louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02953379: Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
Official title: Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2016-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Signed Consent of the patient;
* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can

  ´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* Decongestants dependent patients or patients receiving allergen specific immunotherapy;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs);
* History of hypertension, coronary artery disease, cardiac arrhythmias, glaucoma, hyperthyroidism and / or prostatic hypertrophy.

Primary outcomes:
measure: Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief
timeFrame: 14 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04774679: Macroscopic on Cite Evaluation of EUS-FNA Specimen With 22 G Needle
Official title: Macroscopic on Cite Evaluation of EUS-FNA Specimen of Gastrointestinal Tumours With Everyday Needle (22g EUS FNA Needle)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: GI Cancer
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In order for the diagnosis of digestive system tumors and their appropriate treatment afterward, the type of these tumors should be determined by the pathologist. Pathology doctors need sufficient tissue (a small part of the organ thought to be diseased) to make a diagnosis. Tissue samples were taken from the patients by biopsy procedure. It is examined with microscopes by performing various staining and occasionally it is reported that sufficient tissue cannot be provided to make a diagnosis. In this case, patients may be subjected to repeated biopsy procedures. The aim of this study is to investigate whether the biopsy material obtained by endoscopic ultrasonography (EUS) is sufficient for the diagnosis of the pathology physician with the naked eye. Researchers will try to determine to what extent the physician performing the biopsy procedure can predict whether the tissue he has obtained is sufficient for the pathologist. In this way, researchers think that fewer biopsy repetitions will be needed in the future.

Detailed description: This study was designed to improve the acquisition of sufficient tissue (EUS-FNA) with endosonography-assisted fine needle aspiration biopsy, which has been approved and used worldwide for the diagnosis of digestive system diseases. The procedure to be applied in the study is to determine the visible tissue fragments in the sample to be taken after the standard EUS-FNA procedure and to compare it with the diagnosis made by the pathologist. Patients with a tumor detected in the digestive system and referred to the investigation unit for tissue diagnosis will be included in this study. The data obtained in the study will be collected prospectively and will be analyzed retrospectively.

Eligibility criteria: Inclusion Criteria:

1. İn the age range of 18-80 years old
2. Tumour detected withcross-sectional imagined technics in the digestive system

Exclusion Criteria:

1. Refuse to give written informed consent
2. Established bleeding disorder
3. INR\>1.5IU plaelet count \<100000/dL

Primary outcomes:
measure: Correlation of a macroscopically visible fragments in the 22g EUS-FNA needle specimens with final histologic diagnosis
timeFrame: 1-2 weeks
Secondary outcomes:
measure: Area Under the size of the macroscopically visible core size versus histologic core size
timeFrame: 1-2 weeks
Other outcomes:
Locations:
city: Izmit
country: Turkey
facility: Kocaeli University Medical Faculty Hospital
state: Kocaeli
Study officials:
References:
Clinical trial NCT03209479: Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
Official title: Copaxone Subcutaneous Injection Syringe Special Drug Use-Result Investigation (All-Case Investigation) "Prevention of Relapse of Multiple Sclerosis"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Teva Takeda Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 1332
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of all participants with a diagnosis of multiple sclerosis and received their first dose of Copaxone/glatiramer acetate.

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Copaxone subcutaneous injection syringe (hereinafter referred to as Copaxone) in patients with multiple sclerosis in the routine clinical setting.

Detailed description: The drug being tested in this study is called Glatiramer acetate is being tested to treat people who have Multiple sclerosis. This study will look at the safety and efficacy of Glatiramer acetate in patients with multiple sclerosis in the routine clinical setting.

The study will enroll approximately 1000 patients.

• Glatiramer acetate subcutaneous injection syringe

This multi-center trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

- All patients treated with Copaxone from the first day of market launch of the product

Exclusion Criteria:

-None

Primary outcomes:
measure: Percentage of participants who had one or more adverse events
timeFrame: Up to 24 months
measure: Annual Relapse Rate (ARR)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Changes in the number of lesions from brain MRI findings
timeFrame: Up to 24 months
measure: Changes in functional evaluation scores (Expanded Disability Status Scale [EDSS])
timeFrame: Up to 24 months
measure: Changes in functional evaluation scores (Functional Systems [FS])
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda (Note: This product was divested to Teva Takeda Pharma Ltd. in 2024.)
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01615679: Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder
Official title: Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult Attention-deficit/Hyperactivity Disorder
Keywords: Non-interventional study
Attention Deficit/Hyperactivity Disorder
ADHD
Lead sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2012-06-08
Enrollment: 468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with newly diagnosed ADHD who shall be treated with Medikinet(R) adult.

Brief summary: Non-interventional study to gain further information about the therapy progression in routine treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be on the improvement of the clinical global impression (CGI) in comparison to the outcome of randomized, controlled studies.


Eligibility criteria: Inclusion Criteria:

* Adult patients with newly diagnosed ADHD

Exclusion Criteria:

* Known sensitivity to methylphenidate or any of the excipients
* Glaucoma
* Phaeochromocytoma
* During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis
* Hyperthyroidism or Thyrotoxicosis
* Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder.
* Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled)
* pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels)
* pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke
* a history of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H2-receptor blockers or in antacid therapy,

Primary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: 12-14 weeks
Secondary outcomes:
measure: Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report
timeFrame: 12-14 weeks
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie
Study officials:
affiliation: Medice Arzneimittel Pütter GmbH & Co KG
name: Roland Fischer, Dr.
role: STUDY_CHAIR
affiliation: Universität des Saarlandes, Institut für Gerichtliche Psychologie und Psychiatrie
name: Michael Rösler, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02205879: Pregabalin for Alcohol Dependence
Official title: Double Blind Placebo Controlled Randomized Clinical Trial of Pregabalin for Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcoholism
Keywords: pregabalin
patients
treatment
Lead sponsor: St. Petersburg Bekhterev Research Psychoneurological Institute
Sponsor class: OTHER
Collaborators: name: St.-Petersburg Bekhterev Research Psychoneurological Institute, Russian Federation
First posted: 2014-07-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is: Pregabalin is superior to placebo in preventing relapse to drinking and reducing drinking severity

Detailed description: This is a two cell double blind placebo controlled randomized clinical trial of pregabalin for alcohol dependence

Eligibility criteria: Inclusion Criteria:

* Alcohol Dependence by ICD-X criteria

Exclusion Criteria:

* Severe co-morbid psychiatric and somatic diseases

Primary outcomes:
measure: Retention in treatment
timeFrame: three months
Secondary outcomes:
measure: Weekly alcohol consumption
timeFrame: three months
Other outcomes:
measure: Anxiety
timeFrame: three months
Locations:
city: St.-Petersburg
country: Russian Federation
facility: St.-Petersburg Bekhterev Reserach Psychoneurological Institute
Study officials:
References:
Clinical trial NCT01230879: Effect of Ageing on Airway Remodeling
Official title: Study of Bronchoalveolar Lung Remodeling in Subjects From 60 Years Free of Progressive Lung Disease: Structure-function Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aging
Keywords: Aging lung
Airway remodeling
Airway segmentation
Chest CT
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2010-10-29
Enrollment: 101
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to investigate the relationship between aging and morphological changes in the lung. 120 consecutive healthy volunteers over 60 years will be enrolled for this trial.

Detailed description: Chest multidetector CT without injection and spirometry data will be obtained from a multicentric sample of individuals between 60 and 95 years of ageExclusion criteria were current smoking, history of smoking within the past 10 years, any known chronic or acute pulmonary disease. Individuals treated with Amiodarone, Bleomycin or methotrexate were excludedOutcome

Eligibility criteria: Inclusion Criteria:

* People from 60 to 95 years old free from chest disease or history of chest disease

Exclusion Criteria:

* Chronic cough
* Dyspnea
* Sinonasal or chest infection during enrollment
* Myocardial infarction.
* Current smoker or past smoker with more than 10 pack year intoxication

Primary outcomes:
measure: Bronchial wall thickness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Montpellier Hospital
Study officials:
affiliation: University Montpellier Hospital
name: BOMMART Sebastien, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bommart S, Marin G, Bourdin A, Molinari N, Klein F, Hayot M, Vachier I, Chanez P, Mercier J, Vernhet-Kovacsik H. Relationship between CT air trapping criteria and lung function in small airway impairment quantification. BMC Pulm Med. 2014 Feb 28;14:29. doi: 10.1186/1471-2466-14-29.
Clinical trial NCT06811779: Comparison of Effectiveness of Disinfectants
Official title: Comparison of Effectiveness of Sodium Hypochlorite and Chlorhexidine Gluconate for Disinfection of Gutta Percha Cones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Root Canal Infection
Keywords: chemical disinfection
chlorhexidine gluconate
gutta percha
sodium hypochlorite
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a comparative experimental study to compare the efficacy of chemical disinfection agents , sodium hypochlorite and chlorhexidine gluconate in decontaminating gutta percha cones

Detailed description: The study design is a comparative study which was done to compare the efficacy of chemical disinfection agents on decontaminating the gutta percha cones .

In this study, 124 standardized size-80 gutta-percha (GP) cones (Dentsply, Germany) were used to assess the efficacy of chemical disinfectants.

The cones were first sterilized using ethylene oxide to ensure baseline sterility. Following sterilization, 124 cones were allocated into two experimental groups (n = 62 each) for contamination.

group A . gp were immersed in 20ml of Enterococcus faecalis solution group B . gp were immersed in 20 ml of human saliva in patients undergoing root canal therapy

samples were incubated at 37°C for 72 hours to ensure uniform and thorough contamination

after incubation period cones were dried and divide into subgroups based on disinfectant agent applied .

The cones were immersed in disinfectant agent for 1 min and 10 min . Cones were dried again and immersed in brain heard infusion broth samples were again incubated at 37°C for 72 hours The presence of bacterial growth was determined by assessing turbidity in the broth, indicating viable microorganisms.

Eligibility criteria: Inclusion Criteria:

* healthy individual age between 20-40 patient needed root canal therapy

Exclusion Criteria:

* patient not willing to participate in study participants with systemic disease patients with neuromuscular disorder

Primary outcomes:
measure: effectiveness of disinfectants by assessing turbidity in broth using mann whitney test
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Dentistry
state: Punjab
Study officials:
affiliation: Armed Forces Institute of Dentistry
name: Hafiza Hira Amjad, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00631579: Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma
Official title: Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperuricemia
Leukemia
Lymphoma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups.

Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.


Eligibility criteria: Inclusion Criteria:

Patient suffering from:

* acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric acid level ; or
* lymphoma,Stage ≥ III without regard to uric acid level; or
* lymphomas, Stage II with bulky disease; or
* lymphoma or leukemia, without regard to classification or morphology, with uric acid level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of normal (ULN).

Primary outcomes:
measure: Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.
Secondary outcomes:
measure: Pharmacokinetic parameters and anti-SR29142 antibodies
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: K.K.
role: STUDY_DIRECTOR
References:
citation: Ishizawa K, Ogura M, Hamaguchi M, Hotta T, Ohnishi K, Sasaki T, Sakamaki H, Yokoyama H, Harigae H, Morishima Y. Safety and efficacy of rasburicase (SR29142) in a Japanese phase II study. Cancer Sci. 2009 Feb;100(2):357-62. doi: 10.1111/j.1349-7006.2008.01047.x.
Clinical trial NCT05492279: Is Sheep Ghee Cardioprotective?
Official title: Effect of Sheep Ghee on Lipid Profile and High-sensitivity C-reactive Protein: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesterol; Metabolic Disorder
Inflammation
Keywords: Atherosclerosis
cardiovascular disease
high-sensitivity C-reactive protein
inflammation
sheep ghee
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clinical trial randomized
Primary purpose: PREVENTION

Brief summary: Normal volunteers were randomly received Sheep ghee or sunflower oil, and before and after the study lipid profile and HS-CRP were measured.

Detailed description: During outpatient clinic visits, potentially eligible individuals were screened for enrollment according to the inclusion and exclusion criteria.

Patients were randomly allocated into the treatment and control groups via the blocked randomization method.

The control group received a normal diet for eight weeks with 10 g of sunflower oil. In the treatment group, sunflower oil was replaced with 10 g of sheep ghee.

50 patients in each group were enrollment. Patients' information, including demographic data and the serum levels of fasting blood sugar (FBS), LDL, HDL, triglyceride (TG), and hs-CRP, were recorded in datasheets twice: once before treatment with sheep ghee and once eight weeks later.

Eligibility criteria: Inclusion Criteria:

* healthy adults, seeking outpatient visit at professor kojuri cardiology clinic

Exclusion Criteria:

* any history of ischemic heart disease (IHD),
* coronary artery bypass grafting (CABG)
* percutaneous intervention (PCI)
* stroke
* peripheral vascular diseases
* use of anti-hyperlipidemic agents
* unwillingness to participate.
* Need of tight hyperlipidemia control.

Primary outcomes:
measure: LDL cholesterol
timeFrame: 2 months
measure: total cholesterol
timeFrame: 2 months
measure: HDL cholesterol
timeFrame: 2 months
measure: HS-CRP
timeFrame: 2 months
Secondary outcomes:
measure: adverse effect
timeFrame: 2 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Javad Kojuri
state: Fars
Study officials:
References: