louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05260684: Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US
Official title: Comparative Effectiveness of Different Targeted Therapies for BRAF-mutated Unresectable/Metastatic Melanoma in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: BRAF-mutant
Metastatic melanoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 716
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be metastatic melanoma patients receiving targeted combination therapies derived from an anonymized Flatiron Health data combined with patient data from COLUMBUS trial data

Brief summary: This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy.

The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1, 2011.
* Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1, 2011.
* Age ≥18 years at the time of advanced melanoma diagnosis.
* Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results.

Exclusion Criteria:

-• Patients with prior BRAF- or MEK-inhibitor therapy

• Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (92.7 months)
Secondary outcomes:
Other outcomes:
measure: Progression Free Survival (PFS)
timeFrame: COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (92.7 months)
Locations:
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01913184: Lung Bioavailability With Continuous or Discontinuous Nebulization
Official title: EFFECT OF DRUG TARGETING NEBULIZATION ON LUNG DELIVERY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the continuous and sicontinuous delivery of drug with AKITA.


Eligibility criteria: Inclusion Criteria:

* no lung disease
* no allergy

Exclusion Criteria:

* smoker

Primary outcomes:
measure: Lung bioavailability by urinary monitoring
timeFrame: 24h after the nebulization
Secondary outcomes:
measure: Duration of the nebulization
timeFrame: After the nebulization
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
citation: Reychler G, Aubriot AS, Masquelier J, Muccioli GG, Liistro G. Effect of drug-targeting nebulization on lung delivery. Arch Bronconeumol. 2014 Nov;50(11):500-1. doi: 10.1016/j.arbres.2013.10.014. Epub 2013 Dec 29. No abstract available. English, Spanish.
Clinical trial NCT03787784: Automatic Classification of Colorectal Polyps Using Probe-based Endomicroscopy With Artificial Intelligence
Official title: Automatic Classification of Colorectal Polyps Using Probe-based Endomicroscopy With Artificial Intelligence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Probe-based Confocal Laser Endomicroscopy
Artificial Intelligence
Colorectal Polyps
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables real-time histological evaluation of gastrointestinal mucosa during ongoing endoscopy examination. It can predict the classification of Colorectal Polyps accurately. However this requires much experience, which limits the application of pCLE. The investigators designed a computer program using deep neural networks to differentiate hyperplastic from neoplastic polyps automatically in pCLE examination.


Eligibility criteria: Inclusion Criteria:

aged between 18 and 80; agree to give written informed consent.

Exclusion Criteria:

Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium; Inability to provide informed consent

Primary outcomes:
measure: The accuracy of classifying colorectal Polyps using Probe-based endomicroscopy with deep neural networks
timeFrame: 4 months
Secondary outcomes:
measure: Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists
timeFrame: 3 month
Other outcomes:
Locations:
city: Jinan
country: China
facility: Endoscopic unit of Qilu Hospital Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT01582984: Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty
Official title: Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Keywords: consent
Patient Understanding
Knee Arthroplasty
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2012-04-23
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A structured consent process, in combination with one or a number of the aforementioned modalities (nursing education, handout, video, etc), may reasonably be expected to improve surgical informed consent. The investigators hypothesized that overall patient knowledge/retention would be influenced by the type of consent process and that more intensive training and review would result in better patient retention and recall. The investigators further hypothesized that the knowledge retention would decline following the consent process and surgery, but in a stratified manner based on the nature of preoperative teaching.

Detailed description: please see details above

Eligibility criteria: Inclusion Criteria:

1. recommended total knee arthroplasty

Exclusion Criteria:

1. Unwilling to participate
2. Unable to complete questionnaire in English

Primary outcomes:
measure: Knowledge of efficacy and complications
timeFrame: 6-week postoperative
Secondary outcomes:
measure: knowledge regarding procedural questions with regard to the surgery and implants
timeFrame: Day of surgery and 6-week postoperative
measure: knowledge regarding risks of surgery
timeFrame: day of surgery and postoperative 6-weeks
measure: Knowledge regarding peri- and post-operative results
timeFrame: day of surgery and postoperative 6-weeks
measure: Patient satisfaction
timeFrame: day of surgery and postoperative 6-weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis VA Med crt
name: Terence Gioe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05557084: Laparoscopic Clip-Gastroplasty With The Use Of Bariclip
Official title: Laparoscopic Clip-Gastroplasty With The Use Of Bariclip
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Obesity, Abdominal
Surgery
Keywords: Bariclip
B-clamp
GERD
Bariatric Surgery
Obesity Surgery
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators performed a review of data from a prospectively collected database. All patients submitted to primary LVCG were examined. Patients were submitted to LVCG Between July 2021 and March 2022. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.

Brief summary: Sleeve gastrectomy, the most commonly performed bariatric surgery procedure, carries limitations both short-term including postoperative complications such as hemorrhage and gastric fistula and long-term such as weight regain and gastro-esophageal reflux. A new procedure has been proposed to overcome many of these limitations: laparoscopic vertical clip gastroplasty (LVCG) with Bariclip. Primary outcome were major postoperative complications. Secondary outcomes included weight loss, incidence of de-novo GERD and comorbidity resolution.

Detailed description: Methods. The investigators performed a review of data from a prospectively collected database. All patients submitted to primary LVCG were examined. Patients were submitted to LVCG Between July 2021 and March 2022. Collected data included demographic factors, pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.

Eligibility criteria: Inclusion Criteria:

BMI \> 40 BMI \> 35 and comorbidities BMI \> 30 with poorly controlled Diabetes mellitus II or hypertension

Exclusion Criteria:

Alcoholism Drug addiction Psychiatric Disease

Primary outcomes:
measure: % Excess Weight Loss
timeFrame: 1 year
Secondary outcomes:
measure: Post-operative complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Michela Campanelli
state: RM
city: Roma
country: Italy
facility: Department of Bariatric and Metabolic Surgery, San Carlo of Nancy Hospital and University of Rome "Tor Vergata", Rome, Italy
Study officials:
References:
citation: Noel P, Eddbali I, Nedelcu M. Laparoscopic Clip Gastroplasty with the BariClip. Obes Surg. 2020 Dec;30(12):5182-5183. doi: 10.1007/s11695-020-04803-x.
citation: Noel P, Nedelcu AM, Eddbali I, Zundel N. Laparoscopic vertical clip gastroplasty - quality of life. Surg Obes Relat Dis. 2018 Oct;14(10):1587-1593. doi: 10.1016/j.soard.2018.07.013. Epub 2018 Jul 20.
Clinical trial NCT06170684: Conservative Treatment for Atypical Endometrial Hyperplasia and Early Endometrial Cancer
Official title: Clinical Study of Conservative Treatment for Atypical Endometrial Hyperplasia and Early Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atypical Endometrial Hyperplasia and Endometrial Cancer
Lead sponsor: Beijing Obstetrics and Gynecology Hospital
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with atypical endometrial hyperplasia and endometrial cancer who received conservative treatment

Brief summary: Exploring the efficacy and pregnancy outcomes of conservative treatment for atypical endometrial hyperplasia and endometrial cancer. Study the factors related to predicting treatment efficacy.


Eligibility criteria: Inclusion Criteria:

* (1) age ≤ 45 years old, strong desire to preserve reproductive function, and no factors of reproductive dysfunction evaluated before treatment; (2) The pathological type is atypical endometrial hyperplasia or endometrial cancer; (3) Imaging examination confirmed that the tumor was localized to the endometrium; (4) There are follow-up conditions available.

Primary outcomes:
measure: Complete remission rate
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00892684: Does Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation Protect the Child From Allergic Disease?
Official title: Omega-3 Fatty Acid Supplementation in Pregnancy and During Lactation: a Randomized, Double-Blind, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergies
Keywords: Randomized
Placebo controlled
Double blind
Omega-3 fatty acids
Pregnancy
Childhood allergy
Cytokines
Eicosanoids
Polyunsaturated fatty acids
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Pharma Nord
name: The Ekhaga Foundation, Stockholm, Sweden
name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
name: Medical Research Council of Southeast Sweden
name: Ostergotland County Council, Sweden
name: The Swedish Asthma and Allergy Research Foundation, Stockholm, Sweden.
First posted: 2009-05-04
Enrollment: 146
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The incidence of allergic diseases has increased and a relation between allergy and dietary fatty acids has been proposed. Modulation of the maternal immune function during pregnancy may have an impact on future clinical outcomes in the child. The aim of this study was to determine the effects of omega (ω) - 3 long-chain polyunsaturated fatty acid (LCPUFA) supplementation during pregnancy and lactation on the development of allergic disease (i.e., allergic eczema) in the child at 2 years of age. Pregnant women with allergic disease in their immediate family were supplemented daily with 2.7 g ω-3 LCPUFA (n=70) or 2.8 g soybean-oil as placebo (n=75) from gestational week (gw) 25 until the third month of breastfeeding. Skin prick tests, detection of circulating specific IgE antibodies and clinical examinations of the infants were performed at 3, 6, 12 and 24 months of age. The mothers and children were monitored regarding immune modulatory effects during the entire study period.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman, at 25 weeks of gestation, with allergic symptoms (rhinitis, conjunctivitis, eczema, asthma or food allergy) herself or the father to be or an older sibling

Exclusion Criteria:

* Soy allergy
* Fish allergy
* Treatment with anti-coagulation
* Commercial omega-3 supplementation

Primary outcomes:
measure: allergic eczema
timeFrame: 2 years
Secondary outcomes:
measure: changes in laboratory parameters such as prostaglandins and cytokines associated to the intervention and the primary outcome
timeFrame: 25th gestational week, at partus and 12 months after partus for the mothers, in cord blood at 3, 12 and 24 months for the children
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: University Hospital
Study officials:
affiliation: Linkoeping University
name: Karel M Duchén, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06558084: Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
Official title: Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Toxicity, Drug
Progression, Disease
Keywords: Breast cancer
CDK4/6 inhibitor
toxicity
PFS
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from July 2022 till December 2024

Brief summary: To assess CDK4/6i toxicity and effect on PFS in the Egyptian population


Eligibility criteria: Inclusion Criteria:

* Breast cancer patients aged 18 years old or more
* Female patients
* Histologically proven invasive breast cancer
* Histologically proven HR-positive and HER2-negative breast cancer
* Metastatic breast cancer (Stage 4 according to AJCC 8th edition 2017)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 3.
* Adequate hematological and organs function
* Patients receiving CDK 4/6 inhibitor combined with endocrine therapy(Aromatase inhibitors , GnRH agonists, fulvastrent). as a first or second line treatment

Exclusion Criteria:

* - Male breast cancer patients
* Patients in, visceral crisis (defined as : severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease ) that are at risk of life threatening complication in the short term.
* Prior treatment with any CDK 4/6 inhibitor.
* History of any other cancer , unless in complete remission with no therapy for a minimum of 3 years.
* Have active bacterial or fungal infection, or detectable viral infection.

Primary outcomes:
measure: Adverse effect
timeFrame: 2 years
Secondary outcomes:
measure: PFS
timeFrame: 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ainshams University
Study officials:
References:
Clinical trial NCT02282384: An RCT of Oseltamivir in Outpatients With CPD: A Pilot Study.
Official title: A Randomized Controlled Trial of Oseltamivir in Outpatients With Chronic Pulmonary Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pulmonary Disease
Influenza
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* Clinic patients with physician diagnosed chronic obstructive pulmonary disease
* respirologist-diagnosed non-cystic fibrosis bronchiectasis and pulmonary fibrosis (based on appropriate clinical, exposure, and radiological criteria as per American Thoracic Society guidelines)
* Participants will be drawn from the respirology clinics and will be randomized if within 72 hours of meeting criteria for influenza-like illness

Exclusion Criteria:

* residents of nursing homes
* patients who are immunosuppressed
* patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer

Primary outcomes:
measure: non-elective admission to hospital
timeFrame: up to 28 days following randomization
Secondary outcomes:
measure: lower respiratory tract infection
timeFrame: up to 28 days following randomization
Other outcomes:
measure: pneumonia
timeFrame: up to 28 days following randomization
measure: neutrophilic bronchitis
timeFrame: up to 28 days following randomization
measure: acute sinusitis
timeFrame: up to 28 days following randomization
measure: antimicrobial prescriptions
timeFrame: up to 28 days following randomization
measure: visits to medical providers
timeFrame: up to 28 days following randomization
measure: changes in functional status
timeFrame: up to 3 months from randomization
measure: absenteeism from work
timeFrame: up to 28 days from randomization
measure: additional care or support needed in the home
timeFrame: up to 3 months following randomization
measure: laboratory testing using RT-PCR for influenza
timeFrame: up to 28 days following randomization
Locations:
Study officials:
affiliation: McMaster University
name: Mark B Loeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01368484: Effect of Dietary DHA Supplementation on Sperm Quality
Official title: Effect of Dietary DHA Supplementation on Sperm Quality.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SPERM
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
Collaborators: name: University of Barcelona
First posted: 2011-06-08
Enrollment: 120
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is evaluated the effect of dietetic supplementation with DHA on human sperm quality, antioxidant capacity and sperm DNA damage.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of male factor.

Exclusion Criteria:

* Metabolic and genetic diseases.
* Oncological patients.
* Patients with anticoagulants treatment.

Primary outcomes:
measure: sperm concentration
timeFrame: 5 weeks
measure: Sperm motility
timeFrame: 5 weeks
measure: Sperm morphology
timeFrame: 5 weeks
measure: Total capacity antioxidant
timeFrame: 5 weeks
measure: Sperm DNA damage.
timeFrame: 5 weeks
measure: Fatty acids measure.
timeFrame: 5 weeks
Secondary outcomes:
measure: Sperm in ejaculate
timeFrame: 5 weeks
measure: Volume of ejaculate.
timeFrame: 5 weeks
measure: Sperm viability
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Instituto Valenciano de infertilidad
Study officials:
affiliation: IVI Murcia
name: Martinez Soto, Juan Carlos
role: PRINCIPAL_INVESTIGATOR
affiliation: IVI Murcia
name: Landeras Gutierrez, Jose
role: STUDY_DIRECTOR
affiliation: IVI Murcia
name: Nicolas Arnau, Maria
role: STUDY_CHAIR
affiliation: IVI Murcia
name: Fernandez Olmedilla, Laura
role: STUDY_CHAIR
affiliation: IVI Murcia
name: Albero Pilar
role: STUDY_CHAIR
affiliation: University of Barcelona
name: Domingo JC
role: STUDY_CHAIR
References: