louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02464475: Effects of OMT on Interoception
Official title: Effects of Osteopathic Manual Treatment on Interoception: 2- Armed RCT on cLBP Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: osteopathic manipulative treatment
interoception
Lead sponsor: Come Collaboration
Sponsor class: OTHER
Collaborators: name: University of Chieti
First posted: 2015-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent evidence suggested that the anterior insula cortex seems to be the main site of interoception. Several studies showed an association between change in insula function and interoception, bodily perception and consciousness in subjects with chronic pain. Although osteopathic research has been demonstrated to be effective in reducing pain, studies exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the present study is to explore the extent to which osteopathic treatment could modify interoception parameters both measuring brain functional connectivity and clinical questionnaires.


Eligibility criteria: Inclusion Criteria:

* chronic low back pain
* written informed consent signed

Exclusion Criteria:

* congenital disease
* acute pain
* subject below 30 and above 50
* co-morbidities associated with low back pain
* surgical patients
* cardio-vascular, respiratory, gastro-enteric disease
* obese subjects
* diabetics
* dizziness
* subjects into pharmacological prophylaxis
* drug addicted subjects
* subjects undergoing physiotherapy
* subjects with experience in osteopathic treatment

Primary outcomes:
measure: functional connectivity on right anterior insula cortex
timeFrame: 4 weeks
Secondary outcomes:
measure: differences on salience network activities
timeFrame: 4 weeks
measure: acute changes on salience network
timeFrame: 2 hours
measure: resting state network differences between groups
timeFrame: 4 weeks
measure: DTI changes between groups
timeFrame: 4 weeks
measure: changes in GABA concentration
timeFrame: 4 weeks
measure: changes in quality of life
timeFrame: 4 weeks
measure: changes in perception of pain
timeFrame: 4 weeks
measure: changes in disability
timeFrame: 4 weeks
measure: changes in depression symptoms
timeFrame: 4 weeks
measure: changes in anxiety symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: University of Chieti-Pescara
Study officials:
affiliation: University of Chieti-Pescara
name: Francesco Cerritelli, MS, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04830475: NIV Prevents Post-operative Respiratory Failure After Bariatric Surgery
Official title: Non-invasive Ventilation Prevents Post-operative Respiratory Failure in Patient Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Postoperative Respiratory Distress
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospective Analysis
Primary purpose: PREVENTION

Brief summary: Postoperative non-invasive ventilation (NIV) has been proposed as an attractive strategy to reduce morbidity and improve postoperative outcomes in obese subjects undergoing general anesthesia. Bariatric patients present a peculiar negative feature; the increased body mass index (BMI) correlates with loss of perioperative functional residual capacity (FRC), expiratory reserve volume (ERV) and total lung capacity (TLC), decreased up to 50% of preoperative values. The aim of the current randomized trial is to evaluate the efficacy of NIV in post-anaesthesia care unit (PACU) in reducing post-extubation acute respiratory failure and the consequent admission in intensive care units (ICU) after BIBP in obese adult patients.


Eligibility criteria: Inclusion Criteria:

* Morbid Obesity
* Patients undergoing Biliointestinal Bypass (BIBP)

Exclusion Criteria:

* Patients requiring emergency operation with rapid sequence induction
* Patients with suspected presence of difficult airway or pre-existing lung impairment
* Pregnancy
* Asthma
* Severe renal dysfunction,
* cardiac disease resulting in marked limitation of physical activity, corresponding to NYHA class \>II

Primary outcomes:
measure: Intensive care unit admission rate
timeFrame: 72 hours
measure: Blood oxygen saturation (SaPo2)
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
References:
Clinical trial NCT00952575: Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
Official title: A Phase II, Open-label, Randomised, Dose-finding Study to Compare the Efficacy (in Terms of Clearance of RhD-positive RBCs) and Safety of LFB-R593, a Monoclonal Anti-RhD Antibody vs a Polyclonal Anti-RhD Immunoglobulin in Healthy RhD Negative Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Prevention of foeto-maternal allo-immunisation
Lead sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2009-08-06
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation.


Eligibility criteria: Inclusion Criteria:

* Healthy RhD-negative volunteers
* Males and definitively sterile females
* No prior sensitization to RhD antigen

Exclusion Criteria:

* Healthy RhD-positive volunteers

Primary outcomes:
measure: Clearance of RhD-positive red blood cells
timeFrame: within 2 weeks after RBC injection
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel Early Phase Clinical Unit
Study officials:
affiliation: Parexel
name: Thomas Kornicke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00136175: Paclitaxel, Carboplatin and Gemcitabine in the Treatment of Patients With Advanced Transitional Cell Cancer of the Bladder
Official title: Phase II Trial of Paclitaxel, Carboplatin and Gemcitabine in Patients With Locally Advanced Transitional Cell Carcinoma of the Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: Neoadjuvant chemotherapy
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2005-08-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the efficacy and safety of combination chemotherapy (paclitaxel, carboplatin, and gemcitabine) prior to surgery in the treatment of patients with locally advanced transitional cell cancer of the bladder.

Detailed description: This is a Phase II trial of neoadjuvant chemotherapy with paclitaxel, carboplatin and gemcitabine in the treatment of locally advanced transitional cell carcinoma of the bladder. Patients will be stratified based on extent of disease. Patients with T3, N0 disease will receive 3 cycles of chemotherapy and then proceed to cystectomy. Patients with T4 disease or any patient with N1-3 disease will receive 3 cycles of therapy followed by assessment of response. Patients with evidence of response will then receive an additional three cycles of therapy with reassessment of resectability after cycles #6. Correlative Studies: Tumor specimens obtained at initial biopsy will be assayed for expression of p53, Rb and p21.

Eligibility criteria: Inclusion Criteria:

* Patients must have histologically proven locally advanced (T3-4, N0 or Tany, N1-3) urothelial carcinoma of the bladder. Patients with local disease and unilateral or bilateral hydronephrosis will be eligible and included in the T3 arm of the study.
* Tumor specimens must be available for assay of molecular markers.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 2 (a measure of general well being where 0 is asymptomatic and 5 is death)
* Life expectancy of 12 weeks or more
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Patients may not have had prior systemic or intra-arterial chemotherapy and no prior radiotherapy (Patients may have received intravesicular chemotherapy).
* Evidence of distant metastasis
* Unresolved bacterial infection

Primary outcomes:
measure: Percentage of Patients in Arm I with Complete Pathologic Response
timeFrame: 3 Cycles (63 days) of Treatment
measure: Percentage of Patients in Arm II that Obtain to Resectable Disease
timeFrame: 6 Cycles (126 days) of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: The University of Michigan Comprehensive Cancer Center
name: David C. Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03348475: Binge Focused Therapy: A Guided, Self-help, Group-based Approach for Binge Eating Disorder
Official title: Binge Focused Therapy: Examining an Accessible, Cost-effective, Guided, Self-help, Group-based Approach for the Treatment of Binge Eating Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Binge-Eating Disorder
Eating Disorder
Keywords: Guided self-help
Group-based intervention
Binge Focused Therapy
Brain Over Binge
Non-expert guided
Minimally intensive
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 38
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 "Brain Over Binge Recovery Guide" (Hansen, 2016), is a self-help approach that incorporates fundamental aspects of Acceptance and Commitment Therapy, Dialectical Behavioural Therapy, Motivational Enhancement Therapy and addictions treatment. This approach has been streamlined into a guided self-help protocol (Binge Focused Therapy, or BFT) that can be delivered by undergraduate students with minimal mental health experience in 3 group sessions spread over 8 weeks (i.e., Week 1, Week 2, Week 8). The aim of this proof-of-concept study is to provide preliminary data to examine whether this approach is feasible and has clinical potential for patients with binge eating disorder.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older;
* Meets DSM-5 criteria for moderate to severe Binge Eating Disorder (BED) as determined through screening interview by an eating disorder psychiatrist and validated with the Eating Disorder Diagnostic Scale (a self-report screening tool);
* Provides written informed consent.

Exclusion Criteria:

* Currently receiving treatment for BED;
* Is taking a psychotropic medication (e.g., antidepressant, stimulant, etc.) AND the dose has been changed 2 weeks prior to baseline;
* Insufficient knowledge of English.

Primary outcomes:
measure: Change in Binge Eating Frequency
timeFrame: Baseline, Week 8, 1-year follow-up
Secondary outcomes:
measure: Change in Binge Eating Severity
timeFrame: Baseline, Week 2, Week 8, 1-year follow-up
measure: Remission Rate
timeFrame: Week 8, 1-year follow up
measure: Response Rate
timeFrame: Week 8, 1-year follow up
measure: Change in General Eating Disorder Symptomatology
timeFrame: Baseline, Week 8, 1-year follow-up
measure: Change in Locus of Control of Behaviour
timeFrame: Baseline, Week 2, Week 8, 1-year follow-up
measure: Change in Coping Self-Efficacy
timeFrame: Baseline, Week 2, Week 8, 1-year follow-up
measure: Motivation/Confidence/Readiness for Behaviour Change
timeFrame: Baseline and Week 2
measure: Depression, Anxiety and Tension/Stress
timeFrame: Baseline
measure: Participant Satisfaction with Intervention
timeFrame: Week 8
measure: Week 3 - 7 Adherence
timeFrame: Week 8
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
References:
Clinical trial NCT01848275: Full Length Versus Proximal Renal Arteries Ablation
Official title: The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension, Resistant to Conventional Therapy
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.

Detailed description: After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.

Eligibility criteria: Inclusion Criteria:

* office systolic blood pressure of 160 mm Hg or more,
* patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment.
* Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications;
* ≥ 18 years old,;
* did not have any known secondary cause of hypertension;
* had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more.

Exclusion Criteria:

* patients with type 1 diabetes,
* implanted pacemakers or implantable cardioverter defibrillators;
* pregnant women;
* haemodynamically significant valvular disease;
* patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)

Primary outcomes:
measure: Blood pressure
timeFrame: one year
Secondary outcomes:
measure: ablation-related complications
timeFrame: one year
Other outcomes:
Locations:
city: Chongqing
country: China
facility: 2ndChongqingMU
state: Chongqing
Study officials:
References:
Clinical trial NCT06198075: Action Observation Therapy on Balance in Children With Down Syndrome
Official title: Effects of Action Observation Therapy on Balance in Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Action Observation
Balance
Down syndrome
Rehabilitation
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be randomized controlled trial used to evaluate the effectiveness of action observation therapy on balance in children with down syndrome. Subjects with down syndrome meeting the inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique.
Primary purpose: TREATMENT

Brief summary: Down syndrome is a condition in which a child is born with an extra copy of their 21st chromosome hence its other name is trisomy 21. The hallmarks of Down syndrome are mental retardation, hypotonia and characteristic phenotype features. Balance is one of the major issue. Action observation therapy focus on the concept of balance improvement.

Detailed description: The study will be randomized controlled trail used to evaluate the effectiveness of Action observation therapy on balance in children with down syndrome. subjects with down syndrome meeting the inclusion exclusion criteria will be divided into two groups using non-probability sampling technique. Assessment will be done using Pediatric balance scale(PBS) and Timed up and go test(TUG) . Control group will receive regular physical therapy with balance training and experimental group will receive regular physical therapy + Action observation therapy.

Eligibility criteria: Inclusion Criteria:

* Children with age group of 6-12
* Both male and female
* Body Mass Index (BMI) within normal range (57.1%)
* Absence of any psychiatric and physical illness at the time of participation

Exclusion Criteria:

* Uncontrolled seizures
* Any kind of orthopedic condition
* Registered visually impaired
* Severe Atlanto Axial instability
* Unable or unwilling to understand and attempt the task

Primary outcomes:
measure: Pediatric berg balance scale
timeFrame: 6 weeks
measure: Modified Timed up and go test
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Zainab Jabir, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong YA, Lee BH. Effect of Action Observation Training on Spasticity, Gross Motor Function, and Balance in Children with Diplegia Cerebral Palsy. Children (Basel). 2020 Jun 18;7(6):64. doi: 10.3390/children7060064.
Clinical trial NCT01330875: Lumbar Infiltration With Steroids - Effects on Pain Reduction
Official title: Lumbar Infiltration With Steroids - Effects on Pain Reduction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain (the lumbar infiltration itself is not part of this study).

Brief summary: Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study)

Detailed description: Questionnaire are given to patients who got a lumbar infiltration in our clinic of rheumatology. These patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study).

Eligibility criteria: Inclusion criteria:

* Patients who got a lumbar infiltration in our clinic.

Exclusion criteria:

* Infiltration of thoracal or cervical spine.

Primary outcomes:
measure: Pain reduction
timeFrame: week 1 and 3; month 3, 6, 12
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Rheumatology
Study officials:
affiliation: University Hospital Zurich, Division of Rheumatology
name: Sandra Blumhardt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06538675: Process and Outcome Evaluation of Different Psychotherapies
Official title: Process and Outcome Evaluation of Psychotherapeutic Approaches At the Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Mental Illness
Psychiatric Disorder
Mental Disorder
Keywords: psychotherapy
Lead sponsor: University of Salzburg
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult individuals seeking help for their mental health at Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg.

Brief summary: In this study, adult patients and therapists at the Outpatient Clinic for Psychotherapy of the Paris Lodron University Salzburg will complete questionnaires throughout the course of psychotherapy in order to evaluate the course and outcome of psychotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients: indication for psychotherapy, adult patients capable of giving consent, with sufficient knowledge of German to complete the questionnaires, signed treatment contract and declaration of consent
* Psychotherapists: officially registered psychotherapists and psychotherapists in training under supervision (in Austria), signed work contract and declaration of consent

Primary outcomes:
measure: Hopkins Symptom Checklist Short Form (HSCL-11)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: through study completion, an average of 1 year
measure: Generalizied Anxiety Disorder Scale-7 (GAD-7)
timeFrame: through study completion, an average of 1 year
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: through study completion, an average of 1 year
measure: Positive Mental Health scale (PMH)
timeFrame: through study completion, an average of 1 year
measure: Society for Psychotherapy Research Item on Mental Health
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Paris-Lodron-University Salzburg
Study officials:
affiliation: Paris-Lodron-University Salzburg
name: Thomas Probst, Univ.Prof.Dr
role: STUDY_DIRECTOR
affiliation: Paris-Lodron-University Salzburg
name: Franziska Pfannerstill, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Paris-Lodron-University Salzburg
name: Hannah van Alebeek, Dr.
role: PRINCIPAL_INVESTIGATOR
References: