cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating Inhaled AeroLEF (Liposome-Encapsulated Fentanyl)in Normal Healthy Subjects

This was a pilot, phase I, two-period, fasting, bioavailability, safety,and pharmacokinetic study evaluating single dose of i.v. fentanyl (200 µg) and single doses of 2 mL or 3 mL inhaled AeroLEF (500 µg/mL) delivered by nebulization with the AeroEclipse BAN device administered in normal healthy non-smoking subjects.

In Period I, subjects received an intravenous dose of fentanyl (200 µg) administered over 1 minute (Treatment A). Subjects then crossed over to Period II.

In Period II, subjects were randomly assigned to receive either 2 mL (1000 µg fentanyl; Treatment B) or 3mL (1500 µg fentanyl; Treatment C) of AeroLEF delivered by nebulization with the AeroEclipse BAN. Subjects were instructed to continue inhalation of AeroLEF for approximately 1 minute beyond the point of nebulizer sputter to ensure that all aerosolized medication was delivered. There was at least a 1 week washout period between study periods.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking male or female with a minimum age of at least 18 years
* Body weight with aBMI range of 18.5 - 27, with a minimum weight of at least 60 kg.
* Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed, written, Informed Consent Form.
* Normal findings in the physical examination, vital signs (blood pressure between 100-140 - 60-90 mmHg, heart rate between 55-99 beats/min, respiration rate between 12-20 minute) and a 12 lead ECG.
* Negative for drug abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV.
* If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
* No clinical laboratory values outside of the Principal Investigator's acceptable range, unless the Principal Investigator decided that the subject's values are not clinically significant.
* Female subjects: (a) if pre-menopausal, have regular menstrual cycles (28-32 days), and (b) are not pregnant prior to study start and avoids pregnancy during the study and 1 month post drug administration, or (c) were surgically sterile for at least 6 months prior to enrollment, or (d) are post-menopausal for at least 1 year prior to enrollment.

Exclusion Criteria:

* Known history of hypersensitivity to fentanyl.
* Presence or history of cardiac, pulmonary, gastrointestinal, endocrine, neuromuscular, neurologic, hematological, liver or kidney disease, or any condition known to interfere with absorption, distribution , metabolism, or excretion of drugs.
* History of drug abuse or narcotic dependency.
* Use of prescription medication within 30 days preceding entry int the study, including any enzyme inducing/inhibitory drugs (excluding contraceptives).
* Participating in a clinical trial with an investigational drug within 30 days preceding this trial.
* Blood donation within 45 days preceding this trial.
the Efficacy and Safety of Fermented Soybean(Doenjang Powder) on Intestinal Microflora and Immune Enhancement.

This study was conducted to investigate the efficacy and safety of Fermented soybean(Doenjang powder) on intestinal microflora and immune enhancement.

This study was a 4 weeks, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented soybean(Doenjang powder) on intestinal microflora and immune enhancement.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 19 and under 75 years
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* If screening shows that the white blood cell(WBC) is less than 3000/㎕ or more than 8000/㎕
* Those who have a body mass index(BMI) of less than 18.5 kg / m\^2 or greater than 35 kg / m\^2 at the screening
* Those who have a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic and gastrointestinal disorders
* Those who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening
* Those who have received antipsychotic medication within 3 months before screening
* Those who alcoholic or drug abuse suspected
* Those who participated in other clinical trials within 3 months before screening
* Laboratory test by show the following results

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Those who doesn't accept the implementation of appropriate contraception of a childbearing woman
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

* Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1 analysis
* Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance)
* Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following:
* Primary disease refractory to at least 2 regimens;
* Refractory to at least 1 regimen after first relapse;
* Refractory or untreated after second or greater relapse;
* Refractory to first line and relapsed after second line. Chemotherapy combinations may include, but are not limited to: CHOP (Cyclophosphamide, doxorubicin, vincristine, prednisone), R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), R-FCM (Rituximab,Fludarabine, cyclophosphamide, mitoxantrone), ICE(Ifosfamide, carboplatin, etoposide), DHAP (Dexamethasone, cisplatin, cytarabine) and hyper-CVAD (Cyclophosphamide, doxorubicin, vincristine, dexamethasone).

Exclusion Criteria:

* Subjects who are less than or equal to six month from allogeneic hematopoietic stem cell transplant and who are on immunosuppressive therapy or have evidence of graft versus host disease
* Prior investigational therapy within 3 weeks of first dose. Investigational therapy is defined as treatment that is not approved for any indication.
* Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated CNS metastases must be stable for \> 2 weeks prior to Day 1.)
Pilot Study to Verify Effect of Smartpen Coordinated With Glucose Sensor.

The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.

Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 12 - 18 years
2. A clinical diagnosis of diabetes type 1 as determined by investigator for at least 12 months.
3. HbA1c \>7.5% (DCA)
4. Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing to use insulin pens and pen cartridges and are not willing to use an insulin pump or AHCL system
5. Subject is currently using a CGM or is willing to use the Guardian 4 system during the study.
6. Subject and parents agree to comply with the study protocol requirements
7. Subject and parents provide their signature on the Informed Consent Form

Exclusion Criteria:

1. Subject is unwilling or unable to use insulin pen(s).
2. Subject is in plans to use or is already using an insulin pump.
3. Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian 4 system during the study.
4. Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection).
5. Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device.
6. Subject has a positive urine pregnancy test at time of screening.
7. Subject is unwilling to participate in study procedures.
8. Subject is directly involved in the study as research staff.
9. Subject with poorly controlled thyroid or celiac disease.
10. Subject with any risk of exposure to MRI equipment, diathermy devices or other devices capable of generating strong magnetic fields
Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 75
* Patients with essential hypertension {95 mmHg ≤ sitDBP\< 115 mmHg at the end of placebo run-in treatment period}

Exclusion Criteria:

* Patients with mean sitSBP ≥ 200 mmHg
* Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
* Patients with secondary hypertension or suspected secondary hypertension
* Patients with malignant hypertension
* Patients who have received any medications with possible interactions with study drugs
* Patients with uncontrolled diabetes
* Patients with severe heart disease or severe cerebrovascular disease
* Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
* Patients with a history of malignant disease
* Patients with a history of autoimmune disease
* Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
* Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator
1-1-12 Wash-in for Desflurane Low Flow Anesthesia

We propose a new wash-in technique for desflurane low flow anesthesia with fresh gas flow of O2:N2O 1:1 L/min with desfluraene 12%.

The objective of this study is to identify time to achieve alveolar concentration of desflurane at1, 2, 3, 4, 5 and 6%.

The benefits of low flow anesthesia are economic, less pollution, more heat and humidity preservation but it requires appropriate wash-in phase. The current wash-in protocols are complicated and time consuming. We propose a new 1-1-12 desflurane wash-in protocol which is more simple and predictable.

The objective of this study is to identify time to achieve alveolar concentration of desflurane at 1, 2, 3, 4, 5 and 6% with 1-1-12 wash-in protocol.

All patients will receive iv propofol 2 mg/kg as induction agent and succinyl choline 1.5 mg/kg for intubation. Then the ventilation will be controlled to achieve end-tidal CO2 30-35 mmHg with O2:N2O 1:1 L/min with desflurane 12%. Time to achieve alveolar concentration of desflurane at 1, 2, 3, 4, 5 and 6% will be recorded and analyzed. After that, the concentration of desflurane and anesthetic technique will be adjusted to requirement of anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I-II
* age 18-64 years

Exclusion Criteria:

* BMI \> 35
* contraindicated for N2O
* with pulmonary or cardiac disease
PiPT in ADSM With MSD

The study objective is to establish feasibility of implementing a psychologically informed rehabilitation strategy while concurrently assessing its' effectiveness in Active duty service members (ADSM) with musculoskeletal disorders (MSD) seeking care in a US Navy shore-based healthcare setting. This intervention is intended to improve the management of chronic pain in order to optimize ADSM function.

The study team is proposing an observational prospective comparative cohort study. This study tests an implementation/strategy while observing/gathering information on the clinical intervention and related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* ADSM (at baseline; separation from the military post-treatment will not be grounds for exclusion)
* Patients presenting to an NMCP or a branch clinic physical therapy department
* Patients who have only receive their evaluation appointment for their primary complaint
* Patients prescribing for a primary complaint of a MSD (the following ICD-10 codes will be included: M13, M14.8, M15-19, M21-25, M40-43, M46-48, M50-54, M60-71, M73, M75-77)

Exclusion Criteria:

* Patients not eligible to receive outpatient physical therapy
* Patients receiving fewer than four treatment sessions of physical therapy
* Patients who are pregnant
* Patients receiving physical therapy for acute post-surgical recovery
* Patients scheduled for or subject to a Physical Evaluation Board (PEB) at baseline
* Coast Guard
Study of Nutritional Supplement Shakes in People About to Receive Their Debulking Surgery for Ovarian Cancer

The purpose of this study is to find out if it is possible to establish a nutritional support program for people who are scheduled to receive primary debulking surgery.

Design: This will be a prospective observational study to assess the feasibility of implementing a preoperative nutrition supplementation program.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Scheduled to undergo primary surgical debulking of ovarian, fallopian tube and primary peritoneal cancer
* Have a sufficient preoperative window during which the intervention can occur, with the last day of supplementation at least one and no more than two days prior to surgery; scheduling of the procedure should not be delayed due to participation in this investigation

Exclusion Criteria:

* Have received neoadjuvant chemotherapy
* Debulking surgery scheduled less than 8 days from initial visit
* Are scheduled for a minimally invasive procedure
* Unable to tolerate oral intake or have gastrointestinal issues that would prevent or prohibit oral supplement consumption
* Have diabetes mellitus
* Have allergies to the Ensure Surgery Immunonutrition Shake supplement
* Have galactosemia
Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children

Clinical investigation is aimed to assess the performance and safety of web-based ARVO 2.0, for evaluating possible Attention-Deficit/Hyperactive Disorder (ADHD) symptoms in children. Possible ADHD symptoms are recorded by using specific predetermined neurocognitive performance indicators (NPI's), derived during/from the game.

Results of ARVO are compared to the Conners Continuous Performance Test 3rd Edition™ (CPT 3) that is a task-oriented, automated 14-minute computerized assessment of attention-deficit (AD) related problems in individuals aged 8 years and older.

Performance and safety of ARVO and CPT 3 are compared in two clinical investigation populations, 8-13 years old ADHD children and typically developing (TD) children of the same age. Test are performed by the subject while monitoring adult supervises safety of the use.


Eligibility Criteria:
Inclusion Criteria:

ADHD group

The Inclusion criteria:

1. Signed informed consent (by guardian and a child)
2. Age of 8-13 at the time of consent
3. ADHD set by a licensed physician
4. Native language Finnish / Fluent Finnish language

TD group

The Inclusion criteria:

1. Signed informed consent (by guardian and child)
2. Age of 8-13 at the time of the consent
3. Native language Finnish / Fluent Finnish language

Exclusion Criteria:

ADHD group

1. Any diseases of the nervous system (ICD-10, G00-G99)
2. Mental and behavioural disorders due to psychoactive substance use (F10-F19)
3. Schizophrenia, schizotypal and delusional disorders (F20 - F29)
4. Acute severe depression or mania / hypomania (F30, F32, F33)
5. Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
6. Severe mental retardation (F72)
7. Disorders of psychological development (F80, F81, F83, F84)
8. Medication taken for ADHD (methylphenidate, lisdexamfetamine) on the test day (24 hour wash out)
9. Atomoxetine, guanfacine
10. Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision) Diagnosis search completeness criteria: Diagnosis present/absent in patient registry Kanta.

TD group

1. Set ADHD diagnosis.
2. Ongoing process related to setting an ADHD diagnosis, according to guardian's questionnaire.
3. Any diseases of the nervous system (ICD-10, G00-G99)
4. Mental and behavioural disorders due to psychoactive substance use (F10-F19)
5. Schizophrenia, schizotypal and delusional disorders (F20 - F29)
6. Acute severe depression or mania / hypomania (F30, F32, F33)
7. Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
8. Severe mental retardation (F72)
9. Disorders of psychological development (F80, F81, F83, F84)
10. Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision)
In Vivo Proof-of-principle Study of Raman Spectroscopy in Trial Participants With Bladder Tumours

The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the tumor.

The purpose with this clinical investigation is to perform Raman spectroscopy inside the vivid bladder and to acquire Raman spectra of normal and tumour bladder tissue, and in a post-processing step to determine the grade of the bladder tumor.

The recordings and overall results will be compared to standard histo/cytopathological examination of urological tissue to achieve a clinical useful concordance between gold standard histo/cytopathological diagnosis and diagnostic information established by Raman.

The MIB RAMAN SYSTEM in combination with a Raman probe will be used in the operating theatre at Herlev/Copenhagen hospital urology department, where the rigid resectoscopes will be used while the trial participant is under general anesthesia. Each measurement takes about 1-5 seconds and the whole procedure with the fiber optic probes is expected to prolong the operation with 10-15 minutes.

Eligibility Criteria:
Inclusion Criteria:

After booking for surgery the trial participants will be informed orally about the study and written material will be given by a doctor or nurse form the study group. If the trial participant accept to enter the study, written informed consent will be obtained. The trial participant will be informed that they can withdraw the informed consent at any time and the treatment will be according to the guidelines of the department.

Exclusion Criteria:

* Macroscopic hematuria
* Pregnant or breast-feeding women
* Expected poor compliance
* Persons \< 18 years
* Persons who do not read or understand Danish
* Dementia
Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome

The goal of this clinical trial is to compare outcomes of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation (HSCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients. The main questions it aims to answer are:

* The safety of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years.
* The efficacy of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years.

Participants will be randomized to one of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan)

Patients are randomized to one of two reduced intensity conditioning (RIC) regimens: the combination of fludarabine (30 mg/m\^2/day, days -6 to days -2, the total dase is 150 mg/m\^2) and busulfan (3.2 mg/kg/day, days -3 to days -2, the total dose is 6.4 mg/kg) (Flu/Bu) or fludarabine (30 mg/m\^2/day, days -6 to days -2, the total dose is 150 mg/m\^2) and melphalan (70 mg/m\^2/day, days -3 to days -2, the total dose is 140 mg/m\^2) (Flu/Mel). A total of 200 patients (100 to each arm) will be recruited in this study over a period of two years. Patients will be followed for up to 18 months from allogeneic hematopoietic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age equal or more than 18 years old.
* Patients diagnosed with AML or MDS.
* Patients who have related or unrelated bone marrow or peripheral blood donors and plan to undergo hematopoietic stem cell transplantation.
* Hct-specific complication index score (HCT-CI) more than or equal to 3 or the age of Patients ≥55 years.
* Sign the informed consent, promise to abide by the research procedures, and cooperate with the implementation of the whole process of the research.

Exclusion Criteria:

* Patients with central nervous system involvement.
* Patients with HIV seropositive.
* Patients with other serious diseases and a life expectancy of less than six months
* Patients with severe mental or psychological disorders.
* Patients without written informed consent.
The Effect of Vitamin D3 Supplementation on Hepcidin and Ferritin Serum Levels in Children With Chronic Kidney Disease

The goal of this clinical trial is to analyze the effects of in vitamin D3 on serum hepcidin and ferritin levels among children with chronic kidney disease. The main questions it aims to answer is:

"What is the effect of giving vitamin D3 on serum hepcidin and ferritin levels in children with chronic kidney disease?"

We will compare the effect of vitamin D3 administration on hepcidin and ferritin between 2 groups. Group A consists of children with GFR more 90 mL/min/1,73 m2. Group B consists of children with GFR less than 90 mL/min/1,73 m2

Participants will be given the same 2000 IU of Vitamin D/day for 6 weeks.

The primary objective of the study is to analyze the effects of vitamin D3 administration on serum levels of hepcidin and ferritin in children diagnosed with CKD. The research aims to measure these serum levels before and after vitamin D3 supplementation across different stages of kidney function, categorized by glomerular filtration rate (GFR). Specifically, it seeks to determine whether vitamin D3 can effectively reduce hepcidin levels and improve iron status as indicated by ferritin levels. The study employs a structured methodology involving children with CKD, divided into two groups based on their GFR: those with GFR \< 90 mL/min/1.73 m² and those with GFR ≥ 90 mL/min/1.73 m². Serum levels of vitamin D, hepcidin, and ferritin will be measured at baseline (before supplementation) and after a defined period of vitamin D3 administration. The research will utilize statistical analyses to compare these values within and between groups to establish any significant changes attributable to the supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 2 to 18 years diagnosed with chronic kidney diseases at Dr. Wahidin Sudirohusodo hospital
* Parents have signed their child's consent to participate in the study

Exclusion Criteria:

* History of blood transfusion 3 months prior
* Liver dysfunction
* Sepsis
* Routine consumption of Vitamin D
* Routine consumption of iron supplement
* Patients diagnosed with iron deficiency anemia