louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04983134: Women Helping Women - Lung Cancer Screening
Official title: Women Helping Women Lung Cancer Screening (WHW-L)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 46
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Women Helping Women Lung Cancer Screening (WHW-L) Study will be conducted to develop a scalable, easy to apply community-based intervention to increase rates of lung cancer screening and follow-up in high-need/low-resource populations, based on a Transtheoretical Stages of Change theoretical model. The investigators will test the feasibility of using Community Health Workers to recruit (Aim 1) and partner with 60 community members (Aim 2) within 6 months, to take the steps to consult with a doctor, schedule screening, and/or attend screening (Aim 3) \[84 people may be screened for the study assuming some don't continue}.CHWs will use the HealthStreet 12,000+ cohort to identify current or former female smokers (adults 50 to 77 years old) with a smoking history of 25 pack-years who could benefit from LDCT screening for lung cancer and will facilitate steps in their screening receipt. All participants will benefit from the Standard Intervention; additionally, a random sample of 30 will receive the Enhanced CHW Intervention (E-CHW-I). The investigators hypothesize that women who may be at higher risk of lung cancer due to lack of knowledge, access, and resources will take steps to receipt of LDCT in both interventions, with those receiving the Enhanced Intervention more likely to take these steps. Ultimately, such an intervention could lead to a lower lung cancer burden in the target population


Eligibility criteria: Inclusion Criteria:

* women who are 50 to 80 years old
* 20+ pack-years of smoking history
* live within 45 miles of UF Health Shands Hospital or in Duval County, specifically the 12,000+ HealthStreet cohort

Exclusion Criteria:

* women outside the acceptable age range
* insufficient smoking history
* women who live outside the 45 miles of UF Health Shands Hosptial or not in Duval County not in the HealthStreet system

Primary outcomes:
measure: Feasibility of Recruitment - Degree of Agreement Measured with Likert Scale
timeFrame: at baseline visit
measure: Feasibility of Implementation - screening adherence with Community Health Worker
timeFrame: At 4 weeks after intervention completion
measure: Evaluation of Efficacy - number of participants who engaged in a referred screening service
timeFrame: after intervention completion, at the 45-day follow up call
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Cancer Center
state: Florida
Study officials:
References:
Clinical trial NCT05011734: Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.
Official title: Rapid Postoperative Recovery (Fast-track) Pathway in Adolescent Idiopathic Scoliosis: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis Idiopathic
Keywords: Scoliosis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with idiopathic scoliosis treatable by surgical procedure

Brief summary: the study will evaluate the clinical outcomes of an intra- and postoperative fast-track protocol in patients undergoing instrumented posterior arthrodesis surgery for adolescent idiopathic scoliosis.


Eligibility criteria: Inclusion Criteria:

* Ages 14-18 years
* iagnosis of adolescent idiopathic scoliosis requiring an instrumented posterior arthrodesis surgical procedure
* Males and females.

Exclusion Criteria:

* spinal infection
* neoplastic diseases
* heart disease
* hypersensitivity to tranexamic acid
* history of coagulopathy and/or previous thromboembolic events
* severe renal failure

Primary outcomes:
measure: Evaluation of the Fast track protocol
timeFrame: at baseline (Day0)
measure: Evaluation of the Fast track protocol
timeFrame: at baseline (Day0)
measure: Evaluation of the Fast track protocol
timeFrame: at baseline (Day0)
measure: Evaluation of the Fast track protocol
timeFrame: at baseline (Day0)
Secondary outcomes:
measure: Surgical and clinical outcome
timeFrame: at baseline (Day0)
measure: Surgical and clinical outcome
timeFrame: at baseline (Day0)
measure: Surgical and clinical outcome
timeFrame: at baseline (Day0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Itituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: Wang H, Tetteroo D, Arts JJC, Markopoulos P, Ito K. Quality of life of adolescent idiopathic scoliosis patients under brace treatment: a brief communication of literature review. Qual Life Res. 2021 Mar;30(3):703-711. doi: 10.1007/s11136-020-02671-7. Epub 2020 Oct 24.
citation: Lee CS, Merchant S, Chidambaran V. Postoperative Pain Management in Pediatric Spinal Fusion Surgery for Idiopathic Scoliosis. Paediatr Drugs. 2020 Dec;22(6):575-601. doi: 10.1007/s40272-020-00423-1. Epub 2020 Oct 23.
citation: Seki H, Ideno S, Ishihara T, Watanabe K, Matsumoto M, Morisaki H. Postoperative pain management in patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis: a narrative review. Scoliosis Spinal Disord. 2018 Sep 12;13:17. doi: 10.1186/s13013-018-0165-z. eCollection 2018.
Clinical trial NCT06804434: Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
Official title: Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Anesthesia
Perioperative Care
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* ASA score I-III
* surgery for gastric or hepatobiliary or pancreatic neoplasia

Exclusion Criteria:

* pregnancy
* lactation
* neuraxial or regional anesthesia
* chronic treatment with drugs that can influence autonomic nervous system
* diuretics or nitroglycerin administration on the day of surgery
* severe neurological disability
* severe hemodynamic instability
* chronic pain
* chronic opioid treatment
* allergy to any of the study drugs
* severe untreated disease or organ failure
* pacemaker
* emergency surgery
* patient refusal to participate

Primary outcomes:
measure: Intraoperative opioid use
timeFrame: intraoperative
Secondary outcomes:
measure: Intraoperative pulse
timeFrame: intraoperative
measure: Intraoperative blood pressure
timeFrame: intraoperative
measure: Postoperative pain scores
timeFrame: 24 hours
measure: Postoperative opioid use
timeFrame: 24 hours
measure: Lidocaine related adverse events
timeFrame: 24 hours
measure: Opioid related adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Regional Gastroenterology and Hepatology Institute Octavian Fodor
state: Cluj
Study officials:
References:
Clinical trial NCT05358834: Testing Effects of Melatonin on Uterine Contractions in Women
Official title: Testing Effects of Melatonin on Uterine Contractions in Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnant Women
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-05-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will extend recent discoveries that have been made in basic human physiology related to responses melatonin and uterine contractions in late- or full-term pregnant women. The basic physiology work has been conducted in in vitro models of the human myometrium characterizing its responses to melatonin, and in pilot in vivo studies correlating the number of uterine contractions with melatonin concentrations that were manipulated by different types of light exposure. The planned experiments will test a causal link between circulating melatonin levels and uterine contractions in full-term pregnant women by manipulating melatonin levels using exogenous melatonin (i) during the day when endogenous levels of melatonin are very low (Experiment 1), and (ii) during the evening under conditions with lighting that would be expected to suppress the higher evening and nighttime levels of endogenous melatonin (Experiment 2).


Eligibility criteria: Inclusion Criteria:

* nulliparity, age between 18 and 35,
* BMI\<36 pre-pregnancy,
* ≥38 weeks of pregnancy with a single fetus at time of study.

Exclusion Criteria:

* color blind;
* prescription drugs affecting sleep, melatonin, and/or circadian rhythms (e.g., beta blockers, non-steroidal anti-inflammatory drugs);
* a health or pregnancy related condition that might affect melatonin or uterine contractions;
* medical conditions or medications for which melatonin might be contraindicated or there may be a drug interactions (e.g., Central Nervous System depressants/sedatives, Fluvoxamin (Luvox), medications for diabetes, immunosuppressants, anti-coagulants, Nifedipine, Verapamil).

Note: We cannot list all possible exclusionary criteria. Dr. Carolina Bibbo (co-I), our Obstetrics Investigator at Brigham and Women's Hospital (BWH), will make final determination of suitability including any safety concerns for each potential participant.

Primary outcomes:
measure: Daytime: Total number of uterine contractions
timeFrame: 10 hours
measure: Nighttime: Total number of uterine contractions
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Elizabeth B Klerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858234: Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)
Official title: A Multicenter, Open-Label, Phase I Study of MK-0683 in Combination With Bortezomib in Patients With Relapsed and/or Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this clinical study is to determine the recommended clinical doses of vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed and/or refractory multiple myeloma (MM). It was hypothesized that administration of vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to permit further study in participants with relapsed and/or refractory MM. Study results are based on data collected up to the data cut-off date of 20-March-2011.


Eligibility criteria: Inclusion Criteria:

* is ≥20 years of age.
* has an established diagnosis of MM based on the myeloma diagnostic criteria
* has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen
* has adequate organ function

Exclusion Criteria:

* has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation during the study
* has known hypersensitivity to any components of vorinostat or bortezomib
* has active hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus (HIV) positive
* has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors

Primary outcomes:
measure: Number of Participants With Dose-Limiting Toxicity (DLT) During Cycle 1
timeFrame: Up to 21 days
Secondary outcomes:
Other outcomes:
measure: Number of Participants With an Adverse Event (AE)
timeFrame: Up to 346 days (up to 30 days after the final dose of study treatment)
measure: Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Vorinostat Administered With Bortezomib on Days 1 and 11
timeFrame: Predose and 0.8, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Days 1 and 11
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Ogawa Y, Ogura M, Tobinai K, Ando K, Suzuki T, Watanabe T, Ohmachi K, Uchida T, Hanson ME, Tanaka Y, Koh Y, Shimamoto T, Hotta T. A phase I study of vorinostat combined with bortezomib in Japanese patients with relapsed or refractory multiple myeloma. Int J Hematol. 2016 Jan;103(1):25-33. doi: 10.1007/s12185-015-1897-7. Epub 2015 Nov 30.
Clinical trial NCT02738034: Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment
Official title: Cogmed Training Effect in Hypertensive Patients With Cognitive Impairment: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Cognition
Computerized Training
Cogmed
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Systemic arterial hypertension is a disease with high prevalence in several countries, including Brazil. Many studies have correlated hypertension with accelerated loss of cognitive function, especially executive functions. There is some evidence that working memory (WM) is compromised in these populations. However, some computerized training has been developed to rehabilitate the WM, and among them the investigators highlight the Cogmed. Thus, the aim of this study is to evaluate the effects of Cogmed training in the performance of WM and attention of hypertensive patients, as well as the impact of training in the structure and brain function.


Eligibility criteria: Inclusion Criteria:

* Individuals of both genders, of any ethnicity
* Signing the consent form
* Access to computer with internet at home
* Inexperienced to computerized cognitive training
* Hypertensive pre-diagnosed
* Basic schooling of four years
* Cognitive impairment

Exclusion Criteria:

* Marked functional limitation
* Cognitive limitation or serious communication
* Severe neurological and psychiatric diseases
* Stroke history, head trauma or substance abuse

Primary outcomes:
measure: Working memory score
timeFrame: 10 weeks
Secondary outcomes:
measure: Brain function
timeFrame: 10 weeks
measure: Executive functions score
timeFrame: 10 weeks
measure: Verbal memory score
timeFrame: 10 weeks
measure: Visual memory score
timeFrame: 10 weeks
Other outcomes:
measure: Medication adherence score
timeFrame: 10 weeks
measure: Quality of life score
timeFrame: 10 weeks
measure: Perceived Stress score
timeFrame: 10 weeks
measure: Anxiety and Depression symptoms score
timeFrame: 10 weeks
Locations:
city: Sao Paulo
country: Brazil
facility: Regina Silva Paradela
state: São Paulo
Study officials:
References:
Clinical trial NCT04534634: Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）
Official title: An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: B-cell Acute Lymphoblastic Leukemia
Keywords: IFN-α, CAR-T
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).

Detailed description: This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed refractory and relapsed acute B-lymphoblastic leukemia.
2. Age 12-65.
3. Eastern Cooperative Oncology Group (ECOG) score 0-2.
4. Target on leukemia is \>20% positive detected with flowcytometry.
5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification.

5.Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.

6.No other immunotherapy was received within 3 months.

Exclusion Criteria:

1. Patients are pregnant or lactating.
2. Patients with congenital immunodeficiency.
3. Patients with central nervous system leukemia.
4. Patients with uncontrolled active infection.
5. Patients with active hepatitis B or hepatitis C infection.
6. Patients with HIV infection.
7. Patients with atrial or venous thrombosis or embolism.
8. Patients with myo-infarction or severe arrythmia in the recent 6 months.
9. Other comorbidities that investigators considered not suitable for this study.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 2 years
measure: Leukemia-free survival (LFS)
timeFrame: 2 years
measure: Cumulative incidence of relapse(CIR)
timeFrame: 2 years
measure: the duration of CAR-T cells in patients
timeFrame: 2 years
measure: Number of adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: xiaowen tang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01218334: A Comparative Trial of Standard 12 Lead ECG to the 12 Lead ECG Glove to Assess Cardiac Electrical Function
Official title: A Randomized, Single Blind, Comparative Trial of Standardized 12 Lead ECG to the 12 Lead ECG Glove for the Assessmant of Cardiac Electrical Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Electrical Function
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology Patients

Brief summary: The proposed study is a two-arm, randomized, single-blinded, cross-over Phase III clinical trial in which patients in 3 distinct clinical scenarios will receive the 12LEG, followed by the standard ECG, or vice-versa. Each participant will then apply the Hand ECG themselves. The 3 clinical scenarios will be: 1. patients at preoperative assessment for elective cardiac catheterization or electrophysiology procedures; 2. patients coming for outpatient cardiology appointments; 3. Inpatients admitted with a cardiac diagnosis.

The electrophysiologists reviewing ECGs will be blinded to the equipment utilized to obtain the ECG.


Eligibility criteria: Inclusion Criteria:

1. Preop assessment for elective cardiac catheterization or EP procedure.
2. Outpatient cardiology appointments.
3. Inpatients admitted with a cardiac diagnosis

Exclusion Criteria:

1. Age less than 18.
2. Skin breakdown.

Primary outcomes:
measure: comparison of Hand ECG to standard ECG with physician over-read
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Anthony Aizer, MD
role: PRINCIPAL_INVESTIGATOR
References: