louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05427617: Circulating Tumor DNA (ctDNA)-Guided Late-Line Treatment in Patients With Late-Stage Breast Cancer
Official title: Clinical Application of Circulating Tumor DNA (ctDNA) to Guided the Late-Line Treatment for Patients With Late-Stage Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Circulating Tumor DNA
Gene Abnormality
Lead sponsor: Hunan Cancer Hospital
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 223
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cohort study recruited consecutive patients with recent progression of metastatic TNBC after multiple lines of chemotherapy or of HR+ or HER2+ metastatic breast cancer after multiple lines of endocrine or targeted therapy.

Brief summary: This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) to guide late-line therapy in late-stage metastatic breast cancer patients.

Detailed description: This study aims to evaluate the feasibility of plasma ctDNA mutation in guiding late-line treatment for late-stage metastatic breast cancer patients. Meanwhile, this study tries to evaluate the curative effect of ctDNA subtype-guided late-line therapy.

Eligibility criteria: Inclusion Criteria:

* Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
* No available recommendation for the next treatment regimen;
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
* An updated, available pathological HR/HER2 status for metastasis;
* According to RECIST 1.1 standard, there should be at least one measurable target lesion;
* The expected survival time is \> 3 months;
* Those aged 18-70 years old;
* Liver and kidney function and blood routine test meet the following conditions: Neutrophil \> 2.0g/l, Hb \> 9g / L, PLT \> 100g / L; ALT and AST \< 2.5ULN; TBIL \< 1.5ULN; Cr \< 1.0ULN
* Signing informed consent;
* Those willing to accept polygenic testing.

Exclusion Criteria:

* Patients with multiple primary tumors;
* Those who are unable to obtain blood samples;
* Those with a history of immunodeficiency or organ transplantation;
* Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
* The researchers think it is not suitable to participate in this experiment.

Primary outcomes:
measure: Disease Control Rate (DCR)
timeFrame: From the beginning of the treatment to the end of Cycle 2 (each cycle is 28 days) of treatment.
measure: Progression-Free Survival
timeFrame: From date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00812617: Effects of Mineral Water Consumption on Serum Lipid Parameters
Official title: Effects of Mineral Water Consumption on Serum Lipid Parameters: a Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hiroshima University
Sponsor class: OTHER
Collaborators: name: Hita Tenryosui Co., Ltd.
First posted: 2008-12-22
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy as based on medical history and physical examination
* Fasting serum LDL cholesterol \> 100 and/or fasting serum triglyceride \> 100
* Willing to drink mineral water for 12 weeks
* Willing not to serve as blood donor during the study
* Informed consent signed

Exclusion Criteria:

* Female subjects who are pregnant or nursing a child
* Participation in any clinical trial up to 90 days before Day 01 of this study
* Renal or hepatic dysfunction
* Heart disease

Primary outcomes:
measure: Fasting total cholesterol, LDL cholesterol, and triglyceride levels
timeFrame: Every 4 weeks (Overall 20 weeks)
Secondary outcomes:
measure: Fasting serum glucose and HbA1c levels
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Serum uric acid level
timeFrame: Every 4 weeks (Overall 20 weeks)
measure: Serum adiponectin and leptin levels
timeFrame: Week 0, Week 12
measure: Urinary oxidative stress marker
timeFrame: Week 0, Week 12
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: Hiroshima University
Study officials:
affiliation: Hiroshima University
name: Fumiko Higashikawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00167817: Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Official title: Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Smoking
Metabolic
Health
Glucose
Lipids
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with schizophrenia are much more likely to be engaged in smoking and other addictive behaviors, possibly related to biochemical abnormalities in the reward center of the brain. The primary purpose of the present study is to investigate whether switching patients with schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of action, will have an impact on smoking behavior.

Detailed description: This is an 8 week open label trial being conducted in stable adult outpatients with schizophrenia who are smokers. The primary intervention is a switch in the subject's antipsychotic to aripiprazole, flexibly dosed between 15-30 mg/day. The outcome measures include a rating of smoking behavior using the Fagerstrom Test for Nicotine Dependence, and saliva cotinine obtained at baseline and endpoint. Secondary measures include weight, serum glucose and lipids, rating of symptom severity using the PANSS, and both ratings and instrumental measures of motor functioning. We anticipate enrolling up to 25 subjects to obtain the needed 15 completers at the week 8 endpoint.

Eligibility criteria: Inclusion Criteria:

1. Schizophrenia, on stable antipsychotic dose for at least one month
2. Ages 18-65 inclusive
3. Overweight (body mass index of 25 kg/m2 or greater)
4. Daily cigarette smoker (by self-report)

Exclusion Criteria:

1. Inability to provide informed consent
2. Treatment refractory schizophrenia
3. Current treatment with clozapine
4. Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
5. Documented poor compliance with oral antipsychotic medication

Primary outcomes:
measure: Saliva cotinine, Fagerstrom Test for Nicotine Dependence
Secondary outcomes:
measure: Weight
measure: Serum glucose and lipids
measure: Rating of symptom severity using the PANSS
measure: Ratings and instrumental measures of motor functioning
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
affiliation: University of California, San Diego
name: Jonathan M Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478217: PEEP Recruitment-comparison Between Ultrasonographic Assessment and LIP Assessment
Official title: Positive End-expiratory Pressure Induced Lung Recruitment -Comparison Between Ultrasonographic Assessment and Lower Inflection Point Assessment on the Pressure -Volume Loop
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Keywords: lung ultrasonography
pressure-volume loops
ARDS
Lead sponsor: Sisters of Mercy University Hospital
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: intensive care patients

Brief summary: The purpose of this study is to compare lung recruitment in acute lung injury (ALI)/acute respiratory distress syndrome (ARDS) based on lower inflection point with transthoracic ultrasonographic assessment of lung recruitment.

Detailed description: Sedated and sometimes temporary relaxed patients with ALI/ARDS on mechanical ventilation in semirecumbent position are included. Lower inflection point on pressure volume loop on ventilator Draeger Evita 4 with low continuous flow on volume controlled ventilation is measured with zero PEEP. Transthoracic lung ultrasound with linear probe is proceed on both hemithoraces when mechanical ventilation based on measured PEEP is started. We compare if real lung recruitment seen by ultrasound is the same as predicted by lower inflection point.

The procedure is a part of routine everyday respiratory monitoring in our unit.

Eligibility criteria: Inclusion Criteria:

* patients with diffuse ALI/ARDS on mechanical ventilation with visible lower inflection point on dynamic P-V loops

Exclusion Criteria:

* preexisting parenchymal or pleural lung disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Grad Zagreb
country: Croatia
facility: Central intensive care unit, University hospital "Sisters of Mercy"
Study officials:
name: Bojan Rode, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7. doi: 10.1164/rccm.201003-0369OC. Epub 2010 Sep 17.
Clinical trial NCT02687217: Effect of Peri-operative Supplemental Oxygen in Wound Infection After Appendectomy
Official title: Role of Perioperative Hyperoxygenation in Wound Infection Following Surgery for Acute Appendicitis: A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative Hyperoxygenation
Wound Infection
Keywords: PerioperativeHyperoxygenation
Wound Site Infection
Appendicitis
Lead sponsor: Lady Hardinge Medical College
Sponsor class: OTHER_GOV
First posted: 2016-02-22
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study evaluates the role of supplemental hyper-oxygenation given perioperatively on wound site infection after appendectomy. Half of the patients received ≥50% oxygen and half of them received no oxygen during the surgical procedure.

Detailed description: Patient with the diagnosis of acute appendicitis of \>15 years of age group, with no comorbidities who presented to surgical emergency in Dr. Ram Manohar Lohia Hospital were considered for the present study.

30 patients who fulfilled the inclusion criteria and who voluntarily consented for the study were randomly allocated to the two groups- Group A (control group) and Group B (study group).

These patients were operated through Mc-Burney incision given in the right lower quadrant.

Both the groups were comparable in their demographic and preoperative profile. The study group was given ≥50% of oxygen intraoperatively and the control group was given no oxygen.

In postoperative period, oxygen was given to group A at the rate of 4 litre/minute (L/min) and group B at the rate of 6 litre/minute (L/min).

The assessment of the wound was done by using ASEPSIS (Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay) score. A score of more than 20 is considered to be infected.

Fever, raised total leucocyte count, positive pus culture, Ultrasound evidence of fluid collections, removal of sutures and duration of hospital stay were also measured for the evaluation of economic implications due to SSI.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis or Radiological diagnosis of acute appendicitis.
2. Appendectomy through the Mc Burney incision.

Exclusion Criteria:

1. Patients with chronic obstructive pulmonary diseases.
2. Immunodeficiency disease.
3. Patients requiring midline incision.
4. Patients requiring general anaesthesia after failure of spinal anaesthesia.
5. Patients requiring higher oxygen in perioperative period.

Primary outcomes:
measure: ASEPSIS Score
timeFrame: 14 days
Secondary outcomes:
measure: Number of Patients Requiring Additional Investigations
timeFrame: 14 days
measure: Number of Patients Requiring Additional Treatment
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Lady Hardinge Medical College and Associated Hospitals
name: Swati Sattavan, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06218017: Development of an Algorithm to Denoise HFNO-generated Tracheal Sound
Official title: Development of Algorithm to Precise Monitoring Respiratory Sound During Deep Sedation Using the High Flow Nasal Oxygen System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endoscopy, Gastrointestinal
Sedation, Conscious
Keywords: Tracheal sound
Electronic auscultation
High flow nasal oxygen
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study aims to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

Detailed description: During deep sedation without intubation, anesthesia respiratory care and monitoring are of utmost importance. Anesthesia can lead to adverse respiratory effects, increasing the risk of airway obstruction and respiratory depression. High-flow nasal oxygen (HFNO) systems are often used to mitigate these risks. Monitoring tracheal breathing sounds directly using amplification provides better detection accuracy. However, traditional auscultation instruments have limitations, including noise interference and lack of visual functionality. The Airmod Smart Respiratory Monitoring System, with FDA approval in the United States and Taiwan, addresses these issues. It offers respiratory sound recording, noise filtering, event logging, and respiratory rate analysis. Currently, no digital stethoscope on the market can filter out HFNO noise. Therefore, the current study is to develop an algorithm to mitigate the noise generated by the high-flow nasal oxygen system for tracheal sound monitoring in deeply sedated patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing elective gastroinestinal endoscoy requiring deep sedation

Exclusion Criteria:

* Histories of sleep apnea, chronic obstructive pulmonary disease, or oropharyngeal tumor
* Patient who has a hisotry of previous intraoral surgery, tracheal surgery or pulmonary resection surgery

Primary outcomes:
measure: Tracheal sound with and without high-flow nasal oxygen will be measured to develop an algorithm to mitigate the high flow nasal oxygen-generated tracheal noise
timeFrame: 20-30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Tawain University Hospital Hsinchu branch
city: Hsinchu
country: Taiwan
facility: National Tawain University Hospital Hsinchu branch
Study officials:
References:
Clinical trial NCT03072017: Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults
Official title: Monitored Breathing Awareness Therapy for Insomnia Disorder in Older Adults: Phase 1 Open Label Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Advanced Medical Electronics
First posted: 2017-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Insomnia can be a chronic problem that leads to significant daytime fatigue, stress and numerous negative health consequences including depression. Advanced Medical Electronics, in partnership with researchers are the University of Pennsylvania, propose developing an innovative, non-drug, low-risk, intervention that can be implemented on mobile devices for the treatment of insomnia.

Detailed description: Open-label pilot study in 20 older adults with insomnia (sleep onset latency\>30 minutes for at least 3 nights a week) with a two week intervention period.

Eligibility criteria: Inclusion Criteria:

1) Sleep onset latency \> 30 min for at least 3 nights per week

Exclusion Criteria:

1. Unable to perform tests due to inability to communicate verbally/blindness, inability to write and read in English (the study questionnaires are in English and do not exist in validated form for other languages).
2. Cognitive impairment; cognitively impaired patients may not be able to comply with the protocol).
3. History of a diagnosed non-insomnia sleep disorder, such as sleep apnea or circadian rhythm disorder
4. Upper extremity motor impairment that would preclude MBAT therapy (e.g., quadriplegia).

Primary outcomes:
measure: Sleep onset latency
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02086617: Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
Official title: Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: North Karelia Central Hospital
Sponsor class: OTHER
First posted: 2014-03-13
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SCREENING

Brief summary: The purpose of this study is to investigate prevalence of abdominal aortic aneurysms (AAA) among male patients with coronary artery disease (CAD). Secondary purpose is to document cost-effectiveness of ultrasound screening of AAA in selected population.

Ethiology of AAA is known to be common with atherosclerotic arterial diseases, and on the basis of our previous studies (ClinicalTrials.gov ID CAD-AAA-02) the prevalence of AAA seems to be higher in CAD population than unselected male population. This leads to hypothesis that selective screening of these patients (for AAA) could be cost-efficient and life saving option for detecting AAAs before rupture.

Study will be carried out as a single-center prospective screening study. Patients will be selected for this study on basis of their ICD 10 diagnose codes in North Carelian patient information system. Inclusion criteria will be any kind of atherosclerotic heart disease (ICD10 codes I20-I25). Criteria for exclusion are malignant disease, already diagnosed or treated AAA and failure to give informed consent.

800 patient records that meet the inclusion criteria will be reviewed for eligibility. Invitations for screening will be sent for 600 patients with intention to have at least 400 patients screened. Screening will be done by verified sonographers in designated screening appointments.


Eligibility criteria: Inclusion Criteria:

* Male patients with coronary artery disease

Exclusion Criteria:

* Already diagnosed or treated abdominal aortic aneurysm
* Patient's denial to participate
* Malignant disease

Primary outcomes:
measure: Maximum diameter (mm) of abdominal aorta (outer-to-outer wall) in ultrasound
timeFrame: Upon screening (AAA-screening appointment, 10 minutes per patient)
Secondary outcomes:
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: North Carelia Central Hospital
state: Pohjois-Karjala
Study officials:
References:
Clinical trial NCT03627117: Influence of CBD on Episodic Memory in Healthy Subjects
Official title: Randomized Placebo Controlled Cross-over Study Investigating the Influence of CBD on Episodic Memory in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Placebo controlled, randomized, double blind, cross-over design.

Single vape of 0.25ml 5% CBD e-liquid (12.5mg CBD) and single vape of 0.25ml e-liquid, tastes like lemon and madeleine. 15min vape time each.

A total of 34 participants, equal number of male and female. There will be replacement of Drop-Outs until data from 34 participants are completed.

The primary endpoint will be performance in a verbal memory task. The secondary endpoint will be performance in a working memory test.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Normotensive (BP between 90/60mmHg and 140/90mmHg)
* BMI between 18 and 30 kg/m2
* Male or female
* Aged between 18 and 30 years
* Native or fluent German-speaking
* Able and willing to give written informed consent as documented by signature and comply with the requirements of the study protocol
* Willing to donate urine sample to control for pre-Visit CBD/THC consume

Exclusion Criteria:

* Acute or chronic psychiatric disorder including drug or alcohol abuse
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Smoking (\> 5 cigarettes per day)
* Participation in one of our previous studies using the same verbal test in the past 2 years
* Participation in a study with CBD / THC within the 30 days preceding and during the present study
* Known hypersensitivity or allergy to propylene glycol
* Intake of CBD / THC within the 7 days preceding and during the present study in any application form
* Long-term systemic medication or topical steroids to treat an underlying disease within last 3 months
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Enrolment of the investigator, his/her family members, employees and other dependent persons

Primary outcomes:
measure: Verbal memory task
timeFrame: Timepoint 21 minutes after first medication.
Secondary outcomes:
measure: Working memory
timeFrame: Timepoint 15 minutes after medication.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
Study officials:
affiliation: Universität Basel, Birmannsgasse 8, CH-4055 Basel
name: Janine Hotz
role: STUDY_CHAIR
References: