louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02117921: Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
Official title: Mind Body Syndrome (MBS) Therapy for the Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Mind Body Syndrome
MBS
Chronic Pain
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 20
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: To determine if Mind Body Syndrome (MBS) therapy will reduce or eliminate pain in patients suffering from chronic pain syndromes without organic etiology.


Eligibility criteria: Inclusion Criteria:

* Adult patient 18 \> years old
* Chronic pain without clear organic etiology after full evaluation by primary care physician or subspecialist
* Pain persistent for a minimum of 3 days a week for the past three months prior to enrollment

Exclusion Criteria:

* Patients \< 18 years of age
* Diagnosed organic disease as cause of pain, such as but not limited to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis)
* Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia and bi-polar disorder. Mild to moderate depression and anxiety will not be considered as exclusions
* Pregnancy
* Severe depression or recent suicide attempt

Primary outcomes:
measure: Brief Pain Inventory Questionnaire
timeFrame: 4 weeks
measure: SF-12 Health Survey Scoring Demonstration
timeFrame: 4 weeks
Secondary outcomes:
measure: SF-12 Health Survey Scoring Demonstration and Brief Pain Inventory Score
timeFrame: 2 weeks, 4 weeks, 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael W Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01088321: Safety Study of Abatacept to Treat Rheumatoid Arthritis (A)
Official title: Safety of Disease Modifying Antirheumatic Drug (DMARD) and Biologic Treatment of Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 81332
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: United Healthcare

Brief summary: The purpose of this study is to compare the incidence rates of infection among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications


Eligibility criteria: Inclusion Criteria:

* Diagnosis of rheumatoid arthritis
* Claims indicating infusion, injection, or dispensing of abatacept, a DMARD, or a BDM
* Age 18 years or older at the time of drug initiation
* Enrollment in the health plan at least 6 continuous months leading up to the time of study drug initiation

Exclusion Criteria:

* Below 18 years of age at the time of BDM or DMARD initiation
* Lacking six months of continuous enrollment prior to the initiation of one of the study drugs

Primary outcomes:
measure: Infections, specifically hospitalized infection, hospitalized pneumonia, hospitalized and/or IV treated pneumonia, tuberculosis, herpes zoster, and opportunistic infection
timeFrame: Every four months throughout the study
Secondary outcomes:
measure: Anaphylactic reactions
timeFrame: Every four months throughout the study
measure: Multiple sclerosis, lupus, and psoriasis
timeFrame: Every four months throughout the study
measure: Concomitant biologic use
timeFrame: Every four months throughout the study
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT06684821: Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis
Official title: Analgesic Efficacy of Epidural Neuroplasty Using Racz Catheter During Lumbar Fixation in Situ for Lumbosacral Spondylolisthesis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesic Efficacy
Epidural
Neuroplasty
Racz Catheter
Lumbar Fixation
Lumbosacral Spondylolisthesis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 50
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: TREATMENT

Brief summary: This study aims to evaluate the analgesic efficacy of epidural neuroplasty using a Racz catheter during lumber fixation in situ for lumbosacral spondylolisthesis.

Detailed description: Lumbosacral spondylolisthesis, a common neurosurgical disorder, involves the anterior displacement of a vertebra in relation to the one below it. It often leads to back pain and neurologic symptoms.

Epidural lysis of adhesions is a procedure which treat chronic LBP in patients which didn't respond to medical treatments.The technique of Radiofrequency ablation (RFA) uses high-frequency current to produce tissue coagulation and heat. It involves the use of radio waves, applied through a percutaneous probe to generate heat and create a lesion in a spinal sensory nerve

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients suffering from spondylolisthesis grade 0, 1, 2 complaining of low back pain and/or sciatica.

Exclusion Criteria:

* Uncooperative patients.
* Patients in need of discectomy for lumber disc prolapse.
* Patients with severe canal stenosis and in need of spinal laminectomy.
* Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
* Body mass index (BMI) ≥35 kg/m2.
* History of allergy to contrast medium.
* Previously operated traditional spine surgeries.

Primary outcomes:
measure: Degree of Disability
timeFrame: 6 month post-procedure
Secondary outcomes:
measure: Degree of pain
timeFrame: 6 month post-procedure
measure: Degree of patient satisfaction
timeFrame: 6 month post-procedure
measure: Incidence of complications
timeFrame: 6 month post-procedure
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02969421: Pain Perception With Tenaculum Placement
Official title: A Randomized Controlled Study of Patient Pain Perception With Tenaculum Placement During In-office Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial that compares methods of tenaculum placement during intrauterine device insertion and their effect on pain. The two methods being compared are slow tenaculum placement versus tenaculum placement at time of cough. Subjects will be asked to rate their pain using visual analog scale. Primary outcome measured is pain at time of tenaculum placement. Secondary outcomes are overall pain with intrauterine device insertion and provider satisfaction with tenaculum placement.

Detailed description: The two commonly described strategies for tenaculum placement, slow versus having the patient cough while the tenaculum is placed are utilized by providers based on preference and/or their previous training. There is no published study that compares these methods to one another. The investigators aim to compare these strategies, slow tenaculum placement versus the cough method, and their effects on pain at time of placement. 96 subjects will be randomized to each method. The subject will be asked to rate their pain using a 100-mm visual analog scale after speculum placement, after tenaculum is placed, and after completion of the procedure. The provider will be asked to rate their satisfaction with tenaculum placement on a Likert-type 5 point satisfaction scale. 1: not at all satisfied, 2: slightly satisfied, 3: moderately satisfied, 4: very satisfied, 5: extremely satisfied. All data to be collected using REDCap database.

Eligibility criteria: Inclusion Criteria:

* Women ages 18 years and older
* Undergoing intrauterine device placement
* English or Spanish speaking

Exclusion Criteria:

* Primary language other than English or Spanish

Primary outcomes:
measure: Pain With Tenaculum Placement
timeFrame: Directly after tenaculum placement
Secondary outcomes:
measure: Overall Pain With Intrauterine Device Insertion
timeFrame: Directly after intrauterine device is placed
measure: Provider Satisfaction With Tenaculum Placement
timeFrame: Directly after tenaculum is placed
Other outcomes:
Locations:
Study officials:
References:
citation: Lambert T, Truong T, Gray B. Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial. BMJ Sex Reprod Health. 2020 Apr;46(2):126-131. doi: 10.1136/bmjsrh-2019-200376. Epub 2019 Oct 30.
Clinical trial NCT01708421: Symptom Clusters in Children With Leukemia
Official title: Phenotypic and Genotypic Associations With Symptom Clusters During Childhood Leukemia Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Leukemia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-10-17
Enrollment: 338
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children between 3-18 years of age undergoing treatment for leukemia.

Brief summary: The purpose of this study is to examine the phenotypic and genotypic characteristics and their associations with symptom clusters experienced during treatment for childhood leukemia.

Detailed description: A repeated measures research design will evaluate phenotypic and genotypic treatment-related symptom associations experienced by children and adolescents 3-17 years of age with a diagnosis of leukemia.

Eligibility criteria: Inclusion Criteria:

* Phenotypic and genotypic treatment-related symptom associations will be evaluated in children and adolescents 3-18 years of age with a diagnosis of leukemia.

Exclusion Criteria:

* Children without a definite diagnosis of leukemia will be excluded.
* Children must be able to understand and answer the questions on the questionnaires.
* Children with have a cognitive impairment (e.g. Down syndrome) will not be able to complete the questionnaires and will not be eligible for the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Minneapolis
country: United States
facility: Children's Hospitals & Clinics of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: Baylor College of Medicine/ Texas Children's Cancer Center
state: Texas
Study officials:
affiliation: Duke University School of Nursing
name: Marilyn Hockenberyy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01971021: Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.
Official title: Vascular Access in Cancer Patients - PICC vs PORT in a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Ryhov County Hospital
First posted: 2013-10-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label pragmatic
Primary purpose: SUPPORTIVE_CARE

Brief summary: As of today there is very limited scientific knowledge in whicj of the two vascular access devices (PICC-line or venous ports) that offers the lowest complicationrates in cancerpatients. The study group wants to clearify this unsolved matter by comparing the two systems. Our primary endpoint is the presens of catheter related venous thrombosis. We are also looking at all catheter related complications and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* cancer treatment with need for central venous access
* Age \>18 yrs
* Suspected survival \> 4 weeks
* Need of central venous access \>4 weeks

Exclusion Criteria:

* Ongoing uncontrolled systemic infection
* Prescence of significant thrombosis/stenosis in arm or central veins
* Unability to communicate
* Probable upcoming need for dialysis fistula

Primary outcomes:
measure: The occurence of catheter related venous thrombosis
timeFrame: Upon clinical suspiscion during the one the patient i enrolled in the study
Secondary outcomes:
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Dept of Oncology
Study officials:
References:
citation: Taxbro K, Hammarskjold F, Juhlin D, Hagman H, Bernfort L, Berg S. Cost analysis comparison between peripherally inserted central catheters and implanted chest ports in patients with cancer-A health economic evaluation of the PICCPORT trial. Acta Anaesthesiol Scand. 2020 Mar;64(3):385-393. doi: 10.1111/aas.13505. Epub 2019 Nov 27.
citation: Taxbro K, Hammarskjold F, Thelin B, Lewin F, Hagman H, Hanberger H, Berg S. Clinical impact of peripherally inserted central catheters vs implanted port catheters in patients with cancer: an open-label, randomised, two-centre trial. Br J Anaesth. 2019 Jun;122(6):734-741. doi: 10.1016/j.bja.2019.01.038. Epub 2019 Apr 17.
Clinical trial NCT03423121: A Trial of Bile Acid Supplementation in Patients With Multiple Sclerosis
Official title: A Phase 1/2 Trial of Tauroursodeoxycholic Acid Supplementation in Progressive MS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Progressive Multiple Sclerosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to identify the safety and tolerability of bile acid supplementation in patients with progressive Multiple Sclerosis (MS). Participants will also be assessed for an impact of the bile acid on their immune system and gut microbiome. Half of the participants will receive the bile acid tauroursodeoxycholic acid (TUDCA) and half will receive placebo. The investigators believe participants who take TUDCA will have normalization of blood bile acid levels, a normalization of abnormal immune response and a normalization of the gut microbiome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Progressive MS based on Lublin Criteria
* Low bile acid levels identified using targeted metabolomics analysis
* On the same therapy for the past 6 months and not expected to switch therapy in the next 6 months
* No relapse in the past 3 months

Exclusion Criteria:

* No previous history of liver disease or cholecystectomy
* No stage IV/V chronic kidney disease or other severe metabolic derangements (e.g. poorly controlled thyroid disease or diabetes)
* BMI \< 15 kg/m2 and BMI \> 40 kg/m2
* Female patients who are pregnant or nursing, or not willing to use contraception
* Chronic antibiotic use
* Corticosteroid treatment within the past 30 days
* Known history of other neuroinflammatory, neurodegenerative or systemic autoimmune disease

Primary outcomes:
measure: Number of Participants With at Least One Treatment-related Adverse Event
timeFrame: 16 weeks
measure: Number of Total Treatment-related Adverse Events
timeFrame: 16 weeks
measure: Incidence of Treatment-related Adverse Events (AE)
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Fasting Bile Acid Levels in Plasma
timeFrame: Baseline to 16 weeks
measure: Change in Microbiome Alpha-diversity Measured by Shannon Index at the End of the Study
timeFrame: Baseline to 16 weeks
measure: Change in Flow Cytometric Assessments of Peripheral Blood Mononuclear Cells (PBMCs)
timeFrame: Baseline to 16 weeks
measure: Change in Quality of Life Based on Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument
timeFrame: Baseline to 16 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Pavan Bhargava, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770821: Rehabilitation After Intensive Care
Official title: REHABILITATION AFTER INTENSIVE CARE What Effect Does Physiotherapy and Proteinrich Sip Drink Have on Physical Performance, Bodycomposition, Bodyweight and Quality of Life?
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rehabilitation of Muscle Strength
Keywords: sip drink
protein
muscle strength
6 minutes walking test
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Patients with critical illness loose bodymass, mainly muscle. The purpose of the present study is to evaluate wheather tailored physical training and/or a sip drink (proteinrich) have effect on the six minutes walking test (6MWT), muscle strength, body weight, body composition and quality of life after intensive care. This is a single center randomised controled study comprising patients ≥45 years of age staying 5 days or more in the intensive care unit (ICU). The design is factorial. Inclusion takes place when the patient is leaving the ICU.


Eligibility criteria: Inclusion Criteria:

* ICU patients ≥45 years with LOS ≥ 5days

Exclusion Criteria:

* Patients \< 45 years, Cerebral function that make cooperation impossible, Fractures in the spine, pelvis and/or lower extremities, Unable to perform the intervention LOS \< 5 days

Primary outcomes:
measure: 6 minutes walking test (6MWT) (when the patient leave hospital, 12 weeks and 12 months)
timeFrame: One year
Secondary outcomes:
measure: Isometric quadriceps strength, Isometrisk handgrip strength, Bodyweight Bodycomposition (Dexa)
timeFrame: One year
Other outcomes:
measure: Quality of life SF-36 (when leaving hospital, after 12 weeks and 12 months Body weight (leaving the ICU, after 12 weeks, after 12 months) Body composition (leaving the ICU, after 12 weeks, after 12 months)
timeFrame: One year
Locations:
Study officials:
References:
Clinical trial NCT04611321: Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Official title: A Phase Ib/II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of IBI318 in Participants With Advanced Cutaneous Squamous Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Cutaneous Squamous Cell Carcinoma
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-02
Enrollment: 15
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 evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.


Eligibility criteria: Inclusion Criteria:

1. Able to understand and willing to sign the ICF.
2. Adults 18 years of age or older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy at least 12 weeks.
5. Adequate organ and bone marrow function.
6. Histologically confirmed diagnosis of invasive CSCC. .

Exclusion Criteria:

1. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
2. Any investigational drugs received within 4 weeks prior to the first study treatment.
3. Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
4. History of autoimmune disease , present active autoimmune disease or inflammatory diseases
5. Pregnant or nursing females.

Primary outcomes:
measure: Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
timeFrame: 24 months
Secondary outcomes:
measure: Investigator Assessments of Overall Response Rate
timeFrame: 24 months
measure: Duration of response
timeFrame: 24 months
measure: PFS (progression-free survival)
timeFrame: 24 months
measure: Overall Survival
timeFrame: 24 months
measure: AEs and SAEs
timeFrame: 30 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
Study officials:
References:
Clinical trial NCT01673321: Protein Concentrations in Yogurt and Satiety, Food Intake and Glycemia in Healthy Men
Official title: Effect of Varied Protein Concentrations in Greek Yogurt on Glycemic Response, Satiety and Next Meal Food Intake in Healthy Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Glucose Metabolism
Keywords: Yogurt
Milk
Protein
Food intake
Appetite
Glucose
Insulin
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Dairy Farmers of Ontario
name: Mondelēz International, Inc.
First posted: 2012-08-27
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study compared the effects of dairy products, including milk and yogurt, with different amounts of proteins on responses of appetite, glucose and insulin and on food intake at a meal served 120 minutes later in healthy adult male individuals.


Eligibility criteria: Inclusion Criteria:

* Age: 20-30 years
* Body mass index: 20 and 24.9 kg/m2

Exclusion Criteria:

* Breakfast skippers,
* Smokers,
* Dieters,
* Individuals with lactose-intolerance or who are allergic to milk,
* Individuals with gastrointestinal problems and
* Individuals with diabetes or other metabolic diseases

Primary outcomes:
measure: Food intake
timeFrame: 120 minutes after consumption of treatments
Secondary outcomes:
measure: Glycemia
timeFrame: Pre-(0-120 min) and post-(120-260 min) meal periods
Other outcomes:
measure: Appetite
timeFrame: Pre-(0-120 min) and post-(120-260 min) meal periods
Locations:
city: Toronto
country: Canada
facility: Department of Nutritional Sciences, University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: G. Harvey Anderson, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: El Khoury D, Brown P, Smith G, Berengut S, Panahi S, Kubant R, Anderson GH. Increasing the protein to carbohydrate ratio in yogurts consumed as a snack reduces post-consumption glycemia independent of insulin. Clin Nutr. 2014 Feb;33(1):29-38. doi: 10.1016/j.clnu.2013.03.010. Epub 2013 Mar 27.