louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03824366: Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy
Official title: Pilot Study of Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (MAP-RT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignancy
Metastasis
Hemoptysis
Gastrointestinal Bleeding
Pelvic Bleeding
Superior Vena Cava Syndrome
Mediastinal Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of malignancy (biopsy proven or high clinical suspicion with urgent/emergent clinical indications for palliative RT)
* Requires delivery of palliative radiation therapy for the treatment of painful metastasis, hemoptysis, gastrointestinal bleeding, pelvic bleeding, or superior vena cava syndrome/bulky mediastinal disease.
* At least 18 years of age.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Pregnant. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Medical contraindication to undergoing MR imaging.

Primary outcomes:
measure: Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction.
timeFrame: Completion of enrollment (approximately 29 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Hyun Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05601466: Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia
Official title: Clinical Study on QN-023a Targeting CD33 in Relapsed/Refractory Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: AML, Adult
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Hangzhou Qihan Biotech Co.,Ltd.
First posted: 2022-11-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, Phase I study of QN-023a (allogeneic CAR-NK cells targeting CD33) in relapsed/refractory Acute Myeloid Leukemia (AML).

The clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-023a in patients with relapsed/refractory AML,where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.


Eligibility criteria: Key Inclusion Criteria:

* Provision of signed and dated informed consent form (ICF)
* ≥18 years old
* Diagnosis of r/r AML
* Subjects with CD33 positive leukemia cells
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ function as defined in the protocol
* Donor specific antibody (DSA) to QN-023a: MFI \<= 2000

Key Exclusion Criteria:

* Allergic to drug used in this study
* Accept other anti-tumor drug within certain time of day 0 (first QN-023a dose infusion), time window and drug defined in the protocol.
* received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy
* Acute Promyelocytic Leukemia (APL)
* Active central nervous system Leukemia.
* Uncontrolled, active clinically significant infection
* Clinically significant cardiovascular disease as defined in the protocol
* Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* History of central nervous system (CNS) disease such as stroke, epilepsy.
* Females are pregnant or lactating
* Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 28 Days from first dose of QN-023a
measure: The incidence of subjects with Dose Limiting Toxicities within each dose level cohort
timeFrame: 28 Days from first dose of QN-023a
Secondary outcomes:
measure: Overall Response Rate(ORR)
timeFrame: Up to approximately 2 years after last dose of QN-023a
measure: Relapse-free survival (RFS) of participants
timeFrame: Up to approximately 2 years after last dose of QN-023a
measure: Determination of the pharmacokinetics (PK) of QN-023a cells in peripheral blood
timeFrame: Up to approximately 2 years after last dose of QN-023a
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT04016766: Brief Mobile Intervention for Prepartying
Official title: Mobile Application Intervention Targeting the High Risk Drinking Practice of Prepartying
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heavy Drinking
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2019-07-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of the research study is to develop and test a prepartying (aka "pregaming") specific brief mobile app intervention that is intended to help college students reduce their prepartying drinking behavior. Such behavior has been identified as a major contributor to alcohol-related negative consequences among young people. The investigators will first develop the intervention content based on theory and research supporting mechanisms of change in brief interventions with college students and document normative drinking information from 500 college students for inclusion in the intervention content. Investigators will then beta test the intervention with a sample of 14 heavy drinking college students. Focus group feasibility and acceptability feedback will inform the final intervention content. Investigators will then pilot test the mobile-based intervention in a randomized controlled trial of 500 college students who preparty frequently (n = 250 intervention, n = 250 attention control) and determine the efficacy of the intervention on (1) preventing heavy consumption levels during and after prepartying and on (2) reducing students' global levels of heavy drinking and consequences one and three months post-intervention.


Eligibility criteria: Inclusion Criteria:

* full time undergraduate college student
* between the ages of 18 and 24
* report typically prepartying at least once per week

Exclusion Criteria:

* not meeting inclusion criteria

Primary outcomes:
measure: Prepartying frequency
timeFrame: Past month (30 days)
measure: Drinks during prepartying
timeFrame: Past month (30 days)
measure: Drinking frequency
timeFrame: Past month (30 days)
measure: Drinks on drinking days
timeFrame: Past month (30 days)
measure: 21-item Brief Young Adult Alcohol Consequences Questionnaire
timeFrame: Past month (30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
citation: Pedersen ER, Hummer JF, Davis JP, Fitzke RE, Christie NC, Witkiewitz K, Clapp JD. A mobile-based pregaming drinking prevention intervention for college students: study protocol for a randomized controlled trial. Addict Sci Clin Pract. 2022 Jun 18;17(1):31. doi: 10.1186/s13722-022-00314-5.
Clinical trial NCT04647565: Alcohol and Women : Screening in General
Official title: Alcohol and Women : Screening in General Medicine.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholism
Keywords: women reporting alcohol abuse and/or dependence
women recruted during hospitalisation and/or consultation
Alcohol
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-01
Enrollment: 20
Sex: FEMALE
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: Over 18 years old alcoholic womens, medical caring in consultation with addictologist or in hospitalisation for withdrawal.

Brief summary: The alcohol consumption of adults has been decreasing in France since the sixties. When focusing on the particular case of women, this trend goes on the opposite direction. In addition, the impact of drinking alcohol involves an increased severity in women in comparison to men. Furthermore, women consult less often doctors about their alcohol problem due to stigmatisation. Finally, as alcohol consumption is a major public health issue (second preventable cause of death), the aim of this study is to propose an earlier screening of women with alcohol use disorders (AUD) in general medicine.

Detailed description: To improve the screening of women with AUD in general médicine, from their perceptions and experiences, and to create a screening tool to general practitioners.

The chosen method is a qualtitative study through semi-structured interview with women with AUD.

A qualitative assessment of these individual interviews could show various topics.

Eligibility criteria: Inclusion criteria:

- over 18 years old alcoholic women, with one or several addiction, from all social class.

Exclusion criteria:

- not being able to answer the questionnaire

Primary outcomes:
measure: Assessment of women's opinion on an alcoholism screening by general practitioners.
timeFrame: 1 year
measure: Creation of a screening tool dedicated to general practitioners
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Claire MONTADE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06901765: Effectiveness of Kinesio Taping in Patients with Congenital Muscular Torticollis
Official title: Effectiveness of Kinesio Taping in Patients with Congenital Muscular Torticollis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Torticollis Congenital
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 54
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim is to investigate the effectiveness of kinesiotaping application in addition to Congenital Muscular Torticollis exercise on neck joint range of motion, tilt degree and muscle function test. Research Group: In addition to the regular exercise program, patients diagnosed with Congenital Muscular Torticollis will be given kinesio taping for torticollis. Kinesio taping will be applied for 4 weeks, 5 days on and 2 days off. Control Group: Patients diagnosed with Congenital Muscular Torticollis will continue their regular exercise program. No intervention will be applied. Patients will be evaluated with neck joint range of motion, tilt degree and muscle function test before and 3 months after treatment.


Eligibility criteria: Inclusion Criteria:

* Being followed up with a diagnosis of Congenital Muscular Torticollis
* The family's willingness to participate in the study

Exclusion Criteria:

* Presence of cardiopulmonary disease and musculoskeletal deformity that will prevent exercise
* Having an open wound in the area where kinesio taping will be applied or being allergic to tape application

Primary outcomes:
measure: Range of Motion Measurement
timeFrame: 3 months
measure: tilt degree
timeFrame: 3 months
Secondary outcomes:
measure: Muscle Function Scale
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02406365: Diagnostic Imaging Aid for Management of Cervical Lesions
Official title: Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasias
Digital Colposcopy
Precancerous Cervical Lesions
Lead sponsor: Brookdale University Hospital Medical Center
Sponsor class: OTHER
First posted: 2015-04-02
Enrollment: 618
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A handheld digital colposcope which utilizes flurorescent light is being tested for the rapid detection and management of cervical lesions. The handheld research device captures cervical images which with the fluorescent light show the regions of cervical tissue that autofluoresce. The investigators will study the relationship between the level of fluorescence and the samples of tissue (biopsies) obtained from the patient as part of her routine care. The investigators will also compare the efficacy of the hand held device with the data being collected from the other research devices being tested by the team, i.e. the multispectral digital colposcopes.


Eligibility criteria: Inclusion Criteria:

* Women who are at least 18 years old
* Women who are not pregnant as confirmed by a urine test
* Women who are not breastfeeding
* Women who understand the study procedures and can provide written informed consent

Exclusion Criteria:

* Women who do not meet the inclusion criteria
* Women who have had a hysterectomy

Primary outcomes:
measure: Detection of precancerous cervical lesions or cervical cancer
timeFrame: At point of care for colposcopy or treatment with LEEP (5 minutes).
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brookdale University Hospital and Medical Center
state: New York
Study officials:
affiliation: Brookdale University Hospital and Medical Center
name: Michele Follen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00877565: Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography - A Reliable Measure of Systolic Function?
Official title: Is Global Longitudinal Peak Systolic Strain (GLPSS) Derived From Transesophageal Echocardiography a Reliable Measure of Systolic Function? A Multicenter-Study to Compare GLPSS With Ejection Fraction Derived From Biplane Simpson´s Method on TTE and TEE in Patients Undergoing Elective Cardiac and Non-Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Keywords: LVF
Left ventricular systolic function
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-04-08
Enrollment: 400
Sex: ALL
Minimum age (years): 19
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: Patients undergoing cardiac and non-cardiac surgery

Brief summary: Systolic function is a substantial determinant of overall hemodynamics and organ function.

Therefore assessment of left ventricular systolic function (LVF) has been of central interest in Echocardiography. Ejection fraction (EF) measurement has been the gold standard echo-derived measure to describe LVF. However, EF is a blood pool derived and therefore load dependent measure.

Global longitudinal peak systolic strain average is a new parameter derived from speckle tracking tachnique. As a primarily myocardial deformation parameter it is considered to be an equivalent to EF measurement, but maybe less load dependend. The aim of the study is to investigate the reliability of GLPSS average to quantify LVF in the perioperative setting (in cardiac and non-cardiac cases).


Eligibility criteria: Inclusion Criteria:

* Adult patients in the age from 19-90 years
* Cardiac and non-cardiac surgery, where intubation is indicated
* Surgical procedures with a minimum duration of 30 min
* Elective cardiac surgery on patients scheduled for correction of:

  * coronary artery disease with and without previous myocardial infarction
  * dilated cardiomyopathy; HOCM
  * disorders of the atrial or ventricular septum
  * disorders of the aortic root or the aorta
  * left and right heart valvular disease including stenotic and/or regurgitant valvular diseases.

Exclusion Criteria:

* No patient´s consent
* Contraindications for TEE (esophageal-, gastric disorders, haematologic disorders with increased bleeding incidence; ENT-surgery, surgery of the esophageus or stomach)
* Contraindications for positioning (e.g. clinical signs of acute lung edema/acute failing left or right heart, acute coronary syndrome, myocardial infarction in recent history = within 2 weeks prior to operation date)

Primary outcomes:
measure: multivariate regression-analysis
timeFrame: 1, 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Clin. Dept. of Cardiothoracic and Vascular Anaesthesia and Intensive Medicine, Medical University of Vienna
Study officials:
References:
Clinical trial NCT03872765: Outcomes of the Use of CO2 (Carbon Dioxide) Laser in the Treatment of Chronic Anal Fissure
Official title: Cohort Study of Chronic Anal Fissure Management Using CO2 Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Anal Fissure
Lead sponsor: University of Nineveh
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 236
Sex: ALL
Minimum age (years): 26
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Outcomes of using CO2 (Carbon Dioxide) laser in the management of chronic anal fissure as an alternative to conventional methods

Detailed description: The use of CO2 laser in management of chronic anal fissure as a new alternative technique. Interventional study of 236 patients. Comparison to other techniques was made with respect to pain scores and healing time.

Eligibility criteria: Inclusion Criteria:

* Have chronic anal fissure

Exclusion Criteria:

* Acute anal fissure Pregnancy

Primary outcomes:
measure: Pain score after surgery (Degree of pain)
timeFrame: 3 weeks after surgery
measure: Recovery time after surgery (How many days patient takes to recover)
timeFrame: 3 weeks
measure: Incontinence after surgery
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01937065: Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysm
Coronary Heart Disease NOS
Unheralded Corronary Death
Intracerebral Haemorrhage
Heart Failure
Ischemic Stroke
Myocardial Infarction
Stroke
Peripheral Arterial Disease
Stable Angina Pectoris
Subarachnoid Haemorrhage
Transient Ischemic Attack
Unstable Angina
Cardiac Arrest, Sudden Cardiac Death
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: National Institute for Health Research, United Kingdom
First posted: 2013-09-09
Enrollment: 1937360
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1,93 million patients registered in Clinical Practice Research Datalink (CPRD) practices

Brief summary: Study of heterogeneity in associations between social deprivation and the initial presentation of 12 cardiovascular diseases.

Detailed description: This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility criteria: Inclusion Criteria:

* One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
* 30 years or older
* Recorded sex
* Free of symptomatic CVD at inclusion.

Exclusion Criteria:

* Pregnant women in the 6 months before the eligibility date

Primary outcomes:
measure: Hazard ratios for the associations between social deprivation and initial presentation of 12 cardiovascular diseases.
timeFrame: Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
Secondary outcomes:
measure: Lifetime cumulative incidence per quintile of social deprivation
timeFrame: Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
Other outcomes:
measure: Heterogeneity in associations across 12 cardiovascular diseases using the Tau-squared statistic and I-square statistics.
timeFrame: Followed for the duration of general practice registration between January 1997 and March 2010, an expected average of 5 years
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
References: