louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06444152: Prevalence of Epstein-Barr Virus Infection
Official title: Prevalence of Epstein-Barr Virus Infection in HIV Infected and HIV Uninfected Patients Presenting With Lymphomas in Botswana
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lymph Node Excision Biopsy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of Botswana
First posted: 2024-06-05
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Formalin fixed paraffin embedded tissue (FFPE) of lymph node excision biopsy samples from the patient with a diagnosis of lymphoma

Brief summary: This will be a cross sectional, pilot study to determine the burden of EBV related lymphomas in this population. Patient information including demographics and HIV status, history of HIV infection, HIV viral load and CD4 counts and ART history will be retrieved from the integrated patient management system (IPMS) Lymph node excision biopsy samples, collected at NHL between 2012 and 2017, from the patient with a diagnosis of lymphoma will be retrieved using IPMS from National Health Laboratory and analyzed by immunohistochemistry.

Detailed description: Lymph node excision biopsy samples,which have been formalin fixed and paraffin embedded, of 50 HIV-infected and 50 HIV-uninfected patients from the patient with a diagnosis of lymphoma, will be retrieved using IPMS from National Health Laboratory. Archived diagnostic biopsy material will be collected from NHL between 2012 and 2017 (5 years). They will be analyzed by immunohistochemistry using LMP-1/EBNA1/ENNA2 staining, either alone or combined which indicates a diagnosis of EBV infection.

We will compute rates of EBV associated lymphomas among HIV infected and HIV uninfected individuals using descriptive statistics. The students t-test will be used for continuous variables while the Pearson's chi squared test (or Fisher's exact test where appropriate) will be used to compare categorical variables. Significance will be assigned for P values of 0.05 or less

Eligibility criteria: Inclusion Criteria:

* All available lymph node biopsy samples with a diagnosis of lymphoma and complete data of HIV status, HIV viral load and CD4 counts and ART history will be retrieved from IPMS.

Exclusion Criteria:

* Samples with incomplete data

Primary outcomes:
measure: Burden of EBV
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gaborone
country: Botswana
facility: University of Botswana
Study officials:
References:
Clinical trial NCT06583252: Effect of Multimodal Monitoring Cluster Management on Patients with Severe Traumatic Brain Injury
Official title: Effect of Multimodal Monitoring Cluster Management on Patients with Severe Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multimodal Monitoring
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 200
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: Traumatic brain injury

Brief summary: Traumatic brain injury (TBI) is a serious global health problem, with about 27 million new cases each year. Severe head trauma can lead to intracranial hypertension and a range of complications such as cerebral edema and hypoxia of brain tissue. Intracranial pressure monitoring is key to modern TBI treatment, but this approach does not fully reflect all relevant pathophysiological changes. Multimodal monitoring allows for a more comprehensive assessment of the severity of TBI and guidance for individualized treatment to improve patient outcomes by integrating different monitoring methods. Although more research is needed to confirm its efficacy, multimodal monitoring has been recognized as an important clinical decision support tool in neuroscience intensive care. Future studies may further optimize this approach to monitoring and provide a more effective treatment strategy for patients with TBI.


Eligibility criteria: Inclusion Criteria:

1.Age \>18 years, 2.Diagnosis of an acute brain injury (ABI) due to TBI, 3.GCS with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to intensive care unit (ICU) or neuro-worsen-ing within the first 48 hours with no eye opening and the Motor score decreased to ≤5.

-

Exclusion Criteria:

1. Have had a major stroke before.
2. Pregnant or likely to become pregnant. 3 In the opinion of the treatment team, the decrease in GCS (Glasgow Coma Scale) score is solely due to intoxication, sedation, or extracranial injury.

4 Participants are unlikely to comply with all study procedures, including follow-up, in the opinion of the investigator.

5. Have an underlying medical condition with a life expectancy of less than 6 months.

6. There are pre-existing contraindications to MRI examination. 7 suffer devastating TBI, either progressing to brain death at the time of recruitment, or the treating medical team does not commit to continuous, comprehensive aggressive treatment.

Primary outcomes:
measure: Glasgow Outcome Score-Extended at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT05140252: Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid
Official title: Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: de-implementation strategies
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 22
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to learn whether participants find a patient guide to breast cancer treatment decisions acceptable and appropriate for use.

Detailed description: This study seeks to adapt and pilot test de-implementation strategies targeting low-value breast cancer treatments which have persisted despite national recommendations. Breast cancer is an ideal setting in which to study de-implementation given it is common, well-studied, typically presents at an early-stage, and care is provided primarily in a community setting.

Eligibility criteria: Inclusion Criteria

* Early stage breast cancer that is hormone receptor positive (HR+) and human epidermal growth factor negative (HER2-)
* Meet criteria for omission of sentinel lymph node biopsy (SLNB)
* Receiving care at Michigan Medicine

Exclusion Criteria

* Non-English speaking
* Male patients (current data does not support omission of SLNB in men)

Primary outcomes:
measure: Acceptability of Intervention (AIM) Survey
timeFrame: 1 week after receiving decision aid
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 1 week after receiving decision aid
measure: Engagement with the patient decision aid
timeFrame: 1 week after receiving decision aid
Secondary outcomes:
measure: Satisfaction with decision (SWD)
timeFrame: up to 120-days following surgery
measure: Treatment choice
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Lesly A Dossett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schonberg MA, Freedman RA, Recht AR, Jacobson AR, Aliberti GM, Karamourtopoulos M, Nakhlis F, McCarthy EP, Pories SE, Sharma R, Dominici LS. Developing a patient decision aid for women aged 70 and older with early stage, estrogen receptor positive, HER2 negative, breast cancer. J Geriatr Oncol. 2019 Nov;10(6):980-986. doi: 10.1016/j.jgo.2019.05.004. Epub 2019 May 24.
Clinical trial NCT06115252: Partnering to Enhance Emerging Adults' Response to Programs
Official title: Partnering to Enhance Emerging Adults' Response to Programs (PEER)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Use, Unspecified
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: University of Texas
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-11-02
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial (CT) is to learn more about emerging adults' and their peers. Here, we will see how co-participating with a peer in health program might impact brain and behavior change over time.

Eligible youth will be invited to come in for a "Participation Day," during which they and a peer will independently complete questionnaires. With a peer, they will then complete a short health program, and undergo a brain scan (fMRI) while completing activities. Our study team will reach out to each participant individually again 3, 6, and 12 months later to learn about health behaviors over time.


Eligibility criteria: Inclusion Criteria:

* within the specified age range
* agree to be contacted for the 3, 6, and 12 month follow ups
* provide fully informed consent

Exclusion Criteria:

* left-handed
* evidence of brain injury/illness and/or neurological, neurodevelopmental disorder including psychosis and related medications (e.g., antipsychotics; neuroleptics)
* loss of consciousness ≥ 2 minutes
* other fMRI contraindications (e.g., unremovable metal on/in body, pregnant)

Primary outcomes:
measure: Blood oxygen level dependent (BOLD) response to self-talk
timeFrame: Baseline
measure: Blood oxygen level dependent (BOLD) response to dyadic exchange
timeFrame: Baseline
measure: Pearson correlation of self-talk BOLD response percent signal change with youth health behavior assessed with the Timeline Followback
timeFrame: 3-, 6-, and 12-months
measure: Pearson correlation of dyadic exchange BOLD response percent signal change with youth health behavior assessed with the Timeline Followback
timeFrame: 3-, 6-, and 12-months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UConn Health
name: Sarah W. Feldstein Ewing, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Francesca Filbey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06566352: Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy; A Randomized Controlled Clinical Trial
Official title: Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy; A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Different Methods to Minimize Blood Loss During Laparoscopic Myomectomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-08-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation and hospitalization period after laparoscopic myomectomy.

Detailed description: Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine will be important to reduce intraoperative bleeding, time of operation, and hospitalization period after laparoscopic myomectomy.

This will be the first study to investigate the efficacy of Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine in minimizing blood loss during Laparoscopic myomectomy at our university.

Can Laparoscopic myomectomy with temporary bilateral uterine artery occlusion or intramyometrial injection of diluted epinephrine give better outcomes regarding intraoperative bleeding when compared to traditional laparoscopic myomectomy?

Eligibility criteria: Inclusion Criteria:

1. Women aged from 18 to 39 years.
2. Symptomatizing Women (heavy menstrual bleeding or subfertility).
3. FIGO stage (3-7) by ultrasound.
4. Only uterine corpus fibroid.
5. Up to three fibroids by ultrasound.
6. No previous hormonal treatment.

Exclusion Criteria:

1. Patients with bleeding tendency.
2. Patients who refuse to participate in the study or uncooperative patients.
3. Current pregnancy.
4. Any retroperitoneal surgery at pararectal space.
5. More than one cesarean delivery.

Primary outcomes:
measure: blood loss
timeFrame: intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
References:
Clinical trial NCT02965352: Peripheral for Quantify Strength of Children Functional During the Pinch Movement
Official title: Peripheral for Quantify Strength of Children Functional During the Pinch Movement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Strength
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study has developed a peripheral to quantify the functional strength of children without motor change during the movement of grip and pinch. It was possible to know the exact values of these strengths, the range of motion that was made, and also if the grip strength was maintained during all the arc of motion.

Detailed description: Since childhood, it has been necessary to produce sufficient force to grip and pinch, for performing daily tasks independently; therefore, measurements of these forces end up being useful markers to evaluate the performance and the physical development of the child. It was developed a peripheral containing three devices and instrumented for analyzing the force applied during execution of the cylindrical grip movement, pinch pulp-side and pinch pulp-pulp in different situations of the daily life of the volunteer. The data acquisition interface was developed in a software for data recording. For the peripheral functionality tests, thirty volunteers of both genders were selected. They were also students of the Sports Secretary, with no motor abnormalities, between seven and ten years old.

Eligibility criteria: Inclusion Criteria:

* change Absence of skeletal muscle in the upper limbs
* neurological disorder Absence
* Informed Consent signed by the responsible
* with preserved cognitive.
* consent form signed by the volunteer

Exclusion Criteria:

* Having less than 7 years old
* Having more than 10 years old
* To present some compromise skeletal muscle in the upper limbs
* not take part in the research

Primary outcomes:
measure: Force
timeFrame: 15 minutes
Secondary outcomes:
measure: range of motion in angle
timeFrame: 15 minutes
measure: range of motion in percentage
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Mogi das Cruzes
name: Silvia R Boschi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01868932: Treating Wheezing in Children With Hypertonic Saline (TWICS)
Official title: Treating Wheezing in Children With Hypertonic Saline (TWICS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Wheeze
Keywords: wheeze
early childhood
asthma
bronchiolitis
infection triggered
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior symptom relief leading to decreased admission rates from the Emergency Department.

The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group) in a prospective, double blind, randomized controlled, multi-centre clinical trial of children under age 6 years presenting to the ED with acute viral-associated wheezing.

Detailed description: the brief summary captures the essence of the study

Eligibility criteria: Inclusion Criteria:

1. Age under 6 years
2. History of viral upper respiratory infection within previous 7 days
3. Wheezing or crackles detected on chest auscultation
4. Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.

Exclusion Criteria:

1. History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
2. Severe illness at presentation as defined by any of the following

   * respiratory rate greater than 80/min
   * SaO2 less than 88% in room air
   * need for assisted ventilation
3. Use of nebulized HS within previous 12 hours
4. Presence of active varicella infection.

Primary outcomes:
measure: Rates of admission to hospital
timeFrame: duration of hospital ER stay, an average of 4 hours
Secondary outcomes:
measure: Improvement in respiratory distress scores after initial protocol treatment in the ED
timeFrame: time from pre-intervention assessment to post-intervention assessment, an average of 2 hours
measure: Length-of-stay in the ED in the subgroup of patients not admitted
timeFrame: an average of 6 hours
measure: Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
timeFrame: an average of 6 hours
measure: Length of hospital stay in the those who are admitted
timeFrame: length of hospital stay, an average of 3 days
measure: Rate of return visit to ED (for respiratory illness) within 14 days of enrollment
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Queen's University
name: Michael Flavin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05245032: Biologically Focused Therapy of Treatment-Refractory MDS Patients
Official title: Biologically Focused Therapy of Treatment Refractory MDS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Keywords: MDS
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Notable Labs Inc.
First posted: 2022-02-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will be conducted at a single site, namely Stanford's MDS Center.

Brief summary: This non interventional study examines the feasibility of using patient specific therapeutic screening method, ex vivo to enhance current treatment recommendations in a clinically feasible time frame of 30 days.

Detailed description: This study utilizes the Notable Labs personalized testing service using an ex vivo assay, but does not involve actual treatment or treatment determinations. The results of these screenings will be made available to patients and their physicians for their use off study.

The primary objective of the study is:

• To determine the feasibility of selecting patient specific treatment regimens based on ex vivo within 30 days

The exploratory objectives of the study are:

• To identify biomarkers that explain ex vivo drug sensitivity results

Eligibility criteria: Inclusion Criteria:

* Provide informed consent;
* Myelodysplastic syndrome as defined by WHO classification (see Appendix 2), or MDS/MPN with \>= 5% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) 1 and 2 by WHO classification
* Relapsed/refractory disease, defined as failed or are ineligible for hypomethylating agent therapy
* Cytogenetics reported

Exclusion Criteria:

* Hypoplastic MDS
* Patients without adequate marrow samples for ex vivo analysis

Primary outcomes:
measure: Proportion of patients with successful ex vivo results
timeFrame: 30 days
measure: Proportion of patients with successful treatment decisions
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford MDS Center
state: California
Study officials:
affiliation: Stanford Universiy
name: Peter L Greerberg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04303832: Exercise Interventions of Eye Muscles Post Strabismus Surgery
Official title: Exercise Interventions of Eye Muscles Post Strabismus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Amblyopia
Keywords: Strabismus and amplyobia and physiotherapy eye exercise
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: It will be hypothesized that:

* Eye exercises have a positive effect on correction of remaining ocular deviation post strabismus surgery.
* Eye exercises have a positive effect on improving amplyobia.

Detailed description: This study applied to determine the effect of physiotherapy exercises on correction the remaining ocular deviation which still present following the strabismus surgery and also its effect on amplyobia.

Different type of physiotherapy exercises was applied to experimental group for 12 weeks beside the medical treatment applied post-surgery while the control group received traditional treatment only.

The near and far angles of ocular deviation were measured before and after the treatment for evaluation of strabismus and measuring visual acuity for evaluation of amplyobia.

Eligibility criteria: Inclusion Criteria:

* Patients received strabismus operation
* All types of strabismus surgery will be included
* They selected from Outpatient Clinic
* Patients begin the training program after 2 weeks of operation or more than this
* The patient still suffering from amblyopia post strabismus surgery

Exclusion Criteria:

* Muscular disorders that will impair performance during training.
* Neurological disorders.
* Malignant conditions.
* Psychiatric illness, severe behavior or cognitive disorders. Children who can't understand the therapist's instructions and orders.

Primary outcomes:
measure: change in angle of deviation
timeFrame: pre and post 12 weeks
Secondary outcomes:
measure: change in visual acuity
timeFrame: pre and post 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Amany Abdel Wahid, M.Sc
role: PRINCIPAL_INVESTIGATOR
References: