louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04333316: Dual Mobility Cup: Does it Improve Patient's Satisfaction After Total Hip Arthroplastry?
Official title: Principal Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Satisfaction
Hip Osteoarthritis
Keywords: hip arthroplasty
satisfaction
dual mobility cup
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 180
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is prospective study was carried out on 180 patients with a unilateral arthritic hip between January 2011 and August 2018. Patients were divided into two groups, each group included 90 patients. Group A included patients received total hip with a large head (32-36mm.) made of cobalt-chrome. The femoral component was a cementless porous coated stem. The cup was a cementless porous coated Trilogy cup and was inserted press fit with primary additional one to three screws. Group B included those received total hip with a dual mobility cup
Primary purpose: TREATMENT

Brief summary: Although the success of total hip arthroplasty, many patients were dissatisfied postoperatively. Patient's reported outcome measures become of a great importance in assessment of the results after joint replacement. The aim of this prospective study is to evaluate and compare postoperative patient's satisfaction after implantation of two commonly used different designs of total hip arthroplasty.

Detailed description: The investigators conducted a prospective comparative study carried out on 180 patients suffering of hip arthritis between 2011 and 2018. They were randomized into two groups of homogenous demographic and clinical data. Group A was treated by cementless T.H.A. with a large head while group B received cementless T.H.A. with a dual mobility cup. Clinical evaluation and preoperative patient's expectation were assessed and compared to the postoperative satisfaction.

Eligibility criteria: Inclusion Criteria:

* Unilateral hip arthritis
* Age up to 65 years
* Body mass index (BMI) up to 35
* Modified Charnley comorbidity classification equal to A

Exclusion Criteria:

* Neurological deficit (e.g. Parkinsonism, stroke)
* Bone type c not fit for cementless fixation
* Poly-arthritis, active inflammatory arthritis (e.g. rheumatoid arthritis)
* Any patient with psychiatric disorders

Primary outcomes:
measure: patient's satisfaction
timeFrame: about 5 years
measure: clinical evaluation
timeFrame: about 5 years
measure: pain assessment
timeFrame: about 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Samy AM, Mahmoud AA, El-Tantawy A. Dual Mobility Cup: Does It Improve Patient's Satisfaction After Total Hip Arthroplasty? A Prospective Comparative Randomized Study. J Am Acad Orthop Surg. 2021 Nov 15;29(22):e1141-e1150. doi: 10.5435/JAAOS-D-20-00882.
Clinical trial NCT05550116: Clinical Evaluation of White Spot Lesions Treated by S-PRG and ICON
Official title: Clinical Evaluation of White Spot Lesions Treated by S-PRG Coating Material and Resin Sealants in Comparison With Resin Infiltration by Using Spectrophotometer and Laser Fluorescence. (A Randomized Controlled Trial) (WSLs)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesion
Keywords: white spot lesions
ICON
S-PRG
DIAGNOdent
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized with (1:1) prospective, double-blind, controlled trial. Subjects will be randomized to receive S-PRG and the control group receives ICON.

Detailed description: Interventions: - All the procedures will be performed by the same clinician. DIAGNOdent will be used to assess the fluorescence loss of WSLs and the adjacent sound enamel. WSLs in permanent teeth will be treated according to the manufacturer's instructions with:

* Group I (Control group): 20 teeth will be treated with ICON.
* Group II ( EXPERIMENTAL) : 20 teeth will be treated with PRG BarrierCoat.

Observation: - The treatment methods will be assessed immediately after the intervention, 3 months,6 months, and one year. The data will be collected for evaluation of the difference in color and fluorescence loss between the treatment groups, by using DIAGNOdent devices, over different time intervals.

Ethical considerations: The research protocol is approved by the ethical committee, Faculty of Dental Medicine, Al-Azhar University and the enrolled patients should sign a written consent form.

Eligibility criteria: Inclusion Criteria:

* Patients within 20-40 years of age.
* Each patient has 4 or more WSLs.
* Mild and moderate WSLs according to Gorelick's scale.
* Good oral hygiene and willing patients who can attend the study visits.
* a Symmetrical number of permanent teeth in each arch (mesial to second molars).

Exclusion Criteria:

* Active carious lesions.
* Facial surface restorations.
* Intrinsic and extrinsic stains.
* Patients who have a significant medical history or if they smoke.
* Criteria for discontinuation; Mortality and acquiring severe debilitating disease

Primary outcomes:
measure: patients tooth color change
timeFrame: 1 year
Secondary outcomes:
measure: patients tooth caries lesion state
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Wakwak
Study officials:
affiliation: Alazhar Univerisity
name: Khalid Noman, PROF
role: STUDY_DIRECTOR
References:
Clinical trial NCT05201716: Turkish Validity and Reliability of the UW Concerns About Pain Scale
Official title: Turkish Validity and Reliability of the UW Concerns About Pain Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Low-back Pain
Keywords: Concerns
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with Chronic low back pain

Brief summary: Brief Summary:

The aim of this study was to determine the Turkish validity and reliability of ''UW Concerns About Pain Scale'' developed by Dr. Amtmann.

Detailed description: Chronic pain is a common condition, affecting an estimated 20% of people worldwide. The biopsychosocial model of chronic pain is the most current accepted approach to understanding the complexity of pain and disability. One of the most important psychosocial factors in this approach is pain-related self-efficacy, which is defined as the individual's confidence in their ability to tolerate pain and participate in daily activities despite pain. The aim of this study is to determine the Turkish version, validity, and reliability of ''UW Concerns About Pain Scale''. 60 people with chronic low back pain will include in the study. In order to determine the reliability of the scale, the intraclass correlation coefficient (ICC) will be used to determine the level of the relationship between the results of the first and second measurements. Cronbach's alpha coefficient will be used for the homogeneity of the questions in the scale. For construct validity, the correlation coefficient will be used to determine the agreement between the Turkish version of Pain catastrophizing scale and, Turkish version of "Fear Avoidance Beliefs Questionnaire" and The ''UW Concerns About Pain Scale''.

Eligibility criteria: Inclusion Criteria:

1. To be between 18-65 years old
2. Having a complaint of low back pain for at least 6 months
3. Low back pain severity to be 3 points or above according to the Numerical Graded Pain Scale.

Exclusion Criteria:

1. Using antidepressant-derived drugs
2. Having a history of spinal surgery

Primary outcomes:
measure: UW Concerns About Pain
timeFrame: 8 minutes
Secondary outcomes:
measure: Turkish version of Pain Catastrophizing Scale (PCS)
timeFrame: 10 minutes
measure: Turkish version of "Fear Avoidance Beliefs Questionnaire"
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: İsmail SARACOGLU, PhD
role: STUDY_DIRECTOR
affiliation: Kutahya Health Sciences University
name: Cihan Caner AKSOY, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kutahya Health Sciences University
name: Lütfiye AKKURT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Kutahya Health Sciences University
name: Hasan Hüseyin GÖKPINAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670916: Probiotics to Prevent NEC - a Historical Control Study
Official title: Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Enterocolitis
Keywords: Necrotizing enterocolitis
Probiotics
Preterm
Infant
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 714
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newborn infants admitted for special or intensive care

Brief summary: Probiotics is given routinely to infants admitted to the department of neonatology during the first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1 March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009 will be compared.


Eligibility criteria: Inclusion Criteria:

* Gestational age less than 30 weeks
* Admission during the first 3 days of life

Primary outcomes:
measure: NEC
timeFrame: From birth until discharge home
Secondary outcomes:
measure: Death with NEC
timeFrame: Birth to discharge home
measure: Death
timeFrame: Birth to discharge home
Other outcomes:
measure: Positive culture of probiotic bacteria
timeFrame: Birth to discharge from Rigshospitalet
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neonatology, Rigshospitalet
Study officials:
References:
citation: Lambaek ID, Fonnest G, Gormsen M, Brok J, Greisen G. Probiotics to prevent necrotising enterocolitis in very preterm infants. Dan Med J. 2016 Mar;63(3):A5203.
Clinical trial NCT00680316: A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis
Official title: A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme® in 3- to 5-Year-Old Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: Pulmozyme
CF
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 3
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life (HRQOL), and respiratory symptoms in 3- to 5-year-old children with cystic fibrosis (CF). Approximately 40 patients were planned to be enrolled in this study. However, only 3 patients were eligible for random allocation and received treatment: 1 patient in the Pulmozyme group and 2 patients in the placebo group. All 3 patients completed the study assessments but did not have usable pulmonary function test (PFT) data.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Aged 3-5 years
* Diagnosis of cystic fibrosis

Exclusion Criteria:

* Children taking scheduled inhaled Pulmozyme or hypertonic saline within 56 days prior to Visit 1 or any Pulmozyme in the 28 days before Visit 1
* Involvement in a clinical intervention trial within the 4 weeks prior to Visit 1
* Use of an investigational drug or device within 28 days prior to Visit 1
* Any other condition that might increase the risk of participation to the patient in the judgement of the investigator

Primary outcomes:
measure: Change in Reactance at 8 Hz (Xrs8) From Visit 2 to Visit 3 (Change From Baseline at Visit 2 to Visit 3, After Study Drug Treatment).
timeFrame: from Visit 2 to Visit 3 (16 +/- 2 days)
Secondary outcomes:
measure: Change in Reactance at 4, 6, and 10 Hz (Xrs4, Xrs6, and Xrs10)
timeFrame: from Visit 2 to Visit 3 (16 +/- 2 days)
measure: Change in Resistance at 4, 6, 8, and 10 Hz (Rrs4, Rrs6, Rrs8, and Rrs10)
timeFrame: from Visit 2 to Visit 3 (16 +/- 2 days)
measure: Change in Respiratory Symptom Domain Score From the Cystic Fibrosis Questionnaire Revised (CFQ-R) for Parents of Preschoolers and for Preschoolers
timeFrame: from Visit 2 to Visit 3 (16 +/- 2 days)
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Michelle Freemer, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02066116: Kinect-based Upper Limb Rehabilitation System in Stroke Patients
Official title: Effect of Kinect-based Upper Limb Rehabilitation System in Patients With Stroke: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Hemiplegia
Virtual Rehabilitation
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Microsoft Research
name: Ministry of Science and ICT, Republic of Korea
First posted: 2014-02-19
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators have developed the kinect-based upper extremity rehabilitation program and designed this protocol to prove the efficacy of this program.

In brief, subacute stroke patients allocated to intervention group will receive the kinect based-rehabilitation program plus conventional occupational therapy and patients allocated to control group will receive the sham virtual rehabilitation plus conventional occupational therapy, for 10 days.

20 patients with subacute stroke will be allocated into each group and after completing the 10 days intervention, they will be assessed by using objective assessment tools for upper extremity function.


Eligibility criteria: Inclusion Criteria:

* Age from 20 to 80 years
* Stroke within prior 3 months
* Unilateral upper extremity weakness

Exclusion Criteria:

* Uncontrolled medical conditions
* Who cannot obey the simple command
* Who has the hemispatial neglect, visual impairment, apraxia

Primary outcomes:
measure: Change from Baseline in Fugl-Meyer Assessment Scale for upper extremity at 2 weeks
timeFrame: Baseline, 2 weeks after the baseline
Secondary outcomes:
measure: Brunnstrom stage
timeFrame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
measure: Modified Barthel Index
timeFrame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
measure: Box and Block Test
timeFrame: Baseline, 2 weeks after the baseline, 6 weeks after the baseline, 14 weeks after the baseline
measure: Number of movement counts during rehabilitation using accelerometer data
timeFrame: Baseline, 2 weeks after the baseline
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Hospital
state: Gyeonggi-do
Study officials:
affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
name: Nam-Jong Paik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01053416: Pigment Dispersion Syndrome: Natural History and Possible Protective Effect of a YAG Laser Iridotomy
Official title: 10-year Follow up of Patients With Pigment Dispersion Syndrome: Risk Factors for Conversion to Pigmentary Glaucoma and Potential Protective Effect of a Yag-laser Iridotomy in High Risk Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pigment Dispersion Syndrome
Keywords: glaucoma
pigmentary glaucoma
laser iridotomy
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: STUDY AIMS

1. To determine the 10-year conversion rate from pigment dispersion syndrome (PDS) to pigmentary glaucoma (PG)
2. To evaluate the possible protective effect of a Yag-laser iridotomy

Detailed description: 1154 workers in the Parma area will be screened for eligibility to long-term use of video-monitors. Those referred to the Glaucoma Clinic for suspected PDS will be enrolled in the study.

In a prospective study on the natural history of PDS and PG, Richter et al. (Arch Ophtal 104:211-5, 1986) found an association between "active pigment dispersion" and elevated IOP. Therefore, in order to evaluate the "stability" of the pigment, a phenylephrine test will be performed following the method reported by Epstein et al (1978) AJO 85:43-50. The test will be performed by one investigator (SAG)and was considered positive if \> "grade 1+" (i.e. at least 10 particles in a single light beam). Eyes showing a positive test will be considered as "high-risk" for conversion to PG.

Yag laser iridotomy will be performed in patients showing both eyes at high risk. One eye only (randomly chosen) will be treated. the fellow eye will be left untreated and considered as internal control.

Low risk eyes will be followed without any intervention.

Eligibility criteria: Inclusion Criteria:

* Krukenberg spindle
* Slit-like mid peripheral iris defect
* Pigment in \> 270° of AC angle

Exclusion Criteria:

* IOP \> 18 mmHg
* PEX (full mydriasis)
* w/w field defect (Octopus G1 program)

Primary outcomes:
measure: > 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Sezione Di Oftalmologia, Universita' Di Parma
Study officials:
References:
citation: Gandolfi SA, Ungaro N, Tardini MG, Ghirardini S, Carta A, Mora P. A 10-year follow-up to determine the effect of YAG laser iridotomy on the natural history of pigment dispersion syndrome: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1433-8. doi: 10.1001/jamaophthalmol.2014.3291.
Clinical trial NCT01604616: Short Term Postoperative Tamponade Using Perfluorocarbon Liquid for Giant Retinal Tears
Official title: Short Term Postoperative Tamponade Using Perfluorocarbon Liquid for Giant Retinal Tears
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Detachment
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2012-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: man and women above the age of 18 years

Brief summary: The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment ,associated with giant retinal tears.

Detailed description: a retrospective study wich compared 2 groups that had giant tear repair in one group, PFCL was left for few days as an intermediate measure until silicone oil or SF6 gas was used to reattach the retina ,and in the control group SF6 or Silicone oil were used, with no PFCL.

Eligibility criteria: Inclusion Criteria:

* above 18 years of age
* retinal tear at least of 3 clock hours.

Exclusion Criteria:

* less than 18 years of age
* Retinal tear less than 3 hours

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: Joseph pikkel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03767816: The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy
Official title: The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visceral Pain, Postoperative
Keywords: laparoscopic cholecystectomy
erector spinae plane block
visceral pain
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block.

After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation.

NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected


Eligibility criteria: Inclusion Criteria:

1. adults between the ages of 20 and 80
2. scheduled laparoscopic cholecystectomy patient
3. American society of anesthesiologists score 1 or 2
4. Patients who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

1. Patient with side effects on local anesthetics or steroids
2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
3. Patients with uncontrolled medical or psychiatric problem
4. Patient does not agree to participate in the study
5. Patients with deformity at vertebra or chest wall.
6. Patients who are pregnant or lactating
7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)
8. Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.

Primary outcomes:
measure: Difference of analgesic consumption between both group
timeFrame: at 0, 0.5, 1, 2, 6, 12, 18, 24 hours after operation
Secondary outcomes:
measure: compare the Numeric rating scale (NRS)
timeFrame: at 0, 0.5, 1, 2, 6, 9, 18, 24 hours after operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
affiliation: Asan Medical Center
name: JongHyuk Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: