louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01560767: Perioperative Analgesia for Knee Arthroplasty (PAKA)
Official title: Can Periarticular Knee Injection of Multimodal Agents Levobupivicaine, Morphine, Ketorolac and Adrenaline Improve Postoperative Pain and Function Following Primary Total Knee Arthroplasty?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Arthritis
Keywords: Pain relief
Arthroplasty
periarticular knee infiltration
Lead sponsor: University of Warwick
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Peri-articular knee infiltration with Levobupivicaine 150mg, Morphine 10mg and Ketorolac 30mg reduces postoperative pain following primary total knee replacement compared with the current standard treatment of femoral nerve blockade.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing an elective primary unilateral total knee arthroplasty (TKA) under the care of an orthopaedic consultant at University Hospitals Coventry and Warwickshire NHS trust are potentially eligible for the trial.

Exclusion Criteria:

* Those with sufficient cognitive impairment that they would be unable complete questionnaire (cognitive impairment).
* Those patients who lack capacity under the Mental Capacity Act 2005
* Those patients with a pre-operative history of neurological abnormality in the ipsilateral leg e.g. history of stroke, neurogenic pain or previous nerve injury.
* Those patients having spinal anaesthesia.
* Those patients with a specific contraindication to the analgesic agents used:Morphine: Hypersensitivity reaction Ketorolac: Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
* Haemorrhagic diatheses, including coagulation disorders
* Hypersensitivity to ketorolac trometamol or other NSAIDs
* Moderate or severe renal impairment (serum creatinine \> 160 micromol/l)
* Levobupivicaine: Levobupivacaine solutions are contra-indicated in patients with a known hypersensitivity to levobupivacaine, local anaesthetics of the amide type or any of the excipients
* Uncontrolled angina
* 2nd/ 3rd degree heart block

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 18 Hours post operatively
Secondary outcomes:
measure: 4 point pain score
timeFrame: First 48 hours post surgery
measure: Analgesia required
timeFrame: 48 hour period post operativley
measure: Concentration of Levobupivicaine in drain and patient serum samples
timeFrame: 6 hours post operation and pre and post retransfusion
measure: Functional Assessments change over time 18, 48 & 6 weeks
timeFrame: 18 & 48 Hours and 6 weeks post surgery
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University of Warwick, University House,
Study officials:
affiliation: University of Warwick
name: Matthew Costa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01081067: Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children
Official title: Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stool Output
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 134
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CPPHO \[Centro Pediátrico Professor Hosannah de Oliveira (Professor Hosannah de Oliveira Pediatirc Center\] C-HUPES \[Complexo Hospitalar Professor Edgar Santos (Professor Edgar Santos Hospital Complex)\]

Brief summary: Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

Detailed description: Evaluate the effect of probiotics on stool output in children 1 - 18 months old.

Eligibility criteria: Inclusion Criteria:

* children 1 - 18 months of age
* acute diarrhea
* adequately hydrated
* signed informed consent

Exclusion Criteria:

* exclusively or predominantly breast-feeding
* bloody diarrhea
* intercurrent illnesses that may affect study parameters
* use of systemic antibiotics during the 72 hours prior to enrollment
* use of anti-diarrheal medications at the time of enrollment
* use of supplement or infant formula with Lactobacillus rhamnosus 10 days prior to enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine
state: Bahia
Study officials:
affiliation: Professor Edgard Santos University Hospital - UFBA
name: Hugo Ribeiro, Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02321267: Cohort Study of the Clinical Course of Macular Diseases in Kagawa
Official title: Cohort Study of the Clinical Course of Macular Diseases in Kagawa (Kagawa Macula Cohort Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Macular Disease
Keywords: AMD
PCV
RAP
RVO
DME
ERM
MH
mCNV
Lead sponsor: Kagawa University
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Macular diseases often cases severe visual impairment. Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of various macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth. The advance in vitrectomy improve visual outcomes in some maculae diseases, including epiretinal membrane (ERM), macular hole (MH), vitreomacular traction syndrome (VMTS).

Patients with such macular diseases are registered and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.


Eligibility criteria: Inclusion Criteria:

* Patients who visit Department of Ophthalmology, Kagawa University Hospital with macular diseases, such as AMD, PCV, RAP, RVO, DME, ERM, MH, VMTS.
* Patients who are agreed with the participation of this study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change of best-collected visual acuity from baseline at 5 years
timeFrame: Five years after the registration
Secondary outcomes:
Other outcomes:
Locations:
city: Miki
country: Japan
facility: Kagawa University Faculty of Medicine
state: Kagawa
Study officials:
affiliation: Kagawa Univerisity Faculty of Medicine
name: Akiataka Tsujikawa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421967: Postoperative Analgesia After Total Knee Arthroplasty
Official title: Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Arthroplasty, Replacement, Knee
Keywords: Postoperative pain
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-01-15
Enrollment: 80
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: Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization.

The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.


Eligibility criteria: Inclusion Criteria:

* Patients admitted consecutively to primary total knee arthroplasty.
* Provided informed consent

Exclusion Criteria:

* Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
* Severe chronic neurogenic pain
* Medical treated diabetes
* Contraindications for spinal aesthesia and epidural analgesia
* Known hypersensitivity towards study drugs
* Rheumatoid arthritis
* Treatment with narcotics
* Treatment with antidepressants
* Severe obesity BMI\>35
* Treatment with antacid
* Not able to speak and understand Danish

Primary outcomes:
measure: Analgésia consumption
timeFrame: 48 h
Secondary outcomes:
measure: Time to discharge
measure: Cytokine level
timeFrame: 48 h
measure: Pain scores VAS
timeFrame: 72 h
measure: Side-effects
timeFrame: 72 h
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital
Study officials:
affiliation: Glostrup Hospital, Glostrup 2600, Denmark
name: Birgitte V Christensen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731767: The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals
Official title: The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Manipulation
Thrust
Ankle
Ligaments
Lead sponsor: Florida Gulf Coast University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pretest post test study design
Primary purpose: BASIC_SCIENCE

Brief summary: Measure the effect of a common used ankle manipulation on ligament length in the ankle.

Detailed description: The purpose of this study is to determine what the effect of a common ankle manipulation on the supporting ligaments of the ankle.

Design: The researchers will conduct a quasi-experimental study with a method of convenience sampling. The design of this study will allow to determine what the direct effect of a common a commonly used physical therapy ankle manipulation is on the length of the soft tissue connection between the smaller bone in the lower leg and the heel bone and the smaller bone in the leg and the ankle bone.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-65 years old
2. No current trauma to the ankle/ foot-if not present both ankles will be used during this study
3. No hx of fracture or surgical intervention to the ankle

Exclusion Criteria:

1. Red flags identified during the subjects intake. If manipulation is contraindicated the subjects will be removed from the study.
2. History of ankle/ foot trauma within the last 3 months.
3. History of surgery on the ankle/ foot.
4. History of knee, hip, or lower back related issues that would make the application of the ankle manipulation contraindicated.
5. Workers compensation and any pending legal action regarding ankle/ foot related issues.
6. Undergone any ankle manipulation within the last 3 weeks.
7. History of Osteopenia or Osteoporosis.
8. Inability to undergo measuring protocol.

Primary outcomes:
measure: Tendon length
timeFrame: Measure 1 prior to manipulation. Measure 2 immediately after manipulation, within 5 minutes (the same day)
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Coral
country: United States
facility: Integrated Therapy Practice PC
state: Florida
Study officials:
affiliation: FGCU Assistent Professor
name: Rob Sillevis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03178604: Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes
Official title: Comparison Between Classic and Sham Massage on Psychological and Physical Functional Variables in Athletes: A Randomized Pilot-Placebo Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hamstring Contractures
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study we intend to apply a treatment protocol for hamstrings that can be beneficial for a good recovery.

Initially, a sample of athletes with hamstring shortening was chosen. Once the sample is chosen, it will be divided into two groups: group 1 (G.1) who will receives a sham massage, group 2 (G.2) that receives the classic massage.

To finalize the study comparing the results of the two groups to observe the experimental protocol obtains better results.

Material and methods The sample of an athletic club. Recruiting subjects between 18 and 45 years old without other injuries of the lower limb. Subjects with shortening of the hamstring muscles are available through the specific shortening test.

This is a randomized controlled trial. Subjects were randomly assigned to two intervention groups (1 treatment and 1 placebo control). The intervention consists of 4 sessions for 1 month. The sessions have a duration of 45 minutes. Evaluations are performed at the beginning of treatment, at the end of treatment. Participants also perform strengthening exercises three days a week, a total of 3 sets with 15 repetitions each.

Group 1 receives a sham massage of the quadriceps and hamstrings. Group 2 receives a classic massage of the quadriceps and hamstrings. The assessments consist of knee and hip goniometry, lumbar and hamstring flexibility by finger-to-floor testing, and complete the questionnaire Mood Status Profile (POMS), Which evaluates the states of mind.


Eligibility criteria: Inclusion Criteria:

* The sample comes from two athletic clubs of Valencia with subjects between 18 and 30 years old without lower limb injuries, with shortening of the hamstring muscles selected by the specific shortening test.

Exclusion Criteria:

* Muscle-skeletal injuries in any part of the body are excluded from the study.

Primary outcomes:
measure: Popliteal test
timeFrame: 4 weeks
Secondary outcomes:
measure: Hip flexion test
timeFrame: 4 weeks
measure: Range of motion
timeFrame: 4 weeks
measure: Lumbar flexibility
timeFrame: 4 weeks
measure: Emotional state of the athlete
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma Victoria Espí López
Study officials:
affiliation: Faculty of Physiotherapy, University of Valencia, Spain
name: Gemma V Espí López, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06530004: Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
Official title: Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nephrotic Syndrome
Rituximab
Children
Efficacy
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled.

Brief summary: This was a retrospective study. Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled. Personal information, past medical history, clinical examination data and follow-up data before and after the use of RTX were extracted from the medical record system. (1) The median relapse-free survival, the number of relapses and the adverse reactions of RTX were compared before and after RTX treatment, and the clinical efficacy and safety of RTX were evaluated. (2) By comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, B cell reconstitution and adverse drug reactions between prophylactic RTX and post-relapse RTX maintenance regimens; (3) Multivariate analysis of risk factors for recurrence of nephropathy after RTX treatment. (4) growth indicators monitoring patient evaluation and RTX medical economic benefit analysis.


Eligibility criteria: Inclusion Criteria:

* Children clinically diagnosed with FRNS/SDNS/SRNS with complete clinical data;
* age \< 18 years old;
* For the first time using RTX treatment, and used in nephrotic syndrome ease;
* The follow-up for 1 year or more.

Exclusion Criteria:

* Congenital or infantile nephrotic syndrome, secondary nephrotic syndrome (such as lupus nephritis, IgA nephropathy, purpura nephritis, hepatitis B nephritis, etc.);
* Active stage of hepatitis, complicated with severe infection, severe deficiency of immune response, malignant diseases;
* Estimated glomerular filtration rate (GFR) \<60mL/min/1.73m2.

Primary outcomes:
measure: The median relapse-free survival
timeFrame: 1 year
measure: Different sequential group curative effect evaluation
timeFrame: 1 year
Secondary outcomes:
measure: Risk factors for renal disease recurrence after RTX treatment.
timeFrame: 1 year
Other outcomes:
Locations:
city: Xiamen
country: China
facility: First affiliated hospital of xiamen university
state: Fujian
Study officials:
References:
Clinical trial NCT04684004: Hyperglycemia in Patients With Takotsubo Syndrome
Official title: Blood Glucose Values at Hospital Admission and Clinical Outcomes in Patients With Takotsubo Syndrome: Hyperglycemia Effects on Heart Failure Events and Mortality at 24 Months of Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Takotsubo Cardiomyopathy
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be of patients with acute TTC event. The enrolled patients according to inclusion and exclusion criteria will be then divided in normoglycemics vs. hyperglycemics according to blood glucose values at hospital admission.

Brief summary: Patients with Takotsubo cardiomiopathy (TTC) have over-inflammation and over-sympathetic tone. However, these conditions could cause higher rate of heart failure (HF) events and deaths at 2 years of follow-up. Conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of HF and deaths at 2 years of follow-up in TTC patients.


Eligibility criteria: Inclusion Criteria:

* acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as STEMI/evolving coronary syndrome;
* cardiac biomarker modifications (creatine kinase-MB and troponin I);
* systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (LV) chamber, with hyper-contractile basal LV.

Exclusion Criteria:

* patients with previous previous myocardial infarction;
* patients with previous TTC event;
* patients affected by chronic kidney, liver, and cerebrovascular diseases.

Primary outcomes:
measure: The number of HF events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Raffaele Marfella
Study officials:
References:
citation: Paolisso P, Bergamaschi L, Rambaldi P, Gatta G, Foa A, Angeli F, Fabrizio M, Casella G, Barbieri M, Galie N, Marfella R, Pizzi C, Sardu C. Impact of Admission Hyperglycemia on Heart Failure Events and Mortality in Patients With Takotsubo Syndrome at Long-term Follow-up: Data From HIGH-GLUCOTAKO Investigators. Diabetes Care. 2021 Sep;44(9):2158-2161. doi: 10.2337/dc21-0433. Epub 2021 Jun 29.
Clinical trial NCT03415204: Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
Official title: Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty Complications
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post operative pain (POP) is a major obstacle on the road to healing, despite the increasing interest in postoperative pain management and development of pain control modalities (1). Postoperative pain is still insufficiently treated with more than 50% of patients suffering from moderate to severe pain early after surgery .Pain after orthopedic surgery is considered especially difficult to manage. Approximately half of total knee or hip arthroplasty patients present with extreme pain immediately after surgery. Total knee and hip arthroplasty often results not only in severe perioperative pain and debilitation, but chronic pain, joint stiffness, and functional disability many months or even years following the procedure. Various modalities of treating orthopedic POP exist, but the optimal management of postoperative pain remains controversial with no clear consensus of the best method.We suggest that acupuncture can be an effective treatment for post operative pain after total knee or hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* signed informed consent, above 18 years of age, about to undergo total knee or hip arthroplasty

Exclusion Criteria:

* Known mental disease, active cancer disease, coagulopathy, Hepatitis B,C.

Primary outcomes:
measure: average post operative pain during time of hospitalization
timeFrame: average pain score during 5 days following operation
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References: