louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04365777: EEG Characteristics of Different Sedation Depths in Neurosurgery Patients
Official title: EEG Characteristics of Different Sedation Depths in Patients With Supratentorial Glioma in Frontal Lobe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electroencephalography
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged between 18 and 60 years with American Society of Anesthesiology status I or II who were scheduled to receive elective surgery under general anesthesia. Patients with supratentorial glioma in right frontal lobe diagnosed by magnetic resonance imaging were included in the glioma group while patients requiring general anesthesia without intracranial-occupying lesion were included in the control group.

Brief summary: Gliomas are the most common primary intracranial malignancy, and behavioral experiments in patients with supratentorial gliomas under sedation have shown potential neurological abnormalities; however, these behavioral experiments are susceptible to external influences. Therefore, more objective evidence is needed to support and extend the existing conclusions. The purpose of this study is to compare the EEG signatures (such as the EEG signal power) at various levels of anesthetics induced sedation in patients with supratentorial glioma in frontal lobe and in patients without intracranial-occupying lesion.


Eligibility criteria: Inclusion Criteria:

1. Patients with supratentorial glioma in right frontal lobe, and patients requiring general anesthesia without intracranial-occupying lesion;
2. Aged 18-60 years;
3. ASA I to II;
4. All those who sign the informed consent form.

Exclusion Criteria:

1. Obese patients, BMI\>30kg/m2;
2. Patients with Mallampati class III to IV airway anatomy;
3. Combined with other neurological or psychiatric diseases;
4. Combined with disturbance of consciousness;
5. Previous intracranial surgery;
6. Known or suspected cardiac dysfunction;
7. Allergic to intravenous general anesthetics;
8. Long-term history of analgesia, sedation and drug abuse.

Primary outcomes:
measure: 1. The time-frequency characteristics of EEG power changes at different sedation depths in neurosurgical patients.
timeFrame: Prior to anesthesia induction, three minutes after reaching the target level of sedation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing TianTan Hospital
Study officials:
References:
Clinical trial NCT02355977: The Response of Pathogens to the Respective or Combined Treatment of SRP and Local Minocycline in Chronic Periodontitis
Official title: The Response of Periodontal Pathogens to the Respective or Combined Treatment of Scaling and Root Planning and Locally Delivered Minocycline in Patients With Chronic Periodontitis- a Short-term Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis
Minocycline
Surface and root planning
Pocket depth
Sulcus bleeding index
Prevotella intermedia
Lead sponsor: Zhejiang University
Sponsor class: OTHER
Collaborators: name: Academic Centre for Dentistry in Amsterdam
First posted: 2015-02-04
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis.

Detailed description: In this randomized clinical trial, the investigators will evaluate the respective or combinatory efficacy of minocycline and scaling and root planning in the aspects of both clinical parameters \[Pocket depth (PD) and sulcus bleeding index (SBI)\] and the loads of four main periodontal pathogens \[Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg) and Prevotella intermedia (Pi)\]. Real-time quantitative PCR (qRT-PCR) will be used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria in a period of 7 days. The investigators will also try to correlate the reduction of either total or respective bacteria with the improvements of clinical parameters, with an aim to uncovering the potential microbiological mechanism accounting for the efficacy of a therapy.

Eligibility criteria: Inclusion Criteria:

* diagnosed with moderate or severe chronic periodontal disease, and exhibited bleeding on probing and attachment loss, with radiographic alveolar bone loss in four or more teeth

Exclusion Criteria:

* pregnant, had used antibiotics within the last 3 months, had periodontal therapy in the past 6 months or had systemic diseases such as heart disease or hypertension

Primary outcomes:
measure: Pocket Depth
timeFrame: 7 days
Secondary outcomes:
measure: Bleeding on Probing
timeFrame: 7 days
measure: Bacterial Load
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Affiliated Hospital of Stomatology, Medical College, Zhejiang University
name: Shuli Deng, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05486377: Remimazolam vs Desflurane for General Anesthesia for Ablation of Arrhythmia
Official title: Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Remimazolam
Desflurane
Cryoablation
Arrhythmia
General Anesthesia
Keywords: Remimazolam
Desflurane
Arrhythmia
Cryoablation,heart
Cardiovascular disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine that provides good hemodynamic stability compared to conventional anesthetic agents. This study aims to investigate whether remimazolam reduces vasoactive agent use during cryo/radiofrequancy ablation under general anesthesia, compared to desflurane(RCT).


Eligibility criteria: Inclusion Criteria:

* =or \> 20 years
* Admission for General anesthesia for RFCA or cryoablation procedure

Exclusion Criteria:

* No severe adverse effect history or hypersensitivity of benzodiazepines or its additives
* Acute alcoholic intoxication state
* Coma or shock state due to other condition than heart problem.
* Acute narrow-angle glaucoma

Primary outcomes:
measure: Vasopressor CIV
timeFrame: During anesthesia
measure: Hypotension event
timeFrame: During and after anesthesia
measure: Vasopressor (total amount)
timeFrame: During anesthesia
Secondary outcomes:
measure: Induction time
timeFrame: Induction
measure: Recovery time
timeFrame: Recovery
measure: Adverse event
timeFrame: During and after anesthesia (~24hr)
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul national university Bundang hospital
state: Province (optional)
Study officials:
References:
Clinical trial NCT02612077: Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin)
Official title: A Cohort Survey of Patients With Metastatic Colorectal Cancer Starting a Chemotherapy in Combination With Avastin®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-23
Enrollment: 765
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.

Brief summary: This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab.


Eligibility criteria: Inclusion Criteria:

* Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy
* Having received oral and written information about the survey and not objecting to having his/her data computerized

Exclusion Criteria:

- Participating in a clinical trial assessing an anticancer treatment

Primary outcomes:
measure: Progression-free Survival
timeFrame: within 36 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 36 months
measure: Quality of Life - Global Health Status
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Neuilly-sur-seine
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04890977: Engaging Pacific Islanders in Mental Health Treatment
Official title: Engaging Pacific Islanders in Mental Health Treatment Services
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety Disorders
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will create and pilot test a culturally grounded intervention (Talking Story) to increase mental health treatment seeking among Pacific Islanders with mental disorders (e.g., major depressive disorder, generalized anxiety disorder).

Detailed description: For the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilottest of the culturally grounded Talking Story mental health treatment-seeking intervention with 48 Pacific Islander participants (24 intervention arm, 24 wait-list control) in preparation for larger R01 randomized wait-list controlled testing.

Eligibility criteria: Inclusion Criteria:

1. Of Pacific Islander or part Pacific Islander heritage,
2. Must be over 18 years of age,
3. Live in Los Angeles County or surrounding areas,
4. Fluent (oral and reading) in English,
5. Not have dual comorbidities in major depressive disorder, generalized anxiety disorder, and/or alcohol use disorder (they may have one of these disorders and still participate but not two or three).

Exclusion Criteria:

1. Do not meet inclusion criteria,
2. Are unwilling to participate,
3. Fail to provide or retracts consent,
4. Reside outside the target communities.

Primary outcomes:
measure: KAP Model
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: UC Riverside
state: California
Study officials:
References:
Clinical trial NCT02335177: Technology and Human Help at Home After Hospitalisation
Official title: Technology and Human Help at Home After Hospitalisation (T4H): a Randomized Clustered Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Fall
Keywords: Falls
Elderly
Physical activities
Technologies for autonomy
Impact of intervention
autonomy
physical activity program
Lead sponsor: Ages et Vies Association
Sponsor class: OTHER
Collaborators: name: Caisse Nationale de Solidarité pour l'Autonomie
name: National Insurance Fund Vieilleisse
name: Réunica
name: Fondation Macif
First posted: 2015-01-09
Enrollment: 36
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Elderly people are still at risk for falling at home. The objective of the study is to evaluate at home the impact of an intervention for 3 months combining technologies for autonomy and tailored physical activity program. The study is performed among patients aged 75 years and over leaving Charles Foix Geriatrics hospital or already supported by carer of professional home-care service Ages \& Vie and with a loss of autonomy requiring physiotherapy and home support workers. It is a prospective, randomized, single-center, in cluster study which compares a Patient group (interventional group) with the intervention program (technologies + physical activities) with a control group benefiting from usual care home. Our hypothesis is that in the interventional group fewer falls were observed and improved different scores (Timed Up and Go Test,Barthel index, Quality of Life questionnaire of Duke) were reported compared to the control group.


Eligibility criteria: Inclusion Criteria:

* patients hospitalized in Charles Foix Hospital (France) and returning home or already supported by carer of professional home-care service Ages \& Vie
* \> 75 years old with loss of autonomy
* at risk for falling
* able to read and understand the information letter and consent letter
* patient requiring physiotherapy and caregiver at home.

Primary outcomes:
measure: Number of falls
timeFrame: 3 months
Secondary outcomes:
measure: Timed up and Go test score
timeFrame: 3 months
measure: Barthel index
timeFrame: 3 months
measure: Duke questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Ivry sur Seine
country: France
facility: AP-HP Charles Foix
Study officials:
affiliation: Hôpital Charles Foix, AP-HP
name: Meziere Anthony, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meziere A, Oubaya N, Michel-Pellegrino V, Boudin B, Neau M, Robert H, Cara I, Salgado Sanchez L, Baloul S, Piette F, Pautas E, Picou Y, Curtis V, Schonheit C, Canoui-Poitrine F, Moreau C. Exercise Interventions With Trained Home Helpers for Preventing Loss of Autonomy and Falls in Community-Dwelling Older Adults Receiving Home Heath Physical Therapy T4H: A Randomized Controlled Pilot Study. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):E138-E149. doi: 10.1519/JPT.0000000000000287.
Clinical trial NCT02456077: Strengthening Physician Communication About HPV Vaccines
Official title: Strengthening Physician Communication About HPV Vaccines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV Immunization Status
Keywords: MCV4: Meningococcal Conjugate Vaccine
HPV: Human Papillomavirus
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2015-05-28
Enrollment: 93582
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if a multimodal Human Papillomavirus (HPV) immunization program carried out in pediatric and family medicine practices would be more effective in improving adolescent patients' HPV immunization rates than the usual care provided to adolescents in pediatric and family medicine practices.


Eligibility criteria: Inclusion Criteria for immunization rate assessment:

1. 9 years of age or older when presenting for care
2. Patients who present for care one year prior to the start of the intervention and up to two years after the start of the intervention

Exclusion Criteria:

1. Less than 9 years of age when presenting for care
2. Patient is not eligible for HPV immunization

Provider survey:

Providers who are working at participating practices during the two times a cross-sectional survey is administered.

Parent survey:

Parents of adolescents who presented for care within one 1 year prior to the two times a cross-sectional survey is administration.

Primary outcomes:
measure: The percentage of adolescents who initiate the HPV vaccine series
timeFrame: 1 year
Secondary outcomes:
measure: The percentage of adolescents who receive MCV4 vaccine
timeFrame: 1 year
measure: The percentage of adolescents who receive Tdap vaccine
timeFrame: 1 year
measure: Provider HPV vaccine recommendations
timeFrame: 1 year
measure: Parents' experiences and preferences regarding provider communication about HPV vaccines
timeFrame: 1 year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amanda Dempsey, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dempsey AF, Pyrznawoski J, Lockhart S, Barnard J, Campagna EJ, Garrett K, Fisher A, Dickinson LM, O'Leary ST. Effect of a Health Care Professional Communication Training Intervention on Adolescent Human Papillomavirus Vaccination: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2018 May 7;172(5):e180016. doi: 10.1001/jamapediatrics.2018.0016. Epub 2018 May 7.
Clinical trial NCT03091777: Study Evaluating the Equivalence of GDC-229 and Metronidazole Vaginal Gel 0.75% in the Treatment of Bacterial Vaginosis
Official title: A Multicenter, Randomized, Double-Blind, Vehicle Controlled Study Evaluating the Therapeutic Equivalence and Safety of GDC-229 (Investigational Metronidazole 0.75% Vaginal Gel) and Metronidazole 0.75% Vaginal Gel in the Treatment of Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Keywords: bacterial vaginosis
vaginal infection
BV
Lead sponsor: Balmoral Medical company
Sponsor class: INDUSTRY
Collaborators: name: Health Decisions
First posted: 2017-03-27
Enrollment: 871
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish that these two drugs work better than placebo in subjects with BV.


Eligibility criteria: Inclusion Criteria:

1. Non-pregnant female aged ≥ 18 years who is in good general health
2. Diagnosis of BV
3. Willing to refrain from using any intravaginal product (e.g., spermicide, tampon, douche, feminine deodorant spray, diaphragm, vaginal ring birth control, or condom with spermicide or insertion into the vagina of any drug or non-drug product during treatment), other than study treatment for the duration of the trial
4. Subjects of childbearing potential who have a negative urine pregnancy test at the Entry Visit (Visit 1) and agree to use an acceptable form of birth control throughout the study
5. Able to understand and willing to sign the informed consent form (ICF) and able to comply with the requirements of the protocol

Exclusion Criteria:

1. History of alcohol or substance abuse
2. Experienced a clinically significant medical event within 90 days
3. Abnormal pap or high risk human papillomavirus (HPV)
4. History or presence of clinically significant central nervous system (CNS), cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, gynecologic, dermatologic, neurologic, oncologic, or psychiatric disease
5. Pregnant, lactating, or planning to become pregnant or breastfeed during the study period
6. Primary or secondary immunodeficiency
7. Evidence of any vulvovaginitis at screening other than BV
8. History of hypersensitivity or allergy to metronidazole, parabens, other nitroimidazole derivatives, or other ingredients of the GDC 229 (metronidazole 0.75% vaginal gel), metronidazole 0.75% vaginal gel (Oceanside Pharmaceuticals), or vehicle gel
9. Participating in another clinical trial

Primary outcomes:
measure: Clinical Cure
timeFrame: Day 21-30
Secondary outcomes:
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Site 103
state: North Carolina
Study officials:
References:
Clinical trial NCT01054053: Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®
Official title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccination
Keywords: Neisseria meningitidis B:14, P1-7, 16
Serum bactericidal activity
Menbvac
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Institut Pasteur
First posted: 2010-01-22
Enrollment: 218
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children born between 06/04/2004 and 17/04/2008, living Neufchatel en bray.

Brief summary: The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against B:14,P1-7,16 clone related to a protection (\>= 4), before the first vaccination (T0), after the second MenBvac vaccination (6 weeks after the second vaccination), before the third MenBvac vaccination and after the third MenBvac vaccination (6 weeks after the second vaccination) and one year after the third menBvac vaccination.


Eligibility criteria: Inclusion Criteria:

* children born between 06/04/2004 and 17/04/2008, living in Neufchatel en Bray, vaccinated five times by MenBVac
* parental authority(ies)assent

Exclusion Criteria:

* no parental authority(ies)assent
* no blood sample during the third vaccination
* impossibility of third vaccination
* children with guardianship
* children yet vaccinated or non eligible for vaccination

Primary outcomes:
measure: assessment of natural Immunity with measure of percent of children who have hSBA title >= 4 at TO. assessment of antibodies blood persistence during measurement of percent of children who have hSBA title >= 4
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Neufchâtel En Bray
country: France
facility: Maison Du Département
Study officials:
References: