louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05258188: Comparison of Ergon Instruments-Assisted Soft Tissue Mobilization With Compressive Myofascial Release
Official title: Study Comparing the Effectiveness of Ergon Instruments-Assisted Soft Tissue Mobilization Techniques With Compressive Myofascial Release for Plantar Fasciitis: A Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Plantar Fascitis
Randomized Control Trial
Myofascial Release
Soft Tissue Mobilization
Ergon Instruments
Comparison
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate the effects of Virtual Reality and Motor Imagery along with Routine Physical Therapy in motor function and balance in patients with Parkinson disease.

Detailed description: This randomized control trial is the single blinded, single centered study. Standard Protocol Items: Recommendations for Interventional Trials guidelines are used as study protocol. Sixty three patients of Parkinson Disease (Modified Hoehn and Yahr stages I-III) will randomly allocate into three groups.

Group A will be given a 60 min session of Virtual Reality along with Routine Physical Therapy.

Group B will be given a 60 min session of Motor Imagery along with Routine Physical Therapy.

Group C will be given a 40 min session of Routine Physical Therapy and after a short period of rest,20 min for walking and cycling.

These treatment sessions will be given to each group at every alternative day (3 days per week) for 12 weeks.

Outcome measures are

1. Berg Balance Scale
2. Activities Specific Balance Confidence Scale
3. The Unified Parkinson Disease Rating Scale (part III) The Assessments will be recorded at baseline, at 6th and 12th weeks of therapy, and after one month of discontinuation of therapy.

Eligibility criteria: Inclusion Criteria:

* Inability to achieve 20 degrees of active dorsiflexion,
* Heel pain,
* Mid foot pain,
* Heal swelling,
* Mid foot swelling,
* Achilles' tendon tightness diagnosed on the base of Windlass test

Exclusion Criteria:

* Recent foot injury,
* Fracture,
* Infections,
* Surgical procedures,
* Tendon injury,
* Hypermobility,
* Neuromuscular disorders,
* Impaired sensation,
* Open sores,
* Skin disease,
* Active deep vein thrombosis or thrombophlebitis,
* Bruises,
* Varicose veins,
* Burn scars

Primary outcomes:
measure: Range of Motion
timeFrame: 12th Week
measure: Visual Analogue Scale
timeFrame: 12th Week
measure: Foot and Ankle Disability Index
timeFrame: 12th Week
measure: Foot and Ankle Ability Measure
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT02047188: Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI
Official title: Observation of Microvessels and Invasion in Early Colorectal Lesions by Narrow Band Imaging:Combination With Microvessel Count and MMP-7 Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: narrow band imaging,microvessels,matrix metalloproteinase-7
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with early colorectal lesions

Brief summary: Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular architecture on lesion surface.The histology of early colorectal lesions could be predicted under NBI view.However,its capability for estimating invasion depth remains to be verified.The study is based on the hypothesis:NBI can predict histology and invasion depth,combined with the verification of microvessel count and MMP-7 expression.

Detailed description: The microvessel count (MVC) is a classical method of assessing histologic grade.To verify whether NBI could predict histology through microvascular architecture,we measured lesion microvessels by immunohistochemistry.On the other hand,we applied immunohistochemistry of matrix metalloproteinase-7 (MMP-7) to validate the capability of NBI for estimating invasion depth.MMP-7 is directly involved in the processes of growth, invasion, and metastasis of colorectal cancer.Our target was to clarify the diagnostic accuracy of magnifying NBI in early colorectal lesions,combined with the verification of microvessel count and MMP-7 expression.

Eligibility criteria: Inclusion Criteria:

* patients of early colorectal lesions with capillary pattern(CP) type II\&III,initially detected by white-light view and then examined by NBI with magnifying endoscopy.

Exclusion Criteria:

* lesions with CP type I;
* CP type III lesions with an obvious appearance of advanced cancer;
* lesions that had underwent biopsy;
* patients with inflammatory bowel disease(IBD) or familial adenomatous polyposis(FAP)
* patients with previous colorectal surgery;
* having conditions associated with cardiac,hepatic,renal,and coagulopathy diseases.

Primary outcomes:
measure: NBI prediction for lesion histology and invasion
timeFrame: in two weeks after lesion treatment
Secondary outcomes:
measure: immunohistochemical outcome of microvessel count and MMP-7
timeFrame: in three days after immunohistochemistry
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Ren Ji Hospital
name: Xiaobo Li, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03445988: Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study
Official title: Comparative Effectiveness of Pain Cognitive Behavioral Therapy and Chronic Pain Self-Management Within the Context of Opioid Reduction: The EMPOWER Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: opioid, taper, behavioral treatment for pain, randomized
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-02-26
Enrollment: 1462
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will fill several critical gaps in evidence that are preventing patients and physicians from making informed decisions about their pain care. This project will provide patients taking opioids and physicians with the specific evidence they need to choose the most effective route to pain control, reduced pain interference, opioid reduction, and improved role function, thereby improving patient care.

The aims of this study are to (1) reduce or contain prescription opioid use while maintaining pain control and (2) compare the effectiveness of the Chronic Pain Self-Management Program (CPSMP), Cognitive Behavioral Therapy for chronic pain (pain-CBT), and no behavioral treatment within the context of patient-centered collaborative opioid tapering (Taper Only).

The acronym EMPOWER stands for Effective Management of Pain and Opioid-Free Ways to Enhance Relief.


Eligibility criteria: Inclusion Criteria:

* Chronic non-cancer pain (≥ 6 months in duration)
* Currently receiving prescription opioids (≥ 10 MEDD) for ≥ 3 months

Exclusion Criteria:

* Unable to provide informed consent
* Unable to participate in group treatments in a meaningful way (e.g., evident cognitive impairment or lack of English fluency)
* Moderate to severe opioid use disorder

Primary outcomes:
measure: Opioid Tapering Success
timeFrame: Baseline and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Beth Darnall, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03286088: Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
Official title: Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Regurgitation of Any Grade
Lead sponsor: Philips Electronics Nederland B.V. acting through Philips CTO organization
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study primarily aims to collect standard of care clinical data in a wide spectrum of simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing stand-alone software prototype (QFlow), developed by Philips Research Paris (Medisys).

Investigator does not intervene in the care of the patient, but simply collects standard of care images and measurements that are needed for the validation of the investigational software.


Eligibility criteria: Inclusion Criteria:

* both genders
* age between 18 and 85 years old (adult, senior)
* sinus rhythm
* hHemodynamic stable
* mitral valve regurgitation (MVR) of any grade i.e., from mild to severe as determined by assessment of a qualifying TransThoracic Echocardiography (TTE) exam at Saint-Luc University Hospital
* scheduled for TransEsophageal Echocardiography (TEE) at Saint-Luc University Hospital, as part of the subject's routine standard of care
* subjects has functional capacity to give written informed consent

Exclusion Criteria:

* pregnancy
* subject lacks functional capacity to give written informed consent belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures

Among the120 subjects, there will be three (3) sub-groups as follows:

* a first sub-group (A) of 50 subjects with all inclusion criteria and none of the exclusion criteria
* a second sub-group (B) of 50 subjects with additional inclusion criterion: scheduled for cardiac Magnetic Resonance (cMR), as part of the subject's routine standard of care
* a third sub-group (C) of 20 subjects with additional inclusion criterion: scheduled for MitraClip transcatheter mitral valve repair (MitraClip) procedure as part of the subject's routine standard of care

Primary outcomes:
measure: Central diastolic and systolic blood pressures
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Saint Luc University Hospital
Study officials:
References:
Clinical trial NCT06637488: Using Customized Nasal Conformer in Correction of Cleft Nasal Deformity in Patients with Unilateral Cleft Lip
Official title: Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair (a Randomized Controlled Clinical Trial )
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Cleft Lip
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 14
Sex: ALL
Minimum age (years): 10
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to compare the cleft lip repair with and without the usage of customized milled nasal conformers in unilateral cleft lip patients on nostril size , alar cartilage and proportion of symmetry to the normal side .

* Comparing anthropometric measurements similarity between cleft and normal sides such as; nostril width and height , columellar deviation and nasolabial angle.
* Evaluation of degree of similarity using esthetic scales at six months postoperative.

Participants will receive nasal conformers intraoperative with follow up of 6 months.


Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes with unilateral cleft lip.
2. Age range 10 - 24 weeks.
3. Hemoglobin more than 10 gm/dl .
4. Weight more than 10 lbs.

Exclusion Criteria:

1. Syndromic patients.
2. Patients with conditions contradicting operation.
3. Patients with Bilateral cleft lip.
4. Patients with previous surgeries in lip and nose.

Primary outcomes:
measure: Nostril height
timeFrame: 6 months
measure: Nostril width
timeFrame: 6 months
measure: Columellar Deviation Angle
timeFrame: 6 months
measure: Nasolabial Groove Angle
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: faculty of dentistry, Alexandria university
Study officials:
References:
Clinical trial NCT00329888: Comparison of Papillary Balloon Dilatation Vs.Sphincterotomy for Lithotripsy in Difficult Sphincterotomy or Distal CBD Tapering
Official title: Comparison of Endoscopic Papillary Balloon Dilatation and Sphincterotomy for CBD Stones With Difficult Sphincterotomy or Distal CBD Tapering
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Choledocholithiasis
Keywords: Endoscopic papillary balloon dilatation
Endoscopic sphincterotomy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2006-05-25
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Compare endoscopic papillary balloon dilatation vs. endoscopic sphincterotomy for bile duct stones in:

* when sphincterotomy is difficult (periampullary diverticulum, prior sphincterotomy or Billroth II anastomosis)
* when there is distal CBD tapering.

Detailed description: Endoscopic papillary balloon dilatation is an alternative to endoscopic sphincterotomy for treating bile duct stones:

* easier and as effective. But...
* a higher risk of pancreatitis.

Conditions including periampullary diverticulum, prior EST, Billroth-II anastomosis, or distal CBD tapering pose difficulty in EST and lithotripsy with increased risk of complications.

Whether EPBD or EST is superior in efficacy or safety under such circumstances is not clear.

Eligibility criteria: Inclusion Criteria:

* Choledocholithiasis with
* Difficult sphincterotomy:periampullary diverticulum, prior sphincterotomy or Billroth II anastomosis
* or distal CBD tapering.

Exclusion Criteria:

* Patients in whom no endoscopic papillary balloon dilatation or endoscopic sphincterotomy was performed for lithotripsy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wei Chih Liao, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1. Minami A, Nakatsu T, Uchida N, Hirabayashi S, Fukuma H, Morshed SA, Nishioka M. Papillary dilation vs sphincterotomy in endoscopic removal of bile duct stones. A randomized trial with manometric function. Dig Dis Sci 1995;40:2550-4. 2. Bergman JJ, Rauws EA, Fockens P, van Berkel AM, Bossuyt PM, Tijssen JG, Tytgat GN, Huibregtse K. Randomised trial of endoscopic balloon dilation versus endoscopic sphincterotomy for removal of bile duct stones. Lancet 1997;349:1124-9. 3.Komatsu Y, Kawabe T, Toda N, Ohashi M, Isayama M, Tateishi K, Sato S, Koike Y, Yamagata M, Tada M, Shiratori Y, Yamada H, Ihori M, Kawase T, Omata M. Endoscopic papillary balloon dilation for the management of common bile duct stones: experience of 226 cases. Endoscopy 1998;30:12-7. 4. Fujita N, Maguchi H, Komatsu Y, Yasuda I, Hasebe O, Igarashi Y, Murakami A, Mukai H, Fujii T, Yamao K, Maeshiro K. Endoscopic sphincterotomy and endoscopic papillary balloon dilatation for bile duct stones: A prospective randomized controlled multicenter trial. Gastrointest Endosc 2003;57:151-5.
Clinical trial NCT01256788: Post-op Treatment With Hyaluronic Acid Injections
Official title: Prospective Randomized Study Evaluating Clinical Effectiveness of Post-op Treatment With Hyaluronic Acid Injections in Degenerative Joint Disease & Meniscal Tears
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Meniscus Tear
Chondropathy/Degenerative Joint Disease (DJD)
Keywords: viscosupplementation
meniscus tear
degenerative joint disease
Lead sponsor: The Hawkins Foundation
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2010-12-09
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The two treatment groups were:

1. Received saline injection
2. Received viscosupplementation injection
Primary purpose: TREATMENT

Brief summary: This study will look at patients with post-operative treatment of a meniscal tear or degenerative joint disease (degenerative arthritis). They will be randomized into one of three groups: Euflexxa injection, saline (placebo) injection, or no injection. Those who are randomized into the injection group will receive a series of three injections (one a week for 3 weeks), then a "booster" injection at 6 months post-op. Several questionnaires will be given after the first set of injections, then again at a one year follow-up.

The hypothesis is that patients receiving hyaluronic acid injections will have better pain and function scores as compared with placebo and no further treatment at all time points.


Eligibility criteria: Inclusion Criteria:

* Patients in post-op stage of treatment for meniscal tears or chondropathy/DJD
* Over 40 years of age
* A daily knee pain above 20mm on a 100mm visual analogue scale

Exclusion Criteria:

* Previous recipient of viscosupplementation injections
* Had rheumatoid arthritis or other inflammatory arthritis
* Had intra-articular steroid injections within the previous 2 months
* Invasive knee procedures within the past 6 months
* Contraindications to hyaluronate (an allergy)
* Medications that could interfere with the planned interventions

Primary outcomes:
measure: Tegner Activity Level Scale Score
timeFrame: 1 yr postop
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas
state: South Carolina
Study officials:
affiliation: Greenville Hospital System
name: Thomas Pace, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02587988: Trial to Evaluate the Efficacy and Safety of HCP1302
Official title: A Randomized, Double-blind, Multicenter, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients Being Treated With HGP0904
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Hypertension
Keywords: Erectile dysfunction & Hypertension
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 232
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trial to Evaluate the Efficacy and Safety of HCP1302

Detailed description: A Randomized, Double-blind, Multicenter, Phase Ⅲ study to Evaluate the Efficacy and Safety of HCP1302 in Both Erectile Dysfunction and Hypertension Patients being Treated with HGP0904

Eligibility criteria: At Visit1

1. ≥19 age
2. Hypertension Patients who need amlodipine 5mg
3. Abnormal Erectile function ≥ at least 3months based on screening date
4. Patients who are expected to frequent use of Tadalafil (at least two times for weeks)
5. Patients understood the consents and purpose of this trial and signed informed consent form

At Visit2

1. 90≤ sitSBP \< 140 mmHg and 50 ≤ sitDBP \< 90 mmHg
2. Sexual dysfunction rate ≥ 50% for 4 weeks run-in period
3. International Index of Erectile Function(IIEF)- Erectile Function(EF) domain score ≤ 25

Exclusion Criteria:

1. History of hypersensitivity to Amlodipine or Tadalafil
2. Has a severe liver disorder(Child-Pugh Class C) or liver enzyme (AST, ALT) level exceeds 3 times more than normal upper range
3. Has a clinically significant renal failure (Scr \> 2mg/dl)
4. Uncontrolled diabetes mellitus (HbA1C \>12%)
5. At screening date, blood pressure gap of selected arms is sitSBP ≥20mmHg or sitDBP ≥10mmHg
6. Taking PDE-5 inhibitors or other therapeutic agents for Erectile Dysfunction within 7 days based on screening date
7. No reaction to PDE-5 inhibitors

Primary outcomes:
measure: Change of IIEF-EF domain score
timeFrame: baseline and 12 weeks
measure: Change of sitting diastolic blood pressure
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change of sitting diastolic blood pressure
timeFrame: baseline, 4weeks and 8weeks
measure: Change of sitting systolic blood pressure
timeFrame: baseline,4weeks, 8weeks and 12 weeks
measure: Change of IIEF-EF domain score
timeFrame: baseline, 4weeks and 8weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06014788: Is the NPWTi Better Than the Conventional NPWT
Official title: NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Wound Infection Superficial Incisional
Postoperative Wound Infection Deep Incisional Surgical Site
Keywords: NPWTi
conventional NPWT
superficial and deep SSIs
Lead sponsor: Military Medical Academy, Bulgaria
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness of NPWTi and NPWT in superficial and deep surgical site infections using an improvised system with continuous lavage with saline and chlorhexidine. The main question it aims to answer is whether the NPWTi is better than conventional NPWT. Participants will be given NPWTi or conventional NPWT.

Researchers will compare the two groups to see if NPWTi diminishes the rate of recurrent infections and the number of reoperations, shortens the hospital stay, and alleviates the burden on the hospital staff in comparison to the conventional NPWT.


Eligibility criteria: Inclusion Criteria:

* adults over 18 years
* superficial or deep SSIs after laparotomy or laparoscopic surgery

Exclusion Criteria:

* persons \< 18 years
* documented inherited or acquired coagulation disorders or platelet deficiency
* presence of deep space infection (intra-abdominal abscess or ongoing peritonitis)
* prosthetic material infection

Primary outcomes:
measure: eradication of the infection
timeFrame: 6 weeks
measure: the rate of wound closure
timeFrame: 6 weeks
measure: 30-day recurrence rate
timeFrame: 30 days after discharge
Secondary outcomes:
measure: hospital stay
timeFrame: 6 weeks
measure: number of OR visits
timeFrame: 6 weeks
measure: time to wound closure
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Department of Sugery
Study officials:
affiliation: Military Medical Academy, Bulgaria
name: Ventsislav Mutafchiyski, DSc, FACS
role: PRINCIPAL_INVESTIGATOR
References: