louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04852380: Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis
Official title: Clinical Results Of Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis (KOA), Our Experience At Midterm Follow Up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis (KOA); Platelet-rich plasma (PRP);
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 153
Sex: ALL
Minimum age (years): 40
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: One hundred and fiftythree patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and January 2020 with knee osteoarthritis

Brief summary: It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.


Eligibility criteria: Inclusion Criteria:

* Age between 40 and 81;
* Body mass index (BMI) between 21.5 and 29.3;
* Chronic history (for at least 4 months) of knee joint pain;
* Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)

Exclusion Criteria:

* Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale);
* Previous femur and tibia fractures;
* Knee previous surgical treatment (e.g., arthroscopy);
* Hyaluronic acid infiltration within the previous six months;
* Hemoglobin levels \<10 g/dL;
* History of oncohematological disease, infections, or immunodepression

Primary outcomes:
measure: Change in Visual Analogic Scale
timeFrame: Day 0; Month 1; Month 3; Month 6 (after the injection)
Secondary outcomes:
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Study officials:
References:
Clinical trial NCT06191380: Effects of Cycling and Virtual Reality on Thinking Speed in Persons With MS (PACE-MS)
Official title: Effects of a Single Bout of Moderate Intensity Aerobic Cycling Exercise Combined With Virtual Reality on Processing Speed in Persons With Multiple Sclerosis and Mobility Disability
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Leg Cycling
Virtual Reality
Mobility Disability
Processing Speed
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Consortium of Multiple Sclerosis Centers
First posted: 2024-01-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To compare the effects of cycling exercise with different types of virtual reality on processing/thinking speed in persons with multiple sclerosis (MS).

Detailed description: The purpose of this research study is to learn how different types of cycling exercise can improve short-term processing speed, or speed of thinking, in persons with MS. In this study, we will compare the effects of cycling alone to cycling with two different types of virtual reality. Participants will complete all three cycling conditions, one per week. We are studying these types of cycling because there are currently no effective treatment options to improve processing speed in persons with MS and combining exercise with virtual reality is a promising technique.

Eligibility criteria: Inclusion Criteria:

* Speak English as their primary language
* Confirmed MS diagnosis by a neurologist
* Be relapse and steroid-free for at least 30 days
* Mild-to-moderate self-report mobility disability

Exclusion Criteria:

* History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)
* Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)
* Currently use medications that may impact cognition (ex: steroids, benzodiazepines)
* Currently pregnant
* Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)
* No indication of age-related mild cognitive impairment or dementia, based on the MOCA-Blind (i.e., MOCA-Blind ≥19).
* High likelihood of motion sickness
* Regular cyclist, defined as cycling for at least 150 minutes/week

Primary outcomes:
measure: Modified Flanker Task (MFT)
timeFrame: Immediately before the single bout of cycling and 5 minutes after the single bout of cycling.
Secondary outcomes:
measure: Baseline mobility disability
timeFrame: Baseline visit only
measure: Baseline Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline visit only.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Carly Wender, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05930080: Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis: Phase III Clinical Trial
Official title: Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-05
Enrollment: 278
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center, Randomized, Double Blinded, Active-controlled Phase III Clinical Trial to Assess the Efficacy and Safety of SKCPT in Patients with knee Osteoarthritis


Eligibility criteria: Inclusion Criteria:

* Adult males and females aged 20 to 75 years
* Kellgren-Lawrence (KL) grade 1 to 3
* Individuals who voluntarily decide to participate in the study and provide written informed consent form
* Individuals who can understand and follow instructions and can participate in the study during the entire study period

Exclusion Criteria:

* Individuals who have clear secondary osteoarthritis caused by inflammatory, infectious, metabolic arthritis, or other conditions such as rheumatoid arthritis, rather than primary knee osteoarthritis as determined by the investigator
* Individuals with other factors that could potentially affect the assessment of this clinical study due to pain caused by osteoarthritis or other conditions in the hip joint
* Individuals who have undergone knee joint arthroplasty
* Individuals who have undergone open knee surgery (ligament reconstruction, osteotomy) within 3 years prior to the screening visit

Primary outcomes:
measure: K-WOMAC Pain Subscale
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT03404180: Peripheral Nerve Blocks for Above-the-knee Amputations
Official title: Peripheral Nerve Blocks for Upper Leg Amputations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Peripheral Vascular Diseases
Hyperglycaemia (Diabetic)
Hypertension
Coronary Artery Disease
Pulmonary Disease, Chronic Obstructive
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
First posted: 2018-01-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot clinical trial with a single arm
Primary purpose: BASIC_SCIENCE

Brief summary: Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).

Detailed description: Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (LFCN), and obturator blocks to provide surgical anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing above-the-knee amputation or knee disarticulation
* Ability to understand and provide informed consent

Exclusion Criteria:

* Patient refusal or inability to provide informed consent
* True allergy, not sensitivity, to any of the following substances:
* - Local anesthetics
* - Propofol or other sedative agents
* - General anesthetic agents
* Pregnancy
* Severe hepatic impairment
* Evidence of infection at or near the proposed needle insertion site
* Any sensorimotor deficit, whether acute or chronic, as determined by the PI
* Chronic use of opioid medication
* BMI ≥ 35

Primary outcomes:
measure: Chi-squared tests of peripheral nerve block success as a primary anesthetic
timeFrame: Changes from baseline through 30 days post-operative
measure: Analysis of pain scores
timeFrame: Changes from baseline through 48 hours post procedure.
Secondary outcomes:
measure: Mortality
timeFrame: Changes from baseline through 30 days post-operative
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: Malcom Randall VA Medical Center
name: José R Soberón, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00455780: Weight Loss Maintenance in Primary Care
Official title: Weight Loss Maintenance in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Eating
Dieting
Meal replacements
Energy Density
Weight Loss Maintenance
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-04-04
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: After a three month weight loss phase involving the use of meal replacements, participants are randomized into different weight loss maintenance conditions. Aim 1: To test the hypothesis that the meal replacement (MR) and reduced energy density eating (REDE) interventions, when added separately to the LEARN program, will produce superior weight loss maintenance compared to a LEARN-only intervention. Aim 2: To test the hypothesis that the weight loss maintenance condition that combines MRs and REDE will produce better maintenance of weight losses than either individual component and than the LEARN-only condition. Aim 3: To test the hypothesis that the two conditions receiving the REDE intervention will experience longer-lasting improvements in the energy density and nutritional composition of the diet compared to the two non-REDE conditions.


Eligibility criteria: Inclusion Criteria:

* BMI of 30, or BMI of 27 with weight-related comorbidities
* Access to a telephone and voice mail/answering machine
* MUST be seeing a primary care physician working with us on this study (in the greater Philadelphia area)

Exclusion Criteria:

* Previously/currently diagnosed with an eating disorder
* Current bi-polar, depression, substance abuse, or dependence disorder
* Living with someone already enrolled
* Enrolled in another weight loss program
* Current disorder/medications affecting body weight or energy expenditure (e.g. thyroid disease)
* Myocardial infraction within the past three months
* Unstable angina
* Nephrotic syndrome/malabsorptive disease
* Gout attack within the past year
* Lactating/pregnant (or planning within next two years)
* Current/recent history of cancer, neurological disease, high creatinine levels, active hepatic disease

Primary outcomes:
measure: Weight
timeFrame: baseline, 3 months, 12 months, 24 months, 36 months
Secondary outcomes:
measure: Body composition
timeFrame: baseline, 3 months, 12 months, 24 months, 36 months
measure: Blood work results
timeFrame: baseline, 3 months, 12 months, 24 months
measure: Scores on questionnaire-based measures
timeFrame: baseline, 3 months, 12 months, 24 months, 36 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Michael R Lowe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01144780: Investigation of Dysregulated Signaling in MPD Via Multiparameter Phospho-specific Flow Cytometry
Official title: Investigation of Dysregulated Signaling in Myeloproliferative Disorders Via Multiparameter Phospho-specific Flow Cytometry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Myeloproliferative Disorders
Myeloproliferative Disorders (MPD)
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who carries a diagnosis of a myeloproliferative disorder (MPD).

Brief summary: The objective of this study is to better understand the underlying pathogenetic mechanisms of myeloproliferative disorders (MPDs). We will collect peripheral blood samples from MPD patients and utilize multiparameter phospho-specific flow cytometry to investigate dysregulated signaling in blood cells from these patients. This will provide deeper insights into the pathogenesis of MPDs and may lead to the identification of novel targets for therapeutic intervention.


Eligibility criteria: Inclusion Criteria:Any patient who carries a diagnosis of a myeloproliferative disorder (MPD). Exclusion Criteria:Any patient who is not willing to give consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Jason Robert Gotlib
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Stephen Tracy Oh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03427580: Metacognitive and Insight Therapy for Persons With Schizophrenia (RCT MERIT)
Official title: Metacognitive and Insight Therapy (MERIT) for Persons With Schizophrenia: Assessment of Session by Session Progress and Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnosis of Schizophrenia Spectrum Disorders
Keywords: Schizophrenia
Psychotherapy
Metacognitive abilities
Session by session assessment
Outcome
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
First posted: 2018-02-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: People with schizophrenia spectrum disorders are faced with significant metacognitive impairments that include difficulties in their ability to form complex representations of the self and others. These impairments are associated with increased symptoms, impaired subjective self-experiences, and lower social functioning. As a result, interventions that enhance metacognitive capacity have been recently developed and explored. One of these interventions is Metacognitive Reflection and Insight Therapy (MERIT; Lysaker et al., 2014). MERIT is an integrative model of psychotherapy that seeks to promote holistic metacognitive capacity and consequently increase a positive sense of agency and sense of meaning in life among clients with schizophrenia. Several case studies (including in Bar-Ilan's community clinic), as well as a recent pilot study, showed increased metacognitive abilities and a decrease in symptoms following MERIT. The current study will explore both the effectiveness and the change mechanisms that underlie MERIT interventon among clients diagnosed with schizophrenia spectrum disorders, via both pre- and post-measures of the intervention's outcome and session-by-session estimations of the therapeutic process.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of schizophrenia spectrum disorders
* Ability to provide informed consent
* Ability to read and write in Hebrew

Exclusion Criteria:

* No co-morbid nuerological condition
* No hospitalization in the last 6 months

Primary outcomes:
measure: Metacognition Assessment Scale-Abbreviated (MAS-A)
timeFrame: Prior to the begining of the therapy (baseline, pre-treatment), and again at the end of the therapy (six months later, post-treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Bar-Ilan University
Study officials:
References:
citation: Lavi-Rotenberg A, Bar-Kalifa E, de Jong S, Igra L, Lysaker PH, Hasson-Ohayon I. Elements that enhance therapeutic alliance and short-term outcomes in metacognitive reflection and insight therapy: A session-by-session assessment. Psychiatr Rehabil J. 2020 Dec;43(4):318-326. doi: 10.1037/prj0000415. Epub 2020 Apr 9.
Clinical trial NCT03021980: Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial
Official title: Development and Evaluation of SuperFIT: Systems of Underprivileged Preschoolers in Their Home and Preschool EnviRonment: Family Intervention Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Fonds NutsOhra
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2017-01-16
Enrollment: 212
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the effectiveness of SuperFIT, an integrative lifestyle intervention for preschool children. It will consist of both an preschool component and a family component and is aimed at increasing healthy nutrition and physical activity. Half of the participating preschools will implement SuperFIT, while the other half of the preschools will continue as usual.


Eligibility criteria: Inclusion Criteria:

* children attending the participating preschools
* at least one parent has to be able to understand the Dutch language
* Both caregivers (if applicable) of the child give informed consent

Exclusion Criteria:

* There are no exclusion criteria for this study

Primary outcomes:
measure: Change in BMI
timeFrame: from baseline to one year and 1.5 years after baseline
measure: Change in physical activity by an Actigraph accelerometer
timeFrame: from baseline to one year and 1.5 years after baseline
measure: Change in Diet, Food and Nutrition by a 24HR recall
timeFrame: from baseline to one year and 1.5 years after baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Health Promotion, Maastricht University
name: Sanne Gerards, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: van de Kolk I, Gerards S, Verhees A, Kremers S, Gubbels J. Changing the preschool setting to promote healthy energy balance-related behaviours of preschoolers: a qualitative and quantitative process evaluation of the SuperFIT approach. Implement Sci. 2021 Dec 4;16(1):101. doi: 10.1186/s13012-021-01161-9.
Clinical trial NCT03361280: Removal of Beta Blocker Drugs by Hemodialysis
Official title: Beta-blocker Dialyzability in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Diseases
Keywords: hemodialysis
dialytic clearance
pharmacokinetics
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Eight maintenance hemodialysis patients are given one of four beta blocker drugs (atenolol, bisoprolol, carvedilol, metoprolol) three hours prior to a hemodialysis session. Blood samples and spent dialysate are collected during dialysis. On separate dialysis sessions, patients received the other study drugs until they have taken each of the four study drugs. Dialytic clearance is calculated.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age, receiving hemodialysis three times per week for at least 90 days.

Exclusion Criteria:

* gastrointestinal or liver disease, body mass index greater than 40 kg/m2, contraindications for receiving a beta blocker (treatment with contraindicated medications, prior adverse reaction, severe reactive airway disease, hemodynamic instability during dialysis).

Primary outcomes:
measure: Dialytic Clearance
timeFrame: Through study completion, average of one year.
Secondary outcomes:
measure: Dialytic Clearance
timeFrame: Through study completion, average of one year.
Other outcomes:
Locations:
Study officials:
References: