louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04953195: Thyroid Replacement Therapy in Patients With Subclinical Hypothyroidism
Official title: Effect of Thyroid Replacement Therapy on Thyroid Structure in Patients With Subclinical Hypothyroidism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Subclinical Hypothyroidisms
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this experiment is to compared the changes of thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance T1-mapping and various metabolic indexes from baseline to the end of treatment (after the thyroid function had been normal for more than three months)

Detailed description: In patients with autoimmune thyroiditis with mild subclinical hypothyroidism, the study period will include a screening period of not more than 30 days, and a 12-week treatment period compared to baseline. At completion of treatment, Thyroid Stimulating Hormone(TSH), free thyroxine (FT4)，free thyroxine (FT3) will be included. The changes of anti-thyroglobulin antibody, anti-thyroglobulin antibody, T1-mapping and metabolic indexes.

Eligibility criteria: Inclusion Criteria:

* Men or women between the ages of 18 and 75;
* Diagnostic criteria for mild subclinical hypothyroidism :TSH\>10mIU/L, thyroxine and free thyroxine levels were normal
* Positive thyroglobulin antibody and/or Thyroperoxidase antibody
* No previous use of drugs affecting thyroid function

Exclusion Criteria:

* The contraindications indicated in the Chinese instructions of the drug
* Liver function impairment
* Renal function impairment
* Claustrophobia
* Mental disorders

Primary outcomes:
measure: Thyroid Stimulating Hormone changes
timeFrame: Thyroid Stimulating Hormone Changes from baseline and 12 weeks during follow-up
measure: free thyroxine changes
timeFrame: free thyroxine changes from baseline and 12 weeks during follow-up
measure: T1-mapping values of Thyroid MRI
timeFrame: T1-mapping values of Thyroid MRI Changes from baseline and 12 weeks during follow-up
measure: Free triiodothyronine changes
timeFrame: Free triiodothyronine changes Changes from baseline and 12 weeks during follow-up
Secondary outcomes:
measure: anti-thyroid peroxidase antibody changes
timeFrame: anti-thyroid peroxidase antibody changes from baseline and 12 weeks during follow-up
measure: anti-thyroglobulin antibody changes
timeFrame: anti-thyroglobulin antibody changes from baseline and 12 weeks during follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Chao-Yang Hospital, Capital Medical University, Beijing
name: Guang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00383981: Lipid Peroxidation in Workers Exposed to Al,Ga,In,As,and Sb in Optoelectronic Industry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urine
Keywords: malondialdehyde optoelectronic vitamin complex
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2006-10-04
Enrollment: 170
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: To investigate whether exposure to Al, Ga, In, As, and Sb induces lipid peroxidation in humans. Whole blood and urine levels of 170 workers were analysed by use of ICP-MS. MDA, the product of lipid peroxidation was determined by HPLC

Detailed description: If MDA as an index of lipid peroxidation can be induced by these metals. We will suggest reducing exposure to these metals

Eligibility criteria: Inclusion Criteria:

* Optoelectronic workers

Exclusion Criteria:

* Office workers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Department of Public Health Kaohsiung Medical University
name: Yen-Hsiung Liao, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04300881: Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists)
Official title: Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Vitreomacular Traction
Subretinal Edema
Lead sponsor: Wagner Macula & Retina Center
Sponsor class: OTHER
Collaborators: name: ThromboGenics
First posted: 2020-03-09
Enrollment: 2
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years of age
* Symptomatic VMA, VMT, or macular hole
* BCVA 20/30 - CF 3' Snellen equivalent
* Willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments
* JETREA® treatment naïve

Exclusion Criteria:

* Patients who are pregnant, planning to become pregnant, or breastfeeding a child
* Uncontrolled ocular hypertension or glaucoma in study (defined as IOP ≥ 25mm Hg or a cup to disc ratio (CDR) \> 0.8 despite treatment with anti-glaucoma medication)
* Active malignancies within the last 12 months except appropriately treated carcinoma in situ of the crevices, melanoma, and prostate cancers treated with a curative intent
* Inability to comply with study or follow-up procedures
* Women who may become pregnant or lactating or intend to become pregnant during the study
* Known drug allergy to ocriplasmin or eplerenone
* Patients with known contraindications Eplerenone as outlined in the package insert

Primary outcomes:
measure: Changes from baseline in Central Foveal Thickness (CFT) over time
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Changes from baseline in Best Corrected Visual Acuity (BCVA) over time
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
Study officials:
References:
Clinical trial NCT01962181: Identifying Characteristic Signature of Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment
Official title: Identifying Characteristic Signature of Brain Activity of Electroencephalogram Records in Attention Deficit / Hyperactivity Disorder (ADHD) and Ritalin Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: "Attention Deficit Hyperactivity Disorder"
Keywords: EEG Attention Deficit / Hyperactivity Disorder (ADHD) Ritalin machine learning
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment.

Detailed description: In this study we try to identify the signature of brain activity in the EEG of attention deficit disorder (ADHD) patients compared to healthy subjects under different doses of Ritalin (methylphenidate) treatment. All subjects will undergo 1-4 EEG sessions. In each session we will use a different dose of Ritalin or placebo. A detailed neuropsychological tests will be done during the EEG recording. A powerful machine-learning techniques will be used in order to find a specific signature of ADHD and Ritalin treatment in the EEG recording.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, aged 18-50 years.
* Subjects aged 18-50 years diagnosed with ADHD and treated with Ritalin regularly (at least once a week).

Exclusion Criteria:

* Patients previously diagnosed as suffering from a brain disease except for ADHD.
* Patients after traumatic head injury.
* Patients who are unable to express their consent to participate in the study.

Primary outcomes:
measure: Resting oscillation activity and Event-related-Potentials in Attention Deficit / Hyperactivity Disorder (ADHD) and healthy subjects.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Renana Eitan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02980081: Abdominal Plain X-ray in the Emergency Departement
Official title: Abdominal Plain X-ray in the Emergency Departement: Really Usefull?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Diagnostic Imaging
Abdomen, Acute
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 1997
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients during one year in 2 EDs in the state of Geneva, Switzerland, with a prescription of an abdominal plain x-ray

Brief summary: There are only few recognized indications for the realization of plain abdominal X-rays in the emergency departement.

The objective of this study is to explore the reasons for abdominal plain X-rays prescription in the Emergency departments (EDs) of two hospitals.

Detailed description: All abdominal plain x-rays prescription will be reviewed in order to identify reasons for prescribing this exam. The indications will be compared to international guidelines in order to identify whether abdominal plain x-rays are overprescribed. Reasons for overprescription will be identify by chart review.

Eligibility criteria: Inclusion Criteria:

* \>= 16 years
* prescription of an abdominal plain x-ray during their stay in the ED

Exclusion Criteria:

* \< 16 y
* no abdominal plain x-ray prescribed

Primary outcomes:
measure: Indications for abdominal plain x-ray prescription
timeFrame: Within 24 hours after ED admission
Secondary outcomes:
measure: Number and types of other prescribed radiological exams
timeFrame: Within 24 hours after ED admission
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals, ED
Study officials:
affiliation: Hopital de La Tour
name: Omar Kherad, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bertin CL, Ponthus S, Vivekanantham H, Poletti PA, Kherad O, Rutschmann OT. Overuse of plain abdominal radiography in emergency departments: a retrospective cohort study. BMC Health Serv Res. 2019 Jan 14;19(1):36. doi: 10.1186/s12913-019-3870-2.
Clinical trial NCT02954081: APremilast After FumaRic Acid Ester Treatment
Official title: Real-world Benefit of Apremilast Treatment of Patients With Moderate-to-severe Psoriasis After Transition From Fumaric Acid Esters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 687
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Adult patients ≥18 years
* Moderate to severe plaque-type psoriasis according to SmPC

Brief summary: Patient treatment preference and treatment satisfaction of physicians and patients comparing fumaric acid ester therapy with subsequent apremilast treatment


Eligibility criteria: Inclusion Criteria:

* Adult patients ≥18 years
* Moderate to severe plaque-type psoriasis according to SmPC
* Phase I: Patients will be included once they are started on systemic fumaric acid esters (e.g. Fumaderm initial®) for the treatment of moderate-to-severe psoriasis vulgaris. Patients initiated on fumaric acid esters will be followed for a maximum of 24 weeks during phase I. Patients continued on fumaric acid esters beyond 24 weeks or switched to a therapy other than apremilast during or at the end of the 24-week phase I period will no longer be followed.
* Phase II: Patients switched to apremilast during or at the end of the 24-week phase I period will be included in phase II and followed for additional 32 weeks.
* Written informed consent

Exclusion Criteria:

* Prior treatment with biologics
* According to SmPC
* Participation in another clinical trial (parallel inclusion in the National psoriasis registry PsoBest is allowed)

Primary outcomes:
measure: Mean absolute value of the overall TSQM score at week 24 of apremilast (APR) therapy (phase II).
timeFrame: 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06523881: Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery
Official title: Evaluation of the Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Anesthesia; Adverse Effect
Keywords: posterior instrumentation
sleep quality
anesthetics
spine surgery
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 40
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: Investigators aimed to evaluate the impact of the anesthesia method and surgical procedure on the sleep patterns and sleep quality of patients undergoing posterior spinal instrumentation using the Pittsburgh Insomnia Rating Scale-20 (PIRS-20).

Detailed description: A total of 40 participants ASA (American Society of Anesthesiology) I-III aged 18 and over who underwent elective spinal posterior instrumentation was included. The participants were divided into two groups randomly - those with sevoflurane and remifentanil anesthesia and those with total intravenous anesthesia (TIVA) - using the closed envelope method. Participants were evaluated before and after the surgery with the PIRS-20 (surgery one month previously and postoperative 7th day) for sleep quality, VAS (Visual Analogue Scale; recorded preoperative night and postoperative first hour), pain, and State-Trait Anxiety Inventory (STAI) for anxiety (recorded preoperative night and postoperative 7th day) scores.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiology) I-III
* Aged 18 and over
* Who underwent elective spinal posterior instrumentation

Exclusion Criteria:

* Aged 17 and under
* ASA (American Society of Anesthesiology) IV
* Presence of psychological illness
* Presence of psychological illness
* Presence of sleep disorder

Primary outcomes:
measure: Pittsburgh Insomnia Rating Scale-20
timeFrame: Preoperative one month
measure: Pittsburgh Insomnia Rating Scale-20
timeFrame: Postoperative seventh day
measure: Visual Analogue Scale
timeFrame: Preoperative one day
measure: Visual Analogue Scale
timeFrame: Postoperative first hour
measure: State-Trait Anxiety Inventory
timeFrame: Preoperative one day
measure: State-Trait Anxiety Inventory
timeFrame: Postoperative seventh day
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University
state: Nilufer
Study officials:
affiliation: Uludag University
name: Yücel Bilgin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02168881: Oral Misoprostol Versus Vaginal Dinoprostone For Induction Of Labour: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labour Induction
Keywords: labour
induction
misoprostol
dinoprostone
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 342
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is to compare between oral misoprostol in solution and vaginal dinoprostone in induction of labour in primiparous women with singleton pregnancy as regards efficiency and safety to both mother and fetus.


Eligibility criteria: Inclusion Criteria:

* Primigravida
* \>37 wks

Exclusion Criteria:

* Scarred uterus
* Macrosomia

Primary outcomes:
measure: induction delivery time
timeFrame: 2 hourly
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity hospital
Study officials:
References:
citation: Kerr RS, Kumar N, Williams MJ, Cuthbert A, Aflaifel N, Haas DM, Weeks AD. Low-dose oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2021 Jun 22;6(6):CD014484. doi: 10.1002/14651858.CD014484.
Clinical trial NCT03739281: PET/MR Imaging in Lung Cancer
Official title: Advancing Diagnosis and Treatment for Lung Cancer Patients Using Hybrid PET/MR Imaging and Novel Visualization Tools
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this project is to investigate if PET/MR imaging improves the accuracy in visualization and characterization of lung cancer disease, compared to PET/CT.

Detailed description: Lung cancer is the most frequent cancer type and the leading cause of cancer-related death worldwide. Positron emission tomography (PET) coupled with computed tomography (CT) is the standard of care for visualization and staging of lung cancer. Recent clinical introduction of hybrid PET and magnetic resonance (MR) imaging systems has shown potential to improve tumor imaging beyond the limits of PET/CT. However, knowledge about the clinical impact of this new hybrid modality is still limited.

This project aims to investigate how PET/MR may improve the diagnosis and treatment of lung cancer disease, compared to PET/CT: PET/MR may allow early detection of brain and liver metastases, which strongly affects treatment outcome and survival; predictive models based on machine learning may combine image derived biomarkers from PET/MR, histology and health record data, to automatically visualize and characterize the tumor, facilitating computer aided diagnosis and personalized radiotherapy treatment.

Eligibility criteria: Inclusion Criteria:

* Referred to clinical PET/CT examination for investigation of lung disease.

Exclusion Criteria:

* Blood glucose level \>8.3 mmol/l
* MR incompatible objects, e.g. metal implants, inside the body
* Intolerance to gadolinium-based contrast agents, e.g. severe renal disease (GFR\<30).
* Unable to give written consent.

Primary outcomes:
measure: Sensitivity and specificity of PET/MR vs. clinical routine PET/CT
timeFrame: 1-2 weeks after the initial inclusion.
Secondary outcomes:
measure: Prediction of treatment response and progression-free survival
timeFrame: 1 year after inclusion.
measure: Prediction of treatment response and progression-free survival
timeFrame: 2 years after inclusion.
measure: Prediction of treatment response and progression-free survival
timeFrame: 5 years after inclusion.
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Rune Sundset, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00127244: Study Comparing Two Different Methods of Treating Periodontal Disease
Official title: Outcomes of Traditional and Medical Models of Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periodontal Diseases
Lead sponsor: The Forsyth Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Delta Dental Plan Massachusetts
name: Harvard University
First posted: 2005-08-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to:

1. compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and
2. determine the value of the two approaches to periodontal therapy.

Detailed description: This application was developed to test the following hypothesis: A medical model of periodontal therapy, when compared to a traditional model, is as clinically effective, is more valuable, and can be realistically implemented in clinical practice. To accomplish this task a prospective, blinded, community based, cohort trial will be carried out. Two analytical techniques will be employed to compare the outcomes of periodontal therapy: clinical effectiveness and value. The two primary outcome variables for assessing clinical effectiveness will be clinician centered (attachment level) and patient centered (quality of life). The key outcome variable for value determination is cost of care. Value is then determined by dividing the outcome by the cost of care. Thus a similar outcome at reduced cost increases value. This facilitates calculating cost-effectiveness and cost-utility of care, preparing decision analysis trees, and carrying out sensitivity analysis.

There are two significant reasons for testing a medical model of care. If the hypothesis is correct:

1. this would increase access to periodontal care; and
2. it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems.

These points argue for a direct comparison of the medical and traditional models of care.

Eligibility criteria: Inclusion Criteria:

* \>/= 4 or more periodontally involved teeth as defined by pocket depth of \>/= 6mm.
* \>/= 14 teeth.
* \> 18 years of age.
* Reside in the greater Boston area.

Exclusion Criteria:

* Those patients requiring prophylactic antibiotic for dental treatment.

Primary outcomes:
measure: Clinical attachment loss
measure: Quality of life
measure: Tooth loss
measure: Plaque accumulation
measure: Suppuration
measure: Bleeding on probing
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: The Forsyth Institute
state: Massachusetts
Study officials:
affiliation: The Forsyth Institute
name: Richard Niederman
role: PRINCIPAL_INVESTIGATOR
References: