louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04485520: Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans
Official title: Efficacy of the Extract of Carica Papaya as an Inhibitor of Streptococcus Mutans in Students of the Faculty of Dentistry in the Year 2018
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Streptococcus, Other Specified Group
Dental Plaque
Keywords: Saliva
dental plaque
streptococcus mutans
Lead sponsor: Universidad Nacional de Caaguazu
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Papaya has effects on oral pathogenic microorganisms, it also has anticoagulant quality, amebicidal action, antimicrobial, bacteriostatic and antifungal activity on different bacteria, especially on Streptococcus mutans, this can be exploited in the dental area. The objective of the study was to determine the efficacy of Carica Papaya peel extract (suckling) as an inhibitor of Streptococcus Mutans in students of the dental faculty of the National University of Caaguazú in 2018.

Detailed description: Specific objectives

* To determine the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on Streptococcus Mutans by age and sex grouping.
* To quantify the inhibition of the extract of the peel of Carica Papaya (baby) at 3% on the growth of Streptococcus Mutans before, at 10 minutes and 8 days of use in the experimental group.
* Quantify the inhibition of 0.12% Chlorhexidine Gluconate on the growth of Streptococcus Mutans before, after 10 minutes and 8 days of use in the control group.
* Compare the count of Colony Forming Units (CFU) between both groups.

Eligibility criteria: Inclusion Criteria:

* Participants that signed the informed consent

Exclusion Criteria:

* allergic to carica papaya
* ongoing medical or dental treatment that could interfere with the results.

Primary outcomes:
measure: Number of Colony Forming units (Stage 1)
timeFrame: thorough study completion, an average of 24 hours
measure: Number of Colony Forming units (Stage 2)
timeFrame: 10 minutes after mouthwash use
measure: Number of Colony Forming units (Stage 3)
timeFrame: 8 days after mouthwash use
Secondary outcomes:
Other outcomes:
Locations:
city: Coronel Oviedo
country: Paraguay
facility: Facultad de Odontología Universidad Nacional de Caaguazú
state: International
Study officials:
affiliation: Facultad de Odontología, Universidad Nacional de Caaguazu
name: Diego Céspedes
role: PRINCIPAL_INVESTIGATOR
affiliation: Facultad de Odontologia, Universidad Nacional de Caaguazu
name: Ulises A Villasanti Torales
role: STUDY_DIRECTOR
References:
citation: Saliasi I, Llodra JC, Bravo M, Tramini P, Dussart C, Viennot S, Carrouel F. Effect of a Toothpaste/Mouthwash Containing Carica papaya Leaf Extract on Interdental Gingival Bleeding: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Nov 27;15(12):2660. doi: 10.3390/ijerph15122660.
Clinical trial NCT06262620: The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.
Official title: The Comparison of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, Mediastinal Cryobiopsy Via a Tunnel, and Forceps Biopsy Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy: a Multicenter Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphadenopathy Hilar
Lymphadenopathy Mediastinal
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies.

Participants will divided into EBUS-TBNA group, EBUS-TBMC via a tunnel group, and EBUS-TBFB via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBMC via a tunnel, or EBUS-TBFB according to the group.

Researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure;
* Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Exclusion Criteria:

* The lesion is a mediastinal cyst or abscess;
* Combined severe cardiopulmonary diseases, coagulation disorders, poor tolerance to anaesthesia, combined psychiatric disorders or severe neurosis and other relevant contraindications to bronchoscopy;
* EBUS assessment reveals that the lesion is rich in blood flow or adjacent to a large vessel, etc. Consider biopsy to be high risk and inappropriate for continuation of biopsy;
* EBUS did not detect lesions in the hilum and/or mediastinum;
* Those who, in the judgement of the investigator, have poor patient compliance and are unable to complete the study as required due to mental disorders, etc.

Primary outcomes:
measure: Dignostic yield of EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB
timeFrame: 7 days after the biopsy
measure: Incidence rate of adverse events
timeFrame: 7 days after the biopsy
measure: the adequacy of sample acquisition
timeFrame: 7 days after the biopsy
Secondary outcomes:
measure: the adequacy of sample acquisition
timeFrame: 7 days after the biopsy
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Gang Hou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01613820: Ketamine and Scopolamine Infusions for Treatment-resistant Major Depressive Disorder
Official title: Combination of Anticholinergic and Glutamatergic Effects in Treatment-resistant Major Depressive Disorder. A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ketamine infusions resulted in an acute reduction in global depression scores and in severity of suicidal ideation. Scopolamine infusions produced also a significant improvement in depression that was sustained over time.

We therefore plan to investigate the feasibility and efficacy of open-label repeated intravenous administration of ketamine and scopolamine combined in this population of severely depressed, treatment-resistant patients. The results from this study could lead to the development of new strategies for the treatment of patients with TRD.

Detailed description: Patients will undergo two weeks of prospective observation, they will then receive IV infusions of ketamine, scopolamine or both per randomization as augmentation of their ongoing antidepressant regime. The schedule of administration will be twice a week of three weeks. After this phase the subject will be followed with assessments every two weeks for three months.

Eligibility criteria: Inclusion Criteria:

* Outpatients with sever treatment-resistant depression
* Currently depressed
* Currently under regular psychiatric care
* On an aggressive antidepressant regimen, stable for 4 weeks

Exclusion Criteria:

* No history of other major psychiatric illnesses, including bipolar disorder
* No history of psychosis
* No history of drug abuse
* No major medical illness or unstable medical condition.

Primary outcomes:
measure: Hamilton Depression Rating Scale - 28 items
timeFrame: up to 4 months
Secondary outcomes:
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE)
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Depression Clinical and Reseach Program - MGH
state: Massachusetts
Study officials:
affiliation: MGH Department of Psychiatry
name: Cristina Cusin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05114720: Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer
Official title: A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: moxifloxacin
operable breast cancer
adjuvant treatment
disease-free survival
safety
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare disease-free survival (DFS) of patients with operable breast cancer randomised to treatment with standard adjuvant chemotherapy plus moxifloxacin or placebo.

Detailed description: This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 clinical trial. The main purposes of this study are to examine the efficacy and safety of standard adjuvant chemotherapy plus moxifloxacin or placebo as care for patients with operable breast cancer. This study is designed to recruit up to 520 subjects.

Eligibility criteria: Inclusion Criteria:

1. Have provided written and signed informed consent;
2. Histologically confirmed invasive ductal carcinoma;
3. Planned to received (neo)/adjuvant chemotherapy;
4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;
5. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;
6. Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.
7. Compliance with the study protocol.

Exclusion Criteria:

1. Pregnant or breast feeding;
2. Eastern Cooperative Oncology Group (ECOG) score ≥ 2;
3. Hypersensitivity to moxifloxacin or quinolones compounds;
4. Concomitant with other antitumor therapies or participating in other clinical trials;
5. Have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease, or congenital heart disease;
6. Severe uncontrolled co-infection, or severe metabolic disorders;
7. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
8. Poor compliance, unwillingness or inability to follow protocol to continue the study;
9. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.

Primary outcomes:
measure: disease-free survival (DFS)
timeFrame: 10 years
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 10 years
measure: distant disease-free survival (DDFS)
timeFrame: 10 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References:
Clinical trial NCT05344820: The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy
Official title: The Effect of the Art-based Mandala Intervention on the Quality of Life of Cancer Patients Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Chemotherapy Effect
Fatigue
Quality of Life
Rumination
Alexithymia
Keywords: cancer
Chemotherapy Effect
Fatigue
Quality of Life
Rumination
Alexithymia
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

Detailed description: A randomized controlled study on the effect of mandala application on cancer related fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy has not been found in the literature.

The aim of this study is to determine the effect of mandala application on fatigue, quality of life, rumination and alexithymia in cancer patients receiving chemotherapy.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Conscious and no communication problems
* Being literate
* Having a cancer diagnosis
* Receiving chemotherapy treatment (planned to continue treatment for 8 more weeks)
* Willing to participate in our study voluntarily

Exclusion Criteria:

* Not being willing to participate in the research
* Desire to leave the study at any time
* Deterioration of compliance with the working criteria during the time of the study,
* Those who do not participate in up to four mandala applications during the study period
* Those who cannot use a pen
* Those with a diagnosis of psychiatric and neurological disease
* Patients who are scheduled for drug intervention, radiotherapy, surgery other than chemotherapy within 8 weeks

Primary outcomes:
measure: level of quality of life
timeFrame: 1 week
measure: level of fatigue
timeFrame: 1 week
Secondary outcomes:
measure: level of alexithymia
timeFrame: 1 week
measure: level of rumination
timeFrame: 1 week
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Sultan Abdülhamid Training and Research Hospital
state: İstanbul
Study officials:
affiliation: Sultan Abdülhamid Training And Research Hospital
name: Elif Yıldırım Ayaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00474474: Study of the Impact of Virtual Patient Designs on the Reasoning Pattern and Therapeutic Decision Making
Official title: Study of the Impact of How the Virtual Patient's Anamnesis is Designed on the Reasoning Pattern and Therapeutic Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decision Making
Computer-Assisted
Keywords: virtual patient
therapeutic decision making
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2007-05-17
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: There is a lack of evidence of the impact of the information provided in the introduction screen on the students diagnostic and therapeutic decisions. The reasoning pattern may also be altered if positive findings are provided to the student without an active request for it.

The results will be of importance when virtual patients are used for assessing students.

Detailed description: The problem-solving approach is found in virtual patient designs concerned with teaching clinical reasoning and diagnosis. Generally the student has to collect a range of information, usually from menus of possible history questions, physical examination, and lab tests, and make diagnostic and therapeutic decisions based on their findings. The information is not cued - the student have to decide what is relevant. An introduction screen is shown to the student when the virtual patient is initiated. Case author have used it differently - some entered a complete chief complaint and part of anamnesis findings while other have not disclosed anything about the patient. There is a lack of evidence of the impact of the information provided in the introduction screen on the students diagnostic and therapeutic decisions. The reasoning pattern may also be altered if positive findings are provided to the student without an active request for it.

The results will be of importance when virtual patients are used for assessing students.

Eligibility criteria: Inclusion Criteria:

* All the students enrolled in the comprehensive dentistry course at the time of the study (2007)

Primary outcomes:
measure: therapeutic decision making
timeFrame: 1 hour
Secondary outcomes:
measure: Medical history reasoning (required/unnecessary)
timeFrame: 1 hour
measure: Time allocation to the different phases in solving a VP
timeFrame: 1 hour
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: School of dentistry, Karolinska Institutet
Study officials:
affiliation: LIME, Karolinska Institutet
name: Uno Fors
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zary N, Johnson G, Boberg J, Fors UG. Development, implementation and pilot evaluation of a Web-based Virtual Patient Case Simulation environment--Web-SP. BMC Med Educ. 2006 Feb 21;6:10. doi: 10.1186/1472-6920-6-10.
Clinical trial NCT01393574: Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
Official title: Comparing Treatment With Melatonin to Treatment With Stimulants (Methylphenidate) in Children With Attention Deficit Hyperactivity Disorder and Sleep Difficulties
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Sleep Onset Insomnia
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-07-13
Enrollment: 46
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that some children with Attention-Deficit-Hyperactivity-Disorder (ADHD) who also have sleep onset difficulties will improve with Melatonin treatment to an extent similar to that of stimulants treatment.

In order to check this hypothesis children with a new ADHD diagnosis who also have sleep difficulties will be treated with either Melatonin or with stimulants (Methylphenidate) for one month. The main outcome will be improvement of the ADHD symptoms.


Eligibility criteria: Inclusion Criteria:

* children 6-18 years old with a new ADHD diagnosis who are candidates for treatment with stimulants
* Also they suffer from sleep onset insomnia or difficult awakening

Exclusion Criteria:

* Drug treatment for ADHD or for sleep problems in the last 6 months
* Any other chronic medical treatment
* Sleep disorder requiring a different treatment
* Asthma in the last 2 years

Primary outcomes:
measure: ADHD symptoms improvement
timeFrame: a month
Secondary outcomes:
measure: Sleep difficulties improvement
timeFrame: 1 month
Other outcomes:
Locations:
city: Zeriffin
country: Israel
facility: Assaf Haroffeh Medical Center
Study officials:
References:
Clinical trial NCT01080274: Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test
Official title: Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atherosclerosis
Keywords: ergometry
vitamin d
zinc
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-03-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Over 18 years old
* CCT \> 60 ml/min
* No IHD
* No hyper/hypoparathyroidism
* No active malignancy
* Not taking calcium, phosphate

Brief summary: Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality. Low zinc levels are associated with an increased atherosclerotic burden. Therefore we hypothesized that patients with pathological stress test would have low levels of Vitamin D and zinc compared to patients with a normal stress test.

Detailed description: Hypovitaminosis D is generally defined as 25(OH)D levels of \< 20ng/ml, while levels of 21-29ng/ml indicate insufficiency and those above 30ng/ml are regarded as sufficient.

The rational behind the observations associating vitamin D deficiency with CVD is that on the one hand, hypovitaminosis D was found to be associated with traditional risk factors such as hypertension (HTN),diabetes mellitus (dm),obesity, dyslipidemia and metabolic syndrome , on the other hand, experimental data demonstrated that vitamin D could affect cardiac muscle cells directly, control parathyroid (PTH) hormone secretion, regulate the rennin- angiotensin- aldosterone system and the immune system, all of which could influence cardiovascular risk.

Epidemiological studies further support this association, demonstrating high prevalence of hypovitaminosis D among U.S. adults with cardiovascular disease (74%). An association between low vitamin D levels and increased myocardial infarction risk as well as total mortality has been also observed.

Low 25hydroxyvitamin D\[ 25(OH)D\] levels were also independently associated with all cause and CVD mortality among patients scheduled for coronary catheterization.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* CCT \> 60 ml/min
* No IHD
* No hyper/hypoparathyroidism
* No active malignancy
* Not taking calcium, phosphate

Exclusion Criteria:

* Under 18 years of age
* Not fulfilling inclusion criteria

Primary outcomes:
measure: positive stress test
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Mc
Study officials:
References:
Clinical trial NCT01298674: Epidemiological Study of the Prevalence of Age-Related Macular Degeneration in Portugal
Official title: Epidemiological Study of the Prevalence of Age-Related Macular Degeneration in Portugal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 6023
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with 55 or more years-old

Brief summary: This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM) Degeneration in Portugal.


Eligibility criteria: Inclusion Criteria:

* Participants with 55 years-old

Exclusion Criteria:

* None

Primary outcomes:
measure: ARM
timeFrame: 1 month after the screening
Secondary outcomes:
measure: Other ocular disease
timeFrame: 1 month after screening
Other outcomes:
Locations:
city: Lousã
country: Portugal
facility: Health care units of Lousã and Trevim-Sol
state: Coimbra
city: Mira
country: Portugal
facility: ARS Centro - Centro de Saúde de Mira
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José Cunha-Vaz, MD, PhD
role: STUDY_DIRECTOR
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: Rufino Silva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: