louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01440348: Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
Official title: Simultaneous Multiple Cruciate Ligament Reconstructions Using a Single Achilles Allograft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rupture of Posterior Cruciate Ligament
Rupture of Anterior Cruciate Ligament
Keywords: Achilles allograft
cruciate ligament
reconstruction
Lead sponsor: National Police Hospital
Sponsor class: OTHER_GOV
First posted: 2011-09-26
Enrollment: 51
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study introduce cases of simultaneous multiple cruciate ligament reconstructions with a single free tendon Achilles allograft using new technique.


Eligibility criteria: Inclusion Criteria:

* subjects who had any concomitant meniscus or cartilage injuries

Exclusion Criteria:

* subjects who required reconstruction of medial or lateral collateral ligament, or posterolateral ligament complex
* subject who wanted reconstruction with autograft
* subject who denied participation in this study
* subject who would meet the national reimbursement criteria

Primary outcomes:
measure: circumference and length of the Achilles allograft
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Police Hospital
Study officials:
affiliation: National Police Hospital
name: Jung Ho Noh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03389048: Performance Assessment Of The PMD-200 In Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
Official title: Performance Assessment of the PMD-200 (Physiological Monitor Device), a Novel Pain Monitor, in Subjects With Degenerative Lumbar Spine Disease Who Requires Surgical Procedure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Degenerative Diseases, Nervous System
Lead sponsor: Medasense Biometrics Ltd
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Performance assessment of the PMD-200, a novel pain monitor, in subjects with degenerative lumbar spine disease who requires surgical procedure

Detailed description: The proposed study is design to further demonstrates the capability of the Nociception Level, (NoL) Index in identify and discriminate between painful event and non-painful period following pain stimulus of Straight Leg Raising (SLR) test in patients with degenerative lumbar spine disease. This feasibility study may provide first indication for a validation method that will be able to evaluate the outcome of a surgical procedure within the degenerative lumbar spine patient. Currently, there is lack of understanding of long-term outcomes after such surgeries.

In this study, the investigators plan to demonstrate that the NoL Index may serve as an indicator to the surgical procedure outcome. It will compare the objective measurement of the NoL to the patient Visual Analogue Scale (VAS) score and disability questionnaire that will characterize the subject pain perception prior and following the surgical procedure.

Eligibility criteria: Inclusion Criteria:

* Age over 18 and less than 65 (18 \< Age \< 65).
* The subject suffer from unilateral degenerative lumbar spine disease
* The subject suffer from leg pain only in one leg, while no pain in the other leg.
* The subject was hospitalized in the neurosurgery department of the hospital in order to undergoes spinal surgery due to the above disease
* A signed Informed Consent Form (ICF) has been obtain from the subject

Exclusion Criteria:

* The subject has a bi-lateral degenerative lumbar spine disease
* The subject is pregnant

Primary outcomes:
measure: discrimination between nonpainful period to painful period
timeFrame: Through study completion, about one year
Secondary outcomes:
measure: Correlates with changes in pain levels
timeFrame: Through study completion, about one year
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Galil Medical Center
Study officials:
affiliation: Dept. of Neurosurgery Galilee Medical Center, Nahariya, Israel
name: Jean Soustiel, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03494348: RSA Study of Persona TKA With CR vs MC Polyethylene
Official title: Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Radiostereometry (RSA)
Total Knee Arthroplasty
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2018-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.

We plan also to do a 5 year follow-up of the patients with RSA and PROMS.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee necessitating knee replacement
* ASA I-III
* BMI 18 - 35

Exclusion Criteria:

* Joint sepsis in history
* immunosuppresive drugs last 5 years
* Rheumatoid arthritis
* Severe osteoporosis or other metabolic bone diseases
* Neuromuscular diseases
* Personal disorders suspected of limiting rehab and completion of the trial period
* Previous osteotomy of affected limb
* Intra-articular knee fracture of affected limb
* Peroperative fracture
* Severe deformity of affected joint in need of augmentation or excessive release
* Obvious need for more constrained knee than CR

Primary outcomes:
measure: Radiostereometry (RSA)
timeFrame: First postoperative day, 3 months, 1 year, 2 years and 5 years
Secondary outcomes:
measure: Computer Tomography (CT)
timeFrame: Preoperatively and 3 months postoperatively
measure: Conventional radiography
timeFrame: Preoperatively and 3 months postoperatively
measure: General health questionnaire
timeFrame: Preoperatively, 1, 2 and 5 years postoperatively
measure: Knee specific health questionnaire
timeFrame: Preoperatively, 1, 2 and 5 years postoperatively
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Orthopedics, Skane University Hospital, Lund University
Study officials:
affiliation: Dept of Orthopedics, Skåne University Hospital
name: Gunnar Flivik, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03623048: Effect of Natural Antibacterial Mouthwash on Taste, Salivary pH and Bacteria in High Caries Risk pt
Official title: Effect of Propolis and Pomegranate Extract Mouthwash on Taste Alteration, Salivary pH and Antibacterial Activity in High Caries Risk Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Decay, Dental
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 80
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the effect of propolis extract mouthwash and pomegranate extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.

Detailed description: This study will be carried out to evaluate and compare the effect of propolis extract mouthwash and pomegranate (botanical name: Punica granatum) extract mouthwash on taste alteration, salivary pH and antibacterial activity against streptococcus mutans in high caries risk patients.

Thats by taking unstimulated saliva samples at the morning before using the mouthwash, then taking another one after using the mouthwash and finally after 7 days, to make a bacterial culture and measure the salivary pH by a digital pH meter and evaluate taste changes by a questionnaire.

Eligibility criteria: Inclusion Criteria:

* High caries risk patients defined according to American Dental Association (ADA)
* Systematically healthy
* Not taking any medication interfering with saliva secretion
* Subjects who signed informed consent
* Age range from 17-50 years

Exclusion Criteria:

* Subjects suffering from any medical or systematic disease
* Smokers
* Pregnant females
* Allergy to any of the mouthwash ingredients
* Patients older than 50 years

Primary outcomes:
measure: Taste alteration
timeFrame: One week
Secondary outcomes:
measure: Salivary pH
timeFrame: one week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04471948: The Safety and Efficacy of 1064-nm Picosecond Laser With Microlens Array for Pore Tightening; a Pilot Study
Official title: The Safety and Efficacy of 1064-nm Picosecond Laser 1064 With Microlens Array for Pore Tightening; a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enlarged Pores
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and efficacy of 1064-nm Picosecond laser 1064 With Microlens Array for Pore tightening.

Detailed description: The Safety and Efficacy of Picosecond laser 1064 Nanometers With Microlens Array for Pore tightening; a Pilot Study Primary outcome : pore size Secondary outcome : side effect, patient satisfaction, global evaluation the patient recieved laser treament once a month for 3 months and then follow up after last treatment at 1, 3 ,6 month

Enlarged facial pores is one of the skin signs in photoaging. There are 3 major clinical causes of enlarged facial pores: highs sebum excretion, decreased elasticity around pores and increased hair follicle volume. Possible causative factors of enlarged facial pores include many exogenous and endogenous factors include genetic predisposition, seborrhea and chronic ultraviolet light exposure. Picosecond laser are new device which has been used in skin rejuvenation. The main mechanism of action is laser induced optical breakdown (LIOB).

Eligibility criteria: Inclusion Criteria:

* Both male and female age 25-40 years
* No underlying disease

Exclusion Criteria:

* History of retinoid or other keratolytic drugs used within 6 months before enrolled
* History of keloid
* photosensitivity
* Immunocompromised host

Primary outcomes:
measure: Change in pore size by Antera 3D image
timeFrame: change from baseline in pore size at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: woraphong Manuskiatti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04009148: Cascade Testing in Families With Newly Diagnosed Hereditary Breast and Ovarian Cancer Syndrome
Official title: Cascade Testing in Families With Newly Diagnosed Hereditary Breast and Ovarian Cancer Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: BRCA-Mutated Ovarian Carcinoma
BRIP1 Gene Mutation
MSH2 A636P
MLH1 Gene Mutation
MSH6 Gene Mutation
PMS2 Gene Mutation
EPCAM
RAD51C Gene Mutation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: First or second degree faamily member with any of the following mutations: BRCA mutation, SH6, PMS2, EPCAM, RAD51C, RAD51D mutations

Brief summary: Identification of BRCA mutations in ovarian cancer patients may help guide cancer therapies, prognosis, post-operative screening, and other preventative treatments beyond the initial diagnosis. Likewise, genetic testing of ovarian cancer patients for these germline mutations provides invaluable information for families regarding cancer risk, genetic testing, and subsequently indication for risk-reducing surgery. Cascade testing provides a unique opportunity to identify carriers of a deleterious BRCA mutation which can allow for surgical and chemoprevention of prevention of ovarian cancer. There is currently no literature on the rates of referral for the family members.

Detailed description: The objective of this study is to perform a pilot study, offering referral to a genetic counseling and genetic testing for family members of a probands known to have a mutation in BRCA1 or BRCA2. In addition to BRCA1 and BRCA2, the NCCN suggests consideration of risk-reducing surgery for mutations in BRIP1, MSH2, MLH1, MSH6, PMS2, EPCAM, RAD51C, RAD51D, investigators will include these subjects as well in the study.

Eligibility criteria: Inclusion Criteria:

* All subjects must have a diagnosis of epithelial ovarian cancer, Fallopian tube caner or primary peritoneal cancer with a known pathogenic genetic mutation.
* All subjects must agree to participate.
* All subjects must have first or second degree relatives who have not been diagnosed with the same genetic mutation.
* A previous diagnosis of cancer in the subject's first or second degree relative is allowed.

Exclusion Criteria:

* Subjects whose first and/or second degree relatives have already been tested with the subject's known mutations, and no other viable family members are available for testing.

Primary outcomes:
measure: Establishing the CASCADE Cohort
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Bhavana Pothuri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04999748: Consumer Knowledge, Attitude, and Behavior Towards Aging Skin
Official title: Consumer Knowledge, Attitude, and Behavior Towards Aging Skin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatology
Keywords: Skin care, Anti-aging
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 1434
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Open to male and female English-speaking adults(18 years or older)

Brief summary: We will conduct a cross-sectional survey from adults 18 years of age and older to examine consumer knowledge, attitudes and behavior towards aging skin.

Detailed description: We will perform a cross-sectional survey study to understand the significance of age-related skin changes to consumers. We will recruit participants through ResearchMatch (a national free and secure online tool) and collect the following data:

Demographic information, including age, gender, race/ethnicity, geographic location, and yearly household income

* How do participants feel towards their own skin and age-related skin changes?
* Which aging-related skin changes are the most significant?
* What factors affect how participants feel towards their skin?
* What role do age-related skin changes play in other aspects of the participants' lives, such as their social and work life?
* What treatments are participants currently seeking, and what are their goals for these treatments?
* How much do they prioritize these treatments?
* What else are they hoping to do?

Using the demographic information, we will also analyze whether there are differences with:

* Age
* Gender identity
* Racial/ethnic identity
* Marital status
* Geographic location
* Yearly household income

Eligibility criteria: Inclusion Criteria:

* The study will include English-speaking adults (18 years or older) who voluntarily consent to participate in the survey.

Exclusion Criteria:

* Participants under the age of 18 and non-English speaking participants.

Primary outcomes:
measure: Frequency (percentage) of participants with aging-related skin concerns
timeFrame: 2 months
measure: Frequency (percentage) of participants with social and work life impact of age-related skin changes
timeFrame: 2 months
measure: Measure (count) the type of treatments participants are currently seeking for aging skin concerns
timeFrame: 2 months
Secondary outcomes:
measure: Summarize (mean/standard deviations) demographic information
timeFrame: 2 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Fienberg School of Medicine Department of Dermatology
state: Illinois
Study officials:
References:
Clinical trial NCT04042948: Clinical Effect of Preventive Use of Tylenol on Fever After Removal of Drainage Tube in Lumbar Fusion Surgery
Official title: Randomized Controlled Study of Fever Probability, Risk Factors and Preventive Use of Non-steroidal Anti-inflammatory Drugs on Fever After Removal of Drainage Tube After Lumbar Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lumbar Disc Herniation
Lumbar Radiculopathy
Keywords: lumbar spinal stenosis
lumbar fusion surgery
drainage tube
removal of drainage tube
fever
prevention of fever
preventive use of non-steroidal inflammatory drug
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the influence of Non-steroidal Anti-inflammatory Drugs on preventing fever after the removal of drainage tube in the patients who suffered lumbar fusion surgery, if the outcome turn out positive, the preventive use of non-steroidal anti-inflammatory drugs could decrease the possibility of fever happening when we remove the tube.


Eligibility criteria: Inclusion Criteria:

* adult patient
* diagnosis of lumbar spinal stenosis
* perform decompression and fusion surgery and lay a drainage tube
* understand the test and could sign the name

Exclusion Criteria:

* beside the inclusion criteria

Primary outcomes:
measure: the rate of fever after the removal of drainage tube
timeFrame: 24 hours
Secondary outcomes:
measure: the level of WBC
timeFrame: 24 hours
measure: the level of CRP
timeFrame: 24 hours
measure: the level of ESR
timeFrame: 24 hours
measure: the temperature
timeFrame: 24 hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Haidian
Study officials:
affiliation: Peking University Third Hospital, Beijing, China
name: Yun Tian, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05159648: A Study to Evaluate ICU Simulation Experience in the Cardiothoracic Surgical Population to Reduce Post-operative Delirium
Official title: Pre-operative, Multi-sensory ICU Simulation Experience to Reduce Post-operative Delirium in the Cardiothoracic Surgical Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Operative Delirium
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with normal neurologic function scheduled for elective cardiothoracic surgery.

Brief summary: The purpose of this study is to evaluate the effect of a pre-ICU admission virtual reality ICU simulation on post-operative delirium in the elective cardiothoracic surgical population while in the intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Baseline normal neurological function pre-operatively.
* Planned use of mechanical ventilator with endotracheal tube post-operatively after planned cardiothoracic surgical procedure.

Exclusion Criteria:

* Chronic dementia, Alzheimer's disease, or other chronic neurological disease (i.e., Bi-Polar).
* Chronic use of neurological altering medications such as benzodiazepines, psychotropic, anti-depressants, anxiolytics.
* Patient undergoing emergent surgery.
* Use of post-operative cardiopulmonary support devices such as ECMO (extracorporeal membrane oxygenation), intra-aortic balloon pump, total artificial heart, or other similar device.

Primary outcomes:
measure: Confusion Assessment Method for the ICU (CAM-ICU)
timeFrame: Once, during ICU admission within 24 hours of ICU admission.
measure: Subjective Experiential Outcome After ICU Simulation
timeFrame: Once, immediately following the virtual reality ICU simulation session.
measure: Subjective Experiential Outcome After ICU Admission
timeFrame: Once, up to 3 days after transfer out of the Intensive Care Unit.
Secondary outcomes:
measure: Duration of ICU Admission
timeFrame: During ICU admission; average 2 days
measure: Duration of Intravenous Sedation in the ICU
timeFrame: During ICU admission; average 2 days
measure: Duration of Mechanical Ventilation in the ICU
timeFrame: During ICU admission; average 2 days
measure: Use of Anti-psychotic Medications
timeFrame: Throughout ICU admission; average of 5 days
measure: Cardiopulmonary Bypass
timeFrame: During OR case; average 12 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robert Anderson, APRN, CNP, DNP
role: PRINCIPAL_INVESTIGATOR
References: