louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06565299: Cognitive and Speech Disorders in Children With Congenital Heart Defects
Official title: Cognitive and Speech Disorders in 5-7 Years Old Children With Congenital Heart Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognition Disorder
Keywords: cognitive disoders
heart disease
Lead sponsor: Kemerovo State Medical University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 217
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 5-7 years old children with congenital heart defects bofore abd after cardiovascular operation with cardiopulmonary bypass

Brief summary: The study is aimed to found out expressive speech disorders as a sign of neurocognitive development delay in children with congenital heart defects before and after surgery

Detailed description: The study will investigate the influence of congenital heart disease, operation and other health factors on neurocognitive and speech status of 5-7 years old children

Eligibility criteria: Inclusion Criteria:

* children with congenital heart disease that required total correction using cardiopulmonary bypass

Exclusion Criteria:

* patients with heart disease requiring palliative or endovascular correction, as well as children with chromosomal and genetic diseases (determined by karyotyping)

Primary outcomes:
measure: Neurocognitive status
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kemerovo
country: Russian Federation
facility: Aleksandra Aeksandrovna Rumiantseva
state: Kuzbass
Study officials:
References:
Clinical trial NCT04880499: Iron and Vitamin Supplementation in Hip/Knee Surgery
Official title: Emacrit Plus in Prosthetic Hip and Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Hip Arthropathy
Knee Arthropathy
Anemia
Iron Poor Blood
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized controlled trial to evaluate the efficacy of oral iron supplementation plus cofactors in reducing the prevalence of preoperative anemia in a cohort of 60 patients undergoing elective prosthetic hip or knee surgery.


Eligibility criteria: Inclusion Criteria:

* Males and females
* ASA 1, 2, or 3
* No neuropsychiatric conditions
* Acceptance of informed consent
* Elective prosthetic hip or knee surgery

Exclusion Criteria:

* ASA 4
* Present or past neuropsychiatric conditions
* Hip or knee revision surgery
* Use of iron as dietary supplement
* Known erythrocytosis
* Incompatible hypersensitivities
* Iron metabolism disorders
* Lymphoproliferative disorders

Primary outcomes:
measure: Change of blood hemoglobin levels
timeFrame: Baseline and 60 days +/- 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Matteo Briguglio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01933399: Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain
Official title: Comparison of Inextensible and Extensible Lumbosacral Orthoses for the Management of Episodes of Lower Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Back brace
Lumbar orthoses
Lumbosacral orthoses
Low back pain treatment
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis is that the group wearing the inextensible LSO will have improved outcomes over the other two groups (standard care or standard care plus the extensible LSO).


Eligibility criteria: Inclusion Criteria:

* chief complaint of lower back pain, with or without lower extremity (LE) symptoms
* 150 subjects will be recruited from patients seeking treatment for lower back pain from spine specialty orthopaedic clinics, family practice physicians, and out-patient physical therapy clinics

Exclusion Criteria:

* Exclusion criteria are:
* previous spinal surgery
* workman's compensation or litigation is involved
* neurological disease or injury
* systemic inflammatory disease
* pulmonary disease which restricts breathing capacity
* current pregnancy
* acute fracture
* tumor or metastatic disease
* infection
* neurological disease
* the presence of pathological reflexes (e.g., Babinski)
* the presence of lower extremity pain upon cervical motion and / or the presence of two or more of the following signs of nerve compression: diminished lower extremity strength in a myotomal distribution, diminished sensation, and / or absence deep tendon reflexes.

Primary outcomes:
measure: Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Change Score in the Patient Specific Activity Scale
timeFrame: Baseline and 2-weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical Unversity of South Carolina
name: David Morrisette, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005499: Congestive Heart Failure Trends in the Elderly 1970-94
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Heart Failure
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigate trends in the incidence and survival rates of congestive heart failure (CHF) in two successive cohorts of elderly people (1970-74, 1990-94) in a health maintenance organization (HMO).

Detailed description: BACKGROUND:

The study constituted part of a growing body of research designed to understand not only the secular trends in mortality, morbidity, survival, and disability levels for selected major chronic diseases among older persons in the United States, but also the implications of the findings for health care utilization.

DESIGN NARRATIVE:

The design was that of a retrospective study of successive cohorts of a well-defined and well-documented elderly population for the purpose of identifying and explaining trends in congestive heart failure (CHF) incidence, survival, comorbidities and health services utilization during the 25-year period 1970-1994. The study sample consisted of two successive period cohorts of elderly people, identified for each of two five-year periods, 1970-1974 and 1990-94. The study tested the following hypotheses: 1) incidence of CHF had decreased among the younger old (65-74 years of age); 2) incidence of CHF had increased among the older old (75 years of age or above); 3) one-year survival time had increased following onset of incident CHF; and 4) prevalence of hypertension had decreased and prevalence of myocardial infarction and other manifestations of coronary artery disease increased among incident cases of CHF.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Foundation Research Institute
name: William Barker
References:
Clinical trial NCT06600399: Correlation Between Prostate-specific Membrane Antigen Positron Emission Tomography and Arterial Spin Labeling Perfusion Imaging in Glioblastoma
Official title: Similarity of Biological Information Captured by (68)Gallium-prostate Specific Membrane Antigen-11 Positron Emission Tomography and Arterial Spin Labeling Perfusion Imaging in Glioblastoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Keywords: Prostate-specific membrane antigen
Arterial spin labeling
Lead sponsor: Lanzhou University Second Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty-six patients with newly diagnosed or recurrent glioblastoma who underwent conventional MRI, ASL and PSMA PET were prospectively enrolled

Brief summary: Evaluating the relationship between prostate-specific membrane antigen positron emission tomography and arterial spin labeling perfusion imaging, and the correlation with prostate-specific membrane antigen expressed on glioblastoma microvascular.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed or recurrent glioblastoma;
* Adult (≥18 years old);

Exclusion Criteria:

* The patient has a serious underlying disease or mental illness and is unable to cooperate with the imaging examination;
* Have received systematic chemotherapy;
* The image data is of poor or incomplete quality;
* pregnant women;

Primary outcomes:
measure: The similarity of biological information
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
Study officials:
References:
Clinical trial NCT06384599: VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Official title: Adagio Medical VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: Monomorphic Ventricular Tachycardia
VT
Cryoablation
Lead sponsor: Adagio Medical
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 130
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: The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia.

Detailed description: This VT Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings.

Eligibility criteria: Inclusion Criteria:

* IC 1 Male or female the ages of ≥ 18 years
* IC 2 Planned ablation procedure according to the indication for use of the Adagio VT Cryoablation System
* IC 3 Subject willing to comply with study requirements and give informed consent
* IC4 Subject has or will be receiving an ICD prior to hospital discharge

Exclusion Criteria:

* EC 1 In the opinion of the investigator, any known contraindication to a ventricular tachycardia procedure with the Adagio VT Cyroablation System as indicated in the device Instructions For Use (IFU)
* EC 2 Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor
* EC 3 Any other condition that, in the judgement of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than six months, extensive travel away from the research center)

Primary outcomes:
measure: Primary Performance Endpoint
timeFrame: 6 months
measure: Primary Safety Endpoint
timeFrame: 30 Days
Secondary outcomes:
measure: Secondary Performance Endpoint
timeFrame: During the procedure
measure: Secondary Safety Endpoint
timeFrame: 6 months
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Essex Cardiothoracic Centre
state: Essex
Study officials:
References:
Clinical trial NCT00759499: Obtaining and Storing Wound Debridment Samples For Immediate or Future Wound-Related Scientific Study
Official title: Obtaining and Storing Wound Debridment Samples for Immediate or Future Wound-Related Scientific Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Keywords: study of debridement tissue for research purposes.
open wound
Lead sponsor: Southwest Regional Wound Care Center
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 829
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be identified because their wound(s) possesses something of special interest. A special interest wound can include, but will not be limited to wounds that are rapidly deteriorating, wounds diagnosed as pyoderma gangrenosum, wounds showing unusually rapid wound healing, wounds with abnormal microorganisms, non-healing wounds, young wounds, and others.

Brief summary: Debridement Samples being collected for future or immediate research purposes.

Detailed description: Inclusion Criteria

1. The subject must have a full thickness wound.
2. The subject must be a candidate for sharp debridement.
3. The subject must be 18 years of age or older
4. The subject must be mentally competent as determined by the Principal Investigator.

Exclusion Criteria

1. The subject may not be currently incarcerated or pregnant.

* Nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.

Eligibility criteria: Inclusion Criteria:

* The subject must have a full thickness wound.
* The subject must be a candidate for sharp debridement.
* The subject must be 18 years of age or older
* The subject must be mentally competent as determined by the Principal Investigator

Exclusion Criteria:

* The subject may not be currently incarcerated or pregnant.
* Nursing home and hospitalized subjects will not be excluded from this study because these subjects represent a large part of the wounded population.

Primary outcomes:
measure: The intent of this protocol is to salvage wound material that is normally destined for destruction, so it can be used in wound-related scientific studies.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Soutwest Regional Wound Care Center
state: Texas
Study officials:
affiliation: Southwest Regional Wound Care Center
name: Randall D Wolcott, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06403618: Evaluation of the PreCursor-M+® in CIN2
Official title: Evaluation of the PreCursor-M+® Assay Performance in the Management of Women Diagnosed With CIN2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Intraepithelial Neoplasia Grade 2
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with histological diagnosis of CIN2

Brief summary: The goal of this observational study is to to evaluate the accuracy and sensitivity of PreCursor-M+ on a post-aliquot of liquid-based cytology (LBC) cervical samples (biopsy) obtained by physicians in a group of women with histologically-proven diagnoses of CIN2.

The PreCursor-M+® assay is a multiplex real-time methylation specific PCR test that identifies the level of promotor methylation of the host cell genes FAM19A4 and miR124-2, known biomarkers associated with cervical carcinoma and transforming CIN in cervical cells.

To evaluate the clinical course of CIN2 at 2 years after the first diagnosis, with an interval evaluation at 6 months.

After enrolment, women will be divided into two groups: "active surveillance" and "immediate treatment". In the first group, clinical outcomes to be assessed, in relation to the PreCursor-M+ result at baseline, will include regression to \<CIN2, persistence of CIN2, and progression to CIN3+. In the second group, we will evaluate the histological diagnosis at cone specimen (downgrading or upgrading) and the 2-year cumulative incidence of CIN2+ recurrence based on the PreCursor-M+ result at baseline.


Eligibility criteria: Inclusion Criteria:

1. age at diagnosis of 18 years or older;
2. histological confirmation of CIN2 after colposcopic-guided cervical biopsy or conservative surgical treatment, including loop electrosurgical excision procedure (LEEP) and laser conization;
3. known HPV test result at baseline;
4. ability to understand and sign the informed consent;
5. written informed consent given.

Exclusion criteria:

1. unknown HPV test result at diagnosis;
2. vulnerable patients.

Primary outcomes:
measure: Evaluation of methylation of the host cell genes FAM19A4 and miR124-2
timeFrame: 6 months
Secondary outcomes:
measure: Evaluation of clinical course of CIN2 at 2 years after diagnosis
timeFrame: 2 years
measure: Evaluation of overall accuracy of PreCursor-M+
timeFrame: 6 months - 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology, Milan,
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Anna Daniela Iacobone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04356118: Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Official title: Efficacy and Safety of Recombinant Human Endostatin in Non-Small Cell Lung Cancer With Leptomeningeal Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Leptomeningeal Metastasis
Keywords: Recombinant Human Endostatin
Non-Small Cell Lung Cancer with Leptomeningeal Metastasis
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 30
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: The purpose of this study is to observe the clinical effect and safety of Recombinant Human Endostatin in non-small cell lung cancer with leptomeningeal metastasis


Eligibility criteria: Inclusion Criteria:

1. Age over 18 years old
2. Pathologically proven non-small cell lung cancer
3. Karnofsky performance status ≥ 40
4. LM diagnosis was based on the detection of malignant cells in the CSF, the focal or diffuse enhancement of leptomeninges, and nerve roots or the ependymal surface on gadolinium-enhanced MRI .
5. No severe abnormal liver and kidney function;
6. Patients have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Evidence of bleeding diathesis or serious infection
2. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
3. Pregnant or lactating women

Primary outcomes:
measure: Leptomeningeal Metastasis Overall survival
timeFrame: 36 months
measure: Neurological Progression Free Survival
timeFrame: 36 months
measure: The incidence of adverse reactions
timeFrame: 36 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 36 months
measure: Neurological assessment
timeFrame: 36 months
measure: progression-free survival
timeFrame: 36 months
measure: Overall survival
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Hui Bu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01283113: Evaluation of Intra-Abdominal Fat in Patients With Type 2 Diabetes Using a Non-Invasive Method
Official title: Evaluation of Intra-Abdominal Fat Contents in Patients With Type 2 Diabetes Using a Novel Non-Invasive Method of Bioelectric Impedance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type 2 Diabetes
Metabolic Syndrome
Keywords: Visceral Fat
Waist Circumference
Bioelectrical Impedance
Metabolic Syndrome
Obesity
Type 2 Diabetes
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will identify and recruit 500 patients. Participants for this study (men and women) will be recruited for the diabetes outpatient clinic of the Joslin Diabetes Center. Subjects from minority and various ethnic/racial groups will be invited to participate in the study at the same proportional to Massachusetts's population, which is 86.5% white, 6.9 Black, 0.3% American Indian and Alaska, 4.9 Asian, 0.1% Native Hawaiian and Other Pacific Islander and 8.2% of Hispanic or Latino origin. The investigators will monitor our recruitment by gender and race/ethnicity and modify our recruitment procedures if necessary to ensure that there is no selection bias due to these factors.

Brief summary: The main aim of this study is to compare 2 different measurements of visceral fat that can be easily used in clinical practice (waist circumference versus bioelectric impedance) in relation to known risk factors of coronary artery disease in a large cohort of patients with type 2 diabetes and with a BMI range between 20-45 kg/m2


Eligibility criteria: Inclusion Criteria:

* Established type 2 diabetes
* Age 18 - 80
* Body mass index (BMI) between 20-45 Kg/m2.
* Willing to undergo laboratory and anthropometric assessments.

Exclusion Criteria:

* The study will not include women who are pregnant, or are not using reliable birth control methods or who they think that they might be pregnant due to potential risk of fetal affection.
* Subjects with known malignancy, treated or untreated will be excluded (except treated skin melanoma).
* Subjects with major psychological problems or a major eating disorder will be excluded.
* Subjects with heart Pacemaker or any other electronic devices attached to their body will be excluded.
* Subjects with confirmed type 1 diabetes or positive anti GAD antibodies test will be excluded

Primary outcomes:
measure: Visceral fat level
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Osama Hamdy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: