louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02680886: PMCF-study Using Novosyn® Quick Suture Material for Skin Closure
Official title: Post-Marketing Clinical Follow-up (PMCF) Study for Skin Closure to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter, International, Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Closure
Keywords: Rapid Absorbable Suture Material
Children / Adults
Novosyn Quick
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2016-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children and adults

Brief summary: The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature.


Eligibility criteria: Inclusion Criteria:

* Pediatric and adult patients undergoing skin closure
* Small linear minimally contaminated incision / lacerations on the trunk or extremities
* Written informed consent

Exclusion Criteria:

* Emergency surgery
* Facial lacerations or incisions
* Visible dirt in the wounds
* Nonlinear shape
* Patients taking medical consumption that might affect wound healing

Primary outcomes:
measure: Wound infection
timeFrame: 3 months
measure: Incidence of wound dehiscence
timeFrame: 3 months postoperatively
measure: Incidence of Tissue reaction / Inflammation
timeFrame: 3 months postoperatively
measure: Incidence of Suture removal
timeFrame: 3 months postoperatively
measure: Incidence of Re-suturing
timeFrame: 3 months post-operatively
measure: Cosmetic result
timeFrame: 3 months post-operatively
measure: Assessment of the handling of the suture material
timeFrame: intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Hospital Saint Louis
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology
Study officials:
References:
citation: Gfroerer S, Baumann P, Schwalbach AK, Smirnoff A. Prospective international multicenter observational study of Novosyn(R) Quick for skin closures in adults and children (SKINNOQ). BMC Surg. 2019 May 2;19(1):47. doi: 10.1186/s12893-019-0506-8.
Clinical trial NCT02665286: Orphenadrine and Methocarbamol for LBP
Official title: Methocarbamol and Orphenadrine for Acute, Non-traumatic, Non-radicular Low Back Pain: A Randomized, Placebo Controlled, 3-armed Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone

Detailed description: Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. Participants will be followed by telephone one week and 3 months after the ED visit

Eligibility criteria: Inclusion Criteria:

* LBP duration \<= 2 weeks
* No trauma to low back within previous month
* No radicular symptoms
* No history of low back pain or history of only infrequent episodes

Exclusion Criteria:

* Medication allergies or contra-indications
* Not available for follow-up
* Chronic pain syndrome

Primary outcomes:
measure: Functional Impairment as Measured on the Roland Morris Disability Questionnaire
timeFrame: 1 week
Secondary outcomes:
measure: Cases of Moderate or Severe LBP
timeFrame: 1 week
measure: Medications--Patient Self Report of Medication Use
timeFrame: 1 week
measure: Patient Satisfaction With Treatment
timeFrame: 1 week
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Benjamin W Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedman BW, Cisewski D, Irizarry E, Davitt M, Solorzano C, Nassery A, Pearlman S, White D, Gallagher EJ. A Randomized, Double-Blind, Placebo-Controlled Trial of Naproxen With or Without Orphenadrine or Methocarbamol for Acute Low Back Pain. Ann Emerg Med. 2018 Mar;71(3):348-356.e5. doi: 10.1016/j.annemergmed.2017.09.031. Epub 2017 Oct 28.
Clinical trial NCT04312763: A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
Official title: A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Blindness, Acquired
Keywords: Observer-rated instrument
Lead sponsor: Second Sight Medical Products
Sponsor class: INDUSTRY
Collaborators: name: Boston Biomedical Associates
First posted: 2020-03-18
Enrollment: 3
Sex: ALL
Minimum age (years): 22
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 30 users with the Argus II or Orion system from the US will be enrolled.

Brief summary: This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home environment. This study shall be carried out with individuals who have an implanted visual prosthesis device. There are no new implantations or changes to the original implant or external wearables being studied or tested. Additionally, data from the study shall not be used alter standard of care or the user's treatment options.


Eligibility criteria: Inclusion Criteria:

* Subjects implanted with the Argus II or Orion device
* Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
* Subject is able to follow instructions and comply with FLORA-20 scheduling and completion of tasks
* Subject is willing to be filmed while performing the FLORA-20 tasks during the study

Exclusion Criteria:

* Subject is unsuitable for study participation as determined by Investigator's clinical judgment (with Sponsor's final input).

Primary outcomes:
measure: Inter-observer reliability
timeFrame: Single 1 day visit
measure: Intra-observer reliability
timeFrame: Single 1 day visit
Secondary outcomes:
measure: Improvement in Average Performance, ON vs. OFF
timeFrame: Single 1 day visit
measure: Clinical Meaningfulness (Effect Size)
timeFrame: Single 1 day visit
measure: Internal consistency - Cronbach's alpha
timeFrame: Single 1 day visit
measure: Internal consistency - item-total correlations
timeFrame: Single 1 day visit
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Second Sight Medical Products, Inc.
state: California
Study officials:
affiliation: Second Sight Medical Products, Inc.
name: Uday Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00531063: This is a Two-year Follow-up Study to Evaluate the Long-term Safety, Tolerability and Efficacy of 2 Different Doses of Everolimus
Official title: A 2-year Extension to a 1-year Multicenter, Randomized, Open Label, Parallel Group Study of the Safety, Tolerability and Efficacy of Two Doses (1.5 and 3 mg/Day) of Everolimus With Steroids and Optimized Administration of Cyclosporine in de Novo Renal Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Renal transplantation, everolimus, Immunosuppressants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-18
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This extension study is designed to provide long-term safety and efficacy data beyond 12 months up to Month 36.


Eligibility criteria: Inclusion Criteria:

* Patients who are receiving study medication at Month 12 of the one-year study (CRAD001A2306) and sign a new Informed Consent to extend the treatment and observation period beyond Month 12.
* Females patients must agree to continue using an approved method of birth control throughout the study and for 3 months following the last dose of study medication.
* Another Informed Consent was required for the extension amendment. This Informed Consent allowed for separate consent to the amendment study itself, and the retrospective collection of biopsies and/or the yearly protocol biopsies
* Inclusion and exclusion criteria were not changed, except that patients who completed the core study in follow-up became eligible to participate in the amended extension.

Exclusion Criteria:

* Patients who are receiving study medication and do not sign a new Informed Consent to extend the treatment and observation period beyond Month 12 RAD001A2306)

Primary outcomes:
measure: • To assess the incidence of graft loss, death, biopsy-proven acute rejection, antibody-treated acute rejection, biopsy-proven chronic allograft nephropathy, retransplantation or dialysis up to 36 months
Secondary outcomes:
measure: To quantify the incidence of biopsy-proven acute rejection episodes, graft loss, death or lost to follow-up at 6, 12, 24 and 36 months in both groups. To assess the incidence of graft loss, death, biopsy-proven acute rejection,
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT05642663: Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
Official title: Post-marketing, Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity
Keywords: Stapler
ALTUS
Bariatric surgery
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (18 years or older), who underwent bariatric surgery with the use of Altus Powered Stapler

Brief summary: Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.

Detailed description: Up to 300 patients who underwent sleeve, bypass or revisional bariatric surgery with the use of Altus Powered Stapler will be included in the study. The stapler should be used according to the Instructions for Use and according to the local practice.

The Altus Powered Stapler is used in open or laparoscopic surgeries and simultaneously cuts and staples soft tissues. In order to avoid great physical efforts by the physician and ensure excellent tissue suturing, the cutting and stapling mechanism is driven by the 12-volt battery that comes with the stapler.

Patients will be followed by 7, 30 and 90 days and 12 months after the procedure, as per the research center's standard routine.

Eligibility criteria: Inclusion Criteria:

* Patients with grade II obesity (BMI ≥ 35 kg/m\^2) with one or more associated comorbidities;
* Patients with grade III obesity (BMI ≥ 40 kg/m\^2) regardless of associated diseases;
* Patients who underwent sleeve, bypass and revisional bariatric surgery procedure with use of the Altus Powered Stapler;
* The patient must sign and date the informed consent form during a routine follow-up visit, authorizing the use of their surgery data and contact for follow-up.

Exclusion Criteria:

* Impossibility of collecting data related to the surgical procedure
* Impossibility of contact with the patient to obtain the informed consent form

Primary outcomes:
measure: Safety - Conversion to open surgery
timeFrame: Intraoperative
measure: Safety - Number of reinterventions
timeFrame: Up to 1 week
measure: Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding
timeFrame: 30 days
measure: Safety- Fistula formation
timeFrame: 30 days
measure: Safety - Stenosis
timeFrame: 90 days
measure: Performance - Procedure Success
timeFrame: Intraoperative
measure: Performance - Cicatrization of staple line
timeFrame: 90 days
Secondary outcomes:
measure: Post-operative change in weight
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital IGESP
state: SP
Study officials:
References:
Clinical trial NCT04535063: Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia
Official title: Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19 Pneumonia
Lead sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients
Primary purpose: TREATMENT

Brief summary: To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia

Detailed description: COVID-19 convalescent plasma will be infused to patients with severe COVID-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. Data will be compared with match control arm patients without plasma infusion

Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18, and non-pregnant women
* Severe or critical COVID-19 disease define by one or more of the following: blood oxygen saturation ≤ 94% on supplemental oxygen by nasal cannula at least 3 L/min, non-rebreathing mask (NRO2-mask) or on noninvasive ventilation; and pulmonary infiltrates with \>50% increase within 24 to 48 hours in chest-X-ray or chest CT. Life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with PaO2 / FiO2 less than 300 mm Hg, septic shock, and/or multiple organ dysfunction.

  * 10 days from the onset of symptoms or ≤ 7 days on mechanical ventilation. -

Exclusion Criteria:

* More than 10 days from symptoms onset or more than 7 days on mechanical ventilation
* Pregnancy
* Contraindication for plasma infusion because anaphylaxis history
* Patients with high risk of circulatory overload
* Limitation of therapeutic efforts
* Refractory shock define by norepinephrine dose more than 1 ug/k/min
* SOFA score more than 15 points at the moment of the protocol inclusion i Coagulopathy with requirements of plasma infusion

Primary outcomes:
measure: 28 days survival
timeFrame: 28 days
Secondary outcomes:
measure: efficacy of plasma infusion according to antibodies levels in the infuse bags
timeFrame: 28 days
measure: clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization
timeFrame: 28 days
measure: change in clinical WHO ordinal scale from 1 to 10 points
timeFrame: 14 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas
Study officials:
References:
Clinical trial NCT00905463: Prognosis of Lung Transplant Candidates
Official title: Analysis of Prognosis and Patient Reported Outcomes in Lung Transplant Candidates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Transplantation
Respiratory Failure
Keywords: Lung transplant candidates
Health-related quality of life
patient reported outcome
Prognosis
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2009-05-20
Enrollment: 272
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: University hospital clinic for lung transplantation

Brief summary: The purposes of the study are (1) to analyze the baseline patient characteristics cross-sectionally, (2) to analyze the prognosis and its predictive factors and (3) to examine the longitudinal clinical course in the lung transplant candidates in Japan.

Detailed description: The significance of assessing patient reported measurements including health status, dyspnea and psychological status has not been well investigated in the lung transplant candidates. Therefore, in the present study, we aim to examine (1) contributive factors to their health status based on baseline data, (2) whether patient reported measurements would predict patients' prognosis and (3) how they would change for 5 years as compared to physiological measurements.

Eligibility criteria: Inclusion Criteria:

* New lung transplant candidates

Exclusion Criteria:

* Heart and lung transplant candidates
* Uncontrolled severe comorbidities

Primary outcomes:
measure: Prognosis/Mortality
timeFrame: 5 years
Secondary outcomes:
measure: Health status
timeFrame: At entry and every year for 5 years
measure: Dyspnea
timeFrame: At entry and every year for 5 years
measure: Psychological status
timeFrame: At entry and every year for 5 years
measure: Sleep quality
timeFrame: At entry and every year for 5 years
measure: Pulmonary function
timeFrame: At entry and every year for 5 years
measure: Arterial blood gas
timeFrame: At entry and every year for 5 years
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Graduate School of Medicine, Kyoto University
city: Okayama
country: Japan
facility: Okayama University
city: Sendai
country: Japan
facility: Tohoku University
city: Suita
country: Japan
facility: Osaka University
Study officials:
affiliation: Graduate School of Medicine, Kyoto University
name: Hiroshi Date, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02146963: Study of the BDNF-Val66Met Polymorphism in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
Official title: Study of the BDNF- Val66Met Polymorphism in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Dependence
Lead sponsor: Centre Hospitalier Esquirol
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2014-05-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: alcohol-dependent subjects hospitalized for alcohol withdrawal

Brief summary: This study is complementary to the main study "Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal " NCT01491347.

The purpose of this study is to evaluate the Bdnf gene - Val66Met polymorphism in subjects with alcohol dependence according to their alcohol consumption status 6 months after withdrawal (relapse or abstinence), in relation to the presence of psychiatric co-morbidities.


Eligibility criteria: Inclusion Criteria:

* participation to the study "BDNF serum levels evolution during 6 months after alcohol withdrawal" (main study)
* criteria from the main study

Exclusion Criteria:

* criteria from the main study
* released or out from the main study before the follow-up at 4 months after withdrawal

Primary outcomes:
measure: Frequency of the Bdnf gene Val/Val, Val/Met and Met/Met phenotypes as a function of relapse
timeFrame: at the time of inclusion
Secondary outcomes:
measure: serum BDNF levels variations between inclusion and 6 months later (or 4 months if the participants does not come for the 4 months-follow-up).
timeFrame: 6 months after alcohol withdrawal
measure: existence of a psychiatric co-morbidity at the inclusion (major depression, schizophrenia, anxiety disorder)
timeFrame: at the time of inclusion
measure: presence of a psychiatric co-morbidity at 6 months after withdrawal (major depression, schizophrenia, anxiety disorder)
timeFrame: 6 month after alcohol withdrawal
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospitalier Esquirol
Study officials:
affiliation: Centre Hospitalier Esquirol
name: Philippe Nubukpo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02284763: Modeling the Effect of EtCO2 on Cerebral Oxygenation
Official title: Pharmacodynamic Modeling of the Effect of End-tidal Carbon Dioxide on Cerebral Oxygen Saturation in Beach Chair Position Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Surgery
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study was to investigate the relationship between the end-tidal carbon dioxide (EtCO2) and cerebral oxygen saturation (rSO2) and to identify the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.

Detailed description: Even though mild hypercapnia in the beach chair position (BCP) under general anesthesia was effective in reducing cerebral desaturation, there is no comprehensive data with regard to the dose-effect relationship of EtCO2 on rSO2 in the BCP under general anesthesia. Pharmacodynamic modeling can be useful in describing this relationship in which concurrent mean arterial pressure changes and disease state can be considered as covariates. Therefore, we investigated the relationship between the EtCO2 and rSO2 and identified the covariates in the pharmacodynamic relationship between EtCO2 and rSO2.

Eligibility criteria: Inclusion Criteria:

* Age ≥19 years who were scheduled to elective arthroscopic shoulder surgery in BCP under general anesthesia

Exclusion Criteria:

* Previous cerebrovascular disease, orthostatic hypotension, and the American Society of Anesthesiologists physical status IV or V

Primary outcomes:
measure: The parameters of indirect response model
timeFrame: 60 min
measure: The factors that influence the model parameters
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital, Yonsei University College of Medicine
name: Dong Woo Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: