louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00675194: Efficacy of Irinotecan and Capecitabine Versus(vs) Cisplatin and Capecitabine in Patients With Esophago-Gastric Cancer
Official title: A Prospective, Open, Comparative Multicentre Phase II Study for the Evaluation of Irinotecan and Capecitabine Versus Cisplatin and Capecitabine in Advanced Gastric Adenocarcinoma or Gastric-Oesophagal Junction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: cisplatin
capecitabine
gastric
irinotecan
metastatic
chemotherapy
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which Arm (capecitabine + irinotecan versus capecitabine + cisplatin) shows higher response rates in the treatment of advanced gastric-oesophagal cancer

Furthermore, comparison of progression-free survival, 1-year survival, Quality of Life and safety

Detailed description: capecitabine + irinotecan versus capecitabine + cisplatin, as published by Kang et al. (ASCO 2006)

Eligibility criteria: Inclusion Criteria:

* gastric or gastric-oesophagal junction adenocarcinoma
* unidimensional measurable disease
* Karnofsky index \>/=60%

Exclusion Criteria:

* prior chemo- or radiotherapy
* colorectal diseases
* brain metastases

Primary outcomes:
measure: response rate
Secondary outcomes:
measure: safety
measure: progression free survival
measure: 1 year survival
measure: Quality of Life
measure: Analysis of the dose and efficacy of Epoetin beta weekly in anaemic patients
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Johannes Gutenberg Universität , I. Medizinische Klinik und Polokilinik
Study officials:
affiliation: Johannes Gutenberg University Mainz
name: Markus Moehler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03797794: Influence of PESF on Oxygen Saturation, Quality of Life and Exercise Capacity in COPD
Official title: The Influence of Pulsating Electrostatic Field (PESF) on Oxygen Saturation, Quality of Life and Exercise Capacity of COPD Patients, a Single Center, Double Blind, Placebo Controlled Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: COPD
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Tjongerschans hospital
First posted: 2019-01-09
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, dubbel blind, placebo-controlled parallel study
Primary purpose: TREATMENT

Brief summary: The effect of PESF (Pulsating Electrostatic Field) on the oxygen saturation, quality of life and the exercise capacity will be studied in a randomized, dubbel blind, placebo-controlled parallel design with 32 COPD patients GOLD III and IV with a oxygen saturation below or equal to 90%.

The patients will be treated with three 30-minute PESF- or placebo-sessions distributed over 5 days.

Directly before the first session, oxygen saturation, quality of life (CCQuestionnaire), exercise capacity (6-MWT and grip strength) and phase angle (BIA) will be measured and compared to the results directly after the third session. Oxygen saturation is also monitored during 24 hours after each session.


Eligibility criteria: Inclusion Criteria:

* COPD patients, post-bronchodilator FEV1/FVC \<70% and FEV1 \<50% predicted
* oxygen saturation without suppletion \<=90% (home use of oxygen suppletion is allowed, but will be stopped during PESF-treatment)
* Stable medication (no foreseeable need to change therapy)
* Able to understand the purpose and method of research after adequate information and the ability to decide on participation
* Signed informed consent

Exclusion Criteria:

* Known malignant condition with limited life expectancy
* Carrier of electrical equipment (pacemaker, ICD etc)
* COPD exacerbation in the last 3 weeks
* Woman who are pregnant or of childbearing age without effective contraception
* Manifest acute infection
* Patients with manifest decompensatio cordis
* Rehabilitation/reactivation program within 2 months before or during the study

Primary outcomes:
measure: Improvement of oxygen saturation
timeFrame: 5 days
Secondary outcomes:
measure: Improvement of quality of life
timeFrame: 5 days
measure: Improvement of exercise capacity
timeFrame: 5 days
measure: Improvement of phase angle
timeFrame: 5 days
Other outcomes:
Locations:
city: Heerenveen
country: Netherlands
facility: Tjongerschans
state: Friesland
Study officials:
References:
Clinical trial NCT02265094: Associative Memory in Autism Spectrum Disorder
Official title: Associative Memory in ASD Without Mental Retardation : Study in EEG and Neuropsychology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autistic Disorder
Keywords: Autism Spectrum Disorder
Development
Memory
ERD
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: Amiens University Hospital
First posted: 2014-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the neural substrates of associative memory in Autism Spectrum Disorder using both behavioural and EEG assessments.


Eligibility criteria: Inclusion Criteria:

* Right handed children from 10 to 18 years old
* Informed consent signed by the legal representative and adolescent himself.
* Medical Examinations, psychopathology, and cognitive examination in accordance with inclusion and exclusion criteria specific to each population:

  * People with ASD:

    * Participants with ASD without mental retardation with a diagnosis in reference to the DSM V criteria
  * Controls : Participants without ASD

Main exclusion criteria:

* mental retardation,
* schizophrenia,
* ADHD,
* head injury with lost of consciousness

Primary outcomes:
measure: Index of discrimination obtained with the task of associative memory
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: University Hospital, Caen
name: Jean-Marc BALEYTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00845494: Efficacy of a Behavioral Based Education Intervention to Decrease Medication History Errors Among Professional Nurses.
Official title: Efficacy of a Behavioral Based Education Intervention to Decrease Medication History Errors Among Professional Nurses.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Medication Errors
Keywords: Medication history
medication errors
Reduction of admission medication history errors
Lead sponsor: Waukesha Memorial Hospital
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to determine if a behavioral knowledge based education intervention will decrease medication transcription errors among professional nurses when admitting elder patients to a hospital. The hypothesis is those professional nurses who receive the behavioral-cognitive eduction medication taking intervention will have fewer medication errors than those professional nurses who do not.


Eligibility criteria: Inclusion Criteria:

* Nurses working 20 hours a week or more

Exclusion Criteria:

* Nurses working less than 20 hours a week
* Nurse working as a float or pool nurse

Primary outcomes:
measure: Reduction in medication errors on admission medication history form after intervention
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital
state: Wisconsin
Study officials:
References:
Clinical trial NCT04875494: Effects of Physical Exercise Versus Group Therapy on Self-esteem Among Domestic Violence Victims
Official title: Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Violence
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three independant groups including two intervention groups (Physical Exercise vs. Group Therapy) and one control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current study is a randomized controlled trial comparing the effects of 6 weeks of physical exercise training versus group therapy on self-esteem as well as on the various subdomains of physical self-esteem among women who have experienced domestic violence within the last two months at the time of data collection

Detailed description: The present study design includes three arms (two intervention arms): Physical Exercise (Group A), Counseling/Support Group (Group B), and No Intervention (Control, Group C). Random allocation to each group was done in a 1:1:1 ratio at the end of an initial telephone interview by one of the authors. A permutated block design with a block size of three was used. For each participant in Groups A and B, the assigned intervention was started the week following the initial interview, and lasted 6 weeks.

Eligibility criteria: Inclusion Criteria:

* having experienced domestic violence at some time in the past 2 months

Exclusion Criteria:

* not being physically active on a regular basis (less than 20 min of moderate-vigorous physical activity per day during the last year)
* absence of medical contraindication to exercise

Primary outcomes:
measure: Change score for each of the physical and global self esteem subscales from the Inventaire du Soi Physique (ISP-25). This instrument has 25 items each with a 6-point Likert response scale. Higher scores indicate greater self-esteem (physical or global)
timeFrame: baseline (pre-): the day before intervention implementation; post-study: the day following cessation of intervention, 6 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Châlons-en-Champagne
country: France
facility: CIDFF-51
Study officials:
affiliation: Université de Reims Champagne-Ardenne
name: Stephanie CAILLIES, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02963194: Oxytocin Effects on Self and Other Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Behavior
Keywords: self-processing
endowment effect
neuroimage
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To determine whether the neuropeptide oxytocin (OXT) influences self-processing by investigating whether it increases the endowment effect in relation to both self and others.

Detailed description: In a double-blind, between- subject placebo (PLC) controlled design, investigator aimed to measure the effect of intranasal OXT on the endowment effect. All subjects completed a range of questionnaires measuring personality and affective traits and levels of anxiety before self-administration: Positive and Negative Affect Schedule (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), self-esteem scale (SES). Subjects were asked to decide whether to buy or sell their own or others' (their mothers'/ fathers'/ classmate'/ strangers') possessions at various prices. Indifference point and brain activation were inluded into analysis as dependent variables.

Eligibility criteria: Inclusion Criteria:

* healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* claustrophobia;
* medical or psychiatric illness.

Primary outcomes:
measure: Compared the indifference point between buy and sell conditions during the price phase and the specific brain region activation between oxytocin and placebo groups
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03440294: Wetsuit and Life Jacket Induced Effects on Spirometry and VO2 in Windsurfers
Official title: Étude de l'Effet de la Combinaison néoprène et de l'équipement Individuel de Flottaison Sur la Fonction Respiratoire de Repos et Les capacités à l'Effort Chez Les véliplanchistes : étude WINDSURF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation
Exercise
Keywords: windsurfer
wetsuit
spirometry
cardiopulmonary exercise testing
lung function
pulmonary function
oxygen uptake
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the effect of wearing both neoprene suit and life jacket on respiratory capacities at rest and cardiopulmonary capacities during exercise in windsurfers.

Detailed description: Windsurfers will perform resting spirometry and exercise test on cycle ergometer until exhaustion in two conditions: with or without equipment. The investigators will measure Forced Vital Capacity, FEV1 peak flow at rest and oxygen uptake, carbon dioxide consumption, ventilation at each step of the incremental exercise and at exhaustion.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 to 35
* Do not contraindicate any of the investigations in the study
* Being affiliated to a social security system
* free, informed and written consent
* Have already performed a cardiopulmonary exercise test without any electrocardiographic abnormality
* Subject practicing windsurfing (whatever the level of practice (leisure or competition))

Exclusion Criteria:

* Subjects \< 18 years old
* Pregnant woman
* Inability to consent
* Taking any of the following: oral or inhaled Beta 2 short-acting or long-acting mimetics, oral or inhaled corticosteroids, oral anti-leukotrienes.
* Abnormalities in the resting ECG pattern

Primary outcomes:
measure: Forced Vital Capacity (FVC in L) at rest.
timeFrame: 1 day
Secondary outcomes:
measure: Forced Expiratory Volume
timeFrame: 1 day
measure: Peak Flow
timeFrame: 1 day
measure: mean flow rates
timeFrame: 1 day
measure: maximal ventilation
timeFrame: 1 day
measure: carbon dioxide production
timeFrame: 1 day
measure: oxygen consumption
timeFrame: 1 day
measure: tidal volume
timeFrame: 1 day
measure: breathing frequency
timeFrame: 1 day
Other outcomes:
Locations:
city: Brest
country: France
facility: University hospital
Study officials:
affiliation: CHRU de Brest
name: Marie Agnes Giroux-Metges, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00114894: Prevention of Jellyfish Stings
Official title: Field Study of the Prevention of Jellyfish Stings With a Topical Sting Inhibitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bites and Stings
Keywords: Jellyfish
Stings
Marine
Envenomation
Jellyfish stings
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2005-06-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. The field effectiveness is unknown. This is a field test to determine the real world effectiveness.

Detailed description: Jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150 million envenomations annually. Fatalities and hospitalizations occur annually, particularly in the Indo-Pacific regions. A new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings.

Clown fish inhabit within the tentacles of sea anemones, which have stinging cells similar to those of jellyfish, yet clown fish are not stung by the sea anemones. In controlled laboratory environments, the jellyfish sting inhibitor, Safe Sea™ when applied to volunteers' arms, prevented 100% of Chrysaora fuscescens stings and 70% of Chiropsalmus quadrumanus stings. Of the C. quadrumanus stings that occurred, their intensity was diminished. The field effectiveness is unknown. This is a field test to determine the real world effectiveness of Safe Sea to prevent jellyfish stings.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers planning on snorkeling for 30 to 45 minutes.

Exclusion Criteria:

* Pregnancy
* Severe allergy to jellyfish
* Allergy to any topical dermatologic product

Primary outcomes:
measure: Incidence of jellyfish stings
timeFrame: during recreational saltwater exposure (~30 min)
Secondary outcomes:
measure: Occurrence of seabather's eruption
timeFrame: within 48 hours of saltwater exposure
measure: impact of body hair on jellyfish stings
timeFrame: after recreational saltwater exposure
Other outcomes:
Locations:
city: Key West
country: United States
facility: Dry Tortugas National Park
state: Florida
Study officials:
affiliation: University of Minnesota
name: David R Boulware, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boulware DR. A randomized, controlled field trial for the prevention of jellyfish stings with a topical sting inhibitor. J Travel Med. 2006 May-Jun;13(3):166-71. doi: 10.1111/j.1708-8305.2006.00036.x.
Clinical trial NCT01682694: Glucosamine and Chondroitin Effects
Official title: Glucosamine and Chondroitin Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: A common starting dose of glucosamine and chondroitin will reduce inflammation as reflected by a reduction in serum C-reactive protein.

Detailed description: Use of glucosamine and chondroitin have been associated with reduced cancer and overall mortality. The aim of this study is to determine whether a common starting dose of glucosamine and chondroitin (1500 mg/d + 1200 mg/d, respectively) reduces systemic inflammation as reflected by a reduction in high sensitivity C-reactive protein.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Overweight (body mass index kg/m2 (BMI) between 25 and 32.5)
* Non-smoking men and women
* Aged 20-55y

Exclusion Criteria:

* Chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases)
* Pregnancy or lactation
* Currently on a weight-loss diet
* BMI (body mass index) \< 25 or \> 30
* Alcohol intake of greater than 2 drinks/day
* Current use of prescription or over-the-counter medications, (Excluding oral contraceptives and hormone-secreting IUDs), including use of aspirin or NSAIDs more than 2 days per week
* Abnormal renal, liver or metabolic test
* Inability to swallow pills
* Known allergy to shellfish
* Not willing to take pills made from shellfish or animal sources
* Intention to relocate out of study area within next 4 months

Primary outcomes:
measure: hsCRP
timeFrame: 1 year
Secondary outcomes:
measure: untargeted (exploratory) serum metabolomics (differences in small molecule abundance ratios)
timeFrame: 1 year
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
References:
citation: Navarro SL, White E, Kantor ED, Zhang Y, Rho J, Song X, Milne GL, Lampe PD, Lampe JW. Randomized trial of glucosamine and chondroitin supplementation on inflammation and oxidative stress biomarkers and plasma proteomics profiles in healthy humans. PLoS One. 2015 Feb 26;10(2):e0117534. doi: 10.1371/journal.pone.0117534. eCollection 2015.
Clinical trial NCT05464394: Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass
Official title: Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass to Reduce Haemorrhage (PATRY Study): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hemorrhage
Bleeding
Keywords: Gastric bypass
Tranexamic acid
Lead sponsor: Franciscus Gasthuis
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 1524
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The incidence of bleeding after metabolic surgery seems to increase. The administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery.

Objective: This study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.


Eligibility criteria: Inclusion Criteria:

* Primary metabolic procedure;
* Gastric bypass: Roux-en-Y gastric bypass or One-anastomoses gastric bypass;
* ≥18 years;
* Good command of the Dutch or English language.

Exclusion Criteria:

* Patients unwilling to give informed consent;
* Patients with a medical history of bleeding or VTE (defined as, pulmonary embolism (PE) or deep vein thrombosis (DVT));
* Patients who use anticoagulants;
* Arterial bleeding or (iatrogenic) bleeding during the procedure coming from surrounding organs or vascular structures such as the liver or the spleen.

Primary outcomes:
measure: re-intervention rate
timeFrame: 30 days
Secondary outcomes:
measure: the use of haemostatic staple devices
timeFrame: peroperatively
measure: the use of fibrin sealant
timeFrame: peroperatively
measure: blood loss
timeFrame: peroperatively
measure: haemoglobin decrease
timeFrame: 1 day
measure: heart rate increase
timeFrame: 1 day
measure: number of suspicion on haemorrhage
timeFrame: 30 days
measure: number of suspicion on haemorrhage for which extra haemoglobin monitoring
timeFrame: 30 days
measure: VTE
timeFrame: 30 days
measure: complications rates
timeFrame: 30 days
measure: length of hospital stay
timeFrame: 30 days
measure: duration of primary surgery
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References: