louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02440724: The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
Official title: The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Gastric Outlet Obstruction
Keywords: winged stents
Self-expandable Metal Stents(SEMS)
partial covered
uncovered
endoscopic insertion
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 33
Sex: ALL
Minimum age (years): 19
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 usefulness of new designed winged stent(SEMS).


Eligibility criteria: Inclusion Criteria:

1. Gastric outlet obstruction symptom
2. Diagnosis of gastric outlet obstruction by radiologist or endoscopist
3. Gastric outlet obstruction by malignant disease
4. Aged over 19
5. Informed consent

Exclusion Criteria:

1. Gastric outlet obstruction by benign disease or infectious disease
2. Could not endoscopic intervention by poor general condition
3. Refusal of patient

Primary outcomes:
measure: Complication rate(stent migration and tumor ingrowth) of new designed winged stent
timeFrame: up to 16 weeks from stent insertion
Secondary outcomes:
measure: Evaluate the technical success rate of SEMS insertion
timeFrame: up to 16 weeks from stent insertion
measure: Evaluate the clinical success rate of SEMS insertion
timeFrame: up to 16 weeks from stent insertion
measure: Difference of insertion time between previous stent insertion and new designed stent
timeFrame: 1 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: Ji Yong Ahn, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00471224: A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Drug Product
Official title: A Prospective Safety Follow Up Study Of Subjects Enrolled In Study A4321001 And Who Have Received Formulated Drug Product (LOT 8716-098).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Siderosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-09
Enrollment: 16
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A subset of subjects enrolled in study A4321001 and who have received formulated drug product.

Brief summary: This protocol intends to detail investigations necessary to evaluate the ocular safety of subjects enrolled in study A4321001 and who have received formulated Drug Product (Lot 8716-098).


Eligibility criteria: Inclusion Criteria:

* A subset of subjects enrolled in study A4321001 and who have received formulated drug product (Lot 8716-098) will be included in the safety follow up study.

Exclusion Criteria:

None

Primary outcomes:
measure: follow up for ocular safety and clinical features of ocular siderosis
timeFrame: 12 months
Secondary outcomes:
measure: ERG changes
timeFrame: 12 months
measure: Anterior segment and fundal photography
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01711424: An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-10-22
Enrollment: 1209
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: Patients with dry eye

Brief summary: This is an observational study of OPTIVE PLUS® in patients with dry eye disease in a routine clinical setting. Treatment decisions are made by the physician and reflect the physician's current standard of care.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of dry eye
* Physician decision to treat with OPTIVE PLUS® in accordance with the physician's standard practice

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS®
timeFrame: Week 4
Secondary outcomes:
measure: Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS®
timeFrame: Week 4
measure: Tear Break Up Time (TBUT)
timeFrame: Baseline, Week 4
measure: Schirmer Score
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Stuttgart
country: Germany
state: Baden-Wuerttemberg
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT07011524: Study of CM512 Injection in Subjects With Moderate-to-severe Asthma
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of CM512 Injection in Subjects With Moderate-to-severe Asthma.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial evaluating the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of CM512 in subjects with moderate-to-severe asthma.


Eligibility criteria: Inclusion Criteria:

* Able to understand and comply with procedures of the protocol, and voluntarily sign the Informed Consent Form.
* Age ≥ 18 years old and ≤ 75 years old.
* Body mass index (BMI) ≥ 18.0 kg/(m\*m).
* Documented treatment with medium to high dose Inhaled Corticosteroids (ICS) in combination with asthma controller medication for at least 3 months with a stable dose ≥1 month prior to Visit 1.
* Documented history of at least 1 severe asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
* Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5

Exclusion Criteria:

* Women of childbearing potential have a positive pregnancy test result during the screening period; women who are pregnant or lactating.
* With a history of drug abuse within the past 5 years before screening visit.
* Allergic or intolerant to CM512 injection or placebo components, or with a history of severe drug allergies or anaphylactic shock.
* With any medical or non-medical conditions that are not suitable for participation in this study by investigators.

Primary outcomes:
measure: Change from the baseline in Forced Expiratory Volume in one second (FEV1)
timeFrame: Up to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Clinical Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Clinical Hospital of Guangzhou Medical University
name: Ruchong Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04808024: Myofascial Release and Muscle Activity
Official title: Self Myofascial Release (SMR) and Bioelectrical Activity of Muscles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Self Myofascial Release
Muscle Tone Abnormalities
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to assess the impact of SMR intervention in the hamstring muscles on the activity of the biceps and gluteus muscles.

Detailed description: The study will cover 40 men, players of amateur football leagues, aged 18 - 40. The test will include the measurement of sEMG of the biceps and gluteal muscles during the exercise, followed by myofascial self-release (SMR). Muscle sEMG was re-measured immediately after roller therapy.

Eligibility criteria: Inclusion Criteria:

* signing informed consent to participate in the study
* age in the range of 18-40 years

Exclusion Criteria:

* people who had orthopedic injuries to the lower limbs and the lumbar-pelvic-iliac complex in the last year
* people who reported pain in the lower limbs and the lumbar-pelvic-iliac complex on the day of the examination
* people who underwent myofascial therapy in the last 6 weeks
* people with non-specific neuromuscular disorders

Primary outcomes:
measure: 1. Surface electromyography (sEMG) examination before SMR
timeFrame: Before the SMR intervention
measure: Surface electromyography (sEMG) examination immediately after SMR
timeFrame: Immediately after the SMR intervention
measure: Surface electromyography (sEMG) examination 5 minutes after SMR
timeFrame: 5 minutes after the SMR intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia, Katowice, Poland
state: Śląskie
Study officials:
affiliation: Department of Kinesitherapy and Special Methods, SHS in Katowice, Medical University of Silesia in Katowice, Katowice, Poland
name: Magdalena Dąbrowska-Galas
role: STUDY_DIRECTOR
References:
Clinical trial NCT05945524: Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
Official title: Analysis of the Resistance and Sensitivity Mechanisms to Teclistamab by Focusing on Single Immune Cell Examination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Keywords: Teclistamab
Resistance
Immune Cell
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to discover the immune and oncogenomic features that distinguish patients who respond to teclistamab from patients who are primarily resistant. Moreover, phenotypic and genotypic characteristics that occur with secondary resistance to teclistamab will be analyzed.


Eligibility criteria: Inclusion Criteria:

* With multiple myeloma
* Who receive Teclistamab
* Consent form signed

Exclusion Criteria:

* Patient under legal protection

Primary outcomes:
measure: Response to teclistamab at 12 weeks
timeFrame: at day 1 Cycle 4 (each cycle is 28 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU d'Amiens
city: Caen
country: France
facility: CHU de Caen
city: Dijon
country: France
facility: Polyclinique du Parc Drevon
city: Epagny Metz- Tessy
country: France
facility: CH Annecy Genevois
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Necker
city: Pessac
country: France
facility: CHU de Bordeaux
city: Pierre-benite
country: France
facility: CHU de Lyon
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes
city: St Priest-en-jarez
country: France
facility: CH Saint-Etienne
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours
city: Vandoeuvre Les Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: University Hospital, Toulouse
name: Hervé AVET LOISEAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05144724: Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
Official title: Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Respiratory Distress
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room.

Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room


Eligibility criteria: Inclusion Criteria:

* Born between 23+0/7 to 28+6/7 weeks' gestation
* Considered suitable for full resuscitation, i.e., no parental request or antenatal decision to forego resuscitation
* Informed parental consent

Exclusion Criteria:

* Major congenital or chromosomal malformation
* Conditions that might have an adverse effect on breathing or ventilation (e.g., high risk for lung hypoplasia, congenital diaphragmatic hernia)
* Congenital heart disease requiring intervention in the neonatal period
* Hydrops requiring intervention in the neonatal period
* Neonatal resuscitation initiated before NICU team arrival
* Infants who are born outside of study center and transported to center after delivery

Primary outcomes:
measure: Percentage of of eligible participants (=infants requiring PPV) who have the intervention performed correctly without protocol deviation (=cross over to control group when randomized to VTV-group)
timeFrame: Through study completion (total 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Georg Schmölzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00924924: Act Healthy! A Controlled Trial of Worksite Health Promotion
Official title: Act Healthy! A Controlled Trial of Worksite Health Promotion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: health promotion
prevention
worksite wellness
behavior change
healthy volunteers
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 91
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to determine if a worksite wellness intervention using a theoretically-based self-management model increases confidence for carrying out healthy behaviors and improves health practices of participating employees. The research questions are: 1) does the intervention produce between group differences in behavior self-efficacy and actual health behaviors, 2) are self-efficacy and performance of health behaviors related, and 3) do changes in self-efficacy result in changes in behavior.

Detailed description: The purpose of this project is to see if a six-week education program called Act Healthy! led by trained volunteers from the UM T.E. Atkins Wellness Program is able to help people who take the classes improve their confidence in their ability to choose good health behaviors and carry out new behaviors. The project will use the Stanford University Self-management education model and train volunteers to be teachers. People who work on the MU campus will be recruited to take a 50-minute class once a week for six weeks. Class members will complete questionnaires before and after the class and again three months later that ask about their health behaviors and confidence to perform health behaviors. This information will be analyzed to determine if the classes were effective in helping people act in healthier ways.

Eligibility criteria: Inclusion Criteria:

* full-time employee of the University of Missouri

Exclusion Criteria:

* inability to read and speak in English

Primary outcomes:
measure: Self-report of health behaviors
timeFrame: pre-, post intervention; 3-month follow up
Secondary outcomes:
measure: self-efficacy for health behaviors
timeFrame: pre- and post-intervention; 3-month follow up
measure: Stages of change scale
timeFrame: pre- and post-intervention; 3-month follow up
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Marian A Minor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01226524: The Role of Traditional Chinese Medicine in the Treatment of Chronic Childhood Immune Thrombocytopenia (ITP)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Childhood Chronic Immune Thrombocytopenia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Immune thrombocytopenia (ITP) is an autoimmune disorder manifested as isolated low platelet count which results in a tendency for bleeding. Around 10% of childhood ITP does not reach resolution within 1 year thus becoming chronic ITP. Therapeutic modalities at present are aimed to achieve symptomatic relief, do not change the natural course of the disorder and are associated with potential side effects and increase cost. Thus, identifying a new therapy that would decrease the bleeding symptoms, without causing significant adverse effects, could be very beneficial. Preliminary reports demonstrate a beneficial role for Traditional Chinese medicine (TCM) in the treatment of ITP.

Working hypothesis and aims: The use of TCM will improve the status of children with chronic ITP and thus will reduce the need to use conventional medications. The investigators aim to study whether in children with chronic ITP, supplementation with TCM, improves the bleeding symptoms and ITP-related quality of life (QOL) compared to the period prior to the intervention? Methods: The study includes three periods: 1st observation period (1 month), TMC period (3 months) and 2nd observation period (2 months). During all study periods the following data will be collected: bleeding symptoms, bleeding score, platelet count, need for conventional therapy, side effects of therapy and ITP-related QOL.


Eligibility criteria: Inclusion Criteria:

1. Children (\< 18 years) diagnosed with chronic ITP; \>1 year after a first diagnosis and baseline platelet count \< 30,000. The diagnosis of ITP will be the responsibility of the Pediatric Hematology specialist in each participating center.

-

Exclusion Criteria:

1. Children with thrombocytopenia due to other causes. 2. Refusal of child or guardian to participate.

-

Primary outcomes:
measure: To determine whether in children with chronic ITP, does supplementation with Traditional Chinese Medicine remedies, reduces symptomatic bleeding episodes compared to the period prior to intervention?
timeFrame: three month
Secondary outcomes:
measure: To determine whether in children with chronic ITP, does supplementation with TCM remedies, improves the disease related quality of life compared to the period prior to intervention?
timeFrame: three months
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shoshana Revel-Vilk, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01295424: Epidemiology and Cost-effectiveness of Out-Of-Hospital Cardiac Arrest in Finland
Official title: FinnResusci: Epidemiology and Cost-effectiveness of Out-Of-Hospital Cardiac Arrest in Finland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Cardiac Arrest
Intensive Care Unit
Emergency Medical Service
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
First posted: 2011-02-14
Enrollment: 2600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out-of-hospital cardiac arrest patients

Brief summary: Observational study of all out-of-hospital cardiac arrest during 6 months in regional areas of Helsinki University Hospital and Kuopio University Hospital from activation of EMS system until follow up to 6 months of survival.Simultaneous observation of out-of-hospital cardiac arrest primary survivors admitted to all Finnish ICUs.


Eligibility criteria: Inclusion Criteria:

* Out-of-hospital cardiac arrest patients

Exclusion Criteria:

* None

Primary outcomes:
measure: Alive at hospital discharge (time frame: Hospital discharge day)
timeFrame: 12 hours
Secondary outcomes:
measure: CPC (time frame: 1 year after cardiac arrest)
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Tom Silfvast, MD, PhD
role: STUDY_DIRECTOR
References: