louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01367899: CONSERVE Plus Post-Approval Study (PAS)
Official title: Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Other and Unspecified Injury to Hip and Thigh
Keywords: Safety
Efficacy
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 199
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: Patients who have already undergone hip resurfacing in the CONSERVE Plus IDE.

Brief summary: The objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates.

Detailed description: This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under actual conditions of use. Additionally, this study will evaluate the performance of the device in the post approval environment to see if there are any significant changes in device performance as compared to the pre-market IDE Study

Eligibility criteria: Inclusion Criteria:

1. Was previously enrolled in the CONSERVE® Plus IDE as part of the All Enrolled Audited Cohort (N=1366 procedures (1206 patients)) and received the "Original Shell".
2. Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.

Exclusion Criteria:

1. Patient is mentally incompetent.
2. Patient is a prisoner.
3. Patient is an alcohol and/or drug abuser
4. Patient has undergone device revision or removal

Primary outcomes:
measure: Clinical success at Month 120
timeFrame: 10 years
Secondary outcomes:
measure: Radiographic outcomes
timeFrame: 10 years
measure: Metal Ion (serum)
timeFrame: 24 months
measure: Assessment for Adverse Events
timeFrame: 10 years
measure: Measurement of Patient Satisfaction
timeFrame: 10 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Michael Bolognesi, MD
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Bolognesi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03134599: Comparison of Clinical Performance and Subjective Preference of Three Contact Lenses
Official title: Comparison of Clinical Performance and Subjective Preference Out of Three Cosmetic Contact Lenses (Limbal Ring-enhancing Lenses, LRE Lenses)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical performance and subject's preference out of three LRE (Limbal Ring Enhancing) lens types: etafilcon A (Johnson\&Johnson), methafilcon A (Interozzo), and methafilcon A (CooperVision).

Detailed description: This will be a subject-masked, bilateral, randomized, crossover dispensing study to compare clinical performance and subjective preference out of three lens types. Sixty subjects will be assigned into three groups and each group will wear the test and control lenses as matched pairs for one week in random order. Lenses will be worn on a daily wear, daily disposable schedule.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years and above and has full legal capacity as a volunteer Understand the rights as a research subject and willing and able sign a statement of informed consent
* Existing soft contact lens wearers or previous experience of contact lens wear
* Being able to wear the study lenses for at least eight hours a day
* At least 6/9 visual acuity in each eye with the study lenses
* Astigmatism less than 1.50 D (Diopter) in both eyes
* Agreed to follow the protocol and not to participate in other clinical research for the duration of this study

Exclusion Criteria:

* Have an ocular disorder which would normally contraindicate contact lens wear
* Have a systemic disorder or any infectious diseases which would normally contraindicate contact lens wear
* Have previously had any ocular surgery such as corneal refractive surgery
* Have less than 6/9 visual acuity in each eye with the study lenses
* Are currently using any topical medication such as eye drops or ointment
* Have any corneal distortion resulting from previous rigid lens wear or have keratoconus
* Are currently pregnant or lactating
* No previous contact lens wear

Primary outcomes:
measure: Comfort
timeFrame: 1 week per intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: School of Optometry & Vision Science, Catholic University of Daegu, Korea (Rep)
Study officials:
References:
Clinical trial NCT03843099: Physical Activity Choices Everyday- A Pilot Study
Official title: Decisions About Exercise During Weight Loss: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: University at Buffalo
name: Kent State University
name: University of Southern California
First posted: 2019-02-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to test two strategies for weight loss. Participants will be randomly assigned to one of the two 4-week weight loss programs: (1) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which information about a healthy lifestyle is reviewed or (2) a behavioral weight loss program that involves recording weekly weight, physical activity, and caloric intake plus daily exercises in which descriptions of positive future events are reviewed. Throughout the study, participants will complete assessments that examine the effects of the interventions on delay discounting, physical activity, weight, and other important health and psychosocial outcomes.


Eligibility criteria: Inclusion Criteria:

* Age between 18-70
* Body Mass Index between 30-50
* English Speaking
* Have a smartphone that can be used for study activities

Exclusion Criteria:

* Report being unable to walk 2 blocks without stopping
* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
* Are pregnant or plan to become pregnant within 2 months
* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
* History of or current traumatic brain injury, dementia or Alzheimer's disease; a history of Multiple Sclerosis, or other neurological disorders
* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g., relocation, dementia, unable to read and write in English)
* Have no Internet access or unwilling to use personal smartphone for study.

Primary outcomes:
measure: Physical Activity
timeFrame: baseline and week 7
measure: Delay Discounting
timeFrame: baseline and week 7
Secondary outcomes:
measure: Weight
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hartford
country: United States
facility: UConn Weight Management Research Laboratory
state: Connecticut
Study officials:
References:
Clinical trial NCT05894499: Post-Marketing Safety Study in Japan of Shock and Anaphylaxis After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in Persons in at High Risk of Severe COVID-19
Official title: Cohort Survey on Shock and Anaphylaxis in Persons With Underlying Diseases Considered to Be at High Risk of Severe COVID-19 by Using Vaccination Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 13309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was selected from participants who were registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database whose start date of observation in the claim database was within 6 months or more before vaccination with mRNA-1273 vaccine, and those who met the definition of underlying disease based on the claim data for 6 months.

Brief summary: The goal of this study is to confirm the onset status of hypersensitivity reactions including shock and anaphylaxis observed after vaccination with this drug in persons with underlying diseases who are considered to have a high risk of severe exacerbation of COVID-19 and explore risk factors.

Detailed description: Data collected from the JDMC Claims Database between May 2021 to November 2021.

Eligibility criteria: Inclusion Criteria:

* Participants registered to receive the mRNA-1273 vaccine in the Pep Up vaccination history Database
* Participants who have a history of vaccination with the mRNA-1273 vaccine in the Pep-Up vaccination history Database and the observation start date is at least 6 months prior to vaccination with the mRNA-1273 vaccine and have underlying diseases. Data period for confirmation of presence/absence of underlying disease is May 2021 to November 2021.

Exclusion Criteria:

* Underlying diseases that were determined undetectable by the pre-screening of JMDC
* Participants who did not consent to the questionnaire.

Primary outcomes:
measure: Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Either Dose 1 and Dose 2
timeFrame: Up to 2 days post vaccination after either the first or second vaccination
Secondary outcomes:
measure: Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 1
timeFrame: Up to 2 days post vaccination
measure: Number of Participants With Hypersensitivity Reactions Including Shock and Anaphylaxis After Dose 2
timeFrame: Up to 2 days post vaccination
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: CMIC Co., Ltd.
Study officials:
References:
Clinical trial NCT04327999: Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System
Official title: Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System of Patients Following Radioiodine Therapy for Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thyroid Carcinoma
Radioactive Iodine Level
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore whether administration of preservative free artificial tears will decrease the level of detectable radioiodine in the tears and nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and thus decrease the risk of developing radioactive iodine associated nasolacrimal duct obstruction.

Detailed description: Primary Objective:

- To assess whether use of preservative free artificial tears following radioactive iodine administration will lower the level of radioactive iodine in the tears of patients treated with radioactive iodine for thyroid carcinoma.

Secondary Objective:

- To evaluate whether artificial tears would be an effective preventative intervention to decrease the risk of developing nasolacrimal duct stenosis, which has been associated with radioactive iodine administration.

Eligibility criteria: Inclusion Criteria:

* Radio-iodine therapy for thyroid cancer
* Radioiodine therapy ≥100mCi
* Patient wears soft contacts on both eyes

Exclusion Criteria:

* Use of eye drops, other than artificial tears
* History of periocular trauma with tear duct involvement/lacrimal gland trauma
* History of lacrimal drainage disease: canaliculitis, dacryocystitis
* Prior radiotherapy
* Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
* Medical conditions that predispose to NLD stenosis

  * Sarcoid
  * Granulomatosis with polyangiitis
  * Chronic lymphocytic leukemia

Primary outcomes:
measure: Change in Level of Radioactive Iodine in Tears
timeFrame: Over a 4 day period
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt Medical Center
name: Rachel Sobel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03882099: Vitamin D Level and Its Relation to Pre-eclampsia and Eclampsia
Official title: Vitamin D Level in Patients With Pre-eclampsia, Eclampsia and Normal Full Term Pregnant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Deficiency
Pre-Eclampsia
Eclampsia, Antepartum
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study

Brief summary: To compare 25(OH)D level in patients with pre-eclampsia, eclampsia and normotensive pregnant women as well as to study the prevalence of Vitamin D deficiency among the 3 groups.

Detailed description: 200 patients with pre-eclampsia, 100 with eclampsia and 200 normotensive pregnant controls attending Delivery/emergency department in Kasr Al Ainy hospital will be included in the study (from March 2019 till September 2019). 25(OH) D level will be measured for the three groups.

* Preeclampsia is defined as systolic BP \>140 and/or diastolic BP\>90 on two occasions, 4 hours apart in pregnant females\>20 weeks, plus proteinuria \>/= 1+ urine dipstick protein.
* Eclampsia defined as tonic-clonic seizures in women with pre-eclampsia.
* Controls are normotensive pregnant females with no proteinuria and no other medical disorders.
* The determination of 25(OH) D is based on a competitive enzyme-linked immunosorbant assay (ELISA) using the 25(OH)D3/D2 ELISA system (ORGENTIC DIAGNOSTIKA GmbH, Germany)

Inclusion criteria:

Age 20-35 years Gestational age 30-40 weeks

Exclsion criteria:

Twin pregnancy Other medical conditions during prrgnancy Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment.

Eligibility criteria: Inclusion Criteria:

* Age 20-35 years
* Gestational age 30-40 weeks

Exclusion Criteria:

* Twin pregnancy
* Other medical conditions during pregnancy
* Drugs that influence Vit D levels eg.antiepileptics and antituberculous treatment

Primary outcomes:
measure: To compare vitamin D levels in the three groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT03975699: Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
Official title: Implications of a Paediatrician-psychologist Tandem for Sickle Cell Disease Care and Impact on Cognitive Functioning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: paediatric-psychological partnership
child
mental health
integrated care
well-being
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-06-05
Enrollment: 155
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children suffering from SCD and their parents, consulting in one of the 3 hospitals.

Brief summary: Sickle cell disease (SCD) necessitates a paediatric treatment plan that considers the influence of psychological, family and intercultural factors. At the Louis-Mourier Hospital (APHP) in Colombes, France, a paediatric-psychological partnership where a clinical psychologist accompanies the paediatrician at programmed consultations was introduced.

The psychological repercussions of SCD were assessed among children and their parents treated in Colombes and in two other paediatric units without a paediatric-psychological partnership.


Eligibility criteria: Inclusion Criteria:

* Children under 18 years old
* Major form of SCD (SS, SC, Sβ° thal, Sβ+ thal) diagnosed by electrophoresis

Exclusion Criteria:

* Child or parent residing in France less than 6 months
* Having received SCD treatment in more than one centre

Primary outcomes:
measure: Rey-Osterrieth complex figure test scores (ROCF recall scores)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02877199: Anti-E1E2 Antibodies (D32.10 Epitope-binding Antibodies) and HCV Triple Therapy
Official title: Anti-E1E2 Antibodies for the Prediction of Virological Response to Triple Therapy in Treatment-experienced Hepatitis C Virus-cirrhosis Cases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Hepatitis C
anti-E1E2 antibodies
cirrhosis
triple therapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis C virus infected patients with cirrhosis

Brief summary: The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.


Eligibility criteria: Inclusion Criteria:

* HCV patients with compensated cirrhosis (Child-Pugh A)
* HCV genotype 1
* non-responders to a previous course of interferon (IFN)/ribavirin
* receiving boceprevir or telaprevir

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of patients with positive anti-E1E2 antibody level at treatment initiation
timeFrame: Baseline (initiation of treatment)
Secondary outcomes:
measure: Kinetic of Quantification of hepatitis C viral load (HCV RNA)
timeFrame: baseline (initiation of treatment), at week 4, 12, 24, 36, 48 of therapy, at 12 weeks after the end of treatment.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT06747299: The Value of Artificial Intelligence-based 18F-FDG PET/CT in Diferential Diagnosis, Efficacy Prediction and Prognosis Prediction of T-NK Cell Lymphoma: a Clinical Study
Official title: The Value of Artificial Intelligence-based 18F-FDG PET/CT in Diferential Diagnosis, Efficacy Prediction and Prognosis Prediction of T-NK Cell Lymphoma: a Clinical Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: T-NK Cell Lymphoma
Keywords: T-NK cell Lymphoma
PET/CT
Diferential Diagnosis
Efficacy Prediction
Prognosis Prediction
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2024-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pathological histology confirmed as T-NK Cell Lymphoma at Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Brief summary: Based on the PET/CT imaging data of patients with T-NK cell lymphoma, machine learning and deep learning methods are used to extract imaging features, establish a T-NK cell lymphoma prediction model, and provide more scientific and accurate prognosis prediction for the clinic.

Detailed description: This study adopts a multicenter retrospective cohort study design，we provided PET/CT of 200 patients with T-NK cell lymphoma as an external validation set for model validation.

Eligibility criteria: Inclusion Criteria:

1. Pathological histology confirmed as T-NK Cell Lymphoma; 2.18F-FDG PET/CT examination before treatment; 3. Using modern best practice treatment options; 4. Complete clinicopathological and follow-up data were obtained.

Exclusion Criteria:

1. The patient had previously received antitumor therapy;
2. The patient had a history of other tumors;
3. Incomplete clinical information or imaging data;
4. Concomitant other malignant tumors.

Primary outcomes:
measure: Evaluation the value of Artificial Intelligence-based 18F-FDG PET/CT of T-NK Cell Lymphoma
timeFrame: Within 1 week of enrollment and after 3 months treatment
Secondary outcomes:
measure: Progress free survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
state: Shanghai
Study officials:
References: