louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03419689: Study Looking at Biomarkers in Ovarian Cancer
Official title: Biomarker Discovery Project in High Grade Serous Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 510
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a sample study that will collect biological samples (blood, tumor tissue, ascites, and/or other fluids) from gynecological cancer patients for biomarker research. In addition, the results of the testing done on the samples will be given to the participant's treating physician who may use the information to guide treatment decisions.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of stage III or IV high grade serous ovarian, tubal or primary peritoneal cancer.
* Must be 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
* Have a life expectancy greater than or equal to 6 months.
* Able to provide adequate informed consent.
* Willing to undergo blood or fluid collection and tumour biopsy
* Patients enrolled at the time of surgery must agree to have part of their tumour used for the purpose of the study.
* Archival tissue must be available for patients that are enrolled at the time of progression.

Exclusion Criteria:

* Must not have early stage (I and II) high grade serous, tubal or primary peritoneal cancer.
* Must not have other tumour histology other than high grade serous.
* Must not have contraindication to tumour biopsy and/or blood sampling.

Primary outcomes:
measure: Genomic and immune signatures in terms of progression free survival
timeFrame: 10 years
measure: Genomic and immune signatures in terms of overall survival
timeFrame: 10 years
measure: Genomic and immune signatures in terms of response to treatments
timeFrame: 10 years
measure: Genomic and immune signatures in terms of resistance to treatments
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Amit Oza, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05695989: Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
Official title: Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Cholelithiases
Other Disease
Lead sponsor: Levita Magnetics
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2023-01-25
Enrollment: 22
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: The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)

Detailed description: Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Dual Robotic Arm Accessory with the Levita Magnetic Surgical System in laparoscopic procedures

Eligibility criteria: Inclusion Criteria:

* • Subject is at least 18 years of age

  * Subject is scheduled to undergo elective laparoscopic procedure
  * Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria:

* • Subjects with pacemakers, defibrillators, or other electromedical implants

  * Subjects with ferromagnetic implants
  * Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
  * Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
  * Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
  * Subject is pregnant or wishes to become pregnant during the length of study participation
  * Subject is not likely to comply with the follow-up evaluation schedule
  * Subject is participating in a clinical trial of another investigational drug or device Prisoner or under incarceration

Primary outcomes:
measure: Adverse Events- Safety
timeFrame: 30 days
Secondary outcomes:
measure: Rate That the Dual Robotic Arm Accessory (DRAA) is Able to Engage, Move, and Decouple With the Magnetic Surgical System as Controlled by the Surgeon
timeFrame: Surgery time
measure: Conversion Rate to Open Surgery
timeFrame: Surgery time
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Tisne
state: Metropolitana
city: Santiago
country: Chile
facility: Clinica Colonial
city: Santiago
country: Chile
facility: Hospital Fach
Study officials:
affiliation: Hospital Tisne
name: Julio Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03478189: The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction
Official title: The Added Value of Intraoperative CT Scanner and Screw Navigation in Operative Treatment of Displaced Acetabular Fracture With Dome Impaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetabular Fracture
Acetabular Surgery
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient hospitalized in GHPSJ from april 2016 and october 2017

Brief summary: The acetabulum fracture result from a trauma with high energy at the young adult or from a trauma of low energy at the old osteoporotic patient. Anatomic reduction is known to be necessary to give functional result to patient.However, it's technically difficult because of the pelvic bone conformation.

The presence of dome impaction makes the surgery more difficult. Per operatory scanner associated to 3D navigation is proved his value-added in spinal surgery.The aim of the study is show that this association permit a technical improvement for the surgeon in the precision of fracture reduction.and restore the articular congruence.


Eligibility criteria: Inclusion Criteria:

* age\> 18
* surgery for acetabular fracture within 30 days
* with dome impaction

Exclusion Criteria:

* disability of inferior limb

Primary outcomes:
measure: dome impaction reduction measurement
timeFrame: day1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Guillaume RIOUALLON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05883189: Establish the Referenc Range of Antiphospholipid Antibody in Healthy Preganany Women
Official title: Establish the Reference Range of Antiphospholipid Antibody in Healthy Preganany Women: The Prospective Studies for Antiphospholipid Syndrome Related Pregancy Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Focus Health Pregancy Women
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Non-pregnant healthy women, Age 18-45;
2. Pregnant women, Age 18-45, follow through the pregnancy and successful delivery
3. APS pregnant patients diagnosed by clinical department

Brief summary: The study is aim to establish 95th and 99th percentile for healthy pregancy women for antiphospholipid antibodies(aPLs), such as aCL IgG/M/A, B2GP1 IgG/M/A, aPS/PT IgG/M. The outcome of the study is expected to aid Antiphospholipid syndrome patients diagnosis and managment. We also include some obstetirc Antiphospholipid syndrome(APS) patients to analysis the correlation between antiphospholipid antibodies and pregancy outcome, also want to know the prevalenc of aPLs, which can be guide for clinical application for APS diagnosis and treatment.


Eligibility criteria: Inclusion Criteria:

* 120 non-pregnant healthy women, Age 18-45, with at least 1 successful pregnancy , no history of adverse pregnancy outcome, no abortion, still birth, premature delivery, preeclampsia
* 120 pregnant women, Age 18-45, follow through the pregnancy and successful delivery without any adverse pregnancy outcome during the pregnancy process, no abortion, still birth, premature delivery, preeclampsia, no drug treatment
* 60 APS pregnant patients diagnosed by clinical department

Exclusion Criteria:

1. Thrombosis history
2. Rheumatic immune disease
3. Use oral contraception or biological inhibitors
4. History of abortion, adverse pregnancy outcome, common high blood pressure, diabetes

Primary outcomes:
measure: 95th and 99th pencentile data of pregancy and non-pregancy women
timeFrame: Oct. 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01113489: Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
Official title: Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Allergic Rhinitis
Lead sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Sponsor class: OTHER_GOV
First posted: 2010-04-30
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although it is well known that the presence of uncontrolled inflammation in upper airways may compromise the control of asthma and may favor the progression of asthma toward more severe grades of disease, few studies addressed whether therapies aimed to control both upper and lower airway inflammation may be more effective in controlling asthma. Markers of oxidative stress and of inflammation such as Nitrotyrosine and IL-5 are increased in the airways of children with atopic asthma and correlated with the levels of oral and nasal FeNO, and with the grade of atopy. We hypothesize that the treatment with Beclometasone nebulized with a facial mask (for treating both upper and lower airways) will be able to reduce the production of oxidants as well as of IL5 in both districts thus promoting clinical and functional improvements in mild intermittent asthmatic children. The results provided by this study will contribute to further clarify the relationship between nasal and bronchial inflammation.


Eligibility criteria: Inclusion Criteria:

* children with intermittent asthma and allergic rhinitis

Exclusion Criteria:

* children with acute respiratory symptoms in the last 4 weeks
* children with nasal polyposis or bronchial or respiratory tract infections
* children with a severe exacerbation of asthma resulting in hospitalization during the last month

Primary outcomes:
measure: Change in level of oral and nasal fractional exhaled nitric oxide (FeNO)
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in peak expiratory flow (PEF)
timeFrame: Baseline, 4 weeks
measure: change in visual analogue scale score for symptoms of rhinitis
timeFrame: Baseline, 4 weeks
measure: change in obstructive sleep apnea syndrome score
timeFrame: Baseline, 4 weeks
measure: change in forced vital capacity (FVC)
timeFrame: Baseline, 4 weeks
measure: change in symptom scores of wheezing
timeFrame: Baseline, 4 weeks
measure: change in forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline, 4 weeks
measure: change in level of IL-5 in exhaled breath condensate
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Unit of Immunopathology and Pharmacology of the Respiratory System Institute of Biomedicine and Molecular Immunology (IBIM) Italian National Research (CNR)
Study officials:
References:
Clinical trial NCT04297189: A Pilot Program Measuring Effectiveness of Health Coaching Interventions
Official title: A Pilot Program Measuring Effectiveness of Health Coaching Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sedentary Behavior
Nutritional and Metabolic Disease
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Women will participate in a workshop within a group and individual meetings. the workshop will include providing information regarding guidelines for healthy eating, engaging in physical activity, personal training tools to build self-efficacy and to encourage implementing a healthy life style.

Detailed description: Participants are interviewed for eligibility and if appropriate sign consent and undergo measurements of weight, height and blood pressure.

At the first meeting there is a pre-study questionnaires and initial coaching session

Eight group meetings will take place and will include:

up-to-date knowledge on nutrition (by a dietitian), exercise (by a physiotherapist) and coping skills for stress (by a psychologist).

Additionally the meetings will also include coaching tools which the participants will practice during the session. The multidisciplinary team has been trained in coaching tools to evaluate in group settings.

In the last meeting, participants will be asked to fill out post study questionnaires measurements will be taken (weight and blood pressure).

Eligibility criteria: Inclusion Criteria:

* over age 18
* Women who agree to fill out questionnaires
* Women who agree to attend sessions (attending 80% of sessions)
* Women who are fluent in Hebrew

Exclusion Criteria:

* Pregnancy
* Women with significant untreated psychiatric diagnosis
* Insulin-dependent diabetes
* End-stage renal disease
* Unstable Angina
* Women who are not fluent in Hebrew
* Women currently treated by multidisciplinary staff (eg, heart failure, cardio rehabilitation)
* Women who have been enrolled in other programs of the center at the discretion of the staff will not be included in the study
* Women who do not want to make a healthy lifestyle change
* Failure to reach 75% of sessions during the study.

Primary outcomes:
measure: self efficacy
timeFrame: 1 year
measure: Behavioral change
timeFrame: 1 year
Secondary outcomes:
measure: nutrition
timeFrame: 1 year
measure: physical activity
timeFrame: 1 year
measure: weight
timeFrame: 1 year
measure: experiential avoidance
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Tanya Reinfeld, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT00537589: Ultrasound Guided Arthrocentesis
Official title: Randomized Control Trial of Ultrasound-Guided Peripheral Arthrocentesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Joint Pain
Keywords: arthrocentesis
ultrasound
emergency
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2007-10-01
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Does ultrasound guidance improve success rate and decrease aspiration attempts for peripheral arthrocentesis?


Eligibility criteria: Inclusion Criteria:

* Age at or over 18
* Indication for peripheral arthrocentesis

Exclusion Criteria:

* Hemodynamic instability
* Previous arthroplasty of the joint
* Known intraarticular fracture
* Hip arthrocentesis

Primary outcomes:
measure: Success rate for arthrocentesis
timeFrame: within ED visit
Secondary outcomes:
measure: Reduction in aspiration attempts
timeFrame: within ED visit
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Carolinas Medical Center
name: Vivek S Tayal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03452189: The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
Official title: The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized double-blinded placebo-controlled crossover study
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if multiple doses of vancomycin over the course of 3 months will perturb the intestinal flora (microbiome) and result in reduced serum concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the study will permit investigators to assess the variability of serum uremic retention solute concentrations with and without antibiotic over a three-month period.


Eligibility criteria: Inclusion Criteria:

* Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV graft.

Exclusion Criteria:

* Antibiotics received within the last 3 months;
* recent diarrhea
* known allergy to vancomycin
* history of C. difficile infection
* elevation of white blood cell count or fever within one week of enrollment.

Primary outcomes:
measure: Change in Plasma Concentration Measure of Indoxyl Sulphate (IS)
timeFrame: 4 weeks
measure: Change in Plasma Concentration Measure P-Cresyl Sulphate (PCS)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jerome Lowenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06620289: Impact of Dental Desensitization Facilitated by a Child Life Specialist Distress and Cooperation
Official title: The Impact of Dental Desensitization Visits Facilitated by a Child Life Specialist on Pediatric Patients' Distress and Cooperation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Desensitization
Dental Anxiety
Dental Care
Distress, Emotional
Cooperation, Patient
Lead sponsor: Children's Hospital Colorado
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 59
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients and their parents scheduled in the dental center at Children's Hospital Colorado Health Pavillion referred to a child life specialist-facilitated desensitization clinic will be recruited to the study.

Brief summary: The aim of this study is to evaluate whether dental desensitization visits facilitated by a Certified Child Life Specialist (CCLS) significantly impact pediatric patients' distress and cooperation levels from the start of desensitization visit(s) to end of the desensitization visit(s), end of desensitization visit to start of subsequent hygiene appointment, and end of hygiene appointment.


Eligibility criteria: Inclusion Criteria:

* Patients and parents of patients aged 2-25 years who have been referred to the desensitization clinic.
* Patients who meet with a CCLS for dental desensitization.

Exclusion Criteria:

* Patients younger than 2 years old and older than 25 years old.

Primary outcomes:
measure: Frankl Behavioral Rating Scale (FBRS)
timeFrame: From enrollment to the end of study at approximately 3 months.
Secondary outcomes:
measure: Pre-Visit Parent Survey
timeFrame: Before desensitization visit.
measure: Repeated Desensitization Visit - Pre-Desensitization Parent Survey
timeFrame: Before repeated (if applicable) desensitization visits.
measure: Sensory Tolerance Checklist
timeFrame: From enrollment to the end of study at approximately 3 months.
measure: The Children's Fear Scale (CFS)
timeFrame: From enrollment to the end of study at approximately 3 months.
measure: Psychosocial Risk Assessment in Pediatrics (PRAP)
timeFrame: From enrollment to the end of study at approximately 3 months.
Other outcomes:
Locations:
Study officials:
References: