identical to that of the calcitonin prohormone, has been considered as a reliable biomarker for evaluating of bacterial infection and sepsis. In healthy individuals, serum PCT concentrations are undetectable, however, in case of severe bacterial infections and sepsis, it increase rapidly released mainly in peripheral blood mononuclear cells and modulated by bacterial lipopolysaccharides (LPS) and sepsis-associated cytokines. An increase number of studies have demonstrated that PCT-guided strategy is a helpful approach to guide antibiotic administrations and clinical interventions in the intensive care unit (ICU).

However, PCT is induced in the plasmas of patients not only at the presence of bacterial infection, but also in stress conditions such as severe trauma and surgery. In these conditions, the increases are moderate. The mechanism of the nonspecific increase is complicated. Other conditions with elevated PCT concentrations include medullary thyroid carcinoma , cancer, anaphylactic shock, heat shock , cardiac arrest, Kawasaki Disease, and so on. These findings suggest that elevated PCT levels lack the speciality to detect sepsis in critically ill patients.

Tracheotomy is one of most performed surgical procedures to assure airway by making a hole in front of the trachea in ICU. There are studies in literature that show the surgical procedures to the neck area cause a surgical stress, an increase in thyroid hormones. The procedure may due to miscellaneous clinical signs by altering in hormone levels, even creating a thyroid storm. As far as we are aware, there is no study on the impact of tracheotomy on PCT concentration. The aim of the study was to evaluated whether tracheotomy affects PCT concentrations in patients without sepsis. Moreover, the investigators assessed whether operative duration and procedure were correlation with the peak PCT level.

Eligibility Criteria:
Inclusion Criteria:

* without sepsis requiring tracheotomy

Exclusion Criteria:

* those who did not give their consent or declined treatment during the period of observation
* those with any thyroid diseases past history, such as hyperthyroidism, hypothyroidism and thyroidtumor
* those who received high-dose steroid treatment
* those who received renal replacement therapy (RRT)
* those with severe renal injury (Scr \> 300 umol/L)
* those who received antibiotic therapy from 48 hours pre-operation to 72 hours post-operation.
i-Scan for the Detection of Helicobacter Pylori

This study aims to assess whether iScan, an intra-endoscopic imaging technique is an accurate and reliable tool in detecting and characterising Helicobacter pylori (H pylori) and comparing this to standard endoscopic imaging with white light endoscopy (WLE), narrow band imaging (NBI) and histology.

The ultimate goal of endoscopy will be the 'optical biopsy' i.e. forgoing the need to take histological samples to make a diagnosis in order to reduce complication rates, cost and time. There are a number of imaging techniques which promise to improve our diagnostic rates for pathology, but there have been few comparative studies.

This is randomized controlled parallel trial in a 1:1 ratio with examination of the upper gastrointestinal tract with WLE followed by either NBI or iscan.

(Note: Prior to commencement of the study, technical issues and operational changes in our organisation forced the removal of the Pentax 'i-scan' endoscopes. Recruitment to this arm was anticipated, but was ultimately not possible.)

Patients attending the department for routine examinations for dyspepsia and abdominal pain will be randomised into 2 study arms (1WLE and NBI, and the other - WLE and iscan).

The investigator carrying out the procedure will be blinded to the indication for the procedure until a full examination with both white light endoscopy and either NBI or iscan has been used as this could lead to bias. They will determine if H pylori is present, and if so the severity of infection with WLE and again with either NBI or iscan depending on their study arm. Histopathological confirmation of H pylori and an assessment to the degree of infection will be assessed with samples taken using the updated Sydney system (5 gastric samples from different parts of the stomach).

The endoscopists reviewing the images will be blinded to all patient information and indications throughout the study period. Questionnaires will then be given to the endoscopists to determine what endoscopic features led them to their diagnosis.

Eligibility Criteria:
Inclusion Criteria:

• All patients attending for a routine diagnostic endoscopic procedure at St Mary's Hospital NHS Trust for dyspepsia and abdominal pain

Exclusion Criteria:

* Patients attending for a therapeutic endoscopic procedure e.g. variceal banding, stent insertion, balloon dilatation.
* Patients with a known diagnosis e.g. upper gastrointestinal cancer
* Patients previously treated with HP eradication therapy
* Patients who had taken PPI, H2 receptor antagonists and antibiotics within 4 weeks
* Patients with acute gastrointestinal bleeding
* Patients who'd had previous gastric surgery
* Patients with chronic liver disease
* Patients with abnormal coagulation or any other contra-indication to use of standard biopsy in routine diagnostic endoscopic procedures
* Patients who are unable or unwilling to give informed consent
* Patients under the age of 18 years
Band Versus Ring for Tricuspid Regurgitation

Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. This study aims to prospectively compare the efficacy and long term outcomes of flexible band versus rigid ring annuloplasty for the correction of tricuspid regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subject must be 18 years and 80 years at time of consent and must not be a member of a vulnerable population.
* 2. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
* 3. Subjects with moderate or greater tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
* 4. Subjects with moderate tricuspid regurgitation will only be included in the trial if moderate tricuspid regurgitation is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by echocardiography.
* 5. Isolated functional symptomatic tricuspid regurgitation of moderate to severe or greater, with annular dilatation of ≥ 40mm;
* 6. Requirement for concomitant left heart valve surgery;
* 7. Requirement for concomitant coronary artery surgery;
* 8. Requirement for concomitant atrial fibrillation surgery;
* 9. Available and able to return to the study site for post-procedural follow-up examination;

Exclusion Criteria:

* 1. Patient unable or unwilling to provide informed consent;
* 2. Subjects with mild tricuspid regurgitation;
* 3. Emergency surgery;
* 4. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure;
* 5. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment;
* 6. Subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year;
* 7. Subjects with permanent or temporary pacemaker implantation;
* 8. Subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator;
* 9. History of mitral/tricuspid endocarditis within the last 12 months;
* 10. Subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated;
* 11. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding);
* 12. Female patient is pregnant (urine HCG test result positive) or lactating;
* 13. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
* 14. Subjects with left ventricular ejection fraction (LVEF)≤20%.
Validity and Reliability of VO2-max Measurements in Persons With Parkinson's Disease

Each participant would complete four test days and each test day is separated by 7-10 days. At each test day the participants would complete a graded maximal exercise test (VO2max-test), a chair rise (Linear encoder) as well as measuring of basic demographic outcomes (weight, fat%,blood pressure etc.). The first test day would further include a motor (MDS-UPDRS III) and cognitive examination (MoCA), a questionnaire about quality of life (PDQ-39) and one about depression (BDI-II). Furthermore, the first test day would include two test of walking performance (6 minutes walk test and Time Up and Go). Two of the test days would be completed while the participants are off their Parkinson disease medication for at least 12 hours, while the other two test days would be completed while on their Parkinson medication. The order of the tests would be randomized. It is hypothesized that the VO2max test would be reliable and valid when participants are on medication, while off-medication would affect the reliability and validity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 year
* Written informed consent
* Diagnosed with idiopathic Parkinson's disease
* Hoehn \& Yahr ≤ 3
* Taking dopaminergic medication
* Able to complete a maximal aerobic test on a bicycle

Exclusion Criteria:

* Dementia
* Alcohol abuse
* Pacemaker
* Serious cardiovascular, respiratory, orthopedic or other comorbidities excluding maximal exercise participation.
* Pregnancy
Mineralocorticoid Receptor in the Treatment of Severe Depression

The proposed research aims to compare the onset of action and the efficacy of fludrocortisone, a mineralocorticoid receptor agonist vs. spironolactone, a mineralocorticoid antagonist, vs. placebo as augmentation to a selective serotonin reuptake inhibitor (SSRI) in 65 inpatients with severe depression. The study will also explore the utility of the hypothalamic-pituitary-adrenal (HPA) axis in predicting treatment response. The study will be a 5-week randomized and double-blind trial of fludrocortisone vs. spironolactone vs. placebo during three years.


Eligibility Criteria:
Inclusion Criteria:

* Depressed male and female inpatients according to DSM-IV
* Age between 18 and 70 years
* Minimum of 17-items Hamilton Depression Score of 18
* Informed consent signed

Exclusion Criteria:

* Relevant medical or neurological disorders
* Pregnancy or unsure contraception
* Relevant psychiatric comorbidity
* Active alcohol or other substance abuse/dependance
* Contraindications to SSRI, fludrocortisone, or spironolactone
* Steroid medication
Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa

The purpose of this study is to evaluate the short-term safety of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.

A prospective phase I, nonrandomized open-label study of retinitis pigmentosa patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be used to evaluate the short-term safety of intravitreal of ABMDSC: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of ABMDSC: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT \> 50um and not related to macular edema; 4) increase \> 5 letters on BCVA

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of retinitis pigmentosa
* logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse

Exclusion Criteria:

* previous ocular surgery other than cataract
* presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation
* other ophthalmic disease like glaucoma and uveitis
* previous history of blood disorders like leukemia
* known allergy to fluorescein or indocyanine green
* known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.

Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day.

The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 Diabetes mellitus
* Peripheral neuropathy
* Stabilized on pain medication for at least one month
* No previous invasive intervention for pain relief

Exclusion Criteria:

* Local wound or any skin abnormality in the applicable area
* Allergic to capsaicin
* Refuse to participate or give consent
* Has other significant disease or receive medication that may worsen neuropathy