louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01619501: Dysregulation of the C/EBPa Pathway in Human Lung Cancer and Search for New Biomarkers and/or Therapeutic Targets
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2012-06-14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Archived samples from the Department of Pathology (for IHC, FISH) and the Tissue Repository (for fresh tumor samples) at NUHS

Brief summary: The overall goal of this research is to enhance the investigators understanding of the pathways involved in lung cancer, and to identify new biomarkers and/or therapeutic targets. By comparing gene expression between normal lung tissue and tumors growing in lung-specific C/EBPa KO mice, the investigators have identified the Bmi-1 proto-oncogene as being abnormally upregulated in C/EBPa-deleted tumors. Subsequently, the investigators have validated this observation in human lung cancer, implicating the investigators KO mice are an effective discovery tool for lung cancer research. Through similar approaches, the investigators have already identified (Sonic Hedgehog, SHH), and plan to identify other pathways which are abnormally regulated in C/EBPa-/- tumors. In parallel, the investigators will proceed to define the clinical relevance of the SHH pathway and the other newly-discovered molecular aberrations, by analyzing their expression and correlate it to C/EBPa expression on the samples of patients with NSCLC at NUHS. If the investigators preliminary data on Bmi-1 will be confirmed, this proto-oncogene may generate useful correlates that could be used in diagnosis and treatment of lung cancer, as well as identify new prognostic/predictive markers in lung cancer. Similarly, SHH pathway-components may behave as potential biomarkers and therapeutic tools for C/EBPa-related lung cancers.

This proposal seeks to test the hypothesis that pathways which are dysregulated in lung tumors growing in a lung-specific C/EBPa KO model can be utilized as discovery tools to identify genes involved in human lung cancer pathogenesis.


Eligibility criteria: Inclusion Criteria:

Patients with lung cancer

Primary outcomes:
measure: Define the C/EBPa-Bmi-1 axis in human lung cancer
Secondary outcomes:
measure: Validate the relevance of the C/EBPa-SHH pathway in human NSCLC
measure: Identify new downstream targets of C/EBPa in murine lung cancer and test their involvement in human pathogenesis
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Nationa University Hospital
Study officials:
References:
Clinical trial NCT03698201: Blood Biomarker Signature in Glioma
Official title: Are Gliomas in Adults Associated With a Unique Identifying Blood Biomarker Signature?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glioma of Brain
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
Collaborators: name: Royal College of Surgeons, Ireland
First posted: 2018-10-05
Enrollment: 147
Sex: ALL
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: All patients with suspected newly diagnosed glioma with planned surgical intervention will be eligible.

Brief summary: This is an exploratory, translational and non-interventional clinical study. The aim of this study is to identify a blood biomarker signature for glioma.

Detailed description: The identification of biomarkers (proteins, peptides and micro RNAs (miRNAs)) in the serum of patients with glioma would be a new, less invasive approach, which could help in the diagnosis of a glioma, and potentially help guide therapeutic decisions.

The investigators will investigate the existence of biomarker profiles, which can

* distinguish between low and high grade gliomas
* correlate with patient outcomes including response to treatment and survival
* indicate progression from a low to a high grade glioma.

In this study the investigators collect and analyse blood samples taken from patients with suspected newly diagnosed grade II/III glioma or glioblastoma multiforme (GBM). Blood samples will be collected before any surgical intervention (resection or biopsy) and at various follow-up time points until progression or death. Based on the known natural history of gliomas (described above), it is planned to follow patients with grade III/IV tumours, who receive treatment, for up to 3 years and those with grade II-III tumours, (irrespective of treatment) for up to 5 years. Ultimately, the investigators envisage the translation of our observations into the hospital setting to aid the distinction between glioma grade II and grade III/IV.

Eligibility criteria: Inclusion Criteria:

1. All patients with suspected newly diagnosed glioma (grade 2 or 3 or glioblastoma) with planned surgical intervention (resection or biopsy).
2. Patient aged 18 years or older
3. Patients have to be able to give informed consent

Exclusion Criteria:

1. Prior Radiotherapy to the central nervous system
2. Prior Chemotherapy within the last 5 years
3. Any prior central nervous system malignancy

Primary outcomes:
measure: Identification of protein and miRNA biomarker ignatures
timeFrame: 5 years
Secondary outcomes:
measure: Correlation with disease progression
timeFrame: 5 years
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Beaumont Hospital
Study officials:
affiliation: Cancer Trials Ireland
name: Jochen Prehn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04150601: Effects of SIMEOX on Flow and Volume in Healthy Subjects and Patients With COPD
Official title: Evaluation of SIMEOX Technology on Volumes and Flows Generated in Healthy Subjects and Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 48
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects on the SIMEOX technology on flow and volume generated in healthy subjects and patients with COPD

Detailed description: This is a crossover study assessing the immediate physiological effects of SIMEOX and a PEP device on the exhalation phase in healthy subjects and patients with COPD.

Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to residual volume with a PEP device.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects: able to understand the instructions, no acute or chronic respiratory upper or lower airway disease, normal lung function.
* Patients with COPD: able to understand the instructions; FEV1\<80% predicted value, naive to the SIMEOX device.

Exclusion Criteria:

* Healthy subjects: obesity (BMI \> 30kg/m²); active or former smoker; severe scoliosis; cardiovascular or neuromuscular disease.
* Patients with COPD: obesity (BMI \> 30kg/m²); severe scoliosis; cardiovascular or neuromuscular disease.

Primary outcomes:
measure: Change in expiratory volume
timeFrame: 5 minutes
measure: Change in expiratory flow
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
state: Brussels Capital
Study officials:
References:
Clinical trial NCT02088801: Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
Official title: Phase 2 Study of Evaluation of Videolaryngoscopes in Difficult Airway (SWIVITII)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Keywords: Intubation; Difficult
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: In this second phase of the multicenter study the investigators are going to evaluate the use of three different videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with intubation. The investigators are hypothesizing that these three videolaryngoscopes will succeed for intubation at first attempt in at least 90% of all cases using a difficult airway simulation with extrication collars. As the gold standard, a standard Macintosh blade is being used for comparison.

The study consists of 4 arms. Each arm includes 120 patients, sums up to a total of 480 patients.


Eligibility criteria: Inclusion Criteria:

* elective surgery with general anesthesia requiring intubation
* \>18 years old
* ASA I-III

Exclusion Criteria:

* known or presumed difficult airway
* risk of pulmonary aspiration
* refusing to participate

Primary outcomes:
measure: first attempt intubation success rate
timeFrame: intraoperative
Secondary outcomes:
measure: side effects
timeFrame: 1h and 1day after intubation
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bern University Hospital and University of Bern
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Robert Greif, MD MME FERC
role: STUDY_CHAIR
References:
Clinical trial NCT03271801: Skills Training Within a Family-based Obesity Treatment Intervention
Official title: Skills Training in Stimulus Control of Meals and Snacks Within a Family-based Obesity Treatment Intervention
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 2
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is investigating the impact of a skills training program in stimulus control of meals and snacks on zBMI. Participants will be randomized to a standard family-based obesity treatment intervention with education on child health or a standard family-based obesity treatment intervention with experiential learning about meal stimulus control strategies.

Detailed description: Family-based obesity treatment interventions can successfully reduce weight in children, but are often limited in the practice of skills being taught during treatment sessions.

Skills training focused on a particular behavioral strategy can provide parents with an experiential component of learning where the information learned as part of a family-based obesity treatment intervention is also practiced. Health education simply provides knowledge to a family about a topic.

Eligibility criteria: Inclusion Criteria:

* caregiver of child is ≥18 years of age;
* the caregiver has a child between the ages of 4 and 8 years-old who is classified as overweight (body mass index for age ≥ 85th percentile);
* the caregiver and child are able to read, speak and understand English due to delivery of the program in English;
* has transportation to the University of Delaware; and
* is willing and able to commit to the 3-month study.

Exclusion Criteria:

* the child has a medical condition impacting physical activity or eating (e.g. Type

  1 or Type 2 diabetes);
* the child have a medical condition that affects growth (e.g. Prader Willi Syndrome);
* the child is currently participating in a weight management program, and/or taking weight loss medication; or
* the caregiver or child has an inability to participate in regular physical activity.

Primary outcomes:
measure: z-BMI
timeFrame: 3-months
Secondary outcomes:
measure: Energy intake
timeFrame: 3-months
measure: Percent Energy from Fat
timeFrame: 3-months
measure: Food groups servings
timeFrame: 3-months
measure: Physical Activity
timeFrame: 3-months
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Shannon Robson, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02547701: Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
Official title: Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Onychomycosis
Lead sponsor: Polichem S.A.
Sponsor class: INDUSTRY
First posted: 2015-09-11
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.


Eligibility criteria: Inclusion Criteria:

* Age between 2 to 17 years
* Males and females
* Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis.
* Positive mycroscopy examination from the target nail at screening.
* Positive culture for dermatophyte from the target nail at screening.

Exclusion Criteria:

* Patients with onychomycosis caused by yeasts or non-dermatophytes mould.
* Patients with nail psoriasis.
* Patients with nail changes due to eczema, lichen planus or alopecia areata.
* Patients with one-hand two-foot syndrome.
* Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it.
* Use of systemic antifungal drugs in the 6 months prior to screening visit.
* Use of topical nail antifungal drugs in the four weeks prior to screening visit.

Primary outcomes:
measure: Local tolerability
timeFrame: from week 4 up to maximum week 48 of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: One Investigational Site
country: Belgium
facility: Polichem Investigative site
city: One Investigational Site
country: Germany
facility: Polichem Investigative Site
city: One Investigational Site
country: Italy
facility: Polichem Investigative site
city: One Investigational Site
country: Latvia
facility: Polichem Investigative Site
city: One Investigational Site
country: Spain
facility: Polichem Investigative Site
Study officials:
affiliation: Polichem SA
name: Maurizio Caserini, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02763501: Comparing a Randomised Controlled Intervention With Observational Data.
Official title: Comparing a Randomised Controlled Intervention With Observational Data.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: bariatric surgery
gastric bypass
intestinal obstruction
postoperative complication
methods
laparoscopy
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: The Scandinavian Obesity Surgery Registry
First posted: 2016-05-05
Enrollment: 10992
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of participants in a randomised controlled trial (RCT) with observational data from patients operated in Sweden during the same period of time. The primary objective is to compare effects from a complex surgical intervention from RCT and observational data.

Detailed description: Randomised controlled trials (RCT) are "golden standard" for assessing interventions in medical science. Due to ethical or practical reasons, RCTs may however not always be feasible. The study objective was to test if the results from the RCT differ from observational data in a setting with a complex surgical intervention.

Using the Scandinavian Obesity Surgery Registry database we intend to compare patients operated with laparoscopic gastric bypass surgery within a register based RCT from May 1st 2010 until Nov 14th 2011, with all patients operated with the same procedure registered in the database during the same period of time.

Primary end-point measures are severe complications within 30 days (safety outcome) and surgery for small bowel obstruction (efficacy outcome) within 4 years.

Eligibility criteria: Inclusion Criteria:

* The same as acceptance criteria for bariatric surgery according to the 1991 NIH Consensus Statement

Exclusion Criteria:

* retrocolic gastric bypass procedure
* previous bariatric procedures
* primary open procedures
* missing data on handling of the mesenteric defects

Primary outcomes:
measure: severe postoperative complications within 30 days
timeFrame: 30 days
measure: reoperation for small bowel obstruction
timeFrame: 4 years
Secondary outcomes:
measure: postoperative length of stay
timeFrame: 30 days
measure: length of the operation
timeFrame: intraoperative
measure: specific postoperative complications
timeFrame: 30 days
measure: weight-loss at 2 years after surgery
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05424601: Intervention in a Small-scale Study of Game Based Cognitive Change Skills
Official title: Testing the Modular Intervention in a Small-scale Study of Game Based Cognitive Change ER Skills Coaching with or Without EMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Keywords: online therapeutic game
emotional problems
emotional regulation
children and adolescents
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
Collaborators: name: The Executive Agency for Higher Education, Research, Development and Innovation Funding
First posted: 2022-06-21
Enrollment: 165
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy

Detailed description: Preliminary efficacy will be tested in an emotion-regulation framework. Children included in this study will be allocated to play Level 4 of the REThink game on cognitive change or to no intervention Control condition. Children and adolescents in the intervention group will be distributed afterwards in two groups: with or without ecological momentary intervention (EMI) using the PsyPills app for following-up with the cognitive change ER personalized strategy reminder during a real exam situation. Outcomes considered will be stress reactivity (both subjective and physiological) using EMA before, during and after the test (Colombo et al., 2020), and cognitive change, namely irrational and rational beliefs, and reflective functioning improvements.

Eligibility criteria: Inclusion Criteria:

* children and adolescents between 10 and 16 years old
* provided written parental consent
* able to access mobile/internet applications on their device

Exclusion Criteria:

* Intellectual disability or physical limitations precluded the use of the computer program
* Had a major mental health disorder

Primary outcomes:
measure: Levels of rational and irrational beliefs
timeFrame: Baseline
measure: Changes in levels of rational and irrational beliefs
timeFrame: Post-intervention (one week after the intervention)
measure: Emotion regulation abilities
timeFrame: Baseline
measure: Changes in emotion regulation abilities
timeFrame: Post-intervention (one week after the intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Babes-Bolyai University
state: Cluj
Study officials:
References:
Clinical trial NCT04956601: Adjuvant Radiotherapy in Patients With Early Endometrial Cancer
Official title: A Multicenter, Randomized, Controlled Trial of Adjuvant Radiotherapy in Patients With Early Endometrial Cancer Based on Moderate Risk Molecules Classification
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometrial Cancer
Pathology
Radiotherapy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 480
Sex: FEMALE
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 the effect of vaginal brachytherapy as adjuvant treatment after operation when compared to pelvic external beam radiotherapy in patients with early endometrial cancer based on moderate risk molecules classification.

Detailed description: After being informed the study and potential risk，all patients giving written informed consent will be undergo a 1-week screening period determine eligibility for study entry. At week 0, patients who meet the eligibility will be randomized in a 1:1 ratio to vaginal brachytherapy or pelvic external beam radiotherapy. After treatment, patients were followed up regularly.

Eligibility criteria: Inclusion Criteria:

1. Endometrial adenocarcinoma is confirmed by pathology, and the molecular types were microsatellite instability type and low copy type;
2. Stage IA and grade 3 or stage IB (FIGO 2009), without substantial lymph-vascular space invasion;
3. Surgery must have included a hysterectomy and bilateral adnexectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional;
4. ECOG score is 0-2;
5. The interval time between surgery and radiotherapy is no more than 8 weeks;
6. The routine blood examination was normal;
7. Compliance is good and informed consent is voluntarily signed.

Exclusion Criteria:

1. The patients receive chemotherapy;
2. History of previous malignant disease;
3. Previous diagnosis of Crohn's disease or ulcerative colitis.

Primary outcomes:
measure: DFS
timeFrame: 5-year
Secondary outcomes:
measure: Failure mode
timeFrame: 5-year
measure: OS
timeFrame: 5-year
measure: Toxicities
timeFrame: 5-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijng
Study officials:
References: