louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04046497: Artificial Intelligence to Measure Adherence to Oral Medication
Official title: Early-phase Schizophrenia: Practice-based Research to Improve Outcomes (ESPRITO) - Using Artificial Intelligence to Measure Adherence to Oral Medication
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: First Episode Psychosis
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.

Detailed description: The challenge of oral medication adherence in first-episode psychosis (as in any potentially chronic illness) is enormous, and numerous studies have linked non-adherence to increased rates of relapse/ hospitalization. Determining whether a patient is adhering to medication is a challenge. Pill counts, pharmacy records, technology-assisted monitoring, biological assays, and a range of self-report and interviewer-rated scales have been employed. In other areas of medicine such as antiretroviral treatment Direct Observation of Treatment (DOT) has been employed with excellent success both in monitoring and demonstrated improvement of important clinical outcomes. DOT is clearly not feasible in community settings. An artificial Intelligence (AI) platform that can be downloaded as an application onto a smart phone app represents a novel approach to offering DOT to support participant oral medication adherence and thereby improve outcomes. Aims of the project are: 1) to document acceptability to patients of the AI smartphone app based upon participation in the study and 2) to compare rates of hospitalization and emergency room visits between participants who receive the AI smartphone app with participants who receive standard care.

Eligibility criteria: Inclusion Criteria:

* Enrolled in a CSC program
* Prescribed an oral antipsychotic

Exclusion Criteria:

* none

Primary outcomes:
measure: Service Utilization Report Form
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Citrus Health
state: Florida
city: Grand Rapids
country: United States
facility: InterAct
state: Michigan
city: Kalamazoo
country: United States
facility: InterAct of Michigan
state: Michigan
city: Oklahoma City
country: United States
facility: Red Rock
state: Oklahoma
city: Tulsa
country: United States
facility: Family and Children's Services
state: Oklahoma
Study officials:
References:
Clinical trial NCT01351597: A Clinical Trial of Docetaxel and Oxaliplatin in Patients With Recurrent or Metastatic Breast Cancer
Official title: An Open-label, Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Combination Chemotherapy With DoceTaxel(Detaxel) and Oxaliplatin(Oxalitin)in Recurrent or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Breast Cancer
Metastatic Breast Cancer
Keywords: recurrent breast cancer
metastatic breast cancer
docetaxel
oxaliplatin
Lead sponsor: Korean Breast Cancer Study Group
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 51
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.

Detailed description: Recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.

Eligibility criteria: Inclusion Criteria:

1. Women aged : 20\~70 years
2. WHO (ECOG) performance status 0-2
3. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
4. patients had previously not received chemotherapy of recurrent or metastatic lesion.
5. Have given written informed consent and are available for prolonged follow-up

Exclusion Criteria:

1. Patients with previous chemotherapy for recurrent breast cancer
2. Breast cancer recurrence within 12 months after taxane treatment
3. Her-2/neu expression breast cancer
4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
5. Brain metastasis
6. uncontrolled infection, medically uncontrollable heart disease
7. other serious medical illness or prior malignancies
8. Pregnant or lactating women were excluded.

Primary outcomes:
measure: overall response rate
timeFrame: 2 years
Secondary outcomes:
measure: progression free survival
timeFrame: 2 years
measure: toxicity
timeFrame: 2 years
measure: quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Breast Cancer Center, Inje University Paik Hospital
Study officials:
affiliation: Department of Surgery, Breast Cancer Center,Inje University Paik Hospital, South Korea
name: Sehwan Han, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01151397: Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve Sustained Virologic Response (SVR) in Genotype 2, 3 Chronic Hepatitis C Patients?
Official title: Does 3 Months Therapy With Vitamin D + Peg + Ribavirin Improve SVR in Genotype 2,3 Chronic Hepatitis C Patients?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis C
Keywords: SVR
VITAMIN D
Hepatitis C
Genotype 2,3
Naive
RVR
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2010-06-28
Enrollment: 60
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: Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2,3. Studies rarely address the issues of improving host factors. The current study examines

1. Does 3 months therapy with Vitamin D+ Peg + Ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks)
2. whether Vitamin D levels predicts negative treatment outcome.

Detailed description: Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 80% of naïve patients with genotype 2, 3. Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D, a potent immunomodulator, for 3 months therapy could improve viral response. The working hypothesis is that 3 months therapy with Vitamin D + Peg + Ribavirin significantly improves RVR, EVR, and SVR.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years of age
* chronic genotype 2,3 HCV infection
* treatment Naive negative sero for HBV, HDV and HIV viral infections
* absolute neutrophil count of \>1500 per cubic millimeter
* a platelet count of \>90,000 per cubic millimeter normal hemoglobin level

Exclusion Criteria:

* decompensated liver disease (cirrhosis with CP score \>9)
* another cause of clinically significant liver disease hepato cellular carcinoma
* psychiatric Disorder
* chronic heart failure
* pregnant women
* uncontrolled diabetes with retinopathy Arrhythmia Active CAD
* positive sero for HBV, HDV and HIV viral infections or other autoimmune liver disease

Primary outcomes:
measure: sustained virologic response (SVR)rate
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Safed, Israel
country: Israel
facility: Ziv medical center liver unit
Study officials:
References:
Clinical trial NCT03967197: Lidocaine Before Esophageal Manometry and Ambulatory pH Monitoring
Official title: Is Lidocaine Useful Before Esophageal Manometry and Ambulatory pH Monitoring? A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Acute
Keywords: manometry
pH monitoring
lidocaine
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial comparing esophageal manometry and ambulatory pH monitoring test tolerance in the presence versus in the absence of topical lidocaine.

Detailed description: Conventionally, topical nasopharyngeal anesthesia is applied to improve the tolerance of esophageal manometry and ambulatory pH monitoring. However, there is currently no data to support this practice. This randomized controlled trial of lidocaine versus placebo applied before these tests will evaluate the benefit of topical lidocaine anesthesia.

Eligibility criteria: Inclusion Criteria:

Adult patients undergoing esophageal manometry or ambulatory pH monitoring at our center who are able to read and consent to participate in the study.

Exclusion Criteria:

* Patients \< 18 years
* Incapacity to provide consent
* History of lidocaine allergy
* Current pregnancy
* Previous esophageal manometry or ambulatory pH monitoring in the last 14 days
* Previous participation in the study
* Severe cirrhosis (Child-Pugh C)
* Severe chronic kidney disease (eGFR\<30 mL/min/1.73m2)
* Severe heart failure (New York Heart Association Functional Classification 3-4)
* Severe respiratory failure (dyspnea or oxygen-dependent at rest)
* Any active severe incapacitating chronic or acute medical disease
* Active hospitalization
* Ulcerated, atrophic, infected or recently burned (in the last 30 days) nasopharynx
* Recent surgery involving the nasopharynx (in the last 30 days)
* Severe chronic pain (ex. regular daily use of opioids)
* Previous stroke or any neurological lesion with resulting current sensory deficit
* Major neurocognitive disorder
* Any active severe incapacitating chronic or acute psychiatric disease

Primary outcomes:
measure: Presence of pain during catheter insertion
timeFrame: Assessed once immediately after exam on patient questionnaire
Secondary outcomes:
measure: Global patient satisfaction
timeFrame: Assessed once immediately after exam on patient questionnaire
measure: Presence of other complications during catheter insertion
timeFrame: Assessed once immediately after exam on patient questionnaire
measure: Presence of complications during test recording
timeFrame: Assessed once immediately after exam on patient questionnaire
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References:
Clinical trial NCT00656097: A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects
Official title: A Randomized, Single-blind, Controlled, Monocentric Phase II Trial to Compare the Safety and Neutralizing Activity of Simulated Rabies Post-exposure Prophylaxis With CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rabies
Keywords: Rabies post-exposure prophylaxis
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2008-04-10
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo in combination with rabies vaccine in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subjects free of obvious health-problems or with stable condition
* Male or female subjects aged ≥19 to ≤65 years
* BMI between ≥18 and ≤30 kg/m2

Exclusion Criteria:

* Prior history of active or passive rabies immunization
* Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator
* History and/or family history of clinically significant immunodeficiency or auto-immune disease
* Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Primary outcomes:
measure: Safety and tolerability
timeFrame: 42 days
Secondary outcomes:
measure: Rabies virus neutralizing activity
timeFrame: 42 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: MDS Pharma Services , USA
state: Nebraska
Study officials:
affiliation: MDS Pharma Services, 621 Rose Street, Lincoln, NE 68502, USA
name: C. James Kissling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06766097: Chios Mastic Toothpaste and Halitosis and Oral Hygiene in Orthodontic Patients
Official title: The Effect of Chios' Mastic Toothpaste on Halitosis and Oral Hygiene in Orthodontic Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Halitosis
Orthodontic Appliance Complication
Keywords: Halitosis
Mastic
Orthodontic appliance
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is designed as a prospective, randomized, placebo-controlled, double (investigator and patient) blinded study, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of mastic toothpaste or placebo lozenges.
Primary purpose: PREVENTION

Brief summary: The aim of this trial was to investigate the effect of mastic toothpaste on halitosis using as proxy the levels of the Volatile Sulfur Compounds (VSCs), and the effect on plaque and gingival indices in adolescents undergoing orthodontic treatment with fixed conventional labial appliances.


Eligibility criteria: Inclusion Criteria:

Patients eligible for the trial must comply with all of the following at randomization:

• Age between 13 and 18 years for the group with conventional orthodontic appliances.

This age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in Greece). Younger patients might present with cooperation problems.

* Good general health.
* Orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction.
* Total initial VSCs levels above the baseline level of 150ppb.

Exclusion Criteria:

Patients will be excluded for any of the following reasons:

* Active caries
* Periodontitis
* Dental fluorosis / dysplasia of the teeth
* Syndromes, mental disabilities and craniofacial deformities
* Smoking or use of other tobacco products
* Allergy to mastic
* Antibiotics during the last 2 months
* Chlorhexidine in the previous 3 weeks
* Participation in other trials

Primary outcomes:
measure: Modified plaque index (PI-M)
timeFrame: baseline - 2 weeks
measure: Modified plaque index (PI-M)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: School of Dentistry
state: Attiki
Study officials:
affiliation: National and Kapodistrian Univrsity of Athens Greece
name: Iosif Sifakakis, Associate Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00479297: Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Japanese Males
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of ascending single oral doses of SAM-531, an investigational drug, in healthy Japanese male subjects. Secondary: To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531 in healthy Japanese male subjects.


Eligibility criteria: Inclusion criteria:

* Men aged 20 to 45 years (inclusive) at the time of getting informed consent.
* Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥50 kg (BMI = \[weight (kg)\]/\[height (m)2).
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine levels must be within the upper limit of normal for eligibility.

Exclusion criteria

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
* Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing product is prohibited from 72 hours before study day 1.

Primary outcomes:
measure: Safety and tolerability
Secondary outcomes:
measure: Pharmacokinetics and pharmacodynamics
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05654597: French Validation of the CAPTURE Case Finding Tool for Obstructive Respiratory Disease
Official title: French Validation of the CAPTURE Case Finding Tool for Obstructive Respiratory Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Diseases
Lung Diseases, Obstructive
Obstructive Pulmonary Disease
Keywords: COPD
Asthma
Case finding
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 1881
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult men and women over 40 years old will be recruited from a broad range of healthcare professional in primary care across the country. Any patient attending an appointment will be screened for inclusion.

Brief summary: The objective of this multicentre prospective study is to validate CAPTURE as a French case finding tool for undiagnosed patients suffering from obstructive pulmonary disease.

Detailed description: A large number of healthcare professional across the country will screen participants.

Participants willing to participate will have a short interview, and then will have to answer the 5-item CAPTURE questionnaire. They will be assisted to perform a peak expiratory flow measurement with a portable device. The comparison will be made between the CAPTURE decision and a portable spirometry assessing the presence or not of an obstructive disorder.

Patient screened either by the tool or the spirometry will be addressed to a doctor. Follow-up at 6 months will be set up in order to assess the entry or not of those patients to an approved health care pathway.

At the end of each center's participation, a questionnaire will be sent to all healthcare professionals working on the study, to assess the ease of use of spirometry and the CAPTURE tool and its possible implementation in clinical practice.

Eligibility criteria: Inclusion Criteria:

* People aged 40 or more,
* Provision of dated and signed informed consent form,
* Currently being treated by a healthcare professional,
* Patients affiliated to the french social security system.

Exclusion Criteria:

* Patients previously diagnosed with COPD or asthma,
* Patients with any condition making them unable to perform spirometry or answer a short questionnaire,
* Patients unable to give free and informed consent.

Primary outcomes:
measure: Sensitivity, specificity and area under the ROC curve of the CAPTURE tool
timeFrame: Baseline
Secondary outcomes:
measure: Number of patients who have taken steps to enter a healthcare pathway 6 months after the referral to a doctor
timeFrame: 6 months after
measure: Primary care investigators' opinion of the CAPTURE tool used in this study
timeFrame: Baseline to 2 years
Other outcomes:
Locations:
city: Le Havre
country: France
facility: Groupe Hospitalier du Havre
state: Normandie
Study officials:
References: