louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00550797: Study to Evaluate the Safety and Efficacy TPI ASM8 in Subjects With Asthma
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of 14-day Inhaled TPI ASM8 in Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Asthma
Keywords: Steroid-naive, non-smokers
Mild to moderate allergic asthmatic adults
Lead sponsor: Syntara
Sponsor class: INDUSTRY
Collaborators: name: i3 Research
First posted: 2007-10-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The researchers propose to study the airways of asthmatics given TPI ASM8 for 14 days, and examine the protective effects on allergen-induced bronchoconstriction, hyperresponsiveness and airway inflammation.

Detailed description: Early and late asthmatic responses were attenuated by ASM8 and by placebo solution.Methacholine challenge was not affected by study medication. Other parameters were unchanged.

Eligibility criteria: Inclusion Criteria:

* Men and women 18 to 65 years of age
* Intermittent mild to moderate allergic asthma as defined by ATS/ERS criteria
* History of episodic wheeze and shortness of breath

Exclusion Criteria:

* Significant acute or chronic medical, neurologic, cardiovascular or psychiatric illness, asthma exacerbation or respiratory infection in the preceding 6 weeks
* Use of oral/injectable corticosteroids within the last 60 days or currently on any anti-asthmatic drugs, immunosuppressives, nonsteroidal anti-inflammatory drugs or anticoagulants

Primary outcomes:
measure: Safety and allergen-induced maximum decrease in FEV1 for Late Asthmatic Response
timeFrame: Safety (Trial duration) + LAR (Day 14)
Secondary outcomes:
measure: Exploratory Endpoints only: EAR on Day 14, AMP-induced airway hyperresponsiveness on Day 10,eNO on Day 14, PK/PD in sputum and plasma
timeFrame: study duration
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College inLondon
Study officials:
affiliation: Kings College Hospital, London, United Kingdom
name: Brian O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Topigen Pharmaceuticals, Montreal, Quebec/Canada
name: Rene Pageau, M.Sc.Pharm
role: STUDY_DIRECTOR
affiliation: University of Pisa, Pisa, Italy
name: Pierluigi Paggiaro, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Evaluation Unit, Manchester, UK
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Amsterdam, Amsterdam, The Netherlands
name: Peter J. Sterk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Padova, Padova, Italy
name: Piero Maestrelli, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00922597: Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery
Official title: Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery - NO PEACKS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Continuous infusion
Surgery
Severe haemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 26
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with a diagnosis of severe haemophilia A. Physicians should consult the full prescribing information for KOGENATE Bayer before enrolling patients and familiarize themselves with the safety information in the product information.

Brief summary: The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.


Eligibility criteria: Inclusion Criteria:

* In-patients with diagnosis of severe haemophilia A (FVIII \< 1%), heavily pretreated (\> 150 exposure days), without any history of inhibitors, a negative inhibitor test should be available, decision taken by the investigator to administer KOGENATE Bayer via continuous infusion during and after surgery.

Primary outcomes:
measure: Total consumption of FVIII (in IU/kg) during continuous infusion, FVIII:C achieved compared to expected levels, reasons and number of unplanned bolus infusion, amount of blood loss, transfusion requirements
timeFrame: During continuous infusion
Secondary outcomes:
measure: General tolerability and development of inhibitors
timeFrame: Within 14 days to 3 months after termination of continuous infusion
Other outcomes:
Locations:
city: Many Locations
country: Austria
city: Many Locations
country: Germany
city: Many Locations
country: Greece
city: Many Locations
country: Italy
city: Many Locations
country: Netherlands
city: Many Locations
country: Slovenia
city: Many Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02655497: Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints
Official title: Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Baycrest
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2016-01-14
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of cognitive strategies in improving participation in daily activities within older adults who report subjective cognitive decline.

Detailed description: The planned project explores the effects of several interventions designed to promote independence in everyday life, with older adults who identify cognitive complaints. Evidence suggests that 25-50% of community dwelling older adults report cognitive difficulties, such as reduced memory or concentration, in the absence of any diagnosed condition. Cognitive skills are crucial to living independently. The investigators plan to examine two approaches in a randomized controlled trial. Based on our successful pilot study, the investigators hypothesize that this training which combines education on healthy lifestyles and problem solving training to address everyday life difficulties, will be effective in maximizing and maintaining independence of older adults.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling older adults aged 60+
* Fluent in written and spoken English
* Have subjective cognitive complaints (SCC)
* Performance within normal limits on a neuropsychological assessment battery
* Participants must also be able to self-identify specific areas of difficulty in their everyday life that they would like to improve

Exclusion Criteria:

* Significant neurological or psychiatric history (e.g., multiple sclerosis, psychiatric illness requiring hospitalization)
* Concurrent depression
* Anaesthesia in previous 6 months; and substance abuse

Primary outcomes:
measure: Change in the Canadian Occupational Performance Measure (COPM) scores
timeFrame: 8 weeks after pretest and 3 months after intervention finished
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
affiliation: Baycrest Health Sciences
name: Deirdre Dawson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477697: Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
Official title: Effects of Omega-3 Fatty Acid Supplementation on Inflammatory Response in Multisystem Trauma Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Multiple Trauma
Keywords: Trauma
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effects of omega-3 fatty acid supplementation on inflammation in trauma patients. The main hypothesis is that such supplementation will reduce the presence of biomarkers of systemic inflammation, as compared to placebo

Detailed description: This prospective, randomized study will evaluate the effects of omega-3 fatty acid supplementation on inflammatory response in multi-injured trauma patients. Its primary objective is to compare the intensity of inflammation between an active omega-3 group and a placebo group.

Eligibility criteria: Inclusion Criteria:

* Multi-system blunt trauma patients
* Ages 18 through 65 years, inclusive
* Admission to ICU
* Nasogastric or nasoenteric feeding tube in place
* Intention of primary medical team to feed the patient enterally

Exclusion Criteria:

* Expected mortality within 48 hours
* Intracranial hemorrhage
* Pregnant or breast feeding
* Patient, surrogate, or physician not committed to full support
* Refractory shock
* Unable to obtain enteral access
* Presence of partial or complete mechanical bowel obstruction, or ischemia, or infarction
* Current total parenteral nutrition (TPN) use, or intent to use TPN within 7 days
* Current gastrointestinal bleeding
* Requirement for vasopressors

Primary outcomes:
measure: Inflammatory markers
timeFrame: Up to 28 days
Secondary outcomes:
measure: Infectious complications
timeFrame: Up to 28 days
measure: Intensive Care Unit length of stay
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University Hospital
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Krishna Athota, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cincinnati
name: Richard Branson, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00684697: Iron Status and Myelination in Premature Infants
Official title: Double Blind Randomized Placebo Controlled Trial of Iron Supplementation in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurodevelopmental Outcome
Keywords: premature infants iron neurodevelopment
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 100
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Premature infants with iron deficiency if supplemented with more elemental iron than the routine 2mg/kg/day will have improved brain development.


Eligibility criteria: Inclusion Criteria:

* Babies less than or equal to 33 weeks gestational age

Exclusion Criteria:

* Infants with cranio-facial malformations
* Torch infections
* Infants with hearing disorders
* Infants receiving erythropoietin
* Infants with subnormal vitamin E levels
* Infants with severe anemia
* Infants who are not on full feeds
* Infant with in-utero exposure to cocaine

Primary outcomes:
measure: mean interpeak latency Auditory Neural Myelination
timeFrame: 43-45 weeks PMA
measure: mean visual neural myelination
timeFrame: 43-45 weeks PMA
Secondary outcomes:
measure: number of participants with executed function
timeFrame: 3-5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Sanjiv B Amin, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06863597: Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium
Official title: A Multi-Center Randomized, Parallel-Group Study to Compare Knowledge Translation Between Different Media in Pregnant and Lactating Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastfeeding Education
Lactating Mother
Breastfeeding Mothers
Lactation
Breastfeeding
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 380
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pharmacotherapy for lactating women in Hungary presents a unique challenge. While certain medications may pose risks to the infant or reduce breast milk production, the unnecessary avoidance of treatment can also be harmful. Despite this, no dedicated Hungarian website currently provides guidance on the safe use of over-the-counter (OTC) medications for breastfeeding mothers.

To address this gap, the aim is to develop a website that not only meets clinical standards but also presents essential information in a clear, accessible format that helps mothers understand and retain key details by choosing the best medium.

Our main question is: What is the most effective way to educate lactating women about OTC medication use through an online platform?


Eligibility criteria: Inclusion Criteria:

* Target population is adult (\>18 years), 3rd trimester pregnant women; and breastfeeding women after childbirth (max. 7 days postpartum; 24:00), who intend to breastfeed.
* Participants have to have internet access with no regard to the type of internet connection.

Exclusion Criteria:

* A mother will not breastfeed, either because they cannot or do not want it.
* Anyone who do not want to participate in the study.

Primary outcomes:
measure: Knowledge translation
timeFrame: From enrollment in the first week, followed by an assessment after 6 months.
Secondary outcomes:
measure: User-satisfaction
timeFrame: From enrollment in the first week, followed by an assessment after 6 months.
Other outcomes:
measure: Participating mother-specific features
timeFrame: From enrollment in the first week, followed by an assessment after 6 months.
Locations:
Study officials:
affiliation: Semmelweis University, University Pharmacy Department of Pharmacy Administration
name: Dénes Kleiner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01567397: Registry of Dupuytren's Contracture Treatment Outcomes
Official title: Registry of Dupuytren's Contracture Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dupuytren's Disease
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: GWT-TUD GmbH
name: Pfizer
First posted: 2012-03-30
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Dupuytren's Disease

Brief summary: Experience with Microbial Collagenase (trade name Xiapex) in Europe currently is limited to randomised controlled studies.While such studies are essential to determine efficacy and safety of the product (usually compared to placebo), they provide no information on the effectiveness of the drug and further aspects of its use (feasibility, tolerability, quality of life and other patient-related outcomes) in the typical "real-life" setting under clinical practice conditions.Thus, the present study aims to collect data on the

* Drug utilization of Microbial Collagenase in the hand of physicians, with focus on feasibility, treatment patterns, and effectiveness in clinical practice
* Context of Microbial Collagenase therapy (setting, patient characteristics, concomitant treatment, follow-up therapy)
* Effectiveness (with focus on functionality)
* Tolerability
* Patient-related outcomes: patient satisfaction, health-related quality of life
* Physician satisfaction with therapy
* Resource utilization (hospital stays, drug consumption, concomitant medication etc.)
* Long-term outcomes


Eligibility criteria: Inclusion Criteria:

* palpable cord due to Dupuytren's Disease (pretreated or untreated)
* satisfactory knowledge of German to be able to fill out questionnaires
* written informed consent

Exclusion Criteria:

* contraindication to Microbial Collagenase (according to Prescription Information)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Markgröningen
country: Germany
facility: Prof. Dr. Max Haerle
city: Munich
country: Germany
facility: Prof. Dr. Riccardo Giunta
city: Various cities
country: Germany
facility: Several undisclosed sites
city: Vogtareuth
country: Germany
facility: Dr. Joerg Witthaut
Study officials:
affiliation: Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
name: David Pittrow, MD, PhD
role: STUDY_DIRECTOR
affiliation: Institute for Clinical Pharmacology (Director), Medical Faculty, Technical University, Dresden, Germany
name: Wilhelm Kirch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopädische Klinik, Markgröningen, Germany
name: Max Härle, MD
role: STUDY_DIRECTOR
affiliation: Schön Klinik Vogtareuth
name: Jörg Witthaut, MD
role: STUDY_DIRECTOR
affiliation: Hand Surgery, Ludwig-Maximilian-University Munich, Germany
name: Riccardo Giunta, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01621997: Different Retraining Methods vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
Official title: Retraining Via Operation Inspection or Verbal Education vs Usual Care on the Prevention of Peritonitis in Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritonitis
Keywords: peritoneal dialysis
retraining
peritonitis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2012-06-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To examine whether retraining via operation inspection or verbal education can reduce the risk for peritonitis in PD patients.

Detailed description: The design is prospective, randomized, controlled study. At baseline (during the first month), they will receive a standard training program on performing bag exchange and education on the prevention of peritonitis.

Then the participants will be randomized into three groups: retraining via operation inspection (G1), retraining via verbal education (G2) and usual care (G3). Retraining will be performed every 2 months in G1 and G2 group.

During the following 2 years or a longer period, all the participants will be followed up frequently with outcome events recorded.

Eligibility criteria: Inclusion Criteria:

* CAPD patients.
* Medically stable and receiving PD for\<1 week
* age between 18 and 80 years
* self-care or doing bag exchange by a fixed assistant Exclusion Criteria
* followed up at least every 2 months
* dialyzed with glucose lactate-buffered PD solutions produced by Baxter Corp, China

Exclusion Criteria:

* Pregnancy;
* undergoing APD therapy
* Intolerance to the study protocols;
* Severe and unstable condition, acute or chronic inflammation disease;
* a high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months;
* suffering peritonitis before receiving the interventions
* cognitive or psychological dysfunction;
* communication barrier

Primary outcomes:
measure: first-episode peritonitis
timeFrame: 48 months
Secondary outcomes:
measure: first-episode enteric peritonitis,first-episode non-enteric peritonitis
timeFrame: 48 moths
measure: transition transition to haemodialysis, and all-cause death.
timeFrame: 48 moths
Other outcomes:
Locations:
city: Beijing
country: China
facility: Jie Dong
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Jie Dong, MD,PhD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu Y, Zhang Y, Yang B, Luo S, Yang Z, Johnson DW, Dong J. Prevention of peritoneal dialysis-related peritonitis by regular patient retraining via technique inspection or oral education: a randomized controlled trial. Nephrol Dial Transplant. 2020 Apr 1;35(4):676-686. doi: 10.1093/ndt/gfz238.
Clinical trial NCT04930497: Vestibular Socket Therapy With and Without Bone Grafting
Official title: Immediate Implant Placement Using Vestibular Socket Therapy With and Without Bone Grafting (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Management of the jumping gap in the Vestibular Socket Therapy. And to study what is the best technique to manage this gap for optimal esthetic result.

Detailed description: 22 patients were randomly assigned to Group 1: Had received implants with the vestibular socket technique accompanied with bone grafting the jumping gap between the implant and the labial membrane.

Group 2: Had received implants with the vestibular socket technique, but without bone grafting the jumping gap.

Facial bone thickness and height were evaluated using CBCT scans at baseline before tooth extraction and after 6 and 13 months

Eligibility criteria: Inclusion Criteria:

* presence of a hopeless tooth or teeth in the esthetic zone (maxillary anterior area)
* No active infection
* Adequate bone palatally and apically
* Presence of contralateral tooth for the tooth being replaced

Exclusion Criteria:

* Hopeless tooth with acute infection
* heavy smokers (more than 10 cigarettes per day)
* pregnant and patients received recent chemotherapy/radiotherapy (during the previous year)

Primary outcomes:
measure: Change in Facial bone thickness
timeFrame: baseline, 6 months and 13 months
measure: Change in Facial bone height
timeFrame: baseline, 6 months and 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Private Practice Clinic
Study officials:
References: