cyrilzakka/clinical-trials huggingface dataset:
The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Inflammometry

Background Chronic inflammation in peripheral airways plays an important role in the pathophysiology of asthma. Extrafine hydrofluoroalkane (HFA) beclometasone is distinguished from other ICS because of its fine aerosol characteristics. As a result, there is a greater extent of deposition of extrafine HFA-beclometasone in the peripheral airways. Therefore, extrafine HFA-beclometasone may have an extra anti-inflammatory effect in children with asthma.

Aim To analyse the potential extra anti-inflammatory effect of extrafine HFA-beclometasone compared to HFA-flucticasone in children with asthma by means of alveolar nitric oxide (NO) concentration and bronchial NO flux, inflammatory markers in exhaled breath condensate (EBC), and conventional parameters.

Method In a cross-over study design of 6 months, 33 children, aged 6-12 years, with doctor diagnosed mild persistent asthma, were treated with extrafine HFA-beclometasone inhaled from an autohaler and HFA-flucticasone inhaled from a discus. Primary outcome parameters of this study were; alveolar NO concentration and bronchial NO flux. Secondary outcome parameters were inflammatory markers in EBC, lung function parameters, symptoms, presence and duration of exacerbations and adverse effects. All parameters were recorded at baseline and after each treatment period.


Eligibility Criteria:
Inclusion Criteria:

* age 6.5 - 12 years
* children with mild-persistent asthma
* treatment with inhaled corticosteroids(≤ 500 μg HFA-Flucticasone, ≤ 800 μg Budesonide, or ≤ 800 μg HFA-Beclometasone, daily)
* allowed, but needed to be used during the entire study period;

  * short / long-acting β2-agonists
  * leukotrien receptor antagonists
  * antihistamines

Exclusion Criteria:

* Instability of asthma during the past 3 months
* Presence of a disease that may intervene with the results of this study
* Active smoking
* Mental retardation
* Inability to perform the measurements properly
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Eligibility Criteria:
Inclusion Criteria:

* Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
* Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
* Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
* Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1 (V1)
* Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
* Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a concomitant AED

Exclusion Criteria:

* History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
* History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Human Umbilical Cord Mesenchymal Stem Cell Transplantation in Articular Cartilage Defect

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.

Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.

To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients must consent in writing to participate in the study by signing and dating an informed consent document
* Healthy patients with no major history of illness
* Patients must have a diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
* Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
* Patients must have had more than Grade 4 (0\~10 point numeric scale) pain at least for four months
* Patient's damaged cartilage area should be in the range of 2-6cm2

Exclusion Criteria:

* Pregnant women or lactating mothers
* Patients who have received any anti-inflammatory drugs including herb-drug within 14 days
* Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment
* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection
* Impaired liver function, abnormal blood coagulation, combine other tumor or special condition
* Patients who had participated in other clinical trials within three months prior to this study
Clearance of 25-hydroxyvitamin D in Chronic Kidney Disease

The goal of this study is to better understand vitamin D catabolism and how it is affected by CKD and race.

Specifically, the study team will evaluate the metabolic clearance of 25-hydroxyvitamin D3 in individuals with varying degrees of CKD and among participants who self-report race as Caucasian, African American or African. The long-term goal of this work is to enhance the clinical evaluation and treatment of impaired vitamin D metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Self-reported race Caucasian, African American, or African
* Serum total 25(OH)D 10-50 ng/mL
* Estimated GFR:

  * 60 mL/min/1.73m2 (N=40) 15-45 mL/min/1.73m2 (N=40) \<15 mL/min/1.73m2, treated with hemodialysis (N=40)

Exclusion Criteria:

* Primary hyperparathyroidism
* Gastric bypass
* Tuberculosis or sarcoidosis
* Current pregnancy
* Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic encephalopathy, bilirubin \>=2 mg/dL, serum albumin \<=3.5 g/dL, or PT \>= 4 seconds)
* Use of vitamin D3, or vitamin D2 supplements exceeding a mean daily dose of 400 IU, within 3 months (wash-out allowed)
* Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce CYP24A1 within 4 weeks (wash-out allowed)
* Serum calcium \> 10.1 mg/dL
* Hemoglobin \< 10 g/dL
Bone Age Assessment in Children Using Ultrasound Compared to Wrist X-ray

Bone age assessment in children is based on the interpretation of hand x-ray scans according to Greulich and Pyle (GP) standard atlas and frequently used for evaluating growth and puberty in children and adolescents.

To address the disadvantage of repeated irradiation, the need for specialized radiation centers, heavy equipment and subjective reading a new device, SonicBone was developed. SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves, propagating along a measured bone distance. The aim of the study is to evaluate an ultrasound based device, SonicBone, compared to the current method in children. The investigators will be compared the US assessment to available bone age X-ray that exists in the medical files of the patients. The investigators will not do bone age X-ray scans especially for the current study.

Bone age assessment in children is based on the interpretation of hand x-ray scans according to Greulich and Pyle standard atlas and frequently used for evaluating growth and puberty in children and adolescents.

To address the disadvantage of repeated irradiation, the need for specialized radiation centers, heavy equipment and subjective reading a new device, SonicBone was developed. SonicBone utilizes a quantitative ultrasonographic technology of ultrasonic (US) waves, propagating along a measured bone distance. The aim of the study is to evaluate the ultrasound based device, SonicBone, and to compare it to the current method used in children.

The SonicBone device (Rishon Lezion, Israel) is a small (50cm X 25cm X 25cm), portable, bone sonometer, which measures two parameters:

1. speed of propagation through bone (speed-of-sound, SOS, m/sec) of inaudible high frequency waves of a short ultrasound pulse; and
2. attenuation (ATN; the decay rate) of the sound wave by the bone as a function of the distance it travels between a transmitter probe and a receiver probe15. The hand is measured by: 1- wrist (W), measuring SOS and ATN at the distal radius and ulna secondary ossification centers of the epiphyses; 2-metacarpals (MC), measuring SOS and ATN at the distal metacarpal epiphyses; and 3- phalange (P), measuring SOS and ATN along the bent proximal third phalanx shaft, growth plate and epiphysis. The average of those 3 readings is define as the child's bone age by SonicBone. All ultrasonic examinations will be conducted at the Pediatric Endocrinology Clinic, by a trained technician.

X-ray scans will be evaluated independently by a pediatric endocrinologist according to the GP atlas.

Eligibility Criteria:
Inclusion Criteria:

* Children 3.5-18 years old refered to the endocrine pediatric clinic due to short stature or other growth abnormalities

Exclusion Criteria:

* Children with bone disease
* Children who within the last year took medications which might change bone metabolism or mineralization
Study of ARO-HIF2 in Patients With Advanced Clear Cell Renal Cell Carcinoma

The purpose of this study is to evaluate the safety and efficacy of ARO-HIF2 injection (also referred to as ARO-HIF2) and to determine the recommended Phase 2 dose in the treatment of patients with advanced clear cell renal cell carcinoma (ccRCC).


Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* Histologically confirmed locally advanced or metastatic clear cell renal cell carcinoma that has progressed during or after at least two prior therapeutic regimens which must include vascular endothelial growth factor (VEGF)-targeted therapy and checkpoint inhibitor therapy or that has otherwise failed such therapies, is measurable disease per RECIST 1.1 criteria, is biopsy accessible
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Estimated life expectancy of longer than 3 months
* Adequate organ function at screening

Exclusion Criteria:

* History of untreated brain metastasis or leptomeningeal disease or spinal cord compression
* Failure to recover from reversible effects of prior anti-cancer therapy
* Has received systemic therapy or radiation therapy within 2 weeks prior to first dose
* History of solid organ or stem cell transplantation
* Current use of anti-VEGF or mammalian target of rapamycin (mTOR) agents, or chronic immunosuppressive therapy
* Any prior use of hypoxia inducible factor 2 (HIF2) inhibitors within 6 months prior to first dose
* Current use of immune checkpoint inhibitors
* Use of an investigational agent or device within 2 weeks prior to dosing, or current participation in an investigational study
* Known HIV, hepatitis B or hepatitis C
* History of other clinically meaningful disease
* Major surgery within 4 weeks of Screening
* Active malignancy requiring therapy other than ccRCC within 3 years of study entry

Note: Other eligibility criteria may apply per protocol.
Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis

Primary Objective:

To assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Secondary Objective:

To assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses

Following the single dose of study medication, the study period for each patient will be 168 days.

Eligibility Criteria:
Inclusion criteria:

* Japanese male or female patients, aged 40 years or older, with knee osteoarthritis
* Diagnosis of primary knee osteoarthritis, based upon the following:

  * X-ray or magnetic response imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation
  * Patients will be Kellegen and Lawrence classification II or III, and total Western Ontario McMaster (WOMAC) score below or equal to 72
  * Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis

Exclusion criteria:

* Women of child bearing potential
* Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos syndrome, Gaucher's disease, Stickler's syndrome, joint infection, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy
* Presence of local skin abnormality at the affected knee joint
* Any patient who received intra-articular injection within 3 months prior to administration

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
CKD-828(80/2.5mg) Pharmacokinetic Study

The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.


Eligibility Criteria:
Inclusion Criteria:

* A healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
* Have not any congenital or chronic diseases and medical symptom.
* Appropriate for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening).
* Able to participate in the entire trial.
* Signed the informed consent form prior to the study participation.

Exclusion Criteria:

* Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administraion.
* The evidence of acute disease within 28 days prior to the first IP administraion.
* Disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
* Hypersensitivity Telmisartan or Amlodipine.
* SBP\<90mmHg or DBP\<50mmHg.
* Abnormal laboratory result(s): AST or ALT \> 1.25 times of upper limit / Total bilirubin \> 1.5 times of upper limit.
* A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
* Diet(Especially, grapefruit juice-within 7 days prior to the first IP administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Donated whole blood within 60 days prior to the first IP administraion.
* Participated in the other clinical trials within 90days prior to the first IP administraion.
* Medicine within 10 days prior to the first IP administraion? Does the medication affect this trial.
* A pregnant or nursing women who does not use medically acceptable birth control.
* Appropriate for the trial judging from principal investigator.
Cardiovascular Assessment of Pediatric Cancer Survivors

The goal of this observational study is to evaluate cardiac and vascular health status of pediatric cancer survivors.

All pediatric cancer survivors were evaluated with cardiological examination, ECG, transthoracic echocardiography (transesophageal echocardiography when required), NT-proBNP, cTnI, kidney function tests, liver function tests, fasting blood glucose, cholesterol panel, iron, iron binding capacity, ferritin, transferrin saturation, B12, vitamin D, folic acid, urinanalysis, hemogram and a questionnaire about living with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cancer at pediatric age

Exclusion Criteria:

* Having cancer after 18 years of age
Evaluation of Periodontal Ligament Distraction Using a Modified Surgical Technique for Retraction of Maxillary Canines

Surgical modification technique try to get bodily movement during upper canine retraction.

I- Original surgical technique (Liou and Huang technique, 1998) :

On the conventional surgical side, (the control side), the intersepital bone was undermined by two vertical cuts on the mesio-buccal and mesio-palatal line angles of the first premolar socket. They were connected at the base of the socket by an oblique cut. The surgical round bur was held parallel to the long axis of the canine and moved buccolingually, while shaving the interseptal bone buccolingual (back-and-forth) shaving movements were reduced the thickness of the interseptal bone by approximately 1 mm

II- Modified surgical technique:

In the surgical modification side, (the experimental side), intra-alveolar mesio-buccal and mesio-palatal cuts and interseptal bone shaving were done by surgical round bur and copious irrigation, without the oblique cut since it was done blindly in the original surgical technique. A buccal semilunar flap was opened on the apical area of canine-premolar region. The surgical pin helped also in location of the point of initial drilling of the apical horizontal cut from buccal approach, when the surgical pin's socket arm rested on the depth of the socket, the vestibular arm marked the point of access. It also estimated mesiodeistal extension of the apical horizontal cut. The apical horizontal cut was started from the socket apex to half way of the interseptal bone mesiodistally as an extension and for the depth, Mallet and Chisel were used from the cortical bone to reach the mesio-palatal cut. The flap was sutured. This surgical modification step provided more predictability and safer surgery than the blind oblique cut in the original surgical technique.

Eligibility Criteria:
Inclusion Criteria:

1. Orthodontic patients needed extraction of upper first premolars, with age range from 18 - 25 years old.
2. All patients were medically free. (See Appendix II)
3. No previous orthodontic treatment.
4. Adequate oral hygiene and periodontally healthy teeth.
5. The canines were almost leveled and aligned.
6. Maximum anchorage requirements.
7. Healthy canines; no deep carious lesions, no endodontic lesions, no root canal treatment, nor internal or external root resorption.
8. All patients were informed of the procedure and signed the consents.

Exclusion Criteria:

Exclusion Criteria

Subjects were excluded from the study when:

1. They failed to keep several consecutive appointments.
2. Oral hygiene was subjectively judged as deteriorating during the preliminary stages of patient preparation.
3. Compliance with the instructions provided was inadequate.
Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile

The purpose of this randomized, controlled, cross over single meal study is to investigate the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for their intake. The results from this project will increase our knowledge about nutritional value of dairy proteins, which is necessary to decide whether dairy products can be recommended for prevention of weight related bone loss.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females between 18 and 50 years
* BMI 25-40

Exclusion Criteria:

* Physical activity more than 10 hours weekly
* Smoking
* Diagnosed osteoporosis in at least one parent
* Dietary supplements and vitamin pills (during the study and 2 months before the start)
* Vegetarians and vegans
* Lactose intolerant
* Women who are pregnant, breastfeeding or post-menstrual
* Regular intake of medication
* Chronic diseases (including osteoporosis, cancer, diabetes, cardiovascular disease and mental disorders)
* Participation in other clinical trials that could affect the test results
* Donation of blod within 3 months before intervention start
* Hypersensitivity to paraaminobenzoic acid (PABA)
* Not able to comply with the procedures established by the Protocol
Study of Nasal Insulin to Fight Forgetfulness - Device Study

The SNIFF Device study will involve using a device to administer insulin through each participant's nose or intra-nasally. Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. This study is measuring how much insulin the device delivers. In addition, this study will look at the effects of insulin or placebo administered intra-nasally using a nebulizer-like device on memory, blood, and cerebral spinal fluid.

The aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF).

A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels.

The study will consist of a single site, randomized, double-blind trial comparing the acute effects of INI (20 International Units) or placebo delivered with nebulizer-like device on CSF insulin levels, AD biomarkers and memory. At study entry, participants will be randomized to receive either an acute dose of insulin or placebo first, and the other substance on a second visit. Participants who are cognitively normal or who have aMCI (n=30) will be enrolled. The primary outcome measure will be to test the hypothesis that CSF insulin levels will increase 30 minutes after receiving a 20 International Units dose of insulin delivered with a nebulizer-like device, compared to levels achieved 30 minutes after placebo.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Cognitively normal or diagnosis of aMCI
* Stable medical condition for 3 months prior to screening visit
* Stable medications for 4 weeks prior to the screening and study visits
* Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

Exclusion Criteria:

* A diagnosis of dementia
* History of a clinically significant stroke
* Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
* Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus
* Current or past use of insulin or any other anti-diabetic medication within 5 years of Screening visit.
* History of cancer five years prior to screening (history of skin melanoma or stable prostate cancer are not exclusionary)
* History of seizure within past five years
* Pregnancy or possible pregnancy.
* Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa)
* Residence in a skilled nursing facility at screening
* Use of an investigational agent within two months of screening visit
* Regular use of alcohol, narcotics, anticonvulsants, antiparkinsonian medications, or any other exclusionary medications