louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06151886: Life-dependent Home Mechanical Ventilation
Official title: Experiences and Challenges in Life-dependent Home Mechanical Ventilation - a Part of the Air For Life Project
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ventilator Lung
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients assigned with a trained patient care giver to surveil the respiratory treatment (invasive and noninvasive mechanical ventilation) and working on the responsibility of the Respiratory Center East, their relatives as well as trained respiratory patient caregivers working on the responsibility of the Respiratory Center East

Brief summary: In Denmark, life-dependent home-mechanical ventilation (HMV) is given under the surveillance of a specifically trained respiratory patient caregiver (tPCG). The HMV can be invasive through a tracheostomy or non-invasive via a mask.

The purpose of this study is to uncover experiences and challenges associated with having a trained respiratory patient care giver (tPCG) to surveil home-mechanical ventilation (HMV) from the perspective of the patients and their families and to gather information about the expirence of working in a home as a tPCG


Eligibility criteria: Inclusion Criteria:

Patient Age \> 18 years Has trained patient care givers to surveil the respiratory treatment and working on the responsibility of the Respiratory Center East

Parent Age \> 18 years Has a child less than 18 years old with tPCG, working on the responsibility of the Respiratory Center East, to surveil the home-mechanical ventilation

Other relative:

Age \> 18 years Involved in the treatment or support of a relative with tPCG, working on the responsibility of the Respiratory Center East, to surveil the home-mechanical ventilation

Trained patient caregivers (tPCG) Age \> 18 years Employed by an external agency or by the patient (BPA) to surveil home-mechanical ventilation Certified as tPCG working on the responsibility of the Respiratory Center East

Exclusion Criteria:

* No informed consent to participate

Primary outcomes:
measure: Severe respiratory insufficiency questionnaire
timeFrame: Assessed within the last 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: GLostrup
country: Denmark
facility: Department of Anaesthesia, Pain and REspiratory Support
Study officials:
References:
Clinical trial NCT00318786: Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 Diabetes
Official title: Trial to Investigate the Efficacy and the Safety of Thrice-Daily NN2000-Mix70 (NovoRapid 70 Mix) Compared to Twice-Daily NN-X14Mix30 (NovoRapid 30 Mix) in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 289
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. This a clinical trial to study the efficacy and safety of three times a day BIAsp-70 compared to two times a day BIAsp-30 in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Subjects with type 2 diabetes
* Current treatment using intermediate-acting, long-acting insulin (including long-acting insulin analogue) or pre-mixed human insulin for at least 24 weeks
* HbA1c at least 7.5% and below 10.0%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic and/or renal function
* Cardiac diseases
* Uncontrolled hypertension
* Known hypoglycemia unawareness or recurrent major hypoglycemia

Primary outcomes:
measure: Hemoglobin A1C (HbA1C)
timeFrame: After 16 weeks of treatment
Secondary outcomes:
measure: HbA1C, after 28 weeks of treatment; Plasma glucose levels
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Nishida T, Kaku K. 28-week, randomized, multicenter, open-label, parallel-group phase III trial to investigate the efficacy and safety of biphasic insulin aspart 70 thrice-daily injections vs twice-daily injections of biphasic insulin aspart 30 in patients with type 2 diabetes. J Diabetes Investig. 2010 Jun 1;1(3):103-10. doi: 10.1111/j.2040-1124.2010.00015.x.
Clinical trial NCT05243186: Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
Official title: Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Attention Deficit Disorder
Keywords: Attention Deficit Disorder
Cognitive performance
Treadmill
Lead sponsor: Ariel University
Sponsor class: OTHER
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2022-02-16
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will participate in four different sessions of the study that will be randomly crossed over.
Primary purpose: OTHER

Brief summary: Randomized clinical trial in which individuals who have been diagnosed with ADHD and are regularly treated with Methylphenidate will be test for cognitive performance and will be randomly examined in the following four conditions:

* While taking Methylphenidate and sitting at a desk
* While taking Methylphenidate and walking on a treadmill workstation
* Without taking Methylphenidate while sitting at a desk
* Without taking Methylphenidate while walking on a treadmill workstation The investigators will compare the cognitive achievements outcomes and evaluate the efficiency of studying in each of these four conditions.

Detailed description: The rationale of this clinical trial is to identify the intervention that best contributes to better cognition results of adults with ADHD's: physical activity, drug or a combination of the two? The study will enable to determine which factor will improve cognitive results. The findings of this trial will help determine the best treatment method that can be offer to adults with ADHD.

Eligibility criteria: Inclusion Criteria:

\* Insured by Maccabi Health Services

* Diagnosed with ADHD by Neurologist/Psychiatrist/Developmental Doctor
* Take Methylphenidate as part of the treatment for ADHD AND have agreed to not take the drug if asked to
* Understand the language and simple instruction
* Willing to participate in the study and sign the agreement form

Exclusion Criteria:

* Suffer from heart disease or chronic respiratory illness
* Women who are pregnant

Primary outcomes:
measure: Stroop performance
timeFrame: Through study completion, an average of 1 year
measure: Barhatt performance
timeFrame: Through study completion, an average of 1 year
measure: Breaks from work
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ariel
country: Israel
facility: Ariel University
Study officials:
affiliation: Ariel University
name: Liat Korn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korn L, Hassan K, Fainshtein N, Yusov N, Davidovitch N. Non-Medical Use of Prescription Stimulants for Treatment of Attention Disorders by University Students: Characteristics and Associations. Med Sci Monit. 2019 May 21;25:3778-3787. doi: 10.12659/MSM.913973.
Clinical trial NCT01012986: "Reading Subtitles Skills in the Elementary School"
Official title: "Reading Subtitles Skills in the Elementary School"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reading Comprehension
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-11-13
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: students in 2nd and 4th grade

Brief summary: Theme: The reading of fixed texts in school are widely known, however it is not known how they read texts furniture and what skills are required for this type of reading.

Objective: To evaluate the skills of reading film subtitles in students of 2nd and 4th grade of elementary school of a Public School.

Method: Review the level and skills of reading movies subtitles (RMS), through the recounting of a section of film watched, alone, mute and legend, for 60 students (30 2nd grade and 30 of the 4th grade) matched for age and gender.

Detailed description: The purpose of this study was to compare the reading film subtitles skills in students aged 2nd and 4th grade of elementary school (EF) from a public school, and relate the performance of literacy in school with reading film subtitles.

Proceedings: The study included 30 students from 2nd and 30 from 4th grade of a public school at Sao Paulo. The participants' ages ranged from 7 years and 8 months to 9 years and 3 months in the 2nd grade, and 9 years and 9 months to 11 years and one month in the 4th grade. The groups were matched for the genre.

Inclusion criteria: sign a consent to search, be literate, do not have any sensory changes, and never repeated a grade. Each subject, individually, was rated about the level of literacy and reading through the protocol of school literacy; and about reading film subtitles skills.Each subject recounted what he understood and responded to five inferential questions about the movie.The recount was analyzed and scored on a specific protocol based on Castillo (1999).Students could score in four levels: decoding, literal comprehension, comprehension independent and critical reading.

Eligibility criteria: Inclusion Criteria:

* sign a consent to search
* be literate
* do not have any sensory changes
* and never repeated a grade

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
city: São Paulo
country: Brazil
facility: University of São Paulo
Study officials:
References:
Clinical trial NCT00229086: Gatekeeper European 005
Official title: Long Term Follow-up European Gatekeeper Study 005
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: GERD
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04


Eligibility criteria: Inclusion Criteria:

* Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study
* Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent

Exclusion Criteria:

* Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper)
* Developed other medical illness that may cause the subject to be non-compliant
* Extensive Barrett's Esophagus (\>2 cm)
* Unable or unwilling to cooperate with the study procedures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Contact Medtronic for specific site information
state: Minnesota
city: Tolochenaz
country: Switzerland
facility: Contact Medtronic for specific location
Study officials:
affiliation: MedtronicNeuro
name: Medtronic GU Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01716286: Neural Correlates of an Olive Oil Essence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neural Correlated of Different Foods
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: German Federation of Industrial Research Associations
name: Zentrum für Ernährungsmedizin und Prävention
name: German Center for Diabetes Research
name: University of Hohenheim
name: Ludwig-Maximilians - University of Munich
First posted: 2012-10-29
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the current study was to investigate the effect of a low fat meal in comparison to a low fat meal dosed with the fatfree essence of olive oil.


Eligibility criteria: Inclusion Criteria:

* male
* heatly

Exclusion Criteria:

* lactose intolerance
* fMRI cotraindications

Primary outcomes:
measure: change in brain activity (cerebral blood flow change after yogurt intake)
timeFrame: 30 minutes before as well as 30 minutes and 120 minutes after yoghurt intake
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Clinic of Tuebingen, MEG Center
Study officials:
References:
citation: Frank S, Linder K, Fritsche L, Hege MA, Kullmann S, Krzeminski A, Fritsche A, Schieberle P, Somoza V, Hinrichs J, Veit R, Preissl H. Olive oil aroma extract modulates cerebral blood flow in gustatory brain areas in humans. Am J Clin Nutr. 2013 Nov;98(5):1360-6. doi: 10.3945/ajcn.113.062679. Epub 2013 Sep 11.
Clinical trial NCT03975686: Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent SubjectS
Official title: Effects of Neuromuscular Pelvic Realigning Exercises on Pelvic Floor Muscle Function in Continent Subjects: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Stress Urinary Incontinence
Pelvic Asymmetry
Lead sponsor: University of North Georgia
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research study is to investigate the effect of a new neuromuscular approach for correcting pelvic alignment and improving pelvic floor muscle function. Investigators hypothesized that this approach would be significantly superior than no intervention to improve the ability of pelvic floor muscle contraction, measured by transabdominal sonography as bladder base elevation. Participants will be randomized to the intervention and control groups. while intervention group will receive five supervised sessions of pelvic realigning exercises, the control group will receive no intervention. Bladder base elevation will be measured as an indicator of pelvic floor muscle function, before and after one week intervention in both control and intervention groups.


Eligibility criteria: Inclusion Criteria:

Positive Ober's test

Exclusion Criteria:

* pelvic/low back pain in previous 12 months

Primary outcomes:
measure: bladder base elevation
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Dahlonega
country: United States
facility: University of North Georgia
state: Georgia
Study officials:
affiliation: University of North Georgia
name: Mahshid A Chehrehrazi, Student
role: STUDY_DIRECTOR
affiliation: University of North Georgia
name: Mohammad R Nourbakhsh, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03837886: Effects of Sodium Bicarbonate Supplementation on Intermittent and Intense Task
Official title: Sodium Bicarbonate Supplementation Promotes Changes in Performance, Muscle Activity and Strength of Individuals Trained During the Performance of Intermittent and Intense Task? Randomized, Double-blind, Crossover Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sodium Bicarbonate
Alkalosis, Metabolic
Electromyography
Fatigue
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Marcelo Martins Kalytczak
First posted: 2019-02-12
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of this study was to verify if sodium bicarbonate (NaHCO3) suplementation promotes changes in the performance, muscular activity and strength of individuals trained during the intermittent and intense task . Twelve trained adult men will participate in this randomized, double-blind, crossover clinical trial. Each participant should receive two types of intervention with a 14-day interval between conditions: alkalosis (ALK) in which gelatinous capsules containing 0.3 g.kg -1 of NaHCO 3 and placebo (PLA) are administered, in which 0.3 g.kg-1 of Calcium Carbonate (CaCO3). The following results will be considered: electromyographic activity (EMG) of the quadriceps muscle, peak torque, pH, lactate, and perception of effort, recovery and pain questionnaires, which will be collected during intermittent and high intensity DI protocol. ANOVA of repeated measures will be used to verify possible differences between groups.


Eligibility criteria: Inclusion Criteria:

* resistance trained men (minimum 12 moths resistance training experience)

Exclusion Criteria:

* diabetes mellitus;
* respiratory (asthma, COPD), renal, metabolic, rheumatic and cardiovascular disorders;
* acid-base balance disorder;
* continuous use of some type of medication;
* use of high-protein supplementation and creatine supplementation;
* users of anabolic steroids.

Primary outcomes:
measure: Electromyographic activity of the femoral quadriceps evaluated with electromyography equipment
timeFrame: 60 minutes
measure: Peak torque assessed with isokinetic dynamometer equipment
timeFrame: 60 minutes
Secondary outcomes:
measure: Lactate assessed with portable lactometer
timeFrame: 15 seconds
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
References:
Clinical trial NCT02309086: Phase I-II Vaccination of Autologous Dendritic Cells Transduced With Adenoviral Vector Encoding NS3 in Hepatitis C Encoding NS3 in Hepatitis C
Official title: Phase I-II Vaccination Clinical Trial in Patients With Chronic Hepatitis C by Administration of Autologous Dendritic Cells Transduced With an Adenoviral Vector Encoding NS3 Protein
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Centro de Investigación Médica Aplicada (CIMA)
First posted: 2014-12-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3


Eligibility criteria: Inclusion Criteria:

Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment

Exclusion Criteria:

Liver cirrhosis HBV-coinfection Bilirubin \>1.5 times ULN or ALT \>7 ULN Hepatocellular carcinoma Immunodeficiency

Primary outcomes:
measure: Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy on viral load and immune response
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01965886: Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: a Randomized Clinical Trial
Official title: Medial vs Lateral Approach for Total Knee Replacement on Valgus Knee: Prospective and Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: osteoarthritis
knee
arthroplasty
replacement
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Campinas, Brazil
First posted: 2013-10-18
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The most common surgical approach to perform a total knee replacement is called medial parapatellar approach. It's effective and can be applied virtually to all types of knee deformities. The Keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. Some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee but there is no convincing evidence on the literature supporting one or another approach. The objective of this study is to compare the medial vs lateral approach for total knee replacement on valgus knee.

Detailed description: Total knee replacement is a procedure for the treatment of advanced knee osteoarthritis. The most common surgical approach to perform a total knee replacement is called medial parapatellar approach, or simply medial approach. It's effective and can be applied virtually to all types of knee deformities. The Keblish approach is an alternative approach which uses the lateral side of the patella to enter the joint. It's also called lateral parapatellar approach. Some orthopaedic surgeons consider the latter approach a better option when facing a valgus deformity of the osteoarthritic knee. Theoretically, the Keblish approach can promote better soft tissue balance and patellar tracking, but there is no convincing evidence on the literature supporting one or another approach for a total knee replacement on valgus knee. The objective of this prospective and randomized clinical trial is to compare the medial vs lateral approach for total knee replacement on valgus knee.

Eligibility criteria: Inclusion Criteria:

* Severe osteoarthritis (Kellgren \& Lawrence grade 4)
* Valgus deformity of the knee
* Read and sign the informed consent form

Exclusion Criteria:

* Severe pain in other joint (VAS\>6)
* Comorbidities or any condition that contraindicate the procedure
* Previous arthroplasty on the index knee

Primary outcomes:
measure: Knee Score
timeFrame: 1 year
Secondary outcomes:
measure: WOMAC
timeFrame: 2 years
measure: VAS
timeFrame: 2 years
measure: Knee alignment
timeFrame: 6 months
measure: Hemoglobin
timeFrame: 3 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital de Clínicas da UNICAMP
state: SP
Study officials:
affiliation: University of Campinas
name: Alessandro R Zorzi, MsC
role: PRINCIPAL_INVESTIGATOR
References: