louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02159664: Influence of Didgeridoo Practice on UA Obstruction Levels in Moderate OSA
Official title: Influence of Didgeridoo Practice on Upper Airways Obstruction Levels in Moderate Obstructive Sleep Apnea Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea
Keywords: didgeridoo
sleep apnea
drug induced sleep endoscopy
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2014-06-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess the changes in upper airways obstruction levels before and after Didgeridoo practice in moderate OSA patients.

Detailed description: Didgeridoo practice has been shown to improve Obstructive Sleep Apnea (OSA) severity. The aim of our study is to assess the changes in upper airways obstruction levels, evaluated by sleep endoscopy, before and after 3 months of Didgeridoo practice in moderate non obese OSA patients. Severity of OSA will also be documented by polysomnography.

Eligibility criteria: Inclusion Criteria:

* moderate OSA, non obese

Exclusion Criteria:

* not willing play didgeridoo age\<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive

Primary outcomes:
measure: upper airways obstruction levels
timeFrame: 3 months
Secondary outcomes:
measure: apnea-hypopnea index
timeFrame: 3 months
Other outcomes:
measure: subjective sleep quality and sleepiness
timeFrame: 3 months
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
Study officials:
affiliation: CHU St Pierre
name: Marie Bruyneel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00545090: ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.
Official title: An Open-label, Clinical Observation Extension Study to Assess Continuing Safety and Adherence in Patients With Postmenopausal Osteoporosis Receiving Monthly Oral Bonviva
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 561
Sex: FEMALE
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm study will continue drug safety surveillance, and assessment of adherence, in patients with postmenopausal osteoporosis who have received monthly oral Bonviva in ML19930, the BonAdAsia study. All patients completing 6 months in ML19930 will continue to receive Bonviva (150mg po, monthly) for an additional 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* patients responding to oral monthly Bonviva during the BonAdAsia study;
* willing to continue Bonviva treatment for a further 6 months.

Exclusion Criteria:

* none specified.

Primary outcomes:
measure: SAEs, AEs including fractures, adherence to treatment, clinical improvement, osteoporosis symptoms
timeFrame: Throughout study
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
city: Jakarta
country: Indonesia
city: Makassar
country: Indonesia
city: Surabaya
country: Indonesia
city: Manila
country: Philippines
city: Quezon City
country: Philippines
city: Changhua
country: Taiwan
city: Taichung
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Chiang Mai
country: Thailand
city: Khon Kaen
country: Thailand
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02794090: Childhood Obesity Treatment - Telephone Coaching vc Usual Care
Official title: Exclusive Telephone Coaching in Maintaining Weight Loss - An Randomized Controlled Trial of Childhood Obesity Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Behavioral treatment
Telephone coaching
Outpatient clinic
Lead sponsor: Sodertalje Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2016-06-08
Enrollment: 37
Sex: ALL
Minimum age (years): 5
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates if usual physical care visits to an outpatient pediatric clinic can be replaced with more frequent and shorter Telephone coaching Contacts during 18 months.

Detailed description: In this randomized controlled study, patients at age 5 to 14 and enrolled in obesity treatment, were randomized to either usual care according to regular routine or to telephone consultation.The randomization was done at the start of individual treatment and lasted for 18 months. We also studied working time required for the Health care, and the families' experience of the Telephone coaching.

Eligibility criteria: Inclusion Criteria:

* Children 5 to 14 years old who were patients at the outpatient pediatric centre
* All families after that the parents had attended at least 4 of 7 meetings in a parental/education group.

Exclusion Criteria:

* Obesity related syndromes
* Non-Swedish speaking families

Primary outcomes:
measure: Change in BMI Standard Deviation Score (units)
timeFrame: From start of treatment, during intervention and follow-up. In total mean 3,7 years
Secondary outcomes:
measure: Working time required for the Health care personnel
timeFrame: During the intervention 18 months
measure: Families experience of the treatment
timeFrame: During the intervention 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Pernilla Danielsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02610790: BRacelet And Physical actiVity Evaluation (BRAVE)
Official title: Evaluation of Pre- and Post-operative Physical Activity on Postoperative Rehabilitation After Colorectal Surgery With a Connected Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: connected bracelets, footsteps
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 50
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: Patients who undergo colorectal surgery

Brief summary: The aim of this study is to quantify pre- and postoperative physical activity of patients operated on colorectal surgery. Daily physical activity (No. of footsteps) is going to be recorded from 15 days before surgery to the end of hospitalization after surgery in a prospective cohort of consecutive colorectal patients by use of an attached strap. Then, the investigators will propose physical activity thresholds (adapted to the age, gender and patient comorbidities) to optimize the ERAS protocol (Enhanced Rehabilitation After Surgery). Thus, this analysis will allow the investigators to provide patients with physical rehabilitation programs "a la carte" during a hospitalization for colorectal surgery. Connected bracelets will directly involve patients in their care and rehabilitation.

Detailed description: Connected bracelet will be given to 50 consecutive patients undergone colorectal surgery 15 days before surgery. The investigators will measure pre- and postoperative physical activity. It is an observational activity of patient's physical activity during the perioperative period with no intervention.

Eligibility criteria: Inclusion Criteria:

1. Patients with a colorectal surgery

Exclusion Criteria:

1. Limitation of linguistic or cognitive abilities, interfering with the understanding of the study protocol
2. Lack of consent of the study form
3. Emergency Surgery
4. stoma closure

Primary outcomes:
measure: Pre- and postoperative physical activity
timeFrame: 30 days
Secondary outcomes:
measure: Quality of life
timeFrame: 30 days
measure: Quality of sleep
timeFrame: 30 days
measure: Pain
timeFrame: 30 days
measure: Fatigue
timeFrame: 30 days
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Visceral Surgery, University Hospital Center
Study officials:
affiliation: University of Lausanne Hospitals
name: Nicolas DEMARTINES
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02396290: Clinical Effect of Platelet Rich Plasma Combined With Laser on Scar
Official title: Clinical Study on Efficacy and Safety of Platelet Rich Plasma Combined With Laser for Scar Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Scar
Keywords: acne scar
fractional carbon dioxide laser
platelet rich plasma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar

Detailed description: Platelet Rich Plasma may relieve the adverse effect of laser treatment. and it can be expected to improve acne treatment result.

Eligibility criteria: Inclusion Criteria:

* moderate to severe acne scar

Exclusion Criteria:

* taken procedures for acne scar within 6 months
* underlying diabetes mellitus, keloid, or malignancy

Primary outcomes:
measure: Global assessment of acne scar
timeFrame: 12 weeks
Secondary outcomes:
measure: ECCA (échelle d'évaluation clinique des cicatrices d'acné)
timeFrame: 12 weeks
measure: adverse effect assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Seoul National University College of Medicine
Study officials:
affiliation: Department of Dermatology, Seoul National University College of Medicine
name: Dae Hun Suh, PhD
role: STUDY_CHAIR
affiliation: Department of Dermatology, Seoul National University College of Medicine
name: Seonguk Min, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tierney EP, Eisen RF, Hanke CW. Fractionated CO2 laser skin rejuvenation. Dermatol Ther. 2011 Jan-Feb;24(1):41-53. doi: 10.1111/j.1529-8019.2010.01377.x.
Clinical trial NCT01154790: Phase I Study on Multiple Oral Dosing of CG100649
Official title: A Randomized, Double-blind Study Evaluating the Upper Gastrointestinal Safety on Multiple Doses of CG100649 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteers
Lead sponsor: CrystalGenomics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.

Detailed description: Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used CTCAE and normal ranges if relevant.

Eligibility criteria: Inclusion Criteria:

1. 19-55 years old. Body weight is over 50 kg (male) and over 45 kg (female). Body weights must be within 20% of ideal body weight for their height according to the ideal body weight table.
2. No significant congenital/chronic disease. No symptoms in physical examination.
3. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
4. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

1. History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
2. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
3. History of known hypersensitivity to drugs including CG100649.
4. After taking a rest in sitting position for 3 minutes, subjects who have low blood pressure (Systolic BP ≤ 90 mmHg or Diastolic BP ≤ 50 mmHg) or high blood pressure (Systolic BP ≥ 150 mmHg or Diastolic BP ≥ 100 mmHg).

Primary outcomes:
measure: Safety (normal results for safety tests)
timeFrame: 27days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: CrystalGenomics, Inc.
name: Seonggu Ro
role: STUDY_DIRECTOR
References:
Clinical trial NCT01780090: Handheld Technology for Speech Development in Students With Autism
Official title: Handheld Technology for Speech Development in Students With Autism Spectrum Disorders (ASDs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorders
Keywords: autism
prosody
speech
autism spectrum disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Handhold Adaptive
First posted: 2013-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study will result in a software application compatible with the Apple iPad, iPhone and iPod Touch (hereafter termed "iOS devices") which addresses several aspects of prosodic deficits common in speakers with Autism Spectrum Disorders (ASDs) and other communication disorders, using a developmentally appropriate, intuitive interface that requires little technical skill and which can be managed by educators and parents. The program will contain elements that aid in tracking and maintaining individual student progress records, and will be designed for use in the classroom, at home, and in other environments. This study's intended focus is on the feasibility and usability of the software application.


Eligibility criteria: Inclusion Criteria:

* SLPs, in Connecticut Public Schools, who provide intervention to students with autism spectrum disorders.
* Students, ages 4 - 19, who attend school in Connecticut and demonstrate prosodic difficulties secondary to a diagnosis of ASD.

Exclusion Criteria:

* Students with concommitant genetic disorders

Primary outcomes:
measure: Learning of software
timeFrame: 3 months
measure: Usability of software
timeFrame: 3 months
Secondary outcomes:
measure: Student engagement in treatment
timeFrame: 3 months
measure: Software effectiveness
timeFrame: 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Frederick Shic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00260390: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Official title: The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dysthymic Disorder
Keywords: Dysthymic Disorder
HPG hypofunctioning
Testosterone replacement
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
First posted: 2005-12-01
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.

Hypothesis:

Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.


Eligibility criteria: Inclusion Criteria:

1. Male, age 40-80 years.
2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
3. Diagnosis of Dysthymic disorder with onset after age 40.
4. PSA \< 4.0.
5. Normal digital exam of the prostate in the preceding 1 year.
6. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D \> 12).
7. Able to give informed consent.

Exclusion Criteria:

1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
2. Currently being treated with testosterone.
3. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
4. Current suicidal risk.
5. Current (past year) substance abuse or dependence.

Primary outcomes:
measure: Hamilton Depression Scale (HAM-d)
measure: Clinical Global Impression- Change (CGI-C)
measure: Profile of Mood States (POMS)
measure: Beck Depression Inventory (BDI)
measure: Sheehan Disability Scale
measure: Self Anchoring Scale (SAS)
measure: Affective Balance Scale (ABS)
measure: International Index of Erectile Function (IIEF)
measure: Aging Male Symptom rating (AMS)
measure: Clinical Global Impression (CGI)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center, Psychiatric out patient clinical unit
Study officials:
affiliation: Sheba Medical Center
name: Guy Orr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00788190: Treatment of Distal Radius Fractures in Elderly Patients
Official title: Treatment of Distal Radius Fractures in Elderly Patients, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Distal Radius Fractures
Keywords: Distal Radius Fracture
Elderly
Prospective randomized trial
Outcomes
Pain and Function
Surgical Vs. conservative management
Fractures with borderline alignment
Lead sponsor: Hand and Upper Limb Clinic, Canada
Sponsor class: NETWORK
Collaborators: name: LHRI- Lawson Health Research Institute
First posted: 2008-11-10
Enrollment: 65
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to create and test a treatment algorithm to guide the treatment of distal radius fractures in patients 65 and older and to obtain level-one evidence to determine the best method of treating distal radius fractures in this growing population demographic.

Detailed description: * Distal radius fractures with borderline alignment will be randomized to surgical intervention or conservative treatment.
* Patients will fill out subjective questionnaires at 0, 6weeks, 3months, 6 months, and 1 year.
* Patients will perform objective strength tests, dexterity tests and have their range of motion tested at 12 weeks, 6 months and 12 months.

Eligibility criteria: Inclusion Criteria:

* Distal Radius Fracture
* Between 10 and 20 degrees of dorsal angulation
* Between 3 and 5mm of Ulnar positive variance
* Between 1 and 2mm intra Articular Step deformity
* Age 65 and older

Exclusion Criteria:

* Pre-Morbid medical conditions which preclude surgical intervention
* Patients who do not live independently.
* Patients with an open fracture
* Associated soft tissue or skeletal injury to the same limb.
* Pre-existing wrist arthrosis or disability

Primary outcomes:
measure: Primary: Patient pain and disability. Will be quantified with Disabilities of the Arm and Shoulder (DASH) and Patient Rated Wrist Evaluation (PRWE).
timeFrame: 0-1 year
Secondary outcomes:
measure: Secondary: To determine if other baseline factors influence outcome. For example, baseline activity levels (RAPA), home supports, hand dominance, and general mental health will be analyzed.
timeFrame: over 1 year
measure: Secondary: To stratify results by age. (65-75, 77-80, and >80)
timeFrame: 0-1 year
measure: Grip strength, Range of Motion and Dexterity testing of wrists
timeFrame: 3 months to 12 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Hand and Upper Limb Centre
state: Ontario
city: London
country: Canada
facility: Hand and upper Limb Centre
state: Ontario
Study officials:
affiliation: Hand and Upper Limb Centre, St. Joseph's Health Care
name: Joy C MacDermid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hand and Upper Limb Centre, St Joseph's Health Care
name: Ruby Grewal, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05309564: Muscle Weakness Duration After Single Botulinum Toxin Injection in Masseter
Official title: Muscle Weakness Duration Post-injection of a Single Dose of Botulinum Toxin in the Masseter Muscle Bilaterally: a One-year Non-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bite Force
Botulinum Toxins, Type A
Lead sponsor: Region Västerbotten
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
name: Mahidol University
First posted: 2022-04-04
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate the duration of a reduced maximal voluntary bite force after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH \& Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units).

Detailed description: This study aimed to evaluate the duration of a reduced maximal voluntary bite force (MVBF) after a botulinum toxin intervention. Methods: In an intervention group, 25 units of Xeomin® (Merz Pharma GmbH \& Co KGaA, Frankfurt am Main, Germany) botulinum neurotoxin type A were injected into the masseter muscles bilaterally (to a total of 50 units). A control group did not receive any intervention. MVBF was measured in Newtons using a strain gauge meter at the incisors and first molars. The intervention group was comprised of individuals seeking aesthetic treatment for masseter reduction (n = 20), and the control group (n = 12) comprised of volunteers.

Eligibility criteria: Inclusion Criteria:

Healthy subjects seeking aesthetical treatment to reduce masseter muscle volume.

Exclusion Criteria:

Conditions or drugs affecting the central nervous system.

Primary outcomes:
measure: Change of bite force
timeFrame: Baseline, 4 weeks, 3 months, 6 months, 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus
state: Västerbotten
Study officials:
affiliation: Umeå University
name: 2020-03517 Pettersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: