louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03148977: Evaluating MMPs in Burns
Official title: Evaluating a Point-of-Care, Quantitative Matrix Metalloproteinase Assay as a Predictor of Successful Graft Take in Patients Undergoing Cutaneous Auto Grafting for Acute Burn Injury- A Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Burns
Thermal Burn
Thermal Injury
Keywords: Matrix Metalloproteinases
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 98
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult burn patients admitted

Brief summary: The objective of this study is to determine whether our chemical assay can be used to reliably predict graft take or failure in patients undergoing autologous skin grafting for treatment of acute burn injury.

Detailed description: This is an observational pilot study of patients treated at UF Health Shands Burn Center adult service. This is a study to determine the predictive value of quantifying concentrations of specific MMPs. Coupling this with a specialized collection sample collection system and a calibrated fluorimetry allows for the rapid assessment of MMP concentrations. This assay has been validated as a predictor of failed wound healing in a published clinical study involving chronic open wounds.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Admitted with acute burns injuries (flame, contact or scald) requiring at least one surgical excision and grafting operation will be considered for inclusion
* Burn injury less than one week old

Exclusion Criteria:

* Electrical, chemical or cold-induced burn injury
* Total body surface area burn \>50 %
* Pre injury diagnosis of chronic renal insufficiency, liver failure, refusal to accept blood transfusion or withdrawal of care within three days of admission will also be exclusion criteria
* Patients not expected to survive
* Patients presenting with re-injury to previously burned and treated areas.
* Patients who present after receiving burn excision surgery out an outside facility for the current acute injury

Primary outcomes:
measure: Predictability of graft take
timeFrame: 2 years
Secondary outcomes:
measure: Wound healing
timeFrame: 2 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cancer Hospital
state: Florida
city: Gainesville
country: United States
facility: UF Health Shands at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Joshua S. Carson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weigelt MA, Lev-Tov HA, Tomic-Canic M, Lee WD, Williams R, Strasfeld D, Kirsner RS, Herman IM. Advanced Wound Diagnostics: Toward Transforming Wound Care into Precision Medicine. Adv Wound Care (New Rochelle). 2022 Jun;11(6):330-359. doi: 10.1089/wound.2020.1319. Epub 2021 Jul 21.
Clinical trial NCT01153477: Effectiveness of Enhanced Treatments for Drug Dependence
Official title: Effectiveness of an Enhanced Adaptive Continuing Care Model for Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2010-06-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this challenge grant is to conduct an initial test of a new, enhanced version of this protocol (telephone monitoring and counseling - enhanced, or TMAC-E), which has been modified to include the elements of our existing continuing care intervention plus patient-centered changes to boost patient involvement and community linkages. The investigators will recruit 150 cocaine dependent patients in publicly funded, community-based programs and randomize them to treatment as usual or the TMAC-E and follow them for 12 months.


Eligibility criteria: Inclusion Criteria:

* (1) qualify for a DSM-IV diagnosis of cocaine dependence, with some cocaine use in the prior 6 months;
* (2) be 18 to 75 years of age;
* (3) have no current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
* (4) have no acute medical problem requiring immediate inpatient treatment;
* (5) not be in methadone or other modes of Drug and Alcohol treatment, other than Intensive Outpatient Program;
* (6) be willing to be randomized and participate in research;
* (7) because of study follow-up requirements, subjects will be able to provide the name, verified telephone number, and address of at least one contact who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.

Exclusion Criteria:

* have a current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
* have acute medical problem requiring immediate inpatient treatment;
* are in methadone or other modes of DA treatment, other than IOP;
* or cannot provide names of people who can get messages to them for follow up, in the event we cannot locate the participant at their original address and number. Also, if they are court mandated to treatment or otherwise considered a prisoner, they will be ineligible for the study as we have not applied for Subpart C approval.

Primary outcomes:
measure: Time Line Follow Back
timeFrame: 3 month
measure: Time Line Follow Back
timeFrame: 6 month
measure: Time Line Follow Back
timeFrame: 9 month
measure: Time Line Follow Back
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01973777: A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A
Official title: A Pilot Study of Early Expulsion Rates of the IUB™ SCu380A Spherical Copper Intrauterine Contraceptive Device.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: intrauterine device, contraception
Lead sponsor: Wiebe, Ellen, M.D.
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: intrauterine contraceptive device IUB
Primary purpose: PREVENTION

Brief summary: The IUB (Intrauterine ball) is a copper releasing intrauterine contraceptive device consisting of copper beads on a flexible NiTinol wire. It was designed to reduce the pain and bleeding caused by traditional T-shaped copper IUDs and to reduce expulsions. In an initial pilot of 15 women, there were no complications during the 12 months. This observational pilot study of 50 women will determine that the early expulsion rate is not greater than 10% and that there is patient and physician acceptance, so that we can plan a larger randomized controlled trial for efficacy and safety.


Eligibility criteria: Inclusion Criteria:

* requesting non-hormonal intrauterine contraception
* able to return for ultrasound in 6-8 weeks

Exclusion Criteria:

* History of recent pelvic inflammatory disease
* Known anemia
* Dysfunctional uterine bleeding
* Malignancy or suspected malignant disease of female inner or outer genitalia
* Known intolerance or allergy to copper and/or copper IUDs
* Any other significant disease or condition that could interfere with the subject's ability to complete the protocol
* Pregnancy

Primary outcomes:
measure: Expulsion Rate
timeFrame: at 6-8 weeks
Secondary outcomes:
measure: Complication
timeFrame: 12 months
measure: Acceptability
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Willow Women's Clinic
state: British Columbia
Study officials:
References:
Clinical trial NCT06990477: Effect of EIT-guided PEEP On Clinical Outcomes in ARDS Patients: a Pilot Randomized Controlled Trial
Official title: Effect of EIT-guided PEEP On Clinical Outcomes in ARDS Patients With Higher Recuritability: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ARDS (Acute Respiratory Distress Syndrome)
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute respiratory syndrome distress (ARDS) is a clinical common syndrome with high mortality. Mechanical ventilation (MV) is the cornerstone of management of ARDS but can lead to ventilator-induced lung injury. Positive end-expiratory pressure (PEEP), as one of main component of MV, has been widely used in the clinical practice. However, the PEEP selection is still a difficult problem for moderate to severe ARDS patients. EIT, an imaging tool evaluating the regional ventilation distribution at the bedside, can achieve the individual PEEP selection for all mechanically ventilated patients. Our previous study found that moderate to severe ARDS patients with higher recruitability could benefit from EIT-guided PEEP. This article compared the effect of PEEP titrated guided by EIT with fraction of inspired oxygen (FiO2)-PEEP table on the clinical outcomes in patients with higher recruitability.


Eligibility criteria: Inclusion Criteria:

1. Age≥18 years
2. Moderate-to-severe ARDS, defined by the ARDS Definition Task Force in the Berlin definition (partial pressure of arterial oxygen \[PaO2\]:FiO2 ratio ≤200 mmHg with a PEEP ≥5 cmH2O)
3. Patients with tidal volume of 6 mL/Kg would require a driving pressure of ≥ 13 cmH2O and the percentage of collapse monitoring by EIT \>25%
4. Diagnosis of ARDS less than 72 hours

Exclusion Criteria:

1. Expected to be mechanically ventilated for less than 48 hours
2. Severe chronic respiratory diseases requiring long-term home oxygen therapy or noninvasive MV
3. Undrained pneumothorax or subcutaneous emphysema
4. Undergoing extracorporeal membrane oxygenation (ECMO) before enrollment
5. Contraindication to the use of EIT (pacemaker, automatic implantable cardioverter defibrillator, and implantable pumps)
6. Severe neuromuscular disease
7. Hemodynamic instability
8. Contraindications to hypercapnia, such as intracranial hypertension or acute coronary syndrome
9. Severe other organs dysfunction with a low expected survival (7 days) or palliative care
10. Solid organ or hematologic tumors with the expected survival time less than 30 days
11. Participating in other clinical trials within 30 days
12. Pregnancy
13. Refusal to sign the informed consent

Primary outcomes:
measure: 28-day mortality
timeFrame: mortality in Day 28
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06200077: Patient Outcomes of Staged Ridge-splitting Using Piezo-electric Surgery in Atrophic Posterior Mandible
Official title: Clinical Outcomes of Different Staged Ridge-Splitting Techniques Using Piezo-Electric Surgery in Atrophic Posterior Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Ridge Augmentation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 18
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the clinical and radiographic outcomes of different staged ridge-splitting techniques for management of severely resorbed lower jaws in the posterior region. The study is designed as a clinical trial, so that three different interventions would be compared for a conclusion highlighting the relative best of them.

Detailed description: In the context of the care of severely resorbed lower jaws in the posterior region, the purpose of this study is to evaluate the clinical and radiographic outcomes of several stepwise ridge-splitting procedures. The study is supposed to be a clinical trial, with the purpose of comparing three distinct therapies in order to get a result that highlights which of them is the most effective in comparison to the others.

Eligibility criteria: Inclusion Criteria:

* Patients were free from any relevant systemic diseases according to American society of Anesthesiologists classifications.
* Patients of single or multiple missing teeth in the posterior mandible.
* A ridge width of minimum 4mm and a 10 mm ridge height with 2mm minimum above Inferior Alveolar Nerve (IAN) were present in CBCT images.
* Absence of buccal concavities at the planned implant site.

Exclusion Criteria:

* History of any systemic diseases or medication that alters bone metabolism.
* Poor oral hygiene.
* Heavy smoker (more than 20 cigarettes/day) or alcoholic patients.
* Chemotherapy or radiation therapy to the head and neck region in the last 12 months prior to the proposed implant therapy.
* Patients currently on or with a history of bisphosphonate therapy.

Primary outcomes:
measure: Alveolar ridge width
timeFrame: immediately after implant placement, immediately after implant loading and six months after implant loading
Secondary outcomes:
measure: Implant stability
timeFrame: immediately after implant placement, immediately after implant loading and six months after implant loading
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University
state: Dakahlyia
Study officials:
affiliation: Faculty of Dentistry, Mansoura University
name: Mena Tamer, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu GH, Froum SJ, Alodadi A, Nose F, Yu YP, Suzuki T, Cho SC. A Three-Stage Split-Crest Technique: Case Series of Horizontal Ridge Augmentation in the Atrophic Posterior Mandible. Int J Periodontics Restorative Dent. 2018 July/August;38(4):565-573. doi: 10.11607/prd.2907. Epub 2018 Mar 13.
Clinical trial NCT03252054: Memory and Attention Disorders and Malnutrition in Hospital Setting
Official title: Prevalence of Memory and Attention Disorders and Malnutrition in Hospitalized Older Adults (Muistitoimintojen ja Tarkkaavaisuuden häiriöiden ja Vajaaravitsemuksen Yleisyys iäkkäillä Sairaalahoidossa Olevilla Potilailla [Finnish])
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Delirium
Cognitive Impairment
Malnutrition
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Coxa, Hospital for Joint Replacement
name: Tampere University
First posted: 2017-08-17
Enrollment: 151
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients born in 1946 or earlier hospitalized in somatic wards.

Brief summary: This is a cross-sectional observational study that investigates the prevalence of memory disorders, attention disorders (suggesting delirium), and malnutrition in hospitalized older adults (aged 70 years or over) in a tertiary care centre, using rapid screening toos (Six-item screener for memory disorders, Months of the Year Backwards Test for delirium, and NRS-2002 and Mini Nutritional Assessment Short Form for malnutrition).


Eligibility criteria: Inclusion Criteria:

* Hospitalized in Tampere University Hospital (excl. psyciatry, pediatrics, ICU)
* Able to communicate in Finnish

Exclusion Criteria:

* Unable to communicate because of unconciuousness, critical health status, or communication difficulties
* Having a (surgical) procedure at the time of data collection

Primary outcomes:
measure: Prevalence of memory disorders
timeFrame: day of recruitment
measure: Prevalence of attention disorders
timeFrame: day of recruitment
measure: Prevalence of malnutrition and risk of malnutrition
timeFrame: day of recruitment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: consultant
name: Esa Jämsen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05502354: CRP-guided Transanal Drainage Removal After Rectal Surgery
Official title: A Single Arm Study to Investigate the Safety and Efficacy of C Reactive Protein (CRP) Guided Transanal Drainage Tube (TDT) Removal for Anastomotic Leak (AL) Prevention Following Laparoscopic Anterior Resection for Rectal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Anastomotic Leak
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 250
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: PREVENTION

Brief summary: Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma


Eligibility criteria: Inclusion Criteria:

* age from 18 to 75 years old
* male and female
* primary rectal adenocarcinoma
* ASA I, II, or III
* laparoscopic LAR + DST
* with or without preoperative radio- or chemotherapy
* no distal metastasis
* no preoperative bowel obstruction
* no preventive ileostomy or colostomy
* patients and their families can understand and are willing to participate in this study and provide written informed consent

Exclusion Criteria:

* emergency operation
* preoperative abnormal liver function
* tatme or ISR procedure (healing process might differ from anterior resection)
* severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak
* severe perioperative infection unrelated to anastomotic leak
* patients with serious mental illness
* pregnant or breastfeeding women
* patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial

Primary outcomes:
measure: anastomotic rate
timeFrame: 30 days after surgery
Secondary outcomes:
measure: the grades of anastomotic leak
timeFrame: 30 days after surgery
measure: rates of diarrhea after transanal drainage tube removal
timeFrame: from transanal drainage tube removal to 30 days after surgery
measure: visual analogue scale to assess anal postoperative pain
timeFrame: from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
measure: transanal drainage tube-related adverse events
timeFrame: from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Kexin Wang, M.D. Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01591954: A Feasibility Study of a Modular Video Augmentation System for Image-Guided Skull Base Surgery
Official title: A Feasibility/Pilot Study of a Modular Video Augmentation System for Image-Guided Endoscopic Skull Base Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Feasibility of Video Augmentation System
Value of Video Augmentation Navigation
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Current standard of care for complex head, neck and skull base surgery require navigation systems that allow instruments to be tracked optically or electromagnetically while registered to a patient's pre-operative X-ray computed tomography (CT) or magnetic resonance image (MRI). However, conventionally, the CT/MRI data is not registered with video endoscopy. Augmentation of endoscopic video by preoperative data can facilitate navigation around critical structures and robust target resection. The work presented here describes evaluation of a high definition (HD) video-overlay system for endonasal endoscopic skull base surgery. We adopt a modular design that can be extended for other video augmentation applications. The system supports fast automatic camera calibration, comparable in re-projection errors to standard camera calibration tools, while performing within appropriate run time for clinical use. Phantom studies have shown the registration accuracy of the system to be equivalent to that of conventional optical tracking. With this system we are proposing a clinical pilot study in a small number of patients at Johns Hopkins Hospital to evaluate basic feasibility and to gather qualitative assessment of the video augmentation system.


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 18 years of age or older;
* Have an existing clinically ordered CT image within 2 weeks of the study; or
* Have an existing clinically ordered MR image within 2 weeks of the study;
* Provide written informed consent after receiving a verbal and written explanation of the purpose and nature of this clinical study;
* Be able to communicate effectively with clinical study personnel

Exclusion Criteria:

* Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of the procedure;

Primary outcomes:
measure: Qualitative Assessment of Video Augmentation Software by Post-operative Survey of Neurosurgeon and Otolaryngologist
timeFrame: Assessment is immediate, following operation.
Secondary outcomes:
measure: Data Recording for Retrospective Analysis
timeFrame: Data is recorded during case.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Hospital Department of Neurosurgery
name: Gary L Gallia, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: