louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01332812: Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction
Official title: Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Cognitive Dysfunction
Keywords: Dexamethasone
Postoperative cognitive dysfunction
General Anesthesia
neuropsychological tests
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Duke University
First posted: 2011-04-11
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.

Detailed description: Postoperative cognitive dysfunction is related with the use of opioids in the postoperative period, lack of physical activity, fatigue, postoperative pain and quality of life. The use of corticosteroids preoperatively reduces postoperative pain, fatigue, nausea and vomiting in the postoperative period and is frequently used as an adjuvant in anesthesia. This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in the postoperative period of elderly patients undergoing to surgery under general anesthesia.

Eligibility criteria: Inclusion Criteria:

* patients over 60 years,
* underwent surgery for inguinal hernia repair, Nissen procedure, cholecystectomy or other surgeries midsize under general anesthesia and hospital stay expected within 72 hours.

Exclusion Criteria:

* age less than 60 years,
* history of brain disease or dementia, other psychiatric disorders that affect cognition,
* lack of proficiency in Portuguese,
* use of corticosteroids or opioid preoperatively.

Primary outcomes:
measure: Score in neuropsycological tests.
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: General Hospital of the University of São Paulo Medical School
Study officials:
affiliation: Faculty of Medicine of the University of Sao Paulo
name: Maria José C Carmona, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valentin LS, Pereira VF, Pietrobon RS, Schmidt AP, Oses JP, Portela LV, Souza DO, Vissoci JR, Luz VF, Trintoni LM, Nielsen KC, Carmona MJ. Effects of Single Low Dose of Dexamethasone before Noncardiac and Nonneurologic Surgery and General Anesthesia on Postoperative Cognitive Dysfunction-A Phase III Double Blind, Randomized Clinical Trial. PLoS One. 2016 May 6;11(5):e0152308. doi: 10.1371/journal.pone.0152308. eCollection 2016.
Clinical trial NCT05414812: Intervening on Women's Health for Rural Young Breast Cancer Survivors
Official title: Intervening on Women's Health for Rural Young Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Fertility
Contraception
Menopausal Symptoms
Keywords: Oncofertility
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Cancer Resource Center of the Desert
name: El Centro Regional Medical Center
name: Pioneers Memorial Healthcare District
First posted: 2022-06-10
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Interrupted time series design
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young breast cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young breast cancer survivors' engagement in goal-concordant oncofertility care.


Eligibility criteria: Inclusion Criteria:

* Breast cancer (Stages 0-IV) diagnosis
* Primary language English or Spanish
* Receiving oncology care at participating clinical sites
* Living in Imperial County, California

Exclusion Criteria:

- Women who are pregnant at recruitment

Primary outcomes:
measure: Medical record review of engagement in goal-concordant oncofertility care
timeFrame: 12 weeks after oncology visit
Secondary outcomes:
Other outcomes:
Locations:
city: Brawley
country: United States
facility: Pioneers Medical Health District
state: California
city: El Centro
country: United States
facility: Cancer Resource Center of the Desert
state: California
city: El Centro
country: United States
facility: El Centro Regional Medical Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: H. Irene Su, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04294212: Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital
Official title: Medical Termination of Pregnancy : Evaluation of Patients' Practices and Feelings in Brest Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medical Termination of Pregnancy
Keywords: Pregnancy loss
lived from patients
medical termination of pregnancy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients having experienced a medical termination of pregnancy in Brest Hospital

Brief summary: This study evaluate the feelings of patients about a medical termination of pregnancy that they experienced in Brest Hospital. Patients responded to an online questionnaire assessing their feelings at each stage of the medical termination process. Their answers were associated with their medical data.


Eligibility criteria: Inclusion Criteria:

* Patient having experienced a medical termination of pregnancy in Brest Hospital
* Medical termination of pregnancy after 14 weeks
* Induction for natural delivery
* No opposition

Exclusion Criteria:

* Medical termination of pregnancy before 14 weeks
* Selective termination of pregnancy (multiple pregnancy)
* Caesarean
* Patient not speaking french
* Patient's refusal

Primary outcomes:
measure: Overall satisfaction score
timeFrame: One day
Secondary outcomes:
measure: satisfaction score by indicator
timeFrame: One day
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT04003012: Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
Official title: Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Leukemia-Lymphoma
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: A common procedure in children with cancer is the spinal tap, or lumbar puncture (LP), in which a needle is inserted into the spinal canal. In this population, LPs are most commonly performed to collect cerebrospinal fluid (CSF, the liquid surrounding the brain and spinal cord) for diagnostic testing, and to inject medications including chemotherapy. Local analgesic (pain control medicine) during pediatric LP procedures is underutilized and not standardized. The first local analgesic routinely used for LP procedures was lidocaine injection. The discovery of the topical EMLA (lidocaine 2.5%/prilocaine 2.5%) cream, approved by the FDA for local skin use in pediatric patients, has provided an additional option for local LP analgesia. A comparison between topical EMLA vs lidocaine injection for LP pain control in the pediatric population has not been performed. Pediatric oncology patients often require serial LPs for diagnostics purposes and/or chemotherapy delivery. Due to a lack of standardization of LP analgesia in this population, the investigators have designed a prospective, single-blind, randomized control crossover trial to examine EMLA vs. lidocaine injection in reducing pain associated with LP in children being treated for leukemia or lymphoma.


Eligibility criteria: Inclusion Criteria:

* Pediatric cancer patients (aged 3-18) with a diagnosis of leukemia or lymphoma
* Patients are expected to receive serial (i.e. \> 1) LP as outpatients in Charleston Area Medical Center Children's Cancer Center in the course of 12 months for diagnostic and/or treatment purposes

Exclusion Criteria:

* Patients not in the age range
* Non-cancer patients
* Allergy to amide anesthetics
* Patients treated with class I and III anti-arrhythmic drugs (eg, amiodarone, bretylium, sotalol, dofetilide)
* Patients with congenital or idiopathic methemoglobinemia

Primary outcomes:
measure: Post Lumbar Puncture Pain: Wong-Baker Faces Pain Rating Scale
timeFrame: , pain will be assessed at 30 - 60 minutes after waking up after lumbar puncture and 24 hours after lumbar puncture
Secondary outcomes:
measure: Post Lumbar Puncture PRN Pain Medication Usage
timeFrame: 24 hours following lumbar puncture
Other outcomes:
Locations:
city: Charleston
country: United States
facility: CAMC - Women and Children's Hospital
state: West Virginia
Study officials:
affiliation: WVU-Charleston and CAMC
name: Mohamad Badawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06626412: Longitudinal SV2A and MRI in Premanifest HD
Official title: Longitudinal Imaging of Striatal Synaptic Density and Volume in People With Premanifest Huntington's Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Huntington Disease
Keywords: PET
MRI
SV2A
synaptic density
18F-SynVesT-1
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: AIM: to compare the sensitivity of SV2A PET and volumetric MRI to detect longitudinal striatal changes in premanifest HD.

DESIGN: The investigators will include late premanifest HD mutations carriers and matched healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 18F-SynVesT-1 PET and volumetric MRI at baseline and after 2 years.


Eligibility criteria: Inclusion Criteria:

* Age 20-75 years inclusive.
* Capacity to understand the informed consent form.
* HD mutation carriers:

  * HTT (CAG)n ≥ 40
  * HD-ISS \< 2
  * CAP100 score \> 70

Exclusion Criteria:

* neuropsychiatric diseases (other than HD for HD mutation carriers)
* major internal medical diseases
* white matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
* history of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug abuse
* contraindications for MR
* pregnancy
* previous participation in other research studies involving ionizing radiation with more than 1 mSv in the previous 12 months.

Primary outcomes:
measure: Baseline differences in synaptic density.
timeFrame: Data analysis will be done when all subjects have undergone the baseline evaluation.
measure: Baseline differences in brain volume.
timeFrame: Data analysis will be done when all subjects have undergone the baseline evaluation.
measure: Differences in the rate of decline of synaptic density.
timeFrame: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
measure: Differences in the rate of decline of volumetric MRI.
timeFrame: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary outcomes:
measure: Baseline correlations between clinical scores and regional synaptic density or brain volume.
timeFrame: Data analysis will be done when all subjects have undergone the baseline evaluation.
measure: Correlations between progression of the clinical scores and decline of synaptic density or brain volume.
timeFrame: Data analysis will be done when all subjects have undergone the 2-year follow-up evaluation.
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
Clinical trial NCT00681512: The Effect of Berries on Lung Cancer Tumors
Official title: Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
lung cancer
non small cell lung cancer
lung carcinoma
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2008-05-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.

Detailed description: In the United States, more people (161,840 per year) die of lung cancers than of prostate cancer, breast cancer and colon cancer combined. Presently, there are over 43 million current smokers and over 47 million ex-smokers living in the US. Due to the lag time between smoking and the development of cancer, there are significant numbers of ex-smokers and current smokers who may develop lung cancer compared to never smokers.

Recent studies in animals have shown that berries, given as a dietary supplement, are highly effective against certain types of cancers. In a study involving mice with lung tumors, mice that had consumed a mixture of berries developed fewer tumors and had less tumor growth than mice that did not consume berries.

The berries used in this study will consist of blueberries, black raspberries, or a mixture of both.

Eligibility criteria: Inclusion Criteria (lung cancer survivors):

* men treated for lung cancer, women treated for lung cancer and with no child-bearing potential (hysterectomy, tubal ligation, post-menopausal women)

Exclusion Criteria (lung cancer survivors):

* women who are on hormone replacement therapy
* women who are pregnant, or planning for pregnancy
* history of lung transplant
* prison inmate
* inability to take oral medication or food
* known or suspected allergy to berries or berry products
* HIV patients

Inclusion Criteria (volunteers):

* adult men, adult women with no child bearing potential (hysterectomy, tubal ligation, post-menopausal women)

Exclusion Criteria (volunteers):

* women who are on hormone replacement therapy
* women who are pregnant, or planning for pregnancy
* history of lung transplant
* prison inmate
* inability to take oral medication or food
* known or suspected allergy to berries or berry products
* HIV patients

Primary outcomes:
measure: Assessment of blueberry and black raspberry phenolics in plasma and urine
timeFrame: upon completion of 4 to 5 weeks of daily consumption of berry powder
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center
name: Ramesh Gupta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004481: Genetic Study of Sitosterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipid Metabolism, Inborn Errors
Sitosterolemia
Keywords: endocrine disorders
inborn errors of metabolism
rare disease
sitosterolemia
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Medical University of South Carolina
First posted: 1999-10-19
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: NATURAL_HISTORY

Brief summary: OBJECTIVES:

I. Identify the genetic defect and fine map the gene that causes sitosterolemia.

Detailed description: PROTOCOL OUTLINE: Patients, family members, and normal volunteers provide blood samples for genetic studies and may fill out a general health and medication history.

Linkage analysis and microsatellite screening is performed on genomic DNA, especially chromosome 2p21, between microsatellite markers D2S1788 and D2S1352.

Positive results may be reported to the patient and may influence future treatment.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of sitosterolemia Presence of tendon and tuberous xanthomas Premature atherosclerotic disease No family history of premature coronary artery disease Normal or elevated plasma cholesterol levels

OR

* Family member of patient with sitosterolemia

OR

* Normal volunteer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Shailesh B. Patel
role: STUDY_CHAIR
References:
Clinical trial NCT03895281: Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel
Official title: Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Meningitis/Encephalitis
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2019-03-29
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with signs and/or symptoms of meningitis and/or encephalitis

Brief summary: The FilmArray Meningitis/Encephalitis (ME) Panel (hereinafter referred to as FilmArray ME Panel) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.


Eligibility criteria: Inclusion Criteria:

* Residual cerebrospinal fluid samples after routine tests;
* Samples obtained by lumbar puncture;
* Sample volume is not less than 0.5 mL;
* Samples that have not been centrifuged;

Exclusion Criteria:

* Samples from repeatedly enrolled patients;
* Samples that have not been preserved as required

Primary outcomes:
measure: Clinical sensitivity and specificity of the FilmArray ME Panel
timeFrame: 6 days upon sample collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04551781: Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis
Official title: Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Covid-19
post covid-19 fibrosis
low dos steroids
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded randomized controlled trial
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial to study the efficacy of low dose steroid for 14 days in the treatment of post-covid-19 lung infiltrates

Detailed description: : the study included patients with COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest, patients with normal CT chest at discharge, patients on chemotherapy, patients \<18years old, patients with known interstitial lung disease and patients with rheumatoid arthritis or systemic lupus erythematosus were excluded from the study.

Study patients were randomly assigned to either steroid group or control group and were followed up for 14 days, and CT chest was done at end of 14 days and was evaluated by a radiologist how was blinded for study arm, Ct chest was graded either very minimal infiltrates including reticular shadows, hallow sign, and ground glass s (GGO), infiltrates \<25%, and infiltrates \>25%.

The steroid group received 20 mg/day prednisolone for 14 days in addition to symptomatic treatment; the control group received symptomatic treatment without steroids Data collected included patient demographics, symptoms, and its duration at baseline, CBC, Ferritin and D-dime, CT chest at discharge, and after 14 days of inclusions in the study.

Eligibility criteria: Inclusion Criteria:

* COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for COVID-19, and have persistent radiological changes in follow-up chest computed tomography (CT) chest

Exclusion Criteria:

* patients with normal CT chest at discharge, patients on chemotherapy, patients \<18years old, patients with known interstitial lung disease, and patients with rheumatoid arthritis or systemic lupus erythematosus

Primary outcomes:
measure: improved
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Qena
country: Egypt
facility: south-Vally University faculty of medicine
state: Kena
Study officials:
affiliation: south-Vally Universty
name: alaa DR Rashad, MD
role: PRINCIPAL_INVESTIGATOR
References: