louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06050746: Predictive Value of the PBS-score in Children With Clubfoot
Official title: Predictive Value of the PBS-score - A Prospective Observational Cohort Study Evaluating Recurrence of Idiopathic Clubfoot and Need for Additional Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Clubfoot
Keywords: PBS-score
Oxford Foot and Ankle Questionaire-child
Roye's score
Pedobarography
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
First posted: 2023-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with idopatic clubfoot treated at Astrdi lindgren Children´s Hospital

Brief summary: Evaluate the predictive value of the PBS-score in predicting recurrence of idiopathic clubfoot, measured as need for additional treatment.

Detailed description: Using a consecutive inclusion, we aim to include 60 children and register data proposed by the COS for PEVA. All items of the PBS-score are video-documented, and dynamic foot pressure during walking is recorded during a clinical visit at the Motion Analysis Lab at Karolinska University Hospital. Children and caregivers will complete Roye's score, a disease-specific PROM and Oxford Foot and Ankle Questionaire-child (OxFAQc). For children aged 6 years or older, standing radiographic imaging of both feet will be performed. Inclusion criteria include: age 4-8 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English. Included children will be followed prospectively during five years through clinical visits and medical records, where need for additional treatment (casting, braces and/or surgery) is the primary endpoint.

Eligibility criteria: Inclusion Criteria:

* age 4-10 years, a diagnosis of idiopathic clubfoot, ability to walk 10 m repeatedly, and ability to communicate verbally (and in writing for caregivers) in Swedish or English.

Exclusion Criteria:

* Syndromic clubfoot

Primary outcomes:
measure: Need for further treatment
timeFrame: 5 years
Secondary outcomes:
measure: Patient reported outcome measures (PROM)
timeFrame: 5 years
measure: Patient reported outcome measures - The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) is a child - or parent (proxy)
timeFrame: 5 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Astrid Lindgren Children´s Hospital
state: Region Stockholm
Study officials:
affiliation: Astrid Lindgren Children´s Hospital
name: Eva W Broström, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00199446: Study of Istradefylline (KW-6002) for the Treatment of Restless Legs Syndrome
Official title: A Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) in Subjects With Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disorder
Restless Legs Syndrome
Keywords: Sleep -Sleep Disorder
Sleep- Restless Legs Syndrome
Clinical Trial
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin Co., Ltd.
First posted: 2005-09-20
Enrollment: 160
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: The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of 40 mg per day of istradefylline (KW6002) in patients with Restless Legs Syndrome.

Detailed description: Restless Legs Syndrome (RLS) is a very common neurological disorder with a prevalence of approximately 10% in the adult population. It is characterized by an almost irresistible urge to move the legs, usually accompanied by feelings of intense discomfort. The feelings are usually present while at rest and are temporarily relieved by activity. Symptoms are worse in the evening and at night and lead to profound sleep disturbance and daytime fatigue.

Although a number of therapeutic approaches have been used to treat the symptoms of RLS, none have been universally adopted. While it has been shown that some dopaminergic anti-parkinsonian medications are effective in treating RLS, their use may be somewhat limited by side effects associated with long-term dopaminergic activation. Istradefylline may provide a nondopaminergic approach to the treatment of RLS.

This study will compare the efficacy of 40 mg per day of istradefylline in improving the symptoms of RLS with placebo.

Eligibility criteria: Inclusion Criteria:

RLS that is mild to moderate in severity, non-nursing and non-pregnant if female, with an otherwise normal examination.

Exclusion Criteria:

Unable to stop other RLS medication, treatment with excluded medications, abnormal medical status.

Primary outcomes:
measure: Change from baseline in an RLS rating scale score at endpoint (6 weeks of treatment or early discontinuation).
Secondary outcomes:
measure: Change from baseline values in an RLS rating scale score, in the a sleepiness scale, in values for Clinical Global Impression, in quality of life, and in actigraphic measurements.
measure: Safety
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Kyowa Pharmaceutical Inc.
state: New Jersey
Study officials:
affiliation: Kyowa Kirin, Inc.
name: James Williams, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02206646: Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® in Korean Patients With Acute Myocardial Infarction
Official title: Post Marketing Surveillance to Monitor the Safety and Efficacy of Metalyse® (Tenecteplase) in Korean Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-01
Enrollment: 987
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with acute myocardial infarction

Brief summary: To monitor the safety of Metalyse® in clinical practice in patients with acute myocardial infarction over a period of 6 years as required by Korean authorities, with the following observations:

1. Unexpected adverse drug reactions
2. Frequency and nature of adverse events (AEs)
3. Factors on the safety and efficacy profile of the Metalyse® Injection. Efficacy of Metalyse® was also assessed.


Eligibility criteria: Inclusion Criteria:

* none

Exclusion Criteria:

* none

Primary outcomes:
measure: 30-day mortality after the Metalyse® Injection
timeFrame: 30 days
measure: Outcome assessment - 'Improvement' or 'Failure'
timeFrame: 30 days
measure: Number of patients with adverse events
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03173846: Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease (NPAD)
Official title: Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: neurofeedback
episodic memory
real-time functional MRI
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 90
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participating subjects are healthy adults (aged 45-75 at inclusion) already recruited within the ALFA study (http://clinicaltrials.gov/ct2/show/NCT01835717; Estudi 45-65 FPM/2012).

Brief summary: This study aims to predict cognitive decline using a performance endophenotype of neuro-feedback based on functional magnetic resonance imaging in real time in a population at risk for Alzheimer's disease (AD).

Detailed description: In this research project, a longitudinal study in a healthy population that is under increased risk of developing AD will be performed. It is anticipated that some of the participating subjects will develop episodic memory decline within this longitudinal follow-up. The memory binding Test (MBT) and/or the Free and Cued Selective Reminding Test (FCSRT), the most accurate and reliable available episodic memory tests, are going to be performed by the subjects at multiple longitudinal data collection points. The project proposes to develop a real-time functional magnetic resonance imaging (rtfMRI) task, and to test whether the subjects' performance on the task can predict the apparition of cognitive decline. The impact of other relevant biomarkers by adding them to the model: age, gender, number of APOE-e4 alleles, cognitive scores, cerebrospinal fluid (CSF) biomarkers, amyloid Positron Emission Tomography (PET), lifestyle habits and clinical background will be studied.

Eligibility criteria: Inclusion Criteria:

* Adult men and women (aged 45-75) that have participated in the study 45-65/FPM2012.
* Persons that accept the study's test and procedures that are as follows: magnetic resonance imaging and neuropsychological tests.
* Signature of the study's informed consent form, accepting to not receive information with regards to any research results that are not clinically relevant.

Exclusion Criteria:

* Any contraindication to MRI (e.g. pacemaker, claustrophobia, etc.)
* Any condition that according to the investigator's judgement could interfere with the proper execution of the study's procedures and/or its follow-up.

Primary outcomes:
measure: Change in cognition
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Barcelonabeta Brain Research Center
Study officials:
References:
Clinical trial NCT06297746: Subvastus vs. Medial Parapatellar Approaches in Total Knee Arthroplasty With Quadriceps Muscle Elastography
Official title: Comparison of Early Outcomes of Primary Total Knee Arthroplasties Performed Using Subvastus and Medial Parapatellar Approaches and Evaluation of Quadriceps Muscle Elastography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Subvastus Approach
Medial Parapatellar Approach
Shear Wave Elastography
Elastography
Young's Modulus
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: ABSTRACT

INTRODUCTION

Knee osteoarthritis is a common joint pathology causing joint pain and ambulatory limitations. In primary total knee arthroplasty (TKA) surgeries, medial parapatellar (MP) and subvastus (SV) approaches are frequently used. The MP approach provides good exposure and is more widely used. In the SV approach, the vastus medialis muscle is preserved. Some argue that the extensor mechanism may heal earlier with the SV approach. In this study, unlike previous studies, the investigators aimed to quantitatively compare the early outcomes of MP and SV approaches, through shear wave elastography (SWE) measurements isolated over the vastus medialis and vastus lateralis muscles.

MATERIALS AND METHODS

The study included 20 patients with indications for TKA due to primary osteoarthritis, divided into MP and SV groups. SWE measurements of the vastus medialis and vastus lateralis muscles were performed preoperatively and at 3-month follow-up. Clinical scores (Knee Society Score and WOMAC) and straight leg raising time were recorded both preoperatively and postoperatively.


Eligibility criteria: Eligibility Criteria:

Inclusion Criteria:

- Diagnosis of primary osteoarthritis

Exclusion Criteria:

* Diagnosis of secondary osteoarthritis
* Uncontrolled diabetes
* Uncontrolled hypertension

Primary outcomes:
measure: Shear wave values
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpasa, Cerrahpasa Faculty of Medicine
state: Fatih
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Mehmet Fatih Güven
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shinohara M, Sabra K, Gennisson JL, Fink M, Tanter M. Real-time visualization of muscle stiffness distribution with ultrasound shear wave imaging during muscle contraction. Muscle Nerve. 2010 Sep;42(3):438-41. doi: 10.1002/mus.21723.
citation: Dutka J, Skowronek M, Sosin P, Skowronek P. Subvastus and medial parapatellar approaches in TKA: comparison of functional results. Orthopedics. 2011 Jun 14;34(6):148. doi: 10.3928/01477447-20110427-05.
citation: Vaishya R, Vijay V, Demesugh DM, Agarwal AK. Surgical approaches for total knee arthroplasty. J Clin Orthop Trauma. 2016 Apr-Jun;7(2):71-9. doi: 10.1016/j.jcot.2015.11.003. Epub 2015 Dec 3.
Clinical trial NCT01569646: Monocytosis and Culprit Vessel in STEMI Patients
Official title: Significance of Monocytosis and Culprit Vessel in Patients With Acute ST Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI
Keywords: monocytes
culprit vessels
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 226
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI patients,

Brief summary: Increased white blood cell count at the onset of an acute ST elevation myocardial infarction has been shown to be associated of increased incidence of heart failure and mortality. Now monocytes which are a subset of white blood cells may have a prognostic value for patients presenting with acute ST segment elevation myocardial infarction. A monocyte count of greater than 800/mm3 following acute myocardial infarction has been shown to be associated with increased incidence of left ventricular dysfunction. The investigators study would retrospectively collect data on patients with ST elevation myocardial infarction, looking for an association between high monocyte count and the culprit vessel causing the myocardial infarction. The investigators would also investigate whether monocytosis would be a marker of poor prognosis.


Eligibility criteria: Inclusion Criteria:

* STEMI

Exclusion Criteria:

* Patients on antibiotics and steroids

Primary outcomes:
measure: Association between monocyte count and culprit vessel
timeFrame: 1 day
Secondary outcomes:
measure: clinical outcomes of troponin and monocyte in stemi patients
timeFrame: 0 - 6 months
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Duccio Baldari, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04943146: An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity
Official title: An Assessment of Aspirin Plus Prednisone Treatment for Euthyroid Women With Thyroid Autoimmunity Undergoing In Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Diseases
Keywords: Prednisolone
Assisted reproductive technology
Aspirin
thyroid diseases
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Ningbo Women & Children's Hospital
name: People's Hospital of Jinhua
First posted: 2021-06-29
Enrollment: 402
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both TPOAb and TgAb in all the subjects were measured before ART procedure, and their thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L and also they all underwent first embryo transfer without previous IVF history.

Brief summary: Thyroid autoimmunity(TAI) per se have adverse effect on pregnancy outcomes，and aspirin and prednisone were used frequently in antithyroid antibodies(ATA) positive infertile women in clinical practice, but the impact of these medicines is still controversial. Therefore, aim of the study was to investigate whether or not the treatment of prednisone in addition to aspirin was capable of improving reproductive outcomes in euthyroid infertile women.

Detailed description: A multicenter retrospective study performed during the period of 2017 to 2020 and euthyroid infertile women positive for anti-thyroperoxidase antibody (TPOAb) and/or thyroglobulin antibody (TgAb) alone with thyroid stimulating hormone 0.35-4.0mIU/L undergoing first in vitro fertilization and embryo transfer(IVF-ET) cycle were recruited in our study.Data analysis was performed using the Statistics Package for Social Sciences.In the end, the value of prednisone plus aspirin treatment was investigated to make a big contribution on clinical practice.

Eligibility criteria: Inclusion Criteria:

1. Both TPOAb and TgAb in all the subjects were measured before ART procedure
2. Thyroid stimulating hormone (TSH) level ranged from 0.35-4.0mIU/L
3. Women underwent first embryo transfer without previous IVF history.

Exclusion Criteria:

1. Abnormal thyroid function test
2. Women with known autoimmune diseases or clinical presentations of autoimmune disorders

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 3 mouths
Secondary outcomes:
Other outcomes:
Locations:
city: Jinhua
country: China
facility: People's Hospital of Jinhua
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Women and Children's Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT02354846: An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy With Tenofovir in HBsAg-positive Patients With Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: B-cell Lymphoma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 112
Sex: ALL
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: Previously untreated Diffuse Large B-cell Lymphoma (DLBCL) with HBsAg (+) who are suitable for receiving R-CHOP chemotherapy

Brief summary: An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED study)


Eligibility criteria: Inclusion Criteria:

* Males or females aged more than18
* HBsAg-positive DLBCL patients (it is possible to enrol the patients with combined DLBCL and low grade lymphoma such as follicular lymphoma)
* Previously untreated DLBCL patients who are suitable for receiving R-CHOP chemotherapy
* Serum ALT no more than 2 x ULN (including normal ALT)
* Life expectancy 6 months
* A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are no more than 1 years after the onset of menopause.
* Informed consent

Exclusion Criteria:

* Other subtype of lymphoma except DLBCL
* DLBCL patients who are NOT suitable for receiving R-CHOP chemotherapy OR plan to receive other chemotherapy
* patients had been treated with antiviral therapy known to have activity against HBV (e.g., alpha-interferon, lamivudine, telbivudine, clevudine, adefovir, entecavir or tenofovir) within the previous 6 months.
* evidence of hepatocellular carcinoma.
* evidence of decompensated liver disease

Primary outcomes:
measure: Percentage number of patients with hepatitis due to HBV reactivation
timeFrame: 2 years (every 3 months)
measure: Percentage number of patients with hepatitis due to Safety assessment
timeFrame: 2 years (every 3 months)
measure: Chemotherapy disruption due to hepatitis
timeFrame: 2 years (every 3 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02443246: A Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
Official title: A Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitamin D Deficiency
Lead sponsor: Kwang Dong Pharmaceutical co., ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-13
Enrollment: 84
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with that of placebo in adults with Vitamin D Deficiency.


Eligibility criteria: Inclusion Criteria:

* Subjects with vitamin D deficiency

Exclusion Criteria:

* Subjects who experienced a hypersensitivity to the cholecalciferol
* Subjects with renal impairment
* Subjects with Hypercalcemia
* Subjects with Hypercalciuria
* Subjects with clinically doubted calcium stone
* Subjects diagnosed with sarcoidosis
* Subjected diagnosed with pseudo-hypoparathyroidism
* Subjected with malignancy
* Subjects with clinically significant cardiovascular or lung impairment Judged by the investigator
* Subjects with the below laboratory abnormality (Platelet, WBC, Absolute neutrophil count, Albumin, AST or ALT)
* Subjects who are to take vitamin D supplements during the study period

Primary outcomes:
measure: Primary Efficacy Endpoints (serum 25(OH)D concentration)
timeFrame: 12 weeks
Secondary outcomes:
measure: Secondary Efficacy Endpoints (serum 25(OH)D concentration)
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Severance Hospital Seoul, Korea
name: Sung-Kil Lim, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University Hospital, Korea
name: Yun-seok Jeong, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongguk University Ilsan Hospital, Korea
name: Han-seok Choi, Professor
role: PRINCIPAL_INVESTIGATOR
References: