louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00625261: Effectiveness of Early Parent-Based Language Intervention
Official title: Effectiveness of a Parent-Based Language Intervention Group Program for Two-Year-Old Children With Language Delay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Language Delay
Developmental Language Disorders
Keywords: Language delay
Speech and language disorders
Early language intervention
Parent-based language intervention
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2008-02-28
Enrollment: 150
Sex: ALL
Minimum age (years): 24
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to examine the effectiveness of a highly-structured parent-based language intervention group program for two-year-old children with language delay.

Detailed description: Language delay in toddlers is a prevalent problem for pediatric practitioners. As there are no clear guidelines to deal with this problem, in German speaking countries the "wait-and-see"approach is widely chosen, although longitudinal studies have found that children with language delay are at risc for cognitive, behavioral and social-emotional problems.

During the last few years various forms of early language intervention have been increasingly implemented in German speaking countries. However, they have not been evaluated.

Early parent-based intervention could be an economical way in prevention speech and language disorders.

Eligibility criteria: Inclusion Criteria:

* Children with receptive and/or expressive language abilities below norm range measured by the standardized and norm-referenced German developmental language test SETK-2 (Grimm, 2000)

Exclusion Criteria:

* Children with visual impairments, genetic syndromes, metabolic diseases
* Children with previous language intervention

Primary outcomes:
measure: Receptive and expressive language abilities using standardized instruments (SETK-2, SETK 3-5, AWST, HVS, HASE, HSET)
timeFrame: at 2; 6, 3, 4, 5 and 8 years of age
Secondary outcomes:
measure: Parent-report screening questionnaire ELFRA-2 (adoption of the MacArthur Communicative Development Inventories-CDI); cognitive and social-emotional development assessed by standardized instruments,
timeFrame: at 2;6, 3, 4, 5 and 8 years of age
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Pediatric Neurology, Childrens Hospital, University of Heidelberg
Study officials:
affiliation: Department of Pediatric Neurology, Children´s Hospital, University of Heidelberg
name: Anke Buschmann, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02012361: Inspired Helium for Ischemic Protection During Knee Replacement Surgery
Official title: Inspired Helium for Ischemic Protection During Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemia
Keywords: Ischemic preconditioning
Human limb ischemia
Total knee arthroplasty
Supplemental inspired helium
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether breathing in helium reduces indications of injury to the skeletal muscle seen in blood tests after knee replacement surgery.

The ability to reduce the risk of skeletal muscle injury may help improve patient safety by providing protection to the area of the body having its blood supply interrupted during a particular surgery.

Detailed description: During hospitalization, beginning the day after surgery, additional tests will be added to the daily standard of care blood samples. When daily blood samples are not ordered as part of a study participants care after surgery, blood samples only for the study tests, may be done.

Up to 60 study participants will be selected to be in one of two possible groups.

After hospital discharge the study participants physical therapist will be contacted for copies of the notes and reports about the participants progress in physical therapy. This information will be used to evaluate if the different breathing gases have any impact on how quickly people recover after surgery.

Eligibility criteria: Inclusion Criteria:

* Scheduled for an elective total knee arthroplasty
* \> 18 years of age
* Expected to require inhaled oxygen concentrations \< 25%
* Able to provide informed consent

Exclusion Criteria:

* Expected to require inhaled oxygen concentrations \> 25%
* \< 18 years of age
* Member of a defined vulnerable population (e.g. pregnant, mentally handicapped, prisoners, etc.).

Primary outcomes:
measure: Expression of serum markers
timeFrame: up to 5 days
Secondary outcomes:
measure: Recovery of quadriceps function
timeFrame: Up to one year
Other outcomes:
measure: Post-surgical time course of potassium
timeFrame: up to 5 days
measure: Post-surgical time course of urea (BUN)
timeFrame: up to 5 days
measure: Post-surgical time course of lactic acid
timeFrame: up to 5 days
measure: Post-surgical time course of lactate dehydrogenase
timeFrame: up to 5 days
measure: Post-surgical time course of aldolase
timeFrame: up to 5 days
measure: Post-surgical time course of creatinine phosphokinase (CK)
timeFrame: up to 5 days
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Cameron R. Smith, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00503061: A Pharmaceopidemiological Study in Patients Who Use Symbicort SMART
Official title: A Pharmaceopidemiological Study in Patients Who Use Symbicort Turbuhaler as Maintenance and Reliever Therapy (Symbicort SMART) Capturing Over Use and Under Use Via the General Practice Research Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: pharmaceopidemiological
Symbicort SMART
GPRD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population comes from Primary Care Clinics and Pulmonary Experts

Brief summary: To investigate how common it is that patients using Symibort SMART take high average daily doses that are not considered appropriate by their physician (overuse) or are hospitalised due to their asthma at least partly due to underuse.


Eligibility criteria: Inclusion Criteria:

* Asthma diagnosis, patient registered with the prescribing physician for at least one year before the qualifying prescription of Symbicort, prescription of Symbicort SMART after UK launch of the concept

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AZ UK MC
name: Catriona McMahon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ R&D Lund
name: Tomas Andersson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01693861: "Cancersensor" Chemotherapy
Official title: Molecularly Imprinted Polymer Sensors of Modified Nucleosides for Non-invasive Monitoring of Cancer Therapy : Effect of Chemotherapy on Cancerous Proliferation Based on the Dynamic Excretion of Urinary Nucleosides.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: Colorectal
Cancer
Metastatic
Chronotherapy
Urine
Nucleosides
Chemotherapy
Treated with chemotherapy
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2012-09-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer treated at the Department of Medical Oncology of Paul Brousse Hospital

Brief summary: Observational, non randomized study aimed at measuring the effect of chemotherapy in the urinary concentrations of physiological modified nucleosides in 30 patients with metastatic colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed metastatic colorectal cancer;
* 0 to 3 prior chemotherapy lines;
* Signed informed consent;
* Good understanding of the protocol and of the follow-up;
* Estimated life expectancy exceeding 3 months;
* At least one measurable metastatic lesion (RECIST criteria);
* Performance Status (WHO) of 0 to 2;
* Good haematological, hepatic and renal functions.

Exclusion Criteria:

* More than 2 surgical resections of metastases from colorectal cancer;
* Poor performance status (\>2);
* Poor haematological, hepatic or renal functions;
* Uncontrolled chronic disease;
* Serious unhealed wound, ulcer or fracture within the previous month;
* Clinical or laboratory finding suggesting possible abnormalities in nucleosides urinary excretion;
* Pregnancy or breast-feeding during the previous month;
* Transmeridian trip of more than 4 time zones within the prior 2 weeks;
* Person with legal restriction to participate into clinical research, according to the current law in France.

Primary outcomes:
measure: Effect of chemotherapy on urinary excretion of modified nucleosides
timeFrame: 17 days
Secondary outcomes:
Other outcomes:
measure: Identification of modified nucleosides as biomarkers for colorectal cancer
timeFrame: 17 days
Locations:
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
affiliation: INSERM CNRS AP-HP Université Paris Sud
name: Francis Lévi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05414461: Efficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer
Official title: Efficacy of PD-1-inhibitor-based Combination Therapy in Patients With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Immunotherapy improved efficacy and survival in selective patients with metastatic colorectal cancer (mCRC), however, limited data revealed the landscape of immunotherapy efficacy. What's more, potential markers have not been comprehensively evaluated to identify responding patients to further improve efficacy.The investigators conducted a single-arm study to investigate the efficacy of combination immunotherapy in patients with mCRC, and the combined regimen is determined by the physician in charge.


Eligibility criteria: Inclusion Criteria:

* patients who had both baseline measurable lesion(s) and at least one post-baseline radiological disease reassessment
* patients with identified genomic status

Exclusion Criteria:

* patients who received immune monotherapy
* patients who stopped treatment for any reason without identified response assessment.

Primary outcomes:
measure: Durable clinical benefit
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00841061: Cereals as a Source of Iron for Breastfed Infants
Official title: Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2009-02-11
Enrollment: 111
Sex: ALL
Minimum age (years): 28
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.


Eligibility criteria: Inclusion Criteria:

* exclusively breastfed
* birth weight between 2500 and 4200g
* gestational age \>36 weeks

Exclusion Criteria:

* supplementing formula
* no iron drops

Primary outcomes:
measure: plasma ferritin
timeFrame: 280 days
Secondary outcomes:
measure: hemoglobin
timeFrame: 280
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Ekhard E Ziegler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziegler EE, Fomon SJ, Nelson SE, Jeter JM, Theuer RC. Dry cereals fortified with electrolytic iron or ferrous fumarate are equally effective in breast-fed infants. J Nutr. 2011 Feb;141(2):243-8. doi: 10.3945/jn.110.127266. Epub 2010 Dec 22.
Clinical trial NCT06971861: Just ACT for Student Well-being
Official title: Just ACT: School-Based Program Using Acceptance and Commitment Therapy (ACT) to Promote Student Well-being
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acceptance and Commitment Therapy
Psychological Well-being
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: New Life Psychiatric Rehabilitation Association
First posted: 2025-05-14
Enrollment: 96
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Most psychological conditions start developing during adolescent years. This makes adolescence an ideal and critical window for prevention efforts that help enhance stress management and mental health among the younger generations. This pilot study aims to develop a brief prevention program that focuses on youths' well-being and living as guided by their personal values.


Eligibility criteria: Inclusion Criteria:

* age of 35 years or below
* fluency in oral and written Chinese

Exclusion Criteria:

* active or current history of psychosis, bipolar disorder, or personality disorder
* active or current report of suicidal attempts
* active or current suicidal ideations for more than half the days
* any history of intellectual deficits

Primary outcomes:
measure: Attendance
timeFrame: At the end of treatment
measure: Change in psychological flexibility as measured with the Multidimensional Psychological Flexibility Inventory
timeFrame: Before treatment, between the second and third session, within one week after treatment, and one month after treatment
Secondary outcomes:
measure: Treatment retention
timeFrame: At the end of treatment
measure: Change in well-being as measured with the Flourishing Scale
timeFrame: Before treatment, within a week after treatment, and one month after treatment
measure: Change in depressive symptoms as measured with Patient Health Questionnaire (PHQ-9)
timeFrame: Before treatment, within a week after treatment, and one month after treatment
measure: Change in anxiety symptoms as measured with the Generalized Anxiety Disorder (GAD-7)
timeFrame: Before treatment, within a week after treatment, and one month after treatment
measure: Treatment satisfaction
timeFrame: Within a week after treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: New Life Psychiatric Rehabilitation Association
Study officials:
References:
Clinical trial NCT00256061: Assessment of Electrolyte Values in the Intensive Care Unit:Comparison Between Arterial and Venous Blood Gas Analysis and Formal Laboratory Testing
Official title: Assessment of Electrolyte Values in the Intensive Care Unit:Comparison Between Arterial and Venous Blood Gas Analysis and Formal Laboratory Testing
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Electrolyte Values
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE

Brief summary: The study hypothesis is that in critically ill patients there is significant differences between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.

Detailed description: The sudy hypothesis is that in critically ill patients there is a significant difference between electrolyte levels measured using blood gas analysers and by laboratory techniques, and between levels measured on arterial and venous blood samples.

The study aim is determine the agreement between electrolyte levels measure by formal laboratory serum analysis and point-of-care blood gas analysis.

Also, to determine the agreement between electrolyte levels measured on simultaneous arterial and venous blood samples, using both serum and whole blood samples.

Eligibility criteria: Inclusion Criteria:

1. Adult patients 18 years or older admitted to the intensive care unit
2. Patients who have arterial and central venous access insitu for clinical management purposes.
3. Patients who consent to inclusion in the study, or if the patient is not competent, the next of kins' consent.

Exclusion Criteria:

Nil-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Royal Melbourne Hospital, Intensive Care Unit
name: Megan Robertson, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04661761: Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
Official title: Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Keywords: paraffin chewing gum
sialometry
salivary flow rate
mouth dryness
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Determination of salivary flow rate chewing Paraffin pellets (manufactured by Aurosan GmbH) for 7 minutes. At a later timepoint determination of salivary flow rate chewing Saliva-Check Buffer (manufactured by GC Europe) for 7 minutes.
Primary purpose: BASIC_SCIENCE

Brief summary: The study examines two different chewing gums with regard to consistency and its influence on the result of sialometry

Detailed description: The examination (sialometry) is performed on healthy volunteers. The volunteers must chew on a paraffin gum for seven minutes. After each minute, the amount of secreted saliva is spat into a designated cup and evaluated. This test is performed with Aurosan chewing gum and later with GC Europe chewing gum.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* non-smoker
* no medication

Exclusion Criteria:

* physical or mental illnesses
* smokers
* regular medication intake
* pregnant women
* dementia or persons who are unable to judge or persons with guardianship
* minor test persons

Primary outcomes:
measure: Stimulated salivary flow rate (ml)
timeFrame: at baseline (approx 40 minutes)
Secondary outcomes:
measure: Change in consistency of chewing gum
timeFrame: at baseline (7 minutes for each chewing gum)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Center for Dentistry Basel UZB
state: Basel-Stadt
Study officials:
affiliation: University Center for Dentistry Basel UZB
name: Andreas Filippi, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05679661: Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients
Official title: Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Complications
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 590
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. This study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.

Detailed description: This study is a prospective, single center, two-by-two factorial randomized controlled trial to evaluate the feasibility and efficacy of perioperative oral chlorhexidine decontamination and immunonutrition supplementation on postoperative complications in elderly surgical patients. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited and randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care with/without immunonutrition supplementation).

Eligibility criteria: Inclusion Criteria:

1. age≥65 years;
2. undergoing non-cardiac surgery (expected duration \>2 hours);
3. scheduled for general anesthesia and endotracheal intubation;
4. ASA classification I-IV;
5. with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia);
6. inform consent obtained

Exclusion Criteria:

1. emergency surgery;
2. preoperative pneumonia;
3. allergic to chlorhexidine;
4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
5. expected intervention of immunonutrition\<3 days.

Primary outcomes:
measure: postoperative pulmonary complications
timeFrame: within 7 days after surgery
Secondary outcomes:
measure: postoperative pneumonia
timeFrame: within 7 days after surgery
measure: postoperative recovery
timeFrame: within 30 days after surgery
measure: Comprehensive complication index (CCI)
timeFrame: within 30 days after surgery
measure: Length of hospital stay
timeFrame: From date of surgery until discharge day, assessed up to 4 weeks
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital (CAMS)
name: Yuguang Huang
role: PRINCIPAL_INVESTIGATOR
References: