louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01520064: Post Market Registry Study of the AeriSeal System
Official title: Post Market Registry Study of the AeriSeal System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Emphysema
Keywords: Emphysema
GOLD Stage III
GOLD Stage IV
AeriSeal System
Homogeneous
Heterogeneous
Upper Lobe Predominant
ULP
Chronic Obstructive Pulmonary Disease
COPD
Lung Volume Reduction Surgery
LVRS
Bronchoscopic Lung Volume Reduction
BLVR
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2012-01-27
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have been or will be treated with the AeriSeal System

Brief summary: * Obtain and analyze medical record data on patients with advanced emphysema who receive treatment with the AeriSeal System to better understand safety and effectiveness in the post-market setting;
* Provide participating physicians access to specified data sets for the purpose of generating scientific manuscripts about the effects of AeriSeal System treatment.


Eligibility criteria: Inclusion Criteria:

* Advanced Emphysema
* AeriSeal System treatment

Exclusion Criteria:

* have a primary diagnosis of asthma, chronic bronchitis or bronchiectasis
* have had frequent COPD exacerbations within the past year
* require mechanical ventilatory support
* have a pretreatment DLCO \< 20% predicted or \> 60% predicted
* have a pretreatment FEV1 \< 20% predicted AND homogeneous emphysema
* have giant bullae
* have undergone lung transplantation, lung volume reduction surgery, or lobectomy
* are intolerant of corticosteroids or antibiotics
* are pregnant or breast-feeding

Primary outcomes:
measure: Post Market Registry Study of the AeriSeal System
timeFrame: At least 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Donaustauf
country: Germany
facility: Klinikum Donaustauf
city: Gauting
country: Germany
facility: Asklepios Fachkliniken Muenchen-Gauting
city: Halle
country: Germany
facility: Universitatsklinikum Halle
city: Hamburg
country: Germany
facility: Asklepios Klinik Hamburg-Harburg
city: Heidelberg
country: Germany
facility: Thoraxklinik am Uniklinikum Heidelberg
city: Luebeck
country: Germany
facility: Sana Kliniken Luebeck
city: Nurnberg
country: Germany
facility: Klinikum Nuerberg Nord
city: Solingen
country: Germany
facility: Bethanien KH Solingen
city: Beer Sheeva
country: Israel
facility: Soroka Medical Center
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center, Beilinson Campus
Study officials:
affiliation: Aeris Therapeutics
name: Janine McDermott, MS CCRP
role: STUDY_DIRECTOR
References:
Clinical trial NCT03872921: norUrsodeoxycholic Acid vs Placebo in PSC
Official title: Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Primary Sclerosing Cholangitis
Lead sponsor: Dr. Falk Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2019-03-13
Enrollment: 303
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* verified PSC
* Liver Biopsy available for Review
* If pre-treated with UDCA Patient must be on stable dose not exceeding 20mg/kg/bw
* Patients with or without concomittant IBD

Exclusion Criteria:

* History or presence of other concomitant liver diseases
* Presence of Cholangiocarcinoma
* Secondary causes of Sclerosing Cholangitis
* Small Duct Cholangitis in the absence of large duct disease
* Any known relevant infectious disease
* Abnormal renal function
* Any active malignant disease
* Known intolerance/hypersensitivity to study drug

Primary outcomes:
measure: superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)
timeFrame: 2 years
measure: Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Internal Medicine III
city: Hannover
country: Germany
facility: Medical School Hannover
state: Lower Saxonia
Study officials:
affiliation: Medical University of Vienna, Department of Internal Medicine III
name: Michael Trauner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04174521: Association Between Mother and Child Weight Gain: Statistical Methods With Validation
Official title: Association Between Mother and Child Weight Gain: Statistical Methods With Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Childhood
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Pennsylvania
First posted: 2019-11-22
Enrollment: 20670
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers who have delivered at VUMC and their children who are seen by Vanderbilt-affiliated physicians.

Brief summary: Using retrospective data from the Vanderbilt University Medical Center electronic health record, the investigators will study the association between mother's weight / weight change before and during pregnancy and the development of childhood obesity up until 5 years of age.

Detailed description: The investigators are extracting de-identified retrospective data from the Vanderbilt University Medical Center electronic health record for mother-child pairs. From this data, the investigators will study the association between mother weight change during pregnancy and the risk of her child developing obesity during the first 5 years of life. Included mothers must have at least one weight measurement and at least one height measurement; they must have at least one child with weight/length measurements at birth and one additional same day height/weight measurement at or before 5 years of age.

Eligibility criteria: Inclusion Criteria:

* Mother-child pairs in the Vanderbilt University Medical Center (VUMC) electronic health record.
* The mothers must have at least one height measurement.
* The mothers must also have at least one weight measurement during pregnancy.
* The child must have birth length and weight measures and at least one same day height/weight measurement during their first 5 years of life.

Primary outcomes:
measure: Obesity of the Child (in the Mother-child Pair) During the First 5 Years of the Child's Life
timeFrame: first 5 years of child's life
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Bryan Shepherd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01009021: Oral Diclofenac for Retinal Photocoagulation in Diabetic Retinopathy
Official title: Analgesic Effectiveness of Potassium Diclofenac for Retinal Photocoagulation in Patients With High-risk Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
retinal photocoagulation
potassium diclofenac
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to evaluate the analgesic effect of oral potassium diclofenac in patients with proliferative diabetic retinopathy submitted to retinal photocoagulation.

Two groups of patients were followed and the effect of the treatment (diclofenac plus laser) was compared to placebo (placebo plus laser). Pain associated with treatment was recorded using a Visual Analog Scale 15 minutes after the procedure.


Eligibility criteria: Inclusion Criteria:

* 1)high-risk proliferative diabetic retinopathy in both eyes

Exclusion Criteria:

* 1)history of prior laser treatment or vitrectomy; 2) allergy to non-steroidal anti-inflammatory drugs; 3) any condition affecting comprehension of VAS pain score test; 4) Contra-indications for diclofenac use such as pregnancy, bleeding disorders, asthma, or renal failure; 5) use of any analgesic drug for the last 24 hours.

Primary outcomes:
measure: Pain recorded using a Visual Analog Scale
timeFrame: 15 minutes after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Ribeirão Preto School of Medicine Clinics Hospital - USP
state: São Paulo
Study officials:
References:
citation: Lucena CR, Ramos Filho JA, Messias AM, Silva JA, Almeida FP, Scott IU, Ribeiro JA, Jorge R. Panretinal photocoagulation versus intravitreal injection retreatment pain in high-risk proliferative diabetic retinopathy. Arq Bras Oftalmol. 2013 Jan-Feb;76(1):18-20. doi: 10.1590/s0004-27492013000100006.
Clinical trial NCT01885221: A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (UCare-ChewFree)
Official title: A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: smokeless tobacco cessation
social support
partner support
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In an earlier study, the investigators developed a guidebook that taught women supportive behaviors to help their husbands/partners quit smokeless tobacco. This study will create a website using the information in the guidebook, along with interactive features, videos, and forums. The investigators will then conduct a randomized trial comparing an intervention group (receiving website access and the printed guidebook) with a delayed treatment control condition, to learn if the support intervention can effectively teach women supportive behaviors and thereby increase their partners' smokeless tobacco cessation rates.


Eligibility criteria: Inclusion Criteria:

* being the wife or female domestic partner (living together) of a male who is a current user of ST products (snuff or chewing tobacco)
* interested in having him quit ST use
* willing to provide a phone number, mailing address, and e-mail address
* provides informed consent
* the woman and the chewer are both U.S. or Canadian residents age 18 or older
* the woman and the chewer are both able to read English
* the woman and the chewer are both able to access a computer

Exclusion Criteria:

* none

Primary outcomes:
measure: smokeless tobacco cessation
timeFrame: 7.5-month follow-up
Secondary outcomes:
measure: tobacco quit attempts
timeFrame: 7.5 month follow-up
measure: supportive behaviors
timeFrame: 7.5 month follow-up
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Laura E Akers, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Akers L, Andrews JA, Lichtenstein E, Severson HH, Gordon JS. Effect of a Responsiveness-Based Support Intervention on Smokeless Tobacco Cessation: The UCare-ChewFree Randomized Clinical Trial. Nicotine Tob Res. 2020 Mar 16;22(3):381-389. doi: 10.1093/ntr/ntz074.
citation: Akers L, Andrews JA, Gordon JS. A Multimedia Support Skills Intervention for Female Partners of Male Smokeless Tobacco Users: Use and Perceived Acceptability. JMIR Form Res. 2018 Jan-Jun;2(1):e10. doi: 10.2196/formative.9948.
Clinical trial NCT00665821: The Effect of Two Short Education Programs for Nonspecific Low Back Pain in a Workers' Health Care Organization
Official title: Study of the Effect of Two Short Education Programs for the Treatment of Nonspecific Low Back Pain in Patients Seen at a Workers' Health Care Organization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Keywords: nonspecific low back pain
disability
sick leave
catastrophizing
workers
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Hospital Laboral SOLIMAT
First posted: 2008-04-24
Enrollment: 657
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the effect of two different types of health education programs on the disability, beliefs related to low back pain and duration of sick leave in patients seen at a workers' health care organization


Eligibility criteria: Inclusion Criteria:

* low back pain patients, with or without referred or radiated pain
* no systemic disease or criteria for referral to surgery

Exclusion Criteria:

* inability to fill out the questionnaires and scales
* bedridden
* rheumatologic inflammatory disease, cancer or fibromyalgia
* suspicion of fibromyalgia
* spinal fracture

Primary outcomes:
measure: A reduction in low back pain related disability and sick leave.
timeFrame: 365 days
Secondary outcomes:
measure: A reduction in catastrophizing beliefs related to low back pain.
timeFrame: 365 days
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Kovacs Foundation
state: Balearic Islands
city: Toledo
country: Spain
facility: Hospital Laboral SOLIMAT
state: Castilla La Mancha
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca, 07012, Spain
name: Francisco M Kovacs, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Laboral Solimat, Toledo, Spain
name: Andrés Barriga, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burton AK, Waddell G, Tillotson KM, Summerton N. Information and advice to patients with back pain can have a positive effect. A randomized controlled trial of a novel educational booklet in primary care. Spine (Phila Pa 1976). 1999 Dec 1;24(23):2484-91. doi: 10.1097/00007632-199912010-00010.
citation: Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S. Randomised controlled trial of physiotherapy compared with advice for low back pain. BMJ. 2004 Sep 25;329(7468):708. doi: 10.1136/bmj.38216.868808.7C. Epub 2004 Sep 17.
citation: Kovacs F, Abraira V, Santos S, Diaz E, Gestoso M, Muriel A, Gil del Real MT, Mufraggi N, Noguera J, Zamora J; Spanish Back Pain Research Network. A comparison of two short education programs for improving low back pain-related disability in the elderly: a cluster randomized controlled trial. Spine (Phila Pa 1976). 2007 May 1;32(10):1053-9. doi: 10.1097/01.brs.0000261556.84266.0f.
Clinical trial NCT04178421: Computerized Eye-tracking Attention Training for Children With Special Needs
Official title: Computerized Eye-tracking Attention Training for Children With Special Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
ASD
Learning Disorders
Keywords: Sustained attention
Impulse control
Eye-tracking
Special needs
Computerized training
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 96
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with special needs (e.g. autistic spectrum disorder, attention deficit hyperactivity disorder) are found to have sustained attention problems. Several behavioral interventions have been carried out in the past to improve this situation. However, these interventions are often involved a high administration cost. Recently, researchers have been focusing on training the eye gaze fixation using the eye-tracking training games, as some of the research studies reported a correlation between atypical eye gaze patterns with poor sustained attention. The objective of the present study is to evaluate the effectiveness of a computerized eye-tracking attention training. Two batches of 48 primary school students will be recruited from email and the subject pool of the Department of Psychology of The Chinese University of Hong Kong. Participants are dividedly randomly and equally into either intervention or control group. Participants in both groups will undergo pre- and post-assessments measuring the executive function and attention before and after the intervention, respectively. However, there will be eight eye-tracking training sessions for the intervention group, but only the assessments are received in the control group. It is hypothesized that after the training, the performance of the training games and assessments will improve, indicated by increasing accuracy rates, as well as the reaction time of the tasks. The results would provide important information on the value of computerized eye gaze training and would guide the direction of interventions that target on improving the sustained attention and impulse control of children with special needs.


Eligibility criteria: Inclusion Criteria:

* a total of 96 primary school children (aged between 6 to 12 years) with special needs, defined by psychological disorders such as ASD, ADHD, ADD, and Dyslexia

Exclusion Criteria:

* Children with mental retardation will be excluded

Primary outcomes:
measure: Flanker Inhibitory Control and Attention Test (Cognitive Test)
timeFrame: through study completion, an average of 2 year
measure: Dimensional Change Card Sort Test (Psychological Test Battery)
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Neuropsychology Laboratory, Department of Psychology, The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT06437821: Comparative Effect of Graston Technique and Petrissage Technique on Tight Trapezius Muscles in Young Adults
Official title: Comparative Effect of Graston Technique and Petrissage Technique on Tight Trapezius Muscles in Young Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Trapezius Muscle Strain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This research aims to contribute valuable insights into the potential benefits of incorporating the portable wedge device into preventive or therapeutic interventions for calf-related musculoskeletal issues. By combining economical, ergonomic principles and user-friendly features, the proposed device offers individuals a convenient and efficient means to enhance their calf flexibility, ultimately mitigating strain and reducing spasms.

Detailed description: Developing and successfully integrating a portable wedge device could mark a significant breakthrough in preventive and rehabilitative care for musculoskeletal problems associated with the calf region. This innovative device can enhance the overall well-being and musculoskeletal health of individuals suffering from such issues, providing a more effective and convenient treatment solution.

Eligibility criteria: Inclusion Criteria:

* Male and female patients diagnosed with Trapezius tightness
* Age above 18-30
* Presence of active trigger points in the upper trapezius muscle
* Participants who are volunteer for the study
* Patients who suffer from shoulder pain and stiffness due to bad posture

Exclusion Criteria:

* History of whiplash injury
* History of head, neck, cervical spine or shoulder surgery
* History of cervical radiculopathy
* Diagnosed fibromyalgia and myopathy
* History of cancer
* Pregnancy Myofascial therapy within the past month
* Contraindication of dry needling and instrument-assisted soft tissue mobilization technique

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 12 Months
measure: Neck disability index (NDI)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Faqraj Sharif Hospital (Trust) Physiotherapy and Orthopedic Department and Orian ABA Pakistan (Physiotherapy Department)
state: Punjab
Study officials:
References:
Clinical trial NCT04135521: Dose-dense Chemotherapy Versus Intraperitoneal Chemotherapy as First-line Chemotherapy in Advanced Ovarian Cancer
Official title: Far Eastern Memorial Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Ovarian Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive women, who underwent intravenous dose-dense or intraperitoneal chemotherapy as the front-line chemotherapy were reviewed.

Brief summary: To compare dose-dense chemotherapy with intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.

Detailed description: Women aged 20 and above, diagnosed with advanced stage ovarian cancer (FIGO stage II\~IV), who had received debulking surgery, followed by adjuvant chemotherapy (either dose-dense or intraperitoneal) at our institution between 01 January 2006 and 31 December 2018 were included in the study. Patient characteristics, any treatment related side-effects (peri-operative and post-operative complications, chemotherapy related adverse events), treatment response (complete or partial response, stable disease or progressive disease), post-treatment surveillance (disease status: disease-free, recurrence or cancer-related death) will be recorded. Univariate and multivariate logistic regression analysis will be employed to evaluate the survival benefit of the two different chemotherapy methods.

Eligibility criteria: Inclusion Criteria:

* Women with FIGO stage II\~IV ovarian cancer
* At least one cycle of intravenous dose-dense or intraperitoneal chemotherapy had been administered as the front-line chemotherapy.

Exclusion Criteria:

* none

Primary outcomes:
measure: Progression-free survivals between this intraveous and intraperitoneal chemotherapy groups
timeFrame: 10 years
Secondary outcomes:
measure: Overall survivals between this two groups
timeFrame: 10 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References: