louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00424359: Ambulation Study in Multiple Sclerosis
Official title: A Prospective Study of Clinical Indices as Predictors of Ambulatory Effectiveness in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Mulitple Sclerosis
Ambulation
Lead sponsor: Brown, Theodore R., M.D., MPH
Sponsor class: INDIV
First posted: 2007-01-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with Multiple Sclerosis

Brief summary: This is a study comparing clinical tests of walking and balance. The goal of this study is to discover which of those tests are best at predicting walking problems due to MS.

Detailed description: This study includes:

Three study visits to the MS Center at Evergreen; wearing a pedometer for two, one-week periods to record walking during regular daily activities; keeping a diary for any walking problems such as falls and slips.

Subjects must meet the following criteria:

Diagnosis of MS (any form); 18-70 years of age; be on stable MS treatment OR no MS treatment for the last three months; no scheduled hospitalization in the next six months.

Eligibility criteria: Inclusion Criteria:

* Subject must have sufficient cognitive ability to maintain a falls diary and follow instructions for wearing the pedometer
* Subject must have clinically definite MS according to McDonald criteria
* Subject must have EDSS between 0-6.5
* Subject must be aged 18-70
* Subjects must be given informed consent
* Subjects must be stable on disease modifying therapy or no therapy for at least three months before entry into study

Exclusion Criteria:

* No MS relapse within the last 30 days
* Subjects must have no scheduled major hospitalizations or surgical procedures during the study time frame. Hospitalization during the study may result in removal from the study
* Medical conditions other than MS that might significantly impact ambulatory activity (such as angina pectoris) in the judgement of the investigators
* History or suspicion of non-compliance in the judgement of the investigators

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MS Center at Evergreen
name: Theodore R Brown, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00603759: COX-2 Inhibitor With Concurrent Chemoradiation in Locally Advanced Head & Neck Carcinoma
Official title: the Role of COX-2 Inhibitor(CELECOXIB) in Combination With Chemoradiation in Locally Advanced Head & Neck Carcinoma, Phase III Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Head and Neck Cancer
Keywords: COX2 inhibitor
head and neck cancer
chemoradiation
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: department of radiation oncology
First posted: 2008-01-29
Enrollment: 122
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: chemotherapy- and radiotherapy-induced oral mucositis represents a therapeutic challenge frequently encountered in cancer patients.This side effect causes significant morbidity and may delay or interrupt the treatment plan, as well reduce therapeutic index. cyclo-oxygenase 2 (COX-2) is an inducible enzyme primarily expressed in inflamed tissues and tumor. COX-2 inhibitors have shown promise as radio- and chemosensitizer and reduce radio-induced toxicities.

we have conducted a phase III, randomized double blind clinical trial to evaluate the toxicity and efficacy of celecoxib, a selective COX-2 inhibitor, administered concurrently with chemotherapy, and radiation for locally advanced head and neck cancer.


Eligibility criteria: Inclusion Criteria:

* stage III/IV (locally advanced) carcinoma of oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx
* primary treatment with chemoradiation

Exclusion Criteria:

* distant metastasis
* incomplete treatment
* adjuvant chemoradiation after surgery without apparent tumor

Primary outcomes:
measure: efficacy of celecoxib (response rate and local control)
timeFrame: 30 months
Secondary outcomes:
measure: toxicity of celecoxib
timeFrame: 30 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Chemoradiation
Study officials:
affiliation: cancer institute center
name: Mahdi Aghili, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01516359: Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements
Official title: Official Title is Required by the WHO and ICMJE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Injury of Other and Multiple Parts of Small Intestine
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing heart valve replacements under cardiopulmonary bypass

Brief summary: The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.

Detailed description: Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing heart valve replacements under cardiopulmonary bypass

Exclusion Criteria:

* Patients who die during or after operation

Primary outcomes:
measure: score of gut dysfunction
timeFrame: eight months
Secondary outcomes:
measure: The duration of cardiopulmonary bypass
timeFrame: Eight months
measure: The duration for aortic artery clamping
timeFrame: eight months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Ke Xuan Liu, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04165759: HRCT in Prediction of Tumor Invasion in GGO Lung Adenocarcinoma (ECTOP-1008)
Official title: Preoperative Evaluation of High-resolution Computed Tomography to Predict Pathologic Tumor Invasion in Ground-glass Opacity Featured Lung Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adenocarcinoma of Lung
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Fujian Medical University Union Hospital
name: Shandong First Medical University Affiliated Liaocheng Second Hospital
name: Jiangdu People's Hospital, Yangzhou
First posted: 2019-11-18
Enrollment: 620
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: East Asian population

Brief summary: This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1008). It aims to evaluate the correlation between radiological diagnosis based on HRCT and pathological invasiveness.Investigators observe the radiological features and the correlation with the postoperative pathological findings.

Detailed description: Preoperative evaluation of pathologic tumor invasion of ground glass opacity (GGO) featured lung adenocarcinoma is important for selection of appropriate surgical extent. Whether thoracic high-resolution computed tomography (HRCT) scan could precisely predict pathologic tumor invasion remains unknown. Patients with peripheral GGO nodules (GGNs) would be enrolled, and HRCT with target scan would be performed preoperatively. Pathologic tumor invasion (invasive adenocarcinoma \[IAD\] versus adenocarcinoma in situ \[AIS\]/minimally invasive adenocarcinoma \[MIA\]) would be evaluated according to radiologic parameters of HRCT before surgery. Primary endpoint of this trial is the diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT. Secondary endpoint is the diagnostic value of radiologic parameters of HRCT for pathologic tumor invasion of GGO featured lung adenocarcinoma.

Eligibility criteria: Inclusion Criteria:

(1) GGNs on HRCT scan; (2) clinical stage IA; (3) simultaneously no more than three nodules; (5) Age ranging from 15 to 85 years.

Exclusion Criteria:

(1) pathologically confirmed non-adenocarcinoma; (2) patients who did not receive surgery.

Primary outcomes:
measure: Sensitivity
timeFrame: Pathologic reports were available, usually 1 month after surgery
Secondary outcomes:
measure: Value of radiologic parameters for tumor invasion
timeFrame: Pathologic reports were available, usually 1 month after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Haiquan Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05286359: Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
Official title: Multi-site, Prospective, Clinical Performance Evaluation of NxTekTM Malaria Pf Plus Rapid Diagnostic Test Device and NxTekTM Malaria Pf/Pv Plus Rapid Diagnostic Test (RDT) Device for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: Plasmodium infection
Plasmodium falciparum
Plasmodium vivax
Lead sponsor: Abbott Rapid Dx
Sponsor class: INDUSTRY
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2022-03-18
Enrollment: 1023
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.

Detailed description: A prospective cross-sectional multi-center diagnostic accuracy trial in intended-use settings of the:

1. NxTekTM Malaria Pf/Pv Plus Rapid Test Device for the qualitative detection histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) malaria in human whole blood.
2. NxTekTM Malaria Pf PlusRapid Test Device for the qualitative detection of histidine-rich protein II (HRP-II antigens) and pLDH of Plasmodium falciparum (P.f) malaria in human whole blood.

Eligibility criteria: Inclusion Criteria:

* Aged 5years old or older
* Presenting at the trial site with fever or a history of fever (axillary temp ≥ 37.5C) during the preceding 48hours
* Freely agreeing to participate by providing informed consent (and assent, if applicable)

Exclusion Criteria:

* Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines.

Primary outcomes:
measure: Assess the sensitivity, specificity, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTekTM Malaria Pf Plus
timeFrame: 6 months
measure: To assess the diagnostic accuracy of NxTekTM Malaria Pf/Pv Plus.
timeFrame: 6 months
Secondary outcomes:
measure: Estimates of diagnostic accuracy characteristics with 95% confidence intervals of comparator tests (05FK50, 05FK80, 05FK120, LM)
timeFrame: 6 months
measure: Estimates of diagnostic accuracy characteristics with 95% confidence intervals ofthe index tests for the detection of P.f.infections with hrp2 and/or hrp3 deletions
timeFrame: 6 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Medical Parasitology Research Unit, Aklilu Lemma Institute of Pathobiology (ALIPB), Addis Ababa University (AAU).
Study officials:
affiliation: Addis Ababa University
name: Dr. Lemu Golassa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04146259: Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism
Official title: Changes in Circulating Sclerostin Levels During Acute Postsurgical Hypoparathyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoparathyroidism Postprocedural
Keywords: Sclerostin
Hypoparathyroidism
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 109
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with indication for total thyroidectomy

Brief summary: To investigate changes in sclerostin levels following acute post-thyroidectomy hypoparathyroidism

Detailed description: Female patients with thyroid disorders, referred to the Department of Head and Neck Surgery, at Metaxa Anti-Cancer Hospital of Piraeus, for total thyroidectomy.

Based on the development of biochemical hypocalcemia (cCa \< 8.4 mg/dl), subjects were divided into 2 groups: Group A: without postsurgical hypoparathyroidism that served as controls and group B: subjects, with acute postsurgical hypoparathyroidism.

Blood collections were performed in the morning after an overnight fast, in at least 3 different time points; preoperatively, 1st postoperative day and 7th postoperative day for the detrmination of sclerostin levels

Eligibility criteria: Inclusion Criteria:

* Indication for total thyroidectomy

Exclusion Criteria:

* parathyroid disorders, chronic kidney disease (eGFR\< 60 ml/min), treatment with antiosteoporosis drugs, rheumatic disease and history of long term (\>1 month) or current corticosteroid use

Primary outcomes:
measure: change in circulating serum sclerostin levels (pmol/L) during the observation period
timeFrame: 7 days
Secondary outcomes:
measure: the between groups difference in % changes of circulating sclerostin
timeFrame: 7 days
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Symeon Tournis
Study officials:
References:
Clinical trial NCT06995859: Amalgam Restorations Teaching in Pediatric Dentistry
Official title: Amalgam Restorations Teaching in Pediatric Dentistry in Egyptian Universities: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Dental Amalgam
Keywords: dental education
amalgam restoration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric dentistry educators in Egyptian universities with at least one year experience.

Brief summary: To assess the pediatric dentistry educator's perception about teaching and using dental amalgam as restoration for primary teeth.

Detailed description: Dental education has long emphasized the development of clinical skills necessary for restorative procedures. Among these, amalgam restorations have been a foundational component of dental curricula for decades due to their durability, cost-effectiveness, and historical prominence in restorative dentistry. However, in recent years, the use of amalgam has become a subject of debate due to environmental concerns related to mercury content, alongside the increasing popularity of composite materials.

To our knowledge no current data is available regarding teaching amalgam in pediatric dentistry in Egyptian dental universities. So, the aim of this study is to assess the pediatric dentistry educator's perception about teaching and using dental amalgam as restoration for primary teeth. This could help in making improvements to the dental education system ensuring that future dentists are equipped to offer patients the best treatment options based on individual needs, improving overall oral health outcomes.

Eligibility criteria: Inclusion Criteria:

* Participants included will be Pediatric dentistry educators in Egyptian universities with at least one year experience.

Exclusion Criteria:

* Pediatric dentistry educators who are not willing to participate or to complete the questionnaire will be excluded also administrative and non-teaching staff

Primary outcomes:
measure: Pediatric dentistry educator's perception about teaching amalgam restorations
timeFrame: 1 month
Secondary outcomes:
measure: Pediatric dentistry educator's experience and confidence about using dental amalgam as restoration for primary teeth
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Cairo university
Study officials:
References:
Clinical trial NCT04826159: IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
Official title: A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type 2 Diabetes
Diabetic Cardiomyopathies
HFpEF - Heart Failure With Preserved Ejection Fraction
Lead sponsor: Imbria Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Oxford
First posted: 2021-04-01
Enrollment: 50
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: TREATMENT

Brief summary: The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability


Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Elevated HbA1c
* Elevated BMI
* Preserved left ventricular ejection fraction
* Diagnosis of HFpEF (Stage 2 only)

Exclusion Criteria:

* Uncontrolled hypertension
* Contraindication to magnetic resonance scanning
* More than mild to moderate valvular heart disease
* Atrial fibrillation
* History of sustained ventricular tachycardia or cardiac arrest
* Inability to exercise (Stage 2 only)
* Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability

Primary outcomes:
measure: Change in cardiac PCr/ATP ratio at rest (Stage 1 and Stage 2) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972.
timeFrame: Baseline, End of Treatment (up to 16 weeks)
measure: Change in cardiac PCr/ATP ratio with dobutamine stress (Stage 1 only) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972
timeFrame: Baseline, End of Treatment (up to 8 weeks)
Secondary outcomes:
measure: Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs
timeFrame: Baseline through End of Treatment (up to 16 weeks)
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospital
Study officials:
affiliation: Imbria Pharmaceuticals, Inc.
name: Paul Chamberlin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06637059: Artificially Intelligent Model for Accurate Detection of HCC
Official title: Construction of an Artificially Intelligent Model for Accurate Detection of HCC by Integrating Clinical, Radiological, and Peripheral Immunological Features
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular carcinoma; Early detection; Multi-modal; Fusion model; Artificial intelligence
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 1092
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: Benign liver diseases, including but not limited to, hemangiomas, hepatic cysts, focal nodular hyperplasia, and cirrhosis were considered in this study. Participants who had undergone previous treatment for HCC or benign liver diseases, those who had taken medications affecting the hematological system within 2 weeks, or those who had received a blood transfusion within 6 months were excluded from the study.

Brief summary: Purpose: Integrating comprehensive information on hepatocellular carcinoma (HCC) is essential to improve its early detection. The investigators aimed to develop a model with multi-modal features (MMF) using artificial intelligence (AI) approaches to enhance the performance of HCC detection.

Experimental Design: A total of 1,092 participants were enrolled from 16 centers. These participants were allocated into the training, internal validation, and external validation cohorts. Peripheral blood specimens were collected prospectively and subjected to mass cytometry analysis. Clinical and radiological data were obtained from electrical medical records. Various AI methods were employed to identify pertinent features and construct single-modal models with optimal performance. The XGBoost algorithm was utilized to amalgamate these models, integrating multi-modal information and facilitating the development of a fusion model. Model evaluation and interpretability were demonstrated using the SHapley Additive exPlanations method.


Eligibility criteria: Inclusion Criteria:

* Benign liver diseases, including but not limited to, hemangiomas, hepatic cysts, focal nodular hyperplasia, and cirrhosis

Exclusion Criteria:

* Participants who had undergone previous treatment for HCC or benign liver diseases,
* had taken medications affecting the hematological system within 2 weeks
* those who had received a blood transfusion within 6 months

Primary outcomes:
measure: Diagnosis of liver disease through CT imaging
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
state: Zhejiang
Study officials:
References: