louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01509235: Self Drainage in Pediatric Cystic Fibrosis Patients
Official title: Exercise Coupled to Self Drainage in Pediatric Cystic Fibrosis Patients: an Open Label Cross Over Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
Lung function
physical exercise
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 34
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the current study, we designed a cross-over, open label, randomized controlled clinical trial that aim to investigate the superiority of physical exercise coupled with self drainage to a chest physiotherapy in stable cystic fibrosis children. We hypothesized that CF children undergoing physical exercise coupled to self drainage will increase the amount of expectorate secretions compared to conventional CP course, while being more satisfied and without worsening their pulmonary function status.


Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis diagnosis confirmed by 2 positive sudoriparous diagnostic tests
* Age : 7 to 17 years
* Capacity to expectorate
* Clinically stable
* Ability to pedal on a bike and to respect orders for physical session

Exclusion Criteria:

* Haemoptysis \> 50ml
* Permanent non-invasive ventilation
* Respiration or digestive evolutive clinical abnormality
* Exacerbation

Primary outcomes:
measure: weight of sputum that was expectorated
timeFrame: 12 months
Secondary outcomes:
measure: patient's satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Gabriel Bellon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reix P, Aubert F, Werck-Gallois MC, Toutain A, Mazzocchi C, Moreux N, Bellon G, Rabilloud M, Kassai B. Exercise with incorporated expiratory manoeuvres was as effective as breathing techniques for airway clearance in children with cystic fibrosis: a randomised crossover trial. J Physiother. 2012;58(4):241-7. doi: 10.1016/S1836-9553(12)70125-X.
Clinical trial NCT01181635: Can Psychotherapy Reduce Sickness Absence?
Official title: Can Psychotherapy Reduce Sickness Absence?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorders
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if psychotherapy can reduce sickness absence.

Detailed description: Sickness absence due to psychiatric problems is considered a growing problem in Norway. Little research is done to examine if psychotherapy can reduce sickness absence. Since 2007 there is a government sponsored program in Norway (Raskere tilbake) aimed at reducing sickness absence. This study examines if psychotherapy within this program, delivered at an out-patient clinic, actually reduces sickness absence. Levels of absenteeism is measured before, after and 6 months after treatment. This is a quasi-experimental study, where the treatment-group will be compared with a statistical group in the general population, that is socio-demographical similar and has similar history of sickness absence but haven't been to treatment. Changes in levels of symptoms and quality of life will also be measured. The participants will be asked to describe their working environment, and this will be related to outcome-measures.

Eligibility criteria: Inclusion Criteria:

* Patients receiving psychotherapy at Lovisenberg DPS/Raskere Tilbake

Exclusion Criteria:

-

Primary outcomes:
measure: Sickness absence
timeFrame: Before, after and 6 months after treatment.
Secondary outcomes:
measure: Psychiatric symptoms
timeFrame: Before, after and 6 months after treatment.
measure: Quality of life (QALY)
timeFrame: Before, after and 6 months after treatment.
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg diakonale sykehus, Lovisenberg DPS
Study officials:
affiliation: Lovisenberg Diakonale Hospital
name: Bjørn Lau, phd
role: STUDY_DIRECTOR
References:
citation: Victor M, Lau B, Ruud T. Predictors of Return to Work 6 Months After the End of Treatment in Patients with Common Mental Disorders: A Cohort Study. J Occup Rehabil. 2018 Sep;28(3):548-558. doi: 10.1007/s10926-017-9747-5.
citation: Victor M, Lau B, Ruud T. Predictors of return to work among patients in treatment for common mental disorders: a pre-post study. BMC Public Health. 2017 Jul 18;18(1):27. doi: 10.1186/s12889-017-4581-4.
Clinical trial NCT03968835: A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
Official title: A Comparison of the Outcomes of Distal Fingertip Amputations Treated With Either Artificial (Xeroform) or Biological Dressings
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Finger Injuries
Amputation, Traumatic
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 0
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients will be followed for the study. The first 30 patients will be treated with biological dressings and subsequent 30 patients will be treated with artificial dressings.

Brief summary: This is a prospective study looking to evaluate whether the treatment outcomes for patients who sustain a distal fingertip amputation are improved or no different when using biological dressings versus artificial dressings.


Eligibility criteria: Inclusion Criteria:

* All individuals presenting at Bellevue Hospital for evaluation and treatment of a finger amputation distal to the germinal matrix that present along with the amputated distal fingertip unit.

Exclusion Criteria:

* replantation candidate, incomplete distal finger-tip amputation

Primary outcomes:
measure: Time to complete healing up to 3 Months
timeFrame: 3 months
measure: Percentage of graft viability (for biological dressing only)
timeFrame: 1 week
measure: Percentage of graft viability (for biological dressing only)
timeFrame: 3 weeks
measure: Percentage of graft viability (for biological dressing only)
timeFrame: 6 weeks
measure: Percentage of graft viability (for biological dressing only)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Jacques Hacquebord
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03381235: Exercise and RP (AVAMC and Emory)
Official title: The Effects of Exercise on Progression of Disease and Quality of Life in Patients With Retinitis Pigmentosa - a Small Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Keywords: Exercise
Quality of life
Progression of disease
Retinitis
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to look in humans at the relationship between moderate or little exercise and their potential effects on the retina in patients with Retinitis Pigmentosa (RP).

Detailed description: Human studies have shown that regular exercise may have positive effects on common degenerative diseases such as Alzheimer's disease. Exercise has also shown to improve conditions the eye such as macular degenerations, glaucoma, and cataracts. Mice with retinal degeneration which were exposed to exercise showed that it helped to slow the rate of degeneration. The purpose of this study is to look in humans at the relationship between moderate or little exercise and their potential effects on the retina in patients with Retinitis Pigmentosa (RP).

Eligibility criteria: Inclusion Criteria:

* Visual field no less than 10 degrees;
* VA no worse than 20/200 in the better seeing eye.

Exclusion Criteria:

* Not able to tolerate exercise due to an underlying medical condition.

Primary outcomes:
measure: Change in Brain-Derived Neurotrophic Factor (BDNF) level before and after exercise
timeFrame: Baseline, 3 and 6 months follow up.
Secondary outcomes:
measure: Change in retina vasculature before and after exercise
timeFrame: Baseline, 3 and 6 months follow up.
measure: Change in retinal thickness before and after exercise
timeFrame: Baseline, 3 and 6 months follow up.
measure: Change in retinal pigment epithelium (RPE) pigmentation before and after exercise
timeFrame: Baseline, 3 and 6 months follow up.
measure: Change in degrees of vascular attenuation before and after exercise
timeFrame: Baseline, 3 and 6 months follow up.
measure: Change in amount of autofluorescence before and after exercise
timeFrame: Baseline, 3 and 6 months follow up.
measure: Change in Goldmann Visual Field (GVF) scores
timeFrame: Baseline, 3 and 6 months follow up.
measure: Change in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) score
timeFrame: Baseline, 3 and 6 months follow up.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic, Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University
name: Jiong Yan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02187835: Decreased EEG Complexity in Schizophrenia
Official title: Decreased EEG Complexity in Chronic Residual Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electrophysiological Randomness
Entropy
Keywords: complexity
electroencephalogram
entropy
negative symptoms
schizophrenia.
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosed with schizophrenia,

Brief summary: Aim was to detect EEG complexity in a specific group of patients to contribute to the discussion whether schizophrenia is associated with increased or decreased complexity. We included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized that chronic residual schizophrenia is characterized by decreased complexity in EEG.

Detailed description: Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte, NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to the international 10-20 system

Eligibility criteria: Inclusion Criteria:

diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV) were recruited from Neuropsychiatry Istanbul Hospital Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S)

Exclusion Criteria:

-

Primary outcomes:
measure: the mean of the average Logarithmic Energy Entropy values
timeFrame: one day
Secondary outcomes:
measure: Hurst Exponent value
timeFrame: one day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar University, NPIstanbul hospital
state: Umraniye
Study officials:
References:
Clinical trial NCT05991635: Evaluation of a Gatekeeper Training for Pharmacists
Official title: Evaluation of a Gatekeeper Training for Pharmacists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aims to investigate to what extent a gatekeeper training (e-learning) for pharmacists and PTA is effective in changing the attitudes, knowledge, and self-efficacy. Moreover, it aims to examine how they evaluate the training and whether they were able to apply the learned skills in practice.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Have access to internet
* Speak Dutch
* Working as a (public) pharmacist or pharmaceutical technical assistant (FTA)

Exclusion Criteria:

* Hospital pharmacists or industrial pharmacists are not included in this study and thus constitute an exclusion criterion.

Primary outcomes:
measure: Changes in attitudes: Attitudes Towards Suicide Scale (ATTS)
timeFrame: Change from Baseline (before intervention) to post-test (after a week of access to e-learning)
Secondary outcomes:
measure: Changes in self-efficacy: Measurement of Perceived Self-efficacy
timeFrame: Change from Baseline (before intervention) to post-test (after a week of access to e-learning)
measure: Changes in perceptions/myths
timeFrame: Change from Baseline (before intervention) to post-test (after a week of access to e-learning)
measure: Gatekeeper training evaluation
timeFrame: Post-test (after a week of access to e-learning)
Other outcomes:
measure: Socio-demographic characteristics
timeFrame: Baseline
measure: Previous experience with suicide (prevention)
timeFrame: Baseline and post-test (after a week of access to e-learning)
measure: Follow-up
timeFrame: Follow-up (three months after baseline)
Locations:
city: Ghent
country: Belgium
facility: Flemish Centre of Expertise in Suicide Prevention, Ghent University
Study officials:
affiliation: University Ghent
name: Gwendolyn Portzky, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00822835: Study Evaluating Single Doses of ILV-095 in Healthy Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy men and women of non-childbearing potential ages 18 to 50 years old.
2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 kg.
3. Healthy as determined by the investigator on the basis of screening evaluations.
4. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
5. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

1. Presence or history of any disorder that may prevent the successful completion of the study.
2. Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration.
3. Acute disease state (eg, nausea, vomiting, fever, active infection, or diarrhea) within 7 days before enrollment.

Primary outcomes:
measure: Safety and tolerability will be evaluated from adverse events, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.
timeFrame: 3 weeks per group
Secondary outcomes:
measure: Pharmacokinetic parameters
timeFrame: 3 weeks per group
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00174135: Sarcopenia Studies for the Elderly Population in Taiwan
Official title: Sarcopenia Studies for the Elderly Population in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Keywords: Sarcopenia
exercise
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: Health promotion in the elderly has been a major recent public health concern. Sarcopenia is a term utilized to define the loss of muscle mass and strength that occurs with aging. It has been demonstrated to be associated with decreased functional capacity among the elderly. The magnitude of the public health problem posed by sarcopenia is not yet established. The purposes of this study are to investigate sarcopenia and its relationship with functional status in elderly Taiwanese community-dwellers, and to develop the preventive strategy for sarcopenia in the elderly. Firstly, the investigators will recruit 100 volunteers (aged 18-90 years old) to participate in this study. All of the participants will receive bioelectric impedance analysis (BIA), muscle strength and endurance assessment, physical activity level assessment by a seven-day recall questionnaire, protein intake assessment, cognition evaluation (Mini-Mental State Examination) and functional status assessment by the Functional Independence Measurement (FIM) questionnaire. A multiple regression model will be used for statistical analyses. Then, this project will be used to evaluate the efficacy of a 12-week supervised resistance strengthening exercise program for sarcopenia in the elderly. Participants who are defined as having sarcopenia from the previous examination will be randomized into either the exercise or control groups. Subjects in the exercise group will receive resistance strengthening exercises 3 times per week for 12 weeks. All measurements will be performed as described above. The investigators expect that resistance exercises are effective in offsetting age-related decline of muscle mass and strength in the elderly.


Eligibility criteria: Inclusion Criteria:

* 18-90 year old healthy adults

Exclusion Criteria:

* No systemic diseases

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University, College of Medicine
name: Meng-Yueh Chien, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chien MY, Kuo HK, Wu YT. Sarcopenia, cardiopulmonary fitness, and physical disability in community-dwelling elderly people. Phys Ther. 2010 Sep;90(9):1277-87. doi: 10.2522/ptj.20090322. Epub 2010 Jul 8.
Clinical trial NCT04603235: Manual-based Art Therapy for Adolescents With Depression
Official title: Manual-based Art Therapy for Adolescents With Depression: a Pilot Study in Child and Youth Psychiatric Clinic in Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depressive Disorder
Keywords: art therapy
program development
Adolescent Health
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
Collaborators: name: Child and Adolescent Psychiatry, Stockholm
First posted: 2020-10-26
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is a need to evaluate different interventions in order to meet young people's needs of treatment. The study's goal is to find out if manual-based art therapy is a useful method for young people with depression and thus increase the availability of methods of treatment for adolescents with depression in Child and youth psychiatry in Sweden.

The aim is to investigate whether manual-based art therapy is useful as treatment for adolescents with depression by examining feasibility, acceptability and compliant to treatment. Secondary, preliminary study of adolescent depressive symptoms, quality of life and functional level is affected by the treatment.

Method: Data from youths aged 13-17 years old and their parents will be collected with questionnaires and structured interviews. Measurements are taken before and after treatment. Acceptability and feasibility will be examined by participants' presence, drop out and cancellations and also by checking the art therapists' compliance to the manual and investigate their reasons to diverge from the manual


Eligibility criteria: Inclusion Criteria:

* Age 13-17 year
* Depression as main diagnosis

Exclusion Criteria:

* high suicide risk
* ongoing psychosis
* eating disorder
* Untreated PTSD
* Patients are excluded if there is suspicion of violence, abuse, abuse in the home or other vulnerability which requires other interventions to ensure the safety.

Primary outcomes:
measure: Adherence to manual - therapists
timeFrame: 10 weeks
measure: Change of Treatment satisfaction
timeFrame: Change from baseline at 10 weeks
Secondary outcomes:
measure: Change of Depression with Beck Depression Inventory BDI-II
timeFrame: Change from baseline at 10 weeks
measure: Change of quality of life measured with KIDSCREEN-10
timeFrame: Change from baseline at 10 weeks
measure: Change of functional impairment measured with Education,Work and Social adjustment Scale EWSAS-C/P
timeFrame: Change from baseline at 10 weeks
measure: Change of psychiatric symptoms measured with Revised Children's Anxiety and Depression Scale /R-CADS
timeFrame: Change from baseline at 10 weeks
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Södra Älvsborgs Hospital
state: Västra Götaland
Study officials:
affiliation: Region Vastra Gotaland, Sweden
name: Christina Blomdahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: