louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06625658: Evaluation of DPA for Treatment of Upper Anterior Crowding
Official title: Evaluation of Direct 3D Printed Clear Aligners for Treatment of Maxillary Anterior Crowding:(Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Correction of Upper Crowding
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2024-10-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of effectiveness of direct printed clear aligner in relive crowding in maxillary incisor

Detailed description: The present study will be performed to evaluate the effectiveness of direct 3D-printed aligners in the treatment of maxillary anterior teeth crowding

Eligibility criteria: Inclusion Criteria:

* Adult paients .age 18-25y. patients with mild to moderate upper anterior crowding (1mm_6mm)
* Healthy compliant and motivated patient. full dentition except wisdom teeth.

Exclusion Criteria:

* Previous orthodontic treatments. Any systemic disease, pregnancy, or lactating females, with a pocket depth of more than 5mm.

Primary outcomes:
measure: Correction of Maxillary Anterior Teeth Crowding according to little irregularity index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
state: Al Giza
Study officials:
affiliation: Study Principal Investigator Al azhar universty
name: Sara M .Hosny El kabbany, assistant professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01239758: Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
Official title: An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of ACE-031 (ActRIIB-IgG1) in Subjects With Duchenne Muscular Dystrophy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 11
Sex: MALE
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with Duchenne muscular dystrophy (DMD) who participated in Study A031-03. \[Note: This study was terminated based on preliminary safety data. Pending further analysis of safety data and discussion with health authorities, a new ACE-031 trial will be planned.\]


Eligibility criteria: Inclusion Criteria:

* Completion of participation in Study A031-03 and Investigator approval
* Continuation of corticosteroid therapy at the same absolute dose and schedule as on Study A031-03

Exclusion Criteria:

* Participation in any other therapeutic clinical trial
* Plans to have surgery during the course of the study

Primary outcomes:
measure: Number of patients with adverse events.
timeFrame: From treatment initiation to End-of-Study Visit, approximately 24 weeks later.
measure: Change in laboratory parameters and vital signs.
timeFrame: Baseline to End-of-Study Visit, approximately 24 weeks later.
Secondary outcomes:
measure: Percent change in total lean body mass by DXA scan.
timeFrame: Baseline to End-of-Study Visit, approximately 24 weeks later.
measure: Percent change in total body and lumbar spine bone mineral density by DXA scan.
timeFrame: Baseline to End-of-Study Visit, approximately 24 weeks later.
measure: Percent change in muscle strength score by hand-held myometry.
timeFrame: Baseline to End-of-Study Visit, approximately 24 weeks later.
measure: Change in distance traveled in 6 minutes (standardized 6-Minute-Walk Test).
timeFrame: Baseline to End-of-Study Visit, approximately 24 weeks later.
measure: Change in time to travel 10 meters (standardized 10-Meter-Walk/Run test).
timeFrame: Baseline to End-of-Study Visit, approximately 24 weeks later.
measure: Change in pulmonary function tests.
timeFrame: Baseline to End-of-Study Visit, approximately 24 weeks later.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Acceleron Investigative Site
state: Alberta
city: Hamilton
country: Canada
facility: Acceleron Investigative Site
state: Ontario
city: London
country: Canada
facility: Acceleron Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Acceleron Investigative Site
state: Ontario
Study officials:
References:
Clinical trial NCT03106558: Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
Official title: Post-Market Study of Robotic-Arm Assisted Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2017-04-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is an early user evaluation of the robotic-assisted total knee arthroplasty platform. The objective of this surgeon group is to capture data on the defined objectives and provide Stryker with feedback.


Eligibility criteria: Inclusion Criteria:

* Patient requires primary total knee surgery
* Patient is willing and able to comply with postoperative follow-up requirements and self evaluations
* Patient is willing to sign an IRB approved informed consent
* Patient is at least 18 years of age

Exclusion Criteria:

* Patient has a BMI \> 50
* Patient is skeletally immature
* Patient has an active infection or suspected infection in or about the joint
* Bone stock that is inadequate to support fixation of the prosthesis
* Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
* Patients with mental or neurological conditions which may be incapable of following instructions.
* Blood supply limitations
* Collateral ligament insufficiency.
* Patients with prior HTOs or Unis.

Primary outcomes:
measure: Component alignment
timeFrame: 6 weeks post knee arthroplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Athens Orthopedic Clinic
state: Georgia
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05486858: Diaphragm Function in Low Back Pain People
Official title: Differencies in the Contraction Ratio of Diaphragm Muscle Between Low Back Pain and Asymptomatic Individuals.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Low Back Pain, Mechanical
Keywords: LBP
diaphragm
MSK ultrasound
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female participants, over age 18, who were participated in the study voluntarily.

Brief summary: Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. Postural function of diaphragm was screened in supine position and in sitting too in a relaxed and in a contracted state. The thickness of diaphragm was measured and contraction ratio was calculated. Additionally, the stability limits of the trunk were measured. We were curios about the differencies in contraction ratio between asymptomatic and low back pain individuals.

Detailed description: Pathomechanism of nonspecific low back pain is not clear for the researchers yet. Our aim is to evaluate the function of one of the stabilizer muscles of the low back area. Diaphragm's postural function is evident. However, we do not understand its changes of function in low back pain. The postural function of diaphragm was screened with Zonare Zone Ultrasound System in supine position and in sitting too in a relaxed and in a contracted state. The thickness of diaphragm was measured by using an elecric caliper of the ultrasound device and the contraction ratio was calculated. Additionally, the stability limits of the trunk were measured with sitting functional reach and sitting lateral reach tests. We were curios about the differencies in contraction ratio between asymptomatic and low back pain individuals.

Eligibility criteria: Inclusion Criteria:

* capable to get the scene of the measurements
* age is over 18

Exclusion Criteria:

* serious neurologycal disorder, which affects the performance on the functional tests
* previous surgical intervention which has been affected the trunk
* intensive pain, which prevent the individual to perform the needed positions (supine and sitting)
* serious lung disease or breathing disorder

Primary outcomes:
measure: MSK ultrasonography
timeFrame: 20 min
measure: sitting Functional and Lateral Reach Test
timeFrame: 5 min
Secondary outcomes:
measure: Visual analogue scale
timeFrame: 1 min
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: University of Szeged
state: Csongrád-Csanád
Study officials:
References:
Clinical trial NCT01996358: Comparing Intubating Conditions Using Succinylcholine or Rocuronium for Rigid Bronchoscopy
Official title: Comparing Intubating Conditions Using Succinylcholine or Rocuronium/Sugammadex for Rigid Bronchoscopy: a Randomized Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Intubating Conditions
Postoperative Myalgia
Patient Satisfaction
Keywords: Succinylcholine
Rocuronium
Rigid Bronchoscopy
Lead sponsor: Dr. Horst Schmidt Klinik GmbH
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Succinylcholine is commonly used for neuromuscular relaxation for short procedures such as rigid bronchoscopy. A more modern alternative is the application aof rocuronium, reversed by sugammadex. The investigators compare the intubating conditions, incidence of postoperative myalgia (POM) as well as patient satisfaction for these two muscle relaxants.


Eligibility criteria: Inclusion Criteria:

* age \> 18 yr
* scheduled for elective rigid bronchoscopy

Exclusion Criteria:

* known neuromuscular disease
* significant hepatic or renal dysfunction
* family history of malignant hyperthermia
* known allergy to one of the drugs used in this protocol
* pregnancy or breastfeeding

Primary outcomes:
measure: Intubating Condition
timeFrame: after induction of general anaesthesia (after 3-5 minutes)
Secondary outcomes:
measure: Postoperative Myalgia
timeFrame: 72 hours after intervention
Other outcomes:
measure: Patient satisfaction
timeFrame: 72 hours after intervention
Locations:
city: Wiesbaden
country: Germany
facility: Dr. Horst Schmidt Klinik
state: Hessen
Study officials:
affiliation: Dr. Horst Schmidt Klinik
name: Grietje Beck, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT03452358: Survival Rate of Lithium Disilicate Crowns
Official title: Clinical Evaluation of Partial Ceramic Posterior Restorations Cemented Using Immediate Dentin Sealing - a (#) Year Follow up From a Retrospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival
Immediate Dentin Sealing
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2018-03-02
Enrollment: 170
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients participating in this study will be recruited from the patient population of the private dental practice 'Buijs tandartsen' in Groningen, the Netherlands.

Brief summary: A retrospective clinical study will be performed evaluating a large number of partial ceramic restorations (IPS e-Max press, Ivoclar, Liechtenstein) placed in general practice. Evaluation will be based on the well established Hickel criteria (Hickel et al, 2010). Rationale: IPS-e-max press has been made available to the market since 2006. Although millions of these restorations have been placed worldwide, clinical data are available of less than 200 single restorations only, covering observation periods of 2-8 years.(Guess et al, 2009; Etman en Woolford, 2010; Gehrt et al, 2012; Esquivel-Upshaw et al, 2012).

Objective: Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice.

Detailed description: Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice. All included patients were followed-up with special emphasis on the partial restoration(s), every time they visited the dental practice for regular dental check-ups between 2015 and 2017. To assess these restorations a light photograph with a digital camera (Nikon (D7100, 60mm lens), Nikon, Amsterdam, The Netherlands) and an x-ray were taken from the partial posterior crowns and evaluated according to the modified United States Public Health Service (USPHS) criteria.

Eligibility criteria: Inclusion Criteria:

* In order to be eligible to participate in this study, a patient must received one or more lithium disilicate restorations between 2006 and today.

Exclusion Criteria:

* No patients will be excluded from the study.

Primary outcomes:
measure: Survival rate
timeFrame: from 2006 to 2018
Secondary outcomes:
measure: Quality of survival
timeFrame: from 2006 to 2018
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05922358: Phase II Study of Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors
Official title: Observation of Oxaliplatin Hypersensitivity and Neurotoxicity in GI Tract, and Reuse of Oxaliplatin Hypersensitivity in Gastrointestinal Tumors: A Prospective, Open-Label, Multicenter, Phase II Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Tumors
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.

Detailed description: The incidence of oxaliplatin allergy reactions is between 12-15%, while the incidence of severe (grade 3-4) allergic reactions is between 0.5-2%. The purpose of this study is to prospectively investigate the incidence of oxaliplatin allergy and neurotoxicity, and to evaluate the use of effective anti-allergic and desensitization therapies to enable patients who are already allergic to oxaliplatin to complete their prescribed doses smoothly.

Patients with GI receiving oxaliplatin-containing regimens were prospectively observed, and patients with oxaliplatin grade I-III hypersensitivity reactions judged by clinicians based on clinical symptoms and signs entered the oxaliplatin reuse study . For patients with grade I-III oxaliplatin allergy, oxaliplatin skin test with 3 concentration gradients (0.01 mg/ml, 0.1 mg/ml and 5 mg/ml) was performed, and 5% glucose Water served as a negative control. 15-20 minutes to read test results. If the largest diameter of the rash was greater than 3 mm of the negative control, it was judged as a positive result. Afterwards, interventions were performed in different ways according to the grade of oxaliplatin allergic reaction.

Eligibility criteria: Inclusion Criteria:

1. Patients who plan to receive oxaliplatin treatment;
2. Male or female aged 18-75 year;
3. ECOG PS 0-2;
4. The expected survival time is more than 3 months;
5. Capable and willing to accept survey patients

Exclusion Criteria:

1.Patients who were not suitable for the enrollment of this study judged by the investigator

Primary outcomes:
measure: Completion rate of 3 cycles of re-chemotherapy with oxaliplatin
timeFrame: 2 years
Secondary outcomes:
measure: Concordance rate between oxaliplatin skin test results and clinicians' judgment
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04645758: A Study to Analyse the Immediate Effect of Dry Needling and Extra Corporeal Shock Wave Therapy on Hand Grip Strength
Official title: The Immediate Effects of Dry Needling and Extra Corporeal Shockwave Therapy on Hand Grip Strength.A Randomised Controlled Trail.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Weakness Condition
Keywords: Dry needling
Extra corporeal Shockwave therapy
Hand Grip Strength
Post 1 hour
Lead sponsor: Comprehensive Rehabilitation Centre, Medina, Saudi Arabia
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 27
Sex: MALE
Minimum age (years): 21
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to two groups in parallel for the duration of the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: An argument to analyse the Immediate effect of dry needling or extra corporeal shock wave therapy on hand grip strength in normal healthy individuals with a hypothesis of dry needling or shock wave on forearm muscles have influence on the hand grip strength.

Detailed description: After written consent obtained from all the participants randomization and allocation will be done with sealed non transparent envelopes and participants will be assign to two groups Dry needling(DN) and Extra corporeal shock wave therapy (ESWT).Pre and post data of hand grip strength measured with Jamar hand dynamometer.Post data shall be collected precisely after 1 hr of intervention from both groups.

Eligibility criteria: Inclusion Criteria:

* No pain on the visual analog scoring scale of 100 mm scale,
* Muscle power of 4+ on oxford manual muscle testing of forearm and wrist extrinsic and intrinsic muscles
* Full range of motion in all dominant upper extremity joints.

Exclusion Criteria:

* History of previous fractures of the dominant upper extremity,
* Teno-synovitis of flexor tendons ,
* Dequervains synovitis,
* Left hand dominance.

Primary outcomes:
measure: Hand Grip Strength
timeFrame: Post 1 hours of Intervention in both groups
Secondary outcomes:
Other outcomes:
Locations:
city: Medina
country: Saudi Arabia
facility: Comprehensive Rehabilitation Centre
Study officials:
affiliation: Comprehensive rehabilitation centre, Medina Al Munawwarah, Saudi Arabia.
name: Rayan M Al-Fadani, BPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Taibah University of Medical Rehabilitation Sciences
name: Abdullah M Al-Shenqiti, PhD,PT
role: STUDY_DIRECTOR
affiliation: Taibah University of Medical Rehabilitation Sciences
name: Tarek M El-Gohary, PhD,PT
role: STUDY_CHAIR
References:
Clinical trial NCT01987258: The Acute Effect of Interval-walking
Official title: The Acute Effect of Interval-walking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Glycemic control
excess post-exercise oxygen consumption
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Four months of interval walking training (IWT) is superior to energy-expenditure matched continuous walking training (CWT) with regards to weight loss and improvements in glycemic control. The reason for this is unclear. One potential explanation for the differential outcome in weight loss is excess post-exercise oxygen consumption (EPOC), which is defined as the elevated oxygen consumption measured during the hours following an exercise bout. A large EPOC means greater energy expenditure which, if energy intake does not change, leads to a greater weight loss. This weight loss may subsequently improve glycemic control

* Aim 1: To assess the effect of an acute bout of IWT vs. an acute bout of CWT on glycemic control in type 2 diabetics and to assess mechanisms responsible for differences (if any). It is hypothesised that IWT will be more advantageous for improving glycemic control.
* Aim 2: To examine the effect of an acute bout of IWT vs. an acute bout of CWT on EPOC. It is hypothesised that IWT will produce an EPOC of larger magnitude than CWT.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus, type 2

Exclusion Criteria:

* Smoking
* Pregnancy
* insulin dependence
* Contraindication to physical activity (as judged by medical history and screening)
* Evidence of thyroid, liver, lung, kidney or heart disease

Primary outcomes:
measure: Glycemic control
timeFrame: Will be assessed immediately after the intervention using a mixed meal tolerance test (duration: 5 hours) followed by continuous glucose monitoring (duration: 48 hours).
Secondary outcomes:
measure: Excess post-exercise oxygen consumption (EPOC)
timeFrame: Will be assessed immediately after the intervention using a ventilated hood (duration: 5 hours).
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641
Study officials:
affiliation: Centre of Inflammation and Metabolism (CIM), Rigshospitalet, Tagensvej 20, section M7641, DK-2100 Copenhagen, Denmark
name: Kristian Karstoft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karstoft K, Christensen CS, Pedersen BK, Solomon TP. The acute effects of interval- Vs continuous-walking exercise on glycemic control in subjects with type 2 diabetes: a crossover, controlled study. J Clin Endocrinol Metab. 2014 Sep;99(9):3334-42. doi: 10.1210/jc.2014-1837. Epub 2014 Jun 6.