louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00857311: MRKAd5 HIV-1 Gag Vaccine (V520) in Subjects With Chronic Hepatitis C (V520-022) (COMPLETED)
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Probe Study With an Additional Open-Label Control Arm to Evaluate the Safety and Immunogenicity of a 3-Dose Regimen of the MRKAd5 HIV-1 Gag Vaccine in Subjects With Chronic Hepatitis C Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.


Eligibility criteria: Inclusion Criteria:

* Subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study

Exclusion Criteria:

* Subject weighs less than 110 lbs.
* Subject has received treatment for hepatitis C virus infection in the 3 months before enrollment in this study or is anticipated to begin treatment with in 1 year after enrollment
* Subject has any history of anaphylaxis or allergy to vaccine components
* Subject has any history of anaphylaxis or allergy to Tetanus and Diphtheria Toxoids Adsorbed (Td)
* Subject has clinical signs suggestive of cirrhosis
* Subject has had a liver biopsy showing bridging fibrosis or cirrhosis
* Subject is HBsAg positive
* Subject has other known chronic liver disease
* Subject has evidence of hepatocellular carcinoma on liver biopsy
* Subject has had a liver transplant or is anticipated to have a liver transplant within 1 year of enrollment
* Subject has been vaccinated with a live virus vaccine in the past 30 days
* Subject has been vaccinated with an inactive virus vaccine in the past 14 days
* Female subject is pregnant or breast-feeding, Male subject is planning to impregnate
* Subject has active drug or alcohol abuse
* Subject is at high risk for HIV infection

Primary outcomes:
measure: Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE)
timeFrame: up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs
Secondary outcomes:
measure: Number of Participants With Systemic and Laboratory Adverse Events (AE)
timeFrame: up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs
measure: Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen
timeFrame: Week 30 (4 weeks after boost injection)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03801811: Use of the Skin Glue in the Placement of Central Venous Catheters Port a Catch
Official title: Prospective Observational Study on the Safety and Efficacy of Cyanoacrylate Skin Glues to Reduce the Risk of Complications After Insertion of Totally Implantable Central Venous Catheters Port-a-Cath
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Venous Catheter
Keywords: Port
Glue
CVC
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critical ill patients

Brief summary: The use of glue as a device in the implantation of central venous catheters has recently been introduced into European clinical practice, initially with the aim of blocking bleeding at the point of exit of the PICCs, but at the same time also to close the cutaneous incision practiced to create the PORT positioning pocket.

It is possible that the surgical incision created for the insertion of the PORT may undergo complications such as: local bleeding, infections or wounds of the surgical wound.

A solution to this problem could be the application of the cyanoacrylate dermal glue on the edges of the surgical wound, after intradermal suture. The glue would have the purpose of sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect and create a potential barrier against infections.

Detailed description: Patient's informed consent signature for adhesion at the study will be initially requested. With their acceptance, parameters will be recorded anonymously in the Case Report Form, identified by a numeric code, until hospital discharge.

The parameters analized will be related to:

* essential patient data (identification number, gender, age, height weight)
* basic diseases
* associated diseases and risk factors
* origin of the patient (department or home)
* reason for positioning
* hemorrhagic complications detected in the first 24 hours
* hemorrhagic complications detected in the first 7 days
* non-bleeding complications detected at 7 days (local and systemic infections, wound delescence)

The data wil be transferred to an Excel worksheet, in order to conduct a descriptive analysis related to every variable

Eligibility criteria: Inclusion Criteria:

* informed consent signature
* age \> 18 years

Exclusion Criteria:

* Age\> 90 years
* Cianoacrilate allergy
* Presence of bacteraemia
* Informed consent refusal

Primary outcomes:
measure: visible presence of blood around the emergency site
timeFrame: 24 hours
Secondary outcomes:
measure: Early infection of the emergency site;
timeFrame: 7 days
measure: Deischence of the surgical wound
timeFrame: 15 days
measure: Systemic infection
timeFrame: 15 days
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Azienda Ospedaliera Universitaria di Parma
Study officials:
References:
Clinical trial NCT02647411: Increased Prevalence of Myopia in a Ophthalmologic Hospital in Goiânia - Goiás
Official title: Increased Prevalence of Myopia in a Ophthalmologic Hospital in Goiânia - Goiás
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: Prevalence
Myopia
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 16971
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 16.806 students from municipal schools of Goiânia during the period October 1995 to December 2000 In the second study there were selected 165 children from 2 to 14 years old who were referred to the Institute of Goiânia eyes, look at Brazil project within the school environment. The Look Brazil project aims to identify vision problems related to refraction.

Brief summary: The purpose of this study was to evaluate the increased prevalence of myopia among patients in different periods in an ophthalmologic hospital in Goiania. There has been an increase of myopia prevalence around the world especially in some Asian countries. The investigators intend to analyze if this growing tendency is also present in our hospital, and if it exist how much is this growth.

Detailed description: There were compared data collected in two scientific studies carried out in the same ophthalmologic hospital in different periods of time, they evaluated among other factors, the refractive errors of the participants, from this data there were compared the percentage of patients with myopia between the two studies. And analysed how much was the grown of myopia

Eligibility criteria: Inclusion Criteria:

* Patients between 2 and 20 years assessment of Project "Olhar Brasil"
* Patients between 2 and 40 years assessment of Project "Boa visão"

Exclusion Criteria:

* The patients wasn't assessment of Project "Olhar Brasil"
* The patients wasn't assessment of Project "Boa Visão"

Primary outcomes:
measure: Analisys of the percentage of patients with myopia in an ophthalmologic hospital in Goiânia - Goiás based on two prevalence studies made in the same hospital in different periods of time.
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03472911: Retroclavicular Approach to Infraclavicular Block
Official title: Minimum Effective Volume of Bupivacaine 0.5% for Ultrasound-guided Retroclavicular Approach to Infraclavicular Brachial Plexus Block
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bupivacaine
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-03-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults between 18 and 65 years of age with infraclavicular brachial lexus block for elective elbow, forearm, wrist, or hand surgery , were selected in the study.

Brief summary: In this study, the primary objective was to estimate the minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50) for ultrasound-guided retroclavicular approach to infraclavicular brachial plexus block.

Detailed description: Two rules were used to stop the study. First stopping rule was a fixed-sample-size. The investigators used an up-and-down method to estimate the threshold for an all-or-none response for present study design. Therefore, for sample size calculation, the investigators applied the formula by Dixon and Massey, n=2(SD/SEM)2 (SD: standard deviation and SEM: standard error of mean). Second stopping rule included demonstration of minimum of five consecutive up-and-down sequences. On the basis of previous studies with similar binary outcomes, the investigators estimated that a priori a minimum of five negative-positive up-and down deflections was required to calculate MEV50.

Eligibility criteria: Inclusion Criteria:

* patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery
* American Society of Anesthesiologists class I, II or III

Exclusion Criteria:

* patients \<18 years old
* \>65 years old
* body mass index (BMI) \<20 or \>35 kg/m2
* inability to provide written informed consent
* refusal of regional anesthesia
* pregnancy
* contraindication for regional anesthesia

Primary outcomes:
measure: The minimum effective volume of bupivacaine 0.5% resulting in successful block in 50% of patients (MEV50)
timeFrame: 30 minutes
Secondary outcomes:
measure: estimate the minimum effective volume in 95% of patients (MEV95).
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research hospital
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05940311: Versatile Ampification Single-Molecule Detection in Liquid Biopsy
Official title: Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liquid Biopsy
Melanoma (Skin)
Melanoma Stage III
Melanoma Stage IV
Keywords: BRAFV600E
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: VTT Technical Research Centre, Finland
name: Institute of Health Information and Statistics of the Czech Republic
name: Universita degli Studi di Catania
name: FINNADVANCE (FIN)
name: PDC Biotech GmbH
First posted: 2023-07-11
Enrollment: 20
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: BRAF V600E Melanoma patients

Brief summary: The trial will test a paradigm-changing in vitro diagnostic device for Liquid Biopsy enabling facile simultaneous detection of protein and nucleic acid analytes with sensitivity at single-molecule level, e.g. not achievable with any alternative technology. A novel affinity-mediated transport amplification (AMT) method will be tested allowing for the multiplexed quantification of rare biomarkers circulating in blood. The Versilib AMT photonic biosensor will test two analytes: the known actionable DNA mutation BRAF p.V600E, and a melanoma-restricted protein antigen. The results will be compared to digital PCR and ELISA methods.


Eligibility criteria: Inclusion Criteria:

* age: ≥ 18
* PFS≤2
* Patients willing to sign an informed consent;
* Confirmed (cytologically or histologically) cutaneous melanoma diagnosis
* Confirmed BRAF p. V600E tumor status
* Eligible for BRAFi/MEKi treatment or Immune checkpoint blockade in either the adjuvant or advanced settings (the latter typically stages III/IV, high risk).

Exclusion Criteria:

* Life expectancy \<8 weeks
* Other clinical conditions preventing blood drawing compliance, as per physician's choice.

Primary outcomes:
measure: Pilot study, descriptive statistics will be adopted (frequency, average, standard deviation, median, interval). Concordance indexes will be calculated, e.g. between dPCR and ELISA assays on the one hand and Versilib data on the other.
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT06195111: A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With mCRC (REFLECT Study)
Official title: A Real-world Study of Trifluridine/Tipiracil Containing Regimen for the Treatment of Patients With Metastatic Colorectal Cancer (REFLECT Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, being treated for mCRC with Trifluridine/Tipiracil-containing regimen.

Brief summary: A real-world study of trifluridine/tipiracil containing regimen for the treatment of patients with metastatic colorectal cancer. A total of 200 patients planned to be enrolled.

Detailed description: This is a non-randomized, uncontrolled, multicenter real-world study. The total number of subjects is 200. The objective is to observe and evaluate the efficacy and safety of Trifluridine/Tipiracil alone or in combination with other therapies in the treatment of metastatic colorectal cancer in real-world environment. The primary endpoints is Progression-free survival (PFS). Secondary endpoints are overall survival (OS), Objective response rate(ORR), Disease control rate(DCR), progression-free survival (PFS), and Quality of life (QoL).

Eligibility criteria: Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:

* Male and female patients with ≥18 years of age;
* Patients with metastatic colorectal cancer confirmed by histopathology;
* Be willing to use reliable contraceptive methods and refrain from sperm donation throughout the study period and within 3 months after the last dose;
* Voluntarily join the study and provide written informed consent to participate in the study;
* Have traceable medical history during the treatment;
* Doctor believe the patients can benefit from the study.

Exclusion Criteria:

Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study:

* Failure to sign informed consent;
* Patients with contraindications to Trifluridine/Tipiracil;
* Female subjects who have a positive pregnancy test or are breastfeeding;
* Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation.

Primary outcomes:
measure: PFS (Progression-free survival)
timeFrame: Approximately 12 months
Secondary outcomes:
measure: OS (Overall Survival)
timeFrame: Approximately 12 months
measure: ORR（Objective response rate）
timeFrame: Approximately 12 months
measure: DCR (Disease control rate)
timeFrame: Approximately 12 months
measure: Quality of life: EORTC QLQ-C30
timeFrame: Approximately 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00750711: Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters
Official title: Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Typical Atrial Flutter
Radiofrequency Ablation
Irrigated Catheters
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2008-09-10
Enrollment: 200
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: The purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm irrigated catheters for ablation of typical flutter.It's a prospective randomised multicenter study.


Eligibility criteria: Inclusion Criteria:

* All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter

Exclusion Criteria:

* Pregnancy
* Hemodynamic instability
* A recurrence of previous ablated typical atrial flutter

Primary outcomes:
measure: Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
References:
Clinical trial NCT01196611: Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
Official title: Effectiveness of Two Therapeutic Approaches in Female Teachers With Voice Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voice Disorders
Keywords: Voice disorders
Voice
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
First posted: 2010-09-08
Enrollment: 162
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares two different approaches of voice therapy. Vocal Functional Exercises (Stemple,1997) and Voice Amplification using a portable amplifier (Tsi Supervoz II - Tecnisystem do Brasil TSI 1210).

Detailed description: Both approaches combined with Vocal Hygiene Program (Behlau, 2007).The target population are female teachers because they have the highest risk for developing voice problems. For this study the investigators are primarily interested in seeing if Vocal Functional Exercises and Voice Amplification are equally effective at improving vocal functioning in teachers with voice disorders. The Fiberoptic endoscopic evaluation will be done before randomization. All the participants will complete before and after a 6-week treatment phase (a) Voice Activity and Participation Profile (PPAV), an instrument designed to appraise the self-perceived psychosocial consequences of voice disorders to assess the impact of voice disorders on daily activities (b) Audio voice recording for later acoustic analysis, through the Kay Elemetrics Multi Dimensional Voice Program (c) Audio recording for later perceptual analysis through Consensus Auditory-Perceptual Evaluation of Voice (CAPE_V). It is believed that the search for evidence in clinical studies like this can contribute to awareness programs and vocal training for teachers.

Eligibility criteria: Inclusion Criteria:

* Female teacher
* 21-50 years old.
* Full or part time elementary to middle school teacher ( Prefeitura Municipal de Belo Horizonte).
* Minimum 20 hour weekly workload.
* Medical reference to speech therapy due to behavioral dysphonia

Exclusion Criteria:

* Physical education or daycare teachers.
* Professional singers.
* Neurological and/or psychiatric voice disorders

Primary outcomes:
measure: Fiberoptic endoscopic evaluation
timeFrame: One year
measure: Score(CAPE_V); score(PPAV); score on acoustic analysis
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
Study officials:
affiliation: Universidade Federal de São Paulo
name: Mara S Behlau, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Arnaldo L Colombo, PhD
role: STUDY_DIRECTOR
affiliation: Federal University of São Paulo
name: Letícia C Teixeira, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Minas Gerais
name: Ana Cristina C Gama, D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06075511: A Study of Sleeve Gastrectomy Risks and Benefits
Official title: Prospective Study to Assess Fitness in Patients with Renal Failure Undergoing Sleeve Gastrectomy - PROFIT
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Renal Failure
Keywords: Sleeve Gastrectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 0
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: Subjects will be identified through the clinical setting that are diagnosed renal failure and scheduled for sleeve gastrectomy per standard of clinical care.

Brief summary: This research study is being conducted to collect information to improve the outcomes of patients who have renal failure and are scheduled to have a sleeve gastrectomy.

Detailed description: We will collect information on changes in physical performance, activity, blood pressure and glucose metabolism, body composition, and the quality of life prior to and three months after sleeve gastrectomy.

Eligibility criteria: Inclusion Criteria:

* Kidney transplant candidates with obesity.
* Accepted for sleeve gastrectomy (SG).
* Accepted for kidney transplantation if criteria are met after SG.

Exclusion Criteria:

* Not undergoing sleeve gastrectomy.
* Unable to connect through telehealth technology.
* History of medical non-adherence that can affect adherence to the protocol.
* Any other medical condition that in the opinion of the Principal Investigators warrants exclusion for safety reasons.

Primary outcomes:
measure: Change in 6-minute walk distance (6MWD)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) score
timeFrame: Baseline, 12 weeks
measure: Change in total step count
timeFrame: Baseline, 12 weeks
measure: Change in quality of life
timeFrame: Baseline, 12 weeks
measure: Change in glucose metrics
timeFrame: Baseline, 12 weeks
measure: change in insulin, C peptide and glucose metrics
timeFrame: Baseline, 12 weeks
measure: Change in blood pressure
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Aleksandra Kukla, MD
role: PRINCIPAL_INVESTIGATOR
References: