louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02088567: Amniotic Membrane in Total Knee Replacements to Reduce Scarring
Official title: A Prospective Randomized Clinical Trial Using Dehydrated Human Amnion/Chorion Membrane (dHACM) in Total Knee Replacement Patients to Reduce Post-operative Scarring.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scarring
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in total knee replacement patients.


Eligibility criteria: Inclusion Criteria:

1. Are adults ages 18 or older.
2. Are diagnosed with advanced osteoarthritis as determined by clinical exam and necessitate total knee replacement.
3. Have a willingness to comply with follow-up examination.
4. Have ability to give full written consent.

Exclusion Criteria:

1. Has had a previous total or partial joint replacement performed at the same site
2. Has a planned bilateral procedure at this time. Bilateral patients can be enrolled if the procedures are staged.
3. Has signs or symptoms of any other disease which could result in allograft failure, or has experienced allograft failure in the past.
4. Has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening.
5. Is pregnant or may become pregnant during the study.
6. Is a prisoner.
7. Has any condition(s) which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment.
8. Is currently taking medications which could affect allograft incorporation (supervising physician's discretion).
9. Is confined to bed or a wheelchair.
10. Has clinical signs and symptoms of local infection at the site.
11. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
12. Has current diagnosis of cancer at the site.
13. Has had prior radiation therapy treatment at the site.
14. Is currently taking anticoagulant therapy.
15. Is unable to sign or understand informed consent.
16. Has a history of drug or alcohol abuse within last 12 months.
17. Is allergic to Aminoglycoside antibiotics (such as gentamicin and/or streptomycin).

Primary outcomes:
measure: Increased range of motion between both groups as measured by goniometer
timeFrame: 6 weeks
Secondary outcomes:
measure: Incidence of need for manual manipulation of affected knee
timeFrame: 6 weeks
Other outcomes:
measure: Increased Quality of Life as assessed by WOMAC and SF-36
timeFrame: 6 weeks
Locations:
city: Decatur
country: United States
facility: Georgia Knee and Sports Medicine
state: Georgia
Study officials:
affiliation: Georgia Knee and Sports Medicine
name: Maurice Jove, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02082067: Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome
Official title: Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2014-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.


Eligibility criteria: Inclusion Criteria:

* patients undergoing total knee arthroplasty

Exclusion Criteria:

* diabetes
* neurological disorders
* coagulation disorders
* rheumatoid arthritis
* chronic opioids therapy
* allergy to local anesthetic

Primary outcomes:
measure: Up and Go test
timeFrame: 5th postoperative day
Secondary outcomes:
measure: VAS score
timeFrame: up to POD5
measure: Morphine request
timeFrame: up to POD5
measure: Range of motion
timeFrame: 5th postoperative day
measure: Falling risk
timeFrame: 5th postoperative day
measure: Quadriceps strength
timeFrame: 5th postoperative day
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto ortopedico Gaetano Pini
Study officials:
affiliation: ASST Gaetano Pini-CTO
name: Gianluca Cappelleri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04132167: Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis
Official title: Supervised Perturbation Training Results in Changes in Balance and Falling in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Rehabilitation
Multiple sclerosis
Tailored interventions
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical exercise can prevent falls, certain types of exercise may be more effective. Perturbation-based balance training is a novel intervention involving repeated postural perturbations aiming to improve control of rapid balance reactions. The purpose of this study was to estimate the effect of perturbation- based balance training on falls and balance in daily life.Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.

Detailed description: Thirty patients with multiple sclerosis (PwMS) will assess with regard to dynamic balance, walking and falling. Patients randomly will allocate to a personalized (PRG) or traditional (TRG) rehabilitation group.

Eligibility criteria: Inclusion Criteria:

* An age older than 18 years
* Stable phase of the disease without relapses or worsening in the last three months
* Referring fear of falling or a history of falls (at least one fall in the last year).
* Individuals with a high level of balance.

Exclusion Criteria:

* Psychiatric disorders
* Blurred vision
* Severe cognitive impairment
* Severely impaired upright postural control or limited participation in a rehabilitation program
* Cardiovascular and respiratory disorders.

Primary outcomes:
measure: dynamic balance
timeFrame: 6 week
measure: walking
timeFrame: 6 week
measure: walking
timeFrame: 6 week
measure: falling
timeFrame: 6 week
measure: fear of falling
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Hatice Yakut
Study officials:
References:
Clinical trial NCT01112540: Morphine in Acute Abdominal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominal Pain
Keywords: to evaluate the anal. efficacy of IV morph. vs. place. for elderly presenting to the ED with UAP and determine if it has an impact on diag. accu. and phy. exam
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2010-04-28
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT

Brief summary: The investigators primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group. After follow up information was obtained and patients data were recorded on the SPSS data chart, two blinded coauthors (general surgeon and emergency physician) determined the clinically important diagnostic accuracy and change in physical examination. They firstly defined clinically important diagnostic errors, as any disagreement between the preliminary and final diagnosis that might be expected to have adverse effect on the patient's general status. If coauthors decided an instance of diagnostic error as clinically important, this was coded "diagnostic discordance" for statistical analysis. While the preliminary diagnosis was determined as accurate or not different from the final diagnosis, this was coded "diagnostic accuracy" for statistical analysis. Secondary outcome measures included the need for rescue drugs at 30 minutes, the presence of at least one adverse event, demographic features and final diagnosis of the patients.


Eligibility criteria: Inclusion Criteria:

* Elderly (65 years or older) patients with non-traumatic UAP of less than 48 hours' duration were included in the study. Participants were required to have a UAP and report either "mild" or greater pain intensity on a four-point verbal rating scale (VRS) or at least 20 mm on a 100 mm visual analogue scale (VAS).

Exclusion Criteria:

* Exclusion criteria included known allergy or contraindication to morphine, or any opioid analgesic
* Hemodynamic instability (systolic blood pressure less than 100 mm-Hg)
* Use of any analgesic within 6 hours before ED presentation
* Patients refused to participate to the study
* Incooperated to the VAS
* Isolated flank pain or previous study enrollment
* Patients with known renal, pulmonary, cardiac or hepatic failure were also excluded.

Primary outcomes:
measure: Our primary outcome measure was the clinically important change in diagnostic accuracy and physical examination in the morphine vs. placebo group.
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References:
Clinical trial NCT04726540: A Seven-year Follow-up Study of Patient Satisfaction With Three-Implant-Retained Mandibular Overdentures
Official title: A Seven-year Follow-up Study of Patient Satisfaction With Three-Implant-Retained Mandibular Overdentures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Satisfaction Using Implant Retained Overdentures
Keywords: patient satisfaction,implant-retained overdenture,complete denture
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 30
Sex: MALE
Minimum age (years): 58
Maximum age (years): 62
Standard ages: ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients must have been wearing dentures on a regular basis, have been edentulous for a minimum of 3-years, and are capable of reading and writing.

Brief summary: Purpose: This study aimed to compare patients' satisfaction with mandibular overdentures retained by three-splinted implants and conventional complete dentures during a seven-year follow-up period. Materials and Methods: Thirty edentulous male patients (mean age: 60 years) were carefully selected and divided into two equal groups. All patients received a new set of complete dentures. (Group I) patients received three implants in the anterior mandible and were connected after three months with bars, clips and loaded. (Group II) patients' received conventional complete dentures. Patients' satisfaction was recorded for both groups at three weeks (baseline) and after 1, 3, 5 and 7 years. Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction. Results: satisfaction scores of Group I patients was found to be statistically significantly higher than that of Group II patients (p \< .05) at 3, 5 and 7 years follow-up, meanwhile no statistically significant difference was found at baseline or after 12 months. Conclusions: The long-term results suggest that three implants-retained mandibular overdenture with a clip-bar attachment appears to be a successful rehabilitation strategy which is superior to conventional dentures for patients with advanced ridge resorption.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria stipulated that patients must have been wearing dentures on a regular basis, have been edentulous for a minimum of 3-years, and are capable of reading and writing.

Exclusion Criteria:

* insufficient bone volume to install three 13mm. interforaminal implants (Group I), insufficient interarch space. Patients with diabetes, osteoporosis, smokers, psychological problems of removable denture acceptance, gag reflex, absence of a maxillary complete denture and medical or physical considerations that would seriously affect the surgical procedure (Group I) or the follow-up period were also excluded

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Seven years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04709640: Pilot Study to Improve Medication Management in Older Adults
Official title: Tailored, Intervention to Improve Medication Management in Community-Dwelling Older Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 4
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study seeks to determine the acceptability and feasibility of the intervention to improve ability of older adults to management medication with community dwelling older adults.


Eligibility criteria: Inclusion Criteria:

* age 65 years or older
* taking four or more prescription medications
* self-reported decreased medication adherence.

Exclusion Criteria:

* significant cognitive impairment as indicated by a score of 10 or more on the Short Blessed Test
* Resides in an institutionalized setting.

Primary outcomes:
measure: In-Home Medication Management Evaluation (HOME-Rx)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References:
Clinical trial NCT05739240: Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction
Official title: Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction: a Randomized, Single-blinded, Monocentric Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Radius Fracture
3D Printing
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 80
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: The investigators aim to evaluate the effect of a preoperative 3D printed Model (3PAS) of distal intraarticular radius fractures on quality of fracture reduction. Surgical procedure is equal in the 3PAS and in the conventional group. To evaluate the quality of fracture reduction each patient receives a postoperative CAT-scan.


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years
* Surgery criteria fulfilled
* Informed consent
* Intra-articular Fracture of the distal radius (AO 23-B and 23-C) (also including Avulsion of the processus styloideus ulnae AO/OTA 2U3A1.1) in preoperative CAT-Scan

Exclusion Criteria:

* Patient does not want a surgical treatment
* Patient does not want to participate
* Positive history for surgery due to injury of the hurt wrist beforehand
* Positive history for surgery due to injury of the opposite wrist beforehand
* Additional injuries to the hand and forearm (except distal ulna fracture AO 2U3A1.1)
* Pregnancy
* Vulnerable people
* Distal ulna fracture (except AO 2U3A1.1)
* Extraarticular radius fracture (AO 23-A)
* Concomitant injuries which interfere with the planned aftercare (intubated for a long time, additional elbow or shoulder fracture)

Primary outcomes:
measure: Articular step-off of the distal radius joint surface in the postop CAT-scan
timeFrame: 6 weeks
measure: Articular gap of the distal radius joint surface in the postop CAT-scan
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06510140: Interest in Combining Intraoperative ElectroEncephaloGram (EEG) With Assessment of Frailty to Predict Postoperative Delirium in Patients Aged >75 Years Undergoing Major Non-cardiac Surgery
Official title: Interest in Combining Intraoperative ElectroEncephaloGram (EEG) With Assessment of Frailty to Predict Postoperative Delirium in Patients Aged >75 Years Undergoing Major Non-cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-operative Delirium
Keywords: Post-operative delirium
Frailty
General Anesthesia
Electroencephalogram
Electroencephalography
Older patients
Clinical frailty scale
Major non-cardiac surgery
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 55
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients older than 75 yo, undergoing a major non-cardiac surgery under general anesthesia will be included.

Brief summary: Post-operative delirium (POD) is known to be independently associated with pre-operative frailty, pre-operative cognitive status and per-operative ElectroEncephaloGram (EEG). However, no study has focused on the impact of these pre- and peri-operative outcomes on the prediction of Post-operative delirium (POD). Therefore, this study has been designed to assess the performance of a new score that includes pre-operative frailty, and per-operative ElectroEncephaloGram (EEG) in predicting post-operative delirium.


Eligibility criteria: Inclusion Criteria:

* Patients of 75 yo or more undergoing a major non-cardiac surgery

Exclusion Criteria:

* Patients of less than 75 yo
* Cardiac surgery
* Minor surgery
* Opposition to the study protocol
* Presence of a delirium prior to the surgery

Primary outcomes:
measure: Onset of an early Post-operative delirium (POD)
timeFrame: Hour : 48
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Nory ELHADJENE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02874040: Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)
Official title: Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uveal Melanoma
Melanoma, Uveal
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation


Eligibility criteria: Inclusion Criteria:

* Tumor of 7 mm of thickness or more
* Patients treated by proton beam therapy
* Patients aged at least 18 years
* Patients clearly informed of the study, having received the letter of information and signed the consent

Exclusion Criteria:

* Massive extrascleral extension posterior to the equator
* Patients with metastasis at diagnosis.
* Patients with glaucoma before the radiation therapy
* Patients with opaque media preventing transpupillary thermotherapy
* Patients for whom follow up will be difficult due to geographical, social or psychological reasons

Primary outcomes:
measure: Post-treatment complication incidence.
timeFrame: 3 years
Secondary outcomes:
measure: Measure of tumor scar thickness
timeFrame: 3 years
measure: Toxicity and side effects evaluation according to NCI-CTCAE v4.0 scale
timeFrame: 3 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Nathalie CASSOUX, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06740240: 68Ga-FAPI-Biotin PET/CT in Patients With Various Types of Cancer
Official title: 68Ga-FAPI-Biotin PET/CT in Patients With Various Types of Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Tumor
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: As a new dual targeting PET radiotracer, 68Ga-FAPI-Biotin is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAPI-Biotin in patients with various types of cancer and compared them with the results of 68Ga-FAPI or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAPI.

Detailed description: Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. Biotin is overexpressed in various tumor cells and underexpressed in normal cells. We assume that expanding molecular probes targeting FAPI and biotin with dual targets to enhance the targeting ability of the tracer, improve the sensitivity and specificity of tumor lesion detection. 68Ga-FAPI-Biotin is a novel dual targeting tracer. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAPI-Biotin, and performed a head-to-head comparison with 68Ga-FAPI or 18F-FDG PET/CT scans in patients with various cancers.

Eligibility criteria: Inclusion Criteria:

Various solid tumors with available histopathological findings; Signed informed consent.

Exclusion Criteria:

Pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.

Primary outcomes:
measure: Diagnostic value
timeFrame: through study completion, an average of 3 months.
Secondary outcomes:
measure: SUV of tumors
timeFrame: through study completion, an average of 3 months.
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: