louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04200846: Frailty in Liver Transplant Exercise (FLEX) Trial
Official title: Frailty in Liver Transplant Exercise (FLEX) Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Frailty
Liver Transplants
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An interventional pilot trial will be performed with 21 randomized subjects who are aged 18-75 years who are frail according to the LFI to a 3-month exercise intervention (n=14) versus standard of care (n=7) with no change in activity.
Primary purpose: TREATMENT

Brief summary: Frailty is common in patients with end-stage liver disease. It's characterized by reduced strength, low endurance and reduced physical function. While exercise intervention can improve frailty in geriatric patients without liver disease, whether or not exercise intervention can improve frailty in liver transplant candidates remains unknown.

Detailed description: The long-term goal is to better understand how exercise impacts frailty in order to identify treatments that can improve both patient-oriented outcomes and access to liver transplantation for end-stage liver disease patients. The specific objective of this proposal is to generate pilot feasibility data required for future multicenter R01 application to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) which will test the novel central hypothesis that exercise improves frailty and lessens waiting-list mortality. Additionally, another goal of the study is to establish an optimal frailty tool for liver transplant candidates.

Eligibility criteria: Inclusion Criteria:

* Adults age ≥18 or ≤75 years
* Frail as defined by a LFI score of \>4.5
* Under evaluation or listed for liver transplant

Exclusion Criteria:

* Active cardiac symptoms (e.g., chest pain, shortness of breath at rest, palpitations)
* Positive response to Get Active Questionnaire (GAQ) (validated activity questionnaire that indicates if exercise is unsafe)
* Institutionalized/prisoner
* Severe medical comorbidities/psychiatric illness at the discretion of the Study Principal Investigator (PI)

Primary outcomes:
measure: Number of participants able to complete the trial
timeFrame: up to 52 weeks
measure: Incidence of Treatment-Emergent Adverse Events as assessed by GCP guidelines
timeFrame: up to 52 weeks
measure: Rate of enrollment
timeFrame: up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02895646: Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics
Official title: Genomic Study of Genetic Polymorphisms Involved in Immediate Allergic Reactions to Beta-lactam Antibiotics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Beta-Lactams Allergy
Hypersensitivity
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 2356
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population having an immediate IgE-mediated hypersensibility to beta-lactam antibiotics and matched control subjects.

Brief summary: Beta-lactam antibiotics include penicillin and cephalosporins and are among the most prescribed antibiotics. This category of drugs is the most involved in immediate allergic manifestations with 2% reactions in treated subjects and a fatal outcome in 1/50000 treatments. Reactions are IgE-mediated and have a considerable but unknown genetic origin, revealed by studies in groups of different ethnical origins in the same geographical region. There are also some families with a high frequency of allergic reactions without identified Mendelian inheritance.

The purpose of this study is to identify predictive risk factors associated to immediate allergic reactions against beta-lactam antibiotics with a pangenomic approach.

A secondary purpose is to identify rare predictive factors with homozygosity mapping and exome sequencing in various families with high risk of allergy to beta-lactam antibiotics.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Allergy group: Immediate allergic reaction (less than 2 hours after drug administration) to an antibiotic of penicillin or cephalosporin groups
* Allergy group: Positive skin test (intradermal test) with a non-irritant dilution of antibiotic of penicillin or cephalosporin groups

Exclusion Criteria:

* Refusal of participation

Primary outcomes:
measure: Analysis of genetic polymorphisms predictive of risk of beta-lactam immediate allergy
timeFrame: day 0
Secondary outcomes:
measure: Analysis of allelic homozygosity linked to allergen response, in more than 2 allergic individuals of the same family
timeFrame: day 0
measure: Severity of allergic reaction
timeFrame: day 0
measure: Reactivity to skin test
timeFrame: day 0
measure: Serum concentration of specific IgE
timeFrame: day 0
Other outcomes:
Locations:
Study officials:
affiliation: Service de BBMNM, CHU Nancy / unité INSERM U954, Faculté de Médecine, 54500 Vandoeuvre Les Nancy
name: Jean-Louis GUEANT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01520246: Gene Expression in Samples From Patients With T-Cell Acute Lymphoblastic Leukemia
Official title: Signaling in Tumorigenesis and Immunity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Lymphoma
Keywords: adult acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia
adult T-cell leukemia/lymphoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-27
Enrollment: 20
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With T-Cell Acute Lymphoblastic Leukemia

Brief summary: RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial studies gene expression in samples from patients with T-cell acute lymphoblastic leukemia.

Detailed description: OBJECTIVES:

* To test whether the tumor suppressor candidate gene PDLIM2 is downregulated in human cancers such as T-cell acute lymphoblastic leukemia (T-ALL) and to use the human T-lymphotropic virus 1 (HTLV-1)-mediated in vitro transformation of human T cells as control.

OUTLINE: Previously collected cancer and control tissues are analyzed for the expression patterns of PDLIM2 and other control genes. Human T-cells isolated from human blood are also co-cultured with HTLV-1-transformed T-cell lines.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Specimens (e.g., tissue, blood, and bodily fluids) of various cancer cells and or tissues from de-identified patients such as T-cell acute lymphoblastic leukemia (T-ALL)
* Normal control tissue

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: PDLIM2 expression patterns in cancer and control tissues
measure: 8-week survival of human T-cell co-cultured with HTLV-1-transformed T-cell lines
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Gutian Xiao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04511546: Exploratory Study Using a New Head-only PET Scanner
Official title: Exploratory Study of BPET, an Investigational Medical Device Without CE-marking for PET Imaging of the Human Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Diseases
Lead sponsor: Positrigo AG
Sponsor class: INDUSTRY
Collaborators: name: University of Zurich
First posted: 2020-08-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The "BPET prototype" is a small aperture PET scanner. The BPET prototype will be used with patients, which have just finished their regularly scheduled PET examination on a clinical whole body PET system. The radioactive tracer used for this procedure will still be active. This remaining acitivity will be used for an image acquisition with the BPET prototype without the need for an additional radioactive tracer dose.

The control intervention is be a brain PET scan as part of standard clinical routine. It will be done immediately before the scan on the BPET prototype.


Eligibility criteria: Inclusion Criteria:

* Capable of giving Informed Consent as documented by signature (Appendix Informed Consent Form)
* ability to sit still in the head-only PET scanner for 15 minutes
* Are scheduled to receive a regular brain PET scan as part of clinical routine.
* Male and Female patients 18 years to 80 years of age

Exclusion Criteria:

* Contraindications to PET examination,
* Patient height smaller than 160 cm or taller than 200 cm,
* Patient weight more than 120 kg,
* Patient cannot sit upright for at least 15 minutes,
* Metal implants in the head,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, severe dementia, etc. of the participant,
* Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons.

Primary outcomes:
measure: PET image of the brain
timeFrame: 1 day
Secondary outcomes:
measure: Usability (patient feedback for seat comfort)
timeFrame: 1 day
measure: Usability (medical technologist feedback for ease of positioning)
timeFrame: 1 day
Other outcomes:
measure: Assessment of adverse events
timeFrame: During the imaging procedure which should last 15 minutes.
measure: Assessment of device deficiencies
timeFrame: During the imaging procedure which should last 15 minutes.
measure: Identification of new risks
timeFrame: During the imaging procedure which should last 15 minutes.
Locations:
city: Schlieren
country: Switzerland
facility: PET Center Schlieren
state: ZH
Study officials:
affiliation: University of Zurich
name: Martin Hüllner, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04234646: Patient Navigation 2.0
Official title: Patient Navigation 2.0: Addressing the Challenge of Scaling Navigation Through Checklist-based Implementation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northeastern Illinois University
First posted: 2020-01-21
Enrollment: 600
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates whether a "Patient Navigation 2.0 Checklist" intervention is effective in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.

Detailed description: Cancer patient navigation (PN) is an effective strategy for resolving patient barriers to care and improving completion and consistency of cancer screening, follow-up of abnormal findings, and treatment initiation. However, as the current standard one-on-one PN model is challenging to scale across cancers and economically difficult to sustain, the investigators propose to convert one-on-one PN into a learning health system "PN 2.0 Checklist" that will help coordinate navigation workflow and integrate clinical team members with community/local resources. This pragmatic, randomized trial tests whether this checklist strategy is as effective as one-on-one PN in addressing patients' social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.

In this study, half of the participants will be navigated using the "PN 2.0 Checklist". The other half will be navigated using the "One-on-One PN". All participants enrolled in the study will be asked to report their utilization of health services and be asked to complete a patient survey at the beginning of the program and every 6 months.

Eligibility criteria: Inclusion Criteria:

* Age 21 or older
* Reside in one of the eight Chicago zip codes corresponding to Chinatown's geographical boundaries: 60605, 60607, 60608, 60609, 60616, 60623, 60632, 60653
* Self-identify as Chinese
* Not cognitively impaired
* Have the ability to participate in verbal survey in Cantonese, English, Mandarin, or Toishanese

Exclusion Criteria:

* Cognitive impairment
* Incarceration
* Under 21 years of age
* Adult unable to consent

Primary outcomes:
measure: Patient Receipt of Clinical Cancer Preventive Services and Resolution of Social Determinants of Health Barriers
timeFrame: through study completion, an average of 18 months
Secondary outcomes:
measure: Timeliness of diagnostic resolution
timeFrame: through study completion, an average of 18 months
measure: Timeliness of treatment initiation
timeFrame: through study completion, an average of 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern
state: Illinois
Study officials:
affiliation: Northwestern University
name: Melissa Simon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01487746: Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls
Official title: Presence of Minor Anti Phospholipid Antibodies in Blood Samples of Ischemic Stroke Patients and Healthy Controls.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: APLA
APS
Stroke
minor anti body
major anti body
APLA antibodies in Serum
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
First posted: 2011-12-07
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: on a bank of 207 stroke patients serum samples, and also on 40 healthy controls. The samples were collected during the acute phase of the ischemic event.

Brief summary: The investigators expect to find higher levels of both classical and minor antiphospholipid (APL) antibodies among the stroke cases. Furthermore, the investigators expect to find not only classical APLA but also minor antibodies.

The investigators believe that minor antibodies have a major role in the hypercoagulability state.


Eligibility criteria: Inclusion Criteria:

* stroke diagnosis
* blood sampling within 36hrs from the event
* written agreement

Exclusion Criteria:

* a stroke, MI or major operation prior to the current stroke
* hypercoagulable state known in this patient
* a severe chronic disease known at the time of the stroke
* an infection on arrival (based on anamnesis, physical exam and lab tests)
* thrombolytic treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar-saba
country: Israel
facility: Meir health center
Study officials:
References:
Clinical trial NCT06520046: Motor Control Prevention Strategies in Basketball Players
Official title: Motor Control Prevention Strategies for Ankle Sprains in Basketball Players
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Sprains
Motor Disorders
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ankle sprains have always been considered as isolated injury entities, in which the passive ankle stabilisation system suffered an elongation due to trauma. Today, this concept of an isolated injury has evolved into a more holistic concept, interrelated with various components from different sources.


Eligibility criteria: Inclusion Criteria:

* Basketball players aged between 10-18 years old who play regularly in one of the basketball clubs in the city of Salamanca.

Exclusion Criteria:

* previous injuries
* fractures
* use of orthoses and technical aids

Primary outcomes:
measure: Range of motion
timeFrame: At the beginning and at 9 months
measure: Musculature Strength
timeFrame: At the beginning and at 9 months
measure: Presence of Myofascial trigger points
timeFrame: At the beginning and at 9 months
measure: Speed of contraction of the musculature
timeFrame: At the beginning and at 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06204146: The Effect of Massage on Growth And Stress And Stress ,Department of Nursing,
Official title: The Effect of Massage Applied to Preterm Infants On Growth and Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm
Keywords: preterm
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 27
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress. While the population of the research is preterm infants at the neonatal intensive care unit of a Medicalpark Batman Hospital between January 2018 and February 2019, the sample is 60 preterm infants suitable for inclusion criteria. Research data was collected using Preterm Infant Information Form, Preterm Follow-up Form and Newborn Stress Scale. While massage was applied to the infants in the experimental group three times daily for 10 days, the control group received the usual care. Weight, length and head circumference of infants in both experimental and control group were measured by the researcher on 1., 5. and 10. days. In order to evaluate stess level of the massage applied infants, camera records of the infants were taken 15 minutes before and after the massage on 1., 5. and 10. days. Camera records of the infants in the control group were also taken at the same time with those in the experimental group. Camera records were watched and stress level of the infants were evaluated by two observers blind to the research. The data analyses were carried out using In-class Correlation, Frequency, Levene, Two-Way ANOVA for Mixed Measured, Repeated ANOVA tests

Detailed description: The aim of this thesis is to exprementally investigate the effect of massage applied to preterm infants on growth and stress

Eligibility criteria: Inclusion Criteria:

- Gestational age at birth below 36 weeks + 6 days, Body weight over 1000 g, Do not have any diseases or congenital disorders, Babies who are allowed to be massaged by the NICU's neonatologist was determined as .

Exclusion Criteria:

-

Primary outcomes:
measure: Weight
timeFrame: 10 days
measure: length
timeFrame: 10 days
measure: head circumference
timeFrame: 10 days
measure: newborn stres scale
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Emine Sarıkamış Kale
state: Merkez
Study officials:
affiliation: Hasan Kalyoncu University
name: emine sarıkamış kale, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00712946: Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages
Official title: Preoperative Heart Rate Variability and Baroreflex Sensitivity in ASO Patients During Various Sleep Stages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteriosclerosis Obliterans
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Turku University Hospital
name: University of Turku
name: The Finnish Funding Agency for Technology and Innovation (TEKES)
First posted: 2008-07-10
Enrollment: 103
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASO patients admitted to electrive vascualr surgery in Turku University Hospital

Brief summary: The goal of this study is to evaluate the possible preoperative predictive value of altered heart rate variability (HRV) and baroreflex sensitivity in different sleep stages for postoperative adverse cardiac events (i.e. arrhythmia or myocardial ischemia needing hospitalization or medication, myocardial ischemia assessed by enzyme release, myocardial infarction, sudden cardiac death, stroke) in arteriosclerosis obliterans patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 40 years
* ASO
* Elective vascular surgery patient (i.e. infra-inguinal bypass procedure)

Exclusion Criteria:

* Other than sinus rhythm
* Lack of co-operation
* Major surgery less than 3 months preoperatively
* Sleep apnoea
* Dialysis treatment
* CABG less than 3 years earlier

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Anesthesiology and Intensive Care, Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Timo Laitio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: GE Healthcare, Finland
name: Pekka Meriläinen, Prof.
role: STUDY_DIRECTOR
References:
citation: Virtanen S, Utriainen KT, Parkkola R, Airaksinen JK, Laitio R, Scheinin H, Hakovirta H, Laitio TT; BAROSLEEP Study Group. White matter damage of the brain is associated with poor outcome in vascular surgery patients with claudication: a pilot study. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):687-93. doi: 10.1016/j.ejvs.2014.08.025. Epub 2014 Oct 1.
citation: Utriainen KT, Airaksinen JK, Polo O, Laitio R, Pietila MJ, Scheinin H, Vahlberg T, Leino KA, Kentala ES, Jalonen JR, Hakovirta H, Parkkola R, Virtanen S, Laitio TT. Sleep apnoea is associated with major cardiac events in peripheral arterial disease. Eur Respir J. 2014 Jun;43(6):1652-60. doi: 10.1183/09031936.00130913. Epub 2014 Feb 20.
citation: Utriainen KT, Airaksinen JK, Polo O, Raitakari OT, Pietila MJ, Scheinin H, Helenius HY, Leino KA, Kentala ES, Jalonen JR, Hakovirta H, Salo TM, Laitio TT. Unrecognised obstructive sleep apnoea is common in severe peripheral arterial disease. Eur Respir J. 2013 Mar;41(3):616-20. doi: 10.1183/09031936.00227611. Epub 2012 Jun 14.