louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04462783: Emergency Department (ED) Self-Monitoring Pilot COVID-19
Official title: Feasibility of Self-monitoring and Patient Decision Support for Suspected COVID-19 Patients After Emergency Department Discharge
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID
Covid-19
SARS-CoV 2
Keywords: coronavirus
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Vironix Health Incorporated
First posted: 2020-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Some patients will have pulse oximeters or be given one and provide data from these.
Primary purpose: OTHER

Brief summary: This feasibility study is being conducted to understand how discharged emergency department patients who were tested for the SARS-CoV-2 virus (COVID-19) engage with a symptom-tracking web application. Study participants that are enrolled in the study will be asked to enter daily information about their health into the CovidX web application (app.). In addition, patients will answer questions regarding anxiety levels, use a pulse oximeter to record information (if you own one or are given one).

The investigators predict that participants will be able to engage with the CovidX web application over several days to weeks for the purposes of symptom tracking, and may have decreased anxiety over the study period.


Eligibility criteria: Inclusion Criteria:

* Reported symptoms of viral illness during ED encounter
* Tested for SARS-CoV-2 (COVID-19) during ED encounter
* Discharged home from the Emergency Department

Exclusion Criteria:

* Prisoners
* Residents of congregate living facilities who are already being monitored
* Baseline oxygen requirement
* Patients whose primary goals of care are palliative
* Pregnant women

Primary outcomes:
measure: Change in the percent of participants using the CovidX web application (app) on 50% or greater of days
timeFrame: baseline, up to 30 days
measure: Average compliance rate with daily symptom tracking by day 30
timeFrame: Day 30
measure: Recruitment rate
timeFrame: through study completion an average of 1 year
Secondary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety short form 4a
timeFrame: completed at baseline (enrollment), up to 30 days
measure: Change in Coronavirus Anxiety Scale
timeFrame: completed at baseline (enrollment), up to 30 days
measure: CovidX web application usability and utility measured adapted by mHealth App Usability Questionnaire
timeFrame: 30 days
measure: Differences in CovidX web application engagement between patients who do and do not receive a pulse oximeter
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Kathleen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04999683: Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
Official title: Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Osteoarthritis
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: to study the effect of anti-inflammatory diet on clinical and biological outcomes in rheumatoid arthritis

Detailed description: The investigators would like to evaluate how inflammation occurs in the joints of subjects with arthritis, and identify molecules and bacteria that can predict whether a rheumatic subject will flare. Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed of rheumatoid arthritis
* without changes in treatment in the last 3 months

Exclusion Criteria:

* food allergies
* pregnancy

Primary outcomes:
measure: Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
References:
Clinical trial NCT02113683: Validation of MMS Test for Cancer Monitoring
Official title: Validation of MMS Test to Detect Active Tumor Growth of Different Cancer Types Before and After Therapy, as Well as for Subsequent Relapse Control in Comparison to Conventional Methods
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colo-rectal Cancer
Stomach Cancer
Melanoma
Sarcoma
Keywords: colo-rectal cancer
stomach cancer
melanoma
MMS test
therapy monitoring
Sarcoma
Lead sponsor: MedInnovation GmbH
Sponsor class: INDUSTRY
Collaborators: name: Helios Klinikum Berlin-Buch
First posted: 2014-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with primary diagnosis of cancer

Brief summary: The purpose of this study is the validation of MMS test to detect active tumor growth in different cancer types before and after therapy, as well as in the course of therapy and for subsequent relapse control compared to standard methods (clinical examination, imaging, tumor markers). It should be consider whether the MMS test has comparable diagnostic accuracy, and thus can replace more expensive or invasive procedures in future.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of colo-rectal cancer
* Clinical diagnosis of stomach cancer
* Suspected diagnosis of melanoma

Exclusion Criteria:

* Colitis ulcerosa
* Morbus Crohn
* Cancer in time period two years before
* Cancer therapy in time period two years before

Primary outcomes:
measure: active tumor growth before and after cancer therapy
timeFrame: up to 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch, Klinik für Interdisziplinäre Onkologie
Study officials:
affiliation: MedInnovation GmbH
name: Katja Waterstradt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00189683: Xeloda Vs Monitoring in Advanced Colorectal Cancer Responsive to Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Association Européenne de Recherche en Oncologie
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare maintenance chemotherapy with Xeloda to control after best response with first line chemotherapy in advanced colorectal cancer. Main endpoint is progression free survival. A total of 300 patients will be included.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic colorectal cancer (confirmed histologically) with objective response or stabilization after at least 6 cycles of first line chemotherapy (treatment of choice is selected freely by the investigator according to the recommendations and consensus in force),
* The interval between completion of first line chemotherapy and randomization should not exceed 4 weeks
* Age\>18 years
* ECOG status 0 to 2
* Biological criteria prior to any chemotherapy:

Neutrophils\>1.5 109 g/l, platelets\>100 109/l, haemoglobin\>10 g/dl, Creatininaemia\<150 mol/l, bilirubinaemia\<2x normal level

* Signed informed consent
* Life expectancy \> 3 months

Exclusion Criteria:

* Metastatic colorectal cancer treated with more than one modality of first line chemotherapy (including oral fluoropyrimidines)
* Tumour progression after first line chemotherapy or before randomization
* Other tumour pathology
* Symptomatic cerebral metastases
* Any severe uncontrolled disease in addition to colorectal cancer (in particular decompensated cardiac failure (LVEF\<50%) or coronary insufficiency)
* Lack of integrity of the upper GI tract: malabsorption syndrome or major surgery of the stomach or the small intestine
* Severe renal impairment (creatinine clearance \< 30 ml/min)
* Severe psychiatric disorder (other than controlled depressive syndrome)
* Patient participating in another experiment
* Pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: AERO
Study officials:
affiliation: AERO
name: Elizabeth Fabre-Guillevin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BGDO
name: Eric Van Cutsem, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BGDO
name: Marc Polus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03169361: NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"
Official title: NINLARO Capsules Drug Use-Results Survey (All-Case Surveillance) "Relapsed/Refractory Multiple Myeloma"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed/Refractory Multiple Myeloma
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 774
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 myeloma and received their first dose of NINLARO/lenalidomide, and dexamethasone.

Brief summary: The purpose of this study is to evaluate the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

Detailed description: The drug being tested in this study is called Ixazomib (NINLARO). Ixazomib is being tested to treat people who have relapsed/refractory multiple myeloma. This study will look at the safety of NINLARO in participants with relapsed/refractory multiple myeloma in daily clinical practice.

The study will enroll approximately 480 patients.

• Ixazomib 4 mg

This multi-center trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

* All patients who have been confirmed as administration of the drug.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Events (AEs)
timeFrame: Up to 24 Week (From start of administration to the end of 6 cycles)
measure: Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
timeFrame: Up to 24 Week (From start of administration to the end of 6 cycles)
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05086861: Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation
Official title: Oesophageal Pacing to Check Left Atrial Posterior Wall Isolation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Atrial Fibrillation Ablation
Keywords: Oesophageal Pacing
Hybrid Ablation
Persistent Atrial Fibrillation
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 52
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: Patients undergoing hybrid AF ablation second stage catheter ablation have the posterior left atrium mapped to see it if is electrically isolated. This is done via a standard electrophysiogical study in accordance with routine clinical practice.

Investigators propose to check left atrium posterior wall isolation via oesophageal pacing and compare this to findings from invasive study

Detailed description: Oesophageal temporary pacing of the heart is an established treatment in heart block and several catheters are licenced for this purpose with minimal procedural risks. Due to the position of the oesophagus, pacing from the oesophagus could sense and pace the posterior left atrium. If the posterior wall could be demonstrated to be electrically isolated with oesophageal pacing then invasive electrophysiological study such as the second stage of a hybrid AF ablation would be unnecessary.

This would save patients from undergoing invasive left atrial mapping and exposure to the consequent risks of the procedure.

Eligibility criteria: Inclusion Criteria: • subjects capable of giving informed consent,

* Male or female
* Aged between 18 and 80 years
* Undergoing ablation under general anaesthetic with planned isolation of the left atrial posterior wall or who have previously undergone either catheter or surgical ablation for AF with LA posterior wall isolation

Exclusion Criteria:

* Unable or willing to give fully informed written consent
* Turned down for general anaesthetic
* Pregnancy
* Terminal illness
* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate.

Primary outcomes:
measure: Left atrial posterior wall isolation
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Complication rate
timeFrame: Through study completion, an average of 4 years
measure: Feasibility of using device
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
Study officials:
affiliation: University Hospital Plymouth NHS Trust
name: Guy Haywood, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02850861: A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
Official title: A New Surgical Instrument in Treatment of Conlylar Fracture: Condylar Reductor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Fracture
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2016-08-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In condylar fracture surgery, reduction is the most difficult step and the key factor which determined the postoperative outcome. Therefore, the aim of this study is to develop a new instrument, which the investigators call condylar redactor, to assist the surgeon to reduct the condylar segments effectively.

Detailed description: In this prospective cohort study, it involved condylar fractures patients who were received surgical treatment from January 2014 to June 2016. Patients in the experimental group were treated with the condylar reductor, and patients in the control group were treated with the traditional surgical instruments. The primary outcome variable was reduction time and reduction rate. The continuity correction X2 and test student t test were used.

Eligibility criteria: Inclusion Criteria:

* patients aged 18-60 with mandibular condylar fractures were treated in Oral and maxillofacial surgery department, West China hospital of stomatology, China from January 2014 to January 2016.

Exclusion Criteria:

* patients refused to participate in the clinical trial;
* condylar fracture dislocation was not obvious, conservative treatment can be used;
* mandibular condylar comminuted fracture;
* mandibular condyle need to be reconstructed.

Primary outcomes:
measure: intraoperative reduction time
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: West China Hospital of Stomotalogy
name: Lei Liu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01349361: Treatment of Basal Cell Carcinomas With Methyl Aminolevulinate and Daylight
Official title: Treatment of Basal Cell Carcinomas With Methyl Aminolevulinate and Daylight
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Photodynamic Therapy
Basal Cell Carcinomas
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2011-05-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Photodynamic Therapy (PDT) is an effective treatment of basal cell carcinomas (BCC) however the inconvenience of clinic attendance and discomfort during therapy are significant drawbacks. The objective of this study is to evaluate the effect of daylight-mediated PDT of BCC.


Eligibility criteria: Inclusion Criteria:

* superficial BCC

Exclusion Criteria:

* Immunosuppression

Primary outcomes:
measure: complete disappearance of the BCC
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT06969261: Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT
Official title: Adapting the Penny Chatbot for Perinatal OUD Patients: COPILOT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perinatal Opioid Use Disorder
Opioid Use Disorder
Keywords: Maternal Health
Maternal Substance Use
Perinatal OUD
Chatbot
mHealth Interventions
Loneliness
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-13
Enrollment: 20
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To address both loneliness and engagement in perinatal and OUD care among perinatal women, the investigators plan to adapt an existing texting support chatbot, Penny, to make it appropriate for use by women who are pregnant and postpartum and dealing with OUD. The newly adapted chatbot, Penny COPILOT, will allow for two way short message service (SMS) messaging to respond appropriately and accurately to user generated input. The investigative team, in collaboration with the Penn Mixed Methods Research Lab (MMRL) and Penn's Way 2 Health Team, will use intervention mapping guided by the Consolidated Framework for Implementation Science. The investigators will conduct a needs assessment, assemble an advisory board, engage in pretesting to ensure safety and refine content, and pilot test the resultant adapted Penny COPILOT in a sample of 20 perinatal women with OUD to evaluate acceptability, feasibility, and patient satisfaction. The goal is to develop and refine an acceptable, feasible, and satisfactory supportive texting chatbot to promote patient engagement in perinatal and OUD care and decrease perceived loneliness.


Eligibility criteria: Inclusion Criteria:

* Biological females who are currently pregnant or within 6 weeks postpartum.
* Able to read, write, and speak English at a 6th grade level.
* Diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder.
* Receiving prenatal care and OUD care at a Penn affiliated hospital.

Exclusion Criteria:

-Current untreated psychosis, mania, or active suicidality as assessed by the Mini International Neuropsychiatric Interview (MINI).

Primary outcomes:
measure: UCLA Loneliness Scale.
timeFrame: During Aim 3 activities, assessments will occur at Baseline and at 3-month Follow-up.
Secondary outcomes:
measure: Opioid use questionnaire
timeFrame: During Aim 3 activities, assessments will occur at Baseline and 3-month Follow-up.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sara L Kornfield, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05417061: Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
Official title: Serum and Saliva Sirtuin 6, Lipoxin A4, Caspase8 Levels in Correlation With Periodontal Status in Severe Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Diagnose Disease
Keywords: inflammation resolution
periodontitis
cell apoptosis
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Saliva and serum of periodontitis patients collected for analyzing SIRT6, LPXA4, CASP8
Primary purpose: PREVENTION

Brief summary: It has been stated that Sirtuin-6 (SIRT6) play a important role in regulation of inflammation, energy metabolism, homeostasis and apoptosis, and SIRT6 may be assosiciated with many diseases. The aim of this study was to evaluate saliva and serum SIRT6, Lipoxin A4 (LXA4) and Caspase-8 (CASP8) levels in correlation with periodontal clinical status in patients with periodontitis and healthy subjects

Detailed description: 20 patients with Stage III Grade B periodontitis (P) and 20 periodontally healthy individuals (control;C) were included in this study. Clinical periodontal parameters were measured. Saliva and serum levels of SIRT6, LXA4 and CASP8 were analyzed by enzyme-linked immunosorbent assay.

Eligibility criteria: Inclusion Criteria:

* systemically healthy
* clinical diagnosis of periodontitis
* clinical diagnosis of periodontal health

Exclusion Criteria:

* history of regular use of systemic antibiotics anti-inflammatory, or antioxidant drugs (previous 3 months)
* nonsurgical periodontal treatment (previous 6 months)
* surgical periodontal treatment (previous 12 months)
* presence of\<10 teeth
* current medications affecting gingival health (calcium channel blockers, phenytoin, cyclosporine, and hormone replacement therapy)
* diabetes
* diagnosis of rheumatoid arthritis
* pregnancy
* lactating
* smoking
* excessive alcohol consumption.

Primary outcomes:
measure: Pocket probing depth
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
measure: Bleeding on probing
timeFrame: 6 months
Secondary outcomes:
measure: Saliva and serum samples processing and analyses
timeFrame: 2 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University, School of Dentistry
state: Fatih
Study officials:
References: