cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis

Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.

The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.

Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.

Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.

Study hypotheses :

Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.

Primary objective :

To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®


Eligibility Criteria:
Inclusion Criteria:

* Adults and children aged 6 years old and more
* Male or female
* Patients with cystic fibrosis (positive sudoral test, Cl \> 60 mmol/L)
* Followed in a CRCM (CF care centre)
* FEV1 ≥40%
* Informed consent collected from adults or parents or legal guardians and children.
* Affiliation to the National Health Insurance program (Sécurité sociale).

Exclusion Criteria:

* renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl
* recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis superior to 60 ml within 30 days prior to randomization
* Acute pulmonary exacerbation pathology, according to conference of consensus (2002), evaluated by :
* Cough increase
* Sputum increase
* Decrease in tolerance to effort
* Loss of weight, lack of appetite
* Deterioration of respiratory function
* Medical history of intolerance, toxicity or allergy to tobramycin, hypersensitivity to aminoside
The SOX Trial: Compression Stockings to Prevent the Post-Thrombotic Syndrome

The purpose of this study is to determine whether elastic compression stockings used for 2 years are effective in preventing the post-thrombotic syndrome in patients with symptomatic proximal deep venous thrombosis.

The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. At present, there is little to offer for the treatment of this condition. Prevention of PTS is the key to reducing its burden on patients and society. Elastic compression stockings (ECS) could be helpful in preventing PTS, however data on their effectiveness are scarce and conflicting.

Comparison(s): Knee-length, 30-40 mm Hg (Class II), graduated ECS worn on the DVT-affected leg daily for 2 years compared to knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism)
* Who have no contraindications to standard treatment with heparin and/or warfarin, and
* Who provide informed consent to participate

Exclusion Criteria:

* Contraindication to compression stockings
* Limited lifespan (estimated \< 6 months)
* Geographic inaccessibility preventing return for follow-up visits
* Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
* Treatment of acute DVT with thrombolytic agents
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2 to 6 month-old infant
* Available for entire study period

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with a pneumococcal conjugate vaccine.
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
* Known or suspected immune deficiency or suppression.
Verification Study and Reactivity Study for the Validity of QuQu Scale

Examine the construct validity, the test-retest reliability, the concurrent validity with the standard dementia rating scales and the reactivity of a novel dementia rating scale "QuQu scale: QUick QUestion scale" final for the evaluation of patients with Alzheimer's Disease Dementia and Mild Cognitive Impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Alzheimer's Disease Dementia and patients with cognitive concern without Dementia
2. Written Informed consent by each subject and/or a legal representative, and study informant. If the doctor decides that the patient has no trouble in understanding this study, the written informed consent of a legal representative may be exempted. If not, this study needs a written informed consent by a legal representative and the patient except the case where the consent is hardly obtained due to the progression of the disease.

Exclusion Criteria:

1. patients with other types of dementia (e.g. vascular dementia, Levy body dementia, frontotemporal dementia)
2. patients with other diseases which cause secondary dementia prior to Alzheimer's Disease Dementia
3. patients with other severe neurological disease or psychiatric disorder without Alzheimer's Disease Dementia
4. patients with other medical conditions where the investigators determine that it is inappropriate for the subject of this study (e.g. inappropriate for the evaluation of dementia rating scale)
Comparison of Pre-procedural PCR and Culture-based UTI Assessment Prior to Intravesical Botox Injection

This study is a retrospective record review to determine whether a novel multiplex PCR assay can be utilized as a screening method for UTI in patients receiving Botox injection to treat overactive bladder (OAB).

The novel multiplex real-time PCR assay with mixed floral antibiotic resistance profiling offers a higher degree of sensitivity and specificity than conventional culture methods in the identification of UTI pathogens as determined by a previous prospective comparison study. This is a retrospective record review comparing PCR and culture-based assessments for UTI in patients receiving Botox injection to treat overactive bladder (OAB). Investigators aim to determine whether M-PCR/P-AST can be utilized as a screening method for UTI in these patients and whether whether antibiotic prophylaxis, peri-procedural antibiotics, and post-injection antibiotic therapy based on patients' pre-procedural M-PCR/P-AST results in improved response to Botox injection compared to standard of care. The attributes and advantages of PCR testing over the use of traditional urine cultures, and the potential identification of polymicrobial infections with complicated resistance sharing mechanisms, may significantly improve patient care.

Eligibility Criteria:
Inclusion/Exclusion Criteria:

* Subject is male or female
* \>18 years of age at date of injection
* Subject receiving BoNT injection for symptoms of OAB (including urgency, urinary incontinence, and detrusor overactivity) refractory to first-line therapies
A Study of LP-168 in Healthy Volunteers

This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.

This study will enroll 70 healthy subjects, will set 4 SAD and 3 MAD dose cohorts, with 10 subjects in each dose cohort. Subjects will be assigned to L-168 or placebo group by ratio of 8:2 in each cohort. Sentinel subjects will be used in each dose cohort during the single dose phase.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have no history of serious digestive system, central nervous system, cardiovascular system, kidney, respiratory system, metabolism and endocrine, skeletal and muscular system, blood system disease and cancer
* Subjects (including partners) are willing to take effective contraception measures during study and within 3 months after last dose
* Male and female healthy subjects aged 18 to 55 years old
* Male subjects weigh ≥ 50 kg, and female subjects weigh ≥ 45 kg
* Subjects able to understand and comply with study requirements
* Willing to sign the informed consent

Exclusion Criteria:

* Abnormal vital signs, physical examination or laboratory tests with clinical significance
* Abnormal ECG or echocardiography with clinical significance
* Hepatitis B virus, Hepatitis C virus, HIV and syphilis test positive. COVID-19 DNA positive.
* Subjects who have taken any drugs or health care products within 14 or 28 days before administration the study drug
* Subjects who have consumed diets that may alter the activity of liver metabolic enzymes within 7 days before administration the study drug
* Subjects who have consumed tea or alcohol-containing food product within 24hrs before administration the study drug
* Subjects who have a history of dysphagia or condition may affect drug absorption, distribution, metabolism and excretion
* Female subjects are breastfeeding or pregnant
* Subjects who have a history of drug/ alcohol/ tobacco abuse
* Subjects who have had a blood donation or massive blood loss within three months before screening; or had surgery within six months before screening
* Subjects who have participated in other clinical trial within three months before screening
* Subjects have special dietary requirements or cannot tolerate a standard meal
Efficacy of Tooth Bleaching With 35% and 6% Hydrogen Peroxide in Primary Dentition

The aesthetics of dental elements generates great psychological and social impacts, both in the deciduous and permanent dentition. One of the techniques widely used to visually improve the appearance of teeth is bleaching. Bleaching can be performed both at home and in a dental office. In office whitening, the technique used consists of applying the whitening gel to the dental surfaces in concentrations ranging from 25% to 50% of hydrogen peroxide. However, recent studies show that low and medium concentration bleaching agents based on hydrogen peroxide have been effective and present a lower risk of sensitivity to the patient. In view of the above, this study aims to carry out a controlled and randomized clinical trial to compare the effectiveness of dental bleaching in deciduous teeth with hydrogen peroxide at concentrations of 35% and 6%. For this, 38 patients aged 03 to 06 years will be selected, allocated in 2 groups (G1 - Hydrogen Peroxide 35%, n=19 and G2- Hydrogen Peroxide 6%, n=19). Bleaching will be carried out in up to three sessions, with an interval of 7 days between them and the evaluation of color and tooth sensitivity will be carried out 48 hours after each bleaching session. The color assessment will be measured using a digital spectrometer and tooth sensitivity using the Pain Level Scale (Wong-Baker Faces®). Descriptive statistical analysis will be carried out, containing the mean and standard deviation in the calculation and normality and homogeneity tests will be carried out, for subsequent adequate statistical analysis. As a result, it is expected that there is no significant difference between the groups in terms of color variation and that the low-concentration bleaching group has the lowest sensitivity index.


Eligibility Criteria:
Inclusion Criteria:

* Age range from 03 to 06 years old;
* Vital or non-vital teeth (already endodontically treated) with severe to moderate discoloration;
* No active carious lesions;
* No lesions in the oral cavity;
* No report of previous tooth sensitivity.

Exclusion Criteria:

- Patients who during anamnesis report allergies to dyes or latex, who withdraw from participating in the study, as well as those who do not attend the callbacks, will be excluded.
Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure

Many deep carious teeth are treated unnecessarily by root canal therapy, while with using current techniques and advances in compatible dental materials in addition to better understanding of biological response of the dental pulp, many can be treated conservatively via vital pulp therapy procedures.

Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.

The aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.

Ethics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Permanent teeth with mature or immature apices
* Have no significant medical problems
* The tooth should give positive response to cold test and electric pulp test (EPT)
* Probing pocket depth and mobility within normal limits
* No Signs of pulp necrosis including sinus tract or swelling
* Radiographically ; caries either exposing the pulps or reaching more than 2\\3 the distance from the dentino-enamel junction (DEJ) to the pulp
* The tooth can be restored via direct restoration

Exclusion Criteria:

* Medically compromised patients
* Negative response to cold test
* Mobility
* Sinus tract
* Swelling
* Non restorable teeth or badly broken teeth
In Stent ELUTES Study

This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.


Eligibility Criteria:
Inclusion Criteria:

* Patient has given informed consent
* Patient has target lesion in native coronary artery or coronary bypass graft
* Patient has in-stent restenosis \>60%
* Patient has reference artery diameter 2.7-3.5
* Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months.

Exclusion Criteria:

* Patient is less than 18 years of age
* Patient is pregnant or breast feeding
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study.
* Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.
Effect of Liver Injury on Mortality in Coronavirus Disease-2019 Patients Admitted to Intensive Care Unit

In addition to primarily affecting the lungs, coronavirus disease-2019 (COVID-19) disease can also affect many different organs, especially the heart, kidneys, liver and brain. In this group of patients, the impact of an important organ such as the liver can lead to a further deterioration of the clinical course. In this study, critical patients admitted to Gazi Yasargil Training and Research Hospital intensive care unit (ICU) due to COVID-19 between April 1 and October 1, 2020 were retrospectively analyzed. The effect of liver damage on mortality in critical COVID-19 patients was investigated. The necessary permits for the study were obtained from the Scientific Research Platform of the T.R. Ministry of Health. (20.11.2020) Patients diagnosed with COVID-19 on the specified dates, followed in the ICU, older than 18 years, identified as critical/serious according to the World Health Organization and provisional guidelines of the Scientific Board of the T.R. Ministry of Health will be included in the study.

ICU patients without COVID-19, COVID-19 patients under 18 years of age,COVID-19 patients with known liver disease, and COVID-19 patients with mild to moderate symptoms will be excluded from the study.

Patients' age, gender, comorbidity, Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA) scores when first admitted to the ICU, hemogram parameters (white blood cell count, neutrophil, lymphocyte, hemoglobin, platelet count), coagulation parameters (prothrombin time, activated partial thromboplastin time and D-dimer, blood biochemistry results (C-reactive protein, lactate dehydrogenase, creatine kinase , alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, direct bilirubin and indirect bilirubin), procalcitonin and ferritin levels will be recorded. In addition, the number of days spent in the ICU and whether mortality develops or not will be recorded. It will also be recorded whether mortality develops on day 7 and day 28.

Patients will be divided into three groups according to their ALT, AST and total bilirubin levels at the time of admission to the ICU. Group 1 will consist of patients with normal ALT, AST and total bilirubin values. Group 2 will consist of patients whose ALT, AST or total bilirubin levels are up to 3 times upper limit of normal. Group 3 will consist of patients whose ALT, AST or total bilirubin levels are increased more than 3 times upper limit of normal.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COVID-19 on the specified dates, followed in the ICU, older than 18 years, identified as critical/serious according to the World Health Organization and provisional guidelines of the Scientific Board of the T.R. Ministry of Health will be included in the study.

Exclusion Criteria:

* ICU patients without COVID-19, COVID-19 patients under 18 years of age,COVID-19 patients with known liver disease, and COVID-19 patients with mild to moderate symptoms will be excluded from the study.
Combination Chemotherapy Plus Rituximab in Treating Patients With Relapsed Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab in treating patients who have relapsed non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine response rate to cisplatin, cytarabine, and dexamethasone (DHAP) plus rituximab in patients with relapsed CD20+ B-cell non-Hodgkin's lymphoma.
* Determine the percentage of patients able to proceed to transplant after two courses of this treatment regimen.
* Determine the duration of response and overall survival of the patients not proceeding to transplant after two courses of this treatment regimen.

OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22 for the first course only. Patients receive dexamethasone orally or IV on days 1-4, cisplatin IV continuously for 24 hours on day 1, cytarabine IV over 3 hours every 12 hours for 2 doses on day 2, and sargramostim (GM-CSF) subcutaneously on days 3-12 or until blood counts recover. Chemotherapy repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 17-50 patients will be accrued for this study within 11 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed CD20+ B-cell non-Hodgkin's lymphoma

  * Relapsed following chemotherapy and eligible for platinum-containing regimen
* Measurable disease

  * Must be at least 1.5 x 1.5 cm

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 75,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.0 mg/dL

Renal:

* Creatinine no greater than 1.5 times upper limit of normal

Cardiovascular:

* No uncontrolled hypertension

Other:

* HIV negative
* No other active malignancy
* No uncontrolled diabetes mellitus
* No uncontrolled peptic ulcer disease
* No uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Safety and Feasibility of Fasting While Receiving Chemotherapy

Fasting (refraining from eating and drinking) during the day is safe while receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Established diagnosis of cancer
* Signed informed consent
* Adequate CBC and chemistry to receive chemotherapy

Exclusion Criteria:

* Pregnancy
Efficacy Testing of VeCollal Products

To assess VeCollal formula on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Constant drug use
* Students who are currently taking courses taught by the principal investigator of this trial.
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B

This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects, 12 to 65 years old
* Severe hemophilia B (FIX activity of ≤ 2%)
* Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for \> 150 exposure days (EDs)
* No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX
* Written informed consent for study participation
* On-demand subjects only, who have experienced a minimum average of 2 non-trauma induced bleeding episodes requiring treatment with a FIX product during the previous 6 or 3 months

Exclusion Criteria:

* Known hypersensitivity to any FIX product or hamster protein
* Known congenital or acquired coagulation disorder other than congenital FIX deficiency
* HIV positive subjects with a CD4 count \< 200/mm3
* Low platelet count, kidney or liver dysfunction
* Recent life-threatening bleeding episode