louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03877822: Two-day Bed Rest, Insulin Sensitivity and Muscle Protein Synthesis
Official title: The Impact of Two Days of Bed Rest Versus Two Days of Habitual Activity on Insulin Sensitivity and Cumulative Muscle Protein Synthesis in Healthy Young Males
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will firstly undergo 2 days of habitual physical activity, followed by 2 days of bed rest
Primary purpose: BASIC_SCIENCE

Brief summary: The impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males

Detailed description: To study the mechanisms underlying inactivity-induced muscle atrophy, the impact of two days bed rest versus two days of habitual activity on insulin sensitivity and cumulative muscle protein synthesis will be investigated in healthy young males

Eligibility criteria: Inclusion Criteria:

* Male
* Aged 18-40

Exclusion Criteria:

* Smoker
* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes)
* Any diagnosed cardiovascular disease (e.g. deep vein thrombosis or hypertension)
* Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
* A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.
* Any known disorders in muscle metabolism
* Regular use of nutritional supplements (i.e. ingestion more than twice per week during the last month)
* Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws).
* Allergy to lidocaine
* Recent (within the last 6 months) or current musculoskeletal injury (e.g. leg fracture)

Primary outcomes:
measure: Change in whole-body insulin sensitivity
timeFrame: During 2 days of habitual physical activity and 2 days of bed rest. Blood glucose and insulin are monitored for 2 hours following ingestion of a standardized meal
Secondary outcomes:
measure: Change in cumulative muscle protein synthesis
timeFrame: During 2 days of habitual physical activity and 2 days of bed rest
measure: Change in continuous glucose
timeFrame: Continuous glucose, during the 2 days of habitual activity and 2 days of bed rest
measure: Change in muscle volume
timeFrame: Immediately before and immediately after the 2-day bed rest period
Other outcomes:
Locations:
Study officials:
affiliation: University of Exeter
name: Marlou L Dirks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00720239: Taliderm Dressing for Venous Ulcers
Official title: Safety and Wound Healing Efficacy of the TalidermR Wound Dressing a Poly-N-acetyl Glucosamine-derived Membrane Material in Humans With Venous Stasis Ulcers: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Venous Stasis Ulcers
Venous Insufficiency
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will test a new wound healing dressing called Taliderm® on leg ulcers caused by chronic venous insufficiency (CVI). Some people with CVI have poor vein circulation that causes ulcers to develop on the lower legs. This new dressing is hoped to help the ulcers heal more quickly. The study hypothesis is to determine whether the TalidermR Wound Dressing, a poly-N-acetyl glucosamine (pGlcNAc) derived membrane material expedites wound healing in humans with venous stasis ulcers.


Eligibility criteria: Inclusion Criteria:

* Adults ≥45 years of age
* Diagnosis venous partial thickness ulcer diagnosed within the past
* 4 weeks without recent enzymatic, autolytic or chemical treatment
* Viable and clean wound bed with granulation tissue and ≥ 90% free of necrotic debris
* Wound measures between 5 and 20 cm2
* Extends through epidermis and into the dermis

Exclusion Criteria:

* Full thickness ulcers extending beyond the dermis
* Current wound, skin, or systemic infection
* Wound bed ≤90% free of necrotic debris
* Recent treatment with enzymatic, autolytic or chemical agents
* History or collagen vascular disease, severe arterial disease, organ transplant, Charcot, sickle cell
* Insufficient blood supply to ulcer (ankle-brachial index \<.8 or \>1.3)
* History of radiation therapy to the site
* Cellulitis/osteomyelitis/avascular ulcer bed
* Currently receiving hemodialysis
* Pregnancy
* Currently receiving treatment with another investigational drug or device or within the past 30 days
* Unable to comply with the study protocol

Primary outcomes:
measure: wound healing
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Roper St. Francis Hospitals
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Teresa J Kelechi, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00249639: Contingency Management for Attendance - 2
Official title: Contingency Management for Attendance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Keywords: Contingency Management
Substance Abuse Treatment
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: UConn Health
First posted: 2005-11-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of a low-cost contingency management procedure as compared to standard treatment. Using a cross-over design, CM is implemented at different community-based clinics and compared with non-CM in the same facilities. Research staff collects information regarding patients' demographic characteristics, attendance, and outcomes at the clinics. During Phase A (non-CM), standard clinical practice is in place. During Phase B (CM), all patients have the chance to win prizes by coming to treatment. Each participating clinic is randomly assigned to receive either the A or B phase first; each phase is in effect for 16 weeks.


Eligibility criteria: Subjects will be patients in treatment at one of the participating clinics during the study period. There are no other inclusion or exclusion criteria because we wish to make enrollment open to increase generalizability.

Primary outcomes:
measure: Drug use
timeFrame: baseline and each follow-up
measure: Retention
timeFrame: baseline and each follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Nancy Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04193839: Reducing Errors In The Neonatal Intensive Care Unit
Official title: Reducing Errors In The Neonatal Intensive Care Unit. The SAPHET-i Study: Secure, Automated, Functional, High-Tech Therapeutic Approach for iNFANTS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Errors and Other Product Use Errors and Issues
Adverse Drug Event
Keywords: Computerized Provider Order entry
Patient safety
Quality improvement
Medication errors
Adverse events
Bar code medication administration
Neonates
Lead sponsor: Fondazione Poliambulanza Istituto Ospedaliero
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient admitted to the NICU who needs pharmacological intervention is eligible.

Brief summary: This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry in reducing medication erros (MEs) in the Neonatal Intensive Care Unit (NICU)

Detailed description: Medication errors are a burden to the health care system. The neonatal population, in particular the infants admitted to the NICU, are at higher risk of MEs as compared to the adult and pediatric population. Moreover adverse events (ADEs) occur more frequently and may be particularly severe in neonates.

Several strategies have been tried in order to decrease the incidence of MEs in the NICU. Among these, some studies investigated the effectiveness of CPOE in reducing MEs in hospitalised patients. However, results have been inconsistent. So far, no study investigated the association of CPOE + BCMA in neonates.

The investigators designed a monocentric prospective pre and post-intervention observational study to investigate the efficacy of the CPOE plus BCMA as compared to paper order entry in reducing MEs in the NICU population.

Eligibility criteria: Inclusion criteria:

* Admission to the NICU
* Need of pharmacological intervention
* Informed parental consent

Exclusion criteria:

* Lack of parental consent

Primary outcomes:
measure: Number of medication errors
timeFrame: From date of NICU admission up to discharge, up to 18 months
Secondary outcomes:
measure: Number of preventable adverse drug events
timeFrame: From date of NICU admission up to discharge, up to 18 months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto Ospedaliero
Study officials:
affiliation: Fondazione Poliambulanza Istituto Ospedaliero
name: Maria Pierro, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06047639: Bone Anchored Hearing Implants in Chronic Otitis Media
Official title: Benefit of Bone Anchored Hearing Implants in Chronic Otitis Media
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 24
Sex: ALL
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 chronic otitis media whose hearing could not corrected with surgery and also could not use conventional and got bone-anchored hearing implants as a standard of care

Brief summary: The aim of this study is to investigate the cost, functional benefits, and impact on the quality of life of using bone-anchored hearing devices in chronic otitis media patients

Detailed description: Hearing loss is a significant disability that disrupts an individual's communication with others and can have a profound impact on their social life and career. It can lead to social isolation, depression, anxiety, and even early dementia. Chronic otitis is one of the most important ear diseases that can cause hearing loss. Its treatment is surgical, but sometimes even after surgery, hearing rehabilitation is needed. In such cases, the first option is the use of hearing aids. Some patients may be unable to use hearing aids due to excessive ear canal clearance, recurrent ear infections, or outer ear canal problems. In such cases, bone-anchored hearing devices emerge as the most logical option, although they are more costly compared to regular hearing aids. The aim of this study is to investigate the cost, functional benefits, and impact on the quality of life of using bone-anchored hearing devices in the context of our country

Eligibility criteria: Inclusion Criteria:

* Adults
* No difficulty in coming to the hospital for follow-up
* Ability to communicate and express oneself at a level sufficient to interact with researchers
* Having an indication for BAHI due to Chronic Otitis media

Exclusion Criteria:

* Those with severe systemic illnesses (cancer, HIV, etc.)
* Psychiatric patients experiencing compliance issues with hearing tests
* Use of medication or medical devices that could affect the outcome of the study
* Patients who cannot adhere to regular follow-ups and do not use the device will be excluded from the study.

Primary outcomes:
measure: free field hearing level
timeFrame: one year
measure: Speech, Spatial and Qualities of Hearing Scale
timeFrame: One year
measure: World Health Organisation(WHO) Quality of Life Questionarie
timeFrame: One year
Secondary outcomes:
measure: Cost Benefit of the intervention
timeFrame: on year
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fazıl N Ardıç, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002039: An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
Official title: An Open Study of Foscarnet Treatment First Episode CMV-Retinitis in AIDS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Foscarnet
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of foscarnet induction therapy for treatment of AIDS patients experiencing their first episode of cytomegalovirus (CMV) retinitis. To evaluate the safety and efficacy of three different foscarnet maintenance therapy regimens. To determine the pharmacokinetics of intermittent administration of foscarnet with or without concomitant administration of zidovudine (AZT).


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
* Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic and/or hypertensive retinopathy.
* Known allergy to foscarnet.
* Recurrent episode of cytomegalovirus (CMV) retinitis.

Concurrent Medication:

Excluded:

* Nephrotoxic drugs.

Patients with the following are excluded:

* Recurrent episode of cytomegalovirus (CMV) retinitis.
* Any clinically significant pulmonary or neurologic impairment (e.g., patients who are intubated or comatose).
* Corneal, lens, or vitreous opacification which precludes examination of the fundi, or evidence of tuberculotic, diabetic, and/or hypertensive retinopathy.
* Known allergy to foscarnet.

Prior Medication:

Excluded:

* Ganciclovir for cytomegalovirus (CMV) retinitis.
* Foscarnet for CMV retinitis.

Patients with AIDS as defined by the CDC with manifest first episode cytomegalovirus (CMV) retinitis, as identified by its characteristic ophthalmoscopic appearance and verified by fundus photography.

* Patients must be able to give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Foscarnet Research Program / Park Plaza Hosp
state: Texas
Study officials:
References:
citation: Ussery FM, Karol C, Conklin R, Gathe J, Stool E, Redding K. Preliminary results from an on-going prospective evaluation of foscarnet in the treatment of AIDS-associated cytomegalovirus retinitis. Int Conf AIDS. 1989 Jun 4-9;5:551 (abstract no MCP60)
Clinical trial NCT04527939: Analysis of Extraperitoneal Rectal Neoplasms Between 3D Endorectal Ultrasonography and Magnification Chromoendoscopy
Official title: Results of the Comparative Analysis of Invasion Depth of Extraperitoneal Rectal Neoplasms Between Three-dimensional Endorectal Ultrasonography and Magnification Chromoendoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Rectal Cancer Stage I
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Extraperitoneal rectal cancer stage 1
Primary purpose: TREATMENT

Brief summary: ERUS-3D and CMI demonstrated good diagnostic accuracy in parietal staging of rectal extraperitoneal neoplasms, however with greater efficiency of the endoscopic method. The association of studies can improve diagnostic efficacy and influence the most appropriate approach.

Detailed description: Larger lesions present less chance of deep parietal invasion. The methods show moderate agreement with each other for lesion size and distance from the anal verge and good agreement for the rectal wall percentage of involvement. Circumferential or almost circumferential lesions have a greater chance of postoperative stenosis. Patients with more advanced lesions on AP who underwent radical resections had lower overall survival.

Eligibility criteria: Inclusion Criteria: patients with diagnosis of mid or distal rectum neoplasms stage 1 -

Exclusion Criteria: advanced rectal cancer (stage II, III or IV)

-

Primary outcomes:
measure: Degree of parietal invasion (T),
timeFrame: immediately after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Medicine School, Sao Paulo University
Study officials:
References:
citation: Nahas SC, Nahas CSR, Bustamante-Lopez LA, Pinto RA, Marques CFS, Cecconello I. Outcomes of surgical treatment for patients with distal rectal cancer: A retrospective review from a single university hospital. Rev Gastroenterol Mex (Engl Ed). 2020 Apr-Jun;85(2):180-189. doi: 10.1016/j.rgmx.2019.05.009. Epub 2020 Feb 11. English, Spanish.
citation: Kawaguti FS, Franco MC, Martins BC, Segateli V, Marques CFS, Nahas CSR, Pinto RA, Safatle-Ribeiro AV, Ribeiro-Junior U, Nahas SC, Maluf-Filho F. Role of Magnification Chromoendoscopy in the Management of Colorectal Neoplastic Lesions Suspicious for Submucosal Invasion. Dis Colon Rectum. 2019 Apr;62(4):422-428. doi: 10.1097/DCR.0000000000001343.
citation: Pinto RA, Correa Neto IJ, Nahas SC, Rizkalah Nahas CS, Sparapan Marques CF, Ribeiro Junior U, Kawaguti FS, Cecconello I. Efficacy of 3-Dimensional Endorectal Ultrasound for Staging Early Extraperitoneal Rectal Neoplasms. Dis Colon Rectum. 2017 May;60(5):488-496. doi: 10.1097/DCR.0000000000000781.
Clinical trial NCT03026530: Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
Official title: Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Lead sponsor: Region Östergötland
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this prospective, blinded, randomized clinical trial is to investigate whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall postoperative pain and nausea.


Eligibility criteria: Inclusion Criteria:

* elective laparoscopic bariatric surgery (LBS)
* American Society of Anaesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
* written consent

Exclusion Criteria:

* conversion to open surgery
* complication, Clavien-Dindo grade ≥ II

Primary outcomes:
measure: Postoperative Pain
timeFrame: 4, 12, 24, 36 and 48 hours after surgery
Secondary outcomes:
measure: Postoperative Nausea
timeFrame: 4, 12, 24, 36 and 48 hours after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Vrinnevi Hospital, Norrköping, Sweden
name: Ebba Kihlstedt Pasquier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vrinnevi Hospital, Norrköping, Sweden
name: Ellen Andersson, MD, PhD
role: STUDY_CHAIR
References:
citation: Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22.
Clinical trial NCT04235530: Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Thoracic Surgery
Official title: Comparison of Ultrasonography Guided Serratus Anterior Plane Block and Thoracic Paravertebral Block in Video-Assisted Thoracoscopic Surgery: A Prospective Randomized Double-blind Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: thoracoscopic surgery video assisted
serratus anterior
paravertebral block
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: who underwent elective video-assisted thoracoscopic surgery

Brief summary: The aim of this study is comparison of the effectiveness of ultrasound guided serratus anterior plane block and thoracic paravertebral block as a preventive analgesia method after VATS. Our secondary aim is to investigate patient and surgeon satisfaction, duration of block application, postoperative complications and hospital lenght of stay.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 65 years
* ASA (American Society of Anesthesiologists) score I-II

Exclusion Criteria:

* inability to communicate
* body mass index (BMI) \> 35 kg/m2
* infection in the area where the block was to be applied
* allergy to the drugs used
* mentally impaired
* bleeding impaired

Primary outcomes:
measure: pain scores in rest and coughing
timeFrame: 24 hours
measure: consumption of opioids
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative complications
timeFrame: 24 hours
measure: lenght of hospital stay
timeFrame: 48 hours
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Education and Research Hospital
Study officials:
References: