louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00841256: Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children
Official title: ... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinoconjunctivitis
Keywords: specific immunotherapy
SIT
SLIT
sublingual
Lead sponsor: Allergopharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2009-02-11
Enrollment: 207
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.

Detailed description: Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.

Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.

In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.

Eligibility criteria: Inclusion Criteria:

* 4 - \<12 years (at the time of inclusion)
* Positive SPT
* Positive EAST
* Positive CPT

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies

Primary outcomes:
measure: Changes of Symptom-Medication-Score
timeFrame: After 1 year of treatment
Secondary outcomes:
measure: Evaluation of the documentation of adverse events (AEs)
timeFrame: Entire treatment period
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Paediatrie Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Ulrich Wahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wahn U, Klimek L, Ploszczuk A, Adelt T, Sandner B, Trebas-Pietras E, Eberle P, Bufe A; SLIT Study Group. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study. J Allergy Clin Immunol. 2012 Oct;130(4):886-93.e5. doi: 10.1016/j.jaci.2012.06.047. Epub 2012 Aug 29.
Clinical trial NCT02472756: A Study of Rituximab in Combination With Chemotherapy in Relapsed/Refractory Follicular Lymphoma
Official title: Relapsed/Refractory Follicular Lymphoma - Rituximab Therapy in Combination With Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Follicular
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-16
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously treated adult participants with relapsed/refractory FL

Brief summary: This is a Phase 4, open, prospective, non-interventional, multicenter trial for previously treated adult participants with relapsed/refractory follicular lymphoma (FL). Eligible participants with FL will receive 6-8 infusions of induction standard regimen of rituximab plus chemotherapy. Participants with complete or partial remission at end of induction will be assigned to maintenance therapy with rituximab once every 3 months for a maximum of 2 years or until relapse. The choice of the treatment regimen will be established on a per center basis, according to the standard in use in the country and in the center, and each center will use the same regimen through the study. Participants will be followed up for safety and efficacy evaluation in accordance with routine practice.


Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with FL and had already received one or more treatments

Exclusion Criteria:

* Participants who are not eligible for rituximab treatment according to summary of product characteristics (SmPC)

Primary outcomes:
measure: Percentage of Participants With Objective Response
timeFrame: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
measure: Percentage of Participants With Complete Remission (CR)
timeFrame: Baseline until disease progression or death, whichever occurred first (up to approximately 6 months)
measure: Percentage of Participants Who Were Alive at Year 2
timeFrame: Year 2
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Institute of Hematology
city: Belgrade
country: Serbia
facility: Clinical Center Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: NIS
country: Serbia
facility: Clinic of Haematology Cc Nis
city: Novi Sad
country: Serbia
facility: Clinical Center Vojvodine; Clinic for Hematology
city: Sremska Kamenica
country: Serbia
facility: Institute For Oncology Sremska Kamenica; Internal Medicine Department
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06164756: Long Term Follow Up KET-PD
Official title: Long-Term Follow-Up for Subjects Enrolled in the Ketamine for the Treatment of Depression in Parkinson's Disease (KET-PD) Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Parkinson's Disease
Depression
Keywords: Long Term Effect Ketamine Treatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Fox (Michael J.) Foundation for Parkinson's Research
name: Yale School of Medicine Center for Brain Mind Health
First posted: 2023-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of n=56 participants with PD and comorbid depression, age 40-80, are being recruited under the parent clinical trial. As of July 2023, 20 participants have been enrolled. We aim to follow-up our remaining participants longitudinally and, within this, to have 20 prospective participants receive CBT, such that we will have 20 participants in each follow-up arm (CBT vs. TAU), and ultimately 10 in each group (ketamine + CBT, ketamine + TAU, placebo + CBT, placebo + TAU).

Brief summary: The purpose of this study is to examine a) the longer-term effects of ketamine for treating depression in Parkinson's disease (PD) and b) the effects of CBT on maintaining the effects of ketamine.

Detailed description: This is a roll-out study from the ongoing clinical trial (KET-PD trial; NCT04944017, HIC 2000030394). We will adopt an implementation science approach to have participants across ketamine and placebo groups in one of two arms: a) follow-up with treatment as usual (TAU) (at 3 and 6 months post-infusions); b) follow-up with 3 months of Cognitive Behavior Therapy (CBT) post-infusions, delivered remotely once per week, with follow-up assessments at 3 and 6 month timepoints. CBT is expected to have a superior sustained antidepressant response to the TAU follow-up group in both ketamine and placebo arms. We hypothesize that ketamine + CBT will show the most superior antidepressant response at follow-up.

Eligibility criteria: Eligibility is determined in the ongoing parent clinical trial (KET-PD trial; NCT04944017, HIC 2000030394).

Primary outcomes:
measure: Long-Term Change in Depression Severity
timeFrame: 3 Months and 6 Months
Secondary outcomes:
measure: Change in Apathy
timeFrame: 3 Months and 6 Months
measure: Change in Anxiety
timeFrame: 3 Months and 6 Months
measure: Change in Parkinson's Symptom Severity
timeFrame: 3 Months and 6 Months
measure: Change in Dyskinesia
timeFrame: 3 Months and 6 Months
measure: Change in Pain
timeFrame: 3 Months and 6 Months
measure: Change in Fatigue
timeFrame: 3 Months and 6 Months
measure: Change in Anhedonia
timeFrame: 3 Months and 6 Months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Sophie E. Holmes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02251015: Effects of the Use of Occlusal Splint on the Postural Balance of Individuals With Temporomandibular Disorder
Official title: Evaluation of Postural Balance in Individuals With Temporomandibular Disorder by Means of Force Platform After Using Occlusal Stabilizer Splint Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Temporomandibular Disorders
Keywords: Postural balance
Temporomandibular disorders
splints
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder. The research group consists of 49 patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old, both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and magnetic resonance imaging of the temporomandibular joints. The research is a randomized, controlled, prospective clinical study with intervention. Postural equilibrium will be evaluated by means of a force plate. In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation about therapeutic exercises. After 12 weeks, the groups were re-evaluated. The results will be analyzed by categorical data using absolute and relative frequencies as well as continuous data using average, median, standard deviation, 25 and 75 percentiles, besides minimum and maximum values; comparison between the times by non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of 0.05.

Detailed description: approved 06/29/2011

Eligibility criteria: Inclusion Criteria:

* Diagnostic Criteria Temporomandibular Disorders and dentate subjects

Exclusion Criteria:

* Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects

Primary outcomes:
measure: to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.
timeFrame: twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade de São Paulo
state: São Paulo/SP
Study officials:
affiliation: University of Sao Paulo
name: Simone de Oliveira, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03175185: Psychiatric Assessment Of Parents Of Children With ADHD
Official title: Psychiatric Assessment Of Parents Of Children With Attention Deficit Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The people participating in this study will be 100 parents of 50 children who were diagnosed with ADHD and 100 parents of 50 children who are ADHD free as a control group recruited from outpatient clinic of Assiut University hospital.

Brief summary: The aim of this study is to carry out a psychological evaluation for the parents of children diagnosed with attention deficit hyperactivity disorder (ADHD) and parents of children without ADHD as control to detect any psychological problems in those of children with ADHD . These problems may be a precipitating factor to cause ADHD in their child or have a genetic predisposition to be passed to their children. On the other hand these psychological problems may be caused by the difficulties they encounter in raising their ADHD child. The exact relation needs more researches and to be more investigated.


Eligibility criteria: Inclusion Criteria:

* Parents of children diagnosed with ADHD according to the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-V).
* Children are between 4 and 16 years of age for both sexes.
* Children with normal IQ \> 70%.
* Parents are able to give informed consent and able to complete the research assessments.

Exclusion Criteria:

* Parents having chronic debilitating diseases e.g. chronic liver cirrhosis.
* Parents were participating in other clinical research.
* Refusal to participate.

Primary outcomes:
measure: Psychiatric Assessment of the parents
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00434785: A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males
Official title: An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-13
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration.
* Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight \>45 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead ECG.

Primary outcomes:
measure: To assess the safety and PK profile
Secondary outcomes:
Other outcomes:
Locations:
city: Ikebukuro
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04806685: Diabetes Education and A1c Study
Official title: Diabetes Education and A1c Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sleep
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield Foundation of Michigan
First posted: 2021-03-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sleep problems are associated with poor blood glucose control, but current diabetes self-management programs do not include sleep education. This study will randomize participants into two groups: one that receives sleep education and one that does not. The researchers expect both groups to experience reductions in blood glucose. The researchers hypothesize that individuals who receive sleep education as part of their diabetes self-management training will experience greater improvements in blood glucose control, as measured by hemoglobin A1c, compared to the control group.


Eligibility criteria: Inclusion Criteria:

* Individuals with a diagnosis of type 2 diabetes who are patients at the Michigan State University (MSU) Endocrinology clinic,
* a diagnosis of overweight or obesity (Body Mass Index greater than or equal to 25.0 kg/m2),
* the most recent hemoglobin A1c value greater than or equal to 7.5%, and
* the ability to attend online program sessions.

Exclusion Criteria:

* significant psychiatric disorders,
* advanced medical conditions that require alterations to the MNT for DM2, e.g., advanced chronic kidney disease, and
* an inability to follow recommendations due to cognitive deficits.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Body mass index
timeFrame: 12 weeks
measure: Sleep duration
timeFrame: 12 weeks
measure: Sleep quality
timeFrame: 12 weeks
measure: Diabetes self-care
timeFrame: 12 weeks
measure: Epworth Sleepiness Scale
timeFrame: 12 weeks
measure: Insomnia Severity Index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
References:
Clinical trial NCT03900585: Can Interval Walking Influence on Fatigue in the Danish Cohort of Myasthenia Gravis Patients
Official title: Physical Activity and Fatigue in Danish Patients With Myasthenia Gravis - an Intervention Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Myasthenia Gravis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 0
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: TREATMENT

Brief summary: The study is a controlled, randomized intervention trial. Patients are randomized into either an intervention group or a control group. The duration of the study is 10 weeks. Patients in the intervention group participate in a 10 weeks exercise program consisting of 150 minutes interval walking per week administered by an app on the patient's telephone. Patients in the control group live as usually, with a maximum of 30 minutes aerobic exercise per week.

Before and after the 10 weeks study period, patients (from both the intervention and the control group) participate in a 2 hours session of functional testing (e.g. walk tests, test of muscle strength ect.) at Rigshospitalet.


Eligibility criteria: Inclusion Criteria:

* Able to provide signed informed consent.
* Able to read and understand Danish or English.
* Diagnosed with mild to moderate myasthenia gravis (I-IV on the Myasthenia Gravis Foundation of American Clinical Classification, MGFA).
* Documented history of acetylcholine receptor (AChR) or Muscle Specific Kinase (MuSK) antibody positive, or abnormal repetitive nerve stimulation testing (decrement \> 10%) on EMG or abnormal single fiber EMG (conduction block or jitter) or based on their clinical history and symptom improvement with acethylcholinesterase inhibitors.
* If the patient is on oral corticosteroids, the dose must be stable for at least 1 month prior to inclusion.
* If the patient is on cholinesterase inhibitors the dose must be stable 2 weeks prior to inclusion.

Exclusion Criteria:

* MGFA grade V disease
* Other disorders that are not related to MG, or drugs, that interfere with muscle strength, balance and fatigue.
* Serious medical illness (e.g. uncontrolled insulin dependent diabetes mellitus, symptomatic coronary artery disease, and cancer).
* Dementia or pregnancy.
* Unspecified reasons judged by the investigator.

Primary outcomes:
measure: 6 minutes walk test
timeFrame: 6 minutes
Secondary outcomes:
measure: 30-s sit to stand test
timeFrame: 30 seconds
measure: Quantitative Myasthenia Gravis Score
timeFrame: 45 minutes
measure: Myasthenia gravis composite score
timeFrame: 30 minutes
measure: Myasthenia gravis activity of daily living profile (MG-ADL)
timeFrame: 10 minutes
measure: Myasthenia gravis quality of life 15-item score (MG-QoL15)
timeFrame: 3 minutes
measure: Multidimensional Fatigue Inventory (MFI-20)
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: John Vissing, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06375785: Two Different Exercise Methods in Geriatrics
Official title: Comparison of Two Different Exercise Methods in Geriatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly People
Nursing Homes
Keywords: elderly people
LSVT-BIG
Otago
exercise
balance
Lead sponsor: Halic University
Sponsor class: OTHER
Collaborators: name: Fenerbahce University
name: Istanbul Galata University
name: Biruni University
First posted: 2024-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study is to compare slow rhythmic exercises with large amplitude exercises in elderly people


Eligibility criteria: Inclusion Criteria:

* Being 65 years or older
* living in a nursing home
* Knowing how to read and write Turkish
* Cognitive functions are sufficient for communication (Standardized Mini Mental Test score over 21 points)
* Being between 1-5 on the Clinical Fragility Scale
* Not taking medical medications regularly due to pain
* Volunteering to participate in the study

Exclusion Criteria:

* Having vision and hearing problems that affect communication (except for individuals who communicate with glasses and hearing aids)
* Having a disease that causes neurological, orthopedic and musculoskeletal problems
* Having uncontrolled hypotension/hypertension, cardiovascular problems, metabolic and chronic diseases
* anemic individuals
* Having severe cerebrovascular and peripheral venous insufficiency
* Having had an operation in the last year

Primary outcomes:
measure: Timed Up &Go Test
timeFrame: At baseline and at week 12
measure: Performanz Balance System
timeFrame: At baseline and at week 12
measure: Functional Reaching Test
timeFrame: At baseline and at week 12
measure: Six Minute Walking Test
timeFrame: At baseline and at week 12
measure: Tinetti Balance and Gait Assessment
timeFrame: At baseline and at week 12
Secondary outcomes:
measure: Activity-Specific Balance and Confidence Scale
timeFrame: At baseline and at week 12
measure: Five Times Sit to Stand
timeFrame: At baseline and at week 12
measure: Montreal Cognitive Assessment Test
timeFrame: At baseline and at week 12
measure: KATZ Activities of Daily Living Scale
timeFrame: At baseline and at week 12
measure: Clinical Frailty Scale
timeFrame: At baseline and at week 12
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haliç University
state: Eyüpsultan
Study officials:
References: