louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02341833: Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-transplantation Liver Allograft Function
Keywords: Anesthetic preconditioning
Sevoflurane
Liver transplantation
brain-death donors
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.


Eligibility criteria: Inclusion Criteria:

* all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility

Exclusion Criteria:

* haemodynamic instability that precludes safe administration of 2% sevoflurane.

Primary outcomes:
measure: Composite outcome of liver function following liver transplantation.
timeFrame: First week post-transplantation
Secondary outcomes:
measure: • Incidence of primary non function (liver failure requiring emergent re-transplantation)
timeFrame: 30-day and 6-month after transplantation.
measure: • Hospital length of stay.
timeFrame: 30-day and 6-month after transplantation.
measure: • Allograft function (yes/no) at 30-day and 6-month after transplantation.
timeFrame: 30-day and 6-month after transplantation.
measure: • Hospital mortality and at 30-day.
timeFrame: 30-day.
Other outcomes:
measure: Composite outcome of post transplantation kidney function.
timeFrame: First week after transplantation, 30 day and 6-month.
measure: • Delayed graft function : (defined as dialysis during first postop wk; decline in creatinine value
timeFrame: First week after transplantation, 30 day and 6-month.
measure: • Length of delayed graft function.
timeFrame: First week after transplantation, 30 day and 6-month.
measure: • Primary non function (patient who must go back to chronic hemodialysis and must be listed for re-transplantation
timeFrame: First week after transplantation, 30 day and 6-month.
measure: • Hospital length of stay.
timeFrame: First week after transplantation, 30 day and 6-month.
measure: • Hospital mortality and mortality at 30-day.
timeFrame: First week after transplantation, 30 day and 6-month.
Locations:
city: Liège
country: Belgium
facility: Department of Anesthesiology, CHU Liège
Study officials:
affiliation: CHU Liège - Belgium
name: Jean L Joris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00910533: Study on Early Lyme Neuroborreliosis
Official title: Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nervous System Lyme Borreliosis
Keywords: Lyme neuroborreliosis
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine clinical course and the sequelae of early Lyme neuroborreliosis after treatment with ceftriaxone.


Eligibility criteria: Inclusion Criteria:

* erythema migrans within 4 months before neurologic involvement and pleocytosis in patients \>15 years old

Exclusion Criteria:

* pregnancy
* lactation
* history of adverse reaction to a beta-lactam antibiotic

Primary outcomes:
measure: Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis
timeFrame: 1 year follow-up
Secondary outcomes:
measure: Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00957333: Effects of Ketamine on Human Bladders and Its Possible Mechanisms
Official title: Effects of Ketamine on Human Bladders and Its Possible Mechanisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystitis
Keywords: ketamine
bladder dysfunction
bladder mucosa
mechanisms
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2009-08-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: This study is aimed to evaluate the relationship between ketamine abused and bladder dysfunction and its possible mechanisms.


Eligibility criteria: Inclusion Criteria:

* Adult male or female
* Cystitis (the clinicians ruled out the causes of bacterial infection)
* Frequent micturition
* The clinicians are willing to sign the ICF

Exclusion Criteria:

* Suffers from the urinary system disease, is not suitable to carry on the urinary bladder biopsy sampling
* Suffers from other diseases, doctor recognized that is not suitable to carry on the sampling
* The clinicians are not willing to sign the ICF

Primary outcomes:
measure: Substance Abuse Situation Record
timeFrame: 1 day
Secondary outcomes:
measure: Urinary Bladder Capacity
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Wan Fang Hospital
Study officials:
affiliation: Taipei Medical University-Wan Fang Hospital
name: Ruei-Ming Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05559333: CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL
Official title: CLINICAL COMPARISON OF DIFFERENT GLASS IONOMER-BASED RESTORATIVES AND A BULK-FILL RESIN COMPOSITE IN CLASS I CAVITIES: A 48-MONTH RANDOMIZED SPLIT-MOUTH CONTROLLED TRIAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class I Dental Caries
Keywords: glass ionomer cements
bioactive materials
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: randomized-split mouth clinical trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical performances of high-viscosity glass ionomer (GI), glass carbomer (GC), zirconia-reinforced GI (ZIR), and bulk-fill (BF) composite resin restorations.For this purpose, two calibrated operators placed 128 restorations in 30 patients with a mean age of 21 years. The restorations will be evaluated by one examiner at baseline and at 6, 12, 18,24, and 48 months using the modified US Public Health Service criteria. The data will statistically analyzed.


Eligibility criteria: Inclusion Criteria:

* patients presenting 1) at least four single-surface occlusal caries on their posterior molar teeth (first and/or second molars); 2) teeth to be restored had to be vital and without pulpal or periodontal disease, pain, and preoperative sensitivity; 3) teeth should be in occlusion; and 4) must agree to come to follow-up appointments.

Exclusion Criteria:

* patients with 1) poor oral hygiene, serious health problems, and/or heavy bruxism; 2) partly erupted teeth; 3) absence of adjacent and antagonist teeth; 4) teeth with interproximal caries; and 5) inability to attend recalls.

Primary outcomes:
measure: Retention Alpha for at least 90% of the restorations
timeFrame: 24 months
Secondary outcomes:
measure: marginal adaptation score alpha
timeFrame: 24 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References:
Clinical trial NCT05807633: Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section
Official title: Assessment on the Performance of Novosyn® in Patients Undergoing Uterus Closure in Cesarean Section. A Retrospective, Monocenter, Observational Study in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Cesarean Section; Infection
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2023-04-11
Enrollment: 250
Sex: FEMALE
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: patients undergoing uterus closure in cesarean section

Brief summary: The aim of this study is to collect clinical data on the use of Novosyn® applied for the uterus closure in cesarean section. Diverse parameters have been selected to assess that the safety and effectiveness of Novosyn® is comparable to published results, where the rate of SSIs in patients undergoing uterus closure in cesarean section was 10.6%.


Eligibility criteria: Inclusion Criteria:

* Female patients.
* Age ≥ 18 years
* Patients undergoing one of the following gynaecologic surgeries:
* scheduled (elective) cesarean section
* cesarean section in labour
* urgent cesarean section
* Use of Novosyn® following routine clinical practice.
* Patients with available electronic health records (EHR).

Exclusion Criteria:

* Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to comply with the study procedures.
* Participation in any clinical trial

Primary outcomes:
measure: Rate of wound complications including post-cesarean section surgical site infections (SSIs)
timeFrame: within the first 30 days ± 10 days following cesarean delivery.
Secondary outcomes:
measure: incidence of post-surgery complicated wound healing
timeFrame: within the first 30 days ± 10 days following cesarean delivery.
measure: Incidence of reoperations/readmissions
timeFrame: within the first 30 days ± 10 days following cesarean delivery.
measure: Length of Hospital Stay
timeFrame: up to discharge (up to 10 days after surgery)
measure: Need for blood transfusion
timeFrame: within the first 30 days ± 10 days following cesarean delivery.
measure: Incidence of Adverse device effects (ADEs)
timeFrame: within the first 30 days ± 10 days following cesarean delivery.
Other outcomes:
Locations:
city: Manresa
country: Spain
facility: Athaia Xarxa Assistencial Universitaria de Manresa
state: Barcelona
Study officials:
affiliation: Athaia Xarxa Assistencial Universitaria de Manresa
name: Carmen Bergos Sorolla, Dra.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03760133: The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics
Official title: The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics: Randomized Controlled, Open-label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gut Microbiota
Bowel Preparation
Colonoscopy
Keywords: Gut microbiota
Colonoscopy
Bowel preparation
Probiotics
Lead sponsor: Kosin University Gospel Hospital
Sponsor class: OTHER
Collaborators: name: Cell Biotech Co., Ltd.
First posted: 2018-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to investigate the relationship between the change of intestinal bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort after colonoscopy. And the investigators will also analyze the effects of probiotics on the degree of change, recovery, and symptom development in intestinal flora.

Detailed description: The investigators divided two groups. (total number = 100 subjects)

1. with probiotics group - 50 subjects

   * Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
2. without probiotics group - 50 subjects

   * Participants included in this group will not be taken probiotics for 1 month after bowel preparation for colonoscopy.

Eligibility criteria: Inclusion Criteria:

* adults between the age of 30 and 70

Exclusion Criteria:

* subjects with cancer or IBD (inflammatory bowel disease)
* subjects with history of abdominal surgery
* subjects who take medication related to gastrointestinal motility within 3 months
* subjects who take antibiotics within 3 months

Primary outcomes:
measure: The effect of probiotics on the change of gut microbiota after bowel preparation.
timeFrame: eight months
Secondary outcomes:
measure: The occurrence of symptoms
timeFrame: eight months
measure: The correlation between symptoms and gut microbiota..
timeFrame: eight months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
Study officials:
References:
Clinical trial NCT03050333: Efficacy and Safety of Endoscopic Resection
Official title: Efficacy and Safety of Endoscopic Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endoscopic Resection
Gastrointestinal Neoplasms
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Fundacion Miguel Servet
First posted: 2017-02-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a clinical indication for endoscopic resection at the different participating centers will be consecutively included in this study.

Brief summary: An observational, prospective, multicentre and international study. This will be a non-interventional study to evaluate the efficacy and safety of endoscopic resection of gastrointestinal lesions and to determine what are the factors related to complications, and to describe these lesions according to the different morphologic and histologic classifications.


Eligibility criteria: Inclusion Criteria:

* Female and male patients who are at least 18 years old.
* Clinical indication for endoscopic exam and endoscopic resection
* Patients must freely accept their involvement in this study. They shall give a written informed consent

Exclusion Criteria:

* Patients who do not desire to be included in this study

Primary outcomes:
measure: Proportion of complete resections without recurrence
timeFrame: 6 month post-endoscopic resection
Secondary outcomes:
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Eduardo Albeniz Arbizu
state: Navarra
Study officials:
References:
citation: Albeniz E, Gimeno-Garcia AZ, Fraile M, Ibanez B, Guarner-Argente C, Alonso-Aguirre P, Alvarez MA, Gargallo CJ, Pellise M, Ramos Zabala F, Herreros de Tejada A, Nogales O, Martinez-Ares D, Mugica F, de la Pena J, Espinos J, Huerta A, Alvarez A, Gonzalez-Santiago JM, Navajas F, Martinez-Cara JG, Redondo-Cerezo E, Merlo Mas J, Sabado F, Rivero L, Saperas E, Soto S, Rodriguez-Sanchez J, Lopez-Roses L, Rodriguez-Tellez M, Rullan Iriarte M, Elosua Gonzalez A, Pardeiro R, Valdivielso Cortazar E, Concepcion-Martin M, Huelin Alvarez P, Colan Hernandez J, Cobian J, Santiago J, Jimenez A, Remedios D, Lopez-Viedma B, Garcia O, Martinez-Alcala F, Perez-Roldan F, Carbo J, Enguita M. Clinical validation of risk scoring systems to predict risk of delayed bleeding after EMR of large colorectal lesions. Gastrointest Endosc. 2020 Apr;91(4):868-878.e3. doi: 10.1016/j.gie.2019.10.013. Epub 2019 Oct 23.
Clinical trial NCT00683033: Contingency Management for Smoking in Substance Abusers
Official title: Contingency Management for Smoking in Substance Abusers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Keywords: Contingency Management
Cigarette Smoking Cessation
Substance Abusers
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-23
Enrollment: 51
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: Patients (N=102) who meet diagnostic criteria for alcohol, cocaine, marijuana, or opiate abuse or dependence will meet with research staff on two days for quit preparation sessions (2 per day). These sessions include testing a breath sample for evidence of smoking twice each day (separated by at least 5 hours), counseling based on Public Health Service (PHS) guidelines for quitting smoking during the second session each day, and setting a quit date. After these sessions, participants will be randomly assigned to one of two 4-week conditions: (a) standard care or (b) standard care plus prize CM for smoking abstinence with the opportunity to win prizes for submitting samples that meet smoking abstinence criteria (e.g., CO ≤ 6ppm; cotinine ≤ 30ng/mL). Nicotine withdrawal and related measures will be assessed throughout the intervention. Follow-up data will be collected through 6-months post-quit date.


Eligibility criteria: Inclusion Criteria:

* current alcohol, cocaine, marijuana, or opiate abuse or dependence
* smoke ≥ 10 cigarettes per day
* expired CO \> 8 ppm
* self-reported interest in quitting smoking,
* ≥ 18 years old
* willing to provide names, addresses and phone numbers of individuals to assist in locating the participant for follow-up evaluations,
* English speaking

Exclusion Criteria:

* currently receiving behavioral therapy or pharmacotherapy for smoking plan to use pharmacotherapy in this quit attempt
* serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, suicide risk)
* cognitive impairment
* in recovery for pathological gambling

Primary outcomes:
measure: Cigarette smoking abstinence.
timeFrame: Daily through the 4-week intervention and at follow-up interviews 1, 2, 3, and 6 months following the quit date.
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Sheila M Alessi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04934787: ENMS With Balance Feedback for Post-stroke Ankle-foot Rehabilitation
Official title: Exo-neuro-musculo-skeleton With Balance Sensing Feedback for Ankle-foot Rehabilitation After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebrovascular Stroke
Foot Drop
Foot Inversion Deformity
Keywords: Robot
Stroke
Lower limb
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Innovation and Technology Commission, Hong Kong
name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2021-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this work, a novel hybrid ankle-foot robot is designed for gait rehabilitation after stroke, i.e., exoneuromusculoskeleton with balance sensing feedback (ENMS-BSF) by integrating the advantages of soft pneumatic muscle, functional electrical stimulation, exoskeleton and foot balance feedback in one system. With the assistance of the ENMS-BSF the foot drop and foot inversion could be corrected with improved muscle coordination in the paretic lower limb. The device is wearable and light-in-weight for unilateral application during walking. It is hypothesized that with the intervention of the ENMS-BSF the gait pattern of persons after stroke can be improved with long-term rehabilitative effects.


Eligibility criteria: Inclusion Criteria:

* At least 6 months after the onset of stroke
* Have sufficient cognition to follow simple instructions, as well as understand the content and purpose of the experiment (Mini-Mental State Examination (MMSE) score \>21).
* Have mild-to-moderate motor impairment in the affected lower limb with foot drop but be capable of standing and walking without manual assistance.
* Fugl-Meyer Assessment (FMA), total score on the lower limb \<20
* Functional Ambulatory Category (FAC) ≥4
* Berg Balance Scale (BBS) ≥40

Exclusion Criteria:

* The exclusion criteria will be server spasticity at the ankle joint measured by Modified Ashworth Score (MAS) \>3.
* Receiving other lower limb rehabilitative interventions at the same time

Primary outcomes:
measure: Change in Fugl-Meyer Assessment
timeFrame: before, one day after, and 3 months after the training
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: The Hong Kong Polytechnic University
Study officials:
References: