louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04070274: A New Surgery Platform for Calcaneal Surgery: a Clinical Research
Official title: A New Surgery Platform for Calcaneal Surgery: a Clinical Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calcaneus Fracture
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: Study on the method of lateral nursing and surgical operating tables optimization in the calcaneal surgery.

Method:Design combined surgical operating tables grouped according to the time of clinical application.58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and the experimental group with 29 patients. The traditional lateral method and calcaneus lateral surgery platforms are separately applied to compare the sliding of the affected limb during a surgery, the stability of the position, the difference of the surgical instruments fall and the satisfaction of the medical staff.Moreover,30 healthy volunteers are selected to experience the comfort level of the two placement methods.


Eligibility criteria: Inclusion Criteria:

* Ages ranged from 18 to 82.
* ASA Ⅰ or Ⅱ level.

Exclusion Criteria:

* Limited body activity and extremely severe cardiovascular diseases.
* Unwilling to cooperate.
* Mental illness and coagulopathy

Primary outcomes:
measure: The sliding frequency of the affected limb during a surgery with two methods
timeFrame: Intraoperative
measure: The time patients'surgical position can last for in a surgery.
timeFrame: Intraoperative
measure: The frequency of the surgical instruments fall with different methods
timeFrame: Intraoperative
measure: The whole satisfaction level of the patients and medical staffs
timeFrame: From the beginning of operation till 1 days postoperative
Secondary outcomes:
measure: Extra possible adverse effects due to the new surgical platform
timeFrame: From the beginning of operation till 24 hours postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05926674: Does Manual Therapy Provide Immediate Improvement in Lumbar Range of Motion?
Official title: Immediate Effects of Myofascial Release on Lumbar Range of Motion. A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: N/A Healthy Individuals
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a double-arm repeated measures study performed in a single session lasting approximately 30-40 minutes.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to determine if manual therapy can improve lumbar mobility in healthy individuals.

The main questions it aims to answer are:

* Is there an immediate local spinal effect?
* Is there an associated distal effect?

Researchers will compare an experimental group and a control group to examine the effects.

Detailed description: Upon consent, participants will be assessed for lumbar spine mobility using inclinometers, hamstring flexibility using the active knee extension test and the modified sit-and-reach test, and ease of lifting a small, weighted object. After baseline measures are recorded, the participants will receive an intervention that will be either therapeutic (myofascial release) or sham (non-therapeutic hand placement). The choice of intervention received will be previously determined through the use of randomization software. The intervention provided will be applied to the low back and last for a total of 10 minutes. Immediately following the intervention, participants will again be assessed for lumbar spine mobility, hamstring flexibility, and ease of lifting a small, weighted object as noted above.

Eligibility criteria: Inclusion Criteria:

* New York Institute of Technology students
* At least 18 years old
* Good overall health

Exclusion Criteria:

* Pacemaker
* Any previous history of lumbar or connective tissue pathology
* Down syndrome
* Prolonged steroid use
* Oswestry Low Back Disability score of \>10 (ODI)
* Inability to provide informed consent

Primary outcomes:
measure: Lumbar Range of Motion
timeFrame: 3 minutes
measure: Modified Sit and Reach test
timeFrame: 3 minutes
measure: Active Knee Extension test
timeFrame: 3 minutes
measure: Functional Movement Assessment
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYIT
state: New York
Study officials:
affiliation: New York Institute of Technology
name: Mark Gugliotti, DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04193774: Optimization of Sampling and Processing of Samples for Molecular Microbial Research on Ocular Surface Samples
Official title: Optimization of Sampling for Molecular Microbial Research on Ocular Surface Samples and Building a Framework for Comparing Current Sequencing Results Using Different Extraction Protocols.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbiota
Ocular Surface
Keywords: Ocular surface microbiome
Anesthesia
Extraction protocol
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: When the patient is under general anesthesia for another reason, he or she receives a drop of artificial tears in one eye and a drop of anesthetic in the other eye in a randomized way.
Primary purpose: DIAGNOSTIC

Brief summary: The use of anesthetics and the processing of the retrieved samples are major confounding factors that influence the results of microbiome research.

Detailed description: The use of anesthetics is subject of discussion in ocular surface microbiome research. One publication showed a significant lower alpha diversity when using an anesthetic. However, the diluting effect of the anesthetic drop itself was not accounted for. On the other hand, using anesthetics will enable patients to tolerate sampling better and this might allow better sampling. To analyze the effect of anesthetic drops on the composition of the ocular surface microbiome, we sampled volunteers undergoing general anesthesia. By using artificial tears as a control, we aimed at accounting for the diluting effect of the anesthetic. By using volunteers under general anesthesia, we wanted to assure similar pressure with or without topical anesthesia since the executor was not influenced by the patient's reaction.

Furthermore, the effect of different extraction protocols on sequencing results will be assessed by sampling different volunteers in both eyes on non consecutive days.

Eligibility criteria: Inclusion Criteria:

* Willing to undergo sampling of the conjunctiva
* Fluent in written and verbal Dutch
* Capable of giving informed consent

Exclusion Criteria:

* Allergy to oxybuprocaine
* Medication usage in one eye only

Primary outcomes:
measure: Difference in richness of the microbial flora measured as operational taxonomic units
timeFrame: 5 minutes per sampling session
measure: Difference in evenness of distribution of the microbial flora measured as operational taxonomic units
timeFrame: 5 minutes per sampling session
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven, Department of Ophthalmology
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Heleen Delbeke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06095674: ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study
Official title: ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study: Safety, Toxicity and Immunological Effects of Peritumorally Delivered Immunotherapy in Early-stage Cervical Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Cervical Cancer
Keywords: Immune therapy
Check point inhibitor
Peritumoral administration
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
name: Agenus Inc.
First posted: 2023-10-23
Enrollment: 30
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: The ITHACA study is a phase I study evaluating the safety and toxicity of a peritumorally injected PD-1 checkpoint inhibitor, in combination with a multifunctional CTLA-4 inhibitor, in early-stage cervical cancer.

Detailed description: In this single arm, open label phase I study, the investigators will study the safety and toxicity of the combination of a PD-1 checkpoint inhibitor and a multifunctional CTLA-4 inhibitor when injected peritumorally prior to surgery in early-stage cervical cancer. Additional objectives are to describe dose limiting toxicities, to determine the maximum tolerated doses and to study the effects on the tumor and lymph node microenvironment, and on immune subsets in peripheral blood.

Eligibility criteria: Inclusion Criteria:

* early-stage cervical cancer
* scheduled for (radical) hysterectomy and pelvic lymph node dissection

Exclusion Criteria:

* previous treatment with checkpoint inhibitors
* use of immunosuppressive medication within 28 days of the injection of the study medication
* history of other malignancy

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: 2 years
Secondary outcomes:
measure: Maximum tolerated dose
timeFrame: 2 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Constantijne H Mom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05037474: Contemporary Transvenous Lead Extraction Outcomes
Official title: Contemporary Mechanical Lead Extraction Outcomes From a High-volume Center: Patient Characteristics, Procedural Characteristics and Outcomes.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pacemaker Lead Dysfunction
Pacemaker Electrode Infection
ICD
Endocarditis Infective
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing a lead extractions or lead explantation (defined by the EHRA consensus statement) procedure were prospectively enrolled in the database,

Brief summary: Presentation of procedural safety and outcomes data from a high volume TLE centre

Detailed description: Transvenous lead extraction is crucial procedure in the longterm management of patients with implanted pacemakers or cardioverter defibrillators.

Our study presents the patient and procedural characteristics as well as the outcome data of a cohort undergoing transvenous lead extraction (TLE) with olny mechanical extraction tools at a high-volume TLE centre.

Eligibility criteria: Inclusion Criteria:

* all patients undergoing a lead removal procedure

Exclusion Criteria:

* minors

Primary outcomes:
measure: Percentage of patients with complete or clinical successful lead removal
timeFrame: acute setting (during the surgical procedure)
measure: Percentage of patients undergoing TLE with major and minor complication
timeFrame: acute setting (during the surgical procedure)
Secondary outcomes:
measure: long term outcome
timeFrame: >12months follow up
measure: Percentage of patients encountering a major or minor sedation complication during TLE
timeFrame: acute setting (during the surgical procedure)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
state: Bayern
Study officials:
affiliation: German Heart Center
name: Carsten Lennerz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02330874: Validation of the SD-ICU. A Risk Assessment Tool of Unplanned ICU Readmission
Official title: Assessment of the Risk of Unplanned Readmission to the Intensive Care Unit Using the Safe Discharge From ICU (SD-ICU) Score: A Validation Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Keywords: Risk
score
readmission
ICU
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients discharged alive from a general ICU

Brief summary: In a recent study, which included 845 patients that at the time of ICU discharge had at least one risk factor for readmission, the investigators' group developed a new readmission risk score in the ICU, Safe Discharge from ICU (SD-ICU), using parameters easily and routinely measured in ICU: the Charlson comorbidity (ICC), the TISS-28 (Therapeutic Intervention Scoring System - 28), the length of stay in ICU and age. Through ROC curve analysis, the investigators found that patients with a score above 14.5 had a high probability of readmission.

The objective of this study is to validate the Safe Discharge from ICU (SD-ICU) score as a tool to predict unplanned readmissions to the intensive care unit.

All adult patients discharged from a 37 bed general ICU from April 2014 to March 2015 will be included in the study. The SD-ICU score is routinely calculated at the time of discharge from the ICU. Patients will be divided into two groups: those with SD-ICU score\> 14.5 (group 1) and those with a score equal to or less than 14.5 (group 2). The two groups will be compared with respect to the frequency of unplanned readmissions. Stepwise, multivariate logistic regression will be used to investigate the association between the risk factors for readmission used in SD-ICU score and ICU readmission as outcome.


Eligibility criteria: Inclusion Criteria:

* Adult patients discharged from a general ICU

Exclusion Criteria:

* Patients under 18 years old
* Those that were not candidates for ICU readmission (interhospital and home care transfer)

Primary outcomes:
measure: Readmission to the ICU
timeFrame: After ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Luis
country: Brazil
facility: Hospital Sao Domingos
state: Maranhao
Study officials:
affiliation: Hospital Sao Domingos
name: JOSE R AZEVEDO, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02282774: Subtenon Block Combined With General Anesthesia for Vitreoretinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Subtenon Anesthesia
Keywords: Vitreoretinal surgery
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effects of subtenon block (SB) as an adjunct to general anaesthesia on postoperative pain, oculocardiac reflex and postoperative nausea and vomiting for vitreoretinal surgery.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing elective retinal surgery under general anesthesia

Exclusion Criteria:

* ASA physical status \> Grade II,
* psychiatric conditions,
* neurological impairment,
* deafness with whom communication would be difficult in the postoperative period,
* clotting abnormalities,
* contraindications for regional anesthesia,
* drug abuse,
* history of allergy to the study drugs,
* previous vitreoretinal or strabismus surgery,
* endophthalmitis, or inflammatory eye pathology
* taking analgesics, antiemetics or drugs that might affect hemodynamics

Primary outcomes:
measure: the time to first postoperative analgesic dose
timeFrame: 24 hrs
Secondary outcomes:
measure: postoperative pain scores
timeFrame: First 24 hrs after surgery
measure: number of patients requiring rescue analgesics during the 24-h study period
timeFrame: during the whole study (6 months)
measure: consumption of rescue analgesics
timeFrame: during the whole study (6 months)
measure: incidence of oculocardiac reflex
timeFrame: during time of surgery
measure: incidence of postoperative nausea/vomiting
timeFrame: First 24 hrs after surgery
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz University Hospital at King Saud University
Study officials:
affiliation: King Saud University
name: Marwan Abouammoh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03187574: Comparison of Two Vaginal Mesh Kits in the Management of Vaginal Prolapse
Official title: A Prospective Comparison of Two Vaginal Mesh Kits in the Management of Anterior and Apical Vaginal Prolapse: Long Term-results for Apical Fixation and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Prolapse
Keywords: vaginal prolapse, mesh kit, anatomic assessment, quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with grade ≥3 anterior prolapse

Brief summary: Our study is a non-randomized prospective study compared two groups matched for anterior/apical POP-Q grade: 84 received Elevate Ant™ single-incision mesh (group A) and 42 Perigee™ transvaginal mesh (group B). The study hypothesis was that the Elevate Ant™ mesh would provide better apical correction than the Perigee™ mesh. One- and 2-year follow-up comprised anatomic assessment (POP-Q) and QoL (PFDI-20, PFIQ-7, PISQ-12). Success was defined as 2-year POP-Q ≤1. Secondary endpoints were function and complications.


Eligibility criteria: Inclusion Criteria:

* symptomatic patient presenting with POP-Q grade ≥3 anterior or apical prolapse

Primary outcomes:
measure: comparison of anatomic correction rates in the vaginal apex at 1 year between two mesh kits
timeFrame: 1 year post-surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Gery LAMBLIN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04460274: Forecast Number of Covid-19 Cases Worldwide
Official title: Time Series Model For Forecasting the Number of Covid-19 Cases Worldwide - A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Keywords: Covid19, forecasting
Lead sponsor: Turkish Ministry of Health Izmir Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2020-07-07
Enrollment: 7882471
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population consists all confirmed cases of Covid-19 reported from Situation Dashboard of the European Center for Disease Prevention and Control website Coronavirus 19 Situation Report

Brief summary: Coronavirus disease-19 (Covid-19) had an unprecedented effect on both nations and health systems. Time series modeling using Auto-Regressive Integrated Moving Averages (ARIMA) models have been used to forecast variables extensively mainly in statistics and econometrics. The investigators aimed to predict the total number of cases for Covid-19 using ARIMA models of time-series analysis.

Detailed description: Coronavirus Disease 19 (Covid-19) is an infectious disease initially defined in December 2019 before becoming pandemic. Respiratory disease is the main form of disease causing acute respiratory distress as the main cause of death.

Increased number of cases worldwide had put an enormous load on public health resulting lockdowns, quarantines and curfews. Predicting number of cases is hard as the increment of cases between communities differ.

Time series had been used in different fields of science to predict, such as signal processing, mathematical finance, weather prediction. In medicine, time series analysis were used in number of admitted patients to hospitals. Aim of this study is to predict the total number of Covid-19 cases worldwide using time series anaylsis.

Eligibility criteria: Inclusion Criteria:

* Confirmed case of Covid-19

Exclusion Criteria:

* Cases not reported

Primary outcomes:
measure: Number of Confirmed cases of Covid-19
timeFrame: December 31, 2019 to June 15, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Republic of Turkey, Health Sciences University, Izmir Bozyaka Education and Training Hospital
Study officials:
References:
Clinical trial NCT05584774: Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty
Official title: Clinical Outcomes of Percutaneous Endoscopic Lumbar Discectomy Add by Annuloplasty and Nucleoplasty for Lumbar Disc Herniation: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disc Herniation
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 36
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: Recently, percutaneous endoscopic lumbar discectomy (PELD) is also commonly performed for lumbar disc herniation. Following discectomy, the relief of leg pain is common; however, the relief of back pain is less predictable. The association of back pain and lumbar disc herniation is still unclear. PELD and Annuloplasty (PELDA) can relieve back pain associated with disc herniation as well as leg pain through decompression and thermal ablation of annular defects in selected patients. Another problem that rapidly increasing go along with the growing number of microdiscectomies is directly proportional to the number of patients who undergo re-operations due to recurrences. The surgical treatment can be helpful in prevention of re-operations is nucleoplasty. Endoscopic discectomy for lumbosacral herniation supplemented with nucleoplasty can reduce the recurrence and reoperation rates.


Eligibility criteria: Inclusion Criteria:

* Primary single-level lumbosacral intervertebral disc herniation at the L4-L5 or L5- S1 level will perform surgical intervention of percutaneous endoscopic lumbar discectomy
* All patients present with sciatica and back pain that will not improve with conservative treatment for a minimum of 6 weeks
* All patients undergo plain radiographs, magnetic resonance imaging (MRI)
* The patients will require to have an obvious disc herniation that caused compression of a nerve root corresponding to the dermatomal distribution of the leg symptoms.

Exclusion Criteria:

* Patients have foraminal, extra-disc herniation, multilevel disc herniation, spinal stenosis, spondylolisthesis, scoliosis, prior lumbar surgery, spinal infection, spinal tumor, and a history of hip or knee arthritis.

Primary outcomes:
measure: VAS back pain
timeFrame: 48 weeks
measure: VAS leg pain
timeFrame: 48 weeks
Secondary outcomes:
measure: ODI
timeFrame: 48 weeks
measure: complications
timeFrame: 48 weeks
measure: re-operation
timeFrame: 48 weeks
Other outcomes:
Locations:
Study officials:
References: