cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare the Oral Absorption of ASP1941 Among Two Types of Tablets

To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a two-way crossover method in non-elderly healthy male subjects. In addition, the safety of these products will be assessed.

This study is a open-label randomized two-way crossover study. A single dose of two types of ASP1941 tablets are given to non-elderly healthy male subjects (16 subjects for each group, 32 subjects in total).

In case the bioequivalence of the 2 formulations cannot be proved in this study due to insufficient number of subjects, an add-on subject study will be conducted in this clinical trial as needed. Same design and methodology are to be applied to this study and the add-on subject study. The add-on subject study may not be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Body weight (at screening) \>=50.0 kg and \< 80kg
* BMI \>= 17.6 and \< 26.4 (BMI = Weight (kg)/(Height (m))2)
* Healthy, as judged by the investigator/sub-investigator based on physical examinations (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital of the period 1 admission to immediately before study drug administration

Exclusion Criteria:

* Received or scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before the screening or during the period from screening to hospital admission of the period 1 (Day -1).
* Donated or scheduled to donate more than 400 mL of whole blood within 90 days before the screening, more than 200 mL of whole blood within 30 days before screening, blood components within 14 days before screening, or whole blood or blood components during the period from screening to hospital admission of the period 1 (Day -1).
* Received or scheduled to receive medications (including OTC drugs) within 7 days before hospital admission of the period 1 (Day -1).
* A deviation from the normal range of blood pressure, pulse rate, body temperature, or standard 12-lead ECG at screening or hospital admission of the period 1 (Day -1)
* Concurrent or previous drug allergies
* Development of upper gastrointestinal disease (e.g., nausea, vomiting, and stomachache) within 7 days before hospital admission of the period1 (Day-1)
* Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced hepatic disorder, and hepatic function disorder)
* Concurrent or previous heart disease (e.g., congestive cardiac failure, angina pectoris, and arrhythmia requiring treatment)
* Concurrent or previous gastrointestinal disease (e.g., peptic ulcer and reflux esophagitis), except for a history of appendicitis
* Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis), except for a history of renal calculus
* Concurrent or previous endocrine disease (e.g., hyperthyroidism and blood abnormal growth hormone)
* Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)
* Concurrent or previous severe ketosis, diabetic coma, or precoma
* Previous use of ASP1941
KoreaN Cohort Study for Outcome in Pediatric Patients With Chronic Kidney Disease

KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) is a nation-wide, ten-year longitudinal cohort study, launched in 2011. The aim of the study is to assess the characteristics and risk factors of progression and complications of CKD of Korea. Pediatric sub-cohort of KNOW-CKD is planned to enroll 450 children with CKD, stage I to V (pre-dialysis).

Seven major pediatric nephrology centers of Korea enrolled children younger than 20 years who had CKD. Medical history taking, questionaire assessment of socio-economic status, anthropometric measurement, and clinical assessment using laboratory and imaging tests were done. Outcome is development of LV hypertrophy or hypertension, growth, neuropsychological status, behavioral status, kidney growth, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Age: \< 20 yr
* CKD stage 1 through 5 of KDIGO guideline
* predialysis

Exclusion Criteria:

- Dialysis
Ovarian Tissue Cryopreservation in Children

The Institutional Review Board (IRB) protocol is being designed to offer ovarian tissue cryopreservation to female pediatric patients (birth-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential. Because this procedure is currently considered experimental, the establishment of an IRB protocol under which this opportunity can be offered is needed.

Ovarian tissue cryopreservation is currently considered experimental but offers the only opportunity for fertility preservation in pre-menarchal girls faced with a fertility threatening diagnosis or treatment plan.

Eligibility Criteria:
Inclusion Criteria: (All inclusion criteria must be met.)

1. Female, age birth-17 years
2. Meet at least one of the following three conditions:

   1. Have a diagnosis of a medical condition that is expected to result in permanent diminished or complete loss of subsequent ovarian function (e.g. Turner's syndrome) OR have a diagnosis that will create a need for surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of the condition (e.g lupus nephritis) or malignancy and is expected to result in permanent diminished or complete loss of subsequent ovarian function. Unlike in males where a semen analysis provides an objective measure of testicular function, ovarian reserve testing remains subjective by evaluation of hormones. Therefore, to objectively qualify a degree of expected diminished loss of fertility is difficult.
   2. Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries. Girls with ovarian or germ cell tumors requiring removal of all or part of one or both ovaries will also be eligible for inclusion in the study.
   3. Or, have a newly diagnosed or recurrent disease affecting fertility.
3. For patients undergoing elective removal of all or part of an ovary for fertility preservation only, they must have two ovaries.
4. Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

Exclusion Criteria: (Any exclusion criteria will disqualify.)

1. Girls with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
2. Girls whose underlying medical condition significantly increases their risk of complications from anesthesia and surgery.
3. Subjects with extensive disease whose therapy is deemed palliative by the medical oncologist will not be selected.
4. Subjects with suspected severe diminished ovarian reserve, such as a follicle stimulating hormone (FSH) level of \> 15.
Talc Outpatient Pleurodesis With Indwelling Catheter

This study will be a prospective, randomized trial comparing a new protocol to the standard of care. The investigators protocol and the standard of care involves a previously established procedure that will be completed in the investigators pulmonary procedure unit. The study will include using previously, well-established procedures (indwelling pleural catheter placement, talc slurry administration through an indwelling pleural catheter, pleuroscopy with talc poudrage administration) in addition to a new protocol (at home continuous drainage via indwelling pleural catheter).

The study design is a prospective, randomized and controlled trial comparing a new protocol to the standard of care. To the investigators knowledge, there is no similar protocol and this will be a single center, pilot study. The control arm will consist of subjects who meet the inclusion criteria for the study and will receive current standard of care management for paramalignant pleural effusion. This will consist of either an indwelling pleural catheter (IPC) placement with subsequent talc slurry administration and hospital admission for continuous drainage, or schedule medical pleuroscopy with talc insufflation poudrage and subsequent IPC placement for continuous drainage while in the hospital. The intervention arm will consist of subjects who meet the inclusion criteria and then will be scheduled for IPC placement in the pulmonary procedure unit as either an outpatient visit or during their hospital admission (if the subject is already admitted to the hospital and recruited via our inpatient consult service). The subjects in this arm will then go home or back to their original admission status with a drainage bag for continuous drainage on the same day as the procedure. This protocol will utilize a circuit with an IPC connected to a continuous drainage bag via a one-way Heimlich valve. It is important to note that while utilizing this circuit is a new protocol for patients with paramalignant pleural effusions, the protocol is the current standard of care practice for patients with pneumothorax and persistent air leak, and is being utilized regularly for these patients by the investigator's department as standard of care for patient needing long-term chest tubes while at home.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old
* Diagnosis of a paramalignant pleural effusion (defined as a recurrent pleural effusion directly caused by malignancy with known thoracic involvement)
* Estimated life expectancy greater than 3 months
* Full lung re-expansion on chest x-ray after thoracentesis

Exclusion Criteria:

* Age less than 18 years old
* Pregnant or lactating subject
* Any history of prior pleural talc administration
* History of an indwelling pleural catheter placed on the side of the active paramalignant pleural effusion
* Estimated life expectancy less than 3 months
* Active clinical heart failure
* Inability to return for frequent follow up appointments
* Current incarceration
High Flow Nasal Oxygen Therapy in Pediatric Hypercapnic Respiratory Failure During Perioperative Stage

Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure.

Humidified high flow nasal oxygen therapy decreases dilution of the inhaled oxygen and, by matching patient's peak flow, allows accurate delivery of the set FiO2 throughout the whole inspiratory phase.The purpose of this study is to determine the impact of hign-flow nasal therapy on pediatric hypercapnic respiratory failure by comparing with nasal continuous positive airway pressure

Eligibility Criteria:
Inclusion Criteria:

1. Age ranges from 1 to 18 years
2. Hypercapnic respiratory failure:

   PaO2\<60mmHg and PaCO2 \>50 mmHg
3. Candidate for non-invasive respiratory support as a result of:

   1. an intention to manage the patient with non-invasive (no endotracheal tube) respiratory support
   2. an intention to extubate the patient being managed with intubated respiratory support to non-invasive support

Exclusion Criteria:

1. Participation in a concurrent study that prohibits the use of HHFNC
2. Active air leak syndrome
3. Patients with abnormalities of the upper and lower airways; such as Pierre- Robin, Treacher-Collins, Goldenhar, choanal atresia or stenosis,
4. Patients with significant abdominal or respiratory malformations including tracheo-esophageal fistula, intestinal atresia, omphalocele, gastroschisis, and congenital diaphragmatic hernia
5. PaCO2\<50mmHg
A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

The purpose of this study is to observe the safety and efficacy of Modigraf in de novo pediatric allograft liver and kidney transplantation recipients. This study will also monitor dose changes and tacrolimus whole blood trough levels of Modigraf based immunosuppression regimen.


Eligibility Criteria:
Inclusion Criteria:

* Participant's parent(s) or their legal representative(s), and participant where applicable agrees not to participate in another interventional study while participating in the present study from 1 month before screening to the end of the study.

Exclusion Criteria:

* Participant has previously received another organ transplant.
* Participant has a high immunological risk, defined as a panel reactive antibody (PRA) score \> 50% in the previous 6 months (only applicable for kidney transplantation recipients).
* Cold ischemia time of the donor kidney longer than 30 hours (only applicable for kidney transplantation recipients).
* Bilateral kidney transplantation recipients (only applicable for kidney transplantation recipients).
* Participant receives an ABO incompatible donor organ.
* Participant has significant kidney impairment, defined as having serum creatinine ≥ 230 μmol/L (≥ 2.6 mg/dL) prior to transplantation (not applicable for kidney transplantation recipients).
* Participant has significant liver disease, defined as having elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or total bilirubin (TBL) levels 3 times the upper value of the normal range prior to transplantation (not applicable for liver transplantation recipients).
* Participants with malignancies or a history of malignancy within the last 5 years.
* Participant has a significant, uncontrolled systemic infection and/or severe diarrhea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus or has an active peptic ulcer.
* Recipient or donor known to be human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) positive.
* Participant requires systemic immunosuppressive medication for any indication other than transplantation.
* Participants taking or requiring to be treated with medication or substances prohibited by this protocol.
* Known allergy or intolerance to steroids, macrolide antibiotics, basiliximab, or tacrolimus.
* Participants with severe primary disease/complications/poor general condition which may be unsuitable for participating in this study.
* Participant is currently participating in another clinical trial and/or has been taking any other study drug within 1 month prior to screening.
* Participant is unlikely to comply with the visits scheduled in the protocol.
Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens

The purpose of this study is to determine whether powdered ginger root (encapsulated ginger) is effective for reducing the frequency, duration and severity of both acute and delayed nausea and vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to give written informed consent.
* Have a diagnosis of cancer and currently receiving chemotherapy containing cisplatin (any dose).
* Scheduled to receive antiemetics: granisetron (kytril), hydrocortisone.
* Must be able to complete study questionnaires.
* Must be able to swallow capsules.

Exclusion Criteria:

* Have no clinical evidence of current or impending bowel obstruction.
* Concurrent radiotherapy that is classified as high or intermediate risk of causing emesis.
* Pregnant or lactating.
* Patients taking therapeutic doses of coumadin (individuals on low-dose to maintain peripheral or central venous catheters are allowed), aspirin (individuals taking low-dose 80mg aspirin are allowed), or heparin.
* Patients with a history of a bleeding disorder(s) in past 6 months and those experiencing thrombocytopenia.
Comparison of CO-OP and GDT on Occupational Performance and Functional Status in the CP

This study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of CO-OP and GDT interventions on occupational performance and functional status in children with CP compared with their usual care.

Cerebral palsy (CP) is a group of neurological disorders that affect movement, muscle tone, and posture, causing activity limitations that originated in the developing fetal or infant brain that are attributed to non-progressive disorders. Symptoms such as spasticity and contracture in CP cause a decrease in functional skill level with limitations in daily living activities such as learning a new skill or self-dressing and handwriting. In this disease, the simultaneous presence of sensory, cognitive, perceptual, and behavioral impairments significantly undermines the acquisition and execution of functional skills, autonomy in daily living, and active engagement in leisure activities. This study was planned to investigate and compare the impact of CO-OP and GDT on the occupational performance and functional status of children with CP.

Eligibility Criteria:
Inclusion Criteria:

* being between 5-10 years of age
* being diagnosed with CP
* having adequate language abilities to make contact with a therapist and be informed during intervention.

Exclusion Criteria:

* they were receiving any other treatment
* they had been diagnosed with mental retardation
* they had serious vision or hearing problems.
Measuring the Incidence of Hospital Readmissions Based on Adverse Drug Events

An ADE is defined as harm caused by a drug or the inappropriate use of a drug. Retrospective record reviews in several countries have shown that anticoagulants frequently lead to hospital readmissions. In this study a hospital readmission is defined as an admission to the emergency department of the Jessa hospital. The objective of this study is to determine the incidence of one week and 30-day readmissions caused by (preventable) ADE's due to anticoagulants.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received an anticoagulant on their last day of admission
2. Patients who were readmitted within 30 days
3. Patients who were diagnosed using the pathology registration of the emergency department of the Jessa hospital

Exclusion Criteria:

1. Patients who didn't receive an anticoagulant on their last day of admission
2. Patients who were not readmitted within 30 days
3. Patients who were not diagnosed using the pathology registration of the emergency department of the Jessa hospital
4. Patients with missing data
Fitness Training in Children

We hypothesize that improvement in cardiovascular fitness is associated with a greater improvement in insulin sensitivity than improvement in body composition (loss of body fat) is associated with insulin sensitivity. Towards that we are randomizing children who are overweight, or children with low fitness levels to exercise intervention 2 or three times per week.


Eligibility Criteria:
Inclusion Criteria:

* obesity
* low fitness

Exclusion Criteria:

* diagnosis of diabetes
* inability to exercise
Phase II Study of TAS-106 to Treat Head and Neck Cancer

The purpose of this study is to determine whether TAS-106 is effective to patients with recurrent or metastatic head and neck cancer refractory to platinum based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 ≤ years old at study entry
* Histologically confirmed head and neck carcinoma
* Received prior platinum based regimen and developed disease progression or recurrence
* Measurable disease according to RECIST guidelines

Exclusion Criteria:

* Radiological or clinical evidence of brain involvement or leptomeningeal disease
* ≥ grade 2 peripheral neuropathy
* History of another malignancy
Study of Treatment Choice in Patients With Localized Prostate Cancer

RATIONALE: Gathering information about patients with prostate cancer may help doctors learn more about how patients choose treatment options.

PURPOSE: This study is looking at treatment choice in patients with localized prostate cancer.

OBJECTIVES:

Primary

* To evaluate the importance of prostate cancer treatment characteristics to men with localized prostate cancer.
* To determine to what extent men will choose the strengths and weaknesses of one treatment over a different set of strengths and weaknesses of another treatment when making a choice between them.

Secondary

* To determine the correlation between attributes that are important to men and baseline demographics, functional status, and disease risk characteristics.

OUTLINE: This is a multicenter study.

Patients complete a 'discrete choice experiment' questionnaire presenting three treatment options based on 8 aspects of treatment. Attributes relevant to men with prostate cancer (e.g., sexual health, urinary function, return to normal activities \[work, gardening, sports, shopping\]) that apply to surveillance, radical therapies and new minimally-invasive therapies have been selected for consideration. Baseline demographics such as age, working/retired/unemployed/household income, prostate cancer characteristics (PSA level, Gleason grade, stage), baseline functional status (genitourinary function), and final treatment choice will also be collected in order to ascertain whether there is any relationship and association between patient preferences for treatment and these baseline demographics. Individuals will be asked to choose between the three treatment profiles.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histological diagnosis of adenocarcinoma of the prostate on transrectal or transperineal template prostate biopsies

  * Clinical stage ≤ T2c N0 M0 (radiological T3a allowed)

    * Local staging imaging as per guidelines to demonstrate localized disease (e.g., MRI, CT, and/or bone scan)
  * No metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
* No prior prostate surgery for cancer control (e.g., radical prostatectomy, high-intensity focused ultrasound ablation, cryosurgery, or photodynamic therapy) or other treatment for prostate cancer
* Gleason grade ≤ 7
* Serum PSA ≤ 15 ng/mL

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior radiotherapy
* No androgen suppression/hormone treatment within the previous 12 months for prostate cancer