louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04004585: A Sedentary Behaviour Reduction Intervention for People With COPD
Official title: Get Up For Your Health: A Behaviour Change Intervention to Reduce Sedentary Behaviour for People With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Sedentary behaviour
Behaviour change
Theoretical Domains Framework
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Chronic obstructive pulmonary disease (COPD) is a major cause of disability. Individuals with COPD are more likely to spend prolonged periods of time in sedentary behaviour (SB) and less in light physical activity compared to their healthy peers. SB is associated with exercise intolerance, reduced motivation to exercise, lower self-efficacy and more frequent acute exacerbations among people with COPD. To date, there is very limited information regarding behavioural approaches to reduce SB in people with COPD. The aim of this study is to examine the feasibility of a new 4-week theory-informed behaviour change intervention to reduce SB in individuals with COPD.


Eligibility criteria: Inclusion Criteria:

* A diagnosis of COPD confirmed by spirometry Forced expired volume to forced vital capacity ration (FEV1/FVC) less than 0.7
* An ability to ambulate.
* An ability to provide informed consent.

Exclusion Criteria:

* Presence of co-existing conditions that may prevent participation in the intervention.

Primary outcomes:
measure: Enrollment rate
timeFrame: 4 weeks
measure: Completion rate
timeFrame: 4 weeks
measure: Participants satisfaction
timeFrame: 4 weeks
measure: Adherence to wearing the activity monitor
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in sedentary time
timeFrame: Baseline - week 4 (post-intervention)
measure: Change in number of sit-to-stand transitions
timeFrame: Baseline - week 4 (post-intervention)
measure: Change in daily number of steps
timeFrame: Baseline - week 4 (post-intervention)
measure: Change in self-efficacy
timeFrame: Baseline - week 4 (post-intervention)
measure: Change in outcome expectations
timeFrame: Baseline - week 4 (post-intervention)
measure: Change in knowledge of sedentary behaviour
timeFrame: Baseline - week 4 (post-intervention)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Roger Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Dina Brooks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wshah A, Selzler AM, Hill K, Brooks D, Goldstein R. Embedding a Behavior Change Program Designed to Reduce Sedentary Time Within a Pulmonary Rehabilitation Program Is Feasible in People With COPD. J Cardiopulm Rehabil Prev. 2022 Jan 1;42(1):45-51. doi: 10.1097/HCR.0000000000000624.
Clinical trial NCT04901585: Enterotomy Closure and Minimally Invasive Gastrectomy
Official title: Enterotomy Closure After Minimally Invasive Distal Gastrectomy With Intracorporeal Anastomosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: intracorporeal gastrectomy
enterotomy closure
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent laparoscopic or robotic partial gastrectomy for gastric cancer with Roux en Y or Billroth II reconstruction

Brief summary: All consecutive patients from January 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis.

Detailed description: Different ways to fashion intracorporeal anstomoses will be investigated: robotic vs laparoscopic approach; laparoscopic HD vs 3D vs 4K technologies; single layer vs double layer enterotomy closure. Additionally double layer enterotomies will be analysed layer by layer, comparing running vs interrupted suture, presence vs absence of deep corner suture and type of suture thread (barbed, braided, non braided suture)

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* laparoscopic or robotic partial gastrectomy for gastric cancer
* Roux en Y or Billroth II reconstruction

Exclusion Criteria:

* Age \< 18 years
* open gastrectomy
* total gastrectomy
* Billroth I reconstruction

Primary outcomes:
measure: Postoperative complications
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples Federico II
Study officials:
References:
Clinical trial NCT06105385: Suboccipital Myofascial Release Technique in Young Adults
Official title: Investigation of the Instant Effects of the Suboccipital Myofascial Release Technique on Cervical Proprioception, Joint Range of Motion and Balance in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Release
Keywords: Suboccipital Myofascia
Release Technique
Cervical Proprioception
Range of Motion
Balance
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: When the literature is examined, although it is known that the suboccipital muscles are rich in proprioceptive receptors and have significant effects on balance, the effects of myofascial and neural relaxation of the suboccipital muscles on balance and proprioception are not fully understood. In this study, the investigators aim to examine the immediate effects of the SMV technique on balance and proprioception in young adults. With this study, by revealing the effects of the SMV technique on balance and proprioception, a different treatment option will be offered to clinicians working in the field of physical therapy and rehabilitation and interested in the rehabilitation of patients who may have balance and proprioception problems. It will also provide insight to academics working in this field in terms of the applicability of this technique among different patient groups.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-25
* Being healthy and not having one of the diseases specified in the exclusion criteria

Exclusion Criteria:

* Individuals with neck pain, neck trauma (fracture, whiplash syndrome), balance and proprioception problems, vestibular system problems, vertigo, cervical surgery, vision and hearing problems, any rheumatological, orthopedic, cardiovascular and neurological problems that may affect the cervical region

Primary outcomes:
measure: Joint Position Error Measurement
timeFrame: Before and Immediately After the Treatment Process
measure: Cervical Joint Range of Motion Measurement
timeFrame: Before and Immediately After the Treatment Process
measure: Balance Assessment
timeFrame: Before and Immediately After the Treatment Process
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Faculty Member
name: Fatih Tekin, Ass. Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT02582385: In-situ Cytokines Expression in the CNS in Amyotrophic Lateral Sclerosis (ALS)
Official title: In-situ Cytokines Expression in the CNS in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis (ALS)
Cytokines
Neuropathology
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Archived/residual histopathology slides and paraffin blocks from residual autopsy material from patients who died with amyotrophic lateral sclerosis.

Brief summary: The investigators aim at exploring the differential/topographical in-situ expression of cytokines in the central nervous system (CNS) of patients who died with amyotrophic lateral sclerosis (ALS), using archived histopathology slides and residual paraffin blocks from autopsied cases. Previous studies from the investigators and other groups showed that inflammatory cytokines are implicated in several neurological affections, particularly neurodegenerative conditions. However, in-situ cytokine expression has never been studied so far in ALS. The investigators wanted to see if these neuro-mediators are involved in the neuromolecular chain/cascade underlying ALS.


Eligibility criteria: Inclusion Criteria:

* patients who died with amyotrophic lateral sclerosis, having been autopsied.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: in situ cytokine detection: interleukin 18
timeFrame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
measure: in situ cytokine detection: interleukin 1
timeFrame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
measure: in situ cytokine detection: interleukin 6
timeFrame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
measure: in situ cytokine detection:TNF-a
timeFrame: retrospective study performed on archived paraffin blocks, autopsies performed between 2000 and 2005
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Hazim Kadhim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05413785: Hepatitis C Treatment in Probation and Parole Office
Official title: Prospective Cohort Study to Determine Effectiveness of Telemedicine-based on Site Hepatitis C Management in Probation and Parole Office
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
HCV
Keywords: parole
probation
telemedicine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2022-06-10
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This prospective cohort study compares aims to determine the efficacy and effectiveness of telemedicine-supported on-site linkage to care and treatment in a community probation and parole office (P\&P office) setting and compare the results with a historic control with referral to care. Research participants will be followed in the P\&P office when they report to their officer during regularly scheduled appointments. Participants will receive treatment without having to travel to a specialist's office. The telemedicine visit will include a consultation with an experienced HCV provider such as a hepatologist or an advanced practice provider and a specialty pharmacist who will educate about and monitor HCV treatment. The UK specialty pharmacy will be available to participants and the HCV management team through a 24-hour support line. Participants will be treated per HCV guidelines and insurance preference.


Eligibility criteria: Inclusion Criteria:

* Clients who will be supervised in the probation and parole office for at least 5 months
* History of hepatitis C
* Able to obtain health insurance
* Capacity to provide written, informed consent
* Life expectancy \>1 year

Exclusion Criteria:

* Negative HCV RNA
* Pregnant or breast-feeding
* HIV or HBV co-infection
* Liver cirrhosis with Child-Turcotte-Pugh score 6 or greater at baseline lab work
* Subjects with impaired capacity to provide informed consent

Primary outcomes:
measure: HCV treatment uptake rate of HCV RNA positive participants
timeFrame: 6 months
Secondary outcomes:
measure: HCV treatment uptake rate
timeFrame: 6 months
measure: Determine visit adherence
timeFrame: 6 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jens Rosenau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04728685: Effects of Lumbar Traction on the Straight Leg Raise Test and Pain
Official title: Effects of One-fifth, One-third, and One-half of the Bodyweight Lumbar Traction on the Straight Leg Raise Test and Pain in Prolapsed Intervertebral Disc Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolapsed Intervertebral Disc
Keywords: Mechanical Traction
Prolapsed intervertebral disc
straight leg raise test
pain
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm parallel groups
Primary purpose: TREATMENT

Brief summary: Disc prolapse causes impairment of function by nerve root compression compelling the patient to seek medical advice for low backache. Traction is one of the physical modalities frequently used for the treatment of lumbar disc herniations. So the purpose of the study is to determine the effect of one-fifth, one-half, and one-third of body weight traction on the straight leg raise test and pain.

Detailed description: A total of 45 patients suffering from lumbar PIVD and having neurological symptoms will be selected for the study. Lumbar PIVD will be confirmed from MRI. Participants will be divided into three groups with 15 participants in each group. group A. for one-fifth of body weight traction, group b for one-third of body weight traction, and group C for one-half of body weight traction. SLR and pain will be measured before traction and after traction. A goniometer will be used to measure SLR and VAS will be used to measure pain.

Eligibility criteria: Inclusion Criteria:

* Back pain for less than 3 months
* Positive unilateral Straight Leg Raise test which includes reports of back and leg pain or paraesthesia below 45-degree hip flexion
* At least one additional neurological sign should be present including- (a) Diminished Achillis/Hamstring tendon reflex, tested in the supine position or (b) Hyposthesia in any of the L4-S2 dermatome, or (c) Muscle weakness in any of the L4-S2 myotome.
* MRI evidence of L-4-L5 or L5-S1 disc prolapse or both.

Exclusion Criteria:

* Malignancy, Tuberculosis, Osteoporosis, Osteomyelitis of the vertebral column
* Cord compression, Pregnancy, Hypertension, Cardiovascular disease, Joint hyper mobility
* Subjects who could not tolerate the traction force secondary to being in an acute stage of back pain.
* Subjects who have taken previous physiotherapy treatment in the last three months for back pain.

Primary outcomes:
measure: Straight Leg Raise test
timeFrame: upto 1 month
measure: Visual analog scale
timeFrame: upto 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, MPTh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761085: Methadone in Pediatric and Adult Sickle Cell Patients
Official title: Methadone in Pediatric and Adult Sickle Cell Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-09-26
Enrollment: 47
Sex: ALL
Minimum age (years): 7
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 7 years and less than or equal to 40 years
* Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
* Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
* Admitted to the inpatient unit for further treatment
* Started on morphine patient controlled analgesia and infusion for pain management

Exclusion Criteria:

* Diagnosis of acute chest syndrome
* New focal neurologic findings or clinical concern of stroke
* Aplastic crisis with hemoglobin 2 g/dl below steady-state value
* Allergy to morphine or methadone
* Any other medical condition that the attending physician deems to be a contraindication to therapy
* Liver or renal insufficiency or failure, and congestive heart failure

Primary outcomes:
measure: To Determine the Pharmacokinetics of Methadone in Children and Adults With Sickle Cell Disease Experiencing a VOE.
timeFrame: 96 hr
Secondary outcomes:
measure: Pain Relief
timeFrame: 72 hr
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital/St. Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Evan D Kharasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horst J, Frei-Jones M, Deych E, Shannon W, Kharasch ED. Pharmacokinetics and analgesic effects of methadone in children and adults with sickle cell disease. Pediatr Blood Cancer. 2016 Dec;63(12):2123-2130. doi: 10.1002/pbc.26207. Epub 2016 Aug 30.
Clinical trial NCT01482585: Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy
Official title: Prospective Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Adenocarcinoma
Keywords: lung adenocarcinoma
prognosis
tumor aggressiveness
imaging biomarker
genetic biomarker
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Korean Foundation for Cancer Research
First posted: 2011-11-30
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with stage I or II lung adenocarcinoma who plans curative operation

Brief summary: to determine the values of imaging and genetic biomarkers for prediction of tumor aggressiveness and prognosis in patient with early stage lung adenocarcinoma to Identify unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate the long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a guideline for planning an appropriate follow-up examination and management


Eligibility criteria: Inclusion Criteria:

* A. Clinically and radiologically suspected lung adenocarcinoma
* B. Newly-diagnosed Stage I or II from the clinical work up including PET/CT
* C. Performance status of 0 to 1 on the ECOG scale
* D. Age 20 years or older
* E. Able to tolerable DECT imaging required by protocol
* F. Able to give study-specific informed consent

Exclusion Criteria:

* A. Prior malignancy
* B. planning of Definitive RTx 나 neoadjuvant CCRTx
* C. Poor cardiopulmonary reserve

Primary outcomes:
measure: Prediction of tumor aggressiveness
timeFrame: five years
Secondary outcomes:
measure: prognosis of early stage lung adenocarcinoma following operation
timeFrame: five years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Young Mog Shim, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06065085: The Effect of Education Given to Individuals With Hypertension by Mobile Phone
Official title: The Effect of Education Given to Individuals With Hypertension by Mobile Phone on DASH Diet Compliance, Quality of Life, Mindfulness and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Mobile Education
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2023-10-03
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study was planned as randomized controlled trial in order to evaluate the effect of the mobile education given to the individuals with hypertension on DASH diet compliance, healthy lifestyle behaviours, quality of life, mindfulness and stress levels.

The study was conducted as a randomized controlled trial with 134 individuals with hypertension (68 experimental, 66 controlled) who applied a university hospital in Edirne between the dates on 20.01.2022 and 18.05.2023. The data were collected by "Patient Information Form", "Healthy Lifestyle Behaviour Scale II", "EQ-5D General Quality of Life Scale", "Mindful Attention Awareness Scale" and "Percieved Stress Scale" were used. An education application was installed on the mobile phones of the experimental group. Individuals with hypertension were provided with a training for three months through the mobile application. Data collection forms were filled in by the individuals with hypertension in the experimental and controlled groups at the beginning and at the 3rd month via the mobile application. The data were analyzed in SPSS 26 (Statistical Package for the Social Sciences) program with the Shapiro-Wilk test, Student's t-test, Paired-Sample t-test, Chi-Square test, Fisher's Exact test, Fisher-Freeman-Halton test and Pearson correlation coefficient. The results were evaluated at % 95 confidence interval and the significance was evaluated at p\<0,05 level.


Eligibility criteria: Inclusion Criteria:

* Those diagnosed with Primary Hypertension (at least 1 month ago),
* Over 18 years,
* No communication barriers,
* Being literate,
* Volunteering to participate in the research,
* Individuals with hypertension who own a smartphone.

Exclusion Criteria:

* under 18 years old,
* Having a communication barrier,
* Those with chronic kidney disease,
* Individuals with hypertension and heart failure.

Primary outcomes:
measure: Mobile Education
timeFrame: three months
Secondary outcomes:
measure: Healty Lifestyle Behaviour
timeFrame: three months
Other outcomes:
measure: Quality of Life (EQ-5D General Quality of Life Scale)
timeFrame: three months
measure: Stress
timeFrame: three months
measure: Mindfulness
timeFrame: three months
Locations:
city: Edirne
country: Turkey
facility: Trakya Üniversitesi
state: Merkez
Study officials:
References: